cyrilzakka/clinical-trials huggingface dataset:
Misoprostol for Secondary Prevention of Postpartum Hemorrhage at the Community Level in India

This study compares two community-level strategies: selective administration of 800 mcg sublingual misoprostol to women at 350 mL blood loss for secondary prevention of postpartum hemorrhage (PPH) with universal use of 600 mcg oral misoprostol at the time of delivery for primary prevention of PPH. The study hypothesizes that at community-level births, secondary prevention for women is non-inferior (based on clinical parameters) to universal prophylaxis provided to women for primary prevention of PPH. This cluster-design non-inferiority trial has the potential to inform service delivery programs on clinical outcomes, program feasibility, cost and acceptability of two different community models of PPH care using misoprostol.

Rationale for Research: There is an absence of concrete data on the programmatic and cost-effectiveness of different service delivery models for prevention and treatment of postpartum hemorrhage with misoprostol, prompting a discussion of whether resources are best spent on misoprostol for primary prevention at lower levels (with treatment carried out at higher levels via referral) or whether immediate proactive treatment strategies should be considered. As the training and policy implications of universal prevention versus selective treatment approaches vary, simple and effective service delivery models are urgently needed to help governments and organizations decide how to best focus their limited resources. This study proposes to study the efficacy of a hybrid strategy (i.e., secondary prevention) that combines elements of prevention and treatment. Results of this study could provide a new model of care that will medicate fewer women, save costs and address the clinical conundrum of guessing at the safety of administering a prevention dose of misoprostol followed quickly by a larger treatment dose.

Study design: This randomized cluster trial will recruit women with deliveries attended by auxiliary nurse midwives (ANMs) that occur at homes or at health sub-centers. ANMs will be randomized to administer the intervention as described in the primary or secondary prevention arm.

Eligibility Criteria:
Inclusion Criteria:

1. delivering at home or sub-center with an auxilliary nurse midwife (ANM)
2. able and willing to provide informed consent
3. meeting Ministry of Health Guidelines for home or sub-center delivery

Exclusion Criteria:

1. high-risk pregnancy
A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)

This study is comparing the medicine RYBELSUS® to other medicines in people with type 2 diabetes who need extra treatment. All medicines used in this study are tablets which lower blood sugar in people with type 2 diabetes. The purpose of the study is to see how well RYBELSUS® is at lowering blood sugar compared to other tablets when used in addition to metformin. Participants doctor will give participants either RYBELSUS® or any other blood sugar lowering tablets - which treatment participants get is decided by chance. The doctor treating participants diabetes will give participants a prescription for the medicine and tell how to take it. The study will last for about 1 year. Participants will have 2 planned visits with their doctor which are part of the usual routine diabetes management: the first visit is when participants are included in the study, the second visit is a 1-year follow-up visit. In addition, the study personnel will contact participants up to 3 times during this period and to follow-up on information from participant doctors visits. Participant will be asked to respond 3 times to 4 questionnaires via their personal smartphone or tablet or paper if participant do not have access to one during the study. All clinic visits are part of the usual routine diabetes management and are covered by participants health insurance plan. The study team will collect information from these visits recorded in the medical chart. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility Criteria:
Key inclusion criteria

* Treatment with metformin as monotherapy prior to eligibility assessment that has failed to result in adequate glycemic control at the discretion of the investigator or treatment provider. However, prior short-term treatment with an oral glucose lowering agent or insulin for up to 14 consecutive days in addition to metformin is allowed if discontinued prior to screening.
* Current member of a health plan which includes pharmacy benefits.
* HbA1c greater than or equal to 7% within last 90 days prior to the day of screening or to be taken before randomization.
* Further intensification with an additional glucose-lowering oral agent including oral semaglutide is indicated according to approved prescribing information to achieve glycemic target at the discretion of the treatment provider.

Key exclusion criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using contraception.
* Any disorder which in the investigator's or treatment provider's opinion might jeopardize patient's safety.
Transcutaneous Spinal Cord Electrical Stimulation Combined With Kunming Locomotor Training for the Treatment of Spinal Cord Injury

Spinal cord injury (SCI) is a common and severe traumatic central nervous system injury in clinical practice. Currently, the treatment of SCI remains a worldwide challenge.International studies have confirmed that TSCS is an effective non-invasive technique to activate the body's movement-related circuits. This method utilizes a unique stimulation waveform that is transmitted through electrodes placed on the skin of the spine and spreads through the dorsal roots (DRs) to activate the spinal cord neural circuits.The main objective of this study is to have patients with chronic incomplete (AIS B/C/D) spinal cord injuries wear "transcutaneous spinal cord electrical stimulator " and undergo "Kunming locomotor training" for 6 months, observe the synergistic effects of the two, and evaluate whether this treatment method can improve patients' motor functions.


Eligibility Criteria:
Inclusion Criteria:

* 1. Chronic (≧6 months) paraplegics (T1-T10) with incomplete(AIS B/C/D) spinal cord injury Incomplete aged 16-50 years;
* 2.Subjects must be able to read, understand, and complete the Visual Analogue Scale;
* 3.Subjects voluntarily sign the informed consent form approved by the ethics committee.

Exclusion Criteria:

* 1. Obvious renal, cardiovascular, hepatic, and mental diseases;
* 2.Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;
* 3. Limb contracture deformity;
* 4. Modified Ashworth \> Grade 2;
* 5. Unhealed fractures;
* 6. The subject is currently participating in other studies;
* 7. The researcher's opinion is that the subject does not comply with the research protocol and/or is not suitable to participate in this study.
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects

The primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.

Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387) were 2 identically designed, Phase 3, 12-week, randomized, double-blind, double-dummy, parallel-group, multicenter studies recruiting subjects from distinct sites. These studies evaluated the efficacy, safety, and tolerability of levodopa-carbidopa intestinal gel (LCIG) in the treatment of levodopa-responsive subjects with advanced PD who had persistent severe motor fluctuations, despite optimized treatment with oral levodopa-carbidopa, concomitant with other available antiparkinsonian medications. Participants were randomized to either LCIG active gel + placebo capsules or levodopa-carbidopa immediate release (IR) active capsules + placebo gel. Both treatment arms received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration, active LCIG or placebo gel. Data from these 2 studies were combined for analysis. The decision to combine the study data for analysis was made before enrollment was completed for both studies.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
* Levodopa-responsive participants who demonstrate some identifiable 'on response,' established by Investigator observation
* Demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated

Exclusion Criteria:

* Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism
* Undergone surgery for the treatment of PD
* Contraindications to levodopa
* Subjects with any neurological deficit that may interfere with the study assessments
HAIC Compared With TACE in Huge Hepatocellular Carcinoma

This study intends to compare the efficacy of transcatheter arterial chemical embolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) for patients with intermediate-advanced huge hepatocellular carcinoma.

Transcatheter arterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC) are effective and safe for hepatocellular carcinoma (HCC). For huge HCC (≥10 cm), the prognosis of this high tumor-burden subtype usually indicates poor outcome and big challenge. TACE is difficult to completely embolize all tumor arteries, so patients have limited benefit from pure hepatic artery embolization. At the same time, excessive embolization will lead to massive tumor necrosis in a short time, and inflammatory necrosis factor will enter the blood, resulting in systemic inflammatory response. HAIC have showed good efficacy especially for advanced huge HCC (≥10 cm) complicated with portal vein tumor thrombus and arteriovenous fistula, and HAIC therapy can be performed with better and higher tumor control.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of primary HCC.
2. Age between 18 and 75 years;
3. The maximum tumor size ≥10 cm;
4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
5. limited metastases (≤5).
6. Child-Pugh class A or B;
7. Eastern Cooperative Group performance status (ECOG) score of 0-1;
8. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
9. Prothrombin time ≤18s or international normalized ratio \< 1.7.

Exclusion Criteria:

1. recurrent HCC;
2. Extrahepatic metastasis \>5;
3. Obstructive PVTT involving mesenteric vena cava (PVTT IV).
4. Serious medical comorbidities.
5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
6. Eastern Cooperative Group performance status (ECOG) score of ≥2;
7. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
8. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Study Of Weight Development Over Time

The investigators will study the influence of fat cell size/number and adipose function on weight development over very long time periods (years). By comparing fat biopsies obtained at baseline and after \>7 years, the investigators will determine the association between adipose morphology/function and changes in weight or development of cardiometabolic complications (e.g. insulin resistance, type 2 diabetes, dyslipidemia and hypertension).

The investigators will ask all subjects that have previously been examined at the investigators laboratory (from 1992 and forward) in studies of adipose tissue function if they are interested to participate in a new study. The minimal follow up time is 7 years.

Saved blood samples and samples from old fat biopsies will be analyzed together with samples from new examinations.

The investigators plan to examine the subjects in the same way as performed at the baseline examinations. This includes estimation of total body fat using bioimpedance, venous blood samples for determination of insulin, glucose and lipids, subcutaneous fat biopsies with determination of fat cell size/number, lipolysis/lipogenesis as well as analysis of adipokine secretion.

In selected patients, baseline examinations included DEXA-measurement (dual energy x-ray absorptiometry) for determination of body fat distribution as well as hyperinsulinemic euglycemic clamp. In these cases, the same type of examinations will be repeated at their follow up visits.

Eligibility Criteria:
Inclusion Criteria:

* Participated in previous examination at our lab at least 7 years ago.
* No blood samples or adipose samples saved from last examination

Exclusion Criteria:

* Decline to participate after invitation.
* Serious illness or mental disorder.
* Warfarin or other new oral anticoagulant that increase risk of bleeding.
Correlates of Angiographic Changes and Coronary Events

To examine the appropriateness of angiographic and ultrasound endpoints as predictors of subsequent clinical coronary events. Follow-up data from the Cholesterol Lowering in Atherosclerosis Study (CLAS) were used.

BACKGROUND:

A multitude of coronary angiographic trials have been conducted using various endpoint measures based on repeated coronary angiograms. Relative to coronary event trials, angiographic trials require both a smaller sample size and reduced trial length. While such trials have assumed that angiographic endpoints are valid surrogate measures for clinical coronary events, this assumption has not been completely tested. Although several coronary angiographic endpoints are available for trial outcomes, no single method has been uniformly accepted as optimal. Because of this, the utility and validity of coronary angiographic progression for predicting future clinical coronary events remains unsettled.

The recent advent of carotid ultrasonography to assess arterial intima-media thickness (IMT) offers the exciting potential for a noninvasive measure of atherosclerosis. Because of its noninvasiveness, carotid IMTallows the extension of anti-atherosclerotic trials to both asymptomatic and frail subjects, for whom coronary angiography might be medically unethical. Because there is currently only limited support for the association of carotid IMT with clinical events or coronary atherosclerosis, the validity of carotid IMT as a potential surrogate for either endpoint has not been established.

The Cholesterol Lowering Atherosclerosis Study (CLAS) was a coronary angiographic trial testing the efficacy of colestipol-niacin therapy in 188 nonsmoking, 40-59 year old men with previous coronary artery bypass graft surgery. Coronary artery atherosclerosis change was evaluated both by human consensus panel and by quantitative coronary angiography (QCA). In addition, B-mode ultrasounds of the common carotid artery was conducted every six months to provide measures of carotid IMT. Since the competion of the two-year CLAS study, subjects have been followed for up to 12 years. This long term follow-up of the CLAS cohort permits examination of the appropriateness of angiographic and ultrasound arterial endpoints as predictors of subsequent clinical coronary events. Angiographic and ultrasound (carotid IMT) endpoints also allow for testing of the associations between these various serial measures of atherosclerotic progression.

The results of these analyses will provide important information on the validity of these measures, which are in current use as trial endpoints, as surrogates for clinical coronary events.

DESIGN NARRATIVE:

The study used angiographic and ultrasound carotid intima medial thickness endpoints for testing the associations between these various serial measures of atherosclerotic progression and subsequent coronary heart disease.

Eligibility Criteria:
Male Nonsmoker Prior coronary artery bypass graft surgery
Phase 1 Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors.

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors. After the maximum tolerated dose (MTD) or the optimal biological dose is identified, an expansion cohort of \~20 advanced renal cell carcinoma patients will be enrolled to further characterize the safety and tumor response by CT.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no effective therapy.
* Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.
* Life expectancy of at least 12 weeks.
* No immuno deficiency.
* Adequate organ system function, defined as follows:

  * Absolute neutrophil count (ANC) ≥1.5 x 10\*\*9/L
  * Platelets ≥100 x 10\*\*9/L
  * Hemoglobin ≥10 g/dL
  * Total bilirubin ≤1.5 times the upper limit of normal (ULN)
  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5x the upper limit of normal (ULN) if no liver involvement or ≤2.5x the upper limit of normal with liver involvement.
  * Creatinine ≤ 1.5 x ULN.
* At least 4 weeks or 5 half-life after receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization.
* Willingness and ability to comply with trial and follow-up procedures.
* Ability to understand the nature of this trial and give written informed consent.

Exclusion Criteria:

* Not recovered from prior anti-cancer therapy or surgery.
* Have taken strong cytochrome P450 3A4 inhibitors or inducers in the last 2 weeks.
* Concomitant use of drugs with a risk of causing prolonged corrected QT interval and/or Torsades de Pointes.
* Patients with a history of intolerance to, or significant toxicity with, VEGFR tyrosine kinase inhibitor(s) (TKI).
* Females who are pregnant or breastfeeding.
* Those in reproductive ages who refuse to use contraception.
* Those with concurrent condition(e.g. psychological, neuronal, cardiovascular, respiratory conditions or infections) that in the investigator's opinion would jeopardize compliance with the protocol.
* Patients with known central nervous system (CNS) metastases.
* Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of CM082 (X-82).
* Patients with known GI disorders such as vomiting, diarrhea.
* Patients who are hepatitis B virus positive.
* Drug abuser.
Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children

Deep Brain Stimulation for the Treatment of Severe Refractory Self-Injurious Behaviour in Children with Autism Spectrum Disorder: A Randomized Trial

To evaluate the effectiveness of deep brain stimulation (DBS) of the nucleus accumbens for the treatment of severe refractory, repetitive self-injurious behavior (SIB) in children with Autism Spectrum Disorder. Secondary objectives are to examine the effects of DBS on subtypes of SIB through functional analysis.

The proposed study is a single-center, double-blinded, block-randomized crossover trial.

Twenty (20) participants will be recruited and enrolled in this trial to undergo bilateral nucleus accumbens DBS. After recovery, participants will be randomized to a 3 month block of active stimulation or the DBS will remain off. After a two week washout period, the participants will cross over to the other group. At the end of the second block, all patients will have their DBS devices activated during an open label period. All participants will have baseline assessments that will be repeated at the end of each block.

Expected study duration is 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 5-17 at the time of enrollment
* DSM-5 diagnosis of Autism Spectrum Disorder
* History of repetitive self-injurious behaviour, as reported by parents and documented on clinical assessment, either at the time of enrollment into the study or in prior medical records. The definition of self-injury is contextual, but requires ongoing, intermittent or continuous manifestation of self-mediated physical injury to the child.
* Foreseeable risk of serious future self-harm.
* Screening by study team for presence automatically reinforced self-injurious behaviour (ASIB) subtype 2 or subtype 3 based on caregiver history.
* Failure or non-eligibility of medical therapy with ongoing repetitive self-injurious behaviours, at 6 months or more after initiation of therapy.
* Parents or legal guardians, including caregivers, informed and able to provide written consent.
* Able to comply with all testing, follow-up visits, and study appointments and protocols for 12 months following the end of the duration of the study.

Exclusion Criteria:

* Substance dependence or abuse in the last 6 months, excluding caffeine and nicotine.
* Any contraindication to MRI scanning.
* Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that may incur significant risk from a surgical procedure.
* Pregnancy.
Study of DS-1123a in Advanced Solid Tumours

This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.
* Eastern Cooperative Oncology Group performance status (PS) of 0 or 1.

Exclusion Criteria:

* Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment:

  • Cardiac failure (NYHA ≥ ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, deep-vein thrombosis or clinically severe thromboembolic event, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia),
* Severe or uncontrolled concomitant disease.
* Clinically active brain metastases defined as symptomatic or requiring treatment.