louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01783262: The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis. A Double Blind Randomized Controlled Study.
Official title: The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis Trapezial-metacarpal Joint
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2013-02-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Evaluate if extracorporeal shock wave therapy is more effective than sham treatment in patients with trapezial-metacarpal osteoarthritis in pain relief and functional improvement.


Eligibility criteria: Inclusion Criteria:

* according to the Eaton et al. classification the inclusion criteria involved those patients with stage III, participants had to have a history 6 months of pain and they were 18 years of age or older. Exclusion criteria were also the presence of degenerative or non-degenerative neurologic conditions, in which pain perception is altered, a history of coagulopathy, cancer, cardiac pacemaker, calcaneal fracture, and pregnancy.

Exclusion Criteria:

* Exclusion criteria were also the presence of degenerative or non-degenerative neurologic conditions, in which pain perception is altered, a history of coagulopathy, cancer, cardiac pacemaker, calcaneal fracture, and pregnancy.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention
measure: Duruöz Hand Index (DHI)
timeFrame: The change in the mean of DHI at 3 and 6 months follow up
measure: Disabilities of the Arm, Shoulder, and Hand questionnaire
timeFrame: The changes in mean at 3 and 6 months follow up
Secondary outcomes:
measure: grip and pinch tests
timeFrame: The change in mean at 3 and 6 months follow up
Other outcomes:
Locations:
city: Rome
country: Italy
facility: La Sapienza University
Study officials:
References:
Clinical trial NCT06770062: Multimodality Evaluation of Left Ventricular Remodeling In Mitral Regurgitation: A Pilot Study
Official title: Multimodality Evaluation of Left Ventricular Remodeling In Mitral Regurgitation: A Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Left Ventricular Systolic Dysfunction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with chronic severe primary mitral regurgitation undergoing robotic mitral annuloplasty at Mayo Clinic Rochester

Brief summary: The purpose of this research is to determine the feasibility of a larger, future study proposing a multimodal approach using cardiac CT and MRI to assess the risk of developing left ventricular (LV) systolic dysfunction in patients with mitral regurgitation (MR).


Eligibility criteria: Inclusion Criteria:

* Age \>= 18
* Male or Female
* A diagnosis of severe chronic primary mitral regurgitation
* Undergoing isolated robotic mitral annuloplasty at Mayo Clinic Rochester
* Patients must have the ability to consent or have an appropriate representative available to do so.

Exclusion Criteria:

* Prior valve intervention,
* Concomitant valve surgery at the time of mitral annuloplasty (e.g. tricuspid annuloplasty, aortic valve replacement).
* Concomitant \>= moderate regurgitation or stenosis in any other valve by preoperative echocardiography
* History of prior myocardial infarction
* History of cardiomyopathy unrelated to mitral regurgitation (e.g. dilated, hypertrophic, infiltrative)
* Pregnancy. Women of childbearing potential will be verbally screened by clinical staff during as part of routine pre-MRI evaluation. If a subject is unsure whether they could be pregnant, a negative pregnancy test will be performed prior to scanning.
* Implantable devices that would be a contraindication to MRI
* Severe allergy to gadolinium MRI contrast

Primary outcomes:
measure: Recruitment Rate
timeFrame: 2 years
measure: Dropout Rate
timeFrame: 2 years
measure: Systolic Dysfunction
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Arman Arghami, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Alex Bratt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00237562: Feasibility of the Management of Severe Cervical Dysplasia in a Single Visit
Official title: Single Visit Cervical Cancer Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Intraepithelial Neoplasia
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-10-12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 1. Implement a single-visit program (SVP) for cervix cancer prevention in clinics serving a multi-ethnic population of women;
2. Set up an efficient system for interpretation of Pap smears for patients in the SVP that will minimize waiting time;
3. Determine the follow-up rates and compare them between women assigned to the SVP and a usual care program (UCP);
4. Determine satisfaction and compare it between women assigned to the SVP and the UCP;
5. Determine the cost-effectiveness and compare it between the SVP and UCP

Detailed description: Women were recruited from underserved communities to participate in this single visit cervix cancer project. Large loop electrosurgical excision procedure (LEEP) was performed on SVP subjects with either a diagnosis of HGSIL/AGUS or suspicion of carcinoma. All other subjects with abnormal Papanicolaou smears were referred to our abnormal cytology clinics or received care in the community.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* No history of invasive cervical cancer
* Not pregnant

Exclusion Criteria:

* Absence of a cervix
* Abnormal vaginal bleeding
* Cervical cancer screening within the previous 12 months
* A known bleeding disorder
* Reluctance to be randomized
* Unwillingness to follow the study protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Alberto Manetta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brewster WR, Hubbell FA, Largent J, Ziogas A, Lin F, Howe S, Ganiats TG, Anton-Culver H, Manetta A. Feasibility of management of high-grade cervical lesions in a single visit: a randomized controlled trial. JAMA. 2005 Nov 2;294(17):2182-7. doi: 10.1001/jama.294.17.2182.
Clinical trial NCT00606762: Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy
Official title: A Prospective Randomized, Controlled Study Comparing Low Pressure Versus High Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholelithiasis
Keywords: laparoscopic cholecystectomy
low pressure pneumoperitoneum
Lead sponsor: Sterling Hospital
Sponsor class: OTHER
First posted: 2008-02-05
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The physiological changes and postoperative pain are directly related with the degree of intra-abdominal pressure kept during the laparoscopy. The present study aims to examine difference between low pressure pneumoperitoneum (8 mm Hg)and High pressure pneumoperitoneum (12 mm Hg)during laparoscopic cholecystectomy in terms of pain, cardio-pulmonary function, arterial blood gas changes etc.


Eligibility criteria: Inclusion Criteria:

* symptomatic gall stone disease

Exclusion Criteria:

* pyocele
* gangrene of gall bladder
* history of cholangitis
* simultaneous CBD stones
* gall stone pancreatitis
* who does not give consent if they will be randomized to LPLC

Primary outcomes:
measure: Pain
timeFrame: 24 hours
Secondary outcomes:
measure: Pulmonary function
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Sterling Hospital
state: Gujarat
Study officials:
affiliation: Sterling Hospital, Ahmedabad
name: Vismit P Joshipura, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04849962: Acute Consumption of Pecan-enriched Meal
Official title: Comparison of Metabolic and Antioxidant Responses to a Breakfast Meal With and Without Pecans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Pecans are a nutrient-dense food, but it is unknown whether substituting pecans for a portion of the butter in a traditional breakfast meal improves post-meal responses.

Detailed description: This study was a randomized, double-blind control trial consisting of 2 study visits for 2 different treatments. The treatments were high-fat breakfast muffins containing either butter (control) or pecans. The investigators recruited healthy, normal-weight adults between the ages of 15 and 45y. Study visits were completed in a random order with at least 72 hours between each visit. Anthropometrics, questionnaires, and fasting and postprandial blood samples were collected at each visit.

Hypothesis: The pecan-enriched meal will blunt the post-meal increase in glucose, insulin, triglycerides (TG), and lipid peroxidation while improving all measures of subjective appetite and TAC compared to the traditional meal without nuts.

Eligibility criteria: Inclusion Criteria:

* Healthy adult men and women
* Normal-weight (body mass index = 18-24.9kg/m2)

Exclusion Criteria:

* Allergies to test meal ingredients (gluten, eggs, or nuts)
* Medication/supplement usage
* Chronic disease
* Pregnancy or plans to become pregnant
* Special diets
* Tobacco use

Primary outcomes:
measure: Change in triglycerides (TG) and glucose
timeFrame: Change from baseline to 3 hours postprandially
measure: Change in lipid peroxidation
timeFrame: Change from baseline to 3 hours postprandially
measure: Change in total antioxidant capacity
timeFrame: Change from baseline to 3 hours postprandially
measure: Change in insulin
timeFrame: Change from baseline to 3 hours postprandially
Secondary outcomes:
measure: Change in angiopoietin-like proteins-3 (ANGPTL3) and -4 (ANGPTL4) responses
timeFrame: Change from baseline to 3 hours postprandially
measure: Change in hunger and satiety responses
timeFrame: Change from baseline to 3 hours postprandially
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia - Department of Foods and Nutrition & Department of Food Science and Technology
state: Georgia
Study officials:
affiliation: University of Georgia
name: Chad M Paton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03932162: Gene Expression Changes In Young and Geriatric Skin
Official title: Gene Expression Changes in Young and Geriatric Skin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: UVB Phototherapy Burn
Insulin-like Growth Factor 1
Aging
Lead sponsor: Wright State University
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study does not involve any particular diagnosis. The goal of this research study is to explore the effects of artificial sunlight (ultraviolet B radiation; UVB) on the skin of young adults versus geriatric adults. Sunlight exerts many effects on the body. There is evidence that in response to ultraviolet B radiation (UVB), which are the burning rays of sunlight, young adult skin responds differently than geriatric skin. In fact, researchers feel that this difference in how the skin reacts to UVB is why skin cancers are found in older skin. Researchers believe that a major difference between young adult and geriatric skin is that young skin has a lot of a protein called insulin-like growth factor-1 (IGF-1), whereas geriatric skin has very little. The current study will test how young adult versus geriatric skin responds to UVB, and if geriatric skin treated with an injection of small amount of IGF-1 drug will then act like young skin.


Eligibility criteria: Inclusion Criteria:

* Male/Female
* White skin (Fitzpatrick types I and II)
* Age 21-30 or 65 and older
* Able to comprehend procedures/risks

Exclusion Criteria:

* Known photosensitivity
* Currently on photosensitizing medications
* Diabetes Mellitus
* History of abnormal scarring
* History of skin infections
* Known allergy to lidocaine local anesthetic
* Pregnancy or nursing
* Other serious health issues

Primary outcomes:
measure: Change in expression genes involved in protecting skin cells from UVB damage in younger skin and geriatric skin injected with IGF-1 from baseline
timeFrame: 2 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
Study officials:
affiliation: Wright State University
name: Jeffrey B Travers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05169762: Feminizing Treatment in Transgender Women and Non-binary Persons
Official title: Feminizing Treatment in Transgender Women and Non-binary Persons BODY IDENTITY CLINIC - ESTROGEN
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transgenderism
Keywords: gender affirming hormone treatment
estrogen
cardiovascular risk
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2021-12-27
Enrollment: 100
Sex: MALE
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: transgender women

Brief summary: Cohort study in 100 transgender women treated with gender affirming hormone treatment. Follow up affter 1year, 3 years, 5 years and 10 years, Outcomes regarding cardiovascular effects of hormone treatment.

Detailed description: Cohort study in 100 transgender women treated with gender affirming hormone treatment. Follow up affter 1year, 3 years, 5 years and 10 years,

Outcomes:

Non-calcified and calcified plaque formation by contras coronary CT angiograms Heartfunction by ekko Cardiovaskular risk markers, f. eks. bp Markers of cardiovascular risk in blood and urine

Eligibility criteria: Inclusion Criteria:

* assigned male at birth and eligeble for gender affirming feminizing treatment

Exclusion Criteria:

none

-

Primary outcomes:
measure: coronary plaque formation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: OdenseUH
Study officials:
affiliation: Odense University Hospital
name: Dorte Glintborg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06407362: Effects of Volume and Pressure-Controlled Ventilation on Cerebral SpO2, PI, and PVI Index in Septoplasty
Official title: Evaluation of the Effects of Volume-Controlled and Pressure-Controlled Ventilation on Cerebral Oxygen Saturation, Perfusion Index, and Pleth Variability Index in Septoplasty Surgical Cases: an Observational Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilation Mode
Pleth Variability Index
Perfusion Index
Regional Cerebral Oxygen Saturation
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 patients with American Society of Anesthesiologists (ASA) score I-III between the ages of 18-80 were undergoing septoplasty surgery

Brief summary: Objective: This study was designed to evaluate the accuracy of Pleth Variability Index (PVI), Perfusion Index (PI) and Regional Oxygen Saturation (rSO2) in both ventilation modes in patients undergoing septorhinoplasty operation under general anaesthesia. Materials and Methods: After anaesthesia induction, ventilation was provided with volume control for 20 minutes. Heart Rate (HR), PI, PVI, Oxygen Saturation (SpO2), Non-Invasive Blood Pressure (NIBP) and rSO2 values were recorded every 5 minutes. At the 20th minute of the surgical procedure, the ventilation mode was set as the pressure-controlled mode. After switching to pressure-controlled mode, HR, PI, PVI, SpO2, NIBP and rSO2 values were recorded every 5 minutes for 20 minutes.


Eligibility criteria: Inclusion Criteria:

* patients with American Society of Anesthesiologists (ASA) score I-III between the ages of 18-80 were included

Exclusion Criteria:

* Those patients with any Liver and/or Kidney Failure
* obese patients (Body Mass Index (BMI) 30 and above)
* trauma patients
* cancer patients
* ASA IV patients
* those patients with emergency surgery
* cardiac arrhythmia
* implanted pacemakers
* those with a history of chronic pain

Primary outcomes:
measure: Pleth Variability Index (PVI) in patients under different ventilation modes
timeFrame: while the surgery procedure
measure: Perfusion Index (PI) in patients under different ventilation modes
timeFrame: while the surgery procedure
measure: Regional Cerebral Oxygen Saturation (rSO2) in patients under different ventilation modes
timeFrame: while the surgery procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital
Study officials:
References:
Clinical trial NCT03087162: Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori
Official title: Once Daily Dose Dexlansoprazole Levofloxacin Based Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: H Pylori Eradication
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: New drug regimen for Helicobacter pylori eradication, the investigators compare once daily dose dexlansoprazole levofloxacin based quadruple therapy and twice daily dose dexlansoprazole levofloxacin quadruple therapy for helicobacter pylori eradication.

Detailed description: Once daily dose dexlansoprazole should be non inferior to twice daily dose in the eradication of Helicobacter pylori infection.

Eligibility criteria: Inclusion Criteria:

1. Age 18-75 year-patient
2. Diagnosed as positive Helicobacter Pylori testing by any of the following methods:

   * Rapid urease test or Histology
3. Inform consent

Exclusion Criteria:

1. Previous history of Helicobacter pylori eradication
2. Contraindications or allergic reactions to the study drugs
3. Previous gastric surgery or advanced gastric cancer or other malignancy or other severe concurrent diseases
4. Decompensated Liver cirrhosis or chronic kidney disease (GFR\< 30)
5. Mental disorders or alcohol or drug addiction
6. Pregnancy or lactation

Primary outcomes:
measure: Eradication rate (percentage)
timeFrame: Jan17-Nov17, Total 11 months
Secondary outcomes:
measure: To compare drug compliance
timeFrame: jan17-Nov17, Total 11 months
measure: To compare drug adverse event
timeFrame: jan17-Nov17, Total 11 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Parin siriwat
Study officials:
affiliation: Ramathibodi Hospital
name: Akrawit Pulsombat, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00656162: Ultrasound Detection of Radiographically Negative Fractures of Elbow in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures, Bone
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-04-10
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with clinically suspected but x-ray negative elbow trauma

Brief summary: Fractures of an elbow are common in children. Accurate initial diagnosis is crucial for the management of the fractures of an elbow. In young children the fractures may be suspected clinically but missed on x-rays due to mostly non-ossified cartilage that is not visible on a regular x-ray. We propose that every x-ray negative, but clinically suspicious elbow trauma in children can be additionally evaluated using high resolution US.


Eligibility criteria: Inclusion Criteria:

* Signing Informed consent

Exclusion Criteria:

* Unwillingness to sign informed consent.
* Any fracture of the same hand or forearm before or after an avaluated event.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References: