bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial of CBASP for Individuals With Co-occurring Chronic Depression and Alcohol Dependence
Condition: Depressive Disorder; Major Depressive Disorder; Dysthymic Disorder; Alcohol-Related Disorders; Alcoholism
MeSH terms: Alcoholism; Alcohol-Related Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Dysthymic Disorder
Study type: Observational

Summary: 
      This study examines the effectiveness of Cognitive Behavioral Analysis System of
      Psychotherapy (CBASP) in reducing both alcohol consumption and depressive symptoms in adults
      who are chronically depressed and alcohol dependent.
    

Detailed description: 
      This study examines the effectiveness of Cognitive Behavioral Analysis System of
      Psychotherapy (CBASP) in reducing both alcohol consumption and depressive symptoms in adults
      who are chronically depressed and alcohol dependent. Participants will receive a 20-session
      course of CBASP psychotherapy over a period of 21 weeks and will be assessed for severity of
      pretreatment psychological abuse and trauma as well as pre and posttreatment interpersonal
      functioning. Two primary hypotheses are to be tested: 1) demonstrate that CBASP is effective
      in reducing depressive symptoms (Hamilton Rating Scale for Depression-24 ratings) and alcohol
      consumption (drinks per drinking day) in this chronically depressed alcohol dependent cohort
      when posttreatment ratings are compared to pretreatment levels; and 2) demonstrate that
      acquisition of feeling safe with the therapist and acquisition of the ability to perceive the
      interpersonal consequences of one's behavior will significantly increase from pre to
      posttreatment levels and will be associated with reductions in drinking and depressive
      symptoms.
    

Intervention name(s): Cognitive Behavioral Analysis System of Psychotherapy
Intervention type(s): Behavioral
Intervention description(s): Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is a behavioral intervention that addresses the unique behavioral characteristics of chronically depressed individuals, most of which are highly relevant for alcoholics as well. CBASP has a structured, individualized, and collaborative (patient and clinician) design. The intervention emphasizes teaching effective coping strategies and employing motivational, cognitive, behavioral, and interpersonal techniques. Individual therapy (1 hour) sessions occur on a weekly basis for a total of 20 sessions over a period of 21 weeks.
Other intervention name(s): CBASP
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited via a community sample.
The Effects of Hormones in Growth Hormone-Treated Girls With Turner Syndrome
Condition: Dwarfism; Turner's Syndrome
MeSH terms: Dwarfism; Turner Syndrome; Gonadal Dysgenesis; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes.
      Patients with Turner syndrome are typically short, have abnormal physical features, and lack
      the physical changes normally associated with puberty. In addition, some patients with Turner
      syndrome have low bone density (osteoporosis) and differences in learning abilities.

      This study will research the effects of steroid hormones on patients with Turner syndrome. It
      will look closely at how taking steroid hormones effects the patient's rate of growth as well
      as the patient's ability to learn. In addition the study will investigate how different
      hormones (androgen and estrogen) work when given together as a combination.

      All patients asked to participate in this study will receive growth hormone injections.
      However, half of the patients will receive an additional sex steroid hormone (oxandrolone) in
      the form of a pill. The other half of the patients will receive a placebo or "sugar pill".
      This will allow the researchers to determine if the combination of the hormones produces
      different results than growth hormone alone.

      The study will last approximately 2 years. After 2 years of research the patients may qualify
      for an additional 2 years of treatment. Patients may benefit directly from this research with
      increased growth and improved ability to learn.
    

Detailed description: 
      Turner syndrome is associated with short stature, multiple physical stigmata, and absent
      pubertal development. We propose to: (1) examine the effects of sex steroids (androgen) on
      multiple variables (growth rate, GH binding protein, IGF-I, and cognitive function), in the
      setting of supplemental growth hormone administration and (2) to investigate any synergistic
      or additive effects of the androgen and estrogen combination on the above variables.
    

Intervention name(s): Humatrope; Oxandrolone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxandrolone
Primary purpose: Treatment
Keywords: Turner's Syndrome; Short Stature; Cognitive Function; Sex Steroids; Turner Syndrome; TS
Anxiety and Recurrent Abdominal Pain in Children
Condition: Abdominal Pain; Anxiety
MeSH terms: Abdominal Pain; Anxiety Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aims to determine whether citalopram is a useful, well-tolerated, and safe
      treatment for children and adolescents ages 7 to 18 years with functional abdominal pain. The
      study hypothesis is that citalopram will be better than placebo in producing clinical
      improvement and reductions in abdominal pain. It is also hypothesized that citalopram and
      placebo will not differ in terms of safety and tolerability.
    

Detailed description: 
      This study aims to determine the relative efficacy, tolerability, and safety of the
      citalopram in the treatment of pediatric functional recurrent abdominal pain (FAP) in
      children and adolescents ages 7 to 18 years, inclusive. The goal is to recruit and randomize
      100 subjects to citalopram or placebo. Secondary aims include to determine if citalopram is
      superior to placebo in reducing comorbid anxiety and depressive symptoms in children and
      adolescents with FAP, to explore potential mediators (i.e., anxiety, depression) and
      moderators (e.g., age, gender, referral from primary or specialty care) of treatment
      response, and to explore the durability and tolerability of citalopram treatment 18 weeks
      following completion of the double-blind treatment phase with the goal of generating data
      useful to the development of future studies. The study is novel in conducting recruitment,
      assessment, and treatment in traditional medical settings. Limited exclusion criteria and the
      delivery of study assessments and interventions within routine practice settings provide for
      considerably greater external validity than the typical efficacy study.

      Study hypotheses:

        1. Citalopram will be superior to placebo in producing clinical improvement and reductions
           in abdominal pain.

        2. Citalopram and placebo will not differ in tolerability or safety.
    

Intervention name(s): Citalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.; Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.
Other intervention name(s): Celexa
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Abdominal Pain; Anxiety
Combination of Chemotherapy and Gefitinib as First-line Treatment
Condition: Non-Small-Cell Lung Cancer
Study type: Interventional

Summary: 
      The results of fastact2 show that chemotherapy plus erlotinib significantly prolonged PFS and
      OS of patients with NSCLC. However, outcome of the combination therapy are similar to those
      reported in several trials of single-agent EGFR TKIs. So which is the optimal first-line
      treatment for patients who harbored a sensitive EGFR mutation? The investigators need a
      head-to-head study to reply.
    


Intervention name(s): pemetrexed plus carboplatin; gefitinib
Intervention type(s): Drug; Drug
Other intervention name(s): Alimita plus carboplatin; Iressa
Intervention MeSH terms: Carboplatin; Pemetrexed; Gefitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung adenocarcinoma,EGFR mutation, chemotherapy, gefitinib
Optimization of the ex Vivo Challenge: Reproductive Infections and Contraception
Condition: HIV
MeSH terms: Infections
Study type: Observational

Summary: 
      The development of surrogates to predict HIV prevention product safety and efficacy is a high
      priority. An ex vivo challenge model is one such promising surrogate. Colonic tissue exposed
      to rectally applied microbicides in vivo and then challenged with HIV in the lab showed
      significant reduction in HIV replication when compared to tissue exposed to placebo gel.
      Currently, the ex vivo challenge model for ectocervical and vaginal tissue is under
      development at the Dezzutti lab at the Magee Womens Research Institute in Pittsburgh, PA.
      Currently the Reproductive Infectious Disease Research Group is conducting a study designed
      to answer important questions about the ex vivo challenge model:which HIV virus is the best
      to use in the laboratory and what is the best indicator of HIV infection. The proposed study
      delineated here will investigate the effect of BV, HSV and contraceptive use on the model .
      There will be two arms to the study; the first will investigate the impact of HSV and BV
      status and the second, contraceptive use. Vaginal and cervical biopsies will be collected
      from participants for the ex vivo challenge model.
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention-specimen collection study only
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        non-pregnant, HIV negative, healthy 18-45 year old women
      
Keywords: BV, HSV; contraceptive; ex vivo challenge model
Quality Study of Anesthetic Technique on Breast Cancer Surgery
Condition: Postoperative Pain; Quality of Recovery; Satisfaction
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Previous studies have shown that paravertebral block (PVB) has the potential to reduce pain
      and side effects after breast surgery when used in addition to general anesthesia or
      sedation.The investigators would like to further discern the impact of GA or PVB on the
      postoperative QoR, pain and satisfaction.
    


Intervention name(s): PVB
Intervention type(s): Other
Intervention description(s): paravertebral block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intervention With Omega Fatty Acids in High-risk Patients
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      In order to reduce cardiovascular risk, current European guidelines recommend a diet low on
      saturated fatty acid through replacement with polyunsaturated fatty acids (PUFA).
      Polyunsaturated fatty acids can be classified into omega-3 and omega-6. However the results
      from recent meta-analyses investigating coronary risk outcomes did not clearly support a low
      intake of saturated fatty acids and a high intake of omega-3 or omega-6. The aim of this
      study is to investigate the short term effects of a high intake of PUFAs on microvascular
      function, lipids, inflammation and other cardiovascular risk factors in inactive patients
      with increased waistline.
    


Intervention name(s): Omega-3 Fatty Acid; Omega-6 Fatty Acid
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Experimental: Omega-3 fatty acid In the intervention period the participants will receive a daily supplement of omega-3 fatty acids for 8 weeks, where the dosage are 3 and 4 g/day for women and men, respectively. The omega-3 supplement is a hydrolyzed and reesterified TAG fish oil, containing 33 area percent eicosapentaenoic acid and 22 area percent docosahexaenoic acid.; Experimental: Omega-6 fatty acid In the intervention period the participants will receive a daily supplement of omega-6 fatty acid for 8 weeks, where the dosage are 20 and 27 g/day for women and men, respectively. The omega-6 supplement is a high-quality organic, cold pressed and filtered safflower oil, containing 68-83% linoleic acid, 5-15% saturated fatty acid, 8-21% oleic acid, 0,0-0,5% ALA and maximum 2% other fatty acids.
Other intervention name(s): Omega-3; N-3 Fatty Acid; Fish oil; N-3 PUFA; Omega-6; N-6 Fatty Acid; N-6 PUFA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma
Condition: Gastric or Gastroesophageal Junction Adenocarcinoma
MeSH terms: Adenocarcinoma; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomized, multicenter, open-label, dose-exploration and dose-expansion study to
      evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and
      immunogenicity of MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy or
      tremelimumab monotherapy in participants with metastatic or recurrent gastric or
      gastroesophageal junction adenocarcinoma.
    


Intervention name(s): MEDI4736 + tremelimumab; MEDI4736 + tremelimumab; MEDI4736; Tremelimumab; MEDI4736+tremelimumab; MEDI4736 + tremelimumab
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): MEDI4736 will be administered by IV infusion in combination with tremelimumab.; MEDI4736 will be administered by IV infusion in combination with tremelimumab.; MEDI4736 will be administered by IV infusion.; Tremelimumab will be administered by IV infusion.; MEDI4736 will be administered by IV infusion in combination with tremelimumab.; MEDI4736 will be administered by IV infusion in combination with tremelimumab.
Intervention MeSH terms: Durvalumab; Tremelimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Immunotherapy; Antibodies, Monoclonal; Tremelimumab; MEDI4736
Propranolol in Post Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      Problem and Objectives: There is currently no pharmacological treatment for curing post
      traumatic stress disorder (PTSD). The investigators will test whether propranolol when given
      immediately after trauma evocation is able to decrease the strength of the traumatic memory,
      and by extension, the severity of PTSD symptoms associated with that memory.

      Hypotheses:

        1. The subjects will show a significant pre/post decrease in PTSD symptoms.

        2. Those gains will be maintained at follow-up.

      Study Design: Open pharmacological trial.

      Method: On the first visit (V1), the subjects will describe their traumatic experience in
      writing and will receive the propranolol. A script describing this experience will be
      constructed to be used in the subsequent encounters to elicit the trauma memory. A week later
      (V2), before receiving the propranolol, subjects will be asked to read aloud their trauma
      script while imagining it as vividly as possible for 10 minutes. This weekly treatment will
      be repeated 6 times (from V1 to V6). A total of 6 doses of propranolol will be given. A
      self-report measure will be used to monitor improvement in PTSD symptomatology on the
      following visits: V1, V4, V6, V7 and V8 (3 month follow-up).

      Statistical Analyses: A repeated measure ANOVA (pre-test, post-test, and 3-month follow-up)
      using the PTSD symptom score will be conducted.. Three t-tests will be performed to examine
      simple effects. The alpha level will be set at p = .05 (two-tailed). Fisher's exact test will
      be used to examine whether Ss still meet the diagnostic criteria for PTSD at the end of the
      study.

      Clinical Implications: If this treatment is effective, a randomized controlled trial will be
      launched. This treatment has the potential to become the first pharmacological treatment
      designed to cure PTSD.
    


Intervention name(s): propranolol
Intervention type(s): Drug
Intervention description(s): propranolol by mouth (per os)
Other intervention name(s): betablocker
Intervention MeSH terms: Propranolol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adults; PTSD; trauma; AZF; propranolol; reconsolidation; Post traumatic stress disorder; chronic form; PTSD (Post-Traumatic Stress Disorder)
Pharmacotherapy and Intensive Treatment - 2
Condition: Cocaine-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate desipramine and carbamazepine in reducing cocaine
      craving; increase outpatient treatment capacity and evaluate their incidence of psychiatric
      disorders.
    


Intervention name(s): Carbamazepine
Intervention type(s): Drug
Intervention MeSH terms: Carbamazepine
Primary purpose: Treatment
Keywords: cocaine dependence
A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients
Condition: End-Stage Renal Disease Patients on Hemodialysis
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The main goal of this study is to determine whether the American Heart
      Association-recommended fish oil dose is efficacious, safe, and tolerable in hemodialysis
      patients. The secondary objective is to test the effects of fish oil supplementation on
      inflammatory and cardiovascular markers.
    


Intervention name(s): Fish oil capsules; matched placebo capsules
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Effect of The Use of a Videolaryngoscope and/or Stylet on Intubation Time in Obese Patients
Condition: Intubation Time
Study type: Interventional

Summary: 
      Although many researchers would agree that obesity per se is not a risk factor for difficult
      intubation, there are many well known obesity-related challenges in airway management
      including difficulty with mask ventilation, more frequent and rapid oxygen desaturation,
      increased oxygen consumption, and increased sensitivity to the respiratory depressant effects
      of anesthetic and analgesic drugs. Hence, in these conditions, rapid and nontraumatic
      intubation gain higher interest. There is controversy about using videoaryngoscopy (VL) in
      obese patients in these difficult situations. The primary aim of this study is to compare, in
      terms of intubation time, VL,VL plus stylet and direct-laryngoscopy(DL) plus stylet
      combination with DL alone in obese patients.
    

Detailed description: 
      Patients who will be scheduled for surgeries requiring endotracheal intubation, with a body
      mass index (BMI) more than 30 kg/m2, will be included to this study. During preanesthetic
      visit (performed by an anesthesiologist not involved in this study) history of difficult
      intubation, measurement of common predictive indices for difficult intubation (BMI,
      thyromental distance, neck circumference, Mallampati grade, interincisal [or intergingival]
      distances), and evaluation of status of dentition and neck movement will be noted.

      In the operating room, all patients will be connected to standard monitoring devices.
      Anesthesia induction will be carried out according to our hospital obese patient anesthesia
      management protocol. Then, after induction of anesthesia, the patients will be intubated one
      of four pre-defined protocols that will be determined via randomization during a
      preanesthetic visit by a person who is unfamiliar with the research protocol.

      Primary hypothesis of this study is; using a video-laryngoscope plus stylet will reduce the
      time required to achieve successful tracheal intubation in obese patients.
    

Intervention name(s): Endotracheal Tube Alone; Endotracheal Tube+ Stylet; Endotracheal Tube + Video-laryngoscope; Endotracheal tube + stylet with Video-laryngoscope
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Intubating the trachea with an endotracheal tube alone ( without stylet).; Intubating the trachea with an endotracheal tube + stylet.; Intubating the trachea with an endotracheal tube + Video- laryngoscope; Intubating the trachea with an endotracheal tube + stylet + Video-laryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obese Patients; Stylet Procedures; Video Laryngoscope; First-attempt intubation
Changes of Cerebral Glucose Metabolism and After 12 Weeks of Escitalpram Treatment in Panic Disorder
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Panic disorder is one of the most prevalent psychiatric disorders and recently abnormal fear
      network is known to be implicated in the pathophysiology of panic disorder. The fear network
      involves many brain regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus
      coeruleus, parahippocampal gyrus, frontal cortex, and thalamus. Escitalopram, a highly
      selective serotonin reuptake inhibitor, is usually effective for panic dis order, but there
      is little information on how escitalopram affects the fear network.

      The specific aim of this study is to test the following hypotheses using 18F-FDG positron
      emission tomography (PET)

        1. Patients with panic disorder will show abnormal activity of the fear network compared to
           healthy comparison subjects.

        2. Patients with panic disorder will show normalized activity of the fear network after
           12-weeks of treatment with escitalopram.

        3. The changes of fear work after the treatment will be associated with psychological
           variables and neurohormones.
    


Intervention name(s): Lexapro
Intervention type(s): Drug
Intervention description(s): 12 week treatment with lexapro
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Panic disorder; PET; Escitaopram