bioihbjkbjnl/mcl2 huggingface dataset:
Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
Condition: Lymphoma, Non-Hodgkin; HIV Infections
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional

Summary: 
      To determine the safety and effectiveness of a combination chemotherapy-radiation-zidovudine
      (AZT) treatment for patients with peripheral lymphoma.

      Other chemotherapies have been tried in patients with AIDS related lymphomas, but the results
      have not been satisfactory. This study will show whether the combination of chemotherapy,
      radiation, and AZT is more effective and less toxic than previously used treatments.
    

Detailed description: 
      Other chemotherapies have been tried in patients with AIDS related lymphomas, but the results
      have not been satisfactory. This study will show whether the combination of chemotherapy,
      radiation, and AZT is more effective and less toxic than previously used treatments.

      All patients will receive combination chemotherapy and AZT. The combination chemotherapy will
      be repeated every 3 to 4 weeks for a maximum total of 6 cycles. Each cycle will consist of
      doxorubicin, bleomycin, cyclophosphamide, and vincristine on day 1, dexamethasone on days
      1-5, and methotrexate on day 15. Patients with meningeal or bone marrow disease will receive
      radiation and intrathecal cytarabine (ARA-C) while those without will receive ARA-C without
      radiation. Patients with documented lymphomas in the central nervous system at initial workup
      will start radiation as soon as possible and intrathecal ARA-C (t.i.w. until cerebrospinal
      fluid is clear then every month for 1 year); patients with normal lumbar puncture, brain
      scan, and bone marrow at first diagnosis will begin radiation on day 1 of cycle 3 of
      chemotherapy. Lumbar punctures for evaluation will be done four times during the first cycle,
      on days 1, 8, 21, and 28. AZT will be administered every 4 hours, 7 days a week, beginning at
      the completion of combined chemotherapy, once the patient has achieved a complete remission
      of the lymphoma, and continuing for 1 year.
    

Intervention name(s): Bleomycin sulfate; Vincristine sulfate; Doxorubicin hydrochloride; Cyclophosphamide; Allopurinol; Methotrexate; Cytarabine; Leucovorin calcium; Zidovudine; Dexamethasone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Cytarabine; Zidovudine; Dexamethasone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Methotrexate; Vincristine; Bleomycin; Allopurinol; Levoleucovorin
Primary purpose: Treatment
Keywords: Vincristine; Lymphoma; Methotrexate; Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin; Drug Therapy, Combination; Combined Modality Therapy; Acquired Immunodeficiency Syndrome; Antineoplastic Agents, Combined; Zidovudine; Bleomycin
Contribution of the Cerebellum In Sensory-motor Adaptation Via Gamma Oscillations: the Case of Dystonia
Condition: Primary Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional

Summary: 
      Dystonia, a disabling disease with uncontrolled movement disorders was considered to be a
      manifestation of basal ganglia dysfunction, yet there is accumulating evidence from animal
      and human experiments that the cerebellum plays a prominent role in the pathophysiology of
      dystonia. Our recent results suggest a deficient cerebellar sensory encoding in dystonia,
      resulting in a decoupling of the motor component from the afferent information flow resulting
      from changes in the environment. An overall loss of gabaergic-mediated inhibition is at the
      forefront in dynamic changes in neural circuitry described in dystonia. In the mature brain
      gabaergic control the generation of temporal synchronies and oscillations in the
      glutamatergic neurons. Taken these all together with the results of a pilot experiment, the
      investigators hypothesize that deficient synchronies in the fast gamma range are one of the
      key mechanisms leading to abnormal communication inside the cerebello-cortical network in
      dystonia. The investigators aim first to demonstrate it by means of MEG (Magneto
      encepholography) recordings allowing to reconstruct the spatio-temporal dynamics of gamma
      oscillations in the nodes of the cerebello-cortical network. The investigators then aim to
      re-establish (if lost) or boost (if decreased) the defective synchronies by applying to the
      cerebellum at high gamma frequency a non invasive transcranial alternative current
      stimulation.
    


Intervention name(s): active cerebellar stimulation; sham cerebellar stimulation
Intervention type(s): Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: magnetoencephalography; non invasive brain stimulation; cerebellum; gamma rhythms
Efficacy and Safety of Fumaric Acid Esters (Fumaderm®) in the Treatment of Patients With Cutaneous Lupus Erythematosus
Condition: Lupus Erythematosus, Cutaneous
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the therapeutic effect of fumaric acid esters
      (Fumaderm®) in the treatment of Cutaneous Lupus Erythematosus with respect to proportion of
      responders based on the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI)
      activity score for skin lesions at baseline and after 24 weeks of treatment or at the latest
      assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF).
    

Detailed description: 
      At screening, patients meeting the inclusion and exclusion criteria will be asked to provide
      written informed consent. Male patients and female patients without childbearing potential
      will also complete other screening procedures including vital signs, physical examination,
      and patients and physicians efficacy assessments.

      Treatment will be started as soon as possible after screening and not later than 1 month
      after screening.

      The patients will receive a treatment either with Fumaderm® initial and/or Fumaderm®
      enteric-coated tablets. Fumaderm® initial will be usually administered during the first three
      weeks of treatment and / or during the trial when adaptation of the daily dosage will be
      required due to the occurrence of adverse reactions, e.g gastrointestinal.

      Throughout the trial, daily use of sunscreens (sun protection factor, SPF≥50) will be
      recommended to all patients. The management of CLE may also involve the use of topical
      medications, such as topical steroids, or systemic rescue medications, such as antimalarials.

      All patients will be evaluated with the RCLASI, PAGI and VAS after 12 weeks and at the end of
      treatment. Adverse Events (AE) will be recorded at each visit until 4 weeks after the end of
      therapy. Serious Adverse Events (SAE) must be reported if they occur up to 4 weeks after the
      end of therapy.
    

Intervention name(s): Fumaric acid esters
Intervention type(s): Drug
Intervention description(s): Starting from 1 tablet Fumaderm® initial per day, with titration up to 6 tablets Fumaderm® per day; in case of side effects, the dose will be adapted to the highest tolerable levels
Other intervention name(s): Fumaderm® initial; Fumaderm®
Intervention MeSH terms: Dimethyl Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: C17.300.475; C17.800.480
A Post Breastfeeding Follow-Up Study
Condition: Breast Feeding
Study type: Observational

Summary: 
      The purpose of this clinical study which is to evaluate the benefits of lactation support
      intervention, in conjunction with maternal nutritional supplementation during the last
      trimester to 12 weeks postpartum in comparison to pre- and postnatal care on 1) breast
      feeding practices (primary objective), and 2) cognitive development in children within 28
      months 16 days - 32 months 30 days (secondary objective).
    

Detailed description: 
      This is an observational study involving mothers and their child at 30 months old as a follow
      up to the breastfeeding intervention study that they have participated in and completed
      during the period from the last trimester to 12 weeks postpartum.

      The assessors will be blinded to subject's treatment group assignment from the intervention
      phase.

      There are no products given to any subject.

      The primary variable is duration of any breastfeeding from birth.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study involves mothers and their child at 30 months old as a follow up to the
        breastfeeding intervention study that they have participated in and completed during the
        period from the last trimester to 12 weeks postpartum
Assessment of Liver Glucose Metabolism in Diabetic Subjects
Condition: Newly Diagnosed Type 2 Diabetes (During the Last 12 Months)
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Type 2 diabetes is associated with hepatic insulin resistance. One consequence of insulin
      resistance of the liver is an altered hepatic glucose metabolism. This study investigates
      whether the whole body (M-value) and hepatic insulin sensitivity obtained by hyperinsulinemic
      euglycemic clamp is influenced by a preceding intravenous glucose tolerance test (Botnia
      Clamp) in subjects with type 2 diabetes.
    

Detailed description: 
      The hyperinsulinemic euglycemic clamp represents the gold standard for measuring peripheral
      insulin sensitivity. The insulin sensitivity is described by the M-value,which is calculated
      from glucose infusion rates during the last 30min of the clamp.

      Glucose is metabolised in the periphery: 50% by neural tissues, 20% by splanchnic bed and
      liver, 15% by skeletal muscle, 5% by adipose tissue and 10% by blood cells and other tissues.
      Under hyperinsulinemic conditions there is a strong shift in glucose utilization: 85%
      skeletal muscle and 15% by neural tissues, splanchnic bed and liver, adipose tissue, blood
      cells and other tissues. The contribution of skeletal muscle varies with different insulin
      sensitivity.

      We now want to investigate whether there is a difference in tissue-specific insulin
      sensitivity measured from a Botnia clamp (intravenous glucose tolerance test (ivGTT) and
      following clamp) and a single hyperinsulinemic euglycemic clamp? After a 60min ivGTT blood
      glucose levels in type 2 diabetic subjects are still elevated compared to baseline. High
      blood glucose levels can influence several parameters and may also affect insulin
      sensitivity. Until now, it is not proven, that the clamp preceding ivGTT does not have a
      significant influence on the M-value.
    

Intervention name(s): intravenous glucose tolerance test; hyperinsulinemic euglycemic clamp
Intervention type(s): Biological; Biological
Intervention description(s): Administration of a 30% weight-adapted glucose bolus intravenously.; Intravenous administration of 20% glucose and insulin over 3 hours
Other intervention name(s): ivGTT; HEC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: type 2 diabetes; insulin sensitivity; hyperinsulinemic euglycemic clamp
Anti-Scarring Efficacy and Safety of Intradermal Juvista (Avotermin) in Healthy Males
Condition: Cicatrix
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was undertaken to investigate safety and scar-improvement activity of different
      applications of Juvista (avotermin), administered to surgical incisions made to the skin of a
      healthy population of male volunteers aged 18-45 years. The study addressed two issues:
      whether Juvista (avotermin) administered at 200ng/100μl/linear cm wound margin is more
      effective than 50ng/100μl/linear cm for scar improvement and, secondly, whether dosing once
      only (before wounding) or twice (before and after wounding) is optimal for scar improvement.
    


Intervention name(s): Juvista (avotermin) plus placebo, standard-care (within-subject controls)
Intervention type(s): Drug
Intervention description(s): Intradermal Juvista (avotermin) at 50ng or 200ng per 100μl per linear cm of wound margin
Other intervention name(s): Juvista; RN1001; Avotermin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cicatrix, scarring, TGF-beta3, avotermin, Juvista
Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia
Condition: Megaloblastic Anemia Nos; Pernicious Anemia
MeSH terms: Anemia; Anemia, Pernicious; Anemia, Megaloblastic
Study type: Interventional
Phase: Phase 4

Summary: 
      Demonstrate the effectiveness of a single dose of a multivitamin complex for the treatment of
      megaloblastic anemia
    

Detailed description: 
      The investigators will administrate a single intramuscular dose of hydroxocobalamin
      10,000mcg, Thiamin 100mg, Pyridoxine 50mg.

      To assess response to treatment, a complete blood count (CBC) will be performed weekly during
      the first month of treatment, after the first month a CBC will be taken monthly for 6 months.

      Also to confirm the diagnosis and assess response the investigators will measure levels of
      methylmalonic acid, homocysteine, and hydroxocobalamin at the beginning of the study, 3 and 6
      months.
    

Intervention name(s): Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg
Intervention type(s): Drug
Intervention description(s): Single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg.
Other intervention name(s): Bedoyecta Tri
Intervention MeSH terms: Thiamine; Pyridoxine; Hydroxocobalamin; Vitamin B 12
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability Study of EG-1962 in Aneurysmal Subarachnoid Hemorrhage
Condition: Ruptured Cerebral Aneurysm; Ruptured Berry Aneurysm
MeSH terms: Subarachnoid Hemorrhage; Intracranial Aneurysm; Aneurysm; Hemorrhage
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase 1/2a Multicenter, Controlled, Randomized, Open Label, Dose Escalation, Safety,
      Tolerability, and Pharmacokinetic Study Comparing EG-1962 and Nimodipine in Patients with
      Aneurysmal Subarachnoid Hemorrhage
    

Detailed description: 
      This is a Phase 1/2a multicenter, controlled, open label, and randomized, study.

      Part 1 of the study is a single dose escalation period to determine the MTD of EG-1962.
      During this period, a maximum of 6 dose level cohorts with up to 12 patients per cohort will
      be enrolled. In each cohort, patients will be randomly assigned in a ratio of 3:1 to receive
      either intraventricular EG 1962 or enteral nimodipine, respectively. The first cohort will
      receive 100 mg EG 1962. Upon completion of the dose escalation period, a safe and tolerable
      dose will be selected for further study.

      Part 2 of the study is a treatment period to assess the safety and tolerability of the
      selected dose of EG-1962.

      The safety and tolerability of a single intraventricular dose of EG 1962 will be compared to
      enteral nimodipine (60 mg given every 4 hours orally or via nasogastric or gastrostomy tube)
      for 21 days.
    

Intervention name(s): Nimodipine; Nimodipine Microparticles
Intervention type(s): Drug; Drug
Intervention description(s): Based upon Investigator Judgement; Based upon Investigator Judgement
Other intervention name(s): Nimodipine Softgel; Nimodipine Tablet; EG-1962
Intervention MeSH terms: Nimodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ruptured saccular aneurysm; nimodipine; safety; tolerability; Subarachnoid hemorrhage
Innovative Tool to Analyse Synovial Fluid of Patients With Knee Ostearthritis After IA Injection of Synvisc-one®
Condition: Knee Osteoarthritis; Intra-Articular Injection
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The objective of this trial is to assess the clinical pertinence of an innovative analytical
      tool (SYNODIAG) to analyze the Synovial Fluid (SF) composition and guide the patient
      treatment in a Proof of Concept (PoC) study using OA patients receiving IA injection of
      SYNVISC ONE®.
    

Detailed description: 
      In a recent study on animal model (results not yet published), the use of drop deposition
      combined to Raman spectroscopy provided for the first time the Raman spectral signature of
      healthy SF. Tribological analysis of simple dried drops of SF showed the potentiality to
      observe physical and chemical changes due to OA process. HA concentration was correlated with
      the dried drop area and the increase of protein content was correlated with the height of the
      peripheral rim. Spectral acquisitions detailed/specified these observations as degradation of
      cartilage and bone tissues was measured using specific Raman band ratios. These results
      suggested that DDRS could be an innovative tool in OA clinical research. In this context, the
      Sponsor would like to assess the clinical pertinence of this innovative analytical tool in a
      PoC study using OA patients receiving IA injection of SYNVISC ONE®.
    

Intervention name(s): Synvisc-One
Intervention type(s): Device
Intervention description(s): SYNVISC-ONE® (Hylan G-F 20), 10 mL single-injection viscosupplement Status : CE marked (CE 0086) class III Medical Device The IP is used according to its usual dosage, administration and indication
Other intervention name(s): SYNVISC; Hylan G-F 20
Intervention MeSH terms: Hylan
Intervention model: Single Group Assignment
Intervention model description: Proof of Concept (PoC), monocentric, non-comparative, interventional trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Osteoarthritis; food supplement; SYNVISC; Synovial Fluid analysis
Correlation Study Between Socio-economical Deprivation and Oral Health in Children of 9 Years of Age
Condition: Tooth Decay; Missing Tooth/Teeth
MeSH terms: Tooth Loss; Anodontia; Dental Caries
Study type: Observational

Summary: 
      Retrospective, observational cohort study.

      Objectives :

      To search for correlations between socio-economical deprivation and oral health in french
      children of 9 years of age.

      To study the annual use of oral and dental care of children from 6 to 9 years of age
      depending on their geographical and socio-economical environment, and the medical demography
      ; To identify and study the share of the cohort not using oral and dental care, and the
      socio-economical and geographical factors implicated in this non-use of care.

      The study will use data from the french nationwide healthcare systems database (SNDS) and
      data from the french national institute of statistics and economic studies (INSEE).
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients born in 2008
      
Keywords: Oral health; Odontology; Epidemiology; Public health; Deprivation
Kinesiophobia in Prostate Cancer
Condition: Prostate Cancer; Kinesiophobia; Physical Inactivity
MeSH terms: Prostatic Neoplasms; Kinesiophobia
Study type: Interventional

Summary: 
      This study aimed to investigate the effects of prostate cancer on patients' physical
      activity, kinesiophobia, fatigue and functionality.

      This research is a prospective study to be conducted on volunteer individuals between the
      ages of 40-75. People diagnosed with prostate cancer (study group) and healthy adults who
      have not been diagnosed with prostate cancer before (control group) will be included in the
      study. The demographic characteristics, physical activity levels and quality of life of all
      individuals participating in the study will be evaluated with an online form. In demographic
      data, physical, sociodemographic data such as age (years), height (cm), body weight (kg),
      body mass index (kg/m2) and disease-specific information will be recorded. Physical activity
      level will be measured with the International Physical Activity Survey short form (UFAA),
      fatigue with the Functional Evaluation of Chronic Disease Treatment-Fatigue Questionnaire,
      fear of movement with the Causes of Fear of Movement Questionnaire, and quality of life with
      the Functional Evaluation of Cancer Treatment-Prostate Version questionnaire (KHTFD-Y).
    


Intervention name(s): survey evaluation
Intervention type(s): Other
Intervention description(s): assessment of physical activity, fatigue, fear of movement, and quality of life
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research