bioihbjkbjnl/mcl2 huggingface dataset:
Study Comparing Two Types of Psychotherapy for Treating Depression and Substance Abuse
Condition: Alcohol Abuse; Cannabis Abuse; Major Depressive Disorder; Substance-Related Disorders
MeSH terms: Marijuana Abuse; Alcoholism; Substance-Related Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Integrated Cognitive Behavioral Therapy or
      Twelve Step Facilitation Therapy is most effective for treatment of dually diagnosed veterans
      with depressive and substance use disorders.
    

Detailed description: 
      Depression is the most frequent co-occuring mental health disorder among adults with
      substance use disorders, and such comorbidity is often associated with poorer treatment
      outcomes. Although there is an urgent need for effective treatments specific for
      dual-diagnosis adults, few studies have been conducted to address this need.

      Comparison: This study will compare substance use and depression symptoms of individuals in
      two different psychotherapy groups: Integrated Cognitive Behavioral Therapy and Twelve Step
      Facilitation Therapy. Symptoms and substance use will be compared during the active treatment
      phase (24 weeks) and for one year following the end of the active treatment.
    

Intervention name(s): Integrated Cognitive Behavioral Therapy; Twelve Step Facilitation Therapy
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Alcohol Abuse/Dependence; Alcohol Use Disorders; Cannabis Abuse/Dependence; Depression; Dual diagnosis; Dysthymia; Stimulant Abuse/Dependence; Substance Use Disorders
High Versus Free Humidity Incubators; A Randomized Clinical Trial
Condition: Ongoing Pregnancy Rate
Study type: Interventional

Summary: 
      To compare Top quality embryos either day3 or day 5, Pregnancy rate and most importantly
      ongoing pregnancy rate between high humidity incubators and humidity free incubators
    

Detailed description: 
      When the IVF started the majority of incubators designed to support high humidity because the
      designers and IVF specialists believed that the humidity will maintain stable ph and Temp.

      Recent reports suggest that humidity is recommended and the others suggest no difference So
      we decide to go for this RCT. Nevertheless; high humidity is maintained in vivo (uterus and
      fallopian tubes) due to the fluid content and stable body temperatures at 37°C. David
      McCulloch reported 15% reduction of the miscarriage rate after changing the humidity from 76%
      to 100% (Textbook of Assisted Reproductive Techniques: Laboratory Perspectives, Fourth
      Edition). Some embryologists claim that the humidity free incubators may increase the chance
      of chemical pregnancy and early fetal loss (Private center IbnSina IVF, Sohag, Egypt.
      unpublished data). This observations are never tested in a well designed randomized clinical
      trial (RCT) to eliminate the probability of chance and to reach a solid evidence.

      The question that should be asked : is high humidity culture should be applied or there is no
      difference between dry and high humidity culture conditions?
    

Intervention name(s): The Embryos will be cultured on a humidity free incubator; The Embryos will be cultured on a >95% humidity incubator
Intervention type(s): Other; Other
Intervention description(s): We will set the humidity level to 0.0% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.; We will set the humidity level to 95% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      The purpose of this study is to assess an iPhone application to increase adherence to
      maintenance medications in subjects with ulcerative colitis.
    

Detailed description: 
      Inflammatory bowel disease is a chronic condition that requires maintenance medication to
      maintain clinical remission. During clinical remission patient can be free of symptoms for
      long periods of time. Inflammatory bowel disease patients have been shown to have adherence
      rates around 40-60%. Non-adherence in patients in clinical remission is high with rates
      around 60%. Non adherence in patients in clinical remission can have significant impact
      because it can lead to higher rates of clinical flares and increased health care cost.

      This will be a single-blinded randomized controlled trial to evaluate if patients randomized
      to an iPphone application vs. control can increase the adherence of their maintenance
      medication. The trial will last three months and we hope to enroll 99 patients.

      The primary outcome will be adherence measured by the medication possession ratio. The
      secondary objective will be to evaluate if a validated adherence questionnaire can predict
      adherence in patients with inflammatory bowel disease.

      Having an intervention that can increase adherence can provide better care for patients. Also
      having a validated survey tool can accurately identify non-adherence in inflammatory bowel
      disease patient would be a valuable tool for patient care.
    

Intervention name(s): iPhone Application
Intervention type(s): Other
Intervention description(s): All subjects will receive the iPhone App on their phone however not all subjects will have the intervention (medication notifications) turned on.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Outcome of Idiopathic Macular Hole
Condition: Idiopathic Macular Hole
MeSH terms: Retinal Perforations
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the role of cataract surgery and cystoid macular
      edema (CME) on reopening of idiopathic macular holes (IMH).
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        One hundred and thirty patients (135 eyes) with stage 2, 3, or 4 IMH were included after
        successful IMH repair
      
Keywords: idiopathic macular hole; cataract; edema; Reopening
Magnetic Seizure Therapy for Bipolar Mania
Condition: Bipolar Disorder, Manic
MeSH terms: Seizures; Bipolar Disorder
Study type: Interventional

Summary: 
      This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and
      its safety for bipolar mania. Half of the participants will receive MST, while the other half
      will receive electroconvulsive therapy (ECT).
    

Detailed description: 
      Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive
      therapy (ECT).

      Widespread stimulation of cortical and subcortical regions is inevitable for ECT since the
      substantial impedance of the scalp and skull shuts most of the electrical stimulus away from
      the brain. Nevertheless, magnetic pulses are capable to focus the stimulus to a specific area
      of the brain because they can pass the scalp and skull without resistance. In Addition,
      electric current will penetrate into deeper structures, while magnetic stimulus are only
      capable to reach a depth of a few centimeters. As a consequence, MST are able to generate
      focus stimuli on superficial regions of the cortex while ECT can't, which may give MST the
      capability to produce comparable therapeutic benefits with the absence of apparent cognitive
      side effects.
    

Intervention name(s): Magpro X100 + Option; ThymatronSystem Ⅳ Electroconvulsive System; treatment as usual (TAU)
Intervention type(s): Device; Device; Other
Intervention description(s): In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.; In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of modified ECT in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks; Participants will engage in their inpatient treatment program as-usual.
Other intervention name(s): magnetic seizure therapy; electroconvulsive therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: magnetic seizure therapy; electroconvulsive therapy; bipolar mania; cognition; randomized controlled trial
Vaccine Acceptance in Pregnant Minority Women
Condition: Pregnancy
Study type: Interventional

Summary: 
      The purpose of study will be to test two vaccine education strategies to learn how they
      impact flu and pertussis (Tdap) vaccination rates and attitudes regarding vaccination during
      pregnancy after participating in the intervention. The education strategies will be based on
      the elaboration likelihood model (ELM). This model is based on experimental psychology and
      has been previously used to increase breast cancer screening rates. These education
      strategies will be delivered through routine prenatal care visits to black/African-American
      women in Atlanta.
    


Intervention name(s): Maternal Vaccine Education
Intervention type(s): Behavioral
Intervention description(s): It is assumed that the women will also receive vaccine education materials from the OB/GYN practices as part of routine care. The intervention for all three arms will be conducted during routine prenatal office visits. Participants will complete a baseline questionnaire to assess attitudes regarding vaccination and will then be randomized to one of three enrollment arms and will be exposed to an intervention designed to take no longer than 20 minutes, so that patients can complete it during the time they are waiting to be seen. While participants are completing the handheld/electronic tablet device-based intervention, the study recruiter will observe them and document dose exposure to the messages being presented. The enrolled women will be contacted a month after the expected date of delivery and a follow up interview will be conducted to ascertain their vaccination status for receipt of influenza vaccine in pregnancy and Tdap during pregnancy or immediately post-partum.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Keywords: pregnancy,; vaccine acceptance,; vaccination,; influenza,; pertussis,; Tdap,; minority,; African-American
Food-effect, Drug-Drug Interaction (DDI), and Formulation Bridging Study
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study.
    


Intervention name(s): TD-1473; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): oral capsule/tablet, QD; oral solution, QD
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy volunteers; drug-drug interaction; itraconazole; CYP3A; P-gp; Inflammatory Bowel Disease; IBD; Irritable Bowel Syndrome; IBS
Nutritional Assessment Tool in Childhood Chronic Liver Disease
Condition: Chronic Liver Disease
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      Study Cohort:

      All Children (Age: 3 months- 18 years, corrected age upto 2 years for preterm children) with
      Chronic Liver Disease attending Pediatric Hepatology Out Patient Department/In Patient
      Department
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All Children (Age: 3 months to 18 years, corrected age upto 2 years for preterm children)
        with CLD attending Pediatric Hepatology OPD/IPD.
A BCG Challenge Model Study to Assess Anti-mycobacterial Immunity Induced by BCG and a Candidate TB Vaccine, MVA85A
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the BCG 'challenge' model a four-arm study design
      has been chosen. Twelve subjects will be recruited into each arm of the study. Allocation of
      BCG-naïve volunteers to either group A or B, and BCG-vaccinated volunteers to either group C
      or D, will be performed on a one-to-one alternating basis. Subjects in each group will be
      challenged by BCG administered intradermally. Prior to challenge, pre-existing immunity to TB
      will be induced by vaccination with BCG, MVA85A, and both in combination (when compared to
      BCG- & MVA85A-naïve individuals). BCG quantification will be assessed by analysing the tissue
      obtained in a punch biopsy of volunteers' skin over the site of BCG 'challenge' vaccination.
      Any reduction in BCG quantification between groups will then be correlated to existing (and
      future) laboratory assays of vaccine-induced immune responses in order to identify potential
      immunological correlates of protection.
    


Intervention name(s): BCG: 100 microlitres ~ 2-8 x 105 pfu; MVA85A: 1 x 108 pfu BCG: 100 microlitres ~ 2-8 x 105 pfu
Intervention type(s): Biological; Biological
Intervention description(s): BCG vaccination at day C (challenge day) then punch biopsy at day C+14; MVA85A vaccination at day C-28 followed by BCG vaccination at day C (challenge day) then biopsy at day C+14
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mycobacterium tuberculosis; BCG; MVA85A
Safety Study of Chimeric Vaccine to Prevent ETEC Diarrhea
Condition: Escherichia Coli Infection
MeSH terms: Escherichia coli Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine if immunization with a chimeric E. coli protein,
      dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin.
    

Detailed description: 
      The purpose of the study is to evaluate the safety and immunogenicity of dsc14cfaEsCTA2/LTB5
      (Chimera) and dscCfaE administered with and without LTR192G by intradermal (ID) immunization
      and to gather additional data on the administration of dsCfaE and LTR192G via transcutaneous
      immunization (TCI) route. If vaccines are found to be safe and adequately immunogenic in
      humans, a down-selection would occur and a phase 2b vaccination/challenge study would be
      undertaken to further evaluate vaccine safety and allow a preliminary assessment of efficacy
      of one of these candidates by the ID or TCI route. With favorable evidence for safety,
      immunogenicity, efficacy, complemented by advances in standard methodology to combine
      multiple adhesins with an appropriate LT enterotoxoid form, a multivalent vaccine would be
      constructed and evaluated for further clinical development.
    

Intervention name(s): Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5; Recombinant fimbrial adhesin dscCfaE; Modified E. coli heat labile enterotoxin LTR192G
Intervention type(s): Biological; Biological; Biological
Other intervention name(s): Chimera; dscCfaE; LTR192G
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Antigravity Shoes on Improving the Quality of Gait in Children With Spastic Diplegia
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Improving the quality of gait in the diplegic children is a major concern in the
      rehabilitation program. Thirty children with spastic diplegia were distributed equally into 2
      groups, group A (control) and group B (study). Group A had received the traditional physical
      therapy program for 30 minutes and 30 minutes traditional gait training, while group B had
      received 30 minutes gait training with antigravity shoes in addition to the traditional
      exercise program for 30 minutes, percentage of stance and swing phase of gait were measured
      by 2 D gait analysis for children of both groups pre and after 3 successive months of
      treatment program, also function level of gait were assessed pre and post treatment by GMFCS
      .
    

Detailed description: 
      Thirty children with spastic diplegia, their age ranged from 6 to 8 years old, were
      distributed equally into 2 groups: group A (control) and group B (study) They could walk with
      limitation or holding on according to GMFCS (level II &III). (Palisano et al., 2008).
      Increased time for stance phase and decreased swing phase time was recorded when evaluated by
      2D gait analysis.

      Control group (A):

      The children in this group had received traditional physical therapy exercise program
      designed for those cases for 30 minutes in addition to gait training program for 30 minutes /
      day, 3 times / week for 3 successive months.

      Study group (B):

      The children in this group received the same traditional exercise program for 30 minutes in
      addition to gait training program for 30 minutes using the antigravity shoes.

      evaluation was done before and after treatment. treatment include traditional exercises for
      gait and balance for both groups in addition to use the antigravity shoes for study group.
    

Intervention name(s): gait training
Intervention type(s): Other
Intervention description(s): training for improving the quality of gait through adjusting gait cycle phases time and improving the functional level and independence during gait
Other intervention name(s): gait rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups study and control
Masking: None (Open Label)
Primary purpose: Treatment
Inflammation Following Mepolizumab and Oral Corticosteroids in Asthma
Condition: Asthma
MeSH terms: Asthma; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the project is to study the persistence of inflammation after addition of an
      interleukin-5 (IL-5) blocker in severe eosinophilic asthma as a study of untreated pathways
      in these patients.
    

Detailed description: 
      Mepolizumab, a humanized monoclonal antibody (mAb) antagonizes IL-5 and through a selective
      inhibition of eosinophilic inflammation, reduces the number of eosinophils in sputum and
      blood, leading to a reduction in asthma exacerbations and a need for systemic
      glucocorticoids. Once this therapy has been initiated for severe eosinophilic asthma, the
      additional role of oral corticosteroids is questionable as their main target is reduction of
      eosinophils and hence responsiveness to oral corticosteroids in patients in a stable state of
      asthma may reduce.

      Using two weeks of high dose prednisolone versus placebo in a crossover design after 12 weeks
      of mepolizumab therapy will allow an understanding of the pathways that remain steroid
      responsive following IL-5 suppression.

      This is an exploratory study with no single primary end point. The objective of the study is
      to assess the change in airway inflammation following oral corticosteroids versus placebo and
      the airway inflammation while on mepolizumab in stable state of asthma.

      Note: Mepolizumab is not an intervention in this study; it is initiated as part of usual NHS
      care.
    

Intervention name(s): Prednisolone; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Given daily for 2 weeks; Given daily for 2 weeks
Other intervention name(s): Placebo
Intervention MeSH terms: Prednisolone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Severe asthma; Mepolizumab; IL5; Steroid resistance; Eosinophilic asthma; Type 2 inflammation
Complete Occlusion of Coilable Aneurysms
Condition: Intracranial Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the safety and effectiveness of Pipeline Embolization Device to coil embolization
      for the treatment of coilable wide-necked intracranial aneurysms
    


Intervention name(s): Pipeline Embolization Device (PED); Coil embolization
Intervention type(s): Device; Device
Intervention description(s): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach.; Placement of bare platinum coils into the target aneurysm with balloon remodeling allowed.
Other intervention name(s): Pipeline Embolization Device, PED
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neurovascular embolization; therapeutic embolization
A Study to Evaluate the Efficacy and Safety of ALS-L1023 in Subjects With NASH
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study is to evaluate safety and efficacy of ALS-L1023 in patients
      with Non-alcoholic steatohepatitis
    

Detailed description: 
      Besides the main objectives, there are other objectives as follows:

        1. To evaluate efficacy of ALS-L1023 for liver fibrosis and steatosis by noninvasive
           imaging biomarker MRI-PDFF and MRE

        2. To determine optimized dose of ALS-L1023 in NASH disease
    

Intervention name(s): Placebo oral tablet; ALS-L1023 1,200mg; ALS-L1023 1,800mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo; ALS-L1023; ALS-L1023
Other intervention name(s): Placebo; ALS-L1023 tablet; ALS-L1023 tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Rituximab Combined With ESHAP in Patients With Relapse or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and toxicity of Rituximab combined with
      ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) in the patients with diffuse
      large B cell lymphoma (DLBCL).
    

Detailed description: 
      The salvage therapy in the patients with DLBCL is still controversial. The investigators
      conducted this study to evaluate the efficacy and tolerability of Rituximab combined with
      ESHAP in the patients with DLBCL. The patients enrolled were defined to be relapsed or
      refractory after the first-line chemotherapy like CHOP or other CHOP-like regimens.
    

Intervention name(s): Rituximab combined with ESHAP
Intervention type(s): Drug
Intervention description(s): Rituximab 375mg/m2 d1, VP-16 40mg/m2 d1-4, Ara-C 2g/m2 d5, DDP 25mg/m2 d1-4, Met 500mg/m2 d1-5
Other intervention name(s): R-ESHAP
Intervention MeSH terms: Rituximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DLBCL; Rituximab; ESHAP; Efficacy; Toxicity