bioihbjkbjnl/mcl2 huggingface dataset:
Food Effect and Bioavailability of Deflazacort Formulations in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center, single-dose, randomized, 5-period crossover study designed
      to assess the comparative bioavailability and food effect of deflazacort. A total of 45
      subjects will be randomly assigned to receive 1 of 5 treatment sequences. Each dosing
      sequence will be enrolled in parallel and all subjects will receive all 5 treatments in a
      crossover fashion.
    

Detailed description: 
      This is a Phase 1, single-center, single-dose, randomized, 5-period crossover study designed
      to assess the comparative bioavailability and food effect of deflazacort. A total of 45
      subjects will be randomly assigned to 1 of 5 treatment sequences. Each dosing sequence will
      be enrolled in parallel and will receive all 5 treatments in a crossover fashion.

      Subjects will be screened within 28 days of the first dose of study drug. Subjects will check
      into the clinical pharmacology unit (CPU) on the day prior to dosing (Day -1 for Period 1)
      and will stay in-house through the 24 hour assessments in each study period. Safety
      assessments will be performed at screening, check-in for each period, and at 24 hours after
      each dose per the Schedule of Assessments .Additionally, a safety follow-up phone call will
      be performed on Day 36 (± 2 days).

      Subject participation is expected to last approximately 64 days, including a 28-day screening
      period and a 36-day on study period (consisting of 5 treatment periods, washout periods
      lasting 7 days, and the safety follow-up phone call).
    

Intervention name(s): Deflazacort
Intervention type(s): Drug
Other intervention name(s): DFZ
Intervention MeSH terms: Deflazacort
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Black Women's Wellness Project
Condition: Weight, Body; Knowledge, Attitudes, Practice
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The proposed randomized controlled trial will evaluate an educational self-management
      intervention in 450 African American women and weight management. It will be the first to use
      a culturally tailored in-person and telephone approach to address all aspects of wellness and
      social determinants for African American women to achieve optimal long term wellness for both
      self and family.
    


Intervention name(s): PRIDE counseling intervention
Intervention type(s): Behavioral
Intervention description(s): Step-by-Step program to create positive lifestyle change geared toward wellness and long term healthy living through group sessions and telephone counseling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Weight Management; Obesity; African American; Women
A Study To Evaluate ASN002 In Subjects With Atopic Dermatitis
Condition: Dermatitis, Atopic; Dermatitis Eczema; Dermatitis, Eczematous
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a dose escalation study to test the safety, tolerability and preliminary efficacy of
      ASN002 in people with moderate to severe atopic dermatitis (AD).
    

Detailed description: 
      This study is a dose escalation study to determine a safe and tolerable dose of ASN002 for
      people with moderate to severe atopic dermatitis. This study will also characterize the
      pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and skin biopsies.
      Subjects will also be assessed for improvement in their atopic dermatitis. There will be a
      screening period (up to 30 days) and a treatment period for 4 weeks with a 14 day follow up
      with an end-of-study visit.
    

Intervention name(s): ASN002; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Daily dose of ASN002 for 28 days; Placebo for ASN002 for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: eczema
Enhanced Recovery Protocol in Urogynecologic Surgery
Condition: Urinary Incontinence; Cystocele; Rectocele; Pelvic Organ Prolapse
MeSH terms: Rectocele; Urinary Incontinence; Cystocele; Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      Enhanced recovery after surgery (ERAS) has been shown to improve postoperative outcomes in a
      variety of surgical conditions. However, data regarding its role in urogynecologic surgery is
      limited. This study aimed to investigate the role of the ERAS protocol on postoperative
      outcomes in patients undergoing urogynecologic surgery.
    

Detailed description: 
      Enhanced recovery after surgery (ERAS) or in other words "fast-track" protocol roughly
      purposes to improve patient satisfaction, reduce complications and shorten the hospital stay.
      Chronic diseases, nutrition, and any volume depletion are corrected prior to surgery and less
      invasive surgical techniques are utilized to this end The impact of ERAS protocols in
      decreasing length of stay (LOS), reducing postoperative pain, improving early ambulation and
      decreasing the rate of potentially serious medical complications have been studied in
      patients undergoing colorectal, urologic, gastric and pancreatic surgery previously. However,
      data regarding the role of ERAS protocol in improving postoperative outcomes and
      postoperative compliance in patients undergoing urogynecological surgery is limited.

      The present study purposes to clarify the role of the ERAS protocol on postoperative outcomes
      in patients undergoing urogynecologic surgery.
    

Intervention name(s): Enhanced recovery after surgery (ERAS) protocol
Intervention type(s): Procedure
Intervention description(s): Preoperative:
Counseling before hospital admission Fluid, and carbohydrate loading Avoiding prolongation of the fasting period Avoiding bowel preparation or its application only in selective cases Application of antibiotic prophylaxis Application of thromboprophylaxis Avoiding premedication
Intraoperative:
Use of short-acting anesthetic agents Refraining from using drains Refraining from salt, and water overload Maintenance of normothermia (heating the body, and use of warmed up intravenous fluids)
Postoperative:
Refraining from the use of nasogastric tube Prevention of nausea, and vomiting Refraining from salt, and water overload Earlier removal of catheters Initiation of oral intake at an early period Use of nonopioid oral analgesics/NSAIDs Early mobilization Adherence to the protocol, and auditing results
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Imatinib Mesylate in Combination With Hydroxyurea Versus Hydroxyurea Alone as an Oral Therapy in Patients With Temozolomide Resistant Progressive Glioblastoma
Condition: Glioblastoma Multiforme; Astrocytoma
MeSH terms: Glioblastoma; Astrocytoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III study comparing Imatinib mesylate and hydroxyurea combination therapy
      with hydroxyurea monotherapy in patients with temozolomide resistant progressive
      glioblastoma.
    


Intervention name(s): Imatinib mesylate; Hydroxyurea
Intervention type(s): Drug; Drug
Intervention description(s): Imatinib was supplied as 100 mg and 400 mg tablets packaged in polyethylene bottles.
Other intervention name(s): Glivec®; Litalir®
Intervention MeSH terms: Imatinib Mesylate; Hydroxyurea
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Open label; Imatinib mesylate; hydroxyurea; temozolomide; resistant; protein tyrosine kinases; adenocarcinoma; glioblastoma multiforme; astrocytoma; brain tumor; brain cancer
A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the ability of RDX013 to lower serum potassium in
      patients with chronic kidney disease with elevated serum potassium levels
    


Intervention name(s): RDX013; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RDX013 is an experimental drug that is a potassium secretagogue; Placebo treatment that looks identical to experimental treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: In Part A, treatment arms will be dosed based on the results from the previous arm. For Part B, one treatment arm from Part A will be selected
Masking: Single (Participant)
Primary purpose: Treatment
Emergency Agitation in T&A
Condition: Healthy
Study type: Interventional

Summary: 
      Sevoflurane has been used commonly in pediatric anesthesia since 1990. However, it has caused
      more emergency agitation (EA) that other inhalation agents and the incidence is up to 80%.
      Therefore, lower minimum alveolar concentration of sevoflurane will reduce the EA when it is
      used with remifentanil in pediatric general anesthesia.
    


Intervention name(s): remifentanil; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): General anesthesia is maintained witn sevoflurane and remifentanil.; General anesthesia is maintained with only sevoflurane and with normal saline instead of remifentanil
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: healthy pediatric patients undergoing tonsillectomy and adenoidectomy
Validation of RespiLife for Detection of Respiratory Suppression
Condition: Respiration Disorders
MeSH terms: Respiration Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for
      detection of respiratory rate and oxygen saturation in human subjects. This includes
      evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and
      oxygen saturation.
    

Detailed description: 
      The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for
      detection of respiratory rate and oxygen saturation in human subjects. This includes
      evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and
      oxygen saturation.
    

Intervention name(s): Respilife monitor
Intervention type(s): Diagnostic Test
Intervention description(s): Respilife monitor
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Evaluation of the device on people with normal and suppressed respiration
Masking: None (Open Label)
Primary purpose: Diagnostic
Sleep Intervention
Condition: Mental
Study type: Interventional

Summary: 
      A trial that tests whether implementation intentions improve sleep among adoelescents.
    


Intervention name(s): "If-then" plans; Control
Intervention type(s): Behavioral; Other
Intervention description(s): "If-then" plans (or "implementation intentions") involve linking in memory critical situations (e.g., temptations) with appropriate responses (e.g., substitution); Exposure to critical situations (e.g., temptations) and appropriate responses (e.g., substitution) but not linked in memory
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Differential Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) on Platelet, Endothelial and Vascular Function
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study was to determine whether supplementation with oils enriched with
      long chain n-3 PUFA, either EPA or DHA, had a differential effect on platelet, endothelial
      and vascular function.
    

Detailed description: 
      Relatively few studies have made a head-to-head comparison of DHA (22:6n-3) with EPA
      (20:5n-3). The understanding of this differential effect may be of great interest in
      populations with low EPA intake such as vegetarians, who may choose to supplement their
      dietary intake of long-chain n-3 PUFA in the form of DHA-rich algal oil.

      This study aimed to investigate the effect of supplementation with oils rich in either EPA or
      DHA (3g/day, 6 weeks) in healthy young males on platelet, endothelial and vascular function,
      as well as other CVD risk factors. The primary outcomes were platelet monocyte aggregates and
      endothelial progenitor cells - novel markers of platelet and endothelial function, measured
      by flow cytometry, Secondary outcomes included capillary density, measured by capillaroscopy
      to assess changes in microvascular function, pulse wave analysis, digital volume pulse and
      ambulatory blood pressure. Other secondary outcomes included lipid profiles (TAG,
      cholesterol, NEFA), glycaemic control (HOMA, QUICKI) and oxidative stress (isoprostane). The
      omega-3 index (erythrocyte EPA+DHA) was used as a marker of compliance.
    

Intervention name(s): EPA-rich triacylglycerol oil; Placebo - olive oil (BP specification); DHA-rich triacylglycerol oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Eicosapentaenoic acid; Docosahexaenoic acid; Cardiovascular risk; Platelet function; Endothelial function; Vascular function; young males
Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria
Condition: Erythropoietic Protoporphyria
MeSH terms: Protoporphyria, Erythropoietic
Study type: Interventional

Summary: 
      OBJECTIVES:

      I. Determine the efficacy of cysteine hydrochloride in preventing or decreasing
      photosensitivity in patients with erythropoietic protoporphyria.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, crossover study.

      Patients are randomly assigned to 1 of 2 groups to receive cysteine hydrochloride orally
      twice daily, 2 capsules with breakfast and 2 with lunch. Group 1 receives cysteine
      hydrochloride in drug ingestion period 1 followed by placebo in period 2. Group 2 receives
      placebo in period 1 followed by cysteine hydrochloride in period 2. Both groups ingest
      placebo for 1 week between the periods. Each drug ingestion period lasts 8 weeks.

      Follow up phone calls are made at the end of months 1 and 3. All patients schedule follow up
      visits at the end of each drug ingestion period.
    

Intervention name(s): cysteine hydrochloride
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: erythropoietic protoporphyria; inborn errors of metabolism; porphyria; rare disease
Pharmacokinetically-guided on the Individualization of Pembrolizumab Administration in the Treatment of Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      Pembrolizumab with or without chemotherapy has become the standard therapy in advanced
      non-small cell lung cancer (NSCLC), with a fixed dose of 200mg every 3 weeks. The
      investigators performed this study to explore the clinical efficacy and safety of
      pharmacokinetic (PK)-guided pembrolizumab administration in advanced NSCLC.
    

Detailed description: 
      In this prospective, open-label, single-arm exploratory study, the investigators enrolled
      advanced NSCLC patients without sensitizing EGFR or ALK mutation in Sun yat-sen university
      cancer center. Eligible patients received pembrolizumab 200mg every 3 weeks with or without
      chemotherapy for four cycles, then for patients without progressive disease, pembrolizumab
      was administrated in new dose-intervals according to steady state plasma-concentration (Css)
      of pembrolizumab until disease progression. Primary endpoint was the progression-free
      survival. Patients with Css of pembrolizumab also underthe investigatorsnt genetic
      polymorphism analysis of variable number of tandem repeats region (VNTR) in neonatal Fc
      receptor (FcRn).
    

Intervention name(s): pembrolizumab
Intervention type(s): Drug
Intervention description(s): Eligible patients received pembrolizumab 200mg every 3 weeks with or without chemotherapy for four cycles, then for patients without progressive disease, pembrolizumab was administrated in new dose-intervals according to steady state plasma-concentration (Css) of pembrolizumab until disease progression
Other intervention name(s): keytruda
Intervention MeSH terms: Pembrolizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pembrolizumab; Pharmacokinetics; Non-small Cell Lung Cancer
Study of PEG-rIL-29 (or PEG-IFN Lambda) in Subjects With Chronic Hepatitis C Virus Infection
Condition: Hepatitis C, Chronic
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Interleukin 29 (IL-29) is a substance that is produced in the body to help fight viral
      infections. The purpose of this study is to test the safety and antiviral effects of
      PEG-rIL-29 (a man-made form of IL-29) when it is given either by itself at different doses or
      in combination with the approved dose of ribavirin (an antiviral drug) to subjects with
      hepatitis C infection who have received no prior treatment for this disease or who have
      relapsed following previous treatment with PEGylated interferon alpha (PEG-IFN-α), or other
      form of IFN-α, and ribavirin.
    

Detailed description: 
      This is a 3-part study of PEG-rIL-29 in subjects with chronic genotype 1 hepatitis C virus
      infection who have either received no prior treatment with a PEGylated IFN-α (or other form
      of IFN-α) or who have relapsed following prior treatment with a PEGylated IFN-α (or other
      form of IFN-α) and ribavirin. Part 1 of the study will evaluate the safety and tolerability
      of escalating doses of PEG-rIL-29 when given as a single agent either every other week or
      weekly over a 4-week period to treatment-relapsed subjects. Part 2 of the study will evaluate
      dose levels and/or schedules of PEG-rIL-29 in combination with daily oral ribavirin
      administered over a 4-week period to treatment-relapsed subjects. Part 3 of the study will
      evaluate dose levels and/or schedules of PEG-rIL-29 in combination with daily oral ribavirin
      administered over a 4-week period to subjects who have received no prior treatment.
    

Intervention name(s): PEGylated recombinant interleukin 29 (PEG-rIL-29)
Intervention type(s): Drug
Intervention description(s): subcutaneous administration either weekly or every other week
Other intervention name(s): PEGylated interferon lambda (PEG-IFN lambda)
Intervention MeSH terms: Interferons
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PEGylated recombinant interleukin 29; interferon lambda; interleukin 29; hepatitis C; virus; infection; liver
Fiberoptic Intubation and Transillumination-guided Fiberoptic Intubation：Success Rate and Time in Untrained Medical Personnel
Condition: Transillumination-guided Fiberoptic Intubation Intubation
Study type: Interventional

Summary: 
      Fiberoptic Intubation is the preferred technique to difficult airway. However, when performed
      by untrained anesthesiologists, bronchoscopic intubation has a high rate of failure. We want
      to know if the Transillumination-guided Fiberoptic Intubation technique can improves the
      success rate and time for tracheal intubation performed by inexperienced anesthesiologists;
      whether this technique improves the success rate and for normal intubations when performed by
      inexperienced anesthesiologists as well is unknown. Therefore, the authors compared the
      success rate and time of Fiberoptic Intubation versus the Transillumination-guided Fiberoptic
      Intubation performed by anesthesiologists inexperienced in Fiberoptic Intubation.
    


Intervention name(s): Transillumination-guided Fiberoptic Intubation
Intervention type(s): Device
Intervention description(s): Light guided, Non-invasive
Other intervention name(s): Light guided Bronchoscopic Intubation Technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Transillumination-guided; Fiberoptic Intubation; time; success rate; intubation
Response of Inflammatory Markers to Circuit Weight Training in Diabetic Patients
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Study group included 30 male diabetic patients , they performed circuit weight training
      exercises for 12 weeks in addition to their medications. However, the control group included
      10 patients received medical treatment.

      Interleukin 6 and tumor necrosis factor alpha were measured before and after the study
      duration for both groups.
    

Detailed description: 
      The study group included 30 male diabetic patients who participated in circuit weight
      training (CWT) program as following; 60 minutes training\day for 3 days per week for a period
      of 12 weeks.

      The training session started by a proper warm up for 5-10 min in the form of mild stretching
      of the muscles of upper limb(pectorals,shoulder girdle muscles) and muscles of lower
      limb(flexors, extensors, abductors and adductors of the hip and knee) ( to minimize the risk
      of musculoskeletal injury). Then start the active phase of resisted exercises through using
      free weights ( dumbbels for upper limb and sand bags for lower limb) The frequency and
      intensity increased gradually as follows; Intensity of progress of CWT gradually increased
      intensity by 2.5% of one repetition maximum every two weeks. Moderate resistance used in
      which of 60-65% of 1RM in the first month then the intensity increased to 70-75% of 1RM in
      the second month and finally the intensity of exercises increased to 75-80% of 1RM during the
      third month. The sets of exercises intervened by 1 min rest in between each set of
      repetitions. At last the session ends by 10 min of cooling down in the form of relaxation
      exercises.

      Statistical procedures:

      In this study, the descriptive statistics (the mean, the standard deviation, maximum,
      minimum, and range) will be calculated for all subjects in the study including IL6 and tumor
      necrosis factor alpha variables.

        -  Paired sample t-test will be used to compare the difference between before and after
           treatment results of IL6 and tumor necrosis factor alpha in each group.

        -  Paired T test to compare means of variables before and after training.
    

Intervention name(s): circuit weight training program
Intervention type(s): Other
Intervention description(s): 30 male diabetic patients performed circuit weight training for 12 weeks
Other intervention name(s): Resisted exercises using free weights
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus.; Inflammatory markers; Circuit weight training