bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Exercises With Pilates Ball on Balance, Reaction Time and Dual-task Performance of Kindergarten Children
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of exercises conducted with pilates ball
      on balance, reaction time, quality of life, and behavior among preschool children.

      60 volunteers, aged 4 and 5 years old, who continue kindergartens will randomly be grouped
      into two as study group (SG) (n=30) and control group (CG) (n=30). Exercises including
      pilates ball will be applied to SG children for 40 minutes, twice a week, 6 weeks. CG will
      continue normal daily routines for 6 weeks.

      Sociodemographic information of all people will be recorded after their parents signed
      informed consent form. Single Leg Standing (eyes open and close) for static balance,
      Functional Reach Test (FRT)for dynamic balance, Ruler Drop Test for reaction time, dual task
      performance methods will be used.
    

Detailed description: 
      Exercises are generally suggested starting from primary school children. However, exercise
      habit should be given to people from earlier ages. Moreover, doing exercise can be beneficial
      to improve motor skills of this age and this improvement can support other developmental
      areas of these children. Thus, this study aims to investigate the effects of an exercise
      routine on balance, reaction time and dual task performance of preschool children. This
      exercise program includes pilates ball to make more fun for this age group. All movements are
      conducted with the same pilates ball. Exercises are conducted with individual sessions in the
      kindergartens of children.
    

Intervention name(s): Exercise with pilates ball
Intervention type(s): Other
Intervention description(s): Pilates ball exercises are used to give various sensory stimulation and increase motor skills. Children usually enjoy these kind of exercises as there is ball in every movement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: preschool children; physical fitness; exercise; physical activity
Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer; Metastatic Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Diagnostic procedures, such as lymphography, may improve the identification of
      patients with metastatic colorectal cancer.

      PURPOSE: Clinical trial to study the effectiveness of lymphography in determining the
      presence or absence of metastatic colorectal cancer in patients.
    

Detailed description: 
      OBJECTIVES: I. Confirm that injection of isosulfan blue into the mucosa or serosa immediately
      adjacent to a colorectal cancer results in the lymphatic transport of that agent initially to
      a specific regional lymph node that can readily be identified on visual inspection,
      dissected, and histologically evaluated for the presence or absence of metastatic disease.

      OUTLINE: All patients receive an injection of isosulfan blue into peritumor serosa upon
      intraoperative identification of the primary tumor, prior to mesenteric mobilization. If
      colonoscopy is otherwise indicated, the injection may be delivered to the peritumor mucosa
      via colonoscopy during the case. The mesentery adjacent to the injection is inspected and the
      lymphatic pattern and nodes demonstrated by the isosulfan blue are diagrammed and
      photographed. The sentinel node(s) are surgically dissected and evaluated. If needed, a
      second injection of isosulfan blue may be given. Prior to mobilization of liver for resection
      of metastases, isosulfan blue is injected subcapsularly around the metastatic lesion.

      PROJECTED ACCRUAL: There will be 10 patients accrued into this study.
    

Intervention name(s): isosulfan blue; lymphangiography; sentinel lymph node biopsy
Intervention type(s): Drug; Procedure; Procedure
Primary purpose: Diagnostic
Keywords: stage I colon cancer; stage II colon cancer; stage III colon cancer; stage IV colon cancer; stage I rectal cancer; stage II rectal cancer; stage III rectal cancer; stage IV rectal cancer; adenocarcinoma of the colon; liver metastases
Continuous Infusion and Bolus Doses of Rocuronium During Lumbal Discectomy, Muscle Strength and Patient Recovery
Condition: Rocuronium; Lumbar Discectomy; Recovery
Study type: Interventional

Summary: 
      The continuous infusion of rocuronium during general anesthesia for a lumbar discectomy
      enables better muscle strength recovery, and a better quality of patient recovery as measured
      by questionnaire.
    

Detailed description: 
      Rocuronium is a non-depolarising neuromuscular blocking agent that can be administered in
      bolus doses or via continuous infusion during general anesthesia. Due to the specificity of
      the knee-chest position in a lumbar discectomy, many complications during anesthesia and
      surgery are possible. Therefore an effective and balanced intraoperative neuromuscular block
      is needed.

      Studies so far have not included a comparison on muscle strength and quality of patient
      recovery of the effect of continuous infusion and bolus doses of rocuronium during anesthesia
      for lumbar discectomy.

      The hypothesis of this research was that the continuous infusion of rocuronium during general
      anesthesia for a lumbar discectomy enables better muscle strength recovery, and a better
      quality of patient recovery as measured by questionnaire.

      The aim was to compare the influence of the continuous infusion and bolus doses of rocuronium
      on patient recovery. Therefore the investigators assessed how continuous infusion and bolus
      doses of rocuronium affect the recovery of muscle strength as measured by a hand-grip
      dynamometer. The quality of patient recovery was assessed by standardised questionnaire
      (Qor-40 - Quality of recovery questionnaire).

      The aim was also to evaluate the applicability of the Croatian version of Qor-40
      questionnaire in clinical practice.
    

Intervention name(s): Rocuronium
Intervention type(s): Drug
Intervention description(s): Rocuronium administered in continuous infusion or multiple bolus doses
Other intervention name(s): general anesthesia
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: rocuronium; Qor-40; lumbar discectomy; muscle strength
Safety and Pharmacokinetics Study of amlodipine10mg and candesartan32mg
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Clinical trial to evalate the pharmacokinetic interactions and safety between single dose of
      amlodipine10mg and candesartan32mg and combiation dose amlodipine10mg with candesartan32mg in
      healthy male volunteers.
    


Intervention name(s): Candesartan32mg; Amlodipine10mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Amlodipine; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Safety; Male
Effective Dose of Statin Post PCI
Condition: Statin Dose
Study type: Interventional

Summary: 
      In this study post coronary stenting patients, were enrolled to receive moderate dose versus
      high dose statin for 1 year, and the result of major adverse cardiovascular events were
      recorded
    

Detailed description: 
      In this randomized double-blind clinical trial, the study population was all patients with a
      recent history of PCI who referred to the professor kojuri cardiovascular clinic for the
      first post-procedure visit. In the first visit, patients were randomly divided into two
      groups Both groups were treated with Rosuvastatin 40 mg as high potency statin for one month
      after PCI. In the first group, after one month, the statin level changed to Rosuvastatin 5 mg
      daily (moderate intensity). In the second group, 40 mg of Rosuvastatin was continued for one
      year. Then, the participants were evaluated in terms of MACEs, including any hospitalization
      due to acute coronary syndrome, as well as history of stroke and myocardial Infarction,
      subsequent unplanned revascularization and cardiac death. The HS-CRP also checked between two
      groups
    

Intervention name(s): moderate statin dose; high dose statin
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg rosuvastatin per day; 40 mg rosuvastatin per day
Intervention MeSH terms: Hydroxymethylglutaryl-CoA Reductase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blind randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PCI; Stable Angina; statin therapy
Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW in Healthy Male Volunteers.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety and pharmacokinetics of BI 224436 ZW
    


Intervention name(s): BI 224436; Placebo to BI 224436
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Fludarabine/Busulfan and Cyclophosphamide Conditioning for Adult Lymphoid Malignancies
Condition: Lymphoid Malignancies
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Allogeneic stem cell transplantation is potential curative therapy for adult lymphoid
      malignancies. Based on our previous study, the condition with iv-busulfan (iv-BU) and
      cyclophosphamide (CTX) is feasible with low toxicity and transplantation mortality and
      long-term survival is comparable to most data reported with slightly higher relapse rate
      particularly for patients in CR2. In this study, the investigators aim to further improve the
      conditioning with Fludarabine + iv-BU and to use CTX after stem cell transfusion as
      consolidation for lymphoid malignancies and graft-versus-host disease (GVHD) prophylaxis.
    

Detailed description: 
      Patients with adult lymphoid malignancies received conditioning with Fludarabine + iv-BU. The
      GVHD was consisting of D+3 and D+4 CTX after stem cell transfusion. CSA will be added for all
      patients after D+5.
    

Intervention name(s): FLu-Bu-Cy
Intervention type(s): Drug
Intervention description(s): Fludarabine at 30mg/m2 daily followed by iv-Busulfan at 3.2mg/kg daily for a total of 4 days from Day-6 to -3 and cyclophosphamide as 60mg/kg daily for 2 days on Day +3 and +4, CSA 3mg/kg starting after D+5.
Other intervention name(s): Study group
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: efficacy; safety; conditioning; fludarabine; busulfan; cyclophosphamide; adult
Birth Control Patch Study
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      400 healthy women needed contraception will be asked to participate in this study. Half will
      be given EVRA, half will be given FC Patch low. They will be expected to apply the patches
      for 21 days of their cycle, for 7 cycles in total. The study will compare the patterns of
      menstrual bleeding on these two treatments, plus how effective they are at preventing
      pregnancy, general safety, and their acceptability to the participants.
    


Intervention name(s): Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016); Norelgestromin/Ethinylestradiol (EVRA)
Intervention type(s): Drug; Drug
Intervention description(s): 0.55mg ethinylestradiol and 2.1mg gestodene; 0.6mg ethinylestradiol and 6mg norelgestromin
Intervention MeSH terms: Ethinyl Estradiol; Gestodene; Norelgestromin; Femovan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Transdermal Patch; Bleeding; Pregnancy
Bioequivalence Study of Anplag® 90mg (Ticagrelor) Tablet & Brilinta® 90 mg (Ticagrelor) Tablet in Healthy Adult Male Pakistani Subjects Under Fasting Condition
Condition: Healthy Individuals
Study type: Interventional
Phase: Phase 1

Summary: 
      Single oral administration of study drugs (i.e. Anplag® & Brilinta®) in Two periods after at
      least 10 hours fasting. The periods will be separated by a washout period of 7 days. The
      purpose of this study is to compare the bioavailability of Anplag® 90mg (Ticagrelor) Tablet
      with Brilinta® 90 mg (Ticagrelor) Tablet under fasting conditions in healthy Pakistani male
      subjects.
    

Detailed description: 
      The subjects will be randomly assigned in period 1 to T or R sequence and will be
      administered the study drugs T (Anplag® 90 mg) or R (Brilinta® 90 mg) with 240 mL ambient
      temperature water following at least 10 hours fasting. Blood samples will be withdrawn at
      pre-determined time points for estimation of plasma drug concentration upto 48 hours post
      dose. the subjects will be crossed over in Period 2 separated by a washout period of 7 days
      and administered RT sequence in period 2. Similar procedure of blood sampling will be applied
      for estimation of plasma drug concentration upto 48 hours post dose.
    

Intervention name(s): Anplag (Ticagrelor 90 mg); Brilinta (Ticagrelor 90 mg)
Intervention type(s): Drug; Drug
Intervention description(s): Ticagrelor 90 mg Immediate Release tablet; Ticagrelor 90 mg Immediate Release tablet
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: single centre, cross over, single dose, two period, randomized, open label Bioequivalence Study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence Study; Pakistani Population; Bioavailability comparison
Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm
Condition: Asthma
MeSH terms: Bronchial Spasm
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to evaluate whether 2 puffs of fixed combination of aerosolized
      120 mcg salbutamol sulphate (equivalent to 100 mcg of the base) + 20 mcg ipratropium bromide
      confers significant additional protection against metacholine induced bronchoconstriction in
      asthmatic atopic patients when compared to 2 puffs of aerosolized 100 mcg salbutamol alone.
    


Intervention name(s): Salbutamol sulfate/Ipratropium bromide; Salbutamol
Intervention type(s): Drug; Drug
Intervention description(s): Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff; Salbutamol 100 mcg per puff
Other intervention name(s): CombiventTM; Ventolin®
Intervention MeSH terms: Bromides; Albuterol; Ipratropium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A 3-Way Crossover Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics of different dose levels and dose formulations of
      pegilodecakin in healthy adult participants.
    

Detailed description: 
      An open label, randomized, single dose, 3-way crossover study to evaluate the
      pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy
      adult participants.
    

Intervention name(s): Pegilodecakin
Intervention type(s): Biological
Intervention description(s): Pegilodecakin Alone
Other intervention name(s): LY3500518; AM0010
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a nonrandomized, fixed-sequence, open-label study to evaluate the effect of a single
      dose of fedratinib on the PK, safety, and tolerability of single doses of digoxin,
      rosuvastatin, and metformin in healthy subjects. The subjects will participate as follows:

        -  Screening phase

        -  Treatment phase (includes baseline)

        -  Follow-up telephone call Subjects will be screened for eligibility during the screening
           phase. Subjects who meet all inclusion criteria and none of the exclusion criteria will
           return to the clinical site on Day -1 for protocol-specified assessments, and will be
           domiciled at the clinical site from Day -1 through the morning of Day 22.

      During the study, blood samples will be collected at prespecified times for PK and PD. Urine
      samples will be collected at prespecified times for urinary PK evaluation of metformin.
      Subject safety will be monitored throughout the study.
    


Intervention name(s): Fedratinib; Digoxin; Rosuvastatin; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral; Oral; Oral; Oral
Intervention MeSH terms: Metformin; Digoxin; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Adult Subjects; Fedratinib; Drug Interactions; Transporters
The Role of Vasopressin in the Social Deficits of Autism
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Researchers at the Stanford University School of Medicine are seeking participants for a
      study examining the effectiveness of vasopressin, a neuropeptide, in treating children with
      autism spectrum disorder. Difficulty with social interactions is characteristic of people
      with autism, who often have problems interpreting facial expressions or maintaining eye
      contact while talking with someone. There are currently no effective medicines available to
      treat social problems in individuals with autism. Neuropeptides, such as vasopressin and
      oxytocin, are molecules used by neurons in the brain to communicate with one another.
      Vasopressin is closely related to oxytocin, which is currently being tested as a treatment
      for autism, and has been shown to enhance social functioning in animals. Animal studies have
      shown that when the proper functioning of vasopressin is experimentally altered, animals
      develop a variety of social deficits, including impaired memory for peers and a reduced
      interest in social interaction. Researchers found that when vasopressin was administered to
      mice with a genetically induced form of autism, their social functioning improved.
      Vasopressin is already approved by the Food and Drug Administration for use in humans, and
      has proved to be a successful treatment for some common pediatric conditions, including
      bedwetting. Similar to oxytocin, it also has been shown to improve social cognition and
      memory in people who do not have autism. The researchers will test the effects of vasopressin
      on social impairments in 50 boys and girls with autism, ages 6 to 12 years old. The study
      will last four weeks for each participant. Participants will receive either vasopressin or a
      placebo nasal spray. At the end of this phase of the study, those who received the placebo
      will have the option of participating in a four-week trial during which they will be given
      vasopressin. Stanford is the only site for the study. Participants do not need to live
      locally but will need to come to the Stanford University Department of Psychiatry and
      Behavioral Sciences for study visits.
    


Intervention name(s): Vasopressin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
Intervention MeSH terms: Vasopressins; Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Isometric Handgrip Home Training to Lower Blood Pressure in Hypertensive Older adulTs
Condition: Hypertension
MeSH terms: Hypertension; Hypotension
Study type: Interventional

Summary: 
      This Study evaluates the effect of 20 weeks of isometric handgrip (IHG) home training in
      adults aged 50 years or more. Half of the participants will serve as a control group and will
      only receive hypertension-guidelines on lifestyle changes.
    

Detailed description: 
      Hypertension markedly increases the risk of cardiovascular diseases and overall mortality.
      Lifestyle modifications such as increased levels of physical activity are recommended as the
      ﬁrst line of anti-hypertensive treatment. A recent systematic review showed that isometric
      handgrip (IHG) training was superior to traditional endurance and strength training in
      lowering resting systolic blood pressure (SBP). The average length of previous IHG training
      studies is approximately 7.5 weeks with the longest being 10 weeks. Therefore, presently it
      is unknown if it is possible to further lower blood pressure levels beyond the 10 week mark.
      Recently, the investigators developed a novel method for monitoring handgrip intensity using
      a standard Nintendo Wii Board (Wii). The primary aim of this study is to explore the effects
      of 20-weeks IHG home training facilitated by a Wii in hypertensive older adults (+50 years of
      age) in lowering SBP compared to usual care. Secondary aims are to explore if/when a leveling
      off effect on SBP will occur during the 20-week intervention period in the training group and
      to explore adherence and potential harms related to the IHG home training.

      Methods: Based on previous evidence, the investigators calculated that 50 hypertensive older
      adults (+50 years of age) is needed to achieve a power of 80% or more. Participants will be
      randomly assigned to either an intervention group (IHG home training +
      hypertension-guidelines on lifestyle changes) or to a control group (hypertension-guidelines
      on lifestyle changes). Participants in the intervention group will perform IHG home training
      (30% of maximum grip strength for a total of 8 min per day per hand) three times a week for
      20-weeks.
    

Intervention name(s): IHG home training
Intervention type(s): Other
Intervention description(s): Participants of the intervention group will follow the IHG home training protocol for 20 weeks. The IHG training consists of isometric contractions applied with the hands on a Wii.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Isometric handgrip training; home training; older adults; Hypertension
Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children
Condition: Diarrhoea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool
      weight, when compared to placebo, in the treatment of acute diarrhoea in children.
    


Intervention name(s): Smecta (Diosmectite), duration of treatment - 7 days
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment