bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I Study in Young Healthy Women to Investigate the Effects of Laquinimod on Standard Oral Contraceptive When Both Treatments Are Given Together
Condition: Pharmacokinetics; Pharmacodynamics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, randomized, double blind, placebo controlled, 2-way crossover
      drug-drug interaction (DDI) study to assess the effect of laquinimod on the PK and PD of
      ethinylestradiol (EE) and levonorgestrel (LNG) a commonly used oral contraceptive
      combination.
    


Intervention name(s): laquinimod; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral laquinimod 0.6 mg capsules (with oral contraceptives tablets containing 30 μg ethinylestradiol and 150 μg levonorgestrel (Microgynon®); Placebo (with oral contraceptives tablets containing 30 μg ethinylestradiol and 150 μg levonorgestrel (Microgynon®)
Other intervention name(s): TV5600
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Dose-response of Cannabis and Driving
Condition: Driving Impaired; Cognitive Impairment; Abuse Cannabis
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      Epidemiological studies have established a link between collisions while driving and cannabis
      use. With the changing legal landscape around cannabis, there is much interest in determining
      per se limits of cannabis while driving. The present study will evaluate driving on a driving
      simulator after smoking placebo or cannabis with 3 different levels of THC. THC is the active
      component in cannabis and blood, urine and oral fluid levels of THC will be correlated with
      driving impairment.
    

Detailed description: 
      Participants will attend the laboratory for 4 separate sessions, separated by about a week.
      In each session, participants will receive one of 3 doses of smoked cannabis or a placebo.
      Participants will not know which dose they are receiving. Participants will complete
      questionnaires, do cognitive tests and drive on a driving simulator before and after smoking
      the cannabis or placebo cigarette. Blood, urine and oral fluid will be collected throughout
      the 7-8 hour session to determine levels of THC and its metabolites. These values will be
      correlated with measures of driving impairment.
    

Intervention name(s): Cannabis; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will smoke as much of the cigarette as they wish; Participants will smoke a placebo cigarette
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a within-subjects, counterbalanced, placebo-controlled study of placebo or 3 doses of cannabis
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pivotal Response Treatment Package for Young Children With Autism
Condition: Autism Spectrum Disorder (ASD); Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This is a research study examining the effectiveness of a pivotal response treatment package
      (PRT-P) in targeting language skills in young children with autism.
    

Detailed description: 
      Researchers at the Stanford University School of Medicine are seeking participants for a
      research study examining the effectiveness of a pivotal response treatment package (PRT-P) in
      targeting language skills in young children with autism. Research has demonstrated that
      behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in
      the core symptoms of autism. Researchers have begun to develop strategies to investigate the
      effectiveness of combining a parent training program teaching parents how to implement PRT
      with in-home, therapist-implemented treatment. To determine the effectiveness of a PRT-P, it
      will be compared to a delayed treatment group (DTG) by conducting a randomized controlled
      24-week trial. This research will allow us to help in the development of therapeutic
      approaches that can meet the increasing service demands for families. We hope that
      investigating interventions that aim to improve core deficits will aid clinicians in
      providing better care for children with autism.
    

Intervention name(s): Pivotal Response Treatment Package (PRT-P)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder (ASD); Autism
Adapting an Evidence-based Sexual Assault Prevention Intervention for Women Undergraduates for Online Delivery
Condition: Sexual Assault
Study type: Interventional

Summary: 
      Sexual assault on college campuses is a prevalent public health problem, with 1 in 3 women
      experiencing sexual assault during her time in college. It is a major cause of injury, mental
      health concerns, sexually transmitted infections, and poor educational outcomes in youth and
      young adults. The Enhanced Assess, Acknowledge, Act (EAAA) sexual assault resistance
      intervention is the only intervention that has been shown to reduce sexual assault
      victimization for college women in a randomized controlled trial. EAAA is a 12-hour, peer
      facilitator-led, in-person intervention proven to reduce attempted or completed rape
      victimization by over 50% among female undergraduates, with durable effects lasting more than
      two years. Despite its unique efficacy, uptake of EAAA has been limited, in large part
      because universities prefer less costly interventions that can be administered online;
      unfortunately, no online intervention has been proven to reduce victimization.

      This project seeks to adapt the existing EAAA intervention for online delivery to groups of
      students by live facilitators using a systematic adaptation process called ADAPT-ITT. After
      adapting and refining the intervention, the proposed work seeks to collect feasibility,
      acceptability, and efficacy-related outcome data.

      The project has three aims:

        1. Aim 1: Following the ADAPT-ITT framework, pilot a minimally adapted internet-delivered
           EAAA (IDEA3) with undergraduate women (n=12), collecting data on acceptability
           immediately following the intervention.

        2. Aim 2: Produce a fully adapted IDEA3 intervention that retains core elements of the
           in-person intervention crucial for efficacy, while capitalizing on unique strengths of
           the online modality.

        3. Aim 3: Test the feasibility and acceptability of IDEA3 through a pilot trial and examine
           intermediary outcomes shown to be strong mediators of EAAA's effect on reducing
           victimization (n=64).

      The investigators hope this intervention may prevent as many as 50% of sexual assaults
      experienced by college women, comparable to the existing in-person intervention from which
      this online intervention is being adapted. Once the intervention has been finalized, the
      investigators plan to disseminate the intervention and make it widely available to
      institutions through the SARE Centre, a non-profit partner on the study that currently
      disseminates the in-person version of the intervention, EAAA.
    


Intervention name(s): IDEA3 Intervention
Intervention type(s): Other
Intervention description(s): Delivery of IDEA3 intervention, a 12-hour online sexual assault resistance intervention for college women.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
In Vivo Clinical Trial of Porous Starch - Hydroxyapatite Composite Biomaterials for Bone Regeneration
Condition: Open Fracture of Foot
MeSH terms: Fractures, Open
Study type: Observational

Summary: 
      Biodegradable scaffold is an accepted and commercialized medical alternative choice for bone
      regeneration. In this project we will used our new invention, porous starch- hydroxyapatite
      composite, for in vivo clinical trial.
    

Detailed description: 
      The products were prepared from medical grade Thai rice starch mixed with high purity (>97%)
      hydroxyapatite powder from fresh cow bone, and already passed in vivo animal biocompatility
      test, then processed by freeze-drying. There were 44 volunteers from orthopedic and
      neurosurgical division, 4 and 40 patients, respectively.
    

Intervention name(s): bone void filler
Intervention type(s): Device
Intervention description(s): Bone void filler device prepared from porous starch-hydroxyapatite composites for bone regeneration
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        There were 44 volunteers from orthopedic and neurosurgical division.
      
Keywords: Rice starch; Porous composite; Biomaterial; Bone regeneration; Clinical trial; Hydroxyapatite
Imaging and Understanding BOS in Lung Transplantation
Condition: Bronchiolitis Obliterans Syndrome
MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome
Study type: Observational

Summary: 
      This study is a prospective, non-randomized, longitudinal, observational study that will
      recruit about 5 lung transplant patients per year for 3 years.
    

Detailed description: 
      This study is a prospective, non-randomized, longitudinal, observational study that will
      recruit about 5 lung transplant patients per year for 3 years. We will follow these patients
      at 6 months and 1 year with Hyperpolarized Helium-3 Magnetic Resonance Imaging and image
      guided bronchial biopsies to detect early BOS and to better understand BO disease
      progression. The biopsies will provide future research for rapid determination of cellular
      and molecular mechanisms that lead to BOS and to facilitate identification and validation of
      translatable pharmaceutical targets.
    

Intervention name(s): Hyperpolarized Helium-3 MRI
Intervention type(s): Drug
Intervention description(s): Subjects will inhale Hyperpolarized Helium-3 gas during the MRI. This gas enhances images and the data collected will be used to determine if it can be used to detect BOS earlier than current standard of care.
Other intervention name(s): Hp-He3 MRI
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who have had or are scheduled for lung transplant
      
Biospecimen description: 
      Biopsies of transplanted and explanted lung tissue
    
Keywords: Helium; MRI; Lung transplantation
A Phase II Safety and Tolerability Study With SEN0014196
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The principal aim of this study is to obtain safety and tolerability data when SEN0014196 is
      administered orally over 12 weeks to male and female patients with Huntington's Disease.
    


Intervention name(s): SEN0014196; SEN0014196; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg oral once daily tablet; 200 mg oral once daily tablet; oral once daily tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Development of a Screening Tool to Detect and Stage Cachectic Cancer Patients
Condition: Cachexia
MeSH terms: Cachexia
Study type: Observational

Summary: 
      The aim of the study is to develop a screenings tool that will enable hospital nurses to
      detect and stage cancer cachectic patients. The early detection and staging of cancer
      cachexia will assist the oncology team in providing the cachectic cancer patient tailor-made
      patient care.
    

Detailed description: 
      In this cross-sectional study, the participants will complete 4 times a set of questionnaires
      and measurements. The data that will be collected is:

      age; sex; height; weight; type of tumour; classification of malignant tumours (TNM);
      progression of tumour and used therapy; blood sample to analyse albumin, creatine,
      hemoglobin, LDH and CRP; use of parental nutrition; dietary assessment; use of nutritional
      supplements; Quality of Life by using the EORTC-QlQ; Subjective Global Assessment; presence
      of Percutaneous endoscopic gastrostomy; use of enteral or parenteral nutrition; body
      composition based on a Bio Impedance Assessment; hand grip strength and mid upper arm
      circumference. Based on all these data points a easy to use tool/score for a hospital setting
      will be created. During the first assessment the measurements will be done in the morning and
      the evening to test the reproducibility.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population from which the groups or cohorts will be selected (e.g., primary care
        clinic, community sample, residents of a certain town). (Limit: 1000 characters)
      
Biospecimen description: 
      The blood sample that will be collected is part of the routine hospital assessment. The
      biomarkers that will be measured are albumine, creatine, CRP, hemoglobin and Lactate
      dehydrogenase (LDH).
Long Term Follow-up of Persistent Pain, Sensory Disturbances and Lymphedema After Breast Cancer Treatment
Condition: Breast Cancer; Pain; Post Operative Pain; Lymphedema; Neuropathy
MeSH terms: Breast Neoplasms; Lymphedema; Pain, Postoperative
Study type: Observational

Summary: 
      Persistent pain, sensory disturbances, lymphedema and functional impairment are frequently
      occurring late effects of breast cancer treatment. The investigators have previously
      published data on 3253 women treated for breast cancer in Denmark in the period 2005-2006.
      Very few studies have examined how these late effects change in time. The aim of this study
      is to examine in a well defined patient population any change in the prevalence of persistent
      pain, sensory disturbances, lymphedema and functional impairment, as well as risk factor
      profile.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Woman treated for breast cancer in Denmark 2005-2006, and participated in the study in 2008
      
Keywords: Breast cancer; persistent pain; neuropathic pain; lymphedema
Acmella Oleracea in the Analgesia of the Digital Rectal Examination
Condition: Analgesia in the Digital Rectal Examination
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to develop an herbal gel based on Acmella oleracea and do a
      comparative analysis to evaluate the intensity of pain during the digital rectal examination
      comparing to lidocaine gel group and ultrasound gel group.
    

Detailed description: 
      The aim of the study is to develop an herbal gel based on Acmella oleracea and do a
      comparative analysis to evaluate the intensity of pain during the digital rectal examination
      comparing to lidocaine gel group and ultrasound gel group.

      We are conducting a randomized, controlled, single-blind clinical trial of man undergoing to
      digital rectal examination, with 150 participants. Will be recruit at the Urologic Clinic of
      the Samuel Libânio Clinical Hospital and Urologic Clinic CISAMESP in Pouso Alegre.
      Participants divided into three groups, A. oleracea gel group, lidocaine gel group and
      ultrasound gel group. The digital rectal examination always performed by the same doctor, on
      the same position. A visual analogue scale (VAS) will be the standard method to evaluate the
      pain levels. The VAS will be explained to all patients, 0 = no pain and 10 = the most severe
      pain.
    

Intervention name(s): Acmella oleracea gel; Lidocaine 2 % Topical Cream; Ultrasound gel
Intervention type(s): Biological; Drug; Other
Intervention description(s): Study group will use Acmella oleracea gel during the digital rectal examination.; Control group will use lidocaine 2% gel during the digital rectal examination.; Control group will use ultrasound gel during the digital rectal examination.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Prostatic neoplasms; Digital Rectal Examination; Phytotherapy; Pain; Analgesia; Spilanthes oleracea
Seminal TEX101 as a Predictor of Recovery of Spermatogenesis in Azoospermic Men With Palpable Varicocele
Condition: Azoospermia, Nonobstructive; Varicocele
MeSH terms: Azoospermia; Varicocele
Study type: Interventional

Summary: 
      The aim of the study is to assess if seminal TEX 101 can predict the restoration of
      spermatogenesis and appearance of sperms in the ejaculate after micro-surgical
      varicocelectomy among azoospermic patients.
    

Detailed description: 
      Male patients (40) cases attending the outpatient clinic of Andrology at KASR EL-AINI
      university hospitals, all patients presented with azoospermia, age:18-43 years, complaining
      mainly of infertility or accidently discovered azoospermia during premarital check-up or
      chronic testicular pain caused by longstanding varicocele. Infertile Non Obstructive
      Azoospermia (NOA) (n=40) subjected to varicocelectomy and patients evaluated 3 months after
      varicocelectomy by semen analysis, then according to results population divided into 2
      groups: Group A (Responders): Patients with positive semen analysis for

      sperms 3 months after varicocelectomy.

      Group B (Non Responders): Patients with no sperms in semen analysis

      in 3 and/or 6 months after varicocelectomy.

      Method of Estimation of human TEX101 in semen:

      A 1 ml collected semen samples were centrifuged for 20 minutes at 1000xg at 4 o C, then
      supernatant of each sample was collected for estimation of TEX101. The human TEX101 (Testis
      expressed 101) was assayed by commercially available ELISA kit supplied by Wuhan Fine Biotech
      Co., Ltd. China.

      Principle of the procedure:

      This kit was based on sandwich enzyme-linked immune-sorbent assay technique. Anti- TEX101
      antibody was pre-coated onto 96-well plate. The biotin conjugated antibody was used as
      detection antibodies. The standards, test samples and biotin conjugated detection antibody
      were added to the wells subsequently, and washed with wash buffer.

      HRP-Streptavidin was added and unbound conjugates were washed away with wash buffer. TMB
      substrates were used to visualize HRP enzymatic reaction. TMB was catalyzed by HRP to produce
      a blue color product that changed into yellow after adding acidic stop solution. The
      intensity of yellow is proportional to the target amount of sample captured in plate.
    

Intervention name(s): micro-surgical varicocelectomy
Intervention type(s): Procedure
Intervention description(s): Sub-inguinal micro-surgical varicocelectomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Varicocele; Azoospermia; TEX 101
Evaluation of the Efficacy of the Bipolar Sealer Aquamantys 6.0 in Patients Undergoing Total Hip Arthroplasty
Condition: Hip Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The present prospective, single-center, clinical trial is designed to evaluate the hemostatic
      efficacy of the hemostatic sealer Aquamantys 6.0™ in patients managed with total hip
      arthroplasty (THA). It is hypothesized that Aquamantys 6.0™ can improve hemostasis following
      total hip arthroplasty. Comparison of the functional and clinical results between THA
      patients having been exposed to Aquamantys 6.0™ versus a control group will be analyzed using
      several outcome measures including the Harris Hip Score and a pain scale. The primary
      variable of interest is transfusion requirements - specifically, number of patients managed
      with blood transfusion during the hospital stay after surgery. However, of secondary interest
      will be: 1) number of units transfused, 2) estimated intraoperative total blood loss, 3)
      change in pre- and post-operative hemoglobin levels, 4) total narcotic usage during hospital
      stay, 5) length of stay, 6) functional and pain outcomes (Harris Hip Score and Pain Scale),
      and 7) adverse events.
    


Intervention name(s): Bipolar Radiofrequency (Aquamantys 6.0); Standard Bovie Electrocautery
Intervention type(s): Device; Device
Other intervention name(s): Aquamantys 6.0
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Trial of Positively Smoke Free Group Therapy for HIV-infected Smokers
Condition: Tobacco Use in Persons Living With HIV
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Positively Smoke Free group therapy is more
      effective at promoting cessation than standard care.
    

Detailed description: 
      There are 1.1 million persons living with HIV (PLWH) in the US, 60% of them smoke cigarettes,
      and 75% of these are interested in quitting. Almost none are currently accessing smoking
      cessation interventions designed to meet their specific needs and concerns.

      Cigarette smoking is responsible for 24% of deaths among PLWH, and 30% of non-AIDS defining
      malignancies. It is driving the alarming rise in cardiac events and lung cancers in this
      highly vulnerable population. The lack of access to proven, effective, culturally appropriate
      tobacco cessation services represents a health disparity of the first order. The psychosocial
      profile of the PLWH-smoker community, characterized by high rates of psychiatric comorbidity,
      drug and alcohol use, and low levels of social support, suggests that achieving high
      cessation rates will be a great challenge.

      Positively Smoke Free (PSF) is an intensive, multisession, group cessation program
      specifically developed for PLWH smokers. A pilot study of PSF yielded promising results. This
      proposal aims (1) to perform a definitive efficacy study of PSF by comparing 6-month
      biochemically confirmed abstinence rates in subjects randomized to PSF vs. standard care in a
      cohort of 450 PLWH smokers, (2) to determine the sociobehavioural moderators and mediators
      associated with successful cessation, and (3) to complete a careful cost analysis of PSF in
      order to estimate the incremental cost per quit associated program participation.

      If PSF is proven to be effective it will establish a new treatment option for PLWH smokers.
      Determination of moderators and mediators of program success will provide insight into the
      mode of action of the intervention and will help guide the development of additional
      treatment strategies in the future. Finally, the cost analyses will provide critical
      information about the feasibility of program dissemination and implementation.
    

Intervention name(s): Positively Smoke Free group treatment; Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): See Arm Description; See Arm Description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment