bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I clinical study was designed to evaluate the safety of novel recombinant HPV
      16/18 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women
      18-55 years of age at enrolment. Approximately 30 study subjects will receive the novel HPV
      vaccine administered intramuscularly according to a 0-1-6 month schedule.
    


Intervention name(s): HPV 16/18
Intervention type(s): Biological
Intervention description(s): Participants would intramuscularly receive 90mcg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: human papillomavirus vaccine
The Trauma Recovery and Resiliency Research Project
Condition: Posttraumatic Stress Disorders
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      The overall purpose of this study is the assessment of treatment outcome among traumatized
      patients seeking individual and/or group therapy at the Victims of Violence Program. The
      study gathers information from patients using quantitative (self-report) and qualitative
      (interview-based) approaches, to determine changes in symptom patterns and domains of
      functioning relevant to psychological trauma.
    

Detailed description: 
      The focus of the Trauma Recovery and Resiliency Project is primarily the evaluation of
      treatment outcome among complexly traumatized patients seeking individual and/or group
      therapy at the Victims of Violence (VOV) Program, a specialty clinic located in the
      Outpatient Psychiatry Department of the Cambridge Health Alliance and affiliated with Harvard
      Medical School. The project has two major components: (1) All patients seeking VOV treatment
      are administered a battery of self-report measures assessing symptoms associated with complex
      trauma (i.e., interpersonal trauma that is usually repeated and prolonged) (2) A subsample of
      patients are interviewed using the Multidimensional Trauma Recovery and Resiliency Interview
      (MTRRI) and its companion rating scale (MTRR; Harvey et al, 1994, 2000, 2003) to assess
      trauma impact, recovery and resiliency on eight domains of psychological functioning. Data is
      analyzed using quantitative and qualitative approaches to evaluate treatment effectiveness
      and elucidate the recovery trajectories of patients receiving VOV treatment. Two subprojects
      include (a) preparation of a treatment manual documenting the Women's Trauma Recovery Group,
      and (b) pilot testing a new interview-based measure of complex trauma symptoms, the Symptoms
      of Trauma Scale (SOTS).
    

Intervention name(s): Individual therapy; Group therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Stage-based individual therapy for trauma survivors; Stage-based group therapy for trauma survivors
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Trauma survivors receiving outpatient treatment.
      
Keywords: Complex trauma; Trauma recovery; Resiliency; Posttraumatic stress; Individual psychotherapy; Group psychotherapy
Robot-assisted Training for Stroke Recovery
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The robot assisted therapy is one of the new developed technologies for recovery after
      stroke. This study aimed to evaluating the effect of robotic gait therapy for motor recovery
      after stroke.
    

Detailed description: 
      This study designed an assessor-blinded, randomized, controlled clinical study. The
      participations followed the study protocol and were randomly divided into the control group
      and Walkbot group. The control group received conventional functional rehabilitation for 40
      min/session, 2 sessions/day, 5 days/week for 4 weeks, 40 sessions in all. Whereas the Walkbot
      group received conventional physical therapy (session I for 40 min/day) companied with
      Walkbot training (session II for 30 min/day) 5 days a week for 4 weeks, 40 session in all.
      After 4-week intervention all subjects received conventional physical therapy only, 40
      min/day, 5 days/week for 4 weeks. During the test period, general rehabilitation and drug
      treatment can be done at the same time.
    

Intervention name(s): Walkbot group; Control group
Intervention type(s): Device; Device
Intervention description(s): The physiotherapist typed patient's information then Walkbot would adjust itself to this data and the exoskeleton legs lengthen or shorten to the patient. The computer screen would provide information about speed, duration, cadence and distance. The monitor in front of the patient can offer image and feedback during the therapy process for patients.
The whole Walkbot training process was observed by one physiotherapist and should be always ready to adjust the unloading, duration, speed and guidance force of Walkbot according to patients' different situation such as muscle spasticity, gait quality, labor-consuming and observe the changes of patients' state.; The control group received conventional functional rehabilitation for 40 min/session, 2 sessions/day, 5 days/week for 4 weeks, 40 sessions in all. After 4-week intervention all subjects received conventional physical therapy only, 40 min/day, 5 days/week for 4 weeks. During the test period, general rehabilitation and drug treatment can be done at the same time.
Other intervention name(s): Walkbot; conventional treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; robot-assisted therapy; conventional therapy; motor function
Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
      chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
      die. Combining chemotherapy with radiation therapy may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of radiation therapy and cisplatin in
      treating patients who have advanced head and neck cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the rate of local regional recurrence at one year in patients with
      advanced head and neck cancer treated with boost radiotherapy and cisplatin. II. Determine
      the feasibility of treatment delivery, patient tolerance, and acute and late toxicities in
      these patients on this regimen. III. Determine the overall survival, disease free survival,
      and distant relapse rates of these patients on this regimen.

