louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05487677: Subscapularis Repair Augmentation for Total Shoulder Arthroplasty
Official title: Augmentation of Subscapularis Repair in Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Injuries
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients undergoing reverse shoulder arthroplasty will be recruited, consented, \& enrolled. Patient will be randomized to standard repair with sutures versus standard repair with BioBrace augmentation of the repair.
Primary purpose: TREATMENT

Brief summary: The primary purpose of this research is to compare the images obtained by ultrasound between a standard repair of the subscapularis tissue and after repair with a Biobrace. The secondary purpose is to determine if there are any clinical differences.

Detailed description: The investigators would like to learn if subscapularis repair augmentation with the Biobrace in total shoulder arthroplasty (reverse and anatomic) will result in sonographic and/or clinical improvements. This will allow for improvements in technique and better outcomes for patients going forward.

Eligibility criteria: Inclusion Criteria:

* Total Shoulder Arthroplasty

Exclusion Criteria:

* Vulnerable population

Primary outcomes:
measure: Difference in continuity of subscapularis tissue on ultrasound
timeFrame: 6 weeks, 6 months after surgery
measure: Difference in thickness of the subscapularis tissue on ultrasound
timeFrame: 3 months, 1 years after surgery
measure: Evaluate arthritis on shoulder x-ray
timeFrame: Surgery
measure: Difference in signs of loosening or wear patterns in shoulder X-Ray
timeFrame: 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Secondary outcomes:
measure: American Shoulder & Elbow Surgeons Score (ASES) score
timeFrame: 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
measure: Shoulder examination for the difference in Passive Range of Motion
timeFrame: 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
measure: Shoulder examination for the difference in Active Range of Motion
timeFrame: 3 months, 6 months, 1 year, 2 years after surgery
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Michael T Freehill, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04724577: 12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer
Official title: Phase I Study on Carbon Ion Radiotherapy in 12 Fractions for Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiotherapy
Prostate Cancer
Keywords: localized prostate cancer
carbon ion radiotherapy
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 30
Sex: MALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: dose escalation study for carbon ion radiotherapy in prostate cancer
Primary purpose: TREATMENT

Brief summary: The arm of this study is to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer in our center.

Detailed description: The radiation dose of 51.6GyE in 12 fractions is currently widely used in Japan, and clinical studies of 51.6GyE/12Fx have also been carried out for SBRT. There are some differences in equipment and carbon ion treatment planning system used between Japan and our center. Therefore, we designed this phase I clinical study to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed adenocarcinoma of prostate
* Stage cT1-3N0M0 localized prostate cancer
* No lymph nodes or distant metastasis
* Age ≥ 45 and \< 85 years of age
* Karnofsky Performance Score ≥70
* No previous pelvic radiation therapy (RT)
* No previous prostatectomy
* No previous invasive cancer (within 5 years before the prostate cancer diagnosis)
* Ability to understand character and individual consequences of the clinical trial
* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

Exclusion Criteria:

* No pathologically confirmed adenocarcinoma of the prostate
* Pelvic lymph node metastasis (N1)
* Distant metastasis (M1)
* Previous pelvic radiotherapy
* Previous prostatectomy

Primary outcomes:
measure: Acute toxicity
timeFrame: 3 months after the completion of CIRT
Secondary outcomes:
measure: Biochemical failure free survival,bFFS
timeFrame: From the complation of CIRT,a median of 5 years
measure: Overall survival
timeFrame: From the diagnosis of prostate cancer,a median of 5 years
measure: Progression free survival
timeFrame: From the complation of CIRT,a median of 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
Study officials:
References:
Clinical trial NCT00746577: Organizational Factors Influencing Practice Improvement in Community Based Care
Official title: Organizational Factors Influencing Practice Improvement in Community Based
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Treatment Services
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Richmond Behavioral Health Authority (RBHA)
name: National Institute on Drug Abuse (NIDA)
First posted: 2008-09-04
Enrollment: 910
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Purpose of the Study:

The Richmond Behavioral Health Authority's Substance Abuse Services Division and Virginia Commonwealth University's Institute for Drug and Alcohol Studies are working on an important research study to improve the quality of substance use disorder treatment services offered by RBHA and its contracted services providers. Specifically, this preliminary research will provide the information needed to conduct a planned series of program-specific interventions, designed to increase the adoption of evidence-based practices (EBPs) within specific programs. A major goal of the study is to better understand what factors influence the adoption of EBPs, and what adoption strategies work best for which types of staff, which types of programs, and under what conditions.

Description of Staff Involvement:

In this study, staff will be asked to complete questionnaires about themselves, their workplaces, and their perceptions about the services their organization provides. Some of these questionnaires will be given to staff when they first enter the study, and others may be given to staff before and about 9 months after a 3-day Practice Improvement Workshop (please note that each agency may or may not be selected to complete the workshop).

Description of Client Involvement:

Clients at each participating site will be asked to complete a brief survey about the services they receive at that site. This survey will occur at the initial timepoint, and at several later timepoints. This survey is confidential and anonymous.


Eligibility criteria: Inclusion Criteria:

* Substance abuse staff members (who work with adults) working at Richmond Behavioral Health Authority (RBHA) and its contracted providers
* Clients seen at RBHA and its contracted providers during specific periods, who are at least 18 years of age

Exclusion Criteria:

* Being under 18 years of age

Primary outcomes:
measure: Survey
timeFrame: Pre and post intervention
Secondary outcomes:
measure: Data from database of client information
timeFrame: Pre and post intervention
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Richmond Behavioral Health Authority
state: Virginia
Study officials:
affiliation: Richmond Behavioral Health Authority (RBHA)
name: James C May, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02049177: Investigation of the Role of Human Papilloma Virus (HPV) in the Prognosis of Head and Neck Cancer
Official title: Alcohol Related Cancers and Genetic Susceptibility in Europe Follow-up - North-West England
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: Cancer
Epidemiology
Head and Neck
HPV
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: International Agency for Research on Cancer
First posted: 2014-01-30
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases that were previously identified for the HPV-AHEAD case-control study.

Brief summary: Human papilloma virus (HPV) is a recognised cause of some head and neck cancers. Important questions remain however, regarding the role of specific types of HPV, their effect on prognosis and different subtypes of oral, pharyngeal and laryngeal cancer, interaction with other risk factors (such as smoking and alcohol), and potential geographical differences in the effect of HPV.

Via the Alcohol-Related Cancers and Genetic Susceptibility in Europe (ARCAGE) study, which is an international collaboartive case-control study conducted in 15 centres in 11 European countries, and pooling our results with the HPV-AHEAD consortium, we will conduct a systematic analysis of HPV subtypes known or suspected to be involved in head and neck cancer. This will involve investigation of HPV risk by tumour site (oral, oropharynx, hypopharynx, larynx), tumour stage, country, sex and age, and whether risk is modified by exposure to other known or suspected carcinogens including tobacco, alcohol and medical history.

It is intended that this work will contribute to the development of evidence that may feed into treatment protocols for these cancers as well as evaluations of the feasibility for extending HPV vaccine programs.


Eligibility criteria: Inclusion Criteria:

* Consent to follow-up and use of tissue samples

Exclusion Criteria:

* No existing consent

Primary outcomes:
measure: HPV type
timeFrame: From surgical/biopsy samples taken in 2002/2003, to be typed in 2014
Secondary outcomes:
measure: Vital status
timeFrame: 2014
measure: Cancer Reccurrence
timeFrame: 2002-2014
measure: Secondary cancers
timeFrame: 2002-2014
Other outcomes:
Locations:
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Infirmary
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital
city: Manchester
country: United Kingdom
facility: The Christie Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
Study officials:
References:
Clinical trial NCT00768677: Topiramate for Binge Eating Disorder Among Adolescents
Official title: Open-Label Study of Topiramate for Binge Eating Disorder and Bulimia Nervosa Among Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Bulimia Nervosa
Keywords: binge eating behavior
adolescents
Lead sponsor: The Zucker Hillside Hospital
Sponsor class: OTHER
First posted: 2008-10-08
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study of topiramate to see whether topiramate decreases binge eating behavior among adolescents and young adults. The investigators did also checked whether topiramate affected cognitive function or not.


Eligibility criteria: Inclusion Criteria:

Subjects (aged 12 to 23) were included if they

* Met the criteria of bulimia nervosa or eating disorder NOS with binge-eating behavior in DSM-IV-TR,
* Had weight \> or = 100th % of expected body weight for their age,
* Engaged in binge eating at least once a week for 9 out of the 12 weeks prior to the study entry, and
* Were judged by a clinician to be stable enough to be treated for their psychiatric condition as an outpatient (i.e, no acute suicidality, hallucination, unstable vital signs or persistently abnormal laboratory results due to eating disorder).

Exclusion Criteria:

* Subjects whose psychotropic medications had been changed within 4 weeks prior to the entry or who had started psychotherapy within 3 months prior to the entry were excluded.
* Subjects were also excluded if they were taking carbonic anhydrase inhibitors, carbamazepine, phenytoin, phenobarbital, valproic acid, evening primrose oil or oral contraceptives.
* Other exclusion criteria were: history of substance use disorders within the 6 months prior to study, IQ \< or = 70, medical conditions causing weight loss (i.e., hyperthyroidism, diabetes mellitus type 1, malignancy) or that contra indicate treatment with topiramate (nephrolithiasis or glaucoma), history of non response or poor tolerance to topiramate in the past and history of non-adherence to medication treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital
state: New York
Study officials:
References:
Clinical trial NCT06566053: Establishment of a Predictive System for Perioperative Risk Assessment and Electronic Flowcharting Response Strategies in Thoracic Surgery
Official title: Establishment of a Predictive System for Perioperative Risk Assessment and Electronic Flowcharting Response Strategies in Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Perioperative Complications
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: Changsha Xinghong Network Technology Co.
First posted: 2024-08-22
Enrollment: 10000
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: Patients admitted to the Department of Thoracic Surgery of the Second Xiangya Hospital of Central South University for surgical treatment.

Brief summary: 1. To establish a risk assessment scale for thoracic surgery for the Chinese population, and to classify patients; risk according to the relevant scale;
2. Combining the guidelines for the management of acute and critical illnesses in thoracic surgical care units and the characteristics of diagnosis and treatment operations, to make an AI-assisted diagnosis and treatment process software;
3. Evaluate whether the software can provide timely and correct diagnosis and treatment recommendations for critically ill patients, shorten the time for homogenized training of specialist intensivists, and reduce the hospitalization cost of patients under the review of resident training instructors of various specialties.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the Department of Thoracic Surgery of the Second Xiangya Hospital of Central South University for surgical treatment.

Exclusion Criteria:

* Patients admitted to the Department of Thoracic Surgery of the Second Xiangya Hospital of Central South University without surgical treatment.

Patients under the age of 18.

Primary outcomes:
measure: Acute Respiratory Distress Syndrome
timeFrame: 2024.8-2024.12
Secondary outcomes:
measure: In hospital mortality
timeFrame: 2024.8-2024.12
measure: Length of hospital stay
timeFrame: 2024.8-2024.12
measure: Length of ICU stay
timeFrame: 2024.8-2024.12
measure: Length of postoperative stay
timeFrame: 2024.8-2024.12
measure: Duration of mechanical ventilation
timeFrame: 2024.8-2024.12
measure: Duration of HFNC
timeFrame: 2024.8-2024.12
Other outcomes:
Locations:
city: Changsha
country: China
facility: the Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT03299153: The Effects of Barberry Juice Consumption in Patients With Type 2 Diabetes
Official title: The Effects of Barberry Juice Consumption on Glycaemic Control, Lipid Profile, Blood Pressure and Oxidative Stress in Patients With Type 2 Diabetes: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to investigate the effect of barberry juice (BJ) as a natural antioxidant, on cardiovascular risk factors in patients with type 2 diabetes (T2DM). In a randomized clinical trial study, 46 T2DM patients, 30-70 years old recruited from "Diabetes Association of Iran-Babul ". Patients were randomly allocated to either the BJ group (n=23) who consumed 200 ml of BJ daily for eight weeks, or the control group (n=23) with no intervention. At the baseline and the end of 8-week intervention, blood pressure and biochemical markers were conducted.


Eligibility criteria: Inclusion Criteria:

* Fasting blood glucose\>100 mg/dL (5.6 mmol /L)
* Systolic blood pressure\>130 mmHg or diastolic blood pressure\>85mmHg
* Triglycerides\> 150 mg/dL (1.7 mmol/L)

Exclusion Criteria:

* taking insulin
* smoking
* using antioxidant supplements

Primary outcomes:
measure: fasting blood glucose
timeFrame: 8 weeks
measure: total cholesterol
timeFrame: 8 weeks
Secondary outcomes:
measure: LDL- cholesterol
timeFrame: 8 weeks
measure: HDL- cholesterol
timeFrame: 8 weeks
measure: Triglyceride
timeFrame: 8 weeks
measure: HbA1c
timeFrame: 8 weeks
measure: Systolic BP
timeFrame: 8 weeks
measure: Diastolic BP
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00171353: A Study to Describe Vascular and Renal Effects and Safety of Valsartan in Patients With High Blood Pressure
Official title: A Study to Describe Vascular and Renal Effects and Safety of Valsartan 80 and 160 mg in Arterial Hypertension Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: arterial hypertension
albuminuria
valsartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 109
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: One hundred twenty patients with arterial hypertension and albuminuria (some amount of albumin in urine) are given valsartan 80 mg and then160 mg to normalize blood pressure. Hydrochlorothiazide (diuretic) 12.5-25 mg added if necessary.


Eligibility criteria: Inclusion Criteria:

* Arterial hypertension without previous regular treatment
* Urinary albumin excretion rate above 30 mg / 24h
* 30-65 years old

Exclusion Criteria:

* Reno-vascular arterial hypertension
* Therapy resistant edema
* Chronic heart failure, angina pectoris
* Diabetes mellitus

Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in urine albumin excretion after 24 weeks
measure: Change from baseline in an ultrasound measurement of blood flow after 24 weeks
Secondary outcomes:
measure: Effect of blood pressure changes on urine albumin excretion rate and blood vessel function
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04099953: Does Hemodialysis Affect Upper Extremity Functional Capacity, Physical Activity and Physical Function of Patients?
Official title: Atılım University, Physiotherapy and Rehabilitation Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Hemodialysis
chronic renal failure
upper extremity
physical activity
physical function
Lead sponsor: Atılım University
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Study
Primary purpose: SCREENING

Brief summary: This study was planned to determine the effects of upper extremity functional capacity, physical activity level and physical functions of patients receiving hemodialysis treatment.

Detailed description: Upper extremity functional capacity, physical activity level and physical functions were evaluated in healthy subjects and hemodialysis patients.

Eligibility criteria: Inclusion criteria:

In study group,

* with cooperation
* hemodialysis treatment for at least 3 months
* with single-sided fistula

In the control group,

* healthy volunteers with no history of trauma or surgery in the upper extremity,
* with cooperating

Exclusion Criteria:

* Individuals with orthopedic problems associated with chronic renal failure,
* Upper limb functions affected

Primary outcomes:
measure: Evaluation of The Upper Extremity Functional Level
timeFrame: Evaluations were made after hemodialysis patients rested for half an hour after treatment.
Secondary outcomes:
measure: Evaluation of Physical Activity Level
timeFrame: Evaluations were made after hemodialysis patients rested for half an hour after treatment.
measure: Evaluation of Physical Function Level
timeFrame: Evaluations were made after hemodialysis patients rested for half an hour after treatment.
Other outcomes:
Locations:
city: Gölbaşı
country: Turkey
facility: Atılım University
state: Ankara
Study officials:
affiliation: Atılım University
name: Fatma Cansu AKTAŞ, MsC
role: PRINCIPAL_INVESTIGATOR
References: