bioihbjkbjnl/mcl2 huggingface dataset:
A Placebo-Controlled, Phase I, Pilot Clinical Trial to Evaluate the Safety and Immunogenicity of ENV 2-3, a Yeast-Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59 in Individuals With HIV Infection (Placebo Patients Receive MF59 Emulsion Only)
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety and immunogenicity of Env 2-3 in combination with MTP-PE/MF59
      adjuvant in adult volunteers with HIV infection.

      By vaccinating those who have HIV infection, perhaps the replication (reproduction) of
      existing viral strains can be suppressed and the asymptomatic period early in the infectious
      process can be prolonged. One potential way to do this is to boost HIV antigen-specific CD4
      responses, which may in turn increase the effectiveness of CD8 killing of HIV infected cells.
    

Detailed description: 
      By vaccinating those who have HIV infection, perhaps the replication (reproduction) of
      existing viral strains can be suppressed and the asymptomatic period early in the infectious
      process can be prolonged. One potential way to do this is to boost HIV antigen-specific CD4
      responses, which may in turn increase the effectiveness of CD8 killing of HIV infected cells.

      Eight patients are entered in the pilot portion of the study, thirty patients are entered on
      Part A and fifteen patients are entered on Part B. In the pilot study, patients receive 30
      mcg Env 2-3 vaccine plus 0 - 10 mcg MTP-PE/MF59 adjuvant. Patients on Part A receive one of
      the following: MF59 emulsion only; 100 mcg MTP-PE/MF59 only; 30 mcg Env 2-3 with MF59
      emulsion only; or 30 mcg Env 2-3 vaccine with 100 mcg MTP-PE/MF59. Patients on Part B receive
      either 100 mcg MTP-PE/MF59 only or 30 mcg Env 2-3 vaccine plus 100 mcg MTP-PE/MF59. Treatment
      is administered on days 0, 28, and 112, and patients are followed for up to 10 months. Per
      amendment, patients may receive two additional doses of 30 mcg Env 2-3 or placebo in
      MTP-PE/MF59 at 7 and 10 months (Parts A and B) or 9 and 12 months (Pilot study) after their
      initial inoculation.
    

Intervention name(s): MTP-PE/MF59; Env 2-3
Intervention type(s): Biological; Biological
Primary purpose: Treatment
Keywords: Vaccines, Synthetic; Recombinant Proteins; Adjuvants, Immunologic; Acquired Immunodeficiency Syndrome; HIV Envelope Protein gp120; AIDS Vaccines; HIV Therapeutic Vaccine
Active-Controlled Study to Assess the Efficacy and Safety of DFD-05 in Subjects With Common Warts
Condition: Common Warts
MeSH terms: Warts
Study type: Interventional
Phase: Phase 2

Summary: 
      DFD05 vs. Active01 in the treatment of common warts
    


Intervention name(s): DFD05 Cream; Active01 Cream
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen
Condition: Hemophilia A; Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a
      six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.
    


Intervention name(s): Recombinant Factor VIIa BI (rFVIIa BI); Recombinant Factor VIIa BI (rFVIIa BI)
Intervention type(s): Biological; Biological
Intervention description(s): Administered approximately every 3 hours as an intravenous bolus injection on-demand; Administered as a single intravenous bolus injection on-demand
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: with Factor VIII (FVIII) or Factor IX (FIX) inhibitors
Assess the Effect of Daily Treatment of Vardenafil 20mg or Sildenafil 100mg and Placebo on Sperm Function
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on
      sperm function
    


Intervention name(s): Levitra (Vardenafil, BAY38-9456); Sildenafil; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg daily dosing; 100 mg daily dosing; Matching placebos
Intervention MeSH terms: Sildenafil Citrate; Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Erectile Dysfunction; Sildenafil; Vardenafil; Spermatogenesis; Sperm concentration; Sperm count; Morphology; Motility; Reproductive hormonal
IL-2 for Multi Drug Resistant Nephrotic Syndrome
Condition: Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the study is to design an open-label phase 1-2 trial to assess safety and clinical
      and immunologic effects of repeated administration of recombinant low dose IL2 (Proleukin) in
      5 patients with idiopathic nephrotic syndrome unresponsive to drugs (steroids, calcineurin
      inhibitors, Rituximab), following the therapeutical scheme indicated for crioglobulinemic
      nephropathy:

      cycle1: IL2 1x106 /m2 s.c for 5 consecutive days cycle2: IL2 1.5 x106 / m2 s.c for 5
      consecutive days, starting from 3 weeks after the first cycle.

      cycle3: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 6 weeks after the first
      cycle.

      Cycle 4: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 9 weeks after the first
      cycle.

      Current therapy with steroids and calcineurin inhibitors (Prograf) will be maintained during
      the first cycle and progressively reduced during the subsequent cycles.

      The first cycle will be performed during hospitalization in the investigators Unit;
      subsequent cycles will be performed at nephrology outpatients. All laboratory values normally
      utilized in the follow up of patients affected by idiopathic nephrotic syndrome will be
      evaluated during the first week of treatment and at the end of the protocol, together with
      specific cellular values (Tregs, B cells, NK).
    


Intervention name(s): Proleukin®
Intervention type(s): Drug
Other intervention name(s): IL-2
Intervention MeSH terms: Aldesleukin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of CellCept for Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Mycophenolate Mofetil (CellCept) is an FDA approved, well tolerated, oral medication used to
      prevent the body's immune system from attacking transplanted organs. It has never been
      studied in patients with pancreatic cancer but some preliminary studies have shown that it
      may antagonize tumor growth. The goals of this study are to find out how much of this drug
      can safely be taken by patients with advanced pancreatic cancer and to assess the variation
      of the level of the drug in the blood. Patients will take the drug twice a day at a given
      dose and the safety of the drug will be monitored through patient symptoms and blood tests.
      The disease burden will be assessed by radiographic studies at the beginning and end of the
      study. The patient will take the drug for a total of eight weeks.
    

Detailed description: 
      Mycophenolate Mofetil (CellCept) is a prodrug whose active metabolite, mycophenolic acid
      (MPA), acts as an immune suppressant by inhibiting de novo guanosine synthesis. CellCept is
      FDA approved to prevent rejection of transplanted organs. It is well tolerated, orally dosed,
      and has some known antitumor effects. It has never been studied in pancreatic cancer and the
      maximum tolerated dose is not known. In vitro studies in our lab with human pancreatic cancer
      lines found that MPA was a potent inhibitor of pancreatic cancer cell growth and induced
      apoptosis. The objectives of this study are to identify the maximum tolerated dose of
      CellCept in patients with advanced pancreatic cancer that have failed at least two prior
      chemotherapy regimens and assess its pharmacokinetics.
    

Intervention name(s): Mycophenolate mofetil
Intervention type(s): Drug
Intervention description(s): Dose escalation increasing successively from 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, and 5.0 grams p.o. bid.
Each patient will be treated for eight weeks (56 days).
Intervention MeSH terms: Mycophenolic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Power Mobility on Young Children With Severe Motor Impairments
Condition: Cerebral Palsy; Arthrogryposis; Spinal Muscular Atrophy; Other Central Nervous System or Musculoskeletal Disorders
MeSH terms: Musculoskeletal Diseases; Arthrogryposis; Cerebral Palsy; Muscular Atrophy; Muscular Atrophy, Spinal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose this study is to determine the effects of power mobility on the development and
      function of young children of young children whose severe physical disabilities limit their
      exploratory behaviors and may unnecessarily restrict their cognitive, communication, and
      social-emotional development.
    


Intervention name(s): Power mobility
Intervention type(s): Other
Intervention description(s): Project staff will use structured power mobility training program to teach the children to use the power mobility devices. Project staff will schedule 1-hour sessions with each family 3 times per week for the first month of the project and will decrease in the following manner as the child becomes proficient and develops basic wheelchair maneuvering skills: two one-hour session per week for 4 weeks; one one-hour session per week for 4 weeks; two one-hour sessions per month for 4 weeks; one one-hour session per month for the remainder of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: power wheelchairs; power mobility; young children
Comparison of the Genotoxicity of Desflurane and Propofol
Condition: DNA Damage; Anesthesia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate if the anesthetics propofol and desflurane can
      damage DNA according to comet essay in patients submitted to lumbar disc surgery.
    

Detailed description: 
      It is expected that DNA damage information provide the possible genotoxic effects of
      inhalational and intravenous anesthetics and contribute to the establishment of strategies
      aimed at reducing the risks to exposed patients.
    

Intervention name(s): Anesthetics, General Desflurane Maintenance; Anesthetics, General Propofol Maintenance
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of dna damage of desflurane maintenance with propofol maintenance according to comet analysis; Comparison of dna damage of propofol maintenance with desflurane maintenance according to comet analysis
Intervention MeSH terms: Propofol; Anesthetics; Desflurane; Anesthetics, General
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Desflurane; Intravenous anesthetics; propofol; comet essay
The Impact of the Social Cognitive Theory Based Educational Program on Women-headed Households' Social Health : A Field Trial
Condition: Social Behavior; Health Behavior
Study type: Interventional

Summary: 
      The goal of this field trial was to compare in emale-headed households. The main question it
      aims to answer are:

      determine the effect of education based on social cognitive theory on the social health of
      female-headed households in female-headed households in Gonabad.

      Women in the intervention group participated in face-to-face and virtual meetings based on
      social cognitive theory structures for 4 weeks. The control group did not receive any
      training related to the intervention.
    


Intervention name(s): test group
Intervention type(s): Other
Intervention description(s): Women in the intervention group participated in face-to-face and virtual meetings based on social cognitive theory structures for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Antidiabetic Effects on Intrahepatic Fat
Condition: Non-Alcoholic Fatty Liver Disease; Type2 Diabetes
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a 24-week single-center, open-label, parallel controlled group comparing gliclazide,
      liraglutide, and metformin effects on diabetes with nonalcoholic fatty liver disease.
    

Detailed description: 
      Following enrollment, eligible participants were randomized (1:1:1) using computer-generated
      random numbers to the metformin (Glucophage, Bristol-Myers Squibb), liraglutide (Victoza,
      Novo Nordisk), or gliclazide (Diamicron, Servier) groups. All patients were informed about a
      proper diet and exercise. For the metformin group (n = 31), the dosage was 250 mg thrice a
      day during the first week, 500 mg thrice a day during the second week, and 1000 mg twice a
      day from the third week to the conclusion of the study. For the gliclazide group (n = 31),
      the initial dosage was 30 mg before breakfast, which was gradually titrated to a maximum of
      120 mg/day to achieve a fasting capillary plasma glucose of <7.0 mmol/L. For the liraglutide
      group (n = 31), the dosage was 0.6 mg/day during the first week, 1.2 mg/day during the second
      week, and 1.8 mg/day from the third week to the conclusion of the study.At the end of the
      study, data will be collected and analyzed.
    

Intervention name(s): Liraglutide; Metformin; Gliclazide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): the dosage of liraglutide was 0.6 mg/day during the first week, 1.2 mg/day during the second week, and 1.8 mg/day from the third week to the conclusion of the study; the dosage of metformin was 250 mg thrice a day during the first week, 500 mg thrice a day during the second week, and 1000 mg twice a day from the third week to the conclusion of the study; the initial dosage of gliclazide was 30 mg before breakfast, which was gradually titrated to a maximum of 120 mg/day to achieve a fasting capillary plasma glucose of <7.0 mmol/L
Other intervention name(s): Victoza,Novo Nordisk; Glucophage,Bristol-Myers Squibb; Diamicron MR,Servier
Intervention MeSH terms: Metformin; Liraglutide; Gliclazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liraglutide; Metformin; Gliclazide
Overcoming Psychiatric Barriers to the Treatment of Hepatitis C
Condition: Hepatitis C; Substance Use Disorders; Mental Disorder
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Substance-Related Disorders; Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that
      will assist patients with hepatitis C in overcoming barriers that prevent them from becoming
      appropriate candidates for interferon therapy.
    

Detailed description: 
      The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that
      will assist patients with hepatitis C in overcoming barriers that prevent them from becoming
      appropriate candidates for interferon therapy. Patients who have been deferred from therapy
      due to mental health or substance abuse issues will work with the team psychologist on
      following through with the hepatologist's treatment recommendations that would lead to
      becoming eligible for interferon therapy.
    

Intervention name(s): psychosocial intervention
Intervention type(s): Behavioral
Intervention description(s): motivational enhancing case management intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: hepatitis C; mental disorder; substance use; psychosocial intervention
Photobiomodulation In the Masseter and Temporal In Patients With Temporomandibular Joint Dysfunction
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Joint Diseases
Study type: Interventional

Summary: 
      Background: According to the International Association for the Study of Pain (IASP), the term
      temporomandibular disorder (TMD) regards a subgroup of orofacial pain, the symptoms of which
      include pain or discomfort in the temporomandibular joint, ears, masticatory muscles and neck
      on one or both sides as well as joint sounds, limited mandibular movements or mandibular
      deviation and difficulties chewing. Phototherapy, such as low level laser therapy (LLLT) and
      light-emitting diode (LED) therapy, is one of the resources used to treatment muscle pain.
      Thus, there is a need to investigate therapeutic resources that combine different wavelengths
      as well as different light sources (LLLT and LED) in the same apparatus.

      Question: The aim of the proposed study is to evaluate the effects of phototherapy on pain,
      activity of the masticatory muscles (masseter and anterior temporal bilaterally) and joint
      mobility in individuals with temporomandibular disorder (TMD). A further aim is to determine
      the cumulative effect 24 and 48 hours after a six session.

      Methods/Design: A placebo-controlled, double-blind, randomized, clinical trial will be
      carried out involving 30 women between 18 and 40 years of age with a diagnosis of myogenous
      TMD. The participants will then be randomly allocated to two groups totaling 15 individuals
      per group. Group 1 submitted to a session of phototherapy with 39,27 Joules per point one
      group will receive placebo therapy (0 Joules). The following assessment tools will be
      administered on four separate occasions (baseline and immediately after, 24 h after and 48 h
      after phototherapy). Pain intensity will be assessed using the visual analog scale for pain,
      meter for range of movement, and electromyographic EMG analysis on the masseter and anterior
      temporal muscles.

      Discussion: The study will support the practice of evidence-based to the use of phototherapy
      in individuals with a myogenous TMD. Data will be published after the study is completed.
    


Intervention name(s): phototherapy; phototherapy placebo
Intervention type(s): Other; Other
Intervention description(s): The portable PainAway® nine-diode cluster (Multi Radiance Medical®, Solon, OH, USA) will be employed. This system has one 905 nm laser diode, four 875 nm LED diodes and four 670 nm LED diodes. The aperture size of device is 4 cm2.; The placebo portable. The aperture size of device is 4 cm2 .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of an E-learning Program for Assessing Pressure Ulcer Risk and Pressure Ulcer Classification - a Pilot Study
Condition: Learning; Efficiency
MeSH terms: Pressure Ulcer
Study type: Interventional

Summary: 
      The purpose of this study is to determine wether e-learning is a more effective than
      traditional classroom teaching at norwegian nurses ability to use the Braden risk assessment
      scale and pressure ulcer classification.
    

Detailed description: 
      Most pressure ulcers (PU)can be prevented and assessment of the patient skin and risk factors
      for pressure ulcers is the first step. Epidemiological studies are also an important element
      in the prevention of PU and requires consistent registration based on standardized
      definitions and tools. Staff knowledge is critical in this work. However showed a Norwegian
      pilot study on the prevalence of PU deficient knowledge among nursing staff in terms reliable
      classification of PU and PU-assessment of risk. The pilot study showed the need for training
      to reduce the incidence of pressure ulcers and to ensure data quality in future studies.

      E-learning is an alternative to traditional courses and will help to streamline and
      standardize training by allowing a larger number of personnel be reached with this method of
      training. It is not designed Norwegian e-learning program that addresses the use of risk
      assessment instrument or classification of PU. We have developed one program to train
      personnel in the PU-classification and risk assessment and plan to evaluate this. The program
      will be an important contribution to the PU-prevention as well as the program will be used in
      the execution of a multicenter prevalence study of PU-prevalence.

      Nurses will randomly assign to a lecture, e-learning or to a control group. The lecture and
      e-learning are based on the same content. The nurses will score five patient cases with
      braden scale before and after intervention and 20 pictures of pressure ulcers in different
      categories before and 40 after intervention. The control group will only do a pretest.
    

Intervention name(s): e-learning; traditional classroom training
Intervention type(s): Other; Other
Intervention description(s): Braden scale and pressure ulcer classification; Braden scale and pressure ulcer classification
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Keywords: e-learning; education