louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00244504: Moxonidine in Patients Undergoing Vascular Surgery
Official title: The Effects of Small Doses of Moxonidine in Patients Undergoing Vascular Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cardiac Disease
Vascular Surgery
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2005-10-26
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigating the perioperative effect of moxonidine. In a randomized double-blind fashion, patients undergoing vascular surgery will receive moxonidine 0.2 mg or placebo from the day before surgery until day 4 after surgery. Holter-EKG for 48 h, starting just before surgery. Repeated 12-lead EKG, measurements of Troponin I and BNP, clinical visitations, follow-up interviews at 6 and 12 months


Eligibility criteria: Inclusion Criteria:

* abdominal aortic or peripheral vascular surgery

Exclusion Criteria:

* unstable angina,
* severe symptomatic heart failure (NYHA IV)
* systolic blood pressure at rest \< 100 mmHg
* bradycardia (\<50/min)
* higher grade AV heart block
* creatinine clearance \< 30 ml/min
* pregnancy
* no consent

Primary outcomes:
measure: over-all mortality
timeFrame: 30 days and 12 months
Secondary outcomes:
measure: Ischemia detected by Holter-ECG ST alterations or troponin T elevation
timeFrame: 7 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University hospital
state: CH
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Miodrag Filipovic, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bolliger D, Seeberger MD, Lurati Buse GA, Christen P, Gurke L, Filipovic M. Randomized clinical trial of moxonidine in patients undergoing major vascular surgery. Br J Surg. 2007 Dec;94(12):1477-84. doi: 10.1002/bjs.6012.
Clinical trial NCT06433804: Clinicopathological Parameters of HER2 Low Breast Cancers
Official title: Exploring the Clinicopathological Parameters of HER2 Low Breast Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HER2 Low Breast Cancers
Lead sponsor: Vardhman Mahavir Medical College And Safdarjung Hospital
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All histologically proven cases of breast cancer in the 2 years from January 2022- December 2023

Brief summary: This was a retrospective cohort study which included all histologically proven cases of breast cancer in the 2 years from January 2022- December 2023 at a tertiary care centre.

This study was performed in line with STROCSS criteria. The following clinicopathological data was retrieved from the histopathological records- age, tumor size, nodal involvement, lymphovascular/ perineural invasion, and Bloom Richardson grading.

Routine histopathological processing was done followed by immunohistochemical analysis for ER, PR, HER2, Ki67 and AR. All the cases were categorised into Luminal A, B, Her2 enriched and triple-negative breast cancer based on the surrogate molecular classification. Further, all the cases were categorised into HER2 negative (no staining or incomplete weak membrane staining in ≤10% tumor cells), HER2 3+ (complete membranous staining) and HER2 low (1-2+ staining without amplification on ISH) based on consensus of two pathology consultants. The present study aims to evaluate the clinicopathological parameters of the HER2 low breast cancers.


Eligibility criteria: Inclusion Criteria:

* All histologically proven cases of breast cancer in the 2 years from January 2022- December 2023

Exclusion Criteria:

* Benign breast tumors

Primary outcomes:
measure: Age (in years)
timeFrame: JANUARY 2022- DECEMBER 2023
measure: Tumor stage (categorised from T1-T4)
timeFrame: JANUARY 2022- DECEMBER 2023
measure: N stage (categorised from N0-N3)
timeFrame: JANUARY 2022- DECEMBER 2023
measure: Tumor grade (categorised from G1-G3)
timeFrame: JANUARY 2022- DECEMBER 2023
measure: Surrogate molecular classification (Categorised as luminal/ triple negative)
timeFrame: JANUARY 2022- DECEMBER 2023
measure: Androgen receptor expression (Denoted as present or absent)
timeFrame: JANUARY 2022- DECEMBER 2023
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: VMMC SJH
Study officials:
References:
Clinical trial NCT00215904: D-serine Adjuvant Treatment for Parkinson's Disease
Official title: D-serine Adjuvant Treatment for Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Lead sponsor: Herzog Hospital
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 13
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The proposed experiment will evaluate the effects of the NMDA receptor full agonist D-serine (\~2g/day) on persistent symptoms of Parkinson's Disease and on antiparkinsonian drugs-induced dyskinesias.

D-serine will be used as add-on therapy to on-going medications received by Parkinson's Disease patients. The rational for this study stems from observations made in pervious clinical trials with schizophrenia patients, in which it was demonstrated that D-serine adjuvant treatment resulted in:1)improvement of parkinsonian side effects induced by antipsychotic drugs and 2) improvement of depression and negative (i.e apathy, blunted effects, anhedonia) symptoms which are similar to symptoms encountered in Parkinson's Disease.

The study will have a crossover design in accordance to which each patient will receive, in random order D-serine and placebo for a 6 weeks period each. Thus, any participant will have the opportunity to receive the experimental treatment.


Eligibility criteria: Inclusion Criteria:

* PD diagnosis
* ≥2 on UPDRS items 32,33
* receive treatment with L-dopa alone or in combination with other antiparkinsonian medications.

Exclusion Criteria:

* current or previous history of other neurological disorders
* unstable medical conditions
* renal pathology
* pregnant female patients excluded

Primary outcomes:
measure: UPDRS scores
timeFrame: 6 weeks
measure: PANSS scores
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Ezrath Nashim - Herzog Memorial Hospital
Study officials:
affiliation: Ezrath Nashim - Herzog Memorial Hospital
name: Uriel Heresco-Levy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gelfin E, Kaufman Y, Korn-Lubetzki I, Bloch B, Kremer I, Javitt DC, Heresco-Levy U. D-serine adjuvant treatment alleviates behavioural and motor symptoms in Parkinson's disease. Int J Neuropsychopharmacol. 2012 May;15(4):543-9. doi: 10.1017/S1461145711001015. Epub 2011 Jul 7.
Clinical trial NCT02060604: Pilot Study of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration
Official title: A Randomised Controlled Trial of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wet Macular Degeneration
Keywords: ketorolac
NSAIDs
wet macular degeneration
choroidal neovascularization
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The addition of an anti-inflammatory agent could be a valid option for controlling choroidal neovascularization, as simply inhibiting VEGF addresses neither the multifactorial pathogenesis of choroidal neovascularization nor the underlying cause of VEGF production.


Eligibility criteria: Inclusion Criteria:

1. ability to provide written informed consent and comply with study assessments for the full duration of the study;
2. age \>40 years;
3. presence of treatment-naïve neovascular AMD with a visual acuity between 20/25 and 20/200 on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Inclusion criteria for AMD were neovascularisation, fluid, or haemorrhage under the fovea.

Exclusion Criteria:

1. any previous intravitreal treatment;
2. previous laser treatment in the study eye;
3. myopia \>7 dioptres in the study eye;
4. concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma);
5. concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal;
6. known sensitivity to any component of the formulations under investigation.

Primary outcomes:
measure: mean change in study eye visual acuity as measured by the best-corrected ETDRS letter score
timeFrame: 12 months
Secondary outcomes:
measure: mean change in central macular thickness
timeFrame: 12 months
measure: mean number of intravitreal injections over the 12-month period
timeFrame: 12 months
measure: adverse ocular events at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
state: BS
Study officials:
affiliation: University of Brescia, Italy
name: Andrea Russo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Brescia, Italy
name: Luisa Delcassi, MD
role: STUDY_CHAIR
affiliation: University of Brescia, Italy
name: Francesco Semeraro, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00953004: Flax Mucilage and Apparent Nutrient Digestibility
Official title: Effect of Flaxseed and Flaxseed Mucilage on Energy Digestibility, Lipid Profile and Appetite
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: dietary fiber
obesity
apparent energy digestibility
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim is to study the effects of flaxseed mucilage, rich in dietary fiber on apparent fat and energy digestibility in young adults.

Detailed description: A 3 times 1-wk randomised crossover dietary intervention study, where the full diet is provided to 17 young subjects along with different flaxseed mucilage preparations. During the last five days, fecal samples are collected. Fasting blood samples are collected on day 1 and 8 in each period and appetite sensation is registered three times daily before the main meals.

Eligibility criteria: Inclusion Criteria:

* 18-40y
* BMI 22-28
* healthy

Exclusion Criteria:

* smoking
* medication
* excess PA

Primary outcomes:
measure: Fat and energy digestibility
timeFrame: mean over period
Secondary outcomes:
measure: appetite
timeFrame: three times daily
measure: gastrointestinal distress
timeFrame: continously
measure: lipid profile
timeFrame: end of each period
measure: glucose and insulin
timeFrame: end of each period
measure: fecal output and transit time
timeFrame: mean of each period
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: University of Copenhagen, Department og Human Nutrition
Study officials:
affiliation: University of Copenhagen
name: Arne Astrup, PhD, Dr med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kristensen M, Jensen MG, Aarestrup J, Petersen KE, Sondergaard L, Mikkelsen MS, Astrup A. Flaxseed dietary fibers lower cholesterol and increase fecal fat excretion, but magnitude of effect depend on food type. Nutr Metab (Lond). 2012 Feb 3;9:8. doi: 10.1186/1743-7075-9-8.
Clinical trial NCT06660004: Creatine HCl and Creatine Ethyl Ester Supplementation in Perimenopausal and Menopausal Women
Official title: The Effects of 8-Week Creatine HCl and Creatine Ethyl Ester Supplementation on Cognitive Performance, Multidimensional Fatigue, Brain Metabolism, and Biochemical Indices in Perimenopausal and Menopausal Women
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Menopausal
Perimenopause
Keywords: creatine
brain metabolism
cognition
fatigue
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 36
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of of dietary supplementation with creatine HCl and creatine ethyl ester supplementation on cognitive performance, multidimensional fatigue, brain metabolism, and biochemical indices in perimenopausal and menopausal women


Eligibility criteria: Inclusion Criteria:

* Body mass index 18.5 - 29.9 kg/m2
* Free of major chronic diseases or acute disorders (including AD and dementia (MMSE score \> 25 points)
* MENOPAUSAL: no menstrual cycle for consecutive 12 months (with no other obvious causes)
* PERIMENOPAUSAL: Still menstruating (regular or irregular) but have at least one of the following symptoms: (1) hot flashes, (2) sleep disturbances, (3) mood swings, and (4) concentration difficulties
* Given written informed consent

Exclusion Criteria:

* History of dietary supplement use 4 weeks before the study commences
* Pregnancy (or planning pregnancy)
* Abnormal values for lab clinical chemistry (\> 2 SD)
* Unwillingness to return for follow-up analysis
* Participation in other clinical trials

Primary outcomes:
measure: Fatigue
timeFrame: Change from baseline fatigue at 8 weeks
Secondary outcomes:
measure: Time to exhaustion
timeFrame: Change from baseline time to exhaustion at 8 weeks
measure: Brain creatine
timeFrame: Change from baseline brain creatine concentrations at 8 weeks
measure: Cognitive interference
timeFrame: Change from baseline fatigue at 8 weeks
measure: Amyloid b
timeFrame: Change from baseline time to exhaustion at 8 weeks
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: FSPE Applied BIoenergetcis Lab
state: Vojvodina
Study officials:
affiliation: Applied BIoenergetics Lab
name: Sergej Ostojic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ostojic SM, Stea TH, Ellery SJ, Smith-Ryan AE. Association between dietary intake of creatine and female reproductive health: Evidence from NHANES 2017-2020. Food Sci Nutr. 2024 Apr 30;12(7):4893-4898. doi: 10.1002/fsn3.4135. eCollection 2024 Jul.
Clinical trial NCT00000604: Influence of CPB Temperature on CABG Morbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Neurologic Manifestations
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 1999-10-28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: To compare three accepted modes of myocardial preservation, warm, tepid, and cold blood cardioplegia, coinciding with normothermic (37 degrees centigrade), tepid (32 degrees centigrade) and hypothermic (8 to 10 degrees centigrade) cardiopulmonary bypass (CPB) to define differences in neurologic function in coronary artery bypass graft (CABG) patients.

Detailed description: BACKGROUND:

A pilot study of warm versus cold perfusion and preservation was completed in 32 patients prior to the ongoing study. The findings of the pilot study showed 53 percent of patients had evidence of new neurologic disturbance at postoperative day four. Only the neurologic dysfunction could be correlated with warm versus cold perfusion (37.5 percent warm versus 75 percent cold, P less than 0.05). The changes in neurologic function had abated or clearly improved by one month of follow-up, and the distinction in neurologic dysfunction grading was no longer apparent between the two groups.

DESIGN NARRATIVE:

Patients were randomly assigned to cold, tepid, or warm blood cardioplegia, coinciding with normothermic, tepid, and hypothermic cardiopulmonary bypass. All patients received a standard anesthetic protocol combining narcotic and inhalational anesthesia. Each patient entering the study had extensive clinical data collected prospectively incorporating most aspects of measurable determinants related to myocardial preservation. Additionally, neurologic tests were performed by a blinded neurologist and rated by an objective scoring system, the Mathew scale. The studies were performed preoperatively, on the third or fourth postoperative day, and at one month following surgery. Hematologic data were measured for fibrinolytic potential.

Eligibility criteria: Patients, referred for elective or urgent coronary revascularization, not having ongoing angina instability, requiring three or more bypass grafts, and under 70 years of age.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Engelman RM, Pleet AB, Rousou JA, Flack JE 3rd, Deaton DW, Kulshrestha P, Gregory CA, Pekow PS. Does cardiopulmonary bypass temperature correlate with postoperative central nervous system dysfunction? J Card Surg. 1995 Jul;10(4 Suppl):493-7. doi: 10.1111/j.1540-8191.1995.tb00683.x.
citation: Engelman RM, Pleet AB, Rousou JA, Flack JE 3rd, Deaton DW, Gregory CA, Pekow PS. What is the best perfusion temperature for coronary revascularization? J Thorac Cardiovasc Surg. 1996 Dec;112(6):1622-32; discussion 1632-3. doi: 10.1016/S0022-5223(96)70021-1.
Clinical trial NCT06245304: Physiologic Pacing for Symptomatic First-Degree Heart Block
Official title: Physiologic Pacing for Symptomatic First-Degree Heart Block
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Symptomatic First-degree Heart Block
Lead sponsor: Ascension Health
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2024-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms).

Detailed description: The purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms). Patient will undergo a comparative effectiveness study where patients with symptomatic first-degree heart block (pr interval ≥250ms) undergo left bundle pacing (3830 lead) and are randomized to DDD-50 vs Managed Ventricular pacing-50 (MVP-50; AAI-DDD 50) and undergo a crossover at 3 months. This study will compare two standard of care options utilizing Food and Drug Administration (FDA) approved devices. Patients are evaluated at baseline, 3 months, and 6 months in terms of patient symptoms, exercise capacity, arrhythmia burden, and patient activity.

Eligibility criteria: Inclusion Criteria:

* Aged 18 or above
* Ventricular Ejection Fraction (EF) \> 50%
* New York Heart Association (NYHA) class II-IV
* PR interval ≥250ms
* Narrow QRS duration (≤140ms) or prolonged QRS duration with typical Right Bundle Branch Block (RBBB) morphology on 12 lead ECG and sinus rhythm

Exclusion Criteria:

* Permanent atrial fibrillation (AF)
* Patients who are unable to perform a 6 minute hall walk
* Other serious medical condition with life expectancy of less than 1 year
* Lack of capacity to consent
* Pregnancy
* Contraindication to use of the relevant study device or leads (as per current manuals from manufacturer)

Primary outcomes:
measure: Quality of Life per the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
timeFrame: 6 months after pacemaker implantation.
Secondary outcomes:
measure: Exercise capacity
timeFrame: 6 months after pacemaker implantation.
measure: Atrial fibrillation burden
timeFrame: 6 months after pacemaker implantation.
measure: Patient activity
timeFrame: 6 months after pacemaker implantation.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Ascension Saint Thomas Midtown
state: Tennessee
Study officials:
References:
Clinical trial NCT00888004: Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients
Official title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy and Tolerability of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Severe L-dopa Induced Dyskinesias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
L-dopa Induced Dyskinesia
Keywords: Parkinson's
L-dopa
dyskinesia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-04-24
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of administration of AFQ056 in combination with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease patients.


Eligibility criteria: Inclusion Criteria:

* Patients with Parkinson's Disease
* Patients with L-dopa induced dyskinesia for at least 3 months
* Patients with L-dopa treatment for at least 3 years, stable for 1 month minimum

Exclusion Criteria:

* History of severe allergy to food or drugs
* Very low or high body weight.
* Prior surgery for Parkinson's Disease
* Smokers Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa
timeFrame: 20 days
Secondary outcomes:
measure: Safety and tolerability of administration of AFQ056 in combination with L-dopa
timeFrame: 20 days
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Leun-Biskirchen
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Tubingen
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Berg D, Godau J, Trenkwalder C, Eggert K, Csoti I, Storch A, Huber H, Morelli-Canelo M, Stamelou M, Ries V, Wolz M, Schneider C, Di Paolo T, Gasparini F, Hariry S, Vandemeulebroecke M, Abi-Saab W, Cooke K, Johns D, Gomez-Mancilla B. AFQ056 treatment of levodopa-induced dyskinesias: results of 2 randomized controlled trials. Mov Disord. 2011 Jun;26(7):1243-50. doi: 10.1002/mds.23616. Epub 2011 Apr 11.