bioihbjkbjnl/mcl2 huggingface dataset:
Tocilizumab as Add-On Treatment For Residual Positive, Negative, and Cognitive Symptoms of Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Neurobehavioral Manifestations; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, double-blind clinical trial of tocilizumab vs. placebo as add-on treatment for
      residual positive, negative, and cognitive symptoms in schizophrenia. The primary study
      hypothesis is that individuals receiving tocilizumab will show greater improvements in their
      PANSS total scores than those taking placebo.
    

Detailed description: 
      One of the main mediators of the effects of infection/inflammation in the human body is
      cytokines. Recent data suggest that cytokines, and in particular IL-6, may mediate the
      effects of lifetime or prenatal infection on schizophrenia risk. Preclinical models of
      schizophrenia support a convergence between a role for IL-6 in the pathophysiology of
      schizophrenia and the major neurochemical hypotheses of schizophrenia-the dopamine and
      glutamate hypotheses. Namely, IL-6 dysfunction or excess promotes schizophrenia-like
      behaviors and schizophrenia-like biochemical and electrophysiological profiles, while IL-6
      knockout or neutralization mitigates these abnormalities. Furthermore, plasma IL-6 levels are
      elevated in acutely psychotic but not treated patients, and Positron Emission Tomography
      (PET) studies have shown active inflammation in the brains of individuals with psychosis.
      Finally, treatment of individuals with schizophrenia with non-specific anti-inflammatory
      agents, such as celecoxib and aspirin, has suggested a role for anti-inflammatory agents in
      schizophrenia. These data also suggest that studies of immunologic agents that more
      specifically target the underlying pathophysiology of schizophrenia may be more efficacious.
      Tocilizumab (Actemra®) is an FDA-approved humanized monoclonal antibody against the IL-6
      receptor used for treatment of rheumatoid arthritis in individuals who have not responded to
      at least one TNF-alpha therapy and for juvenile idiopathic arthritis
    

Intervention name(s): Tocilizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 8mg/kg intravenously via iv drip over 60 min; intravenously via iv drip over 60 min
Other intervention name(s): Actemra; Saline Drip
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Omega-3 Supplementation and Attention-deficit-hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      It is assumed that only 1/5 of children diagnosed with attention-deficit-hyperactivity
      disorder (ADHD) are treated. New treatment modalities are urgently needed. Omega-3 fatty
      acids have been used in this setting, yet results are conflicting. The parent omega-3 fatty
      acid alpha-linolenic acid (ALA) has only been used in one trial. 40 children diagnosed with
      ADHD will be randomized to consume either ALA or placebo for two months. Baseline and end
      assessments will include ADHD-related questionnaires and a computerized test. The
      investigators hypothesize that ALA supplementation will prove beneficial for children with
      ADHD.
    


Intervention name(s): omega-3 fatty acid alpha-linolenic acid (ALA); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 grams of ALA-containing plant oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; methylphenidate; omega-3
Evaluation of Play and Care Together (PACT) Implementation
Condition: Resilience; Psychosocial Wellbeing; Peer Problem
Study type: Interventional

Summary: 
      This study aims to evaluate the effectiveness of PACT intervention in improving resilience,
      life skills, and psychosocial skills among children and peer supporters. The evaluation will
      be carried out in the Public Schools of Karachi, Sindh, Pakistan.
    

Detailed description: 
      Right to Play is a non-governmental organization that offers play-based life skills education
      in public schools of Pakistan. This project aim to improve psychosocial wellbeing, resilience
      and social and emotional life skills of students enrolled in secondary schools of Lyari in
      Karachi South, Sindh, Pakistan through "Play and Act Together (PACT)" curriculum. The Aga
      Khan University will evaluate effectiveness of their intervention that will be offered in
      public schools of Karachi. Data will be collected from grade 6 students(children) and grade 7
      or 8 peer supporters at baseline, midline and endline of the study. Moreover, throughout PACT
      intervention, fidelity monitoring would be ensured randomly for 3 sessions out of 10 through
      a checklist to evaluate accuracy of PACT intervention delivered. Furthermore, feasibility
      checklist would be filled by each participant at the end of the study to analyze the
      satisfaction, feasibility of PACT intervention and important learnings from PACT curriculum.
      After the intervention, focus group discussion will took place to learn about the experiences
      of children, peer supporters and adult coaches who received PACT intervention.
    

Intervention name(s): PACT Intervention
Intervention type(s): Behavioral
Intervention description(s): PACT Intervention is a group based session delivered by Peer supporters and adult coaches on PACT module. There will be 10 sessions, one per week for 90 to 120 minutes each.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The assessment will be carried out parallel in the intervention and the control arm.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Resilience among children; Life skills; Peer social behavior
Assessing Urinary Hormones in Female Cancer Survivors
Condition: Effects of Chemotherapy
Study type: Observational

Summary: 
      Women of late to mid reproductive age may participate in a study using novel methodology to
      identify subtle changes in the reproductive endocrine axis via daily urine hormone analysis,
      which may have important implications for reproduction and may signal reproductive
      senescence.
    

Detailed description: 
      Women with a reduced follicular pool either from natural aging or previous chemotherapy, may
      not have any clinical signs or symptoms and traditional measures of ovarian reserve, such as
      basal Follicle Stimulating Hormone may be within the normal range. However, there may be
      alterations in the luteal or follicular phases(shortened follicular phase and luteal
      insufficiency) due to compromised follicle competency and alterations in the H-P-O axis.
      Therefore this aim uses novel methodology to identify subtle changes in the reproductive
      endocrine axis which may have important implications for reproduction and may signal
      reproductive senescence. Compared to yearly follicular measures of reproductive hormones,
      daily urine hormone analysis provides a more integrative assessment.

      Three groups of subjects will be recruited:

      Group 1: Otherwise healthy, mid-reproductive aged women between the ages of 20 and 35 years
      previously exposed to high dose alkylating agent therapy (or have an alkylator score of 1 or
      more), and at least 1 year from cancer treatment.

      Group 2: healthy, mid-reproductive aged women between the ages of 20 to 35 who have not been
      exposed to cancer therapy.

      Group 3: healthy, late reproductive aged women between the ages of 43-50 who have not been
      exposed to cancer therapy, nor have a history of infertility.

      Subjects in all groups must have regular menstrual cycles every 21-35 days, and have a uterus
      and both ovaries. Each participant will complete daily urinary collections for 2 menstrual
      cycles to assess reproductive hormones. The ultimate goal of this work is to better estimate
      the reproductive window, or time to menopause.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Regularly menstruating postmenarchal, mid-reproductive aged female cancer patients
             treated with high dose alkylating agent chemotherapy or with an alkylator score of 1
             or more.

          -  Unexposed, regularly menstruating mid-reproductive aged women, and unexposed,
             regularly menstruating late reproductive aged women.
      
Biospecimen description: 
      daily urinary collections for 2 menstrual cycles
    
Keywords: fertility; hormones; healthy; chemotherapy; oncofertility; alkylating agent; fertility after cancer; late effects; survivorship; healthy volunteers; perimenopause; middle age
COMPARISON OF THE PERCEPTION OF PAIN BETWEEN ORTHODONTIC TREATMENT WITH Invisalign ® AND TREATMENT WITH BRACKETS
Condition: PAIN
Study type: Observational

Summary: 
      This study aims to compare the pain experienced by patients undergoing orthodontic treatment
      with Invisalign ® corrective aligners with that of patients undergoing orthodontic treatment
      with conventional braces. Because the aligners are removable, nearly invisible and don't
      involve metal that can irritate teeth and gums, we are expecting less pain in the Invisalign
      Treatment and less affectation of the quality of life.
    

Detailed description: 
      The aims of the study are to determine:

      the presence of pain, the magnitude of pain, the duration of pain, and the location of pain.

      The hypotheses of this study are:

        -  Treatment with Invisalign ® aligners result in less pain than the braces

        -  Treatment with Invisalign ® aligners result in less irritation to the soft tissues with
           braces

        -  Pain should increase each time the aligners are put in the mouse and decrease until
           disappearing on the third day.

        -  The quality of life will be most affected by treatment with braces than with Invisalign
           ®.

        -  Null Hypothesis: There is no difference at all points between the two treatments.
    

Intervention name(s): Invisalign
Intervention type(s): Device
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients are recruited from the Department of Orthodontics at the University of Montreal.
      
Keywords: PAIN; ORTHODONTIC TREATMENT; INVISALIGN
The Effect of Hippotherapy Simulator in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Hippotherapy simulators imitate the passive movements of the horse, producing simple
      movements similar to those of the horse. Hippotherapy simulators are intended to improve
      sitting balance, postural control and trunk balance.

      The aim of this study was to research the therapeutic effects of hippotherapy simulator on
      sitting balance, trunk control and upper extremity skills in individuals with Cerebral Palsy
      (CP).
    

Detailed description: 
      Spastic CP will be participate the study between the ages of 4 and 18 years. Children's
      classified with GMFCS and MACS.

      The eligible participants will be allocated two groups, including hippotherapy simulator
      training group and traditional physiotherapy control group. All the assessments will be
      performed before and after the training in the 8-week training groups.

      The control group individuals will be given a traditional physiotherapy two days per week for
      a total of 8 weeks (traditional physiotherapy session will last 45 minutes). Hippotherapy
      simulator training group will receive a traditional physiotherapy and hippotherapy simulator
      training, two days a week for a total of 8 weeks (30 minutes traditional physiotherapy
      session+15 minutes hippotherapy simulator training). All sessions will be performed in the
      clinic with the specialist physiotherapist.
    

Intervention name(s): Hippotherapy simulator training; Traditional physiotherapy
Intervention type(s): Other; Other
Intervention description(s): Hippotherapy simulator training will be designed for the individual basis.; Traditional physiotherapy within a specific program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral palsy; Hippotherapy simulator
Effects of Two Hypocaloric Diets on Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The investigators evaluated whether an energy-restricted protein diet with low glycaemic
      index carbohydrates and soluble fibers (LC-P-LGI) would be more effective than a conventional
      diet (LC-CONV) on weight-loss and related metabolic variables.
    

Detailed description: 
      The subjects (9 men and 5 post-menopausal women) were randomly allocated, in a cross-over
      design, to two periods of 4 weeks of an energy restricted diet of 1200 kcal as either a
      conventional diet (LC- CONV) or a special energy restricted diet compensated by proteins
      (LC-P-LGI). The two nutritional periods were separated by a wash-out interval of 8 weeks.
      Before the start of the study, all subjects were instructed to maintain their usual lifestyle
      during the experimental period.Anthropometric parameters, glucose and lipid homeostasis and
      inflammatory markers were evaluated before and after each dietary period.Body fat and
      fat-free mass distributions were measured by a dual-energy X-ray absorptiometry (DXA, GE
      Lunar Prodigy Corporation, Madison, WI, USA) before and after each dietary period at the
      fasting state.
    

Intervention name(s): LC-P-LGI diet; LC-CONV
Intervention type(s): Other; Other
Intervention description(s): a hypocaloric diet low in lipids (25%) which is compensated by proteins (35%) with no change in carbohydrate content.; 4-week CONV period consisted in the subjects' consumption of 1200 Kcal/ day (25% protein, 31% lipids, 44% carbohydrates).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: obesity; dietary treatment; high protein diet; Low glycaemic index; adipocytes; fat mass; systemic inflammatory markers; improvement of complications; effect on weight loss
sCD163 and sMR in Wilsons Disease - Associations With Disease Severity and Fibrosis
Condition: Wilsons Disease
MeSH terms: Hepatolenticular Degeneration
Study type: Interventional

Summary: 
      The aim is to investigate macrophage activation markers and correlations to liver fibrosis in
      patients with Wilsons Disease. Researchers wish to investigate associations to neurologic and
      metabolic liver function. Researchers will assess this by comparing blood samples with
      fibrosis and liver function analyses. This study provides new insight into macrophages and
      their involvement in Wilsons Disease.
    


Intervention name(s): Fibroscan; Ultrasound; Galactose; Liver biopsy; Functional hepatic nitrogen clearance
Intervention type(s): Procedure; Procedure; Drug; Procedure; Procedure
Intervention description(s): Liver fibrosis will be determined using fibroscan, and reported as changes in the amount of fibrosis in the liver. The fibroscan is a non-invasive procedure; Ultrasound is a non-invasive procedure; Galactose elimination capacity is performed to evaluate metabolic liver function.
The metabolic liver function test galactose elimination capacity requires a 6-hour fast, the infusion of galactose, blood sampling from the ear lobe, and collection of urine for 4 hours.; Histological disease activity at time of diagnosis evaluating if any liver fibrosis; Functional hepatic nitrogen clearance to evaluate metabolic liver function Functional hepatic nitrogen clearance requires a 12-hour fast, two venflons, the infusion of alanine, and urine sampling for 4 hours
Other intervention name(s): Galactose elimination capacity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: sCD163; liver cirrhosis; disease severity
Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) Glaucoma Drainage Implant
Condition: Primary Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      To assess the safety and performance of the MIDI Arrow in patients suffering from glaucoma
      that is inadequately controlled on maximum tolerated medical therapy with intraocular
      pressure ≥ 18 mm Hg and ≤ 40 mm Hg
    

Detailed description: 
      This will be a monocentric, non-randomized, single arm clinical study in which each patient
      meeting the inclusion criteria and not excluded per the exclusion criteria will be implanted
      with a MIDI Arrow in the anterior chamber of the eye. Patients will be followed for at least
      24 months with an expected enrollment period of up to 24 months. Safety of the shunt will be
      evaluated with indirect and direct microscopic evaluation of the implanted and non-implanted
      eyes pre and post operatively, and at defined follow-up intervals for hypotony, inflammation,
      infection, migration of the shunt, visual acuity, as well as a number of other defined
      potential complications. The effectiveness of the shunt will be evaluated by measurement of
      intraocular pressure at defined intervals.
    

Intervention name(s): MIDI Arrow
Intervention type(s): Device
Intervention description(s): Implantation of MIDI Arrow
Other intervention name(s): Glaucoma drainage device implantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Safety, Tolerability and PK of NPT520-34 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the PK, safety and tolerability of orally administered NPT520-34 in healthy
      subjects at single and multiple doses that may be therapeutically relevant.
    


Intervention name(s): NPT520-34 (125 mg); Placebos (125 mg)
Intervention type(s): Drug; Drug
Intervention description(s): NPT520-34, 125 mg oral capsules (size 1); Placebo, 125 mg oral capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 1; Safety; Tolerability; Pharmacokinetics; Parkinson's Disease; Amyotrophic Lateral Sclerosis
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this expanded access program (EAP) is to provide expanded access to esketamine
      treatment and collect additional safety data and quality of life until esketamine is
      commercially available for participants with Treatment-Resistant Depression (TRD).
    


Intervention name(s): Esketamine
Intervention type(s): Drug
Intervention description(s): Participants will receive esketamine at doses of either 56 mg or 84 mg intranasally once or twice a week based on the investigator's clinical judgment.
Other intervention name(s): JNJ-54135419
Intervention MeSH terms: Esketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)
Condition: Posttraumatic Stress Disorder; Depression; Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness of group psychotherapy designed
      specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder
      (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily
      routine.
    

Detailed description: 
      The purpose of this study is to test the effectiveness of a group psychotherapy designed
      specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder
      (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily
      routine. We will compare two group therapies, one of which has been examined in previous
      studies for veterans with PTSD. Both group therapies have been shown to reduce symptoms of
      anxiety and depression in some veterans. However, neither group therapy has been proven to be
      more effective than treatment as usual for PTSD.
    

Intervention name(s): Cognitive Behavioral Social Rhythm Group Therapy; Present Centered Group Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 weeks, 2h structured group therapy; 12 weeks, 2h relatively unstructured group therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Posttraumatic Stress Disorder; Depression; Sleep Initiation and Maintenance Disorders; Insomnia; Psychotherapy, Group; Cognitive Behavioral Therapy; Randomized Controlled Trial; Veterans; Social Rhythms
An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 2

Summary: 
      An open label exploratory study designed to evaluate the safety, efficacy, and
      pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin
      receptor type 2 biased agonist) in subjects with acromegaly that are treated with
      somatostatin analogue (SSA) based treatment regimens.
    


Intervention name(s): Paltusotine
Intervention type(s): Drug
Intervention description(s): Paltusotine, capsules, once daily by mouth
Other intervention name(s): CRN00808
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acromegaly; ACROBAT; EDGE; Paltusotine