bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Local Only Anesthesia Versus Sedation in Patients Undergoing Bilateral Carpal Tunnel Release
Condition: Bilateral Carpal Tunnel Syndrome (Diagnosis)
MeSH terms: Carpal Tunnel Syndrome
Study type: Interventional

Summary: 
      The study design is a prospective randomized control trial. Four surgeons will enroll up to
      30 patients in the study. Patients will be asked to participate if they plan to undergo
      bilateral carpal tunnel release with one of the study surgeons, are greater than 18 years of
      age but younger than 89, have had no prior carpal tunnel surgery, and agree to undergo carpal
      tunnel surgery under two different types of anesthesia. If patients meet these criteria and
      agree to participate in the study, they will be consenting to have one hand operated on with
      local only anesthesia and the other hand with local anesthesia with sedation. The patient
      will randomly be assigned to have one of the two anesthetic methods for the first carpal
      tunnel release, followed by the other anesthetic for the second carpal tunnel release. The
      two surgeries will be completed by the same surgeon and may be performed at any time interval
      apart; however, the investigators will recommend that patients get the second surgery within
      4 weeks of the first. The particular surgical technique of carpal tunnel release will be
      performed according to the individual surgeon's preference, but the same technique will be
      used on both wrists. The surgeon will discuss the proposed advantages and disadvantages of
      each anesthetic method prior to enrolling the patient (advantages and disadvantages discussed
      above). The treating surgeons will continue to utilize their standard surgical technique on
      each side, regardless of a patient's participation in the study.
    


Intervention name(s): Local only anesthesia vs Local with sedation anesthesia
Intervention type(s): Procedure
Intervention description(s): The investigators are comparing two approved sedation types that are using during carpal tunnel surgery.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome
Condition: Nephrotic Syndrome; Membranous Nephropathy
MeSH terms: Nephrotic Syndrome; Nephrosis; Glomerulonephritis, Membranous; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I study is a single arm, multi-dose study that will evaluate steady-state apixaban
      pharmacokinetics (PK) and pharmacodynamics (PD) in subjects with Nephrotic Syndrome (NS) vs
      healthy control subjects. This study will enroll 20 subjects diagnosed with NS and 10 healthy
      control subjects. Comparing differences in steady-state apixaban PK/PD parameters between
      subjects with NS and healthy volunteers will be essential to identifying a safe and effective
      apixaban dose and dose administration schedule for future randomized controlled trials
      (RCTs).
    


Intervention name(s): Apixaban 5 MG
Intervention type(s): Drug
Intervention description(s): 1 - 5 mg tablet taken orally twice a day
Other intervention name(s): Eliquis
Intervention MeSH terms: Apixaban
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment
      of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells
      in the brain function better. CERE-110 uses a virus to transfer a gene that makes Nerve
      Growth Factor (NGF), a protein that may make nerve cells in the brain healthier and protect
      them from dying. The virus used in CERE-110 does not cause disease in people. CERE-110 has
      been carefully studied in laboratory animals and is in the early stages of being tested in
      people.

      Fifty patients with mild to moderate Alzheimer's disease will participate in this study. Half
      of the study subjects will have CERE-110 injected into the brain during a surgical procedure,
      while the other half will undergo a "placebo" surgery where no medication will be injected.
      All study participants will be followed for at least two years after surgery.
    


Intervention name(s): CERE-110: Adeno-Associated Virus injection Surgery; Placebo Surgery
Intervention type(s): Drug; Procedure
Intervention description(s): Injecting CERE-110 2.0 X 10^11 vg into brain during surgical procedure.; Placebo Surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's disease; Dementia; Memory loss; Cognitive impairment; Nerve growth factor; NGF; Neurotrophic factors; Gene therapy
Study of LY2140023 in Schizophrenia Comparing LY2140023, Olanzapine, and Placebo
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Assess the efficacy of a new drug (a receptor agonist that modulates the glutamatergic
      activity) in the treatment of schizophrenia.

      The primary objective of this study is to determine if a mGlu2/3 agonist dosed for 28 days is
      superior to placebo in the treatment of patients with schizophrenia as measured by the
      Positive and Negative Symptom Scales (PANSS) total score.
    

Detailed description: 
      The primary objective of this study was to determine if LY2140023 dosed at 40 mg twice daily
      (BID) for 28 days was superior to placebo in the treatment of patients with schizophrenia as
      measured by the Positive and Negative Syndrome Scale (PANSS) total score. The secondary
      objectives of the study were to assess the safety and tolerability of LY2140023 compared with
      placebo and olanzapine; efficacy of LY2140023 compared with placebo in change from baseline
      to Visit 8 in the PANSS positive symptom subset score; efficacy of LY2140023 compared with
      placebo in the responder rate (defined as 25% or more decrease from baseline to Visit 8) in
      the PANSS total score; efficacy of LY2140023 compared with placebo in responder rate (defined
      as 25% or more decrease from baseline to Visit 8) in the PANSS positive symptom subset score;
      efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the PANSS
      negative symptom subset score; efficacy of LY2140023 compared with placebo in change from
      baseline to Visit 8 in mood and anxiety as measured by the Hamilton Anxiety Scale (HAMA)
      total score; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8
      in the Clinical Global Impression-Severity (CGI-S); effect of LY2140023 on prolactin levels
      of the patients after 4 weeks of treatment; efficacy of olanzapine compared with placebo on
      the PANSS total score; pharmacokinetics of LY2140023 and LY404039 in patients, and to explore
      the relationship between exposure and efficacy.
    

Intervention name(s): LY2140023; olanzapine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of a Natural Health Product on Urinary Estrogen Metabolites
Condition: Breast Cancer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if a supplemental formula can beneficially alter
      the ratio of urinary estrogen metabolites.
    

Detailed description: 
      The active botanical constituents in femMED Breast Health Formula contain lignans, compounds
      with anti-estrogenic activity, that have been shown to exert an estrogenic effect during the
      follicular phase [i.e. when estrogen is low] and an antiestrogenic effect in the luteal phase
      of a female menstrual cycle. These are plant-derived chemicals that can act as weak mimics of
      estrogen in the body. Overall these compounds have been found to be helpful in stabilizing
      the natural cyclical fluctuation of estrogen levels.

      The trial will be a double-blind, placebo-controlled parallel study in which 100 subjects
      will be recruited to one of two arms of the study: one arm will consist of pre-menopausal
      women; another will consist of post-menopausal women. Each arm of the study will be carried
      out concurrently and in one phase, with no washout period. The placebo assignment will be
      randomized within each arm of the study.

      Subjects in each arm of the study will follow the same protocol. Urine and blood samples will
      be collected from each group at both the first and last visit, and subjects will receive a
      month's supply of treatment or placebo at the first visit, which they will consume on a daily
      basis until their second lab visit 28 days later. Urine samples will be analyzed for the
      following estrogen metabolites: 2-OH-estrone and 16-α OH-estrone. Blood samples would be
      collected and assessed for levels of enterolactone. Pre and post-supplementation results will
      be assesses for any differences by statistical comparison.
    

Intervention name(s): FemMED Breast Health Formula
Intervention type(s): Dietary Supplement
Intervention description(s): Two capsules daily, with meals. FemMED Breast Health Formula containing lignans.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Urinary Estrogen Metabolites; 2-OH Estrone; 16-alpha-OH Estrone; Urinary 2/16a Estrogen Metabolite Ratio
Changes in Unstable Ankles After Balance Training
Condition: Ankle Injury
MeSH terms: Ankle Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is evaluating reflex board training to see if it will help people who frequently
      roll their ankles. We are investigating several tests that evaluate the ability of the
      neuromuscular system to control ankle movement. This study is in 2 parts:Part 1 looks at
      changes after 1 day of reflex training; Part 2 looks at changes after 6 weeks of reflex
      training. It is thought that the reflex training will improve measures of static and dynamic
      balance as well as spinal reflex measures.
    

Detailed description: 
      Research has utilized multiple measures in an effort to detect chronic ankle instability
      (CAI). Recently, investigations have focused on assessment of sensorimotor function in those
      who suffer from CAI. These measures have included traditional and functional postural control
      variables, as well as measures of joint position sense, neuromuscular control and
      recruitment, and nerve conduction velocity. This study seeks to modulate sensorimotor
      measures through both short- and long-term reflex training. This information may help to
      better assess sensorimotor deficits associated with CAI, to focus future research, evaluate
      rehabilitation protocols and to improve our understanding of this chronic disability.
    

Intervention name(s): Checking stability of ankle
Intervention type(s): Procedure
Intervention description(s): Flexing and walking
Other intervention name(s): Flexibility study
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ankle; sensorimotor; reflex; training
Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics
Condition: Chronic Endometritis
MeSH terms: Endometritis
Study type: Interventional
Phase: Phase 2

Summary: 
      Chronic Endometritis (CE) is related to infertility and entails a challenging management.
      This study investigates the treatment of off-label intrauterine antibiotic infusion (IAI)
      combined with oral antibiotic administration (OAA), and it assesses respective performance
      against the gold standard treatment of OAA. Data sourced herein reports on treatment
      efficiency and fertility restoration for both patients aiming to conceive naturally or via In
      Vitro fertilization (IVF).
    


Intervention name(s): Oral antibiotic administration; Intrauterine antibiotic infusion
Intervention type(s): Drug; Drug
Intervention description(s): per os antibiotic administration as the standard line of strategy for treating CE of doxycycline at a dosage of 100mg twice a day for 14 days and metronidazole of 500mg twice a day for 14 days; intrauterine infusion of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CE treatment; infertility; oral antibiotic administration; intrauterine antibiotic infusion
Better Disease Control by Multidrug Regimen in Scabies
Condition: Scabies
MeSH terms: Scabies
Study type: Interventional

Summary: 
      Scabies is associated with significant discomfort and social taboo. Existing treatment
      regimen frequently fails due to lack of patient compliance. We compared single use regimen to
      existing standard repeat application regimen for treatment of scabies.
    


Intervention name(s): Permethrin Lotion 5%; Permethrin Lotion 5% and Oral Ivermectin 200 mcg/kg
Intervention type(s): Drug; Drug
Intervention description(s): Topical permethrin 5% lotion to apply on day 1 and repeat after 1 week.; Topical permethrin 5% lotion and oral ivermectin 200 mcg/kg to be taken on day 1 only.
Intervention MeSH terms: Ivermectin; Permethrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Scabies; Permethrin; Ivermectin; Combination Regimen
Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional

Summary: 
      Multi-center, prospective open-label extension study of noninvasive peripheral nerve
      stimulation (NPNS) with the NTX100 Neuromodulation System for patients with
      medication-refractory moderate- severe primary RLS
    

Detailed description: 
      This is an extension study only inviting subjects who have previously completed the RESTFUL
      Study (NCT04874155).

      Each study subject is enrolled into one of the following Arms:

      Arm 1 (Direct Roll-Over Extension): 24-week open-label NPNS followed by 8-weeks of no
      treatment, no delay after completion of the RESTFUL Study

      Arm 2 (Control Group): 24-weeks of no treatment
    

Intervention name(s): NTX100 Neuromodulation System
Intervention type(s): Device
Intervention description(s): Active Noninvasive peripheral nerve stimulation device programmed to active mode
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome
Condition: Epilepsy; Dravet Syndrome
MeSH terms: Epilepsies, Myoclonic; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children
      and young adults with Dravet syndrome.
    

Detailed description: 
      This study was a 2:2:1:1 randomized, double-blind, 14-week comparison of two dose levels of
      GWP42003-P (10 milligram/kilogram [mg/kg]/day and 20 mg/kg/day) versus placebo (10 mg/kg/day
      dose-volume equivalent and 20 mg/kg/day dose-volume equivalent; presented as pooled placebo
      in the study). A 28-day screening period prior to randomization (to establish baseline
      parameters) preceded the treatment period, which consisted of a 2-week titration period
      followed by a 12-week maintenance period. The study aimed to determine the efficacy, safety,
      and tolerability of GWP42003-P compared with placebo. 20 mg/kg/day was recommended by the
      Data Safety Monitoring Committee (DSMC) after assessment of safety and pharmacokinetic data
      from Part A of study GWEP1332 (NCT02091206). The first participant did not enroll into this
      study until the DSMC reviewed the safety data from Part A of study GWEP1332 (NCT02091206).

      Following study completion, all participants were invited to continue to receive GWP42003-P
      in a separate open-label extension study (GWEP1415; NCT02224573).
    

Intervention name(s): GWP42003-P; Placebo Control
Intervention type(s): Drug; Drug
Other intervention name(s): Cannabidiol; CBD; Epidiolex; Placebo
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cannabidiol; CBD; GWP42003-P; Epidiolex
L-PRF Versus A-PRF on Palatal Wound Healing
Condition: Palate; Wound
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Different approaches are used to reduce post-operative complications associated with the
      palatal wound site after free gingival graft (FGG) harvesting. The aim of this study was to
      compare the effects of L-PRF and A-PRF on palatal wound healing after free gingival graft
      harvesting and patients' quality of life.
    

Detailed description: 
      Thirty-six patients between the ages of 18 and 60 years (11 males and 25 females) who had
      completed Phase 1 periodontal treatments and for whom FGG surgery was indicated for isolated
      gingival recession defects limited to one or two teeth with shallow vestibule and
      insufficient keratinized or attached gingival width were included in the present study.

      Three different treatments were performed on palatal wound areas: L-PRF (L-PRF group, n =
      12), A-PRF (A-PRF group, n = 12) and palatal stent (control group, n = 12) OHIP-14 scores,
      VAS scores (for pain), analgesic tablet intake, and epithelialization condition were recorded
      for different time points.
    

Intervention name(s): L_PRF; A-PRF; Palatal stent
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Palatal epithelialization, pain (Visual Analog Scale (VAS) recording), analgesic tablet use and Oral Health Impact Proﬁle-14 (OHIP-14) questionnaire scores were recorded after L-PRF placing on palatal wounds; Palatal epithelialization, pain (Visual Analog Scale (VAS) recording), analgesic tablet use and Oral Health Impact Proﬁle-14 (OHIP-14) questionnaire scores were recorded after A-PRF placing on palatal wounds; Palatal epithelialization, pain (Visual Analog Scale (VAS) recording), analgesic tablet use and Oral Health Impact Proﬁle-14 (OHIP-14) questionnaire scores were recorded after palatal stent placing on palatal wounds
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: free gingival graft; platelet rich fibrin
Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects
Condition: Healthy Adult Male
Study type: Interventional
Phase: Phase 1

Summary: 
      The ratios of the geometric means of the ODT formulation to those of the reference
      formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of
      brexpiprazole (OPC-34712)).
    


Intervention name(s): OPC-34712
Intervention type(s): Drug
Other intervention name(s): Brexpiprazole
Intervention MeSH terms: Brexpiprazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The objective of this research is to evaluate the effectiveness of couples Voluntary
      Counseling and Testing for HIV (CVCT) compared to individual VCT (IVCT) in preventing MTCT,
      and in increasing preventive behaviors and minimizing spousal abuse among HIV positive women.
      We hypothesize that offering CVCT will not decrease uptake of VCT among women. This research
      will be carried out in 3 antenatal clinics in Dar es Salaam, Tanzania.
    


Intervention name(s): Couples VCT; Individual VCT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Offer women coming to antenatal clinics to have their husbands come with them for couples VCT; Women to receive individual VCT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Voluntary Counseling and Testing; HIV; HIV seronegativity
Motivational Interviewing in Orthodontic Patients
Condition: Oral Hygiene
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether motivational interviewing is effective in
      improving oral hygiene in orthodontic patients wearing fixed appliances.
    


Intervention name(s): Motivational interviewing
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Calling for Care: Cell Phones for Mood Telemetry in Teens
Condition: Bipolar Disorder; Cyclothymia; Borderline Personality Disorder
MeSH terms: Bipolar Disorder; Personality Disorders; Borderline Personality Disorder; Cyclothymic Disorder
Study type: Interventional

Summary: 
      We will modify our existing VMQ/VADIS mood telemetry software to run on a Motorola platform,
      and enhance it to collect information on both mood symptoms (currently covered by the
      VMQ/VADIS) as well as daily life stressors (currently outside the VMQ/VADIS' scope). By doing
      so, we will be able us to examine the role of daily stressors in the lives of teens with and
      without mood swings, to identify how changes in mood triggered by stressful events are
      similar to or different from mood changes linked to the bipolar disorder, borderline
      personality disorder, or other forms of affective instability.
    


Intervention name(s): Mental health telemetry (MHT)
Intervention type(s): Other
Intervention description(s): Use a cell phone equipped with MHT software to complete a self-report mood symptom questionnaire daily at a fixed time of day, as well as additional discretionary questionnaires following any significantly stressful events.
Other intervention name(s): Mood telemetry
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Mental health telemetry; Mood telemetry; Mood; Bipolar disorder; Affective instability; Cyclothymia; Electronic diaries; Mood diaries; Mood swings