bioihbjkbjnl/mcl2 huggingface dataset:
ALX-0171 Safety Study in Adults With Hyperresponsive Airways
Condition: Respiratory Syncytial Virus Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single-centre, open label study to evaluate the occurrence and subsequent
      reversibility and prevention, of bronchoconstriction following single and repeated oral
      inhalations of ALX-0171 in adults with hyperresponsive airways.

      This phase I study is an exploratory study and serves to evaluate the occurrence and
      reversibility of bronchoconstriction upon inhalation of ALX-0171. The study is an open label
      trial with a sequential administration regimen of placebo and verum in all planned study
      subjects. Each subject will start the treatment with a single dose of ALX-0171 placebo (=
      formulation buffer) followed by escalating doses of ALX-0171 verum.

      Eventually a second administration of ALX-0171 placebo may take place at the end of the study
      (as defined per protocol).
    


Intervention name(s): ALX-0171
Intervention type(s): Biological
Intervention description(s): Escalating dose of ALX-0171 during maximum 3 consecutive days: from 2.1 mg to maximum 200 mg per inhaled dose followed by daily dose of 70 mg, 140 mg or 200 mg per dose for maximum 4 consecutive days
Intervention MeSH terms: Gontivimab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Study of EOC202 Plus Paclitaxel in Chinese Patients With Metastatic Breast Cancer
Condition: Solid Tumor, Adult
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Open label, single arm, dose-escalation phase I study in ambulatory patients receiving first
      line chemotherapy for metastatic breast cancer. The treatment comprises of the standard 6
      cycles of weekly paclitaxel (80 mg/m² IV at D1, D8 and D15 of a 28 day cycle) and two EOC202
      doses (6 and 30 mg SC at D2 and D16 of a 28 day cycle) for 6 cycles. After completion of the
      combined therapy, the patients can continue to receive up to 6 cycles of EOC202 maintenance
      monotherapy (once every cycle on day 1 of each cycle).
    

Detailed description: 
      This study is an open label, single arm, dose-escalation phase I study, performed in
      ambulatory setting with patients receiving first line chemotherapy for metastatic breast
      carcinoma. The standard 6 cycles of paclitaxel (80 mg/m² at D1, D8 and D15 of every 4-week
      cycle) will be given to subjects. Twenty mg i.v. dexamethasone will be given in the first
      cycle before each paclitaxel infusion. Corticosteroids will not be administered after the
      first chemotherapy cycle if the first 3 i.v. infusions of paclitaxel have been well
      tolerated.

      Two EOC202 dose levels, 6 mg and 30 mg will be given to subjects during the cycle and be
      evaluated in successive cohorts of patients. For each dose level, 3 patients will be
      administered one subcutaneous dose every 2 weeks for a total of 24 weeks (12 injections in
      total), separated by 13-day administration-free intervals.

      The 30 mg dose will be dosed to 3 new patients if the 6 mg dose has been deemed safe and well
      tolerated.

      Cohort A - 3 patients at the 6 mg dose - will receive EOC202 administration in seriatim
      separated by four-week intervals for DLT observation. If safety/tolerability are acceptable
      at the end of the DLT observation periods, the study will proceed to the next dose.

      Cohort B - 3 patients at the 30 mg dose - will receive EOC202 administration in seriatim
      separated by four-week intervals for DLT observation. If safety/tolerability are acceptable
      at the end of the 4-week observation periods, the study will proceed to the next phase.

      Cohort C will comprise of additional 6 patients as the PK dose expansion group based on the
      recommended dose for expansion (RDE). The study procedure is the same with the corresponding
      dose group.

      All patients will participate in a pharmacokinetic (PK) and pharmacodynamic (PD) study which
      involves additional blood samples.
    

Intervention name(s): EOC202; Paclitaxel
Intervention type(s): Biological; Drug
Intervention description(s): EOC202 will be SC injection.; Paclitaxol will be IV injection
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Copolymer 1 for Relapsing-Remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES:

      I. Compare tolerance to and therapeutic impact of copolymer 1, a mixture of synthetic
      polypeptides, with placebo in patients with relapsing-remitting multiple sclerosis.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by
      participating institution.

      One group receives copolymer 1, a mixture of synthetic polypeptides composed of 4 amino
      acids, subcutaneously each day for 2 years.

      The other group receives an injection of placebo daily for 2 years.
    

Intervention name(s): copolymer 1
Intervention type(s): Drug
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Allocation: Randomized
Primary purpose: Treatment
Keywords: multiple sclerosis; neurologic and psychiatric disorders; rare disease
A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and
      tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2
      diabetes mellitus. The starting dose of R1511 will be 100mg po bid for 5 1/2 days; this dose
      will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid
      for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability,
      pharmacokinetic and pharmacodynamic data of the previous dose. The anticipated time on study
      treatment is <3 months, and the target sample size is <100 individuals.
    


Intervention name(s): Placebo; RG1511
Intervention type(s): Drug; Drug
Intervention description(s): po bid; Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparing the Clinical Characteristics of Male LADA, T1DM and T2DM Patients
Condition: Diabetes
Study type: Observational

Summary: 
      Diabetes is a common chronic disease in most parts of the world. Diabetes-related
      complications are harmful to the human body. Different types of diabetes have different
      levels of harm to the human body. There are also fewer studies on the relationship between
      specific types of diabetes and clinical diseases such as osteoporosis and Hypogonadism.
      Therefore, clarifying the differences in the clinical characteristics of adult men with
      late-onset autoimmune diabetes (LADA) ,Classical type 1 diabetes (T1DM) and type 2 diabetes
      (T2DM) will help to further understand the effects of diabetes on bone metabolism and sex
      hormones.
    

Detailed description: 
      Diabetes is a common chronic disease in most parts of the world. Diabetes-related
      complications are harmful to the human body. There are also fewer studies on the relationship
      between specific types of diabetes and clinical diseases such as osteoporosis and
      Hypogonadism. This study aimed to compare the prevalence of hypogonadism and osteoporosis
      among male patients with latent autoimmune diabetes (LADA), type 1 diabetes (T1DM) and type 2
      diabetes (T2DM) and investigate the protective factors for hypogonadism and osteoporosis in
      these patients. This cross-sectional study evaluated male patients with LADA, T1DM, and T2DM
      who visited the endocrinology department of Shanghai Tenth People's Hospital for diabetes
      management. Sex hormones, lipid profiles, sex hormone-binding globulin (SHBG), glycosylated
      hemoglobin A1c, beta-cell function, uric acid, and osteocalcin were determined in serum
      samples. Therefor，clarifying the differences in the clinical characteristics of adult men
      with LADA, T1DM and T2DM will help to further understand the effects of diabetes on bone
      metabolism and sex hormones.
    

Intervention name(s): No interventions
Intervention type(s): Other
Intervention description(s): This clinical study is a retrospective study, and no interventions have been implemented for patients.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        600 diabetes Patients from Shanghai Tenth People's Hospital were enrolled in this study.
      
Biospecimen description: 
      Take a blood sample from the patient and extract serum from it for testing
Prexasertib in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors
Condition: Childhood Solid Neoplasm; Recurrent Malignant Solid Neoplasm; Recurrent Primary Central Nervous System Neoplasm; Refractory Malignant Solid Neoplasm; Refractory Primary Central Nervous System Neoplasm
MeSH terms: Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial studies the side effects and best dose of prexasertib in treating
      pediatric patients with solid tumors that have come back after a period of time during which
      the tumor could not be detected or does not respond to treatment. Checkpoint kinase 1
      inhibitor LY2606368 may stop the growth of tumor cells by blocking some of the enzymes needed
      for cell growth.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of
      prexasertib (LY2606368) administered as an intravenous (IV) infusion over 60 minutes, every
      14 days of a 28-day cycle to children with recurrent or refractory solid tumors.

      II. To define and describe the toxicities of LY2606368 administered on this schedule.

      III. To characterize the pharmacokinetics of LY2606368 in children with recurrent or
      refractory cancer.

      SECONDARY OBJECTIVES:

      I. To preliminarily define the antitumor activity of LY2606368 within the confines of a phase
      1 study.

      II. To examine checkpoint kinase (CHK)1/2 expression status in archival tumor tissue from
      solid tumor pediatric patients using immunohistochemistry.

      III. To evaluate tumor tissue for deletion and/or mutation of tumor protein 53 (TP53) as a
      potential biomarker of Chk1 inhibition.

      IV. To evaluate autophosphorylation of Chk1 and H2A histone family, member x (H2AX) in
      peripheral blood mononuclear cells as a potential pharmacodynamic marker of LY2606368
      activity.

      OUTLINE: This is a dose-escalation study.

      Patients receive prexasertib IV over 60 minutes on days 1 and 15. Treatment repeats every 28
      days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up periodically.
    

Intervention name(s): Laboratory Biomarker Analysis; Pharmacokinetic (PK) study; Prexasertib
Intervention type(s): Other; Other; Drug
Intervention description(s): Correlative studies; Correlative studies; Given IV
Other intervention name(s): LY2606368
Intervention MeSH terms: Prexasertib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers
Condition: Metastatic Breast Cancer; Metastatic Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing
      Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese
      hamster ovary (CHO) cells. A randomized, double-blind, single-dose, parallel phase I study
      comparing trastuzumab for injection with Herceptin ® in healthy male volunteers was conducted
      to evaluate the similarities in pharmacokinetics, tolerability, safety and immunogenicity of
      Trastuzumab for injection and Herceptin®.
    


Intervention name(s): Trastuzumab for injection; Herceptin
Intervention type(s): Drug; Drug
Intervention description(s): Trastuzumab for injection manufactured by Chia Tai Tianqing. Trastuzumab is a humanized IGG1-class monoclonal antibody produced by CHO cells. Its mechanism of action is to prevent the attachment of human epidermal growth factor to Her2 by attaching itself to Her2, thus blocking the growth of cancer cells. In addition, Trastuzumab can also stimulate the body's own immune cells to destroy cancer cells.; Herceptin is the brand name of Trastuzumab for injection manufactured by Roche. Trastuzumab is a humanized IGG1-class monoclonal antibody produced by CHO cells. Its mechanism of action is to prevent the attachment of human epidermal growth factor to Her2 by attaching itself to Her2, thus blocking the growth of cancer cells. In addition, Trastuzumab can also stimulate the body's own immune cells to destroy cancer cells.
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Anti-mullerian Hormone(AMH) Levels as a Predictive Factor of Response to Weight Loss Treatment in Obese Infertile Women With Poly Cystic Ovary(PCOS)
Condition: Infertility
MeSH terms: Infertility; Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a prospective before & after clinical trial to compare the basal and 3 months
      after diet anti-mullerian hormone levels between responders and non-responders to weight loss
      diet in obese infertile women with PCOS population
    

Detailed description: 
      The study population comprised of all obese infertile PCOS patients aged 20-40 years which
      underwent 3 months weight loss diet in royan institute, Tehran Iran.

      The study is conducted over 12 wk energy restriction. All subjects have the same dietary
      protocol. At baseline, week 12 the levels of AMH,Follicular Stimulating Hormone (FSH),
      Lutienizing Hormone(LH),Prolactin (PRL), androgens, sex hormone-binding globulin (SHBG),
      glucose, and insulin were measured and Free Androgen Index (FAI) and Insulin Resistance (IR)
      indices is calculated. The laboratory tests are determined by radioimmunoassay in the
      Laboratory of Endocrinology of Royan institute. AMH is measured in duplicate using an
      ultrasensitive ELISA kit (AMH-ELIZA Kit; Beckman Coulter, Marseilles, France) according to
      manufacturer instructions. All measurements are performed using a single kit and at the same
      time in the Laboratory of clinical Immunology of Royan institute.

      Data collection will be performed by using questionnaire to be filled as per the available
      records and laboratory results. Data analysis will be done through descriptive and perceptive
      statistical methods.
    

Intervention name(s): Weight loss diet
Intervention type(s): Other
Intervention description(s): Control the patients diet to make them loosing weight
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anti-mullerian hormone (AMH) level, poly cystic ovarian syndrome obese infertility weight loss diet
Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis
Condition: Prurigo Nodularis; Nodularis Prurigo; Prurigo; Pruritus
MeSH terms: Pruritus; Prurigo; Neurodermatitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objectives of the study are to evaluate the effects of two doses of nalbuphine
      HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in
      patients with prurigo nodularis and to evaluate the safety and tolerability in the study
      population.
    


Intervention name(s): nalbuphine HCl ER tablets 90 mg BID; nalbuphine HCl ER tablets 180 mg BID; Placebo tablets BID
Intervention type(s): Drug; Drug; Drug
Intervention description(s): nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks; nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks; Placebo tablets BID administered for 10 weeks
Other intervention name(s): nalbuphine ER; nalbuphine ER; sugar pill
Intervention MeSH terms: Nalbuphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Itch; Chronic Itch; nalbuphine
A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The principal aim of this study is to obtain safety and tolerability data when PXT002331 is
      administered orally as single and multiple doses to healthy subjects.
    


Intervention name(s): PXT002331
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop
      tumor cells from dividing so they stop growing or die.

      PURPOSE: This phase II trial is studying how well SB-715992 works in treating patients with
      locally advanced, recurrent, or metastatic liver cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of SB-715992, in terms of response rate and stable disease rate,
           in patients with locally advanced, recurrent, or metastatic hepatocellular carcinoma.

        -  Determine the toxicity of this drug in these patients.

        -  Determine the early progression rate and response duration in patients treated with this
           drug.

        -  Determine the pharmacokinetics of this drug in these patients.

        -  Correlate pharmacokinetics with safety and efficacy of this drug in these patients.

        -  Correlate tumor expression of β-tubulin and kinesin spindle protein with clinical
           outcomes in patients treated with this drug.

      OUTLINE: This is a non-randomized, multicenter study.

      Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the
      absence of disease progression or unacceptable toxicity.

      All patients are followed at 4 weeks. Patients with ongoing stable or responding disease are
      followed every 3 months until relapse.

      PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-14
      months.
    

Intervention name(s): ispinesib
Intervention type(s): Drug
Intervention description(s): SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult primary hepatocellular carcinoma; advanced adult primary liver cancer; localized unresectable adult primary liver cancer; recurrent adult primary liver cancer
Phase II Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents
Condition: Glioma
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the combination of Temozolomide and
      Cisplatinum is effective in the treatment of malignant glial tumours of children and
      adolescents
    


Intervention name(s): Temozolomide, Cisplatinum
Intervention type(s): Drug
Intervention MeSH terms: Temozolomide; Cisplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
EHR Embedded Comparative Effectiveness Studies--CPS
Condition: Degenerative Spondylolisthesis
MeSH terms: Spondylolisthesis
Study type: Observational

Summary: 
      Randomize Everyone is a research project to develop new informatics systems and statistical
      methods for supporting randomization processes in EHR systems to do comparative effectiveness
      research. Two demonstration projects are being conducted in the Dartmouth Hitchcock Medical
      Center, designed to evaluate different weight loss interventions and common practices in the
      treatment of chronic low back pain.
    

Detailed description: 
      EHR Embedded Comparative Effectiveness Studies-CPS will be held in the Center for Pain and
      Spine at Dartmouth-Hitchcock Medical Center. This study consists of randomizing enrollees to
      either activity restriction or no activity restriction following lumbar discectomy.
    

Intervention name(s): Activity Restriction; Activity as Tolerated
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Standard post-operative activity instructions (i.e., no bending, twisting, or lifting more than 10 lbs for 4 weeks, no return to work until cleared to do so).; Instructions advising activity as tolerated and return to work based on patient discretion
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients eligible for discectomy