bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Health Education on School Children
Condition: Intestinal Helminthiasis
MeSH terms: Helminthiasis
Study type: Interventional
Phase: Phase 1

Summary: 
      There is a sever lack in application of health education intervention for Soil Transmitted
      Disease (STH) in rural communities and in school children among Orang Asli in Pahang in
      Malaysia, and also there is a lack of information on the effect of different health education
      aspects on STH control in Malaysia, so the investigators think that introducing such new
      national educational package and for the first time in Malaysian's school will help children
      to make some behavior changes specially for the school children aiming to use these children
      as an educator agents to their families and preschool brothers and sisters, to build a base
      for this issue and to reduce STH intensity in these rural areas, which in turn will determine
      the best approach to health education intervention to be applied to other rural areas in
      Malaysia.
    

Detailed description: 
      The World Health Organization established that infections with STH among school¬children
      cause malnutrition, intellectual retardation and cognitive and educational deficits.

      Although school-based intervention specifically the deworming antihelminths drugs programme
      were introduced into school but still Orang Asli villages in Malaysia having a high intensity
      and higher prevalence rate for STH, therefore the objective of this article was to review
      other intervention means mainly the health education intervention into school children and
      rural community, where most of these studies concluded that health education intervention was
      successful in increasing knowledge and changing some of practices among people and children
      which in turn decreases the prevalence and intensity of the STH. Also we think applying such
      intervention in Malaysia would be a benefit to change knowledge and attitude towards STH, and
      it will be the first research study to be applied in this field.
    

Intervention name(s): Health Education package
Intervention type(s): Other
Intervention description(s): Health Education package that covers key health messages about the proper personal hygiene practices will be given to school children in the intervention school. The package consisted of many items such as posters, comic book, song video, competitions, drawing activities, puppet show, etc.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Health Education; Soil-transmitted helminthiasis; Ascaris; Trichuris; Hookworm; Prevention and control
Cardiac Electrophysiological Study
Condition: Atrial Flutter
MeSH terms: Atrial Flutter
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to measure the effects of AZD1305 on cardiac electrophysiological
      properties and intracardiac pressures
    


Intervention name(s): AZD1305
Intervention type(s): Drug
Intervention description(s): Intravenous infusion
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Botox for the Treatment of Overactive Bladder Secondary to Benign Prostatic Obstruction
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, randomized, double-blind study comparing intravesical injection of
      BOTOX to placebo. Study subjects will be randomized (1:1 ratio) to one of the following
      treatment groups:
    

Detailed description: 
      Group 1 n=20 BOTOX® 200U Group 2 n=20 Placebo BOTOX® (saline) At Visit 2 (Treatment, Day 0),
      subjects will receive one injection cycle of BOTOX (200U) or placebo (saline). The study
      duration is approximately 284 days and consists of a Screening Visit (Day -7 to -14), a
      Treatment/Randomization Visit (Visit 2, Day 0), and Follow-up Visits at 7, 30, 90, 180, and
      270 Days. Telephone Follow-ups will be made 3 days following the injection cycle.

      Subjects demonstrating an insufficient response to treatment may receive an open-label
      injection cycle of BOTOX (200U) at Day 90. Subjects receiving this injection will re-commence
      Follow-up Visits and be followed for an additional 270 days.
    

Intervention name(s): Botox; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Botox injection; Placebo injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OAB
Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack
Condition: Transient Ischemic Attack
MeSH terms: Ischemic Attack, Transient; Ischemia
Study type: Observational

Summary: 
      It is hypothesized that the addition of formal cardiac rehabilitation to standard care will
      result in long-term improvements in cardiovascular fitness and functional capacity in
      individuals who have suffered a transient ischemic attack (TIA) or minor stroke.

      Furthermore, it is proposed that the addition of cardiac rehabilitation will influence
      depressive symptoms and cognition.
    

Detailed description: 
      A transient ischemic attack (TIA) is defined as an episode of neurological dysfunction caused
      by focal brain ischemia lasting less than 24 hours. Once an individual has suffered a TIA,
      preventative measures can be taken to target modifiable risk factors, one of which is
      physical inactivity. The current proposal focuses on the use of an established model of care
      (cardiac rehabilitation (CR)) and applies it to those who have suffered a TIA in order to
      maximize physical activity and minimize risk of future cardiovascular events. This will be a
      one-group pre/post design study with a 3 month non-intervention period. Participants will
      undergo measures at baseline and 3 months (non intervention period) then after 6 months of
      cardiac rehabilitation (cardiovascular fitness, 6 minute walk test, cognition, and depressive
      symptoms).
    

Intervention name(s): Cardiac Rehabilitation
Intervention type(s): Behavioral
Intervention description(s): Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        TIA
      
Keywords: cardiac rehab
Spinal Manipulation for Treatment of Chronic Headaches
Condition: Headache Disorders
MeSH terms: Headache Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine the effectiveness of spinal manipulation in reducing pain in people
      with chronic headaches accompanied by neck pain. This study will also determine the number of
      spinal manipulation treatments necessary for optimal pain relief.
    

Detailed description: 
      Spinal manipulation is the signature therapy of chiropractic care involving manual adjustment
      of joints in the neck and back. Data indicate that spinal manipulation is an effective
      treatment for back pain and chronic headaches, particularly cervicogenic headaches, which are
      caused by problems in the cervical spine. However, studies that have determined the optimal
      frequency and duration of spinal manipulation treatment are limited. This study will
      determine the feasibility of conducting a large spinal manipulation clinical trial. This
      study will also determine the effectiveness of spinal manipulation in treating cervicogenic
      headaches and neck pain and the optimal number of treatments necessary to sustain spinal
      manipulation benefits.

      Participants will be randomly assigned to receive weekly sessions of either spinal
      manipulation or light massage treatments for 8 to 16 weeks. Self-report scales will be used
      to assess participants' headache frequency, pain, satisfaction with treatment, and overall
      physical and mental health. Assessments will occur at study entry, at the end of each week,
      and at the end of the study.
    

Intervention name(s): massage; massage; spinal manipulation; Spinal manipulation
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): 8 light massage treatments and hot pack; 16 light massage treatments and hot packs; 8 high velocity, low amplitude spinal manipulation treatments and hot pack; 16 high velocity, low amplitude spinal manipulation treatments and hot pack
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Headaches; Spinal manipulation; Massage; chiropractic
Quorn in Community Health Experiment
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      In overweight individuals (BMI > 27.5 kg/m2), does daily consumption of mycoprotein
      containing Quorn Food products lower blood cholesterol compared with daily meat/fish
      consumption?
    


Intervention name(s): Quorn Foods products; Meat/fish products
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 180 g mycoprotein (wet weight; corresponding to 45 g dry weight) per day (equates to approx. 215 g Quorn Foods products, depending on the product); Standard meat/fish products matched to Quorn group for protein intake
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Memantine Treatment Study of Pathological Gambling
Condition: Pathological Gambling
MeSH terms: Gambling
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the proposed study is to evaluate the efficacy and safety of the drug memantine
      in individuals with pathological gambling (PG). Thirty subjects with DSM-IV PG will receive
      10 weeks of open-label treatment with memantine. The hypothesis to be tested is that
      memantine will be effective and well tolerated in patients with PG. We hypothesize that
      memantine will reduce the severity of gambling symptoms and improve patients' overall
      functioning. This study will provide needed data on the treatment of a disabling disorder
      that currently lacks a clearly effective treatment.
    


Intervention name(s): Memantine Hydrochloride
Intervention type(s): Drug
Intervention description(s): 10 mg/day for two weeks, dose increase to 20 mg at week 3, 30 mg at week 4 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks.
Other intervention name(s): Namenda
Intervention MeSH terms: Memantine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pathological Gambling; Compulsive Gambling; Gambling Addiction; Gambling; Treatment; Memantine; Pharmacology
Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
Condition: Brain Injuries
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the
      injury for a total of 120 hours to severe traumatic brain injury patients improves their
      recovery.
    


Intervention name(s): Progesterone; Lipid emulsion without progesterone
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.; Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
Other intervention name(s): BHR-100
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brain Injury; Trauma
Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation
Condition: Cardiac Pacing; Complications; Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      The aim of this study was to compare the safety and efficacy of warfarin versus placebo,
      administered for 6 months, in the prevention of thromboembolic complications after
      transvenous cardiac devices implantation in high-risk patients.
    

Detailed description: 
      Venous lesions following cardiac devices implantation are a common complication of
      transvenous access that may cause disease manifestations and difficulties during
      reoperations. These lesions tend to develop early, and their incidence decreases gradually
      within 6 months after device implantation. Ventricular dysfunction and previous transvenous
      temporary leads ipsilateral to the permanent implant are risk factors identified in a
      previous study performed at our institution and other risk factors have been reported
      recently.The usefulness of prophylactic therapeutic strategies to prevent these
      complications, however,remains unknown. This randomized trial examined the effects of
      warfarin in the prevention of these complications in high-risk patients. After device
      implantation, patients were randomly assigned to receive either placebo or warfarin.
      Periodical clinical and laboratorial evaluations were performed to anticoagulant management.
      Following the six-month period, every patient was submitted to a digital subtraction
      venography.
    

Intervention name(s): Warfarin
Intervention type(s): Drug
Intervention description(s): Single daily dose of Warfarin (5 mg/orally), adjusted to achieve an International Normalized Ratio (INR) between 2 to 3.5 times the normal value during six months
Other intervention name(s): oral anticoagulants
Intervention MeSH terms: Warfarin; Anticoagulants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cardiac pacing; pacing complication; venous thrombosis; warfarin; anticoagulation; randomized trial
Feasibility Study of the TruSculpt Radiofrequency Device
Condition: Tissue Tightening
Study type: Interventional

Summary: 
      A single-center, prospective, open-label feasibility study of the truSculpt radiofrequency
      device.
    

Detailed description: 
      A single-center, prospective, open-label study to evaluate the safety and efficacy of the
      Cutera truSculpt radiofrequency device for optimal delivery of thermal energy to the skin.
    

Intervention name(s): TruSculpt
Intervention type(s): Device
Intervention description(s): All subjects will receive 1 truSculpt radiofrequency treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)
Condition: Antiphospholipid Syndrome; Thrombophilia Due to Antiphospholipid Antibody; Systemic Lupus Erythematosus
MeSH terms: Thrombophilia; Lupus Erythematosus, Systemic; Antiphospholipid Syndrome
Study type: Observational

Summary: 
      This 12 week study will observe patients with and without systemic lupus erythematosus who
      have persistent antiphospholipid antibodies in the blood who are starting a medicine called
      hydroxychloroquine. It will measure if these patients have a change in a blood test called
      the annexin A5 resistance assay over that 12 week period.
    

Detailed description: 
      Antiphospholipid Syndrome (APS) is an autoimmune disorder of blood clotting and pregnancy
      loss. It is associated with proteins called antiphospholipid antibodies (aPL) in the blood.
      Blood clotting in this disease occurs for several reasons; one reason involves the
      interaction of aPL with another protein found on the surface of the cells that line blood
      vessels (endothelial cells). This protein, called annexin A5 (AnxA5), forms a shield over the
      surface of these cells. The AnxA5 Resistance Assay is a blood test that can detect when there
      is a problem with the protective AnxA5 shield on endothelial cell surfaces.

      This 12 week study will observe patients with persistent aPL in the blood who are starting a
      medicine called hydroxychloroquine (HCQ). The primary goal of the study is to compare results
      of the AnxA5 resistance assay from patients before they start taking HCQ and after they have
      taken it for 12 weeks to see if the results of the blood test change. Our secondary goal is
      to measure a variety of other blood tests before and after patients have started taking HCQ;
      these tests include D-dimer, Activated Protein C (APC) Resistance, and aPL titers/status (LA
      test, aCL ELISA, aß2GPI ELISA, and anti-Domain-I ß2GPI ELISA).
    

Intervention name(s): Phlebotomy
Intervention type(s): Other
Intervention description(s): Subjects will have blood drawn at each of the 3 study visits.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        For aPL positive groups, subjects must have persistently positive (over at least 12 weeks)
        antiphospholipid antibodies in the blood.
      
Biospecimen description: 
      serum, plasma
    
Keywords: Antiphospholipid syndrome; Antiphospholipid antibodies; Systemic lupus erythematosus; Annexin A5 and Annexin A5 resistance assay
A Study of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, randomized, double-blind, two-period crossover study will evaluate the
      safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of
      multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers. Subjects
      will be randomized to one of 4 treatment sequences of two periods to receive multiple doses
      of RO5285119 plus a single dose of risperidone or risperidone placebo or multiple doses of
      RO5285119 placebo plus a single dose of risperidone or risperidone placebo, with a washout
      period of approximately 3 weeks between treatment periods. Anticipated time on study is up to
      12 weeks (from screening through study completion).
    


Intervention name(s): RO5285119; RO5285119 placebo; risperidone; risperidone placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): multiple doses; multiple doses; single dose; single dose
Intervention MeSH terms: Risperidone
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that pregabalin will decrease post-operative pain scores and
      analgesic use following robot-assisted endoscopic thyroidectomy compared to placebo. The
      primary outcome will be acute postoperative pain, measured by a verbal numerical rating score
      (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome
      will be the incidence of chronic pain and hypoesthesia in the anterior chest at 3 months
      after operation.
    


Intervention name(s): Pregabalin; Vitamin Complex (placebo)
Intervention type(s): Drug; Drug
Intervention description(s): Pregabalin 150 mg orally; Vitamin Complex 150 mg orally
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: thyroidectomy; pain, postoperative; pregabalin
Long Distance Running Training by Older Adults
Condition: Physical Activity; Aging
Study type: Interventional

Summary: 
      The goal of this project is to understand the effect of regular practice of long distance
      running on the posture and movement control of older adults.

      For such, the investigators will conduct an experiment with longitudinal design where
      sedentary elderly individuals will be trained in long distance running for about 4 months.
    

Detailed description: 
      In a study the investigators conducted about elderly runners, the main observed difference by
      the first time was that elderly individuals present greater foot abduction (toe-out) during
      running than young adults. This alteration has been observed in elderly individuals in
      general during walking, and identified as a protective mechanism to not overload the medial
      compartment of the knee joint. It is also known that elderly individuals present a different
      joint torque distribution in the lower limbs during walking in comparison with young adults.
      However, it's not known the relation between the movement patterns, particularly the foot
      abduction pattern, and the mechanical load on the knee joint during running by elderly
      individuals and neither the longitudinal effect of running practice on this relation and on
      the mechanical joint load distribution. Another unknown aspect is the actual effect of the
      running practice on the posture control of elderly individuals.

      With this project, the investigators want to understand why elderly individuals change their
      movement pattern during running, to determine for the same subjects if this altered pattern
      is also present during walking and standing, and to determine the effect of running practice
      on the elderly posture control. Our hypotheses are that the strategy of greater foot
      abduction is present in all movement tasks and that the use of this strategy is related to
      the integrity of the knee joint, even considering the highly active elderly individuals and
      that the practice of running contributes for a better postural control in this population.

      These findings will contribute for a greater understanding of the benefits of the practice of
      running and the adaptations developed by the elderly runners and in this way to contribute
      for the prescription of this activity to the elderly population.
    

Intervention name(s): Long distance training; Walking training
Intervention type(s): Other; Other
Intervention description(s): Long distance training during four months, 3 times per week; Walking training during four months, three times per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: biomechanics; motor control; movement; walking; running; sedentarism; joint moment