bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The long-term goal for this study is to understand the physiological mechanisms of various
      forms of spinal manipulation in order to refine and improve this therapy for appropriately
      selected patients. The objective of this study is to assess the effects of high-velocity
      low-amplitude spinal manipulation and low-velocity variable amplitude spinal manipulation on
      three types of sensorimotor abilities in patients with low back pain.
    

Detailed description: 
      In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research
      will pursue the following specific aim: To determine the effects of 2 weeks (4 applications @
      2 per week) of HVLA-SM and LVVA-SM to the lumbo-pelvic region, compared to a control group
      receiving light effleurage and a sham mechanically assisted adjustment, on sensorimotor
      function as measured by: lumbo-pelvic repositioning ability, standing postural sway and
      response to sudden trunk loading;
    

Intervention name(s): HVLA-SM; LVVA-SM; Sham Intervention
Intervention type(s): Other; Other; Other
Intervention description(s): High velocity, low amplitude lumbo-pelvic manipulation; Low velocity, variable amplitude lumbo-pelvic manipulation; 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation
Other intervention name(s): light effleurage followed by SMT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Dose Ranging Study of RPL554 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: COPD
Study type: Interventional
Phase: Phase 2

Summary: 
      The study investigates the effect of 4 weeks of twice daily treatment of four different doses
      of RPL554 (a phosphodiesterase [PDE]3/4 inhibitor) or placebo in patients with moderate to
      severe chronic obstructive pulmonary disease (COPD). Patients will be equally allocated to
      one of the five treatment options.
    

Detailed description: 
      RPL554 is a dual inhibitor of PDE3 and PDE4 which are known to have a role in modulating the
      inflammatory airway response in respiratory diseases, including COPD. PDE3 inhibitors act as
      bronchodilators whilst PDE4 inhibitors have anti-inflammatory properties and there is also
      evidence to suggest that combined inhibition of PDE3 and PDE4 can have additive or
      synergistic anti-inflammatory and bronchodilator effects. PDE4 inhibitors (administered
      orally) have, however been associated with unfavorable gastrointestinal side effects such as
      nausea, emesis, diarrhea, abdominal pain, loss of appetite and weight loss. Dual PDE3/PDE4
      inhibitors (administered by inhalation) have exhibited both bronchodilator and
      anti-inflammatory actions, with a more favorable side effect profile. It is plausible that
      increased efficacy with reduced side effects may be achievable with administration of a dual
      PDE3/4 inhibitor by the inhaled route compared to orally administered PDE3 or PDE4
      inhibitors.

      The purpose of this study is to investigate the dose response of RPL554 in patients with COPD
      over 4 weeks. This length of time should allow for study of the bronchodilator response,
      measured predominantly by the peak forced expiratory volume in one second (FEV1), and the
      anti-inflammatory response, as measured predominantly by trough FEV1.
    

Intervention name(s): RPL554 suspension; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A dual PDE3/PDE 4 inhibitor; Placebo solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD, bronchodilation, FEV1
A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA
    

Detailed description: 
      A repeat-dose open label randomized incomplete block design in pediatric subjects with
      asthma, ages 4-11 years, to compare systemic exposure and pharmacodynamics of fluticasone
      propionate and salmeterol following ADVAIR HFA 45/21mcg(2 inhalations), ADVAIR HFA 45/21mcg(2
      inhalations) with Aerochamber Plus Spacer and ADVAIR DISKUS 100/50 twice daily
    

Intervention name(s): ADVAIR HFA; ADVAIR DISKUS
Intervention type(s): Drug; Drug
Other intervention name(s): ADVAIR HFA
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics; ADVAIR Inhaler; Asthma; ADVAIR DISKUS
A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an observational, international, open label, pilot study to evaluate the safety,
      tolerability and efficacy of an oral PTH (1-34) preparation produced by Entera Bio in adult
      hypoparathyroid volunteers.
    


Intervention name(s): EnteraBio's Oral Parathyroid Hormone (1-34)
Intervention type(s): Drug
Intervention description(s): Oral administration
Other intervention name(s): Teriparatide
Intervention MeSH terms: Teriparatide; Hormones; Parathyroid Hormone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioavailability of Oral BIRB 796 BS Tablets With and Without Administration of Oral Pantoprazole in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS.

      Safety and tolerability were also assessed.
    


Intervention name(s): BIBR 796 BS; Pantoprazole
Intervention type(s): Device; Drug
Intervention description(s): single dose; 5 days
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study in Healthy Adults Who Sometimes Take Drugs for Pleasure to Investigate the Safety and Tolerability of GRT0151Y and to Find Out Which Single Dose of the Compound is Maximally Tolerated
Condition: Pain; Acute Pain; Chronic Pain
MeSH terms: Chronic Pain; Acute Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the maximum dose of GRT0151Y that is tolerable and
      to explore the safety profile of the drug.

      For each Treatment Period (Visits 2-5), dosing will be separated by at least one week.
      Participants in this study will receive up to four doses of the study drug and up to two
      placebo (an inactive substance) preparations, one at a time on each of up to six visits.
      Participants will receive a single dose of either GRT0151Y or placebo beginning with the
      lowest dose of study drug 150 milligrams (mg), followed by 200 mg, 250 mg, 300 mg, 350 mg and
      400 mg doses of the study drug. Participants will only be allowed to proceed to the next
      higher dose of GRT0151Y (or placebo) if the previous dose was well tolerated. Neither the
      participant nor the study staff will know whether participants are receiving GRT0151Y or
      placebo.
    


Intervention name(s): GRT0151Y dose escalation; Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single doses of 150, 200, 250, 300, 350 and 400 mg (3, 4, 5, 6, 7 or 8 capsules of 50 mg); Matching placebo capsules (3, 4, 5, 6, 7 or 8 capsules)
Intervention model: Single Group Assignment
Intervention model description: During each treatment period, participants randomly received either GRT0151Y or matching placebo, in a manner that no participant received placebo in two consecutive periods.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of adding Symlin to an
      established regimen of insulin glargine in subjects with type 2 diabetes who are not
      achieving glycemic targets.
    


Intervention name(s): pramlintide acetate
Intervention type(s): Drug
Intervention description(s): Clear, colorless, sterile solution for SC injection
Intervention MeSH terms: Pramlintide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: diabetes; Amylin; Symlin; pramlintide; insulin glargine
Association of Type 1 Diabetes Mellitus in Offsprings With Positive Parental History of Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To measure the association between a parental history of diabetes and the odds of an
      offspring being Type 1 diabetics.

      Secondary Objectives:

        -  To document the profile of Type 1 diabetes patients.

        -  To document the glycemic parameters (Fasting blood glucose [FBG] and glycosylated
           hemoglobin [HbA1c]) of Type 1 diabetes.

        -  To capture the current therapeutic management.
    

Detailed description: 
      The overall duration of this study is expected to be 12 months. The recruitment period for a
      given center will be four months following site initiation of that center. telephonic
      follow-up for all the patients shall be conducted after 15 days ± 5 days.

      *Each patient (cases as well as controls) will be required to undergo laboratory tests for
      insulin autoantibodies and hemoglobin A1c tests. Both the tests will be conducted through
      centralized laboratories for all recruited patients.

      Since the result of insulin auto-antibodies test is one of the inclusion criteria, it is
      mandatory for all patients to undergo this test, and detailed information for the same has
      been included in the informed consent form.
    

Intervention name(s): Blood draw for insulin auto-anti body tests*
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: N/A
Route of administration: N/A
Intervention MeSH terms: Antibodies
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis (Feasibility Study)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This study evaluates the feasibility of a 12-week internet-based exercise and physical
      activity counseling intervention for people with Multiple Sclerosis (MS).
    

Detailed description: 
      Due to high inactivity rates in persons with Multiple Sclerosis (pwMS) physical activity
      promotion for this target group is needed. The internet is an attractive and feasible medium
      for physical activity promotion, however interventions have to be adapted to the special
      needs of pwMS. This study aims to evaluate the feasibility of a 12-week internet-based
      exercise and physical activity counseling intervention.

      26 pwMS will be enrolled in the study. All of them receive the intervention. Focus groups and
      interviews will be conducted with participating pwMS to determine acceptability of the
      intervention and to explore participants experiences. Compliance with the intervention will
      be monitored. Additionally, changes in objective physical activity, subjective physical
      activity, fatigue, walking ability and level of depression will be calculated.
    

Intervention name(s): Physical activity counseling; Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Physical activity counseling consists of two phone or video calls with a therapists, two group video calls with a therapist and a complementary e-learning course.; Participants will agree with their therapist on an exercise plan (endurance and resistance training) that will be made available through the studies mobile app. Frequency and duration of endurance and strength training shall be prescribed in accordance with exercise guidelines for pwMS. However, they can be adjusted according to participants prior physical activity level and their available time slots for exercise during the week.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis; e-health; physical activity promotion; exercise; feasibility; online; internet based
Comparison of Clinical Efficacy Between Dynamic Dip Screw and Cannulated Compression Screw for Fresh Femoral Neck Fracture
Condition: Femoral Neck Fractures
MeSH terms: Fractures, Bone; Femoral Neck Fractures
Study type: Interventional

Summary: 
      For fresh femoral neck fracture internal fixation, both DHS and CCS can make strong fixation
      of hip and have good recovery. There is no statistical difference in complications after
      surgery between the two procedures. Patients with DHS internal fixation have earlier
      postoperative weight bearing, which is conducive to functional exercise of the injured limb.
      DHS internal fixation system is recommended for patients with unstable fractures and severe
      osteoporosis.
    

Detailed description: 
      Objective: To compare the clinical effect of dynamic hip screw (DHS) and cannulated
      compression screw (CCS) in the treatment of fresh femoral neck fracture. Methods: A
      retrospective study was conducted to analyze the data of 91 patients with fresh femoral neck
      fracture treated with DHS or CCS in our hospital from January 2012 to June 2016.The cases
      were divided into two groups according to internal fixation: 44 cases in the DHS group and 47
      cases in the CCS group. By comparing operative time, intraoperative bleeding, postoperative
      load, Harris scoring and the complications such as postoperative necrosis of femoral head and
      shortening of femoral neck appearance, we evaluated the clinical curative effect of two kinds
      of fixation.
    

Intervention name(s): internal fixation implantation of dynamic hip screw; internal fixation implantation of cannulated compression screw
Intervention type(s): Device; Device
Intervention description(s): Dynamic hip screws (DHS) are a femoral head-sparing orthopedic device used to treat femoral neck fractures.; Cannulated Screw is designed to provide a minimally invasive method of anatomical fixation.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Femoral neck fracture; Internal fixation of fracture; Dynamic hip screw; Cannulated compression screw
Early Detection of Pulmonary- and Pulmonary Vascular Disease in Sjögren Syndrome
Condition: Sjögren Syndrome; Pulmonary Hypertension
MeSH terms: Sjogren's Syndrome; Hypertension, Pulmonary; Vascular Diseases; Syndrome
Study type: Observational

Summary: 
      According to the literature available pulmonary hypertension is present in 12 to 23% of
      patients suffering from Sjögren Syndrome. However epidemiological data are based on
      non-invasive measurements using echocardiography. Furthermore, no data are available
      regarding exercise hemodynamics in those patients.

      This study investigates pulmonary hemodynamics at rest and during exercise in patients
      suffering from primary and secondary Sjögren Syndrome. Patients under suspicion for pulmonary
      hypertension (PH) will be offered further investigations including right heart
      catheterization.
    

Detailed description: 
      Patients with primary and secondary Sjögren Syndrome will be investigated using
      echocardiography, exercise echocardiography, pulmonary function testing, laboratory testing,
      electrocardiogram and 6 minute walking test. Those patients under clinical suspicion for
      pulmonary hypertension will be offered further investigations including right heart
      catheterization to rule out or verify the diagnosis of manifest pulmonary hypertension.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with primary or secondary Sjögren Syndrome.
Pharmacokinetic Study Comparing Blood Levels of Dasatinib in Healthy Participants Who Received the Tablet Formulation With Those Who Received Liquid and Tablet-dispersed Formulations
Condition: Pharmacokinetic Study in Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the blood levels of dasatinib in healthy participants
      who received tablet formulation with those of healthy participants who received liquid and
      tablet-dispersed formulations of the drug.
    


Intervention name(s): Dasatinib as tablets; Dasatinib as liquid; Dasatinib as dispersed tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 50-mg tablets plus 240 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day; 100 mg administered as 10 mL of liquid drug (10 mg/mL) plus 230 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day; 2 50-mg dispersed tablets in 30 mL of 100% orange juice followed by 15 mL of orange juice plus 195 mL noncarbonated, nonrefrigerated water. Liquid (oral solution), single dose, 1 day.
Other intervention name(s): Dasatinib/BMS-354825; Dasatinib/BMS-354825; Dasatinib/BMS-354825
Intervention MeSH terms: Dasatinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Efficacy of 500µg Roflumilast Once Daily Versus Placebo Over 12 Weeks in Patients With Diabetes Mellitus Type 2. A Double Blind, Parallel Group, Proof of Concept Clinical Study
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a proof of concept study to confirm in a standardized manner the therapeutic
      efficacy of roflumilast in type 2 diabetes mellitus patients.
    


Intervention name(s): Roflumilast
Intervention type(s): Drug
Intervention description(s): 500µg, once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus Type 2; Roflumilast
A Study of 5-FU Versus MTX+5-FU in Gastric Cancer With Peritoneal Metastasis
Condition: Gastric Cancer; Neoplasm Metastasis
MeSH terms: Neoplasm Metastasis; Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis
    

Detailed description: 
      Peritoneal metastasis is common in advanced gastric cancer and is considered an incurable
      disease state. Peritoneal metastasis may cause serious complications, such as intestinal
      obstruction, massive ascites, and hydronephrosis associated with the clinical presentation of
      abdominal pain and fullness, vomiting, constipation, malnutrition and renal dysfunction.5-FU
      continuous infusion remains the mainstay for chemotherapy against gastric cancer. On the
      other, sequential MTX+5-FU was reported to be effective in advanced gastric cancer with
      peritoneal metastasis in some phase II studies. Therefore, the randomized phase III study of
      5-FU versus sequential MTX+5-FU in gastric cancer with peritoneal metastasis was conducted.
    

Intervention name(s): 5-FU continuous infusion; MTX + 5-FU sequential therapy
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric cancer; peritoneal metastasis; randomized trial; 5-FU; MTX
Atomoxetine and Oxybutynin in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Obstructive sleep apnea (OSA) is common and has major health implications but treatment
      options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle
      activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared
      to normal subjects. Until recently, the search for medicines to activate pharyngeal muscles
      in sleeping humans has been discouraging. However, exciting new animal research has shown
      that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle
      activity to waking levels. In this protocol the investigators will test the effect of
      atomoxetine (a norepinephrine reuptake inhibitor) and oxybutynin (an antimuscarinic drug)
      administered together on OSA phenotype traits and OSA severity during sleep.
    


Intervention name(s): Combination product of Atomoxetine and Oxybutynin; Placebo, 2 tablets
Intervention type(s): Drug; Drug
Intervention description(s): Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 2 hours before sleep; Placebo 2 tablets 2 hours before sleep
Other intervention name(s): Strattera + Ditropan
Intervention MeSH terms: Oxybutynin; Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment