cyrilzakka/clinical-trials huggingface dataset:
Fecal Microbiota Transplantation for the Treatment of Obesity

This is a randomized controlled pilot study to assess the microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with obesity. The investigators will prospectively enroll 20 adult patients who are obese (Body Mass Index of 35kg/m2 or higher) after providing written informed consent. The study participants will be randomized 1:1 to either the treatment arm or the placebo arm. The treatment arm will receive an induction FMT with capsules followed by a monthly maintenance dose of oral capsules for 12 weeks total. The placebo group will receive a placebo capsules for induction followed by monthly intake of oral placebo capsules for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Obesity defined as a BMI of 35kg/m2 or higher

Exclusion Criteria:

1. Triglycerides \> 500 mg/dL
2. Use of antibiotics \<8 weeks prior to participation
3. Use of probiotics \<4 weeks prior to participation
4. Alcohol use of greater than 20g/daily or suspicion of alcohol abuse and dependence
5. Substance abuse, current
6. LFTS greater then 3x the ULN
7. Cirrhosis.
8. DM type 2 that is insulin dependent, treated with GLP1-agonists, or poorly controlled on oral medications (HbA1C \> 10%)
9. Use of any weight loss medication or participation in a weight loss study or program such as Weight Watchers
10. History of recent weight change (weight loss or weight gain in the two months preceding trial enrollment). This is defined as a gain or loss of 10 or more pounds in the preceding 2 months
11. Patients who are pregnant or breastfeeding
12. Patients who are unable to give informed consent

14. Patients who have previously undergone FMT 15. Patients who have a confirmed malignancy or cancer 16. Patients who are immunocompromised 17. Participation in a clinical trial in the preceding 30 days or simultaneously during this trial 18. Previous gastric or small intestinal surgery that alters gut anatomy such as fundoplication, gastric resection, gastric bypass, small bowel resection, and ileocectomy 19. Other comorbidities including: systemic lupus, inflammatory bowel disease, or Chronic kidney disease as defined by a GFR \<60mL/min/1.73m2 44 20. History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia 21. Any condition, based on clinical judgment that may make study participation unsafe 22. History of severe food allergies 23. Use of immune modulators including methotrexate, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, Interleukin-10, or Interleukin-11 24.Treatment with infliximab, adalimumab, certolizumab, natalizumab, vedolizumab or thalidomide 25. Congenital or acquired immunodeficiencies
EXPLORATORY ASSESSMENT OF THE EFFECTS OF CYCLO 3 ® FORT (Ruscus Extract, Hesperidin Methyl Chalcone, Ascorbic Acid) OR MICRONISED PURIFIED FLAVONOID FRACTION ON VASCULAR PARAMETERS AND BIOMARKERS IN WOMEN SUFFERING FROM CHRONIC VENOUS DISEASE (CEAP C2 OR C3), OVER 8 WEEKS

Chronic Venous Disorder is the most prevalent vascular disease. It is multifactorial pathology that has an important impact on quality of life and represents a significant public health concern, due to its very high frequency in all European and American (north and south) countries.

Venous pathology develops when venous pressure is increased and return of blood is impaired through several mechanisms. Wish induce leg symptoms (tingling, aching, burning, pain, muscle cramps, sensation of swelling, sensations of throbbing or heaviness, itching skin, restless legs, leg tiredness and/or fatigue.

The aims of this research is to study the effects on microcirculatory activity (activity on very small vessels) of CYCLO 3 ® FORT, MPFF (Micronised Purified Flavonoid Fraction) and Placebo after 8 week of treatment by Microscan, and Duplex, two imaging non-invasive technologies will be performed to obtain measurements of microcirculatory parameters in standardized and reproducible conditions for all the participants. In addition, will assess, in blood samples, the inflammatory biomarkers .


Eligibility Criteria:
Inclusion Criteria:

1. Inclusion criteria

   * Non-menopausal women aged from 18 to 50 years
   * Symptomatic Primary chronic disorder C2 or C3 of advanced CEAP
   * Regular menstrual cycle
   * Use an efficient method of contraception
   * Having signed her written informed
2. Non-inclusion criteria 2.1 Related to pathology:

   * Superficial and or deep venous thrombosis
   * Venous insufficiency including history of deep venous thrombosis, post thrombotic syndrome, venous dysplasia, compressive syndrome
   * History of venous strapping or phlebotomy/ surgery of the evaluated leg
   * Sclerosing injection within 6 month before inclusion
   * Oedema from other etiology
   * Paresthesia, cramps of the lower limbs from other origin 2.2 Related to treatment:
   * Hypersensitivity, allergy or intolerance to study drugs
   * Iron storage disorder
   * Intake of venotonic treatment (oral or topic) ,triptan ,diuretics ,calcium blockers, beta blockers, ACE inhibitors, angiotensine II inhibitors, vasodilatators and/or vasoconstrictors within 1 month before inclusion
   * Intake of NSAID,corticosteroids,ergotamine, dihydroergotamine or any ergot alkaloids,vitamin C nutraceutical or phytotherapy products with potential venotonic effect within 2 weeks before inclusion 2.3 Related to the population:
   * History of diabetes
   * BMI≥ 30
   * Grade V and VI on Fitzpatrick classification
TF-antigen Targeting Molecular Probe for PET Imaging in Solid Tumors

The objective of the study is to construct a noninvasive approach using 124I-labeled monoclonal antibody radiotracer to detect the Thomsen-Friedenreich antigen (TF-antigen, CD176) expression of tumor lesions in patients with solid tumors and to identify patients benefiting from TF-antigen targeting treatment.

Analysis plan: 1. Recruit 3-5 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution, and tumor uptake information via whole-body PET/CT imaging; 2. Recruit 20 participants to analyze in vivo safety and tumor targeting information; 3. Recruit all participants for a final summary.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years, male or female;
2. ECOG performance status score of 0 or 1;
3. Expected survival time ≥ 6 months;
4. At least one measurable tumor lesion exists according to RECIST 1.1 criteria (e.g., lung cancer, gastric cancer, colorectal cancer, breast cancer, pancreatic cancer, hepatocellular carcinoma). The lesion must be eligible for biopsy within one month before or after a PET scan, and the patient must be able to provide 2-3 tissue slices of the lesion;
5. Subjects must fully understand and voluntarily agree to participate in the study and sign an informed consent form.

Exclusion Criteria:

1. Pregnant or breastfeeding women, or women planning to become pregnant during the study period or within three months after drug administration, as well as individuals donating sperm or eggs;
2. Individuals known or suspected to be allergic to the investigational drug or any of its components;
3. Individuals with significantly impaired liver or kidney function;
4. Individuals unable to comply with PET examinations or those with conditions such as claustrophobia that prevent them from undergoing PET scans.
A Study of the Inflammatory Pathways Associated With Chronic Obstructive Pulmonary Disease Exacerbations

The purpose of this study is to observe how the inflammatory pathways differ in subjects with chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD (AECOPD).

This is an observational study in adult male and female subjects with COPD to collect blood, endobronchial tissues and BAL to investigate the inflammatory genes/pathways associated with AECOPD at the time of exacerbation (ie, active disease) and at 6 weeks later (ie, stable disease).

Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed acute exacerbations of chronic obstructive pulmonary disease
* Current or ex-smoker with a tobacco history of 15 or more pack years
* Females of childbearing potential must use birth control for the duration of the study.

Exclusion Criteria:

* Evidence or history of clinically significant disease
* Subjects with asthma
* Subjects taking anti-leukotriene medications
A Study of SIM0270 Combined with Everolimus Vs. Treatment of Physician's Choice in Patients with ER+/HER2- Advanced Breast Cancer (SIMRISE)

This Phase III, randomized, open label, multicenter study will evaluate the efficacy and safety of SIM0270 combined with everolimus compared to physician's choice of treatment in subjects with ER+/HER2- locally advanced or metastatic breast cancer who have had previous treatment with CDK4/6 inhibitor.


Eligibility Criteria:
Inclusion criteria:

1. Subjects with histologically or cytologically confirmed ER+/HER2- locally advanced or metastatic breast cancer
2. Subjects must have at least one RECIST 1.1 measurable disease and /or at least 1 lytic or mixed (lytic + sclerotic) bone lesion
3. For women who are post menopausal must meet criteria as defined in the protocol.For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for screening period and the duration of study treatment
4. Have disease that has demonstrated progression on or after prior treatment:

   1. subjects had received 1 to 2 endocrine therapies in the locally advanced or metastatic setting with disease recurrence/disease progression while being treated with adjuvant endocrine therapy for ≥ 24 months and/or endocrine therapy in the locally advanced or metastatic setting, and derived a clinical benefit from therapy
   2. subjects had received ≤ 1 chemotherapy in the locally advanced or metastatic setting.
5. Eastern Cooperative Oncology Group Performance Status 0-1
6. Adequate organ function

exclusion criteria:

1. Prior treatment with a oral selective estrogen receptor degrader (SERD) or other investigational-ER-directed therapy, or any PI3K-AKI-mTOR inhibitors
2. Treatment with any investigational therapy within 28 days prior to study treatment.Treatment with moderate/strong CYP3A inhibitors or P-gP inhibitor within 14 days prior to first dose or moderate/strong CYP3A inducer within 28 days prior to first dose
3. Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
4. Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
5. Active cardiac disease or history of cardiac dysfunction, as defined in the protocol
6. Pregnant or breastfeeding
Blood Volume Analysis and Renal Outcomes in Hemodialysis

The objective of the proposed study is to demonstrate that serial blood volume analysis (BVA) using RI-BVA (BVA-100, Daxor, NY) can be used to guide changes in prescription of dry weight for hemodialysis patients. The knowledge of a patient's ideal BV and degree of hypervolemia using these measurements can be used to change the prescription of DW in an objective way instead of the current standard of practice, which is based on subjective prescription of dry weight. A first study was conducted to determine the rate of plasma volume (PV) re-expansion for each patient as a guide to rate of fluid removal (results published, refer to citations). A second study was conducted in order to assess the value of a BVA measurement in guiding prescription of clinical DW. A follow up BVA would then be done in order to check if patients were closer to ideal BV than prior to changing dry weight.

In the first study the investigators demonstrated that BV measurement using BVA-100 is useful to determine absolute BV as well as changes in BV and correlates reasonably well with CLM-III measurements. Individual refilling ability can be determined as well. This may prove useful in prescribing and monitoring ultrafiltration rates, establishment of optimal BV in HD patients and reducing morbidity and mortality associated with chronic HD.

In the current study the investigators hypothesize that BVA can be used in the longer term to evaluate the adequacy of the current clinically estimated dry weight in dialysis patients and can be used to titrate EDW in order to improve overall volume status and decrease the incidence of blood volume misinterpretation. The investigators enrolled 12 eligible patients. Participants underwent post-hemodialysis blood volume analysis (BVA) as a baseline measurement. Based on their Blood Volume (BV) status, their prescribed estimated dry weight (EDW) was adjusted. After 3 to 6 months, participants underwent a repeat BV measurement. The investigators compared the second value to the first in order to judge whether an improvement in BV status occurred if the dry weight prescription was changed, or to judge stability if it was not.

Eligibility Criteria:
Inclusion Criteria:

* Age \>21 years
* Primary diagnosis of either chronic or acute kidney disease
* Currently receiving HD treatment
* Thrice-weekly or twice-weekly HD schedule
* Treated with standard bicarbonate HD for at least the preceding 6 months

Exclusion Criteria:

* Pregnant women or nursing mothers
* Known hypersensitivity to iodine, eggs, albumin or any other component of the Volumex injection kit
* Current enrollment in another investigational treatment protocol for dialysis
* Kidney transplantation
* Malignancy requiring chemotherapy
* Unmeasurable blood pressure with a sphygmomanometer
* Active hematological disease
* Active gastrointestinal bleeding
* Severe malnutrition (predialysis serum albumin \<2.6 g/dL)
* Persistent condition of intradialytic blood pressure instability (hypotensive episodes in \>80% of regular dialysis sessions) within the previous one month period
Phase 2 Safety and Efficacy Study of a Vitamin D Compound (DP001) in Postmenopausal Women With Low Bone Mineral Density

This study will evaluate the effect of a 1-year administration of the vitamin D analog 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3 (DP001) on bone mineral density (BMD), safety, and tolerability.

DP001 is a vitamin D analog that has been shown to stimulate bone formation in pre-clinical studies. In a Phase 1B study of postmenopausal women, an increase in the bone formation marker, osteocalcin, was evident without an increase in serum calcium. The aim of this study is to determine if 1-year administration of DP001 to postmenopausal women with osteopenia results in a significant increase in BMD at doses that are safe and well tolerated.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal female subjects, defined as amenorrheic for at least 5 years
* Body Mass Index of 18 to 35
* Osteopenic
* Generally healthy
* Informed consent

Exclusion Criteria

* History or evidence of acute or unstable chronic hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, or neurologic diseases
* Current or recent treatment with any medications or products affecting vitamin D metabolism, calcium balance, bone turnover, or an investigational drug therapy
* 12-lead electrocardiogram demonstrating QTc (QT interval corrected for heart rate) \>450 milliseconds at screening
* Abnormal creatinine clearance
* Elevated urinary calcium levels
* Vitamin D deficiency
* Excessive dietary calcium or vitamin D intake
* Current use of any illicit drug and/or history of alcohol abuse
A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir

This study is designed to determine the influence of food on the absorption and relative bioavailability of oral ganciclovir by comparing the absorption of oral ganciclovir in a fed and fasting state at steady state plasma levels.


Eligibility Criteria:
Inclusion Criteria

Patients must have the following:

* Confirmation of HIV infection by HIV antibody testing, p24 antigen, or culture of HIV.
* Documented confirmation of present or past CMV infection.
* Must understand the nature of the study, agree to tests required in the protocol, and must understand and sign an informed Consent form approved by the appropriate Institutional Review Board and by Syntex.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Uncontrolled diarrhea or clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain.

Concurrent Medication:

Excluded:

* Antimetabolites. Interferons. Other nucleoside analogs. Zidovudine (AZT). Any investigational drug.

Patients with the following are excluded:

* Any concomitant conditions listed in Exclusion Co-Existing Conditions.
* Karnofsky score \< 70.
* Hypersensitivity to acyclovir.
* Displaying signs of dementia or decreased mentation which would interfere with the ability of the subject to follow protocol schedule.

Prior Medication:

Excluded:

* Anti-cytomegalovirus therapy including ganciclovir therapy for treatment of CMV disease.
* Excluded within 4 days of study entry:
* Antimetabolites.
* Interferons.
* Other nucleoside analogs.
* Zidovudine (AZT).
Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 and Exploration of Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment - Open Label Extension (CT04 OLEP)

The purpose of this study is to evaluate the safety and tolerability of ascending oral doses of CHF 5074 after prolonged administration to patients with mild cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of amnestic or non-amnestic Mild Cognitive Impairment.
* Mini-Mental State Examination score higher than 24 at screening.
* MRI scan of the brain at screening with fluid-attenuation inversion recovery (FLAIR) and T2\*-weighted gradient-recalled-echo (GRE) sequences.

Exclusion Criteria:

* Diagnosis of Alzheimer's disease according to the (DSM-IV-TR) or NINCDS-ADRDA criteria.
* Any medical condition that could explain the patients cognitive deficits.
* CT or MRI brain imaging results obtained within 12 months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance
* MRI scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm).
* Geriatric Depression Scale (30-point scale) score \> 9 at screening.
* History of stroke.
* Modified Hachinski ischemic scale score \> 4 at screening.
* Women of childbearing potential.
* Vitamin B12 or folate deficiency.
* Diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening.
* Current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease.
* Concomitant use of donepezil at doses \> 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose.
* Concomitant use of memantine at dose \> 20 mg/day.
* Concomitant use of psychoactive drugs (sedatives, hypnotics, etc).
Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease

This will be an open-label, non-randomized multi-center study designed to assess the safety and efficacy of Adipose-derived Stem Cell (ASC) IV implantation. The therapy is composed of cells isolated from a patient's own adipose tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.

In the context of the proposed study, adipose derived stem cells (ASC) constitute an autologous cell product that is delivered to the patient via intra-venous injection. In this study, we propose to investigate the immunosuppressive potential of the non-manipulated non-cultured stromal vascular fraction obtained via liposuction. Endpoints will be measured both by improvement of the forced evacuation volume in one second (FEV1) and distance covered in a 6 minute walk distance test (6MWD). The stromal vascular fraction comprises stromal cells isolated from total fat via enzymatic digestion ex-vivo. These cells are not cultured but are isolated from adipose tissue using a sterile tissue process in under two hours. The process includes rinsing in a saline solution to remove red blood cells, draining, and enzymatic digestion (collagenase) which isolates endothelial cells from adipose tissue. Post-processing, the pellet obtained via centrifugation is filtered and delivered to the patient who remains sedated within the same ambulatory center.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 85, inclusive
* A prior diagnosis of moderate to severe COPD
* GOLD IIa, III, IV

Exclusion Criteria:

* Pregnant or lactating
* Life expectancy \< 6 months due to concomitant illnesses.
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Any illness which, in the Investigators judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results
* Subjects on chronic immunosuppressive or chemotherapeutic therapy
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
* Subjects with Alpha-1 antitrypsin deficiency (an inherited disorder that can cause lung disease and liver disease).
* Unwilling and/or not able to give written consent
* Patient is positive for hepatitis (past history of Hepatitis A is allowed)
* Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient
* Cerebral aneurysm clips