louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01204931: Can We Predict Who Has Gastroesophageal Reflux Disease (GERD)?
Official title: Can We Predict Who Has GERD? Systematic Evaluation of Role of pH Monitoring and the Specific Physiologic pH Parameters in Defining GERD, Bravo, Impedence and SISAP
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: reflux
gastroesophageal reflux disease
GERD
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2010-09-17
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult subjects presenting to Vanderbilt University Medical Center Gastroenterology outpatient clinic with symptoms consistent with gastroesophageal reflux disease (GERD)

Brief summary: Gastroesophageal reflux disease (GERD) is currently defined as "a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications". Doctors often diagnose and treat GERD based on symptoms of heartburn and regurgitation. In recent years, the prevalence of partial or non-response to Proton Pump Inhibitors (PPI) has increased resulting in diagnostic testing with esophagogastroduodenoscopy (EGD) or ambulatory pH monitoring. Most patients do not have endoscopic evidence for reflux. Thus, in this group pH monitoring has emerged as an important physiologic test to determine the degree of esophageal acid exposure and to assess the association between patients' persistent symptoms and acid reflux events. The aims of this study are to assess the sensitivity and specificity of symptom associated indices and determine the best parameter for predicting GERD from a list of conventional pH measurement findings.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects ages 18 or older
* Presenting to the Vanderbilt GI outpatient clinic with symptoms of GERD
* Undergoing upper endoscopy and wireless pH monitoring (standard of care)
* Erosive disease: presence of esophageal mucosal injuries documented
* Non-erosive disease: normal esophagogastroduodenoscopy (EGD) with symptoms
* Control group: normal subjects without symptoms of GERD

Exclusion Criteria:

* Anti-reflux therapy within 7 days prior to the pH study
* Previous neck, esophagus, or stomach surgery
* Major motility disorders
* Previous neck, esophagus, or stomach cancer or radiations

Primary outcomes:
measure: Symptom Index (SI) and Symptom Associated Probability (SAP)
timeFrame: Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring
measure: Predicting gastroesophageal reflux disease (GERD)
timeFrame: Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center GI Outpatient Clinic
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Michael Vaezi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04204031: Objective Evaluation of the Number of Use Hour of Oxygen Therapy in Patients Receiving Supplemental Oxygen
Official title: Objective Evaluation of the Number of Use Hour of Oxygen Therapy in Patients Receiving Supplemental Oxygen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Respiratory Failure With Hypoxia
Chronic Obstructive Pulmonary Disease
Keywords: Long term oxygen therapy
adherence
electronic monitoring
Lead sponsor: Haute Ecole de Santé Vaud
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
name: Ligue Pulmonaire Genevoise
First posted: 2019-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to measure the actual use time in patients receiving supplemental oxygen using a new easy-to-use electronic remote monitoring device (TeleOx™)

Detailed description: The first phase of the study is observational. Oxygen use time of patients with chronic respiratory failure under long term oxygen therapy will be objectively measured using a electronic remote monitoring device (TeleOx™) over 15 days. The actual use time will be compared to their oxygen prescription.

Participants whose actual time of use will be less than prescribed will be offered an intervention which will consist of a presentation of the adherence record. The participant will also be asked about the presence of possible barriers concerning the use of oxygen therapy. The collaborator in charge of home visits will attempt to resolve these barriers as much as possible. Only participants with an actual time of use less than prescribed will be offered this intervention and will continue the monitoring over a period of 15 additional days.

Eligibility criteria: Inclusion Criteria:

* Long term oxygeno-therapy patients in stable condition without pulmonary exacerbation in the month before inclusion
* Oxygen prescription for at least 15 hours/day

Exclusion Criteria:

* under 18 years old

Primary outcomes:
measure: Oxygen use time
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Haute Ecole de Santé Vaud (HESAV)
Study officials:
affiliation: Haute Ecole de Santé Vaud
name: Olivier Contal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01277731: Methylprednisolone Replacement for Dexamethasone-induced Hiccup
Official title: Pilot Study of Methylprednisolone Replacement for Dexamethasone-induced Hiuup Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dexamethasone
Hiccup
Lead sponsor: Gyeongsang National University Hospital
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dexamethasone is a potent synthetic member of the corticosteroid. It is given to cancer patients undergoing chemotherapy to counteract emetic side effect and essential drug for the chemotherapy-treated patients. Hiccup is common adverse effect of corticosteroid especially on dexamethasone varying from 3% to 60% of given patients. Discontinuance of dexamethasone relieves most hiccupping cases, but vomiting/nausea rates increase. It is not clear whether hiccup side effect is limited to the dexamethasone only or other corticosteroid group.

Methylprednisolone, synthetic corticosteroid as similar as dexamethasone, could be considered as antiemetic agent for the patients with receiving chemotherapy. The investigators perform this pilot study under hypothesis that replacing dexamethasone with methylprednisolone could maintain antiemetic role and prevent hiccup.


Eligibility criteria: Inclusion Criteria:

* Age olderthan 21
* A Patient on chemotherapy who was diagnosed malignant tumor
* A Patient who is newly developed hiccup in the course of chemotherapy
* A patient with the willingness to comply with the study protocol during the study period and capable of ccomplying with it
* A patient who signed the imformed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages

Exclusion Criteria:

* A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications
* A patient with uncontrolled diabetes
* A patient who developed uncontrolled serious infection or other uncontrolled serious concomitant diseases
* A patient with disease progression after run-in period who is expected to receive another chomotherapeutic agents with different level of emetic risk

Primary outcomes:
measure: Prevention rate of dexamethasone induced hiccup
timeFrame: 24hrs after chemotherapy
Secondary outcomes:
measure: Prevention rate of nausea and vomiting
timeFrame: acute; 24 hours, delayed; 7 days after chemotherapy
Other outcomes:
Locations:
city: Jinju
country: Korea, Republic of
facility: Gyeongsang University Hospital
Study officials:
affiliation: Gyeongsang University Hospital
name: Jung Hun Kang, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01147731: A Drug Interaction Study With Albiglutide and Warfarin
Official title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Warfarin When Coadministered With Albiglutide in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: pharmacokinetics
albiglutide
warfarin
Healthy volunteers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This open-label study evaluates the pharmacokinetics of warfarin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of warfarin.

Detailed description: This Phase I open-label study evaluates the pharmacokinetics of warfarin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of warfarin.

Eligibility criteria: Inclusion Criteria:

* male healthy volunteers in good health
* no clinically significant diseases or clinically significant abnormal laboratory values
* body mass index (BMI) is \>/=18 kg and ≤30 kg/m2
* nonsmoker

Exclusion Criteria:

* positive test results for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
* any clinically relevant abnormality
* history of any anaphylactic reaction to any drug
* history of significant cardiovascular or pulmonary dysfunction
* history of excessive bleeding
* current or chronic history of liver disease
* history of alcohol or substance abuse
* history of thyroid disease or dysfunction
* history of gastrointestinal surgery or disease
* history of pancreatitis
* previously received any GLP-1 mimetic compound (e.g., exenatide)

Primary outcomes:
measure: The pharmacokinetic parameters (AUC and Cmax) of R and S-warfarin isomers with and without albiglutide
timeFrame: 52 days
Secondary outcomes:
measure: The effect of albiglutide on the pharmacodynamics of warfarin as determined by the International Normalisation Ratio (INR).
timeFrame: 52 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Bush M, Scott R, Watanalumlerd P, Zhi H, Lewis E. Effects of multiple doses of albiglutide on the pharmacokinetics, pharmacodynamics, and safety of digoxin, warfarin, or a low-dose oral contraceptive. Postgrad Med. 2012 Nov;124(6):55-72. doi: 10.3810/pgm.2012.11.2613.
citation: Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.
Clinical trial NCT00281931: Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients With Prolymphocytic Leukemia
Official title: Phase II Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab in Patients With B-PLL
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prolymphocytic Leukemia
Keywords: prolymphocytic leukemia
Lead sponsor: German CLL Study Group
Sponsor class: OTHER
First posted: 2006-01-25
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving fludarabine and cyclophosphamide together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with rituximab works in treating patients with B-cell prolymphocytic leukemia.

Detailed description: OBJECTIVES:

* Determine the overall and progression-free survival of patients with B-cell prolymphocytic leukemia treated with immunochemotherapy comprising fludarabine, cyclophosphamide, and rituximab.
* Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a non-randomized, open-label, multicenter study.

Patients receive fludarabine IV and cyclophosphamide IV on days 1-3. Patients also receive rituximab IV on day 0 in course 1 and on day 1 in courses 2-6. Treatment repeats every 28 days for up to 6 courses.

PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of B-cell prolymphocytic leukemia

  * Previously treated disease
* All Binet stages allowed

PATIENT CHARACTERISTICS:

* Life expectancy \> 3 months
* ECOG/WHO performance status 0-3

PRIOR CONCURRENT THERAPY:

* No more than 3 prior treatment regimens

Primary outcomes:
measure: Overall survival
measure: Progression-free survival
measure: Toxicity
Secondary outcomes:
Other outcomes:
Locations:
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
Study officials:
affiliation: HELIOS Hospital, Erfurt, Germany
name: Michael Herold, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06988631: Sensorimotor Organization in Individuals With General Joint Hypermobility
Official title: Investigation of the Effect of Foot Sole Sensory Training on Sensorimotor Organization in Individuals With General Joint Hypermobility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Joint Hypermobility
Keywords: joint hypermobility
food sense
Sensorimotor
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is the first to examine the effect of sole sensory training on sensorimotor organization in individuals with GEH. Individuals with a Beighton score of 5 and above were included in the study. Within the scope of the study, individuals with general joint hypermobility (GEH) were divided into intervention and control groups by the Randomization method. The intervention group received sole sensory training in the home environment. Both groups were given a foot care brochure. The individuals' sole sensory and balance skills were evaluated before and after the intervention. As a result of the study, the intervention aimed to prevent injuries and disabilities that may occur due to joint laxity by improving sole sensory and balance.


Eligibility criteria: Inclusion Criteria:

* Persons with a Beighton score ≥5 without any systemic disease
* Asymptomatic persons

Exclusion Criteria:

* People who have had an upper or lower extremity injury in the last 3 months,
* People who have a history of fractures or surgery in the last year,
* People who have been pregnant in the last year,
* Those diagnosed with Ehlers-Danlos Syndrome (EDS), hypermobile Ehlers-Danlos syndrome (hEDS), or hypermobility spectrum disorders (HSD)

Primary outcomes:
measure: Light touch sensation
timeFrame: 2 weeks
measure: Two-Point Separation sensation
timeFrame: 2 weeks
measure: Vibration sense
timeFrame: 2 weeks
Secondary outcomes:
measure: Proprioception
timeFrame: 2 weeks
measure: Muscle Strength
timeFrame: 2 weeks
measure: Balance
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum technical university
state: State/Province
Study officials:
References:
Clinical trial NCT01766531: Evaluation of Nutritional Status in ICU : Interest for the Measurement of Body Composition by Body Bioelectrical Impedance and Comparison With Several Methods
Official title: Evaluation of Nutritional Status in ICU : Interest for the Measurement of Body Composition by Body Bioelectrical Impedance and Comparison With Several Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Body Composition
Keywords: Bioelectrical impedance
Nutrition
Phase angle
ICU patients
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Center of study in Human Nutrition, INRA, Department of Clinical Nutrition
First posted: 2013-01-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis.

Detailed description: Prospective, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis (phase angle, fat mass, muscle mass, fat-free mass, body water); comparison with four methods for assessing nutritional status. ; compare length of mechanical ventilation, length in ICU and energy expenditure rest between malnourished and non-malnourished patient.

Eligibility criteria: Inclusion Criteria:

* ICU patients
* Written informed consent
* Adult patient

Exclusion Criteria:

* Pregnant patient
* Cardiac -pacemaker

Primary outcomes:
measure: Evolution of fat-free mass
timeFrame: From day 4 to day 7
measure: Evolution of fat-free mass
timeFrame: from day 8 to day 14
measure: Evolution of fat-free mass
timeFrame: from day 14 to day 28
Secondary outcomes:
measure: Performance of the impedance to measure body evolution
timeFrame: in the first three days, from day 4 to day 7, from day 8 to day 14, from day 14 to day 28
measure: Evolution of phase angle using bioelectrical impedance analysis
timeFrame: in the first three days, from day 4 to day 7, from day 8 to day 14, from day 14 to day 28
measure: Comparison with four methods for assessing nutritional status
timeFrame: in the first three days, from day 4 to day 7, from day 8 to day 14, from day 14 to day 28
measure: Compare length of mecanical ventilation, length in ICU and energy expenditure rest between malnourished ans non-malnourished patient
timeFrame: in the first three days, from day 4 to day 7, from day 8 to day 14, from day 14 to day 28
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sébastien PERBET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06692231: Impact of Hospital Pharmacist Intervention on Medication Management in Dialysis Patients
Official title: Impact of Hospital Pharmacist Intervention on Medication Management in Dialysis Patients After Assessment of Health Literacy Level
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Renal Dialysis
Health Literacy Level
Kidney Disease, Chronic
Keywords: clinical pharmacist
end stage renal disease
Lead sponsor: Centre Hospitalier de Vichy
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 70
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: The goal of this clinical trial is to learn if an intervention of a hospital pharmacist could help, dialysis patients managed his treatment. In a first time, the health literacy level will be assed.

The main questions it aims to answer are:

What is the impact of the clinical pharmacist intervention on the understanding level and management level of his treatment by the patient? Does the intervention of the pharmacist has an effect on the biologicals parameters of the patient? Researchers will compare a group with a pharmacist intervention VS a group without pharmacist intervention for dialysis patients.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age
* On dialysis (peritoneal dialysis, hemodialysis) for at least 3 months
* Prescription for at least 5 daily medications
* Patient who has not received any pharmaceutical consultation from a hospital pharmacist as part of his or her treatment for chronic renal failure.

Exclusion Criteria:

* Patient does not speak and/or understand French
* Patient's cognitive state does not permit an interview
* Patient not autonomous in managing his or her daily medication (e.g.: patient in nursing home)
* Patient refusal

Primary outcomes:
measure: Level of understanding and treatment management
timeFrame: 12 months
Secondary outcomes:
measure: level of health literacy
timeFrame: 12 months
measure: Assessment of patient-reported compliance with medication
timeFrame: 12 months
measure: Kalemia evolution
timeFrame: 12 months
measure: Phosphatemia evolution
timeFrame: 12 months
measure: Calcemia evolution
timeFrame: 12 months
measure: PTH evolution
timeFrame: 12 months
measure: Vitamine D evolution
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: Assessment of compliance with medication
timeFrame: 12 months
Other outcomes:
Locations:
city: Vichy
country: France
facility: Centre hospitalier de Vichy
Study officials:
References: