bioihbjkbjnl/mcl2 huggingface dataset:
Sildenafil Administration to Treat Neonatal Encephalopathy
Condition: Neonatal Encephalopathy
MeSH terms: Brain Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Despite improvements in neonatal care, birth asphyxia in term newborns remains a serious
      condition causing significant mortality and long-term morbidity, including cerebral palsy and
      mental retardation. Currently, no treatment exists to repair brain injuries secondary to
      neonatal asphyxia. The only available treatment for this condition is hypothermia that may
      prevent but not repair the development of brain injury. The success of this therapy is
      limited.

      Sildenafil already is used with some newborns for other purposes (i.e., persistent pulmonary
      hypertension), but, surprisingly, its effect on the newborn brain has never been studied
      systematically. The findings of the investigators in the rat model of term neonatal
      encephalopathy demonstrated that the administration of sildenafil following asphyxia promotes
      brain injury recovery. Thus, the investigators hypothesize that sildenafil may improve
      neurodevelopmental outcome in term asphyxiated newborns, in whom hypothermia treatment has
      failed to prevent the development of brain injury.
    

Detailed description: 
      Before being able to run a large multicenter randomized trial to prove this hypothesis, the
      investigators need to run a phase Ib pilot trial to ensure the feasibility and safety of
      using sildenafil in this population of newborns. Thus, for this phase Ib study, the
      investigators hypothesize that sildenafil can be safely used with term asphyxiated newborns
      treated with hypothermia. The investigators will test this hypothesis with the following
      specific aims:

        1. Safety (primary): ensure that sildenafil can be safely used in asphyxiated newborns
           treated with hypothermia;

        2. Tolerability (secondary): study the pharmacokinetics and pharmacodynamics of sildenafil
           in these newborns;

        3. Efficacy (exploratory): determine whether sildenafil improves neurodevelopment at 2
           years of age, decreases brain injury on day 30 of life and decreases neuroinflammation.
    

Intervention name(s): Sildenafil; Ora-Blend
Intervention type(s): Drug; Drug
Intervention description(s): sildenafil 2 mg/kg/dose per os twice a day for seven consecutive days (from day 2 of life to day 9 of life) if brain injury on day 2 of life; Ora-Blend, 2 mg/kg/dose per os twice a day for seven consecutive days (from day 2 of life to day 9 of life) if brain injury on day 2 of life
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: birth asphyxia; brain; hypoxic-ischemic encephalopathy; neonate; neuroprotection; neurorestoration; newborn; sildenafil
Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of a Lipid- Based Lubricating Eye Drop
Condition: Visual Acuity
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single visit, randomized, double masked, bilateral, non-dispensing, 2×2 crossover
      study to assess visual acuity.
    


Intervention name(s): Blink® Tears eye drops; Investigational lipid eye drops
Intervention type(s): Drug; Drug
Intervention description(s): Control Drops; Test Drops
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Saturated Fat on Large Low-density Lipoprotein (LDL) and High-density Lipoprotein (HDL)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The purpose of the study is to test whether increased saturated fat intake results in
      increased levels of larger LDL and HDL particles in individuals with LDL Pattern B.
    

Detailed description: 
      Increased saturated fat intake is known to elevate plasma levels of both low-density
      lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C), however,
      less is know regarding the effect of saturated fat on lipoprotein subclasses. We previously
      showed that, in the context of a reduced carbohydrate diet, saturated fat induced increases
      in LDL cholesterol were apparently due to increases in large, more buoyant LDL without
      increases in small, dense LDL. This finding was supported by a previous dietary intervention
      study showing a correlation between saturated fat intake and large LDL. In both cases, this
      increase in large LDL was correlated with an increase in large HDL. In this study, we will
      test the following specific hypotheses regarding changes in plasma lipoproteins induced by a
      diet high in myristic acid and other saturated fats derived primarily from dairy sources in
      individuals with LDL subclass pattern B: 1) there will be a coordinate increase in levels of
      large HDL particles that are considered anti-atherogenic and large LDL particles that are
      less strongly associated with increased CVD risk than smaller LDL; 2) this change in
      lipoprotein profile will result in a higher proportion of pattern B individuals converting to
      LDL subclass pattern A (predominance of larger LDL); and 3) the coordinate increase in large
      HDL and LDL is due to a common underlying pathway. The latter hypothesis will be addressed by
      assaying cholesterol ester transfer protein (CETP), hepatic lipase (HL), and lipoprotein
      lipase (LPL).
    

Intervention name(s): Saturated Fat Diet; Saturated Fat Diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Moderate carbohydrate (35%E), moderate protein (25%E), high fat diet (40%E) with 8%E saturated fat; Moderate carbohydrate (35%E), moderate protein (25%E), high fat (40%E) diet with 20%E saturated fat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Saturated fat; LDL size; Large LDL; Large HDL
Efficacy Study of GLYC-101 to Evaluate Outcomes After Post-laser Ablation
Condition: Wounds
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Study is intended to evaluate safety and efficacy parameters in patients treated with
      GLYC-101 gel or placebo after laser ablation.
    

Detailed description: 
      The proposed pilot-study will document feasibility, safety and efficacy of topically applied
      Glucoprime gel (GLYC-101 gel 1.0 %) in promoting wound healing in healthy volunteer subjects
      undergoing retro-auricular Carbon Dioxide Laser Skin Resurfacing (CO2 LSR). The study will
      observe the effects of the topical agent over the course of 1 month following the treatment.
      as a preparation for study GLYC-101-1b (Double-blind, randomized, placebo-controlled Phase 2
      Pilot Study to investigate the safety and efficacy of 1.0 % topically applied GLYC 101
      compared to placebo, in patients undergoing Carbon Dioxide Laser Skin Resurfacing).
    

Intervention name(s): Placebo gel; GLYC-101 gel (1.0 %)
Intervention type(s): Drug; Drug
Intervention description(s): Administration of Placebo gel on Day 1, 3 and 5 post ablation.; Administration on Day 1, 3 and 5 post laser ablation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: burn wounds; wound healing
A Proof of Concept Study for the DNA Repair Driven by the Mesenchymal Stem Cells in Critical COVID-19 Patients
Condition: COVID-19 Pneumonia
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Our aim in this study is to determine the positive effect of stem cell therapy applied on
      critically ill patients with coronavirus infection on DNA repair genes.

      Patients diagnosed with COVID-19 infection are divided into two equal (n:30) groups.
      Group-1(n/15): Patients in critically ill condition receiving conventional therapy, Group-2
      (n/15): Patients in critically ill condition receiving conventional therapy and systemically
      transplanted MSCs. The DNA repair pathway will be examined as 11 genes in 5 different parts.
      Investigated parameters:

        1. Base excision repair

        2. Nucleotide excision repair

        3. Recombinational repair

        4. Mismatch repair

        5. Direct reversal Investigated parameters: broad biochemical analysis, apoptosis, clinical
           outcome, and mortality rates.
    

Detailed description: 
      Our aim in this study is to determine the positive effect of stem cell therapy applied on
      critically ill patients with coronavirus infection on DNA repair genes.

      Patients diagnosed with COVID-19 infection are divided into two equal (n:30) groups.
      Group-1(n/15): Patients in critically ill condition receiving conventional therapy, Group-2
      (n/15): Patients in critically ill condition receiving conventional therapy and systemically
      transplanted MSCs. The DNA repair pathway will be examined as 11 genes in 5 different parts.
      Investigated parameters:

        1. Base excision repair

        2. Nucleotide excision repair

        3. Recombinational repair

        4. Mismatch repair

        5. Direct reversal Investigated parameters: broad biochemical analysis, apoptosis, clinical
           outcome, and mortality rates.
    

Intervention name(s): Mesenchymal Stem Cells Transplantation
Intervention type(s): Biological
Intervention description(s): Mesenchymal Stem Cells Transplantation applied as three intravenous infusions with 30 days intervals
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; Critical Case; DNA Repair; DAN damage
Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel or Doxorubicin in Locally Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      After a core biopsy of the tumor is obtained, patients with locally advanced breast cancer
      are randomized to receive 4 cycles of full dose doxorubicin (75 mg/m2 e3w) or docetaxel (100
      mg/m2 e3w). After the fourth cycle, patients are submitted to surgery to ascertain
      pathological response. They then receive the opposite drug, hormones, Herceptin, and
      radiation as indicated.
    

Detailed description: 
      The aim of the study is to define the genetic signature which predicts the response to single
      drug doxorubicin versus docetaxel. 250 patients will be included. cDNA microarrays will be
      produced and the genetic pattern will be correlated with the response to doxorubicin and
      docetaxel. Secondary aim is the prediction of response by means of IHC determinations (her2,
      ER, PgR, Ki67, protein TAU), FISH (topoisomerase II alpha, her2) and PCR (topoisomerase II
      alpha).
    

Intervention name(s): docetaxel; doxorubicin
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg/m2 every 3 weeks times 4; 75 mg/m2 every 3 weeks times 4
Other intervention name(s): taxotere; adriamycin
Intervention MeSH terms: Docetaxel; Doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; neoadjuvant chemotherapy; genetic signature; doxorubicin; docetaxel
Efficacy of Three ACTs for the Treatment of Falciparum Malaria in Maradi Niger
Condition: Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 4

Summary: 
      Study treatments:

        -  Artemether-lumefantrine

        -  Artesunate-amodiaquine

        -  Dihydroartemisinin-piperaquine

      Location:

      Maradi, Niger

      Principal Objective:

      To measure the clinical and parasitological efficacy of the three artemisinin combination
      therapies over a period of 42 days from the start of treatment and with polymerase chain
      reaction assay (PCR) adjustment.

      Secondary objectives:

        -  To determine the blood concentration of the non-artemisinin component of the treatment
           (lumefantrine, desethylamodiaquine or piperaquine) at day 7

        -  To assess the incidence of adverse events during the follow-up period;

        -  To measure speed of parasite clearance

      Methods:

      In vivo non comparative study as for WHO standardised protocol. The study also measure the
      concentration of the non-artemisinin component.

      Target population:

      Children under 5 years of age consulting the integrated health centres of Andoumé and
      Dix-sept portes in Maradi.

      Sample size:

      221 patients per study treatment; 663 patients in total.

      Treatment allocation:

      Random.

      Outcomes:

        -  Early treatment failure,

        -  Late clinical failure,

        -  Late parasitological failure,

        -  Adequate clinical and parasitological response.

      Analysis:

        -  Cumulative success or failure rate (Kaplan-Meier analysis).

        -  Proportions of early treatment failures, late clinical failures, late parasitological
           failures, and adequate clinical and parasitological response (called also Per-protocol
           analysis).
    


Intervention name(s): Artesunate-amodiaquine; Dihydroartemisinin-piperaquine; Artemether-lumefantrine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): antimalarial ACT; antimalarial ACT; antimalarial ACT
Other intervention name(s): AS-AQ Winthrop® Sanofi Aventis; Euratesim, Sigma-Tau; Coartem, Novartis
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Piperaquine; Artemether, Lumefantrine Drug Combination; Amodiaquine; Artenimol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malaria; artemisinin; artemisinin-based combination therapies; Plasmodium falciparum; efficacy
Pharmacokinetics and Safety of WAL2014 (Talsaclidine) Administered Orally to Healthy Adult Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a
      multiple dose to healthy adult male volunteers in double blind manner.
    


Intervention name(s): WAL2014; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Talsaclidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Behavioral Activation for Dementia Caregivers
Condition: Dementia Caregivers
MeSH terms: Dementia
Study type: Interventional

Summary: 
      This project was designed to test a model targeted intervention for dementia caregivers
      telephone program consisting of both psychoeducation and behavioral activation components to
      reduce the burden of caregivers. The program is delivered by telephone to increase
      accessibility and sustainability for caregivers.
    

Detailed description: 
      The study compared two telephone interventions using a four-month longitudinal randomized
      controlled trial. For the first four weeks, all participants received the same
      psychoeducation program via telephone. Then for the following four months, eight biweekly
      telephone follow-up calls were carried out. For these eight follow-up calls, participants
      were randomized into either one of the two following groups with different conditions. For
      the Psychoeducation with BA (PsyED-BA) group, participants would receive eight biweekly
      sessions of BA practice focused on pleasant event scheduling and improving communications.
      For the Psychoeducation only (PsyED Only) group, there would be eight biweekly sessions of
      general discussion of psychoeducation and related information
    

Intervention name(s): Behavioral activation; Psychoeducation
Intervention type(s): Behavioral; Other
Intervention description(s): Activity scheduling, monitoring, review and re-scheduling; Education on dementia, caregiving stress, event scheduling and communication skills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Optical Biopsy of Human Skin in Conjunction With Laser Treatment
Condition: Malignant Melanoma; Merkel Cell Carcinoma; Basal Cell Carcinoma; Squamous Cell Carcinoma; Atypical Nevi; Congenital Nevi; Seborrheic Keratosis; Paget's Disease; Dermatofibroma; Kaposi's Sarcoma; Port Wine Stain; Hemangioma; Tattoos; Scleroderma; Burns
MeSH terms: Sarcoma, Kaposi; Carcinoma, Merkel Cell; Carcinoma; Melanoma; Carcinoma, Basal Cell; Hemangioma; Nevus; Hemangioma, Capillary; Histiocytoma, Benign Fibrous; Port-Wine Stain; Keratosis; Keratosis, Seborrheic
Study type: Observational

Summary: 
      This study is to compare the ability of optical biopsy. Research can use light enters the
      skin, collected, analyzed by the computer, and a picture created for the pathologist to
      conventional histologic examination compare with the pathologist looking at the piece of
      tissue through a microscope makes the diagnosis.
    

Detailed description: 
      The Optical measurements provide quantitative optical property values that reflect changes in
      tissue perfusion, oxygen consumption, and cell/matrix development. Each measurement requires
      less than 5 minutes to execute. The measurements will be taken before and after skin
      treatment.This non-invasive, non-contact technique has great potential as a means to diagnose
      different skin problems without the need to obtain a piece of tissue from the skin.
    

Intervention name(s): Optical Biopsy imaging
Intervention type(s): Device
Intervention description(s): Optical Biopsy imaging
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic, community sample
Versartis Trial in Children to Assess Long-Acting Growth Hormone
Condition: Pediatric Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 1b/2a study of VRS-317 (long-acting growth hormone) in pediatric patients
      with growth hormone deficiency. During Phase 1b, pediatric patients each will receive a
      single subcutaneous injection of VRS-317. During the Phase 2a stage, patients will receive 6
      months of VRS-317 treatment at dose levels selected from the Phase 1b stage. The primary
      endpoints for the study are to determine the safety and efficacy of repeat dose VRS-317.
    

Detailed description: 
      In Phase 1b, separate cohorts of patients will be tested in a single ascending dose format.
      Safety review committee meetings will take place prior to escalating to each increasing dose
      level. Enrolled patients will be monitored for 60 days for safety with PK/PD and safety labs
      collected.

      Two dose levels will be selected after completion of Phase 1b to be tested during Phase 2a (6
      months of continuous VRS-317 treatment). Safety and PK assessments will be made during the
      Phase 2a stage. Patient heights will be measured by stadiometer.
    

Intervention name(s): Experimental: VRS-317
Intervention type(s): Drug
Intervention description(s): Active treatment arm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Growth hormone; Growth hormone deficiency; Growth; Pediatric growth hormone deficiency; Long acting growth hormone; GHD; PGHD; VRS 317; Exten; Versartis
Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius?
Condition: Radius Fractures
MeSH terms: Fractures, Bone; Radius Fractures
Study type: Interventional

Summary: 
      Promising results have been reported after volar locked plating of unstable dorsally
      displaced fractures of the distal radius. It offers stable fixation and early mobilization.
      The investigators' aim is to test if volar locked plating results in better
      patient-perceived, objective functional and radiological outcomes compared to the less
      invasive external fixation that has been the standard operation for decades.
    


Intervention name(s): closed reduction and external fixation; Internal fixation with a volar locked plate
Intervention type(s): Procedure; Procedure
Intervention description(s): Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation; Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate
Other intervention name(s): External fixation: Hoffman compact; Volar locked plate brand: Königsee by Swemac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Distal radius fractures; Fractures of the distal radius; Volar plate; External fixation
Reverse Walking With And Without Whole Body Vibration in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      To determine the effects of reverse walking with and without Whole-body vibration on postural
      balance in children with cerebral palsy.
    

Detailed description: 
      Current study concluded that reverse walking with and without whole body vibration were
      effective in improving postural balance, reach and quality of life in cerebral palsy
      children. However (whole body vibration+ reverse walking) provides more clinical benefits
      than reverse walking alone in improving postural balance, side reach and quality of life.
      Whereas both techniques were equally effective in improving forward reach in cerebral palsy
      children.
    

Intervention name(s): Reverse Walking+Baseline treatment; Whole Body Vibration + Reverse Walking+Baseline treatment
Intervention type(s): Other; Other
Intervention description(s): Reverse Walking+Baseline treatment; Whole Body Vibration + Reverse Walking+Baseline treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: postural balance