bioihbjkbjnl/mcl2 huggingface dataset:
Hyperthermia As A Conservative Treatment For Carpal Tunnel Syndrome. A Randomized "Sham" Controlled Trial
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome; Hyperthermia
Study type: Interventional

Summary: 
      The purpose of this study is to verify the short-term effects of hyperthermia (HT) in pain
      relief and in functional impairment in patients affected by mild to moderate idiopathic
      carpal tunnel syndrome.

      A single blind randomized sham-controlled trial was performed. A 23 patients were affected by
      idiopathic CTS, 11 of them were affected by bilateral CTS.

      the intervention consists of Hyperthermia device treatment, treated for 20 minutes per
      session, a total of 8 sessions. Primary outcome is pain (Visual analogic scale).
    

Detailed description: 
      Background: Non-surgical treatment is generally administered to patients with mild to
      moderate symptoms. Many of these treatments used heat modality. Hyperthermia is a relative
      recent device which produces deep heating.

      Objective: The purpose of this study is to verify the short-term effects of hyperthermia (HT)
      in pain relief and in functional impairment in patients affected by mild to moderate
      idiopathic carpal tunnel syndrome.

      Design: A double blind randomized sham-controlled trial. Setting: Outpatient physical
      therapy, institutional clinic. Participants: 23 patients were affected by idiopathic CTS, 11
      of them were affected by bilateral CTS.

      Intervention: Hyperthermia (HT) device treatment, treated for 20 minutes per session, a total
      of 8 sessions.

      Measurement: Primary outcome is pain (Visual analogic scale). Secondary outcomes were
      self-reported pain intensity and physical functioning questionnaire (Levine/Boston),
      ultrasonographic (median nerve cross sectional area mnCSA) and neurophysiological data.
    

Intervention name(s): group A: HYPERTHERMIA; No intervention
Intervention type(s): Other; Other
Intervention description(s): All patients were treated for 8 sessions, twice a week, for a total of 4 weeks of treatment. All patients were evaluated at baseline (T0) and after 4 weeks (T1). The first two sessions were sham-treatment for both groups; the intervention tool was switched in off, only bolus was activated
Other intervention name(s): HT produce heating.; simulated intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Mass Balance Study With MT-7117
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, open-label, mass balance study in healthy male subjects utilising a
      single oral dose of [14C] MT 7117.
    


Intervention name(s): [14C] MT-7117
Intervention type(s): Drug
Intervention description(s): 14-C MT-7117
Intervention model: Single Group Assignment
Intervention model description: Open Label
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mass Balance Study with MT-7117
Pharmacokinetics of Piperacillin, Given as Continuous Infusion to Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      At the Department of Infectious Diseases, Aarhus University Hospital, continuous infusion
      with piperacillin/tazobactam for a period of 2 weeks, has been used for several years in
      patients with cystic fibrosis, suffering from acute pulmonary exacerbations (APE).

      It is an outpatient treatment. To assess the efficacy and quality of the treatment, a blood
      test every 3rd day is taken to determine the concentration of Piperacillin in blood-plasma.
    

Detailed description: 
      Patients with cystic fibrosis (CF) are often colonized with multidrug-resistant
      microorganisms, which increases the risk of suboptimal dosing of antibiotics as the time
      above the minimum inhibitory concentration (T>MIC) is suboptimal. Continuous infusion of
      beta-lactam antibiotics is more likely to optimize T>MIC than intermittent infusion. At the
      Department of Infectious Diseases, Aarhus University Hospital, continuous infusion with
      piperacillin/tazobactam for a period of 2 weeks, has been used for several years in patients
      with CF, suffering from acute pulmonary exacerbations (APE). It is an outpatient treatment,
      and the patients are given 16 g of piperacillin per 24 hours. To assess the efficacy and
      quality of the treatment, a blood test every 3rd day will be required to monitor the
      blood-plasma concentration of piperacillin, as well as C-reactive protein (CRP) and white
      blood cell count (WBC).
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Cystic Fibrosis, suffering from acute pulmonary exacerbations.
      
Biospecimen description: 
      Whole blood
    
Keywords: Cystic Fibrosis; Continuous infusion; Pharmacokinetics
Comparison Study of Operation and PEIT for Small, Solitary Hepatocellular Carcinoma (HCC)
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      The purpose of this study is to choose the preferred treatment modality for solitary, small
      hepatocellular carcinoma.
    

Detailed description: 
      To compare the below things between operation group and percutaneous ethanol injection
      therapy (PEIT) group:

        1. Survival

             -  5 year overall survival rate

             -  Disease free survival rate

        2. Recurrence

             -  Cumulative recurrence rate
    

Intervention name(s): Operation; Percutaneous ethanol injection therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): No drug needed; 99% ethanol, 2-4cc per one session, two to three sessions per single procedure for one week
Other intervention name(s): surgery; PEIT
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCC, operation, percutaneous ethanol injection
High Carbohydrate vs. High Fat Diets in the Treatment of Obesity (JBR 0512)
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to compare the ability of low calorie high carbohydrate and low
      calorie high fat/protein diets to decrease abdominal fat in overweight and obese subjects.
      The investigators will also test the effects of these diets on secondary outcomes including
      body composition, fluid and electrolyte balance, lipids and lipoproteins, blood pressure,
      arterial compliance, glucose and insulin metabolism, bone turnover, and measures of satiety.
    

Detailed description: 
      Participation in this study requires 2 screening visits to the outpatient clinic, and if
      participants qualify, 10 inpatient study weeks.

      Subjects will be admitted to the Rockefeller University Hospital for the 10 week in-patient
      phase of the study. The first 2 weeks consist of a weight stabilization period, during which
      subjects will be required to consume an average American diet. This is followed by the 6 week
      weight loss period where subjects will be randomized to either a low calorie high
      carbohydrate or a low calorie high fat/protein diet. On both diets there will be a 50%
      calorie deficit compared to the weight stabilization period. This will be followed by a 2
      week weight maintenance period during which calories will be added to the diet to maintain
      the new weight. Appropriate adjustments will be made to keep the subject's weight stable.

      During the entire inpatient study, subjects will consume one multivitamin per day (Centrum,
      always complete, from A to Zinc) and one iron supplement per day. In addition, unlimited
      access to zero calorie liquids (water/diet soda) will be available and will be encouraged to
      maintain one's usual activity level.

      Females of reproductive age, need to make sure that they do not become pregnant during the
      inpatient study. Urine will be tested for pregnancy once during the stabilization and weight
      maintenance phases of the study.
    

Intervention name(s): Low calorie high carbohydrate diet; Low calorie high fat/protein diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 65% carbohydrate, 15% protein, 20% fat (7% SFA, 8% MFA, 4% PUFA), P/S 0.63, 152 mg cholesterol/1500 kcal; High Fat/Protein Diet: 10% carbohydrate, 25% protein, 65% fat (26% SFA, 25% MFA, 9% PUFA), P/S 0.33, 458 mg cholesterol/1500 kcal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: overweight; obese; diet
Initial Test of the Time to Talk CARDIO (Creating a Real Dialogue In the Office) Program
Condition: Cardiovascular Disease; Cardiovascular Risk Factors
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This research focuses on communication practices between patients and health care
      professionals, like nurses, doctors, or physician assistants. The goal is to help improve
      communication about heart health issues.

      This pilot (or Beta) study is designed to test our ability to recruit an appropriate sample
      of participants, and determine our ability to deliver and evaluate the effects of a web-based
      intervention. The investigators hypothesize that exposure to the intervention will result in
      measurable changes in self-reported knowledge, attitudes and behavior regarding communication
      between patients and health care professionals.

      Participants in this research study are being recruited from the people who currently receive
      care at the Richmond Family Health Center of the Oregon Health & Science University. People
      who participate in this study will be between 55 and 70 years old, speak English as their
      preferred language, and have one of several possible diagnoses related to heart health. These
      could include, for example, hypertension, diabetes, asthma, or obesity.

      Additionally, the investigators are recruiting a small number of health care professionals
      from the Richmond Family Health Center. Their participation will be similar to but separate
      from the participation of patients.

      All participants will take two web-based surveys. Some participants will use a web-based tool
      that hopes to help improve communication between health care professionals and patients.

      The surveys contain questions that explore the knowledge, attitudes, and behaviors of
      participants related to heart health and communication between health care professionals and
      patients.

      Data analysis will focus upon identifying any changes that occurred in knowledge, attitudes,
      or behaviors with respect to health communication after using the web-based tool, as well as
      learning about what influences the quality and nature of communication between health care
      professionals and the patients they serve.
    


Intervention name(s): Time to Talk CARDIO website
Intervention type(s): Device
Intervention description(s): This interactive web-based training device involves the completion of a brief survey regarding communication experiences between patients and health care professionals. The pattern of responses to the survey generates a personalized set of short instructional videos which demonstrate effective communication skills.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Health communication; Health literacy; Patient; Health Care Professional; Satisfaction
A Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy
Condition: Sedation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as a
      procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and
      safety profile comparing to propofol.
    

Detailed description: 
      This is an multi-center,single-blinded,parallel-group,dose-finding study using Remimazolam or
      propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are
      randomized to different treatment groups (including 4 for Remimazolam Tosilate and 1 for
      propofol).Lidocaine and fentanyl are permitted during a diagnostic upper GI
      endoscopy.Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.
    

Intervention name(s): Remimazolam Tosilate; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Initial dose plus supplemental doses as necessary.; Initial dose plus supplemental doses as necessary.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Study to Evaluate the Food Effect on Pharmacokinetics Profile and Safety of CKD-393
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the food effect on pharmacokinetic profiles and safety of CKD-393 in
      healthy volunteers
    

Detailed description: 
      A randomized, open-label, single dose, crossover study to evaluate the food effect on
      pharmacokinetic profiles and safety of CKD-393 in healthy volunteers
    

Intervention name(s): CKD-393
Intervention type(s): Drug
Intervention description(s): PO, QD
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
FTIH to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses of GSK1322888 in Healthy Caucasian and Japanese Volunteers
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the First Time In Human study for the motilin receptor agonist, GSK1322888.
      GSK1322888 is a potent and selective small molecule motilin receptor agonist, distinct from
      the motilide compound structures. The aims of this study are to assess the safety, tolerance,
      and pharmacokinetics of single oral doses of GSK1322888 and to identify a well-tolerated and
      safe dose that will accelerate gastric emptying of a 13C stable isotope-labeled test meal in
      healthy volunteers.

      The study will include assessment of ECGs, vital signs, safety laboratory sampling, adverse
      events, pharmacokinetics, and the 13C-Octanoic Acid Breath Test to measure gastric emptying.
    


Intervention name(s): GSK1322888; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg, 5 mg or 25 mg capsule; matching placebo capsules
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: safety; motilin agonist; single dose; ascending dose; GSK1322888; migrating motor complex; tolerability; FTIH; gastric emptying
Automated Telephone Nutrition Support
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The Automated Telephone Nutrition Support (ATNS) study investigates the effect of automated
      telephone nutrition support on diet and glycemic control among Spanish-speaking diabetics in
      Oakland.
    

Detailed description: 
      The Automated Telephone Nutrition Support (ATNS) study is a joint effort between the
      University of California at San Francisco, La Clinica de la Raza, and patients living with
      diabetes in Fruitvale (Oakland). Our goal is to see if motivated people with diabetes are
      able to get their blood sugar under better control by choosing a healthier diet. Since it's
      hard to eat a healthy diet, one of the ways we are trying to help is by calling people,
      having them record what they've eaten, and reminding them of the right foods to eat. The
      innovative part is using an automated telephone system to call them to have them record their
      dietary choices and giving them feedback immediately regarding what to modify as appropriate.
    

Intervention name(s): Automated Telephone Nutrition Support
Intervention type(s): Behavioral
Intervention description(s): See Intervention Group description.
Other intervention name(s): ATNS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Telephone; Nutrition Support; Automated; Low English Proficiency; Hispanic; Latino
Bimatoprost Ocular Insert Pharmacokinetic Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the
      ocular surface to lower the intraocular pressure (IOP) in patients with open-angle glaucoma
      or ocular hypertension.

      This study will evaluate the pharmacokinetic aspects of the Bimatoprost Ocular Insert in
      healthy (non-glaucoma) subjects.
    

Detailed description: 
      This study is designed to provide pharmacokinetic (PK) data with respect to the relative
      systemic exposure to bimatoprost and bimatoprost acid after administration of a single 13 mg
      Bimatoprost Ocular Insert for 1 week in medically stable adult subjects with or without
      primary open angle glaucoma (POAG) or ocular hypertension (OHT).
    

Intervention name(s): 13mg Bimatoprost Ocular Insert
Intervention type(s): Drug
Intervention description(s): 13mg Bimatoprost Ocular Insert in each eye.
Intervention MeSH terms: Bimatoprost
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given
      weekly in patients with advanced or recurrent non-small cell lung cancer
    


Intervention name(s): Paclitaxel
Intervention type(s): Drug
Intervention description(s): Solution, IV, 100 mg/m², weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent
Other intervention name(s): Taxol; BMS-181339
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Liraglutide on Subclinical Atherosclerosis in Patients With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Atherosclerosis; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the trail is investigate the effect of liraglutide 1.8mg as add-on to insulin for
      6 months on carotid intima media thickness and cardiovascular risk factors in subjects with
      type 1 diabetes mellitus.
    


Intervention name(s): Liraglutide
Intervention type(s): Drug
Intervention description(s): Application of liraglutide 1.8 mg subcutaneous daily for 6 months to evaluate subclinical atherosclerosis, by means of carotid doppler US, lipid profile in patients with type 1 diabetes mellitus
Intervention MeSH terms: Liraglutide
Intervention model: Single Group Assignment
Intervention model description: Application of liraglutide 1.8 mg subcutaneous daily for 6 months to evaluate subclinical atherosclerosis, by means of carotid doppler US, lipid profile in patients with type 1 diabetes mellitus
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liraglutide; Diabetes Mellitus, Type 1; Atherosclerosis
Safety and Efficacy of POL6326 for Mobilization/Transplant of Sibling Donor in Patients With Hematologic Malignancies
Condition: Acute Myeloid Leukemia in Remission; Adult Acute Lymphoblastic Leukemia in Remission; Chronic Myelogenous Leukemia (CML); Non-Hodgkin's Lymphoma (NHL) or Hodgkin's Disease (HD) in 2nd or Greater Complete Remission, Partial Remission; Chronic Lymphocytic Leukemia (CLL); Multiple Myeloma (MM); Myelodysplastic Syndrome (MDS); Myeloproliferative Disorders
MeSH terms: Leukemia; Multiple Myeloma; Lymphoma, Non-Hodgkin; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hodgkin Disease; Neoplasms, Plasma Cell; Myelodysplastic Syndromes; Myeloproliferative Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Determine the safety and tolerability of POL6326 when used as a single mobilization agent.
    

Detailed description: 
      Current protocols use G-CSF to mobilize hematopoietic progenitor cells from matched sibling
      donors. This process requires from four to six days of G-CSF injection and is associated with
      significant morbidity, most notably bone pain. POL6326 is associated with few side effects
      and collection of cells occurs on the same day as POL6326 administration.

      This study will evaluate the safety and efficacy of this novel agent for hematopoietic
      progenitor cell mobilization and allogeneic transplantation based on the following
      hypotheses:

        1. Donors mobilized with intravenous POL6326 will require fewer collections than have
           previously been seen for donors mobilized with subcutaneous plerixafor.

        2. Healthy HLA-matched donors receiving one or two infusions of POL6326 will mobilize
           sufficient CD34+ cells (at least 2.0 x 106 CD34+ cells/kg recipient weights) following
           leukapheresis to support a hematopoietic cell transplant.

        3. IV POL6326 will result in more rapid kinetics and a higher maximum (peak) of human CD34+
           stem cells mobilized from human normal allogeneic donors compared to previous donors who
           were mobilized with plerixafor.

        4. The hematopoietic cells mobilized by IV POL6326 will be functional and will result in
           prompt and durable hematopoietic engraftment following transplantation into
           HLA-identical siblings with advanced hematological malignancies using various
           non-myeloablative and myeloablative conditioning regimens and regimens for routine GVHD
           prophylaxis.
    

Intervention name(s): POL6326; Leukapheresis; PBSC Transplant
Intervention type(s): Drug; Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment