bioihbjkbjnl/mcl2 huggingface dataset:
Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome
Condition: Fetal Demise; Fetal Growth Restriction; Preeclampsia; Abruptio Placentae; Thromboembolism
MeSH terms: Pre-Eclampsia; Fetal Growth Retardation; Fetal Death; Abruptio Placentae; Thromboembolism
Study type: Interventional

Summary: 
      The risk of venous thromboembolism increases in pregnancy. Thrombophilia whether genetic or
      acquired, is a hypercoagulable disorder that may increase the risk of venous thromboembolic
      events. Clinically, these events are presented as maternal deep vein thrombosis and pulmonary
      emboli. Thrombophilias are also associated with adverse fetal outcomes including intrauterine
      growth restriction, intrauterine fetal death, severe preeclampsia, placental abruption and
      recurrent abortions.

      Pregnant women who experienced one or more of the above complications are advised to be
      examined for the presence of the genetic or the acquired form of thrombophilia.

      Low molecular weight heparin prophylaxis, an anticoagulant, is advised for pregnant women
      with a history of thromboembolism, and many experts recommend prophylaxis for pregnant
      patients with a known thrombophilia and history of adverse pregnancy outcomes associated with
      these hypercoagulable states.

      Physiologic changes in normal pregnancy, including weight gain, increased renal clearance and
      volume of distribution, may decrease the availability of low molecular weight heparin
      (Enoxaparin or Dalteparin), or produce a less predictable response in pregnant women compared
      with nonpregnant women. There are no clear recommendations for use of prophylactic low
      molecular weight heparin in pregnancy. Clinicians tend to use doses suggested for nonpregnant
      patients. Regarding pregnant patients taking enoxaparin or dalteparin, the American College
      of Obstetricians and Gynecologists states that "because of the lack of data regarding
      adequate dosing during pregnancy, anti-factor Xa levels may be monitored".

      Two recently published studies demonstrated that plasma anti-factor Xa levels during
      pregnancy were lower than expected, indicating that many pregnant patients may receive a
      subprophylactic dosing.

      Our objective is to check pregnancy outcome among thrombophilic women treated with an
      adjusted enoxaparin thromboprophylaxis dosage according to anti-factor Xa plasma levels
      compared to women with fixed dosage.
    


Intervention name(s): enoxaparin
Intervention type(s): Drug
Intervention description(s): enoxaparin dosage will be adjusted according to anti-factor Xa plasma levels
Intervention MeSH terms: Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: placental syndrome; maternal thromboembolic event; enoxaparin; anti-factor Xa
Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser
      therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with
      acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject
      between 4.5 and 24 hours of stroke onset.
    


Intervention name(s): NeuroThera® Laser System
Intervention type(s): Device
Intervention description(s): Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke
Phase 2 Study of TD-9855 to Treat Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study study is to determine whether TD-9855 is effective in treating
      patients with fibromyalgia.
    


Intervention name(s): TD-9855 Group 1; TD-9855 Group 2; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia
The Effect of Vitrification Versus Slow Freezing on Day 3: a Randomised Controlled Trial.
Condition: Cryopreservation of Embryos
Study type: Interventional

Summary: 
      Randomized controlled trial (RCT) testing the hypothesis that vitrification is superior to
      slow freezing.
    


Intervention name(s): cryopreservation technique
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
HOME Study: a Combination Support Package to Increase Uptake of PrEP and HIV/STI Testing
Condition: HIV Prevention; Sexually Transmitted Diseases; Pre-Exposure Prophylaxis
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      Home HIV self-testing has been FDA approved and allows users to read their own HIV test
      results at home, while home sexually transmitted infection (STI) test self-collection allows
      men to use a swab at home and mail it in for testing. The purpose of this study is to learn
      how Men who have Sex with Men (MSM) use these new testing options, a set of online support
      tools, and the option to test with someone to support them (a testing "buddy").

      We will also evaluate whether the online tools help these men to connect with HIV prevention
      services such as Pre-Exposure Prophylaxis (PrEP) if they test HIV negative, and to HIV care
      services if they test HIV positive.
    

Detailed description: 
      Participants will be randomized 2:1 after enrollment to the intervention and control
      condition. Data obtained from this study will be used to inform the further tailoring and
      distribution of an intervention for young Black and Latino MSM to increase utilization of
      home HIV self-testing and linkage to HIV treatment and Pre-Exposure Prophylaxis (PrEP).
    

Intervention name(s): HOME Study intervention; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Access to home HIV test kits, home STI self-collection kits, the HOME Study website, and the SexPro HIV risk assessment tool.; Counseling about the importance of quarterly HIV/STI testing and a PrEP information pamphlet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PrEP; HIV prevention; Risk reduction; STI prevention; Home HIV testing; HIV testing; STI testing
Weight Loss and Changes in Cardiovascular Risk Markers With a Low Glycemic Diet Compared With a Standard Diet
Condition: Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Weight Loss
Study type: Interventional

Summary: 
      Overweight and obesity is increasing in most countries, including Norway, and the optimal
      diet for reducing weight is under discussion. The present study in overweight and moderate
      obese individuals compares a low glycemic load diet with a standard low-fat diet (as
      recommended from the National Nutrition Council) in an open, randomized trial over 12 months,
      with changes in weight loss and changes in cardiovascular risk markers as endpoints.
    

Detailed description: 
      Overweight and obesity is rapidly increasing in most countries, including Norway, and at
      present there is controversy regarding what diet should be recommended for reducing weight
      and the complications of obesity.

      The present study is performed in in 200 overweight and moderate obese individuals, that is
      in men with body mass index (BMI) from 28 to 40, and women with BMI 28-35. To be included,
      the participants should also have at least one component of the metabolic syndrome.

      After a medical examination and check for inclusion and exclusion criteria, the participants
      are randomized to one the two following diets: 1) A low-glycemic load diet aiming at a
      macronutrient composition with 25-30% of energy from protein, 35-40% from fat and 30-35% from
      carbohydrate or 2) A low-fat diet aiming at a macronutrient composition with 15% of energy
      from protein, 25-30% from fat and 55-60% from carbohydrate.

      Each group will have 9 dietary counselling sessions in the course of the study; baseline,
      week 2, month 1,3,4,5,6 and 9. Recommended total energy intake will be individualized based
      on the metabolic rate at rest for each subject, and using a physical activity level of 1,4. A
      500 kcal/day deficit relative to the daily energy requirements will be recommended.

      The primary objective will be to compare the effects of the two different diet
      recommendations with respect to the one-year change in body weight.

      As secondary objectives the study will compare the consequences of the two strategies with
      respect to 3, 6, and 12 months development of the variables glucose/insulin, insulin
      sensitivity index, number of metabolic syndrome factors, high sensitive C-reactive protein,
      lipids, lipoprotein B and anthropometric indices (waist /hip ratio). Serum will be frozen for
      additional parameters as leptin, adiponectin, ghrelin and ICAM. Also to be studied is an
      additional weight at 18 months follow-up, when no more advice is given past the 9-month
      visit.
    

Intervention name(s): Diet counseling
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity,; weight loss,; diet counseling; low-glycemic load
A Study to Evaluate Safety and Immunogenicity of AERAS-402
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I study will be conducted as a randomized, double-blind, placebo-controlled study
      in healthy adult subjects who are HIV-negative, BCG-vaccinated, and have no evidence of
      tuberculosis infection. The study will be conducted at one clinical research site in India.

      The available live tuberculosis vaccine, Bacillus Calmette-Guérin (BCG), provides incomplete
      protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or
      "booster", while not toxic, does not provide much additional protection. AERAS-402 presents
      tuberculosis antigens in the setting of a new, live, replication-deficient adenovirus vaccine
      that may increase T cell-mediated immunity and thus protection from tuberculosis. Since
      BCG-vaccinated individuals are the population for which AERAS-402 might be indicated,
      AERAS-402 will be administered to individuals already vaccinated with BCG.
    


Intervention name(s): AERAS 402; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL IM injection of 3 x 1010vp AERAS-402 on Study Days 0 and 28; 0.5 mL IM injection of 0vp (Placebo) on Study Days 0 and 28
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vaccine; TB; tuberculosis
First Safety Study in Humans of a Single Dose of CPG 52364
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Determine the safety and tolerability of the study drug, CPG 52364, when given as liquid or
      capsule. Another purpose is to determine how the drug enters and leaves the blood stream and
      body tissues over time.
    


Intervention name(s): Placebo Comparator: Cohort 1 Placebo; 52364 3 mg; Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo; 52364 10 mg; 52364 30 mg; 52364 100 mg; 52364 1 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Drug: placebo for cohort 1 as single dose; 3 mg capsule single dose administered orally as a single dose; Drug: Placebo for cohorts 2, 3, 4 and 5 administered as a single dose; Drug: 52364 30 mg capsule as a single dose; Drug: 52364 30 mg capsule administered as a single dose; Drug 52364 100 mg capsule administered as a single dose; 1 mg powder diluted in liquid or placebo (liquid alone) administered orally as a single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: treatment, parallel assignment, double blind, randomized, placebo control, safety study,SLE (Systemic Lupus Erythematosus)
Long-Term Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder (AD/HD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is long-term extension study to evaluate long-term safety and efficacy of
      Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder
      (AD/HD).
    


Intervention name(s): Atomoxetine hydrochloride
Intervention type(s): Drug
Intervention description(s): 0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
Other intervention name(s): LY139603; Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aripiprazole IM Depot in the Acute Treatment of Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase 3, multicenter, randomized, active-controlled trial to assess the efficacy
      and safety of aripiprazole Intramuscular Depot in the acute treatment of adults with
      schizophrenia. The trial will include a 13-day screening phase and a 12-week acute treatment
      phase with a 14(±2)-day safety follow-up.
    

Detailed description: 
      Screening Phase: The screening phase will begin when informed consent is signed and be a
      maximum of 13 days. The investigators will assess the subjects who meet all eligibility
      criteria and collect the characteristic information of the subjects, such as demographic,
      medical history, etc. If subjects have been exposed to aripiprazole in the past (ie,
      tolerability has been established), then subjects will enter a washout period for 3～7 days
      from prior antipsychotic medications and other prohibited concomitant medications. If the
      investigator may reasonably verify that subject has been off antipsychotics for at least 3～7
      days and has a history of tolerating aripiprazole, then the subject may have a screening
      phase of < 7 days as long as the subject has had at least a 3～7-day washout phase from other
      antipsychotic medications. Subjects are required to be hospitalized during the entire
      screening phase.

      12-week Acute Treatment Phase: At baseline, eligible subjects will be randomized in a 1:1
      ratio to either aripiprazole IM depot or aripiprazole tablet. For 14 days beginning with the
      first injection, subjects randomized aripiprazole IM depot will receive concomitant oral
      aripiprazole and subjects randomized to aripiprazole tablet will receive 12 weeks concomitant
      injection placebo.

      Safety Follow-up Phase: All subjects will be followed-up for safety via telephone contact
      14(±2) days after the last trial visit.
    

Intervention name(s): Aripiprazole IM Depot; Aripiprazole tablet
Intervention type(s): Drug; Drug
Intervention description(s): Aripiprazole IM depot 400 mg/300 mg (when not tolerated); Oral aripiprazole tablets 10 to 20 mg daily
Other intervention name(s): Aripiprazole Intramuscular Depot; Aripiprazole TAB
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Aripiprazole Intramuscular Depot; Acute treatment
International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The objective of the study is for clinical staff to gain experience using the proposed
      artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home
      usability prior to initiating a large randomized controlled trial.
    

Detailed description: 
      Participation in this study will require 5 study visits over 2-4 weeks.

        -  Visit 1: screening/enrollment visit to assess study eligibility.

        -  Visit 2: continuous glucose monitor (CGM) training and initiation session based upon
           current or prior use of a CGM; if subject doesn't currently use a CGM, subject will be
           trained and may be asked to wear the CGM at home for 1 week.

        -  Visit 3: subjects will be taught how to use the study insulin pump.

        -  Visit 4: subjects will be trained on the use of inControl and wear it at home for 14
           days.

        -  Visit 5: subjects will return study equipment and to complete questionnaire.
    

Intervention name(s): Artificial Pancreas
Intervention type(s): Device
Intervention description(s): Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump and continuous glucose monitor. This AP system is designed to help control blood sugar in people living with type 1 diabetes.
Other intervention name(s): inControl Diabetes Medical Platform
Intervention MeSH terms: Pancrelipase
Intervention model: Single Group Assignment
Intervention model description: The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial. Study subjects will wear the study insulin pump and CGM for approximately 2-4 weeks.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Artificial Pancreas; Closed Loop Control; Continuous Glucose Monitor (CGM)
Muscle Damage and Disuse Atrophy
Condition: Muscle Disuse Atrophy
MeSH terms: Muscular Disorders, Atrophic; Atrophy
Study type: Interventional

Summary: 
      Limb injury generally requires a period of recovery during which time the limb is often
      immobilised (e.g. with a cast or brace) resulting in a rapid loss of skeletal muscle. Despite
      the importance of muscle loss during injury, our understanding of how it occurs is
      incomplete. Several factors are likely to contribute, including a lack of muscle contraction
      and injury induced inflammation. In this study, the investigators will recruit healthy
      volunteers who will spend 7 days in a knee brace to replicate leg immobilisation. Prior to
      immobilisation, half of the participants will perform a single session of strenuous
      resistance exercise which is known to cause muscle damage and initiate an inflammatory
      response. This is designed to replicate the muscle damage and inflammation that occurs with
      injury. The remaining half of participants will not perform this exercise, allowing us to
      look at the additive effect of muscle damage and inflammation on muscle loss with
      immobilisation.
    


Intervention name(s): Eccentric exercise
Intervention type(s): Procedure
Intervention description(s): 300 eccentric contractions of the knee extensors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Muscle damage; Inflammation; Immobilisation
Comparison of 2 NovoFine® Needles on the Reflux of Insulin
Condition: Diabetes; Diabetes Mellitus, Type 1; Delivery Systems
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe. This trial aims to ensure that there is no substantial
      clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and
      NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.
    


Intervention name(s): NovoFine® needle 6 mm; NovoFine® needle 8 mm
Intervention type(s): Device; Device
Other intervention name(s): NEEDLEN; NEEDLEN
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Effect of Rifampicin, Ketoconazole, and Omeprazole on the Pharmacokinetics of Sativex
Condition: Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Known Inducer of CYP3A4; Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Potent Inhibitor of CYP3A4; Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a CYP2C19 Inhibitor
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the effect of rifampicin, ketoconazole and omeprazole on the pharmacokinetics
      of a single dose of Sativex and to evaluate the safety of Sativex when given in combination
      with these other drugs.
    

Detailed description: 
      An open-label, randomised, crossover, drug interaction study. Subjects were divided into
      three groups and within each group, subjects were randomised to one of two treatment
      sequences. Subjects received 4 sprays of Sativex alongside either doses of rifampicin,
      ketoconazole or omeprazole.
    

Intervention name(s): Sativex and rifampicin; Sativex and rifampicin; Sativex and ketoconazole; Sativex and ketoconazole; Sativex and omeprazole; Sativex and omeprazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose of 4 sprays Sativex on Day 1, Rifampicin 2 x 300 mg capsules on Days 2-10, Sativex dose of 4 sprays and rifampicin 2 x 300 mg capsules on Day 11.; Rifampicin 2 x 300 mg capsules on Days 1-9, Sativex x 4 sprays and rifampicin 2 x 300 mg capsules on Day 10, Single dose of Sativex 4 sprays on Day 18.; Single dose of 4 sprays Sativex on Day 1, ketoconazole 2 x 200 mg tablets on Days 2-5, Sativex x 4 sprays and ketoconazole 2 x 200mg on Day 6.; Ketoconazole 2 x 200 mg tablets on Days 1-4, Sativex x 4 sprays and ketoconazole 2 x 200 mg tablets on Day 5, Single dose of 4 sprays Sativex on Day 9.; Single dose of 4 sprays of Sativex on Day 1 Omeprazole 2 x 20 mg on Days 2-6. Sativex x 4 sprays and omeprazole 2 x 20 mg on Day 9.; Omeprazole 2 x 20 mg on Days 1-5, Sativex x 4 sprays and omeprazole 2 x 20 mg on Day 6, Single dose of 4 sprays Sativex on Day 9.
Intervention MeSH terms: Rifampin; Ketoconazole; Nabiximols; Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Sativex; Cytochrome P450; Pharmacokinetics; Cannabinoids; ketoconazole; omeprazole; rifampicin