bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility Study for Abused Chinese Immigrant Women
Condition: Intimate Partner Violence; Depression; Anxiety; PTSD
MeSH terms: Depression
Study type: Interventional

Summary: 
      Intimate partner violence (IPV) is a serious social and public health issue. In the U.S.,
      more than 1 in 3 women experience physical or sexual violence, and/or stalking by an intimate
      partner during their lifetime. IPV has significant physical and mental health consequences
      such as injury, chronic pain, and depression. Chinese immigrants have been overlooked and
      underserved and represent an especially vulnerable group of IPV victims, as they are less
      likely to seek help through IPV service agencies, women's shelters, hospitals, or law
      enforcement. Effective IPV intervention programs that are culturally appropriate, accessible,
      and acceptable are essential to this underserved population. However, no studies have been
      conducted with abused Chinese immigrant women to help them deal with IPV and reduce mental
      health consequences.

      Therefore, the study adapted a structured IPV intervention from the Domestic Violence
      Enhanced Home Visitation Program (DOVE) as well as incorporate self-compassion and relaxation
      techniques for Chinese immigrant women experiencing IPV. The intervention is called
      Self-Compassion, Health, and Empowerment (SHE). The study will test the feasibility and
      acceptability of the SHE to reduce IPV and improve mental health well-being for abused
      Chinese immigrant women residing in the US.
    


Intervention name(s): Self-Compassion, Health, and Empowerment (SHE); The Control Condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The SHE intervention includes 8 weekly sessions and 24-hour access to the intervener for any additional support needed. The first and last sessions will be delivered over the phone with the woman based on a brochure. The brochure describes the four major components: a) IPV information, b) Danger Assessment, c) Safety Planning, and d) Resources. It will be discussed with the woman in an interactive manner so that the woman is encouraged to describe her experiences and choose her options as they proceed. Session 2-7 focus on providing mental health self-care resources, which are deep breathing, progressive muscle relaxation, visualization, general introduction and overview of self-compassion, mindfulness, and loving-kindness.; Women randomized to the control group will be provided with the same brochure and mental health care resources.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Influence of Piribedil (Clarium®) on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Non-Ergot Dopamine Agonists
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical trial is to investigate the effects of the non-ergot dopamine
      agonist piribedil on vigilance and cognitive performances in patients with Parkinson's
      disease in comparison with other oral non-ergot dopamine agonists.

      It should be tested whether piribedil is superior to continued pramipexole or ropinirole
      treatment regarding improvement of reduced vigilance and cognitive performance in patients
      with Parkinson's disease.
    

Detailed description: 
      Treatment of motor symptoms associated with PD by non-ergot dopamine agonists has been proven
      to be effective, both as monotherapy and in combination with levodopa. Non-motor symptoms
      like cognitive or sleep-related disorders and disturbed vigilance, however, are common in PD
      and can significantly worsen health and quality of life of the patient and family members.
      Some of these non-motor symptoms may also be caused by the antiparkinsonian medication per
      se. The Committee for Proprietary Medicinal Products (CPMP) initiated a review of dopamine
      agonists in relation to episodes of sudden onset of sleep already in 2000 which resulted in
      special warnings of somnolence and sudden sleep attacks in the non-ergot dopamine agonists'
      summary of product characteristics.

      Beneficial effects of piribedil on parameters of vigilance and cognition have been described
      in several studies. But, as it seems, no study has been performed so far to identify such
      effects in the setting of a comparative study with different oral non-ergot dopamine agonists
      in patients with PD, and utilizing vigilance and cognitive parameters as primary and main
      secondary objective. The neuropsychological tests being applied in this study are validated
      and routinely used tests in studies investigating different aspects of attention or vigilance
      and cognition.
    

Intervention name(s): piribedil; pramipexole or ropinirole
Intervention type(s): Drug; Drug
Intervention description(s): Oral application of piribedil at an equivalent dose of pramipexole or ropinirole according to a defined equivalence scheme (dose range 100 - 300 mg per day) for 11 weeks.; continuation of pre-study treatment regimen
Other intervention name(s): Clarium®
Intervention MeSH terms: Pramipexole; Ropinirole; Piribedil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson; piribedil; vigilance; dopamine agonist; cognition
Effects of Intraoperative GDFT on the Postoperative Brain Edema
Condition: Fluid Therapy; Brain Edema; Brain Tumor
MeSH terms: Brain Edema; Edema
Study type: Interventional

Summary: 
      Whether a fluid protocol aiming for protecting vital organ perfusion or fluid restriction is
      favorable to post-craniotomy outcomes such as brain edema remains uncertain. To our
      knowledge, there has been no extensive and quantitative analysis of brain edema following
      SVV-based GDFT in neurosurgical patients with malignant supratentorial glioma. So the study
      aims to observe the effect of the stroke volume variation-based GDFT on the postoperative
      brain edema and decrease the incidence of postoperative complications in neurosurgical
      patients with malignant supratentorial gliomas.
    


Intervention name(s): GDFT; traditional fluid therapy
Intervention type(s): Other; Other
Intervention description(s): Target parameter will be titrated with fluid bolus, and thus individual amount varied depending on the parameter value at that time. Maintenance of oxygenation, hemoglobin, blood glucose, core temperature and hemodynamics, such as mean arterial pressure and heart rate, will be applied according to the same standard for each patient.; Fluid therapy will be done without goal directed. Maintenance of oxygenation, hemoglobin, blood glucose, core temperature and hemodynamics, such as mean arterial pressure and heart rate, will be applied according to the same standard for each patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Clopidogrel
Condition: Elevated Lipoprotein(a); Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open label, single sequence, two treatment, two-period drug-drug
      interaction study to evaluate the effect of multiple doses of ISIS 681257 on the
      pharmacokinetics of multiple doses of clopidogrel
    


Intervention name(s): ISIS 681257; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Xmg dose administered as a subcutaneous injection; 75mg tablet administered orally
Intervention MeSH terms: Clopidogrel
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Scientific Research Barriers by Gender and Other Characteristics in Physiatry
Condition: Gender Bias; Researcher-Subject Relations
Study type: Observational

Summary: 
      The ever-increasing population and life expectancy worldwide lead to a higher prevalence of
      physical disabilities and diseases, which increases the need for physical medicine and
      rehabilitation research. In our study, we aimed to evaluate various aspects of the barriers,
      particularly gender disparities, faced by physical medicine and rehabilitation professionals
      who wish to conduct scientific research.
    

Detailed description: 
      Physicians in physical medicine and rehabilitation must also put in tremendous effort and
      manage their time meticulously to contribute to scientific research (SR). Research requires
      knowledge, experience, and institutional support, such as financial incentives, technical
      facilities, and trained personnel. In this field, research productivity is increasingly
      important due to the rising prevalence of conditions such as age-related disability and
      chronic pain, which put pressure on the healthcare system and affect people's quality of
      life. Turkey's publication productivity in physical medicine and rehabilitation has also
      increased steadily in recent years, with a significant number of articles published between
      2015 and 2020. However, gender disparities in academic leadership positions persist in this
      field as well, with women lagging behind men in the number of scientific publications. While
      bibliometric studies are useful for assessing the current state of scientific performance,
      survey studies are necessary to identify obstacles that deter researchers and increase
      research productivity. Unfortunately, few studies have used this approach in physical
      medicine and rehabilitation, and no such study has been conducted in Turkey.
    

Intervention name(s): Research Barriers Scale
Intervention type(s): Other
Intervention description(s): This scale was prepared after a detailed literature review and sent to five physiatrists for review and feedback. It consists of 21 items with Likert-type responses and two open-ended questions. It is designed to measure the barriers that individuals or groups face in conducting research. The scale includes a list of potential barriers and asks respondents to rate the extent to which they experience each barrier. Examples of barriers that may be included in such a scale could include lack of funding, limited access to resources or equipment, time constraints, difficulty finding participants or accessing data, institutional or administrative hurdles, and so on.
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Physical medicine and rehabilitation physicians who consented to participate in the study.
The Aerobic and Cognitive Training System
Condition: Healthy Aging
Study type: Interventional

Summary: 
      This study will determine the effects of simultaneous exercise and cognitive training on
      cognitive function in healthy older adults. Specifically, this study will compare the use of
      a tablet-based cognitive training system while exercising with exercise alone, cognitive
      training alone, and a neutral control condition on cognition.
    


Intervention name(s): Simultaneous exercise and cognitive training; Exercise training; Cognitive Training; Neutral video
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants in this arm will engage in a 12-week intervention that combines physical exercise and cognitive tablet-based training. This intervention involves use of an exercise bicycle while engaging in cognitive tasks on a tablet computer three times per week.; Participants in this arm will engage in a 12-week exercise intervention that involves use of an exercise bicycle three times per week.; Participants in this arm will engage in a 12-week intervention that involves cognitive tablet-based training three times per week.; Participants in this arm will engage in a 12-week intervention that involves watching neutral videos on a tablet computer three times per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Biportal Endoscopic Discectomy Versus Microdiscectomy: RCT, Non-inferiority Trial
Condition: Lumbar Herniated Intervertebral Disc
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional

Summary: 
      This study is to compare the clinical outcome between the biportal endoscopic discectomy and
      microdiscectomy in herniated intervertebral disc of lumbar spine
    


Intervention name(s): Biportal endoscopy; Microdiscectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Biportal endoscopic spine surgery (BESS); Using microscope for discectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Herniated intervertebral disc; Discectomy; Microscope; Biportal endoscopy
Effect of a Probiotic, Lactobacillus Gasseri BNR17, on Body Composition and Weight Management in Overweight Adults
Condition: Weight Management
MeSH terms: Overweight; Body Weight
Study type: Interventional

Summary: 
      Lactobacillus gasseri BNR17™ has shown promise in several pre-clinical and randomized
      controlled clinical trials for weight management outcomes. The current randomized,
      double-blind, placebo-controlled, parallel-arm trial will further assess L. gasseri BNR17™ on
      body composition and weight management, and in a study population that is distinct to prior
      randomized controlled trials on the strain. The study will recruit 126 overweight adult
      participants who will be randomly assigned to consume L. gasseri BNR17™ or placebo once daily
      for 12 weeks.
    


Intervention name(s): Lactobacillus gasseri BNR17™ capsule; Placebo capsule
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Once per day (QD), 12 weeks; Once per day (QD), 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization)
Condition: Breast Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether HKI-272 affects the rhythms of the heart
      (cardiac repolarization).
    


Intervention name(s): neratinib; Placebo; Moxifloxacin
Intervention type(s): Drug; Other; Drug
Intervention description(s): HKI-272; Placebo
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Thorough QTc study
DDI Study of Evobrutinib and Carbamazepine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of multiple doses of carbamazepine on
      two single doses of evobrutinib pharmacokinetics (PK) in healthy participants. Study details
      include:

      Study Duration: up to 54 days. Treatment Duration: 25 days. Visit Frequency: Participants
      will be resident in the Clinical Research Unit from Day 1 to Day 20 and return on Day 26 for
      a Safety Follow-Up visit.
    


Intervention name(s): Evobrutinib; Carbamazepine
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single dose of film-coated evobrutinib tablet (TF2) on Day 1 and Day 19.; Participants will receive carbamazepine tablet twice daily from Days 2 to 25.
Other intervention name(s): M2951
Intervention MeSH terms: Carbamazepine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Clinical Pharmacology
Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor
Condition: Brain and Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining chemotherapy with radiation therapy may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of irinotecan followed by radiation
      therapy and temozolomide in treating children who have newly diagnosed brain tumor.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the efficacy of adjuvant irinotecan in children with newly diagnosed high grade
           gliomas, brain stem glioma, or high risk grade II astrocytomas in terms of complete and
           partial response rate in patients with postoperative measurable disease, and in terms of
           the rate of freedom from recurrence in patients with no postoperative measurable
           disease.

        -  Determine the 3 year overall and progression free survival rates in this patient
           population when treated with adjuvant irinotecan followed by radiotherapy and
           temozolomide.

        -  Assess the hematopoietic toxicity of temozolomide following local radiotherapy in this
           patient population.

      OUTLINE: Patients receive postoperative irinotecan IV over 60 minutes daily for 5 days on
      weeks 1-2. Treatment repeats every 3 weeks for 2 courses. Following completion of irinotecan
      and if appropriate, patients may undergo a second surgical resection.

      Within 2 weeks following completion of chemotherapy or within 4 weeks of following a second
      resection, patients receive image guided external beam radiotherapy 5 days per week for 6
      weeks. Patients with residual tumor less than 3.5 cm in maximal diameter may undergo boost
      radiosurgery.

      At 4 weeks following completion of radiotherapy, patients receive oral temozolomide for 5
      days. Treatment repeats every 3 weeks for 6 courses.

      Patients are followed every 3 months for 2 years, then every 4 months for 3 years.

      PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 5 years.
    

Intervention name(s): irinotecan hydrochloride; temozolomide; conventional surgery; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Irinotecan; Temozolomide
Primary purpose: Treatment
Keywords: childhood high-grade cerebral astrocytoma; childhood high-grade cerebellar astrocytoma; childhood oligodendroglioma; untreated childhood brain stem glioma; untreated childhood cerebellar astrocytoma
A Randomized, Double-Blind, Active Control Trial Comparing Effects of Telmisartan, Candesartan and Amlodipine, Alone or Plus Metformin, on Non-Diabetic, Obese Hypertensive Patients
Condition: Hypertension; Obesity
MeSH terms: Hypertension; Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The epidemic of obesity is associated with a considerable rise in the incidence of the
      metabolic syndrome, type 2 diabetes mellitus, and hypertension. Insulin resistance plays an
      important role in the pathogenesis of obesity related hypertension. These patients are at
      high risk to suffer from cardiovascular events. However, current guidelines for treatment of
      hypertension do not provide specific recommendation for the pharmacotherapy of obese
      hypertensive patients due to lack of prospective randomized intervention studies in
      non-diabetic obese hypertensive patients.

      Aside from their antihypertensive effects, angiotensin II receptor blockers (ARB) were shown
      to improve insulin sensitivity. Furthermore, metformin is commonly used to treat the obese
      type 2 diabetes mellitus. Metformin can also lower body weight and increase insulin
      sensitivity. In a prospective, double-blind, double-dummy, randomized, parallel-group study,
      we will evaluate the effects of ARB (telmisartan and candesartan) or amlodipine combination
      with metformin on weight gain, visceral fat, and metabolic parameters in obese hypertensive
      patients without diabetes mellitus compared with obese hypertensives on ARB or amlodipine
      treatment alone. This study will help to develop future comprehensive treatment strategies
      and guidelines for obesity related hypertension.
    


Intervention name(s): Telmisartan plus Metformin; Telmisartan; Candesartan; Candesartan plus Metformin; Amlodipine; Amlodipine plus Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Telmisartan 80mg 1/d, Metformin 250mg 2/d; Telmisartan 80mg 1/d; Candesartan 8mg daily; Candesartan 8mg 1/d Metformin 250mg 2/d; Amlodipine 5mg 1/d; Amlodipine 5mg 1/d, Metformin 250mg 2/d
Other intervention name(s): Telmisartan Alone; Candesartan Alone; Amlodipine alone
Intervention MeSH terms: Metformin; Amlodipine; Telmisartan; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; Abdominal obesity; Treatment