bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Weight Reduction on Sleep and Alertness in Long-distance Truck and Bus Drivers
Condition: Abdominal Obesity
MeSH terms: Obesity, Abdominal; Weight Loss
Study type: Interventional

Summary: 
      The study is a year-long health-behaviour intervention in obese, male truck-drivers to lose
      weight moderately by 10%, using monthly individual counseling. The investigators hypothesize
      that lifestyle modification (increased physical activity, changes in eating habits, and
      improved schedule for sleep) through weight loss improves daytime alertness and quality of
      sleep, reduces daytime sleepiness, and improves cardiovascular risk factors and
      health-related fitness.
    

Detailed description: 
      Daytime sleepiness, i.e., being fatigued at work is an important risk factor for traffic
      accidents involving commercial vehicles. Sleep-related disturbances and daytime fatigue may
      be partly related to obesity, which is common among truck drivers. This study is a randomised
      12-month health-behaviour intervention in obese, male truck-drivers. We hypothesize that
      lifestyle modification (increased physical activity; decreased energy intake; and improved
      schedule for sleep), aimed to reduce weight moderately by 10%, improves daytime alertness and
      quality of sleep, reduces daytime sleepiness, and improves cardiometabolic health and
      health-related fitness. The primary aim is weight loss. We will recruit 140 participants aged
      30-62 years and with abdominal obesity. The participants are randomised into an intervention
      (INT) and control (CON) group, for 12 months. The INT group gets individual lifestyle
      counseling monthly. After 12 months, the CON group receives weight-loss counseling for 3
      months. Assessments (psychological vigilance test, sleep duration, dietary intake, physical
      activity, metabolic syndrome, health-related fitness) take place at months 0, 12 and 24. We
      expect to develop counseling strategies (leading to weight loss through changes in lifestyle)
      that can be used to improve sleep, alertness and cardiometabolic health in occupational
      health care.
    

Intervention name(s): weight loss counseling
Intervention type(s): Behavioral
Intervention description(s): individual monthly lifestyle counseling, face-to-face (6 times, each 45 min) and by telephone (7 times, each 30 min), on how to decrease energy intake and change eating habits to improve quality of dietary fat and carbohydrate, how to increase daily walking steps; and how to improve sleep quality (sleep hygienic tips)
Other intervention name(s): lifestyle counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: abdominal obesity; weight reduction; diet; exercise training; lifestyle activity; health-related fitness; walking; actigraphy; lifestyle modification; sleep; sleep hygiene; alertness; daytime sleepiness; metabolic syndrome; counselling; health education; truck drivers; bus drivers; randomized controlled trial
Effect of Bifidobacterium Breve B-3 on Body Fat in Obese Adults
Condition: Obesity
Study type: Interventional

Summary: 
      Comparison of a randomized, double-blind, and control-group study for the effect of oral
      ingestion of Bifidobacterium breve B-3 on body fat reduction in obese adults
    

Detailed description: 
      Our aim is to investigate the effect of oral ingestion of Bifidobacterium breve B-3 on body
      fat reduction in adults by a randomized, double-blind, and control-group study.
    

Intervention name(s): Bifidobacterium breve B-3; Control group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 160 mg of Bifidobacterium breve B-3 is orally administered per day for 12 weeks.; 160 mg of placebo is orally administered per day for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Retinol-induced Dermatitis in Aged Skin
Condition: Aged Skin; Photoaged Skin
MeSH terms: Dermatitis
Study type: Observational

Summary: 
      Topical therapy with retinoids is the only proven medical therapy for aged/photoaged human
      skin. However, topical therapy with retinoids often result in unwanted cutaneous dermatitis,
      including erythema and scaling. The reseachers intend to investigate the dose, frequency of
      use, and time dependence of topical retinol-induced dermatitis. The researchers intend to
      evaluate retinoid-induced dermatitis biochemically, including retinol regulation of retinoid
      responsive genes that control retinoid metabolism and serve as markers for retinoid
      bioactivity. The researchers will also investigate the role of EGF receptor pathway in
      retinoid-induced dermatitis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be between the ages of 21-60 years of age, with moderate clinical
        photodamage, and either gender.
      
Biospecimen description: 
      Skin biopsies will be taken; however, they are not intended to be used for DNA extraction.
    
Keywords: Aged skin; Photoaged skin; Retinol; Topical retinoids
Characterization and Risk Factors of Folliculitis After Hair Transplantation
Condition: Folliculitis
MeSH terms: Folliculitis
Study type: Observational

Summary: 
      We retrospectively reviewed 1317 patients who had undergone HT and completed 9-month
      follow-up between January 2018 and June 2021 at 4 medical centers. The incidence of
      postoperative folliculitis and the patient demographics were assessed. Logistic regression
      analysis was used to identify the risk factors, and the characteristics of different types of
      folliculitis were compared.
    

Detailed description: 
      Postoperative folliculitis is a common complication after hair transplantation (HT) and
      requires effective preventive interventions. This study aimed to characterize postoperative
      folliculitis and determine the risk factors in patients underwent HT. The study was conducted
      at 4 clinical sites: Nanfang Hospital of Southern Medical University, the First Affiliated
      Hospital, Zhejiang University School of Medicine, the Affiliated Hospital of Guilin Medical
      University, and Peking University Third Hospital. Data of 1317 patients who had undergone HT
      and completed a 9-month follow-up from January 2018 to June 2021 were collected. The
      incidence of postoperative folliculitis and the patient demographics were assessed. Logistic
      regression analysis was used to identify the risk factors, and the characteristics of
      different types of folliculitis were compared.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Data of 1317 patients who had undergone HT and completed a 9-month follow-up from January
        2018 to June 2021 were collected.
      
Keywords: folliculitis; hair transplantation; Follicular Unit Extraction
Influence of Sit Muscle Strength Training and Game on Elderly
Condition: Aging; Physical Disability; Dementia; Elderly
MeSH terms: Dementia
Study type: Interventional

Summary: 
      Objective: The study aims to understand the physical function, body composition, mental
      state, behavior, depression, and life quality change of the elderly in a long-term care
      before and after the intervention. Four interventional activities are sitting strength
      training, games, sitting strength training with games, and health education.
    

Detailed description: 
      Expected results: (1) The program will facilitate arrange activities that are beneficial to
      the body and mind, activate bodily functions, and promote the quality of life of the elderly
      in Taiwan. (2) The program can compare the effectiveness of different trainings for the
      elderly and provide a reference for future implementation planning. (3) Evidence of the
      empirical study of this program can provide future comparisons with other domestic and
      foreign studies.
    

Intervention name(s): Sit muscle strength training; Game training; Sitting strength + game training; Health education
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Sit muscle strength training using a sand bag grip ball conducted twice a week. Each exercise session will begin and end with a 5-15 minute warm-up and cool-down routine. The exercise program consists of 20-40 minute chair-based resistance exercises.; Game training (including ball activities, clay courses, massage, puzzles, painting conducted four times a week). Each section 30-60 minutes.; Sitting strength training (using sandbag training conducted twice a week) and game training (such as ball activities and clay courses) conducted twice a week).; Health education (conducted once a month). Each section 50-60 minutes. The topics are oral hygiene, medicine safe, living safe, food safe.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
COMPARISON OF DEXMEDETOMIDINE AND REMIFENTANIL FOR POSTOPERATIVE PAIN IN TRANSPHENOIDAL Pituitary SURGERY
Condition: Postoperative Pain
MeSH terms: Pituitary Diseases; Pain, Postoperative
Study type: Observational [Patient Registry]

Summary: 
      In patients with pituitary adenoma scheduled for endoscopic transsphenoidal pituitary
      surgery, it was aimed to compare the efficacy of postoperative pain relief of a selective α-2
      agonist "Dexmedetomidine" and the rapid and short-acting opioid "Remifentanil" using the
      "Numerical Rating Scale" (NRS) administered alongside propofol in perioperative maintenance
      anesthesia. .
    


Intervention name(s): Dexmedetomidine; Remifentanyl
Intervention type(s): Drug; Drug
Intervention description(s): Efficacy of dexmedetomidine on postoperative pain in patients undergoing transsphenoidal pituitary surgery; Efficacy of remifentanyl on postoperative pain in patients undergoing transsphenoidal pituitary surgery
Intervention MeSH terms: Dexmedetomidine; Remifentanil
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing transsphenoidal pituitary surgery
      
Keywords: DEXMEDETOMİDİNE; REMİFENTANYL; pituitary SURGERY
Bioequivalence Study of Rotigotine Transdermal Patch With Two Different Formulations in Healthy Japanese Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate and compare the drug amount delivered to the body after each single
      administration of Rotigotine patch with 2 different formulations in healthy Japanese
      subjects.
    


Intervention name(s): Rotigotine PR 2.1.4; Rotigotine PR 2.2.1
Intervention type(s): Drug; Drug
Intervention description(s): Treatment B: Rotigotine transdermal patch (2 mg/24 h [10 cm^2]). Reference; drug product PR 2.1.4. Single application of 1 patch for 24 hours.; Treatment A: Rotigotine transdermal patch (2 mg/24 h [10 cm^2]). Test; drug product PR 2.2.1. Single application of 1 patch for 24 hours.
Other intervention name(s): Neupro; Neupro
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Rotigotine; Neupro®; Transdermal Patch; Bioequivalence
Safety Study of the Inhibition of Agouti-related Protein (AgRP) for the Management of Obesity and Weight Loss
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      Multiple pathways including peripheral and central hormones and neurotransmitters are
      involved in the regulation of food intake and body weight. One of the most studied pathways
      involves the melanocortin receptor. Agouti-related protein (AgRP) and alpha-melanocyte
      stimulating hormone (alphaMSH)have been shown to play an integral role in food intake and
      body weight.

      It is reasonable to speculate that if there is an imbalance of alphaMSH and AgRP exist in
      obese individuals and inhibiting the activity of AgRP may be of therapeutic benefit in
      treating obesity.
    


Intervention name(s): TTP435; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Class 1; Class 2; Weight Loss; AgRP; TTP435; alphaMSH; Agouti-Related Protein; alpha-melanocyte stimulating hormone
Inpatient Exposure Therapy and Response Prevention & Cognitive Remediation Therapy for Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      Exposure and response prevention (AN-EXRP) will help individuals with anorexia nervosa
      improve their eating behavior.
    

Detailed description: 
      Anorexia nervosa (AN) is a serious illness associated with substantial morbidity and a
      mortality rate among the highest of any psychiatric illness. The rate of relapse is
      disturbingly high, with up to 50% of patients requiring re-hospitalization within a year of
      discharge. Current treatments are inadequate in helping older adolescents and adults achieve
      sustained recovery. Importantly, eating behavior remains disturbed after weight restoration:
      patients demonstrate restrictive eating in their self-selected foods and in standardized
      meals, and caloric intake in standardized meals is inversely related to pre-meal anxiety.
      Emerging data suggest that eating behavior is particularly important in post-hospital course,
      and that significantly altering eating behavior is critical in improving outcome for these
      individuals. Furthermore, caloric intake in standardized meals has been shown to be related
      to pre-meal anxiety. This study evaluates the potential utility of two psychotherapeutic
      interventions in improving eating behavior prior to hospital discharge. Each individual
      receives, in random order, Cognitive Remediation Therapy for 4 weeks and Exposure and
      Response Prevention for AN for 4 weeks. The investigators hypothesize that these
      interventions will lead to improvement in eating behavior, measured by food diaries and
      standardized meals.
    

Intervention name(s): Exposure Therapy for AN (AN-EX/RP); Cognitive Remediation Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 Sessions, 3 times per week. 90 minute sessions. Group therapy twice per week.; 12 Sessions, 3 times per week. 45 minute sessions. Group therapy twice per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tirofiban Intracoronary Bolus-only Versus Intravenous Bolus Plus Infusion in STEMI Patients
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this randomized trial is to compare the efficacy of high dose tirofiban
      administered as either an intracoronary bolus alone or as an intravenous bolus followed by a
      maintenance infusion with respect to microvascular perfusion and long term left ventricular
      infarct size, volumes and function.
    

Detailed description: 
      Primary percutaneous coronary intervention (PCI) is currently the treatment of choice for
      patients with acute ST elevation myocardial infarction (STEMI). Nevertheless, despite
      restoration of normal epicardial flow, myocardial perfusion remains impaired in approximately
      half of patients and is associated with a poor prognosis. A variety of invasive and
      non-invasive techniques have been proposed to evaluate microvascular perfusion and several
      invasive hemodynamic measures have been closely associated with microvascular damage.In order
      to improve microvascular perfusion after primary PCI, a variety of treatment strategies have
      been developed, such as adjunctive administration of glycoprotein IIb/IIIa inhibitors (GPIs).
      Although current ACC/AHA guidelines recommend that small molecule GPIs should be administered
      as a bolus followed by 18 hours of continuous infusion, changes in clinical practice may
      obviate the need for a maintenance infusion in current practice.

      We hypothesized that when tirofiban is administered via intracoronary route, a bolus-only
      strategy may even be superior to intravenous bolus plus infusion strategy in maintaining
      myocardial perfusion. In order to evaluate microvascular function, we used a guidewire tipped
      with pressure and temperature sensors and measured the coronary hemodynamic parameters, as
      the index of microvascular resistance and coronary flow reserve, measures which have been
      closely associated with microvascular damage. In order to increase the predictive value of
      these indices, we performed these measurements four to five days after MI, because it has
      been shown that the extent of microvascular dysfunction changes, particularly within first 48
      hours after reperfusion and stabilizes between 2 days and 1 week after perfusion
    

Intervention name(s): tirofiban intracoronary bolus-only; tirofiban intravenous bolus plus infusion
Intervention type(s): Drug; Drug
Intervention description(s): administer tirofiban bolus intracoronary during primary percutaneous coronary intervention with no additional maintenance infusion; administer tirofiban bolus intravenously and maintain infusion for up to 18 hours
Other intervention name(s): Aggrastat; Aggrastat
Intervention MeSH terms: Tirofiban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary angioplasty; tirofiban; microcirculation
Effectiveness and Safety of Yisaipu Combined With Tripterygium Wilfordii for Active RA
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      In this 24-week, multi-center, randomized, double-blind study, the investigators will
      evaluate the efficacy and safety profile of subcutaneously injected Yisaipu, a Tumor Necrosis
      Factor Receptor Fusion Protein, combined with oral Tripterygium Wilfordii for patients with
      active rheumatoid arthritis.
    

Detailed description: 
      This study evaluates the efficacy and safety of YISAIPU plus Tripterygium wilfordii (T2w) for
      the treatment of RA patients. YISAIPU is a recombinant human tumor necrosis factor receptor
      fusion protein, and tripterygium wilfordii is a chloroform/methanol extract of Tripterygium
      wilfordii Hook F.

      Objectives:

        1. To compare the efficacy of YISAIPU plus T2w versus MTX monotherapy for the treatment of
           signs and symptoms of RA.

        2. To evaluate the safety of YISAIPU plus T2w in patients with RA for 24 weeks.

      Design:

      This is a randomized, 24-week, double-blind, parallel group study, and 506 patients with
      active RA will be randomized in a 1:1:1:1 ratio to one of the following four parallel
      treatment arms:

        1. Methotrexate monotherapy

        2. T2w monotherapy

        3. YISAIPU plus methotrexate

        4. YISAIPU plus T2w

      Escape:

      On week 13, all participants with inadequate response, defined as a <30% improvement of
      swollen and tender joint counts from baseline, will switch to YISAIPU plus T2w treatment
      throughout the study.

      Endpoints :

        1. ACR20, ACR50 and ACR70 response rates at 12 and 24 weeks.

        2. DAS 28 (CRP) and DAS 28 (ESR) at 12 and 24 weeks.

        3. EULAR response rates at 12 and 24 weeks.

        4. Health assessment questionnaire (HAQ) at 12 and 24 weeks.

        5. Patient assessment of arthritis pain at 12 and 24 weeks.

        6. Patient and physician global assessment of arthritis at 12 and 24 weeks.
    

Intervention name(s): Tripterygium Wilfordii; Methotrexate; Yisaipu
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral Tripterygium Wilfordii 20mg thrice daily for 24 weeks.; Oral methotrexate 7.5-15mg per week for 24 weeks. The starting dose was 7.5mg per week, then increased to 15mg (max 0.3mg/Kg) per week in 4 weeks. Folic acid at the dose of 5 mg per week were applied to all participants.; Yisaipu, a Tumor Necrosis Factor Receptor Fusion Protein, was subcutaneously injected at a dose of 50 mg once a week for 24 weeks.
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Methotrexate; Tripterygium; TNF inhibitor