cyrilzakka/clinical-trials huggingface dataset:
Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women.

Menopause is a physiological event and is defined as the loss of ovarian follicular activity, with consequent permanent cessation of menstrual cycles. Its diagnosis is made retrospectively after 12 months of amenorrhea, with no pathological cause involved. This period is marked by several changes in the female organism, mainly the genitourinary syndrome (GUS), which is a collection of signs and symptoms resulting from the state of hypoestrogenism. Almost half of postmenopausal women will experience symptoms of GUS, with vaginal dryness being the most prevalent, followed by dyspareunia and vulvovaginal irritation. The aim of the study is to evaluate the effect of photobiomodulation with red LED (ligth emitting diode) on the symptoms of vulvovaginal atrophy in postmenopausal women. A randomized and controlled clinical trial will be developed, which will include postmenopausal women with signs and symptoms of vulvovaginal atrophy. Participants will be allocated into two groups: those who will undergo photobiomodulation with intravaginal LED, and those who will receive vaginal cream with estriol. Objective and subjective improvement of atrophy will be assessed using the Vaginal Health Index and the visual analog scale, respectively. Vaginal pH, cell maturation index and changes in sexual function through the Female Sexual Function Index questionnaire will also be assessed. The variables will be analyzed at the time of admission, in one and three months after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women (amenorrhea for less than 12 months);
* presence one or more symptoms of vulvovaginal atrophy (dyspareunia, dryness, irritation and vaginal burning);
* Vaginal Heath Index ≤ 15 (signs of atrophy);
* normal cytopathology of uterine cervix in the last year.

Exclusion Criteria:

* previous or current history of gynecological neoplasia;
* who used hormonal or non-hormonal treatment for vulvovaginal symptoms of menopause;
* current or recent genitourinary lesions or infectious processes in the genitourinary tract (last month);
* current or recent (last month) systemic treatment with antifungals, antibiotics or corticosteroids;
* presence of genital prolapse;
* presence of contraindications to the use of vaginal estrogen (current, previous or suspected diagnosis of breast cancer, malignant estrogen-dependent tumors, uninvestigated uterine bleeding, untreated endometrial hyperplasia, deep venous thrombosis and current or previous pulmonary thromboembolism, known thrombophilia, recent or active arterial disease, acute liver disease, porphyria, use of drugs that may interact with estriol and hypersensitivity to the components of the vaginal cream formula).
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19

The primary objectives are:

Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)

* To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2
* To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation

Phase 1/2 (Cohort 1)

* To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation
* To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo


Eligibility Criteria:
Key Inclusion Criteria:

* Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal \[OP\], or saliva) ≤72 hours prior to randomization and no alternative explanation for current clinical condition. A historical record of positive result from test conducted ≤72 hours prior to randomization is acceptable.
* Has symptoms consistent with COVID-19, as determined by investigator, with onset ≤10 days before randomization
* Hospitalized for ≤72 hours with at least 1 of the following at randomization; patients meeting more than one criterion will be categorized in the most severely affected category:

  1. Cohort 1A: With COVID-19 symptoms but not requiring supplemental oxygen
  2. Cohort 1: Maintains O2 saturation \>93% on low-flow oxygen as defined in the protocol
  3. Cohort 2: High-intensity oxygen therapy without mechanical ventilation as defined in the protocol
  4. Cohort 3: On mechanical ventilation

Key Exclusion Criteria:

* Phase 1 Only: Patients maintaining O2 saturation \>94% on room air
* In the opinion of the investigator, unlikely to survive for \>48 hours from screening
* Receiving extracorporeal membrane oxygenation (ECMO)
* Has new-onset stroke or seizure disorder during hospitalization
* Initiated on renal replacement therapy due to COVID-19

NOTE: Other protocol defined inclusion / exclusion criteria apply
Consequences of Hypoglycaemia on Cardiovascular and Inflammatory Responses

People with Type 1 diabetes (T1DM), type 2 diabetes (T2DM) and healthy volunteers will undergo a hypoglycaemic clamp to to investigate the effect of hypoglycaemia on cardiovascular and inflammatory responses.

Objectives: The overall aim of the present study is to investigate the effect of hypoglycaemia on cardiovascular and inflammatory responses, molecular mechanisms and epigenetic profiles in various groups of people with diabetes type 1, type 2 and healthy volunteers.

Study design: Intervention study

Intervention: All subjects will undergo a hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp (nadir 2.8 mmol/L), during and after which blood and urine will be sampled for further examination for up to one week.

Eligibility Criteria:
Inclusion Criteria:

Overall inclusion criteria

* Ability to provide written informed consent
* Must be able to speak and read Danish (for Hillerød-site) and Dutch (for Nijmegen-site)
* Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump) (except for group 5)
* Body-Mass Index: 19-40 kg/m2
* Age ≥18 years, ≤ 80 years
* Blood pressure: \<140/90 mmHg
* Duration of diabetes \> 1 year (except for group 5)
* HbA1c \< 100 mmol/mol

Group specific

* Group 1: HbA1c \>64 mmol/mol
* Group 2: impaired awareness of hypoglycaemia (IAH) as assessed by a score of ≥3 on the modified Clarke questionnaire, ≥4 on the Gold questionnaire and a positive score on the Pedersen-Bjergaard questionnaire.
* Group 3: normal awareness of hypoglycaemia (NAH) as assessed by a score of \<3 on the modified Clarke questionnaire, \<4 on the Gold questionnaire and a negative score on the Pedersen-Bjergaard.
* Group 4: Insulin treatment for at least 1 year
* Group 5/6: HbA1c \<42 mmol/mol

Exclusion Criteria:

* - Severe medical or psychological conditions interfering with the perception of hypoglycaemia other than IAH such as brain injuries, epilepsy, a major cardiovascular disease event or anxiety disorders
* Use of immune-modifying drugs or antibiotics
* Treatment with glucose-modifying (other than insulin, SGLT-2 inhibitors and metformin) agents (e.g. prednisolon)
* Use of anti-depressive drugs
* Pregnancy or breastfeeding or unwillingness to undertake measures for birth control
* Use of statins (e.g. stop statins \>2 weeks before performing blood sampling. This can be safely done in the context of primary prevention)
* Any event of cardiovascular disease in the past 5 years (e.g. myocardial infarction, stroke, heart failure, symptomatic peripheral arterial disease)
* Auto-inflammatory or auto-immune diseases
* Any infection in past three months
* Previous vaccination in the past three months
* Laser coagulation for proliferative retinopathy in the past six months
* Proliferative retinopathy
* Diabetic nephropathy as reflected by an albumin-creatinine ratio ˃ 30 mg/gor an estimated glomerular filtration rate (by MDRD) ˂60ml/min/1.73m2
* History of pancreatitis (acute or chronic) or pancreatic cancer
Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Patients With Advanced Or Metastatic Merkel Cell Carcinoma

This Phase 2/3, multicenter, randomized, double-blind, placebo-controlled trial will evaluate Objective Response Rate (ORR) of IFx-Hu2.0 as an adjunctive therapy to pembrolizumab in adult patients (≥18 years) with advanced or metastatic Merkel Cell Carcinoma. A total of 118 participants will be randomized to receive either IFx-Hu2.0 or placebo intralesional injection in a single lesion, followed by pembrolizumab.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age.
2. Life expectancy equal to or greater than six months.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
4. Must be recurrent and/or unresectable Stage III or Stage IV American Joint Committee on Cancer (AJCC) (8th edition) and have histologically confirmed Merkel cell carcinoma

   1. Must have at least one injectable lesion equal to or greater than 3 mm.
   2. Must have measurable disease as defined by RECIST v1.1.
5. Subject should be CPI naïve i.e., no prior therapy with CPI including but not limited to Pembrolizumab, avelumab, ipilimumab, nivolumab.
6. Tumor tissue from an archival core biopsy or resected site of disease must be provided for biomarker analyses. If archival tissue is not available, then a new biopsy should be performed.
7. Adequate hematological, hepatic, and renal function according to laboratory ranges and medical criteria defined within the study protocol.

Exclusion Criteria:

1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with protocol requirements.
2. Subjects with active brain metastases with the exception of treated brain metastases that have imaging proving stability at least 4 weeks after treatment, no new metastases, and not requiring steroids.
3. Subjects with recurrent resectable MCC
4. Subjects with prior systemic chemotherapy
5. Pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study.
6. Active, known, or suspected autoimmune disease. Potential subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. Low-grade autoimmune toxicity is NOT an exclusion under this criterion.
7. A condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients

The purpose of the study is to determine the effect of conversion from calcineurin inhibitor based therapy to Rapamune based therapy in patients with mild to moderate renal insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Treatment with a calcineurin inhibitor
* Patients with mild to moderate renal insufficiency

Exclusion Criteria:

* Patients with acute rejection
* Patients who received a transplant more than 10 years ago
Online Diabetes Education Project (ODEP)

This pilot randomized control trial will be testing an empowerment-based virtual group diabetes self-management education and support (DSME/S) for African American/Black adults with type 2 diabetes living in Detroit. Participants will be randomized to either a control group or the virtual DSME/S group.

This pilot randomized control trial will be testing an empowerment-based virtual group diabetes self-management education and support (DSME/S) for African American/Black adults with type 2 diabetes living in Detroit. Participants interested in participating in this study will first be consented then they will complete a baseline health assessment including a questionnaire and physiologic testing. Using a 50/50 randomization scheme, participants will be randomized to either a control group or the virtual DSME/S group and be told of their placement. Participants randomized to the control group will receive community resources, diabetes specific newsletters, and pedometers. Participants randomized to the virtual DSME/S group will receive 10-weekly 1-hour virtual DSME/S sessions with a certified diabetes care and education specialists through Zoom for Health at the University of Michigan, a HIPPA compliant platform. After the intervention is complete and then again 3 months later, participants in both groups will be invited to complete an additional health assessment.

However, due to low recruitment we removed the control arm and offered all participants virtual DSME/S.

Eligibility Criteria:
Inclusion Criteria:

* Agee 18 or older, Black, a diagnosis of T2D for one year duration or longer, ambulatory status.

Exclusion Criteria:

* Non-ambulatory, serious health conditions (morbid obesity and severe symptomatic heart disease, visual impairment, renal failure, and peripheral neuropathy), psychiatric illness (severity requiring hospitalization) or cognitive deficit (illness determined using the Montreal Cognitive Assessment tool) and serious diabetes complications (e.g. blindness) that would impede meaningful participation
A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis

The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab.

Complement 5a and its receptor C5aR (CD88) are involved in the pathogenesis of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

This is a randomized, double-blind, active-controlled Phase 3 study to evaluate the safety and efficacy of the orally-administered, selective C5aR inhibitor CCX168 (avacopan) in inducing and sustaining remission in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) treated concomitantly with Rituximab or Cyclophosphamide/Azathioprine.

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis
* Male and female subjects, aged at least 18 years, with newly-diagnosed or relapsed associated vasculitis (AAV) where treatment with cyclophosphamide or rituximab is needed; where approved by Regulatory Agencies, adolescents (12-17 year old) may be enrolled
* Use of adequate contraception
* Positive test for anti-proteinase 3 (PR3) or anti-myeloperoxidase (MPO)
* At least 1 major item, or at least 3 non-major items, or at least the 2 renal items of proteinuria and hematuria on Birmingham Vasculitis Activity Score (BVAS)
* Estimated glomerular filtration rate ≥15 mL/minute/1.73 m\^2 at screening

Exclusion Criteria:

* Pregnant or breast-feeding
* Alveolar hemorrhage requiring pulmonary ventilation support at screening
* Any other known multi-system autoimmune disease
* Required dialysis or plasma exchange within 12 weeks prior to screening
* Have a kidney transplant
* Received cyclophosphamide within 12 weeks prior to screening; if on azathioprine, mycophenolate mofetil or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide or rituximab dose on Day 1
* Received intravenous glucocorticoids, \>3000 mg methylprednisolone equivalent, within 4 weeks prior to screening
* Have been taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening
* Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred (i.e., CD19 count \> 0.01x10\^9/L); received anti-tumor necrosis factor (TNF) treatment, abatacept, alemtuzumab, intravenous immunoglobulin (IVIg), belimumab, tocilizumab, or eculizumab within 12 weeks prior to screening
* For patients scheduled to receive cyclophosphamide treatment, urinary outflow obstruction, active infection (especially varicella zoster infection), or platelet count \<50,000/μL before start of dosing
* Participated previously in a CCX168 study
A Study to Assess Plasma Ammonia Time-Normalized Area Under the Curve and Rate of Ureagenesis in Healthy Adult Subjects

The objective of the study is to characterize 24-hour plasma ammonia levels, characterize urea production rates in healthy normal subjects.

During Part 1, eligible subjects will be asked to participate in 3 inpatient visits, each lasting up to 3 days (Day -1 to Day 2). Each visit will assess 24-hour ammonia levels in plasma and rate of urea production for 4 hours following ingestion of \[1-13C\]sodium acetate. Sodium acetate is used as a tracer to measure the rate of ureagenesis.

During Part 2, eligible subjects will be asked to participate in 1 inpatient visit, lasting up to 3 days (Day -1 to Day 2). The visit will assess 24-hour ammonia levels in plasma and rate of urea production for 4 hours following ingestion of \[1-13C\]sodium acetate. Sodium acetate is used as a tracer to measure the rate of ureagenesis.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18 and 30 kg/m2, inclusive.

Exclusion Criteria:

* History of liver disease as evidenced by any of the following: portal hypertension, ascites, splenomegaly, esophageal varices, hepatic encephalopathy, or a liver biopsy with evidence of stage 3 fibrosis.
* Significant hepatic inflammation or cirrhosis as evidenced by imaging or any of the following laboratory abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than the upper limit of normal (ULN), total bilirubin \>1.5 × ULN, alkaline phosphatase \>2.5 × ULN. NOTE: the ALT and/or AST levels may be repeated.
* Subject has a history of gout.
* Plasma ammonia level that is not within normal limits at Screening in the opinion of the Investigator or Sponsor.
* Received any vaccine within 14 days prior to Screening.
* Pregnant, lactating, or intending to become pregnant at any time during the study.
* Blood transfusion within 8 weeks prior to Screening.diuretics, cyclophosphamide and other cytotoxic agents, tolbutamide, chlorpropamide, diazoxide, dichlorphenamide, pyrazinamide, probenecid, theophylline/aminophylline, riluzole, warfarin and other antithrombotic agents, supplements containing aluminum hydroxide, or iron supplements within 30 days of Part 1or Part 2.
Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus

The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18 years with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion criteria:

* Children and adolescents with type 2 diabetes mellitus
* Insufficient glycaemic control (HbA1c \<=10.5%) despite diet and exercise and/or metformin and/or stable basal or MDI insulin
* Negative for Islet Cell Antigen and Glutamic Acid Decarboxylase autoantibodies and fasting C-peptide levels \>= 0.85 ng/ml
* BMI \> 50th percentile for age and sex

Exclusion criteria:

* Uncontrolled hyperglycaemia with a glucose level \> 240 mg/dl (\> 13.3 mmol/l)
* History of acute metabolic decompensation such as diabetic ketoacidosis within 3 months before the screening visit with the exception of acute de-compensation at the time of type 2 diabetes diagnosis
* Treatment with weight reduction medications within 4 weeks before randomisation
The Weigh Forward, Financial Incentives for Maintenance of Weight Loss

This study aims to evaluate the effectiveness of financial incentives in improving and maintaining weight loss.

The study will evaluate the effectiveness of financial incentives in improving maintenance of weight loss. The investigators propose a 2-arm randomized controlled trial in which 258 participants who lose at least 5 kgs in a weight loss program will be randomized to one of the following: 1) daily weigh-ins and weekly feedback, 2) daily weigh-ins,weekly feedback, and a weekly escalating lottery-based financial incentive.

Study participants will be obese volunteers recruited from a major community-based weight loss program (Weight Watchers), who have lost at least 5kg during the 4-6 months prior to enrolling in the study. Upon enrollment, these participants will have an active online membership with Weight Watchers. Among these participants, the following will be assessed: 1. Assess the effectiveness of escalating lottery rewards, relative to the control group, on maintenance of weight loss over the ensuing 6 months (Phase I); 2.The degree to which weight loss is maintained in the intervention group relative to usual care during the 6 months following the cessation of the interventions (Phase II).

During Phase I, incentives will be provided to some study participants (escalating lottery arm) for the first 6 months and participants will be followed for 6 more months to examine effects following cessation of incentives.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 30-80
* BMI between 30 and 45 prior to starting Weight Watchers
* Have a documented weight loss of at least 5kg in the past 4-6 months before enrolling
* Stable health
* Have an online Weight Watchers membership

Exclusion Criteria:

* Substance abuse
* Bulimia nervosa or related behaviors
* Pregnancy or breast feeding
* Medical contraindications to counseling about diet, physical activity, or weight reduction
* Unstable mental illness
* Screen positive for pathological gambling on the basis of the 10 item DSM-IV criteria (excluded if meets 5 or more criteria)
* Individuals unable to read consent forms or fill out surveys in English