bioihbjkbjnl/mcl2 huggingface dataset:
Epidemiological Study In Hypertensive Patients: Assessment Of Risk Factors Prevalence And Of Patients' Management
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      To assess the pattern of hypertension in the population in terms of presence of additional
      risk factors (ARF) and cardiovascular risk stratification.
    

Detailed description: 
      routine physician visits
    

Intervention name(s): Usual Care
Intervention type(s): Other
Intervention description(s): Normal care for hypertensive patients with risk factors for CHD
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult Hypertensive Patients managed in primary care
      
Keywords: Epidemiology, hypertension, risk factors, coronary heart disease, patient management, compliance with medication
Plant Based Diet, Ethnicity, and the Gut Microbiome
Condition: Diet Modification; Microbial Colonization
MeSH terms: Communicable Diseases; Infections
Study type: Interventional

Summary: 
      Samples will be collected to determine human genetic variation, fecal and oral microbial
      communities, and metabolome products. Several evolutionary and ecological diversity metrics
      will be distilled to test: a) if microbiome variation within each ethnicity is less than that
      between ethnicities; b) if microbiome variation is finely structured according to genetic
      relatedness; and c) if dietary variation impacts human genome x microbiome associations.
    

Detailed description: 
      To characterize the human gut microbiome under highly controlled dietary intake in healthy
      normal weight adult participants who differ by ethnicity: White non-Hispanic and Black
      non-Hispanic adults. Samples will be collected to determine human genetic variation, fecal
      and oral microbial communities, and metabolome products. Several evolutionary and ecological
      diversity metrics will be distilled to test: a) if microbiome variation within each ethnicity
      is less than that between ethnicities; b) if microbiome variation is finely structured
      according to genetic relatedness; and c) if dietary variation impacts human genome x
      microbiome associations.
    

Intervention name(s): Plant Based Diet
Intervention type(s): Other
Intervention description(s): Plant Based Diet for 4 Days Compared to Habitual Diet
Intervention model: Single Group Assignment
Intervention model description: Pre Post Design
Masking: None (Open Label)
Primary purpose: Basic Science
Nintendo Wii Virtual Reality Application In Dementia
Condition: Age-Related Memory Disorders
MeSH terms: Dementia; Memory Disorders
Study type: Interventional

Summary: 
      •This study was planned to investigate the effects of the Nintendo Wii virtual reality
      application on muscle strength and fall risk in individuals with AD.

      The aim of the present study is to investigate the effect of the virtual reality application
      on muscle strength and fall in individuals with Alzheimer' Dementia (AD).
    

Detailed description: 
      Purpose: This study was planned to investigate the effects of the Nintendo Wii virtual
      reality application on muscle strength and fall risk in individuals with AD.

      Method: The study included a total of 32 volunteers between the ages of 65-80, with mild or
      moderate AD diagnosed. These individuals were divided into 2 groups as a training group and
      control group. The training group was trained with games from different categories such as
      balance and aerobic exercises with a Nintendo Wii virtual reality device 2 times a week for a
      period of 6 weeks, with 1 session lasting for 30 minutes. Mini-Mental State Test, Knee
      Extension Muscle Strength, Timed Up and Go Test, Tinetti Falls Efficacy Scale results of
      individuals were recorded in the evaluation.
    

Intervention name(s): Nintendo Wii Virtual Reality Application
Intervention type(s): Other
Intervention description(s): The training group was trained with games from different categories such as balance and aerobic exercises with a Nintendo Wii virtual reality device 2 times a week for a period of 6 weeks, with 1 session lasting for 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer's Dementia; Muscle strength; Fall; Virtual reality
Physical Endometrial Manipulation and Its Effect on ICSI
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Unexplained infertility is clinically diagnosed when there are no apparent or clear factors
      causing infertility on regular infertility assessment tools . Failure of implantation is a
      possible factor causing unexplained infertility . Implantation is the main rate limiting step
      in IVF outcome. Implantation is described at cellular and molecular level by adhesion or
      fixation of good quality embryo to receptive endometrium within a critical period of time
      which is called the window of implantation .
    

Detailed description: 
      Testing the effect of Physical manipulation of the endometrium on the quality of the
      endometrium prior to ICSI cycle and if it increases the success rate
    

Intervention name(s): Hydrotubation
Intervention type(s): Device
Other intervention name(s): Sonohysterography; Endometrial scratching
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 640 were enrolled but 608 were analyzed
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: ICSI - physical - Manipulation - scratching
Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the safety and tolerability of AIR001 Inhalation
      Solution when administered under conditions of hypoxia and to identify dose levels of drug
      resulting in a reduction in pulmonary arterial pressure under these hypoxic conditions.
    


Intervention name(s): Sodium Nitrite Inhalation Solution; Placebo and AIR001 Inhalation Solution (Expansion arm)
Intervention type(s): Drug; Drug
Intervention description(s): a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization; On Day 1, subjects will receive a single placebo-form dose of inhaled nebulized AIR001 Inhalation Solution (containing diluent and excipient solutions alone). On Day 2, the same subjects will receive a single administration of AIR001 Inhalation Solution at the minimum pharmacologically active and safe dose identified from dose levels 1-4. Subjects will be blinded to the treatment schema.
Other intervention name(s): AIR001 Inhalation Solution; AIR001 Inhalation Solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression
Condition: Depression; Sleep; Sleep Disorder; Sleep Disturbance; Sleep Fragmentation; Sleep Initiation and Maintenance Disorders; Insomnia; Insomnia, Psychophysiological; Insomnia Due to Other Mental Disorder; Insomnia Related to Another Mental Condition
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Dyssomnias; Sleep Deprivation; Depression; Depressive Disorder; Mental Disorders
Study type: Interventional

Summary: 
      The aim of this trial is to investigate the effects of a single bout of aerobic exercise on
      sleep in patients with depression.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      The primary objective of this study is to evaluate whether a single bout of aerobic exercise
      improves sleep efficiency more than a control condition in patients with depression.

      SECONDARY OBJECTIVES:

      Secondary objectives are to assess the effects of a single bout of aerobic exercise on 1)
      sleep continuity, 2) sleep architecture, 3) pre-sleep arousal, 4) subjective sleep quality,
      5) daytime sleepiness, 6) nocturnal blood pressure, 7) heart rate variability, and 8) the
      frequency and severity of adverse events.

      DESIGN:

      This will be a two-arm parallel group, randomized, outcome assessor blinded, controlled,
      superiority trial. According to sample size calculation a total of 92 patients will be
      randomized using minimization. The trial will take place in the first five days of the
      patients' psychosomatic in-patient rehabilitation in the clinic OBERWAID, St.Gallen,
      Switzerland. The study visits are scheduled is as follows:

      Day 0-2: Screening, inclusion, and graded exercise test to determine exercise intensity of
      intervention

      Day 3: Questionnaires for background information

      Night 1 (day 3-4): Baseline polysomnography and sleep related questionnaires

      Day 4: Randomized allocation (control or exercise condition) and performing corresponding
      intervention

      Night 2 (day 4-5): Follow-up polysomnography and sleep related questionnaires

      Day 5: Daytime sleepiness questionnaire
    

Intervention name(s): Aerobic exercise, bicycle ergometer
Intervention type(s): Behavioral
Intervention description(s): Exercise performed below individual anaerobic threshold for 30 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Sleep; Depression; Heart rate variability; Blood pressure; randomized controlled trial; polysomnography
Pilot Study of Anlotinib With STUPP Regimen for Patients With Newly Diagnosed Glioblastoma
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to test the the efficacy and safety of Anlotinib in combination
      with STUPP regimen for patients with newly diagnosed glioblastoma.
    


Intervention name(s): Drug is Anlotinib.; Drug is Temozolomide Capsule.; Radiotherapy was initiated 4 to 6 weeks postoperatively.
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Anlotinib 8 mg/day (Chia-tai Tianqing Pharmaceutical Co., Ltd.) was given orally on days 1 to 14 per 3-week cycle for 2 cycles during concomitant therapy and maximally 8 cycles during adjuvant chemotherapy. One week after discontinuation of adjuvant chemotherapy, anlotinib 8 mg/day was given for maintenance .; Temozolomide 75 mg/m2/day was taken for maximally 49 days during concurrent chemoradiotherapy. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients received adjuvant temozolomide for 5 days every 28 days, first cycle 150 mg/m2/day and subsequent cycles 200 mg/m2/day for maximally 6 cycles .; Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0 Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy.
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prediction of Cognitive Properties of New Drug Candidates for Neurodegenerative Diseases in Early Clinical Development
Condition: Alzheimer Disease; Battery
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The early assessment of new drugs for Alzheimer's disease remains difficult because of the
      lack of predictive end-point. The use of a battery including different parameters could
      improve this early development of new drugs. Nevertheless, the interest of such a battery
      should previously be validated with the yet marketed AD drugs
    

Detailed description: 
      The aim of the present study is to test the effect of a 15-day treatment with donepezil on a
      mixed battery associating cognitive assessment, imaging and neurophysiological tests in
      healthy volunteers.

      This multicenter, randomized, placebo-controlled, cross-over study is double-blind controlled
      and is conducted in 3 centers located in France (Lille, Marseille and Toulouse).

      18-30 years old, healthy volunteers, without any neurological or psychiatric impairment, will
      complete 2 test sessions in a randomized order: one with a 15-day treatment with donepezil,
      the other with placebo, and will be submitted to a mixed battery during the 14th and 15th day
      of the treatment. The primary outcome of the study will be based on cognitive assessment,
      imaging parameters and neurophysiological parameters.
    

Intervention name(s): Donepezil .; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.; the placebo will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.
Other intervention name(s): ARICEPT ® Donépezil; Orally Disintegrating Tablets (ODT): 5 mg.
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer; Donepezil; biomarkers; battery; cognition; imaging; neurophysiological
Comparison of Premixed Insulin With Basal-plus Insulin in Type 2 Diabetes Patients
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of efficacy and safety of different insulin regimens between basal bolus and
      premixed insulin in poorly controlled type 2 diabetes
    

Detailed description: 
      This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in
      approximately 140 patients with type 2 diabetes from Mackay Memorial Hospitals and Mackay
      Memorial Hospital Taitung branch. After enrollment, eligible patients will be randomized in a
      1:1 ratio to either Basal-plus therapy(BPT) or Preprandial premix therapy(PPT). The
      effectiveness of advancing insulin therapy will be assessed at baseline and at 12 and 24
      weeks after initiation of study prescription. The safety will be followed during the 24-week
      study period. All study procedure will be conducted after obtaining informed consent.
    

Intervention name(s): switch twice-daily insulin
Intervention type(s): Drug
Intervention description(s): compare two different insuiln regimen in basal insuln base and premixed insulin.
NovoMix 30, drug class:biphasic insulins Lantus, drug class: long-acting insuiln Levemir, durg class: long-acting insulin NovoRapid, drug class: rapid-acting insulin
Other intervention name(s): NovoMix® 30 Penfill®, lantus®, levemir®, NovoRapid®
Intervention MeSH terms: Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: premix insuiln, basal-plus insulin
Deaf Weight Wise 2.0: A Healthy Lifestyle Intervention With Deaf Adults Who Are Overweight or Obese
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of the Deaf Weight Wise 2.0 (DWW 2.0) study is to test an evidence-based,
      comprehensive program to modify obesity-related health behaviors with Deaf people ages 21 to
      70 who use American Sign Language (ASL) as their primary language. Participants will be
      randomized to one of four arms: immediate intervention vs. intervention delayed one year, and
      in-person group intervention vs. individual intervention delivered via videophone. The
      investigators' primary hypothesis is that participants in the immediate DWW 2.0 intervention
      will increase their physical activity and reduce their caloric intake and body weight
      compared with those in the delayed intervention group (no intervention yet).
    


Intervention name(s): Deaf Weight Wise 2.0
Intervention type(s): Behavioral
Intervention description(s): Deaf Weight Wise 2.0 is a group or individual intervention lead by trained, American Sign Language fluent Deaf counselors, who utilize an existing evidence-based curriculum that emphasizes healthy eating, exercise, and lifestyle components. It is a behavior change intervention that uses motivational interviewing techniques to help participants identify/recognize their own unhealthy behaviors, help individuals build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise activities ("Do It!"), experiential learning activities ("Try It!" such as learning how to read a nutrition label or modify a recipe to make it healthier), and group activities related to food preparation or sampling healthy foods ("Taste It!"). Self-monitoring using daily food diaries and weekly "weigh-ins" is also a key component. The intervention also includes a 6-month follow up and maintenance phase.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Deaf; American Sign Language; Overweight; Obese
Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women
Condition: Maternal Obesity; Gestational Weight Gain; Obstetric Complications
MeSH terms: Obesity, Maternal; Weight Gain; Gestational Weight Gain
Study type: Interventional

Summary: 
      Obesity is a serious and increasing health problem in the Western World with about one third
      of all pregnant women in Denmark being overweight. Among these are more than 11% severe
      obese.

      Obesity in pregnancy is related to higher maternal morbidity and perinatal morbidity and
      mortality. Observational studies indicate that the rate of pregnancy complications among
      obese pregnant women can be limited if weight gain during pregnancy is restricted.

      Aims of the trial is to study the effects of diet and physical training during pregnancy
      among Danish obese women. Also to describe the metabolic effects of lifestyle intervention
      during pregnancy.

      360 obese pregnant women with Body Mass Index (BMI) > 30 are randomized to lifestyle
      intervention group or control group. The intervention is composed of individual dietician
      counselling and physical training. The physical training includes weekly aerobic exercises in
      a fitness center and lifestyle coaching in small groups.

      Both groups will be examined during pregnancy with extra ultrasound scanning of the fetus,
      blood pressure, and metabolic markers. All women receive vitamin supplementation to assure
      sufficient intake.
    


Intervention name(s): Lifestyle intervention; Control; Physical activity, dietetic counselling
Intervention type(s): Other; Other; Behavioral
Intervention description(s): Dietician counselling and physical training; Repeated measuring of maternal weight gain, blood samples and ultrasound; The active intervention consisted of two major components: dietary counseling and physical activity. Dietary counseling was performed by trained dieticians on four separate occasions at 15, 20, 28 and 35 weeks gestation.
Energy requirements for each participant were individually estimated according to weight and level of activity during pregnancy. Women in the active intervention group were encouraged to be moderately physically active 30-60 minutes a day.Women in this group also had free full time membership in a fitness center for six months. In the fitness centers they had closed training classes with trained physiotherapists for one hour each week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Analgesic Efficacy of Dexamethasone in Different Routes of Administration in Transverse Abdominis Plane Block
Condition: INFERTILITY
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Transverse abdominis plane (TAP) block is a regional anaesthesia technique that provides
      analgesia to the parietal peritoneum as well as skin and muscles of the anterior abdominal
      wall. In the past, a number of adjuvants have been added to the local anaesthetics in
      peripheral and neuraxial blocks resulting in an effective and long lasting analgesia.In
      recent times, dexamethasone has been increasingly used as an adjuvant to local anaesthetics
      in peripheral nerve blocks. Dexamethasone has a long and efficient glucocorticoid structure
      and also has anti-inflammatory property. It also blocks the C- fibers of pain pathway. When
      added to local anaesthetics as an adjuvant in peripheral nerve blocks, it has shown to
      prolong the analgesia time. A number of previous studies have also shown an opioid sparing
      effect of steroids, when used intravenously perioperatively. Though previous studies have
      shown that addition of dexamethasone to local anaesthetics in transverse abdominis plane
      block prolongs the duration of block, however it is not known whether this effect of
      dexamethasone is due to its peripheral action or because of its systemic absorption. Thus, in
      this study planned to compare the effectiveness of dexamethasone on quality and duration of
      analgesia when used as an adjuvant with local anaesthetics in transverse abdominis plane
      block versus when given systemically by intravenous route along with transverse abdominis
      plane block using local anaesthetics only, in patients undergoing gynaecological laparoscopic
      procedures under general anaesthesia.
    


Intervention name(s): Perineural Dexamethasone acetate; Intravenous dexamethasone acetate
Intervention type(s): Drug; Drug
Other intervention name(s): Decoin; Decoin
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral Nerve Excitability
Condition: Healthy Volunteers
MeSH terms: Hyperalgesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effect of intravenous ropivacaine and lidocaine
      on the receptive field of primary sensory afferents and their influence on the vascular bed.

      *Trial with medicinal product
    


Intervention name(s): ropivacaine (Naropin)
Intervention type(s): Drug
Intervention description(s): intravenous infusion 1 mg/kg bw
Other intervention name(s): Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment