louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01391169: Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses
Official title: Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritonitis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2011-07-11
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a control matched prospective study evaluating the use of seromuscular flap for high risk anastomoses.

Detailed description: 30 eligible patients have been enrolled in the study then each case was matched to a control of patients who undwerwent resection anastomosis with primary anastomosis only in the same study period in terms of age, gender, comorbidity, diagnosis.

Eligibility criteria: Inclusion Criteria:

* all patients with high risk anastomoses

Primary outcomes:
measure: anastomotic leak
timeFrame: 5 weeks
Secondary outcomes:
measure: operative time
timeFrame: 2 hours
measure: wound complications
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
affiliation: Mansoura University
name: ramadan ellithy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04093869: Improving Lung Transplant Outcomes With Coping Skills and Physical Activity
Official title: Improving Lung Transplant Outcomes With Coping Skills and Physical Activity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post-Lung Transplantation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 180
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: This study evaluates the effectiveness of a coping skills and exercise (CSTEX) intervention among post lung transplant patients aimed to reduce distress and improve functional capacity. Half of the patients will receive CSTEX and half will receive the standard of care plus transplant education (SOC-ED).

Detailed description: The study will aim to evaluate the effectiveness of the CSTEX intervention in (i) reducing distress and (ii) improving functional capacity. It is hypothesized that compared to SOC-ED, the CSTEX intervention will result in 1) greater reductions in global distress measured by an established psychometric test battery; and 2) greater improvements in functional capacity assessed by distance walked on a standard Six Minute Walk test (6MWT).

Eligibility criteria: Inclusion Criteria:

* Single or bilateral first lung transplant recipient; discharged from the hospital and at least 6 weeks post-transplant; completed post-transplant pulmonary rehabilitation within the past 18 months; on stable medication regimen; proficient in the English language

Exclusion Criteria:

* Illness such as malignancies that are associated with a life-expectancy of \< 12 months; current pregnancy; inability to read or to provide informed consent; multi-organ transplant recipient or repeat lung transplant.

Primary outcomes:
measure: Change in Global Psychological Distress
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in Functional Capacity
timeFrame: Baseline to 12 weeks
measure: Change in Physical Activity
timeFrame: Baseline to 12 weeks
measure: Change in Sleep Quality
timeFrame: Baseline to 12 weeks
measure: Change in Quality of Life
timeFrame: Baseline to 12 weeks
measure: Change in Frailty
timeFrame: Baseline to 12 weeks
measure: Change in Problem-Focused Coping
timeFrame: Baseline to 12 weeks
measure: Change in Emotion-Focused Coping
timeFrame: Baseline to 12 weeks
measure: Change in Avoidant Coping
timeFrame: Baseline to 12 weeks
measure: Change in Self-Efficacy
timeFrame: Baseline to 12 weeks
measure: Chronic Lung Allograft Dysfunction (CLAD) Free Survival
timeFrame: Up to 3 years post-treatment
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT04968769: Comparison of Ischemic Compression Therapy and Kinesiotaping in Chronic Neck Pain
Official title: Comparison of Ischemic Compression Therapy and Kinesiotaping on Blood Flow, Tissue Stiffness, Pain and Range of Motion in Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Trapezius muscle
trigger point
ultrasonographic imaging
blood flow
chronic pain
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study
Primary purpose: TREATMENT

Brief summary: Objective: The purpose of this study was to compare the effects of ischemic compression (IC) and kinesio taping (KT) treatments on blood flow, tissue stiffness and thickness, pain, and joint range of motion on the upper trapezius muscle of individuals with chronic neck pain.

Methods: In this study 22 individuals between the ages of 20-35 were randomly assigned to 3 groups: Group1, which received IC; Group2, received KT; Group3 (control) received exercise, for 2 days and 4 weeks. Pain was measured with VAS, pain threshold with J-Tech Algometer, range of motion with BASELINE Digital Inclinometer, ultrasonographic measurements for blood flow, tissue stiffness and tissue thickness using Acuson S3000. All measurements were performed twice; before and after treatment.


Eligibility criteria: Inclusion Criteria:

* A score ar least 3 and above 3 on the Visual analogue scale
* Presence of palpable taut band and at least one trigger point on the taut band
* Presence of referred pain with palpation of the trigger point

Exclusion Criteria:

* Analgesic use within the previous 24hours
* History of cervical surgery
* Receiving myofascial pain treatment within the previous month of the study

Primary outcomes:
measure: pain intensity
timeFrame: 4 weeks
measure: pain threshold
timeFrame: 4 weeks
measure: range of motion
timeFrame: 4 weeks
measure: Ultrasonographic Measurements
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
References:
Clinical trial NCT00884169: Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-04-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED

Brief summary: This study is to investigate the efficacy and safety of M518101 in male and female plaque psoriasis patients with refractory plaques.


Eligibility criteria: Inclusion Criteria:

* Who are able and willing to give signed informed consent
* Who are male or females aged between 18 and 65 years with plaque psoriasis confirmed by the Investigator.
* Who have less than 20% of body surface area (BSA) afflicted with plaques
* Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.

Exclusion Criteria:

* Who have a history of allergy to vitamin D3 derivative preparations.
* Who have a history of relevant drug hypersensitivity.
* Who have a history of contact dermatitis induced by a topical medicine.
* Who are pregnant or lactating.
* Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
* Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study.
* Whose serum calcium levels exceed the upper limit of reference range
* Who have used any investigational medicinal product and/or participated in any clinical study within 24 weeks
* Who have been treated with systemic therapy within 8 weeks
* Who have been treated with biologics within 12 weeks
* Who have been treated with topical therapy during the wash-out and lead-in period.

Primary outcomes:
measure: Severity of plaque psoriasis
Secondary outcomes:
measure: Investigator and Patient overall assessment
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Thomas' Hospital
Study officials:
References:
Clinical trial NCT00006169: Behavioral Treatment of Weight Gain in CF
Official title: Behavioral Treatment of Weight Gain in CF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cystic Fibrosis
Keywords: Nutrition
Behavior Therapy
Cystic Fibrosis
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2000-08-09
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief summary: The current study examines the efficacy of two treatments to help children with cystic fibrosis (CF) meet their dietary calorie requirements of 120% to 150% of the recommended daily allowance of energy and the effect of these treatments on weight gain and maintenance. One treatment provides children with CF and their parents nutrition education about the best foods for meeting their dietary needs. The second treatment gives children with CF and their families similar nutritional information plus behavioral parenting methods for motivating children to eat the recommended foods. Children with CF and their families are seen weekly for 7 treatment sessions across 9 weeks for the active phase of treatment. Families are then followed for 2 years after treatment in order to better understand how long the treatments are effective and to determine the health benefits of better nutrition status and weight gain.


Eligibility criteria: Inclusion Criteria:

* Weight percentile for age or height below 40th for age and sex
* Pancreatic insufficiency

Exclusion Criteria:

* Developmental delays
* Pseudomonas cepacia
* Supplemental enteral or parenteral nutrition

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center, Cincinnati
state: Ohio
Study officials:
affiliation: Children's Hospital & Medical Center
name: Lori Stark
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stark LJ, Quittner AL, Powers SW, Opipari-Arrigan L, Bean JA, Duggan C, Stallings VA. Randomized clinical trial of behavioral intervention and nutrition education to improve caloric intake and weight in children with cystic fibrosis. Arch Pediatr Adolesc Med. 2009 Oct;163(10):915-21. doi: 10.1001/archpediatrics.2009.165.
Clinical trial NCT01609569: Pro-calcitonin Marker as Indicator of Ischemia in Patients With Complicated Coronary Intervention.
Official title: Utility of Pro-calcitonin as an Indicator of Ischemia in Patients Undergoing Percutaneous Coronary Intervention With Subsequent Coronary Complications.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Disease
Lead sponsor: Saint Michael's Medical Center
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The aim of this study is to determine on preliminary basis weather an elevated pro-calcitonin level can be used to assess ischemia as a result of coronary artery complications during percutaneous coronary intervention (PCI).

Detailed description: Pro-calcitonin is a type of protein found in the blood. This protein has recently be found to be elevated in patients with diseases of the arteries of the heart such as heart attack.

Percutaneous coronary intervention (PCI) is widely used in the treatment of many patients with blockage in the arteries of the heart.

the investigators normally used a marker called troponin after cardiac catheterization. However, this marker may not be specific.

Pro-calcitonin has been found to be a useful marker for the detection of myocardial injury. the value of Pro-calcitonin as a marker for the identification of myocardial damage undergoing PCI has not yet been studied.

Eligibility criteria: Inclusion Criteria:

* patients older than 18 years old.

Exclusion Criteria:

* no consent.
* suspicion of sepsis.
* Patients with elevated troponin or procalcitonin before enrollment.
* patients who had non-elective angioplasty (e.g. rescue angioplasty, primary angioplasty, salvage angioplasty, or emergency angioplasty)

Primary outcomes:
measure: Pro-calcitonin blood level
timeFrame: "0,24 hours post cardiac intervention"
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
Study officials:
affiliation: Saint Michael's Medical Center
name: Habib Habib, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Michael's Medical Center
name: Fayez Shamoon, MD,FACC
role: STUDY_DIRECTOR
affiliation: Saint Michael's Medical Center
name: yaser elnhar, MD
role: STUDY_CHAIR
affiliation: Saint Michael's Medical Center
name: Vincent Debari, PhD
role: STUDY_CHAIR
affiliation: Saint Michael's Medical Center
name: Ashraf Jmeian, MD
role: STUDY_CHAIR
affiliation: Saint Michael's Medical Center
name: Ahmad Isbitan, MD
role: STUDY_CHAIR
References:
citation: Sinning CR, Sinning JM, Schulz A, Schnabel RB, Lubos E, Wild PS, Papassotiriou J, Bergmann A, Blankenberg S, Munzel T, Bickel C; AtheroGene Study Investigators. Association of serum procalcitonin with cardiovascular prognosis in coronary artery disease. Circ J. 2011;75(5):1184-91. doi: 10.1253/circj.cj-10-0638. Epub 2011 Mar 3.
Clinical trial NCT00370669: Effect of Intravitreal Bevacizumab on Clinically Significant Macular Edema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetic Macular Edema
Keywords: Bevacizumab
CSME
MPC
Triamcinolone acetonide
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-09-01
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to compare the effect of intravitreal bevacizumab alone or in combination with triamcinolone acetonide with laser photocoagulation on clinically significant macular edema (CSME)

Detailed description: we entered 150 eyes into the study that recruitment of cases finished recently.Eligible eyes randomly assign to one of the study arms including intravitreal bevacizumzb, intravitreal bevacizumzb/triamcinolone and macular photocoagulation groups. Every patient needs at least 1 year followup. During this time BCVA, OCT, FA will be done for each patient and inaccording to interpretation of datas and fundus exam repeatation of injection will be done.

Eligibility criteria: Inclusion Criteria:

* case with clear media IOP below 23 mm/Hg female after menopause at least for 12 months or had 2 contraceptive roots visual acuity between 20/50 to 20/320

Exclusion Criteria:

* no PRP or N.d YAG laser in past 6 months no intraocular surgery in past 12 months
* CVA in past 12 months blood sugar above 250
* active infection in extraocular adnexa

Primary outcomes:
measure: visual acuity
measure: central macular thickness
Secondary outcomes:
measure: Leakage in fluorescein angiography
measure: intraocular pressure
measure: cataract progression
measure: anterior chamber reaction
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Masoud Soheilian
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Masoud Soheilian
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soheilian M, Garfami KH, Ramezani A, Yaseri M, Peyman GA. Two-year results of a randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus laser in diabetic macular edema. Retina. 2012 Feb;32(2):314-21. doi: 10.1097/IAE.0b013e31822f55de.
citation: Soheilian M, Ramezani A, Obudi A, Bijanzadeh B, Salehipour M, Yaseri M, Ahmadieh H, Dehghan MH, Azarmina M, Moradian S, Peyman GA. Randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus macular photocoagulation in diabetic macular edema. Ophthalmology. 2009 Jun;116(6):1142-50. doi: 10.1016/j.ophtha.2009.01.011. Epub 2009 Apr 19.
Clinical trial NCT04361669: Hospice Quality Score Assessment Post Pharmacist Intervention
Official title: Assessing the Impact of Pharmacist Interventions on Hospice Quality Scores
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Respiratory Disease
Cardiovascular Diseases
Neurologic Disorder
Dementia
Cancer
Keywords: National Quality Forum Score
HCAHPS
Medication refill
Number medications
Lead sponsor: Tabula Rasa HealthCare
Sponsor class: INDUSTRY
First posted: 2020-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will be hospice population who received services for 6-months (e.g., between April 2020 to October 2020) and information including: age (excluding patients 89 years or older), gender, medication risk score, NQF score, HCAHPS score, time to fill medication order set, type of chronic condition, and number of medications will be studied.

Brief summary: The study aims to investigate the impact of pharmacist delivered interventions on hospice patients quality metric scores.

Detailed description: The objective of this study is evaluate a program at a hospice involving activities designed to improve the site's National Quality Forum (NQF) and Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores. These scores are calculated by the hospice using existing patient satisfaction survey scores (HCAHPS). The institution quantifies their compliance with national quality metrics (NQF) and reports this existing data to the pharmacist providing counseling services to their patients. The pharmacist assesses for areas for improvement and provides additional counseling services to improve the continuity and quality of care. The pilot program is scheduled to launch April 2020 and the researchers will look to assess for changes in the NQF scores, HCAHPS scores, and time for their partnering pharmacy to refill the first set of prescriptions.

Eligibility criteria: Inclusion Criteria:

Adult patients who were referred to hospice by a healthcare provider

Exclusion Criteria:

Patients 89 years or older

Primary outcomes:
measure: National Quality Forum Score
timeFrame: 6 months
measure: Consumer Assessment of Healthcare Providers and Systems
timeFrame: 6 months
measure: Time to refill
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tabula Rasa HealthCare
state: Arizona
Study officials:
affiliation: Tabula Rasa HealthCare
name: Jennifer Bingham, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06145269: Recanalization Rate of Acute DVT
Official title: Recanalization Rate of Acute Deep Venous Thrombosis Related to Therapeutic Modality- Comparative Study; New Oral Anticoagulants (NOACs) Vs. Conventional Treatment.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Acute DVT of Lower Extremity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rporting and evaluation of the rate of recanalization of acute DVT of the lower limb at one year follow-up comparing the results of using NOACs vs. conventional treatment.

Detailed description: Deep vein thrombosis (DVT) is an important cause of disability and mortality in our society . The incidence of DVT significantly increases with age, being more prevalent in women than men . The location of DVT is also an important factor to be studied because of its association with pulmonary embolism and development of post-thrombotic syndrome (PTS) , Currently, duplex ultrasound scanning (DUS) is the method of choice for diagnosis of DVT because it is non-invasive, provides real-time imaging, and has high sensitivity and specificity especially for detection of proximal DVT .

The new oral anticoagulants (NOACs), are poised to replace warfarin for treatment of the majority of patients with venous thromboembolism (VTE), With a rapid onset of action and the capacity to be administered in fixed doses without routine coagulation monitoring, NOACs have been shown to be noninferior to conventional anticoagulant therapy for prevention of recurrence with less bleeding.

Most studies have reported that more advantages than disadvantages for NOACs when compared with VKAs, with the most important advantages of NOACs including safety issues (ie, a lower incidence of major bleeding), convenience of use, minor drug and food interactions, a wide therapeutic window, and no need for laboratory monitoring. Nonetheless, there are some conditions for which VKAs remain the drug of choice.

Eligibility criteria: Inclusion Criteria:

* • Patients suffering from first attack of acute DVT (De novo) of the lower limb who (only femoral-popliteal type) aged 18 - 80 years.

Exclusion Criteria:

* Patients suffering from recurrent DVT.
* Patients with acute DVT candidate for CDT (limb threatening acute DVT).
* Patients suffering from acute DVT with malignancy.
* Pregnant and Lactating females.
* Patients with severe renal Impairment (CrCl \<30mL/min), Severe hepatic impairment.

Primary outcomes:
measure: Recanalization rate of the thrombosed vein with the two comparable groups.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: