bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Evaluation of a Short Illumination Duration (35 Minutes) When Performing PDT of AK Using the Dermaris ®
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional

Summary: 
      This clinical study aims aims to evaluate the clinical outcomes of SDL-PDT (simulated
      daylight Photodynamic Therapy) using the Dermaris in patients treated for AK lesions of the
      scalp at our medical dermatology center using only 35 minutes low-intensity light exposure.
    

Detailed description: 
      25 patients, with phototype 1 to 3, with grade I-II AK of the scalp will be treated. Only
      patients with a minimum of 9 clinically diagnosed grade I and II AK lesions of the scalp
      (according to the classification of Olsen) suggesting the existence of field cancerization,
      will treated with SDL-PDT (simulated daylight Photodynamic Therapy) using the Dermaris®
      (Surgiris, France) and therefore included in the study after application of MAL cream (Metvix
      ®, Galderma, Switzerland) to the treatment area. After debridment of all treated areas with
      sandpaper, Metvix will be applied and illuminated with with Dermaris 10 minutes later
      (leading to drug-light interval (DLI) of 10 minutes) with an irradiance of 2.9 mW/cm2 and a
      duration of 35 minutes The primary endpoint will be the rate of patients with less than two
      AK lesions at six-month post-treatment. Secondary endpoints will include scores of pain,
      erythema, crusts, discomfort and during or/and post the treatment.

      A ﬁrst follow-up visit will be scheduled seven days after the treatment. At this visit,
      crusts will be clinically rated by a dermatologist, while patients scored discomfort they had
      experienced during the six-day post-treatment. At the second follow-up visit conducted three
      months after the treatment, AK lesions will be counted by a dermatologist without
      differentiation between new and recurrent lesions. A second SDL-PDT using the Dermaris will
      be performed on the day if AK lesions are still present. At last, in case of remaining AK
      observed at 6 month follow up, a third treatment session with the same parameters will be
      carried out.

      The study is approved by the Ethical clinical committee of the Centre Dermatologique du Roy
      and conducted in accordance with the ethical principles of the Declaration of Helsinki (2008)
      and the International Conference on Harmonisation - Good Clinical Practices and in compliance
      with local regulatory requirements.
    

Intervention name(s): Metvix + Dermaris
Intervention type(s): Combination Product
Intervention description(s): Photodynamic Therapy
Intervention MeSH terms: Methyl 5-aminolevulinate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Photodynamic Therapy; Actinic Keratoses; White Light; Methyl ALA
Immune Parameters in the Cord Blood of Newborns Exposed to Malaria in the Womb
Condition: Malaria
MeSH terms: Malaria
Study type: Observational

Summary: 
      This study, conducted by the Malaria Research and Training Center at the University of
      Bamako, Mali, and the NIAID, will examine how exposure to the malaria parasite in the womb
      affects the developing immune system of newborns. Little is known about how such exposure in
      the womb may affect the immune system or alter the risk of malaria or responsiveness to
      vaccination after birth. A better understanding of this process may provide information
      useful for childhood vaccination strategies in areas where malaria is widespread.

      Women 18 years of age and older who live in Bancoumana and are in their last trimester of
      pregnancy and in good health may be eligible for this study.

      Participants have blood samples drawn from a finger stick and through a needle placed in a
      vein two times for this study: when they enroll in the study and again when they go to the
      Bancoumana Health Center to deliver their baby. After the baby and placenta are delivered,
      blood is collected from the umbilical cord and placenta.

      ...
    

Detailed description: 
      In malaria endemic areas the fetus is at risk for in utero exposure to Plasmodium falciparum
      or its soluble products. Little is known about how this exposure modulates the developing
      fetal immune system, or how this may alter the risk of malaria or responsiveness to
      vaccination after birth. A clearer understanding of this process may inform childhood
      vaccination strategies in malaria endemic areas. The objective of this cross-sectional
      exploratory study is to define the immune profile associated with in utero exposure to P.
      falciparum by analyzing cord blood samples collected at a site of high malaria transmission
      in Mali, and to compare this profile to that of U.S. cord blood samples. Pregnant women will
      be invited to participate in this study during the 3rd trimester of pregnancy. A finger stick
      blood draw will be collected from the mother at enrollment and peri-partum to determine if
      she is infected with P. falciparum. Cord blood and placental blood samples will be collected
      post-partum and processed to obtain mononuclear cells and serum. Cord blood can be obtained
      from the placenta after delivery without risk to mother or infant and will be used for
      research purposes only. Mononuclear cells will be analyzed by flow cytometry to characterize
      subsets of B, T and innate immune cells. Functional assays such as the B and T cell ELISPOT
      assay and measurements of cytokines in response to in vitro stimulation will also be
      performed.
    

Time perspective: Other
Keywords: Cross-Sectional; Plasmodium Falciparum Malaria; Cord Blood; Immunology; Mali; Malaria
Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure
Condition: Heart Failure With Reduced Ejection Fraction
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effect of treatment with omecamtiv mecarbil
      compared with placebo on exercise capacity as determined by cardiopulmonary exercise testing
      following 20 weeks of treatment with omecamtiv mecarbil or placebo
    

Detailed description: 
      Oversight Authorities:

      United States: Food and Drug Administration Canada: Health Canada France: National Agency for
      the Safety of Medicine and Health Products Germany: Federal Institute for Drugs and Medical
      Devices Hungary: National Institute of Pharmacy and Nutrition Italy: Italian Medicines Agency
      Netherlands: Medicines Evaluation Board Poland: Chief Pharmaceutical Inspectorate Sweden:
      Medical Products Agency
    

Intervention name(s): Omecamtiv Mecarbil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral omecamtiv mecarbil twice daily for up to 20 weeks with dose level determined by periodic blood testing; Oral placebo twice daily for up to 20 weeks
Other intervention name(s): CK-1827452; AMG-423
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years
Condition: Encephalitis, Tick-borne
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the safety and immunogenicity of the third
      vaccination with one of three different concentrations of a TBE vaccine in all volunteers who
      completed two vaccinations in one of the three treatment groups of Baxter study 205 (safety
      and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy volunteers aged 6 to 16
      years).
    


Intervention name(s): Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The study evaluated the long-term safety of Desvenlafaxine Succinate (DVS) Slow Release (SR)
      during open-label treatment in adult outpatients who had a primary diagnosis of major
      depressive disorder (MDD). The study also evaluated the long-term response of subjects
      receiving DVS SR for clinical global evaluation, functionality, general well-being, pain, and
      absence of depressive symptoms (remission).
    


Intervention name(s): Desvenlafaxine Succinate
Intervention type(s): Drug
Intervention description(s): Tablet were taken at a daily dose of 200 to 400 mg/day for a duration up to 10 months
Other intervention name(s): DVS-233 SR
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: major depressive disorder; desvenlafaxine; antidepressant
Role of Colonic Short Chain Fatty Acids in Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The excess production of colonic short-chain-fatty-acids (SCFA) has been implicated in the
      promotion of obesity, but colonic fermentation of dietary-fiber to SCFA may also play a role
      in preventing diabetes. The investigators aimed to compare the effects of two fermentable
      fibers (inulin and resistant-starch) on postprandial SCFA, glucose, insulin, free-fatty acids
      (FFA) and gut hormone responses and to compare the responses in healthy overweight and obese
      (OWO) vs lean (LN) participants. Methods: Using a randomized, single blind, crossover design,
      13 OWO and 12 LN overnight fasted participants were studied on 3 separate occasions. On each
      day they consumed a 300 mL drink containing 75g glucose (Control) or 75g glucose plus 24g
      inulin (IN), or 28.2g resistant-starch (RS). A standard lunch was served 4 h after the test
      drink.
    


Intervention name(s): Glucose; Inulin; Resistant Starch
Intervention type(s): Other; Other; Other
Intervention description(s): 75g glucose; 75g glucose plus 24g inulin; 75g glucose plus 28.2g resistant starch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Cytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study examines the immunologic and virologic effects of prophylactic CMV specific CTL in
      recipients of T cell depleted stem cell transplant (TCD SCT) at Duke University Medical
      Center (DUMC), by measuring levels of CMV DNA and virus specific T cell precursors at
      intervals post-infusion.
    

Detailed description: 
      Human cytomegalovirus (CMV) is a benign infectious agent in the normal host, but in
      immunocompromised individuals, such as recipients of stem cell or organ transplants, this
      virus is a major cause of morbidity and mortality. While pharmacologic agents exist to treat
      CMV disease, these medications have numerous side effects, the most serious of which is
      myelosuppression. Considering the risk associated with persistent infection and the potential
      for CMV specific CTL to restore immunity, we propose to study the immunologic and virologic
      effects of CMV pp65 specific CTL given to SCT recipients prophylactically, levels of CMV pp65
      specific CTL and CMV DNA will be measured from CTL recipients and a control group randomized
      to not receive CTL.

      All treatments will be given at Duke University Medical Center (DUMC).

        1. Patients will have a complete set of vital signs and physical examination prior to each
           infusion. Pulse oximetry will be monitored prior to, during, and for 30 minutes after
           the T-cell infusion. Thirty minutes prior to the CTL infusion, patients will be
           pre-medicated with 15 mg/kg (maximum 1 g) of acetaminophen p.o. and 1.0 mg/kg
           diphenhydramine I.V. (maximum 50 mg). Cells will be thawed in the Cell Therapy lab at
           DUMC, an aliquot sent for gram stain and culture, and viability will be determined.
           Cells with > 70 % viability will be transferred to the clinical unit and infused over
           5-10 minutes.

        2. CMV CTL will be infused when available between days 30 and 40 post-transplant at a dose
           ranging from 2- 5 x 105 cells/kg. This dose range was established since there may be
           variability in the numbers of CTL expanded from these donors.

      This trial intended to be a Phase 1/2 trial, but it never progressed to Phase 2 before
      completion.
    

Intervention name(s): CMV Specific Cytotoxic T Lymphocytes
Intervention type(s): Biological
Intervention description(s): CMV Specific Cytotoxic T Lymphocytes will be infused between days 30 and 40 post-transplant at a dose ranging from 2- 5 x e5 cells/kg.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4
Condition: Chronic Hepatitis C Virus Infection
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or
      without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.
    

Detailed description: 
      Egyptian participants infected with HCV GT4 were classified into two groups: group 1 (easy to
      treat) was treated with a dual therapy of SOF/DCV daily for 12 weeks and group 2 (difficult
      to treat) was treated with a triple therapy of SOF/DCV/RBV daily for 12 weeks.

      SOF dose was 400 mg/day given orally DCV was given in a dose of 60 mg/day, orally. RBV was
      given as oral tablets in the morning and in the evening based on patient's weight and
      tolerability (starting dose 600 mg/day to reach 1200 mg/day.
    

Intervention name(s): (SOF and DCV); (SOF, DCV, and RBV)
Intervention type(s): Drug; Drug
Other intervention name(s): Daklinza is a trade name of daclatasvir; Sovaldi is a trade name of sofosbuvir; Daklinza is a trade name of daclatasvir; Sovaldi is a trade name of sofosbuvir
Intervention MeSH terms: Sofosbuvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sofosbuvir; Daclatasvir; Ribavirin; HCV GT 4
An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is an open-label, non-randomized, efficacy, safety and pharmacokinetic (PK) study
      comparing octocog alfa and rVIII-SingleChain. The study consists of three parts, a PK period
      (Part 1), a continuation of dosing safety and efficacy period (Part 2) and a safety,
      efficacy, and repeat PK period (Part 3) and also includes a surgical sub-study for subjects
      enrolled in Parts 2 and 3.
    


Intervention name(s): rVIII-SingleChain; Octocog alfa
Intervention type(s): Biological; Biological
Intervention description(s): In Part 1 of the study, subjects received a single intravenous infusion of 50 IU/kg recombinant, single-chain coagulation factor VIII (rVIII-SingleChain) preceded by a 4-day washout period. In Parts 2 and 3 of the study, subjects received repeat injections of rVIII-SingleChain either as an on-demand or prophylaxis regimen at a dose and frequency determined by their study doctor. Subjects participating in the Part 3 PK analyses received a single infusion of 50 IU/kg rVIII-SingleChain and a repeat dose of the same strength of rVIII-SingleChain after 3 to 6 months. Subjects from Parts 2 and 3 participating in the surgical substudy received an individualized dose regimen of rVIII-SingleChain, based on the type of surgery and the clinical status of the subject.; In Part 1 of the study, subjects received a single intravenous infusion of 50 IU/kg of octocog alfa preceded by a 4-day washout period. Octocog alfa is the international nonproprietary name (INN) for recombinant human coagulation factor VIII.
Other intervention name(s): Recombinant Factor VIII (rFVIII); CSL627; Human coagulation factor VIII (rDNA)
Intervention MeSH terms: Factor VIII
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immediate Simultaneous Bilateral Cataract Surgery
Condition: Bilateral Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      To evaluate the safety and efficacy of treating visually significant bilateral cataract with
      the newer technique of Immediate Simultaneous Bilateral Cataract Surgery (ISBCS) versus the
      conventional technique of Delayed Sequential Bilateral Cataract Surgery (DSBCS) in a select
      patient population.
    


Intervention name(s): ISBCS; DSBCS
Intervention type(s): Procedure; Procedure
Intervention description(s): same-day cataract surgery; bilateral surgery delayed by 1-3 weeks amongst eyes
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bilateral Cataract; Simultaneous Cataract Surgery; ISBCS
Sitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea
Condition: Uncontrolled Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study has been designed to investigate the comparative effects of sitagliptin vs.
      pioglitazone as add-on treatments in patients with type 2 diabetes who were uncontrolled on
      the full-dose of metformin and sulfonylurea
    


Intervention name(s): Sitagliptin 100mg; Pioglitazone 30 mg
Intervention type(s): Drug; Drug
Intervention description(s): Sitagliptin arm took sitagliptin 100 mg daily in combination with metformin 500 mg QID and gliclazide 80 mg TDS for 52 weeks; Pioglitazone arm took pioglitazone 30 mg daily in combination with metformin 500 mg QID and gliclazide 80 mg TDS for 52 weeks
Intervention MeSH terms: Pioglitazone; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physical Functioning Following Total Hip Arthroplasty
Condition: Osteoarthrosis, Balance Control, Voluntary Movement Control
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      Adults suffer from Osteoarthrosis of hip joint that willing to participate in the study will
      be tested with well-established measuring techniques of Balance control using force plate
      before 3 month and 6 month after Total Knee Arthroplasty (THA) in the movement and
      Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized
      stabilogram-diffusion parameters from each of the COP data sets collected during quiet
      standing. These parameters include diffusion coefficients, critical displacement, critical
      time and scaling exponents for both lateral and anterior-posterior sway directions (Collins &
      De Luca, 1993). Each of the Times (before 3 month and 6 month after the THA) in two task
      conditions (eyes closed and eyes close conditions). Participants will be required to stand on
      the platform 10 times for 30 s For each trial, they will be instructed to sway as little as
      possible. In addition step execution test and Late life function and disability
      questionnaires will be also examined.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        30 adults suffer from Hip OA prior THA
      
Biospecimen description: 
      no biospecimens are to be retained
    
Keywords: Balance; Voluntary stepping; function; disability; fear of falls; Total Hip Arthroplasty
Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma
Condition: Barrett's Esophagus
MeSH terms: Adenocarcinoma; Barrett Esophagus
Study type: Interventional

Summary: 
      Prospective randomized study comparing radiofrequency ablation and cryotherapy for the
      endoscopic treatment of Barrett's esophagus. The study is powered to assess clinical
      equivalence (non-inferior) of the treatment regimens.
    

Detailed description: 
      Adult patients found to be suitable candidates for endoscopic treatment of Barrett's
      esophagus (BE) with high-grade dysplasia (HGD) and/or early adenocarcinoma of the esophagus
      will be asked to participate in this study. Patients will be randomized to receive either
      radiofrequency ablation or cryotherapy. All treatments will be performed using standard MGH
      GI Unit protocol. A total of fifty subjects will be enrolled.

      Patients who have contraindications to endoscopic treatment (e.g., bleeding diathesis,
      pregnancy, severe medical comorbidities, advanced liver disease) or who decline participation
      in the study will be ineligible. Patients unable to provide their own consent will also be
      excluded.

      This is a single-site study to be conducted at MGH.

      After obtaining written informed consent, the patient will be randomized to receive either
      radiofrequency ablation or cryotherapy. Treatments will be carried out in accordance with
      standard MGH GI Unit practice. The primary endpoint of the study is the percentage of
      Barrett's esophagus ablated at the first follow-up visit (typically 2-3 months following
      therapy). At this point, the patient's role in the study will be terminated. They will
      continue to receive routine follow-up by their physician as needed.
    

Intervention name(s): Radio-Frequency Ablation; Cryotherapy
Intervention type(s): Device; Device
Other intervention name(s): Barrx; Trufreeze, CSA Medical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment