bioihbjkbjnl/mcl2 huggingface dataset:
Radiation Therapy in Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet
      known if giving radiation therapy after stem cell transplantation is more effective than stem
      cell transplantation alone in treating relapsed or refractory non-Hodgkin's lymphoma.

      PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in
      treating patients who have relapsed or refractory non-Hodgkin's lymphoma and have undergone
      autologous stem cell transplantation.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the 3-year progression-free survival of patients with relapsed or refractory
           aggressive non-Hodgkin's lymphoma treated with high-dose chemotherapy and autologous
           hematopoietic stem cell transplantation with or without involved-field radiotherapy.

        -  Compare the overall survival of patients treated with these regimens.

        -  Compare 3-year progression-free disease within and outside radiotherapy fields in
           patients treated with these regimens.

        -  Compare quality of life of patients treated with these regimens.

        -  Compare the toxic effects of these regimens in these patients.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      response to pre-salvage chemotherapy (primary refractory disease vs relapse), response to
      post-salvage chemotherapy (complete/unconfirmed complete vs partial), and participating
      center. Within 6-8 weeks after completion of autologous hematopoietic stem cell
      transplantation, patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients undergo involved-field radiotherapy (IFRT) 5 days a week for 3-5 weeks
           in the absence of unacceptable toxicity.

        -  Arm II: Patients undergo observation only. Quality of life in arm I is assessed at
           baseline, on day 1 of IFRT, at weeks 2 and 4 during IFRT, at 1 month, 4 months, every 3
           months for 2 years, every 6 months for 1 year, and then annually for 2 years. Quality of
           life in arm II is assessed at baseline, 1 month, 2 months, every 3 months for 2 years,
           every 6 months for 1 year, and then annually for 2 years.

      Patients are followed at 1 month, every 3 months for 2 years, every 6 months for 1 year, and
      then annually for 2 years.

      PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this
      study within 4.2 years.
    

Intervention name(s): radiation therapy
Intervention type(s): Radiation
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Waldenstrom macroglobulinemia; recurrent adult diffuse large cell lymphoma; recurrent adult Burkitt lymphoma; recurrent adult T-cell leukemia/lymphoma; anaplastic large cell lymphoma
Study of the Spermatic Characteristics of Patients With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional

Summary: 
      The objective of this project is to estimate the prevalence of spermatic abnormalities in
      patients with Fabry disease.The main objective of this project is to estimate the prevalence
      of spermatic abnormalities in patients with Fabry disease.
    

Detailed description: 
      Fabry disease is a lysosomal storage burden of X-linked genetic transmission due to
      alpha-galactosidase deficiency. This enzyme deficiency causes deposits of
      globotriaosylceramide in virtually all cell types of the body. The majority of hemizygous men
      develop a severe multisystemic disease dominated by renal failure, neurological and cardiac
      involvement. There is a specific treatment based on enzyme replacement therapy.

      The incidence of Fabry disease is estimated between 1/60000 and 1/3500 in the general
      population.

      Infertility in Fabry disease is poorly documented. Only a few cases have been reported, from
      alteration of spermogram to azoospermia. The identification of deposits suggestive of Gb3 in
      light microscopy and electron microscopy at the level of the genital tract argues in favor of
      the attack of this device. The low prevalence of Fabry disease requires a cross-sectional
      multicenter study to determine the frequency of alterations in sperm characteristics, their
      impact on fertility, and the possible effect of substitution therapy, in order to establish
      appropriate measures. adequate preventive measures.

      The objective of this project is to estimate the prevalence of spermatic abnormalities in
      patients with Fabry disease.The main objective of this project is to estimate the prevalence
      of spermatic abnormalities in patients with Fabry disease.
    

Intervention name(s): Semen collection
Intervention type(s): Procedure
Intervention description(s): Semen collection for seminogram and spermocytogram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Drug Interaction Study With Rifampicin and Afatinib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study is to investigate the effect of the P-gp inducer
      rifampicin on the pharmacokinetics (PK) of afatinib in healthy male volunteers
    


Intervention name(s): Afatinib; Afatinib; Rifampicin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose; single dose; multiple doses
Intervention MeSH terms: Rifampin; Afatinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brain's Response to Chocolate
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Observational

Summary: 
      The purpose of this study is to test how the brain responds when individuals eat enjoyable
      foods such as chocolate. Eating certain foods can make one want to keep eating even when
      feeling full, caused by dopamine in the brain. The researchers believe this dopamine response
      can be measured by looking at the individual's eye.
    

Detailed description: 
      With obesity at an all-time high, understanding eating behavior beyond physical need is a
      priority. Food reinforcement is driven by central dopamine activity. However, objective
      measurement of brain dopamine-related behavioral events is hindered by the lack of
      non-invasive, accessible techniques that are amenable to testing in a "naturalistic"
      environment. The goal of this project is to develop a non-invasive, accessible methodology to
      measure dopaminergic responses to food in a natural setting. This research will use a novel,
      hand-held electroretinograph (ERG) that does not require eye dilation and uses a skin
      electrode to measure retinal dopamine activity. Previous work establishes that retinal
      dopamine activity can be used as a proxy for central dopamine function. The ability to assess
      both subjective behavioral variables and central dopaminergic responses simultaneously will
      provide an ideal approach for innovative studies of the control of eating behavior.
    

Intervention name(s): Chocolate
Intervention type(s): Other
Intervention description(s): Participants will be asked to taste commercially available chocolate varying in sugar, fat and percent cocoa (milk, 70%, 85% and 90% cocoa).
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Community sample
Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (STAR)
Condition: Multiple Sclerosis, Relapsing Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The rationale of this study is to assess the safety profile, efficacy and adherence to Rebif®
      New Formulation in real life settings with a multinational approach, as well as the impact of
      this improved formulation (with regards to adverse events [AEs]) to subjects' adherence.
    

Detailed description: 
      This international, multicentric, prospective, observational study is being conducted to
      assess the safety profile, efficacy and adherence to Rebif® New Formulation in real life
      settings in subjects with relapsing remitting multiple sclerosis (RRMS), as well as the
      impact of this improved formulation (with regards to adverse events [AEs]) to subjects'
      adherence. Three hundred and fifty subjects from approximately 80 sites across seven
      countries will be enrolled in the study. Subjects will be treated with IFN beta-1a (Rebif®
      New Formulation) in real life settings according to the clinical and paraclinical course and
      laboratory findings as routinely evaluated by the physician. Data related to AEs; subjects'
      adherence to treatment, reasons for treatment discontinuation; number and reasons of missed
      injections; and the clinical and paraclinical data on efficacy regarding relapses will be
      captured. Data will be reported prospectively throughout the duration of the study (12
      months) at two visits (at month 6 and month 12) following the initial visit; at baseline,
      data can be recorded retrospectively from the subjects' medical file. All the data will be
      evaluated descriptively.

      OBJECTIVES

      Primary objective

        -  To assess the local tolerability of Rebif® New Formulation in real life settings with a
           multinational approach.

      Secondary objectives

        -  To assess the safety profile, subjects' adherence to and efficacy of Rebif® New
           Formulation
    

Intervention name(s): Rebif® New Formulation
Intervention type(s): Drug
Intervention description(s): The recommended dose of Rebif® is 22 or 44 μg administered three times per week by subcutaneous injection.
Other intervention name(s): Interferon beta1-A
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects diagnsoed with RRMS from approximately 80 sites across seven countries.
      
Keywords: Multiple sclerosis; Relapsing remitting; Rebif
Comparison of USG- Guided Modified Pectoral Nerve Block and Erector Spinae Plane Block on Postoperative Analgesia in Video Assisted Thoracoscopic Surgery
Condition: Postoperative Analgesia; Video-assisted Thoracoscopic Surgery
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      This study aims to compare the effects of the erector spinae plan block (ESP) and modified
      pectoral nerve block (PECS II) on postoperative analgesia in patients undergoing video-
      assisted thoracoscopic surgery (VATS).
    

Detailed description: 
      55 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo VATS, were
      randomized and divided into two groups. (26 patients in each of the PECS and ESP groups).
      Three patients were excluded from the study because thoracotomy was performed. ESP block was
      performed for ESP group and a modified pectoral nerve block was performed in the PECS group.
      Postoperative analgesia was provided by intravenous morphine infusion using a
      patient-controlled analgesia device. Postoperative 24-hour total morphine consumption and
      duration of analgesia were the primary outcome measure. Perioperative remifentanil use,
      numeric rating scale values, time of the first analgesic request, and additional analgesic
      consumption were recorded.
    

Intervention name(s): erector spina plane block; modified pectoral nerve block
Intervention type(s): Procedure; Procedure
Intervention description(s): The investigators performed erector spina plane block to that patient group for postoperative analgesia; The investigators performed modified pectoral block to that patient group for postoperative analgesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Modified Hook Wiring Technique for Greater Tuberosity Fractures, a Prospective Study
Condition: Greater Tuberosity Fractures
MeSH terms: Fractures, Bone; Shoulder Fractures
Study type: Interventional

Summary: 
      the purpose of this study is to assess functional and radiological outcome of open reduction
      and internal fixation of isolated displaced greater tuberosity fractures (more than 5mm
      displacement) in adults advocating modified hook wiring with a follow-up period of one year.
    

Detailed description: 
      after being informed about the study and potential risks, all enrolled cases giving informed
      consent will undergo fixation of their fractured greater tuberosity, then physiotherapy.
      patients will be followed up till full union, clinical and radiological follow up for at
      least one year utilizing approved clinical scores and radiological criteria for healing. any
      complication will be recorded.
    

Intervention name(s): fixation of greater tuberosity fractures
Intervention type(s): Procedure
Intervention description(s): deltopectoral approach for shoulder, then open reduction and fixation of displaced greater tuberosity fractures using hooked Kirshner wires
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Remifentanil on the Bispectral Index in Women Undergoing Caesarean Delivery Under General Anaesthesia
Condition: Intraoperative Awareness
MeSH terms: Intraoperative Awareness
Study type: Interventional

Summary: 
      Patients undergoing caesarean delivery under inhalation anaesthesia are at a high risk of
      awareness, especially in the period before delivery. The investgators assessed the effects of
      remifentanil on the bispectral index (BIS) in the interval before delivery.
    

Detailed description: 
      Sixty primipara undergoing elective cesarean delivery were randomly assigned to receive
      remifentanil 1 μg kg-1 (R1) or 0.5 μg kg-1 (R0.5), or saline (control) over 15 s with
      induction of anesthesia using propofol 2 mg kg-1 and suxamethonium 1.5 mg kg-1.The
      investgators assessed the average value of BIS at the time period of before, induction ,
      intubation, skin incision, peritoneum incision , uterine incision , and delivery. The
      investgators also determined the neonatal Apgar scores, and conducted umbilical artery blood
      gas analysis.
    

Intervention name(s): remifentanil
Intervention type(s): Drug
Intervention description(s): the effects of remifentanil on the average value of BIS at the time period of before induction , induction , intubation , skin incision, peritoneum incision, uterine incision, and delivery
Other intervention name(s): saline
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: remifentanil; bispectral index; Caesarean delivery; general anesthesia
A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of golimumab in
      patients with active rheumatoid arthritis despite DMARD (Disease-modifying antirheumatic
      drugs) therapy. Another objective is to evaluate the pharmacokinetics of golimumab.
    

Detailed description: 
      This study is designed as a placebo-controlled study of golimumab monotherapy for the purpose
      of demonstrating the safety and effectiveness of golimumab, a new, fully human anti-TNF
      (Tumor necrosis factor) a monoclonal antibody produced by mean of HuMab mouse technology.
      Other reasons for using the study design are as follows: the effects of golimumab given alone
      must be confirmed as in the case of other drugs; and golimumab may be used even in patients
      not on the treatment with methotrexate (MTX). There will be 3 treatment groups in the study
      as follows: CNTO148 50 mg group, CNTO 148 100 mg group, and Placebo group.
    

Intervention name(s): CNTO 148; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 116.; Placebo identical in appearance to CNTO 148 given as a subcutaneous (under the skin) injection once every 4 weeks until week 12 and then CNTO148 50mg SC injections every 4 weeks from week 16 until week 116.
Other intervention name(s): Golimumab
Intervention MeSH terms: Golimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; Fully Human anti-TNFa monoclonal antibody; CNTO148; Golimumab
A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Who Take Anti-depressive Medication
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is open to adults between 18 and 65 years of age who have depression (major
      depressive disorder). People with a current depressive episode lasting between 2 months and
      one and a half years can join the study. This study is for people for whom existing
      treatments for depression do not work sufficiently.

      The purpose of this study is to test how well a medicine called BI 1569912 is tolerated and
      whether it may help people with depression.

      It is planned to test 4 different dosages of BI 1569912 in this study. Each participant gets
      either one BI 1569912 dosage or placebo. It is decided randomly, which means by chance, who
      gets which treatment. Participants take BI 1569912 or placebo as tablets once during the
      study. Placebo tablets look like BI 1569912 tablets but do not contain any medicine.
      Participants also continue taking their usual medicine for depression throughout the study.

      Participants are in the study for about 5 weeks. During this time, they visit the study site
      4 times, with a stay at the study site for 9 days.

      The doctors check the health of the participants and note any health problems that could have
      been caused by BI 1569912. The participants fill in questionnaires about their depression
      symptoms.
    


Intervention name(s): BI 1569912; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 1569912; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in AML Patient Not Eligible for Transplant
Condition: Acute Myeloid Leukemia
Study type: Interventional
Phase: Phase 2

Summary: 
      AML is the most common acute leukemia in adults. Most patients can undergo allogeneic stem
      cell transplantation as a possible cure; however, many patients are not candidates for
      allogeneic transplant due to age, overall health, psychosocial factors, and/or lack of
      available donors. Therefore, these patients are unable to receive the therapeutic benefits of
      the "graft-versus-leukemia" effect of donor immune cells. The aim of this study is to
      hopefully break immune tolerance to AML cells to provide better outcomes in patients with
      non-favorable risk AML.
    

Detailed description: 
      Non-favorable risk AML patients will undergo a preparative regimen of lymphodepletion of
      Flu/Mel followed by autologous transplantation. Anti-PD-1 therapy of pembrolizumab will begin
      on Day +1 following stem cell transplantation and will be administered every 3 weeks for a
      total of 8 doses. According to the literature, the risk of 2-year relapse is estimated to be
      60-80% in patients with non-favorable risk AML in CR-1. With this protocol, investigators
      hypothesize that following lymphodepleting chemotherapy and pembrolizumab, the 2-year relapse
      risk will decrease to less than or equal to 35%. The one-sided Wald test at 5% significance
      level will be used to test the hypothesis. The size of 20 patients yields the power of 90.5%
      assuming that the actual 2-year leukemia-free survival is 60%.
    

Intervention name(s): Fludarabine; Melphalan; Pembrolizumab
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Pembrolizumab; Fludarabine; Melphalan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML
Sertraline and Naltrexone for Alcohol Dependence
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a double-blind, placebo-controlled outpatient trial to improve, through the
      addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent
      individuals currently taking naltrexone (Revia).
    


Intervention name(s): naltrexone (Revia); sertraline (Zoloft)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Naltrexone; Sertraline
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Endometrial Gene Expression in Different Protocols of Endometrial Preparation for Embryo Transfer'
Condition: Endometrial
Study type: Observational

Summary: 
      Do differences in endometrial gene expression exist after different protocols of endometrial
      preparation for embryo transfer? The recent apparition of endometrial receptive arrays
      technology let us know if endometrial is receptive or not in patients with some problems of
      infertility as implantation failure, for that we want to know if this technology would tell
      us if the different kind of protocols for endometrial preparation origin differences that
      could explain some of the founded results.
    

Detailed description: 
      Do differences in endometrial gene expression exist after different protocols of endometrial
      preparation for embryo transfer? The clinical results in different publications showed
      different results, some of them described the natural cycle superior as the substituted
      cycles, and in contrast other large series showed superior results in substituted cycles than
      natural but with an increased of pregnancies losses. The recent apparition of endometrial
      receptive arrays technology let us know if endometrial is receptive or not in patients with
      some problems of infertility as implantation failure, for that we want to know if this
      technology would tell us if the different kind of protocols for endometrial preparation
      origin differences that could explain some of the founded results.
    

Intervention name(s): Endometrial Biopsy
Intervention type(s): Procedure
Intervention description(s): 4 endometrial biopsy
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 5 volunteers from our egg donation program were included in the study from
        Setember 2014 to jnuary 2015
      
Biospecimen description: 
      endometrial biopsies for ADN analysis
    
Keywords: ERA