bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Effects of Urotensin-II and Soluble Epoxide Hydrolase Inhibitors on Skin Microvessel Tone in Patients With Heart Failure, and in Healthy Volunteers
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      Urotensin II (U-II) is newly discovered protein that may play an important role in human
      health and disease. U-II has been found to be a potent vasoconstrictor (narrower of blood
      vessels) which therefore may be involved in important diseases such as chronic heart failure
      - CHF (weak heart muscle disease). Many vasoconstrictors have been found to have effects on
      key organs such as the heart. Preliminary data by our group have demonstrated this is true of
      U-II. Recent evidence shows that in CHF, U-II levels in the blood are increased.

      The proposed study seek to determine the effect of blocking a possible downstream mediator of
      U-II on blood vessels by administration of soluble epoxide hydrolase inhibitor (sEHI). There
      will be 2 study groups 1) Healthy volunteers and, 2) CHF patients.

      Each arm of the study will run independently and will require 16 participants each (16 normal
      subjects and 16 CHF subjects). Participants will be screened to ensure that they are
      eligible. CHF patients will be required to withdraw from their CHF medication 24 hours prior
      to the study day (except for diuretics). On the study day, sEHI will be administered on the
      skin of participants in 3 asceding dosages. The technique to be used is iontophoresis. This
      is a non invasive technique in which a small amount of the compound is placed on the skin of
      the forearm. The drug is delivered across the skin by passing a small electric current over
      the area. The change in blood flow is then measured and analysed. We will also administer
      U-II agonist, noradrenaline, and distilled water (all via iontophoresis). Noradrenaline will
      be used a positive constrictor control. Change in blood flow will be assessed by Laser
      Doppler Velocimetry.

      If it is found that the sEHI is able to prevent blood vessel constriction in CHF patients,
      then it may represent a major therapeutic advance in the management of CHF.
    


Intervention name(s): Urotensine II; Soluble epoxide hydrolase
Intervention type(s): Drug; Drug
Intervention description(s): A few drops of the drug will be administered to the skin by iontophoresis.; A few drops of the drug will be administered to the skin by iontophoresis.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Urotensin II; Soluble epoxide hydrolase; Iontophoresis; Healthy volunteers
Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The loss of motivation has emerged as a critical symptom in schizophrenia that is
      consistently linked to functional disability for affected individuals. Despite advances in
      treatment, there have not emerged any effective treatments for this loss of motivation, which
      ultimately hinders our ability to promote recovery for individuals with schizophrenia. To
      address this critical unmet therapeutic need, this study aims to investigate a novel
      computerized motivation rehabilitation program using virtual reality to treat motivation loss
      in schizophrenia.
    

Detailed description: 
      Motivational deficits have emerged as a critical determinant of functional disability in
      schizophrenia (SZ). Despite significant advances in our understanding and treatment of the
      illness, effective therapeutic strategies for motivational deficits have remained elusive.
      This has ultimately hindered our ability to promote recovery for individuals with SZ so that
      they can return to their premorbid level of functioning. An emerging therapeutic approach in
      SZ has utilized computerized remediation strategies, with recent efforts focused on cognitive
      deficits. To date, however, such a therapeutic strategy has not been developed for the
      critical motivational deficits in SZ. In light of the detrimental functional consequences of
      motivational deficits in SZ, there is a clear need for effective therapeutic strategies for
      the treatment of these motivational deficits experienced by affected individuals. To address
      this unmet therapeutic need, this pilot therapeutic trial will investigate the efficacy of a
      novel virtual reality-based motivation rehabilitation program in schizophrenia.
    

Intervention name(s): VR Motivation Training
Intervention type(s): Behavioral
Intervention description(s): Computerized treatment with a virtual reality-based motivation training program, administered for 1 hour per week for 8 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual Reality; Negative Symptoms
Cyrotherapy vs. APC in GAVE
Condition: Watermelon Stomach
MeSH terms: Gastric Antral Vascular Ectasia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To see if either method of treatment for Watermelon Stomach shows better results
    

Detailed description: 
      Watermelon stomach (WS) is endoscopically recognized by characteristic stripes of
      angioectasias involving primarily the antrum, and causes transfusion-dependent anemia in the
      majority of patients. Current endoscopic treatment options, including argon plasma
      coagulation (APC) Endoscopic cryotherapy is a novel technique that has the potential to
      safely and more effectively treat WS by virtue of its mechanism of injury and mode of
      application.
    

Intervention name(s): cryotherapy; Argon Plasma Coagulation
Intervention type(s): Procedure; Procedure
Intervention description(s): The Polar Wand device (GI Supply, Wayne, PA) is FDA 510(k) approved for endoscopic tissue ablation in the GI tract. It consists of a portable cryogen-containing unit and a single-use flexible cryogen spray catheter, designed for use with CO2 that is supplied in standard 20-lb cylinders. Controlled delivery of the cryogen is achieved by a foot pedal, and the tip of the catheter is maintained at about 1 cm from the mucosa. A cryogenic spray is applied to all vascular lesions until a whitened appearance of the mucosa is achieved within 3-5 seconds. Affected areas will be 'painted' by the spray catheter starting at the pylorus and sweeping proximally.
A proton pump inhibitor, at double dose, will be prescribed for 1 month after each APC or cryotherapy session to promote mucosal healing post therapy.; As per current clinical standard, the APC 300 device (ERBE Inc., Marietta, GA) will be used in this study. Targeted ablation of all vascular ectasias as best possible will be performed in standard fashion using an end-firing probe at a setting of 60 W and 2 L/min argon flow rate.A proton pump inhibitor, at double dose, will be prescribed for 1 month after each APC or cryotherapy session to promote mucosal healing post therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Watermelon Stomach; Cryotherapy; Argon Plasma Coagulation
Effect of MET on Meralgia Paraesthesia Postpartum "Muscle Energy Technique"
Condition: Meralgia Paresthetica; Femoral Neuropathy
MeSH terms: Paresthesia; Femoral Neuropathy
Study type: Interventional

Summary: 
      To investigate the effect of muscle energy technique on Femoral meralgia paraesthesia in a
      postpartum female. BACKGROUND: meralgia paraesthesia is one of the serious disorders in the
      postpartum female which results in pain and less physical activities.

      ………HYPOTHESES:

      This study hypothesized that:

      muscle energy technique will have a significant effect on Femoral meralgia paraesthesia in
      postpartum female
    

Detailed description: 
      Thirty meralgia paraesthesia postpartum females will participate in this study.

      The patients will randomly be divided into two equal groups; the control group received the
      conventional selected exercise program and the study group received the same exercise
      training program in addition to muscle energy technique, three times per week for four weeks.

      The evaluation methods by Femoral nerve conduction velocity will be measured via the
      Neuropack S1 MEB9004 EMG device before the exercise program and after finishing the exercise
      program, and also the Pelvic compression test and Pain numeric rating scale
    

Intervention name(s): muscle energy technique; conventional selected physical therapy
Intervention type(s): Other; Other
Intervention description(s): the patient was supine and the therapist fix the lower limb of the affected side then ask the patient to perform isometric contraction for abductors maintained for 3-5 seconds, then the patient was instructed to stop, exhale and relax then the therapist perform further adducted the patient's knee of the affected side as a stretching exercise for Three to five repetitions of these directions were performed.; life style modification
Transcutaneous electrical nerve stimulation (TENS)
Flexibility stretching exercises to the hip flexors
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: the control group received the conventional selected exercise program and the study group received the same exercise training program in addition to muscle energy technique
Masking: None (Open Label)
Primary purpose: Treatment
Terlipressin in Septic Shock in Cirrhosis
Condition: Liver Cirrhosis; Septic Shock
MeSH terms: Shock, Septic; Liver Cirrhosis; Shock; Fibrosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Septic shock is a frequent and severe complication in cirrhosis. Current mortality rate
      ranges between 50 and 80% of cases. Refractory shock, hepatorenal failure and variceal
      bleeding are the main causes of death of these patients. Terlipressin administration could
      prevent these complications and improve survival in this setting.

      Aim: To evaluate the effects of terlipressin administration on hospital survival in cirrhotic
      patients with severe sepsis or septic shock.

      Methods: Prospective, open labelled, controlled trial evaluating 72 cirrhotic patients with
      severe sepsis or septic shock who will be randomized to receive terlipressin plus
      alpha-adrenergic drugs or only alpha-adrenergic drugs at shock diagnosis. Patients will be
      submitted to continuous systemic hemodynamic monitoring (S. Ganz catheter or Vigileo).
      Changes in vasoactive systems and cytokines levels will be also evaluated.
    

Detailed description: 
      Prospective, open labelled, RCT evaluating 72 cirrhotic patients with severe sepsis or septic
      shock (36 per arm) who were randomized to receive terlipressin plus alpha-adrenergic drugs or
      alpha-adrenergic drugs in the first 24h after septic shock diagnosis. Impact of terlipressin
      administration on shock reversal, changes in vasoactive systems, inflammatory response,
      incidence of variceal bleeding and type-1 HRS and ICU and hospital mortality was investigated
    

Intervention name(s): Terlipressin; alpha adrenergic drugs
Intervention type(s): Drug; Drug
Intervention description(s): Terlipressin 2-12 mg/24h intravenously in continuous infusion. Duration: until 24h after shock resolution.; Dopamine (1-20 µg/Kg/min) and/or norepinephrine (0.05-4 µg/Kg/min) until shock resolution
Other intervention name(s): Glypressin; Dopamine and/or norepinephrine
Intervention MeSH terms: Terlipressin; Dopamine; Norepinephrine; Adrenergic Agents
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Septic shock; Cirrhosis; Survival
A Study to Evaluate Efficacy, Tolerability, Pharmacodynamic and Pharmacokinetics of Multiple Oral Doses of TAK-831 in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether TAK-831 is superior to placebo in improving
      cerebellar function as measured with the average percentage of conditioned responses during
      the eyeblink conditioning (EBC) test.
    

Detailed description: 
      The drug being tested in this study is called TAK-831. TAK-831 is being tested to treat
      people with schizophrenia.

      The study will enroll approximately 32 patients. Participants will be randomly assigned to
      one of the two treatment sequences which will remain undisclosed to the patient and study
      doctor during the study (unless there is an urgent medical need):

        -  TAK-831 500 mg followed by matching placebo

        -  Matching placebo followed by TAK-831 50 mg

      The first 16 participants will receive TAK-831 500 mg during the treatment period in which
      they are assigned to TAK-831. Following an interim analysis, there will be a study-wide
      decision about whether to treat the additional 16 participants with TAK-831 500 mg during the
      active treatment period to or treat them with TAK-831 50 mg during this period. After the
      interim analysis, the participant and study doctor will not be aware of which TAK-831 dose is
      being used.

      This single center trial will be conducted in United States of America. The overall time to
      participate in this study is approximately 81 days. Two treatment periods will be
      administered for 8 consecutive days, separated by a 14 to 21-day washout. Participants will
      be admitted to the clinic for two overnight stays at the beginning of each treatment period
      and one night at the end of each treatment period. After the second treatment period, a final
      follow-up safety assessment visit will be conducted approximately 10 to 14 days after the
      last administration of study drug.
    

Intervention name(s): Luvadaxistat; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-831 Tablets.; Matching Placebo Tablets.
Other intervention name(s): TAK-831
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Anxiety Intervention for Preschool Children With ASD
Condition: Anxiety Disorder; Autism Spectrum Disorder
MeSH terms: Anxiety Disorders; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This study evaluates the feasibility, acceptability, and preliminary efficacy of a treatment
      program for anxiety in preschool children with autism spectrum disorder.
    

Detailed description: 
      Anxiety is highly prevalent in individuals with ASD with lifelong impact. In this population,
      anxiety often emerges when children are very young, yet there are no evidence-based
      treatments for this age group. Cognitive-behavioral treatment (CBT) successfully reduces
      anxiety levels in young, typically developing children and older children with ASD. This
      study pilots the DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR)
      program, which is an integrated treatment program that utilizes CBT modified for young
      children with ASD. The treatment includes heavy doses of parent training to reduce
      accommodation of the child's anxiety symptoms and interventions targeting fear of
      uncertainty, a common fear in children with ASD. The feasibility, acceptability, and
      preliminary efficacy of this treatment program will be studied.
    

Intervention name(s): DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR)
Intervention type(s): Behavioral
Intervention description(s): DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR) - a parent-mediated cognitive-behavioral treatment modified for young children with ASD
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 randomized, double-blind, placebo-controlled, 3-arm, parallel design study
      to evaluate the efficacy and safety of VX-150 in treating acute pain following bunionectomy.
    


Intervention name(s): VX-150; HB/APAP; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants received VX-150 1500 milligram (mg) as first dose, followed by VX-150 750 mg dose every 12 hours (q12h) for 2 days.; Participants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days.; Participants received placebo matched to VX-150 and HB/APAP for 2 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Multiple Dose Effect of Oxytocin on Males With High or Low Trait Anxiety
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To examine whether multiple doses of oxytocin have different effects on behavior and neural
      indices in males with high or low trait anxiety.
    

Detailed description: 
      In the present study, healthy male subjects' trait anxiety levels will be assessed by the
      sub-trait inventory of the State-Trait Anxiety Inventory (STAI). According to subjects' trait
      anxiety scores, they will be divided into high or low anxiety experimental groups.

      Next, experiments will investigate the acute effect (single dose) and chronic effect (3 doses
      or 5 doses) of oxytocin on brain functional connectivity during resting-state and brain
      activation in response to watching emotional stimuli using functional magnetic resonance
      imaging (fMRI). Also the brain structure data (T1 and diffusion tensor imaging, DTI) of
      subjects will be collected. After finishing the scanning tasks, subjects will be required to
      rate the emotional valence, intensity and arousal of the pictures shown in the scanner.

      During the course of the study subjects will complete a number of questionnaires: Empathy
      Quotient (EQ), Cheek and Buss Shyness scale (CBSS),Interpersonal Reactivity Index
      (IRI),Childhood Trauma Questionnaire (CTQ),Beck depression inventory (BDI), State-Trait
      Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale
      (LSAS),Positive and Negative Affect Schedule (PANAS),d2 attention test, and the Visual
      Analogue Scale for anxiety.
    

Intervention name(s): Oxytocin nasal spray; Placebo nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal administration of oxytocin 24 international units per dose.; Intranasal administration of placebo 24 international units per dose.
Other intervention name(s): Oxytocin treatment; Placebo control
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: multiple doses; oxytocin; trait anxiety
Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      The purpose of this observational study is to broaden the knowledge of the known safety and
      efficacy profile of Keppra® (Levetiracetam) oral solution in epileptic infants younger than
      12 months when treated according to routine clinical practice. Their data will be collected
      until they reach the age of 13 months.
    

Detailed description: 
      This non-interventional sentinel sites post-authorization safety study (PASS) aims to collect
      additional data on use of Keppra® (Levetiracetam) oral solution in clinical practice, and on
      efficacy and safety of Keppra® (Levetiracetam) in infants younger than12 months. Epileptic
      patients between the age of 1 month and 11 months inclusive can be invited for participation
      to the non-interventional sentinel sites PASS, after the physician has decided to initiate
      therapy with Keppra® (Levetiracetam) oral solution (100 mg/ml bottle) and patient has so far
      been treated with Keppra® (Levetiracetam) for no longer than 10 days. The patients will be
      followed and their data will be collected until they reach the age of 13 months.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients coming to day clinic for consultation by specialist
      
Keywords: Levetiracetam; Keppra® Oral Solution; Keppra® in Children
Water-based Versus Land-based Exercise for Breast Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Physical activity and exercise have demonstrated to be an integral part of the
      cancer-continuum care. Despite strong evidence suggesting that both endurance and strength
      training should be encourage in cancer patients, there is still controversy regarding
      exercise dosage, frequency, volume and optimal environment of delivery. In this randomised
      controlled trial we aim to compare water-based versus land-based exercise in breast cancer
      survivors to decrease cancer-related fatigue (CRF), improve Health-Related Quality of Life
      (HRQoL), exercise tolerance, muscle strength and physical activity levels.
    


Intervention name(s): Water-based Exercise Group; Land-based Exercise Group
Intervention type(s): Other; Other
Intervention description(s): The intervention consist will of a water-based exercise protocol; The intervention will consist of a land-based exercise protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise Therapy; Aquatic Therapy; Health-Related Quality of Life; Cancer-related Fatigue; Exercise Tolerance; Physical Activity