bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Study of Picosecond and Nanosecond Pulse Durations Using a Q-switched Nd:YAG Laser for Tattoo Removal
Condition: Tattoo Removal
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of laser tattoo removal with
      picosecond pulse durations as compared to treatment with nanosecond pulse durations using a
      single novel Q-Switched (QS) Nd:YAG laser.
    

Detailed description: 
      This is a randomized, split-tattoo, open-label, single-center study of up to 25 subjects with
      tattoos containing black or dark blue ink, alone or in combination with other colors. It will
      compare the safety and efficacy of nanosecond and picosecond pulse durations with the Cutera
      Picosecond Q-Switched Nd:YAG laser for tattoo removal.
    

Intervention name(s): enLighten Laser
Intervention type(s): Device
Intervention description(s): Picosecond pulse-duration or Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tattoo removal; Q-switched laser; Nd:YAG laser; nanosecond laser; picosecond laser; laser therapy; tattoo; pulsed-laser; laser treatment; remove tattoo; tattoo clearing; tattoo lightening; tattoo lighten; resistant tattoo
Exercise in Migraine and Co-existing Tension-type Headache and Neck Pain
Condition: Migraine; Tension-type Headache; Neck Pain
MeSH terms: Migraine Disorders; Tension-Type Headache; Headache; Neck Pain
Study type: Interventional

Summary: 
      The purpose of this study is to study the effect of a physical exercise program on patients
      suffering from migraine and co-existing tension-type headache and neck pain. The
      investigators hypothesized that migraine patients are ofte physically inactive because of
      their headache and that they will benefit from a specific exercise program.
    

Detailed description: 
      Migraine and tension-type headache are among the most common neurological diseases and are
      causing reduced quality of life, private and socio-economic consequences in terms of medical
      consumption and work-related absenteeism. The clinical experience shows that physical
      activity, like cycling and brisk walking, can prevent migraine attacks, but the evidence of
      the efficacy is sparse.

      The primary aim of the study is to investigate the acute and the long term effect of exercise
      on patients suffering from migraine and co-existing tension-type headache and neck pain.

      The project will be the first of its kind that explores the effect of an exercise program on
      patients who both suffer from migraine, tension-type headache and neck pain. We expect that
      the participants from the exercise program will achieve a reduced pain impact on everyday
      life, an improved fitness and quality of life, and a decrease of absence days and medication
      use.
    

Intervention name(s): Exercise treatment
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Frequency and Presentations of Chronic Pain Following Breast Cancer Surgery: An Observational Study in a Tertiary Care Hospital of Pakistan
Condition: Breast Cancer Female; Chronic Pain
MeSH terms: Breast Neoplasms; Chronic Pain
Study type: Observational

Summary: 
      This study is designed to evaluate the frequency and presentations of chronic persistent pain
      in patients after breast cancer surgery at our tertiary care hospital. Results of this study
      will help us to understand the magnitude of problem in our population and making
      institutional guidelines for appropriate management of such patients.
    

Detailed description: 
      After approval from the Departmental Research Committee and Institutional Ethical Review
      Committee all adult female patients with known carcinoma of breast who are scheduled for
      elective definitive breast cancer surgery (Mastectomy) from 1st July 2016 to 30th December
      2016 will be enrolled in this audit. Inclusion of patients will be done once operative
      procedure is finalized and consent taken in breast clinic. Those patients who did not give
      consent and those patients who need reoperation on same side for recurrence of cancer or any
      reason will be excluded from this study.

      Data will be obtained from patient's medical record, interview of patient on follow up visit
      at breast clinic and telephonic communication with patient. Variables have been defined and a
      special form has been designed for data collection. All patients will be followed for next
      three months and those who have persistent pain will be followed for six months after
      operation.

      Follow up information will be obtained from patient visiting breast clinic. For any missing
      data patient's medical records will be reviewed and patient will be contacted to know if they
      have chronic post-surgical pain or not. Audit forms will be filled by authors according to
      their availability. The primary investigator or author at breast clinic will keep all forms
      for safe record keeping which shall later be used for data analysis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        all adult female patients with known carcinoma of breast who are scheduled for elective
        definitive breast cancer surgery (Mastectomy)
      
Keywords: Breast cancer surgery; Persistent pain
Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction
Condition: Erectile Dysfunction; Arterial Hypertension; Endothelial Dysfunction
MeSH terms: Erectile Dysfunction; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to assess the correlation of FMD of brachial artery and carotid
      intima media thickness with ED severity and clinical response to vardenafil in hypertensive
      men.
    

Detailed description: 
      To achieve this objective, a prospective study will be conducted, with hypertensive patients
      ranging from 50 to 70 years, presenting vasculogenic erectile dysfunction for over six months
      and sexually actives. All patients will be assessed for clinical and laboratorial data,
      endothelial dysfunction, endothelium independent vasodilation and carotid intima media
      thickness at the inclusion of the study. They will receive medical orientations from the same
      urologist and will return after four attempts with 20 mg of vardenafil.
    

Intervention name(s): Vardenafil
Intervention type(s): Drug
Intervention description(s): vardenafil 20 mg on demand or vardenafil daily or placebo
Other intervention name(s): Levitra
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: erectile dysfunction; arterial hypertension; flow mediated vasodilation; endothelial dysfunction; carotid intima media thickness; vardenafil
Study of Hepatocellular Carcinoma in Cirrhotic Patients
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      The project is based on a case-control study including cirrhotic patients with (200 cases)
      and without (400 controls) Hepatocellular carcinoma. The determination of sample sizes in
      proteomic or spectroscopic studies has to be adapted to the high dimensional setting. The
      proteomic analysis will be conducted by Clinical Innovation Proteomic Platform of Dijon. Two
      approaches will be used in the proteomic study: A global approach based on the comparison of
      proteomic spectra profiles obtained after mass spectrometry analysis (MALDI-TOF). The
      particularity of this study with regard to previous studies is : the procedures used to
      purify the sub proteomes (Five automated methods including depletion fractionation and
      purification will be applied), the qualification of the generated data with the introduction
      of quality controls, the high number of samples included in the study. The second approach
      BIA-MS (Biomolecular interaction analysis mass spectrometry) is targeted approach allows the
      capture, quantification and characterization of proteins.

      The quality controls allow to quantify the various variability sources and to validate that
      biological variability is higher than technical variability. All the samples will be treated
      and analyzed with the same protocols, 100 samples will be used to validate the marker and
      statistical models developed after analysis of the first 500 samples. The infra-red
      spectroscopy analysis will be conducted by MéDIAN team, CNRS UMR 6237 of Reims university.
      The first 300 samples after feature selection reference spectra, are classified into
      different classes by means of mathematical classification methods such as multivariate
      statistical processes of pattern recognition, neuronal networks, support vector machines and
      methods of case-based classification or machine learning, genetic algorithms or methods of
      evolutionary programming. The analysis of a second set of samples (300) will validate the
      different mathematical classification methods developed.

      In the global study the investigators will unravel the relationship between proteomic,
      spectroscopic and metabolic/nutritional data. The description of these relationships will use
      canonical analysis and multi-block analysis in a more general extent. The goal of these
      methods is to explore relationships that may exist between several groups of quantitative
      variables observed on the same set of individuals.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patient
Activation of Brown Adipose Tissue Metabolism Using Mirabegron
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Could sympathomimetics and sympatholytics drugs safe for the management of Type 2 Diabetes
      (T2D)? Based on recent evidence, we propose that pharmacological stimulation of Beta-3
      adrenergic receptor (ADBR3) at higher doses of Mirabegron may be required to elicit changes
      in glycemia, but should be combined with Beta-1 adrenergic receptor (ADRB1) antagonists to
      suppress the unwanted effects on the cardiovascular system.

      Together, several results establish a previously unappreciated cross-talk between Gs-coupled
      ADRB1 and ADRB3 in adipose tissue for the control of glucose homeostasis. Moreover, these
      data suggest that antagonizing ADRB1 may be a good way to significantly lower the dose of
      ADRB3 agonist required for glucose control.

      Therefore, we believe that there are therapeutic opportunities in targeting adrenergic
      receptors for the treatment of T2D at least in young/middle aged people.
    

Detailed description: 
      In brief, participants will take part in 2 metabolic studies (A and B) performed in random
      order and at an interval of 7 to 14 days. Each metabolic study will last 8.5 hours with a
      baseline period of 2.5 hours. Participants will ingest either 200 mg of the ADRB3 agonist
      mirabegron (Myrbetriq, Astellas Pharma Canada) alone (study A) or in combination with 10 mg
      of bisoprolol, an ADRB1-antagonist (study B), at time 0.

      The radioactive PET tracers (PET: positron emission tomography) used in this study are the
      [11C]-acetate and [18F]-FDG to estimate BAT oxidative metabolism and glucose metabolism,
      respectively. The perfusion of [6,6 D2]-glucose, [1,1,2,3,3-2H]-glycerol and
      [U-13C]-palmitate stable isotopes will also be performed in this study from time -150 min. to
      +300 min to examine the systemic appearance rate of glucose, glycerol and fatty acids,
      respectively. These studies will be almost identical (same perfusion of stable and
      radioactive tracers, same number of PET acquisitions) except for the drug which will be
      administered orally at time 0.
    

Intervention name(s): Mirabegron; Bisoprolol Fumarate
Intervention type(s): Drug; Drug
Intervention description(s): Mirabegron: a single dose of 200 mg mirabegron (4 tablets of 50 mg); a single dose of 10 mg (2 tablets of 5 mg)
Other intervention name(s): Myrbetriq; Apo Bisoprolol
Intervention MeSH terms: Bisoprolol; Mirabegron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Efficiency of γδ T Cell Against Breast Cancer(Her-, er-, and pr-)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study, effects of γδT cells on human breast cancer (her2-, er-,pr-) in combination
      with tumor reducing surgery, for example cryosurgery going to be investigated.
    

Detailed description: 
      Breast tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the
      patient will be separated from peripheral blood. After making them potential cancer killer γδ
      T Cell and DC-CIK, they will be infused to the patients as immunotherapy.
    

Intervention name(s): DC-CIK; γδ T Cell; Combination
Intervention type(s): Biological; Biological; Biological
Intervention description(s): DC-CIK cells will be used against tumor cells.; γδ T cells will be used against breast tumor.; γδ T/DC-CIK cells will be used against breast tumor.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: γδ T Cell; breast cancer; her2-; er-; pr-
Controlled Attenuation Parameter (CAP) in Liver Allografts
Condition: Liver Transplant; Liver Steatosis; Liver Disease; Primary Non-function; Early Allograft Dysfunction
MeSH terms: Liver Diseases; Fatty Liver
Study type: Observational

Summary: 
      The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis
      using liver biopsies as reference. Secondarily, investigators will correlate transient
      elastography (TE) and CAP results, analyze possible associations between CAP/TE and
      post-liver transplant (LT) clinical outcomes, and evaluate the change in CAP after LT. The
      study aims to include as many donors as needed to achieve at least 120 transplanted liver
      allografts.
    

Detailed description: 
      This is a coordinated study utilizing 3 recruitment centers (University of Arkansas for
      Medical Sciences [UAMS], Stanford University, and Mayo Clinic) 2 liver pathology reading
      centers (University of Michigan and Mayo Clinic), and 1 coordinating center (University of
      Arkansas). The cohort study with a cross-sectional component for the primary aim has been
      completed (through independent Institutional Review Board [IRB] agreements) at UAMS, Stanford
      University, and the Mayo Clinic. The samples collected at the three recruitment centers will
      be sent to the biopsy center at the University of Michigan and Mayo Clinic for evaluation.
      The Liver Transplant Program at each of the 3 recruiting centers will identify study subjects
      during the process of liver allocation to their listed recipients. Criteria for recruitment
      are as follows:

      Inclusion criteria - Liver Recipient

        -  Men and women, Age 18-years old to 80-years old inclusive Inclusion criteria - Liver
           Donor

        -  Valid TE with Fibroscan 530, defined as:

             -  At least 10 valid measurements

             -  Interquartile Range (IQR)/Median stiffness value <30% (only in cases with >7.1 kPa)
                Exclusion criteria - Liver Recipient

        -  Patient did not undergo liver transplantation Exclusion criteria - Liver Donor

        -  Donation after circulatory death (DCD)

        -  No liver biopsy obtained during organ procurement process
    

Intervention name(s): Fibroscan 402/530
Intervention type(s): Device
Intervention description(s): Fibroscan 402/530 obtained before procurement in the donor and at 1 to 3 months post-transplant in the liver recipient.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Allograft procured and transplanted into recipients.
Oxytocin HIV Meth Study
Condition: Amphetamine Use Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this pilot study is to determine the tolerability, feasibility, and
      preliminary effectiveness of intranasal oxytocin administration prior to motivational
      enhancement group therapy sessions on laboratory-based measures of addiction, social
      connectedness, and stress responsivity in methamphetamine(meth)-using men who have sex with
      men (MSM). The investigators propose a randomized, double-blind, study of intranasal oxytocin
      versus placebo 40 IU prior to each of six Motivational Interviewing Group Therapy (MIGT)
      sessions in 28 mixed HIV sero-status MSM initiating treatment for amphetamine use disorder.
    

Detailed description: 
      The high prevalence of amphetamine use disorder (AUD) among men who have sex with men (MSM)
      leads to significant health disparities, including increased risk for HIV sero-conversion.
      Reducing methamphetamine use mitigates HIV risk. Currently no psychopharmacological agent
      exists for the treatment of AUD; innovative interventions are desperately needed. Oxytocin, a
      social neuropeptide, has well-studied anti-addiction effects in animal models of substance
      dependence. The use of intranasal oxytocin for a variety of human substance use disorders is
      under early investigation, although no one has studied oxytocin's effects in AUD. In other
      populations, oxytocin's effects are known to vary depending on social context. Psychosocial
      treatment alone has been shown to reduce methamphetamine and HIV risk in MSM at a
      community-based clinic in San Francisco, The Stonewall Project. The investigators propose a
      randomized, double-blind pilot study of psychopharmacological-psychosocial combination
      therapy, administration of intranasal oxytocin versus placebo prior to six Motivational
      Interviewing Group Therapy (MIGT) sessions, in 28 mixed HIV sero-status MSM initiating
      treatment for AUD. The investigators aim to assess: 1) tolerability, 2) feasibility for
      larger randomized controlled trials, and 3) exploratory measures of efficacy, including: a)
      urine levels of methamphetamine and metabolites, b) methamphetamine craving, c) engagement in
      MIGT through third-party coding of videotaped group sessions and self-reported measures of
      group connectedness, d) psychophysiological stress responses to group engagement, and e)
      sexual risk taking.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 IU; 40 IU
Other intervention name(s): Syntocinon; Saline
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: oxytocin; tolerability; HIV; men who have sex with men (MSM); addiction
A Phase II Study With Low-dose Recombinant Human IL-2 for the Treatment of Primary Sjögren's Syndrome
Condition: Primary Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Sjögren's Syndrome (pSS) is an autoimmune disorder characterized by
      keratoconjunctivitis sicca and xerostomia. In addition, various extraglandular manifestations
      may develop. Several immunomodulating agents have been attempted in the treatment of pSS
      without achieving satisfactory results. Currently, there is no approved systemic treatment
      for pSS. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune
      diseases, which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that
      low-dose IL-2 could be a novel therapy in active pSS patients. This clinical study will test
      the efficacy and safety of low dose IL-2 treatment in pSS. The investigators perform a
      single-centre, double-blind pilot trial with hrIL-2 in pSS. The investigators evaluate the
      effectiveness and safeness of low-dose hrIL-2 for primary Sjögren's Syndrome by randomized
      controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).
    

Detailed description: 
      Each pSS patients (n=60) with Scores>=6 on ESSDAI received low-dose IL-2 or placebo (active
      group: placebo group =1:1, 1 million units every other day subcutaneously (HrIL-2 1X 106, ip,
      Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3 cycles. The
      end points were safety, clinical and immunologic response.
    

Intervention name(s): hrIL-2 active; hrIL-2 placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 million U doses of human recombinant interleukin-2 s.c. injection active group: placebo group =1:1; 1 million U doses of placebo s.c. injection active group: placebo group =1:1
Other intervention name(s): Human recombinant IL-2; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Compare the Pharmacokinetics of Mycophenolate Mofetil Metabolites From Four Tablet Formulations in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, randomized, open label, 4-treatment, 4-period, 4-sequence, 4-way
      crossover study to compare the pharmacokinetics of mycophenolate mofetil (MMF) metabolites
      from 4 tablet formulations in healthy participants.
    


Intervention name(s): Renodapt; Mycept; Cellmune; CellCept
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Renodapt will be administered as 500 milligrams (mg) tablet orally on Day 1 in any treatment periods.; Mycept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.; Cellmune will be administered as 500 mg tablet orally on Day 1 in any treatment periods.; CellCept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment