louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02941510: Inhaled Budesonide for Altitude Illness Prevention
Official title: Inhaled Budesonide for Altitude Illness Prevention
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Altitude Sickness
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized, double-blinded study administering budesonide, a medication to reduce inflammation in the lungs, to healthy volunteers to examine effects on altitude illness prevention by spending 18 hours overnight at 14,000 ft elevation.

Detailed description: A randomized, double-blinded study will be conducted to validate the results of previous literature on the use of budesonide in the prevention of altitude sickness. It will be conducted using healthy participants overseen by experienced wilderness medicine and altitude researchers from the Altitude Research Center at University of Colorado Denver. Participants will be recruited from the Denver community and prescreened for eligibility via phone. 100 participants, after consenting, will have baseline data and blood collected and will begin budesonide therapy 72 hours prior to being taken from Denver to Pikes Peak, where they will be observed at altitude for 18 hours. Patients will have the opportunity to withdraw consent at any time and will be monitored continuously by physician-researchers. Data collection and blood draws will be performed at specific time points and analyzed for efficacy of budesonide vs. placebo in the incidence of altitude sickness.

Eligibility criteria: Inclusion Criteria:

* healthy, altitude naive, 21-40 years old

Exclusion Criteria:

* smokers
* pregnancy
* hx of asthma
* current inhaled steroid use
* those with diseases or disorders known to be affected by hypoxia or the drugs used in this study such as

  * migraine or other chronic headaches,
  * sickle cell trait or disease, or
  * diabetes
* history of significant head injury or seizures
* taking any medication (over-the-counter or prescription) or herbal supplements
* a known hypersensitivity reaction to budesonide
* inability to be headache-free when consuming the amount of caffeine in two six ounce cups of coffee or less per day
* exposure to high altitude above 2000m in the previous 1 month or
* those who have been on an airline flight over six hours (Airplane cabins are pressurized to an elevation that can approximate exposure to high altitude)

Primary outcomes:
measure: Changes in Inflammation
timeFrame: During 18 hours at elevation compared to baseline.
measure: Incidence of Acute Mountain Sickness (AMS)
timeFrame: During 18 hours at elevation compared to baseline.
measure: Changes in Gene regulation
timeFrame: During 18 hours at elevation compared to baseline.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Ryan Paterson, MD, DiMM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04786210: Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid
Official title: A Prospective Triple-Blinded Single-Center Study of Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid Treatment for Keloids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Keloid Scar
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a split-scar study with a target sample size of 20. There are two interventions: fractional erbium:YAG-assisted drug delivery of 5-fluorouracil and fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide. Patients will undergo treatments in a series of 4 treatments at approximately 4 week ± 1 week intervals. Investigators will monitor for safety and continued benefit after the end of the interventional treatment.


Eligibility criteria: Inclusion Criteria

1. Age 18-89
2. Has one large keloid scar or at least two similar but separate keloid scars
3. Keloid present for at least 1 year

Exclusion Criteria

1. Currently pregnant
2. Currently breastfeeding
3. Have taken oral retinoids within 6 months of study initiation
4. Has had keloid treatment within 1 month of study initiation
5. Has active infection at treatment site
6. Has active malignancy
7. Presence of pedunculated keloid(s) or keloid(s) that are judged to be best treated with surgical excision first
8. Hypertrophic scars
9. Known hypersensitivity to TAC or 5-FU
10. Chronic systemic corticosteroid or immunosuppressive medication use
11. Has intolerance to anesthesia
12. Has known connective tissue disease
13. Has known infectious disease

Primary outcomes:
measure: Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit
timeFrame: Baseline, Week 16
measure: Change in Modified Hamilton Score
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change in Scar Measurement From Baseline to Final Visit
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone
name: Nayoung Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01247012: Minimization of IntraLipid Versus Omegaven
Official title: A Randomized Controlled Trial of Minimization of Intralipid Versus Omegaven for the Treatment of Severe Cholestasis- A Pilot Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cholestasis
Parenteral Nutrition Associated Liver Disease (PNALD)
Lead sponsor: Children's & Women's Health Centre of British Columbia
Sponsor class: OTHER
Collaborators: name: Child and Family Research Institute
First posted: 2010-11-24
Enrollment: 40
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver disease (PNALD). The purpose of this study is to determine the effect of treatment with a smaller amount lipid minimization) of our standard soybean oil based intravenous lipid emulsion (Intralipid) versus a fish-oil based lipid emulsion (Omegaven) in infants with severe cholestasis.

Detailed description: Infants meeting eligibility will be randomized to receive either 1g/kg/day of Intralipid® 20% or 1g/kg/day Omegaven® 10%. Infants randomized to Intralipid® whose conjugated bilirubin level rises \>100umol/L will be crossed over to receive 1g/kg/day Omegaven®. Monitoring includes liver function tests (AST, ALT,ALP, GGT, Conjugated Bilirubin), Fatty Acid Profile (RBC and serum fatty acids; triene/tetraene ratio), INR (coagulation profile) and cytokine measure (inflammatory markers).

Eligibility criteria: Inclusion Criteria:

* infants admitted to neonatal intensive care unit
* severe cholestasis, defined as conjugated bilirubin greater than 35
* receiving at least 60% calories by IV infusion and expected to require intravenous nutrition for at least an additional 28 days
* signed consent

Exclusion Criteria:

* hepatitis (TORCH or other viral infection)
* primary liver disease as etiology of cholestasis
* clinically severe bleeding not able to be managed with routine measures
* lethal congenital abnormalities
* congenital heart disease associated with right heart dysfunction

Primary outcomes:
measure: Feasibility
timeFrame: up to 1 year
measure: Clinical endpoint
timeFrame: up to 1 year
Secondary outcomes:
measure: Total duration of parenteral nutrition
timeFrame: up to 1 year
measure: Growth
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Children's & Women's Health Centre of BC
state: British Columbia
Study officials:
affiliation: Children's & Women's Health Centre of BC
name: Susan Albersheim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's & Women's Health Centre of BC
name: Avash J Singh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's & Women's Health Centre of BC
name: Rebecca Sherlock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02567812: Database of Pelvic Inflammatory Disease
Official title: Prospective Data Collection of Patients With Pelvic Inflammatory Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Pelvic Disease
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pelvic inflammatory disease or pelvic inflammatory disorder (PID) is an infection of the upper part of the female reproductive system namely the uterus, fallopian tubes, or the ovaries. Often there may be no symptoms. Signs and symptoms, when present may include lower abdominal pain, vaginal discharge, fever, burning with urination, pain with sex, or irregular menstruation. Untreated PID can result in long term complications including infertility, ectopic pregnancy, chronic pelvic pain, and cancer.

Brief summary: The aim of this prospective study is to collect data on in-patients with pelvic inflammatory disease(PID) at Kangbuk Samsung Hospital.

Detailed description: The aim of this prospective study is to collect data on in-patients with pelvic inflammatory disease(PID) at Kangbuk Samsung Hospital. If patients agree to participate in this clinical trial, patient's data (such as age, body mass index, preoperative findings, laboratory findings, radiologic findings, operative findings, pathologic findings, postoperative findings) will be collected in a research database. The research database will be updated, every 6 month, to include data on patient's disease outcome and follow-up care. Although most data will be collected form the medical record, patient may agin be contacted so that researchers can collection some data if it is not in the medical record.

Eligibility criteria: Inclusion Criteria:

* All in-patient with PID who diagnosed at Kangbuk Samsung Hospital

Exclusion Criteria:

* Secondary PID caused by other surgical problem or disease
* An inability to fill-up the informed consent

Primary outcomes:
measure: PID database
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Taejong Song, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06337812: Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)
Official title: Fiber Supplementation to Increase Short Chain Fatty Acid Production in Patients With Type II Diabetes and Heart Failure With Preserved Ejection Fraction - the FERMENT HFpEF Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type2diabetes
Heart Failure With Preserved Ejection Fraction
Keywords: Fiber Supplementation
Potato Starch
Gut microbiome
Resistant starch
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study team is studying how increasing dietary fiber, specifically through adding potato starch to participant's diet, may impact the species of bacteria in participant's gut microbiome. The study team also wants to understand if adding potato starch to participant's diet helps these bacteria make more short chain fatty acids, a byproduct the team thinks may benefit participant's health.


Eligibility criteria: Inclusion Criteria:

* A confirmed clinical diagnosis of stable HFpEF on maximally tolerated Heart Failure (HF) medical regimen (without changes in dosage in the prior month)
* Left ventricular ejection fraction of \>50% documented in the prior 12 months
* A confirmed clinical diagnosis of Type II diabetes (T2DM) with glycated hemoglobin \<10% without changes in medical regimen in the past month.

Exclusion Criteria:

* Current usage of pre- or probiotic usage
* Antibiotic usage in the past 6 months
* Current participation in another interventional clinical trial
* History of potato allergy or potato starch allergy, inflammatory bowel syndrome, inflammatory bowel disease, bowel resection, Roux-en-Y gastric bypass surgery, celiac disease, Crohn's disease, or colorectal cancer
* Hypoglycemic episode with blood glucose 70 milligrams per deciliter (mg/dL) within the last month
* Stage IV-V chronic kidney disease
* Pregnancy (self-reported)
* Comorbidity limiting survival to \< 12 months

Primary outcomes:
measure: Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool
timeFrame: Baseline, approximately 4 weeks
measure: Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma
timeFrame: Baseline, approximately 4 weeks
measure: Changes in propionate levels - stool
timeFrame: Baseline, approximately 4 weeks
measure: Changes in propionate levels- plasma
timeFrame: Baseline, approximately 4 weeks
measure: Changes in acetate levels- stool
timeFrame: Baseline, approximately 4 weeks
measure: Changes in acetate levels- plasma
timeFrame: Baseline, approximately 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Scott Hummel, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00226512: To Determine the Role of Adding Campath-1H or ATG Given In-vivo in Addition to Fludarabine and Low Dose Busulfex on Outcome in Patients Treated With Reduced Intensity Conditioning
Official title: Phase III Trial of a Non-myeloablative Preparative Regimen With Fludarabine and Busulfan With or Without Anti-lymphocyte Antibodies (Campath-1H or ATG) for Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome Undergoing Allogeneic Stem Cell Transplantation From an HLA Compatible Donor
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2005-09-27
Enrollment: 203
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: Multi-institutional randomized phase III trial of a non-myeloablative preparative regimen with fludarabine and busulfex with or without anti-lymphocyte antibodies (monoclonal humanized Campath-1H administered s.c. or polyclonal rabbit anti-T lymphocyte antibodies (ATG), combined with low dose and short course cyclosporine A (CSA) and methotrexate (MTX) as the sole agent for prevention of graft-vs-host disease (GVHD) for patients with acute myelogenous leukemia or myelodysplastic syndrome undergoing allogeneic stem cell transplantation from an HLA compatible donor.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of AML or MDS, with no lower or upper age limit:
* a) Induction failure
* b) First or subsequent remission
* c) Untreated first relapse
* Patients must have an HLA compatible donor willing and capable of donating peripheral blood stem cells (first choice) or bone marrow progenitor cells using conventional techniques and blood lymphocytes if indicated (HLA compatible defined as 5/6 or 6/6 matched related or 10/10 molecular matched unrelated donor (A,B,C,DR,DRB1).

Exclusion Criteria:

* Donor contraindication (HIV seropositive confirmed by Western Blot, Hepatitis B antigenemia).
* Evidence of bone marrow disease.
* Unable to donate bone marrow or peripheral blood due to concurrent medical condition.

Primary outcomes:
measure: To determine the efficacy of s.c. Campath-1H or ATG in decreasing the incidence and severity of acute and chronic GVHD in patients with AML and MDS treated with non-myeloablative stem cell transplantation.
Secondary outcomes:
measure: Investigate the role of different conditioning regimens on:
measure: Infection, engraftment relapse rate and disease free survival.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Shimon Slavin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03141112: The Benefits of Early Initiation of Continual Renal Replacement Therapy in Patients With Severe Sepsis
Official title: The Benefits of Early Initiation of Continuous Renal Replacement Therapy (CRRT) in Patients With Severe Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Sepsis
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient in severe sepsis (reaching criteria for severe sepsis), both gender, age over 18 years old, admisset in ICU.

Brief summary: The study will evaluate the benefit of early initiation of CRRT in the initial phase of severe sepsis in patients admitted to the ICU. Primary evaluated end-point is 28-day mortality. Secondarily evaluated end-point is length of ICU-stay, length of stay in hospital, duration of mechanical ventilation. There are two groups. One group of participants with early CRRT initiation and another group with late CRRT initiation. Reference group no CRRT.

Detailed description: The aim is to determine the optimal timing of initiation of CRRT with respect to the degree and duration of acute kidney injury (AKI) in ICU patients. The CRRT parameters and the duration of therapy will be monitored, depending on initial biochemical and clinical values of the patient. Part of the study is the follow-up of patients with a 3-month delay.

Eligibility criteria: Inclusion Criteria:

* reaching criteria of severe sepsis, ICU admission

Exclusion Criteria:

* pregnant women, younger than 18 years, reaching contraindications for initiation of renal replacement therapy

Primary outcomes:
measure: mortality
timeFrame: 28 days
Secondary outcomes:
measure: duration of mechanical ventilation
timeFrame: 28 days
Other outcomes:
measure: length of stay
timeFrame: 3 months
Locations:
Study officials:
affiliation: UH Olomouc, Czech Republic
name: Radovan Uvizl
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00411112: Sentinel Node in Colon Cancer
Official title: Sentinel Node Study in Colon Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Keywords: Sentinel node
Isosulphan blue
Isotopic detection
Survival
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2006-12-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: More than 20% of patients operated on for colon cancer without node metastasis will develop visceral metastases. The purpose of the study is to determine sentinel lymph nodes with two methods: blue injection and isotopic detection. Sentinel nodes will then be analyzed by immunohistochemy to detect micrometastases. No adjuvant therapy will be proposed to the patient if there are only node's micrometastases and survival will be analyzed in regard to the presence of these micrometastasis.


Eligibility criteria: Inclusion Criteria:

* adult
* colon cancer
* open surgery

Exclusion Criteria:

* emergency surgery
* metastases

Primary outcomes:
measure: Survival without recurrence after 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Générale et Digestive - Hôpital de Hautepierre
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Cécile Brigand, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01882712: Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Persistent Facial Erythema
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Erythema
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-06-20
Enrollment: 0
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: The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily for 29 days versus vehicle control, in subjects with moderate to severe chronic persistent vascular facial erythema


Eligibility criteria: Inclusion Criteria:

* Male or female, who is at least 18 years of age or older at screening visit.
* Presence of chronic persistent vascular facial erythema for ≥ 3 months by history.
* A Clinician's Erythema Assessment (CEA) score of ≥3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
* A Patient Self Assessment (PSA) score of ≥3 at Screening and at Pre-dose (T0) on Baseline/Day 1.

Exclusion Criteria:

* More than 2 facial inflammatory lesions (papules, pustules, and nodules).
* Presence of areas of significant scaling or crusting on the face.
* Presence of psoriatic lesions on the face.
* Presence of any other dermatological condition of the face that, in the opinion of the Investigator, may significantly interfere with the interpretation of the clinical trial results.

Primary outcomes:
measure: Composite success on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)
timeFrame: Day 29
Secondary outcomes:
measure: Composite improvement on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References: