louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02423330: A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula
Official title: A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Anal Fistula
Rectal Fistula
Fistula in Ano
Transsphincteric Fistula
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 1
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: This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to treat anal fistulas.

Detailed description: The treatment of anal fistulas remains a challenging clinical problem. Fistulotomy is highly effective, but carries a significant risk of postoperative incontinence. A variety of surgical procedures that do not divide the sphincter muscle may be offered to patients, however none of them are as effective as fistulotomy.

The LIFT (ligation of intersphincteric fistula tract) procedure is a newer option for the treatment of transsphincteric fistulas. Initial results have been promising. However, some fistulas recur after the LIFT procedure because the divided ends of the fistula tract recanalize. Insertion of a barrier into the intersphincteric space may prevent this process. Strattice is acellular porcine dermis, will be used for this purpose.

This prospective trial will evaluate the safety and efficacy of the Strattice-LIFT procedure for the treatment of transsphincteric anal fistulas.

Eligibility criteria: Inclusion Criteria:

1. Subject is 22 years of age or older
2. Subject is willing to comply with study related procedures
3. Subject is not pregnant
4. Subject has a transsphincteric fistula
5. Subject is medically fit to undergo LIFT
6. Subject has a draining seton for a minimum of 6 weeks

Exclusion Criteria:

1. Crohn's disease
2. Pelvic radiation treatment
3. Known or suspected HIV/AIDS
4. Known sensitivity to pork products
5. Abscess or fistula etiology other than cryptoglandular
6. Abdominal malignancies
7. Patients with \<1 year life expectancy
8. History of smoking
9. Known anorectal dysfunction (fecal incontinence)
10. Chronic use of steroids or other agents which may affect wound healing
11. ASA ≥ 2
12. Unable to consent to study
13. Unable to complete 1 year follow up

Primary outcomes:
measure: Healing of the anal fistula
timeFrame: 6 months
Secondary outcomes:
measure: Healing of the anal fistula
timeFrame: 1 year
measure: Postoperative Pain
timeFrame: 1 year
measure: Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT00573430: ARIA (Atacand Renoprotection In NephropAthy Pt.)
Official title: A 28-week, Randomised, Open-label, Parallel-Group, Multi-Center Study To Find the Effective Dose of Candesartan Cilexetil (Atacand) for Renoprotection in Korean Hypertensive Patients With Non-diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-diabetic Nephropathy With Hypertension
Keywords: Candesartan Cilexetil
Non-diabetic Nephropathy
hypertension
urine protein creatinine ratio
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-12-14
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to the end of 28-week treatment


Eligibility criteria: Inclusion Criteria:

* hypertension; a)135mmHg \< Systolic Blood Pressure \<180mmHg and/or 85 mmHg \< Diastolic Blood Pressure \<100 mmHg. or b) The subject has been treated with antihypertensive medication
* proteinuria (urinary protein/creatinine ratio between 500 mg/g and 5000 mg/g)

Exclusion Criteria:

* Current serum-creatinine \> 265 mmol/L (\>3 mg/dL).
* Current serum-potassium \> 5.5 mmol/L
* Known hypersensitivity to angiotensin (AT)1-receptor blocker

Primary outcomes:
measure: The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks
timeFrame: baseline to 28 weeks
Secondary outcomes:
measure: Change of Systolic and Diastolic Blood Pressure From Baseline
timeFrame: baseline to 28 weeks
measure: Inflammatory Marker (Hs-C-peptide Reactive Protein)
timeFrame: baseline to 28 weeks
measure: Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation
timeFrame: 28 weeks
measure: Treatment-emergent Adverse Events
timeFrame: Baseline to 28 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Severance Hospital
name: Da Suk Han
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00378430: " Patients Attitude Towards Physicians and Health Screening Issues Among First Generation Asian-Indian Immigrants to United States".
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Health Screening
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2006-09-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Aim - To better understand expectations and attitudes of first generation immigrants from India to USA.

Background - The is large difference in healthcare system as practiced in India and in USA. Most people who have lived in India for certain period of their life have basic understanding of health-care system in India. In general it is the physician who makes choices for patients there , also the concept of health screening is less prevalent. After immigrating to USA these immigrants are exposed to new healthcare system. We donot have any data showing their attitudes to some specific questions and physician preference in general. We also have significant concentration of these ethnic group in the central valley.

With this questionnaire study we hope to get better understanding of their beliefs and expectations. We have tried to keep the questions simple and straightforward.


Eligibility criteria: Inclusion Criteria:

* First generation immigrants from India to USA
* Currently living in USA
* Planning to live in USA and utilize local healthcare facilities

Exclusion Criteria:

* Age \< 18
* People born in USA

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: UCSF , Fresno
state: California
Study officials:
affiliation: University of California, San Francisco
name: Harminder Longia, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05529030: COVID-19 Booster Readiness Survey
Official title: COVID-19 Booster Readiness Survey
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination Refusal
Keywords: Communication
Surveys and Questionnaires
Vaccination
Economics, Behavioral
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 12036
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this administrative survey is to inform health system logistics by assessing the attitudes towards towards the bivalent COVID-19 boosters held by healthcare workers (HCWs) at a large, rural health system. It will also test, prospectively, the effect on interest in the bivalent COVID-19 booster of different framing approaches in a survey question sent to employees of a large, rural health system.

Detailed description: The Food and Drug Administration has authorized two bivalent COVID-19 boosters with the expectation that the Centers for Disease Control will soon recommend them. The researchers plan to survey the HCWs at a large, rural health system on their attitudes on the bivalent booster.

This survey will gather data on HCWs' interest in a bivalent booster, reasons for hesitancy, risk perception about COVID-19 infection and its complications, and prior COVID-19 infection and vaccination.

Respondents will also be randomly assigned to see different versions of the question asking if they are interested in a bivalent booster with different framing approaches, such as protection of the self or protection of patients (for patient-facing employees). Information on prior vaccination and perceptions of risk will also be gathered and used as covariates in the analysis.

Eligibility criteria: Inclusion Criteria:

* Employee at the health system

Primary outcomes:
measure: Count of employees who indicate interest in the booster
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Michelle N Meyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03764930: Attention to Retinoblastoma Diagnosed in the Trauma Setting
Official title: Attention to Retinoblastoma Diagnosed in the Trauma Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinoblastoma
Wounds and Injury
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those children who experienced accidental ocular trauma with or without brain involvement before diagnosis of unsuspected RB was studied.

Brief summary: To study the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma.

Detailed description: Retrospective study of the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma and to alert ophthalmologists to the possibility of RB in children presenting with or without trauma-related symptoms and signs.

Eligibility criteria: Inclusion Criteria:

* The consecutive patients with RB managed at the ocular oncology service of Zhongshan Ophthalmic Center, Sun Yat-sen University, between January 2013 and August 2018.

Exclusion Criteria:

* The patients who didn't have undergone trauma before diagnosis of RB.

Primary outcomes:
measure: Survival Status
timeFrame: between January 2013 and August 2018
Secondary outcomes:
measure: Trauma incidence of RB patients
timeFrame: between January 2013 and August 2018
measure: RB incidence of pre-school patients with trauma history
timeFrame: between January 2013 and August 2018
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Huasheng Yang, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05605730: Maitland Thoracic Mobilization Versus Mulligan Thoracic Mobilization in Kyphotic Patients With Shoulder Impingement Syndrome
Official title: Maitland Thoracic Mobilization Versus Mulligan Thoracic Mobilization in Kyphotic Patients With Shoulder Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Kyphosis Thoracic
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 45
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In recent years the management of shoulder impingement syndrome (SIS) included the thoracic spine as it was proved that it's highly correlated to pathologies in shoulder joint. SIS is proved to be associated with kyphotic posture. Also, It was proved that changing sitting posture affects the measured ROM of shoulder joint and this implicates the influence of changing thoracic position on shoulder mechanics. Explanations were made regarding the role of thoracic spine in affecting the shoulder joint through two ways. Firstly, through affecting the mechanics of scapular movements and secondly through altering the length tension relationship of shoulder musculature. This study would aim at studying the most effective thoracic mobilization in the treatment of SIS.


Eligibility criteria: Inclusion Criteria:

* Shoulder impingement syndrome SIS clinically diagnosed by using Hawkins-Kennedy test, the painful arc test, and the infraspinatus muscle strength test; and for a rotator cuff tear, the infraspinatus and the drop-arm test and supraspinatus muscle strength tests.
* Subjects will be diagnosed of having postural kyphosis proved by a physician referral or modified Cobb's angle of more than 40 degrees (x-ray).

Exclusion Criteria:

* The participants with any musculoskeletal abnormalities eg. Glenohumeral instability.
* Neurological abnormalities.
* Surgical operation of the last 4 months will be excluded from the study.
* Shoulder corticosteroid injection at any time in the past.
* Engaging in any athletic physical activities.

Primary outcomes:
measure: Active ROM of shoulder joint would be measured utilizing goniometric method
timeFrame: 6 weeks
measure: Kyphotic angle utilizing photographic method
timeFrame: 6 weeks
measure: The Arabic version of the Disability of Arm, Shoulder and Hand (DASH-Arabic)
timeFrame: 6 weeks
measure: Pain will be assessed using visual analogue scale.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT05122130: Effect of Melatonin on Palatal Wound Healing (Randomized Controlled Clinical Trial)
Official title: Effect of Topically Applied Melatonin (N-ACETYL-5-METHOXY TRYPTAMINE) Loaded Gelatin Sponge on Palatal Wound Healing (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Wound Heal
Keywords: Gelatin sponge
melatonin
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the effect of topical melatonin loaded gelatin sponge on donor palatal site healing, after palatal graft harvesting.

Detailed description: Autogenous soft tissue grafts can be considered the gold standard treatment for many muco-gingival problems. The most common site for harvesting soft tissue grafts is the palate. Many harvesting techniques have emerged, but the epithelialized graft harvesting technique is one of the most reliable and effective techniques as it imparts the superficial section of the connective tissue which contains the highest amount of lamina propria. Unfortunately, it leaves an open palatal wound healed by secondary intention, increasing pain and post-operative morbidity. In order to overcome these inadequacies investigators will cover the donor site with melatonin loaded gelatin sponge and evaluate its effect on the healing process.

Eligibility criteria: Inclusion Criteria

1. Patients who have at least one site of natural dentition or dental implants that need to be treated by free palatal graft surgery for indications including progressive recession, planned prosthodontics, presence of a mucogingival deformity, or a lack of keratinized gingiva.
2. Patients who have at least 4 mm thickness of palatal mucosa (at donor site)

Exclusion Criteria:

1. History of smoking.
2. Patients who have any known disease that interfere with periodontal surgery.
3. Patients who have any dermal or autoimmune diseases.
4. Patients who have any previous adverse reactions to the products (or similar products) used in this study.
5. Pregnant and lactating women.
6. Patients who have a palatal infection.

Primary outcomes:
measure: palatal wound healing
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Intensity of pain
timeFrame: Up 2 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
affiliation: Alexandria University
name: salma Nabil, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03892330: Combination Therapy of Anthracyclines for Children With Nephroblastoma
Official title: A Multicenter, Randomized, Double-blind, Prospective Study to Evaluate the Efficacy and Safety of Vincristine, Dactinomycin/Cyclophosphamide Combination Therapy Combined With Liposomal Doxorubicin/Doxorubicin/Pharmorubicin/Pirarubicin in 0.5-14 Year Old Children With Nephroblastoma.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: 0.5-14 Year Old Children With Nephroblastoma
Keywords: Nephroblastoma
Anthracycline
Liposome doxorubicin
Doxorubicin
Pharmorubicin
Pirarubicin
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to estimate the efficacy and side effects of study drugs in children with nephroblastoma who are treated with combination therapy.


Eligibility criteria: Inclusion Criteria:

1. Age 6 months old to 14 years old.
2. No smoking history.
3. Pathologically confirmed nephroblastoma.
4. Informed consent and assent has been obtained before any study assessment is performed.
5. Good compliance.
6. Need to be applied to anthracycline chemotherapy according to the diagnosis and treatment recommendations for Chinese children with nephroblastoma (current version CCCG-WT-2016).
7. Need to be applied to doxorubicin according to the diagnosis and treatment recommendations for children with nephroblastoma (CCCG-WT-2016).

Exclusion Criteria:

1. Patients with cardiovascular disease in addition to nephroblastoma.
2. Patients with digestive, neurological, circulatory, renal or liver disease, blood disorders or growth abnormalities unrelated to the tumor.
3. Patients have been treated with chemotherapy or cardiotoxic nephrotoxic drugs in the past 4 weeks.
4. Patients have participated in other clinical trials in the past 4 weeks.
5. Patients with mediastinal disease.
6. Patients who have undergone mediastinal radiotherapy due to other tumors or received other treatments that may cause heart damage.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 5 years
measure: Time to treatment failure (TTF)
timeFrame: 5 years
measure: Five-year Event free survival (5-year EFS)
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shenjing Hospital
state: Liaoning
Study officials:
References:
Clinical trial NCT02271230: Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure
Official title: Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 25871
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study will examine whether an intervention with vitamin D or fish oil supplements can reduce the risk of heart failure among adult men and women during a follow up period of up to five years (starting from the time of randomization into the parent VITAL trial). The investigators hypotheses are that both vitamin D and fish oil supplements will each reduce the risk of heart failure.

Detailed description: For this ancillary study of the ongoing parent VITAL trial, we will adjudicate incident heart failure cases occurring during a time period of up to five years starting from randomization of subjects in the parent VITAL study. Intention-to-treat analysis will be used to assess the efficacy of vitamin D as well as omega-3 fatty acids.

Eligibility criteria: Inclusion Criteria:

* Men aged 50 or older or women aged 55 or older
* Be consuming no more than 800 IU of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium+vitamin D supplements, medications with vitamin D \[e.g., Fosamax Plus D\], and multivitamins), or, if taking, willing to decrease or forego such use during the trial;
* Be consuming no more than 1200 mg/d of calcium from all supplemental sources combined, or, if taking, willing to decrease or forego such use during the trial;
* Not be taking fish oil supplements, or, if taking, willing to forego their use during the trial

Exclusion Criteria:

* prevalent heart failure
* History of cancer (except non-melanoma skin cancer), heart attack, stroke, transient ischemic attack, angina pectoris, CABG, or PCI
* History of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or Wegener's granulomatosis;
* Allergy to fish or soy

Primary outcomes:
measure: Number of Participants With New Heart Failure Hospitalization
timeFrame: 5 years
Secondary outcomes:
measure: Number of Recurrent Heart Failure Hospitalization
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: