louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05346341: Evaluation of the Effect of Minimally Invasive Procedures Used in Management of Salivary Ductal Pathologies on Patients' Symptomatology and Gland Function
Official title: Evaluation of the Effect of Minimally Invasive Procedures Used in Management of Salivary Ductal Pathologies on Patients' Symptomatology and Gland Function - A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Salivary Gland Stone
Salivary Gland Diseases
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 31
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of the current study was to evaluate the minimally invasive techniques in the management of salivary gland ductal pathologies


Eligibility criteria: Inclusion Criteria:

* All patients manifesting with either submandibular or parotid salivary gland ductal pathologies including:
* Sialolithiasis (salivary stones).
* Salivary ductal stenosis or stricture.
* Children with juvenile recurrent parotitis.
* Sjogren's syndrome.
* Radio-iodine induced sialadenitis.

Exclusion Criteria:

* Patients who are unfit for surgery.
* Patients with previous submandibular or parotid surgical resection.
* Patients with salivary tumors either benign or malignant.

Primary outcomes:
measure: Subjective salivary gland performance
timeFrame: up to 12 months
measure: Objective salivary gland performance (salivary flow measurement)
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Aya Sakr, M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02327741: Efficacy of Long Term Plavix Therapy Post Angioplasty
Official title: Evaluation of Safety, Benefits and Complications of Long-term Dual Antiplatelet Therapy in Patients With Angioplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Percutaneous Coronary Intervention
Keywords: Dual antiplatelet therapy
clopidogrel
percutaneous coronary intervention
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Baqiyatallah Medical Sciences University
First posted: 2014-12-30
Enrollment: 1010
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1010 patients post stenting were enrolled to receive Plavix more than 12 months and less than that and rate of bleeding, complication and major cardiovascular adverse events ( MACE) were compared to evaluate safety and feasibility of long term Plavix therapy post stenting.

Detailed description: 1010 patients from registry of angioplasty and stenting in Shiraz and Baghiatolah hospital were enrolled and long term Plavix therapy more than and less than 12 months were compared between two groups of patients prospectively and rate of major adverse cardiovascular events ( MACE) (death, myocardial infarction, cerebrovascular accidents and revascularization) and rate of bleeding were compared between 2 groups.Syntax score and American heart association ( AHA) score of coronary involvement were measured and MACE was compared to these scores.

Eligibility criteria: Inclusion Criteria:

* post stent ( lesion more than 70% and vessel more than 2.25 mm )

Exclusion Criteria:

* allergy to acetylsalicylic acid or clopidogrel,
* planned surgery within 24 months of percutaneous coronary intervention unless the dual antiplatelet therapy could be maintained throughout the perisurgical period
* history of bleeding diathesis
* major surgery within 15 days
* active bleeding
* previous stroke in the past 6 months
* concomitant or foreseeable need for oral anticoagulation therapy
* pregnancy, life expectancy \<24 months, participation in another trial
* inability to provide informed consent

Primary outcomes:
measure: Number of Patients With Major Bleeding Need Transfusion
timeFrame: 12 months
measure: Number of Patients With Myocardial Infarction Need Hospital Admission
timeFrame: 12 month
measure: Number of Patients With Central Vascular Accidents Proved by CT Scan
timeFrame: 12 months
measure: Number of Patients With Death Due to Cardiac Causes
timeFrame: 12 months
measure: Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty
timeFrame: 12 months
measure: Number of Patients With Minor Bleeding
timeFrame: 12 months
Secondary outcomes:
measure: Tolerability - the Number of Patients , Who Are Able to Take Plavix Concerning Compliance and Economic Issues
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: shiraz university of medcal sciences
name: javad kojuri, M.D. M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06396741: Changes in the Quadriceps Muscle After Dry Needling Treatment
Official title: Determination of Biomechanical Changes in the Quadriceps Muscle After Dry Needling Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Muscle Tightness
Muscle Strain
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The present study aims to examine the mechanical changes following dry needling of the quadriceps muscle.

To this end, structural and mechanical changes in quadriceps muscle activity will be measured using M-mode ultrasound.

The quadriceps muscle strength will also be assessed with dynamometry. In addition, the knee joint range will be checked by means of a goniometry procedure.

The subjects will be assessed before and after the application of a dry needling technique on the quadriceps muscle to determine possible changes in the measured variables.


Eligibility criteria: Inclusion Criteria:

* Healthy subject.

Exclusion Criteria:

* Low back pain
* Hip pain
* Sciatica
* Belenophobia
* Be medicated with anticoagulants
* Knee surgery
* Knee osteoarthritis
* Fibromyalgia
* Pregnancy

Primary outcomes:
measure: Muscle thickness
timeFrame: before and after one week. The muscle thinckness will be measurement in centimeters
Secondary outcomes:
measure: Quadriceps muscle strength
timeFrame: before and after one week.
measure: knee range of motion (flexion)
timeFrame: before and after one week
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Centro Investigación Fisioterapia y Dolor
state: Madrid
Study officials:
affiliation: Centro de Investigación Fisioterapia y Dolor
name: Samuel Fernandez-Carnero, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04013841: Bowel Preparation Impact on the Intestinal Microbiome: Oral Preparation vs Enema
Official title: Bowel Preparation for Left Side Colon Surgery Impact on the Intestinal Microbiome: Oral Preparation vs Enema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-07-10
Enrollment: 40
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: Mechanical bowel preparation for left-sided colorectal surgery remains standard in most cases. However, there are some discrepancies on how to prepare the bowl, while rectal enema and oral agents are both available methods.

The knowledge of intestinal microbiome role on surgical outcomes is increasing, since few recent reports linked microbiome composition to postoperative complications, such as anastomotic insufficiency. Although, it is not clear how the bowel preparation affects the gut microbiome. Therefore, different bowel preparation techniques impact on gut microbiome will be studied.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 y.;
2. Signed informed consent;
3. Left-side colorectal resection for colorectal cancer;

Exclusion Criteria:

1. Anticipated ileostoma;
2. Allergy to oral preparation agents;
3. Multivisceral surgery;
4. Emergency surgery;
5. History of inflammatory bowel disease;
6. History of surgery disrupting gastrointestinal tract integrity;
7. Signs of tumor obturating the lumen of the bowel;
8. Pregnancy;

Primary outcomes:
measure: Intestinal microbiome composition
timeFrame: 6 days after surgery
Secondary outcomes:
measure: Intestinal microbiome composition
timeFrame: 30 days after surgery
measure: Intestinal microbiome composition
timeFrame: 6 and 30 days after surgery
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: National Cancer Institute
Study officials:
References:
Clinical trial NCT04078841: Treating Post-Lyme Disease Syndrome With Acetogenins
Official title: Using ReaLife+ to Treat Post-Lyme Disease Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Post-Lyme Disease Syndrome (PLDS)
Lead sponsor: Optimal Health Research
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 30
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: To access the effectiveness of Acetogenins in treating Post-Lyme Disease Syndrome (PLDS).

Detailed description: To access the effectiveness of Acetogenins in treating Post-Lyme Disease Syndrome (PLDS). After failure of antibiotic therapy to relive persistent symptoms of Lyme Disease, the use of Acetogenins to elevate Post-Lyme Disease Syndrome.

Eligibility criteria: Inclusion Criteria:

1. A positive Western Blot for Lyme Disease that has been treated with antibiotics but the symptoms persist post treatment.
2. Must be able to swallow and mixed powder drink.

   -

Exclusion Criteria:

1. Non Positive Western Blot test.
2. Positive Western Blot test where the indivual has not been treated with antibiotics.

   -

Primary outcomes:
measure: Blood test
timeFrame: 3 months
measure: PROMIS Fatigue Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Optimal Health Research
state: Utah
Study officials:
affiliation: IRB Chair
name: Dr Jeppsen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05299541: Nutritional Support in Patients With Nutritional Risk. How we Can Improved the Prognosis and Quality of Life
Official title: Nutritional Support in Patients Who Have Been Diagnosed at Nutritional Risk in the Hospital and Discharged Home. How we Can Improved the Prognosis and Quality of Life.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malnutrition
Quality of Life
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Many malnourished hospital patients remain after discharge. We aimed to enhance the meal experience after discharge by delivering meals together with physical support at the home and tested if this increased food intake affected survival and quality of life.

Patients and Methods: 60 discharged patients suffering from nutritional (MUST\>2) and financial frailty were included. Control group (C) took their regular nutrition at home for 6 months and study group (S) received a daily dinner tray sponsored by the municipality. Hazalla philanthropic organization encouraged the patients at lunch for 6 months. Body composition (Quadstat 4000, Bodystat, UK), energy requirements (Fitmate- COSMED, Italy) were measured at recruitement. Primary outcome was 180 days survival. In addition, in the recruitment stage and after a period of 3 and 6 months, depression and anxiety questionnaire (HADS), quality of Life Questionnaire-SF36and FIM questionnaire - designed to examine the level of independence of patients with disability were performed at days 0, 90 and 180. Statistical analysis used T- Test and ANOVA Repeated Measures. The study was approved by local IRB.


Eligibility criteria: Inclusion Criteria:

* MUST =\>2
* Region of living Bney-Brak or Petah-tikwa
* Fine cognitive state

Exclusion Criteria:

* Progressive cancer
* Dementia
* Fiddling by PEG or Enteral nutrient via Naso gastric tube
* Psychiatrics disorder

Primary outcomes:
measure: Improve quality of life
timeFrame: 6 months
measure: Improve quality of life
timeFrame: 6 months
measure: Improve quality of life
timeFrame: 6 months
measure: changed Mortality
timeFrame: 6 months
measure: changed financials costs per patient in health system
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin medical center
Study officials:
affiliation: Rabin Medical Center
name: Pierre Singer, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04480541: A Pilot Study of Roadmap 2.0 in Oncology Caregivers and Patients
Official title: A Pilot Study of Roadmap 2.0 in Oncology Caregivers and Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Quality of Life
Keywords: Mobile Health Technology
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 138
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will investigate the use of a mobile health app (Roadmap 2.0) intervention in caregivers of patients with cancer. In this study participants will be given the Roadmap 2.0 app, with a focus on the positive aspects of caregiving (positive activity components), and a Fitbit. The primary objective of this pilot study is to test the feasibility and acceptability of using the mobile health app.

Detailed description: Health information technology tools may enable caregivers and patients to become more active participants in their healthcare.This study is not to provide any treatment, but rather to investigate the use of this mobile health technology-mediated intervention (Roadmap 2.0).

Eligibility criteria: Inclusion Criteria:

1. The caregiver must have an eligible patient (defined in items 5 - 9, below)
2. The caregiver must be of age ≥18 years.
3. The caregiver should be comfortable in reading and speaking English and signing informed consents.
4. The caregiver should provide at least 50% of care needs.
5. An eligible patient is one who identifies the eligible caregiver as their primary caregiver (i.e., provides at least 50% of care needs). The caregiver who provides consent will be deemed the caregiver who participates in the study. In adolescents who are at the age to provide assent, she/he will designate the caregiver who provides \>50% of their care, and that caregiver will sign the consent document.
6. An eligible patient is age ≥5 years.
7. An eligible patient is able to sign informed consent/assent forms.
8. Patients and caregivers agree to provide informed consent that is in regulatory compliance and IRBMED-approved.
9. The caregiver and patient must have his/her own smartphone or tablet to participate.

Primary outcomes:
measure: Roadmap 2.0 login rate
timeFrame: Day 120
measure: Enrollment rate
timeFrame: At time of enrollment
Secondary outcomes:
measure: Survey completion rate
timeFrame: Day 120
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Sung Won Choi, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03976141: New Topographic Classification of Knee Bone Marrow Lesions
Official title: Validation of a New Topographic Classification of Bone Marrow Lesions of the Knee
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Bone Marrow Lesions
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: exam in 2018

Brief summary: the investigator are studying a new topographic classification of bone marrow lesion in the knee and validating it.


Eligibility criteria: Inclusion Criteria:

* age over 18 with mri with lesion consent given

Exclusion Criteria:

* under mri previous surgery tumors no consent

Primary outcomes:
measure: The researchers will calculate the prevalence of BMLs in knee MRI and calculate the intra-observer and inter-observer reliability of the new classification proposed.
timeFrame: The lesions will be evaluated on knee MRI performed in the period between January 2017 to December 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: 2) 1° Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
state: Milan
Study officials:
References:
Clinical trial NCT01372241: Faith Moves Mountains: An Appalachian Cervical Cancer Prevention Project
Official title: An Appalachian Cervical Cancer Prevention Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: Papanicolaou test
Cervical cancer screening
Randomized controlled trial
Faith-placed
Appalachia
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-06-13
Enrollment: 345
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether a faith-placed lay health advisor intervention is effective in increasing use of Pap smears among middle-aged and older Appalachian women.

Detailed description: Project development relied on principles of community based participatory research. Participants were recruited from faith institutions in four distressed Appalachian Kentucky counties. Investigators at the University of Kentucky worked closely with local staff who implemented study procedures in the field.

Eligibility criteria: Inclusion Criteria:

* Outside of cervical cancer screening guidelines at the time of study initiation
* Able to provide informed consent

Exclusion Criteria:

* History of cervical cancer
* History of hysterectomy

Primary outcomes:
measure: Proportion of participants self-reporting receipt of Pap test
timeFrame: One month post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Whitesburg
country: United States
facility: Faith Moves Mountains
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Nancy Schoenberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: Mark Dignan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schoenberg NE, Hatcher J, Dignan MB, Shelton B, Wright S, Dollarhide KF. Faith Moves Mountains: an Appalachian cervical cancer prevention program. Am J Health Behav. 2009 Nov-Dec;33(6):627-38. doi: 10.5993/ajhb.33.6.1.
citation: Studts CR, Tarasenko YN, Schoenberg NE, Shelton BJ, Hatcher-Keller J, Dignan MB. A community-based randomized trial of a faith-placed intervention to reduce cervical cancer burden in Appalachia. Prev Med. 2012 Jun;54(6):408-14. doi: 10.1016/j.ypmed.2012.03.019. Epub 2012 Apr 3.
Clinical trial NCT03042741: Vaccine Against Atherosclerosis in Patients With Overweight Problems or Obesity
Official title: Phase II Trial of Daily Dose of Oral Vaccine Against Atherosclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Atherosclerosis
Lead sponsor: Immunitor LLC
Sponsor class: INDUSTRY
Collaborators: name: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
First posted: 2017-02-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group on experimental drug compared against group receiving placebo in randomized, blinded phase III study to evaluate effect on lipid profile, i.e., LDL, HDL, triglycerides and total cholesterol
Primary purpose: TREATMENT

Brief summary: Atherosclerosis vaccine, V6, has been through two small-scale Phase II open label clinical trials. It has shown significant improvement in lipid profile in patients with overweight or obesity

Detailed description: The proposed study will evaluate daily dose of one V6 pill administered for one month in placebo-controlled, randomized, double-blind phase 3 trial in men and women with baseline waist diameter over 90 and 80 cm respectively. The effect of V6 will be assessed by changes in lipid profile, i.e., LDL, HDL, TG and TC; anthropomorphic indices, i.e., circumference of waist, mid-arm, and hips; arterial blood pressure and fasting glucose levels at baseline versus post-treatment timepoint.

Eligibility criteria: Inclusion Criteria:

* Baseline waist diameter over 90 and 80 cm for men and women, respectively

Exclusion Criteria:

* Pregnant and lactating women
* Individuals with clinical symptoms or diseases who in opinion of study investigators are not eligible to participate

Primary outcomes:
measure: Immunotherapy of atherosclerosis
timeFrame: 1 month
Secondary outcomes:
measure: Effect on anthropomorphic indices of obesity
timeFrame: 1 month
measure: Effect on hypertension
timeFrame: 1 month
measure: Effect on glucose levels
timeFrame: 1 month
Other outcomes:
Locations:
city: Ulaanbaatar
country: Mongolia
facility: Immunitor LLC
state: CA
Study officials:
affiliation: Immunitor Inc.
name: Allen Bain, PhD
role: STUDY_CHAIR
References:
citation: Bourinbaiar AS, Jirathitikal V. Effect of oral immunization with pooled antigens derived from adipose tissue on atherosclerosis and obesity indices. Vaccine. 2010 Mar 24;28(15):2763-8. doi: 10.1016/j.vaccine.2010.01.032. Epub 2010 Jan 29.
citation: Bourinbaiar AS, Jirathitikal V. Safety and efficacy trial of adipose-tissue derived oral preparation V-6 Immunitor (V-6): results of open-label, two-month, follow-up study. Lipids Health Dis. 2010 Feb 2;9:14. doi: 10.1186/1476-511X-9-14.