bioihbjkbjnl/mcl2 huggingface dataset:
An Open-Label, 2 Treatment Period,Study To Study The Drug Interaction Between Repeated Doses Of Itraconazole And Single Dose Pharmacokinetics (PK) Of PF-06648671 In Healthy Adults.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the effect of multiple doses of itraconazole, the potent cytochrome
      P450 enzymes (CYP3A) inhibitor, on the pharmacokinetics of PF-06648671 following a single
      dose administration in healthy subject.
    

Detailed description: 
      Based on in vitro data, PF-06648671 was predominantly metabolized by CYP3A and therefore
      there is a potential risk that PF-06648671 PK will be affected by co-administered drugs that
      can inhibit CYP3A activity. This is a clinical drug interaction study to evaluate this
      potential drug interaction in human. In this study, healthy volunteers will take a single
      dose of 25 mg PF-06648671 in period 1 followed by at least 7 day washout. In period 2, same
      subjects will take 200 mg itraconazole oral solution once a day for 3 days, followed by
      co-administration of 200 mg oral solution and a single dose of 25 mg PF-06648671 on day 4
      which are dosed approximately one hour apart with itraconazole is given first. The
      PF-06648671 PK will be collected 0-48 hours after dose in period 1 and 0-240 hrs in period 2.
      Safety will also be monitored throughout both periods.
    

Intervention name(s): PF-06648671; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive a single dose of PF-06648671 25 mg oral suspension on day 1 in period 1 and a single dose on Day 4 in period 2.; Subjects will receive itraconazole 200 mg oral solution once a day for 14 days in period 2
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-06648671; GSM; CYP3A; drug interaction
Determinants of Muscle Strength in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Aim of this study is to determine in chronic kidney disease patients:

        -  the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C
           reactive protein and decrease in serum albumin) on voluntary muscle strength impairment

        -  the relationship between voluntary muscle strength and muscle mass

        -  the relationship between voluntary muscle strength and lean body mass

        -  the correlation between voluntary muscle strength and physical activity
    

Detailed description: 
      Aim of this study is to determine in chronic kidney disease patients:

        -  the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C
           reactive protein and decrease in serum albumin) on voluntary muscle strength impairment
           (estimated by handheld dynamometer)

        -  the relationship between voluntary muscle strength and muscle mass (estimated by
           creatinine index)

        -  the relationship between voluntary muscle strength and lean body mass (estimated by
           bioelectrical impedance analysis)

        -  the correlation between voluntary muscle strength and physical activity (the physical
           activity being estimated by the "Voorrips" score questionnaire)
    

Intervention name(s): Handheld dynamometer; Creatinine index; Electrical bioimpedance analysis; "Voorrips" score questionnaire; Inflammatory and nutritional status
Intervention type(s): Device; Biological; Device; Other; Biological
Intervention description(s): Evaluation of muscle strength; Evaluation of muscle mass using plasma creatinine level; Evaluation of lean body mass; Evaluation of physical activity; Evaluation of C reactive protein and albumin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: chronic kidney disease; malnutrition inflammation atherogenesis syndrome; muscle strength; muscle mass; lean body mass; physical activity
ALT-801 in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety and tolerability in healthy overweight and
      obese volunteers administered single or multiple repeated doses of ALT-801.

      This study has 2 parts. Part 1 involves a single dose of ALT-801 taken as a subcutaneous (SC)
      injection and will be approximately 36 days in duration. Part 2 involves 12 doses of ALT-801,
      once a week for 12 weeks, as a SC injection and will be approximately 116 days in duration.
      Each participant will enroll in only one part.
    


Intervention name(s): ALT-801; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Injected subcutaneously (SC); Injected subcutaneously (SC)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: NASH; Nonalcoholic Steatohepatitis
Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Itopride is a new compound that is already marketed in Japan and in some countries of Eastern
      Europe under the name of Ganaton. It is used to treat symptoms associated with gastroparesis.
      Due to inadequate gastric emptying, these patients often have symptoms of bloating, nausea
      and vomiting following ingestion of a meal. The goal of this study is to evaluate the effects
      of Itopride on gastric motor function and glycemia in patients with diabetes.
    

Detailed description: 
      This is a mechanistic study evaluating in a cross-over design the effects of Itopride
      hydrochloride.

      The primary objective of this study is to evaluate the acute effects of itopride
      hydrochloride (200 mg three times daily) on gastric emptying of solid and liquid meal
      components in patients with type 1 and type 2 diabetes mellitus. Secondary objectives are to
      evaluate the effects of itopride hydrochloride on the glycaemic response to a meal,
      "meal-related" upper gastrointestinal symptoms and intragastric meal distribution.
    

Intervention name(s): Itopride; Placebo
Intervention type(s): Drug; Other
Intervention description(s): oral, three times daily; oral, three times daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide
Condition: Healthy Volunteers; Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will look at how two different versions of semaglutide reach and stay in the blood
      after injection. The study aims to show similar levels of semaglutide in the blood when using
      the different versions. Participants will get both versions of semaglutide. The order in
      which participants receive the versions is decided by chance. Participants will get the
      medicines as an injection under the skin of the belly with the use of a pen-injector. The
      study will last for about 11 to 17 weeks. Participants will have 27 visits with the study
      doctor. At 2 visits, participants will stay in the clinic for 4 days and 3 nights.
      Participants may have to stop the study if the study doctor thinks that there are risks for
      their health. Women cannot take part if pregnant, breast-feeding or planning to become
      pregnant during the study period.
    


Intervention name(s): Semaglutide
Intervention type(s): Drug
Intervention description(s): Two doses of semaglutide given by subcutaneous (s.c., under the skin) injection with different drug product concentration and separated by 6 to 8 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation Study of the Effects of Sulphurous Water in the Treatment of Knee Osteoarthritis.
Condition: KNEE OSTEOARTHRITIS
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The objectives are to evaluate the effects of immersion bath with sulphurous water in pain,
      joint mobility and quality of life in patients with knee osteoarthritis. Patients will
      undergo three weekly baths in sulphurous water and not sulphurous, twenty minutes each, for
      ten weeks.

      The expected results are: reduction of pain, improved range of motion of the lower limbs with
      consequent increase in muscle mass improvement in postural balance, which will come due to
      the reduction of pain and improvement movements of the lower limbs; greater independence in
      performing the activities of daily living, better quality of life.
    

Detailed description: 
      The baths were performed in individual tubs, properly disinfected, supplied with thermal
      water and sulphurous thermal sulphurous not at a temperature 37-39 ° C, which encompass the
      optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects
      drank two cups of water, 300 ml before and after the baths, in order to avoid an imbalance
      water. Treatment consisted of 30 individual treatment sessions, three times a week, lasting
      twenty minutes each session, for ten weeks. The experiment was performed at the Therms
      Antonio Carlos, institution belonging to the Municipality of Poços de Caldas, Minas Gerais,
      Brazil.
    

Intervention name(s): SULPHUROUS WATERS IMMERSION BATHS; NOT SULPHUROUS WATERS IMMERSION BATHS; CONTROL GROUP
Intervention type(s): Other; Other; Other
Intervention description(s): SULPHUROUS WATERS IMMERSION BATHS: The baths will be held in individual tubs, properly disinfected, supplied with sulphurous thermal water at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects will drink two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water.; NOT SULPHUROUS WATERS IMMERSION BATHS:The baths will be held in individual tubs, properly disinfected, supplied with not sulphur thermal water at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects will drink two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water.; CONTROL GROUP: This group did not receive any treatment, only received some verbal directions as to the care that should be taken to prevent and control the knee pain.
Other intervention name(s): Balneotherapy; Termalism; Balneotherapy; Termalism
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: KNEE OSTEOARTHRITIS; BALNEOTHERAPY; SULPHUROUS WATERS; WOMAC; LEQUESNE; HEALTH ASSESSMENT QUESTIONNAIRE; SHORT FORM - 36; VAS
Esophageal Echo Assessment of LV Function During Acute Normovolemic Hemodilution Using Crystalloid or Hypertonic Saline
Condition: Acute Hypovolemia
MeSH terms: Hypovolemia
Study type: Interventional

Summary: 
      The purpose of this study is to examine how the heart functions when a calculated amount of
      blood is removed and how two fluids, Lactated Ringer's (considered the standard replacement
      fluid) and Hypertonic Saline, re-expand the vascular system.
    

Detailed description: 
      This investigator-initiated, single-center, prospective, randomized, clinical experimental
      design will enroll 30 patients scheduled for elective radical prostatectomy, cystectomy, or
      cystoprostatectomy, and anterior/posterior spinal fusions, which includes routine acute
      normovolemic hemodilution (ANH) as a technique to decrease the need for banked blood
      transfusions. The purpose of this study is to compare two methods of volume replacement
      during the ANH procedure. Patients will be randomized to receive either standard crystalloid
      replacement with Lactated Ringers (LR) or 5% hypertonic saline. Selected measurements will be
      obtained by transesophageal echocardiography (TEE) for assessing changes in left ventricular
      volume and function associated with blood loss and replacement. This study will use the
      Accuson Cypress Cardiovascular System and the V5M transesophageal echocardiography probe
      (Siemens Medical Solutions, Malvern, PA). The TEE measurements will be recorded on magnetic
      optical discs and assessed off-line by the researcher after the data collection is completed
      using the proprietary software included in the ultrasound system. In addition, stroke volume
      variation measurement (SVV), Cardiac Output (CO), Cardiac Index (CI), and Stroke Volume Index
      (SVI) will be measured using the Vigileo (TM) arterial pressure monitor with the FloTrac (TM)
      sensor (Edwards Lifesciences, Irvine, CA).
    

Intervention name(s): Volume resuscitation (Crystalloid); Volume resuscitation (Hypertonic Saline Solution)
Intervention type(s): Other; Other
Intervention description(s): Crystalloid vs. Hypertonic Saline Solution; Crystalloid vs. Hypertonic Saline Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TE echo; hemodilution; hypertonic; saline; Arterial Pressure Cardiac Output
Weight and Metabolic Effects of an Almond Enriched Hypocaloric, Low Fat Diet on Overweight and Obese Persons
Condition: Obesity; Metabolic Syndrome X; Hyperlipidemia; Hypertension
MeSH terms: Overweight; Metabolic Syndrome; Hyperlipidemias
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this trial is to study the safety, tolerability and efficacy of an almond
      enriched hypocaloric diet on weight loss and weight maintenance, as well as on established
      and emerging cardiovascular risk factors in approximately 112 overweight and obese persons.
    

Detailed description: 
      A randomized, non-blinded, controlled clinical trial using a parallel design of a
      hypocaloric, low fat (<30% energy from fat) diet with or without 2 oz of almonds over 18
      months. Interim analyses will be conducted at 3, 6, 9 and 12 months. The study will be
      divided into 3 phases. Phase 1 (months 0-6) will be an active, intensive weight loss phase.
      During phase 1, all subjects will meet once a week in the evening for 1.5 hours. Phase 2
      (months 6-12) will be a less intensive weight loss phase. During phase 2 groups will meet
      every other week in the evening for 1.5 hours. The last phase will be the weight maintenance
      phase or phase 3 (months 12-18).
    

Intervention name(s): Almond enriched diet; Low fat caloric diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will consume 2 oz. of almond per day in addition to a low-fat diet; Low fat caloric diet
Other intervention name(s): AED; LFD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity,; Metabolic Syndrome,; BMI
Innate Immunity and the Allergic Response
Condition: Nasal Allergies
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a certain cell type (the CD49d+ neutrophil) is
      associated with the presence or development of allergic disease.
    

Detailed description: 
      A specific subset of neutrophils (CD49d+) will be recruited to the nasal tissue of
      individuals with allergic disease, and that these cells will also be found in the peripheral
      blood of allergic subjects. Normal subjects (those without atopy) and those treated for
      atopic disease will lack the presence of these cells.
    

Intervention name(s): allergen challenge
Intervention type(s): Other
Intervention description(s): nasal challenges with antigen to which they are sensitive to
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Interferon Alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
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. Peripheral stem cell transplantation may allow the doctor to give
      higher doses of chemotherapy drugs and kill more tumor cells. Interferon alfa may interfere
      with the growth of cancer cells.

      PURPOSE: Phase II trial to determine the effectiveness of giving interferon alfa after
      chemotherapy and peripheral stem cell transplantation to patients who have stage III or stage
      IV multiple myeloma and who have been treated with high-dose melphalan.
    

Detailed description: 
      OBJECTIVES: I. Determine the effectiveness of interferon alfa-2b maintenance following high
      dose melphalan chemotherapy for patients with advanced multiple myeloma. II. Determine the
      response rate to high dose dexamethasone therapy using sequential noncrossresistant
      chemotherapies for patients with advanced multiple myeloma.

      OUTLINE: Patients receive high dose dexamethasone on days 1-4, 9-12, and 17-20, followed by 4
      weeks rest. Cyclophosphamide (CTX) is administered intravenously in combination with mesna
      following dexamethasone therapy. Sargramostim (GM-CSF) is initiated subcutaneously 1 day
      later and is continued for 10 days to support stem cell collections, which begin 10-14 days
      after CTX induction. Following 4 weeks of rest, melphalan (L-PAM) is administered over 1
      hour. Stem cell rescue is begun 48 hours after L-PAM therapy. Three to 4 months after the
      first L-PAM course, a second L-PAM and stem cell rescue is undertaken. Interferon alfa-2b
      (IFN-A) maintenance is administered 3 times per week following bone marrow recovery from the
      first or second L-PAM courses. Patients achieving complete remission following the first
      course of L-PAM may proceed directly to IFN-A maintenance. Patients achieving greater than
      grade 3 nonhematologic toxicity or not achieving an absolute neutrophil count of greater than
      1,000/mm3 by day 21 posttransplant are not eligible for dose escalation.

      PROJECTED ACCRUAL: A minimum of 30 patients will be enrolled.
    

Intervention name(s): recombinant interferon alfa; sargramostim; cyclophosphamide; dexamethasone; melphalan; peripheral blood stem cell transplantation
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Interferons; Interferon-alpha; Dexamethasone; Cyclophosphamide; Melphalan; Sargramostim
Primary purpose: Treatment
Keywords: refractory multiple myeloma; stage III multiple myeloma
Vocal Cord Movement Assessment Using Airway Ultrasound.
Condition: Vocal Cord Movement Assessment by Airway Ultrasound
Study type: Observational [Patient Registry]

Summary: 
      Total of 100 patients are included in this is a prospective observational study to evaluate
      the role of airway ultrasound (USG) in assessing vocal cord mobility in patients undergoing
      thyroid surgery. patients will be scanned preoperatively by airway ultrasound which will be
      compared to post operative ultrasound scans.
    

Detailed description: 
      All 100 patients between age groups of 15-70 years, will be scanned pre-operatively to see
      vocal cord mobility as a reference value. A proper acoustic window is mandatory for optimal
      visualization of laryngeal structures. Visibility of false vocal cords, true vocal cords and
      arytenoids will be given one point each for one side, maximal score will be 6. According to
      points the acoustic window scoring for glottis aperture will be graded as fair, when both
      false vocal cords are visible (score1-2), along with false cord when both arytenoids are
      visible scored good (score3-4) and if single or both true vocal cords are visible then scored
      as very good(score5-6). After the surgery the same patient will be scanned again for vocal
      cord mobility at 4hours of extubation . Any change in mobility will be recorded. If any
      change will be observed, direct laryngoscopy (DL) will be done to confirm the diagnosis. Any
      complication in the post-operative period will be recorded.
    

Intervention name(s): airway ultrasound for vocal cords movement assessment.
Intervention type(s): Device
Intervention description(s): Glottic aperture will be scanned using 7.5 megahertz (MHz) linear transducer portable ultrasound machine. after getting the best acoustic window, true, false vocal cords arytenoid movements will be visualized. Individual cord will be focused and doppler velocity will be measured for both the cords.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients undergoing thyroid surgery.
Metabolism and Pharmacokinetics of [14C]- BIBW 2992 MA2 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study was to investigate the metabolism and pharmacokinetics of BIBW 2992 MA2
      after a single oral dose of [14C]-radiolabelled BIBW 2992 MA2 in healthy male volunteers.
      Metabolites in human plasma and excretions were measured, the structures of the metabolites
      analysed and compared with metabolites in animals. In addition, the mass-balance of
      excretion, the protein binding of [14C]-radioactivity, the plasma concentrations of BIBW 2992
      MA2, and the [14C]-radioactivity in blood cells, plasma, urine and faeces were measured. The
      safety and tolerability of BIBW 2992 were also investigated.
    


Intervention name(s): [14C]- BIBW 2992 MA2
Intervention type(s): Drug
Intervention MeSH terms: Afatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment