cyrilzakka/clinical-trials huggingface dataset:
the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy

To investigate the potential association between gut microbiota and central serous chorioretinopathy (CSC), we have observed in our clinical practice that CSC patients often experience chronic gastrointestinal issues. This observation has led us to hypothesize that CSC may be associated with gut dysbiosis. The Bifidobacterium genus is widely recognized as a beneficial gut bacterium, and numerous well-established Bifidobacterium supplements are available on the market. To explore this possible connection, we will collect fecal samples from both CSC patients and healthy individuals. Using whole-metagenome shotgun sequencing, we will compare the gut microbiota compositions of the two groups to determine if significant differences exist. Additionally, we will randomly assign patients to two groups: one group will receive Bifidobacterium supplements for at least one month, while the other group will receive a placebo. We will then assess whether the group receiving the supplements experiences faster recovery and lower relapse rates compared to the placebo group.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 60 years
* Diagnosis of acute central serous chorioretinopathy (CSC) (affected eye: ① FFA and ICGA showing typical CSC manifestations, ② presence of subretinal fluid (SRF) at the macular fovea, ③ disease duration ≤ 6 months)
* Best Corrected Visual Acuity (BCVA): 53 to 86 letters
* Other: No significant systemic diseases, signed informed consent, and able to commit to follow-up

Exclusion Criteria:

* Presence of significant systemic diseases
* BCVA of 20/200 or worse
* Presence of choroidal or retinal atrophy in the macular fovea of the affected eye
* Presence of choroidal neovascularization (CNV), age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), diabetic retinopathy (DR), choroidal hemangioma, pigment epithelial detachment (PED), etc., in the affected eye
* High myopia in the affected eye
Transcranial Static Magnetic Field Stimulation of Frontal Cortex

The purpose of this study is to see if a new brain stimulation technique, static magnetic field stimulation (tSMS), which involves holding a static neodymium magnet over the scalp, can influence normal rhythms of brain activity.

The investigator's primary objective is to determine the feasibility of modifying frontal brain activity using static magnetic fields. The investigator's will be examining the effects of static magnetic field of the spectral power of EEG data with healthy human participants.

This is a within-subjects design, where each participant will receive sham and active stimulation on the left and right frontal cortex. EEG data will be collected during each stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed, healthy, 18+ years old
* Capacity to understand all relevant risks and potential benefits of the study (informed consent)
* Willing to comply with all study procedures and be available for the duration of the study - Speak and understand English

Exclusion Criteria:

* Medical history of Psychological/Emotional Disorders (depression, anxiety, bipolar, etc.)
* (For females) Pregnancy or breast feeding
* Diagnosis of eating disorder (current or within the past 6 months)
* Diagnosis of Obsessive-Compulsive Disorder (lifetime) Attention Deficit Hyperactivity Disorder (currently under treatment)
* Neurological disorders and conditions, including, but not limited to:
* History of epilepsy
* Seizures (except childhood febrile seizures and Electroconvulsive therapy-induced seizures)
* Dementia
* History of stroke
* Parkinson's disease
* Multiple sclerosis
* Cerebral aneurysm
* Brain tumors
* Medical or neurological illness or treatment for a medical disorder that could interfere with study participation (e.g., unstable cardiac disease, HIV/AIDS, malignancy, liver or renal impairment)
* Prior brain surgery Any brain devices/implants, including cochlear implants and aneurysm clips
* Any metal in/on the body, e.g., dental braces, glasses, piercings
* Traumatic brain injury
* Thick hair that would create distance between the magnet and the scalp
* Taking hormonal birth control or hormonal supplements (e.g., testosterone injections) - Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
Efficacy of Low Dose Sugammadex in Reversal of NMB in Laparoscopic Barbaric Surgery

the investigators aimed to compare the efficacy and safety of sugammadex at doses of 1.5, 2, and 4 mg/ kg for the reversal of moderate rocuronium-induced neuromuscular blockade in laparoscopic bariatric surgery.

Patients were randomly assigned using a randomization-computer program into three groups according to the dose of sugammadex administrated (according to the IBW after T2 of TOF):

Group I: patients were given 1.5 mg / kg. Group II: patients were given 2 mg / kg. Group III: patients were given 4 mg / kg.

Eligibility Criteria:
Inclusion Criteria:

* morbidly obese patients of both sex (BMI \> 40 kg.m-2)
* scheduled for elective laparoscopic bariatric surgery (gastric bypass or sleeve surgery) under general anesthesia using rocuronium for tracheal intubation and maintenance of NMB
* aged between 18 and 60 years and classified as ASA II - III

Exclusion Criteria:

* liver and renal dysfunction,
* disabling neuropsychiatric disorders,
* history of stroke, brain trauma in the last 12 months
* hypersensitivity to anesthetics, history of myocardial infarction, congestive heart failure
* difficult tracheal intubation, and known or suspected disorder affecting NMB.
A Two-stage Translation of the Chinese Version Menstrual Distress Questionnaire

This study attempted to do the two-stage design of the translation of the MDQC (Menstrual Distress Questionnaire Form C-Cycle) Chinese version, and to do the validity and reliability test.

Premenstrual syndrome is defined as recurrent moderate physical, psychological, behavior symptoms that occur during the luteal phase of menses and resolve with menstruation. It affects 20 to 32 percent of premenopausal women.

A diagnosis of PMS consists of determining the timing of the symptoms in relation to menses, meaningful change between post- and premenstrual symptom severity, and a clinically significant severity of the symptoms. The ICD-10 requires only one distressing symptom for a diagnosis of PMS. The American College of Obstetricians and Gynecologists (ACOG) diagnosis is that it occurs 5 days before menses and remit within 4 days of onset of menses no recurrence at least until day 13 of the cycle. A differential diagnosis to distinguish PMS from other medical and psychiatric conditions is important for appropriate treatment. No hormone or laboratory test indicates a PMS diagnosis. The current diagnostic standard requires confirmation of subjective symptom reports by prospective daily diaries. The Menstrual Distress Questionnaire (MDQ) is a method for measuring perimenstrual symptoms. It is a 46-item self-report inventory for use in the assessment of physical or psychological symptoms that occur in the premenstrual, menstrual, or intermenstrual phases. There are two forms of the MDQ: form C (Cycle) and form T (Today). Form C of the MDQ is designed for screening. Women use this form to describe their symptoms and reactions during each of the three phases of their most recent menstrual cycle. It may be administered at any time during the cycle. Form T is designed for treatment evaluation, and research application.

This study attempted to do the two-stage design of the translation of the MDQ (Form C-Cycle). Previous studies have translated only 14 items of the MDQ (Form C - Cycle) and only done the internal reliability test. This study is expected to do a two-stage translation of the MDQ (Form C - Cycle) Chinese version, and to do the reliability and validity test.

Eligibility Criteria:
Inclusion Criteria:

1. A eumenorrheic healthy woman with a regular menstrual cycle for three months, predictable, and a period between 24-38 days that lasts less than 8 days.
2. No hormonal contraceptives have been used in the past six months.
3. No history of smoking, drinking or drug abuse.

Exclusion Criteria:

1. Women with systemic diseases, cardiovascular diseases, liver diseases, kidney diseases, diabetes or thyroid diseases.
2. Taking any medicine due to chronic disease
3. Women with mental illness
A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors

The purpose of this study is to compare two capsules of topotecan made by slightly different methods. This will be done by giving the drug made by the two different methods to patients orally and testing blood levels.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Patients with confirmed advanced solid tumors.
* No prior chemotherapy within 5 years of the diagnosis of SCLC (small cell lung cancer).
* At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.
* Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

Exclusion criteria:

* Women who are pregnant or lactating.
* Patients of child bearing potential refusing to practice adequate contraception.
* Patients with uncontrolled vomiting.
* Active infection.
* Patients with clinical evidence of any gastrointestinal (GI) conditions which would alter GI absorption or GI motility.
* Patients requiring treatment with cyclosporin A.
* Severe medical problems other than the cancer, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
* Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for cancer treatment.
* Use of investigational drug within 30 days prior to the first dose of study medication.
A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors

This is a multi-center, open-label, phase Ib/II study. First, the aim of the phase Ib part is to estimate the MTD(s) and/or to identify the recommended phase II dose(s) (RP2D) for the combination of MEK162 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. The dose escalation part of the study will be guided by a Bayesian Logistic Regression Model (BLRM). At least 18 patients are expected to be enrolled in the dose escalation part.

Following MTD/ RP2D declaration, patients will be enrolled in three phase II arms to assess efficacy of the combination as well as to better understand the safety, tolerability, PK, antibody concentrations and PD of the combination at MTD/RP2D. Phase II arm 1 will consist of approximately 25 patients with KRAS-mutant colorectal adenocarcinoma. Phase II arm 2 will consist of approximately 20 patients with metastatic pancreatic adenocarcinoma. Phase II arm 3 will consist of approximately 28 patients with mutant BRAFV600 melanoma.

Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. All patients will be followed up - at minimum patients must complete the safety follow-up assessments 30 days after the last dose of the study treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years
* Patients with advanced solid tumors (CRC, melanoma) with documented somatic KRAS or BRAFV600 mutations in tumor tissue. Patients with metastatic pancreatic adenocarcinoma may be enrolled irrespectively of KRAS or BRAFV600 mutational status.
* Patients must have relapsed or progressed following standard therapy or patients for whom no standard anticancer therapy exists.
* Measurable disease as determined by RECIST v1.1. World Health Organization (WHO) Performance Status (PS) ≤ 2.
* Adequate organ function
* Negative serum pregnancy test

Exclusion Criteria:

* Prior therapy with MEK- or IGF-1R- inhibitor
* History or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or retinal degenerative disease
* Patients with known history of severe infusion reactions to monoclonal antibodies
* Patients with primary CNS tumor or CNS tumor involvement
* History of thromboembolic event requiring full-dose anticoagulation therapy
* Clinically significant cardiac disease
* History of another malignancy within 2 years
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply
The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic Patients

The investigators aimed to add flaxseed with high content of n-3 polyunsaturated fatty acids to low fat yogurt to obtain beneficial without adverse effects of it. In this parallel randomized controlled trial the investigators recruited 70 diabetic patients and randomly allocated to control and treatment groups. Participants in treatment group consumed 30 gr flaxseed in 200 gr low fat yogurt, while controls consumed 200 gr just low fat yogurt daily. Lipid profile, fasting blood sugar, glycosylated hemoglobin, systolic and diastolic blood pressure, weight, waist circumference and body mass index were measured at the first and end of the trial.

Nutritionists have concern about consumption of full fat dairy in diabetic patients due to their content of saturated fatty acids. The investigators aimed to add flaxseed with high content of n-3 polyunsaturated fatty acids to low fat yogurt to obtain beneficial without adverse effects of it. In this parallel randomized controlled trial the investigators recruited 70 diabetic patients and randomly allocated to control and treatment groups. Participants in treatment group consumed 30 gr flaxseed in 200 gr low fat yogurt, while controls consumed 200 gr just low fat yogurt daily. Lipid profile, fasting blood sugar, glycosylated hemoglobin, systolic and diastolic blood pressure, weight, waist circumference and body mass index were measured at the first and end of the trial.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 20 and 35 kg/m2 -
* treated with oral hypoglycemic agents (Metformin or Glibenclamide)
* no use of insulin
* fasting blood glucose≥ 126 (but less than 400 mg/dl)or 2 hours blood sugar ≤ 200 mg/dl
* no pregnancy and lactation
* Blood lipids and blood pressure-lowering agents must remained unalteredwithin the last 3 months.

Exclusion Criteria:

* Participants were excluded if they smoked, used alcohol, took dietary supplements containing Omega 3, phytoestrogens, antioxidants and fiber regularly, had been diagnosed with GI disease or renal, liver, cancer , inflammatory disease, had food allergies or intolerances
Decrease the Frequency of Inappropriate Intravenous Lines in Internal Medicine

Aim: to determine whether a nationwide teaching program delivered to medical doctors can decrease the use of inappropriate intravenous lines in internal medicine

Nationwide multicentre randomized prospective controlled trial enrolling 59 french internal medicine departments. During the first study visit, we collected data of patients with intravenous infusions from each participating centre in order to determine the number and frequency of inappropriate intravenous lines. Using a computerized randomization process (on a 1:1 basis), the participating centres were randomized; Half centres (interventional group) received an educational program consisting of educational material and two educational sessions; the other half did not receive the educational program (control group). The educational program provided medical doctors with posters and slides containing information on valid indications for the prescription and use of intravenous infusions (inability to drink or eat, malabsorption, medication only available intravenously with no oral equivalent). Based on a previous pilot study, we assumed that the the frequency of inappropriate intravenous lines with be approximately 20% at baseline and hypothesize that the nationwide teaching program will decrease this frequency by 50%.

Eligibility Criteria:
Inclusion Criteria:

* Internal medicine department
Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients

Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.

This trial will be a double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of levofloxacin administered as MP-376 of three dosage regimens given for 28 days by the aerosol route to CF patients.

Study with completed results acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria (selected):

* \> 16 years of age
* Confirmed Diagnosis of Cystic Fibrosis
* Positive sputum culture for P. aeruginosa within the past 18 months
* Patients are able to elicit a forced expiratory volume in 1 second (FEV1) \>/= 25% but \</= 85% of predicted value at screening
* Have received at least 3 courses of inhaled antimicrobials over the preceding 12 months
* Clinically stable with no changes in health status within the last 30 days
* Able to reproducibly produce sputum and perform spirometry

Exclusion Criteria (selected):

* Use of any nebulized or systemic antibiotics within 30 days prior to baseline
* History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
* Evidence of acute upper within 10 days or lower respiratory infections within 30 days prior to dosing
* Creatine clearance \< 50mg/ml, aspartate transaminase (AST), alanine transaminase (ALT) or total bilirubin \>/= 3 x upper limit of normal (ULN) at Screening
Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.

To determine, in subjects with Type 1 Diabetes Mellitus:

1. Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal inhaled insulin plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2-3 mixed Regular/NPH insulin injections per day.
2. The toleration and safety of inhaled insulin therapy and its effects after 6 months, if any, on measures of pulmonary function.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes for more than 1 year
* Stable insulin regimen of at least 2 injections per day

Exclusion Criteria:

Any smoking within the last 6 months. Smoking is not permitted at any time during this study.

* Subjects on insulin pump during 2 months prior to screening.
* Subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.
COVID-19 Booster Study in Healthy Adults in Australia

This is a double-blinded, randomised study to determine the safety, reactogenicity, and immunogenicity of a bivalent mRNA Moderna COVID-19 vaccine or a protein-based Novavax COVID-19 vaccine given as a fourth dose in healthy adults in Australia.

This is a blinded, two-arm randomised study to determine the safety, reactogenicity and immunogenicity of a fourth dose of SARS-CoV-2 vaccines in Australia in adults 18 years or older who have received their third dose of COVID-19 vaccine at least six months previously. Participants will be randomised to receive either bivalent Moderna (mRNA-1273.214) or Novavax. A separate non-randomised control arm (no vaccine given), frequency matched by age to the vaccine groups will also be enrolled for comparison. A total of 200 participants per group will be recruited.

Eligibility Criteria:
Inclusion Criteria:

1. Have received three doses of COVID-19 vaccines at least 6 months earlier.
2. No confirmed SARS-CoV-2 infection on PCR or RAT within the last 3 months.
3. Willing and able to give written informed consent.
4. Aged 18 years or above.
5. Willing to complete the follow-up requirements of the study.

Exclusion Criteria:

1. Currently receiving immunosuppressive medication or anti-cancer chemotherapy.
2. Known HIV infection.
3. Congenital immune deficiency syndrome.
4. Received immunoglobulin or other blood products in the three months prior to potential study booster vaccination.
5. Study staff and their relatives.
6. Have a history of a severe allergic reaction to any COVID-19 vaccines or have a medical exemption to receiving further COVID-19 vaccines.
7. Cannot read or understand English.
Microbial Associations in Periodontal Health and Disease

The purpose of this study is to determine the clinical and microbiological effects of systemically administered metronidazole alone or in combination with professional plaque removal on periodontally diseased patients.

Major goals of periodontal research are to differentiate pathogenic from host compatible plaque microbiotas and to optimize treatments to convert the former to the latter. To this end, in the previous award period the composition of supra and subgingival plaques, the associations among species both within and between supra and subgingival plaques, and differences between plaques from healthy and diseased individuals were determined. One major finding was the frequent detection of anaerobic periodontal pathogens at low numbers in supragingival plaque of periodontally diseased and to a lesser extent healthy subjects. Weekly professional supragingival plaque removal for 3 months in 18 periodontitis subjects demonstrated astonishing reductions in the subgingival microbiota which were maintained for 9 months after cessation of the professional program. The composition of the microbiota at 12 months in these subjects was similar to that found in periodontal health. In another of our studies, systemically administered metronidazole produced similar effects. Thus, in SA1 a 2 year randomized clinical trial will be performed comparing the effects of 1) SRP alone or in combination with 2) weekly professional supragingival plaque removal, 3) systemically administered metronidazole or 4) a combination of the 2 on clinical parameters and supra and subgingival plaque composition. 200 periodontitis patients will receive SRP under local anaesthesia and will be randomly assigned to the 4 treatment groups. All subjects will be evaluated clinically and for supra and subgingival plaque composition at 2 weeks, 3, 6, 12, 18 and 24 months. Supra and subgingival plaque samples will be taken separately from the mesial aspect of each tooth and evaluated individually for their content of 40 bacterial species using checkerboard DNA-DNA hybridization providing over 3.6 million bacterial counts. The results will determine if the beneficial effect of the individual therapies persist beyond one year and whether combined treatment produces even greater benefit to the patient.

Eligibility Criteria:
Inclusion:

* \> 35 years of age
* \> 20 teeth
* \> 5% sites (approx. 8 sites) with pocket depth \> 4 mm and / or 5% sites with attachment level \> 4 mm

Exclusion:

* \> 50% of sites with pocket depth or attachment level \> 4 mm
* Pregnancy or lactation
* Periodontal or antibiotic therapy in the previous 12 months
* Any systemic condition which might influence the course of periodontal disease or treatment (e.g. diabetes, AIDS)
* Any systemic condition which requires antibiotic coverage for routine periodontal procedures (e.g. heart conditions, joint replacements etc.)
* Any known allergy to metronidazole