bioihbjkbjnl/mcl2 huggingface dataset:
Protein Ingestion Before Training Low
Condition: Protein Metabolism
Study type: Interventional

Summary: 
      A randomized interventions study using a crossover design. Ten well trained triathletes or
      bikeriders will be included for to undergo two trail separated by about 3 weeks. The night
      before the trail each subject will performe a high intense interval trainings session on an
      ergometer bike. during the night an infusion of aminoacid tracers will be initiated. The
      subject is woken at 6.30 a.m. Blood samples and a musclebiopsy will be collected prior to the
      morning bike ride at 8.00a.m. Immediately before the morning bike ride is started the subject
      will ingest a drink of 0,5g protein or a non-caloric placebo (random order). During the bike
      ride and the following 4,5 hours blood will be drawn with regular intervals. at time point 0,
      60 and 180 min after the training session biopsies are collected.
    


Intervention name(s): Protein ingestion; Non-caloric placebo ingestion
Intervention type(s): Other; Other
Intervention description(s): A protein drink was ingested prior to the 90min bike ride in one of the completed trails (order randomised).; A placebo drink was ingested prior to the 90min bike ride in one of the completed trails (order randomised).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Endurance exercise; Dietary protein
The Role of Extracellular pH on Spermatozoa's Directional Movement in Vitro
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      The purpose of this research project is to determine whether or not the directional movement
      of spermatozoa is influenced by a pH gradient by examining spermatozoa in vitro.
    


Intervention name(s): Extracellular pH
Intervention type(s): Other
Intervention description(s): Extracellular pH gradient
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Males who come in to have their semen quality assessed.
Erector Spinae Plane Block for Postoperative Analgesia for Laparoscopic Cholecystectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many
      indications has been identified by case reports in the literature. As the investigators have
      considered that erector spinae plane block could be efficacious for providing postoperative
      analgesia in laparoscopic cholecystectomy, the investigators have implemented application of
      this blockade into practice at the clinic. Main purpose of this study is to evaluate the
      analgesic effect of ultrasound guided erector spinae block in laparoscopic cholecystectomy.
    


Intervention name(s): erector spinae plane block; Intravenous morphine patient controlled analgesia device
Intervention type(s): Other; Device
Intervention description(s): ultrasound guided erector spinae plane block will be administered to this group.; Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: erector spinae plane block; laparoscopic cholecystectomy; postoperative pain
Comparing Effect of Short Sleep Duration on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of the present study is to evaluate the effect of sleep duration on weight loss
      of obese and overweight adult when they are in a weight loss plan (NovinDiet Protocol). The
      investigators aim is to compare the effects of short term sleep duration with normal sleep
      duration with respect to body weight (and abdominal adiposity).
    


Intervention name(s): Diet
Intervention type(s): Other
Intervention description(s): Intervention 'Diet+ short sleep versus normal sleep
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Caloric Restriction; weight loss; sleep
Comparison Between the MacGrath MAC Videolaryngoscope and the MacIntosh Laryngoscope for Oro-tracheal Intubation for Patients With Less Than 2 Criteria of Difficult Intubation in Elective Surgery.
Condition: Laryngoscopy
Study type: Interventional

Summary: 
      The MILAR trial is a multicenter randomised , prospective, controlled, single-blind,
      superiority French clinical trial, with a 1: 1 distribution of patients to compare intubation
      during the first laryngoscopy between the MacGrath MAC videolaryngoscope and the MacIntosh
      laryngoscope for patients with less than 2 criteria of difficult intubation in elective
      surgery.
    

Detailed description: 
      Tracheal intubation is a common procedure in the operating room to secure the airway in
      patients receiving muscle relaxants .

      Two devices are currently used for this purpose with various indications: the French Society
      of Anesthesia and Resuscitation (SFAR) recommends a direct laryngoscopy with MacIntosh blade
      in first intention for patients with less than 2 criteria of difficult intubation (ID). The
      SFAR recommends first-line video laryngoscopy in patients with two or more criteria of
      difficult intubation. Video laryngoscopy improves glottic vision, difficult intubation score,
      and intubation success rate at the first attempt, compared to the direct laryngoscopy with a
      Macintosh blade.

      Currently, it is estimated that 15% of direct laryngoscopies with a MacIntosh blade result in
      failure of orotracheal intubation (IOT) on first attempt, whereas tracheal intubation with a
      video laryngoscopy is a better solution to secure the airway.

      Our hypothesis in this study is that the MacGrath MAC videolaryngoscope allows to intubate at
      the first laryngoscopy 91% of patients with less than 2 difficult intubation criteria,
      against the expected 85% with the MacIntosh blade.
    

Intervention name(s): Laryngoscopy with Mac Grath; direct laryngoscopy
Intervention type(s): Device; Device
Intervention description(s): Patients of this group will benefit MacGrath MAC video laryngoscopy for intubation after curarization; Patients of this group will benefit direct laryngoscopy for intubation after curarization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: MacGrath MAC; curarization; intubation; MacIntosh; laryngoscope
ATG in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis
Condition: Hematopoietic Stem Cell Transplantation; Antithymocyte Globulin; Viral Infection
MeSH terms: Virus Diseases; Graft vs Host Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the incidences of GVHD and viral infections in
      haploidentical hematopoietic stem cell transplant recipients receiving different dose of
      antithymocyte globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. Our
      first objective was to investigate the optimal dose of ATG for aGVHD and second object was to
      evaluate the effect of different dose of ATG on post-transplant viral infection.
    

Detailed description: 
      Allogeneic hematopoietic stem cell transplantation (allo-HSCT)is the only therapeutic option
      for many hematological malignancies. Unfortunately, about 75% of patients who require
      allo-HSCT lack human leukocyte antigen (HLA)-matched donors. The alternative is hematopoietic
      stem cells from an HLA-mismatched family donor. However, this strategy, which is called
      haploidentical HSCT, may be associated with high risk of early death and severe GVHD.

      Opportunistic infections are common complications after allo-HSCT. Due to the absence of
      effective preventive and therapeutic drugs for most viruses, viral infections has become one
      of the most important causes of death. The immunosuppression regimen including ATG has been
      shown effective to prevent severe GVHD in haploidentical HSCT. But this strategy delays
      immune reconstitution, and therefore increase the risk of viral infection.

      The optimal dose of the different ATG preparations with respect to prevention of GvHD is not
      fully understood today. The total doses between 6 mg/kg to 15 mg/kg are effective for
      prevention of GVHD, but the dose above 10 mg/kg may increase the development of viral
      infection.

      In this trial, we will focus on the incidence of aGVHD and viral infections in patients
      treated with 7.5mg/kg or 10mg/kg of ATG. The incidence of GVHD and viral infections will be
      compared between different dose arms.
    

Intervention name(s): ATG
Intervention type(s): Drug
Intervention description(s): ATG will be intravenously infused via a central venous catheter in 3 or 4 days, from day -4 or -3 until day -1. The other conditioning drugs administered before transplantation include cytosine arabinoside (Ara-C), busulfan (Bu),cyclophosphamide (Cy), Semustine(Me-CCNU), and ATG. All transplant recipients will receive cyclosporine A (CsA), mycophenolate mofetil(MMF), and short-term methotrexate for aGVHD prevention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: haploidentical hematopoietic Stem Cell Transplantation; Antithymocyte globulin; viral infection
Evaluating the Link Between Neighborhood Environments and Obesity Among African American Women
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      African American women have higher rates of obesity than women of any other racial or ethnic
      group in the United States. Obesity can have many causes, including genetic and environmental
      factors. This study will examine how neighborhood environments influence the occurrence of
      obesity among African American women.
    

Detailed description: 
      Obesity, which leads to higher rates of diabetes, cancer, and heart disease, is an
      increasingly important public health problem. In 2000, over 78% of African American women
      were overweight, and over 50% were obese. Several factors can contribute to obesity,
      including genetics, diet, and environmental factors. Individuals who live in an environment
      in which it is difficult to maintain an active lifestyle are more prone to obesity. The Black
      Women's Health Study (BWHS) is an extensive long-term study that is gathering data from women
      across the country to examine the occurrence of various diseases among African American
      women. Using BWHS study data and specific information on participants' neighborhoods,
      including street layout and the presence of sidewalks, this study will determine if
      neighborhood environments influence the prevalence of obesity among African American women.

      This study will use already-collected data on physical activity and body mass index of BWHS
      study participants who live in New York, Los Angeles, and Chicago; there are no additional
      study visits specifically for this study. A transportation and urban planning expert will
      compile data regarding the pedestrian environment of neighborhoods in all three cities,
      including the nature and density of land use, proximity to parks, presence of sidewalks,
      speed and volume of traffic, and street structure. Census data regarding participants'
      socioeconomic status will also be collected.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The Black Women's Health Study cohort comprises 59,000 African American women recruited
        mainly from subscribers to Essence magazine who returned the baseline 1995 survey.
      
Keywords: Body Mass Index
The Effect of Exercise on Anxiety and Cognition in Students at University
Condition: Exercise; Anxiety; Depression; Cognition
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      RATIONALE: Exercise may improve the mood and cognition in young people.

      PURPOSE: It has been well-known that physical exercise can generally benefit the mental
      health. However, most evidences that physical exercise improves psychiatric symptoms come
      from retrospective or cross-sectional studies. Moreover, the studies on the effect of
      physical exercise in the young adults' mental health were limited. This randomized-controlled
      trial aims to determinate the effects of a chronic and aerobic exercise on the mood and
      cognition of young people.
    

Detailed description: 
      OBJECTIVES: The anxiety and depression symptoms in young people are worth paying attention
      to, in China and worldwide. Meanwhile, cognitive function is very important for young
      people's learning and work. This project aims to evaluate the effectiveness of the moderate
      aerobic exercise to alleviate anxiety and depression in young people.

      DESIGN & METHODS: Undergraduate and graduate students aged 18-35 years will be randomly and
      evenly assigned to exercise and control groups. Subjects assigned to exercise group will
      receive an running exercise intervention more than 30 minutes and 3 times per week for 8
      weeks. The control group will be advised not to engage in physical activities. Outcome
      measures include the score of the Self-rating Anxiety Scale (SAS), Self-rating Depression
      Scale (SDS), the response time of Schulte Grid test, and the response time of Stroop
      Colour-Word Test at baseline and post-intervention in two groups. In addition, these
      assessments will be followed up at week 20 (3 months after the end of intervention).
    

Intervention name(s): Chronic aerobic exercise
Intervention type(s): Behavioral
Intervention description(s): Participants in the experimental group will exercise more than 30 minutes each time and 3 times weekly for 8 weeks. The chronic aerobic exercise in the present trial is running. The heart rate is required to 60% -85% of the maximum heart rate during exercise. Maximum heart rate = 220 - age.
Other intervention name(s): Workout
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Relative Bioavailability of Dabigatran and Diclofenac After Dabigatran Etexilate and Diclofenac Single Dose Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the relative bioavailability of dabigatran with and without concomitant
      administration of diclofenac and the relative bioavailability of diclofenac with and without
      concomitant administration of dabigatran etexilate
    


Intervention name(s): Dabigatran etexilate; Diclofenac
Intervention type(s): Drug; Drug
Intervention MeSH terms: Diclofenac; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Step 1 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients
Condition: Mechanically Ventilated Patients
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, dose-escalation clinical trial conducted in mechanically ventilated
      patients receiving sedation no longer than 24 hours. The efficacy, safety, and
      pharmacokinetics of remimazolam besylate were evaluated using a randomized, single-blind
      design.
    


Intervention name(s): Remimazolam besylate; Remimazolam besylate; Remimazolam besylate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): After a loading dose of 0.08mg/kg, a maintaining dose of 0.1mg/kg/h is given; After a loading dose of 0.08mg/kg, a maintaining dose of 0.2mg/kg/h is given; After a loading dose of 0.08mg/kg, a maintaining dose of 0.4mg/kg/h is given
Other intervention name(s): A maintaining dose of 0.1mg/kg/h; A maintaining dose of 0.2mg/kg/h; A maintaining dose of 0.4mg/kg/h
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
A Drug-drug Interaction Study Between GLPG1205 and a Cocktail of CYP450 Substrates in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a Phase I, randomized, double-blind, placebo-controlled, 2 period cross-over,
      drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1205 or
      placebo (daily from Day 1 to Day 12) on a single dose pharmacokinetic profile of a cocktail
      of CYP450 substrates administered to healthy male subjects. The cocktail of CYP450 substrates
      will consist of 10 mg warfarin (CYP2C9 substrate), 20 mg omeprazole (CYP2C19 substrate) and
      100 mg caffeine (CYP1A2 substrate).

      Fourteen healthy male subjects will receive during two treatment periods from Day 1 to Day 12
      a daily dose of GLPG1205 or placebo. On Day 13, a single dose of the cocktail of CYP450
      substrates will be co-administered either with GLPG1205 or with placebo. The two treatment
      periods will be separated by a wash-out period of at least 28 days.

      Also, the safety and tolerability of multiple oral doses of GLPG1205 administered with or
      without a cocktail of CYP450 substrates in healthy male subjects will be evaluated.
    


Intervention name(s): GLPG1205; Placebo; Cocktail of CYP450 substrates
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once daily administration of 2 GLPG1205 capsules from Day 1 to Day 13; Once daily administration of 2 matching placebo capsules from Day 1 to Day 13; Single administration on Day 13 of cocktail of CYP450 substrates: warfarin tablet, omeprazole capsule and caffeine oral solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Steady State Pharmacokinetics of Telmisartan, Ramipril or the Combination Following Repeated Oral Doses to Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective was to investigate the effect of concurrent dosing of 10 mg ramipril and
      80 mg telmisartan on the multiple-dose pharmacokinetics of telmisartan and ramipril.
      Therefore the relative bioavailability of telmisartan and ramipril given in combination was
      determined in comparison with either telmisartan or ramipril given alone.
    


Intervention name(s): Telmisartan; Ramipril
Intervention type(s): Drug; Drug
Other intervention name(s): Micardis®; Delix®
Intervention MeSH terms: Telmisartan; Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Controlled Trial of Erenumab in Migraine Prevention
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to assess the efficacy and safety of erenumab for prevention of
      migraine in Japanese adults with episodic migraine (EM) and chronic migraine (CM).
    

Detailed description: 
      Migraine prevention is an area of a large unmet medical need, with existing therapies often
      having modest efficacy and poor tolerability. Calcitonin gene-related peptide (CGRP) receptor
      antagonism is a novel approach to migraine preventive therapy. Erenumab is a human monoclonal
      antibody against canonical CGRP receptor. The present study is a phase 3 trial intended to
      assess the efficacy and safety of erenumab for prevention of migraine in Japanese adults with
      episodic migraine (EM) and chronic migraine (CM).

      The study consists of a screening period (up to 7 weeks, including a 4-week baseline period),
      a 24-week double-blind treatment period (DBTP), a 28-week open-label treatment period (OLTP),
      and an 8-week safety follow-up period (12 weeks after the last dose of investigational
      product).
    

Intervention name(s): Erenumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection once a month; Administered by subcutaneous injection once a month
Other intervention name(s): AMG 334; Aimovig®
Intervention MeSH terms: Erenumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 135585 XX in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to investigate safety, tolerability, pharmacokinetics and
      pharmacodynamics of BI 135585 XX following multiple dose administration over 14 days
    


Intervention name(s): BI 135585; Placebo to BI 135585
Intervention type(s): Drug; Drug
Intervention description(s): oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days; oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States
Condition: Whooping Cough
MeSH terms: Whooping Cough
Study type: Observational

Summary: 
      The purpose of this study is to estimate the effectiveness of maternal immunization with
      Boostrix at preventing pertussis in infants in the United States.
    


Intervention name(s): Not applicable / dataset analysis
Intervention type(s): Other
Intervention description(s): Not applicable / dataset analysis
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Infant subjects, born to mothers exposed, or unexposed to Boostrix or any Tdap vaccination,
        coming from 6 emerging program network sites.
      
Keywords: Whooping Cough; Boostrix; Tdap; effectiveness; pregnancy; infants