bioihbjkbjnl/mcl2 huggingface dataset:
Motor Control Exercises and Neural Mobilization in Posture of Older Adults
Condition: Postural Control
Study type: Interventional

Summary: 
      The aim of this research is to find and compare the effect of Motor control exercises with
      and without neural mobilization on postural control of older adults.
    

Detailed description: 
      Randomized controlled trials done at Bilqees Eidhi and Afiyat old age home Lahore.The sample
      size was 40. The subjects were divided in two groups, 20 subjects in Motor control exercise
      group and 20 in Motor control exercise with neural gliding group. Study duration was of 6
      months. Sampling technique applied was purposive non probability sampling technique. Only
      65-80 years of older adults included in study. Tools used in the study are time up and go
      test(TUG), Gait speed, Static balance and Quality of life(OPQOL35). Data was analyzed through
      SPSS 21.
    

Intervention name(s): Motor control exercise; Motor control exercise with mobilization
Intervention type(s): Other; Other
Intervention description(s): Motor control exercise was given with total of 8 sessions for 30 min for 4 weeks twice a day. Each exercise was performed 10 repetitions for 10 sec.; this was given motor control exercise for 30 min, 4 weeks twice a day plus neural gliding applied for 3 sets of 10 repetitions on each session. Neural gliding applied 5 min before motor control exercise. Total 8 sessions were given
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Motor control exercise; Neural mobilization; postural control
Nefazodone in the Treatment of Cocaine Dependence and Depression - 4
Condition: Cocaine-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and
      depression comorbidity.
    

Detailed description: 
      The objective of this study is to determine the safety and efficacy of nefazodone (Serzone )
      in depressed cocaine dependent subjects. This is a hypothesis-testing study which will
      explore whether cocaine usage will be reduced in the nefazodone treatment group compared to a
      placebo control group.
    

Intervention name(s): Nefazodone; Psychosocial Treatment
Intervention type(s): Drug; Behavioral
Intervention description(s): All subjects attended a weekly 1-hour therapy session during the 8 week treatment period.
Other intervention name(s): Serzone; Indivdual Manual-quided relapse prevention therapy; or Individual Dug Counseling
Intervention MeSH terms: Nefazodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cocaine Use Disorders Dependence Depression
Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B Vaccine
Condition: Hepatitis B
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the persistence of antibodies against hepatitis B, approximately 5 to 6 years
      after the first dose of the hepatitis B in the primary vaccination study.
    

Detailed description: 
      All subjects who participated in the primary vaccination study, where subjects who received
      GSK Biologicals' hepatitis B vaccine and who will consent to participate in this long-term
      follow-up study, approximately 5 to 6 years after the primary vaccination study. The study
      will be conducted in only 3 centres out of the 4 centres in the primary vaccination study.
    

Intervention name(s): Hepatitis B vaccine
Intervention type(s): Biological
NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis
Condition: Erosive Esophagitis; Reflux Esophagitis; Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to decide if controlling stomach acid is related to healing of
      erosive esophagitis after treatment with esomeprazole magnesium (NEXIUM®) 10 mg and 40 mg
      once daily.
    


Intervention name(s): esomeprazole magnesium (oral medication)
Intervention type(s): Drug
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Safety Study of Radiofrequency Ablation of Locally Advanced Pancreatic Cancer
Condition: Locally Advanced Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the safety of radiofrequency ablation of locally
      advanced pancreatic cancer that can not be surgically removed with the current standard
      procedures. Complications after the operation will be registered. Moreover a pain score will
      be determined, length of hospital stay, chemotherapy, survival, progression free survival and
      a tumour marker.
    

Detailed description: 
      Pancreatic cancer is the fourth leading cause of cancer related death in the Western world.
      At time of diagnosis, 20% of patients present with a resectable tumour, 40% with an
      irresectable locally advanced tumour (without metastases) and 40% with metastatic disease.
      The median survival of patients with irresectable locally advanced pancreatic cancer is only
      6 months. Currently, there is no effective treatment for these patients. Therefore, there is
      an urgent need for new therapies. Radiofrequency ablation (RFA) is a technique that has been
      demonstrated to be effective in the treatment of several irresectable tumours. RFA produces
      local tumour destruction through high frequency alternating current flowing from an electrode
      implanted directly into the tumour and causing frictional heating. The purpose of this study
      is to determine the safety of RFA-pancreas in patients with non-metastasized, irresectable,
      locally advanced pancreatic cancer.
    

Intervention name(s): radiofrequency ablation (RFA)
Intervention type(s): Procedure
Intervention description(s): RFA with CELON bipolar probes. Settings: Power 30 watts, total energy 15 KJ.
Other intervention name(s): CELON Power System, CE mark 0197
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic cancer; locally advanced; irresectable; Radiofrequency; RFA
Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the 1 month safety and tolerability after multiple
      oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Metformin
    


Intervention name(s): AZD1656; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be treated with tolerable dose twice daily for another 24 days.; Subjects will be treated with tolerable dose twice daily for another 24 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type II Diabetes
Effect of Exercise on the Absorption of Inhaled Human Insulin in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is conducted in Europe. This clinical pharmacology trial investigates the effect of
      exercise on the pharmacokinetics and pharmacodynamics of inhaled insulin in subjects with
      type 1 diabetes.
    


Intervention name(s): inhaled human insulin
Intervention type(s): Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and maximum tolerated dose (the highest
      dose that can be given safely) of recombinant Interleukin-2 (rIL-2) in HIV-infected children.
      This study also evaluates the effect of rIL-2 on the immune system of these patients.

      IL-2 is a substance naturally produced by the body's white blood cells that plays an
      important role in helping the body fight infection. HIV-infected patients do not produce
      enough IL-2, and it is hoped that the use of rIL-2 may improve immune system function in
      these patients. First, it is necessary to determine the safety and effectiveness of this drug
      in HIV-infected children.
    

Detailed description: 
      According to study records, IL-2 has not been tested in HIV-infected children. Experience
      with IL-2 in pediatric populations is extremely limited. Pahwa et al. gave 30,000 units/kg
      daily IV to a child with severe combined immunodeficiency. This dose was well tolerated and
      the patient improved clinically as well as immunologically. Part A is necessary to determine
      the maximum tolerated dose of IL-2 in infected children. Part B will determine the efficacy
      of the maximum tolerated dose in infected children.

      Part A: Children will receive rIL-2 intravenously for 5 days every 8 weeks for 3 cycles. The
      study will enroll 4 patients in each of 3 dose levels. Dose escalation may occur if all 4
      patients in a dose level tolerate therapy without evidence of Grade 3 (or higher) toxicity.
      If 1 of 4 subjects in any dose level experiences at least Grade 3 toxicity, 2 additional
      patients will be enrolled in that dose level. If 1 of these 2 additional patients experiences
      at least Grade 3 toxicity, dose escalation will not proceed. NOTE: Once Part A is completed
      and the maximum tolerated dose is established, children who participated in Part A and
      received less than the maximum tolerated dose will be offered additional therapy consisting
      of 3 cycles of rIL-2 at the maximum tolerated dose.

      Part B: Children will receive rIL-2 intravenously at the maximum tolerated dose established
      in part A. Treatment will be given for 5 days every 8 weeks for 3 cycles. [AS PER AMENDMENT
      6/4/98: Children will receive rIL-2 intravenously at the lowest dose for 5 days every 8 weeks
      for 6 cycles. Patients who received this dose in part A will also be offered this regimen.]
    

Intervention name(s): Aldesleukin
Intervention type(s): Drug
Intervention MeSH terms: Aldesleukin
Allocation: Randomized
Primary purpose: Treatment
Keywords: Interleukin-2; Immunity, Cellular; Dose-Response Relationship, Drug; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Viral Load
A Study Designed to Determine the Safety and Pharmacological Response ofMKC253 Inhalation Powder in Adults With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      20 eligible subjects will be enrolled into the treatment phase of the trial.
    

Detailed description: 
      Trial objectives are to determine the safety & pharmacological response of MKC253 Inhalation
      Powder.
    

Intervention name(s): MKC253 Inhalation Powder; Technosphere Inhalation Powder; subcutaneous injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inhalation Powder, prandial; Inhalation Powder, prandial; 10µg Exenatide, prandial
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetic adult male, diabetic postmenopausal women
Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
Condition: Neoplasm Malignant
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objectives:

        -  To determine the maximum tolerated dose (MTD) and safety of Cabazitaxel when
           administered to advanced solid tumor patients with varying degrees of hepatic impairment

        -  To determine the pharmacokinetics (PKs) of Cabazitaxel in patients with varying degrees
           of hepatic impairment

        -  To correlate PK variables with pharmacodynamic (PD) safety parameters in order to guide
           prescribers with regard to dosing in this patient population

        -  To assess the effect of cabazitaxel at recommended dose of 25mg/m^2 on CYP3A enzyme
           activity using midazolam as probe in an additional cohort of cancer patients with normal
           hepatic function.
    

Detailed description: 
      The study consists of:

        -  a screening phase (maximum length of 21-day).

        -  a treatment phase with 21-day study treatment cycles. Cycle lengths may be extended up
           to maximum of 12 additional days in case of unresolved toxicity.

      Patients continue to receive treatment until they experience, unacceptable toxicities/AEs,
      disease progression ,withdraw their consent, or the investigator decides to discontinue the
      patient, or study cut-off, whichever comes first.

        -  a 30-day follow-up visit after the last dose of study medication.

      The cut off date is when the last patient treated has completed cycle 1 and the subsequent 30
      days follow-up.

      Patients may continue to be treated as long as they are benefiting from study treatment and
      have not met study withdrawal criteria.
    

Intervention name(s): Cabazitaxel (XRP6258)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:solution for infusion
Route of administration: intravenous
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Evaluate PK and Safety Profile of Oral MAD of Separately Using TG-2349, DAG181 or Combination in Healthy Chinese Volunteers
Condition: Healthy Chinese Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the drug-drug reactions between TG-2349 and DAG181, and the pharmacokinetics and
      tolerability profile in healthy Chinese volunteers to be the reference for protocol designs
      of subsequent clinical trials.
    

Detailed description: 
      This is a single center, randomized, open-label, two-arm, parallel design, phase I study that
      using TG-2349 or DAG181 alone, or TG-2349 plus DAG181 to evaluate the drug-drug reactions,
      the pharmacokinetics, and tolerability profile in healthy Chinese volunteers. The results
      will be the reference for protocol designs of subsequent clinical trials.
    

Intervention name(s): TG-2349 (400 mg) plus DAG181 (200 mg); DAG181 (200 mg) plus TG-2349 (400 mg)
Intervention type(s): Drug; Drug
Intervention description(s): Dosing period 1 (Day 1 to 7): TG-2349 400 mg； Dosing period 2 (Day 8 to 14): TG-2349 400 mg + DAG181 200 mg; Dosing period 1 (Day 1 to 7): DAG181 200 mg； Dosing period 2 (Day 8 to 14): TG-2349 400 mg + DAG181 200 mg
Intervention MeSH terms: Yimitasvir
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, open-label, two-arm, parallel design
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy Chinese volunteers; TG-2349; DAG181; pharmacokinetics; safety; multiple ascending oral doses
A Pharmacokinetics Study of MultiHance in Pediatric Patients
Condition: Central Nervous System Pathology
Study type: Interventional
Phase: Phase 1

Summary: 
      Compare relative exposure in the younger age group in order to supplement the PK profile
      already determined in older children and adults
    


Intervention name(s): Multihance
Intervention type(s): Drug
Intervention description(s): 0.5M administered as a single injection
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa
Condition: Recessive Dystrophic Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this clinical trial is to investigate the efficacy (by monitoring overall
      improvement of EB symptoms) and safety (by monitoring adverse events) of three doses of
      allo-APZ2-EB administered intravenously to patients with recessive dystrophic epidermolysis
      bullosa (RDEB).
    

Detailed description: 
      This is an interventional, single arm, non-randomized, open label, phase I/IIa clinical trial
      to investigate the efficacy and safety of the IMP allo-APZ2-EB in patients with RDEB.

      Patients will undergo treatment with the IMP (three repeated intravenous applications) and
      will be followed up for efficacy for 12 weeks. To assess long-term safety of allo-APZ2-EB one
      follow-up visit at Month 12 and one follow-up visit at Month 24 post IMP applications is
      included.

      Determination of the EB linked symptoms and quality of life will be assessed by using the
      EBDASI score, the iscorEB, the change in pain and itch perception, and patient's quality of
      life in EB. The wound healing process will be documented by photography.
    

Intervention name(s): allo-APZ2-EB
Intervention type(s): Biological
Intervention description(s): intravenous infusion of allo-APZ2-EB
Other intervention name(s): allogeneic ABCB5-positive mesenchymal stem cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica; Skin Abnormalities; Congenital Abnormalities; Skin Diseases, Genetic; Somatic Cell Therapy; Mesenchymal Stem Cells; ABCB5; Allogeneic
A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
Condition: Bioequivalence
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      ioequivalence study between two inhaler products of fixed dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder
    

Detailed description: 
      A bioequivalence study of a single dose of the fixed-dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder administered from Fluticasone
      propionate 500 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent
      Pharmaceuticals (test-Τ) as 2 inhalations and ADVAIR DISKUS® 500/50 mcg inhalation powder/GSK
      (reference-R) in healthy volunteers under fasting conditions. The study will be one-center
      crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded.
    

Intervention name(s): Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent; ADVAIR DISKUS® 500/50
Intervention type(s): Drug; Drug
Intervention description(s): 2 inhalations of Test and Reference product in each study period; 2 inhalations of Test and Reference product in each study period
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: One-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded study
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: bioequivalence; fluticasone propionate; salmeterol xinafoate; ADVAIR
Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers
Condition: Vision Disorders
MeSH terms: Vision Disorders
Study type: Interventional

Summary: 
      This study is being conducted to evaluate Bausch & Lomb PureVision Multi-Focal contact lenses
      compared to the Bausch & Lomb SofLens59 contact lens when worn by adapted soft contact lens
      wearers on a daily wear basis.
    


Intervention name(s): PureVision Multi-Focal contact lenses; SofLens59 contact lens
Intervention type(s): Device; Device
Intervention description(s): Contact lenses to be worn on a daily wear basis for 2 weeks.; Contact lenses to be worn on a daily wear basis for 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety of and Immune Response to a West Nile Virus Vaccine (WN/DEN4delta30) in Healthy Adults
Condition: West Nile Fever
MeSH terms: West Nile Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      West Nile (WN) virus infection is an emerging disease. Infection with WN virus may lead to
      paralysis, coma, and death. The purpose of this study is to determine the safety of and
      immune response to a two-dose regimen of a WN vaccine in healthy adults. The vaccine is based
      on a live attenuated vaccine developed against dengue virus.
    

Detailed description: 
      WN is widely distributed in Africa and Europe, where it is usually associated with mild
      illness. In the United States, WN is considered a public health threat because severe illness
      caused by WN infection has caused paralysis, coma, and death, especially in the elderly. This
      study will evaluate the safety and immunogenicity of a live attenuated chimeric virus,
      WN/DEN4delta30, which is derived from the DEN4 dengue virus and wild-type WN serotypes.

      This study will last at least 32 weeks. Participants in Cohort 1 will be randomly assigned to
      receive 1X10^4 plaque-forming units (PFU) WN/DEN4delta30 or placebo at study entry and Day
      180. Cohort 2 will be randomly assigned to receive a higher dose of WN/DEN4delta30, 10^5 PFU,
      or placebo at study entry and Day 180. Immediately after receiving their injections,
      participants will be observed for 30 minutes for immediate adverse reactions.

      After each vaccination, participants will be asked to monitor their temperatures three times
      every day for 16 days. Study visits will occur every other day after each vaccination until
      Day 16, followed by three additional visits at selected days through Day 180
      post-vaccination. Blood collection, medical history, vital signs measurement, and a targeted
      physical exam will occur at all visits. Participants will also be required to keep
      temperature diaries until Day 16 after vaccination. Female participants will have a urine
      pregnancy test performed within 60 days of study entry, and on Days 28, 42, 150, 180, 208,
      and 222. Pregnancy prevention counseling will occur at selected visits.
    

Intervention name(s): WN/DEN4delta30 vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Live attenuated WN/DEN4delta30 vaccine (one of two doses); Placebo for WN/DEN4delta30 vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Chimeric West Nile Virus; West Nile Virus; Dengue Virus