cyrilzakka/clinical-trials huggingface dataset:
Monosialoganglioside in Acute Ischemic Stroke: a Randomized, Blinded and Multicenter Confirmatory Study

A multicenter, randomized, double-blind, parallel, placebo-controlled trial design is used to evaluate the efficacy and safety of GM1 injection in the treatment of patients with acute ischemic stroke.

It is estimated that 1706 patients will be enrolled and randomly assigned to the treatment group and the placebo control group in a 1:1 ratio. Normally, the duration of this study is approximately 90 days.

Treatment was continued for 12\~14 days, and follow-up was conducted until the 90th day from the first dose.

The trial is divided into three phases: screening/baseline phase, treatment phase, and follow-up phase.

Screening/baseline period: After the subjects sign the informed consent form, they enter the screening/baseline period for screening examination.

Treatment period: Qualified subjects are randomly divided into groups in a 1:1 ratio and receive continuous treatment for 12\~14 days (12\~14 times) with GM1 injection and placebo respectively. During the treatment period, relevant examinations and evaluations required by the protocol will be carried out.

Follow-up period: Subjects who have completed treatment will enter the follow-up period until the 90th day of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-80 years old；
* Patients with anterior circulation cerebral infarction; first stroke onset or past stroke without obvious neurological deficit (mRS score≤1)；
* Within 24 hours of onset；
* 7 ≤NIHSS score ≤ 20；
* Signed informed consent.

Exclusion Criteria:

* Patients with hereditary abnormal glucose and lipid metabolism (gangliosidosis, such as Tay-Sachs disease and retinal degeneration);
* Hemorrhagic stroke;
* Disturbance of consciousness (NIHSS1a≥1)，or cerebral arteritis, brain tumor, brain trauma, intracranial infectious diseases;
* Planed endovascular treatment;
* Uncontrolled hypertension: systolic pressure ≥200 mmHg or diastolic pressure ≥110 mmHg;
* Bleeding tendency (except for thrombolysis) or severe bleeding within 3 months;
* Patients with malignant tumor or serious diseases;
* Along with epilepsy, arthritis and other disease, which have effect on neurological assessment;
* History of autoimmune diseases, spinal trauma, various demyelinating diseases, including acute inflammatory demyelinating polyneuropathy (Guillain Barre syndrome);
* Unable or unwilling to cooperate due to mental diseases;
* Abnormal liver and renal function: ALT, AST \> 2 times of the upper limit of normal value, or Cr \> 1.5 times of the upper limit of normal value；
* Hypersensitivity to monosialoganglioside and excipients of test drug;
* History of drug abuse；
* Pregnant or lactating women, pregnant plan or unwilling to use effective contraception during the trial period;
* Participating in other clinical trials within 3 months;
* Other conditions which are unsuitable for this trial assessed by researcher.
The Efficacy of Estrogen Therapy Against Adhesion Reformation After Hysteroscopic Adhesiolysis

Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. Intrauterine balloon has been used for the prevention of intrauterine adhesions. It has been reported that dried biological amnion graft was used to prevent adhesion after the operation of intrauterine adhesions. Estrogen is also used for postoperative prevention of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Disposable balloon uterine stent，which is an innovative intrauterine balloon，is specially designed to fit into the cavity of the uterus. Does Disposable balloon uterine stent and amniotic products combine estrogen therapy improve clinical outcomes? Therefore, this study was conducted.

Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double (participant and outcomes Assessor) Primary Purpose: Prevention

Eligibility Criteria:
Inclusion Criteria:

* age 20-40 years；
* previously diagnostic hysteroscopy confirmed adhesion score \>5， according to the American Fertility Society （AFS）classification of IUA；
* complains of menstruation disorder and reproductive dysfunction；
* informed consent.

Exclusion Criteria:

* premature menopause,
* presence of other intrauterine lesions (e.g. polyps, myoma, septa), and
* presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases),
* adhesions limited to the lower uterine cavity or the cervical canal.
Comparison of Midline With Lateral Skin Incision in Simultaneous Bilateral TKA

This is a RCT which compare skin numbness, kneeling ability and functional outcome between midline incision and lateral incision in patients undergoing simultaneous bilateral TKA


Eligibility Criteria:
Inclusion Criteria:

* The patient undergoing simultaneous bilateral TKA
* Normal skin sensation on both knees
* Informed consent
* Good cognitive function

Exclusion Criteria:

* Previous surgical wound around the knee
* Peripheral vascular disease
Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)

The clinical study evaluates the safety of montelukast and compares montelukast to ketotifen, used as a control drug, in terms of improvement in morning peak expiratory flow (am pef) over first 2 weeks in patients with pediatric bronchial asthma aged 6 to \< 15.

The effect of body weight on the efficacy and safety of montelukast will also be evaluated in this study.


Eligibility Criteria:
Inclusion Criteria:

* Intermittent asthma, mild persistent asthma, moderate persistent asthma, or severe persistent asthma patients with 2 or more mild or moderate attacks at baseline

Exclusion Criteria:

* Patient using anti-asthma treatment or therapy including corticosteroids or oral anti-allergic drugs
* Patient with complications that will impair the judgment of efficacy of this drug
* Patient with convulsive disorders such as epilepsy or such a history
* Patient with liver disease, renal impairment, heart disease or such other complication
Comparison of the Effects of Dexmedetomidine and Propofol on the Cardiovascular Autonomic Nervous System During Spinal Anesthesia

Spinal anesthesia induces bradycardia and hypotnesion, because itself decreases parasympathetic activity and increases sympathetic activity. These imbalance of autonomic nervous system can be measured by heart rate variability. Propofol and dexmedetomidine, which are used for sedation during spinal anesthesia, also affect autonomic nervous system, but the exact effects are not well known. The purpose of this study is measuring the effects of propofol or dexmedetomidine on autonomic nervous system in spinal anesthesia.

Spinal anesthesia induces bradycardia and hypotnesion, because itself decreases parasympathetic activity and increases sympathetic activity. These imbalance of autonomic nervous system can be measured by heart rate variability. Propofol and dexmedetomidine, which are used for sedation during spinal anesthesia, also affect autonomic nervous system but the exact effects are not well known. Moreoever, the effect of spinal anesthesia combined with sedation agent on autonomic nervous system has not been evaluated. The purpose of this study is measuring the effects of propofol or dexmedetomidine on autonomic nervous system in spinal anesthesia. The current study is prospective randomized pilot study. Patients are assigned to propofol group and dexmedetomidine group. Using electrocardiaogram analysis, the change of autonomic nervous system will be measured from preoperative to end of surgery.

Eligibility Criteria:
Inclusion Criteria:

* age 20\~60 years old
* Scheduled lower extremity surgery under spinal anesthesia

Exclusion Criteria:

* Arryhthmia
* Uncooperative patients
* Diabetes
* On medication: beta blocker, psychiatric medicine
* Thyroid function abnormality
Encouraging Cognitive Screenings at African American Churches

This pilot study plans to examine feasibility and outcomes of a culturally/religiously-tailored church-based dementia screening intervention among older adult African American church members and community members who use church outreach services in 4 African American churches.

The primary aim of this study is to conduct an exploratory pilot study to examine feasibility and outcomes of a culturally/religiously-tailored church-based dementia screening intervention among older adult African American church members and community members who use church outreach services in 4 African American churches (N=100). Our secondary outcomes are to assess the impact of the intervention on dementia-related stigma and linkage to care. Intervention content is based on the Theory of Planned Behavior; intervention delivery is based on the Social-Ecological Model - both guided by a faith community engagement approach. Trained faith leaders will deliver the tailored intervention through multilevel church outlets: individual self-help resources (e.g., risk checklist, commitment to screening cards); group ministry discussion guides/seminar on dementia; church-wide services using sermon guides, responsive readings, and church bulletin inserts; and church-community level text messages, dementia screening, and linkage to care services. Two screening events will be held at each church. We will also conduct a process evaluation that will include post-test study focus groups.

Specific Aim 1. Test a religiously/culturally-tailored, church-based dementia screening intervention on receipt of dementia screening, stigma, and linkage to care use among an older adult African American church-populations at 4 months.

Hypothesis. The tailored church-based dementia screening intervention will evidence increased screening and linkage to care rates, and lower dementia-related stigma beliefs at 4 months.

Specific Aim 2. Evaluate predictors of receipt of dementia screening at 4 months among older adult African American church-populations to determine modifiable screening facilitators/barriers.

Specific Aim 3. Conduct a process evaluation to examine study intervention implementation facilitators, barriers, and dose along with exposure and satisfaction to identify essential intervention components.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥55
2. Regular church member (attending church \> monthly) or community member receiving church outreach services (\>3 times annually)
3. Willing to participate in two surveys (baseline and 4 months)
4. Willing to provide contact information for at least 2 other persons
5. Residing in the Kansas City metropolitan area
6. Provide a working contact email address or number

Exclusion Criteria:

* None
Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells

In this trial, it will be studied whether early addition of the long acting insulin analogue Glargine is capable of increasing the number and differentiation of endothelial progenitor cells (EPC) in patients with type 2 diabetes, which can be seen as a marker of vascular regenerative potential and cardiovascular risk. In addition, the effect of Glargine on microvascular function will be studied. This will be done using laser Doppler measurements of the skin; in addition, MRI of the heart will be performed which is capable of quantifying the perfusion reserve of the myocardium and additional functional aspects of ventricular function. A beneficial effect of early addition of bedtime Glargine on EPC and vascular as well as myocardial function in this study might argue for a change in the therapeutic approach in type 2 diabetes and possibly improve the cardiovascular outcome in patients affected.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* Oral antidiabetic therapy
* Age 35 - 70
* 6,5%\< HbA1c ≤ 9%
* Ability of subject to understand character and individual consequences of clinical trial
* Written informed consent must be available before enrollment in the trial
* For women with childbearing potential, adequate contraception (Pearl Index \< 1%, e.g. birth control pill) and negative blood pregnancy test
* 6,5%\< HbA1c ≤ 9%
* Ability of subject to understand character and individual consequences of clinical trial
* Written informed consent must be available before enrollment in the trial
* For women with childbearing potential, adequate contraception (Pearl Index \< 1%, e.g. birth control pill) and negative blood pregnancy test

Exclusion Criteria:

* MODY
* Malignant disease
* Hematopoietic disorders
* Impairment of renal function (Serum creatinine \> 1,5mg/dl)
* autoimmune disease
* treatment with immunosuppressive drugs
* Psychiatric disease
* Myocardial ischemia during previous 6 month
* Acute coronary syndrome
* pAVK IIb, III, IV (Fontaine-Ratschow)
* Erythropoietin treatment
* Glitazone treatment during two weeks before inclusion
* Insulin treatment during two weeks before inclusion
* Pregnancy and lactation
* History of hypersensitivity to the investigational product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product
* Participation in other clinical trials and observation period of competing trials, respectively
* No subject will be allowed to enroll in this trial more than once.
MK2461 in Patients With Advanced Cancer (2461-001)(COMPLETED)

This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II Dose (RP2D), pharmacodynamic, and clinical activity of MK2461.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 years of age, with adequate organ function, and an ECOG performance of \<2
* Patients must be willing to undergo pre-study and post dose tumor biopsy and have tumor accessible to biopsy (waived during Part A)

Exclusion Criteria:

* No chemotherapy, radiotherapy, or biological therapy with 4 weeks of study participation
* Patients must not have primary central nervous system tumor
* Patient has had prescription or non-prescription drugs or other products known to be metabolized by CYP3A4 that cannot be discontinued prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study medication
Interest of Light Therapy in Hematology - The PHOTO-TREAT Study

Chemo-induced mucositis is a common complication in patients treated for hematologic malignancies. They can manifest itself as a simple local irritation with erythema and inflammation but can also progress to erosions and ulcerations of the entire oral mucosa and are also responsible for an increased risk of infection in these immunocompromised patients.

The only therapies currently offered are local care and intravenous analgesics. Studies in pediatric hematology show the effectiveness of prevention and low-dose laser treatment in chemo-induced mucositis, both in terms of reducing the number of mucositis developed but also in terms of reducing the grade of mucositis. This currently results in a recommendation for the use of photobiomodulation by international bodies such as ESMO (European Society for Medical Oncology).

During this research, the investigators aim at validating the efficacy and impact of photo-biomodulation in the management of chemo-induced mucositis in hematology department of Strasbourg Cancer Institute (ICANS).

Eligibility Criteria:
Inclusion Criteria:

* Adult patient;
* Patients:

In induction of acute myeloblastic leukemia OR Allografts in first remission with myeloablative conditioning OR Autografts in the context of aggressive lymphoma;

* Signature of informed consent;
* Patient registered with social security.

Exclusion Criteria:

* Patient under guardianship or curatorship
* Pregnant and breastfeeding woman
* Allergy to polyurethanes
Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings

The purpose of this study is to determine whether participation in the study intervention, which involves collaboration between the study interventionist and the participant's primary care physician, will reduce symptoms of pain and depression in HIV+ patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Pain (pain duration for at least six months with a mean score of 5 or higher on the BPI Pain Interference Scale)
* Pain severity of 40 or higher on a Visual Analog Scale (0-100) indicating "worst pain in the last week"
* At least one trial of PCP-recommended medication (i.e. acetominophen, NSAIDS, skeletal muscle relaxants) judged through interviews with patients and PCPs
* QIDS score of ≥ 9 (depression severity)
* Stable dose of an antidepressant, if using, for the previous 2 months
* Age 18 or older
* HIV+

Exclusion Criteria:

* Lifetime DSM-IV diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition
* Current DSM-IV diagnosis of substance dependence for alcohol, sedative/ hypnotic drugs, stimulants, or cocaine
* Suicidal ideation or behavior requiring immediate attention
* In psychotherapy or in a multidisciplinary pain management program
* Expected surgery in the next 6 months
* Pain thought to be due to cancer, infection, or inflammatory arthritis
* Pregnancy
Assessment of the Safety of SAR342434 and Humalog® When Administered as Continuous Subcutaneous Insulin Infusion

Primary Objective:

* Assess the safety of SAR342434 and Humalog when used in external pumps.

Secondary Objectives:

* Intervals for infusion set changes.
* Incidence of insulin pump alarms for infusion set occlusion.
* Patient observation of infusion set occlusion.
* Adverse events including bruising at the infusion site and injection site reactions.

The study duration for each patient will be approximately 10 weeks.

Eligibility Criteria:
Inclusion criteria :

* Male and female subjects above the age of 18.
* Patients with type 1 diabetes mellitus for at least 1 year prior to the screening visit.
* At least 1 year of insulin treatment with at least 6 months of continuous subcutaneous insulin infusion (CSII) treatment with an external insulin pump.
* Signed written informed consent.

Exclusion criteria:

* HbA1c ≥8.5% at screening.
* Diabetes other than type 1 diabetes mellitus.
* History of abscess at the infusion site within 3 months prior to the screening visit (Visit 1).
* Use of oral glucose-lowering agents or any injectable glucose-lowering agents other than insulin during the 3 months before screening.
* Hospitalization for diabetic ketoacidosis (DKA) in the last 6 months before screening visit.
* Hypoglycemic unawareness as judged by the Investigator in the last 6 months before the screening visit.
* History of severe hypoglycemia requiring treatment by emergency room admission or hospitalization in the last 6 months before screening visit.
* Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening that in the judgment of the investigator or any sub investigator would preclude safe completion of the study.
* Known history of drug or alcohol abuse within 6 months prior to the time of screening.
* Use of investigational drug(s) within 3 months or 5 half-lives, whichever is longer, prior to the screening visit.
* Patients who had previously received SAR342434 in any other clinical trial.
* Pregnancy and lactation: Women of child bearing potential (WOCPB) (premenopausal, not surgically sterile for at least 3 months prior to the time of screening) not using highly effective (ie, with low failure rate \<1% per year) method(s) of birth control throughout the study and/or unwilling to be tested for pregnancy.
* Any contraindication to the use of Humalog as defined in the national product labels; history of hypersensitivity to Humalog or to any of the excipients.
* Patients is an employee or relative of an employee of the Sponsor.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study of IBI351 in Healthy Subjects

This is a randomized, open-label, two-cycle clinical study to evaluate the drug interaction, food effect and pharmacokinetics of IBI351 and esomeprazole in healthy subjects. A total of two cohorts were planned to be enrolled in each cohort. Cohort 1: This cohort investigated the effect of esomeprazole on the pharmacokinetics of IBI351 in healthy subjects. Cohort 2: This cohort investigated the effect of food on the pharmacokinetics of IBI351 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. voluntarily sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol.
2. healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
3. body weight is not less than 50 kg, and body mass index (BMI) is within the range of 19 \~ 26 kg/m2 (including cut-off value).

Exclusion Criteria:

1. have taken any products containing alcohol or have a positive alcohol breath test (≥ 20 mg/100 ml) within 24 hours before taking study medication.
2. hepatitis B surface antigen HBsAg positive.
3. hepatitis C virus antibody positive.
4. positive AIDS antigen/antibody or Treponema pallidum antibody
Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

This is a multi-center randomized controlled evaluator-masked trial designed to compare metagenomic deep sequencing (MDS) versus standard of care testing for improvement of outcomes for intraocular infections. Patients with presumed intraocular infections who meet the eligibility criteria will be randomized to receive MDS testing results or not to receive MDS testing results. All patients will receive standard-of-care testing to guide management. Enrolled patients will be followed at week 2, week 3-6 (randomization visit), and at 4 weeks after the randomization visit. The proportions of patients who received the appropriate therapy and the proportions of patients with improved outcome will be compared between arms. Patient quality of life, MDS performance, and the provider certainly of belief will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Presumed infectious anterior uveitis, or intermediate uveitis, or posterior uveitis, or panuveitis
* Presumed post-operative endophthalmitis
* Unilateral or bilateral
* 18 years and older

Exclusion Criteria:

* Insufficient specimen for MDS
* Age \< 18 years of age
* Pregnancy
* Unable to consent