bioihbjkbjnl/mcl2 huggingface dataset:
Throwing Device Trial
Condition: Overuse Injury
MeSH terms: Cumulative Trauma Disorders
Study type: Interventional

Summary: 
      The primary objective of this study is to collect motion-capture data on movements common to
      baseball play in order to develop an algorithm for a wearable device for the prevention and
      rehabilitation of sports-related overuse injuries. Secondary objectives include evaluating
      the feasibility of wearing the throwing device during simulated baseball play.
    

Detailed description: 
      With the rise in competitive sports participation in pediatric and adolescent populations,
      there has also been an increase in overuse injuries. Current methods of overuse injury
      prevention, such as pitch-counting, fail to account for differing techniques or effort and
      often ignore the elevated risk for children participating in two or more sports emphasizing
      the same body part. This wearable device seeks to more accurately monitor overuse to prevent
      and aid rehabilitation of overuse injuries.

      Subjects will be asked to fill out a short survey about their athletic activities. They will
      wear a prototype of a minimal risk throwing device during simulated baseball play in a sports
      medicine session or at the Human Motion Laboratory. Various motion data from the device and
      from the Motion Lab analysis will be collected to create and refine an algorithm to quantify
      workload and throwing movements.

      The primary endpoint of this study is to quantify motion capture data on movements common to
      baseball play. The secondary endpoints include quantifying injury associated with different
      baseball movement using the proposed system, development of algorithms to quantify workloads
      associated with injury during common baseball movements and validation of basic device
      measurements (Pilot Phase).
    

Intervention name(s): Throwing Device
Intervention type(s): Device
Intervention description(s): The Innovative Design Labs ( IDL) PhySens will be used to monitor the physical motions of subjects during standard sports-related actions (e.g. throwing a baseball). For this test, the PhySens Carrier will be attached via clothing rivets to a fabric sleeve or strap made of compliant materials commonly used in clothing and wearable products (e.g. nylon, spandex, neoprene).
Intervention model: Single Group Assignment
Intervention model description: a wearable prototype device for monitoring upper extremity sports related forces translated to the body during activity. The system will track exposure to injurious forces and monitor adherence to sport specific overuse standards and prescribed rehab regimens.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Healthy subjects; Athletes; Baseball; Sports research; overuse injuries
Clinical Trial on Efficacy of rTMS to Improve ECT in Treatment-Resistant Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional

Summary: 
      It's a prospective, multicentric, randomized, controlled study concerning 56 patients with
      treatment-resistant depression (TRD). The main objective of this study was to evaluate the
      efficacy of priming repeated Transcranial Magnetic Stimulation (rTMS) sessions before
      Electroconvulsive therapy (ECT) for treatment of TRD patients. The primary outcome will be
      the depressive symptoms intensity measured with the Hamilton Rating Scale For Depression
      (HAMD-21 items) after 5 ECT. The secondary outcome is to evaluate the safety and most
      particularly the cognitive effects of this association.
    

Detailed description: 
      Included patients are adults, aged between 18 and 70 years, with major depression (Hamilton
      Rating scale for Depression, HAMD ≥ 15). Patients don't have any experience concerning
      repeated Transcranial Magnetic Stimulation (rTMS).

      Patients with treatment-resistant depression (TRD) were assigned to two treatment groups in
      addition to their current pharmacotherapy regimen : one group received 5 active-rTMS before
      Electroconvulsive therapy (ECT) and the other one received sham-rTMS before ECT. The
      depressive symptoms and the cognitive functions are evaluated before rTMS, after 5 rTMS and
      after 5 ECT.
    

Intervention name(s): active rTMS-ECT; sham rTMS-ECT
Intervention type(s): Device; Device
Intervention description(s): 5 High Frequency (20Hz) rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT; 5 sham rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: treatment-resistant-depression; rTMS; ECT; Augmentation strategy
Ultrasound Assessment of the Carotid Intimal Medial Thickness in Obese Subjects; Weight Loss
Condition: Osteoarthritis; Obesity
MeSH terms: Osteoarthritis; Weight Loss
Study type: Observational

Summary: 
      This is a substudy to a randomised trial investigating the effect of liraglutide on body
      weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In
      the parent trial, patients will be subjected to an 8-week diet intervention phase including a
      low-calorie diet and dietetic counseling, after which patients will be randomised to receive
      either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on
      re-introducing regular foods and a focus on continued motivation to engage in a healthy
      lifestyle.

      This substudy aims to investigate any changes in the carotid intima media thickness (CIMT)
      assessed by ultrasound in relation to an initial 8-week weight loss intervention.
    


Intervention name(s): Dietary Supplement: Intensive dietary intervention
Intervention type(s): Dietary Supplement
Intervention description(s): Participants receive a hypo-caloric formula diet containing 800 to 1,000 kcal/day. The formula diet consists of ready-to-use meal bars and powders to mix with water to make shakes, soups, or porridge. The weight loss programme consists of an 8-week period with full meal replacement by a standard liquid energy intake protocol. To facilitate compliance with the programme, participants will be scheduled for weekly facility-based group sessions with 6-8 participants led by a dietician. The recommendations for daily nutrient intake will be met.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals
        with knee osteoarthritis
      
Keywords: Osteoarthritis; Obesity; Liraglutide 3 mg; Liraglutide; Ultrasound
RDEA3170 Tablet and Capsule Bioavailability Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules
      compared with RDEA3170 tablets.
    


Intervention name(s): RDEA3170,10 mg; RDEA3170, 2.5 mg; RDEA3170, 5 mg; RDEA3170, 10 mg; RDEA3170, 2.5 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.; Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.; Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.; Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.; Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
Other intervention name(s): Cohort 1; Cohort 1; Cohort 1; Cohort 3; Cohort 3
Intervention MeSH terms: Verinurad
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Regional Anesthesia for Modified Radical Mastectomy With Axillary Lymph Node Dissection
Condition: Breast Cancer
Study type: Interventional
Phase: Phase 3

Summary: 
      local and regional anesthesia have been introduced with the goal of reducing the side effects
      associated with general anesthesia and IV opioid analgesia.our hypothesis is that
      ultrasound-guided interscalene brachial plexus block and erector spinae plane block will
      provide efficient surgical anesthesia and postoperative analgesia after modified radical
      mastectomy.
    

Detailed description: 
      inadequate analgesia after modified radical mastectomy with axillary lymph node dissection
      may occur with most of regional anesthesia. pain in the axilla and upper limb is related to
      ineffective block of medial and lateral pectoral nerves as long thoracic and thoracodorsal
      nerves, leading to inadequate analgesia.The aim of this study is to evaluate the efficacy and
      safety of ultrasound-guided interscalene brachial plexus block and erector spinae plane block
      for providing surgical anesthesia and postoperative analgesia after modified radical
      mastectomy.
    

Intervention name(s): regional anesthesia
Intervention type(s): Other
Intervention description(s): combination of erector spinae plane block and interscalene block for anesthesia in modified radical mastectomy surgeries with axillary lymph node dissection
Intervention MeSH terms: Anesthetics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics
Condition: Chronic Gout; Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Subjects will undergo a placebo and allopurinol phase to better understand the effects of the
      reduced function BCRP Q141K variant on allopurinol pharmacokinetics and pharmacodynamics.
    


Intervention name(s): Allopurinol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): lactose placebo pill
Other intervention name(s): Zyloprim; Aloprim
Intervention MeSH terms: Allopurinol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: allopurinol
Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.
    

Detailed description: 
      First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.
      Patients will proceed through a screening period, treatment period, and follow-up period of
      approximately 4 months' duration. There will be 4 dose cohorts including active drug and
      placebo dosing.
    

Intervention name(s): IMO-2125; Saline placebo
Intervention type(s): Drug; Drug
Intervention description(s): IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system; saline placebo given subcutaneously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis C; unresponsive to pegylated interferon and ribavirin therapy; hepatitis C virus
Clinical Study of Intermittent Positive Pressure Breathing (IPPB)
Condition: Lung Diseases; Lung Diseases, Obstructive; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy of long-term intermittent positive pressure breathing (IPPB)
      treatment when used as an adjunct to the overall care of ambulatory outpatients with chronic
      obstructive pulmonary disease. The evaluation compared the use of IPPB with use of a powered
      nebulizer.
    

Detailed description: 
      BACKGROUND:

      Intermittent positive pressure breathing may be a useful adjunct therapy for patients with
      chronic obstructive pulmonary disease. It is, however, quite expensive; moreover, in 1976 its
      treatment efficacy had not been determined. Although the effectiveness of IPPB had been
      previously studied, the influence of long-term treatment was not known for the following
      reasons: The individuals studied had been too few and were not randomly assigned to treatment
      groups, the patient groups were not homogeneous and their clinical and functional status were
      not well-documented, and precise descriptions of the manner in which IPPB was administered
      were not recorded.

      Based on these facts, a conference on the Scientific Basis of Respiratory Therapy,
      co-sponsored by the American Thoracic Society and the Division of Lung Diseases, issued a
      recommendation to develop a controlled clinical study of IPPB. Contracts were awarded to five
      clinical centers and a data center in November 1976. Planning of the trial ended in November
      1977. Recruitment began in April 1978 for the 985 individuals who took part in this trial and
      ended in October 1980. Patients enrolled after March 31, 1980, were followed for 30 months
      instead of 36 months. Follow-up was completed in May 1983.

      DESIGN NARRATIVE:

      Randomized, fixed sample of 985 patients. Eligible patients were assigned to a treatment
      group using intermittent positive pressure breathing or to a control group using a powered
      nebulizer for treatment 3-4 times a day. Treatments continued for 3 years. Endpoints related
      to quality of life and respiratory function and capability.
    

Intervention name(s): intermittent positive-pressure breathing
Intervention type(s): Procedure
Allocation: Randomized
Primary purpose: Treatment
Surgical Prep in Hand Surgery
Condition: Surgical Scrubbing; Disinfection
Study type: Observational

Summary: 
      The purposes of this study are to identify the common bacterial flora on the hand and
      evaluate the efficacy of readily available skin-preparation solutions in the elimination of
      bacterial pathogens from the surgical site following skin preparation. The null hypothesis is
      that there is no difference in the efficacy of Chloraprep, Duraprep, and betadine in
      pre-operative skin preparation in clean, elective hand surgery cases.
    


Intervention name(s): Skin culture
Intervention type(s): Other
Intervention description(s): Culture swab used to culture skin adjacent to incision
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients undergoing clean, elective hand surgery without implants
Endoscopic Gastric Reduction for Weight Management
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed study is a prospective, pilot study to assess the feasibility of a novel
      endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for
      the primary treatment of obesity. The investigators aim to recruit ten subjects with a body
      mass index between 30-40 for this study. Vertical sutures will be performed using the
      endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum
      toxin(approximately 30 units) will be injected around the sutures insertion sites in half of
      the subjects randomly to slow down muscular grinding of the stomach to see if it improves
      durability of the procedure.
    


Intervention name(s): Botulinum toxin; Overstitch Endoscopic Suturing System
Intervention type(s): Drug; Device
Intervention description(s): In this study, Botulinum toxin will be injected in half of the subjects not as a primary treatment modality for obesity, but to retard the muscular grinding gastric activity arount the suture insertion sites to see if it improves the durability of the gastroplasty.; The gastroplasty will be accomplished by a series of intralumenally placed full thickness interrupted sutures through the gastric wall, using the FDA-approved (510K) endoscopic suturing device, the Overstitch Endoscopic Suturing System.
Other intervention name(s): Botox
Intervention MeSH terms: Botulinum Toxins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Weight loss; Gastric reduction (volume); BMI 30-40
A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to prove that the handling (also referred to as pharmacokinetics) of the
      following drugs PF-06439535, Avastin® (bevacizumab) that is licensed for use in the United
      States (bevacizumab-US) and Avastin® (bevacizumab) obtained from Europe (bevacizumab-EU) is
      similar in healthy male volunteers after receiving a single intravenous dose of either drugs.

      During the course of the study, the similarity in pharmacokinetics will be assessed by
      sampling the levels of drug in the blood, and by comparing these levels among the different
      administration arms of PF-06439535, bevacizumab-US and bevacizumab-EU. Safety, tolerability,
      and immunologic response to the administered drugs will also be evaluated throughout.
    


Intervention name(s): PF-06439535; Avastin; Avastin
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.; Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.; Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
Other intervention name(s): PF-06439535, a potential biosimilar to bevacizumab; Bevacizumab (European Union); Bevacizumab (United States)
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Bioequivalence; Biosimilarity; Similarity; PK; Phase 1; Bevacizumab; Healthy Volunteers; Single-Dose; Oncology
Safety Study of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) in Infants Early in Life
Condition: Polio
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II, observer-blind, randomized study on the safety, reactogenicity, immunogenicity and
      impact on intestinal shedding of a single dose of monovalent high-dose inactivated poliovirus
      type 2 vaccine (m-IPV2 HD) or a single dose of standard trivalent inactivated poliovirus
      vaccine (t-IPV) when given concomitantly with the third dose of bivalent oral poliovirus
      vaccine (b-OPV) to infants early in life
    


Intervention name(s): b-OPV; m-OPV2; m-IPV HD; t-IPV
Intervention type(s): Biological; Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the
      Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe
      hepatic impairment.
    


Intervention name(s): GS-5816
Intervention type(s): Drug
Intervention MeSH terms: Velpatasvir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C (HCV) Infection; Moderate Hepatic Impairment; Severe Hepatic Impairment
Study Evaluating DVS-233 SR And Venlafaxine ER In Adult Outpatients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the antidepressant efficacy and safety of DVS-233 SR with those of placebo in
      adult outpatients with MDD.
    


Intervention name(s): DVS-233 SR
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty: a Randomized Trial
Condition: Knee Chondral or Osteochondral Defect
MeSH terms: Osteochondrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Numerous surgical techniques have been developped for the treatment of chondral and
      osteochondral defects of the knee. Among those techniques autologous chondrocyte
      transplantation (ACT) was promising but have potential drawbacks. A novel development by TBF
      is available. The aim of this randomized trial is to compared this new ACT technique to
      mosaicoplasty. Final outcomes were measured at 2 years using clinical evaluation scoring
      system (International Knee Documentation Committee), MRI and arthroscopy with biopsy. 64
      patients are needed to detect a mean IKDC difference of at least 15 points with 90% power at
      a 5% alpha level. Twelve surgical centers in France are involved.
    


Intervention name(s): Autologous chondrocytes transplantation; Mosaicoplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Cartilage was harvested, then transferred for cell isolation and culture. Cells are suspended in agarose and transferred to cylindrical molds and surgically implanted 4 weeks later.; Osteochondral patch are sampled and then implanted during the same surgical procedure
Other intervention name(s): Tissue Bank France
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: knee; chondral defect; osteochondral defect