bioihbjkbjnl/mcl2 huggingface dataset:
Implementability and Effectiveness of the Safety Planning Intervention for Suicidal Behavior
Condition: Suicide; Suicide, Attempted; Suicidal Ideation
MeSH terms: Suicide; Suicidal Ideation; Suicide, Attempted
Study type: Interventional

Summary: 
      The Safety Plan Intervention (SPI) has demonstrated to reduce suicide reattempts and to
      increase the ambulatory follow-up in american war veterans. This study evaluates the
      implementability and effectiveness in a significantly different population in a real world
      setting.
    

Detailed description: 
      We will perform a Effectiveness-implementation Hybrid Design (Curran et al. 2012) to study
      firstly the feasibility of implementing the SPI in our clinical setting and secondly its
      effectiveness. The experimental arm will consist in a group of patients who visit the ED for
      a suicide-related concern in which the SPI is performed. This will be in the Emergency
      Department , unless for clinical reasons, the ED psychiatrist decide to postpone it to the
      first psychiatric appointment (which will be before one week of the ED visit as part of the
      treatment as usual).

      Right after the SPI is performed, both the patient and the clinician will complete
      questionnaire with satisfaction and acceptability measures. Subjects will be followed for 6
      months. At this time medical records will be consulted to obtain suicide reattempts rates and
      follow-up adherence.

      At all times, the anonymity of the participants will be preserved and will require heading of
      informed consent, as well as other ethical aspects indicated by the Ethics Committee.
    

Intervention name(s): Safety Plan Intervention
Intervention type(s): Behavioral
Intervention description(s): The SPI has 6 key steps: (1) identify personalized warning signs for an impending suicide crisis; (2) determine internal coping strategies that distract from suicidal thoughts and urges; (3) identify family and friends who are able to distract from suicidal thoughts and urges and social places that provide the opportunity for interaction; (4) identify individuals who can help provide support during a suicidal crisis; (5) list mental health professionals and urgent care services to contact during a suicidal crisis; and (6) lethal means counseling for making the environment safer (Stanley & Brown, 2012)
Other intervention name(s): Security Plan
Intervention model: Single Group Assignment
Intervention model description: Interventional cohort (Safety Plan Intervention)
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Suicide; Suicidal behavior; Suicidal attempt; Suicide prevention; Safety Planning Intervention
CKD-330 Drug-Drug Interaction Study (Candesartan)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of
      Candesartan between free combination of Candesartan and Amlodipine and Candesartan
      monotherapy.
    


Intervention name(s): Candesartan 32mg; Candesartan 32mg/Amlodipine 10mg
Intervention type(s): Drug; Drug
Intervention description(s): Candesartan 32mg 1T, PO, QD for 9days; Candesartan 32mg 1T, PO, QD for 9days/Amlodipine 10mg 1T, PO, QD for 9days
Other intervention name(s): Atacand Tab. 32mg; Atacand Tab. 32mg/Norvasc Tab. 10mg
Intervention MeSH terms: Amlodipine; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Racial Differences in the Natriuretic Peptide Response to Glucose Challenge
Condition: Healthy; Natriuretic Peptides; Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The purpose of the study is to discover any racial dissimilarity in the response of
      Natriuretic peptide (NP) system to acute metabolic influences such as a high carbohydrate
      challenge
    

Detailed description: 
      Previous studies have shown an association between reduced levels of circulating natriuretic
      peptides (NPs) and obesity in humans. This association is especially pronounced in those with
      metabolic syndrome traits and elevated plasma insulin. As previously conducted study has
      shown that an increase in NPs with weight loss in obese individuals is "primary" and not
      secondary to alteration in cardiac structure or function.

      Previous experimental data suggests that Atrial NP (ANP) has a wide range of favorable
      metabolic effects including that activation of brown fat and improvement in skeletal muscle
      oxidative capacity and glucose utilization. New evidence suggests that ANP activation
      directly modulates insulin sensitivity and energy homeostasis, suggesting that ANP
      suppression could promote more obesity/insulin resistance. Moreover, ANP exerts potent
      lipolytic effects in vitro and in vivo. The previous study has shown that a high-carbohydrate
      challenge in healthy volunteers is associated with a reduction in N-terminal-proANP
      (NTproANP) but not N-terminal-proB-type NP (NTproBNP) levels. Nonetheless our outcomes were
      predominantly in Caucasians and warrants replication in other racial groups.

      There is no data on the ANP response to high-carbohydrate challenge in African Americans, a
      racial group with disproportionately greater rates of obesity, insulin resistance, and
      diabetes as compared to Caucasians. So the investigators have proposed to conduct a pilot
      study in otherwise healthy, normotensive subjects to examine NP system, especially the
      effects on MRproANP in response of high-carbohydrate challenge.
    

Intervention name(s): Study diet; Glucose Challenge
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).; Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Each participant will be enrolled into one of the two groups by race.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Racial differences
Safety and Pharmacokinetic Study of NPT 2042 Soft-gelatin Capsules Administered Orally to Healthy Adult Subjects
Condition: Epilepsy; Alzheimer Disease; Epilepsy Intractable
MeSH terms: Alzheimer Disease; Epilepsy; Drug Resistant Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study NPT 2042 CL 101 is a first in human (FIH) study to evaluate the safety and
      pharmacokinetics (PK) of single and repeated ascending doses of NPT 2042 in healthy adult
      male and female subjects.
    

Detailed description: 
      The long-term goal of this program is to develop NPT 2042 an adjunct antiseizure treatment
      for patients with medically intractable epilepsy. Prior to evaluating efficacy in the
      intended patient population, safety and pharmacokinetics of NPT 2042 will be investigated.
    

Intervention name(s): NPT 2042 (bumetanide analog) or Matching Placebo
Intervention type(s): Drug
Intervention description(s): Soft gelatin capsules
Intervention MeSH terms: Bumetanide
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CNS Disorder; Seizure Disorder
Effect of Acupressure on Fatigue in Hemodialysis Patients
Condition: End-stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Fatigue
Study type: Interventional

Summary: 
      OBJECTIVE: To investigate the effect of acupressure on fatigue in patients with end-stage
      renal disease (ESRD) undergoing hemodialysis (HD) as well as assess sleep quality and
      psychological status HYPOTHESIS TO BE TESTED: Upon intervention completion, the experimental
      group will exhibit lower severity of fatigue and depression/anxiety and improved sleep
      quality compared to the control group.

      DESIGN AND SUBJECTS: A randomized controlled trial with experimental and control groups. A
      total of 116 patients with ESRD who screen positive for fatigue severity ≥ 4 (using a
      single-item indicator of fatigue, which ranges from 0 to 10 points) will be recruited.

      STUDY INSTRUMENTS: Brief Fatigue Inventory (BFI), Pittsburgh Sleep Quality Index (PSQI), and
      Hospital Anxiety and Depression Scale (HADS) INTERVENTION: A 4-week acupressure intervention
      was performed by the principal investigator (PI) for every subject by applying the rate of
      two rotations per second, three times a week.

      MAIN OUTCOME MEASURES: Primary: fatigue. Secondary: sleep quality, depression, and anxiety.

      DATA ANALYSIS: Multiple regression was used to analyze between-group differences in BFI and
      PSQI, while ordinal logistic regression was used to analyze the subscales of the HADS.

      EXPECTED RESULTS: The proposed acupressure intervention is useful for alleviating fatigue and
      related symptoms (sleep quality, depression, and anxiety) experienced by patients with ESRD.
    

Detailed description: 
      The prevalence and impact of fatigue and related symptoms in patients with ESRD have been
      clearly demonstrated in the literature, which also emphasizes the need for evidence-based
      interventions targeting symptom management in such patients. The main challenge is
      identifying an intervention that is not only effective in managing hemodialysis-related
      symptoms, but also feasible, acceptable, and safe for this patient group. The proposed study
      primarily aims to test the effects of acupressure intervention on fatigue in ESRD patients
      receiving HD using the robust study design of a randomized controlled trial.
    

Intervention name(s): True acupressure; Sham acupressure
Intervention type(s): Other; Other
Intervention description(s): Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides).
Total time: 18 minutes/acupressure therapy.; Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides).
Total time: 18 minutes/acupressure therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: End-stage renal disease; Hemodialysis; Acupressure; Fatigue; Sleep; Anxiety/depression
Pharmacokinetics and Pharmacodynamics of Mepolizumab Administered Subcutaneously in Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Mepolizumab is a humanized immunoglobulin G (IgG1) monoclonal antibody (mAb) that exhibits
      dose proportional and time-independent pharmacokinetics. The study will be conducted in 2
      parts. Part A: it will be pharmacokinetic (PK) and pharmacodynamic (PD) study conducted to
      support the use of mepolizumab in children aged 6 to 11 years with severe eosinophilic asthma
      and characterize the PK/PD of mepolizumab 40 milligrams (mg) or 100 mg administered
      subcutaneously depending on participant body weight. Part B: It is a long-term safety /
      pharmacodynamic phase in which extended treatment for a further 52 weeks will be offered on
      an optional basis to those subjects eligible for continued treatment. Participants with
      bodyweight <40 kilogram (kg) will be dosed with mepolizumab 40 mg and participants with body
      weight >=40 kg will be dosed with mepolizumab 100 mg subcutaneously in upper arm or thigh at
      Visit 2 (Week 0). Approximately 40 male or female participants aged 6 to 11 years will be
      screened to achieve approximately 28 eligible participants entering the treatment phase to
      allow availability of 20 evaluable participants, with a minimum of six participants enrolled
      in the <40 kg bodyweight group. The total duration of the study will be 22 weeks and will
      include a run-in period of 1-2 weeks, a treatment period of 12 weeks and a follow-up phase of
      8 weeks. A participant will be considered having completed the study if the participant
      completes all phases of the study including the follow-up phase (Week 20 [visit 8]).
    


Intervention name(s): Mepolizumab
Intervention type(s): Drug
Intervention description(s): Mepolizumab is supplied as 100 mg lyophilised cake in sterile vials for subcutaneous administration in upper arm or thigh. The vial will be reconstituted with sterile water for injection prior to individual use.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetics; pediatric; Mepolizumab; subcutaneous; eosinophilic asthma; pharmacodynamics
Clinical and Health Economic Impact of Robot-assisted Surgery vs Conventional Laparoscopy : the Case of Gastric Bypass
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      The purpose of this study is to gather clinical and economic evidence on the use of robotics
      for bariatric surgery (gastric bypass).

      This monocentric, randomized, single blind, controlled study will evaluate post-operative
      pain, quality of life and appetite, post-operative complication incidence. It will also
      provide information on direct and indirect costs of surgery.
    

Detailed description: 
      Robot-assisted Surgery Versus Conventional Laparoscopy in Bariatric Surgery (Gastric Bypass):
      a prospective, single-blind, randomized, non-inferiority, and controlled study The main
      evaluation criterion is 24h post-operative pain assessed using visual analog scale (VAS).
      Secondary criteria included for clinical assessment: post 24h pain, excess weight loss,
      quality of life, appetite, complications, conversion rate; and for health-economics
      assessment : duration of surgical steps, length of stay, return to normal activity and their
      conversion to cost, consumables, estimation of indirect costs and benefits (e.g., robotics
      perception, publication).

      In this study, main inclusion criteria include major obesity (IMC ≥ 35) with co-morbidities
      or morbid obesity (IMC ≥ 40), scheduled gastric bypass surgery Main contraindications are
      previous bariatric surgery and previous major abdominal surgeries To test robotic-assisted
      surgery non-inferiority on VAS pain score 24h post-surgery, a total of 128 patients (64 per
      arm) is to be included (alpha 2,5%; power 90%; drop-out rate: 5%).

      The study will include 12 months of follow-up post-surgery for each patient. The total study
      duration is 2 years and 3 months.
    

Intervention name(s): Gastric bypass
Intervention type(s): Procedure
Intervention description(s): Gastric bypass
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Gastric bypass; Robot-assisted surgery; Conventional laparoscopy; Pain assessment; Health economics outcomes
Efficacy of Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation in Hemodialysis Patients
Condition: Complication of Dialysis; Chronic Kidney Disease; Muscle Loss; End Stage Renal Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effect of 6 months of daily beta-hydroxy
      beta-methylbutyrate (HMB) supplementation on the physical function and the health of bones,
      arteries and heart in hemodialysis patients.
    

Detailed description: 
      Patients with renal failure receiving hemodialysis experience an increased rate of skeletal
      muscle protein catabolism which is associated with a number of co-morbid conditions including
      declines in muscle mass and strength, significantly increased fall risk, and reduced quality
      of life (QOL. Therefore, interventions to prevent muscle loss in hemodialysis are needed.
      Pharmacological agents have been investigated to treat muscle loss in dialysis patients;
      however, many of these treatments are expensive and have undesirable side effects. As a
      result, low-cost interventions designed to attenuate losses in muscle mass and strength in
      hemodialysis patients are needed.

      Beta-hydroxy beta-methylbutyrate (HMB) represents a potential low-cost nutritional
      intervention to attenuate muscle loss in hemodialysis patients. HMB is a metabolite of the
      amino acid leucine that has been shown to safely increase muscle mass in other clinical
      populations with prevalent muscle loss, such as the elderly, cancer, and AIDS patients
      primarily through reductions in skeletal muscle protein catabolism. The primary purpose of
      the trial is to determine if oral supplementation with HMB attenuates muscle loss, improves
      muscle strength, physical function, fall risk and QOL in hemodialysis patients. Alterations
      in protein and gene expression associated with skeletal muscle protein turnover will be
      measured to investigate the mechanism for changes in our primary outcomes. We hypothesize
      that HMB supplementation will attenuate declines in muscle size and strength in hemodialysis
      patients.
    

Intervention name(s): HMB; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Following this initial round of testing,participant will be assigned to daily HMB supplementation for 6 months. You will be asked to consume a 1000mg HMB capsule 3 times per day, 7 days per week, for 6 months.; The placebo group will consume non-nutritive placebo pills daily for 6 months.
Other intervention name(s): beta-hydroxy-beta-methylbutyrate, calcium-hmb
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: hemodialysis; physical function
Expandability of Aging Adipose Tissue
Condition: Aging; Obesity
Study type: Interventional

Summary: 
      The purpose of this pilot study is to determine whether adipose tissue loses some of its
      ability to expand in response to overfeeding in older compared to younger men. The
      investigators hypothesize that the adipose tissue response to overfeeding may be weakened in
      older when compared to younger men, thereby leading to worsened ectopic storage depots for
      older men.
    

Detailed description: 
      This pilot study will begin to address whether adipose tissue biology changes with advancing
      age. Specifically, we will test whether adipose tissue loses some of its ability to expand in
      response to overfeeding in older compared to younger men. To test this possibility the
      Investigators will recruit overweight and mildly obese older (age 55-75y) and younger (age
      25-40y) men and collect adipose tissue biopsies before and after 7 days of overfeeding. The
      investigators will test how well the cells in adipose tissue expand in response to
      overfeeding and whether this differs between younger and older men.
    

Intervention name(s): Overfeeding
Intervention type(s): Other
Intervention description(s): Consumption of 40% excess calories for 7 consecutive days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Adipose tissue; Overfeeding
A Trial to Investigate Efficacy and Usability of Published Best Practice to Control Glycaemia
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the efficacy of enhanced published best practice
      paper-based insulin titration protocol for glycaemic control in hospitalised patients with
      type 2 diabetes for the length of hospital stay.
    


Intervention name(s): Insulin Aspart, Insulin Glargine
Intervention type(s): Drug
Intervention description(s): The Intervention is a paper based protocol, which provides suggestions for new insulin doses (basal-bolus regime).
Intervention MeSH terms: Insulin; Insulin Glargine; Insulin Aspart
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women
Condition: Female Sexual Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to assess the bioavailability of total testosterone through
      pharmacokinetic profiles obtained following (a) single administration of three doses of TBS-2
      b) multiple administration TBS-2.

      In addition, assessing the bioavailability of free testosterone, dihydrotestosterone, SHBG
      and estradiol through pharmacokinetic profiles was also conducted.
    

Detailed description: 
      This is a 2 Period study that requires overnight stays in clinic. Blood samples are required
      at all visits including sampling at predefined time periods during the overnight stays.

      Period I

      Subjects were checked-in on Day 1 Period I to start their baseline testosterone measurement
      (dependant on menstrual cycle, preferably within 48hr of start of the menstrual cycle). They
      remained institutionalized until Day 4 morning, and were checked out after the 48 hour blood
      draw and study close-out for those that did not continue with Period II.

      Period II (Multi-Dose)

      At the end of Period 1, a total of 8 subjects sampled from these 3 cohorts, who were willing
      and able to continue with the multiple-dose portion of the study were selected to participate
      in Period 2. Subjects were institutionalized starting on Day 1 of Visit 3 until Day 5 morning
      of Visit 3, and were checked out after the 48 hour blood draw and study close-out.
    

Intervention name(s): Low dose testosterone nasal gel, single dose; Medium dose testosterone nasal gel, single dose; High dose testosterone nasal gel, single dose; Medium dose testosterone nasal gel, multiple dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Low dose testosterone nasal gel, single dose; Medium dose testosterone nasal gel, single dose; High dose testosterone nasal gel, single dose; Medium dose testosterone nasal gel, multiple dose
Other intervention name(s): TBS-2; TBS-2; TBS-2; TBS-2
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: testosterone; pharmacokinetics