bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Grade III Traction-mobilization in End-range Joint Position in Patients With Hip Osteoarthritis
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 3

Summary: 
      Lower limb osteoarthritis is a major health problem in the westernized countries. The current
      gold standard treatment is joint replacement. However clinical guidelines recommend physical
      therapy as first option for these patients. Manual therapy has reported good reports in
      function, range of motion and pain in patients with hip osteoarthritis. The main aim of this
      study is to test the effects of a manual therapy protocol based on manual traction
      mobilization of the hip joint in an end range position and compare them with the effects
      achieve with the same protocol based on manual traction mobilization of the hip joint in a
      resting position. The investigators will use the caudal traction mobilization described by
      Kaltenborn. The study will test the effects of both treatments in passive range of motion,
      function and pain after three weeks of treatment, three weeks after finalizing the treatment
      and six weeks after.
    


Intervention name(s): Manual caudal traction mobilization in resting position; Manual caudal traction mobilization in end range position; Selftreatment
Intervention type(s): Other; Other; Other
Intervention description(s): Each subject is advice to do some exercises at home
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Tailored Interactive Intervention to Increase CRCS
Condition: Colorectal Cancer Screening
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The primary goal of this research project is to conduct a 5-year prospective randomized trial
      of a theory-based intervention to increase patient completion of colorectal cancer screening
      (CRCS) among patients ages 50 to 64 years old.
    

Detailed description: 
      Specific Aim 1: Identify behavioral, social, and environmental factors associated with CRCS
      in male and female patients ages 50 to 64 years old in a primary care practice in Houston,
      Texas.

      1.1. Update literature reviews of CRCS adherence. 1.2. Conduct secondary analysis of relevant
      data from other projects. 1.3. Conduct focus groups with primary care patients to determine
      their knowledge, attitudes, and beliefs about CRCS and to gather data to use for development
      of the educational intervention.

      Specific Aim 2: Develop a personal computer (PC)-based tailored interactive intervention
      based on the transtheoretical (stages of change) model to increase CRCS in accordance with
      American Cancer Society (ACS) CRCS guidelines.

      Specific Aim 3: Evaluate the effectiveness of the PC-based tailored interactive intervention
      for increasing CRCS through a randomized controlled trial.

      Specific Aim 4: Analyze the relationship between a number of predictor variables and CRCS
      completion in order to develop a more complete conceptual framework for understanding
      screening adherence.

      Specific Aim 5: Conduct a cost-effectiveness analysis of the PC-based tailored interactive
      intervention for increasing CRCS in a primary care setting.
    

Intervention name(s): PC-based tailored intervention; Printed educational materials
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients will receive a tailored interactive PC-based intervention at a freestanding kiosk.; Patients will receive generic printed educational materials about CRCS in the PEC when they arrive at the Main Campus for their appointment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Colorectal Cancer Screening; Computer Interactive Intervention; Predictors; Cost Effective Analysis; Transtheoretical Model
Growth Factor Enhanced Matrix With Subepithelial Connective Tissue Graft or Collagen Membrane in Treatment of Gingival Recession
Condition: GINGIVAL RECESSION
MeSH terms: Gingival Recession
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aimed to compare, the effectiveness of Growth Factor Enhanced Matrix (GEM 21s) ®
      combined either with free connective tissue graft or collagen membrane in the treatment of
      Miller class II gingival recession.
    

Detailed description: 
      Materials and Methods: Twenty sites in 10 patients, with class II Miller gingival recession
      were allocated randomly to be treated by (GEM 21s) ® with free connective tissue graft
      (groupI) or GEM 21s with collagen membrane (groupII). Plaque index, bleeding on probing,
      recession width, recession depth, height of keratinized tissue and digital measurements were
      recorded at baseline, 1, 3 and 6-months'. Probing pocket depth, clinical attachment level,
      gingival thickness and Radiographic parameters were recorded at baseline and 6 months'. Root
      coverage percentage were recorded 6 months postoperative and wound healing index were
      recorded at 1,3 and 6-months' post-operative .
    

Intervention name(s): GROUPI; GROUP II
Intervention type(s): Procedure; Procedure
Intervention description(s): 10 sites treated with Free connective tissue graft (FCTG) + growth factors enhanced matrix 21 s GEM 21S + coronally advanced flap (CAF); 10 sites treated withCollagen membrane + GEM 21S + coronally advanced flap (CAF)
Other intervention name(s): free connective tissue graft; growth factors enhanced matrix 21s (GEM21s); coronally advanced flap; collagen membrane; coronally advanced flap
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gingival recession; free subepithelial connective tissue graft; collagen membrane; growth factor enhanced matrix 21 s
Safety and Tolerability of BI 685509 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the safety and tolerability of BI
      685509 in healthy male subjects following oral administration of multiple rising doses.

      Secondary objectives are the exploration of the pharmacokinetics (PK), dose proportionality,
      the attainment of steady state, as well as investigation of linearity and pharmacodynamics
      (PD) of BI 685509 after multiple dosing.
    


Intervention name(s): BI 685509; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): to be given for a total of up to 15 days; to be given for a total of up to 15 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To assess the safety of a sunscreen product under supervised outdoor-use conditions with the
      target consumer
    


Intervention name(s): BAY987517; Sunscreen Lotion (RB# T78-190B)
Intervention type(s): Drug; Drug
Intervention description(s): Applied liberally to the skin (Formulation: RB# Z16-071); Applied liberally to the skin
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
To Demonstrate the Effect of Food on the Bioavailability of Glipizide
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the effect of food on the bioavailability of Glipizide.
    


Intervention name(s): 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast.; 10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast.; 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast.
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Glipizide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physiologic Approach to Sodium Supplementation in Premature Infants
Condition: Postnatal Growth Disorder
MeSH terms: Growth Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Postnatal growth failure occurs in up to 50% of very low birth weight (VLBW, <1500 grams at
      birth) infants as assessed by discharge weight. This study will evaluate if a sodium
      supplementation algorithm guided by spot urine sodium measurements can improve postnatal
      growth.
    

Detailed description: 
      Postnatal growth failure is a significant morbidity in very low birth weight (VLBW, <1500
      grams at birth) infants. Efforts to promote growth and optimize nutritional support have
      included earlier initiation of parenteral nutrition and increased caloric and protein
      administration. While these advances in nutritional practices have resulted in improved
      growth, up to 50% of VLBW infants continue to experience postnatal growth failure (defined as
      discharge weight <10th percentile by Fenton growth charts) and over 25% experience severe
      postnatal growth failure (<3rd percentile). Current nutritional recommendations for sodium
      provision to preterm infants is 3-5 mEq/kg/d and fails to take into account the degree of
      renal immaturity present in extremely preterm infants. The investigators hypothesize that the
      sodium supplementation algorithm will improve in-hospital somatic growth (weight, length, and
      head circumference) between 2 weeks of postnatal age and 36 weeks postmenstrual age over
      current sodium replacement practices. The algorithm will be evaluated in a prospective,
      pragmatic, randomized trial. Infants in the sodium supplementation algorithm group will have
      a spot urine sodium concentration determined every two weeks beginning on the 14th postnatal
      day and continuing until 36 weeks postmenstrual age with sodium supplementation provided
      according to the algorithm.
    

Intervention name(s): Sodium supplementation guided by urine sodium concentration algorithm
Intervention type(s): Drug
Intervention description(s): 4 mEq/kg/d sodium added the first time urine [Na] below threshold; for each subsequent time urine [Na] below threshold, add additional 2 mEq/kg/d.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postnatal Growth Disorder; Growth and development
Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a
      single oral drug. The purpose of this study is to assess the long term safety and
      effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride in
      lowering overall blood glucose levels when added to metformin in people with type 2 diabetes
      not at target blood glucose levels on metformin alone.
    


Intervention name(s): vildagliptin; glimepiride; Metformin; Vildagliptin matching placebo; Glimepiride matching placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Other intervention name(s): LAF237, Galvus
Intervention MeSH terms: Metformin; Glimepiride; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type 2 diabetes; vildagliptin
Open Label Study to Assess the Efficacy and Safety of AKB-9778 in Subjects With Macular Edema Due to RVO
Condition: Retinal Vein Occlusion
MeSH terms: Retinal Vein Occlusion
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2a open-label study to assess the efficacy and safety of subcutaneous 15mg AKB-9778
      administered twice daily for 84 days in subjects with macular edema due to RVO.
    

Detailed description: 
      Subjects will participate in the study for up to 168 days. Up to 20 subjects will be enrolled
      in the study.

      Subjects will self-administer study medication as subcutaneous (SC) injections in the abdomen
      (preferably) twice per day; the first dose each day should be administered in the morning and
      the evening dose should be administered within 8 to 16 hours after the morning dose.

      Safety assessments will be conducted at each study visit during treatment and AEs will be
      collected throughout the Treatment period and during the 56-days observation period visits.
    

Intervention name(s): AKB-9778
Intervention type(s): Drug
Intervention description(s): Phase 2a open-label study to assess the efficacy and safety of subcutaneous 15mg AKB-9778 administered twice daily for 84 days in subjects with macular edema due to RVO.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Human Substance Balance and Biotransformation of [14C]SHR0302
Condition: Rheumatoid Arthritis (RA)
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to evaluate the absorption, metabolism and excretion of
      [14C]SHR0302 in healthy Chinese adult male subjects.
    


Intervention name(s): SHR0302、[14C]SHR0302
Intervention type(s): Drug
Intervention description(s): 8 mg SHR0302/ 80 µCi [14C]SHR0302, once, D1
Intervention model: Single Group Assignment
Intervention model description: This is a single-arm and open-label drug interaction study.
Masking: None (Open Label)
Primary purpose: Basic Science
Ginger Capsules for the Prophylactic Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The main objective of the study is to evaluate ginger efficacy as an prophylactic treatment
      of migraine.
    

Detailed description: 
      Patients with the diagnosis of migraine according to the IHS criteria will receive capsules
      of 200 mg of ginger extract (5% active ingredient) or placebo (cellulose) to be taken three
      times a day for 12 weeks.
    

Intervention name(s): Extract of ginger; Cellulose
Intervention type(s): Other; Other
Intervention description(s): Migraine patients (both genders) will receive capsules of 200 mg of ginger extract (5% gingerols) to be taken three times a day for 12 weeks.; Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Migraine; Ginger; Prophylactic treatment
A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness
Condition: Type 1 Diabetes Mellitus With Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      VC02-101 will evaluate an experimental cell replacement therapy intended to provide a
      functional cure to subjects with Type 1 Diabetes and Hypoglycemia Unawareness.
    

Detailed description: 
      The purpose of this trial is to test if VC-02™ combination product can be implanted
      subcutaneously in subjects with Type 1 Diabetes and Hypoglycemia Unawareness and maintained
      safely for up to two years. It will also test if VC-02 is an effective treatment for these
      subjects.
    

Intervention name(s): VC-02 Combination Product
Intervention type(s): Combination Product
Intervention description(s): PEC-01 cells loaded into a Delivery Device
Other intervention name(s): PEC-Direct
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: There are two Cohorts in this study design. Cohort 1 enrolls up to 15 subjects total. After Cohort 1 enrollment is completed, Cohort 2 enrollment then occurs with up to an additional 60 subjects.
Masking: None (Open Label)
Primary purpose: Other
Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.
Condition: Dental Plaque; Side Effects
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 2

Summary: 
      In the current study we tested the hypothesis that new 0.05% Cetylpyridinium chloride (CPC)
      mouthrinse formulations containing 0.12% or 0.03% chlorhexidine digluconate (CHX): 1) yield
      similar or better clinical results regarding the inhibition of de novo plaque growth compared
      to those achieved with an already marketed 0.12% CHX mouthrinse (Perio-Aid Treatment without
      alcohol. Dentaid, Spain), 2) reduce the side effects caused by the marketed 0.12% CHX formula
      and 3) that these mouthrinses have no negative microbiological effects, and they control
      total bacterial loads.
    


Intervention name(s): Placebo: PCB; 0.12%NF; 0.03%NF; PAT
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.; Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.; Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.; Patients were asked to rinse every 12 hours, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
Other intervention name(s): saline solution; Perio-Aid Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: chlorhexidine digluconate; gingivitis; cetylpyridinium chloride; mouthrinse; dental plaque; de novo; in vivo
Mindfulness Based Stress Reduction Intervention
Condition: Intervention Study
Study type: Interventional

Summary: 
      The aim of the current study is to find out the impact of Mindfulness based stress reduction
      intervention on psychosocial factors associated with distress tolerance and quality of life
      among youth . The study is conducted on the youth age ranging from 15-24 years from districts
      Mardan and Nowshera of KP. Standardized tools are used to screen highly vulnerable cohort for
      further intervention. Eligible participants who scored higher on psychological distress,
      vicarious traumatization, and low on distress tolerance and quality of life and show their
      consent were recruited for the Intervention Phase. Participants were assigned randomly to
      experimental and control groups in intervention phase. Participants in the experimental group
      were given Mindfulness Based Stress Intervention (MBSR) training in the settings conducive
      for research.
    


Intervention name(s): Mindfulness Based Stress Reduction Intervention
Intervention type(s): Behavioral
Intervention description(s): MBSR is Mindfulness based intervention designed by Kabat-Zinn (1990) in order to deal with the stress and other psychological issues among individuals. This has been very effective intervention across different cultures . In this 8 week intervention participants will be given some home tasks to practice for at least 40 minutes a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study of Cetuximab(Erbitux) With Cisplatin and Capecitabine(Xeloda)as 1st Line Treatment in the Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate whether cetuximab (Erbitux®) with cisplatin and
      capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective.
    

Detailed description: 
      Gastric cancer remains one of the major causes of cancer deaths around the world, especially
      in Asia. Previous study of ML17032 has proved that XP(capecitabine plus cisplatin)is
      effective in advanced gastric cancer, with the overall response rate of 41%, the median PFS
      of 5.6 month. Recently, the EGFR monoclonal antibody of cetuximab has shown to be successful
      in treating advanced colorectal cancer with or without chemotherapy. Since EGFR also express
      in gastric cancer, A single arm, open, multicenter phase II study of cetuximab in combination
      with cisplatin and capecitabine as first line treatment in patient with advanced gastric
      cancer.If applicable, the value of mutations in k-ras, b-raf, P53, and EGFR copy number to
      predict the clinical response to cetuximab in advanced gastric cancer patients will also be
      accessed.Tumor tissue from study patients will be checked for k-ras, b-raf, and P53 mutation
      by sequencing and for EGFR copy number by chromogenic in situ hybridization. DNA will be
      extracted from paraffin-embedded samples.
    

Intervention name(s): cetuximab, cisplatin, capecitabine
Intervention type(s): Drug
Intervention description(s): Product 1: Cetuximab(Erbitux®) Dosing schedule: 400mg/m2 initial dose and then 250mg/m2 ,weekly dose Mode of administration: intravenously Product 2: capecitabine Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks Mode of administration: orally Product 3: cisplatin Dosing schedule: 80mg/m2, day 1 of every 3 weeks Mode of administration: intravenously
Intervention MeSH terms: Capecitabine; Cetuximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cetuximab; cisplatin; capecitabine; first line treatment
Study of NPO-11 in Patients Undergoing Gastrointestinal Endoscopy
Condition: Patients Undergoing Gastrointestinal Endoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      Chinese patients who require gastrointestinal endoscopy will receive an intra-gastric single
      dose of NPO-11 20ml. The superiority of NPO-11 compared to placebo as a premedication for
      endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on
      the proportion of patients having no gastric peristalsis.

      The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions
      observed between informed consent and 7 days after administration in comparison with the
      placebo group.
    


Intervention name(s): NPO-11; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 ml NPO-11; 20 ml NPO-11(Placebo)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic