bioihbjkbjnl/mcl2 huggingface dataset:
Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors
Condition: Schizophrenia; Cigarette Smoking
MeSH terms: Schizophrenia; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 8-week double-blind placebo controlled parallel group study of the efficacy of
      varenicline (Chantix) for smoking cessation in schizophrenic patients, and its effect on
      cognitive function in patients with schizophrenia.At some sits evaluation of smoking measures
      is extended to 12 weeks. Correlations will be made with biological predictors of efficacy: a)
      measures of nicotinic receptors in lymphocytes b) DNMT1 and GAD67 mRNA in lymphocytes.
      Subjects will be current cigarette smokers or history of regular smokers.
    

Detailed description: 
      This was a double-blind placebo controlled study of varenicline and matched placebo in
      patients with a diagnosis of schizophrenia or schizoaffective psychosis who were treated with
      antipsychotic medication and were cigarette smokers. Three sites (2 U.S., 1 Israel) were
      supported by the Stanley grant. A similar independently supported study was conducted in
      Beijing, China. We were allowed to access these data and combine them for our analysis of
      results. Subjects at each site participated in a protocol which was approved by their
      institutional IRB. All subjects signed informed consent.

      The study evaluated multiple measures of cigarette smoking, cognitive functions by MATRICS
      battery (Measurement and Treatment Research to Improve Cognition in Schizophrenia), and
      psychiatric symptoms by PANSS (Positive and Negative Symptom Scale), SANS (Schedule For
      Assessment Of Negative Symptoms), and Calgary Depression scales. Lymphocytes were collected
      for measurement of epigenetically related mRNA's.
    

Intervention name(s): Varenicline; Placebo for varenicline
Intervention type(s): Drug; Drug
Intervention description(s): Varenicline 1-2 mg/day; Placebo
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: schizophrenia; smoking; nicotine; cognitive deficits; nicotinic receptors; Cognitive Deficits in Schizophrenia
A Study of ATI-50002 Topical Solution for the Treatment of Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study is to assess the safety, tolerability and efficacy of
      ATI-50002 Topical Solution, 0.46% in subjects with non-segmental facial vitiligo.
    

Detailed description: 
      This is a multicenter, open-label study designed to evaluate the safety, tolerability and
      efficacy of ATI-50002 Topical Solution 0.46% in subjects with non-segmental facial vitiligo.
      Subjects will be required to have a clinical diagnosis of non-segmental facial vitiligo
      effecting at least 0.25% of total body surface area (TBSA) (excluding upper and lower
      eyelids, mucosal lip areas, and forehead and chin areas covered by the stereotactic
      positioning device for photography) with at least one area of the face with normal
      pigmentation. Twenty-four eligible subjects will receive ATI-50002 Topical Solution, 0.46%,
      BID for 24 weeks.
    

Intervention name(s): ATI-50002 topical solution
Intervention type(s): Drug
Intervention description(s): Topical Solution administered twice daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
BE of Euthyrox® Tablets (Merck Nantong Versus Merck Darmstadt Sites)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate bioequivalence (BE) between Euthyrox® tablets
      manufactured at Merck Nantong (Test Euthyrox) versus the tablets manufactured at Merck
      Darmstadt (Reference Euthyrox).
    


Intervention name(s): Test Euthyrox®; Reference Euthyrox®
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single oral dose of Test Euthyrox® either in treatment period 1, 2, 3 or 4.; Participants will receive single oral dose of Reference Euthyrox® either in treatment period 1, 2, 3 or 4.
Other intervention name(s): Levothyroxine sodium; Levothyroxine sodium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Euthyrox®; Bioequivalence; Thyroid-Stimulating Hormone; Thyroxine
Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI
Condition: Tubal Factor Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      2groups with peritoneal adhesions after cesarean delivery will be allocated to either
      laparoscopic tubal adhesiolysis or to IVF/ICSI
    

Detailed description: 
      This randomized clinical trial will be conducted at Tanta university hospitals in fertility
      and MIS units. Two hundred and fifty 2ry infertility patients with confirmed post C.S
      adhesions will be included in the study and those patients will be divided randomly in two
      groups:

      Group A:

      125 patients will be undergoing laparoscopic tubal adhesiolysis and\or tuboplasty then a
      widow of 12 months post operatively is given for natural conception.

      Group B:

      125 patients will undergo IVF-ICSI procedures. The primary outcome measure of the study will
      be the rate of clinical pregnancy.

      Inclusion criteria:

        -  patient's age not exceeding 35 years old

        -  confirmed post caesarean section tubal adhesions (by diagnostic laparoscopy report or
           video CDs) as a solitary cause of their 2ry infertility.

      Exclusion criteria:

        -  patient's age >35 years

        -  other causes of infertility as male factor contribution, any ovulatory or
           endocrinological disorder,

        -  diagnosed any degree of endometriosis

        -  patients with history of recurrent pregnancy loss.

        -  couples with prolonged sexual abstinence for any reason Detailed explanation of the
           aims, procedures, steps and nature of the study for the participants will be done and a
           written consent will be signed by each patient before inclusion.

      After allocation laparoscopic tubal adhesions will be dissected and normal anatomy and
      function will be restored. In the other group IVF/ICSI will be commenced The follow up with
      both groups will extend to 1year or till pregnancy is aggrieved The outcomes of the study
      were pregnancy rates and affordability
    

Intervention name(s): Tubal adhesiolysis; IVF/ICSI
Intervention type(s): Procedure; Drug
Intervention description(s): 125 patients will undergo tubal adhesiolysis or tuboplasty; 125 patients will undergo IVF-ICSI procedures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Community-based Intervention for Cervical Cancer Screening Uptake in Nepal
Condition: Cervical Cancer Screening
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      This study aims to evaluate the effect of a Female Community Health Volunteer (FCHV) led
      community-based educational intervention through home visits increasing cervical cancer
      screening uptake.
    

Detailed description: 
      Cervical cancer is the major cause of cancer deaths among women in Nepal. Screening is one of
      the most effective tools for early diagnosis, prevention, and treatment. However, skilled
      health professionals and tools available for cervical cancer screening are limited in low and
      middle-income countries (LMICs) including Nepal. The World Health Organization (WHO) and
      Alliance for Cervical Cancer Prevention (ACCP) recommends that countries, areas, or
      institutions seeking to initiate or strengthen cervical cancer screening programs should
      consider introducing or expanding Visual Inspection with Acetic acid (VIA) until more
      appropriate and affordable HPV-based tests become available. 'National Guideline for Cervical
      Cancer Screening and Prevention in Nepal, 2010' includes VIA as a screening method for
      cervical cancer. Current studies reveal Nepalese women's participation in cervical cancer
      screening is low. Thus, there is a need for appropriate, cost-effective and sustainable
      interventions to increase VIA screening uptake at the primary health care level across Nepal.

      The primary objective of this study is to evaluate the effect of a Female Community Health
      Volunteer (FCHV) led community-based educational intervention through home visits increasing
      cervical cancer screening uptake. The primary outcome of the study is to increase the
      cervical cancer-screening uptake in the intervention group. This will be the first
      community-based cluster-randomized trial designed to mobilize FCHVs for increasing cervical
      cancer screening uptake in Nepal.
    

Intervention name(s): FCHV home visit
Intervention type(s): Behavioral
Intervention description(s): Behavioral: FCHV visit Female Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages Other Name: FCHV Home Visit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cervical cancer screening; Community health worker; Community-based; Female community health volunteers; Non-communicable diseases; Randomized controlled trial; Nepal
Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this open label, two stage, phase II study is to evaluate the efficacy and
      tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary
      thyroid carcinoma.
    


Intervention name(s): ZD6474 (vandetanib)
Intervention type(s): Drug
Intervention description(s): oral once daily tablet
Other intervention name(s): Caprelsa™ (vandetanib); SAR390530
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Caprelsa (vandetanib); ZD6474
A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7
      mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based
      on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months
      and 6 years of age, with AOM.
    


Intervention name(s): cefdinir (Omnicef); amoxicillin
Intervention type(s): Drug; Drug
Intervention description(s): oral suspension (7 mg/kg, ql2hr) for 5 days; oral suspension (45 mg/kg/day, q l2 hours) for 10 days
Other intervention name(s): ABT-198; Omnicef; cefdinir
Intervention MeSH terms: Amoxicillin; Cefdinir
Allocation: Randomized
Masking: Single (Investigator)
Primary purpose: Treatment
Family Help Program: Pediatric Recurrent Headache and Abdominal Pain
Condition: Pediatric Recurrent Headache & Abdominal Pain
MeSH terms: Recurrence; Headache; Abdominal Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the
      effectiveness of the Strongest Families distance intervention compared to usual or standard
      care that is typically provided to children with mild to moderate Recurrent
      Headache/Abdominal Pain symptomology. This is a single-centre trial based at the IWK Health
      Centre. The primary outcome is change in diagnosis.
    

Detailed description: 
      The purpose of the Family Help Program is to deliver, primary care mental health services to
      children and their families in the comfort and privacy of their own home. Approximately 106
      children (9-12 years of age)suffering from mild to moderate (but clinically significant)
      symptoms of pediatric Recurrent Headache/Abdominal Pain will be randomized.

      The intervention is delivered from a distance, using educational materials (manuals,
      video-tapes, audio-tapes) and telephone consultation with a trained paraprofessional "coach"
      who is supervised by a licensed health care professional. The telephone coach delivers
      consistent care based on written protocols, with on-going evaluation by a professional team.

      Fifty percent of the eligible participants will receive Family Help Program telephone-based
      treatment and 50% will be referred back to their family physician to receive standard care as
      determined by that physician. Those receiving standard care will be evaluated for outcome
      results and then compared to the Family Help treated participants. It is anticipated that
      Family Help treatment will be proven to be as or more effective than standard care.
    

Intervention name(s): FHP Pain
Intervention type(s): Behavioral
Intervention description(s): Evidence-based psychological and behavioural Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Intrauterine Insemination and Luteal Fase Support
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective is to test the hypothesis that luteal phase support with vaginal progesterone
      leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary
      outcome) when compared to no luteal phase support in a program of intrauterine insemination
      (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of
      the luteal phase will be recorded (secondary outcome) in order to detect luteal phase
      defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase
      prolongation in case of luteal phase support which may be a burden for the patients waiting
      for the outcome of the treatment.
    


Intervention name(s): crinone (progesterone 8%, vaginal application)
Intervention type(s): Drug
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intrauterine insemination; luteal phase; gonadotrophins
The Effectiveness of Intervention on Insulin Injection
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of the study is to assess the effectiveness of an intervention for insulin injection
      initiation based on the Transtheoretical Model (TTM) for insulin-naïve patients with type 2
      diabetes mellitus (T2DM).
    

Detailed description: 
      According to the Transtheoretical Model (TTM) proposed by Prochaska and Diclemente, people
      will experience different stages of change before the actual behavioral change takes place.
      Ineffectiveness of intervention to instigate behavioral change is largely due to failure to
      take into account the stage of change in which individuals are. The TTM suggests that
      decisional balance, which reflects the relative difference between pros and cons, is
      important for influencing the stage of change. In order to achieve behavioral change, the
      perceived pros of changing must be strengthened to outweigh the cons. In addition, individual
      must be self-convinced that the behavioral change is important for themselves. Furthermore,
      the process for behavioral change can be provided to facilitate behavioral change in
      individuals. The theory of TTM has yet been used to improve the behavior of insulin
      initiation in insulin-naïve patients with T2DM. Thus, this study aims to assess the
      effectiveness of an intervention for insulin injection initiation based on the TTM in
      insulin-naïve patients with T2DM.
    

Intervention name(s): TTM Intervention for Insulin Initiation; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.; Regular patient education on insulin injection at the control arm hospital.
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with T2DM at a clinic in southern Taiwan are assigned to the intervention arm, whereas patients with T2DM at the endocrinology department of a hospital in northern Taiwan are placed in the control arm. Eligible patients that match the inclusion criteria are recommended by doctors to initiate insulin treatment. Research assistants will explain the objectives of this study to eligible participants. Subsequently, baseline data will be collected from participants by research assistants after the participants sign the consent forms. Afterwards, the participants in the intervention arm will receive the intervention. For the control arm, the participants will receive regular patient education originally administered at the hospital.
Masking: None (Open Label)
Primary purpose: Other
Safety Study of Cancer Stem Cell Vaccinie to Treat Breast Cancer
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors
      into immunosuppressed mice, preventing an assessment on the immunologic interactions and
      effects of CSCs. In this study, the investigators examined the vaccination effects produced
      by CSC-enriched populations from histologically distinctmurine tumors after their inoculation
      into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic and more
      effective as an antigen source than unselected tumor cells in inducing protective antitumor
      immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which bound to
      CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from peripheral
      blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were capable of
      killing CSCs in vitro. Mechanistic investigations established that CSC-primed antibodies and
      T cells were capable of selective targeting CSCs and conferring antitumor immunity.
    

Detailed description: 
      To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the
      investigators will harvest peripheral blood and tumor specimen from patients with Breast
      Cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the
      Breast Cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow
      tumor cells from the tumor specimen of the Breast Cancer patient using a similar protocol as
      investigators reported .

      Aim 1: To demonstrate, in vitro, the relative cellular anti-Breast Cancer CSC immunity
      induced by Breast Cancer CSC-DC primed cytotoxic T cells.

      Aim 2: To determine, in vitro, specific binding and lysis of Breast Cancer CSCs by antibodies
      produced by purified B cells from PBMCs stimulated with Breast Cancer CSC-DC.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients who unresectable after Cryotherapy
      
Biospecimen description: 
      We will keep the CSC of every patient
A Study to Investigate the Effects of Cortexolone 17α-propionate (and Its Metabolites) on Healthy Volunteers' Heart
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, double blind placebo controlled Phase I study which will assess the
      safety, tolerability and PK of Cortexolone 17α-propionate (and its metabolites), and its
      effects on the QTc interval when administered as multiple doses to healthy adult volunteers.
      Volunteers will receive a morning and evening dose (12 hours apart) of 225 mg (3 mL
      Cortexolone 17α-propionate applied topically as a 7.5 % solution (75 mg in 1 mL), giving a
      total daily dose of 450 mg (6 mL) per individual.
    

Detailed description: 
      Thirty-two volunteers will be enrolled and evaluated (i.e. complete the study). Subjects will
      be dosed in four groups of eight (purely for logistical reasons relating to the procedure
      times expected with dosing and ECG). Volunteers will receive either the active drug or
      matching placebo in a 3:1 ratio. Therefore within each cohort, six volunteers will receive
      the active drug and two will receive matching placebo.

      Volunteers will be screened within 20 days prior to entering the study on Day -1. Each
      volunteer will receive verbal and written information followed by signing of the ICF prior to
      any screening procedures taking place. Volunteers will be admitted to the study unit on Day
      -1, dosed twice daily on Days 1-3 and once on Day 4 (morning dose only). They will be
      discharged on Day 6 and will have a telephone follow-up on Day 14. If they report any
      relevant Adverse Event (AE) they will be invited to attend the unit for an outpatient visit
      as close to Day 14 as is possible.
    

Intervention name(s): Cortexolone 17α-propionate solution; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single topical application to be applied twice daily (0 hour and 12 hour) on Days 1-3 and Once Daily (0 hour) on Day 4.; matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Thirty-two volunteers will be enrolled and evaluated (i.e. complete the study). Subjects will be dosed in four groups of eight (purely for logistical reasons relating to the procedure times expected with dosing and ECG). Volunteers will receive either the active drug or matching placebo in a 3:1 ratio. Therefore within each cohort, six volunteers will receive the active drug and two will receive matching placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: QT/QTc Interval
A Study of ABT-165 in Subjects With Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and
      preliminary efficacy of ABT-165 when administered as monotherapy and in combination with
      paclitaxel or 5-fluoruracil, folinic acid and irinotecan (FOLFIRI) or ABBV-181 with/without
      paclitaxel in subjects with advanced solid tumors. Enrollment to Cohorts A, B were completed
      and for Cohorts C and D are recruiting.
    


Intervention name(s): paclitaxel; FOLFIRI; ABT-165; ABBV-181
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Paclitaxel will be administered by intravenous infusion.; 5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion.; ABT-165 will be administered by intravenous infusion at escalating dose levels.; ABBV-181 will be administered by intravenous infusion.
Intervention MeSH terms: Paclitaxel
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ABBV-181; ABT-165; cancer; neoplasm; advanced solid tumor; colorectal cancer