bioihbjkbjnl/mcl2 huggingface dataset:
Project Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities
Condition: Substance Use; Mental Health
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This study provides substance use and mental health treatment for young sexual and gender
      minority adults in Durham and Charlotte, NC and seeks to provide intensive wraparound
      services that address factors that influence substance use and mental health among this
      population such as minority stressors and lack of social support, housing instability, lack
      of access to affirmative health care, and limited job opportunities.
    

Detailed description: 
      Project Uplift provides evidenced-based substance use and mental health treatment, intensive
      case management, and peer support services for sexual and gender minorities, ages 18-35. The
      program is based in two metropolitan areas in North Carolina, Durham and Charlotte, and will
      offer services for approximately 80 sexual and gender minority young adults. Survey data
      collected from participants at baseline and at the end of the 6-month program will be used to
      evaluate the effectiveness the comprehensive care program.
    

Intervention name(s): Project Uplift
Intervention type(s): Behavioral
Intervention description(s): Substance use and mental health treatment for young sexual and gender minorities in Durham and Charlotte, NC in conjunction with intensive wraparound services that address factors that influence substance use and mental health among this population.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sexual and Gender Minorities; Substance Use and Mental Health Treatment; Mental Health; Substance Use; Minority Stress; Young Adults; Intensive Case Management; Peer Support
Investigation of the Effects of Physical Activity in Women at Risk of Osteoporosis
Condition: Osteoporosis Risk
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The goal of this clinical trial is to investigate the effects of the increase in the physical
      activity level of women at risk for osteoporosis in the post-menopausal period on the
      physical fitness, functional fitness age and quality of life. The main question it aims to
      answer is:

      • Does the increase in the level of physical activity positively affect the physical fitness
      parameters (strength, endurance, balance, agility and flexibility), functional fitness ages
      and quality of life of post-menopausal women with moderate to high osteoporosis risk?

      Participants in the intervention group were given the Otago Exercise Program, which will last
      3 days a week and an average of 30 minutes per day for 12 weeks. The exercises were done
      one-by-one with a physiotherapist. No program were applied to the participants in the control
      group, and they were asked to continue their daily living activities in the same way.

      Researchers will compare two groups to see if there is a difference in effects of Otogo
      Exercise Program on physical fitness, functional fitness age, and quality of life.
    

Detailed description: 
      The osteoporosis risks of the participants were calculated according to the Osteoporosis
      Self-Assessment Tool for Women (OST). Women have medium and high risk were included in the
      study.

      Otago Exercise Program includes strengthening exercises consisting of knee extension, knee
      flexion, hip abduction, ankle dorsi flexion, and 12 balance exercises consisting of plantar
      flexion and squatting, walking backward, walking and rolling back, sideways walking, tandem
      stance, tandem gait, standing on one leg, heels walking on toes, walking on tiptoe, sitting
      and standing, climbing and descending stairs, and backward tandem walking.

      • In addition, moderate-intensity walking exercise for 30 minutes a day, 2 days a week, was
      recommended to the patients in experimental group.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Doing Otago Exercise Program, which lasting 3 days a week and an average of 30 minutes per day under the supervision of a physiotherapist. Also doing walking exercise for 30 minutes a day, 2 days a week for total of 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Functional Fitness Age; Osteoporosis; Otago Exercise Program; Post-Menopausal Woman; Quality of Life; Physical Fitness
Arginine Synthesis in Healthy Adult Humans
Condition: Healthy
Study type: Interventional

Summary: 
      Arginine synthesis in mammals is a complex process involving at least 8 enzymes and
      intracellular and interorgan transfer of substrates.

      The investigators have shown in our neonatal studies that there is no conversion of glutamate
      to arginine but proline label appears in ornithine, citrulline and arginine. It is clear
      therefore that arginine is synthesized in human neonates from proline.

      In adults the source of the carbon backbone is less clear.
    

Detailed description: 
      Through a series of test in healthy adults using tandem mass spectrometry with carbon labeled
      GLN and nitrogen labeled PRO to determine the dietary source for the carbon chain of ORN, CIT
      and ARG. Additionally, using Nitrogen labeled GLN, we will identify the source of the
      nitrogen atoms in these amino acids.

      Using guanidino - 15N2 arginine, 1-13C Glutamine, 2-15N Glutamine and 15N Proline we will be
      able to:

        1. determine the flux of arginine and proline in healthy adult volunteers

        2. determine and compare the flux of carbon and nitrogen labeled glutamine

        3. demonstrate whether glutamine or proline provides the carbon backbone for ornithine,
           citrulline and arginine in adults.

        4. the source of the N atoms in ornithine, citrulline and arginine.
    

Intervention name(s): 2-15N glutamine; 15N2 arginine and 15N proline; 1-13C glutamine
Intervention type(s): Other; Other; Other
Intervention description(s): Glutamine with N15 isotope tracer; Arginine and Proline isotope tracers; Glutamine carbon isotope tracer
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Arginine synthesis; 15N2 arginine, 1-13C Glutamine, 2-15N Glutamine, 15N Proline
Impact of Pregnancy on Buprenorphine Pharmacokinetics and Pharmacodynamics
Condition: Opiate Addiction; Pregnancy
MeSH terms: Opioid-Related Disorders
Study type: Observational

Summary: 
      The primary purpose of this study is to determine whether buprenorphine and metabolite
      exposure (reflected as the dose-adjusted plasma concentration x time curve [AUC]) differs
      during pregnancy and between pregnancy and the postpartum state.The study will define the
      pharmacokinetics of buprenorphine and determine if there is a better way to gauge dosing
      based on objective, physiological parameters of satiety. The study will define neonatal
      exposure to buprenorphine through breast milk.
    

Detailed description: 
      Currently, the standard of care for an opioid-dependent pregnant woman in most institutions
      is methadone, however, buprenorphine (BUP) is also used for this indication, as it is
      FDA-approved for opioid addiction although not specifically for pregnant women. There has
      been increasing evidence that BUP may have comparable efficacy to methadone, and may have
      fewer severe neonatal complications especially neonatal abstinence syndrome (NAS) and
      decreased severity of adverse reactions. The dosing of BUP currently is based on studies in
      men and non-pregnant women (adjusted to the patient's symptomatology using the Clinical
      Opiate Withdrawal (COW) score, some of which is subjective and some based on objective
      physiological parameters) and limited animal data that related plasma concentrations of BUP
      to the degree of saturation of the µ receptor in the brain.

      The study team will define the pharmacokinetics and limited pharmacodynamics of BUP in early
      and late pregnancy and the postpartum period and determine what contributes to the variation
      in plasma concentrations and response and will also relate plasma concentrations of BUP and
      its major metabolites to physiologic parameters that can be used to gauge the amount of drug
      in mother's plasma. It is expected to demonstrate that higher doses of BUP are needed
      throughout pregnancy and that the dosing regimen can be adjusted using patient covariates and
      biophysical measurements in addition to the COW scores.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample of pregnant women who are receiving sublingual BUP (subutex) in a
        supervised hospital or outpatient clinical setting because of their opiate addiction.
      
Biospecimen description: 
      Venous Blood, Hair, Urine, Saliva, Placenta, Umbilical Cord Blood/Tissue, Postpartum Breast
      Milk
    
Keywords: Buprenorphine; Opiate Substitution Treatment
Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Pantoprazole 80 mg in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

        -  Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on
           Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with
           pantoprazole 80 mg/day compared to given alone in healthy male subjects

        -  Compare the pharmacokinetic profiles of clopidogrel active metabolite when clopidogrel
           is given either alone or concomitantly with pantoprazole

      Secondary Objective:

        -  Compare the pharmacokinetic profiles of clopidogrel when clopidogrel is given either
           alone or concomitantly with pantoprazole
    

Detailed description: 
      The total study duration per subjects is 8 - 9 weeks broken down as follows:

        -  Screening: 2 to 21 days before the first dosing

        -  Period clopidogrel/placebo: 7 days including 5 days treatment

        -  Period clopidogrel/placebo + pantoprazole: 14 days including 12 days treatment

        -  Washout between periods: at least 14 days after last dosing with respect to clopidogrel
           treatment

        -  End of study: 7 to 10 days after the last dosing
    

Intervention name(s): Clopidogrel; Placebo; Pantoprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: matching tablet
Route of administration: oral; Pharmaceutical form: delayed-release tablet
Route of administration: oral
Other intervention name(s): SR25990; PROTONIX
Intervention MeSH terms: Pantoprazole; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Schistosomiasis in Women of Reproductive Age in Burkina Faso: Implications for Control
Condition: Schistosomiasis; Anaemia; Pregnancy
MeSH terms: Schistosomiasis
Study type: Observational

Summary: 
      Cross-sectional study of prevalence and intensity of schistosome infection in pregnant women,
      follow-up into postpartum, and the association of schistosome infection with haemoglobin
      concentration, compared to a group of non-pregnant women.
    

Detailed description: 
      The objective of this study is to investigate the epidemiology of schistosomiasis and anaemia
      among pregnant and non-pregnant women in Burkina Faso and explore the implications for the
      national schistosomiasis control programme and future studies.

      Specific objectives are:

        -  to determine the prevalence and intensity of schistosome infection in pregnant women
           attending for antenatal care and in non-pregnant women of reproductive age in an area
           which is hyperendemic for S.haematobium infection and in which there is little or no
           S.mansoni infection

        -  to determine the prevalence and intensity of schistosome infection in pregnant women
           attending for antenatal care and in non-pregnant women of reproductive age in an area in
           which S.mansoni infection is common

        -  to determine Haemoglobin concentration in pregnant women attending for antenatal care
           and in non-pregnant women of reproductive age in the regions described above

        -  to investigate the association between infection and haemoglobin concentration in
           pregnant and non-pregnant women

        -  to determine the prevalence of other parasitic infections in pregnant women and
           non-pregnant women including hookworms, ascaris, trichuris and malaria

        -  to demonstrate the research team's ability to follow-up pregnant women recruited at
           antenatal care clinics onto the postpartum period
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        antenatal care clinics child immunization program
      
Biospecimen description: 
      urine faeces blood
    
Keywords: schistosomiasis; anaemia; pregnancy
Subjective Well Being of Patients Receiving Atypical Antipsychotics as Monotherapy or Cotherapy With Mood Stabilizers
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      Cross - Sectional study requiring one visit at the investigators office for the data
      collection.

        -  Target Group: Patients that suffer from Bipolar Disorder Type 1.

        -  YMRS - HAMILTON and GAF scales are going to be used to assess the clinical outcome. The
           findings are going to be based on the different scores reported by Specialists (before
           the patients started to use as a therapy atypical antipsychotics / at the time that the
           visit actually takes place for the cause of the study.) We predefine the time period
           that the patient should be using atypical antipsychotics at minimum (2 months).

        -  The first 9 consecutive patients that visit the Specialist and meet the entry criteria
           and signs the ICF will be recruited in the study.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Target Group:Patients that suffer from Bipolar Disorder Type 1 who are treated with
        atypical antipsychotics as monotherapy or cotherapy with mood stabilizers
      
Keywords: Bipolar Disorder; antipsychotics; social functioning; mood stabilizers; Bipolar Disorder Type I; atypical antipsychotics; monotherapy; cotherapy
Reassessment of Premedication in Surgery
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test the level of anxiety in patients, the day before surgery
      (late afternoon) and immediately prior to surgery in 3 parallel groups of patients.

        -  one receiving placebo before going to sleep (before sleep), the day prior surgery and
           placebo when awakening (awakening), the day of surgery

        -  one receiving zopiclone (7.5 mg) before sleep and placebo at awakening

        -  one receiving placebo before sleep and alprazolam (0.5 mg)at awakening

      double blind, randomized controlled study
    

Detailed description: 
      Eligibility:

        -  18 to 65 years old

        -  elective surgery

        -  in-hospital preoperative night

      Outcome measures:

        -  anxiety scales

        -  demographic data
    

Intervention name(s): Zopiclone; Alprazolam; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 7.5 mg before sleep, the evening before surgery; 0.5 mg at awakening, the day of surgery; given night before surgery and at awakening, the day of surgery
Other intervention name(s): Imovane; Xanax
Intervention MeSH terms: Alprazolam; Zopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Premedication; Benzodiazepine; Anti-anxiety agents; Anxiety; Surgery; Adult; Human
Hot and Cold Compress in Hemodialysis
Condition: Hemodialysis Complication; Muscle Spasm; Fatigue
MeSH terms: Spasm; Fatigue
Study type: Interventional

Summary: 
      Aims and objectives. To examine and compare the effects of hot and cold compresses
      administration on muscle cramps, fatigue, and comfort in hemodialysis (HD) patients.

      Background. Muscle cramps and fatigue are common complications in HD patients and reduce
      patient comfort. Among the nursing interventions stated for the management of these
      complications in the literature, hot and cold therapy are remarkable. To the best of our
      knowledge, the present study is the first research up to date that examined and compared the
      effects of hot and cold compress administrations on abovementioned complications in HD.

      Design. This placebo-controlled randomized trial was conducted in two hemodialysis centers
      between February and October 2020.

      Methods. The study sample consisted of 69 patients, stratified and randomly allocated to two
      intervention groups and placebo group. For patients of each group, the implementation of the
      study continued for four weeks, 12 HD sessions.
    

Detailed description: 
      Hemodialysis (HD) is a common renal replacement therapy used in the treatment of End-Stage
      Renal Disease (ESRD) worldwide. Although HD is a life-saving treatment for people with ESRD,
      it causes some acute and chronic complications. Muscle cramps and fatigue are two of the most
      common complications in HD, and these also cause reducing comfort. Management of
      complications in HD patients and ensuring an optimal comfort level are pivotal for nurses.
      According to the literature, recommended nursing practices for the management of cramps in HD
      patients include hot and cold therapy methods. Besides, preventing cramps can improve comfort
      by reducing fatigue. Therefore, this study aimed to examine and compare the effects of hot
      and cold compresses administration on muscle cramps, fatigue, and comfort in hemodialysis
      (HD) patients.
    

Intervention name(s): Hot and Cold compress, nursing interventions
Intervention type(s): Other
Intervention description(s): using thermal compress at 38-39 °C (hot) and 15-16 °C (cold) on the distal regions of both lower extremities of the patients
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: placebo controlled randomized trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hemodialysis; muscle cramp; fatigue; comfort; nursing care; complementary therapies
A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate how the body absorbs and removes LY2605541,
      insulin lispro, and a mixture of both from the blood. The study has two parts. Participants
      may enroll in only one part. Each part has four treatment periods in a fixed order. The study
      will last approximately 8 weeks, not including screening. Screening is required within 28
      days prior to the start of the study.
    


Intervention name(s): LY2605541; Insulin Lispro
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneous (SQ); Administered SQ
Other intervention name(s): Humalog
Intervention MeSH terms: Insulin Lispro
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Dexmedetomidine-Propofol and Ketamine-Propofol During Upper Gastrointestinal System Sedation
Condition: Anesthesia; Reaction
Study type: Observational [Patient Registry]

Summary: 
      Sedation with dexmedetomidine-propofol or ketamine-propofol was planned in patients with
      upper gastrointestinal endoscopy.
    

Detailed description: 
      Patients between 18 and 60 years in American Society of Anesthesiologists (ASA) I and II
      groups were included. Patients that had severe organ disease, allergies to study drugs,
      refused to participate in the study were excluded. Cases were randomized into the
      dexmedetomidine-propofol group (Group D, n=30) and ketamine-propofol group (Group K, n=30).
      Cardiac monitoring, peripheral oxygen saturation, bispectral index (BIS) monitoring were
      performed. Group D received 1mg/kg dexmedetomidine+0.5mg/kg propofol intravenous (iv) bolus,
      0.5 μg/kg/h dexmedetomidine+ 0.5 mg/kg/h propfol infusion. Group K received 0.125 mL/kg
      bolus, 0.125 mL/kg/h ketamine+ propofol = ketofol infusion (ketofol was prepared with 4 mg
      propofol+2 mg ketamine). Patients were followed up with a Ramsay Sedation Scale (RSS) of≥4.
      Mean, standard deviation, mean, lowest-highest frequency and ratio values were used in
      descriptive statistics of the data, SPSS 22.0 program was used for the analyses.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Group D received 1mg/kg dexmedetomidine+0.5mg/kg propofol intravenous (iv) bolus, 0.5 μg/kg/h dexmedetomidine+ 0.5 mg/kg/h propfol infusion. Group K received 0.125 mL/kg bolus, 0.125 mL/kg/h ketamine+ propofol = ketofol infusion (ketofol was prepared with 4 mg propofol+2 mg ketamine).
Other intervention name(s): propofol; ketamine
Intervention MeSH terms: Dexmedetomidine; Ketamine; Propofol
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients between 18 and 60 years in American Society of Anesthesiologists (ASA) I and II
        groups were included. Patients that had severe organ disease, allergies to study drugs,
        refused to participate in the study were excluded. Cases were randomized into the
        dexmedetomidine-propofol group (Group D, n=30) and ketamine-propofol group (Group K, n=30).
      
Keywords: Dexmedetomidine, Ketamine, Propofol, Sedation