bioihbjkbjnl/mcl2 huggingface dataset:
Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands
Condition: Behavioral Risk for HIV
Study type: Interventional
Phase: Phase 2

Summary: 
      This grant involved the development, implementation, and assessment of the feasibility and
      acceptability of an HIV prevention intervention for at-risk wives in Mumbai, RHANI Wives
      (Raising HIV Awareness among Non-Infected Indian Wives). The RHANI Wives intervention was
      adapted from the HIV Intervention Program (HIV-IP), a community-based, multi-session HIV
      intervention with demonstrated effectiveness among Latinas whose primary risk for HIV was
      from their primary male partner (Raj et al. 2001).

      Specific aims of this study are as follows:

        1. To adapt HIV-IP, a culture and gender-tailored HIV intervention for Latinas with
           demonstrated effectiveness in reducing risk for HIV, and to create RHANI Wives for use
           with at-risk Indian wives.

        2. To determine the feasibility and acceptability of RHANI Wives with at risk wives* in
           India. A two-group cluster randomized trial will involve random assignment of 12
           neighborhood clusters (25 women/cluster) to receive the intervention (n=150) or a
           control condition (n=150). Intervention effects on the more proximal and likely safer
           sex mediating outcome of marital communication for this feasibility trial will be
           assessed via surveys at baseline and 3 month follow-up.

      NOTE: Only 220 participants were able to be recruited into the study.

      *At risk wives are defined as having a husband at higher risk for transactional sex based on
      wife's reports of his risky alcohol use (drunk in past 30 days, 3+ drinking days in past 7
      days) or partner violence perpetration
    


Intervention name(s): RHANI WIves
Intervention type(s): Behavioral
Intervention description(s): The RHANI Wives intervention included four household individual sessions and two small group community sessions delivered over 6-9 weeks. The intervention was based on Social Cognitive Theory (SCT)10 and the Theory of Gender and Power (TGP). SCT application supported focus on HIV/STI knowledge and condom skills building, as well as safer sex social norms and motivation. TGP guided the intervention focus on problem solving and skills building toward marital communication; embedded in this was gender equity counseling and support. The TGP approach allowed women to take a more active and assertive stance with husbands. Group sessions reinforced individual session knowledge and skills building and provided local social support.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; condom use; India; women
Qvar vs FP in Pediatrics
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The primary aim of this study was to compare the absolute and relative effectiveness of
      asthma management in paediatric patients in the UK on inhaled corticosteroid (ICS)
      maintenance therapy as extra-fine HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI)
      compared with fluticasone propionate (FP) pMDI.
    

Detailed description: 
      Comparison of asthma control with extrafine-particle hydrofluoroalkane-beclometasone (EF
      HFA-BDP) vs fluticasone propionate (FP) in paediatric patients (5-11year olds). Patients
      identified from the General Practice Research Database (GPRD) and the Optimum Patient Care
      Research Database (OPCRD). Two analyses were conducted:

        1. Comparison of outcomes achieved by EF HFA-BDP and FP in 5-6year old patients with those
           achieved in 7-11yr old patients.

        2. Comparison of outcomes achieved by EF HFA-BDP used with or without a spacer to those
           achieved by standard particle fluticasone propionate (FP) used with a spacer.
    

Intervention name(s): Extra-fine hydrofluoroalkane beclometasone dipropionate; Fluticasone propionate
Intervention type(s): Drug; Drug
Other intervention name(s): Qvar®
Intervention MeSH terms: Fluticasone; Xhance; Beclomethasone
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Asthma patients who initiate ICS therapy as one of:

        HFA-BDP pMDI FP pMDI
      
Keywords: hydrofluoroalkane beclomethasone; fluticasone; paediatrics; real-life; observational; primary care
Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects
Condition: Acute Repetitive Seizures; Breakthrough Seizures
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 12 month safety study to evaluate the safety of repeated doses of NRL-1
    

Detailed description: 
      This is a Phase 3, repeat dose, open-label, safety study in Epilepsy subjects who have
      frequent breakthrough seizures or Acute Repetitive Seizures (ARS). NRL-1 will be administered
      as needed to treat bouts of those seizures over a 12-month period of time. Doses will be
      defined as 5 mg, 10 mg, 15 mg, or 20 mg based on the subject's body weight. A diary will be
      used to record the seizure and NRL-1 administration.
    

Intervention name(s): NRL-1
Intervention type(s): Drug
Other intervention name(s): Intranasal diazepam
Intervention MeSH terms: Diazepam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Seizures; Epilepsy
Interferon Alfa-2b With or Without Radiation Therapy in Treating Patients With Melanoma That Has Metastasized to Lymph Nodes in the Neck, Under the Arm, or in the Groin
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Interferon
      alfa-2b may interfere with the growth of cancer cells. It is not yet known whether giving
      radiation therapy with interferon alfa-2b is more effective than giving interferon alfa-2b
      alone in treating melanoma.

      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus
      interferon alfa-2b with that of interferon alfa-2b alone in treating patients who have
      melanoma that has metastasized to lymph nodes in the neck, under the arm, or in the groin.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the effectiveness of postoperative hypofractionated radiotherapy in
      combination with high dose interferon in preventing regional relapse in patients with
      malignant melanoma with any number of nodes with clinical extracapsular extension or previous
      nodal basin recurrence. II. Evaluate the effectiveness of this therapy in prolonging relapse
      free and overall survival in this patient population. III. Evaluate the toxicity of this
      therapy in this patient population.

      OUTLINE: This is a randomized study. Patients are stratified according to prior nodal basin
      recurrence, site of disease, and extracapsular extension. Following surgery, patients are
      randomized to receive either interferon alfa-2b alone or five treatments of radiotherapy
      followed by interferon alfa-2b. Patients receive radiotherapy 2 days a week for 2.5 weeks.
      Patients receive interferon alfa-2b IV over 20 minutes daily for 5 days for a total of 28
      days, followed by subcutaneous injections 3 times a week for 48 weeks. Patients are followed
      every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter.

      PROJECTED ACCRUAL: Approximately 167 patients will be accrued for this study within 3 years.
    

Intervention name(s): recombinant interferon alfa; radiation therapy
Intervention type(s): Biological; Radiation
Intervention MeSH terms: Interferons; Interferon-alpha
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage III melanoma; stage IV melanoma; recurrent melanoma
Lymphocyte Count, ATG Dose and Incidence and Severity of GVHD in Pediatric Recipients of HSCT
Condition: Hematopoietic Stem Cell Transplantation
Study type: Observational

Summary: 
      Despite increasing success rate in hematopoietic stem cell transplantation (HSCT) control of
      graft versus host disease (GVHD) remains a significative burden in mortality and morbidity. A
      lot of strategies could lower the incidence and gravity of the disease and immunosuppressive
      treatment as GVHD prophylaxis still represent the main method.

      Although immunosuppressive treatment showed a good effect on GVHD mortality a lot of studies
      also highlight an increase of relapse and infection related mortality that jeopardize the
      effect on overall survival of HSCT recipient. Using anti thymocyte globulin (ATG) as GVHD
      prophylaxis shares the same double-edge effect as other immunosuppressive treatment although
      is still unclear how manage dose and timing of the infusion to minimize promoting effect on
      infections and maximize protective effect on GVHD. Biological effect of ATG lead to a dose-
      related delay in all class of T-cell reconstitution but our data are mostly from adult
      studies with high doses between 30 and 60 mg/kg due to the more important burden of GVHD in
      HSCT adult population. As for other treatment in HSCT conditioning we would like to study a
      personalized approach for ATG treatment: some studies focus on tuning of ATG dose for kilos
      but previous evidence showed that the same dose could made too little or too much
      immunosuppressive effect for different patients, even though same age and same stem cell
      source.
    


Intervention name(s): Lower lymphocyte/ATG ratio; Higher lymphocyte/ATG ratio
Intervention type(s): Other; Other
Other intervention name(s): Lymphocyte/ATG ratio <0.01; Lymphocyte/ATG ratio >0.01
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric recipients of hematopoietic stem cells transplantation
      
Keywords: Gvhd prophylaxis; pediatric patients; hematopoietic cell transplantation
Emory Teaching Kitchen Collaborative
Condition: Healthy Lifestyle
Study type: Interventional

Summary: 
      The aim of the project is to evaluate the feasibility and acceptance of a teaching kitchen
      program as a worksite wellness program at Emory University
    

Detailed description: 
      The teaching kitchen model is an innovative, multidisciplinary approach for motivating and
      establishing healthful habits and behaviors. The self-care program combines didactic
      information with experiential learning in nutrition, culinary arts, exercise, yoga, and
      mindfulness. The aim of the project is to evaluate the feasibility and acceptance of teaching
      kitchen program as a worksite wellness program at Emory University. Changes in biomarkers and
      self-reported behaviors will be evaluated up to one year.
    

Intervention name(s): Teaching kitchen program
Intervention type(s): Behavioral
Intervention description(s): The teaching kitchen program will include five 4-hour Saturday classes every other weekend over the course of 10 weeks (5 sessions totaling 20 hours of instruction). It will be taught by subject matter experts from the Emory University faculty and staff as well as potentially from the community. The classes will include the scientific rationale, practical applications, and recommendations for implementing self-care components into participants' daily lives. Experiential learning will include hands-on cooking demonstrations, mindfulness-based lunches, a yoga session, and a group exercise session. Rather than being prescriptive, the lectures and demonstrations are geared to inspire self-designed and personalized alterations in dietary patterns and behaviors that will match participants' culture, preferences, and health conditions. Biometrics and survey instruments will be assessed at 4 times: at baseline, after the 10-week program, and at 6 and 12 months after the program.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Kitchen Collaborative; Healthful habits; Worksite wellness program; Mindfulness
Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer
Condition: NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The Phase 2 study described in this protocol will serve to evaluate the antitumor activity,
      safety and pharmacokinetic profile of Imprime PGG when combined with cetuximab and
      concomitant paclitaxel and carboplatin therapy in patients with previously untreated advanced
      NSCLC. Additionally, this study will provide guidance for the design of more definitive
      efficacy studies of Imprime PGG in NSCLC patients.
    


Intervention name(s): Imprime PGG Injection; Cetuximab; Paclitaxel; Carboplatin
Intervention type(s): Biological; Biological; Drug; Drug
Intervention description(s): 4 mg/kg i.v. over 2 hrs, weekly, in three week cycles; initial loading dose of 400 mg/m^2 over 120 min and subsequent doses at 250 mg/m^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle; 200 mg/m^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles; dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Other intervention name(s): Erbitux; Abraxane; Taxol; Onxol; Nov-Onxol; Paraplatin
Intervention MeSH terms: Paclitaxel; Carboplatin; Cetuximab; Albumin-Bound Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Imprime PGG; NSCLC; Cetuximab
An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      This study consisted of 2 parts: a double-blind (DB) phase and an open-label extension (OLE)
      phase. Only the OLE phase is described in this record. The OLE phase was a safety study. All
      participants received GWP42003-P initially titrated to 20 milligrams (mg)/kilograms (kg)/day;
      however, investigators subsequently decreased or increased the participant's dose to a
      maximum of 30 mg/kg/day (no minimum).
    


Intervention name(s): GWP42003-P; Clobazam
Intervention type(s): Drug; Drug
Intervention description(s): GWP42003-P was presented as an oral solution containing 100 mg/milliliter (mL) cannabidiol (CBD) in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants received up to a maximum of 30 mg/kg/day.; Participants were taking CLB upon entry into the OLE phase of the trial. CLB was not an investigational medicinal product (IMP) for the OLE phase and was not administered by the Sponsor, but was administered at the physician's discretion, as required for each participant. CLB could be stopped, if clinically indicated, without impact on analysis.
Other intervention name(s): Cannabidiol (CBD); Epidiolex; CLB
Intervention MeSH terms: Cannabidiol; Clobazam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cannabidiol (CBD); GWP42003-P; Clobazam; Epidiolex
Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Phenytoin.
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single centre, open-label, multiple doses, two parallel study groups each receiving two
      formulations in a one-sequence design
    

Detailed description: 
      Single centre, open-label, multiple doses, two parallel study groups each receiving two
      formulations in a one-sequence design:

      Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of phenytoin (PHT) in
      last phases;

      Group B: Pre-treatment with PHT, treatment with PHT and ascending doses of ESL in last phases
    

Intervention name(s): BIA 2-093; Phenytoin
Intervention type(s): Drug; Drug
Other intervention name(s): Eslicarbazepine acetate; ESL; PHT
Intervention MeSH terms: Eslicarbazepine acetate; Phenytoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Tp-e Interval and Tp-e/QT Ratio in Dermatomyositis and Analysis of Their Relationship With Inflammation
Condition: Dermatomyositis; Myocardial Repolarization; Inflammation
MeSH terms: Dermatomyositis; Inflammation
Study type: Observational

Summary: 
      The goal of this observational study is to investigate ventricular repolarization utilizing
      Tp-e intervals and Tp-e/QT ratios in patients with DM. The main questions it aims to answer
      are:

        -  1.Exploring the changes in ventricular repolarization parameters (QT interval, QTc
           interval, QTd, Tp-e interval, Tp-e/QT ratio) in patients with dermatomyositis, providing
           quantifiable indicators for early detection of arrhythmia in dermatomyositis patients;

        -  2.Exploring the role of inflammation in ventricular repolarization in DM patients,
           providing a basis for in-depth research on the diagnosis and prevention of arrhythmia in
           DM patients.
    


Intervention name(s): disease
Intervention type(s): Other
Intervention description(s): Do you have dermatomyositis
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Dermatomyositis patients from November 2011 to November 2022 who visited our hospital, and
        a healthy control group consisting of the same number of gender and age matched healthy
        adults in a physical examination center.
Comparison of Aliskiren and Amlodipine on Insulin Resistance and Endothelial Dysfunction in Patients With Hypertension and Metabolic Syndrome
Condition: High Blood Pressure; Metabolic Syndrome; Insulin Resistance; Endothelial Dysfunction
MeSH terms: Hypertension; Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to determine the effects of Aliskiren on insulin resistance
      (IR) and endothelial dysfunction (ED) in patients with high blood pressure and metabolic
      syndrome. The efficacy of Aliskiren was compared to Amlodipine.
    


Intervention name(s): Aliskiren; Amlodipine; Placebo Aliskiren; Placebo Amlodipine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Aliskiren 300 mg tablets taken orally once daily; Amlodipine 5 mg capsule taken orally once daily; Placebo Aliskiren taken orally once daily.; Placebo Amlodipine taken orally once daily
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: High Blood pressure; Hypertension; metabolic syndrome; insulin resistance; endothelial dysfunction; pre-diabetic; amlodipine,; aliskiren,; IGT,; IFG,; MBF
Desmopressin Acetate 0.2 mg Tablets, Fasting
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the single-dose relative bioavailability of TEVA
      and Aventis Pharmaceuticals (DDAVP®) 0.2 mg desmopressin acetate tablets following a 0.8 mg
      dose under fasting conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA bioequivalence statistical methods
    

Intervention name(s): Desmopressin Acetate 0.2 mg Tablets; DDAVP® 0.2 mg Tablets
Intervention type(s): Drug; Drug
Intervention description(s): 4 x 0.2 mg, single-dose fasting; 4 x 0.2 mg, single-dose fasting
Intervention MeSH terms: Deamino Arginine Vasopressin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
High-definition Transcranial Direct Current Stimulation (HD-tDCS) Verbal Learning
Condition: Verbal Learning and Memory
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This project will use a new form of non-invasive brain stimulation called high-definition
      transcranial direct current stimulation (HD-tDCS) to facilitate verbal learning. This form of
      stimulation is similar to transcranial direct current stimulation (tDCS) but allows for more
      spatially focused stimulation. We hypothesise that HD-tDCS when applied to regions of the
      brain important for learning and memory will improve verbal learning and memory compared to
      sham HD-tDCS.
    


Intervention name(s): HD-tDCS
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Comparison of the Effects of Oxycodone Versus Fentanyl on Airway Reflex to Tracheal Extubation and Postoperative Pain
Condition: Coughing Responses at Tracheal Extubation
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study was performed to compare the effects of oxycodone and fentanyl on airway and
      hemodynamic responses and postoperative pain during recovery period in patients undergoing
      laparoscopic cholecystectomy.
    

Detailed description: 
      This study was approved by the committee of Institutional Review Board of the Yeungnam
      University Hospital, Daegu, Republic of Korea. 90 patients were enrolled in this study and
      written informed consent was obtained from all patients. We included patients with ASA
      physical status classification I or II, and aged 18-65 years scheduled for elective
      laparoscopic cholecystectomy.

      Patients were assigned to one of three groups by computer-generated randomization, fentanyl
      group (group F, N=30), oxydodone group (group O, N=30), or control group (group C, N=30). 10
      minutes before completion of surgery, patients received 2 mL mixture of fentanyl 1 ㎍/kg or
      oxycodone 0.08 mg/kg with isotonic saline or isotonic saline 2 mL intravenously in accordance
      with allocated study groups by an anesthesiologist who was blinded to group treatment.

      Airway reflex responses including coughing, breath holding, bucking, and laryngospasm were
      recorded at point of awareness, extubation, and 3 min after tracheal extubation. Hemodynamic
      responses were recorded at the completion of surgery (T1), at the point of awareness (T2), at
      the point of extubation (T3), and 3 min after tracheal extubation (T4). Coughing severity was
      assessed using a 5-point scale. In the recovery room, hemodynamic responses were evaluated
      every 5 min for 30 min. The postoperative pain intensity was assessed 5 and 30 min in the
      postanesthetic care unit (PACU) using numerical rating scale (NRS) ranging from 0 (no pain)
      to 10 (worst possible pain).
    

Intervention name(s): fentanyl; Oxycodone; control
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 mL mixture of fentanyl with isotonic saline; 2 mL mixture of oxycodone with isotonic saline; isotonic saline 2 mL
Intervention MeSH terms: Fentanyl; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: oxycodone, fentanyl, tracheal extubation