louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01888016: Effectiveness of Fascial Manipulation in Rotator's Cuff Surgery Patients
Official title: Effectiveness of Fascial Manipulation in Early Rehabilitation Treatment of Rotator's Cuff Surgery Patients. A Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cuff Rotator Syndrome
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to evaluate the effectiveness of fascial manipulation treatment in terms to reduce pain and improve physical functionality after rotator's cuff surgery. The technique involves deep friction manipulation of fascia's specific spots. Distant from surgical site.

Detailed description: To evaluate the effectiveness of fascial manipulation treatment associated with standard physiotherapies treatment in rotator's cuff surgery patients, we'll randomize about 60 patients for arm's of study. Both arm's will receive 10 standard physiotherapies treatments in 2 weeks while the experimental arm will receive 3 manual intervention on deep fascial tissues, according to fascial manipulation technique, providing a specific motor and manual assessment, and a deep manual intervention over specific fascial alteration.

To evaluate the effectiveness of fascial manipulation treatment we'll use 2 type of outcome measure and we will compare the result of both arms of study.

Eligibility criteria: Inclusion Criteria:

* Rotator's cuff surgery patients that have been operated within the past 4/5 weeks
* Age between 18 to 65 years old

Exclusion Criteria:

* Patients with traumatic shoulder's injury that involved bone's fractures.
* Severe underlying pathologies like rheumatic, neurological and cardio pathologies that affect the correct shoulder treatment
* Patients on anticoagulant treatment

Primary outcomes:
measure: visual analogue scale (VAS)mean
timeFrame: Change from baseline in pain at the end of the rehabilitation cycle (two weeks)
Secondary outcomes:
measure: Constant Murley score
timeFrame: Change from baseline in range of motion at the end of the rehabilitation cycle (two weeks)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Maria Grazia Benedetti, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01410916: Safety and Efficacy Study of Eculizumab in Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
Official title: An Open-Label, Multi-Center Trial of Eculizumab in Patients With Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Shiga-like Toxin-producing Escherichia Coli
Keywords: STEC-HUS
Shiga-like toxin-producing Escherichia Coli Hemolytic-Uremic Syndrome
uncontrolled complement activation
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-05
Enrollment: 198
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This protocol is designed to collect safety and efficacy data on patients that have been or will be treated with eculizumab for STEC-HUS, in the context of the 2011 STEC-HUS epidemic in Germany.


Eligibility criteria: Inclusion Criteria:

1. Patient must be willing and able to give written informed consent/Assent.
2. Adults, adolescents, or pediatric (≥2 months and ≥5kg) patients
3. Patient has been diagnosed with Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)

Exclusion Criteria:

1. Known complement regulatory mutation or family history of complement regulatory mutation
2. Unresolved systemic meningococcal disease
3. 3. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients

Primary outcomes:
measure: Improvement in Systemic TMA & Vital Organ Involvement at 8 weeks of treatment defined as either complete or partial responder based on hematologic normalization/improvement & clinically important improvement in Vital Organs: Brain, Kidney, and Thrombosis
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bielefeld
country: Germany
city: Bielefeld
country: Germany
city: Bonn
country: Germany
city: Bremen
country: Germany
city: Bremerhaven
country: Germany
city: Essen
country: Germany
city: Flensburg
country: Germany
city: Göttingen
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Karlsruhe
country: Germany
city: Köln
country: Germany
city: Lubeck
country: Germany
city: Magdeburg
country: Germany
city: Munchen
country: Germany
city: Munich
country: Germany
city: Munster
country: Germany
city: Oldenburg
country: Germany
city: Ulm
country: Germany
city: Wildeshausen
country: Germany
Study officials:
References:
Clinical trial NCT05645016: Tailoring Overdose Education for Black Churches
Official title: Church-Tailored Opioid Overdose Education and Naloxone Distribution to Target Overdose and Stigma Among African-American Communities
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Opioid Overdose
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The design is a two-arm cluster randomized trial with randomization at the level of the church (4 Churches), and analyses at the level of the individual participants (i.e., church members).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Church-based interventions are culturally acceptable, reduce access barriers, and can be brought to scale in under-resourced communities. For Overdose Education and Naloxone Distribution (OEND) to be efficacious in Black churches, tailoring may be needed. For this audience, standard OEND curricula may need to be adapted to their level of knowledge of substance use disorders (SUDs), and limited general mental health literacy, and specifically address stigma related to SUDs and medications for opioid use disorder (MOUD). Finally, a tailored implementation strategy may need to address contextual variations (e.g., denomination and membership size) across churches. The proposed pilot study aims to identify the socio-cultural modifications that will be needed to adapt our previously developed training (i.e., COEST) to target Black communities of faith. In a pilot randomized controlled trial (RTC) of adapted COEST in a stepped-wedge design.


Eligibility criteria: Inclusion Criteria:

1. Identify as one of the following group members of the Black church: Clergy; Individual with OUD and/or stimulant use disorder; Family member or friend of an individual with OUD; Formerly incarcerated.
2. Age 18 and older.

Exclusion Criteria:

1. Unable to provide informed consent.
2. Less than 18 years old.
3. Does not identify as belonging to one of the four stakeholder groups.

Primary outcomes:
measure: Change in Frequency of Naloxone Utilization/Overdose Intervention
timeFrame: Baseline and 6 Months after COEST training
Secondary outcomes:
measure: Opioid Overdose Knowledge Scale (OOKS)
timeFrame: Baseline and 6 Months after COEST training
measure: Brief Opioid Stigma Scale (BOOS)
timeFrame: Baseline and 6 Months after COEST training
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
References:
Clinical trial NCT06603116: Evaluation of the Clinical Performance of Bioactive Giomer Restoration in Class II Cavities After One Year
Official title: Evaluation of the Clinical Performance of Bioactive Giomer Restoration in Class II Cavities After One Year and in Vitro Investigation of the Surface Roughness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Restoration Failure
Keywords: Bioactive Giomer restoration
Nano hybrid composite
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the clinical performance of the bioactive Giomer restoration in class II cavities after one year using FDI criteria for assessment of dental restorations. Moreover, the surface roughness will be investigated in-vitro using profilometer

Detailed description: * Patients will be selected according to the following inclusion and exclusion criteria from the outpatient Operative clinic, Faculty of Dental Medicine for Girls, Al-Azhar University.
* The patients will be informed about the purpose of the investigation, the clinical procedures and the advantages/risks of the applied materials and techniques. A written informed consent form will be signed from patients prior to study initiation.
* Co-operative patients of age range 20-30 years old with no gender prediction, The patients will be divided into two groups Group (1): Bioactive Giomer restoration. Group (2): Nano-hybrid Composite restoration. Restoration will be evaluated using FDI criteria (functional and biological properties) All the restorations will be clinically evaluated after 1 week (baseline),3 month, 6 months,12 months.

data collected and statistically analyzed

Eligibility criteria: Inclusion Criteria:

* • Each patient should have at least two proximal carious lesions on both sides in the posterior teeth.

  * Adjacent and opposing natural teeth should be present.
  * Patient should be willing to return for follow-up examination and evaluation.

Exclusion Criteria:

* • Patient with poor oral hygiene and motivation.

  * Patient with unrealistic expectations.
  * Patients with disabilities, systemic diseases or severe medically compromised, bruxism, clenching or temporomandibular joint disorders and patients with allergy to any components of the materials.

Primary outcomes:
measure: evaluation of restorations of class two cavities
timeFrame: from one week to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt
Study officials:
affiliation: Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt
name: Maha Niazy, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06861816: Ventilatory Functions and Physical Intolerance in ESRD Adolescents: Response to Program of Walking With Dogs
Official title: Fatigue, Ventilatory Functions, Physical Intolerance, and Life Quality in ESRD Adolescents: Response to Program of Walking With Dogs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
Hemolysis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: adolescents with chronic renal failure going on hemodialysis usually complain many problems including compromised ventilation, early fatigue, early physical intolerance, and bad life quality. incentive spirometer is highly recommended to improve these problems. also, walking program, especially walking with dog, can increase the benefits of incentive spirometer

Detailed description: End stage renal diseased adolescents (numbering forty) will be grouped randomly to two random groups, twenty adolescents in group I or group II. Both groups will trained by incentive spirometer 30 min during the sessions of dialysis three applications weekly for 12 weeks. Group I will additionally walked freely with a dog 30 min three times weekly (in opposite days of hemodialysis). The duration of this trial will be 12 weeks.

Eligibility criteria: Inclusion Criteria:

* adolescents (forty) with ESRD
* patents on regular hemodiaysis

Exclusion Criteria:

* cardiac insult
* respiratory insult
* orthopedic problem
* liver insult

Primary outcomes:
measure: six minute walk testing
timeFrame: it will be measured after 12 weeks
Secondary outcomes:
measure: forced vital capacity
timeFrame: it will be measured after 12 weeks
measure: forced expiratory volume at first second
timeFrame: it will be measured after 12 weeks
measure: maximal inspiratory pressure
timeFrame: it will be measured after 12 weeks
measure: child health questionnaire (physical summary)
timeFrame: it will be measured after 12 weeks
measure: child health questionnaire (mental summary)
timeFrame: it will be measured after 12 weeks
measure: fatigue symptoms inventory
timeFrame: it will be measured after 12 weeks
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: faculty of physical therapy Cairo university
state: Giza
Study officials:
affiliation: Cairo University
name: Ali MA Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04529616: Single Center Exploratory Study To Evaluate The Use Of The RxSight Light Adjustable Lens (LAL) And The Light Delivery Device (LDD) To Improve Visual Outcomes
Official title: Single Center Exploratory Study To Evaluate The Use Of The RxSight Light Adjustable Lens (LAL) And The Light Delivery Device (LDD) To Improve Visual Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Aphakia
Cataract
Keywords: Light Adjustable Lens
Intraocular lens
LAL
Lead sponsor: RxSight, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-27
Enrollment: 79
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate, for the visual correction of aphakia, whether the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory study. No primary effectiveness endpoints will be identified.


Eligibility criteria: Inclusion Criteria:

* Must sign a written Informed Consent form and be willing to undergo cataract surgery for unilateral or bilateral implantation of the RxLAL.
* Age 30 or older on the day the cataract surgery is performed.
* Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source.
* Willing and able to comply with the requirements for study specific procedures and visits.

Exclusion Criteria:

* Study eye with zonular laxity or dehiscence.
* Study eye with diabetes with any evidence of retinopathy.
* Study eye with history of uveitis.
* Subjects taking systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and methoxsalen. LDD treatment in patients taking such medications may lead to irreversible phototoxic damage to the eye. This is only a partial list of photosensitizing medications. Please evaluate all medications that the patient is taking for this effect prior to consideration for implantation.
* Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
* Study eye with history of ocular herpes simplex virus.

Primary outcomes:
measure: Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
timeFrame: 3 months post op
measure: Proportion of Eyes Simultaneously With (1) Monocular UCDVA of 20/25 or Better and (2) Monocular Uncorrected Intermediate Visual Acuity (UCIVA) of 20/32 or Better and (3) Monocular Uncorrected Near Visual Acuity (UCNVA) of 20/40 or Better
timeFrame: 12 months post op
Secondary outcomes:
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: CODET Vision Institute
Study officials:
References:
Clinical trial NCT06237816: CTNow: A Clinical Trials Education Program for Rural Cancer Patients and Oncology Providers
Official title: CTNow: A Clinical Trials Education Program for Rural Cancer Patients and Oncology Providers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Oncology
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2024-02-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall goal of the project is to pilot test CTNow, a multilevel intervention designed to facilitate access and referrals to cancer clinical trials in rural areas through patient and provider education and teleconference resources.


Eligibility criteria: Inclusion Criteria:

* Patients must have been diagnosed with any cancer.
* Patients who have received treatment, are receiving cancer treatment at the time of enrollment, or estimated to start treatment within 90 days.
* Patients must be ≥ 18 years of age. Patients must be able to read, write, and speak English. Study materials and telephone calls are only available in English.

Patients must be residents of Hawaii, Kauai, or Maui counties.

Exclusion Criteria:

* Patients must not have previously participated in a cancer clinical trial. Those who have participated in a cancer clinical trial are not eligible for the study.

Primary outcomes:
measure: Change in patients' awareness and knowledge of clinical trials
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Hawaii Cancer Research Center
name: Izumi Okado, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03379116: A Study on Nutrition Support in Adult Patients With Severe Burns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Burn
Enternal Nutrition
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was a prospective, observational, multicenter trial and was conducted in intensive care units of seven hospitals participating in the treatment of the burn patients. Patients who were at least 18 years of age were eligible if they were expected to survive more than 48 hours.

Brief summary: To delineate nutritional support in adults patients with severe burns to investigate associations between nutritional practice and clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients were at least 18 years of age
* Patients were expected to survive more than 48 hours.

Exclusion Criteria:

* irreversible disease

Primary outcomes:
measure: Mortality at 28 days
timeFrame: 28days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02954016: The ePass Clinical Trial for the Treatment of Obese Subjects
Official title: Safety and Efficacy of the ValenTx EndoPass™ System for the Treatment of Obese Subjects: The ePass Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Weight Loss
Hypertension
Type 2 Diabetes Mellitus
Hyperlipidemia
Lead sponsor: ValenTx, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of the endoscopically implanted ValenTx EndoPass™ System for treatment of adults with severe obesity.

The EndoPass System is indicated for weight loss in adults with a body mass index (BMI) ≥35 and ≤ 50 kg/m2 who have failed more conservative weight loss methods.

Detailed description: * Single-arm, multi-center study conducted in up to 50 subjects at up to 5 sites.
* Subjects will be implanted with the EndoPass device for up to 36 months.
* Body weight, adverse events and device function will be monitored at monthly visits for the first year after implant and quarterly visits thereafter.
* Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic and esophagram assessments of the condition of the implanted device, quality of life and eating behavior questionnaires.
* All subjects will be followed for 12 months after device removal.
* A single device renewal may take place as needed after the initial implant.
* Subject study participation may last up to four years, but is expected to vary with implant duration, which will be determined on a case-by-case basis.

Eligibility criteria: Key Inclusion Criteria:

* 18-60 years of age.
* BMI ≥ 35 and ≤ 50 kg/m2
* Documented failure with non-surgical weight loss methods
* Self-reported maximum and minimum body weights during the past 12 months within 10% of current body weight

Key Exclusion Criteria:

* Pregnancy or intention of becoming pregnant.
* Past history of esophageal, gastric or bariatric surgery.
* Medical conditions contraindicating elective endoscopic or bariatric procedures.
* Insulin-dependent diabetes mellitus

Primary outcomes:
measure: The proportion of subjects affected by serious adverse device effects (SADEs) as defined by International Standards Organization (ISO) standard 14155:2011.
timeFrame: 1 Year
Secondary outcomes:
measure: 12 Month Weight Loss in Kilograms
timeFrame: 1 Year
Other outcomes:
Locations:
city: Mendoza
country: Argentina
facility: Hospital Italiano de Mendoza / Clinica Quiriurgica
city: Monterrey
country: Mexico
facility: Swiss Hospital / Especialidades Bariatrices
state: NL
Study officials:
affiliation: ValenTx, Inc.
name: Roland Maude-Griffin
role: STUDY_DIRECTOR
References: