cyrilzakka/clinical-trials huggingface dataset:
Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19

The purpose of this study is to evaluate the effect of the probiotic Lactobacillus rhamnosus GG (LGG) and the effect of COVID-19 on the microbiome (the microorganisms that live in and on the human body) in exposed household contacts of COVID-19. This is a randomized, double-blind, placebo-controlled study, meaning subjects will be randomly assigned to receive LGG or a placebo (an inactive substance given in the same form as the active substance) and will not know which product they are receiving. Subjects will participate in the study for around 60 days. All subjects must refrain from taking any other probiotics while on study. All subjects must have access to e-mail and the internet to complete study questionnaires. Participation in this study entails taking LGG/placebo for 28 days, responding to questionnaires, and providing stool and nasal swab samples.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=1 year (as children \<1 year may not be able to take oral probiotics)
* Household contact of someone diagnosed with COVID-19
* Willingness to stop taking other probiotics or to not take any other probiotic while on LGG/placebo (taking a probiotic at the time of screening will not be considered a reason for exclusion. However, subjects will be asked to stop taking their probiotic if they enroll on the study).
* Access to e-mail/internet to complete electronic consent via REDCap

Exclusion Criteria:

* Symptoms of COVID-19 at enrollment, including:

  * Fever
  * Respiratory symptoms
  * GI symptoms
  * Anosmia
  * Ageusia -\>7 days since original patient associated with household contact was diagnosed with COVID-19
* Taking hydroxychloroquine or remdesivir for any reason (as this would have the potential to decrease the expected rate of COVID-19 in this population and affect our power and sample size calculations)
* Enrolled in a COVID-19 prophylaxis study (as this would have the potential to decrease the expected rate of COVID-19 in this population and affect our power and sample size calculations)
* Any medical condition that would prevent taking oral probiotics or increase risks associated with probiotics including but not limited to:

  * Inability to swallow/aspiration risk and no other methods of delivery (e.g., no G/J tube)
  * Increased infection risk due to immunosuppression due to:

    * Chronic immunosuppressive medication
    * Prior organ or hematopoietic stem cell transplant
    * Known neutropenia (ANC \<500 cells/ul)
    * HIV and CD4 \<200 cells/ul
  * Increased infection risk due to endovascular due to:

    * Rheumatic heart disease
    * Congenital heart defect,
    * Mechanical heart valves
    * Endocarditis
    * Endovascular grafts
    * Permanent endovascular devices such as permanent (not short-term) hemodialysis catheters, pacemakers, or defibrillators
  * Increased infection risk due to mucosal gastrointestinal due to:

    * Gastroesophageal or intestinal injury, including active bleeding
Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients

Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard weight based ribavirin (investigational treatment arm) or placebo in combination with ribavirin (RBV). Each cohort of 15 patients will be randomized 4:1 to receive the investigational treatment arm (12 patients) or placebo and RBV arm (3 patients).

This is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard ribavirin or placebo plus ribavirin. Each cohort will be randomized 4:1 to receive the investigational treatment arm or placebo and ribavirin. Three varying dose levels of IMO-2125 will be included. In both arms, ribavirin will be dosed based on patient weight.

Approximately 50 patients will be enrolled in France and Russia. Patients will provide informed consent prior to any screening procedures being performed. Screening will occur within 21 days prior to randomization. Enrolled patients who qualify and proceed successfully through the screening period will be randomized to receive 4 weeks of either the investigational treatment arm (IMO-2125 and ribavirin) or placebo and ribavirin, with a 4 week follow-up period.

Patients who are randomized to the investigational treatment arm will receive one of 3 dose levels of IMO 2125 SC once weekly; each patient will receive the same dose throughout the 4 weeks of treatment. In addition to IMO-2125 treatment they will also receive daily ribavirin, which will be given based on the patients weight and will be taken twice daily for a total of 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Documented genotype 1
* HCV-positive with documented detectable plasma viral concentration \> 10,000 IU/mL

Exclusion Criteria:

* Positive test for HIV or HbsAg
* Inadequate bone marrow, liver, and renal function
* Treatment with any IFN-based or other experimental or antiviral therapies - prior or current
* Other significant medical disease
* Concurrent or planned treatment during the study
Weight-based Dosing for Dense Weekly Paclitaxel and Carboplatin in Overweight Patients w/ Body Surface Area (BSA) > 2.0

The purpose of this study is to evaluate the side effects and effectiveness of giving standard paclitaxel chemotherapy in doses based on actual body surface area in combination with standard dosed carboplatin chemotherapy for overweight women.

Primary Objective The primary objective is to prospectively evaluate the Relative Dose Intensity (RDI) and toxicity of weight-based dose dense weekly paclitaxel and carboplatin in overweight patients with a BSA \> 2.0 compared to the Japanese Gynecologic Oncology Group trial (JGOG 2016) during 6 - 9 cycles of chemotherapy.

Secondary Objective(s) The secondary objective is to evaluate progression-free survival in this patient population.

Study Design This is a descriptive study to determine what the relative dose intensity of patients who are overweight with a BSA of greater than 2.0 can achieve.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a histologically confirmed or presumed diagnosis of gynecologic malignancy for whom chemotherapy with paclitaxel and carboplatin is planned.
* Body Surface area \>2.0
* Patients must have adequate:

  * Renal function: Creatinine \<1.5 x Institutional upper limits of normal (ULN)
  * Bone marrow function:

    * Absolute neutrophil count (ANC) ≥ 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors.
    * Platelets ≥ 100,000/mcl.
  * Hepatic function:

    * Bilirubin ≤ 1.5 x ULN.
    * Aspartate aminotransferase (AST) (SGOT) ≤ 2.5 x ULN.
    * Alkaline phosphatase ≤ to 2.5 x ULN.
  * Neurologic function:

    * Neuropathy (sensory and motor) ≤ CTCAE Grade 1.
* Patients must have a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
* Patients must be entered within 12 weeks of diagnosis.
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
* Patients who have received prior chemotherapy.
* Patients with acute hepatitis or active infection that requires parenteral antibiotics.
* Patients with clinically significant cardiovascular disease. This includes:

  * Myocardial infarction or unstable angina \< 6 months prior to registration.
  * New York Heart Association (NYHA) Grade II or greater congestive heart failure
  * Serious cardiac arrhythmia requiring medication. This does not include asymptomatic, atrial fibrillation with controlled ventricular rate.
* Patients who are pregnant or nursing.
* Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study.
* Patients with known allergy to cremophor or polysorbate 80.
An Open Label, Study of the Systemic Exposure to Articaine After Topical Ocular Dosing of AG-920

This is a Phase 1, open-label, non-comparative study in healthy subjects performed in the US. It is designed to assess systemic exposure to articaine and its metabolite articainic acid after dosing a single topical ocular administration of AG-920 in the randomized study eye.

This is a Phase 1, open-label, non-comparative study in healthy subjects designed to assess systemic exposure to articaine and its metabolite articainic acid after dosing a single topical ocular administration of AG-920 in the randomized study eye.

In this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will receive a single dose of study drug in one eye. The study eye will be randomized. The single dose will be administered by the clinic staff as two drops 30 seconds apart in study eye. Subjects will have pharmacokinetic (PK) blood samples taken at multiple periods over 24 hours following dosing. Safety will be assessed by monitoring any changes in heart rate, blood pressure, intraocular pressure, visual acuity, biomicroscopy, and AEs.

The study will consist of 3 clinical visits: Screening Visit, Dosing and PK Blood Level Sampling (0-8 hours) Visit and a Follow Up Visit (with PK blood level sampling 24 hours after study drug treatment).

Eligibility Criteria:
Key Inclusion Criteria:

1. Voluntarily provide written informed consent prior to any study-related procedures being performed.
2. Female subjects of childbearing potential must have negative pregnancy test.
3. Certified as healthy by clinical assessment.
4. Have an Early Treatment of Diabetic Retinopathy Study best corrected visual acuity of 20/200 or better in each eye.
5. Have an Intraocular Pressure between 7 and 30 mmHg inclusive.
6. Are able to tolerate instillation of Over-The-Counter artificial tear product .
7. Blood pressure \< 140/90 mmHg and heart rate \< 100 bpm at screening.

Key Exclusion Criteria:

1. Have previously received AG-920.
2. Have a contraindication to local anesthetics.
3. Have had ocular surgery or general surgery within the past 90 days.
4. Have had an intravitreal injection in either eye within 14 days of treatment.
5. Have a history within the last year of or current ocular surface disease or nasolacrimal duct abnormalities including obstructions or requiring punctal plugs.
6. Have evidence of any current ocular inflammation.
7. Have a known current condition which could cause vision problems.
8. Current ocular allergy symptoms.
9. Have donated or lost more than 400 mL of blood within 12 weeks.
10. Plasma donation within 7 days prior to the first dosing.
DEMOJUAN- DEMOnstration Area for Primary Prevention of Type 2 Diabetes, JUAN Mina and Barranquilla, Colombia

The main aim of this study is to investigate to what extent it is possible to reach normal glucose metabolism and optimal cardiovascular disease (CVD) risk factor levels with early lifestyle interventions in people at high risk of type 2 diabetes compared with those who receive standard therapy (usual care) only.

The project will show the effect of these interventions for the first time in people of low socio-economic levels living in a Caribbean environment.

Type 2 diabetes (T2D) is one of the fastest growing public health problems in both developed and developing countries. The development of T2D is a slow process and involves both genetic and environmental effects. It is commonly agreed that T2D may develop only in people that carry a genetic predisposition to the disease. Based on epidemiological observations about half of the people will develop T2D during their lifetime, and up to 30-35% will have IGT. Therefore, it is likely that more than half of the population carry genes that predispose the development of T2D. In people genetically predisposed to the disease, the probability to develop T2D is very high once exposed to unhealthy lifestyles such as obesity, unbalanced diet and physical inactivity. While we cannot change the genes, the only way to prevent T2D and its serious complications is the modification of lifestyle risk factors. Therefore, it is very important to understand the role of preventive lifestyle intervention as a key treatment in T2D prevention. Once established, T2D is difficult to treat. Despite pharmacologic treatment blood glucose levels trend to increase over time. Thus, the most efficient way to manage T2D is to prevent diabetes from developing. Also complications of T2D can best be postponed by postponing the onset of the primary disease itself. The efforts to prevent the disease need to start as early as possible and address all susceptibility factors. Fortunately, recent studies have convincingly demonstrated that prevention of T2D is possible. This project will show for the first time how lifestyle interventions work in people with IGT in the Caribbean population. The results of this study will be sued for policy making and planning of primary prevention activities not only in the local health-care system but in the entire Caribbean region.

Eligibility Criteria:
Inclusion Criteria:

* 34-69 years-of-age with diagnosed IGT
* Informed consent given.

Exclusion Criteria:

* Patients with pharmacologically-treated diabetes
* Hypertriglyceridaemia under drug treatment
* History of life-limiting diseases or events
* Unwillingness to sign the informed consent.
Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa

200 pregnant women with symptomatic placenta previa with previous bleeding attacks attending Ain Shams University maternity hospital will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).


Eligibility Criteria:
Inclusion Criteria:

* Gestational age 28 weeks of gestation.
* Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using transvaginal ultrasound scan.
* Haemodynamically stable pregnant women.
* Maternal age:20-40years old.
* Pregnant women with placenta previa, and had previous bleeding attacks or admitted with antepartum haemorrhage.

Exclusion Criteria:

* Multiple pregnancy.
* Women with bleeding tendency due to any medical disorder (ITP, thrombocytopenia, coagulopathies),or on anticoagulants .
* Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery.
* Women have hypersensitivity or any contraindication to use of tranexamic acid.
* Pregnant women with placenta previa with doppler showing morbidly adherent placenta.
Dietary Sodium Intake in Acute Heart Failure

This study is design to assess two levels of dietary sodium intake in the treatment of patients with Acute Decompensated Heart Failure.

This study aim at assessing the effect of two levels of dietary sodium intake during seven days in hospitalized patients with Acute Decompensated Heart Failure. It is a prospective cohort, randomized, with blinded intervention groups: low sodium diet (the patients will receive 3 g/day of dietary sodium intake), and normal sodium diet (patients will receive 7 g/day of dietary sodium intake). Besides that, both groups will be submitted to a fluid intake limited to 1000 ml/day.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Acute Decompensated Heart Failure diagnosis, filling the Framingham diagnostic criteria, hospitalized at campus Hospital das Clínicas of Ribeirão Preto.

Exclusion Criteria:

* Creatinine clearance \<30 ml / min / 1.73 m²;
* Acute coronary syndrome;
* Stroke;
* Dementia;
* Severe cognitive impairment;
* Cancer;
* Decompensated diabetes mellitus;
* Severe liver disease;
* Septic shock or with clinical signs of sepsis;
* Chronic renal parenchymal disease prior to the start of the study;
* ADHF secondary to acute renal failure;
* Nutritional disorders or those who are unable to take oral intake because of vomiting, dysphagia or gastroenteritis.
A Study for Patients With Type 1 Diabetes Mellitus

The purpose of the study is to compare the human insulin inhalation powder plus insulin glargine with injected insulin (regular human insulin or insulin lispro) plus insulin glargine on lowering the blood sugar level.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus for at least 24 months
* Injecting insulin (insulin lispro, aspart or regular insulin, insulin lispro/aspart mixtures, or regular human insulin mixtures) in the last 24 months
* HbA1c equal or less than 11 %
* Nonsmokers, had not smoked for at least 6 months and agree not to smoke (cigars, cigarettes or pipes) or use smokeless tobacco for the duration of the study
* Satisfactory lung function results to meet the requirement of the study

Exclusion Criteria:

* Previously received any form of inhaled insulin
* Require a daily total insulin dosage greater than 100 U
* Have a current or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease
* History or presence of liver disease
* History or presence of kidney disease
Scandinavian Diverticulitis Trial

The purpose of this study is to determine whether laparoscopic lavage changes the rate of severe complications in patients with acute perforated diverticulitis who traditionally are treated with primary resection.

Acute diverticulitis is a common disease in the western world. Perforation of the acute diverticulitis with peritonitis is a feared complication and standard treatment (primary sigmoid resection such as Hartmann's procedure) still has unsatisfactory results. Both mortality and morbidity are quite high. Several uncontrolled trials have reported a lower mortality and morbidity when acute perforated diverticulitis is treated with laparoscopic lavage instead of radical surgery. The investigators wish to conduct a randomized multicenter trial in Scandinavia in order to compare the rates of severe postoperative complications in acute perforated diverticulitis if treated by traditional primary sigmoid resection or by laparoscopic lavage. The investigators are planning to include all patients admitted to the participating hospitals with clinical and radiological findings of acute perforated diverticulitis.

Eligibility Criteria:
Inclusion Criteria:

* age over 18
* clinical suspicion of perforated diverticulitis with indication for urgent surgery
* CT scan with free air and findings suggesting diverticulitis
* patient tolerates general anaesthesia
* patients written consent

Exclusion Criteria:

* pregnancy
* bowel obstruction
A Study of SHR0410 in Hemodialysis Patients With Pruritus

The aim of this study is to evaluate the safety, tolerability and pharmacokinetics of SHR0410 in hemodialysis patients with moderate to severe pruritus


Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged 18-65 (inclusive);
2. Weight (\> 50 kg);
3. Patients with end-stage renal disease receiving hemodialysis (including hemodialysis and hemofiltration) three times a week for at least 3 months.
4. VAS≥4 at screening

Exclusion Criteria:

1. New York cardiac function classification (NYHA) ≥ level III in the current or previous 6 months;
2. Pruritus caused by other than end-stage renal disease or its complications..
3. History of malignancy
4. Any physical or mental illness or condition, as determined by the study investigator, that may increase the risk of participating the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial
5. Positive urine drug screening; Or a history of drug abuse;
6. Urine test positive for nicotine;
7. Alcohol breath test positive;
8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or transglutaminase (GGT) was 1.5 times higher than the upper limit of normal value (ULN), or total bilirubin was 1.5 times higher than the upper limit of normal value (ULN);
9. Screening for hepatitis c antibody (HCVAb), syphilis antibody or human immunodeficiency virus (HIV) antibody positive; Or hepatitis B is active;
10. Abnormal electrocardiogram considered inappropriate to participate in this study by the investigator
11. positive for human chorionic gonadotropin (hCG) blood test
12. A history of allergies to opioids
13. Has used opioids within one week prior to the current visit, or cannot avoid to use opioids other than the study drug during the study period;
14. Change the treatment regimen for pruritus within 14 days, or cannot avoid to change the treatment regimen for pruritus during the study period
15. Received Ultraviolet phototherapy within 14 days before screening visit; Or cannot avoid to receive ultraviolet light therapy during the study.
16. Change the treatment regimen of gabapentin, pregabalin, or duloxetine within 14 days before screening visit; Or the treatment regimen of gabapentin, pregabalin, or duloxetine cannot be avoided to be changed during the study period.
17. Change the treatment regimen of medications within 14 days that may affect the judgment of antipruritic effect; Or the treatment regimen cannot be avoided to be changed during the study
18. Using topical antipruritic drugs, such as creams and patches with moisturizing or antipruritic effects at present.
19. Kidney transplantation is expected during the study period;
20. Subjects who had Participated in this trial (defined by signing the informed consent);
21. Subjects who had Participated in clinical trials of any other drugs within the previous 3 months; Or plan to participate in other drug trials during the trial period;
22. Subjects who had Participated in the clinical trial of any medical device within the previous 3 months; Or participate in other medical device tests during the trial period.
A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting

This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW67969, When Administered With Intravenous Ondansetron Hydrochloride for the Prevention of Post-Operative Nausea and Vomiting (PONV) and Post-Discharge Nausea and Vomiting (PDNV) in Female Subjects With Known Risk Factors for PONV Who Are Undergoing Surgical Procedures Associated With an Increased Emetogenic Risk

Eligibility Criteria:
Inclusion criteria:

* Females age 18-55
* Laparoscopic/laparotomic gynecological procedure of laparoscopic gallbladder removal

Exclusion criteria:

* Pregnant or breastfeeding
* Post-menopausal
* Not undergoing general anesthesia
Special Lower Back Pillow Examination

Low back pain is a significant, serious and widespread problem in our world today, both in terms of social and economic burdens. It should be emphasized that even the young adult age group is very often affected by non-specific, low back pain without proven pathoanatomical changes.

We plan to examine the use of a special lower back pillow and the time period of the sitting position. We would like to know how it helps to prevent and treat low back pain. We would like to know more about the people's pillow usage habits.

We are planning a questionnaire survey. We combine our own questions with validated, official questionnaires. Validated forms ask for an assessment of the extent of low back pain and the quality of experienced stress.

Eligibility Criteria:
Inclusion Criteria:

* in case of patients with low back pain: chronic pain
* in case of asymptomatic individuals: no symptomes

Exclusion Criteria:

* serious neurologycal symptomes
* serious scoliosis
* previous surgery which affected the local stabilizers
* serious pulmonar disease