louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04232995: Balance Training in Diabetic Neuropathy
Official title: Efficacy of Balance Training in Comparison to General Exercises Alone in Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathy With Neurologic Complication
Keywords: Diabetes Mellitus type 2
Diabetic neuropathy
Rehabilitation
Balance exercises
Berg Balance Scale
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of balance training in Diabetic Neuropathy. Control group will receive general exercises while Eperimental/ Interventional group will receive Balance exercises along with general exercises.


Eligibility criteria: Inclusion Criteria:

* Age group: 30-60 years
* Diabetes type II patients diagnosed with peripheral neuropathy by medical doctor for at least 5 years
* Neuropathy present (on the basis of Michigan Neuropathy Screening Instrument
* Have balance impairment ( evaluation on Berg Balance Scale)

Exclusion Criteria:

* Neuropathy due to other medical conditions like Vitamin deficiency, Hypothyroidism, Auto-immune/ demyelinating diseases
* Foot ulcers
* Lower limb amputee
* Vestibular diseases
* Retinopathy
* Cardiac problems
* Hemiplegia/ Stroke

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Baseline (Pre treatment)
measure: Berg Balance Scale
timeFrame: At 4th week of treatment
measure: Berg Balance Scale
timeFrame: At 8th week of treatment (Post treatment )
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Institute of Physical Medicine and Rehabilitation, Dow University of Health Sciences
state: Sindh
Study officials:
References:
Clinical trial NCT06245395: Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures
Official title: Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Virtual Reality
Otolaryngology
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2024-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this randomized controlled trial is to determine the efficacy of Virtual Reality in pediatric otolaryngology clinics as distraction analgesia and anxiolysis for patients undergoing otologic procedures.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients, ages 7-17 years old, undergoing an in-office microscope ear examination with possible debridement/instrumentation by a single fellowship trained neurotologist .

Exclusion Criteria:

* 1) patients with a history of chronic pain disorders 2) developmental delay including autism spectrum disorders 3) neurologic or seizure disorders 4) visual impairment 5) claustrophobia

Primary outcomes:
measure: Wong-Baker FACES Pain Scale
timeFrame: during the in clinic procedure
measure: Subjective Units of Distress Scale
timeFrame: during the in clinic procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: WRNMMC
name: Anthony Tolisano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05371795: Comparison on Radiotherapy Permanent Skin Marking With Lancets and an Electric Marking Device
Official title: Research Study: Tattooing of Skin Landmarks in Radiotherapy: Comparison Between the System Traditional and Comfort Marker 2.0® (COMFORTATTOO)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiotherapy
Tattooing
Lead sponsor: Instituto Portugues de Oncologia, Francisco Gentil, Porto
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Comparison on radiotherapy skin set-up markings with lancets versus Comfort Marker 2.0®

Detailed description: A Prospective, unicentric, randomized, controlled, parallel, double-blinded, cohort study comparing radiotherapy skin set-up markings with lancets versus electric marking device (Comfort Marker 2.0® by CIVCO®)

Eligibility criteria: Inclusion Criteria:

* Age at least 18 years old.
* Patients referred to our department to receive external beam radiation therapy.
* Eastern Cooperative Oncology Group performance status of 0 to 1.
* Estimated fractionating schedule of at least 13 once-daily fractions.
* Written informed consent.

Exclusion Criteria:

* Patients requiring either immobilisation thermoplastic masks (for head or head and shoulders) or vacuum cushion.

Primary outcomes:
measure: Patients' comfort
timeFrame: Day 1
measure: Effectiveness
timeFrame: up to 7 weeks
Secondary outcomes:
measure: RTTs' satisfaction
timeFrame: Day 1
measure: Cosmesis
timeFrame: one of the last three days of irradiation
Other outcomes:
measure: Tattoo fading
timeFrame: 6 months from the end of irradiation
Locations:
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Genti
Study officials:
References:
Clinical trial NCT04966195: Stereotactic Body Radiotherapy Based Treatment for Hepatocellular Carcinoma With Extensive Portal Vein Tumor Thrombosis
Official title: Stereotactic Body Radiotherapy Based Treatment for Hepatocellular Carcinoma With Extensive Portal Vein Tumor Thrombosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma Non-resectable
Portal Vein Tumor Thrombosis
Stereotactic Body Radiotherapy
Keywords: Hepatocellular carcinoma
Portal vein tumor thrombosis
Stereotactic body radiotherapy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis
Primary purpose: TREATMENT

Brief summary: Macrovascular invasion (MVI) is common in HCC, Portal vein tumor thrombus (PVTT) is the most common form of MVI in HCC, with an incidence ranging from 44 to 62.2%. About 10% to 60% of HCC patients have PVTT at the time of diagnosis. the prognosis for those with PVTT remains poor, as their median survival is only 2-4 months via supportive care. There is currently no widely-accepted consensus for the management of HCC with PVTT. According to some guidelines in Europe and America, HCC with PVTT is regarded as Stage C per Barcelona Clinic Liver Cancer (BCLC) Staging system, and sorafenib alone is recommended as the treatment of choice. This study is to analyze the safety and efficacy of radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis.


Eligibility criteria: Inclusion Criteria:

1. tumor thrombus involving the main trunk and/or first branches of the portal vein, unsuitable for surgery or TACE;
2. an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2; 3. no refractory ascites;

4. Child-Pugh class A and B, or class C with good performance status; 5. no previous radiotherapy to the liver; 6. more than 700 cc of uninvolved liver

Exclusion Criteria:

1. Have received local or systemic treatments in the past, including but not limited to TACE, immunotherapy, targeted therapy, radiotherapy, radiofrequency therapy, etc.;
2. Diffuse HCC or accompanied by distant metastasis;
3. Severe bleeding tendency or coagulation dysfunction within the previous 6 months;
4. Patients with a history of hepatic encephalopathy

Primary outcomes:
measure: overall survival
timeFrame: from enrollment to death (for any reason).assessed up to 12 months
Secondary outcomes:
measure: objective response rate
timeFrame: from enrollment to progression or death (for any reason),assessed up to 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the second affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT06913595: Low Molecular Weight Heparin vs Direct Oral Anticoagulant After Bariatric Surgery
Official title: Extended Venous Thromboemboism Prophylaxis After Bariatric Surgeries: A Comparison Of Low Molecular Weight Heparin With Direct Oral Anticoagulant
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Deep Venous Thrombosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Extended Venous Thromboemboism Prophylaxis After Bariatric Surgeries: A Comparison Of Low Molecular Weight Heparin With Direct Oral Anticoagulant

Detailed description: This study aims to compare the effectiveness of rivaroxaban versus low molecular weight heparin in reducing the incidence of PMVT after bariatric surgery.

Eligibility criteria: Inclusion Criteria:

- BARIATRIC PATIENTS

Exclusion Criteria:

* BLEEDING TENDENCY

Primary outcomes:
measure: VENOUS THROMBOEMBOLISM
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: mohammed elshwadfy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000495: Prevention of Hypertension: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 1999-10-28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine whether improved nutrition to correct overweight and high sodium intake, and regular frequent moderate rhythmic exercise to improve cardio-pulmonary fitness and to slow heart rate could lower blood pressure and prevent development of hypertension in hypertension-prone individuals.

Detailed description: BACKGROUND:

Diet modification is one of the strategies in the primary prevention of hypertension. Studies of the association between various factors and blood pressure in different populations have shown the occurrence of specific dietary factors associated with elevated blood pressures. The factors include overweight, alcohol consumption and high sodium intake. Heart rate is also an independent predictor of risk of hypertension. Diet and exercise are amenable to intervention to influence blood pressure with the aim of reducing the risk of developing hypertension.

DESIGN NARRATIVE:

In the first phase of the trial participants were randomized to a Monitored (Control) Group or to an Intervention Group receiving individualized intervention to achieve changes in diet and physical activity. The goals of the Intervention Group were: a reduction of at least 10 pounds or 5 percent of body weight for those above desirable weight; a reduction in daily sodium intake to 1800 mg; a modification of alcohol intake to no more than two drinks per day; and an increase in regular, moderate physical activity. The primary endpoint in the first phase of the trial was the comparison of mean blood pressure in the Intervention Group versus the Monitored Group. In the second phase of the trial, all randomized participants were followed for a minimum of five years. The primary endpoints in the second phase were the incidence of high blood pressure and/or hypertension.

Eligibility criteria: Men and women, ages 30 to 44. Normal high blood pressure of 80-89 mm Hg.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Stamler R, Stamler J, Gosch FC, McDonald AM. Primary prevention of hypertension--a randomized controlled trial. Ann Clin Res. 1984;16 Suppl 43:136-42.
citation: Stamler R, Stamler J, Gosch FC, Civinelli J, Fishman J, McKeever P, McDonald A, Dyer AR. Primary prevention of hypertension by nutritional-hygienic means. Final report of a randomized, controlled trial. JAMA. 1989 Oct 6;262(13):1801-7.
Clinical trial NCT02250495: The Sympara VIBE Study for Hypertension
Official title: VIBE: A Clinical Study to Evaluate the Sympara Therapeutic System for the Treatment of Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Hypertension
Lead sponsor: Sympara Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the VIBE study is to evaluate the efficacy and safety of the Sympara Therapeutic System in the treatment of hypertension


Eligibility criteria: Inclusion Criteria:

* Office systolic blood pressure of ≥150mmHg based on an average of three (3) blood pressure reading measured at both the initial screening visit and a confirmatory screening visit OR a mean daytime systolic blood pressure ≥135mm Hg on 24-hour Ambulatory Blood Pressure Measurement
* Receiving and adhering to an appropriate anti-hypertensive treatment regimen, as prescribed by physician
* Minimum six- (6) month history of diagnosis and treatment of hypertension

Exclusion Criteria:

* Previous renal denervation or carotid barostimulation implant
* Secondary causes of hypertension or primary pulmonary hypertension
* Prior surgery or radiation to the area of the carotid sinus, or presence of a stent or other implant in the carotid artery
* Known or suspected baroreflex failure or significant orthostatic hypotension
* One or more hospital admissions for a hypertensive crisis within the past year
* History of myocardial infarction, fibrillation event, unstable angina pectoris, syncope, transient ischemic attach (TIA) or a cerebrovascular accident within six (6) months of the screening period, or has widespread atherosclerosis with documented intrasvascular thrombosis or unstable plaques
* Diabetes mellitus (Type 1)
* Chronic renal disease requiring dialysis
* Kidney or liver transplant

Primary outcomes:
measure: Number of subjects with serious, device-related adverse events as a measure of safety and tolerability
timeFrame: 30 days
Secondary outcomes:
measure: Number of subjects with a reduction in baseline blood pressure following 30 days of Sympara device use as a measure of efficacy
timeFrame: 30 days
Other outcomes:
Locations:
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
Study officials:
affiliation: Monash Health
name: Ian Meredith, AM, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02617095: Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome
Official title: Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dry Eye Syndrome
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2015-11-30
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of T2762 versus Optive® in the treatment of moderate to severe Dry Eye Syndrome.


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent.
* Male or female aged ≥ 18 years old.
* Diagnosis of moderate to severe dry eye syndrome

Exclusion Criteria:

* Pregnancy, lactation.
* Childbearing potential woman who is not using a reliable method of contraception and is not surgically sterilised.
* Inability of patient to understand the study procedures and thus inability to give informed consent.
* Non-compliant patient
* Participation in another clinical study at the same time as the present study.
* Participation to the present study during the exclusion period of another clinical study.
* Already included once in this study.
* Ward of court.
* Patient not covered by government health care scheme

Primary outcomes:
measure: Change of the symptomatology evaluation on a Visual Analogic Scale
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Laboratoires Théa
Study officials:
affiliation: Moorfields Eye Hospital -162 city road - London
name: Frank Larkin, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Augenklinik mit Poliklinik - Swabachanlage 6 - 91054 Erlangen
name: Friedrich KRUSE, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06541795: Evaluation of AcrySof IQ Vivity Extended Vision Intraocular Lenses
Official title: Evaluation of Long-term Safety and Performance of AcrySof IQ Vivity Extended Vision and AcrySof IQ Vivity Toric Extended Vision Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aphakia
Presbyopia
Residual Refractive Cylinder
Keywords: Cataracts
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-08-07
Enrollment: 210
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this post-market study is to describe the long-term safety and performance of AcrySof IQ Vivity and AcrySof IQ Vivity Toric intraocular lens (IOL) models in a real-world setting through routine clinical practice.

Detailed description: This study includes a retrospective chart review to obtain preoperative, operative, and post-operative data, and one prospective visit to collect key long-term safety and performance endpoints in a sample of subjects commercially implanted with the specified IOLs for 3 to 5 years in the real world.

This study will be conducted in the US and in Spain.

Eligibility criteria: Key Inclusion Criteria:

* 22 years old or older at Visit 1.
* Able to understand and sign an approved informed consent form.
* Implantation of AcrySof IQ Vivity and/or Vivity Toric IOL models in both eyes for 3 to 5 years prior to enrollment.
* Documented medical history and required pre-operative baseline information available for retrospective data collection.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Corneal refractive surgery after AcrySof Vivity or AcrySof Vivity Toric IOL implantation.
* Pregnant or nursing at the time of enrollment.
* Childbirth after IOL implantation.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at Visit 1
timeFrame: Visit 1, Year 3-5 postoperative
measure: Incidence of adverse events
timeFrame: Up to Year 3-5 postoperative
measure: Incidence of device deficiencies
timeFrame: Up to Year 3-5 postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Management Operations, Surgical
role: STUDY_DIRECTOR
References:
Clinical trial NCT04951895: Clinical and MRI Finding of The Temporomandibular Joint Posterior Disk Displacement
Official title: Clinical and MRI Finding of The Temporomandibular Joint Posterior Disk Displacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: TMJ Disc Disorder
Keywords: posterior disk displacement
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 900
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The retrospective study included patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University. The sample originally included patients who provided consent to participate in this study and who ultimately underwent treatment for TMJD between 2008 and 2019.

Brief summary: the study aimed to evaluate the clinical and MRI finding of TMJ with posterior disk displacement with predication of the risk factors

Detailed description: : the study aimed to evaluate the clinical and MRI finding of TMJ with posterior disk displacement with predication of the risk factors. Study design: this retrospective study included patients diagnosed as TMJ internal derangement and all the patients examined by MRI from 2008 to 2019. Cases with loss of continuity of articular disk or the posterior attachment of the disk were considered as positive cases.

Eligibility criteria: Inclusion Criteria:

- patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University

Exclusion Criteria:

* Patients were included if they were older than 18 years and diagnosed with TMJD. criteria for this study included systemic diseases (the presence of polyarthritis or other rheumatic diseases), contraindications for MRI (e.g., implanted metal or medical devices, claustrophobia), the presence of neurologic disorders, head and neck cancer, oral submucous ﬁbrosis, a history of TMJ surgery, a history of previous nonsurgical treatment such as occlusal splints, and a history of joint injection with HA/PRP. Trauma patients with subcondylar fracture and patients with congenital and developmental disorders of the TMJ were also excluded from the study.

Primary outcomes:
measure: VAS
timeFrame: baseline (pre treatment)
measure: mouth opening
timeFrame: baseline (pre treatment)
Secondary outcomes:
measure: joint sound
timeFrame: baseline (pre treatment)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine Alazhar University
state: Nasr City
Study officials:
References: