bioihbjkbjnl/mcl2 huggingface dataset:
Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa
Condition: Disorder of Bone Density and Structure, Unspecified
MeSH terms: Bone Diseases; Anorexia; Anorexia Nervosa
Intervention: Recombinant human insulin like growth factor-1 (rhIGF-1)
Intervention description: Twice daily
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Mitogens; Mecasermin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Female
Minimum age: 12 Years
Maximum age: 26 Years
Healthy volunteers: No
Keywords: Bone density; Bone turnover markers; rhIGF-1; Bone structure; Anorexia nervosa

Summary:

      Adolescents and young adults with anorexia nervosa (AN) are at high risk for low bone mineral
      density at a time when healthy adolescents are rapidly accruing bone, with implications for
      peak bone mass and fracture risk in later life. They are also deficient in insulin-like
      growth factor 1 (IGF-1), the bone trophic factor made in the liver in response to growth
      hormone (GH), despite elevated levels of growth hormone. It is possible that deficiency of
      insulin-like growth factor 1, a hormone very important for the maintenance of skeletal
      integrity, may contribute to the severe osteopenia seen in anorexia nervosa. The physiologic
      effects of recombinant human insulin-like growth factor 1 (rhIGF-1) treatment in adolescents
      and young adults with anorexia nervosa have not been studied. The goal of this proposal is to
      investigate the effects of recombinant human insulin-like growth factor 1 on bone density and
      bone microarchitecture in adolescent girls and young adult women with anorexia nervosa over a
      6 month period. We hypothesize that adolescent and young adult anorexia nervosa patients,
      being insulin-like growth factor 1 deficient, will respond to exogenously administered
      recombinant human insulin-like growth factor 1 with elevations in biochemical indices of bone
      turnover and an increase in bone density and improvement in bone structure, or maintain bone
      density (in contrast to the decrease in bone density expected in adolescent girls and women
      with anorexia nervosa who are not treated).
    

Eligibility criteria:

        Inclusion Criteria:

        - Meet criteria for anorexia nervosa (AN) as described in the Diagnostic and Statistical
        Manual of Mental Disorders

        Exclusion Criteria:

          -  Pregnant or nursing

          -  Hematocrit < 30%, K < 3 mmol/L

          -  Any illness (other than AN) known to affect bone and mineral metabolism such as
             diabetes, untreated hypo- or hyperthyroidism, or hyperparathyroidism

          -  History of use of any medicine, such as corticosteroids, known to affect bone density.
             Subjects who are on estrogen will still be eligible to participate in the study
             because our data in adult women with AN do not indicate deleterious effects of
             estrogen in patients receiving rhIGF-
Safety and Efficacy of a Novel Glucagon Formulation in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Intervention: Nasal Glucagon 1 mg; Nasal Glucagon 2 mg; SC Glucagon; Nasal Glucagon 3 mg
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Hypoglycemia; Diabetes mellitus

Summary:

      In this study, participants with Type 1 diabetes received insulin through an infusion into a
      vein to reduce their blood glucose, and then received nasal glucagon (NG) or glucagon for
      injection under the skin, and their blood glucose was measured for 3 hours.

      The main objective of this study was to evaluate the safety and efficacy of intranasal and
      subcutaneous glucagon (SC) in reversing insulin-induced hypoglycemia in participants with
      type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of type 1 diabetes between 2 and 30 years

          -  Receiving daily insulin injections or insulin pump therapy for at least 2 years

          -  If patient is taking Lantus, Levemir or equivalent once-daily in the evening as basal
             insulin, must be willing to transition to once-daily in the morning at least 48 hours
             prior to 1st dosing, and to follow this dosing regimen for the entire duration of the
             study

          -  Body mass index (BMI) greater than or equal to 20.00 and below or equal to 33.00 kg/m2

          -  Female patients must not be pregnant, and must be using effective contraception.

          -  Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes
             or less per day for at least 3 months before day 1 of this study. An ex smoker is
             defined as someone who completely stopped smoking for at least 6 months before day 1
             of this study

        Exclusion Criteria:

          -  History of an episode of severe hypoglycemia (as defined by an episode that required
             third party assistance for treatment) in the previous 6 months before day 1 of this
             study

          -  Score ≥4 on the Clarke Hypoglycemia Awareness survey at screening

          -  Presence or history of pheochromocytoma (i.e. adrenal gland tumor)

          -  Presence or history of significant upper respiratory or allergic (i.e., seasonal
             rhinitis) disease

          -  Presence of clinically significant findings on nasal examination and bilateral
             anterior rhinoscopy

          -  Known presence of hereditary problems of galactose and /or lactose intolerance

          -  History of significant hypersensitivity to glucagon or any related products as well as
             severe hypersensitivity reactions (like angioedema) to any drugs
Study of Multiple Doses of Saxagliptin (BMS-477118)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Saxagliptin; Saxagliptin; Saxagliptin; Saxagliptin; Saxagliptin; Placebo
Intervention description: Tablets, Oral, 2.5 mg, once daily, 12 weeks; Tablets, Oral, 5 mg, once daily, 12 weeks; Tablets, Oral, 10 mg, once daily, 12 weeks; Tablets, Oral, 20 mg, once daily, 12 weeks; Tablets, Oral, 40 mg, once daily, 12 weeks; Tablets, Oral, 100 mg, once daily, 6 weeks; Tablets, Oral, 0 mg, once daily, 6 and 12 weeks
Intervention MeSH terms: Saxagliptin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 423.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects
      with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12
      weeks of double-blind treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes who are drug-naive

          -  Screening HbA1c ≥ 6.8% and ≤ 9.7%

          -  Screening fasting or random C-peptide > 0.5 ng/mL

          -  < 35 years old must be negative for anti-GAD antibodies

          -  Body Mass Index < 35 kg/m2

        Exclusion Criteria:

          -  Symptoms of poorly controlled diabetes

          -  History of diabetic ketoacidosis, hyperosmolar nonketotic coma, or insulin therapy
             within one year of screening

          -  Receipt of oral antihyperglycemic medications for more than six months in total since
             diagnosis

          -  Significant cardiovascular history
Modafinil for Smoked Cocaine Self-Administration
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Modafinil 0 mg; Modafinil 200 mg; Modafinil 400 mg; Cocaine 0 mg; Cocaine 12 mg; Cocaine 25 mg; Cocaine 50 mg
Intervention description: Modafinil (0 mg/day); Modafinil (200 mg/day); Modafinil (400 mg/day); Cocaine (0 mg/day); Cocaine (12 mg/day); Cocaine (25 mg/day); Cocaine (50 mg/day)
Intervention MeSH terms: Cocaine; Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 8.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: cocaine; modafinil; self-administration; DRD4

Summary:

      Modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2
      days/week), but the effects of modafinil on cocaine self-administration in the laboratory
      have not been studied. The present study investigated the effects of modafinil maintenance on
      cocaine self-administration by frequent users (4 days/week) under controlled laboratory
      conditions. During this 48-day double-blind, crossover design study, the effects of modafinil
      maintenance (0, 200, and 400mg/day) on response to smoked cocaine (0, 12, 25, and 50 mg) were
      examined in nontreatment seeking cocaine-dependent individuals (n = 8).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Smokes cocaine

          2. Has patterns of smoked cocaine use in terms of frequency and amount which parallel or
             exceed those administered in the study.

          3. Age 21-50.

          4. Able to give informed consent, and comply with study procedures.

          5. Normal body weight Within normal weight range (for appropriate frame) according to
             1983 Metropolitan Weight tables -

        Exclusion Criteria:

          1. Current seizure disorder, heart disease or a history of serious adverse effects due to
             cocaine.

          2. Dependence on substances (other than cocaine or nicotine) or a history of dependence
             on alcohol

          3. Request for drug treatment

          4. Judged to be noncompliant with study protocol.

          5. Current use of any psychotropic medication.

          6. Clinical laboratory tests outside normal limits that are clinically unacceptable to
             the study physician (BP > 140/90; BUN, creatinine, LFTs > 3x ULN; hematocrit < 34 for
             women, < 36 for men; pseudocholinesterase deficiency)

          7. History of myocardial infarction or ischemia, clinically significant left ventricular
             hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse

          8. Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other
             than transient psychosis due to drug abuse

          9. Current parole or probation Self-report during interview -
Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects
Condition: Chronic Hepatitis C Infection
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: ABT-267; ABT-450; ABT-333; Ritonavir; Ribavirin
Intervention description: Tablet; Tablet; Tablet; Capsule; Tablet
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C,Genotype 1

Summary:

      The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and
      antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir)
      administered as two-day monotherapy followed by ABT-267 in combination therapy with other
      direct-acting antiviral agents (DAAs) ABT-450 with ritonavir (ABT-450/r) and ABT-333 (also
      known as dasabuvir) plus ribavirin (RBV) in patients with chronic Hepatitis C virus (HCV)
      infection without cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between the age of 18 and 70 years, inclusive, at time of enrollment.

          -  Subject has never received antiviral treatment for hepatitis C virus (HCV) infection.

          -  Body mass index (BMI) is ≥ 18 to < 38 kg/m^2. BMI is calculated as weight measured in
             kilograms (kg) divided by the square of height measured in meters (m).

          -  Chronic HCV genotype 1-infection for at least 6 months prior to study enrollment.

          -  Subject has plasma HCV RNA level > 10,000 IU/mL at screening

        Exclusion Criteria:

          -  History of severe, life-threatening or other significant sensitivity to any drug.

          -  Females who are or plan to become pregnant or breastfeeding or males whose partner is
             pregnant or planning to become pregnant.

          -  Recent history of drug or alcohol abuse that could preclude adherence to the protocol.

          -  Positive test result for hepatitis B surface antigen or anti-human immunodeficiency
             virus (HIV) antibodies.

          -  Any current or past clinical evidence of cirrhosis (e.g., ascites, esophageal
             varices), or a liver biopsy or FibroTest/aspartate aminotransferase to platelet ratio
             (APRI) or FibroScan® showing cirrhosis or extensive bridging fibrosis.
An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies
Condition: Malignant Solid Tumor
Intervention: NKTR-102 145 mg/m2; NKTR-102 120 mg/m2; NKTR-102 95 mg/m2; NKTR-102 50 mg/m2
Intervention description: A 90 minute IV infusion of 145 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.; A 90 minute IV infusion of 120 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.; A 90 minute IV infusion of 95 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.; A 90 minute IV infusion of 50 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
Intervention MeSH terms: Etirinotecan pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open Label multicenter extension study advanced solid tumors

Summary:

      The study objective of this open label, multicenter study is to provide access to NKTR-102
      treatment to subjects previously enrolled in a NKTR-102 study who are without signs of
      disease progression since receiving NKTR-102.

      In addition the study will evaluate the safety of continued exposure to NKTR-102, observe
      disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy
      of NKTR-102 in subjects with advanced or metastatic solid tumors.
    

Eligibility criteria:

        Inclusion:

          1. Received prior treatment with NKTR-102

          2. Free of disease progression since receiving NKTR-102

          3. Adequate bone marrow and organ function

          4. Treatment with NKTR-102 in the extension study to begin within 8 weeks after receipt
             of their of last dose of NKTR-102

          5. Agree to use adequate contraception

        Exclusion:

          1. Treatment with other anti-cancer therapy between the last dose of NKTR-102 in the
             prior study and before first dose of NKTR-102 in the extension study

          2. A toxicity that requires a 3rd dose reduction after taking NKTR-102 or are scheduled
             to receive a dose < 70 mg/m2 upon entry into this study

          3. Pregnancy or lactation
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
Condition: UC (Urothelial Cancer)
MeSH terms: Carcinoma; Carcinoma, Transitional Cell
Intervention: pemigatinib; pemigatinib
Intervention description: Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.; Pemigatinib once a day by mouth continuously.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 263.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Urothelial carcinoma; fibroblast growth factor (FGF); fibroblast growth factor receptor (FGFR); FGF/FGFR alterations

Summary:

      The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a
      monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma
      harboring FGF/FGFR alterations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  20 years and older in Japan

          -  Histologically documented metastatic or surgically unresectable urothelial carcinoma;
             may include primary site from urethra, ureters, upper tract, renal pelvis, and
             bladder.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

          -  Life expectancy ≥ 12 weeks.

          -  Radiographically measurable per RECIST v1.1.

          -  Documented FGF/FGFR alteration and have either 1a) failed at least 1 previous
             treatment for their metastatic or surgically unresectable urothelial carcinoma (ie,
             chemotherapy, immunotherapy) or 1b) have not received chemotherapy due to poor ECOG
             status or 2) have insufficient renal function.

        Exclusion Criteria:

          -  Prior receipt of a selective FGFR inhibitor.

          -  Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives
             (whichever is shorter) before the first dose of study drug.

          -  Inability or unwillingness to swallow pemigatinib or significant gastrointestinal
             disorder(s) that could interfere with the absorption, metabolism, or excretion of
             pemigatinib.
Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin
Condition: Obesity
MeSH terms: Body Weight
Intervention: Placebo; Pramlintide and Metreleptin
Intervention description: placebo pramlintide and placebo metreleptin twice daily; Subcutaneous injection, twice daily
Intervention MeSH terms: Pramlintide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 274.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Leptin; Pramlintide; Obese; Symlin; Amylin

Summary:

      Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with
      randomized study medication. The purpose of the extension study is to examine the long-term
      (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide
      and metreleptin, administered as separate subcutaneous (SC) injections, in obese and
      overweight subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed Study DFA102, including all procedures required at the Study Termination
             visit, without major protocol deviations

          -  Male, or female and meets all the following criteria:

               1. Has a negative urine pregnancy test result at Study start(not applicable to
                  hysterectomized females)

               2. If of childbearing potential must practice and be willing to continue to practice
                  appropriate birth control during the entire duration of the study

          -  Able to read, understand, and sign the Informed Consent Form (ICF) and if
             applicable,an Authorization to Use and Disclose Protected Health Information Form,
             answer the study questionnaires, communicate with the investigator, and understand and
             comply with protocol requirements

        Exclusion Criteria:

          -  Is expected to require or undergo treatment with any exclusionary medication.

          -  Is undesirable as a study participant as judged by the investigator
Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: NBI-98854; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of
      NBI-98854 administered once daily (qd) for a total of 8 weeks of treatment. This study will
      enroll approximately 90 male and female subjects clinically diagnosed with Tourette Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a clinical diagnosis of Tourette Syndrome (TS)

          2. Have at least moderate tic severity

          3. Have TS symptoms that impair school, occupational, and/or social function

          4. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g.
             obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]),
             be on stable doses

          5. Be in good general health

          6. Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine,
             phencyclidine, cocaine, or opiates, and a negative alcohol screen

          7. Subjects of childbearing potential who do not practice total abstinence must agree to
             use hormonal or two forms of nonhormonal contraception (dual contraception)
             consistently during the screening, treatment and follow-up periods of the study

        Exclusion Criteria:

          1. Have an active, clinically significant unstable medical condition within 1 month prior
             to screening

          2. Have a known history of long QT syndrome or cardiac tachy-arrhythmia

          3. Have a known history of neuroleptic malignant syndrome

          4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)

          5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors

          6. Have a known history of substance dependence, substance (drug) or alcohol abuse

          7. Have a significant risk of suicidal or violent behavior

          8. Are currently pregnant or breastfeeding

          9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the
             screening period or at baseline or plan to initiate CBIT during the study

         10. Have received an investigational drug within 30 days before screening or plan to use
             an investigational drug (other than NBI-98854) during the study

         11. Have a blood loss ≥550 mL or donated blood within 30 days prior to screening