bioihbjkbjnl/mcl2 huggingface dataset:
Abilify in Bipolar Disorder for 6 Weeks Treatment Effectiveness
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      To demonstrate the efficacy and safety of co-administration of Abilify(aripiprazole) with
      Depakote(divalproate) in the acute phase of 6-week treatment of acute mania in patients with
      bipolar disorder.
    

Detailed description: 
      Further study details as provided by Korea OIAA
    

Intervention name(s): Abilify(Aripiprazole); Depakote(Divalproate)
Intervention type(s): Drug; Drug
Intervention description(s): co-administration of Abilify with Depakote in the 6-week treatment of acute mania in patients with bipolar disorder; co-administration of Abilify with Depakote in the 6-week treatment of acute mania in patients with bipolar disorder
Intervention MeSH terms: Valproic Acid; Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Using CHWs or Mailing Self Sampling Home Tests to Increase Cervical Cancer Screening in South Florida
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The study will test the significance of community health worker (CHW) participation by
      comparing self-sampling provided by a community health worker and self-sampling provided by
      mail. The study will enroll 700 participants in communities that lack access to medical care
      in South Florida.
    


Intervention name(s): CHW and Self-sampling for Cervical Cancer; Mailed Self Sampler
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.; Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: Screen; self-sampler; cervical, cancer; women; community health workers; Hispanic/ Latinas; Haitian; Focus of study is cervical cancer
Strengthening Effect on Hamstring's Passive Mechanical Properties
Condition: Sports Physical Therapy
Study type: Interventional

Summary: 
      The purpose of this study was to investigate effects of different strengthening methods on
      hamstring muscle group's passive mechanical properties and to investigate this effect's
      relation with performance changes in healthy individuals. 42 healthy sedentary male
      participated in this study. Passive mechanical properties and strength of hamstring and
      quadriceps muscles, flexibility of hamstring muscles, anaerobic explosive strength, reaction
      time, agility were measured. Participants randomized evenly into one of three groups;
      eccentric, concentric and neuromuscular electrical stimulation (NMES). After 8 weeks training
      period, participants were measured again.
    


Intervention name(s): Concentric Exercise; Nordic Eccentric exercise; Neuromuscular Electrical Stimulation
Intervention type(s): Other; Other; Other
Intervention description(s): Leg Curl Machine: 1st week - 1st day is 10 maximum repeat test. 2nd week - 2 days of training - 2 sets of 6 repeats. %60 percent of maximum load.
3rd week - 3 days of training - 3 sets of 6-8 repeats. %60-80 of maximum load. 4th-8th week - 3 days of training - 3 sets of 8-12 repeats. when 3 sets of 12 achieved, load was increased with 2.5kg.; st week - 1 day - 2 sets of 5 repeats.
nd week - 2 days - 2 sets of 6 repeats.
rd week - 3 days - 3 sets of 6-8 repeats.
th week - 3 days - 3 sets of 8-10 repeats. 5-8th weeks - 3 days - 3 sets of 12-8 repeats. When achieved 3 sets of 12 repeats with full range, speed was increased.; 8 weeks, three times per week, 15 minutes of bilateral hamstring stimulation. 100 Hz. frequency, 600 microsecond duration rectangular current
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomization into three groups and measurement before and after intervention
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Muscle Tonus; Elasticity; Electric Stimulation Therapy; Physical Conditioning, Human
Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy- a Dose Comparison Trial
Condition: Pregnancy
Study type: Interventional

Summary: 
      The study is randomized blinded trial of Vitamin D supplementation to pregnant women; the
      study participants will receive Vitamin D in supplement form. Pregnant women will be
      individually randomized to three groups receiving a dose of 400, 2000 and 4000 IU/ day till
      the time of delivery.A blood sample will also be collected from the participant at the time
      of recruitment /before the starting of the supplementation for the assessment of Calcium,
      Phosphorus, Alkaline Phosphatase and Vitamin D levels. The second blood sample for vitamin D
      level to assess vitamin D status will be done after completion of the supplementation phase
      at the time of delivery (till 48 hours of delivery). The samples will be sent to Aga Khan
      University laboratory
    

Detailed description: 
      The investigators hypothesize that Pakistani mothers as darkly pigmented, will require
      substantially higher oral supplementation with vitamin D to replenish the micronutrient
      stores and aid to resolve associated maternal and neonatal morbidity due to Vitamin D
      deficiency. The investigators expect that if vitamin D is supplemented to pregnant women,
      their newborn infants would inevitably replenish the micronutrient stores and aid to resolve
      the maternal and neonatal morbidity due to Vitamin D deficiency.This is hospital based double
      blinded trial, study participants divided into three groups which will receive Vitamin D
      supplementation in 400, 2000 and 4000 International Units. The group which will receive 400
      IUs will be treated as control group.
    

Intervention name(s): Vitamin D supplement; Vitamin D supplement
Intervention type(s): Drug; Drug
Intervention description(s): comparison of different dosages of vitamin D; comparison of different dosages of vitamin D Supplement
Other intervention name(s): Brand name: Vitamin D3; LOT ID AKUH COMPOUNDING 2305012014; Brand name: Vitamin D3
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vitamin D; pregnancy; Pakistan
A Study to Assess the Effects of Dissolution Profile on the Pharmacokinetics of Single Oral Doses of Tafenoquine Tablets and Tafenoquine Stable Isotope Labelled Solution
Condition: Malaria, Vivax
MeSH terms: Malaria; Malaria, Vivax
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the effect of Tafenoquine (TQ) 150 mg tablet ageing (dissolution
      profiles) on human exposure of TQ comparing the relative bioavailability of TQ from tablets
      exhibiting different dissolution profiles in healthy subjects. This is a single-centre,
      2-arm, randomized open-label, parallel-group study in healthy subjects. All subjects will
      arrive in the unit approximately 24 hours prior to dosing and will be discharged after the
      72-hour post-dose assessments are completed. Subjects will return for outpatient visits on
      Days 7, 14, 21, 28, and 56 after dosing. A total of 14 subjects (n=7 subjects in each arm)
      are planned to be enrolled. All subjects will receive a single dose of study medication
      (2x150 mg TQ tablets + 30 mg TQ SIL in solution) and participate through a 56-day post dose
      follow-up visit. To enable the application of peripheral microsampling in planned paediatric
      studies, a comparison of the measured pharmacokinetic (PK) exposure via peripheral blood
      collection (via microsampling) to venous collection will also be performed in this study.
    


Intervention name(s): Tafenoquine Control; Tafenoquine dissolution profile X; Tafenoquine SIL
Intervention type(s): Drug; Drug; Drug
Intervention description(s): It will be supplied as a dark pink, capsule-shaped, film-coated tablet plain on both sides containing 150 mg tafenoquine; It will be supplied as a dark pink, capsule-shaped, film-coated tablet plain on both sides containing 150 mg tafenoquine and will be "intermediate aged TQ Product".; It will be compounded at site and will be administered as 0.3 mg/mL (100mL to be dosed, equivalent to 30 mg) aqueous Solution of SIL Tafenoquine.
Intervention MeSH terms: Tafenoquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteer; Malaria; Pharmacokinetics; Tafenoquine
Effects of CS-8080 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purposes of this study are to assess the safety and measure the pharmacokinetics of
      CS-8080 in healthy volunteers.
    


Intervention name(s): CS8080; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CS-8080 tablets will be administered once daily at doses of 1, 3, 10, 20, 50 and 100 mg.; Some subjects will receive matching placebo instead of CS-8080.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacodynamics
Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Study in participants with RA who have an inadequate response to methotrexate.
    


Intervention name(s): Brodalumab; Placebo; Methotrexate; folic acid
Intervention type(s): Drug; Drug; Drug; Dietary Supplement
Intervention description(s): 3 single subcutaneous (SC) injections at day 1 and weeks 1, 2, 4, 6, 8, and 10; 3 single SC injections at day 1 and weeks 1, 2, 4, 6, 8, and 10; Two methotrexate dose adjustments were allowed in the event of methotrexate toxicity, however, doses < 7.5 mg/week necessitated discontinuation from study.; at least 5 mg per week
Other intervention name(s): AMG 827
Intervention MeSH terms: Folic Acid; Methotrexate; Brodalumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Autoimmune Diseases; Musculoskeletal Diseases; Joint Diseases; Arthritis; Connective Tissue Diseases; Arthritis, Rheumatoid; Rheumatic Diseases
A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)
Condition: Relapsing Forms of Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Natalizumab (TYSABRI) is a protein-based drug that is manufactured by Biogen Idec in
      partnership with Elan Pharmaceuticals. Natalizumab is approved in the US and Europe for the
      treatment of Multiple Sclerosis (MS). The purpose of this study is to determine whether the
      amount of natalizumab (TYSABRI) that is present in your blood (plasma) can be reduced or
      eliminated by separating and removing the plasma and replacing it with other fluids, a
      process called plasma exchange.
    


Intervention name(s): Plasma exchange; natalizumab treatment
Intervention type(s): Procedure; Drug
Intervention MeSH terms: Natalizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis (MS)
Effects of Low Calorie Sweeteners on Dietary Intakes, Hunger, Appetite and Satiety
Condition: Eating Behavior
Study type: Interventional

Summary: 
      Although there is evidence that low calorie sweeteners (LCS) do not stimulate hunger or
      appetite, divergent opinions appear regularly both in the scientific literature and in the
      popular press. The goal of this study is to examine the effects of LCS containing beverages
      on appetite and intake in healthy individuals.
    

Detailed description: 
      The study will be a monocentric randomized controlled open trial including two parallel
      groups to examine effects of LCS beverages as compared to water on daily intakes of energy
      and macronutrients. The effects of LCS beverages on hunger, satiety, desire to eat and on the
      selection of sweet or savory foods eating occasions will be assessed.
    

Intervention name(s): Beverage containing low calorie sweeteners; Still water
Intervention type(s): Other; Other
Intervention description(s): Beverage containing low calorie sweeteners; Still water (no flavour)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: low calorie sweetener satiety, intake, hunger
Use of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure
Condition: Bone Diseases
MeSH terms: Bone Diseases
Study type: Interventional

Summary: 
      Localization of small femur lesions for resection can be challenging and may be associated
      with the need for significant fluoroscopic imaging and tissue dissection.
    

Detailed description: 
      This study was performed to evaluate the use of a radiopaque localizer grid along with
      methylene blue staining for resection of small femur lesions in children, and to determine
      this technique's effectiveness at reducing radiation exposure and tissue injury.
    

Intervention name(s): surgical treatment
Intervention type(s): Radiation
Intervention description(s): Use of a radiopaque localizer grid and methylene blue staining as an aid to resect the lesions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: radiopaque localizer grid; methylene blue; reduce radiation exposure
Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors
Condition: Healthy
Study type: Observational

Summary: 
      Peripheral blood stem cells (PBSCs) collected following stimulation with filgrastim are
      commonly used for autologous hematopoietic transplants. PBSCs are also now being used for
      some syngeneic and allogeneic hematopoietic transplants involving HLA-matched sibling donors.
      However, many issues remain unanswered about the use of PBSCs for allogeneic transplants and
      the effects of filgrastim on healthy individuals. The purpose of this study is to determine
      the effectiveness of filgrastim stimulated PBSCs in hematopoietic cell transplants involving
      unrelated donors and to determine the effects of this donation process on unrelated stem cell
      donors.
    

Detailed description: 
      This study establishes and evaluates a system to supply peripheral blood stem cell
      (PBSC)products for use in unrelated donor hematopoietic stem cell (HSC) transplantation. The
      protocol describes processes for donor identification, education and evaluation. Procedures
      for administration and monitoring of the stem cell mobilizing agent filgrastim are included.
      The study also describes procedures for the collection of PBSC products by leukapheresis and
      includes provisions for indefinite donor follow-up.
    

Time perspective: Prospective
Keywords: peripheral blood stem cells; filgrastim-mobilized; allogeneic transplantation; Unrelated Donors for allogeneic transplantation
R5 Integrase Study in HIV-1 Naive Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This is a pilot, open-label study of raltegravir and maraviroc in combination for the
      treatment of antiretroviral naïve patients. The study will enroll 7 antiretroviral naïve
      patients with CD4 counts ≥ 350 and viral loads > 5,000. The subjects will be followed for 48
      weeks. The combination of these two agents has the potential to be a potent regimen with
      minimal metabolic complications. However, they have not been studied in combination
      previously.

      This pilot study proposes to evaluate this combination in antiretroviral naïve patients to
      document the safety and efficacy of this combination in order to provide clinicians with a
      treatment regimen that minimizes the risk of metabolic complications.
    

Detailed description: 
      Seven antiretroviral naïve HIV infected participants will be treated with a combination of
      raltegravir and maraviroc and followed for 48 weeks to determine the time to virologic
      suppression of (HIV-1 viral load < 50 copies/ml).
    

Intervention name(s): Raltegravir and Maraviroc in combination
Intervention type(s): Drug
Intervention description(s): Raltegravir 400 mg tablet twice a day, ~12 hours (10 to 14 hours) apart
Maraviroc 300 mg tablet twice a day, ~12 hours (10 to 14 hours) apart
Other intervention name(s): Raltegravir (Isentress); Maraviroc(Selzentry)
Intervention MeSH terms: Raltegravir Potassium; Maraviroc
Intervention model: Single Group Assignment
Intervention model description: Single arm treatment study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1; CD4; Viral Load; Human Immunodeficiency Virus (HIV)
Metabolic Effects of Exogenous 3-hydroxybutyrate in Patients With Type 1 Diabetes and Healthy Controls
Condition: Type 1 Diabetes Mellitus; Diabetic Ketoacidosis
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Ketosis; Diabetic Ketoacidosis
Study type: Interventional

Summary: 
      The main objective of this clinical trial is to study the metabolic effects of intravenous
      infusion of the ketone body, 3-hydroxybutyrate (3-OHB), in patients with type 1 diabetes and
      healthy control subjects. Moreover, the investigators plan to examine regulatory mechanisms
      of 3-OHB that may be related to diabetic ketoacidosis.

      The hypotheses are:

        1. 3-OHB related inhibition of lipolysis is impaired in patients with type 1 diabetes.

        2. Intravenous infusion of 3-OHB affects signaling pathways involved in the metabolic
           regulation in patients with type 1 diabetes and healthy controls.

        3. 3-OHB infusion improves cardiac function in patients with type 1 diabetes and healthy
           controls.

      The effects of 3-OHB will be investigated by isotopic tracers examinations, fat and muscle
      biopsies and blood samples. To evaluate effects on cardiac function echocardiography will be
      performed.
    


Intervention name(s): 3-hydroxybutyrate
Intervention type(s): Biological
Intervention description(s): 3-hydroxybutyrate is a metabolite, produced in the human body.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover design in 2 different groups, patients with type 1 diabetes and healthy controls.
Masking: Single (Participant)
Primary purpose: Basic Science
Connecting Contact Lenses and Digital Technology
Condition: Asthenopia; Contact Lenses; Ocular Accommodation; Convergence, Excess
MeSH terms: Asthenopia
Study type: Interventional

Summary: 
      This study seeks to address whether or not different types of daily disposable soft contact
      lenses may be a beneficial option for patients complaining of eye strain and visual
      discomfort while using digital devices.
    

Detailed description: 
      This was a prospective, single site, randomized, double-masked, crossover pilot study.
      Subjects were randomized to begin with either multifocal or single vision distance contact
      lenses. The lenses used in this study were the 1-Day Acuvue (AV) Moist spherical
      single-vision soft contact lenses (SSCL) in the 8.5 base curve and the 1-Day AV Moist
      Multifocal (MFSCL) in the low ADD (etafilcon A, 58% water content). The preferred viewing
      distance on digital devices for a similar age group to our study was 63 cm which would
      require a near ADD of +1.59D. A low addition (ADD) yielding up to +1.25D was selected to
      provide an intermediate near addition without compromising distance vision as much as would
      be expected with higher add powers. The multifocal lens utilizes an aspheric center-near
      design. Subjects wore the lenses on a daily wear, daily disposable schedule. Following one
      week (± 2 days) of lens wear, subjects were evaluated and the alternate lenses dispensed.
      Adverse events were collected and assessed at each study visit.
    

Intervention name(s): Test Daily Disposable Soft Contact Lenses; Control Daily Disposable Soft Contact Lenses
Intervention type(s): Device; Device
Intervention description(s): Worn daily for 7 +/- 2 days; Worn daily for 7 +/- 2 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment