bioihbjkbjnl/mcl2 huggingface dataset:
Validation Study of the Korean Version of the EORTC QLQ-HDC29
Condition: Quality of Life After Stem Cell Transplantation
Study type: Observational

Summary: 
      The aim of this study is to evaluate the reliability and validity of the Korean version of
      the European Organization for Research and Treatment of Cancer High-dose Chemotherapy module
      (EORTC HDC-29).
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are diagnosed with hematologic malignancies and who are planned to recieve
        high-dose chemotherapy followed by allo or auto stem cell transplantation in Seoul National
        University Hospital, Korea
Treatment of Executive Dysfunction in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Atomoxetine (Strattera) is a drug that is currently approved for treatment of attention
      deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine works to enhance
      levels of brain chemicals that may be affected in people with executive dysfunction,
      (difficulties with organization, task completion, and priority setting). Thus, atomoxetine
      has the potential to improve executive dysfunction in people with Parkinson's disease (PD).

      The goal of this study is to provide preliminary data on the effectiveness and tolerability
      of atomoxetine for the treatment of executive dysfunction in patients with PD.
    

Detailed description: 
      Parkinson's disease (PD), while defined by its motor abnormalities and associated
      dopaminergic loss, is invariably accompanied by cognitive impairment. Early in the disease
      course, the deficits are characterized by executive dysfunction with difficulties on tasks
      that involve information processing, attention, sorting, planning, set-shifting, and working
      memory and are subserved by neural connections with prefrontal brain regions. There has been
      little effort to identify treatments for these PD-related cognitive impairments, despite
      their disabling and distressing effects. Accordingly, the goal of this proposal is to conduct
      a small pilot study to determine the effectiveness and tolerability of atomoxetine, a
      selective norepinephrine reuptake inhibitor, for the treatment of executive dysfunction in
      patients with PD.

      Atomoxetine (Strattera) is currently approved by the FDA for treatment of attention deficit
      hyperactivity disorder (ADHD) in children and adults. Atomoxetine enhances dopaminergic and
      noradrenergic transmission in frontal regions that are also implicated in executive
      dysfunction and thus has the potential to improve executive dysfunction in PD as well as
      other neurological conditions. Results of the study will be used to develop a larger
      placebo-controlled trial of atomoxetine, if appropriate, as well as inform the design of
      other clinical trials on potential treatments for cognitive dysfunction in PD.

      The overall hypothesis is that atomoxetine will be an effective and safe treatment for
      executive dysfunction in PD.
    

Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention description(s): Open Label uncontrolled active Drug intervention
Other intervention name(s): Strattera (Brand Name)
Intervention MeSH terms: Atomoxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's disease; executive dysfunction; impairment; motor skills; cognitive
Phase II Study of Growth Hormone in Children With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Determine the effect of growth hormone on height, height velocity, body
      weight, and lean body mass in patients with cystic fibrosis.

      II. Determine the effect of growth hormone on pulmonary function in these patients.

      III. Determine the impact of this drug on the quality of life in these patients.

      IV. Determine if the clinical response from this drug is sustained in these patients.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
      treatment arms.

      Arm I: Patients receive growth hormone subcutaneously (SC) daily for 1 year during the first
      year only.

      Arm II: Patients receive growth hormone SC daily for 1 year during the second year only.

      Quality of life is assessed at baseline and then every 6 months for 2 years.
    

Intervention name(s): growth hormone
Intervention type(s): Drug
Intervention MeSH terms: Hormones
Primary purpose: Treatment
Keywords: cardiovascular and respiratory diseases; cystic fibrosis; disease-related problem/condition; genetic diseases and dysmorphic syndromes; quality of life; rare disease
First-in-human, Safety, Tolerability and Pharmacokinetics Study of LRX712 in Osteoarthritic Patients
Condition: Patients With Moderate Knee Osteoarthritis (30 - 65 Years)
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate, for the first time in humans, safety and tolerability of
      single ascending doses of intra-articular (i.a.) injections of LRX712 into the knee of
      patients with moderate osteoarthritis (OA), in order to support the further clinical
      development. This study will also allow establishment of the systemic and local
      pharmacokinetics (PK) of LRX712 and the exploration of biomarkers of cartilage breakdown and
      regeneration in OA patients.
    


Intervention name(s): LRX712; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ascending single dose on Day 1; Ascending single dose on Day 1
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritic patients; Cartilage; Safety
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy
Condition: Breast Neoplasms; Carcinoma, Ductal, Breast; Mammaplasty; Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,
MeSH terms: Breast Neoplasms; Carcinoma, Ductal; Carcinoma, Ductal, Breast; Congenital Abnormalities
Study type: Interventional
Phase: Phase 4

Summary: 
      A post-marketing study evaluating the transplantation of autologous fat augmented with
      Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast
      deformities post segmental mastectomy or quadrantectomy (lumpectomy).
    


Intervention name(s): ADRC-Enhanced Autologous Fat Transplant
Intervention type(s): Procedure
Intervention description(s): Autologous fat harvested from the patient is enhanced with ADRCs derived from a portion of the harvested fat and transplanted into the breast(s) that have a volume deficit post lumpectomy. This is a single arm study with no control. All patients receive cell therapy.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast; Stem Cell; Adipose Derived Stem Cells; Adipose Derived Regenerative Cells; ADRC; Reconstructive Breast Surgery; Breast Reconstruction; Cancer; Carcinoma; Autologous fat transplantation; Autologous fat; Cosmetic breast deformities; Functional breast deformity; Lumpectomy; Segmental mastectomy; Quadrantectomy; breast conservation therapy
A Study To Investigate The Drug-Drug Interaction Potential Of Rifampin OnThe Investigational Agent Palbociclib (PD-0332991)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the plasma pharmacokinetics of a single 125mg oral dose of
      palbociclib in the presence and absence of rifampin-mediated enzyme induction in a
      fixed-sequence two-period study.
    


Intervention name(s): Palbociclib; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): In period 1, patients will receive a single 125mg oral dose of palbociclib alone. Subjects will undergo palbociclib pharmacokinetic sampling at prespecified time points up to 120 hours post palbociclib dose.
In period 2, subjects will receive 12 daily oral doses of 600mg of rifampin and a single 125mg oral dose of palbociclib on day 8. Subjects will undergo palbociclib pharmacokinetic sampling at prespecified time points up to 120 hours post palbociclib dose.; In period 2, subjects will receive 12 daily oral doses of 600mg of rifampin and a single 125mg oral dose of palbociclib on day 8. Subjects will undergo palbociclib pharmacokinetic sampling at prespecified time points up to 120 hours post palbociclib dose.
Other intervention name(s): palbociclib, PD-0332991; palbociclib, PD-0332991, rifampin, rifampicin
Intervention MeSH terms: Rifampin; Palbociclib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: palbociclib; PD-0332991; rifampin; drug-drug interaction study
Nasolacrimal Sac Biopsy in Endoscopic Dacryocystorhinostomy
Condition: Dacryocystitis; Chronic
MeSH terms: Dacryocystitis
Study type: Observational

Summary: 
      During dacryocystorhinostomy (DCR), the lacrimal sac wall biopsy is not routinely performed,
      but it is recommended if there is a suspicion of underlying disease other than preoperatively
      or intraoperatively chronic inflammation. We aimed to evaluate the utility of the
      histopathology examination of fifty patients in AlAzhar Hospitals to put recommendation for
      histopathology examination of such cases.
    

Detailed description: 
      Most of patient with epiphora have different causes of nasolacrimal duct obstruction . This
      study aims to examine how important routine lacrimal sac biopsy is during endoscopic
      dacryocystorhinostomy surgery.

      The study included 50 patients with chronic unilateral epiphora. All patients underwent
      endoscopic dacryocystorhinostomy with nasolacrimal duct biopsy. Histopathologic analysis was
      performed for each specimen to assess the nature of the pathology.
    

Intervention name(s): biopsying
Intervention type(s): Diagnostic Test
Intervention description(s): The procedure was carried out under general or local anesthesia. An otolaryngologist conducts the endoscopic intranasal operation, while an eye surgeon removes tissue from the sac and lacrimal tubes using lacrimal probes passed through the canaliculi.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study includes fifty patients with chronic epiphora due to chronic nasal duct
        obstruction seeking for treatment by endoscopic intranasal dacryocystorhinostomy. Their age
        ranged from (20-70) years from both genders. They were selected from patients attending the
        Ophthalmology and Ear Nose Throat (ENT) clinics, at Al-Azhar University Hospital. Their
        referring ophthalmologist diagnosed all of the patients with lacrimal obstruction.
Dual Task Performance in Community Dwelling Older Adults
Condition: Dual Task; Community Dwelling Older Adult
Study type: Observational

Summary: 
      Dual task performances may be impaired with the impairment in motor performance and cognitive
      functions due to aging. The aim of the present study is to investigate the gender differences
      in dual task performance. A total of 82 community dwelling older adults (41 males and 41
      females) aged between 65 and 75 years were included in the study. Motor performance was
      evaluated with sit-to-stand test, the timed up and go test, 10 m walking test and cognitive
      functions were evaluated with Montreal Cognitive Assessment Test. Dual task performances were
      evaluated as motor-motor and cognitive-motor performance.
    


Intervention name(s): dual task performance
Intervention type(s): Other
Intervention description(s): dual task performance measurement
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Dual task performances may be impaired with the impairment in motor performance and
        cognitive functions due to aging. Because of this, we aimed to investigate the gender
        differences in dual task performance.
      
Keywords: dual task; community dwelling older adult; motor performance; cognitive status
Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Both GLP-2 and GIP reduce the bone resorption (measured as CTX) in healthy persons. In this
      study, we will investigate wether GLP-2 and GIP is reducing CTX in persons with type 2
      diabetes.
    


Intervention name(s): GLP-2; GIP; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): GLP-2 injection; GIP injection; Placebo injection
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a crossover study with the following interventions: GLP-2, GIP, and placebo.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Type 2 Diabetes Mellitus; Bone resorption; Bone formation; CTX; P1NP; GLP-2; GIP; Bone turnover; Bone remodeling
Developmental Screening and Nutritional Intervention of Severe Acute Malnourished Children in Southern Punjab, Pakistan
Condition: Malnutrition in Children
MeSH terms: Malnutrition; Child Nutrition Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      i. To examine the impact of malnutrition on development quotient of children

      ii. To determine the effectiveness of Ready to Use Therapeutic Food (RUTF) in improving the
      development quotient of severe acute malnourished children under five year of age.

      iii. To investigate the outcome of Vitamin D therapeutic doses intervention with RUTF
      rehabilitation on growth and development of malnourished children.
    

Detailed description: 
      1. Research Instrument: For Development quotient Denver 2 screening form and tools will be
           used. Follow up of patients for three months and for recording of their weight Community
           management of acute malnutrition forms will be used. Denver screening tool will be used
           for child development quotient covering all areas of development, fine motor, gross
           motor, language and personal social contact.

        2. Research Settings: The study will be conducted in Dera Ghazi Khan division at, Basic
           Health Units (BHU).

        3. Study design: Randomized Controlled Trial.

        4. Data Collection: Lady Health Visitors (LHWs) will screen the children aged 6 months to
           59 months in their community and will refer the severely malnourished children to
           Outpatient Therapeutic Programs (OTPs).Two groups of malnourished children will be made
           one study and one control group; one group will be treated with RUTF and extra virgin
           olive oil as placebo. Other will with RUTF and two mega doses of Vitamin D randomly,
           first after 15 days of enrollment and second after 15 days of first dose.
    

Intervention name(s): Vitamin D; Ready to Use Therapeutic Food (RUTF)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Two doses of Vitamin D supplementation in ampoules form (ED3) were procured. Ampoule contains Cholecalciferol in 200,000 IU both for oral and intra muscular use.; RUTF is recommended by WHO for sever malnourished children in community settings as a therapeutic diet. The quantity depends upon the child body weight.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-clavulanic Acid
Condition: Oral Anticoagulation; Deep Venous Thrombosis; Atrial Fibrillation; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Atrial Fibrillation; Thrombosis; Embolism; Venous Thrombosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Several case reports indicate that the use of the antibiotic combination amoxicillin and
      clavulanic acid (AM-CLAVAC) can interact with warfarin pharmacodynamics. However, fever per
      se might also be responsible of these warfarin overdose reports, as well as the use of high
      dose paracetamol.

      The aim of the present study is to determine if AM-CLAVAC can increase the pharmacodynamics
      of warfarin among patients at steady state Double blinded cross over controlled study vs
      placebo performed in 12 evaluable patients treated with warfarin with an INR target 2 to 3
      and a stable INR and a stable dose.
    

Detailed description: 
      Double blinded cross over controlled study vs placebo performed in 12 evaluable patients
      treated with warfarin with an INR target 2 to 3 and a stable INR and a stable dose

      One period : seven consecutive days of amoxicillin(2g twice daily)- clavulanic acid (125 mg
      twice daily) association Wash out period of at least 4 weak with the return to a stable INR
      and warfarin dose One period : seven consecutive days of placebo twice daily

      Main outcome INR delta Day7-Day
    

Intervention name(s): Firstly : Amoxicillin-Clavulanic acid and secondly : Placebo; Firstly : Placebo and secondly : Amoxicillin-Clavulanic acid
Intervention type(s): Drug; Drug
Intervention description(s): Amoxicillin : 2g twice daily Clavulanic acid : 125 mg twice daily; Amoxicillin : 2g twice daily Clavulanic acid : 125mg twice daily seven consecutive days
Intervention MeSH terms: Amoxicillin; Clavulanic Acids; Clavulanic Acid; Amoxicillin-Potassium Clavulanate Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Warfarin; Drug interaction; Pharmacogenetics; Amoxicillin; Clavulanic acid
Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to evaluate the safety and analgesic efficacy of
      PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain
      following orthopedic trauma, injury, or surgery.
    

Detailed description: 
      Patients will be randomly assigned to PMI-150 (intranasal ketamine) or placebo and will
      receive repeated doses and be assessed for safety and efficacy.
    

Intervention name(s): PMI-150 (intranasal ketamine); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PMI-150 (intranasal ketamine) at time 0 and scheduled times thereafter.; Placebo (intranasal) at time 0 and scheduled times thereafter.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: orthopedic; ketamine; pain
AZD8529 Multiple Ascending Dose Study in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate safety, tolerability, PK and PD effects of orally administered
      AZD8529 after multiple ascending doses
    


Intervention name(s): AZD8529; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Phase I
A Study of UCB and MSCs in Children With CP: ACCeNT-CP
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The main purpose of this study is to estimate change in motor function 12 months after
      treatment with a single dose of allogeneic umbilical cord blood (AlloCB) or repeated doses of
      umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in children with cerebral
      palsy. In addition, this study will contribute much needed data to the clinical trials
      community on the natural history of the motor function in CP over short-term (less than 1
      year) time periods relevant to the conduct of clinical trials and assess the safety of AlloCB
      and hCT-MSC infusion in children with cerebral palsy.
    

Detailed description: 
      This study is a phase I/II, prospective, randomized, open-label trial designed to determine
      the effect size of change in GMFM-66 score in subjects treated with hCT-MSC or allogeneic CB
      and assess the safety of repeated doses of hCT-MSC in children with cerebral palsy. Children
      ages 2-5 years with cerebral palsy due to hypoxic ischemic encephalopathy, stroke, or
      periventricular leukomalacia may be eligible to participate. All participants will ultimately
      be treated with an allogeneic cell product at some point during the study. Participants will
      be randomized to one of three arms: (1) the "AlloCB" arm will receive one allogeneic CB
      infusion at the baseline visit; (2) the "MSC" arm will receive three hCT-MSC infusions, one
      each at baseline, three months, and six months; (3) the "natural history" arm will not
      receive an infusion at baseline but will receive an allogeneic CB infusion at 12 months.
      Motor outcome measures will be assessed at baseline, six-months, and one-year time points.
      Safety will be evaluated at each infusion visit and remotely for an additional 12 months
      after the final visit. Duration of study participation will be 24 months from the time of
      baseline visit. Randomization to treatment arms will be stratified by GMFCS level at study
      entry and etiology of CP (Stroke vs. Other).
    

Intervention name(s): Infusion of allogeneic umbilical cord blood; Infusion of MSCs
Intervention type(s): Biological; Biological
Intervention description(s): Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.; Subjects will receive 3 infusions of MSCs (baseline, 3 months and 6 months).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: CP; Cerebral Palsy; Stem Cell; Cord Blood; MSCs
Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to compare the effect of treatment with a combination of ear
      solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute
      otitis media.
    

Detailed description: 
      Reduction of pain symptoms will be measured by using the Face, Legs, Activity, Cry,
      Consolability Scale (FLACC) and the Faces pain Scale Revised (FPS-R).
    

Intervention name(s): Antipyrine and Benzocaine otic solution; Antipyrine Otic Solution; Benzocaine Otic Solution; Placebo Otic solution
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): antipyrine 54 mg and benzocaine 14 mg; Antipyrine 54 mg and glycerine dehydrated to 1.0 mL; benzocaine 14 mg and glycerine dehydrated to 1.0 mL; Placebo otic solution will be glycerin that is dehydrated
Intervention MeSH terms: Antipyrine; Benzocaine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment