bioihbjkbjnl/mcl2 huggingface dataset:
Swimming and Water Walking on Spirometry Values
Condition: Child Development; Child Obesity; BMI
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      To study the effects of swimming with water walking in children aged between 6 and 12 years
      in terms of spirometric values.
    

Detailed description: 
      The present research aims to verify if there are differences in body composition and
      spirometric values in children aged between 6 and 12 years who practice swimming complemented
      with water walking at the end of each session and those who only practice swimming. The
      sample consisted of 28 individuals aged 6 to 12 years and was divided into two groups:
      swimming group (SG) with 9 children and swimming complemented with water walking group (SWWG)
      of 19 children. In this study, the investigators wanted to know which were the benefits in
      body composition and for that purpose used a bio-impedance scale Targa Silvercrest Z29777A
      (Germany), and an anthropometric tape to measure the waist circumference. To calculate the
      spirometric values, namely forced vital capacity (FVC), forced expiratory volume in 1 second
      (FEV1) and even peak expiratory flow (PEF) a Cosmed Microquark spirometer was used. In terms
      of statistical procedures, the investigators used the program Statistical Package for the
      Social Sciences version number 20 (SPSS 20.0). The investigators used descriptive statistics
      (minimum, maximum, means and standard deviations), the Shapiro Wilk test for testing the
      normality of the sample, inferential statistics (non-parametric Mann-Whitney tests,
      Friedman's Anova, and for the calculation of the effect magnitude the d-Cohen test). After
      the data treatment, regarding the inter-group analysis (comparison between the swimming group
      and the swimming group with water walking) the investigators observed that there were
      significant differences in three variables at the end of the study, that is, at the end of
      the 3 moments. These variables were weight relative to body composition, forced expiratory
      volume in 1 second (FEV1) and peak expiratory flow (PEF), these values are relative to the
      spirometry evaluation. Concerning intra-group differences (improvement in the swimming group
      and the swimming with water walking group in the three moments evaluated), the SWWG showed
      significant improvements in the variables of weight, muscle mass, fat mass, percentage of
      water, body mass index (BMI), body percentiles, forced vital capacity (FVC) and forced
      expiratory volume in 1 second (FEV1).
    

Intervention name(s): SWWSV
Intervention type(s): Other
Intervention description(s): Behaviours to prevent child obesity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Maximum Use Trial of Ruxolitinib Cream in Adolescent and Adult Participants With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label maximum use trial to evaluate ruxolitinib safety and blood levels after
      its topical application twice daily to affected areas (≥ 25% BSA) in adolescent and adult
      participants with atopic dermatitis (AD) and to determine if its systemic bioavailability
      results in any adverse events.
    


Intervention name(s): Ruxolitinib cream
Intervention type(s): Drug
Intervention description(s): Ruxolitinib 1.5% cream applied twice daily.
Other intervention name(s): INCB018424 phosphate cream
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atopic dermatitis; ruxolitinib cream; maximum use
Promoting Cervical Cancer Screening for Emergency Department Patients
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms; Emergencies
Study type: Interventional

Summary: 
      The purpose of this study is to learn methods to encourage women to get recommended cervical
      cancer screening. Cervical cancer screening is an important part of cervical cancer
      prevention. The study team will determine if the patient is currently up-to-date with
      cervical cancer screening recommendations. If the patient is not up-to-date, then they will
      be randomly assigned to one of two interventions. One intervention consists only of referral
      to a women's health care provider to obtain cervical cancer screening. The other intervention
      consists of receiving a total of 3 text messages at 30-day intervals encouraging follow-up
      for cervical cancer screening.
    


Intervention name(s): Provider Referral; Text Messaging
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be asked if they are up-to-date on their cervical cancer screening. If not they will be referred to a provider. At the end of the study they will receive a 10 minute follow up telephone survey to collect data screening status and views on cervical cancer screening.; Participants will be asked if they are up-to-date on their cervical cancer screening. If not they will be referred to a provider. They will also receive a total of 3 text messages at 30-day intervals encouraging follow-up for cervical cancer screening. They will receive a 10 minute follow up telephone survey to collect data screening status and views on cervical cancer screening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
BKM120 for Patients With PI3K-activated Tumors
Condition: PI3K Pathway Activated Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this signal seeking study was is to determine whether treatment with BKM120
      demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic
      malignancies to warrant further study.
    


Intervention name(s): BKM120
Intervention type(s): Drug
Intervention description(s): BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28-day cycle
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Solid tumor; malignancy; hematologic malignancy; PI3K pathway activation; P13K activated tumors; BKM120; signature; AML; acute myelogenous leukemia; cervical; ovarian; hepatobiliary; buparlisib
Efficacy of Arthrocentesis by Injection of Ringer With or Without Corticosteroid in Treatment of Internal Derangement
Condition: Temporomandibular Joint Dysfunction; Pain; Arthrocentesis
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The study aims to evaluate effectiveness of ringer injection with or without corticosteroid
      during arthrocentesis of the temporomandibular joint in the treatment of internal derangement
      of the temporomandibular joint (TMJ).
    

Detailed description: 
      This prospective clinical study was approved by Local ethical committee and written informed
      consent will be obtained before the trial starts. Criteria for selection of the patients was
      based on history and clinical findings characteristic of internal derangement. All these
      patients were initially treated with NSAIDS for 1 week and occlusal splints for 1 month had
      failed to respond to these conservative treatments. The patients with systemic problems which
      affect bone and joints,psychological problems ,history of maxillofacial fractures and
      orthognathic surgery were excluded from the study. A total of 60 patients with TMJ internal
      derangement with failed conservative management, were subjected to TMJ arthrocentesis. All
      arthrocentesis were performed by the same maxillofacial surgeon. Subjects were randomly
      allocated into two groups (30 cases in each group). Subjects in the group 1 received
      irrigation with Ringer solution and in the group 2 ,subjects underwent irrigation with Ringer
      solution with corticosteroid (Dexamethasone ) .Two examiners evaluated Temporomandibular
      disorder's signs ( mouth opening,click , crepitus and pain) before, one month and 6 months
      after arthrocentesis.
    

Intervention name(s): ringer with corticosteroid; ringer without corticosteroid
Intervention type(s): Drug; Drug
Intervention description(s): 200 mL Ringer solution+1mg dexamethasone after finishing the irrigation; 200 mL Ringer solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: internal derangement,arthrocentesis,corticosteroid
Does Obesity Influence Women Cardiorespiratory Fitness and Daily Physical Activities? (ACTIVOB)
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Many obese individuals experience difficulties in executing household activities. In this
      study, we investigate the cardiorespiratory fitness (CRF) of obese vs. non-obese women, and
      the impact of obesity on cardiorespiratory functioning during daily household activities.
    

Detailed description: 
      Methods: On 48 sedentary female subjects will be assessed by cardiorespiratory exercise
      testing with evaluation of peak oxygen uptake (⩒O2), heart rate (HR) and maximal cycling
      power output. Next, cardiorespiratory functioning will be assessed during household
      activities such as ironing (A1), cleaning floor (A2), walking and climbing stairs (A3).
    

Intervention name(s): cardiorespiratory fitness and daily physical activities evaluations
Intervention type(s): Diagnostic Test
Intervention description(s): The cardiopulmonary exercise testing is performed on a cycle ergometer connected to cardiovascular and respiratory software. Subjects have a facemask, which collected respiratory and metabolic variables.An incremental exercise test is performed up to exhaustion. ⩒O2 is recorded and heart rate is averaged by an electrocardiogram system.
Cardiopulmonary exercise testing during household activities Subjects have to perform 3 everyday life household activities: ironing,cleaning floor,walking and climbing stairs.A wearable ambulatory indirect metabolic system is used with Holter mode to record cardiorespiratory measures.Subjects have to breathe through the K4b2 facemask and turbine.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Women OBESE group VS Women NON-OBESE group
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Obesity; cardiorespiratory fitness; oxygen uptake; household activities; physical activity; sedentary; intensity; obese women
Smoking Cessation and Sexual Health in Men
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 12-week clinical trial investigating the effects of smoking cessation on sexual
      functioning in men. This study consists of 3 sessions and provides 8 weeks of free nicotine
      transdermal patches. It is hypothesized that men who quit smoking, compared to men who smoke
      as usual, will demonstrate improved sexual functioning, measured both physiologically
      (erectile functioning) and subjectively (self-reported sexual functioning).
    

Detailed description: 
      Objective: Tobacco use constitutes the single most preventable cause of disease and death in
      the world today and is responsible for introducing a number of diseases including many types
      of cancer, cardiovascular diseases, and respiratory diseases. Extensive literature indicates
      that cigarette smoking is an independent risk factor for introducing erectile impairment in
      men. Controlled clinical trials examining the effects of smoking cessation on sexual
      functioning are necessary in order to investigate whether quitting smoking improves sexual
      health.

      Design: This is a 12-week clinical trial in which 80 male long-term smokers will be tested at
      baseline (while smoking) and then randomized to an 8-week nicotine patch treatment regimen (n
      = 50) or to a delayed treatment wait list condition (n = 30). All participants will be
      reassessed at mid-treatment (4 weeks), and at 1-month follow-up.

      Main Outcome Measures: Physiological (penile circumferential change via penile
      plethysmography), and subjective (continuous self-report) sexual responses to erotic stimuli
      will be examined, as well as global changes in self-reported sexual functioning.

      Implications: If participants do in fact demonstrate a significant increase in sexual arousal
      and sexual functioning as a result of smoking cessation, these results may have the potential
      for facilitating programs and interventions targeting the prevention and cessation of
      cigarette smoking in men. This would alleviate enormous economic burdens caused by erectile
      dysfunction and other smoking-related diseases.
    

Intervention name(s): Nicotine transdermal patch
Intervention type(s): Drug
Intervention description(s): 8-week nicotine patch regimen (21mg/day during week 1-4, 14mg/day during week 5-6, and 7mg/day during week 7-8).
Other intervention name(s): Nicotine; Nicotine patch
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking; Smoking Cessation; Quit Smoking; Stop Smoking; Nicotine Patch; Nicotine Replacement Therapy; Sexual Functioning; Erectile Functioning; Sexual Health
Safety of Anticoagulant Therapy After Endoscopic Treatment
Condition: Cirrhosis; Portal Vein Thrombosis; Esophageal and Gastric Varices; Anticoagulant-induced Bleeding
MeSH terms: Liver Cirrhosis; Esophageal and Gastric Varices; Thrombosis; Venous Thrombosis; Hemorrhage; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators aimed to verify the efficacy and safety of nadroparin calcium warfarin
      sequential (NWS) anticoagulation therapy after endoscopic therapy in PVT patients with
      cirrhosis and AVB.
    

Detailed description: 
      Acute variceal bleeding is one of the most serious complications of liver cirrhosis and is
      associated with significant morbidity and mortality. Portal vein thrombosis (PVT) aggravates
      portal hypertension and worsens hemorrhage, which Increases the risk of endoscopic therapy,
      and PVT has been shown to be associated with a longer time to variceal eradication, a higher
      risk of variceal relapse and rebleeding. So, PVT should be treated earlier. Data regarding
      the safety and initiation time of anticoagulant therapy in PVT patients with variceal
      bleeding after endoscopic therapy is lacking. Aim of this study is to verify the efficacy and
      safety of NWS anticoagulation therapy in PVT patients with cirrhosis and AVB after endoscopic
      therapy and further to explored the appropriate initiation time of NWS anticoagulation
      therapy after EVL in these patients.
    

Intervention name(s): nadroparin calcium-warfarin sequential anticoagulation
Intervention type(s): Drug
Intervention description(s): The NWS therapy group were given a subcutaneous injection of nadroparin calcium every 12 hours for 1 month and switched to warfarin for 5 months. Warfarin was initiated at least 5 days before nadroparin calcium was stopped. International normalized ratio (INR) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.
Other intervention name(s): anticoagulation
Intervention MeSH terms: Nadroparin; Warfarin; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: endoscopic therapy; endoscopic variceal band ligation; warfarin; nadroparin calcium
Molecular Response After Concurrent Exercise With Low Glycogen
Condition: Healthy
Study type: Interventional

Summary: 
      This is a randomized, counterbalanced crossover design, in which 14 male subjects will
      complete two experimental trials. Each trial will be separated by a minimum of at least 12
      days (range: 12-30 days). The study aims to investigate the effects of low glycogen
      availability on skeletal muscle molecular response after a concurrent exercise day.
    

Detailed description: 
      Two experimental exercise trials; a low carbohydrate (= LOW) and a high carbohydrate (= HIGH)
      trial. During both experimental days subjects will complete an continues submaximal cycling
      bout in the morning followed by a resistance exercise session in the early afternoon. During
      the LOW trial subjects will receive a low carbohydrate mixed meal, during the HIGH trial
      subjects will be provided with a high carbohydrate meal. In addition, on both experimental
      days subjects will receive adequate protein beverages. Lastly, protein will be provided post
      resistance exercise.
    

Intervention name(s): Standard meal containing low or high carbohydrate content
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Concurrent; muscle; glycogen; molecular
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348
Condition: Hypertension and Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-348
    

Detailed description: 
      An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to
      evaluate the pharmacokinetics and tolerability of CKD-348 with coadministration of CKD-828,
      D097 and D337 in healthy adult volunteers
    

Intervention name(s): CKD-348; CKD-828, D097, D337
Intervention type(s): Drug; Drug
Intervention description(s): QD, PO; QD, PO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Learn More About the Safety and the Level of BAY 1747846 in Body Given as Injection Into the Vein at Increasing Single Doses in Japanese Healthy Male Participants
Condition: Contrast Enhancement in Magnetic Resonance Imaging; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical study was to learn more about BAY1747846 compared to placebo when
      given as an injection into the vein in Japanese healthy male participants:

        -  the safety of BAY1747846 when given at increasing single doses

        -  the level of BAY1747846 in the body over time when given at increasing single doses.

      To answer the first question, the researchers compared the number and severity of medical
      problems the Japanese participants had after receiving BAY 1747846 at increasing doses and
      placebo respectively. Doctors keep track of all medical problems that happen in studies, even
      if they do not think they might be related to the study treatments.

      To answer the second question, the researchers determined:

        -  the (average) total level of BAY1747846 in the body, also called AUC

        -  the (average) highest level of BAY1747846 in the body, also called Cmax

        -  how BAY1747846 is removed from the body, also called clearance (CL).
    


Intervention name(s): BAY1747846; Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose; IV injection.; Single dose; IV injection.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Other
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intravenous Infusion of GW328267X in Healthy Volunteers
Condition: Lung Injury, Acute
MeSH terms: Lung Injury; Acute Lung Injury
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single dose evaluation using an open label dose escalating design. Cohort1
      will consist of 3 healthy male volunteers. Each volunteer will receive a slow IV infusion
      over 6 hours consisting of saline for 30 minutes (run in period), 8 mcg/h GW328267X for 1.5
      hours (total dose of 12mcg) and 10 mcg/h GW328267X for 4 hours (total dose of 40 mcg).
      Subjects will have continuous cardiac monitoring throughout the dosing period and up to 2
      hours after cessation of the intravenous infusion. PK measurements and measurement of
      erythropoietin and platelet activation will also be done. Samples for PK will be taken at 30
      minute intervals during the infusion of GW328267X up to and including 1 hour after cessation
      of the intravenous infusion. Samples for erythropoietin and platelet aggregation will be
      done.

      Cohort 2 is optional and may be carried out in the event that the dose of GW328267X given in
      Cohort 1 is both well tolerated and subjects do not meet the stopping criteria. The decision
      to proceed to Cohort 2 and the dose level will be made by the GSK Study Team and the
      Investigator based on safety, tolerability and preliminary PK/PD data obtained in Cohort 1.
      It is planned that the maximum total dose given to any subject will not exceed 150mcg. Cohort
      2 will consist of 3 healthy male volunteers and the study procedures for this additional
      Cohort will be the same as that described for Cohort 1.
    


Intervention name(s): Saline; GW328267X (total dose of 12mcg); GW328267X (total dose of 40mcg)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 30mins run-in period; 8 mcg/h for 1.5 hours (total dose of 12mcg); 10 mcg/h for 4 hours (total dose of 40 mcg)
Intervention MeSH terms: GW 328267
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy male volunteers, intravenous infusion, GW328267X, dose escalation,
An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of LYC-30937-EC given orally
      once daily in subjects with active ulcerative colitis (UC) defined as a total Mayo score
      (TMS) of 4-11 inclusive, with an endoscopic score of ≥ 2 and a rectal bleeding score of ≥ 1
      at screening.
    

Detailed description: 
      Approximately 120 subjects will be randomized to receive either enteric-coated (EC)
      LYC-30937-EC 25 mg PO once daily (QD) or matching placebo PO QD for the duration of 8 weeks.
      Randomization will be stratified based on previous exposure to anti-tumor necrosis factor
      (TNF) agents such that at least 50% of the randomized subjects will be anti-TNF naïve .

      The study will consist of 3 phases:

        -  screening phase: up to 4 weeks

        -  double-blind placebo-controlled phase treatment: 8 weeks

        -  post-treatment follow-up: 2 weeks

      Eligible subjects will be randomized at Week 0 (Study Day 1) to either LYC-30937-EC 25 mg or
      placebo. Screening will occur from Study Days -28 to -1. Randomization and first dosing will
      occur at Week 0/Study Day 1. Double-blind study visits will occur at Weeks 2, 4, and 8, with
      the last dose at Week 8/Study Day 57. Subjects will return at Week 10 for a post-treatment
      safety follow-up visit.
    

Intervention name(s): LYC-30937-EC; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment