bioihbjkbjnl/mcl2 huggingface dataset:
Biomarkers of Iron Homeostasis and Responses to Cystic Fibrosis Pulmonary Exacerbation (CFPE) Treatment
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The goal of this study is to identify chemical compounds in the blood and sputum (i.e.,
      biomarkers) that are associated with objective measurements of health status in patients with
      cystic fibrosis (CF). This study builds upon observations that blood levels of hepcidin-25, a
      protein that regulates how the body uses and stores iron, vary during CF pulmonary
      exacerbation (CFPE).
    


Intervention name(s): Adults - CFPE Treatment
Intervention type(s): Other
Intervention description(s): Hospitalization for comprehensive treatment of CF pulmonary exacerbation, including intravenous (IV) antibiotics, nutritional assessment and support, airway clearance of mucus, use of inhaled mucolytic agents and bronchodilators, glycemic control with insulin, and psychosocial support.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients greater than
      
Biospecimen description: 
      Bacterial DNA and RNA will be isolated from sputum samples and stored for future analyses.
    
Keywords: iron; hepcidin-25; pulmonary exacerbation; interleukin-6
Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg
Condition: Lung Injury, Acute; Ventilator-Induced Lung Injury; Ventilator Adverse Event
MeSH terms: Lung Injury; Ventilator-Induced Lung Injury; Acute Lung Injury; Wounds and Injuries
Study type: Interventional

Summary: 
      Respiratory complications range from 8% to 79% of the frequency after open heart surgery
      where the patient is on-pump operated by cardiopulmonary machine. There were many changes in
      physiology due to anesthesia and cardiac surgery which cause volume and barotrauma
      complications with mechanical ventilation. These complications increase cost by prolonging
      morbidity and morbidity as well as hospital stay. Intraoperative and postoperative mechanical
      ventilation strategies can prevent these complications. CPB stimulates the systemic
      inflammatory response to the secretion of neutrophil, endotoxin and proinflammatory cytokines
      in the complex, increasing the permeability of the capillaries. Although coronary artery
      bypass graft surgery (CABG) is associated with a 0.4% to 2.0% acute respiratory distress
      syndrome (ARDS), mortality is quite high. Lung-protective ventilation strategies commonly
      used for prevention of ARDS. Ferrando et al. have proposed pulmonary ventilation with a tidal
      volume (TV) of less than 10 mL / kg as a pulmonary intraoperative protective ventilation
      strategy. Investigators aimed to compare oxygenation and ventilation parameters with
      respiratory mechanics in patients who underwent open heart surgery and were ventilated with 6
      ml / kg tidal volume and 8 ml / kg TV, which were recommended as lung protective ventilation
      strategies during anesthesia.
    


Intervention name(s): Mechanical ventilation
Intervention type(s): Device
Intervention description(s): Patients will be ventilated with anesthesia machine according to the group they belong to
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
The Smart-phone as a Physical Fitness Monitor - Validity, Sensitivity and Motivation InterWalk
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Low physical fitness may cause several life style related diseases e.g. cardiovascular
      disease, cancer and type 2 diabetes. It is important to develop reliable methods for
      measurement which can be used to follow the development of the physical shape both on an
      individual level and on at population level.

      Associated with the development of new training method known as Interval Walking we developed
      an application for smartphones. The use of the application InterWalk was meant to increase
      physical activity in patients with type 2 diabetes. The application should both be able to,
      1) be a personal trainer when doing interval walking, and 2) measure the individual physical
      fitness performed as a walking test. The latter function was developed to make the training
      more personal and individal adapted, so that the training was neither too hard or too easy.

      It is necessary to test the walking test against a golden standard for measuring physical
      fitness and that the test in the application is able to measure and register changes in
      physical fitness.

      Our hypothesis is that the individual test, in the InterWalk Application is reliable and able
      to register changes in physical fitness in patients with type 2 diabetes. The purpose of this
      project is investigate the reliability of a smartphone-based test of physical fitness, and to
      investigate whether the test is able to register changes in physical fitness during the
      project time (3 month). A secondary aim is to investigate whether individual support during
      the training period, affect the individual effort and time of interval walking per week.
    


Intervention name(s): Support group
Intervention type(s): Other
Intervention description(s): The participants in the intervention group receives the intervention and support consisting of:
Individual Goal Setting: 2-3 functional goals related to everyday life evaluated every 4th week.
SMS send every Sunday with 5 possible responses. depending on the answer of the participant it will cause a telephone call from a project about motivation and barriers for interval walking.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes, InterWalk, Individual Support, Motivation
Gene-polymorphisms Relating to Human Subfertility
Condition: Estradiol Receptor Polymorphism; Progesterone Receptor Polymorphism; IVF; Subfertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Estradiol is synthesized by granulosa cells of ovaries under control of follicle-stimulating
      hormone (FSH) and luteinizing hormone (LH). It is known that Estradiol plays a crucial role
      in maturation and fertilization of oocytes. Furthermore it is involved in development of
      secondary female sexual organs, fertility and maintenance of pregnancy.

      Estradiol influences these processes by binding to estradiol receptors (ER). They are
      ligand-depending transcription-factors. In humans there are two subtypes: ERa and ERb, which
      are synthetized from gene ESR1 on chromosome 6 and ESR2 on chromosome 14. Both subtypes are
      expressed in the ovary. Both genes are polymorph. Especially for ERa subtype several
      polymorphisms and mutations are known which can be linked to breast cancer, spontaneous
      abortions, osteoporosis and the point in time of menarche. Furthermore some studies have
      shown a relationship between certain polymorphisms and the risk of infertility associated
      gynecological malfunctions and the result of IVF treatments.

      Progesterone is a hormone which plays a crucial role in initiation and maintenance of
      pregnancy. It induces the transformation of the endometrium, which facilitates the
      implantation of the fertilized oocyte and supports the pregnancy. Progesterone acts by
      binding to its receptor. The gene for this receptor is polymorph within the population,
      whereas some variants seem to account for implantation failure of embryos.

      In the investigators study the investigators will analyse the role of ERP and PRP
      polymorphisms in the context of IVF treatment. The analyzed genotypes are two polymorphisms
      of ESRI, called Pvu and Xba, as well as a variant of ESRII, ER2. In the progesterone receptor
      gene a single nucleotide exchange at position +331 (G->A) plays a role.

      The parameters correlated with are concentrations of estradiol, progesterone and FSH, number
      of follicles, number of fertilized oocytes and pregnancy rate.

      The investigators hope to optimize established treatment protocols and to improve the chances
      of success of IVF treatments depending on the genotype of the patient.
    


Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        Female patients at reproductive age seeking IVF treatment
      
Biospecimen description: 
      buccal swabs
Study for MR Formulation of PF-06650833 in Healthy Adult Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the tolerability, safety and pharmacokinetics of
      PF-06650833 orally administered as modified release tablets in healthy Japanese subjects.
    


Intervention name(s): PF-06650833; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Efficacy and Safety of Ibuprofen and Caffeine in Dental Pain
Condition: Pain, Postoperative; Tooth Diseases
MeSH terms: Tooth Diseases; Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to compare the efficacy of a combination product
      containing ibuprofen 400 mg and caffeine 100 mg versus either ingredient alone as well as
      placebo for the treatment of post-surgical dental pain over an eight-hour period followed by
      a single dose of study medication (study stage 1). A secondary objective is to evaluate
      efficacy of multiple doses of the combination in comparison to ibuprofen alone over a 5-day
      post-surgical period (study stage 2).
    


Intervention name(s): ibuprofen + caffeine; ibuprofen; ibuprofen; caffeine; ibuprofen + caffeine; placebo; placebo; caffeine; ibuprofen; ibuprofen + caffeine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): FDC tablet; tablet.; tablet; tablet; Fixed Dose Combination (FDC) tablet; tablet; tablet; tablet; tablet; FDC tablet
Intervention MeSH terms: Ibuprofen; Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects Of Sensory Training and Electrical Stimulation on Sole of The Foot Sensations in Patients With Acute Hemiplegia
Condition: Hemiplegia; Stroke, Acute; Sensory Disorders
MeSH terms: Stroke; Hemiplegia; Sensation Disorders
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of the sole of foot sensory education and
      electrical stimulation on proprioceptive and cortical senses in patients with acute
      hemiplegia.
    

Detailed description: 
      Hemiplegia is a syndrome characterized by disorders of motor and sensory functions, speech
      and mental abilities. Hemiplegia is a common neurological problem in the world and is the
      third most common cause of death.

      In addition to motor loss in patients after stroke, sensory problems are accompanied and
      close to 60% of stroke patients experience sensory problems. In a limited number of studies
      in the literature, it is stated that sensory impairment in the lower extremity negatively
      affects standing, walking speed, balance during ambulation and symmetrical gait. At the same
      time, it has been proven that the sole of the foot sense plays an important role in the
      balance of sitting, standing up and performing independent daily living activities. After a
      stroke, sensory training increases functionality, patients with sensory training recover
      faster, mobility, balance and daily life activities become better, and daily life improvement
      is expressed. The purpose of sensory training is to maximize the patient's learning through
      the connection between environment and repetitive activities.

      The aim of this study is to compare the effects of neurodevelopmental physiotherapy program
      combined with sensory training or electrical stimulation on the sole of the foot
      proprioceptive and cortical senses in individuals diagnosed with hemiplegia.

      There is no study on how proprioceptive and cortical sensations will be affected in acute
      hemiplegic patients if sensory training and electrical stimulation are added to the classical
      treatment program. By finding and comparing the effects of active (sensory training) and
      passive treatment (electric stimulation) with this study, it was planned to propose an
      effective treatment protocol for developing the sole of the foot senses to the experts
      working in this field.

      As a result, purpose of the study is to prevent inadequate sensory input in hemiplegic
      patients from adversely affecting quality of life.
    

Intervention name(s): Sensory training; Electrical stimulation
Intervention type(s): Other; Other
Intervention description(s): 15 session,20 minutes sensory training program; 15 session,20 minutes electrical stimulation program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Electrical stimulation; Sensory education; Sensory evaluation; Stroke; Proprioception
Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is an international, multi-center, randomized, double-blind, placebo-controlled
      study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e.,
      endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur
      at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk
      test. Study procedures include routine blood tests, medical history, physical exams, disease
      evaluation, and exercise tests.

      Patients who complete all assessments for 16-weeks will also be eligible to enter an
      open-label, extension phase study (FREEDOM - EXT).
    


Intervention name(s): UT-15C SR; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): treprostinil diolamine sustained release tablets
Other intervention name(s): treprostinil diolamine, treprostinil diethanolamine, UT-15C
Intervention MeSH terms: Treprostinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Assessment of the Safety of Allogeneic Umbilical Cord Blood Infusions in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single site, phase I, prospective study of the safety of intravenous sibling
      cord blood infusion in 15 children ages 1-6 years with Cerebral Palsy (CP). All subjects will
      be treated with sibling cord blood cells. The first six will receive cord blood cells from an
      HLA-matched sibling. The following nine subjects will receive cord blood cells from an
      HLA-mismatched (≥3/6 match) or matched sibling. The duration of study participation will be
      six months from the time of the cord blood infusion.
    

Detailed description: 
      This study is a phase I, prospective, open-label trial designed to assess the safety of a
      single allogeneic sibling cord blood infusion in young children with cerebral palsy. Children
      ages one to six years with uncomplicated cerebral palsy and an available HLA matched or
      haploidentical, qualified, sibling cord blood unit will be eligible to participate. All
      participants will receive a single intravenous infusion of allogeneic sibling cord blood. All
      participants will have an initial clinical evaluation to verify the diagnosis of cerebral
      palsy and determine eligibility. The main endpoint is safety, for which acute infusion
      reactions as well as incidence of infections and graft versus host disease will be assessed.
      Functional outcome measures, described below, will be assessed at baseline and six months
      post sibling cord blood infusion and described.
    

Intervention name(s): sibling umbilical cord blood
Intervention type(s): Biological
Intervention description(s): All subjects will receive a single infusion of allogeneic sibling cord blood. The first six subjects will receive cord blood cells from an HLA-matched sibling. The following 9 subjects will receive cord blood cells from an HLA-mismatched (≥3/6 match) or matched sibling. Six of the 15 subjects must be treated with haplo-identical sibling CB. Duration of study participation will be six months from the time of CB infusion.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To study the safety, tolerance, and pharmacokinetics of a single dose of bis-POM PMEA
      (adefovir dipivoxil) when administered by the oral route in patients with HIV infection.
    

Detailed description: 
      Five patients are entered at each of three dose levels of bis-POM PMEA administered orally in
      a single dose.
    

Intervention name(s): Adefovir dipivoxil
Intervention type(s): Drug
Intervention MeSH terms: Adefovir; Adefovir dipivoxil
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Antiviral Agents; Adenine
A Study of LY2484595 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study will be to evaluate the safety of a single dose of LY2484595 and to
      compare the amount of LY2484595 in the blood of healthy non-Asian subjects, Chinese subjects,
      and first-generation Japanese subjects after receiving a single oral dose of LY2484595 in a
      fasted state, after eating a low-fat meal, and after eating a high-fat meal.
    


Intervention name(s): LY2484595 Reference Formulation (RF); LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): Evacetrapib; Evacetrapib
Intervention MeSH terms: Evacetrapib; Propyl Gallate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Short Term Results of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
Condition: Anal Fissure Chronic; PRP
MeSH terms: Fissure in Ano
Study type: Interventional
Phase: Phase 4

Summary: 
      Autologous PRP currently has many uses in surgical and medical therapy. Compared with other
      regenerative therapies, PRP is easy-to-prepare, low-cost, and does not require complex
      equipment. The use of autologous PRP avoids immunological side effects. Data is lacking on
      the use of PRP in the treatment of anal fissure. This study evaluated PRP as an alternative
      medical treatment for chronic anal fissures.
    

Detailed description: 
      . Chronic anal fissures are mucosal ulcers in the anal canal distal to the dentate line and
      most often present with severe pain and bleeding during defecation. The symptoms of chronic
      anal fissures persist for more than 8 weeks and do not respond well to medical treatment.
      This randomized controlled trial investigated the effects of PRP on the healing of chronic
      anal fissures, which can be considered as nonhealing ulcers. High anal sphincter pressure can
      cause chronic anal fissures by producing mucosal ischemia in the posterior anal canal that
      delays wound healing, ultimately resulting in a chronic nonhealing ulcer. Increased anal
      sphincter pressure induces constipation and spasms in the arterioles that form the mucosal
      blood supply.9 Botulinum toxin, calcium channel blockers, nitrates, or surgery promote
      healing by reducing anal sphincter pressure, and increasing blood flow.

      Autologous PRP has been shown to speed recovery and improve pain and quality of life scores
      of patients treated for chronic wounds.PRP reduced complaints and accelerated
      epithelialization and healing in patients with chronic anal fissures. PRP, which can be
      obtained easily and did not have any harmful patient effects may be an alternative to surgery
      in patients with chronic anal fissures. The duration of symptoms should be considered during
      the evaluation of treatment options.
    

Intervention name(s): prp injection; Anrecta; sitz bath; nutrition regulation
Intervention type(s): Biological; Drug; Behavioral; Dietary Supplement
Intervention description(s): PRP was injected locally in the anal fissure area and glyceryl trinitrate was administered twice daily in the perianal region as in the control group.; self-administered topical glyceryl trinitrate (anrecta), in the perianal area twice a day; participants were told to take a hot water sitz bath once a day; The study participants were told to eat a fiber-rich diet and to drink least 2 liters of water daily
Other intervention name(s): Platelet rich plasma injection; rectoderm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: chronic anal fissure; medical treatment; platelet rich plasma
Phase 0 Microdose Study
Condition: Autoimmune Diseases
MeSH terms: Autoimmune Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a methodology study to evaluate a microdose strategy for Drug-Drug Interaction
      (DDI) which will be useful in the evaluation of the backup compounds for GSK706769, as well
      as possibly other assets. The safety, tolerability and pharmacokinetics will be evaluated in
      healthy adult subjects. This will be an open-label fixed-sequence 2-period study in healthy
      male volunteers after oral administration of [14C]-GSK706769 alone and in the presence of
      Ketoconazole.
    


Intervention name(s): [14C]-GSK706769; Ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): 50µg [14C]-GSK706769 containing 250 nCi; 200 mg Ketoconazole (Q12)
Intervention MeSH terms: Ketoconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Microdose; Drug-Drug Interaction; Ketoconazole; Phase 0