louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03705273: Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup
Official title: Comparison of Dexamethasone Oral Preparations to Assess Palatability and Adverse Effects in Children With Asthma and Croup
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Asthma
Croup
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study of the palatability and acceptability of dexamethasone oral tablets crushed and placed in apple sauce or pudding in comparison with the IV solution mixed with sugar syrup and given orally. It is hypothesized that dexamethasone tablets crushed and administered in apple sauce or pudding will be more palatable and acceptable for pediatric patients receiving dexamethasone for an acute asthma exacerbation or croup.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute asthma exacerbation or croup (laryngotracheitis) in the Vanderbilt Children's Hospital Emergency Department
* Age 1 to 7 years
* Dexamethasone treatment indicated
* No other acute or chronic process accounting for signs and symptoms (e.g., foreign body aspiration, pneumonia, cystic fibrosis)
* Have not received systemic corticosteroid for current episode prior to enrollment

Exclusion Criteria:

* Allergy to dexamethasone or apple sauce and pudding
* Unable to take medication orally

Primary outcomes:
measure: Number of Participants With Nausea
timeFrame: 1 hour
Secondary outcomes:
measure: Number of Participants Requiring Second Dose of Dexamethasone
timeFrame: 1 hour
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Donald Arnold, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01148173: High-dose Chemotherapy and Stem Cell Transplantation for Central Nervous System (CNS) Relapse of Aggressive Lymphomas
Official title: Combined Systemic and Intrathecal Chemotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Transplantation for CNS Relapse of Aggressive Lymphomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin
Keywords: CNS relapse
aggressive lymphoma
HD-ASCT
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Central nervous system (CNS) relapses of aggressive lymphomas are a rare but devastating complication. There is no therapy standard, conventional approaches are palliative. This study investigates an intensive chemotherapy with CNS penetrating drugs followed by high-dose chemotherapy and autologous stem cell transplantation as a potentially curative approach.


Eligibility criteria: Inclusion Criteria:

* highly-malignant non-Hodgkins-Lymphoma, mantle-cell lymphoma or follicular lymphoma 3°
* CNS relapse (meningeal or/and intraparenchymal) with or without systemic lymphoma manifestations
* ECOG performance score ≤2
* no active infection
* negative HIV-serology
* adequate renal function (creatinine clearance \> 50 ml/min)
* adequate bone marrow function (granulocytes \>1500/μl, platelets \> 80000/μl)
* normal bilirubin, AST \< 3 x UNL
* negative pregnancy test

Exclusion Criteria:

* newly diagnosed NHL with primary CNS involvement
* indolent NHL, lymphoblastic NHL or Burkitt lymphoma
* preceding CNS irradiation
* pretreatment of CNS relapse other than corticosteroids
* immunosuppression, concomitant immunosuppressive therapy, status after organ transplantation or allogenous stem cell transplantation
* second cancer other than basalioma or cervical carcinoma in situ within the last 5 years
* unfit to receive an intensive chemotherapy
* pregnancy or breastfeeding
* known intolerance to MTX, ifosfamide, Depocyte, cytarabine, thiotepa, carmustine or etoposide

Primary outcomes:
measure: Time to treatment failure
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Remission rate
timeFrame: 3 months
measure: Toxicity
timeFrame: 1 year
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Agnieszka Korfel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korfel A, Elter T, Thiel E, Hanel M, Mohle R, Schroers R, Reiser M, Dreyling M, Eucker J, Scholz C, Metzner B, Roth A, Birkmann J, Schlegel U, Martus P, Illerhaus G, Fischer L. Phase II study of central nervous system (CNS)-directed chemotherapy including high-dose chemotherapy with autologous stem cell transplantation for CNS relapse of aggressive lymphomas. Haematologica. 2013 Mar;98(3):364-70. doi: 10.3324/haematol.2012.077917. Epub 2012 Dec 14.
Clinical trial NCT01314573: The Impact of High Intensity Exercise Upon EPC Number and Function in Young Women
Official title: The Impact of High Intensity Exercise Upon EPC Number and Function in Young Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exercise Anaphylaxis
Keywords: High intensity exercise training
Vascular health
Endothelial function
Circulating angiogenic cells
endothelial progenitor cells
Aerobic capacity
Arterial stiffness
Traditional and emerging cardiovascular disease risk factors
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2011-03-14
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to examine the effects of different exercise intensity training programs upon blood vessel function and circulating blood cells involved in blood vessel repair in young women. The long term effects of exercise may be beneficial to cardiovascular health and it is important to understand the training methods that are the most beneficial. In particular we aim to determine if brief maximal exercise improves the function and stiffness of blood vessels and enhance blood vessel repair. Two methods of exercising are being compared, exercise bouts involving intermittent exercise and exercise completed all at once, but at a very high intensity.


Eligibility criteria: Inclusion Criteria:

* Young healthy females
* Between 18-25 years old
* No on medication (this includes contraceptives)

Exclusion Criteria:

* Medication use (including oral contraceptives)
* Amenorrhoea
* High blood pressure
* Very active (\>3 hours per week of organized physical activity)

Primary outcomes:
measure: Maximal oxygen uptake
timeFrame: 4 weeks
Secondary outcomes:
measure: Heart rate variability
timeFrame: 4 weeks
measure: Endothelial progenitor cell function
timeFrame: 4 weeks
measure: Flow mediated dialtion
timeFrame: 4 weeks
measure: Arterial stiffness
timeFrame: 4 weeks
measure: Circulating angiogenic cell numbers
timeFrame: 4 weeks
measure: Endothelial progenitor cell function
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: University of Leeds
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: Karen M Birch, BSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04812873: Registry Study of ID & IDA in Korean Patients With Heart Failure
Official title: The Prevalence of ID (Iron Deficiency) & IDA (Iron Deficiency Anemia) in Korean Patients With Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Deficiency Anemia
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-03-24
Enrollment: 465
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Korean patients with heart failure

Brief summary: The prevalence of Iron Deficiency and Iron Deficiency Anemia in Korean HF patient

Detailed description: Epidemiological study to assess The prevalence of ID (Iron Deficiency) \& IDA (Iron Deficiency Anemia) in Korean patients with heart failure

Eligibility criteria: Inclusion Criteria:

* more than 19 years old
* Informed Consent Form
* Hear Failure criteria as belows

  * Heart Failure Sign(more than 1 Sx such as fatigue, dyspnea, ankle swelling)

    * Heart Failure Symptom(more than 1 among Jugular venous pressure (JVP) elevation, pulmonary crackle, peripheral edema) ③ Lung congestion or edema at chest X-ray ④ Objective findings of structural or functional cardiac abnormality(more than abnormality level of BNP or NT-proBNP, abnormality of echocardiography )

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: The Prevalence of Iron Deficiency
timeFrame: 1 day
measure: The Prevalence of Iron Deficiency Anemia
timeFrame: 1 day
Secondary outcomes:
measure: Current Anemia treatment
timeFrame: 1 day
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: JWPharmaceuticals
name: SOOJIN JUN
role: STUDY_DIRECTOR
References:
Clinical trial NCT02636673: Robotic-assisted Versus Laparoscopic Sigmoid Resection
Official title: Robotic-assisted Versus Laparoscopic Sigmoid Resection: a Retrospective Chart Review of Benign and Malignant Sigmoid Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sigmoid Diseases
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2015-12-22
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects that have undergone robotic-assisted or laparoscopic sigmoid resection for benign and malignant disease will be considered for inclusion except those that had emergency procedures.

Brief summary: Retrospective multi-center comparative chart review of robotic-assisted versus laparoscopic sigmoid resection for both benign and malignant disease

Detailed description: The goal is to establish safety and effectiveness of robotic-assisted surgery in sigmoid resection for both benign and malignant disease by evaluation of short-term clinical outcomes through 30 days post index procedure.

Eligibility criteria: Inclusion Criteria:

* All patients that have undergone sigmoid resection for benign or malignant disease

Exclusion Criteria:

* Emergency Procedures

Primary outcomes:
measure: Number of complications observed intraoperatively through 30-days
timeFrame: Intraoperative through 30-days follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth / Colon & Rectal Clinic of Scottsdale
state: Arizona
city: Miami
country: United States
facility: Jackson South Community Hospital
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Hospital
state: Florida
city: New Lenox
country: United States
facility: Progressive Surgical Associates/Silver Cross Hospital
state: Illinois
city: Mt. Kisco
country: United States
facility: Northern Weschester Hospital
state: New York
city: Phildelphia
country: United States
facility: Aria Health
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01443273: Thrombophilic Risk Factors in Preterm and Infants Treated at Ha'Emek Medical Center Between the Years 1990 to 2010
Official title: Thrombophilic Risk Factors in Preterm and Infants Treated at Ha'Emek Medical Center Between the Years 1990 to 2010
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature
Thrombosis
Keywords: Newborns
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2011-09-29
Enrollment: 50
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All newborns (Term and Premature) diagnosed with Neonatal Thrombotic events between year 1990 to 2010.

Brief summary: There are several factor that can be related to Neonatal Thrombotic events. Among them hypercoagulability can be the cause of those events. Factor V Leiden (FVL) and Prothrombin mutation are the most common causes of hereditary thrombophilia. The incidence of in the arab population is known to be higher than the incidence in another western populations. The purpose of this study is to review retrospectively the thrombophilic risk factors that were found in a cohort of premature babies and term newborns treated and investigated at the Neonatal Intensive Care Unit and at the Pediatric Hematology Unit.

Detailed description: All the demographic and clinical data will be summarized. Factors non related to the coagulation system like catheters, severe infections or congenital heart defects will be recorded. Also a full workup of prothrombotic risk factors are routinely performed in those infants. The study included basic coagulation analysis, Protein C, S and Antithrombin III activity, Activated Protein C Resistance, serum homocystein, lipoprotein (a) and Lupus Anticoagulant.

Also the three common genetic factors are analysed including Factor F Leiden (G1691A), Prothrombin Mutation (G20210A) and MTHFR polymorphism (C677T).

Eligibility criteria: Inclusion Criteria:

-All newborns (Term and Premature) diagnosed with Neonatal Thrombotic events between year 1990 to 2010.

Primary outcomes:
measure: The frequency of thrombophilic risk factors in preterms and infants
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit - HaEmek Medical Center
Study officials:
affiliation: Pediatric Hematology Unit - Ha'Emek Medical Center
name: Carina Levin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04660773: PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY UREAMIC PRURITIS
Official title: NARROW BAND UVB PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY PRURITIS IN END STAGE RENAL DISEASE PATIENTS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Refractory Uremic Pruritis
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients will be randomly assigned into 2 groups:

1. Group A: (20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months.
2. Group B: (20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months.


Eligibility criteria: Inclusion Criteria:

1. Age: 20-60 years.
2. End stage renal disease (the last stage(stage 5) of chronic disease which means kidneys are only functioning at 10 to 15 percent of their normal capacity and dialysis or kidney transplant is necessary to stay alive).
3. Refractory uremic pruritis.

Exclusion Criteria:

1. Other causes of pruritis (Dermatological or systemic) e.g. atopic, cholestatic liver disease.
2. Photosensitivity.
3. Contraindication or allergy to pregabalin.
4. Patients on antipruritic drugs e.g. antihistamines, steroids, emollients, opioid agonists.

Primary outcomes:
measure: 5 D-itching scale
timeFrame: two month
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT06692673: Linaclotide for Colonoscopy Bowel Prep
Official title: Use of Linaclotide as a Single Agent Colonoscopy Bowel Preparation Regimen; A Pilot Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Patients Scheduled for Colonoscopy
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if drug Linaclotide can be used as a single agent regimen to adequately prepare bowel for colonoscopy.

The main question it aims to answer is:

Does drug Linaclotide with Gatorade provide adequate bowel preparation for colonoscopy instead of the standard 4 Liters of Polyethylene glycol (PEG)?

Participants will:

Take one 290mg dose of Linaclotide 36 hours before the procedure and One 290mg dose of Linaclotide 8 hours before the procedure + 2 Liters of Gatorade and a clear liquid diet 24 hours before the procedure. As per standard of care, all patients will be made Nil Per Oral (NPO) starting midnight before the procedure.

The colonoscopy report will then be reviewed for Boston Bowel Preparation Score (BBPS) as a marker of bowel preparation quality, insertion time as a marker of procedure difficulty as well as noted pathology and any complications or physician noted comments.

Detailed description: Linaclotide is a novel, FDA approved, intestinal prosecretory agent used to treat chronic constipation and irritable bowel syndrome. Linaclotide reduces colonic transit time and increases luminal fluid secretion. Use of Linaclotide in colonoscopy bowel preparation decreased the volume of oral prep required. We hypothesize that Linaclotide can be used as a single agent regimen to adequately prepare bowel for colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Adult male and female patients (age 18 years to 65) admitted, who are scheduled for a colonoscopy during their admission.

Exclusion Criteria:

* Pregnant patients
* Patients with weight less than 116 pounds
* Patients with prior colon resection surgeries
* Presence of colostomy
* Patients undergoing sigmoidoscopy or pouchoscopy
* Patients unable to swallow pills/tablets
* Patients who would use a G or J feeding tubes to administer medications/preparation regimen
* Patients who are unable to consent for themselves
* Patients with a history of renal failure
* Patients already taking Linaclotide
* Patients who experienced hypersensitivity reactions to Linaclotide in the past

Primary outcomes:
measure: BBPS a cutoff 6 or greater
timeFrame: Within 48 hours post Colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Johan Nordenstam, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03804073: Short Course Radiation Therapy in Palliative Treatment of Head and Neck Cancer
Official title: SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Head and Neck Cancer: an Interventional, Randomized, Multicentric Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Radiotherapy
Palliative Care
Keywords: Short Course Radiotherapy
Symptomatic head and neck lesions
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic head and neck (H\&N) malignant lesions

Detailed description: Standard treatment for H\&N lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme

Eligibility criteria: Inclusion Criteria:

* symptomatic H\&N malignant lesions (primary solid tumors or metastases from solid tumor)
* age\>18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
* no changes in supportive care in the week before radiotherapy

Exclusion Criteria:

* pregnancy
* previous irradiation of the same region

Primary outcomes:
measure: Efficacy of palliation using the short course scheme compared with the standard scheme
timeFrame: 3 months
Secondary outcomes:
measure: acute toxicity in the two treatment groups
timeFrame: 3 months
measure: late toxicity in the two treatment groups
timeFrame: 12 months
measure: Quality of Life (QoL) assessment in the two groups
timeFrame: 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
state: BO
Study officials:
affiliation: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital
name: Alessio G Morganti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03356873: Impact of Correction of Vitamin D Deficiency in Oxidative Stress in Patients With Prediabetes (VICOX)
Official title: Impact of Correction of Vitamin D Deficiency in Oxidative Stress in Patients With Impaired Glucose Tolerance: A Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vitamin D Deficiency
Glucose Intolerance
Oxidative Stress
Insulin Resistance
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to determine the effect of the correction of vitamin D in vitamin D deficient patients (\<15ng/ml) in oxidative stress and insulin resistance in patients with impaired glucose tolerance. Vitamin D deficiency has been associated with chronic low-grade inflammation, diabetes mellitus type 2, cardiovascular risk and increased prevalence of coronary heart disease, cerebrovascular disease and myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* Women, 18 to 70 years, glucose intolerance (post-2 hour 75-grams glucose load \> or equal 140 mg/dl), 25-hydroxy vitamin D concentration \< or equal 15 ng/ml

Exclusion Criteria:

* Diabetes, systemic inflammatory disorders, treatment with statins, metformin or fibrates, renal insufficiency, intestinal malabsorption

Primary outcomes:
measure: Change in anti-oxidant capacity measured in serum
timeFrame: One month
Secondary outcomes:
measure: Change in homeostasis model assessment (HOMA) index measured in serum
timeFrame: One month
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study officials:
References: