bioihbjkbjnl/mcl2 huggingface dataset:
Agreement Between Standard and Continuous Wireless Vital Sign Measurements
Condition: Postoperative Patients
Study type: Observational

Summary: 
      Patients undergoing major surgery are at risk of postoperative complications. Continuous
      wireless monitoring outside the post-anesthesia or intensive care units may enable early
      detection of patient deterioration, but good accuracy of measurements is required.

      This validation study, which is part of the WARD-SX project, aimed to assess the agreement
      between vital signs recorded by standard and novel wireless devices
    

Detailed description: 
      Patients undergoing major surgery are at risk of postoperative complications. Complications
      may be preceded by abnormal vital signs. Standard monitoring at general wards is intermittent
      and manual, leaving the patients unobserved for extended periods.

      The chance to enhance monitoring has arisen with recent technological advances in the form of
      small wearable and wireless devices that continuously record vital signs. Wearable devices
      enable continuous monitoring outside the intensive care unit and post-anesthesia care unit,
      thus enabling early detection of patient deterioration. However, before implementing such
      devices in hospital settings, good accuracy, and precision of measurements is required.

      This validation study, which is part of the WARD-SX project, aimed to assess the agreement
      between vital signs recorded by standard and novel wireless devices
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients planned for major abdominal surgery at Bispebjerg and Frederiksberg, and
        Rigshospitalet.
      
Keywords: wearable devices; continuous; comparison study; validation
Enrichment of Day Centers in Community-based Psychiatry
Condition: Enrichment With Meaning-generating Activities; Rehabilitation as Usual
Study type: Interventional

Summary: 
      This RCT study addresses the topic of improving the possibilities for people with severe
      mental illness (SMI) to be engaged in meaningful daily occupations at community-based
      activity (CBA) centers. Meaningful occupation, which includes not only work-related
      activities, but also leisure, household and social activities, is assumed to generate health
      and wellbeing. It is well established that there is a relationship between satisfaction with
      daily occupations and well-being.

      A Swedish mental health care reform stated that the social services should provide meaningful
      daily occupations to people with SMI. However, evaluations of the effects of the reform
      conclude that the target group's needs for meaningful daily occupation have not been met.

      Thus, on the basis of governmental reports and evaluations, there is an urgent need for
      improving the quality of the activities and support offered at CBA centers. Therefore, the
      overarching aim of this project is to develop and implement an intervention method for
      improving the activities offered and support given at CBA centers, and evaluate the outcomes
      of that intervention.

      Specific aims

        -  Developing and implementing an intervention that means reorganization of CBA centers in
           such a way that they become enriched with characteristics that have been identified as
           rewarding and meaningful in previous research.

        -  Evaluating the outcome of that intervention on:

             -  the unit level, i.e., in terms of changes in the characteristics of the CBA
                centers,

             -  the individual level, in terms of changes among the consumers regarding
                satisfaction with the activities at the CBA center, perceived control, social
                interaction, quality of life, etc.

      Cluster randomization is used. Day centers are randomized to either giving the new
      intervention ("enrichment") or continuing with "care as usual" during the study period, which
      is 14 months. This means that all participants in a day center get the type care their
      specific day center offers during the study period.
    


Intervention name(s): Enrichment with meaning-generating activities
Intervention type(s): Behavioral
Intervention description(s): Gaps in the rehabilitation are identified by staff and researchers in dialogue. Staff gets relevant education. An intervention is tailored by staff and researchers to bridge the gaps. Consumers have a say and the intervention is revised accordingly. The intervention is implemented and continues for 14 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: everyday activities; rehabilitation; mental illness; occupational therapy
Benefits Counseling to Preserve Function Among Disability Applicants
Condition: Veterans' Disability Claims
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will address the problem that claimants with psychiatric disabilities who apply
      for and receive disability benefits go on to work less than those whose claims are denied.
    

Detailed description: 
      The objective of this research is to conduct a 6-month randomized clinical trial comparing
      participants assigned to Benefits Counseling and to those assigned to the control condition,
      VA Orientation. Benefits Counseling is an adaptation of two counseling approaches to foster
      veterans' involvement in work and work-related activity compared to the control condition, VA
      Orientation. The first approach helped recipients of Social Security disability benefits for
      psychiatric illness return to work in part by alleviating beneficiaries' concerns that they
      would lose their benefits if they worked. The second approach is a Motivational Interviewing
      approach that showed great promise in engaging veterans with psychiatric disabilities in
      compensated work therapy.
    

Intervention name(s): Benefits Counseling; VA Orientation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Benefits counseling is designed to improve the quality of life of disability applicants by accomplishing two functions: 1) Providing information concerning what vocational rehabilitation services are available and how they will affect receipt of disability payments, 2) Amplifying applicants' existing motivation to engage in work and related-activities, using a Motivational Interviewing approach.; VA Orientation is designed to provide the Veteran with information regarding the services available, how to access the services and where the service is located on the VA campus.
Other intervention name(s): Motivational Interviewing; New patient orientation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Rehabilitation, Vocational; Compensation and Redress; disability evaluation
Comparison of the Efficiency of Game-Based Exercise Program and Trunk Stabilization Exercise Training in Adolescent Playing Archery
Condition: Athlete; Itch
Study type: Interventional

Summary: 
      The aim of our study is to investigate the effects of a game-based exercise (Exergame)
      program and trunk stabilization exercise training on shooting performance, reaction time,
      trunk muscle endurance and balance in adolescents playing archery. While the importance of
      the effect of trunk stabilization on shooting performance is mentioned in individuals
      practicing archery, it is emphasized that trunk stabilization training increases sportive
      performance and protects against injuries in individuals interested in sports for the upper
      extremity. However, no study is found that directly compared game-based exercise programs and
      trunk stabilization exercise training in adolescents who play archery. Therefore, two
      different training programs will be given to the adolescents playing archery at the Archers
      Foundation Sports Club in Istanbul, and Shooting performance, reaction time, trunk muscle
      endurance, and balance levels will be evaluated before and after the training.
    


Intervention name(s): Trunk Stabilization Exercise Training Group; Game Based Exercise Program Group
Intervention type(s): Other; Other
Intervention description(s): The adolescents in this group who are involved in archery sports will be given 40 minutes of exercise training 2 days a week for 8 weeks. Exercise training will be applied as 5-10 minutes warm-up, 15-30 minutes trunk stabilization exercises, 5-10 minutes cooling down, and stretching exercises. The number of repetitions and difficulty levels of the exercises will gradually increase in the 3rd and 6th weeks.; At least 4 different games selected from Xbox 360 Kinect® games will be applied to adolescents practicing archery sports in this group for a total of 40 minutes with the physiotherapist. The games will be selected from games that include movement patterns similar to the exercises of the trunk stabilization exercise group. Game-based exercise training is planned to be performed twice a week for a total of 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Archery; trunk; balance; exergame; core stability
A Clinical Challenge Study of BCG in Healthy Volunteers
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional

Summary: 
      TB031 is a challenge study comparing two different strains of the Bacille Calmette-Guérin
      (BCG) vaccine at standard and high dose.
    

Detailed description: 
      Currently, to assess vaccine efficacy against tuberculosis (TB) there is no alternative to
      large randomized controlled trials. These efficacy trials for novel TB vaccines are
      difficult, long and very costly. For this reason there is an urgent need for a valid,
      reliable, and strong correlate of protection which can help distinguish between candidate TB
      vaccines undergoing phase I trials, and thereby allow the vaccine development field to
      advance more quickly, and in a more cost-effective manner.

      This study aims to address the current lack of immunological correlates in the TB vaccine
      field. As an alternative to phase II field trials, human challenge models can provide an
      evaluation of preliminary efficacy of vaccine candidates. Challenge models, with their
      concept of deliberate infectious challenge of human volunteers, have been well established
      for pathogens such as malaria, typhoid and dengue, and these models have greatly facilitated
      vaccine development. At present there is no safe human challenge model of Mycobacterium
      tuberculosis (M. tb) infection to enable proof-of-concept efficacy evaluation of candidate
      vaccines.

      Whilst scientists cannot use M. tb as a challenge agent to evaluate efficacy in a clinical
      trial for safety and ethical reasons, they can use another mycobacterium, attenuated
      Mycobacterium bovis, as a surrogate for M. tb infection. Attenuated Mycobacterium bovis is
      the mycobacterial strain in BCG and is safe to use in humans. An effective vaccine against M.
      tb should also be effective against BCG. After injection into humans, BCG replicates, and an
      effective TB vaccine should reduce this BCG replication. The BCG challenge model is based on
      this premise. In the human BCG challenge model, BCG is administered intradermally and the
      degree of BCG growth suppression is quantified by analysing the tissue obtained in a punch
      biopsy of volunteers' skin over the BCG 'challenge' site.

      This study aims to use two different strains of BCG, each at standard and high dose, to
      optimise this BCG challenge model.
    

Intervention name(s): BCG SSI; BCG Tice
Intervention type(s): Drug; Drug
Intervention description(s): Intradermal injection; Intradermal injection
Other intervention name(s): Bacille Calmette-Guérin Statens Serum Institute (BCG SSI); Bacille Calmette-Guérin Tice
Intervention MeSH terms: BCG Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: BCG challenge study
A Study to Assess the Safety, Tolerability and Pharmacokinetics of PAC-14028 Cream in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety/tolerability and pharmacokinetics of
      PAC-14028 cream after transdermal administration in healthy male volunteers.
    


Intervention name(s): PAC-14028; Vehicle
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive PAC-14028 cream applied topically once a day for 9 days; Participants will receive vehicle cream applied topically once a day for 9 days
Other intervention name(s): PAC-14028 cream 0.1%; PAC-14028 cream 0.3%; PAC-14028 cream 1.0%; Vehicle cream
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Pharmacokinetics
Metabolic Effects of Morning 16/8 Fasting
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      A study to address the effects of early-day fasting on fat tissue mobilization in comparison
      to a typical isocaloric Mediterranean and a low-carbohydrate breakfast.
    

Detailed description: 
      The study design meets a cross-over pattern with 3 different morning visits of 6 hour
      duration each. After an informed consent is received from the participant, a crude medical
      history, physical examination and collection of somatometric data through bio-impendance
      analysis will take place. An intravenous catheter will be placed in the participants forearm.

      At zero time point, depending on study visit, participants will either (A) remain fasted (B)
      start consuming ta pre-prepared zero-carbohydrate 500 kcal test meal (C) start consuming ta
      pre-prepared 500 kcal test meal with a composition conforming to a standard Mediterannean
      breakfast. Participants will be given 10 minutes to consume the meal.

      Blood samples will be drawn and visual analogue scales (VAS) for hunger and satiety will be
      filled in at the following time points (min): -15, 0, 15, 30, 60, 90, 120, 180, 240, 300,
      360.
    

Intervention name(s): fasting; Low carbohydrate; Mediterranean
Intervention type(s): Other; Other; Other
Intervention description(s): 6-hour fasting; Consumption of a zero-carbohydrate breakfast; Consumption of a Mediterranean-type breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which
      determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based
      on subject baseline characteristics/predictors of ovarian response.
    


Intervention name(s): Gonal-f; Recombinant human chorionic gonadotrophin (r-hCG)
Intervention type(s): Drug; Drug
Intervention description(s): GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle.; When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.
Other intervention name(s): follitropin alfa; Recombinant Human Follicle Stimulating Hormone (r-hFSH)
Intervention MeSH terms: Chorionic Gonadotropin; Follicle Stimulating Hormone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Assisted Reproductive Technology (ART); Infertility; Ovarian stimulation
A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating
      dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of
      clozapine in 40 patients with schizophrenia or schizoaffective disorder. Modafinil will be
      initiated at 100 mg/d. After 2 weeks, the study drug may be increased to 200 mg/d and after 4
      weeks, study drug may be increased to a maximum of 300 mg/d. Dose escalation will be based
      upon persistence of sedation versus emergence of side effects.
    

Detailed description: 
      This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating
      dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of
      clozapine in 40 patients with schizophrenia or schizoaffective disorder. Modafinil will be
      initiated at 100 mg/d. After 2 weeks, the study drug may be increased to 200 mg/d and after 4
      weeks, study drug may be increased to a maximum of 300 mg/d. Dose escalation will be based
      upon persistence of sedation versus emergence of side effects.

        1. Evaluate tolerability and safety of modafinil compared to placebo using the SAFTEE and
           vital signs.

        2. Evaluate the effect size of modafinil compared to placebo upon wakefulness and fatigue
           using the Epworth Sleepiness Scale (ESS) and the Fatigue Severity Scale (FSS).

        3. Evaluate the effect size of modafinil compared to placebo upon negative symptoms using
           the SANS total score.

        4. Evaluate the effect size of modafinil compared to placebo upon cognitive functioning
           using a standard battery of cognitive tests.

        5. Evaluate the effect size of modafinil compared to placebo upon weight, BMI, waist/hip
           circumference and fasting glucose and lipids.

        6. Effect the variability of response in placebo and modafinil groups for each of the
           outcome measures.
    

Intervention name(s): modafinil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): modafinil 100mg tablets. dose excalation up to 300mg
Other intervention name(s): Provigil
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Clozapine; Cognition; Metabolic Syndrome; Negative Symptoms; Wakefulness; Fatigue
A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The study involves a single dose of a study drug called abemaciclib taken by mouth. The
      purpose of this study will be to measure how much study drug gets into the blood stream and
      how long the body takes to get rid of it when given to participants with mild, moderate, or
      severe liver impairment compared to healthy participants. In addition, the tolerability of
      the study drug will be evaluated.

      This study will last approximately 3 weeks for each participant, including check-in and
      follow-up.
    


Intervention name(s): Abemaciclib
Intervention type(s): Drug
Intervention description(s): Administered Orally
Other intervention name(s): LY2835219
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pulmonary Rehabilitation and Self-esteem in Patients With COPD
Condition: COPD
Study type: Observational

Summary: 
      the aim of this study is to evaluate the evolution of self-esteem during a pulmonary
      rehabilitation program, in COPD patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COPD patients admitted to a pulmonary rehabilitation program
Propionate and Energy Homeostasis
Condition: Obesity
Study type: Interventional

Summary: 
      The research project aims to examine the effect of a dietary supplement called propionate on
      how the human body in healthy adults aged (18- 65 years) responds to during fasting, exercise
      and following a liquid mixed meal test and how that would affect energy homeostasis and
      substrate oxidation.
    

Detailed description: 
      Dietary fibres have long been recognised for their important role in a healthy diet due to
      their negative association with, and even management of, chronic diseases such as obesity,
      diabetes, metabolic syndrome, cardiovascular disease and inflammatory-bowel disease among
      others.Emerging evidence has suggested that these benefits could largely be attributed to
      short chain fatty acids (SCFA) (acetate, propionate and butyrate), the main by-products of
      fibre fermentation in the gut. Previous research has demonstrated that a long-term elevation
      in the SCFA propionate significantly reduced body weight gain in overweight adults and
      reduced liver fat storage.

      The current project will examine potential mechanisms for the positive effect of propionate
      on energy homeostasis and metabolic profile.The effects of propionate on circulating glucose,
      insulin, gut hormones and lipid levels at rest, following moderate-intensity exercise and
      mixed meal tolerance test will be examined.

      To acutely increase propionate absorption from the gut the present project will use a simple
      nutritional supplement: sodium propionate in a hydroxypropylmethyl cellulose (HPMC) capsule.
      This capsule is coated with an enteric film which prevents gastric digestion until the
      capsule reaches the intestine. This nutritional supplement has been used in human volunteers
      in a previously approved ethics application (12/LO/1769: Oral propionate and glucose
      homeostasis). A 5g acute dose of sodium propionate had previously been tested and reported no
      adverse effects . The MHRA have confirmed that encapsulated sodium propionate is not classed
      as an investigative medicinal product.
    

Intervention name(s): Placebo (Sodium Chloride); Exercise; Sodium Propionate
Intervention type(s): Other; Other; Dietary Supplement
Intervention description(s): Participant receive Placebo (Sodium Chloride); 1 hour exercise; Participant receive Sodium Propionate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This protocol consisted of three individual trials. Participants will complete only a single trial.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Short Chain Fatty Acids; Propionate; Energy Expenditure; Lipid Oxidation