cyrilzakka/clinical-trials huggingface dataset:
GA YAZ ACNE in China Phase III

The purpose of this study is to evaluate the efficacy and safety of YAZ (drospirenone 3 mg / ethinylestradiol 20 µg) in comparison with placebo in female patients with moderate acne vulgaris over 6 treatment cycles.


Eligibility Criteria:
Inclusion Criteria:

* Women of age 14-45 years
* \>1 year post-menarche with moderate acne vulgaris who have no known contraindications to combined oral contraceptives
* Otherwise healthy, except for the presence of moderate acne
* Smokers up to a maximum age of 30 (inclusive) at inclusion

Exclusion Criteria:

* Pregnancy, lactation (less than three menstrual cycles since delivery, abortion, or lactation before start of treatment)
* Obesity (Body Mass Index \> 30 kg/m2)
* Hypersensitivity to any ingredient of the study drug
* Any disease or condition that may worsen under hormonal treatment
Imaging the Pathogenesis of Cerebral Small Vessel Disease

Cerebral small vessel disease (CSVD) can lead to vascular cognitive impairment and dementia (VCID). The hallmark of CSVD is the appearance and progression of white matter hyperintensities (WMH) on MRI. The goal of this study it to recruit and follow individuals at risk for WMH progression and use serial MRI scanning to gain insights into the pathogenesis of CSVD.

Vascular Cognitive Impairment and Dementia (VCID) which is attributed in large part to cerebral small vessel disease (CSVD) is prevalent in patients with a history of stroke and vascular risk factors. The hallmark of CSVD is white matter hyperintensities (WMH) seen on T2-weighted MRI. The initial amount, and rate of progression, of WMH is tied closely with the development and progression cognitive deficits. It is hypothesized that one of the early pathologic features in the normal appearing white matter (NAWM), before it progresses to WMH is disruption of the blood-brain barrier (BBB) and loss of micro-structural integrity. The purpose of this study is track the progression of WMH using multiple MRI biomarkers looking at BBB disruption (DCE, DSC, ASL), micro-structural changes (multi-shell DTI), and macrostructural changes (FLAIR, SWI, T1) to better understand the pathogenesis of CSVD. Patients with a history of a stroke, at least one vascular risk factor, and evidence of CSVD on MRI may be eligible for this study. We will follow 50 patients with 3 MRIs performed over 1.25 years

Eligibility Criteria:
Inclusion Criteria:

* Clinical or radiographic evidence of ischemic stroke
* One vascular risk factor (hypertension, hyperlipidemia, or diabetes)
* Evidence of cerebral small vessel disease on MRI

Exclusion Criteria:

* Inability to complete 3 research MRI scans over 1.25 years
Evaluation of Novel Antimicrobial Hand Towels

In March 2012, the investigators initiated a prospective, cluster-randomized, controlled field trial in Kisumu County, located in an area in western Kenya which has the highest under-five mortality rate in Kenya with 149 childhood deaths per 1,000 live births 9. The study was designed to evaluate the effectiveness of an antimicrobial hand towel (hereafter referred to as towel) in preventing diarrheal diseases, acute respiratory infections, self-reported fever, and skin infections in children \<2 years old.

In March 2012, the investigators initiated a prospective, cluster-randomized, controlled field trial in Kisumu County, located in an area in western Kenya which has the highest under-five mortality rate in Kenya with 149 childhood deaths per 1,000 live births 9. The study was designed to evaluate the effectiveness of an antimicrobial hand towel (hereafter referred to as towel) in preventing diarrheal diseases, acute respiratory infections (ARIs), self-reported fever, and skin infections in children \<2 years old.

Eligibility Criteria:
Inclusion Criteria:

* Mother of a child \<2 years old

Exclusion Criteria:

* Inaccessible enumeration area in the rainy season
* Multiple eligible children in a single compound
* Moved between census and round 1
The Umbilical Access in Laparoscopic Surgery

The aim of this study is to access to the abdominal cavity using different incision-types within the umbilical area.

Effects of different incisions on scarring and on the umbilical form will be investigated.


