bioihbjkbjnl/mcl2 huggingface dataset:
Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome; Hyperthermia
Study type: Interventional

Summary: 
      The purpose of this study is to compare and determine the efficacy of letrozole
      administration to that of laparoscopic ovarian diathermy (LOD) in infertile women with
      Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.
    

Detailed description: 
      In the letrozole group, withdrawal bleeding was achieved using 10 mg of dydrogesterone
      tablets for 10 days before stimulation, then 2.5 mg of letrozole oral tablets (Femara;
      Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days up to six
      cycles. All patients in the control group underwent laparoscopic ovarian diathermy, then
      followed up for 6 months.
    

Intervention name(s): Letrozole; Laparoscopic ovarian diathermy (LOD)
Intervention type(s): Drug; Procedure
Intervention description(s): 2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles; Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle.
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic ovary syndrome; clomiphene resistance; letrozole; Laparoscopic ovarian diathermy
Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a
      pregabalin controlled release (CR) tablet administered a) fasted at bedtime, b) immediately
      following a 400 to 500 calorie evening meal, and c) immediately following a 600 to 750
      calorie evening meal as compared to a single dose of the pregabalin immediate release
      (IR)capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin
      controlled release tablet administered with various caloric sized dinners and at bedtime as
      compared to a single dose of the pregabalin immediate release capsule.
    

Detailed description: 
      Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a
      pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR
      capsule
    

Intervention name(s): Pregabalin controlled release, 330 mg, 400 to 500 calorie; Pregabalin controlled release, 330 mg, 600- 750 calorie; Pregabalin controlled release, 330 mg, bedtime; Pregabalin immediate release, 300 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie evening meal; A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie evening meal; A single oral dose of 330 mg controlled release tablet administered at bedtime; A single oral dose of 300 mg immediate release capsule administered in the evening
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pregabalin; pharmacokinetics; bioavailability; bioequivalence
Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures
Condition: Gastroesophageal Reflux; Esophageal Reflux; Gastroesophageal Reflux Disease; GERD
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects (good and bad) of the Laparoscopic Hill
      anti-reflux procedure with the Laparoscopic Nissen anti-reflux surgical procedure to see
      whether one is better than the other.
    

Detailed description: 
      The design is a two-armed prospective single-blinded comparison between the two procedures,
      performed and randomized independently at the Swedish Medical Center Cancer Institute in
      Seattle, WA, and at Legacy Health Systems in Portland, OR, in adult patients with
      uncomplicated gastroesophageal reflux failing medical management. A standardized operative
      technique for each procedures will be utilized at both institutions, and will include
      intraoperative manometrics and intraoperative photographic documentation of the
      gastroesophageal valve, as well as placement of clips at the GE junction to accurately
      identify its location post-operatively. To eliminate "expertise" bias, the investigator from
      each institution will participate in up to 50 of the first of each of the two procedures.
    

Intervention name(s): Laparoscopic Hill Repair; Laparoscopic Nissen Repair
Intervention type(s): Procedure; Procedure
Intervention description(s): With the Hill repair, stitches are placed right where the esophagus and stomach meet and attached to muscle tissue that is fixed to the spine.; With the Nissen repair, the upper part of the stomach is wrapped around the esophagus, with some anchoring of the wrap at several locations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: GERD; laparoscopic surgery; gastroesophageal; reflux
Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive aHUS
Condition: Atypical Hemolytic Uremic Syndrome
MeSH terms: Hemolytic-Uremic Syndrome; Atypical Hemolytic Uremic Syndrome; Syndrome; Hemolysis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether eculizumab is safe and effective in the
      treatment of adolescent patients with plasma therapy-sensitive Atypical Hemolytic-Uremic
      Syndrome (aHUS).
    


Intervention name(s): eculizumab
Intervention type(s): Drug
Intervention description(s): All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
Intervention MeSH terms: Eculizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Analysis of Adherence & Associated Factors in Teenagers Undergoing Treatment of Acne Vulgaris With Differin® Gel 0.1%
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to investigate potential differences in treatment
      adherence by teenagers among four interventions during treatment for acne.
    

Detailed description: 
      Same as above.
    

Intervention name(s): More frequent than normal office visits; Electronic reminders (voice, e-mail, text messages); Parenteral involvement / intervention reminders; No intervention or reminders
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Mode of patient reminder; Mode of patient reminder; Mode of patient reminder; Mode of patient reminder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Cortical Representation of Hyperalgesia Induced by Nerve Growth Factor
Condition: Non-inflammatory Neuropathic Pain; Healthy Subjects
MeSH terms: Neuralgia; Hyperalgesia
Study type: Interventional

Summary: 
      Intraepidermal injection of nerve growth factor results in a non-inflammatory hyperalgesia
      for thermal and mechanical stimuli. This hyperalgesia is similar to the pathological ailments
      of patients with neuropathic pain. The mechanisms of the cognitive modulation of pain and
      hyperalgesia are not yet understood in this group of patients. The investigators plan to use
      NGF injection as a model of non-inflammatory neuropathic pain in healthy subjects to
      investigate the underlying neuronal mechanisms of this hyperalgesia using functional magnetic
      resonance imaging and resting state network analysis.
    


Intervention name(s): NGF injection
Intervention type(s): Biological
Intervention description(s): single injection of NGF into the volar forearm / single injection of NaCl into the volar forearm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Use of NGF injection as a model of non-inflammatory neuropathic pain in healthy subjects
Clinical Study of Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Umbilical cord blood mononuclear cells contain hematopoietic stem cells (HSC), mesenchymal
      stem cells (MSC), endothelial progenitor cells and other pluripotent stem cells, as well as
      immature immune cells, which can differentiate into chondrocytes, hematopoietic, epithelial,
      endothelial and nerve cells. It gives the ability to promote wound healing and vascular
      microcirculation reconstruction, and has the potential to treat many diseasesHowever,
      clinical studies on cord blood mononuclear cells in knee osteoarthritis have not been
      reported in the literature. Therefore, this study aims to explore the safety and
      effectiveness of cord blood mononuclear cells in the treatment of patients with knee
      osteoarthritis.
    


Intervention name(s): normal saline; Cord Blood Mononuclear Cells (UCB-MNCs)
Intervention type(s): Other; Other
Intervention description(s): Intra-articular injection of normal saline; Intra-articular injection of Cord Blood Mononuclear Cells (UCB-MNCs)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cord Blood Mononuclear Cells; Knee Osteoarthritis
Safety and Efficacy of Topical NVC-422 Gel in Impetigo
Condition: Impetigo
MeSH terms: Impetigo
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind study comparing 0.1% NVC-422, 0.5% NVC-422 and 1.5%
      NVC-422 topical gel in children with impetigo.
    

Detailed description: 
      This study is a randomized, sequential group, double-blind study. The first 60 subjects
      enrolled will be randomized to either 0.1% NVC-422 or 0.5% NVC-422. Randomization is 1:2
      where 20 subjects will receive 0.1% NVC-422 and 40 subjects will receive 0.5% NVC-422. If
      there are no safety issues regarding the first 2 doses tested, the next 60 subjects will be
      randomized to either 0.1% or 1.5% NVC-422 with 20 subjects receiving 0.1% and 40 subjects
      receiving 1.5% NVC-422.

      The lesion most representative of the subject's infection will be identified as the target
      lesion. This target lesion will be photographed, graded clinically, and its location
      recorded. At Visit 1, Screening and/or Baseline, a Gram stain will be performed to assess
      presence of Gram-positive cocci. If Gram-positive cocci are present, a swab for culture and
      sensitivity will be obtained. Treatment will began immediately after randomization.

      Treatment will be 3 times per day (TID) for 7 consecutive days, following a morning,
      afternoon, and evening schedule.

      After the start of treatment (Day 1), subjects will be assessed for safety on Day 4 (± 1).
      Clinical and bacteriological assessments of the target lesion will also occur on Day 8 (+1)
      and Follow-up on Day 15 (± 2).
    

Intervention name(s): NVC-422
Intervention type(s): Drug
Intervention description(s): Dermal Gel applied 3 times per day for 7 days
Other intervention name(s): Sodium salt of 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed study is a randomized, double-blind, placebo-controlled, multi-center Phase II
      study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe
      active Crohn's Disease. The study aims to evaluate the optimal dose of SHR0302 and time
      needed in inducing clinical remission in active CD. This is an 12+12 weeks study, in which
      participants who complete the first 12 weeks treatment phase, will have the option to enter a
      blinded active arms 12-week extension phase. Early withdrawn subjects during the first
      treatment phase cannot enter the extension phase. The total duration of the study
      participation, including extension and follow-up, will be approximately 26 weeks.

      With the wealth of scientific evidence on JAK/STAT involvement in IBD, the data from similar
      class of new drugs and the current data on SHR0302 (JAK1 inhibitor), support the rationale to
      proceed with phase II studies to evaluate the efficacy and safety of SHR0302 in patients with
      moderate to severe active CD.
    


Intervention name(s): SHR0302; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).; Placebos
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Neural Mechanisms of Tactile Priming on Social Perceptions - Pilot Study
Condition: Healthy
Study type: Observational

Summary: 
      The investigators measure brain responses of healthy participants while they perform
      evaluation tasks inside the fMRI. For each task the participants were primed with tactile
      stimuli. Results should demonstrate engagement of sensorimotor brain regions after priming,
      hence confirming embodiment theories.
    

Detailed description: 
      Brain responses of healthy participants were recorded with functional magnetic resonance
      imaging (fMRI). While being scanned participants were asked to recommend punishments similar
      to judges or juries for perpetrators across different scenarios. In addition, participants
      were primed before reading the scenario by using different materials. Based on recent
      theories about "embodied cognition" and extralegal factors investigators hypothesize that
      those primes may influence the harshness of punishments recommended by the participants. If
      those processes engage sensorimotor cortices, the results would strongly support theories of
      embodied cognition.

      The results would help the investigators to understand the neural correlates of priming
      processes. These unconscious complex processes of perception may be important for hospital
      patients. Thus, beneficial haptic experiences during the hospital stay may contribute to
      successful recovery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy adult male and female subjects
      
Keywords: Social perceptions
The Order Effect of Acute Concurrent Exercise on Executive Function: An Event-Related Potential Study
Condition: Executive Function
Study type: Interventional

Summary: 
      Executive function is a high-level cognition which plays an important role in our life.
      Meta-analysis study has demonstrated that acute exercise could improve executive function.
      However, it is still unclear whether executive function can be enhanced by the concurrent
      exercise that combines aerobic and resistance exercise. Moreover, the sequence of concurrent
      exercise may result in different blood lactate concentration which may affect executive
      function. Therefore, the purposes of present study are: (1) Measuring the order effect of
      acute concurrent exercise on executive function. (2) Measuring whether order effect of acute
      concurrent exercise on executive function is mediated by blood lactate.
    

Detailed description: 
      Executive function is a high-level cognition which plays an important role in academic
      performance, career, and interpersonal relationship. Meta-analysis study has demonstrated
      that acute exercise could improve executive function, and also observed similar positive
      effect through both aerobic and resistance exercise. However, it is still unclear whether
      executive function can be enhanced by the concurrent exercise that combines aerobic and
      resistance exercise. Moreover, the sequence of concurrent exercise may result in different
      blood lactate concentration which may affect executive function. Therefore, the purposes of
      present study are: (1) Measuring the order effect of acute concurrent exercise on executive
      function. (2) Measuring whether order effect of acute concurrent exercise on executive
      function is mediated by blood lactate.
    

Intervention name(s): resistance-aerobic exercise, RA; aerobic-resistance exercise, AR
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants conduct 5-min warm up, 13-min resistance exercise, 12-min aerobic exercise, and 5-min cool down.; Participants conduct warm up for 5-min, aerobic exercise for 12-min, resistance exercise for 13-min, and 5-min cold down.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomly assigned to three group, namely the resistance-aerobic exercise group (RA), the aerobic-resistance exercise group (AR), and the reading control group (RC). Participants in RA groups were asked to finish 5 min warm-up, 13 min resistance exercise, 12 min aerobic exercise, and 5 min cool down. Participants in AR groups were asked to finish 5 min warm-up, 12 min aerobic exercise, 13 min resistance exercise, and 5 min cool down. Participants in RC group were required to finish 35 min reading. All groups took a 30 min cognitive test before and after the intervention.The blood lactate were collected before, 17 minutes after, and after the intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute exercise; concurrent exercise; inhibition; cognitive flexibility
Testing a Promising Treatment for Youth Substance Abuse in a Community Setting
Condition: Substance Abuse; Delinquency; Mental Health
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aims to address a serious public health problem (i.e., substance abusing
      adolescents) by testing the effectiveness of a promising substance abuse treatment
      implemented in a community-based treatment setting (CM-FAM, a family-based contingency
      management intervention) in comparison to usual treatment services.
    

Detailed description: 
      The overriding purpose of the randomized trial is to examine the effectiveness of a promising
      and efficient outpatient treatment of adolescent substance abuse delivered in a
      community-based treatment setting. Although several evidence-based treatments of adolescent
      substance abuse are emerging, none have experienced widespread adoption in community
      settings. Thus, as noted by the Institute of Medicine (1998) more than a decade ago and
      reiterated more recently, a considerable science-service gap exists in regards to treatment
      of substance abuse in adolescents and adults.

      For the proposed study, 204 adolescents meeting diagnostic criteria for substance abuse or
      dependence will be randomized to either the Contingency Management-Family Engagement (CM-FAM)
      or Treatment as Usual (TAU) conditions. A multimethod, multirespondent approach will be used
      to track clinical outcomes at 3, 6, 9, 12, and 18 months post recruitment. Clinical level
      outcomes pertain to youth substance use, criminal behavior, mental health functioning, and
      key mediators of serious antisocial behavior in adolescents (e.g., self-control, parental
      supervision, association with deviant peers). In addition, the incremental cost of CM-FAM
      will be determined for use in cost effectiveness analyses.

      Aim 1: Over an 18-month post-recruitment follow-up, determine the relative effectiveness of
      CM-FAM vs. TAU in reducing adolescent participants' substance use, criminal activity
      (including incarceration), and mental health symptoms; and evaluate the cost effectiveness of
      CM-FAM in achieving these outcomes.

      Aim 2: Examine possible moderators and mediators of intervention effectiveness. Moderator
      variables will include youth demographic and clinical (e.g., co-occurring disorders)
      characteristics. Mediator variables will include measures of self-control, parenting, and
      association with deviant peers - constructs targeted by CM-FAM.
    

Intervention name(s): Contingency Management-Family Engagement; Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PET/MRI and Biomarkers in Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      Muscle invasive bladder cancer is an aggressive malignancy. Currently the investigators lack
      accurate imaging technologies in clinical staging and estimation of response to neoadjuvant
      chemotherapy as well as prognostic biomarkers.

      In the current study novel imaging modality (MRI/PET) is utilized to stage bladder cancer
      prior to transurethral resection of bladder-tumor and after neoadjuvant chemotherapy. Also
      prognostic biomarkers are studied from TUR-BT tissues, blood and urine to estimate response
      to neoadjuvant chemotherapy.
    


Intervention name(s): MRI/acetate-PET imaging
Intervention type(s): Device
Other intervention name(s): Philips Ingenuity PET/MR device; 11C-acetate as PET-tracer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: bladder cancer; neoadjuvant chemotherapy; radical cystectomy; lymphadenectomy; biomarker