bioihbjkbjnl/mcl2 huggingface dataset:
MR Imaging of Fat Deposition in Adolescents With First Time Antipsychotic Use
Condition: Adiposity
MeSH terms: Obesity
Study type: Observational

Summary: 
      This study will focus on a population of antipsychotic (AP) naïve adolescents and young
      adults and will measure fat accumulation in relation to exposure to atypical antipsychotic
      medications.
    

Detailed description: 
      Atypical Antipsychotics (AAPs) are known to cause metabolic dysfunction, and adolescents are
      especially vulnerable to this effect. The anthropometric measures routinely used to monitor
      these metabolic side effects may, in fact, underestimate risk in the pediatric population as
      they are not a good index of hepatic and visceral adipose tissue.

      This study will measure fat accumulation over a 12 week period in adolescents and young
      adults taking an AAP for the first time. MRI imaging will measure hepatic, and visceral
      adipose tissue at baseline and study end. An Oral Glucose Tolerance Test will measure glucose
      resistance and insulin sensitivity. In an exploratory fashion, investigators will also image
      the brain to assess for volumetric changes which may occur in association with AAP treatment
      and changes in metabolic indices.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants recruited will be selected from clinical settings. Participants will be
        flagged by their care provider and offered the opportunity to participate should they meet
        criteria. As well, participants who are interested in the study and may meet criteria can
        refer themselves to the study.
      
Biospecimen description: 
      Antipsychotic serum levels, GLP-1, glucagon, cytokines, c-peptide
Development of a Face Valid Executive Functioning Task
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The purpose of this study is to develop a task to measure executive thinking skills that can
      be performed in a laboratory setting, but has clear parallels to the thinking demands of real
      life situations, and can be administered to patients such as those with Parkinson's who have
      difficulty moving.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Recruit participants through Volunteer for Health, word of mouth, and from a clinical
        population at the Washington University in St Louis School of Medicine's Neurological
        Clinical Research Unit (NCRU).
      
Keywords: Parkinson's Disease
A Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GZR18 Injection in Chinese Obese/Overweight Patients
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study was a multicenter, randomized, double-blind, placebo-controlled phase Ib/IIa
      clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18
      injection in Chinese adult obese/overweight patients. This study is divided into Part A and
      Part B, which are to be conducted simultaneously.
    


Intervention name(s): GZR18; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 0.6 mg-30 mg; administered the same volume as GZR18
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Yoga and Relaxation on Stress and Quality of Life
Condition: Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The aim of this study is to measure the effects of three stress reduction methods on patients
      with stress and stress associated complaints.
    


Intervention name(s): Integrative Yoga; Iyengar Yoga; Mindfulness
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): A 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice.; A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga).; A 12-week mindfulness intervention designed for the healthy handling of stress.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Yoga; Meditation; Progressive muscle relaxation; Stress; Education
Substance P Challenge in Healthy Participants
Condition: Skin Diseases
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      The objectives of this enabling study are to characterize the wheal and flare responses over
      time following skin challenges with ascending concentrations of Substance P. This will be a
      2-part study: Part 1 will aid in the understanding of the wheal and flare responses following
      Substance P. Part 2 will investigate the variability of the responses. Participants may be
      enrolled into Part 1 or Part 2, not both.
    


Intervention name(s): Substance P; Normal Saline; Histamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive Substance P; Participants will receive normal saline as Negative control; Participants will receive histamine as Positive control
Intervention MeSH terms: Histamine; Substance P; Neurokinin A
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Parts 1 and 2 will run sequentially. Part 1 will include 1 challenge visit; Part 2 will include two challenge visits.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Substance P; Wheal response; Flare response; Skin challenge
Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris
Condition: Severe Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide
      (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to
      Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg
      Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens
      will also be evaluated.
    

Detailed description: 
      Further to this study, eligible Subjects with at least good Global Assessment of Improvement
      at Week 12 will be randomized in a maintenance study (SPR.29075)
    

Intervention name(s): Adapalene BPO Gel associated with Doxycyline Hyclate; Vehicle Gel associated with Doxycycline Hyclate
Intervention type(s): Drug; Drug
Intervention description(s): Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.; Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
Other intervention name(s): Adapalene-BPO gel + Doxycycline; Vehicle gel + Doxycycline
Intervention MeSH terms: Doxycycline; Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne
Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS)
Condition: Alagille Syndrome
MeSH terms: Alagille Syndrome; Syndrome; Substance Withdrawal Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a long-term, open-label study with a double-blind, placebo-controlled, randomized
      drug withdrawal period in children with Alagille Syndrome (ALGS) designed to evaluate the
      safety and efficacy of LUM001 (Also known as maralixibat or MRX).
    

Detailed description: 
      The study is divided into 6 parts: a 6-week open-label, dose escalation period, a 12-week
      open-label stable dosing period, a 4-week randomized, double-blind, placebo-controlled drug
      withdrawal period, a 26-week long-term stable dosing period, and an a 52-week optional
      follow-up treatment period, and a long-term optional follow-up treatment period for eligible
      participants who choose to stay on treatment with LUM001.
    

Intervention name(s): LUM001 (Maralixibat); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LUM001, also known as Maralixibat (MRX) will be administered orally Once Daily (OD). To be administered Twice Daily (BID) for patients who are eligible.; Placebo will be administered orally once daily during randomized withdrawal period
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-label single arm study with a randomized placebo-controlled parallel group period
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      Neuroscience research that has identified potential for recovery (neuroplasticity) following
      incomplete SCI has changed clinical practice away from compensation strategies towards
      optimizing recovery. Important factors include: repetitive exercise, Functional Electrical
      Stimulation (FES) and appropriate feedback. The iCycle combines repetitive exercise with FES
      and provides feedback on performance in a virtual cycle race. Unlike previous devices,
      performance in the race is determined only by voluntary effort (i.e. not torque generated by
      FES plus voluntary effort). In this study with incomplete SCI participants we will test the
      iCycle with six inpatients to refine the protocol and make technical improvements. We will
      then conduct an ABA pilot study (n=10) in which a 3G-connected iCycle is used in people's own
      homes. We will compare usual care (A) with iCycle exercise (B). Changes in neural
      connectivity (TMS evoked EMG potentials), muscle strength and walking will be measured as
      well qualitative analysis of users' views.
    

Detailed description: 
      Background: Functional Electrical Stimulation (FES) cycling can benefit health and may lead
      to neuroplastic changes following incomplete spinal cord injury (SCI). Our hypothesis is that
      greater neuroplastic effects occur when electrical stimulation of peripheral nerves is
      combined with voluntary drive. In this pilot study, we will investigate the effects of a
      one-month training programme using a novel device, the iCycle, in which voluntary effort
      (cortical drive) is encouraged by virtual reality biofeedback during FES cycling.

      Methods: Eleven participants (C1-T12) with incomplete SCI (5 sub-acute; 6 chronic) will be
      recruited and undergo 12-sessions of iCycle training. Function will be assessed before and
      after training using the bilateral ISNC-SCI motor score neurological (motor) function, Oxford
      power grading, Modified Ashworth Score, Spinal Cord Independence Measure, the Walking Index
      for Spinal Cord Injury and 10m-walk test. Power output will be measured during training.
    

Intervention name(s): FES
Intervention type(s): Device
Intervention description(s): Functional Electrical Stimulation during cycling with Virtual Reality Feedback
Intervention model: Single Group Assignment
Intervention model description: Technology development and Observational study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Functional Electrical Stimulation; Cycling; Virtual Reality
To Assess the Effect of HDF Versus High Flux Dialysis on Free Light Chains and Cumulative Albumin Loss, in End Stage Renal Disease Patients.
Condition: End Stage Renal Disease; Hemodiafiltration; Hemodialysis
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Removal of uremic toxins is the main goal of HD, It was improved by using high volume
      convective technique with high flux (HF) dialyzer. This technique removes medium - large
      molecular weight solutes giving higher dialysis adequacy and consequently improving the
      quality of life.

      This study will assess the effect of hemodiafiltration (HDF) versus high flux dialysis on
      free light chains (FLC) reduction as a marker of HD adequacy and its relation to albumin loss
      using dialyzer effective surface area 2.6m2.
    


Intervention name(s): BIOPURE 260HF dialyzer
Intervention type(s): Device
Intervention description(s): Dialyzer with effective surface area 2.6 m2, High-flux polyethersulfone hollow fiber with steam sterilization, myoglobin sieving coefficient (SC) 0.7, membrane cutoff 40,000 Daltons (Allmed Medical Gmbh)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: It is a pilot crossover study, 25 ESRD patients were dialyzed using dialyzer; BIOPURE 260 HF on a single session on two hemodialysis modalities (conventional HD and online post-dilution HDF) with washout period of 2 weeks using high flux dialyzers with maximum surface area 2.0 m2.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: End stage renal disease (ESRD); hemodiafiltration (HDF); hemodialysis (HD); Free light chains; Albumin loss; Kappa and lambda
Comparison of Selective Trunk and Supraclavicular Brachial Plexus Blocks
Condition: Upper Extremity Problem
Study type: Observational

Summary: 
      There are different methods in brachial plexus blocks for hand, wrist, forearm, and elbow
      operations. In this study, the anesthetic efficacy of the ultrasound-guided selective truncus
      methods and the supraclavicular methods for brachial plexus blocks in upper extremity
      surgeries will be compared.
    

Detailed description: 
      Currently, brachial plexus block performed with various approaches is preferred to general
      anesthesia due to its advantages in upper extremity surgeries. These advantages can be listed
      as protecting the patient's consciousness, minimum effect on breathing, reducing airway
      interventions, enabling long-term postoperative pain control, reducing opioid-related side
      effects, limiting metabolic and endocrine changes due to surgery, and early discharge of
      hospital. The supraclavicular approach has a rapid onset of block and a high success rate.
      Close proximity to the pleura is the main disadvantage, but the widespread use of USG in
      peripheral blocks has also reduced the risk of complications related to this proximity. In
      the selective truncus approach defined by Manoj Kumar Karmakar in 2020, three trunks of the
      brachial plexus can be identified separately and selectively blocked under ultrasound
      guidance. It has been suggested that sensory/motor block occurs in all ipsilateral upper
      extremity dermatomes except T2 by selective blocking of the upper, middle, and lower trunks.
      In this study, the selective trunk method and the supraclavicular method will be compared.

      Patients who will undergo upper extremity elbow and below-elbow surgery in the orthopedics
      and traumatology operating room will be included in the study. The primary aim of the study
      is to compare the success rates of supraclavicular and selective truncus blocks in patients
      scheduled for hand, wrist, forearm, and elbow surgery. Comparisons will be made by measuring
      the first analgesic time after surgery. Secondary aims are sensory and motor block success
      rates between the two methods. The block application time, preparation time for surgery,
      number of needle insertions, tourniquet pain, diaphragmatic paralysis rate, complications
      (vascular puncture, paresthesia, horner's syndrome, hoarseness, local anesthetic toxicity,
      pneumothorax) patient satisfaction, surgeon satisfaction and total analgesic amount at the
      end of the postoperative 12 and 24 hours will be recorded.
    

Intervention name(s): Upper extremity surgery
Intervention type(s): Procedure
Intervention description(s): Comparison of 2 different peripheral nerve blocks
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Orthopedic surgery patients between 18-65 years of age who needs upper extremity elbow and
        below-elbow surgery
      
Keywords: nerve block; Pain, Postoperative; Anesthetics, Local
A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as
      monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.
    

Detailed description: 
      This trial is designed to assess the efficacy, safety and tolerability of flexible dose
      brexpiprazole as monotherapy or as combination therapy with Zoloft (Sertraline) in adult
      participants with PTSD.

      This study will consist of a continuous 12-week, double-blind treatment period with a 14-day
      follow-up.
    

Intervention name(s): Brexpiprazole; Sertraline; Brexpiprazole Matching Placebo; Sertraline Matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Brexpiprazole oral tablets.; Sertraline oral capsules.; Brexpiprazole matching placebo oral tablets.; Sertraline matching placebo oral capsules.
Other intervention name(s): OPC-34712; OPC-331; Zoloft
Intervention MeSH terms: Sertraline; Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sleep Enhancing Tools: Pilot Study
Condition: Sleep; Pain
Study type: Interventional

Summary: 
      To demonstrate whether use of sleep enhancing aids (face mask, ear plugs or white noise
      machine) in hospitalized patients can positively affect subjective symptoms of sleep quality,
      fatigue and pain.
    

Detailed description: 
      A randomized, clinical pilot to trial the effect of sleep tools on patients' perception of
      sleep within the hospital setting.

      We propose to conduct this pilot study to improve subjective symptoms of sleep deprivation in
      non-ICU hospitalized subjects by performing a brief intervention, easily performed at the
      point of care. Given the heterogeneity of hospitalized patients with varying ages,
      co-morbidities and other factors (such as pain and fatigue), we felt that an initial pilot
      study should focus on acceptability of three sleep aids (ear plugs, eye masks and white noise
      machine) among hospitalized non-ICU patients. Patients will be able to choose which aid they
      use and will be allowed to change aids during their hospital stay.

      The primary outcomes of this study will be 1) improvement in perceived sleep quality as
      measured by PROMIS, a validated patient-reported outcome information system and 2) quality of
      care measures (length of stay, medication use and participation in therapy sessions).

      PROMIS (Patient Reported Outcomes Measurement Information System) is an NIH sponsored health
      survey tool.

      Information on characteristics (both patient and environment) including demographics, illness
      severity, number of medications, specific medications (such as sedatives and pain
      medications) will be collected to examine which predictors of improved perception of sleep
      quality correlate with use of sleep aids. This study is intended to focus on modifying the
      environment at the patient level rather than addressing the sources of environmental hospital
      noise.

      Our study has the potential to impact this field with a preventative education based
      intervention, using simple tools in the non-ICU setting. It is important to understand this
      is not a study measuring sleep objectively but whether hospitalized patients perceive they
      sleep better if sleep aids are used.
    

Intervention name(s): Sleep Education Presentation; Sleep Tool Demonstration
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep WITHOUT a demonstration of tools to improve sleep.; Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep PLUS a demonstration of tools to improve sleep.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: survey
Clinical Proof-of-concept Study for the Combination BAY60-4552 / Vardenafil for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 Inhibitors
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This study examines the efficacy and safety of the combination treatment BAY60-4552 plus
      vardenafil in patients with erectile dysfunction, who do not sufficiently respond to therapy
      with PDE5 (Phosphodiesterase 5) inhibitors.

      Patients meeting the entry criteria, will receive vardenafil alone in the first four weeks of
      the study to assess the effect of PDE5 inhibitor therapy given alone.

      Patients with an insufficient therapeutic response to vardenafil alone will enter the next
      part of the study, and will be randomly assigned to one of 3 treatments. There is a 1 in 3
      chance of receiving either the combination BAY60-4552 plus vardenafil, or vardenafil alone,
      or placebo. Neither patient nor the treating physician will know which treatment is given
      (double-blinded design).This part of the study will last four weeks Patients will have to go
      to the clinic/hospital for 7 visits during the 8 weeks.
    


Intervention name(s): BAY60-4552 plus Vardenafil; Vardenafil; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment with 3 tablets once daily for 4 weeks (Vardenafil 10 mg plus BAY60-4552 1.0 mg); Treatment with 3 tablets once daily for 4 weeks (Vardenafil 20 mg); Treatment with 3 tablets once daily for 4 weeks (Placebo)
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Combination Drug Therapy; Phosphodiesterase inhibitors