bioihbjkbjnl/mcl2 huggingface dataset:
The Differences of Oocyte Maturation, Granulosa Cell Apoptosis Index Between Electroacupuncture And Sham Groups IVF
Condition: Acupuncture; in Vitro Fertilization; BCL2 Gene mRNA Overexpression; Oocyte Maturation
Study type: Interventional

Summary: 
      Interventional studies compared electroacupuncture group versus sham electroacupuncture group
      to granulosa cell apoptosis index, oocyte maturation, GDF9 and BMP15 levels, and
      fertilization rate in in vitro fertilization program
    

Detailed description: 
      The study was conducted at the Dr.Cipto Mangunkusumo National General Hospital, Indonesia in
      September - November 2018.The inclusion criteria are patients who underwent controlled
      ovarian stimulation with antagonist protocol, age 30-39 years, BMI <29kg / m2. Exclusion
      criteria were not having a skin infection at acupuncture point and not using a pacemaker.
      Then patients were randomly divided into two groups: electroacupuncture and sham
      electroacupuncture. Electroacupuncture therapy was done 6 times at: 2 times before and 4
      times during controlled ovarian stimulation.Apoptotic index of granulosa cells were examined
      by quantitative real time PCR techniques for BAX/BCL-2 expression.Oocyte maturation and
      fertilization rate output parameters are examined by competent embryologists after ovum pick
      up while GDF9 and BMP15 levels were examined by quantitative real time PCR techniques for
      GDF9 and BMP15 mRNA expression
    

Intervention name(s): Electroacupuncture
Intervention type(s): Procedure
Intervention description(s): Electroacupuncture therapy is done at the point of CV3 Zhongji, CV4 Guanyuan, and EXCA-1 Zigong with continuous wave, 2 Hz frequency for 30 minutes. Acupuncture manuals on endocrine ear points, GV20 Baihui, ST36 Zusanli, SP6 Sanyinjiao, BL57 Chengsan and KI3 Taixi for 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: electroacupuncture versus sham electroacupuncture
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Outcomes of Motion-preserving Surgery and Arthrodesis at the Distal Interphalangeal (DIP) Joint
Condition: Distal Interphalangeal Arthroplasty; Distal Interphalangeal Arthrodesis
Study type: Observational

Summary: 
      The objective of this project is to investigate the subjective and clinical outcome in
      patients at least one year after DIP arthroplasty and compare them to matched patients with
      an arthrodesis.

      The primary endpoint is the satisfaction with the treatment result of in the
      motion-preserving DIP surgery at follow-up.
    


Intervention name(s): DIP arthroplasty or arthrodesis
Intervention type(s): Device
Intervention description(s): Arthroplasty of the DIP Joint or arthrodesis of the DIP joint
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a DIP arthroplasty at least one year ago Matched patients with a DIP
        arthrodesis
Mass Balance and Pharmacokinetics of [14C]-CRN00808 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1 healthy volunteer study to assess the mass balance, elimination, and metabolic
      profile of CRN00808. The study will be conducted in 2 parts: Part A, to characterize the
      absorption, distribution, metabolism, excretion, and mass balance of orally administered
      radio-labeled CRN00808; Part B, to determine the absolute bioavailability of CRN00808
      administered using CRN00808 and radio-labeled CRN00808 as intravenous and oral forms.
    


Intervention name(s): [14C]-CRN00808; CRN00808
Intervention type(s): Drug; Drug
Intervention description(s): Investigational drug; Investigational drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. It is not yet known if gemcitabine is more effective with or
      without capecitabine in treating pancreatic cancer.

      PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with or
      without capecitabine in treating patients who have advanced pancreatic cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the overall survival of patients with advanced pancreatic cancer treated with
           gemcitabine with or without capecitabine.

        -  Compare the clinical benefit response, objective tumor response, duration of response,
           and time to progression in patients treated with these regimens.

        -  Compare the toxicity of these regimens in these patients.

        -  Compare the quality of life of patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      metastases (yes vs no), pain (yes vs no), Karnofsky performance status (60-80% vs 90-100%),
      and participating center. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral
           capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks in the absence of
           disease progression or unacceptable toxicity.

        -  Arm II: Patients initially receive gemcitabine IV over 30 minutes weekly for 7 weeks.
           After 1 week of rest, patients receive gemcitabine IV over 30 minutes weekly for 3
           weeks. Treatment then repeats every 4 weeks in the absence of disease progression or
           unacceptable toxicity.

      Quality of life is assessed at baseline, weekly for weeks 2-7, and then before each
      gemcitabine administration.

      Patients are followed every 9 weeks.

      PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this
      study within 3 years.
    

Intervention name(s): Gemcitabine + Capecitabine; Gemcitabine alone
Intervention type(s): Drug; Drug
Intervention description(s): Gemcitabine + Capecitabine; Gemcitabine alone
Intervention MeSH terms: Gemcitabine; Capecitabine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III pancreatic cancer; recurrent pancreatic cancer; adenocarcinoma of the pancreas; stage IV pancreatic cancer
Measuring Cardiac Output and Stroke Volume Using the Physioflow Impedance Device in Pregnant Patients
Condition: Hypotension
MeSH terms: Hypotension
Study type: Observational

Summary: 
      Pregnant patients having a cesarean section (CS) under spinal anesthesia experience a variety
      of hemodynamic changes, such as hypotension due to decreases in cardiac output (CO), stroke
      volume (SV) and/or systemic vascular resistance (SVR). Measurement of these hemodynamic
      parameters classically requires insertion of a pulmonary artery catheter (PAC) into the
      heart. However, this invasive method carries significant complications and its use is now
      reserved for the more critically ill patients. We hypothesize that the Physioflow Impedance
      device can be used as a reliable non-invasive monitor to measure hemodynamic parameters
      during elective CS under spinal anesthesia.
    

Detailed description: 
      The Physioflow Impedance device employs a continuous non-invasive method of measuring ten
      cardiac hemodynamic parameters including flow, resistance, contractility and fluid content.
      It involves the application of electrocardiogram (ECG) leads on the neck and the thorax to
      measure resistance of pulsatile blood flow. Its benefits are that it is non-invasive, low
      cost, and easy to operate. Thoracic impedance has been validated against the gold standard
      method of PAC. Although the Physioflow device has been validated in non-pregnant patients,
      its use in pregnant patients is very limited.

      Moderate to severe hypotension, experienced by these awake patients, can cause significant
      undesirable symptoms of dizziness, shortness of breath, nausea and vomiting, and also
      compromise fetal well-being. The etiology of hypotension is multi-factorial,and it is
      postulated that decreases in cardiac output (CO), stroke volume (SV) and/or systemic vascular
      resistance (SVR) may precede decreases in blood pressure. Continuous measurement of CO and SV
      by the Physioflow Impedance device may provide a better understanding of the cause of
      hypotension so that future management of these patients may include pharmacological
      interventions used prior to hypotension in order to avoid any undesirable symptoms.
    

Intervention name(s): Physioflow Impedance
Intervention type(s): Device
Intervention description(s): 6 ECG leads applied to the neck and thorax for the duration of surgery (approximately 1 hour).
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers having an elective cesarean section.
      
Keywords: Cesarean section; Cardiac Output; Physioflow; Cardiography, Impedance
A Multi-Site Study to Evaluate the Safety and Effect of Study Drug on Participants With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a multicenter, double-blind, study to evaluate the safety and effectiveness of
      treatment with LY2127399 (in addition to the standard of care treatment, methotrexate) for
      participants with Rheumatoid Arthritis. Participants will receive three intravenous doses of
      LY2127399 or placebo. Participants will participate in 10 or more visits to the study site,
      over 6 months. Evaluation of safety and efficacy will be conducted throughout the study.
    


Intervention name(s): LY2127399; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg, 60 mg or 160 mg, IV (in the vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks.; IV (in vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Vitamin E for Prevention of Retinopathy of Prematurity: A Randomized Clinical Trial.
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Interventional

Summary: 
      The retinopathy of prematurity (ROP) is a public health problem, the main causes of ROP are
      prematurity, use of oxygen, malnutrition and oxidative stress. Vitamin E was used beforehand
      however its use was stopped because of its association with sepsis and enterocolitis caused
      by the excipient of vitamin E. The purpose of this study is to use vitamin E to prevent ROP,
      without the previously used excipients.
    

Detailed description: 
      Antioxidant defence mechanisms include cellular and extracellular enzymes. Vitamin E is the
      main fat-soluble vitamin responsible for the protection of cell membranes against
      peroxidation, thus, it protects polyunsaturated fatty acids from peroxidation which is a step
      in the pathogenesis of ROP.

      Previous research on the roles of vitamin E, in the prevention of BPD and ROP was halted
      because of complications involving sepsis and necrotising enterocolitis. These complications
      were caused by the compositions of vitamin E oral presentations, which contain polyethylene
      glycol, propylene glycol, ethanol and, polysorbate 80. These substances, which are used as
      excipients, may generate adverse effects in premature newborns. These preparations were not
      used in this project to avoid the development of necrotising enterocolitis, and because these
      formulations are not commercially available in Mexico.

      The infants were randomly assigned to one of two groups using a computerized random number
      generator sequence; this process was handled by the hospital pharmacy staff. The treated
      group, received vitamin E 12.5 IU orally every 12 hours, from 72 h after birth until 28 days
      of age, the first blood sample collected from the newborns before the intervention was
      considered the baseline, and subsequent samples were obtained at 15 and 28 days of age.

      Control group: received orally sterile water (placebo)
    

Intervention name(s): Vitamin E; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: participants were randomly assigned to one of two treatmenst (A and B) using a computarized random number generator sequence; this process was handled by the hospital pharmacy staff. Group A: received vitamin E 12.5 IU orally every 12 hours, from 72 h after birth until 28 days of age, Group B: received orally sterile water (placebo) orally every 12 hours, from 72 h after birth until 28 days of age,
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Oxidative Damage; Vitamin E; Total Antioxidant Capacity; Retinopathy of Prematurity
Antineoplaston Therapy in Treating Patients With Brain Tumors
Condition: Refractory Brain Tumors
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Current therapies for adults with persistent or recurrent brain tumors provide
      very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy
      suggest that it may prove beneficial in the treatment of adults with persistent or recurrent
      brain tumors.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on adults with persistent or recurrent brain tumors.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the efficacy of Antineoplaston therapy in adults with persistent or
           recurrent brain tumors as measured by an objective response to therapy (complete
           response, partial response or stable disease).

        -  To determine the safety and tolerance of Antineoplaston therapy in adults with
           persistent or recurrent brain tumors.

      OVERVIEW: This is a single arm, open-label study in which adults with persistent or recurrent
      brain tumors receive gradually escalating doses of intravenous Antineoplaston therapy
      (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for
      at least 12 months in the absence of disease progression or unacceptable toxicity. After 12
      months, patients with a complete or partial response or with stable disease may continue
      treatment.

      To determine objective response, tumor size is measured utilizing MRI scans, which are
      performed every 8 weeks for the first two years, every 3 months for the third and fourth
      years, every 6 months for the 5th and sixth years, and annually thereafter.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study
    

Intervention name(s): Antineoplaston therapy (Atengenal + Astugenal)
Intervention type(s): Drug
Intervention description(s): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
Other intervention name(s): A10 (Atengenal); AS2-1 (Astugenal)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anaplastic astrocytoma; Anaplastic astrocytoma/Mixed; Astrocytoma; Astrocytoma/Pilocytic; Brainstem glioma; Glioblastoma multiforme; Glioma; Neurocytoma; Primitive neuroectodermal tumor; Tectal glioma
Cough Frequency in Chronic Obstructive Pulmonary Disease
Condition: COPD Exacerbation
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Acute exacerbations of COPD remain a common cause of morbidity and are associated with a
      sustained increase in the normal respiratory symptoms of dyspnoea, cough, and sputum volume
      and purulence. It has previously been shown that a change in cough symptoms occurs in 51.7%
      of exacerbations in COPD. We wish to record cough during a COPD exacerbation to determine
      whether this can be a objective marker of exacerbation duration and severity.
    

Detailed description: 
      Acute exacerbations of COPD remain a common cause of morbidity and are associated with a
      sustained increase in the respiratory symptoms of dyspnoea, cough, sputum volume and sputum
      purulence. Cough is one of the most commonly reported and key symptoms in COPD patients.
      Cough can also be a useful factor in finding patients at risk of progressive airflow
      obstruction and cough along with the breathlessness is the major cause of distress in
      patients with chronic obstructive airways disease (COPD). There is limited literature looking
      into cough and COPD especially objective assessments.

      in clinical practice and in most clinical trials scoring systems ie quality of life
      questionnaires or visual analogue scores, have been used to measure COPD exacerbation
      severity, although these may give an indication of the perceived severity of the symptom,
      they are inherently subjective and may be influenced by other factors. Shortfalls have
      prompted the development of cough recorders as an objective measure of this symptom. With
      this in mind we propose recruit 30 subjects with non-infective exacerbations of COPD and
      monitor their cough frequency as an inpatient in acute exacerbation and for 45 days post
      hospital discharge in order to elucidate the natural history of cough during and after an
      exacerbation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hospital admissions
      
Keywords: exacerbation; COPD; Cough
Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent（Type 16/18 ）Vaccine
Condition: Cervical Intraepithelial Neoplasia; Cervical Cancer; Vaginal Intraepithelial Neoplasia; Vulvar Intraepithelial Neoplasia; Persistent Infection
MeSH terms: Persistent Infection; Uterine Cervical Neoplasms; Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III clinical trial of the novel recombinant HPV 16/18 bivalent vaccine
      manufactured by Xiamen Innovax Biotech CO., LTD. The primary objective of this study is to
      demonstrate the efficacy of the vaccine against relevant outcomes in healthy women above 18
      years old at enrolment. The secondary objectives are to evaluate the safety, immunogenicity
      and immuno-persistence of the vaccine. Meanwhile, this study tries to compare the difference
      of safety and immunogenicity among different lots. Approximately 6000 study subjects will be
      enrolled and randomly stratified into 2 groups and receive human papillomavirus (HPV)
      vaccine(three different lots) or commercialized hepatitis E vaccine(Hecolin) according to a
      0-1-6 month schedule.
    


Intervention name(s): HPV Vaccine; HEV vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 3 doses at month 0,1 and 6; 3 doses at month 0,1 and 6
Other intervention name(s): Hecolin
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Human Papillomavirus 16; Human Papillomavirus 18; vaccine; Cervical Intraepithelial Neoplasia; cervical Cancer; Vaginal intraepithelial neoplasia; Vulvar intraepithelial neoplasia
An Open-Label Study Of Lamictal In Neurotic Excoriation
Condition: Neurotic Disorders; Obsessive-Compulsive Disorder
MeSH terms: Obsessive-Compulsive Disorder; Neurotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the proposed study is to evaluate the efficacy and safety of Lamictal in neurotic
      excoriation. Twenty subjects with neurotic excoriation will receive 12 weeks of open-label
      treatment with Lamictal. The hypothesis to be tested is that Lamictal will be effective and
      well tolerated in patients with neurotic excoriation. The proposed study will provide needed
      data on the treatment of a disabling disorder that currently lacks a clearly effective
      treatment.
    


Intervention name(s): Lamictal (lamotrigine)
Intervention type(s): Drug
Intervention MeSH terms: Lamotrigine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Skin; Picking; Pick; Neurotic Excoriation
The ONE Study nTreg Trial (ONEnTreg13)
Condition: Immunosuppressive Treatment of Living-donor Renal Transplantation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this trial is to collect evidence of the safety of administering autologous
      CD4+CD25+FoxP3+ natural regulatory T cells (nTregs) to living-donor renal transplant
      recipients. In addition, the study will determine whether post-transplant nTregs infusion
      allows a tapering of conventional maintenance immunosuppression within 60 weeks after
      transplantation.
    

Detailed description: 
      The ONE Study aims to explore the feasibility, safety and efficacy of regulatory cell
      therapies as adjunct immunosuppressive treatments in the context of living-donor renal
      transplantation.The clinical trial presented here (ONEnTreg13) will test autologous,
      polyclonally expanded CD4+CD25+FoxP3+ nTregs as a somatic cell-based medicinal product.

      The objective of this study is to determine whether administration of nTregs to recipients of
      living-donor kidney transplants is safe and able to polarize the immunological response of
      the recipient away from graft rejection and towards graft acceptance, allowing a reduction in
      the doses of pharmacological maintenance immunosuppression.
    

Intervention name(s): autologous CD4+CD25+FoxP3+ natural regulat. T cells (nTregs)
Intervention type(s): Biological
Intervention description(s): autologous CD4+CD25+FoxP3+ natural regulatory T cells (nTregs). nTregs will be infused at escalating doses of 0.5 x 10^6, 1 x 10^6, and 2.5-3 x 10^6 cells/kg body weight in cohorts of three patients each.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intravesical Chemotherapy Treatment of Superficial Bladder Cancer
Condition: Bladder Neoplasms
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II study where chemotherapy (gemcitabine) is given into the urinary bladder.
    


Intervention name(s): Gemcitabine
Intervention type(s): Drug
Intervention MeSH terms: Gemcitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment