bioihbjkbjnl/mcl2 huggingface dataset:
Serum Biomarkers in Diagnosis of Mesothelioma
Condition: Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Study type: Observational

Summary: 
      In this study, the investigators analyzed the efficiencies of hyaluronan, osteopontin,
      C-ERC/mesothelin, N-ERC/mesothelin and syndecan-1 serum levels, both individually and in
      combination, in distinguishing malignant pleural mesothelioma patients from patients with
      metastatic malignant pleural diseases, benign pleural diseases, and benign asbestos pleurisy.
    

Detailed description: 
      In the year 2002, a database for the pleural diseases was constructed to be prospectively
      filled in the department. The findings, outcome features and characteristics of follow-up for
      all cases with pleural diseases have been recorded in this database. The patient data,
      including epidemiological characteristics, smoking status, history of other diseases and
      co-morbid conditions, previous asbestos exposure, medications and additional physical and
      radiological examination findings, including computed tomography scans, both serum and
      pleural fluid laboratory investigational data and indications of invasive procedures, were
      recorded in the database mentioned above. The methods employed in the diagnosis of patients;
      any complications; characteristics such as the stages of diseases, treatments, and course of
      treatments; and results were also recorded in the database. From the date of the first
      database establishment, a "tissue, blood, serum, and fluid specimen bank" was constructed;
      tissue, blood, serum and pleural fluid samples of patients, which had been taken at the
      beginning of diagnosis process, were stored in this bank at -80°C. The blood, serum, and
      pleural fluid samples of patients were stored during the diagnosis process, and if conducted,
      pleural tissue samples taken during invasive procedures were also stocked.
    

Intervention name(s): Mesothelin, hyaluronan, osteopontin, syndecan-1
Intervention type(s): Biological
Intervention description(s): We compere the serum levels of the tumor markers in patients with pleural diseases according to the groups for the diagnosis and differential diagnosis of the diseases.
Other intervention name(s): N-ERC/mesotehlin,; C-ERC/mesotehlin; Osteopontin; Hyaluronan; Syndecan-1
Intervention MeSH terms: Hyaluronic Acid
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with pleural diseases; mesothelioma, metastatic malignant pleural diseases, benign
        pleural diseases and benign asbestos pleurisy.
      
Biospecimen description: 
      Serum samples of the patients
    
Keywords: Mesothelioma,; Pleural diseases,; Mesothelin,; Osteopontin,; Hyaluronan,; Syndecan-1
A Study of the Effects of Erythromycin on the Pharmacokinetics of Relugolix, Estradiol, and Norethindrone in Healthy Postmenopausal Women and on the Pharmacokinetics of Relugolix in Healthy Adult Men
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part, open-label, fixed-sequence, two-period crossover drug interaction study
      to assess the potential effects of erythromycin on the pharmacokinetics of relugolix,
      estradiol (E2), and norethindrone (NET) in healthy postmenopausal women (Part 1) and the
      pharmacokinetics of relugolix in healthy adult men (Part 2).
    

Detailed description: 
      Each study part consists of two sequential treatment periods (Treatment Period 1 and
      Treatment Period 2) in which study participants will receive study treatments in a fixed
      (single)-sequence, crossover manner. In Part 1 of the study, a single
      relugolix/E2/norethindrone acetate (NETA) (40 milligrams [mg]/1 mg/0.5 mg) fixed-dose
      combination (FDC) tablet will be administered alone on Day 1 of Treatment Period 1; in
      Treatment Period 2, erythromycin will be administered on Day 1 to Day 12 (500 mg, four times
      daily [QID]) with co-administration of a single FDC tablet with the morning dose of
      erythromycin on Day 8. In Part 2 of the study, a single 120-mg dose of relugolix will be
      administered alone on Day 1 of Treatment Period 1; in Treatment Period 2, erythromycin will
      be administered on Day 1 to Day 12 (500 mg QID) with co-administration of a single 120-mg
      dose of relugolix with the morning dose of erythromycin on Day 8. There will be a nine-day
      washout interval between administration of study drug (the FDC tablet [Part 1] or relugolix
      120 mg [Part 2]) on Day 1 of Treatment Period 1 and Treatment Period 2.
    

Intervention name(s): Relugolix/E2/NETA FDC; Relugolix; Erythromycin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Relugolix/E2/NETA (40 mg/1 mg/0.5 mg) FDC tablet; oral administration.; Relugolix 120-mg tablets; oral administration.; Erythromycin 500-mg tablets; oral administration.
Other intervention name(s): Rel-CT; MVT-601; TAK-385
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Relugolix
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: In each study part (Part 1 and Part 2), study treatments will be administered in a fixed (single) sequence, crossover manner in two sequential treatment periods (Treatment Period 1 and Treatment Period 2).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relugolix; Estradiol; Norethindrone acetate; Erythromycin; Pharmacokinetics; Norethindrone
Effect of Glycopyrronium in Combination With Tropisetron in Anti-postoperative Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the anti-nausea and vomiting effect between glycopyrronium in combination with
      tropisetron and normal saline in combination with tropisetron for patients receiving elective
      surgery under general anesthesia. Based on this study the investigators intend to explore the
      feasibility of using glycopyrronium as adjuvant drug to prevent postoperative nausea and
      vomiting.
    


Intervention name(s): Glycopyrronium in Combination With Tropisetron; Normal Saline in Combination With Tropisetron
Intervention type(s): Drug; Drug
Intervention description(s): Glycopyrronium (0.2mg) in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.; Normal Saline in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.
Intervention MeSH terms: Glycopyrrolate; Tropisetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the safety and efficacy of BLI4900 as a bowel
      preparation prior to colonoscopy in adult patients.
    


Intervention name(s): BLI4900; PEG Control
Intervention type(s): Drug; Drug
Intervention description(s): BLI4900 Bowel Preparation; Polyethylene glycol-based bowel preparation
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Telehealth-Based Exercise Program to Treat Fatigue in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Interventional

Summary: 
      This is a clinical trial examining a brief motivational intervention to improve adherence to
      exercise among individuals with MS to improve fatigue.
    

Detailed description: 
      This is a 2-arm single blind parallel group RCT comparing a brief telephone based
      motivational intervention to an informational control to improve adherence to exercise among
      individuals with MS. The primary outcome is improvement in fatigue.
    

Intervention name(s): Brief telephone-based counseling; Education counseling
Intervention type(s): Behavioral; Other
Intervention description(s): Brief telephone-based counseling using Motivational Interviewing and physical activity goal setting and problem solving; Mailed informational video of exercise programs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; Fatigue; exercise; telemedicine; motivational interviewing; counseling; depression; physical activity
Sleep Apnoea Syndrome Without Chronic Heart Failure
Condition: Sleep Apnoea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Heart Failure; Syndrome
Study type: Observational

Summary: 
      It is the objective of this study to collect scientific data of sleep apnoea syndrome
      patients´ cardiac and respiratory function by additional sensors.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with or with supected sleep apnoea syndrome
Efficacy and Safety of Chungkookjang on Improvement of Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators performed a 12-week, randomized, double-blind, placebo-controlled crossover
      human trial to evaluate the efficacy and safety of chungkookjang on improvement of metabolic
      syndrome. The investigators measured decrement of body fat parameters, including Body Fat
      Mass, Percent Body Fat, Fat Free Mass, Weight and BMI(body mass index), and monitored their
      blood pressure.
    


Intervention name(s): Chungkookjang; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Chungkookjang(35g/day); Placebo(35g/day)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Efficacy of Dietary Fiber Supplementation (Soloways) in Patients With Specific Genetic Polymorphisms
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This randomized, double-blind, placebo-controlled trial assessed the impact of a dietary
      fiber supplement (glucomannan, inulin, and psyllium) on weight and metabolic parameters in
      individuals with obesity-related genetic polymorphisms (FTO, MC4R, LEP, LEPR). Participants
      were adults aged 18-65 with a BMI ≥ 25 and confirmed genetic predispositions. The study,
      involving 216 participants (108 per group), ran over 12 weeks with assessments at 0, 4, 8,
      and 12 weeks. Primary outcome was Body-weight change in %. The study aimed to clarify the
      role of fiber supplements in genetically predisposed obese individuals.
    


Intervention name(s): glucomannan, inulin, and psyllium; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): the subjects recieved fiber supplement containing glucomannan, inulin, and psyllium; the subjects recieved placebo
Intervention MeSH terms: Psyllium; (1-6)-alpha-glucomannan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: obesity; supplements; body mass index; overweight
Bioequivalence of Two Tablet Forms of MK0974 (0974-045)
Condition: Migraine
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the bioequivalence of two solid dose formulations of MK0974.
    


Intervention name(s): MK0974 Ethanolate formulation; Comparator: MK0974 Hydrate formulation
Intervention type(s): Drug; Drug
Intervention description(s): Single dose MK0974 280 mg tablet in one of two treatment periods; Single dose MK0974 280 mg tablet in one of two treatment periods
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oral Bioavailability of Solid Formulation of GLPG1205 With and Without Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the amount of compound present in the blood (relative
      bioavailability) after a single oral administration of GLPG1205 given as a capsule
      formulation in fasted versus fed conditions in male healthy subjects.

      Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule
      formulation under fasted and fed conditions will be assessed.
    


Intervention name(s): 100 mg GLPG1205
Intervention type(s): Drug
Intervention description(s): A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Peripheral Intravenous Central Catheter Intervention in Preterm Infants
Condition: Preterm; Pain, Acute; Stress; Nursing Caries
MeSH terms: Premature Birth; Acute Pain
Study type: Interventional

Summary: 
      This study will be conducted to evaluate the effect of grasping reflex stimulation applied
      during peripheral intravenous central catheter (PIC) intervention on pain and stress in
      preterm infants receiving treatment and care in the neonatal intensive care unit.
    

Detailed description: 
      The study was planned in a parallel randomized controlled trial design. The population of the
      research will be preterm infants followed in the Newborn Intensive Care Unit of Atatürk
      University Health Research and Application Center between May 2022 and September 2022.
      Randomization in the sample of the study will be done in the computer environment. Sample
      size was determined by power analysis. In the collection of data; Preterm Baby Information
      Form, Preterm Baby Follow-up Form, Neonatal Stress Scale and ALPS-NEO pain and stress
      assessment scale will be used. In the control group, the PIC intervention will be performed
      by the investigator in accordance with clinical procedures. In the experimental group, the
      baby's grasping reflex stimulation will be provided during the PIC attempt.
    

Intervention name(s): Graspin Palmar Reflex Stimulation
Intervention type(s): Behavioral
Intervention description(s): The grasping reflex is an involuntary response involving the hands and fingers. flexion-adduction movement. The reflex resembles the grasping movement of the hand. The reflex can be achieved by moving an object distally across the palm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Preterm; Pain, Acute; Stress; Nursing Caries
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
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. Combining radiation therapy with chemotherapy may kill more tumor
      cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation
      therapy in treating patients who have locally advanced pancreatic cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of gemcitabine, cisplatin, and radiotherapy, in terms of 1-year
           survival, in patients with locally advanced pancreatic cancer.

        -  Determine the toxicity of this regimen in these patients.

        -  Determine the quality of life of patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive
      gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the
      first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy,
      patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every
      28 days for a total of 3 courses in the absence of disease progression or unacceptable
      toxicity.

      Quality of life is assessed at baseline, at completion of radiotherapy, at completion of
      chemotherapy, and 3 months after completion of therapy.

      Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

      PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 12-28
      months.
    

Intervention name(s): cisplatin; gemcitabine hydrochloride; radiation therapy
Intervention type(s): Drug; Drug; Radiation
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III pancreatic cancer; adenocarcinoma of the pancreas; stage IV pancreatic cancer
Combination of Nivolumab and DHAP in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (Nivo-DHAP)
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A clinical study of safety and efficacy of treatment with Nivolumab and DHAP in patients with
      relapsed/refractory Hodgkin's lymphoma
    

Detailed description: 
      A Clinical Study of Safety and Efficacy of Treatment With Nivolumab and Dexamethasone,
      Cytarabine and Cisplatin (DHAP) in Patients With Relapsed/Refractory Hodgkin's Lymphoma
    

Intervention name(s): Nivolumab
Intervention type(s): Drug
Intervention description(s): Combination of 2 cycles of Nivolumab as a monotherapy with 4 cycles of high-dose chemotherapy (DHAP chemoregimen) with Nivolumab
Other intervention name(s): Opdivo
Intervention MeSH terms: Nivolumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Placebo-Controlled Cross Over Trial of Chlorzoxazone Intake
Condition: Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall goals of this study are to (1) expand knowledge about interactions of
      chlorzoxazone with alcohol by assessing the effects of chlorzoxazone compared to placebo in
      moderate and heavy social alcohol users and (2) to compare the effects of chlorzoxazone on
      visual cue induced alcohol craving to placebo in moderate to heavy social alcohol users.
    

Detailed description: 
      The investigators propose a 45-day, double-blind, placebo-controlled crossover study in light
      to moderate and heavy alcohol users.

      The specific aims are to:

        1. Determine if chlorzoxazone alters daily alcohol consumption by comparing the mean drinks
           consumed per day during chlorzoxazone administration compared with the mean drinks per
           day consumed during placebo administration.

        2. To determine if polymorphisms in genes encoding for neurotransmitters or receptors
           involved in alcohol reward, abuse, dependence, craving, or relapse may predict the level
           of response to chlorzoxazone's effects on alcohol consumption or craving.

        3. To investigate any change in alcohol craving during a cue induced craving task where
           participants view and respond to a number of images.
    

Intervention name(s): Parafon Forte
Intervention type(s): Drug
Intervention description(s): Drug: Parafon Forte administered at study visit
Other: Placebo administered at study visit
Other intervention name(s): Chlorzoxazone
Intervention MeSH terms: Chlorzoxazone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Dynamics of the Microbiome in the Premature Infant
Condition: Infection
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The purpose of the study is to describe the dynamics of the microbiome in the premature
      infant as a means to adapt the premature infant gut to affect better health outcomes.
    

Detailed description: 
      The study team will collect samples of blood and stool from preterm infants once a week from
      the first week of life until 8 weeks after delivery. Blood samples will be collected from
      left over blood that is being collected for clinical management. No extra blood draws will be
      done for research purposes only. Samples of leftover breast milk will be collected once
      weekly from the first week of life until 8 weeks after delivery.

      While the baby is in the hospital the study team will collect information about the growth
      and development as well as events that happen during their intensive care nursery (ICN)
      hospitalization.

      In addition, blood and stool will be collected, as well as information about the growth when
      the infant returns to the Duke Special Infant Care Clinic for developmental check-ups at 6
      and 12 months of age. The blood will be approximately 1 teaspoon (5 milliliters) and will be
      done at the same time that labs for clinical management are being done.

      A single maternal blood sample (approximately 2 teaspoons) and stool sample will be collected
      after delivery. Information will also be collected from the medical record.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Very low birth weight infants
      
Biospecimen description: 
      Blood, stool, serum, breastmilk
    
Keywords: Very Low Birth Weight (VLBW); Microbiome
A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the safety, tolerability and potential immune
      response to romosozumab following single subcutaneous (SC; injection under the skin) dose
      administration in healthy postmenopausal Japanese and non-Japanese women.
    


Intervention name(s): Romosozumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Other intervention name(s): AMG 785; EVENITY™
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Amgen; Phase 1; Postmenopausal; Japanese