bioihbjkbjnl/mcl2 huggingface dataset:
Hospital Based Group Intervention for Breast Cancer Patients.
Condition: Breast Cancer; Anxiety; Depression; Quality of Life; Coping
MeSH terms: Breast Neoplasms; Depression
Study type: Interventional

Summary: 
      INCAM-study is a multicenter, prospective, randomized controlled trial. The aim of the study
      is to test the effectiveness of psychoeducative intervention when offered in hospital setting
      as a component of routine breast cancer care. The hypotheses are; - that breast cancer
      patients participating in psychoeducative interventions focusing on coping will experience
      better health-related quality of life than those who participate in the hospital standardised
      psychoeducative intervention. - that coping styles are associated with the immune system.
    

Detailed description: 
      Women operated for breast cancer often experience psychosocial problems for several years.
      Although, meta-analyses have clearly demonstrated that the efficacy of psychosocial support
      groups, little is known about the effectiveness of this intervention when offered in the
      hospital setting as a component of routine breast cancer care.

      A few studies have found that psychological intervention reduce emotional distress and
      enhance immune responses,but if there is an association between coping styles and immune
      system is not clear.

      440 breast cancer patients at two Hospital will be randomized into the study. Both Hospital
      have standardised psychoeducative interventions as a component of routine breast cancer care.
      Both Hospital will have two groups, the standardised groups and the experimental groups.
      Participants will answer the same standardised questionnaires before surgery,2,6,12 months
      and 3 and 5 years after the interventions. Blood sample will be drawn at all assessments. The
      questionnaires are the Hospital Anxiety and Depression Scale, the Mini-mental Adjustment to
      Cancer Scale, the EORTC QLQ-BR32, the Life Orientation Test-Revised.

      All groups are facilitated by two nurse specialists and follow a structured program. The
      standardised groups consists of three weekly 2-hours sessions and the experimental groups
      will consists of six weekly 2-hours session. The intervention protocol has been approved by
      the Norwegian Committee for medical research Ethics.

      Knowledge from this study will be used to develop a manual for hospital based group
      interventions for breast cancer patients.
    

Intervention name(s): Psychoeducative; Support group
Intervention type(s): Behavioral; Other
Intervention description(s): The experimental group consists of five weekly 2-hours sessions, focusing on coping with diagnosis and treatment; Standard Hospital follow-up support group
Other intervention name(s): Intervention group; Standard group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
A Retrospective Study of the Effects of Different Parameters on Motor Symptoms of PD in Bilateral STN Stimulation
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The purpose of this study is to assess the impact of different parameters (voltage, pulse
      width, frequency) of subthalamic nucleus (STN) deep brain stimulation (DBS) on motor symptoms
      in patients with Parkinson's disease (PD).
    

Detailed description: 
      In this observational study, we will retrospectively analyze the one-year follow-up data of
      27 PD patients who received bilateral STN DBS in the First Affiliated Hospital of Sun Yat-sen
      University in the years 2008-2012. The data, including parameter settings and severity of
      motor symptoms indicated by Unified Parkinson's Disease Rating Scale (UPDRS) Part III scores,
      was collected during the patients' annual visit to the hospital for reprogramming. A
      correlation analysis will be conducted to investigate the relationship between change of a
      specific parameter and the subsequent change of motor scores.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        PD patients who received bilateral STN DBS in the First Affiliated Hospital of Sun Yat-sen
        University
A Bioequivalence Study Comparing Irbesartan/Atorvastatin Combination Tablet With Coadministration of Irbesartan and Atorvastatin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetics and safety after oral
      administration of Irbesartan and Atorvastatin in combination as HCP0912
    


Intervention name(s): HCP0912 / Irbesartan and Atorvastatin
Intervention type(s): Drug
Intervention description(s): Irbesartan and Atorvastatin combination tablet / coadministration of Irbesartan and Atorvastatin
Intervention MeSH terms: Irbesartan; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Irbesartan; Atorvastatin; combination
A Study of Veliparib in Combination With Carboplatin and Paclitaxel in Japanese Subjects With Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 open-label study and consists of 3 treatment groups (dose levels) .
      Treatment cycles are 3 weeks in duration. The primary objective of this study is to determine
      the recommended phase two dose (RPTD) of veliparib (ABT-888) when administered in combination
      with carboplatin and paclitaxel in Japanese subjects with solid tumors. Secondary objectives
      are to assess pharmacokinetics and to obtain a preliminary efficacy of anti-tumor activity in
      the subjects.
    


Intervention name(s): veliparib (ABT-888); carboplatin; paclitaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dosing orally twice daily starting Day 1 through day 7 of each cycle. Decisions to move to the next cohort will be based on evaluation of DLTs in the current cohort. Decisions will be made with a discussion between the Sponsor and the principal investigator to dose escalate or de-escalate or add more subjects to the cohort.; Carboplatin will be administered on Day 3 of each cycle, intravenously.; Paclitaxel will be administered on Day 3 of each cycle, intravenously.
Other intervention name(s): paraplatin; taxol
Intervention MeSH terms: Paclitaxel; Carboplatin; Veliparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevention of Intraoperative Nausea and Vomiting During Cesarean Section
Condition: Cesarean Delivery
MeSH terms: Nausea; Vomiting
Study type: Interventional

Summary: 
      The study investigates the incidence of intraoperative nausea and vomiting under spinal
      anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.
    


Intervention name(s): Metoclopramide; Phenylephrine infusion; Combination Group
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Prophylactic Metoclopramide 10 mg given before spinal together with prophylactic phenylephrine infusion; Prophylactic phenylephrine infusion after spinal and placebo antiemetics; Metoclopramide and ondansetron prophylaxis with phenylephrine infusion
Other intervention name(s): Metoclopramide and ondansetron
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Ondansetron; Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Nausea; Vomiting
Oncologic Impact of Pancreatic Fistula
Condition: PDAC of the Body and the Tail of the Pancreas; CR- POPF
MeSH terms: Pancreatic Fistula; Fistula
Study type: Observational

Summary: 
      Clinically-relevant post-operative fistula is a major complication after DP, but it did not
      affect post-operative therapeutic path nor oncologic long-term outcomes. CR-POPF was not a
      predictive factor for disease recurrence and it was not associated with an increased
      incidence of peritoneal or local relapse.
    

Detailed description: 
      POPF is the most common and feared complication after distal pancreatectomy (DP), increasing
      morbidity and mortality. Recent evidences suggest that POPF can also play a role in
      pancreatic cancer recurrence. Adult patients with a diagnosis of pancreatic ductal
      adenocarcinoma (PDAC) of the body and tail of the pancreas, undergoing curative DP, over a
      ten-year period in twelve European Surgical Departments were retrospectively collected from a
      prospective implemented database. Cohort studied included 283 patients, 139 were men (49.1%),
      median age was 70 years-old (range 37-88). A total of 121 POPF were observed (42.8%), 42 of
      them (14.9%) were CR-POPF. Median follow-up period was 24 months (range 3-120). Although
      poorer in the POPF group, overall survival (OS) and disease-free survival (DFS) did not
      differ significantly when comparing patients with and without CR-POPF (p= 0.224 and p= 0.165,
      respectively). CR-POPF was not significantly associated with local or peritoneal recurrence
      (p=0.559 and p=0.302, respectively). Less patients after POPF (76.2% versus 83.8%) benefited
      from adjuvant chemotherapy but the difference was not significant (p=0.228). CR-POPF is a
      major complication after DP, but it did affect neither the post-operative therapeutic path
      nor oncologic outcomes. CR-POPF was not a predictive factor for disease recurrence and it was
      not associated with an increased incidence of peritoneal or local relapse.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All adult patients with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) of the body
        and the tail of the pancreas, undergoing DP with curative intent, over a ten-year period
        (from January 2009 to December 2018) in twelve European Surgical Departments were
        retrospectively collected from a prospective implemented database.
      
Keywords: Clinically relevant pancreatic fistula; pancreatic leak; pancreatic cancer; left pancreatectomy; distal pancreatectomy; oncologic outcome; pancreatic cancer recurrence
The Effect of EX1 Training in Normal Adults
Condition: Aerobic Exercises; Anaerobic Exercises
Study type: Observational

Summary: 
      In this study, when performing aerobic and anaerobic exercise with EX1 applied to normal
      adults between the ages of 19 and 65. The purpose of this study was to determine the effect
      on the muscle activity of the trunk and lower extremities compared with and without EX1.
    

Detailed description: 
      In this study, aerobic exercise and anaerobic exercise for normal adults were divided into
      two visits for a total. For aerobic exercise, the investigators compared the aerobic
      treadmill walking program without EX1 [30 minutes of moderate (64-76% HRmax, 12-14 of RPE)
      aerobic treadmill walking, 40 minutes including warm-up and cool-down times], the aerobic
      treadmill walking program with EX1 [30 minutes of moderate (64-76% HRmax, 12-14 of RPE)
      aerobic treadmill walking, 40 minutes including warm-up and cool-down times] , and the
      high-intensity interval exercise (HIIT) program with EX1 [High-intensity-low-intensity
      interval walking exercise was performed at treadmill speed (High: 90-95% HRmax, 15-17 of
      RPE/Low: 60-70% HRmax, 9-11 of RPE) and EX1 resistance strength (High: resistance intensity
      7- 9/Low: Resistance strength 0-2)] to check the effect on muscle activity, heart rate, and
      respiratory metabolic energy consumption rate.
    

Intervention name(s): aerobic and anaerobic exercises
Intervention type(s): Device
Intervention description(s): [aerobic]
Aerobic treadmill walking program without EX1
Aerobic treadmill walking program with EX1
High-intensity interval exercise (HIIT) program with EX1
[anaerobic]
1. Fitness exercise program with EX1
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Normal adults aged 19 to 65 years
Mortality Reduction After Oral Azithromycin: Mortality Study
Condition: Childhood Mortality
Study type: Interventional
Phase: Phase 4

Summary: 
      Our long-term goal is to more precisely define the role of mass azithromycin treatments as an
      intervention for reducing childhood mortality. We propose a single multi-site
      (multi-country), cluster-randomized trial comparing communities randomized to oral
      azithromycin with those randomized to placebo. We hypothesize that mass azithromycin
      treatments will reduce childhood mortality.
    

Detailed description: 
      We will assess childhood mortality over three years, comparing communities where children
      aged 1-60 months receive biannual oral azithromycin ("Azithromycin" arm) for two years, to
      communities where the children receive biannual oral placebo ("Control" arm) for two years.
      During the third year at the Niger site only, everyone will receive azithromycin.

      This is a cluster-randomized trial; at each site, communities within a contiguous area of
      300,000 to 600,000 individuals will be randomized to azithromycin or placebo using simple
      random sampling.

      Niger contingency study: In the event that mass distributions of oral azithromycin are proven
      to reduce mortality in 1-60 month-old children, then we will treat all communities in Niger
      with mass azithromycin distributions to test whether the intervention continues to reduce
      childhood mortality after the initial 2 years of mass treatments.
    

Intervention name(s): Azithromycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.; Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
Other intervention name(s): Zithromax
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Childhood mortality; Azithromycin; Mass treatment; Infection; Verbal Autopsy
Prospective Population Based Cohort Study on Cognitive and Cardiovascular Aging (MonaLisaPredor)
Condition: Aging
Study type: Observational

Summary: 
      Aging is a long term process, starting early in life, and progressively affecting various
      functions and organs. Cardiovascular diseases and cognitive impairment are two conditions
      related to advancing age and sharing common risk factors. The Mona Lisa- PREDOR study is a
      population-based prospective cohort study carried out to develop risk prediction algorithms
      aimed at identifying people who are the most likely to develop impaired psychometric and
      cognitive functioning and impaired cardiovascular risk, in the coming years.
    

Detailed description: 
      The study is aimed at identifying predictors of impaired changes in psychometric and
      cognitive performances and level of cardiovascular risk, over a seven-year period, and to
      develop risk prediction algorithms. Main secondary objectives are to study response to
      psychometric and cognitive tests according to age, and to estimate the prevalence of the
      frailty syndrome according to age.

      The design is a prospective cohort study carried out among 1500 men and women from the
      general population, aged 42-89 years, and living in South-western France. Except for
      participants aged 80-89 years, all participants have been previously assessed in 2005-2007,
      as regard to their psychometric and cognitive performances and level of cardiovascular risk,
      as part of the Mona Lisa study.

      Data collection includes a detailed questionnaire on previous medical history, drug intake,
      education level, and life habits; a standardised clinical examination; psychometric tests
      (word list learning test, digit symbol substitution test, word fluency test and Stroop test),
      and a fasting blood sample. Level of cardiovascular risk and frailty syndrome were assessed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The design is a prospective cohort study carried out among 1500 men and women from the
        general population, aged 42-89 years,and living in South-western France. Except for
        participants aged 80-89 years, all participants have been previously assessed in 2005-2007,
        as regard to their psychometric and cognitive performances and level of cardiovascular
        risk, as part of the Mona Lisa study.
      
