bioihbjkbjnl/mcl2 huggingface dataset:
Effects of TENS and Interference on Pain, Functional Status and Range of Motion in Shoulder Pain in Stroke Patients
Condition: Hemiplegic Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Effects of TENS and Interference on Pain, Functional Status and Range of Motion in Shoulder
      Pain in Stroke Patients
    

Detailed description: 
      Hemiplegic shoulder pain treatment methods are, analgesics, local steroid injection, physical
      therapy modalities and exercise. There are publications about the use of TENS and
      interferential currents (IFC) in the treatment of hemiplegia related shoulder pain and their
      effectiveness. However when we look at the literature, we did not find a study that evaluated
      the efficacy of TENS and IFC in hemiplegic shoulder pain. For this reason, in this study, we
      aimed to determine the effects of these analgesic treatment modalities on the patient's pain,
      functional status and shoulder range of motion (ROM) in these patients. 60 stroke patients
      with shoulder pain randomized to four treatment groups. 15 patients in Group 1 were given
      TENS treatment to the shoulder area for 25 minutes by conventional method ( 20 sessions, 5
      times a week), then, a classical stroke rehabilitation program was applied under the guidance
      of a physiotherapist.. 15 patients in Group 2 were given shamTENS treatment to the shoulder
      area for 25 minutes ( 20 sessions, 5 times a week), then, a classical stroke rehabilitation
      program was applied under the guidance of a physiotherapist.15 patients in Group 3 were given
      100 Hz IFC treatment to the shoulder area for 25 minutes ( 20 sessions, 5 times a week),
      then, a classical stroke rehabilitation program was applied under the guidance of a
      physiotherapist. 15 patients in Group 4 were given shamIFC treatment to the shoulder area for
      25 minutes ( 20 sessions, 5 times a week), then, a classical stroke rehabilitation program
      was applied under the guidance of a physiotherapist.
    

Intervention name(s): TENS; shamTENS; IFC; shamIFC
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Transcutaneus electrical nerve stimulation (TENS)- analgesic current therapy; shamTranscutaneus electrical nerve stimulation (shamTENS)- analgesic current therapy; Interferential current therapy (IFC)- analgesic current therapy; shamInterferential current therapy (shamIFC)- analgesic current therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Rehabilitation; Exercise; TENS
Acupuncture for Hot Flushes in Menopause
Condition: Menopause; Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional

Summary: 
      In a pragmatic study investigate whether Traditional Chinese Medicine acupuncture-care
      decreases the frequency of hot flushes and increases health related quality of life among
      postmenopausal women. The intervention group will receive 10 sessions of acupuncture, the
      control group will engage in self care only. The study period lasts for 12 weeks.
    

Detailed description: 
      The study objective is to determine whether Traditional Chinese Medicine (TCM)
      acupuncture-care together with self-care is more effective than self-care alone, to relieve
      climacteric complaints among women who seek alternatives to hormonal replacement therapy
      (HRT). Study design is a pragmatic randomised controlled trial with two parallel arms. Study
      participants are postmenopausal women who document a mean value of 7 flushes/24 hours and who
      are not using HRT or other prescribed medication that may influence climacteric complaints.
      The treatment group will receive 10 sessions of TCM acupuncture-care and self-care; the
      control group will engage in self-care only.

      The duration of intervention period is 12 weeks with evaluations at baseline, 4, 8, 12 weeks,
      and follow up at 6 and 12 months after baseline. Primary endpoint is change in daily hot
      flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health
      related quality of life. N in each treatment group: 143 (286 altogether).
    

Intervention name(s): Traditional chinese medicine type acupuncture; Self Care
Intervention type(s): Procedure; Behavioral
Intervention description(s): 10 acupuncture sessions; Lifestyle advice on diet, physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Women; Acupuncture; Menopause; Hot flashes; Health related quality of life
Reverse Cholesterol Transport (RCT) Study
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the use of radiolabeled particulate cholesterol
      administered intravenously in association with albumin, as a method to study reverse
      cholesterol transport (RCT) in humans by analyzing changes in the tracer activity in total
      plasma, lipoproteins and feces.
    

Detailed description: 
      The study will use 3H-cholesterol bound to albumin (particulate cholesterol) to assess the
      ability of HDL to transport cholesterol to the liver to be eliminated. This process is called
      Reverse Cholesterol transport and is one of the main mechanisms by which HDL protect against
      atherosclerotic cardiovascular disease. The availability of a method to assess RCT is
      important for the development of new drugs which affect RCT and may result in useful
      treatments for atherosclerosis.

      This study will evaluate the use of radiolabeled particulate cholesterol administered
      intravenously in association with albumin, as a method to study reverse cholesterol transport
      (RCT) in humans by analyzing changes in the tracer activity in total plasma and lipoproteins.
      The study population is healthy volunteers.
    

Intervention name(s): 3H-Cholesterol
Intervention type(s): Other
Intervention description(s): A single dose of 25-50 μCi 3H free cholesterol -albumin complexes (containing approximately 0.1 - 0.3 mg of cholesterol) will be administered intravenously as a slow bolus injection within 1-2 minutes.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Low HDL; High HDL; HDL; Reverse Cholesterol Transport; RCT; healthy volunteer; 3H; Average HDL
Activation of Polyamine Catabolism in Patients With Acute Pancreatitis
Condition: Pancreatitis; Polyamines
MeSH terms: Pancreatitis
Study type: Observational

Summary: 
      Background: Polyamines are essential compounds in all mammalian tissues. If tissue
      spermidine/spermine levels, however, dramatically decrease, the cellular survival is severely
      endangered. Transgenic animals, where the homeostasis of cellular polyamines can be disturbed
      and tissue spermidine/spermine levels are decreased, acute pancreatitis evolves, indicating
      pancreas to be one of the most vulnerable organs for tissue polyamine catabolism. On the
      other hand, our own data suggests that also in other models of acute experimental
      pancreatitis pancreatic polyamines are changed depending on the severity of pancreatitis in
      such a way that the more severe pancreatitis the lower are the pancreatic polyamine levels.
      Minor changes were observed also in rats undergoing sham operation only. In addition of
      pancreatic enzymes, inflammatory mediators are also involved in the pathophysiology of the
      disease. CRP, IL-6, IL-8, IL-10 and Procalcitonin are useful in predicting the severity of
      the disease, combination of IL-6 and IL-10 at admission can predict organ failure with
      sensitivity of 95 %, specificity of 88 %.

      Hypothesis: Similar to experimental pancreatitis, blood polyamine changes are associated with
      acute pancreatitis also in the man. These changes are dependent on the severity of
      pancreatitis, but not on the etiology of pancreatitis. The changes are specific to acute
      pancreatitis compared with other intra-abdominal emergencies. The changes observed return to
      baseline during recovery. Furthermore, we assume that blood polyamine negatively correlates
      with IL-6, IL-8, and procalcitonin, and positively with IL-10.
    


Observational model: Defined Population
Time perspective: Other
Keywords: pancreatitis; polyamine; cytokine
An Exploratory Haemodynamic Study in Patients With Compensated Cirrhosis and Portal Hypertension
Condition: Compensated Cirrhosis and Portal Hypertension
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hypertension; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this exploratory study was to investigate the effect of serelaxin
      (RLX030) infusion on the hepatic and renal circulation in patients with compensated cirrhosis
      and portal hypertension. Measurements were acquired non-invasively using magnetic resonance
      angiography (MRA) (study part A) and more directly via cannulation of the hepatic portal vein
      during a routine transjugular intrahepatic portosystemic shunt (TIPSS) check procedure (study
      part B), to determine the acute haemodynamic response to serelaxin (RLX030).
    


Intervention name(s): Terlipressin acetate; Serelaxin (RLX030)
Intervention type(s): Drug; Drug
Intervention description(s): IV bolus injection; Part A2: IV infusion for 2-3 hours; duration of infusion depends on time required for completion of MRA data acquisition; Part B: IV infusion for approximately 2 hours
Intervention MeSH terms: Terlipressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Portal hypertension, cirrhosis, TIPSS, MRI, MRA, portal pressure, portal pressure gradient
Effects of Rifampin on the Pharmacokinetics of Nilotinib in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of 600 mg daily oral dose of rifampin (CYP3A4 inducer) on
      the pharmacokinetics of a single 400 mg oral dose of nilotinib in healthy subjects
    


Intervention name(s): Nilotinib
Intervention type(s): Drug
Intervention description(s): Semi-synthetic antibiotic derivative of rifamycin B and is known to induce cytochrome P-450 (CYP) enzymes.
Other intervention name(s): AMN107A, Tasigna
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nilotinib; Rifampin; PK; healthy subjects
The Multi-Media Social Skills Project for Adults
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This study is investigating the development of a social skills training program for adults
      with Asperger's Syndrome or high-functioning autism, ages 18 to 35 years. The Principal
      Investigator for this study is Dr. Michael Murray, the director of the Autism Studies
      Division at the Penn State Hershey Medical Center. The purpose of this study is to adapt a
      social skills training program to address and enhance the social skills of adults with
      Asperger's Syndrome and high-functioning autism.
    

Detailed description: 
      During group study visits, a group of six young adults with Asperger's Syndrome or
      high-functioning autism will meet weekly for about 90 minutes. The purpose of the group
      sessions is to work on everyday social skills such as initiating and maintaining
      conversations, establishing friendships, and dealing with situations such as job interviews
      and dating.

      A generalization session will be held every week after the group therapy session with
      same-age peers who have been screened to participate in the study. The purpose of including
      peers in the class is to give young adults with Asperger's syndrome and high-functioning
      autism a chance to practice the social skills learned in the group study visit with a peer
      group. Study participants will be paired with a typically developing peer for an outing in
      the community to a nearby restaurant or shop or an in-class exercise such as a mock job
      interview.
    

Intervention name(s): social skills therapy
Intervention type(s): Behavioral
Intervention description(s): Sixteen week manual based social skills curriculum targeting social fluency and responsiveness.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Social Skills; Asperger's; High-functioning autism; Young adults
A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Heartburn
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is
      effective in treating patients with night heartburn.
    

Detailed description: 
      This 4 week study of Dexlansoprazole (TAK-390MR) will be conducted by approximately 50
      investigators in the United States in patients suffering from night heartburn.
    

Intervention name(s): Dexlansoprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg capsule, orally, once daily for 4 weeks; 1 capsule, orally, once daily for 4 weeks
Other intervention name(s): TAK-390; T-168390; TAK-390MR; Kapidex; Dexilant
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-Erosive Gastroesophageal Reflux Disease; GERD; heartburn; sleep disturbance; nocturnal Reflux
IMP4297 Food Effect Trial in Healthy Volunteers
Condition: Solid Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I, single-site, open-label, randomized, single-dose, two-way crossover study to
      evaluate the effect of food on the pharmacokinetic characteristics of IMP4297 capsules in
      China
    

Detailed description: 
      This food-effect study plans to enroll 16 (at least 12 to complete the study) subjects.
      Subjects will be randomly assigned to 1 of 2 dosing sequences (fasted or standard high-fat
      breakfast) at a 1:1 ratio generated from a computer. Each dosing sequence will consist of 2
      cycles, with 1 dose in each cycle of the study and a washout period of at least 7 days
      between each dose. Study drug will be administered to subjects in the morning of each
      administration day of each cycle. PK, ECG, vital signs, physical examinations and laboratory
      tests will be performed as specified in the protocol. Tolerability and safety of the
      treatment will be evaluated by monitoring adverse events.
    

Intervention name(s): IMP4297
Intervention type(s): Drug
Intervention description(s): 10mg/capsule.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly) NEO/PEDS
Condition: Subjects With an Existing Intra-arterial Line
Study type: Observational

Summary: 
      To determine accuracy specifications of the pulse oximeter in the NEO/PEDS subject population
    


Observational model: Case-Only
Sampling method: Probability Sample
Study population: 
        The study population will include male and female pediatric and neonatal patients who meet
        the specified sensor weight requirements with an existing intra-arterial line, typically
        found in hospital intensive care areas. Subjects of all racial and ethnic backgrounds may
        be included in the studies.
Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB
Condition: Peripheral Arterial Diseases
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of actovegin in participants
      with peripheral arterial disease (PAD) Fontaine Stage IIB.
    

Detailed description: 
      The study will enroll approximately 366 participants. Participants will be randomly assigned
      to one of the two treatment groups in 1:1 ratio:

        1. Actovegin

        2. Placebo (dummy inactive substance) - this is a tablet/intravenous infusion that looks
           like the study drug but has no active ingredient

      All participants will be asked to take intravenous infusion for 2 weeks followed by oral
      tablets for 10 weeks.

      This multi-center trial will be conducted Russia, Georgia, and Kazakhstan. The overall time
      to participate in this study is 25 to 26 weeks. Participants will make multiple visits to the
      clinic, and 12 weeks after last dose of study drug for a follow-up assessment.
    

Intervention name(s): Actovegin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Actovegin intravenous infusion and tablets.; Actovegin placebo-matching intravenous infusion and tablets.
Intervention MeSH terms: Actovegin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Drug Therapy
Contraceptive Choice Center
Condition: Unintended Pregnancy; Contraception; Family Planning
Study type: Observational

Summary: 
      The Contraceptive Choice Center will use an innovative-model of contraceptive care which was
      developed as a part of the Contraceptive CHOICE Project (CHOICE). This delivery model will
      deliver high-quality family planning services for women and reduce unintended pregnancies and
      births. This intervention will result in improved health for women, improved health care, and
      reduced costs to Medicaid.

      The Center will provide care to women ages 14-45 years of age.
    

Detailed description: 
      The Center will provide high-quality contraceptive care using the innovative model of the
      Contraceptive CHOICE Project. Specifically, the model will provide the following components:
      1) Structured, evidence-based contraceptive counseling; 2) education of providers about
      long-acting reversible contraceptive (LARC) methods and evidence-based guidelines for
      contraceptive provision; 3) removal of patient barriers to family planning services; and 4)
      post-visit contraceptive support. The model addresses the barriers to contraceptive uptake.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We plan to recruit women who are at high risk for unintended pregnancy and birth.
Effect of Gait Training With a Walking Assist Robot on Gait Function and Balance in Patients With Chronic Stroke
Condition: Gait Disorders, Neurologic; Stroke
MeSH terms: Stroke; Nervous System Diseases; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effects of gait training with the new
      wearable hip assist robot developed by Samsung Advance Institute of Technology (Samsung
      Electronics Co, Ltd, Korea) in patients with chronic stroke.
    

Detailed description: 
      Seven chronic stroke patients will participate in this study. All subjects will receive
      training 3 times per week for 8 weeks for 24 training sessions. Each session is directed by a
      licensed physical therapist and lasted 60 min (including rest period of 10 min). Brain
      activity and gait assessment will be performed at visits 0 (baseline), 24 (post-test), and at
      3 months (follow-up) after training.

      Primary objective is to demonstrate the effects of hip assist robot on spatio-temporal
      parameters measured by motion capture system (Motion Analysis Corporation, Santa Rosa, CA,
      USA), muscle activation patterns measured by surface electromyography (sEMG) (Noraxon Inc.,
      Scottsdale, AZ, USA), metabolic energy cost parameters measured by portable cardiopulmonary
      metabolic system (Cosmed K4B2, Rome, Italy) and cortical activation measured by functional
      Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany).

      Secondary objective is to demonstrate the effects of hip assist robot on motor function
      improvement evaluated by Berg Balance Scale (BBS), Dynamic Gait Index (DGI), Timed Up and Go
      (TUG) test, Push and Release (P&R) test, Functional Reach Test (FRT), Korean version Fall
      Efficacy Scale (K-FES), Manual Muscle Test (MMT) and Range of Motion (ROM).
    

Intervention name(s): Samsung Hip Assist v1
Intervention type(s): Device
Intervention description(s): All subjects receive gait training 3 times per week for 8 weeks for 24 training sessions. Each session is directed by a licensed physical therapist and lasted 60 min including rest period of 10 min. Brain activity and gait assessment is performed at visits 0 (baseline), 24 (post-test), and at 3 months (follow-up) after training.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Exoskeleton Device; Gait rehabilitation; Chronic storke
Bioequivalence Study of Clopid® (Clopidogrel) 75 mg Tablet and Plavix® 75 mg Tablet After Oral Administration to Healthy Adult Subjects Under Fasting Condition
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the rate and extent of absorption of Clopid® (Clopidogrel) 75 mg Tablet and
      Plavix® (clopidogrel) 75 mg tablet under fasting condition.
    

Detailed description: 
      Single dose, Randomized, Open-label, 2-Way Crossover, Bioequivalence Study of Clopid® of
      Ferozsons Laboratories Limited and Plavix® of Sanofi Winthrop Industrie France for Sanofi
      Pakistan Following a 75 mg Dose In Healthy Subjects Under Fasting Condition.
    

Intervention name(s): Clopid® 75 mg Tablet; Plavix® 75mg Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of Clopid® 75 mg Tablet (Clopidogrel) was administered after a 10-hour overnight fast.; Single dose of Plavix® 75 mg Tablet (Clopidogrel) was administered after a 10-hour overnight fast.
Other intervention name(s): Clopidogrel; Clopidogrel
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: open label, randomized, single-dose, 2 way cross-over study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Clopidogrel; Platelet Aggregation Inhibitor; Bioequivalence