bioihbjkbjnl/mcl2 huggingface dataset:
Manage Diarrhea in Patients With Multiple Myeloma While Receiving Conditioning Chemotherapy for Autologous SCT
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Diarrhea
Intervention: Serum-derived bovine immunoglobulin/protein isolate (SBI); Colesevelam; Double Placebo
Intervention description: SBI 10 grams (The subject will take a total of 4 packets of SBI; taken as two packets of SBI twice a day mixed with water or blended with certain foods); Colesevelam 1.875 g (The subject will take a total of 12 capsules of Welchol 1.875g per day; taken as 6 capsules twice a day by mouth).; Double placebo twice per day (The subject will take a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
Intervention MeSH terms: Colesevelam Hydrochloride; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      For patients who receive a hematopoietic cell transplant (HCT), there is a risk of developing
      a diarrhea secondary to the chemotherapy which we give. Diarrhea is usually harmless in
      healthy adults; however, in transplant patients, diarrhea can result in dehydration, negative
      impact on quality of life, and prolonged hospitalization. The purpose of this study was to
      see if Colesevelam (Welchol) and Serum-derived bovine immunoglobulin-protein (SBI) result in
      a change in the frequency or consistency of your bowel movements.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years, male or female

          -  Diagnosis: multiple myeloma undergoing Autologous Stem Cell Transplantation (SCT)

          -  Planning to receive conditioning chemotherapy (Melphalan) for autologous stem cell
             transplantation and standard prophylactic antibiotics treatment.

          -  Can drink 200ml of mannitol and agrees to undergo stool, urine, and blood checks 3
             times during the study.

          -  Agrees and able to take the investigational products or placebo starting from the day
             of completing conditioning therapy for a total of 4 weeks

        Exclusion Criteria:

          -  Patients with history of inflammatory bowel disease will be excluded from the study.

          -  Patients with prior GI tract surgical (small or large bowel) resections

          -  The concurrent presence of systemic light chain amyloidosis

          -  Subject has known allergy or intolerance to beef or to any ingredient used in the
             product

          -  Women who are pregnant, breast-feeding and of child-bearing potential
A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: LCZ696; Amlodipine; Hydrochlorothiazide (HCTZ)
Intervention description: Participants received LCZ696 200 mg as the starting dose with optional down titration to 100 mg for tolerance and optional up titration to 400 mg for adequate blood pressure control.; Optional add-on of amlodipine (5-10 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.; Optional add-on of hydrochlorothiazide (HCTZ) (12.5-25 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 341.0
Sex: All
Healthy volunteers: No
Keywords: hypertension; blood pressure; LCZ696; dual-acting; neprilysin; nep inhibitor; vasopeptidase; angiotensin receptor; angiotensin receptor neprilysin inhibitor (ARNi)

Summary:

      The purpose of this study is to assess the long-term safety, tolerability and efficacy of
      LCZ696.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have successfully completed protocol No. CLCZ696A2219 and who, as judged
             by the study investigator, are able to continue in the current study.

          -  Ability to communicate and comply with all study requirements and demonstrate good
             medication compliance during CLCZ696A2219.

        Exclusion Criteria:

          -  Patients who did not complete CLCZ696A2219.

          -  Presence of significant protocol violation in CLCZ696A2219.

          -  Patients who are deemed to be unable to comply with the protocol by the investigator.

          -  Other protocol-defined inclusion/exclusion criteria may apply
Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Intervention: Selonsertib; Placebo to match selonsertib
Intervention description: Tablets administered orally once daily; Tablets administered orally once daily
Intervention MeSH terms: Selonsertib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 334.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetic Kidney Disease; Gilead

Summary:

      The primary objective of this study is to determine the effect of selonsertib (formerly
      GS-4997) on estimated glomerular filtration rate (eGFR) decline in participants with diabetic
      kidney disease (DKD). Participants will be randomized with a 1:1:1:1 allocation to receive 1
      of 3 doses of selonsertib (2 mg, 6 mg, or 18 mg) or matching placebo.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Adult male or females with prior diagnosis of Diabetic Kidney Disease

          -  Type 2 diabetes mellitus diagnosis for at least 6 months

          -  eGFR (MDRD) at screening ≥ 15 mL/min/1.73m^2 to < 60 mL/min/1.73m^2

          -  Urine albumin to creatinine ratio (UACR) as follows:

               -  Stage/Stratum 3a: eGFR range 45 to < 60 mL/min; UACR ≥ 600 mg/g

               -  Stage/Stratum 3b: eGFR range 30 to < 45 mL/min; UACR ≥ 300 mg/g

               -  Stage/Stratum 4: eGFR range 15 to < 30 mL/min; UACR ≥ 150 mg/g

          -  Receiving angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor
             blockers (ARB) at a minimum dose deemed appropriate for the individual by the
             investigator and be at a stable dose for the last three months

               -  Individuals not on ACEi/ARB may be screened if there is documented intolerance to
                  ACE inhibitor and/or ARB

        Key Exclusion Criteria:

          -  Type 1 diabetes mellitus

          -  HbA1c > 9.5%

          -  Non-diabetic kidney disease

          -  UACR > 5000 mg/g on any measurement during screening

          -  End stage renal disease (ESRD; receiving peritoneal dialysis, hemodialysis, or status
             post renal transplantation) or anticipated to occur within the treatment period

          -  Unstable cardiovascular disease

          -  Pregnant or lactating females

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009
Condition: Interpandemic Influenza
MeSH terms: Influenza, Human
Intervention: Seasonal Influenza Vaccine
Intervention description: 1 single intramuscular dose of influenza vaccine, 2008/2009 NH formulation
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prophylaxis of Influenza; Influenza Vaccines; MF59C.1

Summary:

      Trial for annual approval of interpandemic influenza vaccines
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  65 years of age or older

          -  Mentally competent

          -  Willing and able to give written informed consent prior to study entry

          -  Able to comply with all the study requirements

          -  In general good health

        Key Exclusion Criteria:

          -  Any serious chronic or acute disease

          -  History of any anaphylactic reaction and/or serious allergic reaction following a
             vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to
             ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and
             neomycin sulphate);

          -  Known or suspected (or have a high risk of developing) impairment/alteration of immune
             function (excluding that normally associated with advanced age)

          -  Receipt of parenteral immunoglobulin preparation, blood products and/or plasma
             derivates within the past 3 months and for the full length of the study; suspected or
             known HIV infection or HIV-related disease

          -  A bleeding diathesis or condition associated with prolonged bleeding time that in the
             investigator's opinion would interfere with the safety of the subject

          -  Within the past 12 months, they have received more than one injection of influenza
             vaccine

          -  Within the past 6 months, participants had laboratory confirmed influenza disease;
             received influenza vaccine

          -  Within the past 4 weeks participants had received another vaccine; any investigational
             agent

          -  An acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the
             past 14 days
Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Clazakizumab; Placebo (Matching with Clazakizumab)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to identify an appropriate dose of study medication.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Diagnosis of active Rheumatoid Arthritis (RA) by standard criteria (American
             Rheumatism association (ARA) [1987] or American College of Rheumatology/European
             League Against Rheumatism (ACR/EULAR) [2010]) at least 16 weeks prior to screening

          -  ACR global functional status class of 1 to 3

          -  Documented evidence of inadequate response tumor necrosis factor (TNF) inhibitors

          -  All subjects must have been receiving treatment with a minimum dose of 15 mg per week
             of Methotrexate for at least 12 weeks and at a stable dose for 28 days prior to
             screening. A dose as low as 10 mg Methotrexate is permitted if 15 mg could not be
             reached, due to toxicity. In Japan, Korea and Taiwan, a minimum dose of 7.5 mg per
             week is permitted. Additional treatment with Hydroxychloroquine or Chloroquine is
             permitted, if it is at a dose approved for the treatment of RA and the dose has been
             stable for at least 28 days prior to screening

          -  Minimum of 6 swollen and 6 tender joints on a 66/68 joint count at screening and at
             baseline (Day 1)

          -  Elevated High-sensitivity (hs) CRP and/or ESR

        Exclusion Criteria:

          -  Active serious infection

          -  History of or active tuberculosis (TB)

          -  Elevated liver function tests (LFTs)
Study to Investigate the Pharmacodynamic Effect of a Single Dose of AZD2516 in Healthy Male Subjects
Condition: Reflux
MeSH terms: Gastroesophageal Reflux
Intervention: AZD2516, 5 mg; AZD2516, 16 mg; AZD2516, 40 mg; Placebo
Intervention description: Capsule, oral; Capsule, oral; Capsule, oral; Capsule, oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacodynamic effect; Reflux inhibition

Summary:

      The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy
      male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed informed consent

          -  Healthy male subjects

          -  Age 18-45 years, inclusive

        Exclusion Criteria:

          -  Clinically significant illness within the 2 weeks prior to the first dose of study
             drug

          -  History of clinically significant cardiovascular, respiratory, renal, hepatic,
             neurological, mental or gastrointestinal disease

          -  Need for concomitant medications during the study
A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
Condition: Adenoid Hypertrophy
MeSH terms: Hypertrophy
Intervention: Dextromethorphan; Acetaminophen; Dexmedetomidine; Ketamine
Intervention description: Preoperative oral dextromethorphan 1 mg/kg; Preoperative oral acetaminophen 15 mg/kg; Intraoperative intravenous dexmedetomidine 0.5 μg/kg; Intraoperative intravenous ketamine 0.5 mg/kg
Intervention MeSH terms: Acetaminophen; Dexmedetomidine; Ketamine; Dextromethorphan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 4 Years
Maximum age: 8 Years
Healthy volunteers: No

Summary:

      This proposed study will assess analgesic efficacy of a multi-modal, non-opioid analgesic
      regimen for providing surgical analgesia in pediatric patients undergoing adenoidectomy and
      to assess recovery characteristics in the post-anesthesia care unit (PACU) and at home
      following surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients undergoing adenoidectomy ± bilateral ear tube placement

          2. Have a parent/guardian who are compliant with routine medical care, capable of
             subjective evaluation and able to read, understand and sign the informed consent in
             accordance with IRB regulations

        Exclusion Criteria:

          1. An American Society of Anesthesiologists Physical Status ≥ 4 (severe disease that is
             life threatening);

          2. A known hypersensitivity or allergy to any of the study medications;

          3. A history of chronic opioid use prior to surgery;

          4. Coexisting renal or hepatic disease;

          5. Morbid obesity (BMI% ≥ 99).
To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies
Condition: Type 2 Diabetes Mellitus; Impaired Glucose Tolerance
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Intolerance
Intervention: Canakinumab 150 mg; Placebo to Canakinumab
Intervention description: Single subcutaneous injection of Canakinumab 150 mg.; Single subcutaneous injection of Placebo to Canakinumab.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Glimepiride; Insulin Lispro; Insulin, Isophane; Glyburide; Glipizide; Troglitazone; Tolbutamide; Acetohexamide; Insulin, Regular, Pork; Tolazamide; Chlorpropamide; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 246.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus; canakinumab; Pre diabetic; glucose intolerant; oral anti diabetic medication; insulin treatment; metabolic syndrome

Summary:

      This was a 10-week, placebo-controlled, randomized study to investigate the effect of
      injectable IL-1B antagonist, Canakinumab , in participants with impaired glucose tolerance or
      Type 2 Diabetes Mellitus (T2DM) already treated on different background diabetes therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient must fulfill all criteria in one of the following groups:

               -  Impaired Glucose Tolerance (IGT) as diagnosed per protocol and not on an
                  anti-diabetic medicine during the study

               -  Diagnosis of Type 2 diabetes in stable treatment with metformin

               -  Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000
                  mg/day) in combination with a sulfonylurea

               -  Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000
                  mg/day), sulfonylurea and thiazolidinedione combination therapy

               -  Diagnosis of Type 2 diabetes in stable treatment with at least two insulin
                  injections a day with or without metformin

          2. HbA1c between 6.5% and 8%, inclusive, at Screening; this criterion does not apply to
             the IGT group

          3. Age from 18-74 years, inclusive, and of either sex

        Exclusion Criteria:

          1. Type 1 diabetes or diabetes that is a result of pancreatic injury or other secondary
             forms of diabetes

          2. History or current findings of active pulmonary disease (e.g. tuberculosis, fungal
             diseases) as defined in the protocol:

          3. Known presence or suspicion of active or recurrent bacterial, fungal or viral
             infection at the time of enrollment proven.
Study Of 323U66 SR In Major Depressive Disorder
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Intervention: bupropion hydrochloride
Intervention description: Study drug
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: MDD

Summary:

      This study was designed to evaluate the efficacy and safety in major depressive disorder
      patients.
    

Eligibility criteria:

        Inclusion criteria:

          -  Met DSM-IV-TR criteria for major depressive disorder for their current episode for at
             least 8 weeks prior to screening visit.

          -  Must give a written informed consent. But if the patient is under 20, both the patient
             himself/herself and his/her proxy consenter must give written informed consent.

          -  Must have rating scores as outlined.

        Exclusion criteria:

          -  Current or past history of seizure disorder or brain injury.

          -  Current or past history of anorexia or bulimia nervosa.

          -  History of manic episode.

          -  Past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder.

          -  Diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria.

          -  Pregnant, possibly pregnant or lactating.

          -  Must not be suicidal.

          -  Blood pressure of SBP>160mmHg, DBP>100mmHg.

          -  History or complication of cancer or malignant tumour.
A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Combination pill; Ramipril
Intervention description: A once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks.; A once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks.
Intervention MeSH terms: Ramipril
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cardiovascular; fixed; dose; combination; pill; hypertension

Summary:

      The purpose of this study is to compare the effect on systolic pressure of the 3 drugs given
      together in the cardiovascular combination pill (acetylsalicylic acid, simvastatin, and
      ramipril) to the effect on systolic pressure of ramipril given alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be ≥18 years old

          -  Previously untreated systolic pressure result of ≥120<160 mmHg and diastolic pressure
             result of ≥80<100 mmHg

        Exclusion Criteria:

          -  Subjects must not have previously received any anti-hypertensive medication

          -  must not have a systolic pressure <120 mmHg or ≥160 mmHg and diastolic pressure result
             of <80 mmHg or ≥100 mmHg

          -  must not have had a previous coronary artery bypass graft (CABG)

          -  must not have had a previous percutaneous transluminal coronary angioplasty (PTCA)
             with a drug-eluting stent

          -  must not have severe congestive heart failure (New York Heart Classification [NYHC]
             III-IV).