Biospecimen description: 
      Blood
    
Keywords: Cohort study; psychometric tests; cognitive function; cardiovascular risk; prediction algorithm
Experimentally Testing the Effectiveness of a Campus-based Bystander Intervention
Condition: Assaultive Behavior; Violence; Sexual Assault and Rape; Helping Behavior
Study type: Interventional

Summary: 
      The purpose of this study was to examine the impact of a bystander intervention education
      program on college students' attitudes and behaviors associated with bystander intervention
      and sexual violence.
    

Detailed description: 
      This study used a randomized control trial, longitudinal design to determine the impact of a
      peer education theater intervention on undergraduate student attitudes and behaviors related
      to sexual violence and bystander intervention. Students were assigned to either an
      experimental group (receiving 3-4 doses of the intervention ) or a comparison group
      (receiving 1 dose only) and were surveyed six times over an 18 month period.
    

Intervention name(s): SCREAM Theater Dose 1; SCREAM Theater Doses 2 & SCREAM Theater Dose 3; SCREAM Theater Dose 4
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Intervention 1: A three part program: a skit acted out by peer educators that depicts a sexual assault; an in-character question and answer session; and an out-of-character information session.; Dose 2: Scenes from the skit from Session 1 are re-created with small groups of students, but stop at certain points to allow audience members to explore different bystander intervention possibilities.
Dose 3: The six scenes outlined in Session 2 are presented individually to small groups of student participants; specifically outlining potential points of bystander intervention.; Booster Session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: campus sexual assault; bystander intervention
A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004542)
Condition: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the the study is to evaluate the ability of injections of Ji Gami(TM) C to
      induce hair growth in male and female subjects with hair loss.
    


Intervention name(s): Autologous cultured dermal and epidermal cells
Intervention type(s): Biological
Intervention description(s): A piece of occipital scalp is taken from the subject. A mixed population of dermal cells from this tissue are expanded in culture. The cells are then harvested. These cells are then injected into the balding area of the scalp of the original subject.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness; Hair Loss; Baldness
Effect of Pre-warming on Perioperative Hypothermia During HoLEPunder Spinal Anesthesia
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      Inadvertent perioperative hypothermia is an unintentional drop in core body temperature below
      36°C. Intraoperative hypothermia can lead to serious clinical complications such as,
      myocardial ischemia, coagulopathy, immunosuppression, and surgical wound infection.
      Hypothermia develops easily during surgeries that require irrigation fluid, such as
      laparoscopic surgery and transurethral resection of the prostate. Although isothermic
      irrigation fluid was suggested to prevent perioperative hypothermia, it can be difficult to
      warm a large volume of irrigation fluid.

      Re-distribution after induction of anesthesia is the most important cause of perioperative
      hypothermia. The extent of re-distribution is proportional to the gradient between the core
      and peripheral compartments. Pre-warming increases the heat content of the peripheral thermal
      compartment, reducing the gradient for redistribution. Recently, A recent-meta analysis
      suggested that as a single strategy, preoperative forced air warming had significant benefits
      than other warming methods. Also, it was reported that only 20 (or even 10) min of
      pre-warming mostly prevented patients from perioperative hypothermia under general
      anesthesia. However, few studies have examined whether short time pre-warming can reduce
      hypothermia due to a large amount of irrigation fluid during surgery under spinal anesthesia.

      The purpose of this study is to assess whether the application of preoperative forced air
      warming set to high temperature (> 43°C) for brief period can prevent hypothermia or
      shivering during procedures requiring large volumes of cold irrigation.
    


Intervention name(s): pre-warming; no warming
Intervention type(s): Other; Other
Intervention description(s): On arrival at the preoperative care unit, assignments were determined using an opaque sealed envelope opened by investigator with no clinical involvement in the study. In the pre-warming group, the forced-air blanket (COVIDIEN™ WarmTouch™ Full Body/Multi Access Blanket, Covidien Ilc, Mansfield, MA, USA) was positioned over the whole body except head and neck, covered by cotton blanket. Forced air warmer (COVIDIEN™ WarmTouch™ WT6000 Warming Unit, Covidien Ilc, Mansfield, MA, USA) was set to 'high level' (45℃) during 20 min. During the warming procedure, patients were asked every 5 min about their thermal comfort; if they felt overheated, the warmer was lowered to 41℃; patients were covered only with two layers of cotton blanket
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention