bioihbjkbjnl/mcl2 huggingface dataset:
Menstrual Cycle Hormones and Eating Behavior
Condition: Dietary Habits; Food Preference
Study type: Observational

Summary: 
      The purpose of this study is to determine if the phase of the menstrual cycle (opposed versus
      unopposed estrogen phase) affects eating behavior, including types of foods preferred,
      wanting/desire for specific foods, and perception of hunger.
    

Detailed description: 
      This is an observational study to investigate the effect of endogenous estrogen (E2) and
      progesterone (P4) levels on eating behavior and energy-yielding nutrient metabolism. Eating
      behavior will be assessed during a complete menstrual cycle during the first month of the
      study. Participants will track the follicular and luteal phases of their menstrual cycle
      using urinary leuteinizing hormone (LH) kits, they will record information about their food
      intake, eating behaviors, and appetite in their home environments, and they will complete two
      laboratory test days: one test day scheduled during their follicular phase, and one test day
      scheduled during their luteal phase.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy, premenopausal women.
      
Biospecimen description: 
      Serum, plasma and urine samples may be retained for future testing.
    
Keywords: menstrual cycle; estrogen
Partnership Programs to Reduce Cardiovascular Disparities- Morehouse- Emory Partnership
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Observational

Summary: 
      The theme of this Morehouse-Emory Partnership Program focuses on elucidating the etiologic
      basis of ethnic differences in obesity-related CVD and discovering new intervention
      strategies to ameliorate CV health in all communities. The proposed Program uses a
      multi-disciplinary strategy to systematically characterize ethnic differences in
      obesity-related CVD by drawing upon the fields of physiology, psychology, biochemistry,
      vascular biology, public health, nursing and clinical medicine.
    

Detailed description: 
      Emerging evidence indicates that there are ethnicity-specific differences in the profile of
      biochemical, metabolic and physiological perturbations associated with obesity. The
      implications of these ethnic differences remain to be further defined. Several epidemiologic
      studies have shown that vascular disease and its cardiovascular complications, carry
      significantly higher morbidity and mortality in African Americans compared with
      Caucasians.1-3 These observations may be partly explained by a higher prevalence of
      cardiovascular disease risk factors, such as essential hypertension, diabetes mellitus, and
      tobacco use among African Americans.4-6 However, the pathophysiological processes underlying
      this racial predisposition have not been fully elucidated.7 It is likely that the etiologic
      basis of ethnic disparities in cardiovascular disease is multi-factorial and involves dynamic
      gene-environment interactions in which variances in behavior and the social context are
      critical determinants.

      The proposed Program recognizes the importance of incorporating both biological factors and
      social determinants in the analysis of cardiovascular disparities
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        African American and White residents age 30-65
      
Biospecimen description: 
      Blood samples metabolic testing
A Study to Measure Serum Periostin, Asthma-Related Biomarkers and Response to Prednisolone in Adult and Adolescent Patients With Severe Oral Corticosteroid-Dependent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This interventional, open study will evaluate clinical data in relation to biomarkers in
      patients 12 to 75 years of age with severe oral corticosteroid (OCS) - dependent asthma.
      Patients with uncontrolled asthma will be offered an additional escalation of OCS at a dose
      of 0.5 mg/kg for 7 days. Patients enrolled in this study would be eligible to be enrolled in
      a future placebo-controlled intervention study designed to measure the steroid-sparing effect
      of lebrikizumab.
    


Intervention name(s): LABA; corticosteroids; prednisolone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): long-acting beta-agonist treatment; chronic treatment with oral corticosteroids, high dose inhaled corticosteroids; additional 0.5 mg/kg orally for 7 days
Intervention MeSH terms: Prednisolone
Intervention model: Single Group Assignment
Masking: None (Open Label)
A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (MS)
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, randomized, multicenter, comparative, and parallel-group study
      comparing the therapeutic effects of two interferon-beta-1a regimens in relapsing-remitting
      multiple sclerosis (MS). The primary objective is to demonstrate the superiority of Rebif® 44
      microgram (mcg) subcutaneous injection given three times a week (132 mcg per week) to that of
      Avonex® 30 mcg intramuscular injection given once a week.
    


Intervention name(s): Rebif®; Avonex®
Intervention type(s): Drug; Drug
Intervention description(s): Rebif® injection will be administered subcutaneously at a dose of 44 mcg, three times per week, up to 72 weeks.; Avonex® injection will be administered intramuscularly at a dose of 30 mcg, once weekly, up to 72 weeks.
Intervention MeSH terms: Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsing-remitting Multiple Sclerosis; Rebif®; Avonex®; interferon-beta-1a
Norepinephrine for Hypotension in Cesarean Section
Condition: Hypotension; Cesarean Section
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      Hypotension is a very common consequence of the sympathetic vasomotor block caused by spinal
      anesthesia for cesarean section. Maternal symptoms such as nausea, vomiting and dyspnea
      frequently accompany severe hypotension, and adverse effects on the fetus, including
      depressed APGAR scores and umbilical acidosis, have been correlated with severity and
      duration of hypotension. Because hypotension is frequent, vasopressors should be used
      routinely and preferably prophylactically.
    

Detailed description: 
      Phenylephrine has a potent direct α effect, with virtually no β effects at clinical doses,
      however when given at higher than required doses, it may induce baroreceptor-mediated
      bradycardia with a consequent reduction in maternal cardiac output. Although α agonist drugs
      are the most appropriate agents to treat or prevent hypotension following spinal anaesthesia,
      those with a small amount of β agonist activity may have the best profile (noradrenaline
      (norepinephrine) and metaraminol. Phenylephrine is currently recommended due to the amount of
      supporting data.Noradrenaline is the primary catecholamine released by postganglionic
      adrenergic nerves. It is a potent α adrenergic agonist, with comparatively modest β agonist
      activity.
    

Intervention name(s): Norepinephrine; Phenylephrine
Intervention type(s): Drug; Drug
Intervention description(s): prophylaxis for hypotension; standerd prophylaxis for hypotension
Other intervention name(s): noradrenaline; phenylephrine hydrochloride
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: post spinal anesthesia
Secondary Prevention in Type 2 Diabetes: Comparison of Two Different Resistance Exercise Training Protocols
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Skeletal muscle accounts for up to 40% of the total body weight and is responsible for
      approximately 75% of the whole body insulin-stimulated glucose uptake. Resistance training
      has been shown to improve insulin-stimulated glucose uptake in patients with T2DM. Therefore
      the investigators aim to compose the effects of 2 different resistance training protocols in
      combination with aerobic endurance training (AET) on muscle strength, muscle mass and
      glycemic control in type 2 diabetes mellitus patients (T2DM).

      The investigators aim to perform an 8 week randomized controlled training intervention in 32
      T2DM patients. Patients will be randomly assigned to AET (cycle ergometer, 60-70% of heart
      rate reserve) combined with hypertrophy resistance training (HRT, n=16, 2 sets, 10-12
      repetitions, 70% of the one-repetition maximum) or with endurance resistance training (ERT,
      n=16, 2 sets, 25-30 repetitions, 40% of the one-repetition maximum). Body composition, blood
      analyses, physical work capacity and muscle strength will be measured pre- and
      post-intervention.
    


Intervention name(s): Physical exercise training
Intervention type(s): Other
Intervention description(s): aerobic endurance training (cycle ergometer, 60-70% heart rate reserve) hypertrophy resistance training (2sets, 10-12 repetitions, 70% of the one-repetition maximum) endurance resistance training (2 sets, 25-30 repetitions, 40% of the one-repetition maximum)
Other intervention name(s): training intervention; resistance training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes mellitus; type 2 diabetes; T2DM; resistance training; hypertrophy training; endurance training
Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine
Condition: Endometritis
MeSH terms: Endometritis
Study type: Interventional

Summary: 
      Endomyometritis is an "infection in the uterus". It can occur in up to 1 out of 5 women
      having unplanned cesarean deliveries. Antibiotics are routinely given at the time of Cesarean
      delivery, but the infection in the uterus can still occur. When endomyometritis occurs it can
      prolong the woman's stay in the hospital after birth, slow down her recovery time at home,
      and increase medical costs. Methergine is a medication that is routinely used to stop uterine
      hemorrhage (excessive bleeding from the uterus) that sometimes happens after delivery.
      Methergine works by contracting (tightening) the uterus. These contractions also help the
      uterus to expel or remove parts of the placenta that increase the chance of developing a
      uterine infection.

      This research study is being done to learn if routine use of Methergine can lower the chances
      of developing a uterine infection after cesarean delivery. Half of the women in this study
      will receive Methergine for a few days during their hospitalization after cesarean delivery.
      The other half of the women will not routinely receive Methergine.
    


Intervention name(s): Methergine
Intervention type(s): Drug
Intervention description(s): Scheduled methergine 0.2 mg PO every 6hrs for duration of postpartum stay
Intervention MeSH terms: Methylergonovine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
KoMAC Videolaryngoscope for Double-lumen Intubation
Condition: Intubation
Study type: Interventional

Summary: 
      KoMAC videolaryngoscope is a portable intubating device with an angulated single-use blade of
      adjustable size and a liquid crystal display monitor mounted on top of the handle, which is
      similar in shape to the McGrath videolaryngoscope. The purpose of this study was to evaluate
      the efficacy of the KoMAC videolaryngoscope for double-lumen intubation regarding intubation
      time, laryngeal view and ease of intubation, compared to Macintosh laryngoscope.
    


Intervention name(s): KoMAC videolaryngoscope; Macintosh Laryngoscope
Intervention type(s): Device; Device
Intervention description(s): Double lumen endotracheal intubation was performed with the KoMAC videolaryngoscope; Double lumen endotracheal intubation was performed with the Macintosh Laryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: double lumen intubation; videolaryngoscope
Effectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to evaluate the effectiveness of steroid injection and
      immobilization versus no immobilization in treating patients with lateral epicondylitis.
    


Intervention name(s): Depomedrol; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lateral epicondylitis; treatment; steroid; immobilization
A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study was double-blind, randomized, vehicle-controlled study with application of
      Ruxolitinib phosphate cream or vehicle cream in participants with stable plaque psoriasis
      applied once daily for 12 weeks without occlusive dressings. There were 4 treatment groups
      anticipated to have 50 participants in each.
    


Intervention name(s): Placebo Cream; Ruxolitinib Phosphate
Intervention type(s): Other; Drug
Intervention description(s): Cream with no active drug; Ruxolitinib phosphate cream
Other intervention name(s): INCB018424
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase II Study of AP0302 5% Versus a Vehicle Comparator
Condition: Pain; Delayed Onset Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302)
      applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed
      onset muscle soreness.
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel
      5% in reducing pain/soreness associated with delayed onset muscle soreness (DOMS).
    

Intervention name(s): S-Ibuprofen Topical Gel 5%; Vehicle Topical Gel
Intervention type(s): Drug; Drug
Intervention description(s): S-Ibuprofen Topical Gel 5% applied every 6 hours; Vehicle Topical Gel applied every 6 hours
Other intervention name(s): Active Gel; Vehicle Gel
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: muscle soreness
Cognitive Therapy Plus Dietary Intervention for Obesity Treatment
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      This randomized clinical trial was carried out from January 2017 to December 2017 at the
      facilities of the Catholic University of Murcia. Written informed consent was required from
      each patient. The protocols of the present clinical trial follow the CONSORT standards. To
      measure the impact of cognitive training on weight loss in overweight / obese subjects, a
      double-blind study (de facto masking) was designed.

      Both the participants and the statistical assessors were unaware of the study hypothesis.
      Participants were unaware of treatments and possible assignments between groups, and only
      those subjects who were randomly assigned to the cognitive training group were informed that
      such training was part of dietary therapy.

      The principal investigator of the present study (J.J.H.M.) carried out the randomization,
      with the assistance of the Microsoft Excell program, with the help of a macro designed in
      Visual Basic® for that purpose.

      The randomization divided the subjects into two groups, as they were treated with a
      hypocaloric diet plus 12 nutrition education sessions (CONTROL group) or a group that were
      treated with a hypocaloric diet plus 12 sessions of cognitive training (COGNITIVE group).

      In order to obtain a similar size in both groups, a randomization in blocks with a 1: 1
      allocation ratio was performed.

      Cognitive performance measures were performed before and after training. One week before the
      beginning of the cognitive and dietary intervention, the participants performed a series of
      cognitive tests. After 12 weeks of both dietary and cognitive intervention, participants were
      reexamined to measure performance on neurocognitive tests.
    


Intervention name(s): Cognitive Training
Intervention type(s): Behavioral
Intervention description(s): The intervention was carried out with the PC game Brain Exercise TM (Bandai Namco Games Ltd.). Participants held the training sessions on an HP 250 G3 Notebook PC (Windows 10), with a 15-inch screen, and a resolution of 1366x768x40 Hz. The performance achieved by each participant in each session was recorded to analyze the evolution of the subjects. The participants made a total of 12 practice exercises, which implies approximately 30 minutes of duration per session.
Other intervention name(s): Cognitive Rehabilitation Therapy; Executive Function Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity, cognitive therapy, executive function
Serial Movement Assessment in Collegiate Athletes Who Perform Injury Prevention Training
Condition: Injury Leg; Injury, Knee; Injury;Sports; Injury, Ankle
MeSH terms: Wounds and Injuries; Athletic Injuries; Knee Injuries; Ankle Injuries
Study type: Interventional

Summary: 
      Athletic injury can result in decreased athletic performance or removal from sport
      participation. There may also be psychological and financial impacts of athletic injury.
      Additionally, there can be long-term consequences, such as increased risk of subsequent
      injury or arthritis. Therefore, determining ways to prevent athletic injury from occurring is
      critical. Movement quality during sport is related to injury risk. Athletes who move poorly
      are generally at increased risk of injury compared to athletes who move well. Movement
      quality can be improved through exercise-based injury prevention training, thereby decreasing
      injury risk. This purposed of this study is to evaluate movement quality multiple times over
      the course of an athletic season in collegiate athletes who perform injury prevention
      training. The hypothesis is that movement quality will improve over the course of an athletic
      season.
    


Intervention name(s): Exercise-based injury prevention program
Intervention type(s): Other
Intervention description(s): ~10-minute, 4+ times/week exercise-based injury prevention program. Includes flexibility, strengthening, balance, agility and plyometric exercises.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: sport injury; injury prevention; neuromuscular control
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of ALKS 5461.
    


Intervention name(s): ALKS 5461; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant); Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major depressive disorder (MDD); depression; Alkermes; ALKS 5461; samidorphan
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy, safety and tolerability of
      cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD
      who have had an inadequate response to antidepressants alone.
    


Intervention name(s): Cariprazine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cariprazine supplied in capsules; Placebo supplied in capsules
Intervention MeSH terms: Cariprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MDD
Immune Responses to BCG Vaccination in Malawi and the UK
Condition: Immunity, Cellular; Hypersensitivity, Delayed Type
MeSH terms: Hypersensitivity; Hypersensitivity, Delayed
Study type: Interventional
Phase: Phase 2

Summary: 
      BCG vaccination has been found to provide greater protection against TB in the UK than in
      Malawi. This study compares immune responses in BCG-vaccinated and unvaccinated teenagers and
      young adults in Malawi and in the UK.
    


Intervention name(s): BCG
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention