louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02973438: Effects of Intermittent Hypoxia (IH) on Metabolism and Dysglycemia, in Overweight/Obese Persons SCI
Official title: Effects of Acute Intermittent Hypoxia (AIH) on Metabolism and Dysglycemia, in Overweight/Obese Persons With Spinal Cord Injuries (SCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Obesity
Insulin Resistance
Keywords: Spinal Cord Injuries
Obesity
Insulin Resistance
Intermittent hypoxia
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2016-11-25
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to examine changes in blood glucose control and metabolism in individuals with SCI and non injured controls at rest and during exercise after five days of exposure to IH. This response will be compared with breathing normal room air (a SHAM control).


Eligibility criteria: Inclusion Criteria:

SCI only:

1. Lower extremity weakness or paralysis at C5 or below resulting from spinal cord injury for at least one year.
2. ASIA Classification A-D Overweight or obese as classified by a Body Mass Index (BMI) (kg/m2) of ≥ 25.0 (CON) and ≥ 22.0 (SCI).

SCI and non injured control:

Resting SaO2 ≥ 95%

Exclusion Criteria (SCI and non injured control):

1. Currently hospitalized
2. Resting heart rate ≥120 BPM
3. Resting systolic blood pressure \>180 mm Hg
4. Resting diastolic Blood Pressure \>100 mmHg
5. Self-reported history of unstable angina or myocardial infarction within the previous month
6. Previous cardiac surgery or condition that evidences ischemic heart disease
7. Cardiopulmonary complication such as COPD
8. Pregnancy determined by urine testing in sexually active females.

Primary outcomes:
measure: Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR)
timeFrame: Baseline, day 5
Secondary outcomes:
measure: Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test
timeFrame: Baseline, day 5
Other outcomes:
Locations:
city: Miami
country: United States
facility: The Miami Project to Cure Paralysis
state: Florida
Study officials:
affiliation: University of Miami
name: Mark S Nash, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02050438: How Total Knee Prosthesis Dessigns Influence in Quality of Live
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis Knee
Total Knee Replacement
Keywords: Osteoarthritis Knee
Total Knee Arthroplasty
Quality of Life
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 135
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated Total Knee Arthroplasty 6 months previously the observational study

Brief summary: The purpose of this study is to determine whether different kind of prostesis designs influences in the quality of life of patients

Detailed description: Objectiu Criteris d'inclusió Mesura dels resultats

Eligibility criteria: Inclusion Criteria:

* Aged 65-80 years.
* Primary Ostheortritis
* Mechanical Axis 0+/- 7 degrees

Exclusion Criteria:

* Patients with any new important disease after the surgical procedure.
* Important complications related with the surgical procedure, as fractures, infections and vascular lesions.
* Patients not following a rehabilitation program

Primary outcomes:
measure: Quality of Life
timeFrame: 6 months
Secondary outcomes:
measure: Functional Results
timeFrame: 6 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
Study officials:
affiliation: Corporacio Sanitaria Parc Tauli
name: Jordi Villaba-Modol, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02498938: The Association of SERPINA1 Gene Disturbance in Patients With Lung and Gum Disorders
Official title: Evaluation of SERPINA1 Gene Polymorphisms in COPD as a Risk Factor for Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Generalized Chronic Periodontitis
Keywords: Pulmonary disease,chronic obstructive,
generalized chronic periodontitis
SERPINA1 gene polymorphism
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients,both male and female aged between 30-70yrs with COPD nd chronic periodontitis

Brief summary: Chronic obstructive pulmonary disease and periodontitis are chronic inflammatory diseases. The study aims to determine if the genetic polymorphism of SERPINA1 gene in patients with COPD serve as a risk factor for developing periodontitis.

Detailed description: periodontitis is a polymicrobial inflammatory disease caused by various modifiable and non-modifiable risk factors. the non-modifiable risk factors include genetic polymorphisms like the gene coding for alpha-1-antitrypsinase

COPD is a chronic inflammatory disease characterized by deterioration of lung function due to loss of elasticity of the lungs.

SERPINA1 gene product has a protective role on the connective tissue components of both lungs and gums.

Hence, this study tries to determine if the gene polymorphism in COPD serves as a risk factor for developing periodontitis.

Eligibility criteria: Inclusion Criteria:

* Male and female patients aged between 30-70yrs diagnosed with COPD and chronic periodontitis who are willing to participate in the study.

Exclusion Criteria:

* Pateints with other systemic disorders
* patients not willing to participate in the study

Primary outcomes:
measure: SERPINA1 gene polymorphism
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Dr. Sneha Agarwal PG(periodontics)
state: Telangana
Study officials:
affiliation: Panineeya Mahavidyalaya institute of dental sciences and research centre
name: Dr. Sneha Agarwal, PG(perio)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scott DA, von Ahsen N, Palmer RM, Wilson RF. Analysis of two common alpha 1-antitrypsin deficiency alleles (PI*Z and PI*S) in subjects with periodontitis. J Clin Periodontol. 2002 Dec;29(12):1118-21. doi: 10.1034/j.1600-051x.2002.291212.x.
citation: Travis J, Pike R, Imamura T, Potempa J. The role of proteolytic enzymes in the development of pulmonary emphysema and periodontal disease. Am J Respir Crit Care Med. 1994 Dec;150(6 Pt 2):S143-6. doi: 10.1164/ajrccm/150.6_Pt_2.S143.
Clinical trial NCT06319638: Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients
Official title: A Randomized Controlled Study to Explore the Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: Chao Phya Abhaibhubejhr Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-20
Enrollment: 100
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 goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:

Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.

Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Detailed description: Dysphagia, or swallowing difficulty, is a common symptom in Traumatic Brain Injury Patients. The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.

Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years, meeting the diagnosis of Traumatic Brain Injury;
* presence of no contraindication for Stellate Ganglion Block;
* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;
* informed consent form was obtained from the patient.

Exclusion Criteria:

* unable to cooperate in completing treatment and assessment due to personal reasons or other disorders;
* complicated with other intracranial lesions, such as stroke;
* with severe consciousness disorders caused by other diseases.

Primary outcomes:
measure: Penetration-Aspiration Scale
timeFrame: day 1 and day 10
Secondary outcomes:
measure: Modified Barthel Index
timeFrame: day 1 and day 10
measure: Swallowing duration
timeFrame: day 1 and day 10
measure: Functional Oral Intake Scale
timeFrame: day 1 and day 10
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04671238: Absolute Quantification in Bone Scintigraphy
Official title: Absolute Quantification in Bone Scintigraphy: Phantom Evaluation and Clinical Application in Patients Undergoing Follow-up for Vertebral Fractures.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scintigraphy Quantification
Keywords: bone scintigraphy
absolute quantification
Standard Uptake Value
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for SPECT/CT scan of the spine as part of a vertebroplasty workup and selected retrospectively.

Brief summary: While absolute quantification in 18F-FDG PET (Positon Emission Tomography) is widely used in clinical routine, absolute quantification in SPECT (Single Photon Emission Computed Tomography) is under development and its clinical interest remains to be demonstrated. Recent studies carried out on bone scan recordings show the potential interest of quantification indexes such as SUV (Standard Uptake Value).

Detailed description: In oncology, bone scan studies have reported significantly higher SUV values for secondary bone lesions compared with benign osteoarticular lesions , and some have even defined an SUVmax threshold value that points to prostatic bone metastases.

Eligibility criteria: Inclusion Criteria:

* Patients with recent vertebral fractures:

  1. who have had at least two SPECT/CT scan scans of the spine as part of a pre-vertebroplasty check-up,
  2. for which fracture dates were known.

Exclusion Criteria:

1. Minor person
2. Person opposing the use of their data (Posters in waiting rooms explaining that the patient must object if they do not wish their data to be used)

Primary outcomes:
measure: To validate the absolute bone scan quantification in a retrospectively selected patient population
timeFrame: After 1 year
Secondary outcomes:
measure: To calibrate the tomographic images from the gamma camera
timeFrame: 1 day
measure: To evaluate the attenuation correction on phantoms of different density
timeFrame: 1 day
measure: To evaluate absolute quantification on phantoms
timeFrame: 1 day
Other outcomes:
Locations:
city: Vandoeuvre-Lès-Nancy
country: France
facility: CHU de Nancy - Hôpital Brabois
city: Vandœuvre-lès-Nancy
country: France
facility: Chru Nancy
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU of Nancy
Study officials:
affiliation: CHRU of Nancy
name: BALHOUL Achraf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00719238: A Pilot Study to Promote Maternal and Infant Oral Health
Official title: A Pilot Study to Promote Maternal and Infant Oral Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Connecticut Health Foundation
First posted: 2008-07-21
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The long term goals of this project are to develop and implement a combined prenatal and postnatal intervention to decrease early childhood caries. The program is based on risk assessment, diet intervention and counseling. To accomplish these goals a pilot study is needed to determine: 1) The ability to recruit and retain pregnant mothers in an intervention program; 2) The levels of S. mutans in pregnant mothers; 3) The ability of a diet intervention to decrease S. mutans in pregnant mothers.


Eligibility criteria: Inclusion Criteria:

* Age 18 or over;
* Pregnant
* High S. mutans levels

Exclusion Criteria:

* Younger than 18;
* Other health conditions

Primary outcomes:
measure: Sugar intake
timeFrame: 3 months post partum
Secondary outcomes:
measure: mutans streptococci levels
timeFrame: 3 months post partum
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Susan Reisine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00461838: Outcome After Multidisciplinary CO2 Laser Laparoscopic Excision of Deep Infiltrating Colorectal Endometriosis
Official title: Outcome After Multidisciplinary CO2 Laser Laparoscopic Excision of Deep Infiltrating Colorectal Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: colorectal endometriosis
deep infiltrating endometriosis
dysmenorroe
dyspareunia
quality of life
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2007-04-18
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women (n=56) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of colorectal surgeon and/or urologist were selected retrospectively from the list of all patients (n=more than 2000) operated at the Leuven University Fertility Centre (LUFc) between September 1996 and July 2004.

Brief summary: Improved pain, sexuality and quality of life, high fertility and low complication and recurrence rates after multidisciplinary CO2 laser laparoscopic excision of deep infiltrating colorectal endometriosis.

Detailed description: All women (n=56) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of colorectal surgeon and/or urologist were selected retrospectively from the list of all patients (n=more than 2000) operated at the Leuven University Fertility Centre (LUFc) between September 1996 and July 2004.

All 56 multidisciplinary operated patients were asked to complete the Oxford Endometriosis Quality of Life questionnaire, a sexual activity questionnaire and visual analogue scales (VAS) for dysmenorroe, chronic pelvic pain and deep dyspareunia, to compare their status before surgery and at the moment of the evaluation (January 2005).

Eligibility criteria: Inclusion Criteria:

* All women (n=56) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of colorectal surgeon and/or urologist
* operated at the Leuven University Fertility Centre (LUFc) between September 1996 and July 2004

Exclusion Criteria:

* Women who had undergone CO2 laser laparoscopic excision of deep infiltrating endometriosis without active involvement of colorectal surgeon and/or urologist

Primary outcomes:
measure: complication rate, cumulative recurrence and cumulative fertility rate, pain, quality of life and sexual satisfaction
timeFrame: median follow-up: 29 months (range 6 - 76 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
Study officials:
affiliation: University Hospital Gasthuisberg, Catholic University, Leuven, Belgium
name: Christel LC Meuleman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Gasthuisberg, Catholic University, Leuven, Belgium
name: Thomas D'Hooghe, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01214538: Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
Official title: Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Otitis Media
Keywords: Vaccine pneumococcal natural history Acute otitis media
Lead sponsor: NasVax Ltd
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 subjects with acute otitis media infection will be enrolled. The expectation is for ≥50 children with pneumococcal culture-positive MEF (Middle Ear Fluid) and ≥50 children with culture-negative MEF to be enrolled

Brief summary: This clinical study is designed to assess prospectively the sero-responses to various proteins in cases of pneumococcal Acute Otitis Media.


Eligibility criteria: Inclusion Criteria:

* Male and female Jewish and Bedouin children.
* Patients can be either ambulatory or hospitalized.
* Presenting with acute otitis media.
* Tympanocentesis was performed at least in one ear for a clinical indication.
* Culture of middle ear fluid was obtained.
* Parents agreeing to participate in the study and to submit their children for follow-up, blood test and nasopharyngeal/oropharyngeal (NP/OP) cultures.

Exclusion Criteria:

* Having another infection that is likely to be caused by S. pneumoniae.
* Known immunodeficiency.
* Known previous recent pneumococcal infections (\<1 month prior to current visit).

Primary outcomes:
measure: Serological studies of pneumococcal proteins and their development over time following otitis media infections
timeFrame: 3 months per individual
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Ben-Gurion University of the Negev
Study officials:
affiliation: Ben-Gurion University of the Negev
name: Ron Dagan, Prof. MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00364338: Development of Gourmet Medical Cooking Workshop for Lifestyle Changing and Its Affect on Perimenopausal Women
Official title: Development of Gourmet Medical Cooking Workshop for Lifestyle Changing and Its Affect on Perimenopausal Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Perimenopausal
Keywords: gourmet healthy cooking
quality of life
preimenopause
weight
lipids
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-08-15
Enrollment: 0
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Subjects that participate in the practical workshop will improve their metabolic indexes, decrease their weight and improve their quality of life, in contrast to the participants that will take part in the nutritional consulting sessions

Detailed description: Participants will be randomly assigned to a dietary consultation-only control group or to a gourmet medical cooking workshop. The workshop will consist of 9 lessons with the following lessons: introduction, fats, phytoestrogens, carbohydrates and fibers, calcium and low calorie diet, party's recipes, shopping and farewell dinner. All the lessons will start with half an hour theoretical introduction, followed by a 2.5 hours "hands on" session under supervision of a medical chef. The study population will include healthy women attending the menopause clinic. 72 patients will be recruited and will be randomly divided into two groups: an intervention group of 36 will commence the workshop during 2007 and a control group of 36 who will take part in dietitian consulting sessions only. During 2008 the control group will commence the workshop and will add to the study group.

Eligibility criteria: Inclusion Criteria:

* Age of 45-60
* Perimenopause
* Healthy
* BMI over 17

Primary outcomes:
measure: We expect to see change in the following outcomes:
measure: the patient's metabolic state,
measure: the patient's weight
measure: body composite
measure: patient's quality of life.
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: hadassah university hospital
name: ronit kochman, md
role: PRINCIPAL_INVESTIGATOR
References: