bioihbjkbjnl/mcl2 huggingface dataset:
Compare the Outcomes of Zone II Flexor Tendon Repair of the Hand Under General Anesthesia Versus WALANT
Condition: Cut Flexor Hand; Walant; General Anesthesia
Study type: Interventional

Summary: 
      Comparison between results of repair of cut flexor zone II under General anesthesia and
      Walant
    

Detailed description: 
      Cut Flexor is common injury ,has unique characters as they cannot heal without surgical
      treatment, unique anatomy of the tendons running through flexor tendon sheaths to function
      and postoperative management &mobilization to prevent adhesions and improve gliding but risk
      of rupture.

      The hand is divided into five zones (Verdan's). Zone II is described by Bunnel as "No Man's
      Land" historically back to 14th century (area outside London used for executions) because it
      was previously believed that primary repair should not be done in this zone. After
      understanding of flexor tendon anatomy, biomechanics , and healing new techniques of surgery
      and anesthesia repair is possible with good results.

      General anesthesia has been the standard technique for along time. wide awake local
      anesthesia no tourniquet. (WALANT),using safe drugs lidocaine for anesthesia and epinephrine
      for hemostasis, the investigators can do operations while patient is awake.

      WALANT has been recommended by some surgeons to be the next standard for repair of zone 2
      injuries .

      This techniques has a lot of Advantages in repair zone II as 1) intraoperative testing of the
      flexor repair by active movement to exclude any gap. and lets the surgeon see that the repair
      fits through the pulleys with active movement.

      2)sheath and pulley damage are minimized, as flexor tendons are repaired through small
      transverse sheathotomy incisions 3) the surgeon can interview the patient during the
      procedure and assess the ability to comply with the postoperative regimen 4) the risks of
      general anesthesia are avoided in most patients. Negative effects of general anesthesia
      include nausea and vomiting, hospital admission for anesthesia recovery, exacerbation of
      comorbidity issues such as diabetes, aggressive flexion by the patient emerging from general
      anesthesia,and others
    

Intervention name(s): surgery of zone II cut flexor repair
Intervention type(s): Procedure
Intervention description(s): we will repair tendon of FDP only using 6 strand technique using PDS 4/0 core suture - prolene 6/0 running suture
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: repair zone II cut flexor of hand under GA and Walant
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized Controlled Trial
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The Platelet-rich plasma (PRP) has been proved to be efficient in the non-surgical treatment
      of carpal tunnel syndrome (CTS). Here we propose to assess the effectiveness of PRP as
      co-adjuvant in surgical treatment of CTS by open carpal tunnel release.

      Design: Randomized Controlled Trial. Setting: Local Hospital.
    

Detailed description: 
      Carpal tunnel syndrome (CTS) is a common disorder with an estimated annual incidence of
      125-542 in adults, and an estimated prevalence of 1 to 5 percent in the general population.
      CTS is the most frequent compressive focal mononeuropathy and causes pain, paresthesia and
      weakness of the median nerve distribution in patients.

      The treatment of the CTS includes both, conservative and surgical treatment depending on the
      severity of the symptoms.

      Platelet-rich plasma (PRP) has been proved to be efficient in the non-surgical treatment of
      CTS, however its potential used as co-adjuvant in surgical treatment has not been assessed.

      We propose a randomized clinical trial in patients in which the surgical treatment is
      indicated. Participants in the intervention group receive a PRP injection, and in the control
      group a platelet-poor plasma injection after open carpal tunnel release. The evaluation is
      performed pretreatment as well as on the 6st week after treatment. Outcome measures include:
      hand grip strength (primary outcome), pain, sympton severity and functional status.
    

Intervention name(s): Platelet-rich plasma; Platelet-poor plasma
Intervention type(s): Procedure; Procedure
Intervention description(s): Platelet-rich plasma injection; Platelet-poor plasma injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial (Parallel Assignment)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Carpal Tunnel Syndrome; Platelet-rich plasma; Surgery
Comparison of the Efficacy and Tolerability of Solaraze for 3 Versus 6 Months in Patients With Mild to Moderate Actinic Keratosis Located on the Face and Head
Condition: Photosensitivity Disorders
MeSH terms: Keratosis, Actinic; Keratosis; Photosensitivity Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Topical treatment of mild to moderate actinic keratosis located on the face and head with
      Solaraze® is known to be a safe and efficient treatment option. However, it is unclear if an
      expansion of the treatment period to 6 months will increase the rate of complete responses.

      Therefore the investigators will evaluate the efficacy and safety of the treatment of actinic
      keratosis with Solaraze® applied twice daily to the face and head over 3 or 6 months of
      treatment.
    


Intervention name(s): Diclofenac; Diclofenac
Intervention type(s): Drug; Drug
Intervention description(s): Solaraze® (Diclofenac sodium) 2x/day topical for 3 months; Solaraze® (Diclofenac sodium) 2x/day topical for 6 months
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: actinic keratosis; diclofenac sodium
Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC)
Condition: Vaso-occlusive Crisis; Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate whether MST-188 can reduce the duration of
      vaso-occlusive crisis (VOC) in subjects with sickle cell disease. The study will also
      evaluate whether MST-188 can reduce the frequency of rehospitalization of subjects due to a
      recurrence of VOC. Additionally, this study will compare the development of acute chest
      syndrome during VOC in subjects who receive MST-188 to those who do not receive MST-188.
    


Intervention name(s): Saline; MST-188
Intervention type(s): Drug; Drug
Other intervention name(s): vepoloxamer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: sickle cell disease; vaso-occlusive crisis
Pilot Study of Exercise and Peripheral Nerve Function in People With Diabetes - ENRGy2 Addendum
Condition: Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies
Study type: Interventional

Summary: 
      This is an amendment to study posting NCT00970060. Based on preliminary results from that
      study is was determined there needs to be a follow-up exercise intervention study. This study
      has two additional aims than the original study. The objectives are to determine is a
      prolonged exercise routine, 16-weeks, paired with refined measures of effectiveness
      positively impact people with diabetic neuropathy.
    


Intervention name(s): Aerobic Exercise
Intervention type(s): Other
Intervention description(s): Aerobic exercises in the program include cycle ergometers, treadmills, recumbent steppers and elliptical trainers.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Pain; Fitness; Diabetes; Aerobic Exercise
Acupuncture for Migraine Prophylaxis
Condition: Migraine Without Aura; Unilateral Headache
MeSH terms: Migraine Disorders; Migraine without Aura; Headache
Study type: Interventional

Summary: 
      Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A
      open-label randomized controlled trial. 249 participants will be included. Three arms:
      acupuncture in acupoint-meridian， non-acupoint-meridian group, and waiting list.
    

Detailed description: 
      Aim: to attest the abiding efficacy and safety of acupuncture for migraine prophylaxis
      Design: A open-label randomized controlled trial will be performed in Chengdu, Hunan and
      Chongqing province. Two hundred and forty-three participants will be randomly assign to
      acupoint-meridian group, non-acupoint-meridian group, and wait-and-see group. Each
      participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30
      minutes in a session. After all the treatments was accomplished, there will be 5 times
      follow-ups in the impending every 4 weeks. The primary outcome is frequency of migraine
      attacks 16 weeks after inclusion. Secondary outcomes include frequency of migraine attacks at
      the 4th and 24th week, headache severity, MSQ(Migraine Specific Quality of Life Questionnaire
      MSQ Version2.1), etc.
    

Intervention name(s): acupuncture
Intervention type(s): Other
Intervention description(s): apply acupuncture to prevent the migraine attack
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: acupuncture; migraine prophylaxis
Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
Condition: Cholestasis
MeSH terms: Cholestasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effects of a multicomponent lipid emulsion
      containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil
      with a conventional pure soybean oil lipid emulsion on the incidence of neonatal cholestasis,
      infant growth, infant morbidity and the biochemical assessment of liver enzymes.
    

Detailed description: 
      Intravenous lipid emulsions are the major sources of non-protein energy and provision of
      required essential fatty acids.

      The reference lipid emulsion, widely used for many years, is prepared from soybean oil, which
      is rich in omega 6 polyunsaturated fatty acids and phytosterols that contribute to
      hepatotoxicity and their metabolites result in pro-inflammatory eicosanoid production.

      Existing evidence strongly supports a pathogenetic role of inflammation and oxidative stress
      on parenteral nutrition associated liver disease.

      Subsequent development of lipid emulsions has focused on reducing the amount of soybean oil
      and replacing it with other oils.Moreover the omega 3 fatty acids from fish oil are
      metabolized to anti-inflammatory eicosanoids which can prevent inflammatory responses.

      A novel multicomponent lipid emulsion may prevent liver injury, improve growth and decrease
      morbidity in preterm infants.
    

Intervention name(s): multicomponent lipid emulsion; pure soybean oil lipid emulsion
Intervention type(s): Drug; Drug
Intervention description(s): Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.; Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.
Other intervention name(s): SMOF lipid; Intralipid
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: preterm; parenteral nutrition; cholestasis; fish oil
Pharmacokinetic Properties of Various Modified Release Tablet Formulations of Lu AF11167
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetic (PK) properties of various
      modified release tablet formulations of Lu AF11167 (Part A) and to investigate the
      pharmacokinetic (PK) properties of a modified release tablet formulation of Lu AF11167 in a
      fed and fasted state and following multiple dosing (Part B).
    


Intervention name(s): Lu AF11167
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of ALXN1820 in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending
      dose study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics,
      and immunogenicity of ALXN1820 administered subcutaneously (SC) (ALXN1820 SC) and
      intravenously (IV) (ALXN1820 IV).
    

Detailed description: 
      This study will include up to 10 different dosing cohorts, with each cohort consisting of 2
      groups (ALXN1820 group, placebo group). Participants will be randomly assigned in a 3:1 ratio
      to each of these 2 groups, respectively, within all 10 cohorts, to receive either a single or
      multiple doses of ALXN1820 SC, a single dose of ALXN1820 IV, or a single or multiple doses of
      placebo.

      The study will be conducted in healthy adult participants and will also include a multiple SC
      dose cohort in healthy participants of Japanese descent.
    

Intervention name(s): ALXN1820 SC; ALXN1820 IV; Placebo SC; Placebo IV
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ALXN1820 SC will be administered as a manual SC push or SC infusion via a syringe pump. Doses will range from 12.5 milligrams (mg) to a maximum of 2250 mg. Multiple dosing duration will range from 3 to 5 weeks.; ALXN1820 IV (450 mg) will be administered as an IV infusion.; Placebo SC will be administered as a manual SC push or SC infusion via a syringe pump.; Placebo IV will be administered as an IV infusion.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: ALXN1820; Properdin; Pharmacodynamics; Pharmacokinetics
Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis
Condition: Multiple Sclerosis; Cognition
MeSH terms: Multiple Sclerosis; Sclerosis; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary aim is to collect data to determine the correct effect size on the primary
      outcome to aid in the design of a larger study: The primary outcome is to determine if lipoic
      acid and omega-3 fatty acids can improve cognitive function in people with multiple sclerosis
      that have cognitive dysfunction.
    

Detailed description: 
      The study is designed as a randomized, double-blind, placebo-controlled pilot trial. The
      primary aim of the study is to determine if lipoic acid and omega-3 fatty acids can improve
      cognitive function over 12-weeks in people with multiple sclerosis that have a baseline score
      of at least two standard deviations below normative values on any one of four cognitive tests
      that include, Paced Auditory Serial Addition Task (PASAT), Stroop Color-Word Test, California
      Verbal Learning Test-II (CVLT-II), and Controlled Oral Word Association Test (COWAT).

      The secondary aim is to determine treatment effects on markers of endothelial inflammation,
      insulin dysregulation, and mitochondrial dysfunction that may be related to cognitive
      dysfunction by measuring soluble intercellular adhesion molecule-1 (sICAM-1) levels,
      homeostasis model of insulin resistance (HOMA-IR), and MRI phosphorus imaging in a subset of
      study participants. The study will also measure safety by adverse event reports and
      laboratory measures; plasma fatty acid levels; serum lipoic acid levels.
    

Intervention name(s): lipoic acid and omega-3 fatty acids; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid; placebo lipoic acid and placebo oil
Other intervention name(s): thiotic acid; fish oil; fish oil concentrate; placebo lipoic acid and placebo oil
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; cognition; clinical trial; thiotic acid; Omega-3 fatty acids
A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of BI 1810631 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the effect of multiple oral doses of the
      strong CYP3A inducer carbamazepine on the pharmacokinetics of a single dose of BI 1810631 in
      plasma.
    


Intervention name(s): BI 1810631; Carbamazepine
Intervention type(s): Drug; Drug
Intervention description(s): BI 1810631; Carbamazepine
Intervention MeSH terms: Carbamazepine
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hyperglycemia and the Extra-pancreatic Effect of Incretins
Condition: Extra-pancreatic Incretin Effect; Glucose Effectiveness
Study type: Interventional

Summary: 
      Incretin hormones (GLP-1 and GIP) released from the intestine in response to meal ingestion
      augment insulin secretion from the pancreas to help maintain glycemic control. Studies in
      vitro and in vivo have shown that these incretin hormones also have functional effects in
      other tissues independent of the insulin secretory response. Both GLP-1 and GIP stimulate
      insulin secretion in a glucose-dependent manner, however the glucose-dependency of their
      extra-pancreatic effects has not been examined in vivo. By using pancreatic clamp methodology
      during euglycemic and hyperglycemic conditions we will test the hypothesis that
      extra-pancreatic effects of GLP-1 and GIP are glucose-dependent.
    


Intervention name(s): Saline; GIP; GLP-1
Intervention type(s): Biological; Biological; Biological
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Physical Activity Behavior Change for Older Adults After Dysvascular Amputation
Condition: Amputation; Diabetes Mellitus, Type 2; Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This pilot study will use mobile-health technology to deliver an intervention designed for
      lasting physical activity behavior change. The study will assess the feasibility of using the
      Physical Activity Behavior Change(PABC) intervention for Veterans with lower limb amputation.
      This intervention will be delivered using wrist-worn wearable activity sensors and a
      home-based tablet computer to allow real-time physical activity feedback and video interface
      between the participants and the therapist.
    

Detailed description: 
      This pilot study will assess the feasibility of using the Physical Activity Behavior
      Change(PABC) intervention for Veterans with dysvascular lower limb amputation. In addition,
      preliminary efficacy of the PABC intervention will be assessed using a two-group randomized
      cross-over design. Testing will occur at baseline (pre-intervention), three months (end of
      intervention), and six months. The primary aim is to determine feasibility of using the PABC
      intervention with Veterans who have dysvascular amputation by measuring:

        1. participant retention

        2. dose goal attainment

        3. participant acceptability

        4. safety The secondary aim is to preliminary assess efficacy of the PABC intervention by
           measuring accelerometer-based physical activity and self-report disability effect sizes.
    

Intervention name(s): Physical Activity Behavior Change (PABC); Physical Activity Behavior Change (PABC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.; Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amputation; Physical Activity; Rehabilitation
Glycemic Response to Six Meal Replacements in Persons With Type 2 Diabetes Mellitus
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This will be a randomized, cross-over design. Subjects will be randomized to one of six
      interventions on six separate study days, 1 week apart.
    


Intervention name(s): Meal replacement
Intervention type(s): Other
Intervention description(s): The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Silybin - Vitamin E- Phospholipids Complex Reduces Liver Fibrosis in Patients With Chronic Hepatitis C Treated With Peg-IFN-a and RBV
Condition: Liver Fibrosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Chronic hepatitis C is both a virologic and a fibrotic disease, with mortality resulting
      mainly from the complications of cirrhosis and HCC.

      The investigators' aim will be to evaluate the impact on of supplementation with a new
      pharmaceutical complex of silybin-vitamin E-phospholipids in patients with chronic hepatitis
      C treated with Pegylated-Interferon-α2b plus Ribavirin.
    


Intervention name(s): Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vitamin E; Silybin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment