bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Glucose Control, β Cell Function in Response to Short-term Insulin Pump Therapy in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate and evaluate the significance of intravenous
      glucose tolerance test in assessment of β-cell function improvement after short course of
      intensive insulin therapy, trying to illustrate the relationship between fasting plasma
      glucose and acute insulin release under different stage of type 2 diabetes with poor glycemic
      control.
    


Intervention name(s): Insulin LISPRO
Intervention type(s): Drug
Intervention description(s): receive short-term insulin pump therapy by using insulin LISPRO, continue treatment for 7 more days when euglycemia achieved
Other intervention name(s): humalog
Intervention MeSH terms: Insulin Lispro
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Radio-frequency (RF)-Based Plasma Micro-tenotomy for the Treatment of Shoulder Impingement Syndrome
Condition: Rotator Cuff Shoulder Syndrome and Allied Disorders
MeSH terms: Shoulder Impingement Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether radio-frequency (RF)-based plasma
      micro-tenotomy has a positive effective for the treatment of shoulder impingement syndrome
      with cuff tendinosis. Eighty patients with impingement syndrome and cuff tendinosis that
      treated arthroscopic were enrolled in the study. Patients were randomly assigned to receive
      either arthroscopic subacromial decompression alone (ASD group, n=40) or arthroscopic
      subacromial decompression combined with RF-based plasma micro-tenotomy (RF group, n=40).
      Clinical outcome data including VAS(Visual Analogue Scale) pain score, Shoulder range of
      motion (ROM), ASES(American Shoulder And Elbow Surgeons) score, UCLA(University of
      California, Los Angeles) score, Constant-Murley score and SST(Simple Shoulder Test) score
      were recorded preoperatively and at postoperative 3-week, 6-week, 3-month, 6-month and
      1-year.
    


Intervention name(s): RF micro-tenotomy
Intervention type(s): Procedure
Intervention description(s): an additional bipolar RF-based device (TOPAZ, Arthrocare, Austin, TX) connected to a System2000 generator (Arthrocare, Austin, TX) was used to perform the micro-tenotomy. The device functions using a controlled plasma-mediated RF-based process (Co-ablation).The device was placed on the tendon perpendicular to its surface, for 500 milliseconds, and micro-debridement was performed at 5-mm intervals by a 2-row fashion, which covered most of the foot-print region of the supraspinatous tendon and at a depth of 3 to 5 mm
Other intervention name(s): RF-based plasma micro-tenotomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthroscopic subacromial decompression; Bipolar radiofrequency; Tendon debridement; Shoulder surgery
Opiates and Benzodiazepines on Driving
Condition: Driving Behavior
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this research is to assess drug effects (Xanax and Norco) on driving performance.
      Researchers will use the Alertness Memory Profiler (AMP) application to compare results to
      previous related studies.

      This study continues a line of research designed to characterize the effects of common
      recreationally used prescription and illicit drugs with well known stimulant and sedating
      effects and their relationship to results from the Alertness Memory Profiler (AMP) that
      included a set of vigilance and memory tasks.
    

Detailed description: 
      This study uses EEG, EKG, computerized assessment, blood sampling, and driving simulation.

      Individuals recruited will be normal, healthy individuals not currently taking the study
      drugs. The study will involve five visits, a screening visit as well as four dosing visits.
      The dosing visits will have a clean (double placebo) and three drugged visits (Xanax and
      Norco placebo, Xanax placebo and Norco, Xanax and Norco). The screening visit will last about
      two hours and will include drug and pregnancy testing as well as screening for
      physical/psychological health. Each of the dosing visits will last approximately five to six
      hours and will include sleep and food intake surveys, being dosed with study drugs or
      placebos, AMP assessments, a simulator drive, and wellness surveys. There will also be 4 mL
      blood sampling before dosing, before driving, and after driving.
    

Intervention name(s): Xanax 1Mg Tablet; Norco 10Mg-325Mg Tablet; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco; Single dose on two of the four study visits, one in conjunction with 1mg alprazolam; Single dose on two of the four study visits, double dose on one of the four study visits
Other intervention name(s): Alprazolam; hydrocodone/acetaminophen
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Alprazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: driving; Xanax; Norco; simulation
Combination Treatment for Moderate to Severe Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine if a combination of three currently approved acne products are safe and
      effective for the treatment of moderate to severe acne
    

Detailed description: 
      A Phase IV, Open-Label Study Evaluating the treatment for Combination Acne Therapy.
    

Intervention name(s): Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide
Intervention type(s): Drug
Intervention description(s): Solodyn 1 tablet, Q day Ziana Gel, topical Q am Triaz FC, topical Q night
Intervention MeSH terms: Minocycline; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Tretinoin; Benzoyl Peroxide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acne
Effect Of Myofascial Release Technique With Ultrasound Therapy in Adults With Nonspecific Low Back Pain.
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain is common problem the purpose of this research will be to determine the
      comparison of ultrasound therapy and myofascial release technique for treatment of low back
      pain in adults.
    

Detailed description: 
      Low back pain is common problem the purpose of this research will be to determine the
      comparison of ultrasound therapy and myofascial release technique for treatment of low back
      pain in adults. To increase lumbar spine range of motion chest wall mobility and flexibility,
      reduction in level of lumbar disability
    

Intervention name(s): Myofascial Release Technique; Ultrasound Therapy
Intervention type(s): Diagnostic Test; Other
Intervention description(s): myofascial release therapy, the therapist applies light pressure by hand to find myofascial areas that feel stiff instead of elastic and movable. These stiff areas, or trigger points, are thought to limit muscle and joint movements, which can play a part in widespread muscle pain.; Ultrasound physical therapy is a branch of ultrasound, alongside diagnostic ultrasound and pregnancy imaging. It's used to detect and treat various musculoskeletal issues you may have including pain, tissue injury, and muscle spasms
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Evaluation of Retinal Structure With High Resolution Optical Coherence Tomography (OCT)
Condition: Macular Edema; CNV
MeSH terms: Macular Edema
Study type: Observational

Summary: 
      Comparison of different OCT instruments to assess retinal thickness, correlation to
      fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy
    

Detailed description: 
      Comparison of different OCT instruments to assess retinal thickness, correlation to
      fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy
    

Intervention name(s): Examination with an OCT device
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        healthy subjects and patients with macular diseases
      
Keywords: OCT
Impact of an Effort Rehabilitation Program for Overweight/Obese Children/Teens on Quality of Life and Wellbeing
Condition: Pediatric Obesity
MeSH terms: Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      Obese and overweight children or teens can join the Prevention and Care of Pediatric Obesity
      and Pediatric Diabetes Organization of Mulhouse. Those patients who are no longer able to
      exercize because of their physical condition start an effort rehabilitation program at the
      Organization. The study will evaluate the impact of this rehabilitation program on quality of
      life and appetency to physical activity for these children and teens.
    

Detailed description: 
      Because of a National Obesity Plan (2010-2013) initiated by the French government in charge
      of health, the Pediatric Obesity and Pediatric Diabetes Organization of Mulhouse was created
      in 2011.

      This Organization is in charge of children or teens with:

        -  severe or growing obesity associated with respiratory, osteo-articular metabolic
           complications

        -  comorbidities worsened by obesity

      The Organization and the Physical Medicine and Rehabilitation department of the Mulhouse
      Hospital have worked together to create an effort rehabilitation program for obese or
      overweight children. The program, aiming movement rehabilitation, is based on reinforcement
      and endurance activities in a playful atmosphere and in an important motivational dimension.
      A medical examination is performed before the first session to confirm the patient's ability
      to follow an effort rehabilitation program. Each session is supervised by a teacher of
      adapted physical activity.
    

Intervention name(s): Eurofit Tests of Physical Fitness (Eurofit); Child Health Questionnaire (CHQ); Effort rehabilitation program
Intervention type(s): Other; Behavioral; Other
Intervention description(s): Eurofit tests are a physical skills assessment. For the study, tests performed on the 1st and the 13th session of the program, then 3 more times : 2 months, 6 months and 12 months after the 13th weekly session.; The CHQ is a questionnaire about quality of life. The CHQ children form (CHQ-CF87) and the CHQ parent form (CHQ-PF50) are completed each time the Eurofit tests are performed : at the 1st and 13th weekly session then 2 months, 6 months and 12 months later.; Part of the routine practice of the Pediatric Obesity and Pediatric Diabetes Organization of Mulhouse, the program consists in 13 sessions of 1hour30 of adapted physical activity. The physical activity in this program use cycles of games where rules are adapted to the overweight or obese children. The activities are performed in a playful atmosphere, for example using creative games like tchoukball or peteca, with each session aiming a specific objective each time.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: teens; effort rehabilitation; quality of life; wellbeing; physical skills assessment
Clinical Study of DMT in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the acute and subacute effects of an inhaled N,
      N-Dimethyltryptamine in healthy individuals.
    

Detailed description: 
      Participants will receive N, N-Dimethyltryptamine administered in two dosing sessions: an
      initial low-dose safety session and subsequent intermediate-dose treatment, in a fixed order
      and 2h apart.
    

Intervention name(s): N,N-Dimethyltryptamine
Intervention type(s): Drug
Intervention description(s): DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen
Other intervention name(s): DMT; BMND01
Intervention MeSH terms: N,N-Dimethyltryptamine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: N,N-DMT; DMT; N,N-Dimethyltryptamine; Healthy Volunteers
Oral Misoprostol for Labor Augmentation: A Pilot Study
Condition: Arrest of Dilation in Labor
MeSH terms: Dilatation, Pathologic
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I, open-label trial to determine a safe dose of oral misoprostol required to augment
      labor in nulliparous women diagnosed with arrest of dilation.
    


Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): Oral misoprostol
Other intervention name(s): Cytotec
Intervention MeSH terms: Misoprostol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oral misoprostol; labor augmentation; arrest of dilation; nulliparous
Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers
Condition: Acquired Bleeding Disorder; Cardiac Surgery Requiring Cardiopulmonary Bypass; Healthy
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Japan. The aim of this trial is to investigate the safety profile
      of recombinant factor XIII (rFXIII) assessed by the occurrence of adverse events in healthy
      Japanese subjects. In addition pharmacokinetic parameters will be investigated.
    


Intervention name(s): catridecacog; placebo; catridecacog; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single rFXIII dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.; Single rFXIII placebo dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.; Single rFXIII dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.; Single rFXIII placebo dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
Condition: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of hydrolyzed collagen in
      osteoarthritis.
    

Detailed description: 
      The current study is part of a larger project called the CalGo-project. The overall purpose
      of the study is to use bone meal from salmon to promote skeletal health. Specifically, the
      potential for hydrolyzed collagen type II derived from salmon bone meal in ameliorating pain,
      stiffness and function in participants diagnosed with osteoarthritis will be evaluated over a
      time period of 6 months. Past literature indicates that collagen derivatives may be a
      potential supportive strategy in people suffering from osteoarthritis. Osteoarthritis is a
      common but complex joint disease with significant unmet medical needs, as there are currently
      no disease-modifying drugs available. Osteoarthritis represents a global health burden and
      the only curative treatment when pain becomes unmanageable, is joint replacement.

      The dimensions of pain, stiffness, and function will be evaluated using the Western Ontario
      and McMaster Universities Osteoarthritis Index (WOMAC 3.1). Plain x-rays with
      Kellgren-Lawrence grading will be employed to classify the severity of osteoarthritis. 100
      potential participants will be screened for eligibility. Participants who meet the
      eligibility criteria will be randomized in a double-blind manner to receive 10 capsules daily
      of hydrolyzed collagen type II (a total of 5000 mg), 10 capsules daily of salmon bone meal,
      or 10 capsules daily of placebo.
    

Intervention name(s): Hydrolyzed Collagen; Placebo; CalGo
Intervention type(s): Dietary Supplement; Other; Dietary Supplement
Intervention description(s): Hydrolyzed collagen type II derived from the bone powder of Norwegian Atlantic salmon.; Pure maltodextrin.; CalGo is a natural marine collagenic bone powder from salmon. The bone powder is a 100 % microcrystalline hydroxyapatite form of calcium and collagen type 2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: stiffness; pain; knee pain; hip pain; osteoarthritis
Hepatitis B Virus HBeAg-negative Genotype D Patients and Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma; Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Carcinoma; Carcinoma, Hepatocellular; Hepatitis
Study type: Observational [Patient Registry]

Summary: 
      To evaluate the impact of liver fibrosis and other variables [e.g., age, sex, virological
      response (VR), and previous resistance to nucleoside/nucleotide analogue (NUC) therapy] on
      Hepatocellular carcinoma incidence in an Italian population of genotype D HBeAg-negative CHB
      patients treated with long-term NUC therapy.
    

Detailed description: 
      Hepatocellular carcinoma (HCC) usually develops in patients with chronic liver disease,
      particularly patients with liver cirrhosis. Chronic hepatitis B (CHB) is one of the most
      frequent underlying causes of HCC. Several studies have demonstrated that variations in the
      hepatitis B virus (HBV) genotype have different effects on HCC. HBV genotypes C and D had
      lower responses to interferon-based therapy and higher frequencies of basal core promoter
      mutations than genotypes A and B.For this reason, HBV genotypes C and D seem to lead to more
      severe liver disease, including cirrhosis, compared with the other HBV genotypes. Because
      liver cirrhosis is one of the strongest HCC risk factors in CHB patients, antiviral therapy
      may prevent the development of liver complications such as HCC. The aim of this study is to
      evaluate the impact of liver fibrosis and other variables, such as age, sex, virological
      response (VR), and resistance to nucleoside/nucleotide analogue (NUC) therapy, in a
      population of genotype D HBeAg-negative CHB patients treated with long-term NUC therapy.
    

Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        From January 2000 to December 2013, 745 HBV-infected patients were included in the
        database. Of these, 438 were excluded: 226 did not fulfil the diagnosis of CHB, 75 had
        HBeAg-positive CHB, 20 had received NUC for <18 months, 26 had HCC diagnosed before or
        within the first 18 months of therapy, and 61 presented a different HBV genotype. Thirty
        patients had decompensated cirrhosis. A total of 306 HBeAg-negative genotype D patients
        were selected and included in this study.
      
Keywords: Hepatocellular carcinoma; Hepatitis B
Stone Clearance in Patients With Upper Ureteric Stones Using Extracorporeal Shock Wave Lithotripsy Compared With Extracorporeal Shock Wave Lithotripsy Combined With Tamsulosin Therapy
Condition: Renal Stone
MeSH terms: Kidney Calculi; Nephrolithiasis; Ureteral Calculi; Ureterolithiasis; Calculi
Study type: Interventional

Summary: 
      Extracorporeal shock wave lithotripsy (ESWL) is the least invasive and effective treatment
      for upper ureteric stones with a stone clearance rate of 60-90%. Tamsulosin is an
      alpha-blocker widely used in urological practice to relax smooth muscle of the prostate and
      bladder neck. Its role as part of medical expulsion therapy for the treatment of patients
      with kidney and ureteric stones has proved to be of considerable success. However, its role
      in clearing upper ureteric stones as an adjunct to ESWL is controversial. Therefore, this
      study will be conducted to evaluate its role in stone clearance along with extracorporeal
      shock wave lithotripsy in patients with upper ureteric stones
    


Intervention name(s): Extracorporeal shock wave lithotripsy; Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy.
Intervention type(s): Procedure; Procedure
Intervention description(s): Extracorporeal shock wave lithotripsy will given to the patients; Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy will be given to the patients
Intervention MeSH terms: Tamsulosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment