louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00846937: Plant Stanol Ester Beverage and Ileostoma Patients
Official title: Effects of a Plant Stanolester Beverage on Cholesterol Metabolism Among Human Subjects With Ileostoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostoma
Keywords: Cholesterol
Plant stanolester
Beverage
Ileostoma
Serum cholesterol level
serum LDL-cholesterol level
Intestinal cholesterol absorption efficiency
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We aim to examine efficacy of a plant stanolester beverage to lower serum cholesterol and LDL-cholesterol levels, when given with or without a fatty acid preparation. Study subjects are otherwise healthy proctocolectomized ileostoma patients (n=10), who consume stanolester beverage with or without a fatty acid preparation in a random order for one week period after a standardized low-fat meal. Washout period is 4 weeks. Serum lipids, lipoprotein lipids, sterols and fecal sterols and variables of cholesterol metabolism will be examined accordingly.


Eligibility criteria: Inclusion Criteria:

* healthy proctocolectomized subjects with an ileostoma

Exclusion Criteria:

* Chronic illness

Primary outcomes:
measure: serum cholesterol level
timeFrame: After treatment perdiods
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki, Department of Medicine
Study officials:
affiliation: University of Helsinki
name: Markku J. Nissinen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Helsinki
name: Tatu Miettinen, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05941637: An Expanded Access Program to Axitinib is Available for Patients With Advanced Forms of Kidney Cancer (Ductal; Papillary; Chromophobic; Oncocytic) With Mutations in VHL, PBRM1 / BAP1, SETD2, VEGF)
Official title: An Expanded Access Program to Axitinib is Available for Patients With Advanced Forms of Kidney Cancer (Ductal; Papillary; Chromophobic; Oncocytic), Confirmed Mutations in VHL, PBRM1 / BAP1, SETD2, VEGF), for Whom Standard Systemic Therapy Has Failed or Progressed, in Whom There Are no Satisfactory Treatment Alternatives and Who Are Not Eligible for Other Clinical Trials.
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Clear Cell Kidney Cancer
Kidney Cancer
Kidney Cancer With PBRM1/BAP1/VHL/SETD2 Mutations
Lead sponsor: Lynkcell Europe
Sponsor class: OTHER
First posted: 2023-07-12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT

Brief summary: Kidney cancer belongs to a heterogeneous group of tumors and is the most common oncourological disease; up to 80% of cases are clear cell carcinoma.

Detailed description: The study of rare hereditary forms of clear cell kidney cancer (CRP) made it possible to identify the VHL gene, germline mutations which lead to the development of the Hippel-Lindau syndrome, and somatic mutations are characteristic of sporadic CRP. The second most frequent mutation independent of VHLmut is the PBRM1 gene involved in chromatin remodeling. PBRM1 mutations are positively correlated with SETD2 mutations and negatively correlated with BAP1 mutations. Depending on the status of PBRM1/BAP1 mutations, tumors are characterized by different pathomorphological features and prognoses. The main stages of the clonal evolution of SRP, which is already at the early stages and is characterized by pronounced intratumoral genetic heterogeneity, have been determined. However, as PRP progresses, subclones acquire different secondary mutations that contribute to the activation of the same mTOR and VEGF signaling pathways, as well as disrupting the mechanisms of chromatin remodeling and the functioning of TP53. The present program will determine the efficacy of standard doses of axitinib in patients with differentiated mutations in kidney cancer following partial exome sequencing.

Eligibility criteria: Inclusion Criteria:

* Histologically documented metastatic renal cell cancer or cell kidney cancer
* Evidence of measurable disease.
* Adequate renal function (serum creatinine level)
* ECOG Status 0-1
* Patient must provide signed informed consent
* Male or female, age \>/= 18 years

Exclusion Criteria:

* Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors
* Current use or anticipated need for treatment with drugs that are known as potent CYP3A4 or CYP1A2.
* Active gastrointestinal bleeding.
* Severe allergic reactions
* Unwillingness or inability to comply with mandated pretreatment biopsy or therapeutic regimen

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04489615: Identification of Risk Factors for Alteration of the Cellular-arterial Gradient of CO2
Official title: DELTA-CAPNO: Identification of Risk Factors for Alteration of the Cellular-arterial Gradient of CO2 in Pre-hospital Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mechanical Ventilation
Prehospital Capnography Monitoring
Keywords: capnography prehospital
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-07-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients included are the major patients, intubated and ventilated in pre-hospital, transferred by the medical team to the University Hospital of Angers.

The ventilation settings are left to the caregiver's discretion, as is the purpose of Etco2.

Brief summary: Monocentric, prospective, observational and descriptive study on the evaluation of risk factors for alteration of the alveoarterial gradient of CO2 in pre-hospital patients, intubated and then ventilated in an invasive manner; and their impact on intra-arterial fatehospital.


Eligibility criteria: Inclusion Criteria:

* 18 years of age,
* Endotracheal intubation in pre-hospital and mechanical ventilation,
* Monitoring of Etco2 in pre-hospital settings

Exclusion Criteria:

* Identification of a chest wound blowing during pre-hospital care,
* No technical possibility for performing or analysing arterial sampling,
* Death during pre-hospital care,
* A person who has objected to the processing of his data for research at minimal risk and constraints (category 2) or for research on data, as well as persons subject to legal protection measures.

Primary outcomes:
measure: identification of risks factors for alteration of the cellular arterial gradient of CO2 in Pre hospital patients
timeFrame: from january 2020 to april 2021
Secondary outcomes:
measure: Intrahospital mortality
timeFrame: from january 2020 to april 2021
measure: Time of hospital admission
timeFrame: from january 2020 to april 2021
measure: length of mecanical ventilation
timeFrame: from january 2020 to april 2021
measure: Occurence of pneumonia
timeFrame: from january 2020 to april 2021
measure: Acute respiratory distress syndrom (ARDS)
timeFrame: from january 2020 to april 2021
measure: Length of stay
timeFrame: from january 2020 to april 2021
measure: Intrahospital mortality (subpopulation of traumatized patients which had suffered from intracranial hypertension
timeFrame: from january 2020 to april 2021
Other outcomes:
Locations:
city: Angers
country: France
facility: Quentin Carraro
Study officials:
affiliation: UH Angers
name: Quentin qc Carraro, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01211015: Endoplasmic Reticulum Stress in Chronic Respiratory Diseases
Official title: Endoplasmic Reticulum (ER) Stress in Patients With Various Chronic Pulmonary Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ER Stress,
Chronic Airway Disorders,
Lung Cancer,
Interstitial Lung Diseases
Lead sponsor: Chonbuk National University
Sponsor class: OTHER
First posted: 2010-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Control group

   * healthy control (volunteer)
2. Disease group

   * chronic pulmonary lung diseases including asthma, COPD, ILD, and lung cancer

Brief summary: Aim: To investigate whether ER stress is implicated in the pathogenesis of various pulmonary disorders

Measurement:

1. Unfolded protein responses (UPRs) in blood (PBMCs)of patients

   1. CHOP
   2. GRP 78 and so on
2. Unfolded protein responses (UPRs) in blood (PBMCs)of healthy controls

   1. CHOP
   2. GRP 78 and so on


Eligibility criteria: Inclusion Criteria:

* \> 18 yrs
* Definitive diagnosis as chronic pulmonary diseases by physician

Exclusion Criteria:

* Any other chronic medical illness such as DM, HTN, and other malignancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeonbuk
Study officials:
References:
Clinical trial NCT04349215: Validation of the Chinese ObsQoR-11
Official title: Validation of the Chinese Version of the Obstetric Quality of Recovery Scoring Tool (ObsQoR-11) at Early and Intermediate Phases After Elective Caesarean Delivery: a Multicentre Observational Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Delivery
Keywords: Cesarean delivery,the Obstetric Quality of Recovery-11 score, Chinese
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 319
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-cesarean delivery recovery

Brief summary: Investigation of post-cesarean recovery among Taiwanese pregnant women.

Detailed description: Improving postpartum quality of recovery is important particularly for women undergoing cesarean delivery. This is because cesarean delivery is associated with significant postoperative pain and risks of anesthesia-related adverse effects. To improve the quality of recovery after a cesarean delivery, the first step is to find out the most relevant perioperative factors.

In response to this problem, experts including anesthesiologists, obstetricians and midwives from University College London Hospital, Royal Free Hospital, London as well as Stanford University established a set of 11-item questionaire related to postpartum recovery, namely the Obstetric Quality of Recovery-11 score (ObsQoR-11), with a total score of 110. The latest systemic review in 2020 also confirmed that this questionnaire is the best option for recovery assessment after cesarean delivery. However, for women undergoing cesarean delivery in Taiwan, it is still unknown whether this questionnaire is representative or not. Therefore, this study aims to include women undergoing elective cesarean delivery from three hospitals in Taiwan.

Eligibility criteria: Inclusion criteria

1. age\>= 20 yr
2. elective cesarean delivery

Exclusion:

emergent surgery

Primary outcomes:
measure: Validation of the Chinese ObsQoR-11 score
timeFrame: 5 days
Secondary outcomes:
measure: Assessment of reliability, acceptability, and responsiveness of the Chinese ObsQoR-11
timeFrame: 5 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital; Cathay General Hospital
name: Chun-Yu Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00399815: Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C, Chronic
Keywords: Chronic viral hepatitis C
HCV RNA
Fibroscan
Fibrotest
hepatic elastography by MRI
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2006-11-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic hepatitis C

Brief summary: Chronic viral hepatitis C is a frequent liver disease. It is associated with variable degree of hepatic fibrosis. To date, liver histology is still regarded as the gold standard to detect, diagnose and quantify liver fibrosis. This requires to perform a liver biopsy. Severe complications are associated to this procedure in 0.01 to 0.1% of cases. Because of this, the repetition of the biopsy to evaluate the progression of the disease or the response to treatment poses ethical questions. Also, liver biopsy only explore a minimal portion of the liver and liver fibrosis, which is not homogeneous, may be under- or over-estimated.

To avoid risks linked to invasive technique and sampling errors associated to liver biopsy, efforts are being made to develop non-invasive technology to detect and quantitate liver fibrosis.

In this study we will perform in patients with chronic hepatitis C, serum tests, fibroscan (elastography of liver parenchyma determined by ultra-sounds), and elastography of liver parenchyma by MRI.

This study will allow

* to determine whether non-invasive tests effectively measure liver fibrosis
* to compare each non-invase test with results of liver biopsy
* to determine whether a non-invasive test or a combination of non invasive tests may be used to accurately evaluate liver fibrosis in patients with chronic hepatitis C.


Eligibility criteria: Inclusion Criteria:

* alteration of liver function tests (ALT, AST)
* HCV RNA positive

Exclusion Criteria:

* clotting disorder
* ongoing treatment with anti-coagulant or anti-aggregant
* advanced or decompensated cirrhosis (Child-Pugh class C)
* hepatocellular carcinoma
* other cancer
* history of surgery for brain aneurysm
* pace maker or defibrillator
* ocular metal foreign body

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires StLuc, Université catholique de Louvain (UCL)
Study officials:
affiliation: Cliniques Universitaires StLuc, Université catholique de Louvain (UCL), Brussels, Belgium
name: Yves J Horsmans, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01382615: Protocol to Obtain Blood and Bone Marrow Samples for Myeloma Research
Official title: Evaluation of Immune Parameters and Function in Multiple Myeloma Patients and Healthy Individuals' Blood and Marrow Samples
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at Dartmouth-Hitchcock Medical Center's Norris Cotton Cancer Center

Brief summary: The purpose of this study is to collect a blood or bone marrow sample from patients with multiple myeloma and from volunteers without myeloma.

Detailed description: The blood and bone marrow samples will be used in the laboratory to perform focused studies on multiple myeloma.

Eligibility criteria: Inclusion Criteria:

* Participant population is multiple myeloma patients over the age of 18 who are undergoing a scheduled bone marrow collection and/or blood drawing procedure as part of their routine treatment or follow up, and healthy volunteers over the age of 18 who have agreed to have a bone marrow and/or blood harvest as part of a donation to a transplant recipient.

Exclusion Criteria:

* Patients, who in the opinion of their physician, would be adversely affected by removal of an extra15ml of blood and /or an extra 10ml of bone marrow.

Primary outcomes:
measure: Cancer cell response to molecular testing of killing cell parts.
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Kenneth Meehan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03818815: A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
Official title: A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Otitis Media
Lead sponsor: Novus Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2019-01-28
Enrollment: 103
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop a better understanding of the safety, tolerability and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the treatment of Acute Otitis Media (AOM) in infants and children.


Eligibility criteria: Inclusion Criteria includes but is not limited to:

1. Male and female infants and children aged ≥6 months to ≤24 months
2. Diagnosis of Acute Otitis Media (AOM) - moderate to severe bulging of the TM or mild bulging of TM and recent \[less than 48 hours\] onset of ear pain or intense erythema of the TM
3. Score of 5 or more on the 5 question version of AOM-SOS scale1
4. Written informed consent by the child's legal guardian and their willingness to ensure that study instructions are followed, all study-related visits are attended, that treatment administration is given, and Parent/Caregiver assessments are recorded according to the study protocol.
5. Intact tympanic membrane (TM) in both ears (e.g., no perforation)

Exclusion Criteria includes but is not limited to:

1. Allergy to penicillin or cephalosporin
2. History or presence of immunodeficiency disorders
3. Antimicrobial therapy within the 3 days (i.e., 72 hours) prior to Day 1
4. Craniofacial abnormalities (e.g., cleft palate or Down's Syndrome) that may interfere with Eustachian tube function
5. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (e.g., cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
6. Clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Days 1-28
measure: Evaluation of Efficacy (Otoscopy)
timeFrame: Day 4
measure: Evaluation of Efficacy (Otoscopy)
timeFrame: Day 12
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics Oakland Medical Building
state: Pennsylvania
Study officials:
References:
citation: Muniz GB, Shope TR, Bhatnagar S, Shaikh N, Haralam MA, Liu H, Martin JM, Pogoda JM, Hoberman A. Intranasal Surfactant for Acute Otitis Media: A Randomized Trial. Pediatrics. 2021 Dec 1;148(6):e2021051703. doi: 10.1542/peds.2021-051703.
Clinical trial NCT00589615: Effectiveness of an Educational Program in the Prevention of Osteoporosis and Fractures
Official title: Effectiveness of an Educational Program in the Prevention of Osteoporosis and Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fractures
Osteoporosis
Keywords: vitamin D
bone density
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Miina Sillanpää Foundation
First posted: 2008-01-10
Enrollment: 2181
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will elucidate the effectiveness of an educational program in the prevention of osteoporosis and fractures. A random sample of the female population in Southern Finland (Uusimaa region) within the age group of 60-70 years was drawn from the population registry. From 1996 through 2000, 2181 women from the population register were recruited and randomly assigned to the intervention and to the control group. The subjects in the intervention group have been on a multidisciplinary program and the subjects in the control group received osteoporosis prevention information through the media and health care system. An end point is any fracture during the ten-year follow-up.


Eligibility criteria: Inclusion Criteria:

* Age 60-70 years and living in southern Finland (Uusimaa region)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Miina Sillanpää Foundation
Study officials:
affiliation: Helsinki University Central Hospital
name: Matti J Välimäki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evio S, Pekkarinen T, Sintonen H, Tiitinen A, Valimaki MJ. The effect of hormone therapy on the health-related quality of life in elderly women. Maturitas. 2007 Feb 20;56(2):122-8. doi: 10.1016/j.maturitas.2006.06.009. Epub 2006 Dec 8.
citation: Enattah N, Pekkarinen T, Valimaki MJ, Loyttyniemi E, Jarvela I. Genetically defined adult-type hypolactasia and self-reported lactose intolerance as risk factors of osteoporosis in Finnish postmenopausal women. Eur J Clin Nutr. 2005 Oct;59(10):1105-11. doi: 10.1038/sj.ejcn.1602219.