bioihbjkbjnl/mcl2 huggingface dataset:
Stanford Letter or Traditional Advance Directive in Advance Care Planning in Patients Undergoing Bone Marrow Transplant
Condition: Advance Directives; Bone Marrow Transplant
Study type: Interventional

Summary: 
      The purpose of the proposed research study is to evaluate whether bone marrow transplant
      patients prefer the Stanford letter advance care planning tool to the standard Advance
      directive.

      Completion of advance care planning prior to BMT is very important, but not often done. The
      investigators believe that the Stanford Letter will be preferred by patients and will allow
      them to feel more comfortable and share more of their wishes with family members and the
      medical team.
    

Detailed description: 
      PRIMARY OBJECTIVES I. To compare advance care planning (ACP) completion rate amongst bone
      marrow transplant (BMT) recipients receiving the Stanford Letter versus the traditional
      advance directive (AD) through a prospective, pilot randomized controlled trial (RCT).

      SECONDARY OBJECTIVES:

      I. To evaluate differences in patient preference for choice to prolong life following
      completion of the ACP tool in each group.

      II. To assess uncertainty with decision making regarding end of life care following
      completion of the ACP tool in each group.

      III. To explore patient understanding of and satisfaction with the ACP tool in each group.

      OUTLINE: Patients are randomized to 1 of 2 groups.

      GROUP I (INTERVENTION): Patients listen to a dialogue on the purpose of ACP. Patients receive
      a paper copy and online web link to the Stanford Letter and complete and return the form by
      the day of BMT. After completion of the Stanford Letter, patients undergo a semi-structured,
      research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life
      decisions, understanding of the ACP form received, and satisfaction with the ACP form.

      GROUP II (CONTROL): Patients listen to a dialogue on the purpose of ACP. Patients receive a
      paper copy and online web link to the California (CA) Advance Health Care Directive Form and
      complete and return the form by the day of BMT. After completion of the CA Advance Health
      Care Directive Form, patients undergo interview as in Group I.

      After completion of study, patients are followed up periodically.
    

Intervention name(s): Stanford Letter; Interview; Questionnaire Administration; CA Advance Health Care Directive Form
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Receive and complete the Stanford Letter; Undergo semi-structured, research staff-led interview; Ancillary studies; Receive and complete the CA Advance Health Care Directive Form
Other intervention name(s): Communication Intervention; Communication Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
A Study to Learn About the Study Medication, Zavegepant, in Healthy Volunteers
Condition: Biological Availability
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is designed to compare the rate and extent of absorption of four different
      formulations of zavegepant. 52 healthy male and female volunteers will receive a single dose
      of each formulation at least 7 days apart over a period of about 7 weeks and the amount of
      drug in their blood will be assessed over the 24 hour period after each dose.
    

Detailed description: 
      This is a Phase 1, single centre, open-label, single dose, 4-period, crossover study designed
      to compare the pharmacokinetics (PK) of zavegepant from three Test products and a Reference
      product (treatment D).

      52 male and female healthy volunteers will be randomly assigned to one of 4 treatment
      sequences: ACBD, CDAB, BADC, and DBCA.

      In each period, subjects will receive one of the following: Treatment A, B, C, or D on Day 1,
      followed by 24 hours of PK and safety assessments. On Day 2 subjects will be discharged from
      the clinical site and instructed to return after at least a 7 day washout time has passed for
      subsequent periods of treatment.

      The study will include a screening visit from Day -28 to Day -2. Eligible subjects will be
      admitted to the clinical site on Day -1 and will be confined until completion of the
      assessments on Day 2. There will be a washout period of at least 7 days between doses. Study
      Exit procedures will be performed after the last assessment on the morning of Day 2 of Period
      4. Study Exit procedures will be performed as soon as possible in case of Early Termination.

      The total duration of study participation for each subject from Screening through Study Exit
      is anticipated to be approximately 6.5 weeks.
    

Intervention name(s): Zavegepant 100mg non-enteric coated soft gel capsule; Zavegepant 100mg immediate release tablet; Zavegepant 2 x 100mg immediate release tablets; Zavegepant 4 x 25mg enteric coated soft gel capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Zavegepant (PF-07930207/BHV3500) 100mg non-enteric coated soft gel capsule; Zavegepant (PF-07930207/BHV3500) 100mg dodecylmaltoside dosage form immediate release tablet; 2 x Zavegepant (PF-07930207/BHV3500) 100mg dodecylmaltoside dosage form immediate release tablets - total dose 200mg; Zavegepant (PF-07930207/BHV3500) 25 mg enteric coated soft gel capsules - total dose 100mg
Other intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, open-label, single dose, 4-period cross-over, comparative bioavailability study in healthy volunteer participants.
Masking: None (Open Label)
Primary purpose: Basic Science
Clinical Study to Assess Safety, PK and PD Parameters of CDR132L
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, randomized, double-blind, placebo-controlled study to assess safety,
      pharmacokinetics and pharmacodynamic parameters of CDR132L in patients with stable heart
      failure of ischemic origin (NYHA 1-3).
    

Detailed description: 
      Objectives:

      Primary

      • To assess the safety of one single and one repeated dose of CDR132L in patients with stable
      heart failure of ischemic origin (NYHA 1-3).

      Secondary • To characterize the pharmacokinetic (PK) profile of CDR132L in patients with
      stable heart failure of ischemic origin.

      Exploratory

      • To determine the effect of CDR132L on pharmacodynamic (PD) parameters.
    

Intervention name(s): CDR132L
Intervention type(s): Drug
Intervention description(s): i.v. administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Fat-induced Release of GLP-1 in Humans
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      This study compared the incretin-releasing effect of C8-diet oil and tributyrin with that of
      20 ml olive oil on a molar basis in human volunteers.
    

Detailed description: 
      A structured triglyceride (1,3-di-octanoyl-2-oleoyl-glycerol, called C8-diet oil), which upon
      digestion results in generation of two medium-chain fatty acids and 2-oleoyl-glycerol (2-OG),
      may lead to activation of GPR119 only, since medium fatty acids are poor agonists for fatty
      acid receptors.
    

Intervention name(s): Tributyrin; C8-diet oil; Olive oil; Carrot
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): a triglyceride containing three C4-acids; a triglyceride containing 2 C8-fatty acids and one oleic acid at sn-2 position; a triglyceride containing mostly three oleic acids; mainly water and glucose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Short fatty acids; 2-oleoyl glycerol; GLP-1 secretion; C8-diet oil; GIP secretion
Pain and Abdominal Breathing Exercises
Condition: Analgesia; Breathing
MeSH terms: Respiratory Aspiration
Study type: Observational

Summary: 
      Postoperative evaluation of patients who did and did not do preoperative abdominal breathing
      exercises.
    

Detailed description: 
      The respiratory type and pattern of all patients will be recorded before gallbladder surgery.

      In Group P, abdominal breathing training will be given to the patients in this group. They
      will perform abdominal breathing for at least 5 minutes 6 times a day until surgery.

      In Group C,patients who are not given abdominal breathing.

      In the intraoperative period, 10 mg / kg paracetamol and 0.05 mg / kg morphine will be used
      for postoperative analgesia. After surgery, all patients will be given 10 mg/kg paracetamol
      every 8 hours and will be fitted with a patient-controlled analgesia (PCA) device (Tramadol
      HCL). PCA device bolus dose will be set to 20 mg, lock time will be set to 10 minutes and the
      number of buttons per hour will be set as 3.for postoperative analgesia.After surgery, NRS
      scores of the patients will be evaluated (in the recovery room, 1,2,6,12 and 24 hours.

      Preoperative anxiety, postoperative discharge time and analgesic consumption of all patients
      will be recorded.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Gallbladder surgerysurgery patients who will be operated under general anesthesia.
Sleep Hygiene and Relaxation Intervention to Improve Sleep and Fatigue for Children Receiving Maintenance Chemotherapy
Condition: Sleep; Fatigue; Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Fatigue
Study type: Interventional

Summary: 
      This pilot randomized controlled trial examined the feasibility, acceptability and
      effectiveness of an intervention to improve sleep quality and decrease fatigue levels in
      children with a diagnosis of ALL, during maintenance treatment. Families were randomized to
      usual care or the intervention. The intervention included a sleep hygiene and relaxation
      education session with a nurse practitioner, literature for home, two story books, and a
      follow-up phone call. Self-reported measures were used in addition to actigraphy to measure
      children's quality and quantity of sleep.
    

Detailed description: 
      Sleep is an essential restorative function that promotes both physical and cognitive health.
      Previous studies have demonstrated that children on Acute Lymphoblastic Leukemia (ALL)
      maintenance therapy have problematic sleep patterns and experience fatigue. This pilot
      randomized controlled trial examined the feasibility, acceptability and effectiveness of an
      intervention to improve sleep quality and decrease fatigue levels in children aged 4-10, with
      a diagnosis of ALL, during maintenance treatment. Families were randomized to usual care or
      the intervention. The intervention included a sleep hygiene and relaxation education session
      with a nurse practitioner, literature for home, two story books, and a follow-up phone call.
      Self-reported measures were used in addition to actigraphy to measure children's quality and
      quantity of sleep. Sleep tips were evaluated by intervention group families.
    

Intervention name(s): Sleep Hygiene and Relaxation Education
Intervention type(s): Behavioral
Intervention description(s): Intervention group participants receive a nurse-led, one-hour 1:1 educational session including education about sleep in children and a description of what is known about sleep and fatigue issues in children with cancer. The session also includes strategies to improve sleep hygiene in children. Information about relaxation to promote sleep is outlined and two children's books designed to promote relaxation using the principles of deep breathing are given to the parent(s). A handout containing all the information covered is given to the parent(s).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Sleep; Acute Lymphoblastic Leukemia; Fatigue; Sleep hygiene; Relaxation; RCT
Impact of Women's Empowerment Program for Abused Pregnant Women
Condition: Abuse Physical Battered Woman Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Although domestic violence is recognized as major threat in pregnancy, there is no
      intervention has been developed or test to support women in India. To evaluate the effect of
      women's empowerment program administered to abused women in order to reduce domestic abuse,
      improving health status and safety behavior.
    


Intervention name(s): Empowerment Program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Global Postural Reeducation in Chronic Low Back Pain
Condition: Back Pain; Mechanical Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of a Global Postural Reeducation
      (GPR) program in subjects with chronic low back pain.
    

Detailed description: 
      Approximately 80-85% of individuals will experience low back pain during their lifetime. It
      is one of the major concerns of current health care. There is evidence for the effectiveness
      of exercise therapy in patients with chronic low back pain. GPR is a physical therapy method
      developed in France by Philippe Emmanuel Souchard. Although this method is largely used as
      form of treatment in most countries, few studies showed its clinical effectiveness in chronic
      low back pain. This is the first randomized controlled trial, with assessor blind that
      evaluate the GPR effects in chronic low back pain. All outcome measurements are reliability,
      validated and sensitivity for statistical changes using the Visual Analogic Scale- VAS
      (0-10cm), Roland Morris Questionary, SF36 (Quality Life Questionary) and Beck Scale
      (Depression Symptoms).
    

Intervention name(s): Control Group; Global Reeducation Group
Intervention type(s): Other; Other
Intervention description(s): No physical intervention was given, patients were treated only with medication if necessary.; They were treated with medication if necessary and performed GPR session once a week, during 12 weeks. All the 6 postures from GPR were used during the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic low back pain; Postural global reeducation; randomized; physical rehabilitation
Multiplanar Lumbopelvic Control in Patients With Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The purpose of this study was to investigate whether combined assessment of lumbopelvic
      control during sagittal and frontal plane motion (using two common clinical observational
      assessments) discriminates between people with and without LBP than single plane assessment
      alone. It was hypothesized that the two tests used in combination (multiplanar) would perform
      better than each test used independently (single planar) in accurately discriminating patient
      cases from healthy controls.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants with low back pain were recruited from the physical therapy clinic located at
        Regis University as well as clinical practices from the surrounding area. Control subjects
        were a community sample.
      
Keywords: low back pain; lumbopelvic assessment; active straight leg raise; active hip abduction
Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a bioequivalence study of nizatidine Capsules 300 mg of Dr.Reddy's Laboratories
      Limited under fasting conditions
    

Detailed description: 
      Open label, balanced, randomized, two-treatment, two-period, two sequence, single dose,
      crossover, comparative oral bioavailability study in healthy, adult, male human subjects
      under fasting conditions.
    

Intervention name(s): Nizatidine; Axid
Intervention type(s): Drug; Drug
Intervention description(s): Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited; Axid 300 mg Capsules of Reliant Pharmaceuticals, US
Other intervention name(s): Axid 300 mg Capsules
Intervention MeSH terms: Nizatidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Nizatidine; Crossover
A Two-part Study of the Effects of MK-1029 in Allergen-Challenged Asthmatics (MK-1029-003)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a 2-part study in participants with allergen-induced asthma. It included a
      procedural pilot component (Part 1). Part 1 tested the key procedures and timing of Part 2;
      no study drug was administered during Part 1. Part 2 included a pre-randomization placebo
      run-in (Period 1) and 3 treatment periods (Periods 2, 3, and 4) during which participants
      were randomized to receive double-blind placebo, MK-1029 60 mg or MK-1029 500 mg in a
      crossover design. The treatment periods were followed by a minimum 21-day washout. Part 2
      assessed allergen-induced sputum eosinophils and allergen-induced late asthmatic response
      (LAR) compared to placebo.
    


Intervention name(s): MK-1029 10 mg; MK-1029 100 mg; Placebo for MK-1029 10 mg; Placebo for MK-1029 100 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Six capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design; Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design; Six capsules once daily for 5 days in Period 1, and the same in Period 2, 3, or 4 in a crossover design."; Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Cortisol Resistance in Young Sedentary and Endurance-Trained Men
Condition: Cortisol Resistance; Negative Feedback; ACTH; Mineralcorticoid; Glucocorticoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study proposes to examine multiple aspects of the hypothalamic-pituitary-adrenal axis in
      younger endurance trained and sedentary men, and in older sedentary men.
    

Detailed description: 
      Adrenocorticotropin (ACTH) secretion is normally exquisitely regulated through endogenous
      stimulation by corticotrophin-releasing hormone (CRH) and negative feedback inhibition by
      cortisol, resulting in a circadian rhythm of cortisol. Recent evidence suggests that older
      men, and younger men who are endurance-trained athletes, both have reduced sensitivity to
      negative feedback, and perhaps increased basal levels of cortisol and ACTH. To investigate
      these possibilities, we propose to examine multiple aspects of the
      hypothalamic-pituitary-adrenal axis in younger endurance trained and sedentary men, and in
      older sedentary men.

      Subjects will collect saliva during two evenings before additional testing, and will on the
      same evening collect urine for twelve hours, both for cortisol measurements. Blood samples
      will be collected to evaluate the response to dexamethasone. We also will assess ACTH and
      cortisol responses to medications that reduce negative inhibition of ACTH. This testing will
      occur in the evening and will include administration of the glucocorticoid antagonist
      mifepristone, the mineralocorticoid antagonist spironolactone, and/or a look-alike tablet, on
      four occasions.
    

Intervention name(s): Mifepristone; Placebo; Spironolactone; Combined; Dexamethasone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Other intervention name(s): Mifepristone 400 MG; Spironolactone 200 MG; Mifepristone 400 MG and Spironolactone 200 MG; Dexamethasone 0.25 mg
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Spironolactone; Mifepristone; BB 1101
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cortical Resistance; ACTH; Glucocorticoid; Mifepristone; SPIRONOLACTONE; Exercise; Hypothalamic-Pituitary-Adrenal Axis; Healthy Volunteer; HV
Study of Laparoendoscopic Single Site Hysterectomy in Benign and Preinvasive Uterine Disease
Condition: Benign or Preinvasive Uterine Disease
MeSH terms: Uterine Diseases
Study type: Interventional

Summary: 
      To compare the efficacy between single-port and three-port laparoscopic assisted vaginal
      hysterectomy in patients with benign or preinvasive uterine disease
    

Detailed description: 
      This study intended to conduct a randomized trial to determine whether LESS LAVH has a faster
      recovery rate than three-port LAVH.
    

Intervention name(s): Single-port LAVH; Three-port LAVH
Intervention type(s): Procedure; Procedure
Intervention description(s): LESS LAVH was performed using a commercially available four-channel, single-port system. A rigid, 0-degree, 5 mm laparoscope was used.; Conventional LAVH was performed using three ports; a 12, 10, and 5-mm port was placed in the umbilicus, left lower quadrant, and suprapubic area, respectively. A rigid, 0-degree, 12 mm laparoscope was introduced through 12mm port of umbilicus.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LESS; Benign uterine disease; LAVH