bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Prophylactic Administration of Oxytocin in Uniject™ on Postpartum Hemorrhage at Home Births in Ghana
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      This study is designed to test the hypothesis that the intramuscular administration of 10 IU
      of oxytocin in Uniject™ during the third stage of labor by a Community Health Officer (CHO)
      at home births in Ghana will reduce the risk of postpartum hemorrhage by 50 percent relative
      to home births attended by the same type of provider who does not provide a uterotonic drug.
    


Intervention name(s): Oxytocin in Uniject
Intervention type(s): Other
Intervention description(s): 10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby
Other intervention name(s): uterotonic, pitocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hemorrhage; uterotonic; oxytocin; blood loss; community; Ghana; randomized trial
Rosiglitazone in the Treatment of HIV-Associated Hyperlipidemia
Condition: HIV Infections; Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research is to study the effects of rosiglitazone, a drug usually taken
      for Type II diabetes, on HIV-associated hyperlipidemia. HIV-associated lipodystrophy is a
      medical condition characterized by gradual changes in the distribution of body fat. The body
      fat located in the extremities and face disappears while body fat around the abdomen and
      upper back increases. Certain biochemical changes occur in association with these changes in
      fat distribution. Lipid levels particularly serum triglycerides are increased. HDL, the "good
      cholesterol" is decreased. Higher than normal level of insulin or insulin resistance is also
      found in this condition. This latter condition is one of the hallmarks of Type II diabetes.
      The protease inhibitors, a class of HIV medications, are associated with the occurrence of
      HIV-associated lipodystrophy. It has been suggested that a biochemical pathway known as the
      peripheral peroxisomal activating receptor (PPAR) gamma system is blocked leading to the
      onset of this condition.

      Rosiglitazone is a new drug approved by the FDA in 1999 for the treatment of type II
      diabetes. It lowers blood sugar by improving insulin resistance, which as mentioned before,
      is the hallmark of Type II diabetes. It has also been noted to improve blood lipid levels.
      Rosiglitazone works by stimulating the PPAR gamma system. It is hoped that this drug can turn
      on the PPAR system and reverse the HIV-associated lipodystrophy syndrome.
    


Intervention name(s): Rosiglitazone
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-associated hyperlipidemia
Stroke Recovery Research Based on EEG-fMRI
Condition: Motor Neuropathy
MeSH terms: Stroke
Study type: Observational

Summary: 
      This study is aimed to investigate the post-stroke motor recovery of patients with ischemic
      stroke based on their neural features extracted from EEG-fMRI data.
    

Detailed description: 
      A group of patients with ischemic stroke and age/gender matched healthy controls would be
      enrolled in this study. Their features of neural activities based on EEG-fMRI fusion scan
      would be extracted to investigate the mechanisms of motor recovery after stroke.
      Particularly, the correlations of their features of neural networks or local activities to
      their motor function (defined as their Fugl-Meyer scores) at enrollment and their recovery
      time courses consisted of Fugl-Meyer scores in follow-up time points.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        AA population with motor impairment induced by first-ever stroke in a specific duration
        (7-14 days after stroke attack, i.e., early subacute stage) would be enrolled to
        investigate the mechanisms of post-stroke recovery of motor function.
      
Keywords: motor function recovery; ischemic stroke; EEG-fMRI; neural plasticity
A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      A 2 phase study to evaluate disease progression in Parkinson's disease patients taking
      rasagiline
    


Intervention name(s): Rasagiline Mesylate; Rasagiline Mesylate; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): tablet, 1mg once daily; tablet, 2mg once daily; Placebo
Intervention MeSH terms: Rasagiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's; Rasagiline Mesylate
Effect of Shoulder Retraction on Success Rate of Subclavian Vein Catheterization
Condition: Subclavian Vein Catheterization
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the shoulder retraction by placing a saline
      bag between the scapula influences a success rate of subclavian vein catheterization.
    


Intervention name(s): position of shoulder retraction; position of neutral shoulder
Intervention type(s): Procedure; Procedure
Intervention description(s): position of shoulder retraction by placing a saline bag between the scapula; neutral shoulder position during subclavian vein catheterization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: subclavian vein catheterization success rate
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in India Women
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing
      pregnancy rate in women undergoing controlled ovarian stimulation.
    


Intervention name(s): Follitropin Delta (FE 999049); Follitropin Alfa (GONAL-F)
Intervention type(s): Drug; Drug
Intervention description(s): FE 999049 will be administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 will have their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomization. For participants with low AMH (<15 pmol/L) the daily FE 999049 dose will be 12 μg, irrespective of body weight. For participants with high AMH (≥15 pmol/L) the daily FE 999049 dose will be on a continuous scale ranging from 0.19 to 0.10 μg/kg, i.e. dependent on actual AMH and body weight. The daily FE 999049 dose will be fixed throughout the stimulation period and maximum allowed daily dose will be 12 μg. Participants could be treated for a maximum of 20 days.; GONAL-F will be administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F will be 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose will be 450 IU. Participants could be treated for a maximum of 20 days.
Other intervention name(s): REKOVELLE; GONAL-F
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Influence of Fat Perception on Satiety From Consumption of Reduced Fat Snacks
Condition: Appetitive Behavior; Individual Difference; Food Sensitivity; Food Preferences
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The present study aims to investigate the effect of fat level and fat type of a snack on
      self-reported satiety and associated biomarkers. The relevant individual differences will
      also be investigated.
    

Detailed description: 
      The aims are: (1) To determine whether reducing fat in a snack leads to rebound hunger and
      higher food intake at the subsequent meal, (2)To determine whether a low fat snack product
      matched for expected satiety leads to differences in post-ingestive satiety (i.e. mouth-gut
      discordance), (2) To determine whether individual differences in sensory perception influence
      expected or post-ingestive satiety.

      Stage 1, Characterising Volunteers:

      Fat is perceived through three sensory modalities; mouthfeel, taste and odour. Humans vary in
      their perception of fat across all sensory modalities. Volunteers will be characterised on
      their ability to taste fatty acids and perceive mouthfeel.

      Stage 2, Establish Sensory Tolerance in Expected Satiety of a fat reduced snack model:

      Reduced fat products are typically reformulated to match the perceived texture and mouthfeel
      of the original product. This stage aims to quantify sensory tolerance to fat reduction.

      Stage 3, Establish Mouth Gut Discordance of a fat reduced snack model:

      Using a standard preload study design, and the same fat-emulsion snack model from stage 2,
      the investigators will contrast effects of 3 test samples in a balanced cross-over design.
    

Intervention name(s): Expanded Corn Snack
Intervention type(s): Behavioral
Intervention description(s): A standard expanded snack will be used in each of the 3 arms, the content and type of fat added to the snack is varied in the two experimental arms.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a 3 way crossover design using a pre-load study protocol that is standard for behavioural appetite studies. The study will be conducted single-blind, as it is not feasible to blind the researcher to the pre-load food products. Each participant will attend 3 visits, the pre-load study foods will be presented to them with random blinding codes.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Fat; Oral sensitivity; Appetite; Metabolism
Repetitive Magnetic Transcranial Stimulation (rTMS) in the Treatment of Generalized Anxiety Disorder (GAD)
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive method that holds
      promise for treating several psychiatric disorders. Yet the most effective location and
      parameters for treatment need more exploration. Also, whether rTMS is an effective treatment
      for individuals with a DSM-IV diagnosis of Generalized Anxiety Disorder (GAD) has not been
      empirically tested. The goal of this pilot study is to evaluate whether fMRI guided rTMS is
      effective in reducing symptoms of GAD.
    

Detailed description: 
      This study utilized a 3-week open-label design to evaluate the efficacy of fMRI guided rTMS
      in the treatment of GAD.

      We first used functional magnetic resonance imaging (fMRI) during the gambling task to
      localize anxiety-related brain activations in each individual participant, and then used this
      information to guide treatment with repetitive transcranial magnetic stimulation (rTMS).

      TMS was delivered to the target site at a frequency of 1 Hz for 20 minutes (900 total
      pulses). The intensity of the TMS was set to 90% of the passive motor threshold for each
      participant.

      The primary efficacy measures include the Clinical Global Impression of Improvement (CGI-I)
      and the Hamilton Anxiety Rating Scale (HARS). Response to treatment was defined as a
      reduction of 50% or more on the HARS and symptom remission was defined as a CGI-I score of 1
      or 2 ("much improved" or "very much improved" respectively) and a score ≤ 8 on the HARS. Data
      was entered anonymously into an Excel spreadsheet and analyzed by the UCLA Semel Institute
      Statistical Core. The analysis was done on the intent to treat sample using last observation
      carried forward (LOCF). A one-sample paired t-test was used to compare endpoint to baseline
      means on the HARS, with a significance level set at p= 0.05, two-tailed.
    

Intervention name(s): Repetitive transcranial magnetic stimulation (rTMS)
Intervention type(s): Procedure
Intervention description(s): transcranial magnetic stimulation (TMS) at .5 HZ for 20s
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: repetitive magnetic transcranial stimulation (rTMS); functional magnetic resonance imaging (fMRI)
A Pilot Study Investigating Transcranial Direct Current Stimulation (tDCS) to Enhance Mindfulness Meditation
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a new technology applied while listening to a
      mindfulness meditation tape can affect one's ability to achieve a state of "mindfulness." The
      new technology is called transcranial direct current stimulation, or tDCS.
    

Detailed description: 
      Many people initially attempt meditation but cannot get their mind to be still. Or they do
      not get quick results and find it frustrating. Thus, the number of people benefiting from
      meditation would increase if there were a method of making it easier to perform. Moreover,
      establishing the actual brain mechanisms involved in the benefits of meditation would
      potentially open up synergistic treatments and approaches.

      The investigators will investigate the use of a new, non-invasive brain stimulation method
      called transcranial direct current stimulation (tDCS) to augment a state of mindfulness. tDCS
      is a safe, inexpensive, non-invasive brain stimulation modality that has the capability of
      focally increasing or decreasing cortical activity. Anodal stimulation produces positive DC
      stimulation and is associated with increased cortical activity, whereas Cathodal stimulation
      produces a negative DC stimulation and is associated with decreased cortical activity.
      Cortical activity changes occur both during and after stimulation in a dose response fashion
      (higher current density and longer duration of stimulation produces larger and longer lasting
      effects).

      The investigators will be investigating the use of tDCS to augment mindfulness meditation in
      a double-blind, crossover, randomized, sham-controlled trial.
    

Intervention name(s): tDCS via Chattanooga Ionto Iontophoresis System-Phoresor; Sham tDCS Chattanooga Ionto Iontophoresis System-Phoresor
Intervention type(s): Device; Device
Intervention description(s): Small electrical current delivered non-invasively to the scalp. 1mA electrical current to Meditation and Active Stimulation 1 condition. 2mA to Meditation and Active 2 Stimulation condition.; Blinds participants to meditation condition by applying 30 seconds of real stimulation and then turning the device off.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Metformin Hydrochloride 1000mg Tablets Under Fasting Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional

Summary: 
      The objective of this study was to evaluate the relative bioavailability of the test
      formulation of metformin hydrochloride 1000 mg tablets with an already marketed reference
      formulation GLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets (Bristol-Myers Squibb
      Company) under fasted conditions in healthy, male and female adult subjects.
    

Detailed description: 
      This randomized, single-dose, two-way, crossover study was conducted to compare the relative
      bioavailability of two formulations of 1000 mg metformin hydrochloride tablets under fasting
      conditions. The study was conducted with 32 (30 completing) healthy adults in accordance with
      Protocol No. 10640302 (Revision 0). In each study period, a single dose (1 x 1000 mg tablet)
      was administered to all subjects following an overnight fast of at least 10 hours. The test
      formulation was Ohm Laboratories, Inc's (A Group of Ranbaxy Pharmaceuticals Inc.) Metformin
      Hydrochloride 1000 mg Tablets and the reference formulation was GLUCOPHAGE® (metformin
      hydrochloride) 1000 mg Tablets (Bristol-Myers Squibb Company). The subjects received the test
      product in one study period and the reference product in the other period; the order of
      administration was according to the dosing randomization schedule. There was a 7-day interval
      between treatments.

      Blood samples were collected pre-dose and at intervals over 24 hours after each dose. The
      plasma samples for all subjects completing both periods of the study were sent to Helen
      Fassoulas, Director of Operations, Warnex Bioanalytical Services Inc., 3885 boul Industriel,
      Laval, Quebec, H7L4S3 Canada, Telephone: 450-663-6724, Fax: 450-975-8111 for determination of
      metformin concentrations.

      Statistical analysis was performed by Braulio Suarez, M.D., Novum Pharmaceutical Research
      Services, Wilcrest Green Office Park, 3320 Walnut Bend Lane, Houston, Texas 77042-4712, USA,
      Telephone: 832-251-8100, Fax: 832-251-7133.

      A total of 32 healthy adult subjects (30 completing).
    

Intervention name(s): metformin hydrochloride 1000 mg tablets
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence metformin hydrochloride 1000 mg tablets fasting conditions
Diamel in the Treatment of Type 2 Diabetic Patients Receiving Insulin Therapy
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy of Diamel (dietary supplement)
      administration in the treatment of patients with type 2 diabetes receiving insulin therapy.
      The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks.
      The estimated number of patients to be recruited and randomized for the study is 116. Daily
      insulin requirements, blood glucose (fasting and post-prandial) concentrations, glycosylated
      hemoglobin (HbA1c), triglycerides and cholesterol will be assessed at the beginning and after
      24 weeks of treatment.
    


Intervention name(s): Diamel; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks, in combination with the standard treatment consisting in two daily doses of insulin and proper diet.; Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks, in combination with the standard treatment consisting in two daily doses of insulin and proper diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes; Diamel; Dietary supplement
Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      HIV Open-label Prevention Extension (HOPE).
    

Detailed description: 
      A Phase 3B Open-Label Follow-on Trial to Assess the Continues Safety of and Adherence to a
      Vaginal ring Containing Dapivirine in Women
    

Intervention name(s): Dapivirine Vaginal Ring
Intervention type(s): Combination Product
Intervention description(s): Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.
Intervention MeSH terms: Dapivirine
Intervention model: Single Group Assignment
Intervention model description: Participants will receive a silicone elastomer vaginal matrix ring containing 25 mg of dapivirine to be replaced each month for a total period of 12 months of use.
Masking: None (Open Label)
Primary purpose: Prevention
Self Efficacy Levels, Attachment Style and Resiliency of Youth With Type 1 Diabetes
Condition: Type1diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This project will assess self-efficacy levels(SE) ,resiliency and attachment style of
      adolescent with type 1 diabetes and their caregivers.SE and attachment style of patients and
      parents will be compared with each other as well as correlated with diabetes management as
      assessed by A1C and self inventory scale.
    


Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        T1DM patients aged 12 - 18 yrs from Sick Kids Diabetes Clinic and their primary caregiver.
      
Keywords: Self Efficacy; Resiliency; Attachment style and youth with type 1 diabetes