cyrilzakka/clinical-trials huggingface dataset:
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics

The purpose of the INTREPiD study is to compare 1st trimester screening for malaria parasites with a high-sensitivity malaria rapid diagnostic test followed by treatment of test-positive women with artemether-lumefantrine (AL) against usual antenatal care on a composite adverse pregnancy outcome including low birth weight, small for gestational age, preterm, fetal loss, or neonatal death.

INTREPiD is a two-arm, open-label, parallel-assignment randomized trial of a strategy of 1st trimester screening for P. falciparum parasites with a high-sensitivity rapid diagnostic test (HS-RDT). Participants will be women of all gravidities presenting to antenatal clinics in the 1st trimester in sites endemic for P. falciparum malaria in Kenya and the Democratic Republic of the Congo.

Following consent and enrollment, women will be allocated 1:1 to either usual antenatal care or to the intervention. The intervention will be a single screening in the 1st trimester for P. falciparum infection in maternal peripheral blood with a HS-RDT. Women who test positive for P. falciparum on HS-RDT testing will be treated with a single course of Artemether-Lumefantrine (AL) and then returned to usual antenatal care.

Participants will be followed through delivery and then through their offspring's first month of life.

The Hypothesis is that, compared to usual antenatal care, screening women in the 1st trimester for P. falciparum and treating them if positive with AL will reduce the risk of an adverse pregnancy outcome.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 16 years and 40 years (inclusive)
* Viable singleton pregnancy with gestational age estimated less than 13 6/7 weeks (inclusive) by ultrasound
* HIV-uninfected
* Willing to participate in the study schedule
* Planning to remain in the study area for the duration of pregnancy and 1 month after delivery
* Willing to deliver in a study-affiliated health facility

Exclusion Criteria:

* High risk pregnancy that requires referral for specialized care by local guidelines
* Active medical problem at the time of screening requiring higher level care
* Antimalarial receipt in the 2 weeks prior to screening
* Past allergy to Artemether or Lumefantrine or another condition that prohibits the receipt of either drug
* Current participation in another clinical research study
Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects

The purpose of this study is to investigate effectiveness and safety of transcatheter closure of perimembranous ventricular septal defects.

Perimembranous Ventricular septal defect (VSD) is the most common congenital cardiac malformation and constitutes over 20% of all congenital cardiac disease. Though conventional surgery for VSD is a widely accepted procedure with minimal operative mortality, it carries a small but definite risk of morbidity and mortality associated with cardiopulmonary bypass and surgical closure. The newly appeared transcatheter device closure technique provides an alternative to surgical closure. However, the mid-to-long term effects of this technique using occluders is not clear. The aim of this study was to evaluate the safety and effectiveness of transcatheter closure of perimembranous ventricular septal defects using septal occluders.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ventricular septal defects eligible for transcatheter closure.

Exclusion Criteria:

* Patients less than 2 years old. Patients not suitable for transcatheter closure. Patients comorbid with other diseases.
Effect of an Anti-Inflammatory Drug on Gut Mucosa in HIV Infected Patients

The lining of the gastrointestinal tract contains specialized lymphoid tissue that is part of the immune system. Like other parts of the immune system, HIV attacks this lymphoid tissue. This study will evaluate the effect of an anti-inflammatory drug on the lymphoid tissue in the gastrointestinal tracts of people with HIV.

The gastrointestinal tract is the body's largest lymphoid organ. Because it contains significant numbers of activated memory T lymphocytes, it is a prime site for HIV infection and amplification. Mucosal T cells are extremely vulnerable to HIV infection due, in part, to a marked increase in CCR5 co-receptors. Understanding the impact of HIV on the gastrointestinal-associated lymphoid tissue (GALT) is essential and may provide insight into the profound drop in mucosal lymphocytes during early infection, persistence of tissue viral replication in the setting of undetectable plasma viral activity, and compartmentalization of HIV.

Pre-clinical studies have demonstrated that the mucosal compartment in HIV uninfected individuals is characterized by features which enhance vulnerability to HIV infection compared to blood. Once infected, the mucosal response to HIV is inflammation. This study will further evaluate the inflammatory response of mucosal tissue to HIV by examining the effect of the anti-inflammatory drug 5-aminosalicylic acid (5-ASA) on the gut mucosa.

Participants in this study will be randomly assigned to receive either 5-ASA or placebo. Participants will be enrolled in the study for 8 weeks; participants may then elect to continue on 5-ASA for an additional 16 weeks. Participants will have four screening visits in the month prior to beginning the study and four study visits during the 8-week study. Assessments will include medical interviews and physical exams, sigmoidoscopy with mucosal biopsy, and blood tests.

Eligibility Criteria:
Inclusion Criteria

* HIV infected
* Stable plasma viral load between 500 and 100,000 copies/ml for 3 months prior to study entry
* Stable antiretroviral therapy for at least 3 months prior to study entry
* CD4 cell count greater than or equal to 200 cells/mm3
* Mucosal viral RNA greater than or equal to 100 copies/microg total RNA within 2 weeks of study entry

Exclusion Criteria

* Allergy or intolerance to salicylates
* Gastrointestinal tract infection causing diarrhea or colonic inflammation
* Renal or hepatic disease
* Current opportunistic infection
* History of extensive small bowel resection (greater than 1/2 the length of the small intestine)
* History of intestinal mucosal disease (except HIV)
* Chronic, regular use of aspirin and/or anti-inflammatory agents within 7 weeks prior to study entry
* Oral, topical, or rectal steroids or 5-ASA within 3 months prior to study entry
* Certain laboratory abnormalities
* Significant neuropsychiatric symptoms that in the opinion of the study official could impact the conduct or outcome of the study
Lung Ultrasonography vs Fiberoptic Bronchoscopy for Aiding Lung Collapse in Patient Using Double Lumen Tube

The study contains the result from a comparison of diagnostic outcomes about lung collapse by using lung ultrasonography as a new diagnostic test compares to fiberoptic bronchoscopy as the standard test.

The study contains the result from a comparison of diagnostic outcomes about lung collapse by using lung ultrasonography as a new diagnostic test compares to fiberoptic bronchoscopy as a standard test. Both of them detect lung collapse reported as surgical grading lung collapse by the thoracic surgeons. The protocol was performed in a randomized controlled trial whether the subject was allocated to the ultrasonography group or the fiberoptic bronchoscopy group.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, age ≥18 years old
* American Society of Anesthesiologists(ASA) physical status classification I - III
* Scheduled for elective thoracic surgery which requires One lung ventilation(OLV) with Left-sided double lumen tube

Exclusion Criteria:

* Anticipated difficult intubation or with the tracheostomy tube
* Patient with pneumothorax, pleural effusion, emphysema or past history of pleurodesis
* Patient with deranges pulmonary function test (out of forced expiration volume in 1 s, total lung capacity, forced vital capacity \<50% of the predicted values)
* The patient refuses to participate.
Tenecteplase REperfusion in Acute Ischemic sTroke Registry（TREAT）

The aim of the study was to establish tenecteplase thrombolysis database and to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients.

Tenecteplase (TNK), as a newer fibrinolytic agent, has practical delivery advantages over alteplase that would make it a potential alternative. Several randomized controlled clinical trials demonstrated the noninferiority of TNK but the evidence on the effectiveness and safety of TNK in the real-world is insufficient.

This is a multi-center, prospective, registry cohort study that enrolled acute ischemic stroke patients treated with TNK thrombolysis in China.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years;
* Diagnosed as acute ischemic stroke；
* Time intervals ≤ 4.5 hours from stroke onset to thrombolysis with TNK(Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombolysis if the time intervals from stroke onset to thrombolysis was ≥4.5 hours)；
* Thrombolysis with rhTNK-tPA and derivatives.

Exclusion Criteria:

* Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)；
* Already participated in other interventional trials.
PC-300 Tea Effect on Triglyceride Levels

Herbal medicine represents an alternative for treating dyslipidemia. The aim of this project was to evaluate the PC-300 tea (Eryngium heterophyllum egelm + Amphipterygium adstringens) against hypertriglyceridemia.

Baseline samples of serum total cholesterol and triglycerides were obtained and measured again after 1 month of treatment with the following two alternatives: 1) PC-300, one cup half an hour before eating, and 2) bezafibrate 200 mg/d.

It was a descriptive, prospective, longitudinal, and comparative clinical study developed at Ciprés Grupo Médico S.C. (CGM), Toluca, Mexico, from January 2014 to December 2014.

Patients with hypertriglyceridemia were invited to participate in the study. Voluntary subjects were assigned sequentially into two treatment groups: 1) fibrate (bezafibrate) 200 mg/day, and 2) PC-300 tea, one cup half an hour before eating.

Patients were measured (m) and weighed (kg) (Obi, México). Body mass index (BMI) was calculated as weight (kg) divided by height (m) squared. Blood pressure was measured with a calibrated sphygmomanometer (Welch Allyn, USA) after 5 min of rest.

All of the patients were given a low lipid diet. Calculated kcal were based on ideal weight minus 200 kcal/day if overweight.

Results were expressed as mean ± Standard deviation (SD). Differences between initial vs. final values were compared with the Mann-Whitney U test. The normality hypothesis was tested using the Kolmogorov-Smirnov test. A p value of \<0.05 was considered significant. All tests were performed with the SPSS ver. 23 statistical software program.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertriglyceridemia, aged \>18 years and with an educational level at least of primary school.

Exclusion Criteria:

* Patients with hepatic disease and those missing an appointment during the study.
Effect of Blood Flow Restriction on Pain Perception, Grip Strength and Nerve Conductivity in CTS Patients.

The goal of this clinical trial is to investigate the effect of blood flow restriction (BFR) on pain perception, grip strength and nerve conductivity in patients suffering from carpal tunnel syndrome (CTS). The main question it aims to answer is:

Does performing blood flow restriction training decrease pain, improve grip strength and does not alter nerve conduction velocity in patients with (CTS)? The participants will be divided into two groups to be compared: Patients in the control group will receive the conventional physical therapy program only. In contrast, participants in the experimental group will receive blood flow restriction (BFR) training in addition to a conventional physical therapy program (which includes an orthotic device, tendon, and nerve-gliding exercises).

Blood flow restriction (BFR) entails a training technique that partially limits arterial blood flow and completely restricts venous blood outflow within the active musculature during physical activity (Patterson SD, Hughes L, Warmington S, et al.). This method is thought to have begun in the 1970s through Dr. Yoshiaki Soto's Kaatsu resistance training. By restricting the outflow of blood from the limb, the resulting lack of oxygen creates conditions that stimulate muscle growth through cellular signaling and hormonal changes, resembling the effects of higher-intensity training with increased resistance (Wortman RJ, Brown SM, Savage-Elliott I, Finley ZJ, Mulcahey MK). Emerging studies indicate that Exercise-induced hypoalgesia (EIH) delineates a transient decrease in pain sensitivity subsequent to physical activity (Hughes, L., \& Patterson, S. D. (2020)). Moreover, research indicates that individuals diagnosed with carpal tunnel syndrome (CTS) typically exhibit reduced grip strength (Sasaki T, Makino K, Nimura A, et al). Furthermore, acute application of submaximal blood flow restriction (BFR) for approximately \~ 5 minutes does not influence the magnitude or timing of H wave responses (Mendonca, G.V., et al).

Thus, the investigators hypothesized that performing blood flow restriction training will decrease pain, improve grip strength and does not alter the nerve conduction velocity in patients with carpal tunnel syndrome (CTS).

Eligibility Criteria:
Inclusion Criteria:

1. patients diagnosed by a physician according to the American Academy of Orthopedic Surgeon with carpal tunnel syndrome (CTS).
2. age:30-55 years old.
3. females.
4. positive clinical provocative tests for CTS (Tinel test and Phalen test).
5. subjects with a history of paresthesia, numbness, or pain in the median nerve distribution, night waking, and nocturnal pain.

Exclusion Criteria:

1. subjects who had carpal tunnel release surgery.
2. subjects with cervical disc prolapse.
3. subjects with cervical spondylosis.
4. subjects with thoracic outlet syndrome (TOS).
5. subjects with diabetes.
6. subjects with gestational diabetes.
7. subjects with cardiovascular disorders.
8. subjects with hypertension.
9. pregnant women.
Family Motivational Intervention in Schizophrenia

Cannabis use by people with schizophrenia is associated with family distress and poor clinical outcomes. Therefore, an Family Motivational Intervention (FMI) was developed to help parents to motivate their child with a diagnoses of recent-onset schizophrenia to reduce cannabis use.

In a single-blind randomised clinical trail with 75 patients with the diagnosis of schizophrenia, parents will be assigned to either FMI or to routine care. Assessments will be conducted at baseline and at a 10- and 22-month follow-up. The study hypothesis is that FMI will be more effective than routine care in reducing (a) cannabis use in patients and (b) distress and sense of burden in parents.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of schizophrenia or psychotic-related disorder
* Onset of schizophrenia or related disorder within pervious the 10 years
* Cannabis use at least 2 days per week in the 3 months prior to the assessment
* Antipsychotic medication in prescribed or indicated
* At least 10 hours of contact with the parents each week in the last month

Exclusion Criteria:

-
Prospective Tumor Response Evaluation

The purpose of this study is to determine if MRI imaging can detect genetic, proteomic, and metabolomic characteristics of liver tumors. The study also aims to determine if these imaging characteristics are correlated with clinical outcomes.

For each treatment arm, pre-procedural MRI and post procedural MRI will be obtained. Pre-procedural biopsies will be obtained, if possible. Pretreatment genetic expression, proteomic, or metabolomic patterns from the tumor samples will be assessed. Imaging characteristics from tumors will be extracted using automated software-the study will apply a computational analysis system with the capability to extract and analyze imaging characteristics and correlate them to genetic expression, proteomic, and metabolomic tumor characteristics. Imaging findings will be correlated to clinical outcomes and genetic, proteomic, and metabolomic findings to determine association. Imaging findings and genomic, proteomic, and metabolomic tumor characteristics will be correlated to clinical outcomes (time to recurrence, overall survival, 3-month, 6-month, and 1-year survival).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis or suspicion of primary or metastatic liver cancer deemed eligible for TACE, Y-90, percutaneous ablation, and /or electroporation.

Exclusion Criteria:

* Any reason MRI cannot be obtained.
Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes

This was a randomized, double-blinded multicenter cohort study of Finnish children aged 2 to 24 months. The study was designed to evaluate the efficacy of two 7-valent pneumococcal conjugate vaccines (PncCRM and PncOMPC) parallelly, both vaccines compared with the same control vaccine (hepatitis B vaccine).

The primary endpoint was culture-confirmed pneumococcal acute otitis media (AOM) episodes due to all serotypes included in the pneumococcal conjugate vaccine and the primary hypothesis was that, compared to the control vaccine group, the pneumococcal conjugate vaccine would protect infants from culture confirmed AOM caused by pneumococcal serotypes in the vaccine. The efficacy of the two vaccines against any pneumococcal AOM and any AOM was also evaluated.

The children were vaccinated with the pneumococcal conjugate vaccine or the control vaccine at the age of 2, 4, 6 and 12 months and followed at study clinics established specifically for the purpose from 2 to 24 months of age. Whenever AOM was diagnosed during the follow-up, middle ear fluid was aspirated for bacterial culture.


Eligibility Criteria:
Inclusion Criteria:

* infants coming to their own child health center before the age of 13 weeks, and judged to be in good health on the basis of medical history and physical examination
* family living permanently in Tampere, Kangasala or Nokia
* at least one of the parents/guardians is able to communicate fluently in Finnish
* written informed consent obtained from a parent/guardian prior to enrollment in the study

Exclusion Criteria:

* hypersensitivity to any of the components of the vaccines used in the study,
* known or suspected impairment of immunologic function,
* history of invasive pneumococcal disease,
* prior vaccination with any pneumococcal vaccine,
* prior vaccination with hepatitis B vaccine,
* contraindications to routine childhood immunizations
* any medical condition in which, in the opinion of the investigator, the study procedures or vaccinations might cause risk to the health or endanger the well-being of the child
Physical Activity in Women With Infants

This is a study testing ways to motivate new mothers to become more physically active over a one year period.

Mothers of an infant are much less likely to exercise regularly compared with women who have older children or no children. This low level of physical activity (PA) contributes to postpartum weight retention which can predict levels of obesity up to 15 years later. Ethnic minorities have higher rates of inactivity and gain more weight following childbirth, which places them at increased risk for cancer and other chronic diseases consistent with known health disparities for these ethnic groups. Few PA interventions have been designed to increase PA in women with an infant, especially ethnic minority women. This study will test the efficacy of a tailored intervention to increase and maintain PA in a multiethnic population of 268 young, healthy postpartum women living in Hawaii. Women will be recruited from health care settings, mother/baby support groups, and from the media campaigns(TV, radio, newspaper, parents magazines). Subjects will be randomly assigned to either a tailored postpartum counseling intervention on PA or standard care for PA. The tailored PA intervention will address key personal, social, and environmental factors derived from Social Cognitive Theory and the Transtheoretical Model. Also, multimodal contacts (telephone, e-mail, website) will be used to deliver theoretically-derived, culturally sensitive PA counseling,behavioral skills training (e.g., goal setting), and local resources/referrals tailored to a mother with an infant. The standard care condition receives American Heart Association/American College of Sports Medicine print materials/e-mails and referral to PA internet resources.

The primary PA outcome is minutes of moderate/vigorous physical activity (MVPA) per week, as measured by the Active Australia Questionnaire, with validation by accelerometers worn by all subjects. Condition differences in the initiation of PA will be tested at 6 and 12 months post-baseline. Key psychosocial, physiological, and cultural factors will be tested as mediators or moderators of PA, for example: self-efficacy, social support, processes of change, ethnicity, BMI, and cultural values. This study will serve as a model for the design and implementation of PA interventions for at-risk ethnic minority postpartum women.

Eligibility Criteria:
Inclusion Criteria:

* mother of infant aged 2-12 months
* sedentary
* healthy, able to do moderate intensity physical activity
* BMI = 18.5-40
* not planning to become pregnant in next year
* woman aged 18-45
* able speak and read English

Exclusion Criteria:

* pregnant
* planning to leave Oahu, Hawaii in the next year (permanently move away)
* a diagnosis of cancer, coronary heart disease (including atrial fibrillation), insulin-dependent diabetes mellitus (IDDM), and other atherosclerotic cardiovascular diseases (e.g., stroke),
RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.

Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) including paroxysmal or persistent or long-standing persistent, undergoing and De Novo or Redo procedures.

Phenotype patients and demonstrate the prognostication power of Electrographic Flow (EGF®) maps among all subjects using 12-month follow-up outcomes following EGF-guided mapping and ablation.

Subjects with all types of AF who are candidates for catheter ablation of their AF. The study will enroll up to 400 subjects in 25 centers globally.

Eligibility Criteria:
Inclusion Criteria:

1. Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias including atrial fibrillation, atrial flutter and/or atrial tachycardia
2. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law
3. Left atrial (LA) diameter ≤ 5.5 cm or LA volume index ≤ 50 mL/m2 (use whichever measure is available or if both available, use the lesser of the two to qualify)

Exclusion Criteria:

1. De Novo paroxysmal AF
2. AF from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, or pericarditis, etc.)
3. Cardiac surgery or intervention within the past 90 days (e.g. percutaneous coronary intervention, ablation for ventricular arrhythmias, left atrial appendage occlusion devices, atrial septal defect closure devices, transcatheter aortic valve replacement)
4. Presence of transvenous pacing or defibrillator leads or an atrial leadless pacemaker
5. Myocardial infarction within the past 90 days
6. Severe valvular disease or prosthetic valve(s)
7. Contraindication to therapeutic anticoagulation
8. Decompensated heart failure or New York Heart Association (NYHA) Functional Class IV
9. Positive pregnancy test
10. Any other contraindication to an intracardiac mapping and ablation of atrial arrhythmias
11. Enrollment in another investigational study evaluating another device, biologic or drug