Eligibility Criteria:
Inclusion Criteria:

- patient undergoing laparoscopic surgery

Exclusion Criteria:

* pregnancy
* patients following open abdominal surgery
Rescue of Steroidogenic Capacity in Adrenocortical Failure Study (RADS)

This is a pilot study of B lymphocyte depletion therapy in an attempt to salvage adrenal steroidogenic capacity in ten subjects with early autoimmune Addison's disease. During the first twelve weeks of treatment, additional glucocorticoid therapy (prednisolone) will be given to ensure wellbeing and to rest the steroidogenic apparatus that is the target of the autoimmune attack. Glucocorticoids will be gradually withdrawn, in a controlled fashion, and adrenal function re-evaluated at 13, 26, 39 and 52 weeks. The primary endpoint will be restoration of steroidogenic function as judged by conventional endocrine indices of adrenocortical function. B cell depletion may ameliorate the autoimmune attack against adrenal cells, potentially allowing a state of immune tolerance to be restored with subsequent recovery of adrenal steroidogenic capacity.


Eligibility Criteria:
Inclusion Criteria:

* Clear evidence of primary adrenal failure (elevated ACTH, pigmentation, electrolyte disturbance)
* Basal or stimulated cortisol \<400 nmol/l but \>100nmol/l

Exclusion Criteria:

* Active viral infection, pregnancy or breast feeding, previous immunosuppression, diabetes, cardiorespiratory disease, renal failure, hepatic disease, cancer
* Calcified or enlarged adrenals on CT scan, active TB
Physiotherapy in Mutated COVID-19 Patients

The prospective study was conducted at a single location within the COVID-19 department of a city hospital. The study included COVID-19 patients who were hospitalized in the COVID-19 service and consulted for physiotherapy, were between the ages of 18 and 65, and had the capacity and inclination to participate in one daily physiotherapy session five days per week.

A hospital's COVID-19 service recruited 32 participants for the study. Patients were divided into two groups: COVID-19 (n=16; age = 53.81 9.48) and mutation (n=16; age = 55.25 10.12). Both groups underwent physiotherapy consisting of mobilization, normal range of motion, and a respiratory exercise program (COVID-19 group: 9.945.85 days; mutation group: 7.632.83 days). Every patient participated in a once-daily physiotherapy program. The patients' muscle strength, mobility, daily activities, exercise capacity, and perception of fatigue were assessed. To compare groups, the mixed repeated measures ANOVA model was used.

Eligibility Criteria:
Inclusion Criteria:

Patients with COVID-19 who were hospitalized in the COVID-19 service Patients were consulted for physiotherapy Patients with the capacity and willingness to participate in one daily physiotherapy session five days a week

Exclusion Criteria:

* Patients who had an exercise contraindication, were uncooperative, had multi-organ failure, had an acute infection, or were PEG-fed were excluded.
Exploring Men s Prostate Cancer Genetic Risk Perceptions

The exploring men's prostate cancer genetic risk perceptions and willingness to give a biospecimen for genetic risk testing study aims to assess prostate cancer genetic risk and susceptibility beliefs among unaffected men of diverse races/ethnicities who are considering undergoing prostate cancer screening and their willingness of men to provide a biospecimen (saliva sample) and test the samples for prostate cancer aggressiveness and determine risk category based on SNP genetic profile.


Eligibility Criteria:
Inclusion Criteria:

* Racially/ethnically diverse men with emphasis on Men of African Ancestry.
* Age 40 and older .
* No personal prostate cancer history/diagnosis.
* With or without family history of prostate cancer.

Exclusion Criteria:

* Previous personal Prostate Cancer history/diagnosis
* Under 40 years of age
Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of fluorouracil given as a continuous infusion in treating patients with recurrent or metastatic bladder cancer.

OBJECTIVES: I. Determine the response rate and toxic effects of continuous fluorouracil in patients with recurrent locally advanced or metastatic transitional cell urinary tract carcinoma. II. Determine the feasibility of this treatment in this patient population.

OUTLINE: Patients receive continuous intravenous fluorouracil by a Baxter Infusor for 24 weeks. Patients are evaluated for complete and partial response at 8, 16, and 24 weeks after the start of intravenous fluorouracil. Patients experiencing disease progression or unacceptable toxic effects are removed from the study. Patients are followed monthly for 6 months post treatment.

PROJECTED ACCRUAL: A maximum of 45 patients will be accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven recurrent locally advanced or metastatic transitional cell urinary tract carcinoma that has been previously untreated with systemic chemotherapy Pelvic relapse after radiotherapy or surgery No relapse solely within a previously irradiated field Nodal or metastatic disease Lesions within the abdomen or pelvis must be assessed using CT scanning At least one site of disease must be previously unirradiated and assessable for response Bone metastases cannot be used as an indicator lesion Measurable disease

PATIENT CHARACTERISTICS: Age: Not specified Performance Status: Not specified Life Expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Glomerular filtration rate at least 50 mL/min Creatinine clearance at least 25 mL/min

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics
Validation of Indiana's Early Evaluation Hub System

The investigators' objective is to test an innovative method of autism diagnosis that integrates clinical evaluation and assessment of biobehavioral markers in a large high-risk community-referral sample of children in the primary care setting.

Determine whether eye-tracking biomarkers can reliably differentiate young children with and without autism in a community referred sample. The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism in young children. Differences in metrics between children with and without autism will be compared to validate potential eye-tracking biomarkers.

Determine whether a combination of clinical (i.e., EE Hub PCP measures) and eye-tracking biomarkers can be used to accurately predict autism diagnostic outcome in a sample of young children evaluated for autism in the primary care setting.

Eligibility Criteria:
Inclusion Criteria:

Young children ages 14-48 months seen at an EE hub and referred for a comprehensive autism evaluation.

Children must have English-speaking caregivers. Children must have a legal guardian that is able to provide consent.

Exclusion Criteria:

Child is younger than 14 months or older than 48 months. Child's caregiver(s) is/are not English-speaking.
Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF in Malignancies Receiving Chemotherapy

This phase 3 study is aimed to evaluate the safety and efficacy of YPEG-rhG-CSF in reducing the infection manifested by febrile neutropenia in patients with non-myeloid malignancy who receiving Myelosuppressive Chemotherapy which is likely to cause clinically significant febrile neutropenia.


Eligibility Criteria:
Inclusion Criteria:

* Histopathology and/or cytology diagnosed as breast cancer (BC) or non-small cell lung cancer (NSCLC), and patients with breast cancer is suitable to receive TAC(Docetaxel,Doxorubicin combined with Cyclophosphamide) chemotherapy, while patients with NSCLC is suitable to receive DC(Docetaxel combined with Carboplatin) chemotherapy.
* Age ≥18 yrs.
* Weight ≥45 kg.
* Karnofsky Score ≥ 70.
* Life Expectancy ≥ 3 months.
* Peripheral blood test: WBC≥3.5×10\^9 cells/L, PLT≥100×10\^9 cells/L. ANC≥1.5×10\^9 cells/L.
* Understand and voluntarily sign the informed consent form.

Exclusion Criteria:

* Receiving chemotherapy within two months prior to screening.
* Previously or plan to receive radiotherapy (\>25% total bone marrow volume).
* Evidence of tumor metastasis in bone marrow.
* Lack of awareness.
* Uncontrolled infection or using of antibiotics within 72hrs prior to screening.
* Previously received or plan to undergoing bone marrow or organ transplants.
* Patients with bleeding tendency, e.g. prolonged prothrombin time of more than 3 seconds.
* Dysfunction in heart,lung, liver, kidney, or other major organs or systems; ALT\>2.5 ULN (upper limit of normal), TBil \>2.5 ULN (ALT\>2.5 ULN, total bilirubin \>2.5 ULN for patients with liver metastasis), HBsAg positive, anti-HCV positive, evidence of liver decompensation, or Cr \>1.5 ULN.
* Pregnant or lactating females.
* Malignancy other than BC or NSCLC.
* Hypersensitivity to rhG-CSF or any component of the investigational Products.
* Subject enrolled in any other studies within 3 months prior to screening.
* Drug abuser or alcoholics.
* Any other conditions which in the opinion of the investigator precluded enrollment into the study.
Observational Study on Intubation in Septic Shock

Septic shock is common in intensive care and its mortality remains high. While new treatments have not improved survival, optimization of known and widely used techniques has allowed reduction in mortality. Thus improving care given to patients starts with making better use of existing resuscitation techniques. Among these practices, mechanical ventilation is widespread in the management of patients with septic shock. In large studies published in recent years in Europe and North America, 40 to 85% of patients receive invasive mechanical ventilation. It therefore appears that a significant proportion of patients are never intubated during treatment and management of their septic shock. There is no specific recommendation from critical care societies concerning mechanical ventilation in the treatment of septic shock. Apart from indisputable situations such as impaired consciousness or acute respiratoire distress, the decision whether to ventilate mechanically or not is left to the discretion of the physician.

The aim of this study is to analyze intubation practice in septic shock patients and its impact on 28-day survival.

This multicentric and observational study will be conducted in 30 French ICUs.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old
* Admitted in the ICU for septic shock
* Introduction of vasopressors ( norepinephrine or adrenaline ) in the ICU or within 24 hours of ICU admission
* Suspected or proven infection

Exclusion Criteria:

* Intubation before the introduction of vasopressors
* Decision of withdrawing or withholding care at admission
* Pregnant woman
* Patient not affiliated to the social security insurance
* Refusal of participation in the study
Clinical Trial of Safety and Pharmacokinetics of VM-1500 After Multiple Oral Administration in Healthy Volunteers

The purpose of the study to assess safety and tolerability of VM-1500 and to determine main pharmacokinetic parameters of VM-1500 after multiple oral administration in adult healthy subjects.

This is a randomized, double-blind, placebo-controlled, phase Ib study in healthy volunteers with dose escalation to identify the optimal dosing schedule of VM-1500.

A total of 36 subjects will be treated with the VM-1500 or placebo for 14 days with further follow-up for four weeks. Subjects will be randomized into 3 cohorts with 3:1 drug/placebo ratio:

Cohort 1 (n=12): 10 mg VM-1500 for 9 volunteers, Placebo for 3 volunteers; Cohort 2 (n=12): 20 mg VM-1500 for 9 volunteers, Placebo for 3 volunteers; Cohort 3 (n=12): 30 mg VM-1500 for 9 volunteers, Placebo for 3 volunteers; Decision to escalate to the next (higher) dose will be made by the Independent Safety Review Board (ISRB), established specifically for this study. ISRB will base its decision on both the safety data obtained during drug administration in each cohort and analysis of clinical and lab data obtained within the course of the study.

Study time lines:

* Screening period - up to 30 days
* Treatment period - 14 days dosing (Day 1-14)
* 2 hospitalizations: Day 1-3, Day 13-15
* 28 PK samples in plasma: Day1 - predose, 0,25; 0,5; 1; 1,5; 2; 3; 4; 8; 12 hours Day 3, Day 5, Day 7, Day 9, Day 11, Day 13 - before dosing Day 14 (feed condition) - before dosing, 0,5; 1; 2; 4; 8; 12h Day 16, Day 23, Day 30, Day 37, Day 44 PK in blood cells - Day 1 (predose, 4h, 8h), Day 3, 5,7, 9, 11, 13, 14
* Post treatment follow-up period 30 days.

Eligibility Criteria:
Inclusion Criteria:

1. Provided signed written informed consent;
2. Healthy male subjects, 18-50 years of age;
3. Use of adequate and reliable forms of contraception during the study and 3 months after discontinuation of study medication.
4. ICF signed prior to any study-related procedure.

