bioihbjkbjnl/mcl2 huggingface dataset:
The Natural History of Asymptomatic Rotator Cuff Tears
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Observational

Summary: 
      The purpose of this project is to provide information which can help us understand what
      happens over time to rotator cuff tears. In this study, the investigators will follow a
      population of people with rotator cuff tears that do not hurt (asymptomatic) and to establish
      the probability that an asymptomatic rotator cuff tear, identified in the context of
      contralateral symptoms, will become symptomatic over time. To determine with ultrasound the
      probability that a rotator cuff tear will enlarge over time. To determine if symptom
      progression correlates with enlargement of the rotator cuff tear and/or degenerative changes
      on radiographs. In order to obtain data, study subjects will be recalled for follow-up at 1
      year time points over a 5 year period. The study subjects will have repeat physical exam,
      ultrasound and radiographic examinations. A control group of normal patients will also be
      followed for comparison.
    

Detailed description: 
      The specific aims of our study are:

        1. To determine the probability that an asymptomatic rotator cuff tear will become
           symptomatic over time.

        2. To determine which epidemiological factors correlate with symptomatic progression.

        3. To determine if symptomatic progression correlates with enlargement of the rotator cuff
           tear as determined at sonography.

        4. To determine the value of routine sonographic scanning of the asymptomatic shoulder.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients are recruited from orthopaedic surgeon's clinic.
      
Keywords: Rotator Cuff; Ultrasound; Pain; Tear Progression
A Phase I/II Trial of a Tetravalent Live Attenuated DEN Vaccine in Flavivirus Antibody Naive Children
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      One year follow-up on immunogenicity and safety of a booster dose of DEN vaccine administered
      approx. 1 year following the second dose
    

Detailed description: 
      The purpose of this study is to find out more about the two doses of dengue vaccine, over a
      five year period, that the children received in the Dengue-003 study and to study a third
      dose of dengue that will be given to the children

        -  Do children still have dengue antibodies intended to provide protection against dengue
           infection one year after the two doses of vaccine given in study Dengue-003?

        -  Were there any major medical problems that appeared as dengue-like symptoms during the
           one year after vaccinations?

        -  Will a third dose of dengue help to further stimulate the part of the immune system
           intended to help protect against dengue infection?

        -  Is a third dose as safe as the first two doses?

        -  Are the local reactions to a third dose of the vaccine similar to what your child
           experienced after the first two doses?
    

Intervention name(s): DEN vaccine F17
Intervention type(s): Biological
Intervention description(s): The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).
Other intervention name(s): Live attenuated tetravalent dengue (DEN) vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dengue, Vaccine, Thailand
Clinical Trial of Minimally Invasive Robotic Spine Surgery
Condition: Degenerative Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis
Study type: Interventional

Summary: 
      The purpose of this study was to quantify potential short- and long-term benefits of
      robotically-guided minimally invasive spine surgery in instrumentation of degenerative lumbar
      or lumbosacral spine disease in adult patients, in comparison to instrumentation in a
      matching cohort of control patients performed using conventional freehand technique.
    


Intervention name(s): Renaissance, Mazor Robotics Ltd, Caesare, Israel; free hand technique
Intervention type(s): Device; Procedure
Intervention description(s): Renaissance (Mazor Robotics Ltd, Caesare, Israel) is the name of the robot; No specific device is necessary in the "free hand technique"
Other intervention name(s): (Renaissance, Mazor Robotics Ltd, Caesare, Israel)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Investigate the Drug-Drug Interactions of Brivaracetam and Ethanol in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate if Brivaracetam (BRV) influences the psychomotor and cognitive impairing effects
      of Ethanol
    


Intervention name(s): Brivaracetam; Ethanol; Brivaracetam Placebo; Ethanol Placebo
Intervention type(s): Drug; Other; Other; Other
Intervention description(s): Strength: 200 mg (4 x 50 mg)
Form: oral tablet
Frequency: single dose
Description: All subjects will receive a single oral dose of Brivaracetam (BRV) 200 mg, given as 50 mg tablets times 4 followed by an adequate volume of water (approximately 200 ml) in 2 of the 3 crossover periods. This dose will be administered 30 minutes after the initiation of the Ethanol / Ethanol Placebo infusion on Day 1.; Form: intravenous infusion
Frequency: continuous infusion
Description: The ethanol infusion rate is initially based on weight, height, age, and sex. Subsequently, the infusion rate will be adjusted based on Breath Ethanol Measurements to maintain Breath Ethanol Levels (and by extension, blood ethanol levels) of 0.6 g / L.; In 1 of the 3 crossover periods, all subjects will receive 4 Placebo tablets to match the 50 mg Brivaracetam (BRV) tablets. The Placebo tablet will contain the same excipients as the BRV tablets but without BRV.; In 1 crossover period subjects will receive Ethanol Placebo (5% glucose). On Day 1, the continuous infusion of Ethanol Placebo will begin with a 30 minute Loading Phase prior to administration of Brivaracetam (BRV) / BRV Placebo and will continue until 5 hours after administration of BRV/BRV Placebo. During the first 10 minutes, the infusion will be accompanied by an infusion of 5% Glucose via the same line in order to mask the sensation at the beginning of the Ethanol infusion.
Intervention MeSH terms: Ethanol; Brivaracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Brivaracetam; Ethanol; Pharmacodynamics; Pharmacokinetic; Interaction
Trial of Intraperitoneal (IP) Oxaliplatin in Combination With Intravenous FOLFIRI
Condition: Colorectal Cancer; Appendix Cancer; Peritoneal Carcinomatosis
MeSH terms: Carcinoma; Peritoneal Neoplasms; Appendiceal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I dose escalation study to determine how much chemotherapy can be safely
      administered into the abdomen while experiencing the fewest possible side effects.
    

Detailed description: 
      There are two common combinations of chemotherapy drugs used to treat cancer of the colon,
      rectum, or appendix that has spread to the abdomen. One uses 5-fluorouracil (also called
      5-FU), leucovorin and oxaliplatin, and is called FOLFOX. The other uses 5-FU, leucovorin, and
      irinotecan, and is called FOLFIRI. The Food and Drug Administration (FDA) has approved each
      of these combinations as treatment for colon or rectal cancer. Each is given through the
      veins.

      FOLFOX and FOLFIRI do not work well for tumors growing in the abdominal cavity. The
      investigators are trying to determine if giving chemotherapy called oxaliplatin directly into
      the abdominal cavity will have a greater effect on the cancer.

      The FDA has approved oxaliplatin to be given to people through their veins to treat advanced
      colorectal cancer. Giving oxaliplatin directly into the abdomen in this study is experimental
      and is not approved by the FDA. This study will give the standard chemotherapy FOLFIRI
      through the veins and oxaliplatin directly into the abdomen. This is the first time
      intraperitoneal oxaliplatin is being given in combination with FOLFIRI.
    

Intervention name(s): Oxaliplatin
Intervention type(s): Drug
Intervention description(s): Intraperitoneal oxaliplatin will be given along with standard chemotherapy FOLFIRI.
Level 1: Oxaliplatin 25mg/m2 IP every 2 weeks on day #1 of chemotherapy . Level 2: Oxaliplatin 55mg/m2 IP every 2 weeks on day #1 of chemotherapy Level 3: Oxaliplatin 85mg/m2 IP every 2 weeks on day #1 of chemotherapy Level 4: Oxaliplatin 55 mg/m2 IP every 2 weeks on day #1 of chemotherapy (due to DLTs found)
Intervention MeSH terms: Oxaliplatin
Intervention model: Sequential Assignment
Intervention model description: There are three cohorts of patients:
Group #1 is at 25mg/m2 of IP oxaliplatin and has been completed. Group #2 is at 55mg/m2 of IP oxaliplatin is completed. Group #3 is at 85mg/m2 of IP oxaliplatin is currently enrolling. If DLTs found additional 3 subjects will be dosed at the lower dose level cohort.
2 DLTs were found in the 85 mg/m2 cohort therefore 3 additional subjects (Group # 4) will be enrolled to the 55 mg/m2 cohort.
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Explorative Formulation of Insulin Degludec
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the safety,
      tolerability, pharmacokinetics (the exposure of the trial drug in the body) and
      pharmacodynamics (the effect of the investigated drug on the body) of insulin degludec
      (insulin 454), an explorative formulation, not similar to the proposed commerical
      formulation.
    


Intervention name(s): insulin degludec; placebo; insulin degludec; isophane human insulin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ascending single doses - 5 dose levels. Escalation to next dose level will be performed following evaluation of safety data.; Ascending single doses - 5 dose levels; A single dose corresponding to that of isophane human insulin; A single dose of 0.4 IU/kg is administered to subjects with type 1 diabetes while a single dose of 0.6 IU/kg is administered to subjects with type 2 diabetes
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus
Condition: Hip Fractures; Anesthesia Local; Pain, Postoperative
MeSH terms: Pain, Postoperative; Hip Fractures
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective of the trial is to complete a double-blinded randomized controlled trial
      of a lumbar plexus block with the Shamrock technique versus the Lumbar Ultrasound Trident
      technique by estimating the time of performance of lumbar plexus blocks in healthy
      volunteers.

      Secondary objectives include a) estimates of number and depth of needle injections, distance
      of injection site from the midline, minimal electric nerve stimulation to trigger muscular
      response and the type of response, and volunteer discomfort during block injection, b)
      measurements of plasma lidocaine and mean arterial blood pressure, c) examinations of sensory
      block of the dermatomes T8-S3 and motor block of the femoral nerve, the obturator nerve, the
      hip abductor muscles, and the hamstring muscles, d) success rate of lumbar plexus block, e)
      perineural and epidural distribution of local anesthetics added contrast visualized on
      magnetic resonance imaging (MRI) scanning, and f) cost-effectiveness for the Shamrock
      technique versus the Lumbar Ultrasound Trident Technique for lumbar plexus block in healthy
      volunteers.

      The hypothesis is that the Shamrock technique is faster to perform than the Lumbar Ultrasound
      technique, and that the success rate of the Shamrock technique is equal to or higher than the
      Lumbar Ultrasound Trident technique.
    


Intervention name(s): Lidocaine-adrenaline added gadolinium.
Intervention type(s): Drug
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hip surgery anesthesia; Perioperative analgesia
Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved
      treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis
      is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham
      MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic
      uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1
      ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants
      will remain blinded to their group assignment for 3 months. After 3 months, participants will
      be told their treatment group and those assigned to the sham group will be offered
      complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate
      candidates for a 3 month delay in fibroid treatment, such as those with significant anemia.
      The investigators will assess the change from baseline to 1 and 3 months after treatment in
      fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.
    


Intervention name(s): MR Guided Focused Ultrasound; Placebo MR Guided Focused Ultrasound
Intervention type(s): Procedure; Procedure
Intervention description(s): This is an FDA approved noninvasive treatment for fibroids that uses highly focused ultrasound waves to damage fibroid tissue.; This is a placebo treatment that requires a participant to undergo identical procedures as those of the actual MR Guided Focused Ultrasound procedure, but higly focused ultrasound waves are not directed at the uterine fibroid.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibroids; Uterine; Focused Ultrasound; Magnetic Resonance focused ultrasound; HIFU; NOninvasive; Treatment
Effect of Osteopathic Lymphatic Treatment on Plasma Volume, Protein Concentration and Albumin Concentration.
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The goal of this project is to see how much an osteopathic lymphatic treatment (OLT) causes
      an increase in plasma volume, total plasma protein concentration, and albumin concentration.
      This is an important step in understanding the effects of OLT, specifically its effects on
      fluid in the body. The primary role of the lymph system is the return of fluid and proteins
      lost from the blood vessels. Despite this, no research has been done to see what effects an
      OLT has on fluid and protein levels in the blood.
    


Intervention name(s): OLT maneuver; Sham OLT
Intervention type(s): Other; Other
Intervention description(s): direct myofascial release for the thoracic inlet for 30 seconds, supine rib raising for 1 minute on each side of the body, thoracic pumping for one minute, thoracic vacuum for 30 seconds, doming of the abdominal diaphragm for 30 seconds, abdominal pumping for 1 minute, pedal pumping for 1 minute, a second thoracic pump for 1 minute, a second thoracic vacuum for 30 seconds, and a final direct myofascial release for the thoracic inlet lasting 30 seconds; Therapeutic massage performed
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: osteopathic; lymphatic; treatment; OLT; normal
Enhancement of Sleep With Wearables
Condition: Sleep
Study type: Interventional

Summary: 
      Sleep, specifically deep sleep, plays a central role in healthy brain function,
      cardio-vascular processes, mood and quality of life. Auditory stimulation during one night of
      sleep has previously been shown to improve deep sleep and along with memory formation in both
      young and older adults. Yet, it remains unclear whether long-term auditory stimulation
      considerably improves sleep quality over longer time periods and how it affects daytime
      functioning such as cognition, mood, quality of life and peripheral functions (e.g.
      cardio-vascular). Due to the importance of deep sleep for brain and body and the presence of
      many conditions that involve reduced deep sleep (e.g. ageing) assessing the beneficial impact
      of long-term sleep enhancement and its consequences is of central interest.This study will
      assess the effect of auditory stimulation over two weeks (interleaved with a two weeks
      washout period) in a cohort of healthy young and older adults using portable recording and
      stimulation devices.
    


Intervention name(s): Application of tones; No application of tones
Intervention type(s): Device; Device
Intervention description(s): During NREM sleep, tones (max. 60 dB) will be played using a portable, safe, in-home device. This device records biosignals (e.g. brain activity) and precisely times the tones during NREM sleep. It was developed and produced by the ETH Zurich and approved for use in this study by Swissmedic; This is the sham-control intervention; The device will only record biosignals but will not play tones.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the India iPro2 study is to demonstrate that iPro2 Continuous Glucose
      Monitoring System (CGMS) evaluation enables Health Care Professional (HCP)s treating patients
      in India with type 2 diabetes to get a better understanding of their patient's metabolic
      fluctuations, and support appropriate therapeutic intervention.
    

Detailed description: 
      The study will be designed to demonstrate the value of iPro2 in real-world diabetes
      management in type 2 patients in India. It will be an interventional post-market,
      prospective, multi-center study with a data review performed after 30 subjects have completed
      the trial.

      During the course of the study, patients will undergo two iPro2 evaluations:

        -  First iPro2 test (Visit 1 [application] & 2 [removal])

        -  Second iPro2 test (Visit 3 [application] & 4 [removal])

      Patient and HCP questionnaires will be administered at Visit 1, 2, 3, 4 and 5. These
      questionnaires aim to assess the impact of an iPro2 evaluation on the physicians
      understanding of their patient's metabolic fluctuations and its support of therapeutic
      interventions. They will also investigate the subjects understanding (both pre & post iPro2
      evaluation) of the concept of glycemic variability and the importance of compliance to HCP
      recommendations.
    

Intervention name(s): therapy regimen
Intervention type(s): Behavioral
Intervention description(s): Subjects will be recommend changes in therapy regimens.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2
A Study of LY2605541 and Glargine and Exercise in Participants With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure how much of the study drug or insulin glargine gets
      into the blood stream and how long it takes the body to get rid of it. The effect of exercise
      will also be evaluated.

      This study has two parts. In Part A, each participant will receive a daily injection of
      LY2605541 or insulin glargine for about 15 days. Some participants may continue into Part B.
      In Part B, participants will receive a daily injection of LY2605541 or insulin glargine with
      or without exercise. Part B lasts about 6 days.

      Participants will remain on their regular physician-prescribed mealtime insulin throughout
      the study.
    


Intervention name(s): LY2605541; Insulin Glargine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science