bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Cervical Discharge Removal During ET on Pregnancy Rate
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Pregnancy rate may be affected by multiple factors such as embryo transfer techniques. Even
      small differences in embryo transfer methods may affect pregnancy rates. There is an
      inconsistency about the effect of the removal of cervical discharge on embryo transfer
      outcomes. Some studies showed that cervical mucus removal before embryo transfer can increase
      pregnancy rate, however the others could not find any significant effect about the removal of
      cervical mucus on pregnancy or live birth rates. Given to the conflicting evidences, our
      study aimed to determine whether the cervical discharge removal has positive effect on
      pregnancy rate.
    

Detailed description: 
      492 Infertile women who were candidate for fresh embryo transfer during IVF/ICSI cycles were
      eligible for this study if they had two or more good quality embryos. All categories of
      female or male factors infertility except uterine factor infertility were eligible for
      participation in the study. Immediately prior to embryo transfer, women were randomly
      allocated to either treatment (cleaning the cervical canal) or control groups. In treatment
      group, excess mucus and debris were cleared from the cervical canal using a sterile cotton
      swabs. The cervical discharge was scored as mucosal, bloody, combination of mucosal and
      bloody, or infected. Control group had no cervical cleaning before embryo transfer. Then, the
      embryos were loaded into the transfer catheter by the embryologist and were deposited into
      the uterine cavity by one experience physician. The primary endpoint was clinical pregnancy.
      Fertilization, Implantation, abortion, and live birth rates were the other outcomes of
      interest or secondary outcomes.
    

Intervention name(s): Cervical discharge removal; control
Intervention type(s): Procedure; Procedure
Intervention description(s): Cervical discharge will be removed using a cotton swab before embryo transfer during ICSI cycles; Embryo transfer without any intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Cervical mucus, Embryo transfer, ICSI cycle, Pregnancy rate
Fimasartan Achieving SBP Target (FAST) Study
Condition: Essential,Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Fimasartan compared to
      Valsartan and Olmesartan(reference group) in patients with mild to moderate essential
      hypertension. Patients have 2 weeks of placebo run-in and wash out period, 2 weeks of taking
      required dose and 4 weeks of taking double dose.
    

Detailed description: 
      A randomized, double-blind, active control, 3-parallel group comparison clinical study to
      evaluate the anti-hypertensive efficacy and safety of Fimasartan in patients with mild to
      moderate hypertension. Approximately 360 patients will be enrolled in 8 centers in South
      Korea. This study has planned 6 visits during 8 weeks.(2 weeks of placebo run-in and wash
      out, 2 weeks of treatment and 4 weeks of forced titration) All of the subjects who agreed to
      participate in this study and gave written informed consent voluntarily are assessed the
      inclusion and exclusion criteria and receive the investigational product(placebo) at
      screening visit. During more than 14 days of placebo run-in and wash out period, subjects
      have to stop the previous anti-hypertensive drug. After placebo run-in and wash out period,
      Subjects are assessed the final eligibility and started measuring ambulatory blood pressure
      for 24 hours. Subjects who determined to be appropriate for this study are allocated to
      experimental group(Fimasartan 60mg) or control group(Valsartan 80mg) or Reference
      group(Olmesartan 10mg) randomly at ratio 3:3:1.Subjects take their investigational products
      daily for 2 weeks and double dose for 4 weeks. The placebo period will be single-blinded and
      the treatment allocation in this study will be double-blinded.
    

Intervention name(s): Placebo; Fimasartan; Valsartan; Olmesartan medoxomil
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 weeks of placebo PO daily; 60mg 1 tab PO daily for 2 weeks and 120mg 1 tab PO daily for 4 weeks; 80mg 1 tab PO daily for 2 weeks and 160mg 1 tab PO daily for 4 weeks; 10mg 1 tab PO daily for 2 weeks and 20mg 1 tab PO daily for 4 weeks
Other intervention name(s): Kanarb Tab; Diovan Tab; Olmetec Tab
Intervention MeSH terms: Valsartan; Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands
Condition: Albuminuria
MeSH terms: Albuminuria
Study type: Interventional

Summary: 
      Eligible subjects meeting the pathological profile will be recruited at the designated site
      by the study personnel. Following subject consent, the subjects will be evaluated for
      eligibility based on their health condition and history.

      The ACR | U.S. kit, in its original packaging, along with the ACR | U.S. smartphone
      application will be provided to the subject in a simulated home- use environment. All
      subjects will be provided with a list of tasks to complete, including providing a urine
      sample and operating the ACR | U.S. device on 2 mobile phones. After completing the test, the
      lay user will complete a post-test questionnaire. The study observer will also complete a
      questionnaire to collect information regarding the lay users' use of the ACR | U.S.

      The device use will be compared with identified risks to determine if the percentage of
      failures is acceptable. Additionally, measurable usability criteria for specific, critical
      steps will be evaluated.

      Following the usability test performed by the lay user, the subjects' urine samples will be
      tested by the study staff using the comparator device. These results will be considered as
      the "true value".
    


Intervention name(s): ACR | U.S. Urine Analysis Test System; URiSCAN Optima Urine Analyzer
Intervention type(s): Device; Device
Intervention description(s): Each study participant will test their urine sample using the ACR | U.S. test device - a home-use device intended for the semi-quantitative measurement of ACR in the urine (albumin and creatinine ratio) and used to aid in the management of kidney health.; Upon completion of the test using the ACR | U.S. device, each urine sample will be provided to a professional user for further urine analysis test using the comparator device, the URiSCAN Optima Urine Analyzer.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study of Radiolabeled ALXN2050 in Healthy Adult Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study to assess the absorption, metabolism, excretion, and mass balance
      of a single oral dose of carbon-14 ([14C])-ALXN2050 in healthy adult males.
    


Intervention name(s): [14C]-ALXN2050
Intervention type(s): Drug
Intervention description(s): A single dose of 200 milligrams (~85 microcuries) [14C]-ALXN2050 will be administered orally.
Other intervention name(s): ALXN2050; ACH-0145228 (formerly)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Mass Balance; ALXN2050; Factor D Inhibitor; Total Radioactivity; Absorption; Metabolism; Excretion
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in France
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is a National, Multicentre, Observational Registry to study adherence and long term
      outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth
      hormone treatment from hospitals in France and to assess the level of adherence of subjects
      receiving SAIZEN® via Easypod™.
    

Detailed description: 
      Subjects will be enrolled in this observational, multi-center study to assess adherence and
      treatment outcomes. Parents will provide their written agreement to upload their child's data
      in the study electronic CRF.

      Easypod™ is an electromechanical device that delivers growth hormone and also records
      injections' date and time. Adherence data will be primarily derived from injections recorded
      in the Easypod™ device combined with physician data entry of outcome measures (i.e. height &
      weight). This will allow the establishment of adherence profiles and evaluate the link with
      subsequent clinical outcomes.

      Since this is an observational study, there will be no study-specific clinical interventions
      and subjects will be treated according to the clinical and laboratory findings as routinely
      evaluated by the physician. Auxological and laboratory data will be reported prospectively
      throughout the duration of the study. At baseline, available data can be recorded
      retrospectively from the subjects' medical file and Easypod™ device Data will be collected
      retrospectively and prospectively. This will allow the establishment of adherence profiles
      and subsequent clinical outcomes. Collected data will be also analyzed in a multinational
      pooled analysis of comparable national studies.

      Primary Objective:

      • To assess the level of adherence of subjects receiving Saizen® via Easypod™

      Secondary Objectives:

        -  To describe the impact of adherence on clinical outcomes for subject receiving Saizen®
           via Easypod™

        -  To identify adherence subject profiling

        -  To asses the Impact of adherence on insulin-like growth factor-1 (IGF1) ranges/levels
    

Intervention name(s): Easypod™
Intervention type(s): Device
Intervention description(s): Saizen (Somatotropin) as per Summary of Product Characteristics administered by Easypod™
Other intervention name(s): Somatotropin
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Subjects who are taking SAIZEN® for a pediatric registered indications using the Easypod™
        electromechanical device.
      
Keywords: Growth disorders; Saizen; Easypod; Growth hormone; Pediatric subject
Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with
      multiple myeloma that has recurred following bone marrow transplantation.

      PURPOSE: This phase II trial is studying how well giving donor white blood cells works in
      treating patients with recurrent multiple myeloma who have undergone bone marrow
      transplantation.
    

Detailed description: 
      OBJECTIVES:

        -  Assess the response rate of patients with recurrent multiple myeloma after an allogeneic
           marrow transplant from a genotypically HLA identical sibling donor treated with donor
           lymphocyte infusions as salvage therapy .

        -  Evaluate the safety and toxicity of this treatment when used as salvage therapy in these
           patients.

      OUTLINE: Patients receive initial cell dose of donor lymphocytes (CD3+ cells) IV over 15-30
      minutes. Patients with rapidly progressive disease may skip the initial cell dose and proceed
      directly to dose escalation to receive CD3+ cells at a higher cell dose. Patients who achieve
      complete response to the initial treatment may receive up to 2 additional courses of
      escalating doses of CD3+ cells 8-12 weeks apart in the absence of unacceptable toxicity.
      Patients are evaluated at 4 and 8 weeks after each infusion. Patients with disease
      progression at 8 weeks are retreated at that time. Patients who achieve partial response or
      stable disease at 8 weeks are re-evaluated at 12 weeks and may then be retreated.

      Patients are followed every 2 weeks for 3 months, once a month for 9 months, and then every 2
      months thereafter.

      PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study within 2 years.
    

Intervention name(s): therapeutic allogeneic lymphocytes
Intervention type(s): Biological
Primary purpose: Treatment
Keywords: refractory multiple myeloma
Study of Pegylated Human Recombinant Arginase for Liver Cancer (BCT-100-002)
Condition: Neoplasm; Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether recombinant human arginase (PEG-BCT-100) is
      safe and effective in the treatment of advanced hepatocellular carcinoma (HCC).
    

Detailed description: 
      The primary objectives of this study are:

        -  To evaluate any objective tumor responses to PEG-BCT-100 in HCC patients receiving
           weekly doses of PEG-BCT-100 alone.

        -  To perform PK and PD analysis

        -  To measure Quality of Life of the patients

      Secondary objectives of this study are:

        -  To define any toxicity associated with the metabolic and cellular alterations of ADD
           relative to dose and PK of PEG-BCT-100 (rhArgIpeg5000).

        -  To confirm the safety and anti-tumor activity of PEG-BCT-100 at the preferred dose
           (1600U/kg) in 50 patients (at least 18 evaluable subjects) with advanced HCC.

        -  To measure duration of response including Overall Survival and Time to Progression
           analysis
    

Intervention name(s): Pegylated Recombinant Human Arginase I
Intervention type(s): Biological
Intervention description(s): Weekly dose of PEG-BCT-100 for at least 8 weeks (or until disease progression) at 1600U/kg
Other intervention name(s): PEG-BCT-100
Intervention MeSH terms: BCT-100
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neoplasm; Hepatocellular Carcinoma
Tracking Physical Activity Throughout Chemotherapy for Breast Cancer
Condition: Breast Cancer; Physical Activity
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Physical activity during chemotherapy has been shown to increase patient health and wellbeing
      as well as improve outcomes in breast cancer patients. The primary aim of this project is to
      determine the feasibility of incorporating wearable sensors into clinical care by having
      breast cancer patients, undergoing chemotherapy, wear a commercially available monitor
      (Fitbit) that tracks physical activity, sleep, and heart rate monitor.
    

Detailed description: 
      Although there are many benefits of engaging in physical activity during cancer treatments,
      activity levels typically decline throughout treatment. Existing research has primarily
      relied on self-reported activity levels and only captured periodic snap shots or
      retrospective reports of activity levels, which are subject to recall bias. Exactly how
      activity levels change throughout chemotherapy is not known. This study will provide
      minute-by-minute level objective physical activity data across the entirety of the patient's
      chemotherapy treatments. This in depth data will provide a new perspective on the patterns of
      activity levels and help to identify if there are critical times in which to intervene to
      prevent declines in physical activity.

      The investigators will assess the feasibility of the pre-treatment recruitment by documenting
      recruitment rates and participant acceptance of wearing the accelerometer.
    

Intervention name(s): Fitbit
Intervention type(s): Device
Intervention description(s): Women enrolled in the study will be asked to wear a Fitbit from one week prior to chemotherapy until six months post-chemotherapy. The Fitbit is a watch-sized, wrist worn, physical activity tracker. A button, when pressed, displays the wearer's accumulated daily steps, mileage, and steps climbed.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is all women approached to attempt recruitment. Women will be
        recruited through the Medical Oncology Clinics at UCSD Moroes Cancer Center.
Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy
Condition: Dilated Cardiomyopathy; Heart Failure
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 4

Summary: 
      The pathogenesis of dilated cardiomyopathy (DCM) leading to heart failure is closely
      associated with autoimmunity dysfunction. A few studies represented that Qiliqiangxin
      capsule, a Chinese medicine, could enhance heart function in chronic heart failure and
      regulate the balance of TNF-a and IL-10 in myocardial infarction. In this study, to explore
      the effects of Qiliqiangxin capsule on the improving heart function and immunoregulation in
      patients with DCM, patients were recruited, anti-heart autoantibodies and some representative
      cytokines were assayed by enzyme-linked immuno sorbent assay (ELISA), and the efficacy of
      heart function improvement was compared between Qiliqiangxin capsule and placebo under the
      standard treatment of DCM.
    


Intervention name(s): Qiliqiangxin capsule; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Qiliqiangxin capsule is administrated based on the standard heart failure treatment in China. Dosage: 1.2g/times. Frequency: 3 times/day. Duration: The whole study period.; Placebo, similar in color and taste to Qiliqiangxin capsule, is administrated based on the standard heart failure treatment in China. Dosage: 1.2g/times. Frequency: 3 times/day. Duration: The whole study period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Immunomodulation
A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine
Condition: Migraine; Episodic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess whether galcanezumab is superior to rimegepant in the
      prevention of migraine in participants with episodic migraine. The study duration will be
      approximately 6 months.
    


Intervention name(s): Galcanezumab; Placebo; Rimegepant; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered SC; Administered ODT; Administered ODT; Administered SC
Other intervention name(s): LY2951742
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Epidemiology of Insulin Growth Factor (IGF) and Cardiovascular Events
Condition: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Infarction; Cerebrovascular Accident; Heart Failure; Heart Failure, Congestive
MeSH terms: Stroke; Heart Failure; Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Infarction
Study type: Observational

Summary: 
      To explore the role of insulin growth factor in cardiovascular disease in older men and
      women.
    

Detailed description: 
      BACKGROUND:

      Insulin-like growth factor-I (IGF-I) is the main mediator of effects of growth hormone (GH)
      and an important regulator of cell cycle/differentiation and inhibitor of apoptosis.
      Consistent with laboratory studies showing potentially beneficial effects of IGF-I on the
      cardiovascular and cerebrovascular systems, GH-deficient individuals have high cardiovascular
      disease (CVD) mortality and evidence of premature atherosclerotic disease that is reversible
      with GH replacement. In addition, several epidemiological and clinical studies have shown an
      association between low serum IGF-I levels and myocardial infarction (MI) and congestive
      heart failure (CHF) among persons without frank abnormalities of the GH/IGF-I axis.

      DESIGN NARRATIVE:

      The study is the first prospective investigation to assess whether serum levels of IGF-I and
      two of its important binding proteins, IGFBP-3, and IGFBP-1, are associated with incidence of
      confirmed incident cardiovascular disease (CVD) events in older male and female adults.
      Specimens and data for this study will be obtained from the Cardiovascular Health Study
      (CHS), a large, multi-center NHLBI-funded prospective cohort study of 5,888
      community-dwelling men and women 65 years or older. The study uses an efficient case-cohort
      study design to select specimens for testing, involving evaluation of 750 incident myocardial
      infarction (MI)/fatal coronary heart disease (CHD) cases, 500 incident stroke cases, 750
      incident congestive heart failure (CHF) cases, and a comparison sub-cohort of 750 individuals
      selected at random from the study population. The study examines the association between
      baseline serum IGF-I, IGFBP-1, and IGFBP-3 level and the future occurrence of first incident
      MI/fatal CHD, ischemic stroke, and CHF. Multivariate regression models are used to control
      for potential confounding factors including age, sex, race/ethnicity, anthropometry and body
      composition, fasting and 2-hour post-load glucose and insulin levels, dietary intake,
      physical activity, hormone replacement therapy and other medications, and other CVD risk
      markers such as lipids, inflammatory factors, and coagulation/fibrinolysis markers.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Community dwelling adults aged 65 years and older recruited from four US field centers