cyrilzakka/clinical-trials huggingface dataset:
Impact of GSE and Xylitol (Xlear) on COVID-19 Symptoms and Time to PCR Negativisation in COVID-19 Patients

This clinical trial aims to ascertain the impact of GSE and Xylitol (XLEAR) in decreasing the time of negativisation in PCR testing in patients with COVID-19.


Eligibility Criteria:
Inclusion Criteria

* Adults of ages 18 to 90 years of both sexes
* With positive SARS-CoV-2 carriage confirmed by nasopharyngeal PCR
* Signed informed consent
* 1- Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test
* 2- Moderate symptoms: Respiratory symptoms such as cough, mild shortness of breath with mild oxygen desaturation(room air SpO2 \<92% and \>88% or \<88% corrected to \>92% with 2lt of oxygen)

Exclusion Criteria

* Patients with Severe symptoms: Hypoxia (SpO2 \<88% not corrected by 2 lt nc oxygen) plus severe shortness of breath (excluded)
* Patient with very low viral load (threshold cycle \[Ct\] \> 25 per PCR).
* Known hypersensitivity to one of the constituents, particularly to xylitol or GSE
* Under 18 years of age
* Women of childbearing age who are pregnant, breastfeeding mothers, and intend to become pregnant during the study period; unwilling/unable to take a pregnancy test.
* Unable to provide informed consent or decline to consent or unwillingness to adhere to the Standard of Care protocol.
* Patients with severe symptoms -Hypoxia (SpO2 \<88% not corrected by 2 liter non- concentrated oxygen) plus severe shortness of breath
* History of immunodeficiency or are currently receiving immunosuppressive therapy.
* Have had a planned surgical procedure within the past 12 weeks.
* Already part of this trial, recruited at a different hospital.
* Patient unable to perform oro-nasopharyngeal decolonization
* Patients with acute exacerbation of severe comorbidities like heart disorders Chronic Obstructive Pulmonary Disease (COPD), Heart Failure New York Heart Association (NYHA) Class 3 and 4 and/or diseases with severe oxygenation problems
* Patients on Remdesivir and/or other clinical trials.
The Influence of Different Training Regimens on Electrical Stability Following Myocardial Infarction

The hypothesis of the study is that aerobic conditioning following acute heart attack will improve autonomic function and electrical stability of the heart.


Eligibility Criteria:
Inclusion Criteria:

* s/p acute myocardial infarction 14-30 days
* ability to perform exercise

Exclusion Criteria:

* unstable angina
* chronic atrial fibrillation
* severely reduced LV function
* NYHA 4
* severe valvular disease
IORT After Surgical Resection of Brain Metastases

To evaluate the feasibility and efficacy of the Intraoperative Radiation Therapy (IORT) after the resection of a brain metastases to reduce the incidence of local relapse


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, Karnofsky Performance Index ≥ 70.
* Newly diagnosed cerebral or cerebellar lesion (contrast enhancing on a T1- weighted MRI scan) amenable to total resection with no dural attachment.
* Frozen section confirming a metastasis of an extracranial (i.e. non-CNS) tumor.
* Adequate distance to optic nerve(s), chiasm and brainstem (organs at risk for radiotherapy).
* Adequate birth control.
* Informed consent.

Exclusion Criteria:

* Leptomeningeal spread and dural attachment (assessed pre- and intraoperative).
* Frozen section reveals primary CNS tumor, lymphoma, SCLC or germinoma.
* Psychiatric or social condition potentially interfering with compliance.
* Contraindication against anesthesia, surgery, MRI and/or contrast agents.
* Pregnant or breast-feeding women.
The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior

The purpose of this study is to examine how smoking cessation medications (varenicline, bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in non-treatment seeking daily smokers.


Eligibility Criteria:
Inclusion Criteria:

* ages 18-55
* able to read and write in English
* Smokers

Exclusion Criteria:

* any significant current medical or psychiatric conditions that would contraindicate smoking
* current Diagnostic and Statistical Manual IV abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
* positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
* women who are pregnant or nursing
* suicidal, homicidal, or evidence of current severe mental illness
* participants prescribed any psychotropic drug in the 30 days prior to study enrollment
* blood donation within the past 6 weeks
* individuals seeking treatment for smoking cessation or have attempted to quit smoking within the past 3 months
* specific exclusions for bupropion administration not already specified, including: have taken monoamine inhibitors in the past 6 weeks; history of anorexia or bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence in the past year; history of seizure disorder of any etiology
* known allergy to varenicline or taking H2blockers
* participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study
Cervical Priming Before Dilation & Evacuation

The purpose of this study is to compare the efficacy of buccal misoprostol cervical priming to laminaria priming among women undergoing D\&E at 13-20 weeks gestation in the Western Cape Province, South Africa

As misoprostol is increasingly being used for cervical preparation, concerns about its use and about the proportion of women expelling the fetus prior to the D\&E and other side effects mean that rigorous data on possible advantages of osmotic dilators are needed. To address this gap in the literature, we propose to perform an RCT comparing two methods of cervical preparation prior to D\&E:

1. Misoprostol 400 mcg administered buccally approximately 3-6 hours prior to D\&E, repeated once 3 hours after the first dose (a modified version of the current protocol)
2. Laminaria tents inserted into the cervix 18 to 24 hours prior to D\&E

Eligibility Criteria:
Inclusion Criteria:

* Woman seeking TOP between 13 and 20 weeks gestation as determined by ultrasound
* Age 18 or greater
* Willingness to participate in randomized study
* Fluency in English, Afrikaans or Xhosa
* Ability to give informed consent
* Staying within one hour travel time of Tygerberg Hospital for the night prior to the D\&E
* Ability to be contacted by telephone

Exclusion Criteria:

* Active cervicitis
* Multiple gestation
* Fetal demise confirmed by ultrasound examination
* History of bleeding disorder or current anticoagulation therapy
* Allergy to misoprostol
* Currently breastfeeding and unwilling or unable to temporarily discard milk
* More than one prior cesarean delivery
Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters

The purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters.

Primary Outcomes: The ability to withdraw at least 3 ml of blood and infuse more at least 5 mL of sterile saline through the occluded catheter lumen at 15 minutes after receiving initial instillation of study drug.

Secondary Outcomes:

The ability to withdraw at least 3 mL of blood and infuse at least 5 mL of sterile saline through the occluded catheter lumen at 30 minutes following a single instillation of study drug and at 30 minutes following a second instillation of study drug if patency is not restored within 30 minutes of the first instillation.

Safety:

* Adverse events
* Major bleeding events
* Change in laboratory values.

Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent
* Unable to withdraw 3 mL of blood from a central venous access device
* Hemodynamically stable
* Available for follow-up assessments

Exclusion Criteria:

* Inability to infuse at least 2 mL of saline through the catheter
* Catheter placed less than 48 hours prior to detection of occlusion
* Catheter used for hemodialysis of pheresis
* Less than 18 years of age
* Evidence of mechanical or nonthrombotic occlusion
* Receipt of any thrombolytic agent within 24 hours of randomization
* In the opinion of the investigator, subject is at "high risk" for bleeding events of embolic complications, or has a condition for which bleeding constitutes a significant hazard
* Increased risk for drug extravasation
* Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator)
* Known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect
* Participation in any other study of an investigational device, medication, biologic, or other agent within 30 days before enrollment and until the 30-day follow up visit
* Any other subject feature that in the opinion of the investigator should preclude study participation
A Study of BGB-A445 in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer

The main objective of this study is to evaluate the anti-tumor activity of BGB-A445 plus investigational agents in participants with non-small cell lung cancer (NSCLC)

This study will test whether BGB-A445 in combination with other agents can help treat participants with non-small cell lung cancer (NSCLC) who were already treated with other anticancer agents, including anti-programmed cell death protein-1 (anti-PD-1) and anti-programmed cell death protein ligand-1 (anti-PD-L1) antibodies and platinum-based chemotherapy. The main goal of this study is to see if BGB-A445 can increase participant response to treatment, also called the overall response rate.

Only a portion of patients with advanced solid tumors have a durable response to currently available treatments. This represents an unmet medical need to develop improved therapeutic options. Combining immunotherapies with agents having different mechanism of action might improve outcomes for these patients.

This study is designed as a proof of concept to show that BGB-A445-based combination treatment may be able to improve responses and clinical benefit in patients with NSCLC. Stage 1 of the study will take place in China and the Asia Pacific region and Stage 2 will be expanded to take place worldwide. The overall time to participate in this study is approximately 3 years. Treatments in all cohorts will be administered up to 36 cycles (approximately 2 years) until participants experience no benefits, too many side effects, or withdraw consent.

Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic NSCLC (nonsquamous or squamous) that is histologically or cytologically confirmed
* Participants who have received no more than 2 lines of prior systemic therapies which must include anti-programmed cell death protein ligand-1 (anti-PD-(L)1) treatment and a platinum-based chemotherapy administered in combination with, or sequentially before or after the anti-PD-(L)1 treatment
* At least 1 measurable lesion as defined per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Adequate organ function as indicated by laboratory values during screening

Exclusion Criteria:

* With mixed small cell lung cancer
* Has received prior therapy targeting OX40 or any other T-cell agonists
* Has received prior therapy containing docetaxel and/or ramucirumab for advanced or metastatic NSCLC
* Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before the first dose of study drug(s)
* Active leptomeningeal disease or uncontrolled and untreated brain metastasis

NOTE: Other criteria may apply
Resistance Exercise Training During Pregnancy: a Randomized Controlled Trial

The investigators investigated the effects of a supervised maternal exercise training program (performed during the 2nd and 3rd trimesters of pregnancy) on maternal-newborn unit health outcomes in a group of previously sedentary healthy women. A matched control group was assessed over the same time period. Given the fact that most studies in the field have used aerobic exercises, here the investigators largely focused on very light resistance, toning exercises.


Eligibility Criteria:
Inclusion Criteria:

* sedentary (not exercising \>20 minutes on \>3 days per week)
* with singleton
* not at high risk for preterm delivery (no more than one previous preterm deliveries)
* women planning to give birth in the same obstetrics hospital department (Hospital Severo Ochoa, Madrid, Spain)

Exclusion Criteria:

* not being under medical follow-up throughout the entire pregnancy period were not included in the study
* women having serious medical condition that prevent them from exercising safely
VE202 in Patients With Mild-to-Moderate Ulcerative Colitis

A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).

A Phase 2 double-blind, placebo-controlled, randomized study to evaluate the safety, efficacy, and microbiota changes of VE202 in biologic-naïve patients with mild to moderate UC. In Parts 1 and 2 of the study, patients will receive VE202 or placebo for 8 weeks or 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.

Eligibility Criteria:
KEY INCLUSION CRITERIA

1. 18 to 75 years of age
2. Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization
3. Active mild to moderate UC, as defined by the following:

   1. Disease that extends at least 15 cm from the anal verge
   2. A modified Mayo score of 4 to 8 with: (i.) Mayo endoscopic subscore of ≥ 2 based on screening flexible sigmoidoscopy; (ii.) Rectal bleeding score of ≥ 1
4. Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulator for the treatment of UC
5. If receiving corticosteroids, dose must be stable for at least 4 weeks before randomization
6. Doses of other allowable UC medications must be stable for at least 8 weeks before randomization

KEY EXCLUSION CRITERIA

1. Known history of Crohn's disease (CD) or indeterminate colitis
2. A known diagnosis of primary sclerosing cholangitis
3. Allergy to VE202 or any of its components
4. Allergy to vancomycin or any of its components
5. A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to randomization
6. Use of probiotics or herbal, botanical, or traditional medicinal preparations within the 2 weeks prior to randomization (consumption of food products such as yogurt, kefir, kombucha, and herbal teas is permissible)
7. Receipt of Fecal Microbiota Transplantation (FMT) or other fecal-derived preparation within 6 months prior to randomization
8. Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)
9. Receipt of any investigational biologic within 60 days or 5 half-lives prior to randomization, whichever is longer
Duodenostomy to Treat Duodenal Perforation

In this study the investigators focused on duodenal perforations, requiring a tube duodenostomy and have analyzed the main features, that have influenced the surgical choices. Five patients were enrolled. Most of duodenal perforations can successfully be managed by simple repair, while complicated procedures are needed for complex injuries. Tube duodenostomy is a damage control procedure, for large duodenal perforations when further repair techniques are not recommended due to the duodenal damage, hemodynamic instability of the patient or the absence of surgical expertise for complex reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* excessive size of perforation
* extreme presence of intra-abdominal infections.

Exclusion Criteria:

* patients treated by medical therapy, endoscopic techniques, o surgical approaches
A Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of THDBH120 Injection in Healthy Subjects

This study includes single-ascending dose cohorts (SAD cohorts) and multiple-ascending dose cohorts (MAD cohorts). The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of THDBH120 injection in healthy patients.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese subjects aged 18 to 45 years (inclusive), male or female;
* Body Mass Index (BMI) ≥ 19 kg/m2 and ≤ 28kg/m2, male weight ≥ 50 kg, females weight≥ 45 kg;
* Normal or abnormal but not clinically significant physical examination and vital signs at screening.

Exclusion Criteria:

* Have a diagnosis of type 2 diabetes or have had episode of severe hypoglycemia;
* Pulse rate is less than 50 bpm or more than 100 bpm at screening;
* 12-lead electrocardiogram with prolonged QTcF (male \>450 ms, female \>470 ms) or PR\>200ms. Or any other situation in which a 12-lead ECG suggests a risk of ineligibility at screening;
* A history of pancreatitis (including chronic pancreatitis or idiopathic acute pancreatitis), abnormal amylase and lipase with clinical significance or gastrointestinal injury (e.g., chronic gastritis, peptic ulcer, recurrent gastroesophageal reflux disease, cholecystitis, and gallstones) or any gastrointestinal disease that interferes with gastric emptying (e.g., gastric bypass surgery, pyloric stenosis);
* Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
* Use of SGLT inhibitors, DPP4 inhibitors, GLP-1 analogs, GLP-1 receptor agonists, and other drugs that investigators recognize may affect the study during the 3 months prior to randomization;
* Have had a significant change in weight during the 6 months prior to screening, such as weight loss \> 10%, or recent significant changes in diet or exercise habits.
Home-based Family Caregiver-delivered Music and Reading Interventions for People With Dementia

This international study evaluates the impact of home-based caregiver-delivered music and reading interventions for people with dementia. The project aims to address the need for improved informal dementia care by training family caregivers to utilise a music or reading intervention with the person they are caring for. The interventions aim to decrease behavioural and psychological symptoms of dementia as well as improve quality of life and well being of both people living with dementia and their caregivers. Participants will be allocated into a music intervention group, a reading intervention group or standard care group. In addition, the researchers will seek to determine the cost-effectiveness of using the music intervention.

This three-arm parallel-group randomised controlled trial will involve 495 couples (cohabiting caregivers and people with dementia) across 5 countries. Caregivers allocated to the music or reading intervention groups will be given three 2-hour training sessions in the allocated intervention. They will be asked to deliver the intervention to the person they are caring for 5x weekly for 3 months. Data will be collected prior to implementing the intervention, during the intervention (via diaries kept by the caregivers), after the last week of implementing the intervention and 3-months after implementing the intervention.

The investigators will explore whether caregiver-delivered music or reading activities improve behavioural and psychological symptoms for people living with dementia. The researchers will also seek to find out the impact on other aspects of both the person with dementia and their caregiver's quality of life and well being. Additionally, costs associated with the care of the person with dementia will be evaluated to determine cost-effectiveness of delivering a music intervention.

Eligibility Criteria:
Inclusion Criteria:

* Dyads (cohabiting) who are close in relationship and where one member has a diagnosis of dementia according to ICD-10 criteria (Alzheimer's Disease \[AD\], Frontotemporal Dementia, Vascular Dementia \[VD\], Lewy Body Disease, or mixed dementia) as determined by a clinician experienced in diagnosing dementia. Close in relationship refers to a caregiver who may be a sibling, spouse, adult child, friend, niece or nephew or any person who has a close relationship to the person with dementia, that is, anyone who is not a formal paid caregiver.
* Dyads where the person with dementia has a Neuropsychiatric Inventory-Questionnaire (NPI-Q) Score of ≥6 (from a maximum score of 36)

Exclusion Criteria:

* Dyads where either or both the caregiver or person with dementia have significant hearing impairments that are not resolved through the use of a hearing aid device and limit their capacity to enjoy musical experiences
* There will be no further exclusions
Comparison of Covered and Bare Stent in TIPS

Investigators aim to compare the efficacy of 8 mm Fluency covered stent and bare stent in transjugular intrahepatic portosystemic shunt (TIPS) for the treatment of cirrhotic portal hypertension.

From January 2006 to December 2010, the covered (experimental group) or bare stent (control group) was used in 131 and 127 patients, respectively. The recurrence rates of gastrointestinal bleeding and refractory hydrothorax/ascites, the cumulative restenosis rates in 1, 2, 3, 4, and 5-years, the incidence rate of hepatic encephalopathy, the rate of secondary interventional therapy, the 1, 2, 3, 4 and 5-year survival rates were compared between the experimental group and the control group.

Eligibility Criteria:
Inclusion Criteria:

1. portal hypertension patients with defined indications for TIPS treatment;
2. scheduled for elective TIPS; and
3. aged between 18-70 years.

Exclusion Criteria:

1. combined with hepatic encephalopathy before the treatment;
2. combined with portal vein thrombosis;
3. combined with malignant liver tumor or malignancies at the other sites; or
4. combined with hemorrhage of gastrointestinal ulcer.