bioihbjkbjnl/mcl2 huggingface dataset:
Lean and Obese: Dietary Inflammation
Condition: Obesity; Inflammation; Dietary Fat
MeSH terms: Obesity; Inflammation
Study type: Interventional

Summary: 
      In the Lean and Obese Dietary Inflammation (LODI) study, the primary goal is to determine the
      effect of short-term intake of high dietary fat (5 days) compared to low fat intake (5 days)
      in a cross-over design in older adults (men and women) with normal body weight or obesity.
      Inflammation will be examined by measuring serum endotoxin and other markers, as well as the
      fecal microbiota.
    

Detailed description: 
      In the Lean and Obese Dietary Inflammation (LODI) study, short-term intake of a high-fat diet
      (HFD) that is also high in saturated fatty acids will be examined compared to a low-fat diet
      (LFD) in individuals who are normal body weight (BMI 19.5-24.9) or who have obesity (BMI of
      30 - 40 kg/m2). To characterize persons at baseline, this study will examine body
      composition, and serum glucose, endotoxin, inflammation and intestinal permeability during
      fasting and in response to a mixed meal. Also, while it is known that long term intake of
      foods affects the microbiota, it is unclear whether short-term consumption of a HFD will
      shift towards a pro-inflammatory gut microbiota compared to a low fat intake. This will be
      tested in a cross-over design (5 days on a HFD, washout, and 5 days on a LFD) with order
      randomly assigned in older adults (50+ years of age) who have obesity or are normal weight,
      and will also be examined by estimated visceral adipose tissue level.
    

Intervention name(s): Low Fat Diet (LFD); High Fat Diet (HFD)
Intervention type(s): Other; Other
Intervention description(s): Subjects will be asked to adhere to a low fat diet (assigned in random order) and be counseled by a dietitian using 5 days of sample menus, monitored online using a shared nutrient analysis program, and supplied with low fat foods to increase compliance; Subjects will be asked to adhere to a high fat diet that is rich in SFAs (assigned in random order) and be counseled by a dietitian using sample 5 days of menus, monitored online using a shared nutrient analysis program, and supplied with high fat foods to increase compliance
Other intervention name(s): low fat diet; high fat (high SFA) diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: obesity; lean individuals; older adults; microbiome; dietary fat
Inspiratory Muscle Endurance of Adults
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      The aim of this study is to determine the reference value ranges for healthy adults of the
      incremental threshold load test, which evaluates respiratory muscle endurance.
    

Detailed description: 
      Since respiratory muscles are used in daily life at the submaximal level, evaluation of their
      endurance is more meaningful functionally. In addition, evaluation of endurance with
      respiratory muscle strength is effective in determining respiratory muscle dysfunction.
      Failure to routinely evaluate respiratory muscle endurance, which is one of the main
      components of respiratory muscle function, may lead to failure to identify respiratory muscle
      dysfunction in early stage respiratory patients who have not yet developed muscle strength
      loss. However, normal value ranges have not been determined for the respiratory muscle
      endurance test.

      Determining the normal value ranges for this test will help determine muscle fatigue and
      investigate the physiological course in respiratory diseases.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy volunteers between the ages of 18-35
Women's Treatment for Trauma and Substance Use Disorders - 1
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effectiveness of adding Seeking Safety to
      standard substance abuse treatment to adding a control condition: Women's Health Education to
      standard substance abuse treatment.
    


Intervention name(s): Behavior Therapy
Intervention type(s): Behavioral
Primary purpose: Treatment
Keywords: behavioral intervention
Weight Reduction Surgery and Ovarian Function
Condition: Anovulation; Obesity
MeSH terms: Anovulation; Weight Loss
Study type: Observational

Summary: 
      This study will investigate the role of weight reduction surgery on the reproductive
      performance of obese women with ovulation problems. It is hypothesized that surgery offered
      when other methods of weight reduction have failed, may help restore ovulation.
    

Detailed description: 
      We aim to recruit 30 patients suffering from chronic anovulation, with a body mass index of
      35 or more, who failed to achieve weight reduction with other methods such as orlistat,
      metformin, diet and exercise.

      Patients will be approached by one of the investigators in the infertility clinics and the
      assisted conception unit of the Royal Hallamshire hospital. Consent will be obtained by one
      of the designated investigators. The consent form has been designed in accordance with the
      guidelines of the central office for research and ethics committees (COREC). A patient
      information leaflet will be supplied and has been designed according to the COREC guidelines.

      Patients will have a baseline history, clinical examination, hormonal profile (FSH/LH,
      fasting Insulin/glucose ratio, androgen profile, day 21 serum progesterone, serum leptin and
      ghrelin levels) ultrasound examination (ovarian volume and antral follicle count), including
      Doppler blood flow study (ovarian stromal velocity).

      Patients will be offered laparoscopic gastric bypass surgery by Mr Roger Ackroyd, in line
      with the current recommendation for gastric surgery according to NICE guidelines i.e.
      patients with a BMI over 40 or a BMI over 35 with at least one co-morbidity. Patients will be
      reviewed monthly for six months. At each visit the following will be recorded:

        1. Weight, menstrual diary.

        2. Hormonal profile (FSH/LH, fasting Insulin/glucose ratio, androgen profile, day 21 serum
           progesterone, serum leptin and ghrelin levels).

        3. Doppler of ovarian stroma (Pulsitility index, Peak velocity), ovarian volume and antral
           follicle count

        4. Review of symptomatology especially androgenic symptoms.

      End point:

      Completion of six months follow up.
    

Intervention name(s): weight reduction minimal access surgery
Intervention type(s): Procedure
Intervention description(s): Patients will be offered laparoscopic gastric bypass surgery by Mr Roger Ackroyd, in line with the current recommendation for gastric surgery according to NICE guidelines i.e. patients with a BMI over 40 or a BMI over 35 with at least one co-morbidity. Patients will be reviewed monthly for six months.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obese anovulatory women.
      
Keywords: Anovulation; Obesity; bariatric surgery
TEE as a Guide for Fluid Optimization in Major Abdominal Oncosurgery
Condition: Fluid Therapy
Study type: Interventional

Summary: 
      Transesophageal echocardiography (TEE) as guide for tailoring perioperative fluid therapy to
      achieve individualized hemodynamic endpoint, target hemodynamic goals of stroke volume index
      (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen
      delivery.

      Lactate levels as a surrogate indicator of organ perfusion as measured by arterial blood gas
      analysis intraoperatively, after 12 hours and 48 hrs postoperatively
    

Detailed description: 
      TEE as guide for tailoring perioperative fluid therapy to achieve target hemodynamic goals of
      stroke volume index (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2
      and tissue oxygen delivery.

      GDT (goal directed therapy): continuous infusion of crystalloids 2 mL/kg/h.

      If (velocity time integral) VTI <20, 250 mL colloid bolus administered. Dose repeated every
      10 min until goal of VTI >20 met. Norepinephrine titrated to maintain MAP(mean arterial
      pressure) > 65 mm Hg. Blood transfused for haemoglobin <8 g Lactate levels as a surrogate
      indicator of organ perfusion as measured by arterial blood gas analysis at time of incision
      intraoperatively and after 12 hours and 48 hrs. The incidence of postoperative complications,
      morbidity, mortality, duration of mechanical ventilation and ICU stay.
    

Intervention name(s): TEE guided fluid therapy will be administered; Stroke volume variation guided intravenous fluid.
Intervention type(s): Other; Other
Intervention description(s): Transesophageal echocardiography will be used to guide the fluid therapy. Velocity time integral of aorta <20 ,200ml colloid bolus to be administered.; Active Comparator: Group A control group (SVV guided fluid ) Stroke volume variation guided intraoperative intravenous fluid will be administered. SVV >10, 200 ml of colloid bolus to be given
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: TEE as guide for tailoring perioperative fluid therapy to achieve individualized hemodynamic endpoint , target hemodynamic goals of stroke volume index (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen delivery. Lactate levels as a surrogate indicator of organ perfusion as measured by arterial blood gas analysis intraoperatively , after 12 hours and 48 hrs postoperatively.
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Keywords: Fluid management; goal-directed therapy; transesophageal echocardiography
Onsite vs. Virtual Group Fitness in Overweight/Obese Women
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to compare an onsite to virtual whole-body high intensity
      interval training (HIIT) program on anthropometric variables, aerobic fitness measures, and
      vascular markers of cardiac risk in a single study of overweight and obese women.
    


Intervention name(s): HIIT Exercise Training
Intervention type(s): Other
Intervention description(s): The HIIT total session duration will be approximately 30 minutes and will be composed of 10 sets of 60 seconds of high-intensity exercises, >80% of maximum heart rate (MHR), interspersed with a recovery period of 60 seconds of low-intensity exercise at 60% of MHR.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Exercise Program
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Early-Stage Hodgkin's Disease
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation
      therapy in treating patients who have early stage Hodgkin's disease.
    

Detailed description: 
      OBJECTIVES: I. Determine the progression-free and overall survival at 5 and 10 years after a
      short-term Stanford V regimen comprising mechlorethamine, doxorubicin, vinblastine,
      prednisone, vincristine, bleomycin, and etoposide followed by modified involved-field
      radiotherapy in patients with favorable, early-stage Hodgkin's disease. II. Determine whether
      the early and late toxic effects of treatment can be minimized by avoiding staging
      laparotomy, limiting cumulative doses of chemotherapeutic drugs, and reducing the dose and
      volume of radiotherapy in these patients. III. Determine the freedom from second disease
      progression at 5 and 10 years after treatment and treatment-related toxicity in these
      patients. IV. Determine the quality of life of patients treated with this regimen.

      OUTLINE: Patients receive the Stanford V regimen comprising mechlorethamine IV on days 1 and
      29; doxorubicin IV and vinblastine IV on days 1, 15, 29, and 43; oral prednisone every other
      day on days 1-36 followed by tapered doses; vincristine IV and bleomycin IV on days 8, 22,
      36, and 50; and etoposide IV on days 15, 16, 43, and 44. Beginning 2 weeks after completion
      of chemotherapy and when blood counts recover, patients undergo modified involved-field
      radiotherapy 5 days a week for 3-4 weeks. Quality of life is assessed. Patients are followed
      every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 5 years.
    

Intervention name(s): bleomycin sulfate; Stanford V regimen; doxorubicin hydrochloride; etoposide; mechlorethamine hydrochloride; prednisone; vinblastine sulfate; vincristine sulfate; radiation therapy
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Radiation
Intervention MeSH terms: Prednisone; Doxorubicin; Liposomal doxorubicin; Bleomycin; Etoposide; Vincristine; Vinblastine; Mechlorethamine
Primary purpose: Treatment
Keywords: stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma
24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003, Open-Label Spiriva® Respimat® as an Active Control, and Placebo
Condition: COPD
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover
      Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe
      COPD after 4 Weeks of Treatment with PT003, Open-Label Spiriva® Respimat® (Tiotropium
      Bromide) as an Active Control, and Placebo.
    


Intervention name(s): GFF MDI (PT003); Placebo MDI; Spiriva® Respimat® (Tiotropium Bromide)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)
Other intervention name(s): Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI); Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol
Intervention MeSH terms: Glycopyrrolate; Bromides; Formoterol Fumarate; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Microdose Study in Healthy Subjects to Describe Intravenous Pharmacokinetics of GSK3191607
Condition: Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-centre, non-randomized study to investigate the
      pharmacokinetics of GSK3191607, administered as a single intravenous (IV) dose in healthy
      male subjects.

      Six subjects will be administered an IV microdose of radio-labeled [14C]-GSK3191607. The
      study will provide an early readout on human pharmacokinetic parameters. The results of this
      study will be used to estimate the potential duration of anti-parasite effect in humans,
      define predicted clinical oral doses, and hence inform about the compound's potential safety
      margin.

      Each subject will participate in the study for up to 8 weeks, and will have a screening
      visit, one treatment period, eight outpatient visits, and a follow-up visit.
    


Intervention name(s): [14C]-GSK3191607
Intervention type(s): Drug
Intervention description(s): [14C]-GSK3191607 is a solution to be administered intravenously as a single dose infusion over 15 minutes. It is a radio-labeled product; 100 mcg of [14C]-GSK3191607 contains approximately 7.4 kilobecquerel (kBq) of [14C] radioactivity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria; Microdose; GSK3191607
A Study Evaluating the Effect of Albiglutide on Gallbladder Emptying in Healthy Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Albiglutide, a novel analogue of glucagon-like peptide-1 (GLP-1), has been developed and
      approved for the treatment of type 2 diabetes mellitus. The primary objective of this study
      is to assess if a single dose of albiglutide can affect cholecystokinin-induced gallbladder
      emptying. To make this assessment, each study participant will receive a dose of albiglutide
      and a dose of placebo followed by cholecystokinin (CCK) infusion and ultrasound measurement
      of the gallbladder.

      The study will be comprised of two periods and 20 subjects. The screening visit will occur
      within 42 days of the start of Treatment Period 1. The Treatment Periods will be separated by
      a washout period of a minimum of 42 days. Subjects will return for a follow-up visit after 28
      days following the last dose of albiglutide or placebo. The total duration of a subject's
      participation from Screening to Follow-up will be approximately 17.5 weeks.

      This study is a post marketing commitment to the United States Food and Drug Administration
      (USFDA).
    


Intervention name(s): Albiglutide 50 mg; Placebo; CCK (Kinevac)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Albiglutide 50 mg pen is a single-use fixed dose, fully disposable pen injector system for SC delivery in the abdomen containing 67 mg lyophilized albiglutide and 0.65 mL diluents designed to deliver a dose of 50 mg in a volume of 0.5 mL after reconstitution; Placebo is a single-use fixed dose, fully disposable pen injector system for SC delivery of 0.5 mL injector volume in the abdomen; CCK (Kinevac) will be infused intravenously. Kinevac is supplied in vials containing 5 microgram (mcg)/vial. Infusion prepared aseptically by adding 5 mL of Sterile Water for Injection United States Pharmacopeia (USP) to the vial to create a solution of 1 mcg/mL. Infuse 0.003 mcg/kg dose in 100 mL of Sodium Chloride Injection USP, 0.9%
Intervention MeSH terms: rGLP-1 protein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cholecystokinin; ultrasonography; Albiglutide; Gallbladder ejection fraction
Utility of At-home Monitoring of Exercise Capacity by App-based 6-minute Walk Test
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional

Summary: 
      -  Evaluate for accuracy and reproducibility of data collected via the participant-operated
           Walk.Talk.Track. (WTT) app combined with Apple Watch during in-clinic, technician
           proctored 6MWT's.

             -  Determine whether the WTT app on the Apple Watch can accurately collect information
                on distance traveled and heart rate (HR) during in-clinic 6MWT run by American
                Thoracic Society (ATS) guidelines

             -  Determine whether participants can operate the WTT app and Apple Watch effectively
                to gather accurate data in a monitored and home-based setting

        -  Prospectively monitor for changes in WTT app recorded 6MWT results following initiation
           of therapy in a treatment naïve cohort of PAH participants

             -  Evaluate whether changes from baseline in 6 minute walk distance (6MWD) and heart
                rate recovery at one minute (HRR1) as well as other variables that have been
                associated with disease severity in PAH and left-sided heart disease (resting HR,
                heart rate variability [HRV], chronotropic index [CI]) can be identified before the
                12-week follow up when comparing the treatment arm and the control arm

             -  Evaluate whether changes from baseline in the HRR1, resting HR, HRV and/or CI are
                more evident in treatment responders when compared to treatment non-responders.
    


Intervention name(s): Home-based 6 minute walk test
Intervention type(s): Device
Intervention description(s): Participants will receive a loaner Apple Watch with the Walk.Talk.Track. (WTT, produced by PHaware) app downloaded. Participants will perform a daily 6MWT at home using the Apple Watch and WTT app. They will undergo a history and physical, blood draw, echocardiogram and in-clinic 6MWT at the baseline and 12-week follow up visit.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Six minute walk test; Six minute walk distance; Heart rate recovery; Mobile health
MELATOX: Evaluation of Percutaneous Dissolvement of Melatonin When Used as Sunscreen; a Randomized, Placebo Controlled, Double-blind Crossover Study on Healthy Volunteers.
Condition: Solar Skin Damage
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the percutaneous transportation and pharmacokinetics
      of melatonincream 12,5% when used on 80% of the body area. A test battery consisting of
      blood, saliva, urine samples at 1,2,3,4,5,6,7,8,12,24 and 36 hours after cream application.
      Cognitive parameters are investigated using KSS, FTT and CRT tests at above mentioned time
      points.
    


Intervention name(s): Melatonin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Melatonin; Cognitive parameters; pharmacodynamic; pharmacokinetics