bioihbjkbjnl/mcl2 huggingface dataset:
Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis
Condition: Hand Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      The objective of this study is to retrospectively evaluate the symptomatic effects of
      crystalline glucosamine sulfate (GS), prescribed for the actually approved indication of knee
      OA, in addition to conventional therapy, in comparison to the conventional therapy alone in
      patients with primary hand osteoarthritis (HOA).This is a 6-months retrospective comparative
      study including patients with concomitant knee and primary HOA, according to the ACR
      criteria. To be eligible the patients had to present clinical symptoms of hand OA for at
      least 3 months, defined as global hand pain score superior to 40 mm on a 0-100 Visual
      Analogue Scale (VAS) and a Functional Index for Hand Osteoarthritis (FIHOA) score of at least
      6. Furthermore, the patients have had a radiographic evidence of HOA within the previous 6
      months with a Kellgren-Lawrence score of II-III. The participants are stratified into two
      groups based on whether or not crystalline GS at the daily dose of 1500 mg was added to the
      conventional therapy for HOA, including exercise, acetaminophen and non steroidal
      anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase (COX)-2 inhibitors. Primary outcome
      measures are the difference between the two groups in the change of VAS pain and in the
      FIHOA, from baseline after 6 months. Secondary outcomes were health assessment questionnaire
      (HAQ), medical outcomes study 36-item short form (SF-36) and symptomatic drugs consumption.
    


Intervention name(s): Glucosamine Sulfate
Intervention type(s): Drug
Intervention description(s): Therapy with the prescription formulation of crystalline glucosamine sulfate
Other intervention name(s): acetaminophen; non steroidal anti-inflammatory drugs
Intervention MeSH terms: Acetaminophen; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The participants were stratified into two groups based on whether or not (GS Group and
        Control Group) crystalline GS treatment, prescribed for the actually approved indication of
        knee OA, was added to the conventional therapy. This stratification was based on regrouping
        patients with similar clinical characteristics at baseline.
Medical Nutrition Therapy Program and Eating Behavior Questionnaires on Gestational Weight Gain
Condition: Gestational Weight Gain
MeSH terms: Body Weight; Weight Gain; Gestational Weight Gain
Study type: Observational

Summary: 
      Type 2 Diabetes Mellitus (T2DM) and Gestational Diabetes Mellitus (GDM) create complications
      during pregnancy, particularly in women with gestational weight gain (GWG) that falls over
      the recommended limit. On the other hand Medical nutrition therapy (MNT) has been shown to
      reduce some complications in women with T2DM and GDM. The aim of this project was to assess
      the association of MNT consultations and eating behavior with GWG in Mexican women with T2DM
      and GDM.
    

Detailed description: 
      This cross-sectional study conducted at from 2013 to 2014. Fifty seven patients with T2DM or
      GDM were invited to participate. The dependent variable was GWG and the main independent
      variables were MNT and eating behaviors. Data were obtained from medical records or
      interviews. Multiple linear regression models were used to assess associations.
    

Intervention name(s): Medical Nutrition Therapy
Intervention type(s): Behavioral
Intervention description(s): MNT was offered every 2-4 weeks to all pregnant women with T2DM and GDM. Women. MNT is offered as a mandatory part of their prenatal visit and/or hospital stay. The MNT provides an individual food plan with the following recommendations: total calories should be calculated as 30 kcal/kg based on pregestational BMI for an ideal weight. Of the total energy intake 40-45% is provided by carbohydrates, a maximum of 40% is provided by lipids and the remaining percentage by proteins providing moderate-to-low glycemic index foods and fiber consumption, glucose self-monitoring, participating in 15-30 min of daily physical activity after prior authorization of the treating physician, and meeting the minimal energy requirements of pregnancy (never < 1,500 kcal).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women with T2DM or GDM who received as a routine management the Medical Nutrition
        Therapy. The characteristics of the pregnant women usually attended at the
        Maternal-Perinatal Hospital "Mónica Pretelini Sáenz" are: low socioecomic status and
        education, they all receive free medical attention.
      
Keywords: Medical nutrition therapy; Eating behavior; Type 2 diabetes mellitus; Gestational Diabetes
Curves 30/30 Study
Condition: Weight Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether following a high carbohydrate/low fat diet
      or high protein/low fat diet for 30-days several times during six months of participating in
      the Curves fitness and diet program with or without dietary calcium supplementation promotes
      stepwise reductions in body weight, improvements in body composition, and/or improvements in
      markers of fitness and health.
    

Detailed description: 
      The Curves International fitness and weight loss program has become a very popular means of
      promoting health and fitness among women. The program involves a 30-minute circuit training
      program and a weight management program involving periods of moderate caloric restriction
      (1,200 to 1,600 calories per day) followed by short periods of higher caloric intake (2,600
      calories per day). The program is designed to promote a gradual reduction in body fat while
      increasing strength and muscle mass/tone. Researchers in the Exercise & Sport Nutrition
      Laboratory (ESNL) at Texas A&M University have conducted an extensive study on the
      effectiveness and safety of the Curves fitness and diet program. Results of this initial
      study have shown that the program promotes weight loss, improves markers of health, and
      improves fitness. However, we feel that the program may be even more effective with some
      additional nutritional interventions. Calcium has been shown to slow bone loss and more
      recently has been found to help promote fat loss. If this is the case, supplementing the diet
      with calcium may promote greater benefits in women participating in the Curves fitness and
      diet program. The purpose of this study is to determine whether following a high
      carbohydrate/low fat diet or high protein/low fat diet for 30-days several times during six
      months of participating in the Curves fitness and diet program with or without dietary
      calcium supplementation promotes stepwise reductions in body weight, improvements in body
      composition, and/or improvements in markers of fitness and health.
    

Intervention name(s): Curves Calcium; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary Supplement: Curves Calcium
Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU of Vitamin D, 300 mg/d of magnesium, 4 mg/d of zinc, 2 mg/d of copper, 2 mg/d of manganese, 198 mg/d of potassium, 100 mg/d of trace mineral complex, and 2 mg/d of boron); Dextrose Placebo
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo controlled, repeated measures intervention trial
Masking: Single (Investigator)
Primary purpose: Health Services Research
REMOTION: a Trial to Investigate the Feasibility and Potential Effectiveness of a Blended, Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting
Condition: Mental Disorders
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      Emotion regulation has been identified as an important transdiagnostic factor in the
      treatment of mental health disorders. This study aims to examine, for the first time,
      REMOTION, a novel blended therapy intervention aimed at reducing symptom severity and
      improving emotion regulation of patients in an outpatient psychotherapy setting. REMOTION is
      an internet based intervention that is administered as an add-on to psychotherapy. This study
      aims to investigate feasibility and also potential effectiveness of REMOTION in an outpatient
      setting. Participants will be randomly assigned to the study conditions. Outcomes are
      assessed at baseline, after six weeks and after twelve weeks.
    


Intervention name(s): REMOTION; TAU
Intervention type(s): Behavioral; Behavioral
Intervention description(s): REMOTION is an internet-based intervention aimed at transdiagnostically reducing symptom severity and improving emotion regulation of psychotherapy patients. The structure of REMOTION is based on the idea of an extended process model of emotion regulation as postulated by J.J. Gross (2015). The program includes the following modules: introduction, psychoeducation, identification, selection, implementation and monitoring/modification. A variety of elements based on different psychotherapy approaches (Cognitive Behavioral Therapy, Emotion Focused Therapy, Dialectical Behavior Therapy etc.) are integrated in the program. Participants should work through one module per week. REMOTION is administered as an add-on to treatment as usual (TAU), which is psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern.; Treatment as usual (TAU) refers to psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern. Psychotherapy at the outpatient clinic is based on Psychological Therapy (Grawe, 1998) principles, which are largely rooted in academic psychology and which mainly draw on interventions from Cognitive Behavior Therapy. Individual case conceptualization are key in Psychological Therapy, along with general therapeutic factors and a focus on the therapeutic relationship.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transdiagnostic; Blended therapy; Internet-based; Emotion regulation
Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is done to demonstrate bioequivalence of rifampicin component in Myrin© 2
      Fixed-Dose Combination Tablet (each contains 75 mg isoniazid and 150 mg rifampicin, Pfizer
      Inc) with equivalent dose of the reference Rimactane® capsule (each contains 300 mg
      rifampicin, Novartis Sandoz) in healthy Filipino male subjects. This study also aims to
      determine the safety and tolerability of Myrin© 2 tablets and Rimactane® capsules in these
      subjects.
    


Intervention name(s): Myrin© 2 (Rifampicin + Isoniazid); Rimactane® (Rifampicin)
Intervention type(s): Drug; Drug
Intervention description(s): Two (2) fixed-dose combination tablets each containing Rifampicin 150 mg and Isoniazid 75 mg; One (1) capsule of Rifampicin 300 mg
Other intervention name(s): Myrin© 2 (Pfizer Inc.); Rimactane® (Novartis Sandoz)
Intervention MeSH terms: Rifampin; Isoniazid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bioequivalence; rifampicin
Immune System Stimulation by Probiotic Food Supplementation
Condition: Flu Symptom
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of a probiotic supplementation on
      adult volunteers with having caught the common cold more than 4 times in the past year. This
      study is a single center, double-blind, randomized, controlled, parallel-designed,
      prospective trial. Subjects received a probiotic drink containing probiotics of Lactobacillus
      paracasei (108 colony forming units (CFU)/ml), Lactobacilluscasei431® (108CFU/ml) and
      Lactobacillus fermentiumPCC® (106CFU/ml) or an identical placebo without probiotics for a
      12-week study period.

      The incidence of flue and cold during the study period were compared between study groups.

      Blood and fecal samples were collected at baseline and at the end of the intervention. Fecal
      samples were collected for the secretory immunoglobulin A (sIgA) analysis. Blood sample was
      drawn for interferon γ (IFN-γ), interleukin 4 (IL-4), interleukin 10 (IL-10), immunoglobulin
      A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) analysis.
    


Intervention name(s): Weiquan Yogurt with probiotics; Weiquan Yogurt without probiotics
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 150 ml daily consumption for a total of 12 weeks; 150 ml daily consumption for a total of 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety and Efficacy of High Flow Nasal Canula in Patients With Mild Hypercapnia
Condition: Hypercapnia
MeSH terms: Hypercapnia
Study type: Interventional

Summary: 
      Evaluate safety and efficacy of application ( high flow nasal canula) in cases with mild
      hypercapnia, included 30 patients who were hospitalized in Mansoura University chest
      department with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30)
      of different pulmonary disease categories (Chronic obstructive pulmonary disease acute
      exacerbation, pneumonia, Interstitial lung diseases, etc).
    


Intervention name(s): high flow nasal canula
Intervention type(s): Device
Intervention description(s): administration of high flow nasal canula at initial flow 35 liters per minute and Fio2 (fraction of inspired oxygen of 50%) with titration to reach oxygen saturation of 88-92%.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: hypercapnia; high flow nasal canula
Cross-neutralization Capacity of Immune Serum From Different Dosage of Sabin Inactivated Poliovirus Vaccine Immunization
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional

Summary: 
      This study is a supplementary study of an already finished randomised, double-blinded, and
      placebo controlled phase 2 clinical trial of an Sabin strain inactivated poliovirus vaccine
      (sIPV) manufactured by Sinovac Biotech Ltd., Beijing China. The purpose of this study is to
      evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV
      against 10 individual virus strains.
    

Detailed description: 
      This study is a open-labelled study conducted based on an already finished phase 2 study of
      the investigational sIPV in 600 healthy infants aged 2-months old. The purpose of this study
      is to evaluate the cross-neutralization capacity of the serum immuned by the investigational
      sIPV against 10 individual virus strains. Paired pre-immune and post-immune serum from 250
      participants of the phase 2 trial, with 50 in each group including the low-, medium- and
      high- dosage group, control wild poliovirus vaccine (wIPV) group and control sIPV group, was
      selected and sent to China Center for Disease Control and Prevention (CDC) for the
      cross-neutralization assay to determine the neutralizing antibody titer against 10 individual
      virus strains including Sabin strains (type 1, 2, and 3), Salk strains (Mahoney, MEF-1, and
      Saukett), cVDPV (type 1, 2, and 3) and Xinjiang wild strain of type 1(Xinjiang wIPV1).

      All the subjects in this study had been vaccinated at the schedule of month 0,1, and 2 in the
      phase 2 clinical trial.
    

Intervention name(s): Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses; Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses; Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses; Three doses of control wIPV, vaccinated within one-month interval between doses; Three doses of control sIPV, vaccinated within one-month interval between doses
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Antigen content: 7.5, 22.5, and 22.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose; Antigen content: 15, 45, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose; Antigen content: 22.5, 67.5, and 67.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose; Antigen content: 40, 8, and 32 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose; Antigen content: 30, 32, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia (Phase 3)
Condition: Type II Diabetes; Dyslipidemia
MeSH terms: Diabetes Mellitus; Dyslipidemias; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      A Multi-center, Randomized, double-blind, active-controlled, phase 3 trial to evaluate the
      safety and efficacy of Metformin/Atorvastatin in subjects with Type II Diabetes and
      dyslipidemia.
    


Intervention name(s): Metformin/Atorvastatin 1500mg/40mg, QD; Metformin 1500mg, QD; Atorvastatin 40mg, QD
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Endometrial Scratch Effect on Pregnancy Rates in Patients Undergoing Egg-donation IVF
Condition: EMBRYO IMPLANTATION
Study type: Interventional

Summary: 
      Clinical trial about the effect of endometrial scratch on pregnancy rates in patients
      undergoing a treatment with in-vitro fertilization with donor eggs, when doing the
      endometrial biopsy during the cycle prior to the embryo transfer.
    

Detailed description: 
      The aim of this clinical trial is to investigate whether an endometrial scratch during the
      cycle prior to embryo transfer cycle is effective or not in increasing pregnancy rates.
      Previous studies about this issue have not shown clear conclusions about the effectiveness of
      this method.

      The endometrial scratch is a simple technique that consists in performing a mild injury to
      all the internal walls of the uterus with a Pipelle Cournier.

      To achieve the trial objective, all participating patients are randomly divided into two
      groups. Once patients decide to participate in the trial, they are assigned to each group
      according to the randomization list:

      Group A: Patients with transfer of fresh embryos after taking an endometrium biopsy during
      the previous cycle and then following the conventional preparation protocol.

      Group B: Patients with transfer of fresh embryos with the conventional preparation protocol.
    

Intervention name(s): Endometrial scratch
Intervention type(s): Procedure
Intervention description(s): Patients included in the study group will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before embryo transfer.
Other intervention name(s): Scratching
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVF; DONOR EGGS; ENDOMETRIAL SCRATCH; PIPELLE; ONGOING PREGNANCY
A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK573719 In Healthy Volunteers
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being
      developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long
      duration of action of GSK573719 when administered via inhalation in animal models supports
      the potential for use as a once-daily bronchodilator for COPD
    

Detailed description: 
      A single-centre, randomised, double-blind, placebo-controlled, dose-ascending, 3-cohort
      parallel-group study to evaluate the safety, tolerability, pharmacodynamics and
      pharmacokinetics of GSK573719 administered as single doses (750µg and 1000µg) and repeat
      doses over 14 days (250µg-1000µg once-daily) of GSK573719 in healthy male and female subjects
    

Intervention name(s): GSK573719
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: muscarinic receptor antagonist; GSK573719,; chronic obstructive pulmonary disease,