cyrilzakka/clinical-trials huggingface dataset:
A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (SLE).


Eligibility Criteria:
Inclusion Criteria:

* Fulfillment of SLE classification criteria according to either American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) criteria at any time prior to or at screening
* At least one serologic marker of SLE at screening as follows: positive antinuclear antibody (ANA) test by immunofluorescent assay with titer \>/= 1:80; or positive anti-double-stranded DNA (anti-dsDNA) antibodies; or positive anti-Smith antibody
* At both screening and Day 1, moderate to severe active SLE, defined as meeting all of the following unless indicated otherwise: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 (at screening only) with clinical SLEDAI-2K score \>/= 4.0 (at both screening and Day 1), Physician's Global Assessment \>/= 1.0 (out of 3), and currently receiving at least one standard oral treatment for SLE
* If on oral corticosteroids (OCS), the dose must be \</= 40 mg/day prednisone (or equivalent)
* Stable doses of anti-malarial or immunosuppressive therapies
* Participants must be willing to avoid pregnancy

Exclusion Criteria:

* Proteinuria \> 3.5 g/24 h or equivalent using urine protein-to-creatinine ratio (uPCR) in a first morning void urine sample
* Active proliferative lupus nephritis (as assessed by the investigator) or histological evidence of active Class III or Class IV lupus nephritis on renal biopsy performed in the 6 months prior to screening (or during the screening period)
* History of having required hemodialysis or high dose corticosteroids (\>100 mg/d) prednisone or equivalent) for the management of lupus renal disease within 90 days of Day 1
* Neuropsychiatric or central nervous system lupus manifestations
* Serum creatinine \> 2.5 mg/dL, or estimated glomerular-filtration rate \< 30 milliliter per minute (mL/min) or on chronic renal replacement therapy
* History of receiving a solid organ transplant
* Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB)
* Significant and uncontrolled medical disease within the 12 weeks prior to screening in any organ system (e.g., cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, gastrointestinal, or psychiatric) not related to SLE, which, in the investigator's or Sponsor's opinion, would preclude study participation
* History of cancer, including hematological malignancy and solid tumors, within 10 years of screening
* Need for systemic anticoagulation with warfarin, other oral or injectable anticoagulants, or anti-platelet agents
* Evidence of chronic and/or active hepatitis B or C
Dehydroepiandrosterone (DHEA)Supplementation Pre-IVF(In Vitro Fertilization) Cycles

The purpose of this study is to compare the effect of pre-IVF cycles treatment with and without DHEA(Dehydroepiandrosterone) on the ovarian reserve markers, the number of oocytes obtained and IVF(in vitro fertilization) outcomes of DOR(diminished ovarian reserve) patients and the expression of BMP-15(bone morphogenetic protein 15),GDF-9（growth differentiation factor 9) and IGF-I(insulin-like growth factors-1) in follicular fluid.

78 patients were enrolled according to the inclusion criterion. They were randomized into two groups, 40 were in DHEA group and 38 were in control group. The DHEA group received DHEA (Lab Hercules™) 25mg three times a day continuing more than 12 weeks prior to the start of IVF treatment till the day of egg collection and the control group got without any DHEA treatment. All of the IVF women patients were given CC(clomifene citrate)+HMG(human menopausal gonadotropin) protocol for controlled ovarian hyperstimulation. Hormonal profile including E2(estradiol),FSH(follicle-stimulating hormone) ,P(progesterone) ,LH (luteinizing hormone),T(testosterone),AFC(antral follicle account),serum and follicle AMH(anti-Mullerian hormone)levels will be repeated in follicular phase (D2 or 3) of cycle followed by an IVF treatment using CC+HMG protocol based on our standard departmental regimen. Improvement of ovarian reserve markers would be assessed by the change in serum and follicle AMH levels. Cycle characteristics including the dose of gonadotrophins use, duration of stimulation, number of oocytes obtained, number of fertilized embryos and good quality embryos will be recorded and follicular fluid will be saved for the test of DHEA-S(Dehydroepiandrosterone sulfate) and IGF-I. BMP-15 and GDF-9 expression in the follicular fluid were detected with western blot.

Eligibility Criteria:
Inclusion Criteria:

* Patients with antral follicle count \<5 or AMH\<1.1ng/ml and a previous poor ovarian reserve (POR)(\</= 3 oocytes with a conventional stimulation protocol using at least 150 IU FSH per day,at least two episodes)

Exclusion Criteria:

* Patients with polycystic ovary or polycystic ovary syndrome, patients who had previous chemotherapy, pelvic irradiation or ovarian surgery and patients on hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or DHEA).
Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH)

In all the Western populations, the annual incidence of subarachnoid hemorrhage (SAH) increase with age. In patients older than 70 years, the occurrence of SAH exposes them to high risk of morbidity and a poor quality of life.

In this age bracket, the single randomized which compared endovascular coiling to microsurgical clipping (ISAT Study) showed that the relative risk of morbidity increased after coiling. Moreover, some prospectives studies about endovascular coiling described favorable outcome in 48% to 63% of patients, complete occlusion in 51% to 69% and a procedural complication rate in 13% to 19%. From prospectives series, the proportion of favorable outcome after microsurgical clipping was estimated around 66% but the procedural complications are few reported. The outcome for patients treated conservatively was catastrophic. Lastly, the hydrocephalus in this age class is common, occurring in 55% of patients.

The study hypothesis is that, in this age class, no difference exists between the 2 obliteration procedures.

An accurate evaluation of result in term of functional disability, quality of life and prognosis predictive factors seems a judicious question.

The aim of our study was to determine a significant difference in terms of functional disability between microsurgical clipping and endovascular coiling in the elderly population.

Randomized multicenter trial: 2 randomized arms (clipping and coiling) plus 3 observational prospective arms (clipping, coiling, conservative).

Inclusion time: 48 months. Follow up: 12 months. Monitoring: 6 months. Duration of the trial: 66 months. Major end point: proportion of patients with unfavourable outcome at 12 months (mRS \> 2).

Secondary end point: Quality of life at 12 months (EORTC scale), causes of morbidity (mRS \> 2) and mortality, Dysautonomia according to the ADL and IADL scales.

Eligibility Criteria:
Inclusion Criteria:

* 70 years old and more
* Subarachnoid hemorrhage in grade I-IV of WFNS scale
* Ruptured cerebral aneurysm diagnosed on multislice computed tomography angiography or cerebral angiography
* treatment of subarachnoid hemorrhage

Exclusion Criteria:

* Patients in grade V of WFNS scale
* Subarachnoid hemorrhage without cerebral aneurysm
* Patients with cerebral dementia, neurologic or psychiatric antecedents
Paresthesia-Free Fast-Acting Subperception (FAST) Study

Study to evaluate the effectiveness of FAST-SCS (fast-acting paresthesia-free therapy) and additional SCS therapy options in patients with chronic pain using Boston Scientific WaveWriter SCS Systems.


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic pain (predominantly neuropathic) of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
* 22 years of age or older when written informed consent is obtained
* Able to independently read and complete all questionnaires and assessments provided in English
* Signed a valid, IRB-approved informed consent form (ICF) provided in English

Key Exclusion Criteria:

* Any pain-related diagnosis or medical/psychological condition or external factors that, in the clinician's best judgment, might confound reporting of study outcomes
* Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
* Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
* Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
Safety of ADU-1604 in Adults With Metastatic Melanoma

This study is a first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, PK, and PD of ADU-1604 and explore initial clinical activity in adults with metastatic melanoma.

ADU-CL-17 is a first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ADU-1604, an anti-CTLA-4 monoclonal antibody, and explore initial clinical activity in adults with metastatic melanoma. The primary objective of the study is to determine the Recommended Phase 2 Dose (RP2D) of ADU-1604 administered by IV infusion once every 3 weeks for 4 doses.

The study will be conducted in two parts: Dose Escalation followed by Dose Confirmation.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged ≥18 years
2. Histologically-confirmed metastatic or unresectable melanoma
3. Progression of disease following at least one prior therapy, and is not a candidate for, or is intolerant to, established therapy known to provide clinical benefit (i.e. available treatment options have been exhausted). Subjects must have BRAF mutation status confirmed; if a subject is BRAF V600E/K positive, they must have received a BRAF- targeted regimen prior to entering the study, unless the patient was deemed ineligible for such treatment
4. Measurable disease according to RECIST (v1.1) \[NOT required during Dose Escalation\]
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

1. Prior diagnosis of uveal or mucosal melanoma
2. Prior treatment with CTLA-4-directed therapy in the metastatic setting. Use of CTLA- 4-directed treatment in the adjuvant or neoadjuvant setting is acceptable provided the last dose was \>6 months before the first dose of ADU-1604 and there was no discontinuation of treatment due to a treatment-related toxicity.
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome

It has been suggested that the actual obesity epidemy is related to chronic overconsumption of added or free sugars. The increasing popularity of artificial sweeteners attest the population willingness to reduce added sugars intake and to use alternatives to alleviate health impact of free sugar overconsumption. However, recent findings suggest that artificial sweeteners may rather contribute to obesity epidemy and its associated adverse health effects, potentially via a negative impact on gut microbiota. It has been shown in various studies that, for the same amount of sucrose, unrefined sugars (such as maple syrup) are associated with favorable metabolic effects. The polyphenols contained in maple syrup, especially lignans, could contribute to these positive effects. Indeed, the strong impact of those biomolecules on the modulation of gut microbiota and on gastro-intestinal and metabolic health has been demonstrated in several studies. It is therefore highly relevant to test the hypothesis that the substitution of refined sugar by an equivalent amount of maple syrup (5% of daily energy intake) result in a lesser metabolic deterioration, by the modulation of maple syrup on gut microbiota, than the one observed with refined sugar.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 23 and 40 kg/m2
* At least one of the following: Fasting triglyceride \> 1,35 mmol/L, Fasting insulinemia \> 42 pmol/L, fasting glycemia between 5,5 and 6,9 mmol/L and glycated haemoglobin (HbA1c) between 5.7 and 6.4 %
* Understanding of spoken and written french
* Accept to follow study instructions
* If there is natural health product consumption, the dose and frequency of consumption must be stable since 3 months or more

Exclusion Criteria:

* Smoking
* Any metabolic disorder requiring medication or affecting glucose or lipid metabolism
* Aversion for maple taste
* Allergy or intolerance for maple syrup or for an ingredient of the placebo syrup
* Alcohol consumption of \> 2 drinks / day
* Weight change \> 5% of body weight in the last 3 months
* Being in a weight loss attempt
* Antibiotics intake in the last 3 months
* Regular probiotics intake in the last 3 months
* Major surgical operation in the last 3 months or planned in the next months
* Gastrointestinal malabsorption
* Cirrhosis
* Chronic kidney disease
* Pregnant or breastfeeding women or women planning pregnancy in the next months
* Participation in another clinical trial
HEC53856 Phase 1 Study - Single and Multiple Oral Dosing in Healthy Volunteers

To evaluate the safety, tolerability and pharmacokinetics of HEC53856 after single or multiple oral administration, as well as the food effect on the pharmacokinetics, in healthy non-elderly subjects.

This is a Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Tolerability and Pharmacokinetics of HEC53856 capsule in Healthy Adult Subjects. The study consists of three parts, single dose ascending, multiple dose ascending and food effect testing. Within each part participants will be randomized to either drug or placebo.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* age: 18-45 years old(18 and 45 included).
* B.W. male\> 50kg, female\> 45kg, BMI - 18-28 kg/m\^2
* females must not be pregnant and males and females must agree to use contraception during the study.
* able to give informed consent and comply with protocol.
* physical examination and vital signs without clinically significant abnormalities.
* agree to use contraceptive methods after informed consent acquisition through 6 months after the last administration of the study drug.

Exclusion Criteria:

* history or presence of severe gastrointestinal or systemic disorders (e.g. respiratory, endocrine, immunological, dermatological, neurological, psychiatric, renal, hepatic disease etc.)
* history or presence of significant alcoholism or drug abuse within past 5 years
* smokers, who smoke more than 5 cigarettes per day within past 3 months
* heavy drinker, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
* donated blood or massive blood loss within 3 months before screening (\>450 mL）
* have any disease that increases the risk of bleeding or thrombus, such as acute gastritis or stomach and duodenal ulcers;
* clinically significant laboratory findings during screening
* history or presence of clinically significant ECG abnormalities
* participated in drug research study within past 3 months
* used over-the-counter/ prescription/ herbal medications/ supplements within past 14 days.
* Strenuous activity (as assessed by the investigator) is prohibited from 2 weeks prior to admission until discharge from the unit.
* female in pregnancy or lactation.
* viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis.
* the investigator believes that the one should not be included
Early Oral Feeding Versus Traditional Postoperative Care After Cesarean Section.

To determine the effect in the post operative period of early feeding (4 hours after surgery) vs. traditional management (feeding 12 hours after surgery) in uncomplicated cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Cesarean section with regional anesthesia, regardless of gestational age.

Exclusion Criteria:

* Use of magnesium sulphate
* General anesthesia
* Pre gestational or gestational diabetes
* Bowel injury during surgery
Natural History Study of Oculopharyngeal Muscular Dystrophy

The objective of this study is to test a set of clinical outcome measures longitudinally in a cohort of OPMD patients to identify ones that show quantifiable change over time as the disease progresses. The investigators' goal is to delineate the natural history of OPMD.

OPMD patients will undergo a screening evaluation and testing to confirm the participants carry the OPMD mutation. Subjects fulfilling the inclusion/exclusion criteria will be enrolled and followed prospectively at regular intervals to determine the natural history of this disease. Measures of muscle function and swallowing will be made at baseline and at follow-up visits to measure natural clinical progression.

Eligibility Criteria:
Inclusion Criteria:

* OPMD by genetic criteria
* ≥ 18 years old
* English-speaking

Exclusion Criteria:

* Another medical condition that precludes safe completion of study tasks (such as severe cardiac or respiratory disease)
* Another medical condition that causes symptoms similar to OPMD (i.e., ptosis, dysphagia \[trouble swallowing\] or limb weakness).
* History of head or neck cancer, or history of radiation to the head or neck
* A videofluoroscopic swallow study within the 12 months prior to study enrollment
The Effect of Hypertrophic Pyloric Stenosis (HPS) on Sodium Intake in Childhood

The loss of sodium during infancy causes long term changes in sodium intake. Human research shows that the loss of maternal sodium during pregnancy and neonatal after birth causes an increase sodium intake during childhood. A study that examined sodium intake among infants that were treated with diuretics during the post-natal period found changes in sodium intake compared to controls. In this study we will test sodium intake in young children who have suffered from vomiting due to Hypertrophic Pyloric stenosis during early infancy.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 7-13 years
* Status post HPS in infancy

Exclusion Criteria:

* Children with chronic diseases
* Hospitalization due to dehydration after HPS hospitalization
Selections of Subjects With Important Changes in Their Cardiac Repolarization Parameters for the Procurement of Skin and Blood Samples

The study main objective is to assess the changes in the ventricular repolarization (measure by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify subjects with extreme responses and collecting their skin and blood samples.

An ECG is performed after a dose of sotalol on about 100 healthy subjects in order to identify about 20 extreme responders (10 high responders and 10 non responders) assessed as Delta QTcf compare to baseline. The ECG will be measured and the delta QTcf will be calculated on the 20 selected subjects in a second part of the clinical trial, cross over erythromycin/placebo.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 40 years of age
* Caucasian origin
* BMI 19 to 29 kg/m²
* Informed Consent obtained
* National Health Security Number
* Eligible for Phase I as mentioned in the national registry of healthy volunteers
* For woman: use of an effective contraceptive method

Non Inclusion Criteria:

* Asthma
* Heart Rate \< 50 bpm
* Hypotension with systolic blood pressure\< 100 mm Hg.
* atrioventricular block (PR interval \> 200 ms)
* Known Chronic illness (hepatic, renal or cardiac impairment, etc..)
* Raynaud's phenomenon
* Drug known to prolong QT (http://www.azcert.org/medical-pros/drug-lists/drug-lists.cfm) in the last 7 days.
* All chronic treatments are forbidden exceptive : oral contraceptives, paracetamol, vitamins and comfort treatment that do not prolong the QT
* Known family or individual past history of QT prolongation or unexplained syncope
* (QTcF) \> 450 ms
* QRS interval non assessable on ECG at rest or bundle-branch block, QRS \> 100 ms
* Allergy to macrolide type antibiotics
* Known allergy to sotalol or lidocaine
* Positive blood pregnancy test (Inclusion visit)
* Known abnormal haemostasis
* Kaliemia\< 3.5 mmol/L
* Magnesemia\< 0,7 mmol/L
* Under exclusion period or participating to another clinical trial on a new medicinal product
* Creatinin clearance \< 80 ml/min (Cockroft and Gault formula)
* AST-ALT \>3x upper normal limit
DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis

This three-part study will be performed with participants on chronic hemodialysis.

* Part A will assess plasma pharmacokinetics of DS2330a (free form of DS2330b) after a single dose of powder in bottle (PIB) or tablet formulations of DS2330b
* Part B will test the safety, tolerability, and effects on serum phosphate (Pi) of 14-day repeated oral doses of DS-2330b PIB when given alone and when given along with sevelamer carbonate three times a day
* Part C is optional, and will test the effects on serum phosphate (Pi) of 14-day repeated oral doses of DS-2330b tablets when given with sevelamer carbonate

After screening, participants should expect the study to last about 21 days for Part A, and 46 days for Parts B and C.


Eligibility Criteria:
Inclusion Criteria:

* Has a body mass index (BMI) of 18 kg/m\^2 to 40 kg/m\^2 (inclusive)
* Is on prescribed maintenance hemodialysis (three times a week) for at least 3 months before Screening with adequacy demonstrated by a dialysis clearance within 3 months before the first dose of the investigational medicinal product
* Has permanent vascular access \[arteriovenous (A-V) fistula or graft\]
* Is willing to comply with protocol-specified methods for family planning
* For Parts B and C only:

  1. Has protocol-specified acceptable serum Pi levels at Screening and in serum Pi after up to 3 weeks of washout from all Pi binders
  2. Has protocol-specified acceptable serum Ca\^2+ level and intact parathyroid hormone (iPTH) level at screening

Exclusion Criteria:

* Is employed by the clinic or the sponsor
* Has family relationship with another study participant
* Has any history, current condition, or drug use that per protocol or in the opinion of the investigator might compromise:

  1. safety of the participant or their children
  2. safety of study staff
  3. analysis of study results
* For Parts B and C only:

  1. Is not able to take sevelamer carbonate
  2. Has had partial or total parathyroidectomy within the last six months