bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Working Memory Training in Children With Attention-Deficit/Hyperactivity Disorder
Condition: Attention Deficit Disorder With Hyperactivity; Psychophysiology
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Previous studies indicated that children with attention-deficit/hyperactivity disorder (ADHD)
      often suffer from deficits in executive function, such as attentional control, inhibition,
      and working memory. One of these executive functions, working memory, plays a critical role
      in academic performance and classroom behavior. Working memory is essential for performing
      complex cognitive tasks such as comprehension, learning, and reasoning. Several studies have
      shown that training of working memory has positive effects for ADHD and other cognitive
      disorder in children. However, transfer effects across studies appear to be variable and
      inconsistent. Event-related potentials can be a useful tool to gain insights into such
      mechanism. Therefore, the aim of the present study is to investigate both near and far
      transfer effects of N-back training in children with ADHD. In addition, the recording and
      analysis of event-related potentials will be adopted while children with ADHD perform the
      complex visuo-spatial and phonological working memory tasks.
    


Intervention name(s): Working memory training; perceptual training
Intervention type(s): Other; Other
Intervention description(s): n-back training program; visual-perceptual training program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of Different Treatments for Overactive Bladder Syndrome
Condition: Overactive Bladder; Overactive Bladder Syndrome; Overactive Detrusor
MeSH terms: Urinary Bladder, Overactive; Syndrome
Study type: Interventional

Summary: 
      This study aims to investigate the effects of pelvic floor muscle exercises, electrical
      stimulation and taping in patients with overactive bladder
    


Intervention name(s): Pelvic Floor Exercise Group; Kinesio tape; Electrical stimulation
Intervention type(s): Other; Other; Other
Intervention description(s): The exercise program will be tailored according to the pelvic floor muscle strength, including fast and slow contractions. The number and duration of exercises will be increased according to progress..; Kinesio tape application will be performed by ligament technique to the sacral region.; External electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pelvic Floor Muscle Exercise; Kinesio taping; Electric Stimulation
A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study was to investigate long-term safety of risankizumab (BI
      655066/ABBV-066) in participants with moderately to severely active Crohn's disease who
      showed a clinical response or remission on previous treatment with risankizumab in Study
      NCT02031276 (BI trial 1311.6/ AbbVie M15-993) and were now receiving long-term treatment.
      Additional objectives of this study were to further investigate long-term efficacy,
      tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of risankizumab.
    

Detailed description: 
      This was a single group, open-label long-term extension study that assessed the long-term
      safety, efficacy, and pharmacokinetics of risankizumab in participants with moderately to
      severely active Crohn's disease. This study was terminated early by AbbVie to enable
      participants who completed the study to rollover into Study NCT03105102 (AbbVie M16-000
      Sub-Study 3 [Phase 3 OLE study]) for further OLE treatment within the Phase 3 program, which
      allows for risankizumab dose escalation if needed.
    

Intervention name(s): Risankizumab 600 mg IV; Risankizumab 180 mg SC
Intervention type(s): Drug; Drug
Intervention description(s): Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained; Maintenance treatment every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who re-gained their clinical response following the re-induction treatment could continue with maintenance treatment beginning at Visit 5.
Other intervention name(s): BI 655066; ABBV-066; BI 655066; ABBV-066
Intervention MeSH terms: Antibodies, Monoclonal
Intervention model: Single Group Assignment
Intervention model description: Participants with clinical response or remission at the end of Study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993) or at screening for this study were rolled over directly into this study and received maintenance therapy of risankizumab 180 mg administered subcutaneously (SC) every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who lost response or remission between the completion of Study NCT02031276 and enrollment in this study received open-label intravenous (IV) re-induction treatment with risankizumab consisting of 3 infusions of 600 mg IV every 4 weeks (q4w), after which eligibility was assessed if clinical response was re-gained. If clinical response or remission was achieved, participants continued with maintenance treatment of risankizumab 180 mg SC q8w beginning at Visit 5.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ABBV-066; BI 655066; Risankizumab
Clinical Assessment of Insulin Fast Dissolving Film in Treatment of Post Infection Anosmia
Condition: Anosmia
MeSH terms: Anosmia
Study type: Interventional
Phase: Phase 2

Summary: 
      The study aimed to investigate the efficacy of insulin in a new dosage form ( fast dissolving
      film) in treatment of anosmia in patients post infested with Covid-19. The study implication
      based in two methods evaluations

        1. Threshold test

        2. identification test.
    

Detailed description: 
      This study was designed to improve smell disorders after corona infection that is very
      anxious for all patients.

      Inclusion criteria were loss of smell, post covid-19 infection, age from 18 to 70 years and
      accept sharing and follow up.

      The application of dosage form by ENT specialist at otorhinolaryngology clinic at Minia
      University hospital. Dose was 100iu of insulin 3 times weekly for 4 weeks. The new dosage
      form with insulin was compared with a placebo to ensure statistical improvement.

      The tests were performed in each visit. Primary outcome was the improvement of smell sensors
      in those patients
    

Intervention name(s): Insulin film; Fast dissolving film
Intervention type(s): Combination Product; Device
Intervention description(s): Insulin suspension vials; Fast dissolving film
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A Study to Evaluate the Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced NSCLC
Condition: Advanced Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability
      and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with
      recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in
      subjects with advanced lung cancer.
    


Intervention name(s): IBI939; Sintilimab
Intervention type(s): Biological; Biological
Intervention description(s): IBI939 injection; Sintilimab injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Atkins Diet for Difficult-to-Control Headaches in Teenagers
Condition: Chronic Daily Headache
MeSH terms: Headache Disorders; Headache
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 3-month pilot study of 10 adolescents with chronic daily headache. Teens will be
      placed on a modified Atkins diet and followed with 2 subsequent visits to assess for headache
      improvement.
    

Detailed description: 
      Patients are placed on the diet and followed with various measures for 3 months. If the diet
      is helpful it is continued. Patients are still being enrolled as of 9/6/06.
    

Intervention name(s): Modified Atkins diet
Intervention type(s): Behavioral
Intervention description(s): 15 grams of carbohydrates per day - high fat diet
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: headache; Atkins; ketosis; intractable
Photocil (Topical) for the Treatment of Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B
      (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from
      non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light
      in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the
      safety and efficacy of Photocil in the treatment of atopic dermatitis.
    

Detailed description: 
      NB-UVB phototherapy is a common treatment for patients with atopic dermatitis, and has been
      reported to be safe and effective in numerous clinical trials. Clinical trials have reported
      achievement of Atopic Dermatitis Area Severity Index (ADASI)-75 in 50-70% of patients after
      4-6 weeks of NB-UVB treatment.

      Many drawbacks limit patients compliance, access, and acceptance of traditional NB-UVB
      phototherapy. The strict treatment regimen (2-3 sessions per week for an average of 12 weeks
      or more) performed at a specialized phototherapy clinic combined with high cost and low or no
      reimbursement make compliance and access a major drawback.

      In order to address the drawbacks of phototherapy, we developed a novel topical cream -
      Photocil - that selectively delivers NB-UVB therapy when exposed to sunlight. When used with
      natural sunlight, Photocil provides a convenient alternative to traditional clinic based
      phototherapy; thus, has the potential to dramatically increase patient compliance and
      treatment outcome.
    

Intervention name(s): Photocil for Atopic Dermatitis; Placebo - Sunscreen (SPF 2)
Intervention type(s): Drug; Other
Intervention description(s): Photocil for Atopic Dermatitis; Placebo - Sunscreen (SPF 2)
Other intervention name(s): Photocil for Atopic Dermatitis (U.S. FDA NDC: 54841-001-01)
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Tenofovir Abacavir Platelet Activation Study
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      Some but not all observational studies have found that current exposure to abacavir is
      associated with increased risk of cardiovascular events such as myocardial infarction, stroke
      and cardiovascular death. This study aim to investigate possible adverse effect of abacavir
      on platelet reactivity, coagulation and endothelial activation in HIV-1 infected patients.
      The study is an open-labeled cross-over trial, where patients receiving antiretroviral
      therapy containing abacavir switch treatment to a regimen containing tenofovir and vice versa
      for a period of 90 days.
    


Intervention name(s): abacavir (600 mg QD); tenofovir (245 mg QD)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tenofovir; Abacavir
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIV-1; Abacavir; Platelet activation; Thromboelastography; Coagulation
Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART133
Condition: Liver Cancer; Pancreatic Cancer; Brain Tumor; Breast Cancer; Ovarian Tumor; Colorectal Cancer; Acute Myeloid and Lymphoid Leukemias
MeSH terms: Leukemia, Lymphoid; Ovarian Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory
      into patient autologous or donor-derived T cells may make the body build immune response to
      kill cancer cells.

      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in
      treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.
    

Detailed description: 
      I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced
      with the anti-CD133 (cluster of differentiation antigen 133 ) vector (referred to as CART-133
      cells).

      II. Determine duration of in vivo survival of CART-133 cells. RT-PCR (reverse transcription
      polymerase chain reaction) analysis of whole blood will be used to detect and quantify
      survival of CART-133 TCR (T-cell receptor) zeta:CD137 and TCR zeta cells over time.

      SECONDARY OBJECTIVES:

      I. For patients with detectable disease, measure anti-tumor response due to CART-133 cell
      infusions.

      II. To determine if the CD137 transgene is superior to the TCR zeta only transgene as
      measured by the relative engraftment levels of CART-133 TCR zeta:CD137 and TCR zeta cells
      over time.

      III. Estimate relative trafficking of CART-133 cells to tumor in bone marrow and lymph nodes.

      IV. For patients with stored or accessible tumor cells determine tumor cell killing by
      CART-133 cells in vitro.

      V. Determine if cellular or humoral host immunity develops against the murine anti-CD133, and
      assess correlation with loss of detectable CART-133 (loss of engraftment).

      VI. Determine the relative subsets of CART-133 T cells (Tcm, Tem, and Treg).
    

Intervention name(s): anti-CD133-CAR vector-transduced T cells
Intervention type(s): Biological
Intervention description(s): genetically engineered lymphocyte therapy
Other intervention name(s): genetically engineered lymphocyte therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Engaging Fathers for Improving Dietary Diversity in Kaduna State
Condition: Complementary Feeding
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate an intervention to engage fathers in supporting the
      dietary diversity and other complementary feeding practices of their young children.
    

Detailed description: 
      This was pre-post study designed to measure changes in complementary feeding practices and
      document the feasibility and acceptability of an intervention to engage fathers in supporting
      dietary diversity in Kaduna State, Nigeria. This study was conducted as part of the Alive &
      Thrive Nigeria program, implemented by FHI 360 and partners. RTI led the design and
      implementation of the study, with Datametrics Associates Ltd. serving as the data collection
      partner in Nigeria. The study was carried out in 6 wards (2 urban, 4 rural) of Igabi local
      government area in Kaduna State. We collected survey data cross-sectionally from 495
      cohabiting mothers and fathers of children 6-23 months at baseline and endline. Participants
      were randomly sampled within 99 clusters selected proportional to population size. The
      purpose of the surveys was to obtain data on children's complementary feeding, changes in
      fathers' and mothers' knowledge and attitudes related to complementary feeding, and fathers'
      support for complementary feeding, and to measure participants' exposure to the intervention
      components. To measure feasibility and acceptability of the intervention, we conducted 24
      in-depth interviews at the end of the intervention with community and religious leaders and
      Community Health Extension Workers who were involved in implementing the intervention. In
      addition, we conducted separate focus group discussions with mothers and fathers (8 groups
      each) at the end of the intervention to learn about changes in social norms related to
      fathers' engagement in complementary feeding and their experiences with participating in the
      intervention.
    

Intervention name(s): Complementary feeding promotion
Intervention type(s): Behavioral
Intervention description(s): The intervention engaged fathers through community meetings, religious services, and mobile phone text and voice messages. Mothers received home visits from community health extension workers (CHEWs), which fathers also could attend. Social behavior change communication materials included TV and radio messages, sermon guides, counseling cards, pamphlets, posters, and feeding bowls.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Minimum dietary diversity; Minimum meal frequency
Water Bolus Volumes During Continuous Exercise in Heat
Condition: Dehydration (Physiology); Hyperthermia
MeSH terms: Dehydration; Hyperthermia
Study type: Interventional

Summary: 
      Hydration is important to all individuals including occupational workers who complete
      physical activity in the heat. Current best practice guidelines suggest drinking a cup of
      water every 15-20 minutes during activity in a hot environment, but research shows this may
      not be ideal for best maintaining hydration. The goal of this study is to determine if
      larger, more frequent water boluses better maintain hydration than smaller, less frequent
      water boluses during moderate intensity physical activity in the heat.
    


Intervention name(s): Hydration protocol - 237 mL water bolus; Hydration protocol - 500 mL water bolus
Intervention type(s): Other; Other
Intervention description(s): Subjects consume 237 mL of water every 20 minutes during 2 hours of high intensity work in the heat.; Subjects consume 500 mL of water every 40 minutes during 2 hours of high intensity work in the heat.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, counterbalanced, crossover study
Masking: None (Open Label)
Primary purpose: Prevention
Efficiency of the French Translation Social Cognition and Interactive Training (SCIT)Program
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Social cognition and interaction training (SCIT), a group-based treatment that aims to
      improve both processing social information and functioning, may be an effective treatment for
      enhancing the social skills of people with schizophrenia. This study will compare the
      effectiveness of Social cognition and interaction training (SCIT) versus treatment as usual
      (ETP) in helping people with schizophrenia improve their social cognition and social
      functioning so specially on negative symptoms. Many studies show a connection between
      negative symptom and social cognition in schizophrenia.
    

Detailed description: 
      This is a multicenter (6 centers in France), randomized, controlled trial compared people
      aged 18 to 50 years with a diagnostic of schizophrenia according to the Diagnostic and
      Statistical manual of Mental disorders, 4th edition (DSM-IV-TR), the Social Cognition and
      Interaction Training (SCIT) program will be compared to an already validated neurocognitive
      remediation program : therapeutic education program (ETP) Social Cognition and Interaction
      Training (SCIT) is composed of three phases: emotion training, figuring out situations, and
      integration. Social Cognition and Interaction Training (SCIT) will be delivered by therapists
      in 20 weekly sessions over 5 months.

      160 patients will be randomized as follows: - Arm1, experimental: Social Cognition and
      Interaction Training (SCIT): 30h with therapist, videos and photos exercises - Arm 2,
      control: therapeutic education program (ETP): 30h with therapist, only discussion between
      patients.
    

Intervention name(s): Social Cognition and Interaction Training (SCIT); therapeutic education program (ETP)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A randomized, controled trial of social cognition and interaction training ( SCIT) for patients with schizophrenia Spectrum disorders; usual treatment ,30 hours with therapist, only discussion between patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: social cognition; cognitive remediation
A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess
      the safety and immunogenicity between HLX02 and Herceptin® (U.S. and EU).
    


Intervention name(s): HLX02; EU-sourced Trastuzumab (Herceptin®); US-licensed Trastuzumab (Herceptin®)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): subject receive one dose of HLX02; subject receive one dose of EU-sourced Trastuzumab (Herceptin®); subject receive one dose of US-licensed Trastuzumab (Herceptin®)
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Efficacy of Different Vitamin D Supplementation Delivery Methods
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      To test the efficacy of different vitamin D delivery methods on serum 25(OH)D. Participants
      randomly assigned to one of seven groups - three placebo groups and 4 active supplement
      groups receiving 100,000IU vitamin D3
    

Detailed description: 
      Various delivery methods of vitamin D supplementation are available to consumers but there
      have been no studies providing evidence of whether one delivery method is superior to others.
      The researchers wanted to compare the delivery of 100,000IU vitamin D3 by three methods on
      serum 25(OH)D levels. Two methods of oral supplementation (pill [prolonged release] and
      liquid [immediate release]), and delivery through the skin (with and without a penetrator
      enhancer. Placebo groups were pill, oral liquid and skin applied oil
    

Intervention name(s): vitamin D3; Pill; orange syrup; mineral oil; Penetrator
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other; Dietary Supplement
Intervention description(s): 100,000IU; Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate; 100 drops orange syrup; Paraffinum Liquidum,Isopropyl Palmitate,Parfum; Tangerine essential oil (10ml)
Intervention MeSH terms: Vitamin D; Cholecalciferol; Mineral Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment