cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Omija (Schisandra Chinensis) Extract in Subjects With Knee Osteoarthritis

Knee osteoarthritis (KO) is a common arthropathy and a leading cause of disability in elderly adults. Schizandra chinensis(Omija) has been known to have five predominant tastes: salty, sweet, sour, astringent, and bitter. It has also been shown to have various effects on the anti-inflammatory, cardiovascular system, gastrointestinal system, central nervous system, endocrine system, and stress protect. Therefore, this study is designed to evaluate the efficacy and safety on KO of Omija extract.

In the present study, the investigators will assess the efficacy and safety of the formulation of Omija extract(1,200 mg administered twice a day) on the symptoms of knee osteoarthritis (KO) during a 12-week treatment course. In a randomized, double-blind placebo-controlled trial, subjects will be randomly assign to receive oral omija treatment group(n=30) or placebo group(n=30). The primary efficacy outcome measure will be score change in the WOMAC(Western Ontario and McMaster University Osteoarthritis Index) after 12-weeks. Secondary parameters will be included the Lysholm index score, hs-CRP, osteocalcin(OSC), and deoxypyridinoline(DPYR).

Eligibility Criteria:
Inclusion Criteria:

* Males and females 30-70 years old
* mild to Moderate KO(Knee Osteoarthritis) as indicated by WOMAC(Western Ontario and McMaster University Osteoarthritis Index) score ≥ 38
* Able to walk
* Subject agrees not to start any new therapies for OA during the course of the study
* Able to give informed consent

Exclusion Criteria:

* History of underlying inflammatory arthropathy; septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; joint fracture; acromegaly; fibromyalgia; Wilson's disease; ochronosis; haemochromatosis; heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis
* Expectation of surgery in the next 4 months
* Recent injury in the area affected by OA of the knee, i.e. meniscal tear (past 4 months)
* Cartilage reconstruction procedure in the target knee
* Intra-articular corticosteroid injections in the target knee within the last 3 months
* Viscous injections in the target knee within the last 6 months
* Abnormal liver or kidney function tests (ALT or AST \> 2 times the upper limit of normal; elevated creatinine, males\>125 umol/L, females\>110 umol/L)
Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants

Randomized, double-blind placebo-controlled phase I trial with the primary aim to investigate safety and tolerability of three ascending dosing schemes of DM-101-PX in birch pollen allergic adults. As an explorative objective, the trial will also investigate the effect of DM-101PX on the allergic symptoms following birch pollen allergen exposure in a chamber. Expanded access to the study treatment is not available.

The study will be carried out in a single study site located in Canada

Eligibility Criteria:
Inclusion Criteria:

* Either sex or any race, aged 18 to 65 years
* Good general health
* A documented clinical history of moderate to severe birch pollen induced allergic rhinitis or rhinoconjunctivitis with symptoms that interfere with daily activities or sleep and remain bothersome despite the use of relevant symptomatic medication, and have been present over at least 2 previous birch pollen seasons
* Birch pollen specific IgE ≥ 0.7 kU/L
* Positive SPT to birch pollen allergen, with wheal diameter ≥ 3 mm
* Body weight ≥ 50 kg and body mass index within the range of 18-35 kg/m2

Exclusion Criteria:

* History or findings on physical examination of any significant disease or disorder which, in the opinion of the Investigator, could put the subject at risk because of participation in the trial, influence the results of the trial or subject's ability to participate in the trial
* Current diagnosis of persistent asthma, or moderate to severe asthma requiring GINA Step 2 or higher treatment, or asthma partially controlled or uncontrolled according to GINA classification in the 6 months before screening
* Significant rhinitis, sinusitis, significant and/or severe allergies not associated with the birch pollen season
* History of asthma deterioration that resulted in emergency treatment or hospitalization in the past 12 months before screening, or a life-threatening asthma attack at any time in the past
* A Forced Expiratory Volume in one second (FEV1) ≤ 75% of predicted value
* History of severe drug allergy, severe angioedema, or systemic allergic reaction of Grade 3 or grater, according to World Allergy Organization (WAO) scale, due to any cause
Short-term Effects of Aromatase Inhibition in Obese Men

In this study, 50 obese men with a hormonal imbalance will be treated with letrozole or placebo for six months in order to examine the effects on the hormonal balance, and on weight loss. The study will also address the side effects and psychological effects of letrozole as compared to placebo.

The aim of the study is to establish the short-term efficacy and safety of aromatase inhibition in restoring and maintaining eugonadism in hypogonadotrophic hypogonadal men. Secondary aim is to detect the short-term somatic and psychological effects.

Study design: Double blind randomized placebo-controlled trial.

Treatment: 26 weeks of either letrozole or placebo. All patients will start on 1 tablet per week, dose adjustments will be performed if serum testosterone or estradiol are outside the target range. All men will be prescribed a mildly hypocaloric diet.

Endpoints: BMI, body weight, waist circumference, body composition, exercise capacity, serum levels of several hormone markers, glucose tolerance, psychological characteristics.

All patients will be measured 6 times during the study.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 35 and 50
* Male sex
* Ages between 20 and 50
* Serum total testosterone under 10 nmol/l
* Serum luteinizing hormone (LH) under 9 mU/l
* Serum estradiol over 40 pmol/l

Exclusion Criteria:

* Comorbidity
* Serum prostate-specific antigen (PSA) over 4.0 U/l
* Discontinuation of smoking less than six months ago
* Medication known to affect hormonal parameters
eValuating iDA Selection Ability. The VISA Study.

A non-inferiority, prospective parallel group, multi-center, randomized controlled trial to investigate whether selection of a single blastocyst for transfer using the deep learning tool, iDA, results in non-inferior clinical pregnancy rate compared to trained embryologists using standard morphology criteria.


Eligibility Criteria:
Inclusion Criteria:

1. Women undergoing IVF or ICSI with controlled ovarian stimulation with gonadotrophins and the intention to treat by either transfer of a single fresh embryo on day 5 or in case of a freeze all cycle, the first rewarmed embryo.
2. Age: Up to and including the 42nd completed birthday on the day of randomization.
3. Has at least two early blastocysts on day 5.

Exclusion Criteria:

1. Treatment involving donated eggs
2. Intention to perform any form of preimplantation genetic testing
3. The use of IMSI or polarized light in the ICSI process
4. The use of assisted hatching prior to randomization
5. Previous participation in this RCT
6. Where the cycle is carried out for fertility preservation
7. If a day 2-4 transfer is planned
8. Has a reduced likelihood of obtaining two early blastocysts on day 5 as evidenced by either: an AMH level of \<3pmol/L or AFC \<5 (if available)
Predictors of Sequelae Appearance in Shaken Baby Syndrome

This is an observational, prognostic and prospective study. It is about the Prognostic Factors for sequelae in children with a history of Shaken Baby Syndrome (SBS) in the Central region in France. The study hypothesis is the prognosis of the sequelae children develop according to the severity criteria presents in admission to the hospital for the Shaken Baby Syndrome. The severity criteria are clinical high intracranial pressure, presence of a coma, vitreous hemorrhage, an age under 6 months, other cerebral lesion than subdural hematoma (parenchymal lesion, ischemia or cerebral oedema). Children affected by the nonaccidental head injury are today between five and eight years old.

Abusive head trauma is a severe inflicted traumatic brain injury, occuring under the age of 1 year, defined by an acute brain injury (mostly subdural or subarachnoidal haemorrhage), where no history or no compatible history with the clinical presentation is given.

This is secondary to violent shaking, with or without impact, of an infant by an adult, sufficient to cause brain injury. The mortality rate is estimated at 20-25% and growth of child is extremely poor. High rates of impairment are reported : motor deficit (spastic hemiplegia or quadriplegia), epilepsy often intractable, microcephaly with corticosubcortical atrophy, visual impairment even the blindness, language disorders, cognitive (intellectual deficit), behavioral (agitation, aggression, attention deficit, inhibition deficit) and sleep disorders. Several studies on the subject highlighted that an initial severe presentation is associated with worse growth.

These is very limited research on the outcome of inflicted traumatic brain injury and the results are heterogeneous. The study hypothesis is the prognosis of the sequelae children develop according to the severity criteria presented in admission to the hospital for the Shaken Baby Syndrome.

This is an epidemiological, observational, prognostic and prospective study. The severity criteria are clinical high intracranial pressure, presence of a coma, vitreous haemorrhage, an age under 6 months, other injuries than subdural hematoma (parenchymal injuries, ischemia or cerebral oedema).

The severity criteria were chosen by studying others studies on the subject. Children concerned had been admitted to hospital for Shaken Baby Syndrome between 2010 and 2014 in France, in the Central Region. Thus today, they are between five and eight years old. We know that sequelae occur after latency, in particular when children learn to read and write.

Primary purpose is to evaluate prognostic factors to develop sequelae after an inflicted traumatic brain injury as the shaken baby syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Children must be between five and eight years old
* Hospitalization before one year old for a Shaken Baby Syndrome in the Center Region in France

Exclusion Criteria:

* Opposition of the legal representative to use the data
A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)

Two cohorts are being studied based on leptin levels. Cohort A is composed of patients with baseline leptin \<8.0 ng/mL and Cohort B is composed of patients with baseline leptin 8.0 to ≤20.0 ng/mL

The primary objectives will be evaluated for patients in Cohort A only:

* To evaluate the effect of REGN4461 on fasting triglycerides (TG) in patients with elevated baseline fasting TG
* To evaluate the effect of REGN4461 on hyperglycemia in patients with elevated baseline Hemoglobin A1c (HbA1c)

The following secondary objectives of the study will be evaluated for Cohort B and for the combined set of Cohorts A plus B:

* To evaluate the effect of REGN4461 on fasting TG levels in patients with hypertriglyceridemia
* To evaluate the effect of REGN4461 on glycemic control in patients with hyperglycemia

The following secondary objectives of the study will be evaluated for Cohorts A and B separately, and for the combined set of Cohorts A plus B:

* To evaluate the effect of REGN4461 on liver fat in patients with hepatic steatosis
* To evaluate the effect of REGN4461 on hunger
* To evaluate safety and tolerability of REGN4461
* To characterize the concentration profile of REGN4461 over time
* To assess immunogenicity to REGN4461


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of familial partial lipodystrophy as defined in the protocol
* Fasting leptin level ≤20.0 ng/ml, as determined during the screening period
* Presence of significant metabolic abnormalities related to glucose and triglycerides (TGs) as defined in the protocol
* Stable body weight within the 3 months prior to screening (no gain or loss of \>5% current weight)
* Stable diet during the past 3 months defined as no major change in macronutrient composition (eg, starting or stopping diets such as Atkins, Paleo, Vegetarianism, Veganism)
* No clinically meaningful change in medication regimen in the 3 months prior to screening as defined in the protocol

Key Exclusion Criteria:

* Treatment with metreleptin within 3 months of the screening visit
* Patients with a diagnosis of generalized lipodystrophy
* Patients with a diagnosis of acquired lipodystrophy
* Pregnant or breastfeeding women

NOTE: Other protocol defined inclusion/exclusion criteria apply
SURESTEP: Transcranial Direct Current Stimulation in Super Refractory Status Epilepticus

The purpose of this study is to determine whether transcranial direct current stimulation affects super refractory status epilepticus.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of super refractory status epilepticus
* admitted to the intensive care unit
* identifiable epileptogenic focus on EEG

Exclusion Criteria:

* contraindications to scalp EEG
* lice
* scabies
* other hair/skin infection
* scalp psoriasis
* hypersensitivity
* other severe dermatological condition
* previous adverse reaction to collodion
* vagal nerve stimulator
* implantable cardioverter defibrillator
* cardiac pacemaker
Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery

The purpose of this study is to examine AWBAT™-D compared to Mepilex® Ag for the treatment of donor sites in burn surgery.


Eligibility Criteria:
Inclusion Criteria:

* Burn wounds requiring skin grafting
* Matched donor sites available
* 1-30% TBSA

Exclusion Criteria:

* Severe inhalation injury
* Pregnancy
* Co-morbidity which may compromise healing
* Known allergy to pork or pork products
Comparison of Fenofibric Acid Bioavailability From ABT-335 Capsules

The purpose of this study is to evaluate the safety and compare the bioavailability of fenofibric acid from 2 different dosage strengths of ABT-335.


Eligibility Criteria:
Inclusion Criteria:

* A condition of general good health
* BMI 18 to 29

Exclusion Criteria:

* Currently enrolled in another clinical study
* Females who are pregnant or breast-feeding
Tofacitinib For Treatment Of Chronic Pouchitis

A phase 2 pilot study to evaluate the effectiveness of tofacitinib in subjects with chronic pouchitis

The proposed study is a phase 2, open-label study of tofactinib in treatment of patients with chronic pouchitis. Subjects with chronic active pouchitis will be screened and recruited if they meet eligibility criteria. Eligible subjects will undergo baseline clinical evaluation, laboratory testing and a pouch endoscopy. They will then receive oral tofacitinib 10 mg twice daily for 8 weeks. Clinical and laboratory data will be collected at week 4 and week 8, and all subjects will undergo a end of treatment pouch endoscopy at 8 weeks. Clinical, laboratory and endoscopic data at 8 weeks will be compared to the baseline data to evaluate study outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects ages 18 to 80
2. Subjects with a history of proctocolectomy with ileal pouch anal anastomosis (IPAA) for UC at least 6 months prior to screening.
3. Subjects with pouchitis that is chronic, defined by a mPDAI score ≥5 assessed as the average from 3 days immediately prior to the baseline study visit and a minimum endoscopic sub-score of 2 (outside the staple or suture line) with either (a) ≥ 3 recurrent episodes within 1 year prior to the screening treated with ≥2 weeks of antibiotic or other prescription therapy, (b) requiring maintenance antibiotic therapy taken continuously for ≥4 weeks immediately prior to the baseline study visit
4. Women of childbearing potential must have documentation of a negative pregnancy test at screening and must agree to use two highly effective methods of birth control during the study and for at least 1 month after completion of study drug dosing.

Exclusion Criteria:

1. Subjects with IPAA surgery done for Crohn's disease (CD) or familial adenomatous polyposis (FAP) indications.
2. Subjects with primary CD of pouch, isolated or predominant cuffitis or mechanical complications of the ileal pouch.
3. Subjects with prior exposure to tofacitinib.
4. Subjects with a diverting stoma.
5. Subjects with a prior history or risk factors for venous thromboembolism.
6. Subjects with active bacterial, parasitic, fungal, mycobacterial, or viral infection.
7. Subjects with a history of latent or active tuberculosis.
8. Subjects positive for hepatitis B virus (HBV) surface antigen, hepatitis B virus core antibody with a negative hepatitis B surface antibody or with detectable serum hepatitis B DNA.
9. Female subjects who are pregnant or lactating.
10. Female subjects of childbearing potential who are sexually active and do not agree to using two highly effective methods of contraception during the study period.
11. Subjects with clinically significant laboratory abnormalities at study screening.

    * Other eligibility criteria apply
Comparison of Troponin Assay With New POCT Method in the Decision-making Pathway of Patient With Chest Pain Suspected of Acute Myocardial Ischemia in Emergency Room (POCT)

This is a prospective observational study aiming to evaluate the diagnostic accuracy of the high-sensitivity Troponin assay performed with the Atellica VTLi POCT system (by comparison with the results obtained with the Atellica diagnostic system currently in use) and to evaluate the impact of the POCT system on the reduction of decision-making time (particularly of "rule-out"), by evaluating the number of cases in which the conclusion of the decision pathway at 3 h (algorithm currently in use) could have been concluded at 1 h.

Patients accessing the emergency room for chest pain suspected of acute myocardial ischemia, who are asked for Troponin determination for the decision pathway, will be asked to participate at the study. A blood draw will be performed (for determination of Troponin value, with classical method in use and with POCT method) at time:

* Zero (acess at the emergency room)
* 1 h
* 3 h

Eligibility Criteria:
Inclusion Criteria:

* Emergency department access for acute non-traumatic chest pain suspected of myocardial ischemia
* Sign of Informed Consent

Exclusion Criteria:

* Diagnostic electrocardiographic picture for Acute Coronary Syndrome-STEMI (ACS-STEMI)
* Absence of symptomatology in the 12 hours prior to admission to the emergency room
* Post-traumatic chest pain
Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer

RATIONALE: Magnesium oxide may help relieve hot flashes in women with cancer.

PURPOSE: This phase II trial is studying how well magnesium oxide works in treating hot flashes in menopausal women with cancer.

OBJECTIVES:

Primary

* To determine if magnesium oxide supplement will decrease the frequency and severity of hot flashes by 50% in menopausal women with cancer.

Secondary

* To evaluate the effect of magnesium oxide on overall quality of life.
* To evaluate the toxicities of magnesium oxide when administered at commonly used supplement doses.

OUTLINE: Patients receive oral magnesium oxide once daily in weeks 2-5. Patients whose hot flashes are not satisfactorily controlled after 2 weeks of treatment may receive magnesium oxide twice daily in weeks 4 and 5.

Patients complete a daily hot flash diary for 5 weeks beginning 1 week before treatment. Patients also complete quality-of-life, symptom, and self-assessment questionnaires at baseline, once weekly during treatment, and at the completion of treatment.

After completion of study treatment, patients are followed up for at least 30 days.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * History of breast cancer (currently without malignant disease)
  * No history of breast cancer but wishes to avoid estrogen due to a perceived increased risk of breast cancer
* Must have bothersome hot flashes (defined by their occurrence of ≥ 14 times per week and of sufficient severity to make the patient desire therapeutic intervention) for ≥ 1 month before study entry
* Has undergone treatment for cancer (patients other than breast cancer survivors are eligible)

PATIENT CHARACTERISTICS:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Creatinine clearance ≥ 30 mL/min
* No hypersensitivity to magnesium oxide
* No medical or other condition(s) that, in the opinion of the investigator/sub-investigator, may compromise the objectives of the study

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, progestational agents, or gabapentin
* More than 28 days since prior and no other concurrent investigational drugs
* Concurrent tamoxifen, raloxifene, or aromatase inhibitors allowed provided patient has been on a constant dose for \> 4 weeks AND is not expected to stop the medication during the study period
High-Voltage Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion for the Treatment of Chronic Lumbar Radicular and Neuropathic Pain; A Prospective, Doble-blinded and Randomized Controlled Trial

The management of chronic lumbar radicular and neuropathic pain is complex and the treatment success rates are low. Pulsed radiofrequency (PRF) has been described in these cases. In order to determine whether high-voltage PRF show better results than PRF a prospective, doble-blinded and randomized study is conducted in patients with chronic lumbar radicular and neuropathic pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Unilateral pain radiating to the lower extremity (with or without lumbar pain), which clinically corresponds to the path of the corresponding dermatomes.
* Correlation between clinical symptoms and lesion observed by magnetic resonance imaging (MRI).
* Radicular syndrome of three months or more of evolution.
* Normal or pathological electromyogram (EMG).
* Pain with neuropathic characteristics confirmed by the DN4 neuropathic pain questionnaire.
* Patients with a previous positive block diagnosis.
* Patients who have signed the informed consent document.

Exclusion Criteria:

* Patients under 18 years of age.
* Patients with non-radicular low back pain.
* MRI not consistent with the patient\&#39;s symptoms.
* Patients with peripheral neuropathy of the lower extremities.
* Patients with a history or current diagnosis of serious mental disorder.
* Patients with moderate or severe cognitive impairment, or evidence of acute or subacute confusional syndrome.
* Infection at the puncture site.
* Coagulation disorders.
* Pregnant patients.
* Patients who refuse to sign the informed consent document.
* Patients allergic to radiological contrast.