      OUTLINE: Patients receive fractionated radiotherapy 1-2 times daily over 5 consecutive days
      for 6 weeks, and cisplatin IV over 1-2 hours on days 1 and 22. Patients may undergo salvage
      surgery if biopsy proven cancer remains more than 3 months after treatment. Patients are
      followed every 3 months for 2 years, every 6 months for 3 years, then annually until death.

      PROJECTED ACCRUAL: A total of 50-56 patients will be accrued for this study within 7 months.
    

Intervention name(s): cisplatin; radiation therapy
Intervention type(s): Drug; Radiation
Intervention MeSH terms: Cisplatin
Primary purpose: Treatment
Keywords: stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx
Nipple Aspiration, Ductal Lavage, and Duct Endoscopy in Screening Women at Moderate-to-High Risk of Developing Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Screening tests, such as nipple aspiration, ductal lavage, and breast duct
      endoscopy, may help doctors detect cancer cells early and plan more effective treatment for
      breast cancer.

      PURPOSE: This clinical trial is studying how well nipple aspiration, ductal lavage, and
      breast duct endoscopy work in detecting cancer cells in healthy women who are at
      moderate-to-high risk of developing breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the incidence of mild or severe cellular atypia in nipple aspirate fluid of
           healthy women at moderate to high risk of developing breast cancer, defined by family
           history or prior atypical biopsy.

      Secondary

        -  Correlate cellular atypia with breast cancer, biochemical tumor markers, growth factors,
           and genetic and protein markers in these participants.

        -  Determine cancer risk and incidence utilizing these methods of screening in these
           participants.

        -  Observe the natural history of atypia in these participants over a total of 10 years.

        -  Determine whether these techniques may serve as supplementary tools in future screening
           of these participants.

      OUTLINE: Participants under 50 years of age undergo nipple aspiration every twelve months for
      3 years. Participants over 50 years of age undergo nipple aspiration every 18 months for 4.5
      years.

      Participants with significant cellular atypia in nipple aspirate fluid undergo ductal lavage
      and endoscopy.

      Participants are followed annually for a total of 10 years.

      PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study within
      approximately 4 years.
    

Intervention name(s): gene expression analysis; protein expression analysis; cytology specimen collection procedure; laboratory biomarker analysis; physiologic testing; breast duct lavage; endoscopic biopsy; study of high risk factors
Intervention type(s): Genetic; Genetic; Other; Other; Other; Procedure; Procedure; Procedure
Primary purpose: Screening
Keywords: breast cancer
The Comparison of a Technology-Based System and an In-Person Behavioral Weight Loss Intervention
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary aim of this study is to compare the changes in body weight between a
      technology-based system, an in-person behavioral weight loss intervention, and a combination
      of both during a 12 month behavioral weight loss intervention in adults. Sedentary, healthy
      overweight and obese adults will be recruited to participate. Assessments will be conducted
      at 0, 6, and 12 months. This is a randomized trial in which participants will be randomized
      to one of three groups: standard behavioral weight loss (SBWL), standard behavioral weight
      loss plus technology (SBWL+TECH), and technology alone alone (TECH).
    


Intervention name(s): Standard weight loss intervention; Standard weight loss intervention plus technology; Technology only
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): In-person weight loss sessions, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week.; In-person weight loss sessions, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week, plus technology to provide real-time feedback on energy expenditure, plus a website to log dietary intake.; One intervention telephone call per month, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week, plus technology to provide real-time feedback on energy expenditure, plus a website to log dietary intake.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Group Therapy for Women Prisoners With Comorbid Substance Use and Depression
Condition: Substance Abuse; Substance Dependence; Depressive Disorder
MeSH terms: Substance-Related Disorders; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether interpersonal psychotherapy is effective for
      treating co-occurring depression and substance use among women prisoners.
    

Detailed description: 
      Incarcerated women are a vulnerable and rapidly expanding population with high lifetime rates
      of both substance use disorder (SUD; abuse or dependence on alcohol, illegal drugs, or
      prescription drugs; 70%) and depressive disorder (DD; major depressive disorder and dysthymic
      disorder; 20-27%). DDs tend to worsen the course of SUDs for incarcerated women by increasing
      their risk for suicide attempts, contributing to the persistence of substance abuse, and
      reducing the likelihood of a successful transition to an independent, sober life in the
      community. Recent evidence indicates that DDs are common in persons with SUDs, often do not
      remit with SUD treatment, and should be treated. Despite growing recognition that
      co-occurring disorders, such as DDs, among substance abusing incarcerated women present an
      important public health concern, integrated treatments for SUD-DD have not been
      well-developed for or systematically tested in this population. Group Interpersonal
      Psychotherapy (IPT-G) has been shown to be efficacious in treating DD in other populations
      and may be especially pertinent to the needs of incarcerated women with SUD-DD because
      interpersonal difficulties not only affect severity of depression, but are also strong
      predictors of drinking to cope, SUD relapse, and prison recidivism in women.

      This study tests the hypotheses that as adjuncts to prison SUD treatment, IPT-G, relative to
      psychoeducation on co-occurring disorders, will produce at least moderate effect sizes for:

        -  Reduction in the risk and severity of substance use relapse after release from prison

        -  Recovery from depressive disorder and reduction in depressive symptoms

        -  Improvement in social support and interpersonal functioning

        -  Reduction in the severity of legal problems during the 3 month follow-up period
    

Intervention name(s): Group interpersonal psychotherapy (IPT-G); Psychoeducation on co-occurring disorders (PSYCHOED)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Abuse; Drug Dependence; Alcohol Abuse; Alcohol Dependence; Major Depressive Disorder; Dysthymic Disorder; Prisoners; Women
Men Engagement in Women Empowerment for Improving Maternal Mental Health Through Cash Transfer and Life Skills Building
Condition: Empowerment; Domestic Violence; Depression; Self Efficacy
MeSH terms: Depression
Study type: Interventional

Summary: 
      This project aims to offer Life Skills Building (LSB) intervention to Benazir Income Support
      Program (BISP) Cash Transfer (CT) beneficiaries in couples in order to reduce domestic
      violence and depression and improve women empowerment in married women of reproductive age.
      The intervention will be carried out in the rural settlements of district Thatta, Sindh
      Pakistan.
    

Detailed description: 
      The study will assess the impact of Life Skill Building (LSB) to Benazir Income support
      Program (BISP) Cash Transfer (CT) beneficiaries and their husbands in improving maternal
      mental and child health and its combined effect in empowering women and couples. The
      Formative phase of the project was dedicated for the development and modification of National
      level LSB curriculum for men and women. The formative phase was carried out in Thatta
      (Sindh), Rahimyar Khan (Punjab), Lasbela (Baluchistan) and Peshawar (KPK).

      The intervention phase will be conducted in district Thatta, where BISP beneficiaries along
      with their spouses will be offered a LSB training. This intervention will be offered by
      community teachers to ensure sustainability and community trust. The participants will be
      recruited for baseline assessment followed by a comprehensive LSB intervention.The end-line
      follow up assessments (five months of intervention) will be done after the deliver of
      intervention. A qualitative summative inquiry will be done at the completion of the project
      to explore the overall impact of the LSB intervention. Since the project is being implemented
      with the BISP, the cost of intervention can be estimated for the scalability and
      sustainability.
    

Intervention name(s): Life Skills Building Training
Intervention type(s): Behavioral
Intervention description(s): The Life Skills Building intervention is a curriculum based on 10-12 sessions. The sessions will include the skills essential for family harmony and improving overall mental health of the participants
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The intervention and the assessment will be carried out parallel in the intervention and the control arm.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Maternal Depression; Women Empowerment; Life Skills Building
Patient Understanding (Cognitive Debriefing) of a Daily Diary of Gastroparesis Symptoms
Condition: Diabetes Mellitus; Gastroparesis
MeSH terms: Gastroparesis
Study type: Observational

Summary: 
      The primary objective of the study is to evaluate how patients with gastroparesis interpret
      the instructions, item content, and response options of a daily diary questionnaire designed
      to assess the key symptoms of gastroparesis.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Hospital/Clinic Database
      
Keywords: Cognitive Debriefing
Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis
Condition: Peritoneal Dialysis-associated Peritonitis
MeSH terms: Peritonitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Vancomycin is the most commonly used empiric treatment for infectious peritonitis in patients
      on peritoneal dialysis. Current dosing and monitoring for safety and efficacy is empiric,
      especially for those on rapid-cycling modalities. The goal of this study is to understand the
      pharmacokinetics of vancomycin in patients on rapid-cycling peritoneal dialysis modalities in
      order to derive an optimal dosing regimen.
    

Detailed description: 
      Peritoneal dialysis (PD) is a form of renal replacement therapy indicated for those with
      acute kidney injury or end stage renal disease. Currently, two modalities of PD exist and is
      individualized based on patient and life-style specific factors. Continuous ambulatory
      peritoneal dialysis (CAPD) allows 4 - 5 exchanges performed manually whereas automated
      peritoneal dialysis (APD) involves continuous, automated, cyclical exchanges performed by a
      device at home during the night. Peritonitis is a common complication in PD and accounts for
      a large portion of hospital readmission and mortality. Vancomycin is the most common
      antibiotic recommended and has notable gram-positive coverage used empirically during
      suspected peritonitis.

      Despite widespread use, vancomycin lacks good pharmacokinetic characterization in PD. Early
      pharmacokinetic studies using vancomycin were conducted predominantly in patients on CAPD on
      glucose-based prescriptions. Data is non-existent in PD patients administered the novel
      dialysate solution icodextrin, or those treated with overnight APD. The impact of residual
      kidney function (RKF) on vancomycin in PD is also lacking. Enhanced vancomycin clearance in
      RKF may result in under-dosing, while overdosing may result in nephrotoxicity and loss of
      clinically important RKF.

      The investigators will characterize the pharmacokinetic profile of vancomycin following a
      single intraperitoneal dose of vancomycin in icodextrin dialysate to non-infected PD patients
      and examine the relationship between RKF and vancomycin clearance using serum, dialysate and
      urine. The goal is to use this data in non-infected subjects to generate information to guide
      vancomycin dosing in patients on rapid-cycling PD modalities.
    

Intervention name(s): Vancomycin
Intervention type(s): Drug
Intervention description(s): Vancomycin one-time 20 mg/kg intraperitoneal dose.
Intervention MeSH terms: Vancomycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vancomycin; Pharmacokinetics; Pharmacodynamics; Automated Peritoneal Dialysis
Distraction Using VR for Children During IV in an Emergency Department
Condition: Pain; Fear
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      Exploring the use of virtual reality as a distracting intervention strategy for school-age
      children to receive intravenous placement in emergency department, and further understand the
      effectiveness of reducing pain and fear during the invasive procedure.
    


Intervention name(s): Virtual Reality
Intervention type(s): Device
Intervention description(s): virtual reality (VR) as a distracting intervention could reduce pain and fear during an IV placement for school-age children in the emergent department.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: school-age children, emergency treatment, intravenous placement, virtual reality, pain, fear
Study Evaluating The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib In Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if there is an effect on the pharmacokinetics of
      bosutinib when administered with lansoprazole.
    


Intervention name(s): Bosutinib; Bosutinib; Lansoprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 4 x 100-mg oral tablets, single dose; 4 x 100-mg oral tablets, single dose; 2 x 30-mg oral tablets, single daily doses for 2 days
Other intervention name(s): SKI-606; SKI-606; Prevacid
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment