bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of Elidel (Pimecrolimus) 1% Cream to Treat Netherton Syndrome
Condition: Netherton Syndrome
MeSH terms: Netherton Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Netherton syndrome is a genetic condition that can result in abnormal skin functioning.
      People with this condition often have red and scaling skin; sparse or short hair; and
      problems with absorption of medicines or chemicals that are applied to the skin. If these
      chemicals are absorbed at a high level, they may cause health problems. Elidel (pimecrolimus)
      is a new medicine that is available as a cream. It has been shown to help improve the
      appearance of the skin in patients with another skin condition known as atopic dermatitis,
      and is approved by the United States (US) Food and Drug Administration for use in children
      with mild to moderate atopic dermatitis. The purpose of this study is to determine if Elidel
      is safe, to see whether the medication is absorbed through the skin, and to see if side
      effects are associated with its use in children with Netherton syndrome.
    

Detailed description: 
      Patients with Netherton syndrome, a rare genodermatosis, manifest a chronic, eczematous
      dermatitis with erythema and scaling that is often recalcitrant to conventional therapy with
      emollients and topical corticosteroids. These patients display an altered epidermal barrier
      with increased permeability to topical agents and are therefore susceptible to evaporative
      transepidermal water loss and infection. Topical therapy with the calcineurin inhibitors
      tacrolimus and pimecrolimus has been demonstrated to improve the skin integrity and the
      quality of life of patients with several chronic dermatoses, including atopic dermatitis. As
      a result of the underlying skin barrier dysfunction, however, the possibility of significant
      systemic absorption and resultant side effects is a concern when these agents are used in
      patients with Netherton syndrome. Experience with topical tacrolimus 0.1% ointment for
      patients with Netherton syndrome has demonstrated both marked efficacy as well as significant
      systemic absorption of the drug in this patient population. Use of topical pimecrolimus in
      patients with Netherton syndrome has not been reported to date. Investigation of the extent
      of systemic absorption and side effects will help to define the safety and efficacy profile
      of topical pimecrolimus in patients with Netherton syndrome.
    

Intervention name(s): Pimecrolimus 1% Cream
Intervention type(s): Drug
Intervention description(s): Open label single arm
Other intervention name(s): Elidel; Eczema
Intervention MeSH terms: Pimecrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices
Condition: Total Hip Arthroplasty
Study type: Interventional

Summary: 
      We are comparing two pneumatic compression devices, VenaFlow (stationary) and MCS (portable)
      in both the supine an standing position. We will start supine and will take 3 baseline
      measurements of venous velocity and then apply a device and take 3 measurements of the
      increase in peak venous velocity. We will repeat this with the second device. We will then
      have the subject stand and repeat the above with each device. We will randomize the order of
      the devices in the supine and standing position. This study will involve 10 healthy subjects
      of various ages and 10 total hip replacements (THR) patients.
    


Intervention name(s): ActiveCare+SFT Supine; VenaFlow Elite Supine; ActiveCare+SFT Standing; VenaFlow Elite Standing
Intervention type(s): Device; Device; Device; Device
Other intervention name(s): Portable Pneumatic Compression Device Supine; Stationary Pneumatic Compression Device Supine; Portable Pneumatic Compression Device Standing; Stationary Pneumatic Compression Device Standing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Supraphysiological Doses of Levothyroxine as Adjunctive Therapy in Bipolar Depression
Condition: Bipolar Disorder
MeSH terms: Depression; Bipolar Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      There is growing evidence that thyroid axis dysfunction may contribute to the pathophysiology
      of bipolar illness. Open-label studies have consistently demonstrated that the behavioral
      expression of bipolar disorder can be modified by a change in thyroid status, and in many
      instances the course of illness is improved through the use of adjunct thyroid hormone
      treatment. Recent evidence emerged from acute intervention studies that add-on treatment with
      supraphysiological doses of levothyroxine is an effective augmenting agent in patients with a
      major depressive episode. The primary goal of this international multicenter trial (5 sites)
      is to determine in a 13-week, randomized, placebo-controlled design (1 week single-blind
      placebo run-in, 6 week double-blind, 6 week open-label) the efficacy and safety of add-on
      treatment with levothyroxine (300 mcg/d) in combination with mood stabilizer/antidepressant
      therapy in the treatment of patients with bipolar depression. The main hypotheses is:
      treatment with levothyroxine will result in a significantly greater mean reduction of HRSD
      total score and in a higher number of responders and remitters compared to placebo treatment.
      This proposal will build on our pilot data and provide evidence for the use of levothyroxine
      as an effective augmentation strategy in the treatment of bipolar depression.
    


Intervention name(s): L-Thyroxine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): L-Thyroxine as addon to ongoing stable antidepressant and /or mood stabilizing therapy: week 1: 100 mcg; week 2: 200 mcg: week 3 to week 6: 300 mcg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bipolar disorder; Bipolar depression; Thyroid abnormality; mood stabilizer; antidepressants; currently depressed
Epidural Morphine Following Vaginal Delivery
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators believe that pain management following a vaginal delivery can be improved.
      Many women receive epidural medication during labor and delivery, and the investigators felt
      that using the epidural following delivery might improve the first day pain. This study is to
      determine whether a single dose of epidural morphine given to mothers after a vaginal
      delivery will reduce the perineal pain in the postpartum period.
    

Detailed description: 
      Vaginal deliveries comprise 80-85% of all deliveries. Although this is felt to be natural and
      safe, this route can be associated with significant perineal trauma and subsequent postpartum
      perineal pain. The degree of perineal trauma varies from the minimum of vaginal stretching
      and distension associated with labor, to episiotomy and significant perineal tears. In spite
      of the differences in the degree of injury following vaginal delivery, postpartum pain
      therapy is poorly organized and at best consists of simple analgesics and anti-inflammatory
      drugs. The purpose of this study is to determine if a single dose of epidural-administered
      morphine offers additional advantage to an organized program for the management of immediate
      postpartum perineal pain following vaginal delivery.
    

Intervention name(s): Preservative-free epidural morphine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One time dose of preservative-free epidural morphine 2.5 mg given within one hour following vaginal delivery; 5 ml of epidural preservative-free saline given within one hour following vaginal delivery
Other intervention name(s): Morphine; Epidural Narcotics
Intervention MeSH terms: Morphine; Narcotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postpartum perineal pain; Epidural morphine; Randomised clinical trial
Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with
      co-administration of CKD-828, D326 and D337 in healthy adult volunteers
    


Intervention name(s): CKD-348 F1, CKD-348 F2, CKD-828, D326, D337
Intervention type(s): Drug
Intervention description(s): Each arm has a different order for taking IP
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety profile of C2L-OCT-01 PR for up to an
      additional 96-week period in acromegalic patients who completed the C2L-OCT-01 PR-301 study.
    


Intervention name(s): C2L-OCT-01 PR 30 mg
Intervention type(s): Drug
Intervention description(s): Administered by deep IM (gluteus) on Day 1. Beginning on Day 42, drug injection frequency (6, 5 or 4 weeks) and dose modification/adjustment will be allowed for every 3 drug injections based on the mean serum GH and clinical symptoms obtained at the last visit of study C2L-OCT-01 PR-301 and during the course of this study.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acromegaly
A STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the effect of pf-06651600 on pharmacokinetics of single dose sumatriptan.
    


Intervention name(s): Sumatriptan; PF-06651600
Intervention type(s): Drug; Drug
Intervention description(s): 25 milligrams (mg) single dose tablet; PF-06651600 400 mg single dose
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-06651600; Sumatriptan; Drug-drug interaction study; Pharmacokinetics
Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit
Condition: Post-operative Craniotomy Patients; Carotid Endarterectomy and Carotid Artery Stenosis Patients; Post-op Spine Patients Admitted to the NCCU; Endovascular Patients Undergoing Intracranial Intervention; Traumatic Brain Injuries NPO for at Least 12 Hours
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Carotid Stenosis
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient
      pain.

      To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels
      in neurocritically ill patients.

      To assess the effect of an intravenous nonnarcotic pain medication on common side effects
      seen in patients taking other intravenous narcotic pain medication in the neurocritical care
      unit.
    


Intervention name(s): Intravenous acetaminophen; Placebo for IV acetaminophen
Intervention type(s): Drug; Drug
Other intervention name(s): Normal Saline
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Craniotomy
Cold Induced Futile Cycles In White Adipose Tissue
Condition: Metabolism Disorder
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      Investigation of futile cycles in white adipose tissue under cold conditions for
      thermogenesis using two substitutes for glucose metabolism (18F-FDG and 13C-Glucose).
    

Detailed description: 
      Thermogenesis is defined as a process, which generates heat by the depletion of energy-rich
      molecules. Evolutionary, it is an essential process that allows the survival at lower
      temperatures. Since the discovery of brown adipose tissue (BAT) it is believed that this part
      of the adipose tissue can dissipate energy for heat thanks to the uncoupling protein 1
      (UCP1). Since energy expenditure is increased as a consequence of thermogenesis,
      pharmacological induction of this pathway presents an interesting therapeutic target to
      counter obesity. However, recent investigations indicate that white adipose tissue (WAT) is
      much more versatile and probably essentially indispensable for thermogenesis.

      To investigate the mechanism of this futile cycle in WAT we plan to investigate the glucose
      metabolism in 24 healthy volunteers with 2 exams (one with and one without external cooling)
      with two substitutes for glucose. We will use 18F-FDG to quantify the glucose influx into WAT
      using dynamic PET/CT scans and 13C-Glucose to analyze the downstream metabolites.
    

Intervention name(s): External cooling; FDG PET/CT; 13C-Glucose injection
Intervention type(s): Other; Diagnostic Test; Diagnostic Test
Intervention description(s): water-circulating cooling/warming sleeves connected to a medical cooling device (Hilotherm Clinic®, Hilotherm GmbH, Germany) will be placed around the subject's abdomen and lower back. Initially the temperature of the water will be set to 25°C. A mild cold stimulus will be applied by reducing the temperature of the circulating water by approximately 1°C every 2 minutes to a minimum of 10°C.; o 75 MBq 18F-FDG will be injected through the intravenous line on the scanner manually (bolus injection) with a simultaneous start of dynamic FDG-PET/CT scan for 45 minutes and a partial body scan from head to the abdomen after 45 minutes. Total scan time 60 minutes.; 0.5 g 13C-Glucose i.v. infusion over 5 minutes, after termination of FDG injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Non blinded, randomised, open label
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Glucose metablism; futil cycles; FDG PET/CT
Psilocybin and Spiritual Practice
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the effects of psilocybin dose and the frequency and intensity of
      support activities for spiritual practice (e.g., meditation) on a battery of attitudinal and
      behavioral outcome measures in 75 healthy volunteers who are interested in pursuing a program
      of spiritual practices with the intention applying spiritual insights and knowledge to
      everyday life. After screening and study enrollment, each volunteer will be assigned to one
      of five groups that vary in dose, frequency and intensity of support for spiritual practice,
      and number of psilocybin sessions (either 2 or 3 sessions). The psilocybin dose manipulation
      will be double-blind. Volunteers will be told that in each of sessions 1, 2, and 3, he/she
      could receive a very low, low, moderate, moderately high, or high dose of psilocybin. They
      will be told that each participant will receive 2 or more dose levels of psilocybin over the
      2 or 3 sessions, and all participants will have one or more sessions in which he or she
      receives a moderately high or high dose of psilocybin. The duration of each volunteer's
      participation will be approximately 6 to 8 months. Each volunteer will receive several hours
      of preparation with the study guides in the month prior to the first psilocybin session; the
      first two sessions will be separated by one month. Various measures will be assessed before,
      during and immediately after sessions. A battery of longitudinal measures will be evaluated
      immediately after study enrollment, 3 weeks after the second psilocybin session, and 4 months
      after the second psilocybin session (6 months after study enrollment). For purposes of
      controlling expectancies through the 6 month follow-up evaluation, volunteers and guides will
      not know which volunteers or how many volunteers will be scheduled for a third session.
    


Intervention name(s): psilocybin; Intensity of support for spiritual practice; Number of sessions
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): dose manipulation as described in the protocol and to which volunteers are blinded; Volunteers will be assigned to standard or high support, as described in the protocol; Volunteers will be assigned to either 2 or 3 sessions, as described in the protocol
Intervention MeSH terms: Psilocybin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: healthy volunteers; spirituality; psilocybin; meditation
Bisphosphonates and Impaction Grafting in Hip Revision
Condition: Aseptic Loosening of the Hip Prosthesis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary focus of this study is to investigate whether increased bone density of the graft
      in revision arthroplasty of the hip can cause a decreased micromotion of the implant relative
      to the femur.
    

Detailed description: 
      Morsellized compacted bone allograft can be used for revision arthroplasty of the hip.
      Treating the graft locally with an antiresorptive substance such as a bisphosphonate has
      decreased the graft resorption in animal studies and led to a remained bone density in a
      human series of 16 patients. In the present study we investigate if this increased bone
      density of the graft also causes a decreased micromotion of the implant relative the femur.
      36 patients are planned to participate in a 1:1 randomized and prospective study comparing
      the bisphosphonate Clodronate to saline. Primary outcome will be micromotion over the first
      year but also secondary parameters such as late micromotion (between 12 and 24 months),
      re-loosening subjective outcome and safety.

      We hypothesize that rinsing the graft in a bisphosphonate solution prevents its resorption
      and therefore may reduce the risk of mechanical failure. Patients are followed with
      radiograms, RSA (radiostereography) preop, postop, at 6 weeks, at 12 and 24 months and
      subjective months and subjective parameters including Womac and SF 12. The treatment is
      simple, cheap and appears virtually risk-free.
    

Intervention name(s): Clodronate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg/ml, 10 ml, single dose mixed in bone graft at operation; 10 ml, single dose mixed in bone graft at operation
Intervention MeSH terms: Clodronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Surgical procedures operative; Prosthesis implantation; Arthroplasty replacement
Comparison of Transparent Retractable Extension Device and Narrow Band Imaging on Colorectal Adenoma Detection
Condition: Colorectal Cancer Screening
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The investigators previously reported that colonoscopy with a transparent retractable
      extension (TRE) device improved the adenoma detection rate without affecting intubation and
      withdrawal times. On the other hand, colonoscopy using narrow band imaging (NBI) is expected
      to lead to higher rate s of adenoma detection. The investigators compared the effects of TRE
      device on colorectal adenoma detection with those of NBI.
    


Intervention name(s): TRE vs. NBI
Intervention type(s): Device
Intervention description(s): TRE NBI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: colonoscopy; hood; NBI
Management of Fournier Gangrene at Ibn Rochd University Hospital Center
Condition: Fournier Gangrene
MeSH terms: Fournier Gangrene; Gangrene
Study type: Observational

Summary: 
      Case series with retrospective data collection of patients treated for Fournier's gangrene
      between January 2010 and March 2017. The main etiologies, risk factors, postoperative
      complications outcomes and long term follow up results were analyzed.
    

Detailed description: 
      Eight four (84) patients were recruited. The average age of our patients was 49 years (with
      limits of 20 to 76), the male gender dominates our series (83.33%) with a sex ratio of 5M /
      1W, the most frequently found risk factor was diabetes mellitus (37%). The most common
      etiology was anal abscesses (32%). The average time to consultation was 8 days (limits ranges
      from 3 to 30 days). All patients were admitted at a necrosis stage (100%). Anemia was
      identified in 85% of cases. The low platelets were noticed in 44.03% of cases.
      Hypoalbuminemia was found in 93% of cases. All patients (100%) benefited resuscitation
      initially and antibiotic therapy on their admission. They received emergency surgical
      debridement with a cleansing stoma. The average length of hospital stay was 13 days and
      complications occurred in 33% of cases. The mortality rate was 7.14%. then we conclude that
      Fournier's gangrene is a medico-surgical emergency with a high morbidity and mortality rate.
      Early diagnosis as well as antibiotic therapy and the quality of debridement save the
      patients.
    

Intervention name(s): Necrotesectomy associated with cleanleness stoma
Intervention type(s): Procedure
Intervention description(s): Excision of all necrotised tissues after stool diversion and wound dressing using
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        . Patients with Fournier Gangrene
      
Biospecimen description: 
      The pus from purulent and necrotized tissues
    
Keywords: Fournier's Gangrene, stoma, necrosectomy