bioihbjkbjnl/mcl2 huggingface dataset:
Effects in Type of Birth of Physical Exercise During Pregnancy
Condition: Pregnancy
Study type: Interventional

Summary: 
      Abstract:

      Objectives:[The goal is] to confirm if physical activity of medium intensity performed during
      gestation can influence the way of delivery, and observe the adherence to exercise among
      pregnant women with different education levels. Methods: Held at the Center for Breastfeeding
      Incentive in the city of São Sebastião, State of São Paulo (Brazil), between April 7, 2008
      and April 14, 2009, the prospective study involved 66 primigravid women, who were divided
      into two groups: the exercise group (GE) that exercised regularly during pregnancy, and the
      other control group (GC) that did not exercise regularly during same period. The significance
      level adopted in this study was five per cent (p = 0.05).
    

Detailed description: 
      Research was conducted at the Maternal Breastfeeding Incentive Center (Centro de Incentivo ao
      Aleitamento Materno - CIAMA) in São Sebastião, São Paulo, Brazil. The 66 primigravidas were
      allocated to two groups: a control group, with 29 pregnant women who had not performed any
      kind of physical activity during pregnancy, and another group, the exercise group, with 37
      pregnant women who performed supervised aerobic physical exercises twice a week. These
      volunteers needed to attend at least 20 sessions to be included in the research. No pregnant
      women in the control group or the exercise group had performed regular physical activity in
      the year prior to the pregnancy. All participants received verbal information on how the
      research would be conducted, and after agreeing to participate they signed a free and
      informed consent term. The physical activity was prescribed by a physical therapist who
      remained available to address any doubts about the physical activity and about the research.
      The study followed the baselines of the American Congress of Obstetricians and Gynecologists
      (ACOG), where the environment temperature hasn't exceeded 28 °C. The pregnant women were told
      to wear comfortable clothes and to drink water before and during the activity, and not to
      perform physical activity while fasting. They were also instructed to interrupt the activity
      in case they felt dizziness, breathlessness, pain, muscle weakness, dyspnea prior to effort
      or in case they presented calf swelling or pain, bleeding or signs of labor, or, still, if
      they noticed decrease in fetal movements. Two weeks after birth the volunteers were contacted
      by phone to collect information on the type of birth.
    

Intervention name(s): exercise during pregnancy
Intervention type(s): Other
Intervention description(s): supervised aerobic physical exercises twice a week.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Exercise; Pregnancy; Childbirth; Vaginal; Cesarean section
A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of a Single Doses of MMV533.
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, single -centre study in 2 parts. The study designs for each part are well
      established for first-in-human studies and are appropriate to assess safety, tolerability and
      preliminary pharmacokinetics.
    

Detailed description: 
      Part 1:

      Double-blind, randomized, placebo-controlled, sequential ascending single dose study in
      healthy adult participants, 7 cohorts, and 1 additional cohort may be considered if needed
      according to the observed safety, tolerability, and pharmacokinetics results.

      A sentinel dosing strategy will be implemented at each dose level to ensure the best
      conditions of safety. Each cohort will be divided into at least 2 subgroups. The first group
      (sentinel cohort) will include 2 participants that will be dosed on the first day, with 1
      participant receiving MMV533 and 1 participant receiving placebo. The safety and tolerability
      data from the sentinel cohort up to and including 96 hours post-dose will be reviewed by the
      Principal Investigator, the Medical Monitor and the Sponsor´s Medical Director. Following a
      satisfactory safety review, dosing of the remaining participants in the cohort may proceed.

      Part 2:

      Open label, 2-period cross-over, randomized, pilot food effect study to provide preliminary
      information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral
      administration of MMV533 to healthy male and female participants aged between 18-55 years
      old. Part 2 may be conducted in parallel to or after completion of Part 1 at the discretion
      of the SRC. The dose will be selected by the SRC based on PK and safety results obtained in
      Part 1 and also taking into account the human efficacious dose/exposure predicted from
      preclinical efficacy studies in rodent malaria models.
    

Intervention name(s): MMV688533
Intervention type(s): Drug
Intervention description(s): Investigational medicinal product
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1: 8 participants per cohort for 7-8 cohorts (56-64 participants total). Single ascending dose commencing at 5 mg with maximum 400 mg as determined by Safety Review Committee (SRC).
Part 2:
Open label, 2-period cross-over, randomized, pilot food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of MMV533
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety; Tolerability
Evaluation of IL-6 in Synovial Fluid in Obese and Normal Weight Patients Suffering From Gonarthrosis During PTA
Condition: IL-6 Concentration in the Synovial Fluid of Obese Patients is 100% Higher Than the IL-6 Concentration of the Synovial Fluid in Normal Weight Patients
MeSH terms: Osteoarthritis, Knee; Body Weight
Study type: Observational

Summary: 
      Evaluate the concentration of IL-6 in the synovial fluid of obese patients suffering from
      gonarthrosis during knee arthroplasty surgery
    


Intervention name(s): Evaluation of IL-6 biomarkers in synovial fluid
Intervention type(s): Diagnostic Test
Intervention description(s): Evaluation of IL-6 biomarkers in synovial fluid in obese and normal weight patients with gonarthrosis
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population is made up of obese and normal weight patients, of age, undergoing knee
        replacement surgery for gonarthrosis
Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Condition: Arthritis, Juvenile Idiopathic
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effect of etanercept on the clinical benefit, safety, and
      physical functioning (ability to function in daily life) in children and adolescent subjects
      with 3 subtypes of childhood arthritis.
    


Intervention name(s): Etanercept
Intervention type(s): Drug
Intervention description(s): Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
Other intervention name(s): Enbrel
Intervention MeSH terms: Etanercept
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Belotero Post Approval Study
Condition: Nasolabial Folds
Study type: Interventional
Phase: Phase 4

Summary: 
      A prospective, open-label 1-month post-approval study to evaluate the short term safety of
      Belotero® Balance in the re-treatment of nasolabial folds.
    


Intervention name(s): Belotero®
Intervention type(s): Device
Intervention description(s): Hyaluronic acid dermal filler
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD
Condition: Leukemia, Mast-Cell; Mantle-cell Lymphoma
MeSH terms: Lymphoma, Mantle-Cell; Leukemia, Mast-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine if rituximab administered after allogeneic transplantation decreases the
      incidence of chronic graft-vs-host disease (cGvHD)
    

Detailed description: 
      To test if prophylactic anti-B-cell therapy (weekly rituximab) given within 60 to 90 days
      after allogeneic transplantation will decrease allogeneic donor B-cell immunity and possibly
      the incidence of chronic graft-vs-host disease (cGvHD).
    

Intervention name(s): Total lymphoid irradiation; Rituximab; Anti-thymoglobulin, rabbit (ATG, rabbit ATG); Cyclosporine; Mycophenylate mofetil; Filgrastim; Granisetron; Solumedrol; Acetaminophen; Diphenhydramine; Hydrocortisone
Intervention type(s): Procedure; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Total lymphoid irradiation (TLI) administered at 80cGy for 10 days; Rituximab 375 mg/m2 administered as an intravenous (IV) infusion once weekly for 4 doses.; Rabbit anti-thymoglobulin (ATG) administered from Day -11 through Day -7 (5 doses) at 1.5 mg/kg/day, for a total dose of 7.5 mg/kg.; Cyclosporine (CSP) administered orally at 6.25 mg/kg twice-a-day (BID) from Day -3 until through Day +56 post-peripheral blood progenitor cell (PBPC) infusion. Dose may be adjusted to maintain a therapeutic level of cyclosporine, or in response to renal insufficiency. If at Day +56, chimerism assessment demonstrates > 40% donor cells in the CD3+ lineage, and the patient is without evidence of GvHD, then cyclosporine taper will begin (6% reduction per week).; Mycophenylate mofetil (MMF) will be administered at 15 mg/kg po Day 0, at 5 to 10 hours after mobilized PBPC infusion is complete; Filgrastim provided as needed for neutrophil support; Granisetron administered as an anti-nausea agent (anti-emetic) at 1 mg orally 30 to 60 minutes before TLI; Solumedrol, an anti-inflammatory glucocorticoid containing methylprednisolone sodium succinate, administered at 1 mg/kg as a premedication for anti-thymoglobulin (ATG); Acetaminophen administered orally at 650 mg 1 hour prior to infusion of PBPC; Diphenhydramine administered by intravenous infusion at 50 mg 1 hour prior to infusion of PBPC; Hydrocortisone administered by intravenous infusion at 100 mg 1 hour prior to infusion of PBPC
Other intervention name(s): TLI; Rituxan; CSP; Sandimmune; MMF; CellCept; G-CSF; Granulocyte-colony stimulating factor; Neupogen; Sancuso; Medrol; Depo-Medrol; A-Methapred; Tylenol; Benadryl; Westcort
Intervention MeSH terms: Acetaminophen; Diphenhydramine; Promethazine; Cyclosporine; Hydrocortisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Rituximab; Granisetron; Lenograstim; Cyclosporins; Thymoglobulin; Antilymphocyte Serum; Prednisolone hemisuccinate; Prednisolone phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Home-Based HIT in Obese Individuals
Condition: Obese
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study aims to investigate the efficacy of a novel home-based high-intensity interval
      training (Home-HIT) intervention in obese individuals, with elevated cardiovascular disease
      (CVD) risk. It was hypothesised that Home-HIT would 1) have high adherence to the prescribed
      exercise intensity (compliance), 2) improve markers of CVD risk, and 3) lead to favourable
      skeletal muscle adaptations.
    

Detailed description: 
      The applicability of current high intensity interval training (HIT) protocols to the
      sedentary obese population has been disputed by public health experts. Existing HIT
      interventions have been successful only under optimal conditions with high levels of
      supervision and specialised equipment, creating further barriers to exercise in those most in
      need. We aimed to eliminate many of these barriers by modifying existing HIT protocols to
      create a new home-based HIT (Home-HIT) intervention tailored to individuals with low fitness
      and mobility. It was hypothesised that Home-HIT would 1) have high adherence to the
      prescribed exercise intensity (compliance) and 2) improve markers of cardiovascular disease
      (CVD) risk. 32 Obese adults with at least 3 additional CVD risk factors (age 36±2 y; BMI
      34.3±0.8 kg∙m-2; VO2peak 24.6±1.0 ml∙kg∙min-1), completed one of three 12-week training
      programmes 3x/week: Home-HIT (n=9); Laboratory-based supervised HIT (Lab-HIT; n=10) or
      home-based moderate intensity continuous training (Home-MICT; n=13). Adherence and compliance
      were monitored online in almost "real time" using a heart rate (HR) monitor and mobile app.
      The Home-HIT group completed 4 progressing to 8 1min intervals interspersed with 1min of rest
      in an unsupervised place of their choosing. The intervals were composed of simple bodyweight
      exercises that required no equipment. Changes in VO2peak, insulin sensitivity, body
      composition, flow-mediated dilation (FMD) and aortic pulse wave velocity (PWV) were assessed.
      Muscle biopsies were taken to assess changes in capillarisation, mitochondrial density,
      intramuscular triglyceride (IMTG) content and eNOS and GLUT4 protein expression using
      quantitative immunofluorescence microscopy.
    

Intervention name(s): Training mode
Intervention type(s): Behavioral
Intervention description(s): type of exercise training completed for 12 weeks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study
Condition: Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Study type: Observational

Summary: 
      To compare the outcome of Anterior Cruciate Ligament (ACL) reconstruction performed using the
      tibialis allograft to historical outcomes of ACL reconstruction patients and to establish if
      any correlation exists between the age of the graft donor and the clinical outcomes.
    

Detailed description: 
      This is a single-arm, single site, pilot study in patients with a ruptured ACL. A total of
      fifty (50) subjects will be enrolled in this trial. All patients will have been scheduled to
      undergo ACL reconstruction and will receive a BioCleanse Tibialis allograft as part of the
      normal standard of care practiced by the treating surgeon. Follow up is for 2 years.

      However, there is no assignment of graft, specific to donor age, to the patients. All
      treatment will follow standard of care and this study assumes that there will be a normal
      distribution of graft donor ages, from 18 to 65 years of age.

      Patient outcomes will be compared between the 2 groups of tendon donor ages. Neither the
      surgeon nor the patient will be aware of the age of the graft donor, per typical standard of
      care.
    

Intervention name(s): BioCleanse Tibialis tendon
Intervention type(s): Other
Intervention description(s): Outcomes of anterior cruciate replacement will be evaluated
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have had reconstruction of the anterior cruciate ligament and have received a
        BioCleanse Tibialis allograft for ACL reconstruction.
      
Keywords: ACL; Anterior Cruciate Ligament; Torn tendon; ACL Repair; ACL reconstruction
Efficacy of Calcitriol in Recent Onset Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Reduction in vitamin D levels has been reported in subjects with recent onset type 1
      diabetes. Several studies suggest that vitamin D supplementation in early childhood decreases
      the risk of developing type 1 diabetes, therefore vitamin D deficiency might play a role in
      the disease pathogenesis. We investigated whether the supplementation of the active form of
      vitamin D (calcitriol) in subjects with recent-onset type 1 diabetes can protect residual
      beta cell function evaluated by C peptide and improve glycaemic control as evaluated by HbA1c
      and insulin requirement.

      Thirty-four subjects (age range 11-35 years, median 18 years) with recent-onset type 1
      diabetes (<12 weeks duration) and high basal C-peptide >0.25 nmol/l were randomized in a
      double-blind trial to calcitriol (the active form of vitamin D, 1.25-dihydroxyvitamin D3
      [1,25-(OH)2D3] ) at the dose of 0.25 ug/day or placebo, and followed up for 2 years.
    


Intervention name(s): Calcitriol
Intervention type(s): Drug
Intervention MeSH terms: Calcitriol
Cognitive Behavioral Group Therapy for the Management of Menopause Symptoms in Mood Disorders
Condition: Bipolar Disorder; Major Depressive Disorder; Menopause
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Study type: Interventional

Summary: 
      The general objective of this study is to advance insight into non-pharmacological treatments
      for maturing women that impact psychological health and wellbeing of women adapting to
      menopause, a natural but often challenging developmental milestone.
    

Detailed description: 
      This exploratory study proposes to expand the knowledge in the menopausal literature and
      evaluate the effectiveness of cognitive-behavioral group therapy (CBGT) in reducing
      problematic vasomotor symptoms, reducing daily interference and improving quality of life.
      The study will include two homogenous peri- or post-menopausal cohorts (African-American and
      Caucasian) with major depressive disorder or bipolar disorder. The intervention will be
      delivered in groups of 6 to 10 participants per group of both race/ethnicities in an
      outpatient setting during a 6-week time period. The participants will be assessed on the
      degree of hot flash problem rating, hot flash related daily interference, and menopause
      quality of life at screening, baseline, and post-treatment. Participants will also be
      assessed using the following predictor variables at the same time points: body mass index
      (BMI), level of perceived stress, severity of depression, severity of anxiety level of
      pleasure, severity of mania, hot flash beliefs and severity of couple's conflict.
    

Intervention name(s): Cognitive Behavioral Group Therapy
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hot flashes; postmenopause; perimenopause
PC-300 Tea Effect on Triglyceride Levels
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional

Summary: 
      Herbal medicine represents an alternative for treating dyslipidemia. The aim of this project
      was to evaluate the PC-300 tea (Eryngium heterophyllum egelm + Amphipterygium adstringens)
      against hypertriglyceridemia.

      Baseline samples of serum total cholesterol and triglycerides were obtained and measured
      again after 1 month of treatment with the following two alternatives: 1) PC-300, one cup half
      an hour before eating, and 2) bezafibrate 200 mg/d.
    

Detailed description: 
      It was a descriptive, prospective, longitudinal, and comparative clinical study developed at
      Ciprés Grupo Médico S.C. (CGM), Toluca, Mexico, from January 2014 to December 2014.

      Patients with hypertriglyceridemia were invited to participate in the study. Voluntary
      subjects were assigned sequentially into two treatment groups: 1) fibrate (bezafibrate) 200
      mg/day, and 2) PC-300 tea, one cup half an hour before eating.

      Patients were measured (m) and weighed (kg) (Obi, México). Body mass index (BMI) was
      calculated as weight (kg) divided by height (m) squared. Blood pressure was measured with a
      calibrated sphygmomanometer (Welch Allyn, USA) after 5 min of rest.

      All of the patients were given a low lipid diet. Calculated kcal were based on ideal weight
      minus 200 kcal/day if overweight.

      Results were expressed as mean ± Standard deviation (SD). Differences between initial vs.
      final values were compared with the Mann-Whitney U test. The normality hypothesis was tested
      using the Kolmogorov-Smirnov test. A p value of <0.05 was considered significant. All tests
      were performed with the SPSS ver. 23 statistical software program.
    

Intervention name(s): PC-300 tea.; Bezafibrate
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Patients had to drink one cup of the tea half an hour before breakfast, main meal and dinner.; Patients were prescribed 200 mg/day at night.
Other intervention name(s): Herbal tea; Bezalip
Intervention MeSH terms: Bezafibrate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Voluntary subjects were assigned sequentially into two treatment groups: 1) fibrate (bezafibrate) 200 mg/day, and 2) PC-300 tea, one cup half an hour before eating.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eryngium heterophyllum; Amphipterygium adstringens; tea
Feasibility Study - Integrated Sensor and Infusion Set. Trial III
Condition: Type 1 Diabetes; Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to collect performance data on the Integrated sensor and
      infusion set during 3 days of use and demonstrate performance adequacy of the integrated
      sensor and infusion set with glucose sensing and insulin delivery functionalities. The
      hypothesis of this study is that having the infusion of insulin in close proximity to the
      sensor does not interfere with the sensor accuracy. This study focuses on high bolus
      patients. A high bolus is defined as 12 units or more.
    


Intervention name(s): Integrated sensor and infusion set.
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Emotional and Functional Benefits of Poly-L-Lactic Acid
Condition: Facial Volume Loss
Study type: Interventional

Summary: 
      This study will evaluates the emotional and functional benefits of Poly-L-Lactic Acid
      (Sculptra™), a cosmetic product used to fill defects of the skin. All participants will
      receive Sculptra™.
    

Detailed description: 
      Facial volume loss can result in emotional distress and functional impairment in some
      affected individuals. Poly-L-Lactic Acid (Sculptra™) stimulates collagen production in the
      skin thereby replenishing some of the collagen lost to natural aging and ultraviolet damage.
      This study will assess the emotional and functional benefits of Poly-L-Lactic Acid treated
      subject's through self report measurement tools.
    

Intervention name(s): Poly-L-Lactic Acid (Sculptra) injection
Intervention type(s): Drug
Intervention description(s): 1 vial of of poly-l-lactic acid (Sculptra) reconstituted in the usual sterile fashion with 7cc of sterile water and 2cc of Lidocaine without epinephrine. The contents of the vial will be injected as deemed appropriate by the certified injector and agreed upon by the study subject.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other