bioihbjkbjnl/mcl2 huggingface dataset:
Role of Calcium And Vitamin D In Nutritional Rickets And It's Management
Condition: Nutritional Rickets
MeSH terms: Rickets
Study type: Interventional
Phase: Phase 4

Summary: 
      Rickets, a common nutritional disorder, is usually considered to be due to vitamin D
      deficiency. However, in the last few decades many studies have shown that in tropical
      countries, with abundance of sunshine, calcium deficiency may play a more important role in
      the causation of rickets. Studies from adults in India have also shown that calcium intake of
      our population is much below the recommended allowance. The calcium deficiency gets
      compounded by the high level of phytates in the conventional vegetarian diet consumed by the
      majority of the population. There are few studies on children in India / other Asian
      countries on assessment of dietary calcium intake.

      However, recent studies from many nations of the world have also shown a wide spread
      prevalence of vitamin D deficiency in adolescent and adult population. A study done at our
      own hospital has shown a high prevalence of vitamin D deficiency in lactating mothers and
      their infants.

      Since both Calcium and Vitamin D deficiency are likely to be present in children, it is not
      clear what plays a more important role in the etiology of rickets in India or other Asian
      countries.

      The present study is therefore planned with the following objectives:

        1. To study the dietary calcium intake, sun exposure and serum vitamin D levels in children
           with and without rickets.

        2. To compare the role of Calcium Carbonate, Vitamin D and a combination of the two in the
           treatment of nutritional rickets.
    


Intervention name(s): Vitamin D; Calcium Carbonate; Vitamin D and Calcium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vitamin D: 6 lakh IU single im dose Calcium: 75 mg/kg calcium daily for 3 months vitamin D and Calcium: combination of above two; Calcium: 75 mg/kg calcium daily for 3 months; Vitamin D: 6 lakh IU single im dose. along with Calcium: 75 mg/kg calcium daily for 3 months
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nutritional Rickets; Calcium; Vitamin D
A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
Condition: Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with
      lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and
      tolerability of the different doses of lacosamide will be investigated.
    

Detailed description: 
      This phase 2/3 open-label trial is being conducted at approximately 100 sites in the US to
      assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in
      subjects with painful diabetic neuropathy. Approximately 525 subjects will be enrolled. To
      qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging
      in duration from 6 months to 5 years must have completed trials SP665, SP742, or SP768 and,
      in the investigator's opinion, may benefit from long-term administration of lacosamide.
      Subjects will be titrated to their optimal dose of lacosamide (up to 600mg/day). The safety
      and tolerability of the different doses of lacosamide will be investigated throughout the
      trial. In addition, to determine what effect lacosamide has on diabetic neuropathic pain,
      subjects will use a diary to record their daily pain intensity and pain interference with
      sleep and activity. Subjects' quality of life will also be investigated.
    

Intervention name(s): lacosamide
Intervention type(s): Drug
Intervention description(s): Open-label treatment (two times per day) with film-coated tablets include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day throughout individual study period.
Other intervention name(s): SPM927
Intervention MeSH terms: Lacosamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Painful Distal Diabetic Neuropathy
Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults
Condition: Hepatitis C; Hepatic Insufficiency
MeSH terms: Hepatitis C; Hepatitis; Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics (PK) of HCV-796 in subjects with
      chronic hepatic impairment and in matched healthy adults.
    


Intervention name(s): HCV-796
Intervention type(s): Drug
Intervention description(s): HCV-796 1000mg single dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Hepatic Impairment; Healthy Volunteer; Phase 1; Hepacivirus
A Method to Evaluate Glucose-Dependent Insulin Secretion in Healthy Males (MK-0431-179)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of a single dose of sitagliptin on glucose dependent
      insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG)
      procedure.
    


Intervention name(s): sitagliptin; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.; Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.
Other intervention name(s): sitagliptin phosphate; MK0431
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
A Study of the Safety and Clinical Effects of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Study GIPF-002 is a phase 2 study designed to characterize the biologic and clinical effects
      of IFN-g 1b. The objective of the Study is to characterize the biologic and clinical effects
      of IFN-g 1b administered to patients with idiopathic pulmonary fibrosis (IPF). The Study will
      be conducted at multiple sites and enroll 30 patients with IPF who have failed treatment with
      corticosteroids.
    


Intervention name(s): Interferon-gamma 1b
Intervention type(s): Drug
Intervention description(s): 200 mcg, SQ, 3x per week
Intervention MeSH terms: Interferons; Interferon-gamma
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Intermittent Fasting and Caloric Deficit for Weight Loss in Women With Polycystic Ovarian Syndrome
Condition: Polycystic Ovarian Syndrome; Weight Loss; Intermittent Fasting
MeSH terms: Polycystic Ovary Syndrome; Syndrome; Weight Loss
Study type: Interventional

Summary: 
      Time restricted feeding (TRF) has been emerging as a potential weight loss strategy that
      avoids major dietary changes but achieves strong effects. It also improves insulin
      sensitivity through increased human growth hormone. This effect helps to improve the root
      cause of weight gain and has additional benefits for women with PCOS.
    


Intervention name(s): intermittent fasting; Caloric restriction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Women were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours.; Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Facebook-based Physical Activity Intervention for Young Adult Cancer Survivors: the FITNET Randomized Pilot Study
Condition: Physical Activity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine the feasibility and efficacy of a behavioral
      intervention, delivered through an existing social networking website (Facebook), on physical
      activity (moderate-intensity minutes per week) among young adult cancer survivors compared to
      a self-help education condition. For this research study, investigators will conduct a
      12-week randomized trial. After a baseline survey, weekly messages, a pedometer, goal-setting
      tool, physical activity log and discussion prompts will be delivered to the intervention
      group. Comparison group participants will receive links to websites with self-help education
      materials. After 12 weeks, a follow-up survey will be given to both groups. Changes in
      physical activity, quality of life and psychosocial factors will be examined. The
      investigators hypothesize that those receiving the intervention will have improved physical
      activity behaviors at 12-week follow-up relative to those in the comparison group.
    


Intervention name(s): Facebook-based Messages/Website; Facebook-based Self-help Comparison
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Twelve weekly messages, a pedometer, sixteen group discussions, and access to an exercise website to promote increased physical activity.; Twelve weekly messages and a pedometer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Physical Activity; Young Adults; Cancer Survivors
Longitudinal Study of Weight Change Following Lower Limb Amputation
Condition: Amputation Wound; Traumatic Amputation of Toe; Dysvascular Amputation of Lower Limb
MeSH terms: Body Weight Changes; Amputation, Traumatic
Study type: Observational

Summary: 
      The purpose of this study is to assess weight change in a population of Veterans with
      amputations. Little is known about the how weight changes following an amputation. It is
      widely believed that many patients experience weight gain following amputation. This study
      aims to identify magnitude of weight changes following amputation and determine
      characteristics associated with weight gain. Information on weight change trajectories would
      be useful to better understand long-term health consequences associated with amputation and
      to design and target interventions to encourage weight maintenance and general health
      promotion for groups at high risk of weight gain.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Veterans who received care at a VISN20 medical facility between 1997 and 2008
Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis
Condition: Menopause; Postmenopausal Vaginal Atrophy
MeSH terms: Vaginitis; Atrophic Vaginitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to to evaluate the extent of
      systemic absorption of estradiol during treatment with two different doses of estradiol in
      postmenopausal women with atrophic vaginitis.
    


Intervention name(s): estradiol, 10 mcg; estradiol, 25 mcg
Intervention type(s): Drug; Drug
Intervention description(s): One vaginal tablet once daily in the morning during the first two weeks of treatment followed by one vaginal tablet twice weekly in the morning for 10 weeks; One vaginal tablet once daily in the morning during the first two weeks of treatment followed by one vaginal tablet twice weekly in the morning for 10 weeks
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Shared Decision Making for Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The impact of a decision aid for inpatients with schizophrenia on perceived involvement and
      compliance is studied in comparison with routine care.
    

Detailed description: 
      to follow
    

Intervention name(s): Decision aid
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: schizophrenia; shared decision making; compliance; maintenance therapy
Dose-ranging Study
Condition: Abdominal Contour Defects
Study type: Interventional
Phase: Phase 2

Summary: 
      Dose ranging study
    


Intervention name(s): salmeterol xinafoate, fluticasone propionate; Placebo; salmeterol xinafoate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): LIPO-102; Placebo; Salmeterol
Other intervention name(s): LIPO-102
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adiposity
A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA)
      in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the
      F508del mutation (F/F) or heterozygous for F508del with an eligible residual function
      mutation (F/RF).
    


Intervention name(s): TEZ/IVA; IVA; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants weighing <40 kg received TEZ 50 mg/IVA 75 mg FDC tablet and those weighing ≥40 kg received TEZ 100 mg/IVA 150 mg FDC tablet.; Participants weighing <40 kg IVA 75 mg tablet and those weighing ≥40 kg received IVA 150 mg tablet.; Placebo matched to TEZ/IVA FDC; Placebo matched to IVA
Other intervention name(s): VX-661/VX-770; tezacaftor/ivacaftor fixed dose combination; VX-770; ivacaftor
Intervention MeSH terms: Ivacaftor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Office-Based Asthma Screening Intervention
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      In prior work, we found that even children who have been seen by their physicians within the
      prior six months were frequently misclassified as having mild rather than persistent asthma.
      This study evaluations whether systematic office-based screening assists primary care
      physicians in identifying children with significant asthma and improves preventive care for
      asthma. We hypothesize that standardized screening in the office setting will improve the
      physician's ability to (a) identify children with significant asthma and (b) prescribe
      appropriate preventive medications.
    


Intervention name(s): Provider Prompt
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Gemcitabine and S-1 for Advanced Biliary Tract Cancer
Condition: Biliary Tract Neoplasm
MeSH terms: Biliary Tract Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will conduct a phase II study of gemcitabine and S-1 as first-line chemotherapy in
      patient with advanced biliary tract cancer
    

Detailed description: 
      Biliary-tract cancer (BTC) is invasive carcinoma that originates from the epithelial lining
      of the gallbladder and bile ducts. BTC include cholangiocarcinoma (intrahepatic, perihilar,
      and distal biliary-tree tumor) and carcinoma arising from the gallbladder.

      Surgical resection of the primary tumor is potentially curative for BTC, but less than a
      quarter of patients are eligible for resection at presentation. Systemic chemotherapy is the
      principal treatment method for patients with unresectable or metastatic BTC.

      Gemcitabine is a promising agent, which has shown efficacy in biliary tract cancer. As a
      single-agent therapy, gemcitabine shows response rates of 8-36% in BTC[4]. In phase II trials
      with patients in advanced BTC, gemcitabine in combination with capecitabine or platinum
      analogues produced objective response rates of 26-50%.

      The ABC-02 study reported a significant survival advantage for gemcitabine and cisplatin over
      gemcitabine alone in patients with advanced BTC (median overall survival 11.7 vs. 8.1 months;
      P < 0.001).

      Oral anticancer drug S-1 consists of the 5-FU prodrug tegafur with two biochemical
      modulators, 5-chloro-2,4-dihydroxypyridine (CDHP) and potassium oxonate (Oxo). S-1
      monotherapy is active against advanced BTC with objective response rates of 21-35%, and phase
      II trials of S-1 in combination with gemcitabine reported objective response rates of 20-36%.
      Differences between trials in the doses and administration schedules of gemcitabine and S-1
      may be reflected in the ranges of efficacy, dose-intensity, and rates of toxicity observed.

      Even though the efficacy of gemcitabine and S-1 combination is evident for patients with
      advanced BTC in previous phase II trials, there was no clinical study investigating the
      efficacy of gemcitabine and S-1 combination for patients with advanced BTC when this study
      was started. Therefore, we conducted a phase II study to evaluate gemcitabine and S-1
      combination as first-line chemotherapy for patients with advanced BTC.
    

Intervention name(s): Gemcitabine, and S-1
Intervention type(s): Drug
Intervention description(s): Treatment will be delivered as a 3-week cycle.
Gemcitabine 1000 mg/m2 iv on day 1, 8
S-1 60 mg/day po on day 1-14
Other intervention name(s): Gemzar; TS-1
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: biliary tract neoplasm; gemcitabine; S-1
Efficacy and Safety of Two Atypical Antipsychotics vs. Placebo in Patients With an Acute Exacerbation of Either Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to evaluate the efficacy and safety of two atypical antipsychotics vs. placebo in
      patients with an acute exacerbation of either schizophrenia or schizoaffective disorder
    

Detailed description: 
      This study was intended to compare the efficacy and safety of risperidone, quetiapine, and
      placebo in the treatment of patients with acute exacerbations of schizophrenia or
      schizoaffective disorder. The primary tested hypothesis was a comparison of the efficacy of
      risperidone and quetiapine (active combined group) to placebo. Other a priori hypotheses
      tested included comparison of the onset of antipsychotic effect of risperidone to quetiapine
      and placebo, and to evaluate the efficacy, safety, and cost of risperidone compared with
      quetiapine in the treatment of subjects with an acute exacerbation of schizophrenia or
      schizoaffective disorder.

      During the first phase of the study (15 days), patients randomized to risperidone were
      titrated from 1 mg to 4 mg or from 1 mg to 6 mg per day, depending on body weight. Patients
      randomized to quetiapine were titrated from 50 mg to 400 mg or from 50 mg to 600 mg per day,
      depending on body weight. Based on investigators determination of patient clinical response,
      patients in the quetiapine group could be titrated to a maximum of 600 mg or 800 mg per day
      depending on body weight.

      During the second phase of the study (days 15 - 42), patients continue to take the dose of
      study medication taken in the first phase, but additional psychotropic medication could be
      added as clinically necessary to control symptoms in patients who remained sufficiently
      symptomatic (defined as a certain minimum value on a clinical global severity scale.)
    

Intervention name(s): risperidone, quetiapine
Intervention type(s): Drug
Intervention MeSH terms: Risperidone; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Rhinopharyngeal Retrograde Clearance is Effective to Adequate Upper Airways Function in Adults
Condition: Nasal Obstruction; Exposure to Pollution
MeSH terms: Nasal Obstruction
Study type: Interventional

Summary: 
      Professionals working in polluted areas may present increased clinical airways symptoms and
      dysfunction. Rhinopharyngeal retrograde clearance (RRC) has been used to improve mucus
      clearance in infants with bronchitis and bronchiolitis, and instillation the nasal cavity
      with saline has been used to reduce nasal inflammation in rhinitis and sinusopathies. The aim
      of this study was to assess the effects of RRC and RCC combined with saline (RRC+S) on nasal
      mucociliary clearance (MCC), mucus surface property, cellularity and airways symptoms in
      professional motorcyclists.
    

Detailed description: 
      Male motorcyclists (mean age 36 years) were recruited and randomly assigned to RRC or RRC+S.
      Subjects were assessed at baseline and 15 days after interventions for saccharin test, mucus
      contact angle, cellularity in nasal lavage and airways symptoms with the use of SNOT-20
      questionnaire. Data were analyzed by two-way ANOVA for repeated measures with Bonferroni´s
      correction. A passive monitoring-system of nitrogen dioxide was used to assess the individual
      air pollution exposure along the study period. The association between nitrogen dioxide and
      the airways outcomes was analyzed by Spearman correlation test.
    

Intervention name(s): rhinopharyngeal retrograde clearance (RRC)
Intervention type(s): Other
Intervention description(s): The rhinopharyngeal retrograde clearance is a respiratory physical therapy technique that uses a forced inspiratory maneuver to clear the nasopharynx with the aid of saline instillation
Other intervention name(s): RCC+S
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: motorcyclist; nasal mucociliary clearance; physical therapy