louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04924127: Molecular Pathology Research Project of Glioma
Official title: Exploring the Feasibility of the Molecular Pathology Model of Patients With Glioma Via Retrospective Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma, Malignant
Keywords: Molecular pathology
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 976
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glioma patient from Huashan Hospital with Informed Consent Form

Brief summary: Evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes and expend the application of the diagnostic algorithm to surgical practice

Detailed description: A total of 976 gliomas were enrolled in this study. First, in order to evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes, we conducted a retrospective cohort study included 753 frozen tissue samples of patients with different grades of glioma. According to WHO CNS5, all recommended alteration including IDH, 1p/19q, TERT, EGFRamp and 7+/10- were profiled using multiple approaches and a permanent diagnosis was obtained for each patient. Exploring the feasibility of the molecular pathology model of patients with glioma via retrospective research. Compare with the existing molecular pathology system, analyze the combination of IDH and TERT mutations and the feasibility of stratifying the prognosis of patients with glioma.

Moreover, to expend the application of the diagnostic algorithm to surgical practice, we developed a fast detection assay that could detect hotspot somatic mutations in IDH and TERT within 25 minutes and can discriminate TERT and IDH mutations from wild-type alleles with a minimum variant allele frequency (VAF) of 0.2% and 0.5%, respectively. We further validate the simplified diagnostic algorithm on frozen tissue of 223 patients with glioma in another retrospective cohort and performed this assay to evaluate the accuracy of the rapid assay.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Glioma
* Glioma patient with long-term follow-up data and intact clinical data

Exclusion Criteria:

* Glioma patient without Informed Consent Form
* Glioma patient without long-term follow-up data or intact clinical data

Primary outcomes:
measure: Evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes
timeFrame: through study completion, an average of 1 week
measure: Derivation and validation of a simplified diagnostic scheme
timeFrame: through study completion, an average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Jingan District
Study officials:
affiliation: Huashan Hospital
name: Jin-song Wu, MD & PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02701127: Molecular Effects of Vitamin B3 (Niacinamide) in Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Acute Kidney Injury
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a single center, randomized, single-blind, placebo-controlled study to evaluate the safety and biochemical effects of niacinamide on metabolic parameters of the kidney in patients undergoing cardiac surgery.


Eligibility criteria: Inclusion criteria

1. All patients undergoing cardiac surgery with the use of cardiopulmonary bypass at high risk for acute kidney injury. A Cleveland score of 6 or more is used to define patients at high risk for acute kidney injury
2. Age ≥ 18
3. Signed informed consent

Exclusion criteria

1. Pre-existing acute kidney injury
2. Kidney transplantation
3. Off-pump heart surgery
4. Pregnancy
5. End stage renal disease
6. Pregnancy (female subjects of childbearing potential must have a negative serum pregnancy test)
7. Subjects with any kind of dependency on the investigator (e.g. any subject who is under direct supervision of the investigator/co-investigators or employed by the investigator/co-investigators) 8 Subjects held in an institution by legal or official order (e.g. subjects in jail, prison, juvenile offender facility, or treatment facility including those who are in hospitals, alcohol, and drug treatment facilities under court order, and individuals with psychiatric illnesses who have been committed involuntarily to an institution)

Primary outcomes:
measure: Changes from baseline in serum metabolite profile of niacinamide
timeFrame: Baseline and days 1 through 4
Secondary outcomes:
measure: Changes from baseline in urine metabolite profile of niacinamide
timeFrame: Baseline and days 1 through 4
Other outcomes:
measure: Adverse events
timeFrame: From enrollment through day 4, and at day 30
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT00116727: Rheumatoid Arthritis DMARD Intervention and UtilizationStudy
Official title: Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
DMARD
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Immunex Corporation
name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-07-01
Enrollment: 5103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RA patients (by ACR criteria) starting on etanercept alone or in combination with other DMARDs

Brief summary: To systematically collect and document use patterns, effectiveness and safety of DMARD treatments currently used in the management of rheumatoid arthritis. The primary purpose of this study is to estimate the incidence of serious adverse experiences and adverse experiences of interest in patients with rheumatoid arthritis (RA) treated with ENBREL®.


Eligibility criteria: Inclusion Criteria:

* Fulfillment of the 1987 American Rheumatism Association criteria for RA
* Currently requiring the addition of ENBREL® therapy (to be taken alone or in addition to their current DMARD therapy)

Exclusion Criteria:

* Currently or previously enrolled in RADIUS 1
* Currently enrolled in a clinical trial where treatments or patient visits are imposed by a protocol
* Active infections
* Known allergy to ENBREL® or any of its components
* Current treatment with ENBREL®
* Patients who have previously been demonstrated to be intolerant of or refractory to ENBREL® therapy
* Nursing or pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Gibofsky A, Palmer WR, Keystone EC, Schiff MH, Feng J, McCroskery P, Baumgartner SW, Markenson JA. Rheumatoid arthritis disease-modifying antirheumatic drug intervention and utilization study: safety and etanercept utilization analyses from the RADIUS 1 and RADIUS 2 registries. J Rheumatol. 2011 Jan;38(1):21-8. doi: 10.3899/jrheum.100347. Epub 2010 Oct 15.
Clinical trial NCT06602427: Shoulder Proprioception: a Comparative Study on Hand Dominance and Sex
Official title: Shoulder Proprioception: a Comparative Study on Hand Dominance and Sex
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Position Sense
Sex Characteristics
Glenohumeral Joint
Upper Extremity
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: Gamze ÇOBANOĞLU DEMİRKAN
name: Ali ZORLULAR
name: Ahmet GÖKKURT
name: Nihan KAFA
name: Nevin ATALAY GÜZEL
name: Deran OSKAY
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy young adults

Brief summary: The goal of this cross-sectional study is to examine the differences in proprioception sensation depending on sex and dominant side factors in healthy volunteers. Hypothesises:

H0: Shoulder proprioception sensation does not change depending on sex and dominant side factors.

H1: Shoulder proprioception sensation varies depending on sex and dominant side factors.


Eligibility criteria: Inclusion Criteria:

* Individuals who have agreed to participate in the study after being provided with detailed information about the research will be included in the study.

Exclusion Criteria:

* Individuals who have undergone surgery or experienced trauma in the upper extremity, which impairs hand function, strength, and/or sensation, or who have a fracture or acute orthopedic injury within the last 6 months.
* Individuals with a history of neuromuscular disease, traumatic nerve injury, congenital anomaly, skin infections, or other conditions that could affect the assessment.

Primary outcomes:
measure: Shoulder proprioception measurement
timeFrame: Participants will be evaluated only once.
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Barış SEVEN
state: Çiğli
Study officials:
References:
Clinical trial NCT05032027: Oral Probiotics on Radiation Enteritis Stage Ⅱ Induced by Pelvic Concurrent Chemoradiotherapy
Official title: A Randomized Controlled Clinical Study of Oral Probiotics on Radiation Enteritis Stage Ⅱ Induced by Pelvic Concurrent Chemoradiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Cancer, Enteritis, Probiotics,Chemoradiotherapy
Lead sponsor: Jiangxi Provincial Cancer Hospital
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Effect of Probiotics on Raditon Enteritis in Pelvic Tumor Patients Receiving Radiotherapy.

Detailed description: Radiation-induced enteritis is an common and severe side effect of the patients undergoing pelvic radiotherapy. It can lead to dose-limiting and debilitating treatment effect. There is no guideline on an acknowledged intervention that significantly reduces its severity. In previous study, we have abserved that a probiotic combination significantly enhances the immune response of patients and reduces the severity of oral mucositis through modification of gut microbiota. In this stuyd we plan to designe a randomized trial of Probiotics probiotics in patients with pelvic carcinoma.The aim of this study is to determine if regulating intestinal tract flora will reduce the severity of radiation-induced mucositis in patients receiving pelvic radiotherapy. The effect of this intervention on a patient's general well-being was also investigated. The primary end-point of the study was the incidence of grade 3 enteritis. In 2021, 40 patients are estimated to be recruited into the study in Jiangxi Cancer Hospitals, China. 20 patients were randomized to receive Probiotics or placebo during chemoradiotherapy respectively.

Eligibility criteria: Inclusion Criteria:

* Karnofsky score ≥80 pelvic tumor patients receiving chemoradiotherapy in our Cancer Center

Exclusion Criteria:

* any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease or drug allergy to Probiotics

Primary outcomes:
measure: grade 3 entiritis
timeFrame: one month
Secondary outcomes:
measure: AE
timeFrame: one month
measure: immune index
timeFrame: one month
measure: Changes in intestinal flora
timeFrame: one month
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
Study officials:
affiliation: radiation department of Jiangxi cancer hospital
name: Chunling Jiang, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00232427: PiCCO Guided Therapy in Liver Cirrhosis
Official title: Optimized Therapy of Decompensated Liver Cirrhosis by Hemodynamic Monitoring Using the PiCCO System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis
Keywords: Liver cirrhosis
Hemodynamics
Fluid balance
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2005-10-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Prospective comparison of standard therapy in liver cirrhosis versus standard therapy plus intensified hemodynamic monitoring using the PiCCO system.

Detailed description: Patients presenting with advanced liver cirrhosis will receive either standard treatment or standard treatment plus hemodynamic monitoring with the PiCCO device. Fluids and vasoacitve drugs will be administered according to the measurements over a period of 5 days.

Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis Child-Pugh-Score \> 7
* Ascites \> 500 ml

Exclusion Criteria:

* Coronary heart disease
* Apoplexia \< 6 months ago
* Vasculitis
* Thrombosis
* Arterial occlusive disease \> stadium II

Primary outcomes:
measure: Survival
Secondary outcomes:
measure: Renal complications
measure: Length of intensive care
measure: Change in APACHE II
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg, Clinical center
Study officials:
affiliation: Heidelberg University
name: Jens Encke, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02064127: Triage of Abdominal Pain in the Emergency Department
Official title: Evaluation of Triage Criteria for Abdominal Pain in the Emergency Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Pain
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 4000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (\> 16 y) admitted with abdominal pain in the Emergency Departement of a primary and tertiary teaching urban hospital.

Brief summary: The investigators aim to evaluate in a retrospective study the performance of the Swiss Emergency Triage Scale to identify at the door of the Emergency Department patients requiring emergent intervention.

Detailed description: All patients are triaged at the door of our Emergency Department using the Swiss Emergency Triage Scale. Patients with abdominal pain may be triaged in two different emergency levels (level 2: medical evaluation within 20 minutes, level 3: medical evaluation within 2 hours). These levels are determined using a set of specific criteria.

The aim of this study is to evaluate the validity of these specific criteria in order to identify promptly patients with abdominal pain the will require an emergent intervention during their stay in the Emergency Department.

Eligibility criteria: Inclusion Criteria:

* \>= 16 y
* abdominal pain as the main complaint

Exclusion Criteria:

* none

Primary outcomes:
measure: Emergency intervention
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: Time to medical evaluation
timeFrame: participants will be followed for the duration of emergency department stay, an expected average of 5 hours
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: University Hospital, Geneva
name: Olivier T Rutschmann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06313827: e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population
Official title: Effectiveness of an e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cystic Fibrosis
Keywords: e-Health
physiotherapy
Cystic fibrosis
exacerbation
quality of life
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Asociación de Fibrosis Quística - Comunidad Valenciana
First posted: 2024-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to analyse the impact of a telematic assessment and monitoring protocol in people with cystic fibrosis, in order to identify exacerbations early, thus preventing loss of lung function and maintaining quality of life.

Participants will be assigned to one of 3 study groups:

Control group (CG-1): will receive their usual physiotherapy treatment; Treatment group (TG-2): will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment; Treatment and follow-up group (TGF-3): will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment, plus telematic control of exacerbations with feedback from the physiotherapist.


Eligibility criteria: Inclusion Criteria:

* Diagnosed cystic fibrosis
* Family access to an internet-enabled device
* Camera and microphone
* Absence of exacerbations in the last 30 days

Exclusion Criteria:

* Patients with lung transplant or on the waiting list for lung transplantation
* Previous eye surgery (3 months)
* Hemothorax
* Active infection or inflammatory process
* Tumors
* Cognitive problems that make it impossible for them to use telematic devices.

Primary outcomes:
measure: Clinical exacerbation
timeFrame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
Secondary outcomes:
measure: Dyspnea
timeFrame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
measure: Spirometric function
timeFrame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
measure: Oxigenation
timeFrame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
measure: Functional capacity
timeFrame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
measure: Quality of life (QoL)
timeFrame: At baseline (T1) and at 12 months(T3).
Other outcomes:
measure: Motivation to engage in physical activity
timeFrame: At baseline (T1)
Locations:
city: Valencia
country: Spain
facility: Instalaciones de la Universitat de Valencia
Study officials:
References:
Clinical trial NCT00340327: Study Evaluating IMA-638 in Healthy Japanese
Official title: An Ascending Single Dose Study of the Safety and Pharmacokinetics of IMA-638 Administered to Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-06-21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the safety and drug levels for single, ascending doses of IMA-638 in healthy Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* First generation healthy Japanese men and women of non-childbearing potential.

Primary outcomes:
measure: Safety will be measured by evaluating physical examinations, vital signs, electrocardiograms (ECGs), and clinical laboratory test results.
Secondary outcomes:
measure: Drug levels and associated biomarkers will be evaluated.
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00205127: Cardiac Water and Fluoromethane Cardiac PET
Official title: Comparison of Cardiac Perfusion by O15-water and F17-fluoromethane PET
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Cardiac PET imaging
Radiopharmaceutical tracers
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study we are looking at the blood flow to the heart using two different chemical tags or tracers that give off a low level of radiation. The tracers used in this study are called O15-water and F17-fluoromethane. These tracers mix with the blood and will move through the body. The researchers will use positron emission tomography (PET scans)to track the tracers as they moe through the heart and chest.


Eligibility criteria: Inclusion Criteria:

* 1. Age 18 to 40 years old 2. Willing to provide written informed consent

Exclusion Criteria:

* 1. A history of CAD 2. A history of active bronchospasm or asthma on theophylline bronchodilators 3. A history of any cardiac risk factors including: HTN, Diabetes, Hyperlipidemia, Smoking, and premature CAD in immediate family member 4. A history of liver disease or other significant disease 5. Females who are pregnant or lactating

Primary outcomes:
measure: -- implement myocardial perfusion quantification for O15-labeled water at rest and with pharmacologic stress,
timeFrame: assess at time of PET scan
measure: -- determine the biodistribution of fluoromethane in the thorax to see if it is usable for a cardiac perfusion tracer,
timeFrame: assess at time of PET Scan
Secondary outcomes:
measure: --develop initial methods for quantification of myocardial perfusion if applicable for labeled fluoromethane.
timeFrame: assess at time of PET scan
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Univeristy of Wisconsin
name: Charles K Stone, MD
role: PRINCIPAL_INVESTIGATOR
References: