louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01230840: Effect of Wheat Dextrin on Calcium and Magnesium Absorption
Official title: Effect of Wheat Dextrin on Calcium and Magnesium Absorption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonic Inertia
Keywords: fiber
calcium
magnesium
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2010-10-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare calcium and magnesium absorption within subjects with and without chronic consumption of wheat dextrin.


Eligibility criteria: Inclusion Criteria:

- Subjects will be generally healthy Caucasian females aged 19 and older with no known abnormalities of gastrointestinal function, and taking no medications that might alter absorptive performance. BMI will be between 19 and 31 kg/m2

-

Primary outcomes:
measure: Calcium Absorption
timeFrame: within 2-4 weeks
Secondary outcomes:
measure: Magnesium absorption
timeFrame: within 2-4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Creighton University
name: Laura Armas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01655940: Cerebral Oximeter Comparison Study
Official title: Comparison of the FORE-SITE and INVOS Cerebral Oximeters During Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Bypass Patients
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2012-08-02
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac bypass patients having surgery at Nationwide Children's Hospital

Brief summary: In this prospective study to try to standardize the care for patients, the investigators are planning to compare two cerebral oximeters currently in use at NCH in terms of their accuracy in determining the cerebral oxygen saturation as determined by jugular bulb oxygen saturation. Also, the investigators will compare these devices in terms of their response to changes in hemodynamics that occur during cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing cardiac surgery

Exclusion Criteria:

* None

Primary outcomes:
measure: Oxygen saturation
timeFrame: during surgery - Day 1
Secondary outcomes:
measure: Mean arterial pressure
timeFrame: during surgery - Day 1
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT02768740: Hydrocortisone 50 mg Every 6 Hours Compared to Hydrocortisone 300 mg Per Day in Treatment of Septic Shock.
Official title: Double Blinded, Randomized Trial, Comparing Intravenous Bolus of 50 mg of Hydrocortisone Every 6 Hours for 7 Days With a Continuous Infusion of 300 mg Per Day of Hydrocortisone 300-mg Group During 5 Days in the Treatment of Septic Shock.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Septic Shock
Lead sponsor: Association Niçoise de Réanimation Médicale
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 120
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: We performed a multicenter, prospective, randomized, double-blind, pilot study in four adult medical intensive care units. Patients presenting septic shock were rapidly administered one of two regimens of hydrocortisone, either a 50-mg intravenous bolus every six hours during seven days (200-mg group) or a 100-mg initial bolus followed by a continuous infusion of 300 mg daily for five days (300-mg group). Hydrocortisone was stopped abruptly at the end of treatment.

Detailed description: Hydrocortisone hemisuccinate (Hydrocortisone Upjohn) was supplied as a powder in 100 mg vials to be reconstituted with 2 ml of sterile water diluent. The placebo was saline serum supplied as 10 ml ampoules. The study drugs were administered according to two protocols. In the 200-mg group, patients received an intravenous bolus of 50 mg of hydrocortisone every six hours for seven days associated with a continuous infusion of placebo for five days. In the 300-mg group, patients received an initial bolus of 100 mg of hydrocortisone followed by a continuous infusion of 300 mg per day for five days associated with a bolus of placebo every six hours for seven days. In the two groups, hydrocortisone was stopped abruptly at the end of treatment. The investigators had the choice or resuming hydrocortisone at the end of the fifth day if deemed necessary.

Eligibility criteria: Inclusion Criteria:

* patients over 18 years old
* septic shock in accordance with the American College of Chest Physicians/Society of Critical Care Medicine Consensus Committee criteria. Septic shock was managed in accordance with the 2004 edition of the Surviving Sepsis Campaign guidelines.
* no minimal vasopressor dose was needed to enter the trial.

Exclusion Criteria:

* medical history of adrenal insufficiency
* ongoing corticosteroid treatment
* pregnancy

Primary outcomes:
measure: Mortality
timeFrame: 28-day
Secondary outcomes:
measure: Incidence of permanent shock between groups
timeFrame: 28-day
measure: Incidence of shock relapse between groups
timeFrame: 28-day
measure: Incidence of post hydrocortisone hemodynamic rebound between groups
timeFrame: 28-day
measure: Incidence of adverse events between groups.
timeFrame: 28-day
Other outcomes:
Locations:
Study officials:
affiliation: Association Niçoise de Réanimation Médicale
name: Gilles Bernardin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002940: Hydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS
Official title: Hydroxyurea Treatment of EBV-Associated Primary CNS Lymphoma in Children and Adults With AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: AIDS-related primary CNS lymphoma
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2003-11-24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of hydroxyurea in treating patients with Epstein-Barr virus-associated primary CNS lymphoma and AIDS.

Detailed description: OBJECTIVES: I. Estimate the objective response rate of PCNSL in AIDS patients treated with hydroxyurea. II. Investigate whether levels of Epstein-Barr virus (EBV) DNA in the blood or cerebral spinal fluid are correlates of PCNSL disease activity.

OUTLINE: This is an open label pilot study. Patients receive oral hydroxyurea tid. A course of hydroxyurea consists of 4 weeks of therapy. On day 28, after the first course of treatment, tumor size is analyzed by MRI. If no reduction in tumor size is seen on day 28, hydroxyurea dose is increased. If a CR or PR is demonstrated, patients continue on the same treatment at the original dose. MRI evaluation is again taken on day 56 of treatment. Patients with progressive disease at this evaluation are considered to have no treatment response.

PROJECTED ACCRUAL: 15-25 patients will be enrolled. Approximately 8-10 patients will be accrued annually.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically proven EBV-associated primary CNS lymphoma HIV infection confirmed by a positive ELISA and Western blot

PATIENT CHARACTERISTICS: Age: Open to children and adults of any age Performance Status: Karnofsky at least 50% Life Expectancy: At least 4 weeks Hematopoietic: Hemoglobin at least 6.9 gm/dL ANC at least 500/mm3 Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 1.5 x upper limit of normal (ULN) (1.5 to 2.5 x ULN if receiving indinavir) Renal: Creatinine no greater than 1.5 x ULN Cardiovascular: Not specified Other: Not pregnant or nursing Contraception required in fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: Prior or concurrent antiretroviral therapy allowed No prior EBV-associated primary CNS lymphoma therapy within 1 week of study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center - Shreveport
state: Louisiana
city: Memphis
country: United States
facility: Saint Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Karen S. Slobod, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03187340: Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults-2
Official title: Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults: Randomized Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Insomnia
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Advanced Medical Electronics
First posted: 2017-06-14
Enrollment: 112
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. Advanced Medical Electronics, in partnership with researchers are the University of Pennsylvania, propose developing an innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for the treatment of insomnia


Eligibility criteria: Inclusion Criteria: 1) Sleep onset latency \> 30 min for at least 3 nights per week

Exclusion Criteria: 1) Unable to perform tests due to inability to communicate verbally/blindness, inability to write and read in English (the study questionnaires are in English and do not exist in validated form for other languages). 2) Cognitive impairment; cognitively impaired patients may not be able to comply with the protocol). 3) History of a diagnosed non-insomnia sleep disorder, such as sleep apnea or circadian rhythm disorder 4) Upper extremity motor impairment that would preclude MBAT therapy (e.g., quadriplegia).

Primary outcomes:
measure: Sleep onset latency
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03232840: E-learning to Prevent Wrong Site Surgery in Anesthesia
Official title: Evaluation of an E-learning to Prevent Wrong Site Surgery in Anesthesia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Errors : Wrong Site Surgery in Regional Anesthesia
Keywords: wrong site surgery in regional anesthesia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing anesthesia in Lapeyronie Hospital

Brief summary: The purpose of this observational study is to assess the efficiency of an e-learning in order to put into practice some preventive measures to avoid wrong site surgery during anesthesia.

Detailed description: Before the study, the investigators selected 7 preventive measures to avoid wrong site surgery during regional anesthesia combined or not with general anesthesia . These measures were learned to the entire anesthesia team (nurse, resident and anesthesiologist) during conventional meetings. An initial evaluation of the application of these measures will be carried out before the introduction of e-learning. This assessment will be conducted by nurses without the knowledge of the anesthetic team evaluated. After this initial evaluation, e-learning will be broadcast on the hospital intranet. Then a second evaluation of the application of the preventive measures will be carried out 6 month and 1 year after the introduction of e-learning.

Eligibility criteria: Inclusion criteria:

* patient undergoing regional anesthesia with or without general anesthesia

Exclusion criteria:

* general anesthesia without regional anesthesia
* perimedullar anesthesia
* bilateral surgery

Primary outcomes:
measure: Evaluation of the application of each of the 7 preventive measures using a questionnaire filled by a nurse not involved in the regional anesthesia procedure
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
measure: Assessment of the application of each of the 7 preventive measures according to various clinical parameters
timeFrame: 1 day
measure: Evaluation of the application of the preventive measures following the introduction of the e-learning in the anesthesia team.
timeFrame: 6 month and 1 year
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: BIBOULET Philippe, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05752240: Transcranial Direct Current Stimulation of the Primary Motor Cortex to Treat Levodopa-induced Dyskinesias
Official title: Transcranial Direct Current Stimulation of the Primary Motor Cortex to Treat Levodopa-induced Dyskinesias in Patients With Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to evaluate the efficacy of 10 sessions of transcranial direct current stimulation of the primary motor cortex to reduce levodopa-induced dyskinesia


Eligibility criteria: Inclusion Criteria:

* patients with diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria and levodopa-induced dyskinesia;
* age between 30 and 80 years;
* ongoing therapy with levodopa;
* fulfillment of requirements for the application of transcranial magnetic stimulation (TMS), assessed by completion of the TMS screening questionnaire.

Exclusion Criteria:

* patients unable to give informed consent;
* cognitive impairment (MMSE ≤ 24);
* history of epilepsy;
* pregnant women.

Primary outcomes:
measure: Reduction of dyskinesia
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Flavia Torlizzi
Study officials:
References:
Clinical trial NCT02936440: Assessment of Hydration Status Using Bioelectrical Impedance Vector Analysis
Official title: Assessment of Hydration Status Using Bioelectrical Impedance Vector Analysis in Critical Patients With Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Critical Illness
Keywords: acute kidney injury
intensive care unit
bioelectrical impedance analysis
Lead sponsor: Catholic University of Pelotas
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 224
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: Intensive care patients who developed acute kidney injury after ICU admission

Brief summary: The state of hyperhydration in critically ill patients with acute kidney injury (AKI) is associated with increased mortality. Bioelectrical impedance vector analysis (BIVA) appears to be a viable method to access the fluid status of critical patients but has never been evaluated in critical patients with AKI. The objective of this study is to evaluate the hydration status using BIVA in critical patients under intensive care at the time of AKI diagnosis and to correlate this measurement with mortality. A sample of 224 patients with AKI will be evaluated by BIVA and followed until they are discharged or death in intensive care unit and the BIVA vectors will be analysed to define differences in hydration characteristics from each group.

Detailed description: Patients admitted to Intensive Care Unit (ICU) will be assessed by BIVA at the moment of the AKI diagnosis. They will be followed up to 12 weeks, until hospital discharge or death. The association between survival and hydration status, as assessed by BIVA in the first AKI day, will be tested.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years who developed acute kidney injury after admission in Intensive Care Unit

Exclusion Criteria:

* Chronic kidney injury, dialysis-dependent chronic kidney injury, acute kidney injury before ICU admission, kidney transplant, morbidity obesity and limb amputation.

Primary outcomes:
measure: Proportion of survivors in patients with AKI diagnosis during ICU
timeFrame: Up to 12 weeks after AKI diagnosis
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Catholic University of Pelotas
name: Maria Cristina Gonzalez, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06428240: Acute Mesenteric Ischemia, Reality in Catalonia
Official title: Reality of Acute Mesenteric Ischemia in Catalonia, is There a Chance to Improvement?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Mesenteric Ischemia
Keywords: Mesenteric ischemia
Acute Mesenteric ischemia
Abdominal pain
Elderly
Complications
Mortality
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: Germans Trias i Pujol Hospital
name: Parc Taulí Hospital Universitari
name: Hospital de la Santa creu i Sant Pau - Barcelona
name: Hospital Vall d'Hebron
name: Hospital Universitari Joan XXIII de Tarragona.
name: Hospital de Manresa
name: Hospital de Mataró
name: Hospital Universitari Sant Joan de Reus
name: Hospital de Sant Joan Despí Moisès Broggi
name: Hospital d'Igualada
name: Consorci Hospitalari de Vic
name: Hospital Arnau de Vilanova
name: Hospital de Mollet
name: Hospital de Terrassa
name: Hospital Universitari de Bellvitge
First posted: 2024-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study populations is all pacients with the diagnostic of Acute Mesenteric Ischemia that are admitted in the Hospital in Catalonia.

Brief summary: Acute mesenteric ischaemia (AMI) is a notorious disease with a high mortality, the diagnostic and management is truly multidisciplinary, but not very extended. The aim of this study is to analyse the results of the patients admited with an AMI in Catalonia.

Detailed description: Acute mesenteric ischaemia (AMI) is a notorious disease with a high mortality from 50 to 80%. Even though AMI is a relatively rare condition (1:1,000) the incidence rises exponentially with increasing age, in patients older than 75 years, the incidence of AMI has been reported higher than that of acute appendicitis. AMI patients benefit from early assessment in a surgical unit with capabilities to definitive management. The diagnosis and management of AMI are truly multidisciplinary, requiring high index of suspicion and awareness from emergency department physicians, preferably computed tomography angiography with precise interpretation, but usually this is not the truth reality and the diagnostic is delayed as well as the treatment, and the management is not multidisciplinary.

The aim of this study is to analyse the management and results of the patients admitted with an AMI in Catalonia from November 2024 to April 2026.

Eligibility criteria: Inclusion Criteria:

* Diagnostic of Acute Mesenteric Ischemia

Exclusion Criteria:

* Chronic Mesenteric Ischemia
* Ischemic Colitis
* Bowel obstruction strangulation
* Inflammatory bowel necrosis

Primary outcomes:
measure: Mortality
timeFrame: 2024-2026
Secondary outcomes:
measure: Complications
timeFrame: 2024-2026
measure: Management
timeFrame: 2024-2026
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06836440: Impact of Glasses for Vision Problems on Cognitive Function in Rural Older Adults
Official title: The Impact of Spectacle Intervention for Refractive Error and Presbyopia on Cognitive Function in Rural Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognition Disorders
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 963
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this project is to explore whether vision correction can effectively slow cognitive decline in older adults.

The primary question it seeks to answer is: Can providing free near and/or distance vision correction glasses to older adults with refractive errors or uncorrected vision, who have normal baseline cognition and hearing, reduce the rate of cognitive decline over 36 months in a cost-effective manner? Researchers will compare the rate of cognitive decline over 36 months between older adults who receive refractive correction and those who do not.


Eligibility criteria: Inclusion Criteria:

* Older adults who meet all of the following criteria will be eligible to participate in this study:

  * Age ≥ 65 years;
  * Reside in the sample county and plan to remain there throughout the study;
  * Normal baseline cognitive function or mild cognitive impairment (HMSE score \> 18);
  * Presence of uncorrected or inadequately corrected refractive error (i.e., distant vision \< 6/18 or near vision \< N6);
  * Able to accept random assignment and interventions, and willing to adhere to the study protocol;
  * Voluntarily sign an informed consent form to participate in the entire study process.

Exclusion Criteria:

* Age under 65 years;
* HMSE cognitive function score ≤ 18;
* Non-refractive visual decline (e.g., cataracts, glaucoma, or other severe ocular diseases);
* Severe mobility impairment requiring long-term bed rest or wheelchair use;
* Severe systemic diseases, including heart and liver failure, end-stage renal disease, malignancies, major neurological diseases, mental disorders, and/or other conditions that affect life expectancy or interfere with cognitive testing;
* Self-reported hearing impairment, unable to pass the whisper test;
* Use of hearing aids;
* Severe aging or end-of-life status.

Primary outcomes:
measure: **Chinese version of the Global Cognitive Score Scale**
timeFrame: Each participant will undergo cognitive assessments at baseline, 12 months, 24 months, and 36 months to evaluate the impact of the intervention on cognitive decline.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: