louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05978297: Virtual Specialty Clinic for Fibromyalgia Care
Official title: Virtual Specialty Clinic for Fibromyalgia Care
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fibromyalgia
Lead sponsor: Swing Therapeutics, Inc.
Sponsor class: OTHER
Collaborators: name: Swing Care Provider Group
First posted: 2023-08-07
Enrollment: 2500
Sex: ALL
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: All adult fibromyalgia patients who receive clinical care at Swing Care.

Brief summary: This is an ongoing, prospective, and retrospective cohort study of fibromyalgia patients who receive clinical care at Swing Care (a fibromyalgia virtual specialty clinic).

Deidentified data on demographics, clinical outcomes, patients' treatment engagement and preference, as well as patients' satisfaction are obtained and analyzed via retrospective and prospective chart review.

A waiver of informed consent has been approved by the reviewing Institutional Review Board.


Eligibility criteria: Inclusion Criteria:

* Adult patients of Swing Care between 1 Oct, 2022 and 1 Oct, 2027, who received clinical evaluations and/or treatments according to Swing Care's standard clinical care protocol.

Exclusion Criteria: None

Primary outcomes:
measure: Demographic and clinical data obtained via chart review [ Time Frame: 5 years ]
timeFrame: 01 Oct 2022 - 01 Oct 2027
Secondary outcomes:
Other outcomes:
Locations:
city: Covina
country: United States
facility: Swing Care
state: California
Study officials:
affiliation: Swing Care
name: Andrea L Chadwick
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00425997: Efficacy of Valsartan/Hydrochlorothiazide Versus Amlodipine and Hydrochlorothiazide in Patients Hypertension
Official title: A 10-week Multicenter,Forced-titration Study Using 24-hr ABPM to Evaluate the Efficacy of Valsartan/Hydrochlorothiazide (HCTZ) Treatment Regimen vs Conventional Treatment Regimen With Amlodipine and Hydrochlorothiazide (HCTZ) in Patients With Stage 2 Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension, valsartan/HCTZ, amlodipine and HCTZ
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-24
Enrollment: 480
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 will evaluate the efficacy of valsartan/hydrochlorothiazide versus amlodipine and hydrochlorothiazide in patients with Stage 2 hypertension using 24-hr ambulatory blood pressure monitoring (ABPM)


Eligibility criteria: Inclusion Criteria:

* Male or female patients 18 years of age or older
* Diagnosed of having hypertension, defined as a mean seated systolic BP ≥160 mmHg (Stage 2 hypertension)

Exclusion Criteria:

* Symptomatic or severe hypertension
* Patients treated with more than 2 antihypertensive medications
* Clinically known or suspected history of secondary hypertension
* Myocardial infarction, stroke, transient ischemic attack, cardiovascular revascularization/angioplasty in last 6 months
* Diagnosis of heart failure (NYHA Class II-IV)
* Chronic renal or severe hepatic disease

Primary outcomes:
measure: -Change from baseline in mean 24-hr ambulatory systolic blood pressure (BP) after 10 weeks of treatment of valsartan/HCTZ versus amlodipine and HCTZ
Secondary outcomes:
measure: change from baseline in mean 24-hr ambulatory diastolic BP and pulse pressure after 10 weeks of treatment of valsartan/HCTZ versus amlodipine and HCTZ
measure: Change from baseline in mean seated systolic and diastolic BP after 10 weeks of treatment of valsartan/HCTZ versus amlodipine and HCTZ
measure: Compare the proportion of patients achieving blood pressure goal and tolerability after 10 weeks of treatment of valsartan/HCTZ versus amlodipine and HCTZ
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Sites in USA
state: New Jersey
Study officials:
affiliation: Sponsor GmbH
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: Raij L, Egan BM, Zappe DH, Purkayastha D, Samuel R, Sowers JR. Office and ambulatory blood pressure-lowering effects of combination valsartan/hydrochlorothiazide vs. hydrochlorothiazide-based therapy in obese, hypertensive patients. J Clin Hypertens (Greenwich). 2011 Oct;13(10):731-8. doi: 10.1111/j.1751-7176.2011.00499.x. Epub 2011 Jul 14.
Clinical trial NCT06681597: Raspberry Ketone Intake Upregulates Circulating FGF21 and Induces Energy Expenditure in Humans
Official title: The Effect of Raspberry Ketone Intake on Plasma FGF21 Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obesity
Diabetes
NAFLD (Nonalcoholic Fatty Liver Disease)
Lead sponsor: Nanchang University
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate the molecular mechanism of raspberry ketone on regulating obesity, the investigators studied the effect of raspberry ketone intake on FGF21 in plasma.

The age of the volunteers were 18-60 years old, both male and female, without diabetes, hypertension and other diseases.

After ingestion of raspberry ketone (500mg), 2ml of blood was collected at 0 hours, 3 hours and 6 hours , and the FGF21 content in plasma was measured using a commercial reagent kit.

In addition, the investigators also studied the effect of raspberry ketone intake on energy metabolism 0 hours, 0.5 hours, 3 hours and 6 hours after consuming raspberry ketone (500mg).


Eligibility criteria: Inclusion Criteria:

No drugs were taken before the human study

Exclusion Criteria:

Patients with hypertension

Primary outcomes:
measure: Impact of raspberry ketone consumption on plasma FGF21 level
timeFrame: Through study completion, an average of 1 year
measure: Impact of raspberry ketone consumption on energy expenditure
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Nanchang University
state: Jiangxi
Study officials:
References:
citation: Lopez HL, Ziegenfuss TN, Hofheins JE, Habowski SM, Arent SM, Weir JP, Ferrando AA. Eight weeks of supplementation with a multi-ingredient weight loss product enhances body composition, reduces hip and waist girth, and increases energy levels in overweight men and women. J Int Soc Sports Nutr. 2013 Apr 19;10(1):22. doi: 10.1186/1550-2783-10-22.
Clinical trial NCT06333197: Approaches for Open Reduction and Internal Fixation of Mandibular Condylar Fracture
Official title: A Comparative Study Between the Retromandibular Transparotid Approach and Retromandibular Retroparotid Approach for Open Reduction and Internal Fixation of Mandibular Condylar Fracture.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mandibular Fractures
Keywords: Mandibular Condylar fracture
Approaches for mandibular fractures
Transparotid
Retromandibular
Comparative study
Retroparotid
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ALL Patients diagnosed with Extra Capsular Fracture of Mandibular Condyle amenable for surgery.
Primary purpose: TREATMENT

Brief summary: The condylar region is the most frequent anatomical site for mandibular fractures .

Condylar fractures constitute 25.5% to 35.5% of all mandibular fractures. The mandibular condyle fracture is a type of fracture that affects the condyle, which is the knuckle-like projection of the mandible (lower jaw) that articulates with the temporal bone to form the temporomandibular joint (TMJ).

Detailed description: Several approaches have been used for condylar fracture including intraoral, preauricular, submandibular and retromandibular approaches.

The selection of the appropriate surgical approach for condylar neck fracture represents a controversy.

The purpose of this Study is to Compare the outcomes and effectiveness between the retromandibular transparotid approach and retromandibular retroparotid approach for treatment of Condylar Fracture of Mandible.

Eligibility criteria: Inclusion Criteria:

* ALL Patients diagnosed with Extra Capsular Fracture of Mandibular Condyle amenable for surgery.

Exclusion Criteria:

* 1. Open Laceration in the condylar region. 2. Concomitant traumatic Facial Nerve injury. 3. Previous Surgery in Retromandibular region. 4. Severe Obese patients 5. Patients Refusing Surgery.

Primary outcomes:
measure: Facial nerve injury
timeFrame: Up to 6 months
measure: Operative time
timeFrame: Up to 3 hours
Secondary outcomes:
measure: Fracture stability
timeFrame: Up to 3 Months
measure: Mouth opening
timeFrame: Up to 3 Months
measure: Other Complication related to the Approach
timeFrame: Up to 6 Months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05906797: Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.
Official title: Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis: a Randomized-controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Periodontitis
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with periodontitis and without any cardiovascular disease.

Detailed description: A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with periodontitis and without any cardiovascular disease.

60 patients: 30 with periodontitis and 30 with healthy controls and without periodontitis history.

All the patients are assessed for clinical, periodontal, blood and non-invasive ultrasound cardiovascular parameters. Measurements are taken before and after initial periodontal treatment in the periodontal subjects.

Eligibility criteria: PERIODONTITIS GROUP

Inclusion Criteria:

* Clinically diagnosed with periodontitis according to the EFP/AAP 2017 criteria.

Exclusion Criteria:

* Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
* Pregnancy.
* Cardiovascular Diseases.

HEALTHY GROUP

Inclusion Criteria:

* Clinically diagnosed with healthy periodontum withouth periodontitis history according to the EFP/AAP 2017 criteria.

Exclusion Criteria:

* Scaling, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
* Pregnancy.
* Cardiovascular Diseases.

Primary outcomes:
measure: Pulse Wave Velocity carotid-femoral (PWV-CF)
timeFrame: 8 weeks
measure: Pulse Wave Velocity carotid-femoral (PWV-CR)
timeFrame: 8 weeks
measure: Carotid Intima-Media Thickness (CIMT)
timeFrame: 8 weeks
measure: Distensibility Coefficient (DC)
timeFrame: 8 weeks
measure: Advanced Glycation End products (AGEs)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico
Study officials:
References:
Clinical trial NCT01945697: Validation of DNA Methylation Biomarkers for Oral Cancer Detection
Official title: Validation of DNA Methylation Biomarkers for Oral Cancer Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Cancer
Keywords: DNA methylation, biomarkers, oral cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 267
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients come to the Department of Dentistry of National Taiwan University Hospital for oral health care or treatment.

Brief summary: The aim of this study is to evaluate the association between several methylated genes and oral cancers. A prospective case control trial is designed with sample size estimated at least 160 cases. It is expected to enroll at least 100 subjects with precancerous lesion or oral cancer, and \~60 subjects with normal oral mucosa. This study is approved by the National Taiwan University Hospital Research Ethics Committee. After signing the informed consent, all of the subjects will receive an intraoral examination and the oral epithelial cells will be collected. If abnormal oral lesion is observed, it will be photographed, and the biopsy will be performed to confirm the diagnosis. For methylated gene detections, the gDNA will be extracted from the collected cells and standardized assay will be performed. Clinical sensitivity and specificity for these methylated genes will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Subject with age over 20.
* Subject agrees to sign the informed consent form.

Exclusion Criteria:

* Subjects have history of head and neck cancer.
* Subjects have had received chemotherapy for cancers.
* Pregnant Woman
* Subjects whose has oral mucosal lichen planus.
* Subjects whose oral mucosal findings is abnormal, but the diagnosis is unknown.

Primary outcomes:
measure: DNA methylation labeled
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Dentistry National Taiwan University Hospital
Study officials:
affiliation: Department of Dentistry National Taiwan University Hospital
name: Shih-Jung Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00160797: Total Knee Arthroplasty Outcome Study
Official title: MIS™ Minimally Invasive Solutions™ Total Knee Arthroplasty Outcome Study #02-800
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Total Knee Replacement
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2005-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures.

Detailed description: The purpose of this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures. The MIS™ Minimally Invasive Solutions™ Total Knee Arthroplasty System has been cleared for use by the Food and Drug Administration.

You are invited to participate in this data collection study, comparing the MIS system to standard knee replacement systems. The decision about which system and operation will be best for you has already been made by you and your orthopaedic surgeon.

The information will be used to compare minimally invasive surgery and the standard surgery procedures. The results of this study will provide information that will add to the knowledge base of knee replacement surgery.

Eligibility criteria: Inclusion Criteria:

* Presence of a severely disabled joint secondary to painful osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis that warrants primary knee arthroplasty.
* Gender - Males and females will be included. The male-to-female ratio will depend upon the patient population at each institution conducting the study.
* Age - Minimum of 18 years-old.
* Stable Health - The patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
* Patient or patient's legal representative has read and signed the Letter to the Patient form.

Exclusion Criteria:

* Patient is skeletally immature.
* Previous ipsilateral knee arthroplasty.
* Previous Patellectomy.
* Patient is pregnant or breastfeeding.
* Presence of clinically significant disease of the cardiovascular, renal, hepatic, hematologic, respiratory, endocrine, neurological, gastrointestinal, genitourinary, immune systems or other medical condition which is not well controlled.
* Patients who have received an investigational drug or device within the last 30 days.
* Patient is unwilling or unable to cooperate in a follow-up program.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Richard G. Vlasak, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06366997: Diagnosis of Epithelial Ovarian Cancer Using Ovarian Cancer Score (OCS) Test
Official title: Multicenter Clinical Research for Diagnosis of Epithelial Ovarian Cancer Using OCS Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epithelial Ovarian Cancer
Adnexal Mass
Keywords: early diagnosis
ovarian cancer
OCS test
Lead sponsor: Chongqing University Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang Cancer Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: The First Affiliated Hospital of Zhengzhou University
name: 3D Medicines Corporation
First posted: 2024-04-16
Enrollment: 1352
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adnexal masses (i.e., lumps near the uterus or in or around the ovaries, fallopian tubes, or surrounding connecting tissues) are common and are often detected by primary care providers and gynecologists. Adnexal masses are seen in up to 35% of premenopausal women and 17% of postmenopausal women and can occur throughout a woman's life. Although the majority of these masses are benign, they must be evaluated to rule out the possibility of malignant ovarian cancer. Ovarian cancer is one of the most aggressive gynecologic tumors worldwide, with over 31,4000 new cases diagnosed and 21,3000 deaths each year1,2. Ovarian cancer is the most lethal gynecologic malignancy with an overall 5-year survival rate of 45%.

Brief summary: The study is designed to confirm the performance of the 3D Medicines Corporation OCS test in diagnosis of epithelial ovarian cancer in patients with adnexal mass. To this end, blood samples from female patients with adnexal mass required surgical resection from four centers are obtained and analysis in the study.


Eligibility criteria: Inclusion Criteria:

* a) ≥ 18 years of age;
* b) Patients with adnexal masses;
* c) Sign the informed consent form;
* d) Adnexal mass that requires excision;

Exclusion Criteria:

* a) history of chemoradiotherapy;
* b) history of malignancy;
* c) pregnancy;
* d) Adnexal mass not require surgical excision;
* e) The adnexal mass has been diagnosed as malignant before surgery, and the number of cases enrolled in a single institution exceeds 50;
* f) Blood CA125 value greater than 1000 U/ml at initial treatment.

Primary outcomes:
measure: the Performance of Discrimination of Benign Disease and Malignant tumors by the OCS Value.
timeFrame: Data analysis would be completed in three months after all data were collected.
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: No.181, Hanyulu Road, Shapingba District
state: Chongqing
Study officials:
affiliation: Chongqing University Cancer Hospital
name: Qi Zhou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03588897: The Impact of Oral Nutritional Supplements on the Nutritional Status of Elderly Patients
Official title: The Impact of Oral Nutritional Supplements on the Nutritional Status of the Elderly - Randomised Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nutrition Disorders in Old Age
Nutritional Supplement Toxicity
Elderly Infection
Keywords: nutritional status
Nutridrink
elderly nutrition
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Normal diet versus normal diet + nutritional support in elderly patients
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study compares nutritional status of two groups elderly patient aged 65 and more. One group of the patients received nutritional support (Nutridrink Multi Fibre) for 14 days. Nutritional status of the patients were compared 2 months after the start of the intervention.

Detailed description: The aim of the study was to compare nutritional status of two groups of elderly patients (\> 65 years old). Total of 120 patients were randomly assigned into two groups. One group received normal diet whereas the second group received 300 kcal nutritional support (Nutridrink Multi Fibre 2x100 ml) between meals for 14 days. Two months after start of the intervention following examinations were performed:

* functional status of the patient (Barthel's scale, MMSE scale)
* nutritional status based on: weight, height, BMI; Mini Nutritional Assessment, plasma concentration of prealbumin, albumin, transferrin, total lymphocyte count.

The clinical status of the patient was evaluated based on clinical data on different organ infections. In addition costs of supplementary nutrition were taken into consideration.

Eligibility criteria: Inclusion Criteria:

* age \> 65 and general status which enables compliance with study requirements
* Barthel's scale (Barthel scale = Barthel ADL index - an ordinal scale used to measure performance in activities of daily living) points 21-100
* MMSE (Mini Mental State Examination) points 24-30
* no use of laxatives

Exclusion Criteria:

* lack of consent
* neoplasms
* previous enteral nutrition
* Barthel's scale 0-20
* MMSE points 0-23
* BMI \> 25
* laxatives

Primary outcomes:
measure: BMI of the elderly patients
timeFrame: 2 months
measure: Prealbumin plasma concentration
timeFrame: 2 months
measure: Albumin plasma concentration
timeFrame: 2months
measure: Transferrin plasma concentration
timeFrame: 2 months
measure: TLC
timeFrame: 2 months
Secondary outcomes:
measure: Organ infections
timeFrame: 2 months
measure: Complications
timeFrame: 2 months
measure: Functional status of the patient - Barthel's scale
timeFrame: 2 months
measure: Functional status of the patient - MMSE scale
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Clinical Nursery, Jagiellonian University
name: Lucyna Scislo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: