bioihbjkbjnl/mcl2 huggingface dataset:
Sickle Cell Anemia and Cerebral Microcirculation : Multimodal Exploration
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      The aim of this study is to evaluate determinants of cerebral oxygenation and perfusion at
      the microcirculatory level in children with sickle cell anemia (SCA) using combined novel
      investigational tools: Arterial Spin Labeling (ASL) perfusion MR (Magnetic Resonnance)
      imaging, brain Near Infra-Red Spectroscopy (NIRS) and red blood cell (RBC) rheological
      properties.
    

Detailed description: 
      The investigators hypothesize that brain perfusion and/or oxygenation modifications may be
      evidenced in SCA children who have no microarteriopathy and may correlate with
      hemorheological abnormalities and impaired vasomotion. A multimodal approach designed to
      study a. cerebral perfusion and oxygenation, b. flow motion properties and c. blood
      rheological parameters might help to describe the different processes involved in cerebral
      ischemia.
    

Intervention name(s): Physical exams and blood analyzes
Intervention type(s): Procedure
Intervention description(s): Blood samples collection (for DNA, plasma and cells analyzes) ; Hemorheologic analyzes ; ASL sequence on MRI ; Near Infra Red Spectroscopy (NIRS) and associated cardiofrequency analyze.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient included will be patients suffering from Sickle Cell Anemia, and coming at the
        study center in the frame of their annual follow-up visit.
      
Biospecimen description: 
      Blood samples are taken, in order to create Biobank (DNA, serum and plasma)
Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections
Condition: Intestinal Parasitic Infections; Malnutrition; Anemia
MeSH terms: Parasitic Diseases; Intestinal Diseases, Parasitic; Malnutrition; Reinfection
Study type: Interventional

Summary: 
      Intestinal parasitic infections, malnutrition and iron deficiency anaemia (IDA) are still
      considered as public health problems in rural Malaysia especially among Orang Asli children.
      Despite intermittent control programmes, the prevalence of these problems is still high
      suggesting the need of other control and interventions measures. This randomized
      double-blind, placebo-controlled trial was carried out among Orang Asli schoolchildren from
      Sekolah Kebangsaan Betau in Pos Betau, Pahang (200 km northeast Kuala Lumpur) to investigate
      the effects of vitamin A supplementation on intestinal parasitic reinfections, growth, iron
      status and educational achievement.

      HYPOTHESES

        1. Vitamin A supplementation has a negative effect on intestinal parasitic reinfections and
           the worm burden of infections among Orang Asli schoolchildren in Pos Betau, Kuala Lipis,
           Pahang.

        2. Vitamin A supplementation has a positive effect on growth (weight and height) among
           Orang Asli schoolchildren.

        3. Vitamin A supplementation is effective in improving serum iron status among Orang Asli
           schoolchildren.

        4. Vitamin A supplementation has a positive effect on cognitive function and educational
           achievement among Orang Asli schoolchildren.
    

Detailed description: 
      Children from Sekolah Kebangsaan Betau in Pos Betau, Kuala Lipis, Pahang served as the target
      population for this study.

      The selection criteria for study subjects were the following:

        -  Age 7-12 years (according to birth date in birth certificate).

        -  Non-menstruating females (age <13)

        -  No history or evidence of underlying haematological-related diseases such as
           thalassaemia and ovalocytosis.

        -  No evidence of concomitant severe and/or chronic illness such as acute respiratory tract
           infections, mental retardation and neurological deficits.

        -  Consent of parent to participate in the study.
    

Intervention name(s): vitamin A supplements; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): gelatinous and reddish opaque capsules containing 200 000 IU vitamin A; 125 children received placebo capsules
Other intervention name(s): Group B; Group A
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: intestinal parasitic infections; malnutrition; Anemia
A Study to Compare How Tamsulosin is Absorbed to the Body After Administration of Two Types of Tamsulosin Formulation Under Fed and Fasted Conditions in Chinese Healthy Subjects
Condition: Healthy; Pharmacokinetics of Tamsulosin Hydrochloride
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the relative bioavailability of two types of
      prolonged release formulation of tamsulosin hydrochloride in Chinese healthy subjects. The
      safety of tamsulosin formulation is also compared.
    

Detailed description: 
      There will be two studies. One study will be conducted under fed condition, and the other
      study will be conducted under fasted condition. Each study is a single center, randomized,
      single dose, open-labeled, cross-over study.

      Study 1 will be conducted under fed condition:

      Subjects will undergo screening evaluations to determine their eligibility within 7 days
      prior to the study enrollment. Subjects will be admitted to the clinical facility in the
      evening prior to dosing for each period. All subjects will receive tamsulosin formulation-A
      and formulation-B in one of two randomly assigned treatment sequences at 0.5h after the start
      of a standard breakfast. There will be a 7-day washout period between each dose.

      Study 2 will be under fasted condition:

      A single oral dose of tamsulosin formulation-A or formulation-B will be given to subjects
      under fasted condition (fasting for at least 10 hours since 20:00PM the night before the
      administration). Blood will be sampled at the same time point as in Study 1. Also, safety
      evaluation will be performed at the same selected times throughout the study as in Study 1.
    

Intervention name(s): Tamsulosin formulation-A; Tamsulosin formulation-B
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Harnal; Harnal
Intervention MeSH terms: Tamsulosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: prolonged release formulation; adrenergic blocker; Bioequivalence
Antiviral Activity and Safety of Mifepristone at 2 Doses in HIV-1 Infected Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to determine whether mifepristone (VGX-410) has anti-HIV-1
      activity at doses of either 300 mg or 600 mg per day after oral administration for 14 days at
      each dose level.
    

Detailed description: 
      VT004 is a double-blind, randomized, placebo-controlled Phase II study of two doses of orally
      administered mifepristone (VGX-410) (300 and 600 mg) taken as a twice daily (BID) dosage
      (150mg BID and 300mg BID) in a dose-escalating fashion for 14 days at each dose level to
      determine antiviral activity and safety in HIV-1-infected participants. At entry, 18 subjects
      will be randomized in a 5:1 fashion (15 on active drug: 3 on placebo) to receive escalating
      doses of VGX-410 or matching placebo. Patients will be randomized to receive 300 mg (as 150
      mg BID dose) of VGX-410 or matching placebo for 14 days. In patients that complete this dose
      without significant safety concerns or side effects, the dose will be increased to 600 mg (as
      300 mg BID dose) or matching placebo for 14 days. Patients must meet all inclusion/exclusion
      criteria listed below and be seen on a weekly basis by study personnel while on study drug.
      Patients must return ~ one month after finishing the study therapy for examination and safety
      labs.
    

Intervention name(s): VGX-410 (Mifepristone); Placebo for VGX-410 (Mifepristone)
Intervention type(s): Drug; Drug
Other intervention name(s): Mifeprex
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: HIV-1
Parent-delivered Massage for Children With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Through funding from the U.S. Maternal and Child Health Bureau, Teaching Research Institute
      at Western Oregon University (WOU) will be conducting research on the effect of a
      parent-delivered massage program on measures of autism and general development in young
      children with autism. Families will participate in an initial training, and receive 24
      sessions of ongoing support and training from a trained therapist over the first nine months.
    

Detailed description: 
      Children will be randomly divided into treatment groups and wait-list control groups. The
      control groups begin treatment five months after the treatment groups begin.

      All children will be tested on three occasions in the first year: prior to beginning
      treatment, and five and twelve months later. Follow-up testing will be conducted at the end
      of the second year. Results will be shared with parents at the end of each year. Testers will
      remain blinded as to which group is currently receiving treatment.

      There is no cost to parents for participation in this research study. Families meeting the
      eligibility criteria will be accepted into the study on a first-come, first-served basis.
    

Intervention name(s): Parent massage tx group; Parent massage wait-list control group
Intervention type(s): Other; Other
Intervention description(s): The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.; The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Massage; effectiveness; autism; parent stress
Use of an Occlusal Support Device During the Second Stage of Labor
Condition: Pregnancy
Study type: Interventional

Summary: 
      The primary objectives of this study are to determine if the use of an Occlusal Support
      Device (OSD)(Mouthguard) can reduce the duration and intensity of the second stage of labor,
      reduce the incidence of labor complications including Caesarian Sections and improve Apgar
      scores in newborns
    

Detailed description: 
      Prolonged labor, especially during the second stage of active expulsive effort (the pushing
      phase), is associated with increased risk of maternal complications (e.g. tissue trauma,
      postpartum hemorrhage, intra-amniotic infection). Developing an effective method to assist
      and maximize maternal expulsion effort should be of great value in reducing the number of
      complications, also including cesarean section or instrumental deliveries. Past studies
      published in the dental literature have shown that specially designed oral appliances that
      support the dental occlusion may increase the isometric strength of different muscle groups.
      Increased strength of the neck muscles could improve efficiency of the Valsalva maneuver in
      increasing intra-uterine pressure, and thus decreasing the duration of phase II of labor.
      Nulliparous women with uncomplicated singleton pregnancy will be randomly assigned to either
      the study group (Dental appliance) or the no dental appliance group. Duration of labor will
      be measured for both phase I and phase II. Rates for cesarean section and instrument
      deliveries and other complications will be charted as well as Apgar scores .
    

Intervention name(s): Occlusal Support Device; Control
Intervention type(s): Device; Other
Intervention description(s): Bite plate; Control group
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pregnancy; Labor and Delivery; Occlusal Support Device
The Effectiveness of Individual Placement and Support in Chronic Pain Patients
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Individual Placement and support (IPS) is an evidence-based approach originally developed to
      help people with severe mental disorders to obtain and maintain employment. The effectiveness
      of IPS for patients with severe mental illness is well documented, but has never previously
      been tested for patients with chronic pain. In fact, employment support is rarely provided in
      pain clinics, despite an increasing focus on integrating work and health in all patient
      treatment (OECD, 2013). The aim of this study is to investigate the effectiveness of IPS as
      an integrated part of the interdisciplinary treatment for patients with chronic pain in a
      hospital outpatient clinic.
    

Detailed description: 
      Individual Placement and support (IPS) is an evidence-based approach originally developed to
      help people with severe mental disorders to obtain and maintain employment. IPS represents a
      relatively new approach to vocational rehabilitation and incorporates following principles:
      (1) Every person that wants to work, can work given that the person is provided with the
      appropriate work and environment. (2)The goal is employment in regular, competitive
      employment. (3) IPS is integrated with treatment. (4) Job search is individualised; based on
      the participants' preferences and competence. (5) Work incentives planning is provided; which
      includes counselling about how work can influence social security and other public benefits.
      The intention of this benefits counselling is to enable the participant to make informed
      decisions about work (job starts and changes). (6) The job support is not time-limited. (7)
      Finally, IPS differs from more traditional employment services in that it does not involve
      pre-vocational training, often referred to as "train, then place". (8) In IPS job search
      starts as soon as the client expresses an interest in work. Therefore, IPS follows the
      principle "place, then train".

      The effectiveness of IPS for patients with severe mental illness is well documented.
      International research shows that IPS is more effective than other types of employment
      programs for this group of clients. However, the effect of IPS on patients with chronic pain
      in an outpatient hospital clinic is largely unknown.
    

Intervention name(s): IPS; Self-help; Treatment as usual
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Individualized job support provided by an employment specialist; Self-help resources on obtaining employment and coping with chronic pain; Transdisciplinary treatment at the pain clinic. This includes medical, psychological and physiotherapy treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Oral Progesterone for Prevention of Miscarriage in Threatened Abortion
Condition: Threatened Abortion
MeSH terms: Abortion, Spontaneous; Abortion, Threatened
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the effectiveness of oral dydrogesterone in preventing miscarriage in
      threatened abortion. Half of participants will receive oral dydrogesterone, while the other
      half will receive oral placebo.
    


Intervention name(s): Dydrogesterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dydrogesterone tablet; Placebo tablet
Intervention MeSH terms: Dydrogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: threatened abortion
Evaluation of the Safety, Tolerability and Pharmacokinetics of Repeat Oral Doses of GSK962040 Administered to Healthy Adult Subjects.
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability and exposure of repeat escalating oral
      doses of GSK962040.
    


Intervention name(s): GSK962040; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK962040 tablets will be available in dosing strengths of 1 milligram, 5 milligrams, 25 milligrams given orally, once daily, in the morning, in a fasted state.; Placebo tablets will be given orally, once daily, in the morning, in a fasted state.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: motilin; gastric emptying; GSK962040; oral dose
Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia
Condition: Delivery of Health Care
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The purpose of this study is to validate the effectiveness of food supplement Limicol on
      reducing LDL-cholesterol in moderate hypercholesterolemic volunteers.
    

Detailed description: 
      Cardiovascular disease (CVD), foremost among which ischemic heart disease and stroke, are the
      leading cause of mortality and morbidity in France. These diseases are multifactorial origin
      and even if it is not possible to act on risk markers such as age, sex, or heredity, risk
      factors like high cholesterol, smoking , hypertension, obesity, diabetes and physical
      inactivity, are the main target of prevention strategies.The dydlipidémies have a role in the
      formation of CVD in participating in the genesis of atherosclerosis. The cholesterol and
      LDL-cholesterol in particular is subject to oxidation process in plasma. The molecules of
      oxidized LDL-cholesterol, small and dense, easily penetrate the arterial endothelial wall and
      are greeted by macrophages. Following a succession of different processes including
      inflammation, atherosclerotic plaque is formed. The result is either an arteriopathy when the
      arterial lumen narrowing, or atherothrombosis in the event of plaque rupture. Given this
      pathophysiology, reduce blood lipids, including LDL-cholesterol and reducing oxidation and
      inflammation are interesting strategies in the context of cardiovascular prevention. Several
      scientific study showed that nutritional supplementation with some plant extracts such as
      artichokes, garlic, red yeast rice, or the sugar cane policosanol helps to reduce several
      cardiovascular risk factors including regulate concentrations of circulating lipids.

      The objective of this study is to validate the effectiveness of Limicol, formulated with
      proven scientific data on the reduction of LDL-cholesterol in volunteers with moderate
      hypercholesterolaemia (LDL-cholesterol).
    

Intervention name(s): Limicol (plant extract)
Intervention type(s): Dietary Supplement
Intervention description(s): Artichoke extract, anti-caking agents: dicalcium phosphate, calcium citrate, vegetable magnesium stearate, red yeast rice, microcrystalline cellulose, natural vitamin E, garlic extract, sugar cane policosanols, inositol hexanicotinate, vitamin B3, vitamin B2.
Other intervention name(s): Limicol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cholesterol; LDL-cholesterol; Coronary artery disease; Red yeast rice; Plants extract; Cholesterol excess.
Oral Collagen for Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Rheumatoid arthritis (RA) is an autoimmune disease characterized by swelling and inflammation
      of the joints. In RA, the immune system attacks a person's own cells inside joints,
      eventually leading to joint damage and disability. This study will determine if oral bovine
      type II collagen (bovine CII) will lead to decreased joint inflammation in RA patients.
    

Detailed description: 
      RA is an inflammatory disease that causes pain, swelling, stiffness, and loss of function in
      the joints. The study will evaluate the effects of using oral bovine CII on RA patients by
      assessing the levels of inflammation markers such as interferon gamma (IFN-gamma),
      interleukin-10 (IL-10), and transforming growth factor beta (TGF-beta). This study is a
      multicenter clinical trial to be conducted at the University of Tennessee, Memphis (the lead
      center) and the West Tennessee Medical Specialty Clinic (a collaborating site).

      Patients enrolled will be allowed to continue a constant dose of disease-modifying
      anti-rheumatic drugs (DMARDs) and prednisone less than or equal to 7.5 mg/day. Patients will
      be randomly assigned to one of two groups. The low dose group will receive 30 mcg daily for
      10 weeks, then 50 mcg daily for 10 weeks, followed by 70 mcg daily for 10 more weeks; the
      high dose group will receive 90 mcg daily for 10 weeks, then 100 mcg daily for 10 weeks,
      followed by 130 mcg daily for 10 more weeks. Blood will be collected at screening and at
      Weeks 10, 20, and 30. Blood will be analyzed for indicators of inflammation.

      Note: this trial is no longer being conducted as an intervention trial. Accrual has been
      discontinued, although patients previously enrolled are still being followed.
    

Intervention name(s): Oral bovine type II collagen
Intervention type(s): Drug
Intervention description(s): Drug can be interrupted or stopped for suspected adverse events.
Other intervention name(s): CII
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NSAIDs; Oral Tolerance; Drug Interaction; Oral Administration; Interleukin 10; Collagen; Chemotherapy; Human Therapy Evaluation; DMARDs; RA; IL-10