bioihbjkbjnl/mcl2 huggingface dataset:
Neurologic Injuries in Adults With Urea Cycle Disorders
Condition: Brain Diseases, Metabolic, Inborn; Urea Cycle Disorder; Ornithine Transcarbamylase Deficiency
MeSH terms: Brain Diseases; Urea Cycle Disorders, Inborn; Ornithine Carbamoyltransferase Deficiency Disease; Brain Diseases, Metabolic; Brain Diseases, Metabolic, Inborn; Metabolic Diseases
Study type: Observational

Summary: 
      Urea cycle disorders (UCDs) are a group of rare inherited metabolism disorders. The purpose
      of this study is to evaluate how UCD-related neurologic injuries affect adults with one of
      the most common types of UCD.
    

Detailed description: 
      UCDs are a group of rare genetic diseases that affect how protein is broken down in the body.
      The cause of UCDs is a deficiency in one of eight enzymes responsible for removing ammonia, a
      waste product of protein metabolism, from the bloodstream. Normally, ammonia is converted
      into urea and then removed from the body in the form of urine. However, in people with UCDs,
      ammonia accumulates unchecked and is not removed from the body. Toxic levels of ammonia can
      build up and cause irreversible neurologic damage that can affect metabolism, cognition,
      sensation, and movement. This study will focus on the most common enzyme disorder among UCDs,
      ornithine transcarbamylase deficiency (OTCD), a disorder inherited from mothers. Using
      different types of magnetic resonance imaging (MRI), this study will evaluate how UCD-related
      neurologic injuries affect metabolism, cognition, sensation, and movement in adults with
      OTCD.

      Participants in this study will attend an initial study visit that will include a review of
      medical history, current symptoms, impairments, and diet history; urine and blood collection;
      a physical exam; a full neurological exam; and cognitive and motor testing. During this
      visit, participants will undergo imaging studies and additional cognitive and motor testing
      over a 2- to 3-day period. This will include standard MRI studies and four sessions
      consisting of functional MRI (fMRI), diffusion tensor imaging, and 1H magnetic resonance
      spectroscopy. For the fMRI study, participants perform various motor and behavioral tasks
      while in the imaging scanner. Magnetic resonance spectroscopy (MRS) is used to study and
      evaluate the chemical makeup of specific brain areas. Diffusion tensor imaging is used to
      assess myelination of major brain pathways and their alteration in disease states. This study
      will involve one-time participation. There will be no follow-up visits for this study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset
        presentation of OTCD
      
Keywords: UCD; OTCD; Ammonia; Urea Metabolism; Inborn Errors
Efficacy Study of Progesterone Tablet in Post-menopausal Women
Condition: Menopause
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II study intended to determine the effect of progesterone 5, 10 and 20 mg
      tablets compared to progesterone 100 mg capsules on the endometrial thickness of
      post-menopausal women under hormone therapy with estradiol.
    


Intervention name(s): Progesterone
Intervention type(s): Drug
Intervention description(s): comparison of different dosages of drug towards the active comparator
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Dilatrend SR 64mg Capsule After Oral Administration in Healthy Male Volunteers
Condition: Chronic Stable Angina
MeSH terms: Angina, Stable
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect
      on the pharmacokinetics of Dilatrend SR 64mg capsule after oral administration in healthy
      male volunteers.
    


Intervention name(s): Dilatrend 64mg capsule
Intervention type(s): Drug
Intervention description(s): Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet
Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: food effect; pharmacokinetics; healthy male volunteers
Laryngomalacia No Longer An Ambiguity
Condition: Laryngomalacia
MeSH terms: Laryngomalacia
Study type: Observational

Summary: 
      The purpose of this study is to expose some of the factors that may be associated or
      predisposing to development of laryngomalacia.
    

Detailed description: 
      Laryngomalacia is the most common congenital malformation of the larynx and it is a
      self-limited disorder. It is the most common cause of stridor in newborns and infants. It
      results from an abnormal prolapse of supraglottic structures during inspiration. Despite its
      widespread prevalence, the etiology of laryngomalacia is unclear. Most infants will squeaky
      but otherwise well. Although affected patients do not exhibit much in the way of other
      physical symptoms, the unusual voice is worrisome to their parents.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinics
      
Keywords: Laryngomalacia; Factors Associated or Predisposing
Study on the Safety of BAY1817080, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug in Participants With Impaired Liver Function or Normal Liver Function
Condition: Endometriosis Related Pain; Overactive Bladder; Diabetic Neuropathic Pain; Refractory or Unexplained Chronic Cough
MeSH terms: Neuralgia; Endometriosis; Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      BAY1817080 is currently under clinical development to treat pain related to unexplained
      chronic cough or chronic cough not affected by a treatment (refractory and/or unexplained
      chronic cough, RUCC), or a condition where the bladder is unable to hold urine normally
      (overactive bladder, OAB) or a condition in which tissue similar to the tissue that normally
      lines the inside of the womb grows outside the womb (endometriosis).

      In this study researchers want to learn more about the safety of BAY1817080, how it is
      tolerated and the way the body absorbs, distributes and gets rid of the study dug given as
      tablet in participants with mild, moderate or severe hepatic impairment and participants with
      normal liver function matched for age-, gender-, weight and race.

      The study will enroll 36 male and female participants in the age between 18 and 79 years.
      Participants with mild or moderate hepatic impairment and the matching participants will take
      multiple oral doses of study drug depending on the study plan. Participants with severe
      hepatic impairment and the matching participants will take a single oral dose of study drug
      during the study. Data from this study will provide researcher important information for
      further development of the study drug in particular on dose recommendation for patients with
      hepatic impairment.
    


Intervention name(s): BAY1817080; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Study intervention BAY1817080 will be administered orally with tablet(s).; Midazolam will be administered intravenously with dose of 0.1 mg on Day 1.
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Safety; Tolerability; Specific population; Subjects with hepatic impairment
Remifentanil in Extracorporeal Shock Wave Lithotripsy
Condition: Kidney Calculi
MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the analgesic efficacy and side effects induced by
      administration of two different infusion rates of remifentanil, 0,05 mcg/ Kg/ min versus
      0,1mcg/ Kg/ min, in order to determine which one is the most appropriate analgesic treatment
      to face extracorporeal shock wave lithotripsy.
    

Detailed description: 
      Remifentanil is an ultra-short-acting oppioid, which is quickly metabolized by unspecific
      blood and tissue esterases . This feature vouches for a predictable pharmacokinetics and
      makes this drug suitable for administration in continuous intravenous infusion in order to
      achieve patient conscious sedation during non-invasive surgical procedures. Remifentanil
      could be particularly useful in day surgery setting, thanks also to its faster elimination
      than other oppioids. This property ensure a swift recovery from conscious sedation, reducing
      the period of time during which patient remains in recovery room and decreasing also the
      incidence of side effects, like PONV and respiratory depression. Conscious sedation with
      remifentanil can provide patient comfort and cooperation during surgical procedure, since the
      verbal contact with the patient is kept up. Extracorporeal shock wave lithotripsy (ESWL) is a
      non-invasive procedure, contemplated as the first-line treatment for renal and upper ureteral
      stones, if stone diameter is ranged from 5 to 20 mm . It can grind calculi into fine
      particles, that are expelled through micturition. Although many studies have been published
      in regard to continuous intravenous infusion of remifentanil, a small number of them focuses
      on which is the most appropriate infusion rate for ESWL procedure.
    

Intervention name(s): Remifentanil; Remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): Remifentanil is an ultra-short-acting oppioid, which is quickly metabolized by unspecific blood and tissue esterases; GROUP A (N = 114): patients assigned to this group received Remifentanil at infusion rate of 0.05 mcg / kg / min I.V. ; GROUP B (N = 114): in this group Remifentanil was administered at infusion rate of 0,1 mcg / kg / min I.V. Remifentanil was administered intravenously throughout ESWL procedure.
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Remifentanil; Lithotripsy; Conscious Sedation
Bioequivalence Study of Meloxicam Tablets 15 mg of Dr.Reddy's Laboratories Limited Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to determine the relative bioavailability of one 15 mg
      Meloxicam tablet (Dr. Reddy. Laboratories Ltd.,Generics) versus one 15 mg Mobic (meloxicam)
      Tablet (Boehringer Ingelheim Pharmaceuticals Inc., USA) under fed conditions.
    

Detailed description: 
      Twenty eight (twenty six study subjects + two alternate subjects)healthy male and/or female
      subjects participated in an open label, two-period, two-sequence, two- treatment,single dose,
      two-way crossover study with at least 14 days washout between doses conducted under fed
      conditions.
    

Intervention name(s): Meloxicam
Intervention type(s): Drug
Intervention description(s): Meloxicam Tablets 15 mg
Other intervention name(s): Mobic Tablets 15 mg
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Medical Management of Caries in the Primary Dentition Using Silver Nitrate
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This pilot trial compares conventional restorations with a new strategy based on the medical
      management of caries using silver nitrate and fluoride varnish with no restorations.
    

Detailed description: 
      This is a two-arm, parallel group, patient-randomized controlled pilot trial. Children with
      at least one primary tooth where caries extends into dentine. Children will be randomized and
      treated according to one of two treatment approaches;(1) conventional caries management with
      best practice prevention, or (2) medical management of caries using silver nitrate with best
      practice prevention.

      Baseline measures and outcome data (at treatment/review during two year follow-up) are
      assessed through direct reporting, clinical examination including blinded radiographic
      assessment, and child/parent questionnaires.
    

Intervention name(s): Prophylaxis; Fluoride varnish; Silver Nitrate
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): A dental prophylaxis is a cleaning procedure performed to thoroughly clean the teeth. Prophylaxis is an important dental treatment for halting the progression of periodontal disease and gingivitis.; Fluoride varnish is a highly concentrated form of fluoride which is applied to the tooth's surface, by a dentist, dental hygienist or other health care professional, as a type of topical fluoride therapy.; a small amount will be applied to the tooth via a cotton applicator. Silver nitrate is a colorless, odorless, transparent solution used as an escharotic, dehydrating and sclerosing agent.
Other intervention name(s): Prophy; Fluoride
Intervention MeSH terms: Silver Nitrate; Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: silver nitrate; children; dental caries; medical management; quality of life
Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Observational

Summary: 
      Experimental and observational studies have shown that vitamin D deficiency may be associated
      with an increased risk for non-bone diseases and/or abnormal development for the other
      systems of fetus. The aim of this study is to determine the relationship between cord blood
      25-hydroxyvitamin D (25 (OH) D) concentrations and the subsequent risk of morbidities
      including RDS, PDA, NEC, BPD AND ROP in preterm infants.
    

Detailed description: 
      It was shown that vitamin D play important role in the pathogenesis of long term morbidities
      of newborn. Experimental and observational studies have shown that vitamin D deficiency may
      be associated with an increased risk for non-bone diseases and/or abnormal development for
      the other systems of fetus. The aim of this study is to determine the relationship between
      cord blood 25-hydroxyvitamin D (25 (OH) D) concentrations and the subsequent risk of
      morbidities including RDS, PDA, NEC, BPD AND ROP in preterm infants.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Premature infants
      
Keywords: vitamin D, Respiratory distress syndrome, sepsis, preterm
PTCy and Ruxolitinib GVHD Prophylaxis in Myelofibrosis
Condition: Primary Myelofibrosis; Myeloproliferative Disorders
MeSH terms: Primary Myelofibrosis; Myeloproliferative Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A number of groups have demonstrated very low incidence of acute and chronic
      graft-versus-host disease (GVHD) with post-transplantation cyclophosphamide (PTCy) in
      haploidentical and unrelated allogeneic stem cell transplantation (SCT). Still the relapse of
      the underlining malignancy is a problem after this prophylaxis. Ruxolitinib is currently one
      of the most promising drugs in the treatment of steroid-refractory GVHD. On the other hand,
      its primary indication is myelofibrosis, and it was demonstrated that ruxolitinib before
      allogeneic SCT might improve the outcome. This pilot trial evaluates whether the combination
      of PTCy and ruxolitinib facilitates adequate GVHD control, and decreases the risk of graft
      failure and disease progression in myelofibrosis patients.
    


Intervention name(s): Allogeneic hematopoietic stem cell transplantation; Busulfan; Fludarabine monophosphate; Cyclophosphamide; Ruxolitinib; Ruxolitinib
Intervention type(s): Procedure; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Day 0: Infusion of unmanipulated graft; Days -5 through -3: Busulfan 1 mg/kg po qid №10; Days -7 through -2: 30 mg/m2/day iv qd x 6 days; Day +3 and +4: 50 mg/kg/day iv qd; Days -8 through -2 15 mg tid; Days +5 through +100: 7.5 mg bid
Other intervention name(s): HSCT; Cytoxan
Intervention MeSH terms: Cyclophosphamide; Busulfan; Fludarabine; Fludarabine phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myelofibrosis; Ruxolitinib; Cyclophosphamide; Immunosuppressive Agents; Immune System Diseases; Busulfan; Fludarabine; Antineoplastic Agents, Alkylating; Myeloablative Agonists; Hematopoietic Stem Cell Transplantation; Allogeneic
Biomarkers of Response in Blood and Tumor Tissue Samples From Patients With Unresectable Stage IV Squamous Cell Cancer of the Head and Neck Previously Treated With Cetuximab, Cisplatin, and Radiation Therapy
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the
      laboratory may help doctors learn more about changes that occur in DNA and identify
      biomarkers related to cancer. It may also help doctors understand how patients respond to
      treatment.

      PURPOSE: This research study is studying biomarkers of response in blood and tumor tissue
      samples from patients with unresectable stage IV squamous cell carcinoma of the head and neck
      previously treated with cetuximab, cisplatin, and radiation therapy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To expand upon the list of molecular correlates indicated in clinical trial ECOG-E3303,
           including EGFR expression, EGFR phosphorylation, map kinase, AKT, and STAT3.

        -  To correlate the status or expression level of each biomarker with clinical outcome
           (response, progression-free survival, overall survival).

      OUTLINE: Archived tumor and blood specimens are analyzed for human papilloma virus and p16
      status; EGFR gene amplification; levels of ERCC1, XPF, and c-Met proteins; expression and
      activation of several signaling pathways including PI3 kinase gene and mTOR; levels of ErbB2,
      ErbB3, P70S6 kinase, S6 , and Akt; expression of amphiregulin (AR), TGF-alpha (TGF-α),
      heparin-binding EGF-like growth factor (HB-EGF), EGF, epiregulin and c-Met ligand, and
      hepatocyte growth factor by fluorescence in situ hybridization (FISH), automated in situ
      quantitative measurements of protein analysis (AQUA), IHC, PCR, and ELISA.
    

Intervention name(s): fluorescence in situ hybridization; gene expression analysis; polymerase chain reaction; protein analysis; protein expression analysis; enzyme-linked immunosorbent assay; immunohistochemistry staining method; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Genetic; Genetic; Other; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients enrolled on E3303 from whom samples were submitted for research
      
Keywords: stage IV squamous cell carcinoma of the lip and oral cavity; stage IV verrucous carcinoma of the oral cavity; stage IV squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV verrucous carcinoma of the larynx
Administration of Oxygen to Cluster Headache Patients
Condition: Cluster Headache Attacks
MeSH terms: Cluster Headache; Headache
Study type: Interventional

Summary: 
      This study will investigate the possible difference in treatment effect between three
      different oxygen delivery systems in the acute treatment of cluster headaches.
    


Intervention name(s): Open Hudson Mask; Cluster headache mask with 3 L reservoir; Mask 3; Carnét oxygen demand valve; Carnét oxygen demand valve
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): Mask type 1 oxygen; Mask type 2 with oxygen; Mask type 3 oxygen; mask type 3 oxygen; mask type 3 placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: acute treatment
Pilot Study on the Effects of IMOOVE in Parkinson's Disease Patients
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Parkinson's Disease (PD) is one of the most frequent causes of motor dysfunction in aging.

      It is therefore important to use rehabilitative therapeutic approaches that may prevent the
      development of motor complications when possible.

      Imoove® is a device dedicated to rehabilitation and fitness and has the capacity to increase
      muscle tenfold.

      The project is focused on quantifying the efficacy of IMOOVE® as a treatment method for
      improving joint mobility, posture and autonomy in PD.
    

Detailed description: 
      The pathogenesis of PD-related postural abnormalities is probably multifactorial as well as
      widely indefinite, and this could compromise treatment choices and efficacy. In addition to
      dystonia and rigidity, proprioceptive and sensorimotor disintegration as well as peripheral
      degenerative processes (myopathy, skeletal and soft tissue changes) have been proposed as
      causative factors of abnormal trunk postures.

      When the body is educated in the Elispheric® movement it relearns the original vertebral
      motion, and postural control necessary for any action by the body, the professional can then
      perform effective vertebral reeducation.

      The Elispheric® movements are created by a motorised plate. This unique technology impulses
      the body through a centrifugal force in three planes. This force trains the body in its
      natural spirals.

      The performance result is based on the fact that Imoove restores the all freedom of movement,
      strength, precision and it works on the basic skeletal posture.

      It is an exploratory study, in order to verify if the project is adequate, to establish its
      feasibility and to obtain information that allows to determine the size of the sample of the
      definitive study, 30 consecutive PD outpatients will be recruited for the IMOOVE® treatment.
    

Intervention name(s): IMOOVE
Intervention type(s): Device
Intervention description(s): Imoove® is a device dedicated to rehabilitation and fitness and has the capacity to increase muscle tenfold.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: parkinson disease; Imoove; Elispheric movement