louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01825395: Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome
Official title: Use of 3,4-Diaminopyridine(3 4-DAP)in the Treatment of Lambert-Eaton Syndrome (LEMS)
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Lambert Eaton Myasthenic Syndrome
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-04-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS).


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older,
* Diagnosed with LEMS,
* If female, have a negative pregnancy test, and
* If premenopausal, be willing to practice an effective form of birth control during the study,
* Tested and found by ECG not to have a prolonged QT syndrome,
* Agree to have a second ECG at the time of peak drug effect,
* Has understood and signed the Informed Consent.

Exclusion Criteria:

* Is known to have a sensitivity to 3, 4-DAP,
* Has a history of:

  1. past or current seizures,
  2. cardiac arrhythmia,
  3. hepatic, renal or hematologic disease, or
  4. severe asthma,
* Is believed by the investigator to be unable to comply with the protocol.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Steven P Ringel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04097795: Incremental Cost-Utility Study on Prehabilitation Among Older Patients With Colorectal Cancer Undergoing Surgery
Official title: Incremental Cost-utility Study on Prehabilitation for Colon Cancer Surgery in Older Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colorectal Cancer
Surgery
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Leading the Change: Collaboration of health Insurers in the Netherlands
First posted: 2019-09-20
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 70 years and above or patients with an ASA III score who are diagnosed with colorectal cancer and are scheduled for surgery as primary intervention will be recruited in the outpatient clinic of the surgery department of the participating hospitals.

Brief summary: A prospective multicenter observational cost-utility study following older or high-risk patients with colorectal cancer with and without prehabilitation before surgery.

Detailed description: This study will answer the question whether prehabilitation is cost-effective in colorectal cancer surgery among individual patients aged 70 years and above or patients with an American Society of Anesthesiologists (ASA) score of III. We also aim to identify factors facilitating or impairing implementation of prehabilitation such that it is cost-effective.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 70 years or American Society of Anesthesiologists (ASA) score of III
* Scheduled for colorectal cancer surgery

Exclusion Criteria:

* Metastatic disease known preoperatively
* ASA IV score or higher
* Paralytic or immobilized patients (not capable to perform exercise)
* Prior use of neoadjuvant therapy for the same indication
* Not able or willing to provide written informed consent

Primary outcomes:
measure: EQ-5D-5L
timeFrame: 0-6 months
measure: Costs
timeFrame: 0-6 months
Secondary outcomes:
measure: Number of deceased patients
timeFrame: 0-6 months
measure: Morbidity
timeFrame: 0-6 months
measure: (I)ADL dependence by GARS
timeFrame: 0-6 months
measure: (I)ADL dependence by TOPICS-SF
timeFrame: 0-6 months
measure: Return to normal activity
timeFrame: 0-6 months
measure: Care-related burden among informal caregivers
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Winterswijk
country: Netherlands
facility: Streekziekenhuis Koningin Beatrix
Study officials:
affiliation: Department of Geriatric Medicine, RadboudUmC
name: Marcel G Olde Rikkert, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018395: Cardiovascular Mortality Associated With Abnormal Calcium Metabolism
Official title: Cardiovascular Mortality Associated With Abnormal Calcium Metabolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Kidney Disease
Keywords: Calcium Metabolism
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this cohort study is to estimate the risk of cardiovascular mortality associated with abnormal calcium metabolism


Eligibility criteria: All ESRD patients who indicated dialysis in 1990-1993

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
References:
Clinical trial NCT06220695: A Nutrigenetic Intervention in MASLD
Official title: Efficacy of Isocaloric Mediterranean Diet and Low-fat Diet in Overweight/Obese MASLD Subjects With Respect to PNPLA3 Single Nucleotide Polymorphism: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: NAFLD
Fatty Liver
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2024-01-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is designed as a 12-week randomized controlled dietary intervention in individuals who had been diagnosed with NAFLD in the last 6 months and whose body mass index is above 25 at the time of participation in the pre-screening. The study sample is determined as 150 subjects and randomization will be done by stratification according to PNPLA3 genotype. At baseline, hepatic steatosis and fibrosis will be measured with Fibroscan, body composition will be analyzed, and transaminases and sugar and lipid metabolism indicators will be examined. The study will be conducted in parallel groups, with each group receiving equal amounts and intensity of Mediterranean diet or low-fat diet therapy. At the end of the 12-week intervention, baseline measurements will be repeated and the efficacy of the Mediterranean Diet and Low-fat diet therapies will be compared, as well as the effect of PNPLA3 mutation on intrahepatic response will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Able to understand and sign informed consent
* BMI\> 25 kg/m2
* Between 18-80 years
* previous clinical diagnosis of MASLD by abdominal USG, MRI, FibroScan® or liver biopsy

Exclusion Criteria:

* Excessive alcohol use (more than 20 g/day for women and 30g/day for men= \>2 units alcohol/day for women and \>3 units for men)
* Other liver diseases: Hepatitis B virus, Hepatitis C virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, Alpha 1 antitrypsin deficiency
* Secondary causes for steatosis: disorders of lipid metabolism, HCV Genotype 3, total parental nutrition, severe surgical weight loss, medications (amiodarone, tamoxifen, methotrexate, corticosteroids and HAART)
* Celiac disease
* pregnancy and breastfeeding

Primary outcomes:
measure: Decrease in CAP (db/m)
timeFrame: 12 weeks
measure: Decrease in Liver Stiffness (kPa)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Hospital
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Zeynep Banu Gungor, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04295395: Evaluation of the Brain and Renal Regional Oxygenation Using NIRS in Preterm Infants
Official title: Evaluation of the Brain and Renal Regional Oxygenation Using Near Infrared Spectroscopy (NIRS) Method in Very Low Birth Weight (<1500 g) Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Term
Persistent Ductus Arteriosus
Keywords: near-infrared spectroscopy
preterm infant
echocardiography
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 150
Sex: ALL
Minimum age (years): 22
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants with gestation age of \< 32 weeks, birth weight \< 1500g, \> 72 hours of age, will have NIRS monitors placed to measure cerebral and renal regional tissue oxygenation.

Brief summary: This study evaluates the brain and renal oxygenation using near infrared spectroscopy in preterm infants with persistent ductus arteriosus

Detailed description: Patent ductus arteriosus (PDA) is common in preterm infants. In the presence of a large PDA, significant systemic to pulmonary shunting occurs, which may result in pulmonary hyperperfusion and systemic hypoperfusion.

The evidence on PDA effect on brain and renal tissue oxygenation, measured by Near Infrared Spectroscopy is still controversial.

This study aims to evaluate the brain and renal oxygenation using near infrared spectroscopy (NONIN SenSmart model X-100) in 3 groups of preterm infants: 1) closed ductus arteriosus, 2) persistent ductus arteriosus, 3) hemodynamicaly significant ductus arteriosus.

Eligibility criteria: Inclusion Criteria:

* preterm infants with gestation age of \< 32 weeks
* birth weight \< 1500g
* \> 72 hours of age.

Exclusion Criteria:

* cardiovascular, renal, cerebral congenital defects,
* confirmed sepsis,
* no parental consent

Primary outcomes:
measure: Differences of the mean values of regional oxygenation of the brain and renal
timeFrame: from Day 4 of live up to 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Santaros Klinikos Neonatology Center
Study officials:
affiliation: Vilnius University
name: Augustina Jankauskiene, MD
role: STUDY_DIRECTOR
References:
citation: Navikiene J, Virsilas E, Vankeviciene R, Liubsys A, Jankauskiene A. Brain and renal oxygenation measured by NIRS related to patent ductus arteriosus in preterm infants: a prospective observational study. BMC Pediatr. 2021 Dec 9;21(1):559. doi: 10.1186/s12887-021-03036-w.
Clinical trial NCT05140395: ABTEST© Card Clinical Perfomance Study
Official title: Clinical Perfomance Study of the ABTEST© Card in Vitro Medical Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transfusion Reaction
Keywords: Reagent Kits, Diagnostic
Lead sponsor: Diagast
Sponsor class: INDUSTRY
First posted: 2021-12-01
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: in situ used for near patient In vitro Medical device
Primary purpose: OTHER

Brief summary: The study confirms the performance equivalence of the in vitro Diagnostic reagent ABTEST card used with the new reformulated WS solution

Detailed description: The study consists to perform on 100 patients a first pre transfusional control with the reference in vitro reagent ABTEST card (CE Marked reagent) followed by a another pre transfusional control with the in vitro reagent ABTEST card in study (new reformulated WS solution used) .

Eligibility criteria: 66 patients in hematology / oncology departments , including 20 patients with a hemoglobin significantly below the norm (\<8g / dl hemoglobin in the blood), and about to receive a transfusion. 20 patients hospitalized in gastroenterology with a transfusion need 4 internal medicine patients with cold agglutinins, in a transfusion context or not.

10 neonatal patients, background transfusion or Guthrie test.

Primary outcomes:
measure: Agreement between two reagents
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Arras
country: France
facility: CH Arras
Study officials:
affiliation: CH Arras
name: Pascal Huchette, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05867095: Navigated Abdominal Lymph Node Dissections
Official title: Targeted Abdominal Lymph nodE Dissections Randomized for Surgical NavigaTion (TALENT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Image-guide Surgery
Lymph Node Metastasis
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 69
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: Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery, and has the potential of reducing both irradical resections and morbidity. In this study we will randomize patients which will undergo an abdominal lymph node dissection in order to evaluate the actual technical and clinical benefit of navigation

Detailed description: In the study patients will be randomized between the use of a surgical navigation system or not. The operation itself will be performed according to current clinical practice, and the navigation system will be used for better localization and orientation during the procedure.

Eligibility criteria: Inclusion Criteria:

* Scheduled for open abdominal surgery in which targeted removal of one or more pathological lymph nodes is part of the surgical plan

Exclusion Criteria:

* Metal implants in the pelvic area
* Contra-indication for contrast enhanced CT scanning

Primary outcomes:
measure: Number of failed procedures
timeFrame: 3 months
Secondary outcomes:
measure: Surgical time to remove lymph node
timeFrame: After surgery
measure: LN success
timeFrame: 3 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
state: North Holland
Study officials:
References:
Clinical trial NCT06749795: LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis (UC)
Official title: A Randomized, Double-Blind, Placebo Controlled, Multi -Center, Phase 1b Study to Evaluate the Safety and Tolerability of LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Ulcerative Colitis (UC)
Lead sponsor: Liveome Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 1b study to evaluate the safety and tolerability of LIV001 in Patients with Mild-to- Moderate Active Ulcerative Colitis

Detailed description: A randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and tolerability of LIV001 in patients with mild to moderate UC. Patients will receive LIV001 or placebo for 8 weeks. All patients will return to the site for a follow-up visit on week 12.

Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18 to 65 years (inclusive) at Screening.
2. Established diagnosis of UC for at least 3 months prior to Screening, diagnosed by routine clinical, radiographic, endoscopic or pathologic criteria (Confirmed by colonoscopy and pathology records or, if unavailable, diagnosis confirmed by a letter from the subject's general practitioner.)

Exclusion Criteria:

1. Possible or confirmed diagnosis of Crohn's Disease, other form of inflammatory bowel disorder and coeliac disease.
2. History of a condition associated with significant immunosuppression, or chronic administration (\> 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to Visit 3 (subjects taking oral medications for UC, including corticosteroids or immunomodulators, are not excluded).

Primary outcomes:
measure: Number of subjects with adverse events (AEs)
timeFrame: Baseline through Study Completion (Week 12).
measure: Number of subjects with clinical laboratory abnormalities
timeFrame: Baseline through Study Completion (Week 12).
measure: Number of subjects with changes in the 12-lead electrocardiogram (ECG)
timeFrame: Baseline through Study Completion (Week 12).
Secondary outcomes:
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
Study officials:
affiliation: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
name: Piotr Napora, Doctor of Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04422795: The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection
Official title: The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Nail Diseases
Keywords: Nails
Thermomechanical stimulation
Intralesional injection
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the efficacy and safety of a thermomechanical device delivering vibration and cold stimuli in lowering pain during intramatricial nail injections


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 years or older
* Must understand and voluntarily sign an informed consent form
* All patients undergoing intramatricial nail injections at the Weill Cornell Medicine (WCM) Department of Dermatology
* Willingness to participate in the study

Exclusion Criteria:

* Inability of the patient to provide written informed consent for any reason
* Failure to have nail injection performed
* Likely inability to comply with the study protocol or cooperate fully with the research team

Primary outcomes:
measure: The level of pain and change in pain between each time point will be assessed using the Wong-Baker FACES scale with use of thermomechanical device delivering stimuli, without delivering stimuli, and with use of ethyl chloride skin refrigerant spray.
timeFrame: prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction
Secondary outcomes:
measure: Number of participants with at least one adverse event
timeFrame: Patients will be followed for 3 days following their nail injection
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Shari R Lipner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03696095: Local Anesthetic Automated Intermittent Administration vs. Continuous Infusion Via Femoral Nerve Block.
Official title: Continuous Infusion vs. Programmed Intermittent Bolus of Ropivacaine Through Peri-neural Femoral Nerve Catheter After Total Knee Arthroplasty: Impact on Analgesia Quality and Motor Block Frequency.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Postoperative Complications
Keywords: total knee arthroplasty
postoperative pain
programmed intermittent bolus
Continuous femoral nerve block
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 70
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: This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty.

Detailed description: This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty. One group of patients will receive automated intermittent bolus, while the others will get a continuous infusion. In both cases, patients will be able to administer supplementary auto-bolus if required.

Eligibility criteria: Inclusion Criteria:

* admitted for unilateral primary total knee arthroplasty.

Exclusion Criteria:

* ASA score \> 3
* BMI \> 40
* refusal of loco-regional technique.
* psychiatric disease.
* inability to understand/ use the Local anesthetic delivery pump.
* local anesthetic allergy,
* porphyry,
* uncontrolled epilepsy,
* severe cardiac arrhythmia.

Primary outcomes:
measure: Frequency of unplanned analgesia interventions.
timeFrame: up to 72 hours after surgery
Secondary outcomes:
measure: Pain difference
timeFrame: up to 72 hours after surgery
measure: Motor block frequency
timeFrame: up to 72 hours after surgery
measure: Mobilization quality during physiotherapy sessions.
timeFrame: up to 72 hours after surgery
measure: local anesthesia technique related complications
timeFrame: until catheter removal 48 hours after surgery
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU Liege
Study officials:
affiliation: University of Liege
name: Annis Orfi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00621595: The Effects of Breakfast on Brain Function
Official title: The Effects of Breakfast on Cognitive Functioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: School Breakfast
Diet
Nutrition
Brain Function
Cognition
USDA
Healthy Children
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2008-02-22
Enrollment: 166
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test cognitive abilities of 8-11 year old children under conditions of fasting or receiving a full school breakfast.


Eligibility criteria: Inclusion Criteria:

* 8-11 years old
* Between 25th and 95th percentile, BMI-for-age

Exclusion Criteria:

* food allergies or some intolerances
* uncorrected vision
* IQ \< 80
* Other chronic conditions thought to interfere with the study as determined by the investigator

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: University of Arkansas for Medial Science
name: R Terry Pivik, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: