louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04150094: Intravaginal Vibratory Stimulus and Pelvic Floor Muscle Training
Official title: Intravaginal Vibratory Stimulus and Pelvic Floor Muscle Training to Treat Female Urinary Incontinence: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized blinded trial with non-probabilistic sampling for convenience. Our goal is to compare PFMT with intravaginal vibratory stimulus versus PFMT alone on the treatment of female urinary incontinence.

Detailed description: This is a randomized blinded trial with non-probabilistic sampling for convenience. Our goal is to compare PFMT with intravaginal vibratory stimulus versus PFMT alone on the treatment of female urinary incontinence. Women with an indication for conservative treatment of urinary incontinence will be referred to the Pelvic Floor Physiotherapy Team by the Medical Team of the Ambulatory of Urogynecology and Obstetrics of the Hospital de Clínicas de Porto Alegre and those who are in compliance with the inclusion criteria proposed for the research will be invited to participate in the study.

Eligibility criteria: Inclusion Criteria:

* Women with urinary incontinence;
* Know how to perform a voluntary pelvic floor muscle contraction;
* Have not undergone pelvic floor muscle training in the last 6 months;
* Understand the instruments used in research.

Exclusion Criteria:

* Latex allergy;
* Neurological diseases;
* Pelvic organ prolapse \> grade 2;
* Pain during vaginal palpation and / or introduction of the vaginal probe;
* Vaginal atrophy;

Primary outcomes:
measure: Change in urinary incontinence
timeFrame: 8 weeks
Secondary outcomes:
measure: Impact in quality of life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: José Geraldo Lopes Ramos
state: RS
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Jose Geraldo Lopes Ramos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00997594: Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation
Official title: Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Adrenal Tumors
Keywords: adrenal gland
Lead sponsor: Mie University
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate changes in adrenal hormones during adrenal radiofrequency (RF) ablation.

Detailed description: Adrenal radiofrequency (RF) ablation has been increasingly used for the treatment of unresectable adrenal tumors. But one of the major complication is a increase in blood pressure. Hormonal release during RF ablation is considered the cause of hypertension. But there has been no evidence that adrenal hormones affects changes in blood pressure. In this prospective study, we evaluate the changes in adrenal hormones during RF ablation and clarify the cause of hypertensive crisis.

Eligibility criteria: Inclusion Criteria:

* Unresectable adrenal tumor which will be treated by radiofrequency (RF)ablation
* Blood pressure is 140mmHg or less before RF ablation
* Age of 20-years or more
* Performance status of 0 or 1
* Agreement from the patient

Exclusion Criteria:

* Platelet count of 50,000/mm\^3 or International normalized ratio (INR)\>1.5

Primary outcomes:
measure: Increase in Catecholamine
timeFrame: One day
measure: Serum Cathecholamine Levels
timeFrame: around one year
measure: Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation
timeFrame: 1 week
Secondary outcomes:
measure: Increase in Cortisol
timeFrame: 1 day
Other outcomes:
Locations:
city: Tsu
country: Japan
facility: Mie University Hospital
state: Mie
city: Tsu
country: Japan
facility: Mie University
state: Mie
Study officials:
affiliation: Mie University School of Medicine
name: Koichiro Yamakado, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04211194: Registry for Upper Gastrointestinal Bleeding
Official title: The Orange County Bleeding Consortium (OCBC): Registry of Patients Undergoing Endoscopic Procedures for Upper Gastrointestinal Bleeding in AdventHealth Hospitals in Central Florida
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peptic Ulcer Hemorrhage
Peptic Ulcer, Acute With Hemorrhage
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 2999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will come from patient who are undergoing endoscopic treatment for upper gastrointestinal bleeding at AdventHealth Hospitals.

Brief summary: This project aims to evaluate the data on all patients undergoing endoscopic therapy for upper gastrointestinal bleeding.

Detailed description: This project is being performed to evaluate the outcomes of patients undergoing endoscopic procedures for upper gastrointestinal bleeding at all AdventHealth hospitals in Central Florida. This information will enable quality control of patients undergoing treatment for upper gastrointestinal bleeding across all campuses in the AdventHealth system in Central Florida and hence improve the delivery ot care extended to the investigator's patients.

Eligibility criteria: Inclusion Criteria:

* Patient is 18 years of age or greater
* Patient is undergoing endoscopic treatment for upper gastrointestinal bleeding

Exclusion Criteria:

* Under the age of 18
* Patient not undergoing endoscopic treatment for upper gastrointestinal bleeding

Primary outcomes:
measure: Mortality Rate
timeFrame: 30 days
Secondary outcomes:
measure: Rate of Reintervention
timeFrame: 30 days
measure: Rate of Recurrence
timeFrame: 30 days
measure: Rate of Readmission
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: 30 days
measure: Costs
timeFrame: 30 days
measure: Treatment success
timeFrame: 30 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Center for Interventional Endoscopy
state: Florida
Study officials:
affiliation: AdventHealth Orlando
name: Shyam Varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01908894: Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Injection Site Toleration
Official title: A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Biodel
Sponsor class: INDUSTRY
First posted: 2013-07-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.

Detailed description: The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.

The secondary objectives are to assess other pharmacokinetic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, to assess pharmacodynamic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-123 and BIOD-125 compared to Humalog®

Eligibility criteria: Inclusion Criteria:

1. Age: ≥18 - ≤70 years
2. BMI: ≥18 - ≤30 kg/m2
3. Diagnosed with type 1 diabetes mellitus for at least 1 year
4. Insulin antibody ≤10 μU/mL at screening

Exclusion Criteria:

1. Type 2 diabetes mellitus
2. History of \>2 severe hypoglycemic events within the 3 months prior to screening
3. Serum C-peptide \>1.0 ng/mL
4. Hemoglobin A1c (HbA1c) \>10.0%
5. Females who were breast feeding, pregnant, or intending to become pregnant during the study
6. A sexually active person who was not using adequate contraceptive methods
7. Positive serology for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
8. Abnormal ECG, safety lab, or physical examination results that were deemed clinically significant by the investigator

Primary outcomes:
measure: Speed of absorption (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog.
timeFrame: 0-30, 0-60, 0-90, 0-480, and 120-480 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00868894: Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension
Official title: A Randomized, Double-masked, Placebo- and Active-controlled, Multi-Center, Dose Escalation Trial of DE-104 Ophthalmic Solution in Japanese and Non-Japanese Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-25
Enrollment: 49
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 investigate safety, efficacy, and the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Provided signed, written informed consent.
* 18 years of age and older.
* Diagnosed with primary open-angle glaucoma or ocular hypertension.
* If a subject is a female of childbearing potential she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
* Presence of any abnormality or significant illness that could be expected to interfere with the study.

Primary outcomes:
measure: To compare the safety and efficacy of two concentrations of DE-104 ophthalmic solution with placebo and 0.005% latanoprost in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.
timeFrame: 15 days
Secondary outcomes:
measure: To investigate the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.
timeFrame: 15 days
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
city: Pasadena
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Honolulu
country: United States
state: Hawaii
city: Kailua
country: United States
state: Hawaii
city: New York
country: United States
state: New York
Study officials:
References:
Clinical trial NCT02676960: Feasibility Study: MRI on 6 Months, 1 Year, and 2 Years Old Children Without Sedation
Official title: Feasibility Study: MRI on 6 Months, 1 Year, and 2 Years Old Children Without Sedation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 15 healthy term infants age \~6 months, up to 15 healthy term infants age \~1 year and another up to 15 healthy toddlers at age 2 years, up to 15 healthy children age 3 to 5 years.

Brief summary: The purpose of this study is to perform brain scans using magnetic resonance imaging (MRI) instrument on children aged 6 months up to 5 year old children. This procedure is usually done with sedation but the study will see if it can be done without sedation.

Detailed description: MRI examination of term infants without sedation at a later age (than newborn) can be feasible.

Eligibility criteria: Inclusion Criteria:

* Term born
* Mother is 18 years or older

Exclusion Criteria:

* Any previous or current neurological illness or other serious medical conditions
* Any conditions deemed by the investigators that are not suited for a MRI scan.

Primary outcomes:
measure: Number of participants that can perform an MRI exam without sedation
timeFrame: From the time of the start of the MRI until the end of the MRI exam (~2 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Nutrition Center
name: Xiawei Ou, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01115660: Stroke Education Intervention Trial - Pilot
Official title: AVAIL interVention Trial (Adherence Evaluation After Ischemic Stroke - Longitudinal): Pilot Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Intracranial Hemorrhage
Transient Ischemic Attack
Keywords: stroke
patient education
medication adherence
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
First posted: 2010-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objectives of the trial of a medication-coach program for patients with stroke or transient ischemic attack are to pilot test the study design, the intervention components and the data collection forms and refine them for a larger trial whose goal will be to improve long-term adherence to stroke prevention medications.


Eligibility criteria: Inclusion Criteria:

* Patients at Wake Forest University Baptist Medical Center (WFUBMC) over age 18
* Diagnosed with acute ischemic stroke, transient ischemic attack or intracranial hemorrhage
* provide consent to participate

Exclusion Criteria:

* discharged to nursing home, acute rehabilitation center, inpatient hospice, or other acute hospital
* homeless
* non-English speakers
* patient and proxy unable to participate in telephone conversation

Primary outcomes:
measure: Feasibility of Intervention (Ability to Reach Patients at 3 Months)
timeFrame: 3 months
Secondary outcomes:
measure: Follow up Appointment With MD
timeFrame: 3 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: WFUBMC
state: North Carolina
Study officials:
affiliation: DCRI
name: Eric D Peterson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sides EG, Zimmer LO, Wilson L, Pan W, Olson DM, Peterson ED, Bushnell C. Medication coaching program for patients with minor stroke or TIA: a pilot study. BMC Public Health. 2012 Jul 25;12:549. doi: 10.1186/1471-2458-12-549.
Clinical trial NCT02575560: Weekly Use First-generation EGFR-TKI in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)
Official title: High Dose Weekly Use First-generation EGFR-TKI Instead of Daily Regular Dose in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: EGFR-TKI Resistant Mutation
Keywords: Progression-Free Survival
Lead sponsor: Qingdao Central Hospital
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: histological confirmed local advanced or metastatic lung adenocarcinoma with EGFR mutation diagnosed by 2nd generation sequence system.

Brief summary: EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small cell lung cancer with EGFR gene mutation. The median progression free survival time is around 11 months with the first generation EGFR-TKI. Patients with acquired resistance with first generation EGFR-TKI usually with EGFR exon 20 mutation (T790M). Change the drug administration maybe prolong patients PFS and evently prolong OS.

Detailed description: 1st generation EGFR-TKI has reversible binding to EGFR, it also bind to T790M in a high dose which is account about 60% patients acquired resistance to the drug. Resistance patients may be benefit to a bolus drug use to block T790M gene.

Eligibility criteria: Inclusion Criteria:

* NSCLC with EGFR mutation progressed after first generation EGFR-TKI, or progressed after chemotherapy and 1st generation EGFR-TKI or progressed after 1st generation EGFR-TKI and chemotherapy. Expected survival more than 3 months with a ECOG ≤3.

Exclusion Criteria:

* liver function (ALT, AST) and renal function 2 times higher than normal limit; IPD; uncontrolled diarrhea; severe anemia.

Primary outcomes:
measure: Progression Free Survival Time (PFS)
timeFrame: an average 1 year
Secondary outcomes:
measure: Overall Response Rate(ORR)
timeFrame: an average half year
measure: Overall Survival Time (OS)
timeFrame: an average 2 year
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shandong
Study officials:
affiliation: Qingdao Central Hospital
name: ketao lan
role: STUDY_CHAIR
References:
Clinical trial NCT06418360: Efficacy of TECAR Therapy in Patients With Knee Osteoarthritis
Official title: Evaluation of The Efficacy of TECAR Therapy in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Energy Transfer Capacitative and Resistive Therapy
Keywords: knee pain, osteoarthritis, capacitative and resistive energy transfer therap
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: The aim of the present study was to investigate the treatment efficacy of TECAR therapy, a modern application that has been increasingly used in recent years, compared to conventional physical therapy applications in the treatment of knee osteoarthritis, according to the evaluation of the clinical findings of patients.

Methods: A total of 54 patients, aged between 40 and 75 years, were randomly divided into two groups. Both groups received CPT. Group 2 received TECAR therapy in addition to CPT, applied three times a week for two weeks, for a total of 6 sessions. All patient's knee joint range of motion (ROM) was measured goniometrically, isometric quadriceps muscle strength was measured, and pain levels were assessed using the Visual Analog Scale (VAS), and disability levels were assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) before treatment, at the end of treatment, at 1 month, and at 3 months.


Eligibility criteria: Inclusion Criteria:

* 3 months of conservative treatment for unresponsive knee pain
* Kellgren-Lawrence grade 2-3 on radiographic evaluation
* Agreed to participate in the study.

Exclusion Criteria:

* History of physical therapy (electrotherapy/exercise) in the past 3 months
* Intra-articular injection therapy in the past 3 months,
* History of surgery or trauma to the affected knee
* Inflammatory or neurological disease affecting the lower extremities
* Active vasculitis or severe peripheral vascular disease
* Pregnancy or lactation
* Diagnosed restless legs syndrome
* Neoplasia
* Local sensory impairment,
* Local or systemic acute infections
* Severe osteoporosis
* Pacemaker
* Psychiatric disorder and cognitive impairment.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Before and the after treatment 0th day , 1th month, 3rd month
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: Before and the after treatment 0th day, 1th month, 3rd month
measure: Range of Motion (ROM)
timeFrame: Before and the after treatment 0th day, 1th month, 3rd month
Secondary outcomes:
measure: The Diers Myoline Isometric Muscle Strength Measurement System
timeFrame: Before and the end of treatment 0th day, 1th month, 3rd month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Özge TEZEN
Study officials:
References:
Clinical trial NCT06842160: Photoplethysmography (PPG) Algorithm with Smartwatch in Evaluation of Atrial Fibrillation Burden After Catheter Ablation
Official title: Photoplethysmography (PPG) Algorithm with Smartwatch in Evaluation of Atrial Fibrillation Burden After Catheter Ablation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation (AF)
Keywords: Atrial Fibrillation Burden、 Catheter Ablation
Photoplethysmography
Wearable devices.
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone catheter ablation for atrial fibrillation and meet age and health standards are able to use electrocardiographic watches for long-term monitoring

Brief summary: The purpose of this study is to evaluate the effectiveness of a smart electrocardiogram watch based on the PPG algorithm in monitoring the atrial fibrillation burden of patients after catheter ablation.


Eligibility criteria: Inclusion Criteria:

1. Atrial fibrillation patients diagnosed by electrocardiogram
2. Received catheter ablation procedure
3. Willing to use long-range electrocardiogram monitoring equipment

Exclusion Criteria:

1.Patients who are allergic to electronic devices or unable to wear watches

Primary outcomes:
measure: Incidence of Stroke
timeFrame: March 30, 2025 to March 30, 2035
measure: Incidence of Heart Failure
timeFrame: March 30, 2025 to March 30, 2035
measure: All-Cause Mortality Rate
timeFrame: March 30, 2025 to March 30, 2035
measure: Cardiovascular Mortality Rate
timeFrame: March 30, 2025 to March 30, 2035
measure: Rate of Rehospitalization
timeFrame: March 30, 2025 to March 30, 2035
measure: Incidence of Bleeding Events
timeFrame: March 30, 2025 to March 30, 2035
measure: Postoperative Atrial Fibrillation Burden
timeFrame: March 30, 2025 to March 30, 2035
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
References: