louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01039831: White Matter Pathology in Parkinson's Disease (PD)
Official title: The Role of White Matter Pathology in the Development of the Postural Instability and Gait Disturbance (PIGD) Type of Parkinson's Disease (PD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: White Matter Lesions
Postural Instability Gait Disorders
Keywords: PIGD
tremor
falls
white matter
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-12-25
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 120 patients with idiopathic Parkinson's disease (PD) will be studied. Subjects will be divided into two groups: Patients with PIGD and patients with tremor dominant.

Brief summary: The relationship between WM lesions (WM) and Postural Instability Gait Disorders (PIGD-PD)in Parkinson's disease patients is largely unknown. We hypothesize that sub-clinical WM pathology may be a major contributing factor to PIGD-PD. We will compare two groups of patients with Parkinson's disease (PD): those with PIGD and patients with dominant tremor (n=120)to assess the role of brain WM changes.

Detailed description: To compare brain WM burden using MRI in PD patients with and without PIGD. Diffusion tensor imaging (DTI) analysis techniques will be applied.We will quantify PIGD-related symptoms including cognitive function, balance and gait and their associations with MRI findings.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of idiopathic PD, as defined by the UK Brain Bank criteria
2. Age between 50 and 80 years
3. Hoehn and Yahr stage II-III
4. On anti-parkinsonian medications
5. Mini-Mental State Exam score ≥ 25

Exclusion Criteria:

1. Brain surgery in the past including implanted Deep Brain Stimulation
2. Clinically significant co-morbidities likely to affect gait e.g., acute illness, significant rheumatic, orthopedic disease, dementia, or major depression
3. Unable to walk independently
4. Inability to comply with the protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Director of the Neurology Department, Tel Aviv Sourasky Medical Center, Israel
name: Nir Giladi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02897882: Acute and Chronic Pain in Lung Transplantation: Prevalence, Associated Factors, Taken Care
Official title: Acute and Chronic Pain in Lung Transplantation: Prevalence, Associated Factors, Medical Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this project is to estimate the frequency and the characters of the chronic pains by a follow-up which begins during the registration on the waiting list of transplant and which ends at the end of the third year following the lung transplantation. It is a forward-looking study of prevalence entering within the framework of the common care. After lung transplant, pain will be evaluate with questionnaires every day during the hospitalisation, and then after 1 month, 3 months, 6 months, 1 year, 2 years and 3 years.


Eligibility criteria: Inclusion Criteria:

* Patients benefiting from a lung transplant
* Patients on a list for a lung transplant from may 2010

Exclusion Criteria:

* Patients refusing to participate in the study

Primary outcomes:
measure: Chronic pain measured by a digital scale
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Marc Fischler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06601582: Effectiveness of a Intraoperative Blood Recovery System in Cardiovascular Surgery in Brazil
Official title: Effectiveness of a Intraoperative Blood Recovery System in Cardiovascular Surgery Using Cardiopulmonary Bypass in Brazil. Randomized Crontrolled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Surgery
Blood Loss, Surgical
Keywords: Cardiovascular Surgery
Operative Blood Salvage
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized trial to evaluate the effectiveness of a intra operative blood recovery system in reducing the need for allogeneic transfusion in cardiovascular surgeries using cardiopulmonary bypass

Detailed description: To evaluate the effectiveness of a intra operative blood recovery system in reducing the need for allogeneic transfusion in cardiovascular surgeries using cardiopulmonary bypass, a randomized clinical trial will be conducted. The study will be conducted at a teaching hospital, which is a reference for major cardiac surgeries and receives patients from the Brazilian Unified Health System (SUS). The patients will be randomly assigned to two groups: with and without the use of the system, and allocation concealment will be performed. Continuous variables will be analyzed through frequency distributions and appropriate descriptive measures (mean or median), while categorical variables will be presented through frequency distributions. For categorical variables, the confidence interval will be calculated, conventionally set at 95%. For continuous variables, the T-test will be used to measure differences, while for categorical variables, the McNemar statistical test will be used. For all analyses, a significance level of 5% will be used, and the data will be analyzed according to the intention-to-treat principle.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing CABG or Valve surgery singly.

Exclusion Criteria:

* Emergency cardiac surgery;
* Previous heart surgery;
* End-stage chronic kidney disease;
* Inability to receive a blood transfusion (refusal);
* Anemia (hemoglobin less than 10g/dl);
* Thrombocytopenia (platelet count less than 100,000/mm3);
* Coagulopathy (RNI \> 1.5);

Primary outcomes:
measure: Blood transfusion rate
timeFrame: 2 days
Secondary outcomes:
measure: Hospital mortality
timeFrame: 30 days
measure: Hospital Stay
timeFrame: 30 days
measure: ICU stay
timeFrame: 30 days
measure: Mechanical ventilation
timeFrame: 30 days
measure: Re-operation for bleeding
timeFrame: 30 days
measure: Need for renal replacement therapy
timeFrame: 30 days
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Integral Medicine Institute Professor. Fernando Figueira-IMIP
state: Pernambuco
Study officials:
References:
Clinical trial NCT04028531: Understanding Chronic Lymphocytic Leukemia
Official title: Understanding Chronic Lymphocytic Leukemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-07-22
Enrollment: 2750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Monoclonal B-cell lymphocytosis or Chronic Lymphocytic Leukemia in any phase of their disease.

Brief summary: The purpose of this study is to collect human Chronic Lymphocytic Leukemia tissue samples and medical information, in order to find out more about the causes and biology of chronic lymphocytic leukemia.

Detailed description: The purpose of this study is to collect human Chronic Lymphocytic Leukemia tissue samples and medical information, in order to find out more about the causes and biology of chronic lymphocytic leukemia, for the potential development of more effective therapies for this disease.

Eligibility criteria: Inclusion Criteria:

* New and existing patients seen for treatment of monoclonal B-cell lymphocytosis
* Any low grade lymphoproliferative disorder
* Chronic Lymphocytic Leukemia in the Dana Farber Cancer Institute Hematologic Oncology Clinic or elsewhere

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence of novel genomic prognostic markers in Chronic Lymphocytic Leukemia
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Jennifer Brown, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03140631: Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation
Official title: Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Catheter Ablation
Keywords: atrial fibrillation
catheter ablation
protamine sulfate
anticoagulation reversal
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 153
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: The objective of this study is to evaluate the safety, efficacy and efficiency of rapid anticoagulation reversal with protamine sulfate versus routine activated clotting time (ACT) monitoring in patients undergoing catheter based ablation of atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Patient's referred for radiofrequency ablation (RFA) or cryoablation for atrial fibrillation or atrial flutter (left atrial).
* Age ≥ 18 year
* Patients who are mentally and linguistically able to understand the aim of the trial, comply with the trial protocol, verbally acknowledge the risks, benefits, and alternatives in this trial.

Exclusion Criteria:

* Previous intolerance or allergy to heparin products.
* Current or prior administration of protamine products
* History of femoral access site complications including hematoma, AV fistula, pseudoaneurysm, aneurysm.
* Known lower extremity venous thrombosis.
* Coagulopathy or blood dyscrasias.
* Active malignancy.
* Thrombocytosis (platelet count \>600k/ul) or thrombocytopenia (platelet count \<100k/ul)
* Planned use of vascular closure device

Primary outcomes:
measure: Time to Ambulation
timeFrame: 0 to 24 hours
Secondary outcomes:
measure: Count of Participants Who Experienced Vascular Access Site Complications
timeFrame: checked at 30 and 90 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
Study officials:
affiliation: University of Michigan
name: Hakan Oral, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02186431: Contact Lenses and Infiltrative Keratitis
Official title: Contact Lenses and Infiltrative Keratitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratitis
Keywords: Contact lenses
Lead sponsor: State University of New York College of Optometry
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events, to those without a history of complications. This will be accomplished via measurement of select anti-inflammatory tear proteins before, during and after contact lens wear.


Eligibility criteria: Inclusion Criteria:

* Soft contact lens wearers
* Healthy (control), or with history of infiltrative keratitis (case)
* Has a wearable pair of glasses
* Refractive error between +8.00 D and -12.00 D, with less than 1.50 D of astigmatism

Exclusion Criteria:

* Smoker
* Pregnant or nursing
* Systemic disease that would effect tear proteins
* Punctal plugs
* Use of eye drops in the last week

Primary outcomes:
measure: Tear protein levels
timeFrame: After 4-6 hours of daily wear and after one night extended wear
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: SUNY College of Optometry, Clinical Vision Research Center
state: New York
Study officials:
affiliation: State University of New York College of Optometry
name: Kathryn Richdale, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01453231: Quality of Life and Body Image in Women Underwent Thighplasty
Official title: Quality of Life and Body Image in Women Underwent Thighplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: bariatric surgery
plastic surgery
thigh
obesity
body image
quality of life
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-10-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity is a chronic disease now considered a major public health concern in the global context, as it causes or exacerbates many diseases limitations in providing quality of life and higher treatment costs. The increase in the number of patients undergoing bariatric surgery and the excess skin and subcutaneous tissue adjacent to slimming collaborate in the search for growth by plastic surgery. Currently several techniques of thighplasty has been submitted but no studies were found that evaluated the characteristic clinical and emotional resulting from this procedure. This study has as a goal to evaluate the body image and quality of life in women submitted to thighplasty.

Detailed description: The patients have been evaluated for two different questionnaires, the Body Dysmorphic Disorder Examination (BDDE) and Impact Weight on Quality of Life - Lite (IWQoL-Lite). The sample consists of 50 patients with the desire to undergo to the thighplasty. However 25 are from study group and 25 control group. Just the study group was undergoing plastic surgery. The questionnaires have applied by signing the consent form, after 3 and 6 months both groups. This study is a clinical trial, control, primary, longitudinal, no random, analytical, held in a single center.

Eligibility criteria: Inclusion Criteria:

* abdominoplasty previous
* control of systemic disease
* Adults at the age of 35 and 50 years old
* had reached massive weight loss less by bariatric surgery or similar than 30 kg/m2 for a minimum of 12 months or more.
* gender: female
* For control group: it supposed to be on the waiting list for thighplasty
* For study group:they are supposed to be scheduled for thighplasty

Exclusion Criteria:

* illiterate
* pregnant women and/or women who have been nursing for one year or less
* non-controled of systemic disease

Primary outcomes:
measure: questionnaire about quality of life and body image
timeFrame: during 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University Federal of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Ana Tedesco, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00219531: Effect of Menstrual Cycle on Central Nervous System (CNS) Processing of Gut Stimuli in Irritable Bowel Syndrome (IBS) and Control
Official title: Effect of Menstrual Cycle and Irritable Bowel Syndrome on the Central Nervous System Processing of Gut Stimuli
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Irritable Bowel Syndrome
Keywords: functional MRI
pain perception
anxiety
brain-gut axis
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: American College of Gastroenterology
First posted: 2005-09-22
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with menstrual cycle

Brief summary: The hypothesis of the study is that women perceive intestinal stimulation (rectal balloon distention) differently in different phases of the menstrual cycle, i.e there is an effect of hormones on the sensory pathway, and that this difference is reflected in the Central Nervous System processing of this signal. We also hypothesize that there is a difference in perception between control subjects and subjects with the irritable bowel syndrome.

Detailed description: There is discrepancy in the literature concerning the effect of the menstrual cycle on bowel function and pain syndromes such at irritable bowel syndrome. In addition, recent studies indicate a difference in the CNS processing of rectal stimulation in normal subjects and patients with IBS. This study will determine the differences in the perception of rectal balloon distention in the follicular and luteal phases of the menstrual cycle, in control subjects with no bowel symptoms and volunteers with IBS, and will compare the CNS processing of this signal using functional MRI , again in the two phases of the menstrual cycle.

Comparisons: between control subjects without GI symptoms and those with irritable bowel syndrome.

Eligibility criteria: Inclusion Criteria:

* controls - normal bowel function
* Irritable bowel syndrome - Rome II criteria
* Normal menstrual cycle

Exclusion Criteria:

* irregular menses
* pregnancy
* use of psychotropic medication
* claustrophobia
* metal implants
* metal in eyes

Primary outcomes:
measure: Sensitivity to rectal distention
timeFrame: during the study period only
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine and Penn State Milton S. Hershey Medical Center
name: Ann Ouyang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wrzos HF, Li Q, Ouyang A. Visceral and somatic pain thresholds in healthy and IBS volunteers across the menstrual cycle. The American Journal of Gastroenterology 98: S265, 2003
Clinical trial NCT03950531: The Effect of Bronchiectasis on the Exacerbation and Mortality in COPD
Official title: The Effect of Bronchiectasis on the Exacerbation and Mortality of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiectasis
Chronic Obstructive Pulmonary Disease
Keywords: Bronchiectasis
Chronic Obstructive Pulmonary Disease
Exacerbation
Computed Tomography
Lead sponsor: Ministry of Health, Turkey
Sponsor class: OTHER_GOV
First posted: 2019-05-15
Enrollment: 122
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with COPD exacerbation

Brief summary: Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways and lungs that develops against harmful particles or gases with exacerbations. Coexistence of bronchiectasis with COPD may lead to worsening of the functional parameters as well as alteration of the microbiological pattern in exacerbations and may negatively affect the exacerbation result parameters.

Detailed description: Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways and lungs that develops against harmful particles or gases with exacerbations. COPD exacerbations are characterized by worsening of dyspnea, coughing and expectoration. Exacerbations requiring hospitalization are the main cause of morbidity and mortality in COPD. Bronchiectasis is the irreversible extension of the bronchi. Usually follows with chronic sputum cough, airway obstruction and recurrent infection episodes. The association of bronchiectasis and COPD has long been known and its incidence is in the range of 30-50%. Coexistence of bronchiectasis with COPD may lead to worsening of the functional parameters as well as alteration of the microbiological pattern in exacerbations and may negatively affect the exacerbation result parameters.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent thoracic tomography in the last year according to index exacerbation date were included in the study

Exclusion Criteria:

* Cases that mimic COPD exacerbation (pneumonia, pulmonary thromboembolism, pulmonary congestion, pneumothorax, pleural effusion, lung malignancy, asthma, asthma-COPD overlap syndrome) and patients admitted to the intensive care unit were excluded from the study.

Primary outcomes:
measure: Charlson Comorbidity Index
timeFrame: 1 hour
Secondary outcomes:
measure: Spirometry
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: Gazi University Faculty of Medicine
name: Nurdan Kokturk, Professor
role: STUDY_CHAIR
References: