cyrilzakka/clinical-trials huggingface dataset:
Study of the Incidence of SARS-CoV-2 Infection (COVID-19)

This is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study.

The health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality.

The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.


Eligibility Criteria:
Inclusion Criteria:

* Any major subject, voluntary, exposed to the public from 11 May 2020 informed of the study by partner institutions (Departmental Council 06), affiliated to a social security scheme,

Exclusion Criteria:

* Subject protected by law under tutorship or guardianship, or who cannot participate in a clinical study under the terms of Article L. 1121-16 of the French Public Health Code
Systematic Screening for Primary Immunodeficiencies in Patients Admitted for Severe Infection in Pediatric Intensive Care Unit

Severe infections in pediatric intensive care unit are not uncommon. Historically, the diagnosis of hereditary (primary) immune deficiency required a combination of recurrent clinical signs and biological stigmas. This paradigm is currently being questioned, and grows the hypothesis of a potential underlying genetic susceptibility in any severe infection. To date, the proportion of severe infections explained by an underlying immune deficiency is unknown.

The aim of this prospective study is to assess the incidence of primary immune deficiencies in children with severe infection, regardless of their etiology.


Eligibility Criteria:
Inclusion criteria:

* Inclusion age less than 16 years
* Inclusion age \> 3 months of actual age for term infants and \> 3 months for former preterm infants.
* Documented severe infection (bacterial, viral, fungal) at the University Hospital Center of Montpellier, Toulouse or Marseille
* Severe infections concerned by the study: any infection requiring hospitalization in pediatric intensive care (more than 24 hours) including:
* meninges or brain lesions, pleuro-pneumopathy, any infection associated with sepsis and/or an opportunistic germ, septic shock, etc.
* Encephalitis and encephalomyelitis of infectious origin
* Child benefiting from a social security system
* Collection of parental/legal representative consent

Exclusion criteria:

* Undocumented severe infections
* Acute bronchiolitis
* Children admitted with isolated SRV bronchiolitis without further complications from the infection;
* Previous comorbidity explaining the infection and/or stay in ICU/Continuing Care: Primary or known secondary immune deficiency; burns; risk factors for non-infectious epilepsy (encephalopathy, known epilepsy, head trauma), pneumonia caused by swallowing disorders or tracheotomy or chronic lung disease, asthma, meningitis favored by cochlear implants, breach of blood-brain barrier or neuromeningetic material, deep infection on implanted material or within 48h after surgery, cardiovascular decompensation; any other chronic conditions that may contribute to infection;
* Inability to obtain consent from parents/legal guardians.
Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients

Antipsychotics such as risperidone could induce amenorrhea in schizophrenic patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of metformin for antipsychotic induced amenorrhea in schizophrenia patients.


Eligibility Criteria:
Inclusion Criteria:

* schizophrenia patient
* amenorrhea for more than three months after antipsychotic treatment

Exclusion Criteria:

* liver or renal diseases
* pregnant or lactating women
* cardiovascular diseases
* hypertension or diabetes mellitus
Effect of Vitamin D Supplementation as Adjuvant Therapy in Neonatal Jaundice in Combination With Phototherapy

Neonatal jaundice frequently occur during initial week of life. Neonatal jaundice is one of the leading causes of hospital admission and readmission. Some studies have suggested that the healthy newborns with hyperbilirubinemia outside the physiological range have notably reduced serum vitamin D levels. This deficiency is inversely associated with neonatal hyperbilirubinemia, suggesting that low vitamin D levels could be a potential risk factor for jaundice among neonates.


Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Admitted between 3-28 days of age.
* Indirect hyperbilirubinemia with TSB levels between 14-20 mg/dL
* Born via either cesarean or vaginal delivery
* Birth weight greater than 2500 grams

Exclusion Criteria:

* Prior phototherapy treatment
* Preterm birth (gestational age below 37 weeks).
* SpO2 \< 95% at the time of admission
* Severe respiratory distress or failure
* Neonatal sepsis
* Congenital anomalies
* Parents/guardians unwilling to let their neonates be part of this study.
S8947-9800-9911-0016A Vitamin D Insufficiency in Determining Prognosis in Patients With Newly Diagnosed Follicular Lymphoma

RATIONALE: Studying samples of serum from patients with cancer in the laboratory may help doctors identify and learn more biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying vitamin D insufficiency in determining prognosis in patients with newly diagnosed follicular lymphoma.

OBJECTIVES:

* To evaluate the role of pre-treatment serum 25(OH)D with regard to progression-free survival and objective response among patients with newly diagnosed follicular lymphoma, within the context of a uniformly treated and evaluated Phase III clinical trial in the modern therapeutic era.

OUTLINE: This is a multicenter study.

Pre-treatment serum samples are analyzed for 25(OH)D levels to determine vitamin D sufficiency or insufficiency.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed CD20+ follicular lymphoma
* Enrolled on clinical trial SWOG-S0016, SWOG-9800, or SWOG-9911
* Pre-treatment serum available through SWOG-8947

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Comparative Study of the Efficacy of Oral Versus Intravenous Hydration as a Preventive Measure of Contrast-induced Nephropathy (CIN) in Patients With Renal Insufficiency (RI) Grade III Under Study Conducting Computed Tomography (CT)

This study evaluates if oral hydratation is as effective as endovenous hydratation in the prophylaxis of contrast-induced nephropathy in patients renal insufficiency grade III under study conducting contrasted computed tomography.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes over 18 years
* Candidates for a study with computed tomography and intravenous contrast
* A glomerular filtration rate between 30 and 45 mL / min including both determinations
* They have signed the written informed consent after being informed of the objectives and the nature of the case or be unable to have the authorization or agreement of its

Exclusion Criteria:

* refuse to participate in the study
* pregnancy or lactation
* Other risk factors for Contrast Induced Nephropathy: diabetes mellitus type I, have an age of 75 years or above, heart failure (defined by a scale New York Heart Association 3 or 4), hypotension (defined as systolic blood pressure \<100), being treated with nephrotoxic medications.
* Any disease or a history that, in the investigator's opinion, could confound the results of the study or pose an additional risk to patient treatment.
Continuous Deep Sedation Until Death

This research is a descriptive observational study conducted in multicenter (intensive care and continuing care units) in France. All data collected is part of the patient record. The main objective is to describe the end-of-life sedative practices following a decision to limit or stop therapy in intensive care unit and continuing care unit.

All participating sites will include last 10 consecutive major patients deceased following a decision to limit or stop therapeutics. The study include only data from patients died before January 1, 2020. In the case report form the following information will be entered:

* the characteristics of the unit of intensive care or continuing care unit.
* Patient Characteristics
* Characteristics of sedative practices

Eligibility Criteria:
Inclusion Criteria:

* Adult patients at the time of death (\>18years)
* Died in intensive care or in continuing care unit
* Patient died before January 1st, 2020.
* Patients deceased following a decision to limit or stop therapeutics

Exclusion Criteria:

* Patients who died of brain death or unexpected cardiac arrest at death of unsuccessful cardiopulmonary resuscitation
* Patient who expressed during his lifetime his opposition to the use of his data for scientific research
Scripps-eMed Covid-19 Study: A Prospective Monitoring Study for Those Individuals Treated With Paxlovid

A prospective monitoring study for those individuals treated with Paxlovid

The purpose of this study is to understand the epidemiology and pathophysiology of Paxlovid rebound in patients with acute Covid-19 infection who have been prescribed the Paxlovid per standard of care.

The study will be a collaborative effort between Scripps and eMed, digitally recruiting 800 participants who have tested positive for Covid-19 and have agreed to be prescribed Paxlovid on the eMed platform.

The vision of the study is to understand Paxlovid rebound and ultimately inform management of acute Covid-19 infection.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Covid positive
* Qualified for Paxlovid prescription (treatment decision already made prior to enrollment)

Exclusion Criteria:

* Non-english speaking
* Resides outside of the United States
NICU Asthma Education and Secondhand Smoke Reduction Study

Premature infants have a significantly increased risk for developing respiratory illnesses and asthma. Secondhand smoke (SHS) also is clearly associated with increased breathing problems in children, thus exposure to smoke makes it substantially more likely for a premature infant to develop wheezing. The overall goal of this study is to test whether comprehensive asthma education combined with a home-based secondhand smoke reduction program can reduce exposure to smoke and prevent respiratory illness among premature infants. Our hypotheses are:

* More premature infants whose families receive asthma education combined with a SHS reduction intervention will live in smoke-free environments compared to infants receiving only asthma education (control group).
* Caregivers receiving the SHS reduction program will have higher rates of quit attempts and less relapse into smoking compared to caregivers in the control group.
* Infants whose families receive the combined intervention will experience less respiratory illness compared to infants in the control group.


Eligibility Criteria:
Inclusion Criteria:

* ≤32 weeks gestation
* Planned discharge to home from the Neonatal Intensive Care Unit
* Parent or caregiver must consent to the intervention
* The first sibling discharged, for twins or infants from a multiple birth pregnancy

Exclusion Criteria:

* Inability to speak and understand English
* No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate home)
* Family residence outside the greater Rochester area (more than 30 miles away)
* Children in foster care or other situations in which guardian consent cannot be obtained
* The child having significant medical conditions, including serious heart disease, cystic fibrosis, or other conditions that could interfere with the assessment of respiratory-related outcome measures
A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.

To evaluate and estimate the safety and efficacy of the combination of fluconazole and flucytosine as treatment for acute cryptococcal meningitis in patients with AIDS.

Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin B plus flucytosine.

Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin B plus flucytosine.

Patients in each cohort receive a lower dose of fluconazole alone or in combination with flucytosine, or a higher dose of fluconazole alone. Doses in subsequent cohorts are escalated if safety data in the previous cohort is satisfactory. Patients are evaluated weekly for the first 4 weeks and every 2 weeks thereafter. Therapy continues until 8 weeks after the CSF becomes culture negative, up to a maximum of 26 weeks.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiviral therapy (AZT, DHPG).
* Prophylaxis for Pneumocystis carinii pneumonia.
* Treatment for intercurrent opportunistic infection.

Concurrent Treatment:

Allowed:

* Radiation therapy for mucocutaneous Kaposi's sarcoma.

Patients must have:

* AIDS.
* Evidence of Cryptococcal neoformans in culture or lumbar CSF OR clinical and CSF findings compatible with cryptococcal meningitis.
* No evidence of acute or chronic meningitis of any etiology other than cryptococcosis.
* Life expectancy of at least 2 weeks.

Prior Medication:

Allowed:

* Prior antiviral therapy (AZT, DHPG).
* Prophylaxis for Pneumocystis carinii pneumonia.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Relapsing on maintenance triazole therapy for cryptococcal meningitis.
* Unable to take oral medication.

Concurrent Medication:

Excluded:

* Concomitant use of any antifungal agent other than study drug.

Patients with the following prior conditions are excluded:

History of allergy to or intolerance of imidazoles, azoles, or flucytosine.

Prior Medication:

Excluded:

* More than 1 mg/kg amphotericin B.
* Systemic antifungal agents within 7 days prior to study entry.
Blueberry Intake and Infant Gut Health

The objective of this project is to investigate the effects of blueberries on gut microbiota, inflammation and innate immunity in breastfed infants during early complementary feeding (\~5 to 12 months of age).

Some details are intentionally left to out to preserve the scientific integrity of the study, and they will be included in the record after the study is completed.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* Full term (gestational age ≥ 37 weeks)
* No prior exposure of solid foods
* Exclusively breastfed (\< 2 weeks of cumulative formula exposure)
* Willing to consume blueberry/placebo powder

Exclusion Criteria:

* Having health conditions that would affect normal growth
* Pre-term
* Consumed formula for more than two weeks
* Not willing to consume the blueberry/placebo powders
A Translational Study of Bevacizumab in Participants With Metastatic Colorectal Cancer

This open-label, prospective, single-arm, multicenter study will evaluate the relationship of the markers of inflammation and progression-free survival (PFS) in participants with previously untreated metastatic colorectal cancer. The study consists of two phases: Phase A treatment: oral capecitabine plus infusional oxaliplatin (XELOX) plus bevacizumab, or modified infusional 5-fluorouracil (5-FU), leucovorin (LV) and oxaliplatin (mFOLFOX6) plus bevacizmab administered until first disease progression. Participants will then continue with Phase B treatment: infusional 5-FU, LV and irinotecan (FOLFIRI) plus bevacizumab until second disease progression. The anticipated time on study treatment is 4 years.


Eligibility Criteria:
Inclusion Criteria:

For resected primary tumor participants, and participants with primary tumor in situ:

* Previously untreated metastatic colorectal cancer and not a candidate for curative resection
* World Health Organization (WHO) performance status of 0-1
* Life expectancy of greater than or equal to (\>/=) 3 months
* Eligible for XELOX, mFOLFOX6, FOLFIRI and bevacizumab treatment in accordance with local standards of care and pharmaceutical benefits scheme guidelines

Additional inclusion criteria for participants with primary tumor in situ:

* Intact primary tumor of the colon or the rectum not requiring surgical intervention prior to study start
* Minimal or asymptomatic primary tumor

Exclusion Criteria:

Resected primary tumor participants, and participants with primary tumor in situ:

* Previous chemotherapy for metastatic colorectal cancer
* Previous neoadjuvant or adjuvant chemotherapy less than 6 months prior to study start
* Radiotherapy within 28 days prior to enrollment or not recovered from a radiotherapy
* History of non-colorectal cancer (participants are eligible if disease-free for \>/=5 years and the risk of recurrence is deemed low)
* Presence of active inflammatory bowel disease
* History of gastrointestinal perforations
* Peritoneal disease
* History of significant bleeding event
* Significant vascular disease
* Peripheral arterial thrombosis or other thrombotic event within 6 months before study start

Additional exclusion criteria for participants with primary tumor in situ:

* Prior endoscopic management of the current tumor
* Acute diverticulitis
* Presence of intra-abdominal abscess
* Active gastroduodenal ulcer
Safety Study of Black Cohosh Use by Postmenopausal Women on the Liver

Black Cohosh extract is a form of phytoestrogen (estrogen of plant origin) that is effective in controlling bothersome hot flushes, while avoiding the dangers of using hormones. Recent case reports pointed to potential toxicity of black cohosh on the liver. The investigators are trying to verify or refute such allegations.

The aim of this prospective longitudinal clinical trial is to evaluate changes in total hepatic blood flow and liver functions among postmenopausal women using black cohosh (cimicifuga racemosa) extract for twelve consecutive months for relief of vasomotor symptoms.

Prior to using a daily dose of 40 mg of a dry extract preparation of cimicifuga racemosa (Klimadynon®) and twelve months after, total hepatic blood flow will be assessed by color Doppler ultrasound. Moreover, prothrombin time \& concentration, serum albumin, bilirubin, gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* an age over 40 years
* with a lapse of one year after the last menstruation
* symptomatic women without gynecological illness
* after naturally occurring menopause
* had never used hormonal therapy or had stopped using them for \>6 months
* accepting to participate after receiving adequate description of the study
* accessible for regular follow-up.

Exclusion Criteria:

* vaginal bleeding
* active or chronic liver disease and /or abnormal liver functions
* present or past thromboembolic disease
* present or past neoplasia of the breast or uterus
* an endometrial thickness \>5 mm by TVS
* use of alternative or complementary medicines or herbs for menopausal symptoms within the previous three months
Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)

The purpose of this study is to assess the safety and efficacy of IMM0306-02 in patients with refractory or relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL).


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* Diagnosed with B-NHL
* Relapsed after or be refractory to at least 2 line of standard therapy

Exclusion Criteria:

* Active central nervous system (CNS) metastases
* Positive Direct Antiglobulin Test (DAT)
* Active autoimmune disorder
* Skin disorders that do not requires hormone replacement therapy
Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project

TGCT is a rare disease that is difficult to manage, surgical resection is the primary treatment currently available. To date no disease registry exists and there is little data available detailing the management of patients with diffuse TGCT (d-TGCT), the burden of d-TGCT for patients (including pain, joint stiffness, swelling, reduced mobility and quality of life) or the economic impact of d-TGCT.

This study aims to collect data by an observational disease registry involving no intervention to the patient or changes to investigators treatment decisions.

GCT is a rare, benign, but potentially locally aggressive and recurrent disease. Treatment pattern and treatment initiation, continuation or changes are solely at the discretion of the physician and the patient.

There will be no attempt to influence the prescribing patterns of any individual treating physician. All medication will be prescribed in the usual standard of care and will not be provided by the study sponsor.

Participation in the study will in no way influence payment or reimbursement for any treatment received by patients during the study.

It is the responsibility of the investigator and his study staff to enter all relevant patient data required for this registry in the electronic Case Report Form (eCRF) and in the patients' medical records.

Approximately 15 sites from up to 6 European Countries (France, Germany, Italy, The Netherlands, Spain and United Kingdom) and 4 sites from the US are planned to participate. The sites will be specialized sites that treat d-TGCT regularly.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent for participation in the study (ICF)
* Patients with d-TGCT (diagnosed histologically) confirmed naïve or recurrent case

Exclusion Criteria:

* As this is a non interventional study, no explicit exclusion criteria have been defined