Exclusion Criteria:

1. HIV, hepatitis B, C antibodies in plasma;
2. Clinical relevant laboratory abnormalities;
3. Active tobacco, alcohol or drug abuse;
4. Anticipated non-compliance with the protocol;
5. Patients who have taken any investigational drug 3 months prior to the start of the study;
6. Plasma donorship, surgery 12 weeks prior to the start of the study;
7. Current significant gastrointestinal, renal, liver, bronchopulmonary, biliary, neurological, cardiovascular, oncologic, allergic, or ophthalmologic diseases, including history of cataracts/lens opacities.
Intensity Modulated Radiation Therapy (IMRT) Radiotherapy for Treating Prostate Pelvic Nodes

The purpose of this study is to examine the clinical feasibility and efficacy of uing IMRT to escalate the biologically effective dose to the pelvic lymph nodes in a short course of radiation therapy. An increased total and biologically effective dose will be delivered to the pelvic lymph nodes (56 Gy at 2 Gy/fraction). The prostate will receive standard "short course" IMRT of radiation (70 Gy at 2.5 Gy/fraction).


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer stage T-T3
* Predicted risk of lymph node involvement \> 15%
* Gleason \> 7

Exclusion Criteria:

* Distance metastases
* Use of anti-coagulant therapy
Containment Measures and Eating Disorders

Since March 17, 2020, the French government has implemented national containment measures due to the COVID-19 epidemic. Quarantine is an unpleasant experience : Separation from relatives, loss of liberty, concern about the infectious status, boredom, can negatively affect mental health, with the emergence of anxiety and depressive symptoms.

In addition, confinement can disrupt usual physical activity, a major destabilization criterion for patients suffering from eating disorders (ED). Finally, conditions of confinement can harm social support, yet identified as a protective and resilience factor in stress contexts. Thus, the current context of confinement and social distances could be source of an increase in eating behavior disorders symptoms in people suffering from ED.

Investigators will recruit 40 patients with eating disorders. All patients were initially assessed in the daily hospital of the Endocrinology, Diabetes, Nutrition Department (Montpellier University Hospital) from January to march 2020.

All participants will performed a phone interview to assess eating disorder symptoms, caracteristicus of containment, 1 month after the beginning of the containment, and 1 month after the end of the containment.

Eligibility Criteria:
Inclusion criteria:

* Adult women
* Surferring from ED
* Assessed in the ED daily hospital (UH of Montpellier) from January to March 2020

Exclusion criteria:

* minors
* refusal to participate
Metabolomic Profile of Patients Undergoing Myocardial Perfusion SPECT

The aim of this study is to analyze metabolomic pattern of patients after cardiac stress in order to detect differences based on the type of stress (physical or pharmacological with adenosine agonists) and result of test (positive or negative for ischemia) and to indentify biochemical markers with prognostic value. Clinical data of enrolled patients regarding demographics, cardiovascular risk factors, pretest probability and previous cardiovascular disease will be recorded. Follow up will be at one, three and five years and will be performed by clinical recordings or phone call when necessary. Blood samples of patients undergoing myocardial perfusion SPECT (Single Photon Emission Computed Tomography) are taken before, immediately after stress and 2h after stress. Serum samples will be analyzed by nuclear magnetic resonance in order to know metabolomic profile.

The aim of this study is to analyze metabolomic pattern of patients after cardiac stress in order to detect differences based on the type of stress (physical or pharmacological with adenosine agonists) and result of test (positive or negative for ischemia) and to indentify biochemical markers with prognostic value. Clinical data of enrolled patients regarding demographics, cardiovascular risk factors, pretest probability and previous cardiovascular disease will be recorded. Follow up will be at one, three and five years and will be performed by clinical recordings or phone call when necessary. Blood samples of patients undergoing myocardial perfusion SPECT are taken before, immediately after stress and 2h after stress. Serum samples will be analyzed by nuclear magnetic resonance in order to know metabolomic profile.

Eligibility Criteria:
Inclusion Criteria:

* Patients men or women ≥ 18 years of age
* Patients with prescription of cardiac perfusion SPECT

Exclusion Criteria:

* Patients with loss of consciousness or confuse, not able to read the information and to sign the writting consent
* Pregnant women
* Patients with dobutamine indications in the stress protocol