louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00533013: Comprehensive Heart Failure Disease Management Community Program
Official title: Comprehensive Program for Disease Management in Heart Failure Patients in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-09-21
Enrollment: 1360
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 determine whether a nurse-led, comprehensive disease management program is effective in reducing recurrent hospital admissions and deaths in community dwelling patients with moderate to severe heart failure.

Detailed description: Heart failure remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Heart failure is associated with increasing costs for healthcare, mainly for recurrent hospital admissions. Disease management programs aimed to improve patients outcome while containing healthcare costs,were employed in heart failure patients with varying results. Such programs contain various components, including patient education and empowerment, monitoring patients' adherence to therapy, telemonitoring of vital parameters, etc. Designated heart failure clinics were also employed in care given to these patients.

Eligibility criteria: Inclusion Criteria:

1. Adult patients with NYHA-Stage III-IV heart failure recruited in the community;
2. Adult patients with NYHA-Stage II-IV heart failure recruited after hospital admission for decompensated heart failure

Exclusion Criteria:

* Other severe disease (e.g. end stage renal disease, metastatic cancer); bedridden or severely compromised functional status due to other diseases; drug or alcohol abuse; Severe cognitive impairment; People unconnected to telephone

Primary outcomes:
measure: hospital admissions for heart failure or all-cause mortality
timeFrame: 5 years
Secondary outcomes:
measure: Health-related Quality of Life;
timeFrame: 5 years
measure: Functional status
timeFrame: 5 years
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Maccabi Health Services
Study officials:
affiliation: Maccabi Healthcare Services, Israel
name: Haim Silber, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Ofra Kalter-Leibovici, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Galit Kaufman, RN
role: STUDY_DIRECTOR
References:
citation: Kalter-Leibovici O, Freimark D, Freedman LS, Kaufman G, Ziv A, Murad H, Benderly M, Silverman BG, Friedman N, Cukierman-Yaffe T, Asher E, Grupper A, Goldman D, Amitai M, Matetzky S, Shani M, Silber H; Israel Heart Failure Disease Management Study (IHF-DMS) investigators. Disease management in the treatment of patients with chronic heart failure who have universal access to health care: a randomized controlled trial. BMC Med. 2017 May 1;15(1):90. doi: 10.1186/s12916-017-0855-z.
Clinical trial NCT05102513: Unilateral Cleft Lip Closure - Development of a New Hybrid Technique
Official title: Unilateral Cleft Lip Closure - Development of a New Hybrid Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complete Unilateral Cleft Lip
Keywords: Cleft Lip
Cleft Lip Repair
Unilateral Cleft Lip
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 20 complete unilateral cleft lips are operated; 10 are treated with the Millard II technique and 10 are treated with the new hybrid technique
Primary purpose: TREATMENT

Brief summary: Unilateral cleft lips can be treated with different incision techniques. According to a survey by the American Cleft Palate Association, the Millard II technique is currently used by the majority of US cleft surgeons. In this technique, a cleft-sided advancement flap is pivoted from the cleft side into the rotation flap of the non-cleft side, which serves, among other things, to lengthen the lip. However, the rotational component is often insufficient to sufficiently lengthen the lip on the cleft side. The result is a raised red lip, a shortened edge of the philtrum or a so-called pipe-hole deformity. In order to compensate for these "deficiencies", a triangular flap is currently being formed in the area of the white roll, which is intended to provide sufficient lengthening.

However, the scar of the triangular flaps runs exactly opposite to the aesthetic unit. In addition, it often provides a step formation within the white roll. Knowing the weaknesses of the previous techniques, a further development of the incision was made. The rotational flap of the Millard II technique was extended by extending the incision into the columella - similar to the well-known Mohler technique. The caudal part of the advancement flap of the Millard II technique was extended by a wave incision as known from the Pfeifer procedure.


Eligibility criteria: Inclusion Criteria:

* Complete unilateral cleft lip and palate

Exclusion Criteria:

-

Primary outcomes:
measure: Measurement of the length of the philtral colomn on the cleft and non-cleft side
timeFrame: perioperatively to 6 month postoperatively
measure: Angle of the columella
timeFrame: perioperatively
measure: Distance from the midpoint of the columella to the lateral alae
timeFrame: perioperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Mund-, Kiefer- und Gesichtschirurgische Klinik
state: Bayern
Study officials:
affiliation: Mund-, Kiefer- und Gesichtschirurgie Erlangen
name: Marco Kesting, Prof Dr Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05401513: Pilates Method in Helicopter Pilots With Low Back Pain
Official title: Effects of an Exercise Program Based on the Pilates Method in Brazilian Air Force Helicopter Pilots With Low Back Pain: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
physiotherapy
muscle fatigue
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyze the effects of an exercise program, based on the Pilates method, on the low back pain and muscle fatigue of Brazilian Air Force helicopter pilots.

Detailed description: Methods: This is a randomized controlled trial composed by Brazilian Air Force helicopter instructors. The volunteers will be submitted to an initial evaluation composed by painful sensation, analyzed through the Numerical Pain Scale, disability associated with low back pain, using the Roland Morris Disability Questionnaire, and back muscle fatigue, through the Ito test. The pilots will be randomly assigned to the Exercise Group (exercise program based on the Pilates method, twice a week for 12 weeks) and Control Group (no intervention). After the sixth and 12th week of the beginning of the intervention program a new evaluation will be carried out, identical to the initial one.

Eligibility criteria: Inclusion Criteria:

* Brazilian Air Force helicopter instructors - Natal Air Base;
* Nonspecific low back pain for more than 3 months with a score of 2 or more at Numerical Pain Rating Scale.

Exclusion Criteria:

* Be undergoing physiotherapeutic treatment during the study period;
* Corticosteroids treatment in the last two weeks;
* Anti-inflammatory treatment in the previous 72 hours;
* Have specific spinal pathologies, such as spondylitis, spondylolysis, spondylolisthesis, disc herniation with radiculopathy or those who have had spinal surgery in the last year or who have a recent history of spinal fracture.

Primary outcomes:
measure: Painful sensation
timeFrame: Change from baseline in low back pain sensation at 6 weeks and 12 weeks after the intervention protocol
Secondary outcomes:
measure: Functional disability associated to back pain
timeFrame: Change from baseline in disability at 6 weeks and 12 weeks after the intervention protocol
measure: Back muscle fatigue
timeFrame: Change from baseline in back muscle fatigue at 6 weeks and 12 weeks after the intervention protocol
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Federal University of Rio Grande do Norte
state: RN
Study officials:
References:
Clinical trial NCT01946113: Mineral-Homeostasis in Continuous Renal Replacement Therapy
Official title: Phosphate, Magnesium and Calcium-Homeostasis in Patients With Acute Renal Failure and Continuous Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Renal Failure
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: intensive care unit patients with acute renal failure undergoing renal replacement therapy

Brief summary: Acute renal failure is a common complication in intensive care unit patients. In 10% of cases renal replacement therapy becomes necessary. Current devices have increase filter patency and efficacy. However, magnesium, calcium and phosphate are eliminated as well. However, the extend of this elimination hase not been quantified. Thus, we want to

1. record retrospectively how often abnormal values for phosphate, magnesium and calcium occurred during routine renal replacement therapy in 2011 and 2012.
2. prospectively evaluate the same parameters during routine treatment in 2013 and 2014


Eligibility criteria: Inclusion Criteria:

* intensive care unit patients with acute renal failure undergoing continuous renal replacement therapy
* older than 18 years of age

Exclusion Criteria:

* age less than 18 years
* pregnancy
* contraindications against continuous renal replacement therapy

Primary outcomes:
measure: Incidence of hypo-phosphate,-magnesium and calcaemia
timeFrame: approximately 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Interdisziplinäre Intensivstation Universitätsklinikum Düsseldorf
Study officials:
affiliation: Department of Anaesthesiology, Duesseldorf University Hospital
name: Detlef Kindgen-Milles, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01110213: Goal Setting and Lifestyle
Official title: Goal Setting and Decisional Balance Applied to Physical Activity and Fruit & Vegetable Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Diet
Keywords: Aging
physical activity
diet
goal setting
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: University of Hawaii Cancer Research Center
First posted: 2010-04-26
Enrollment: 43
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of this feasibility study is to determine if a theory-based lifestyle intervention consisting of telephone counseling is associated with improvements in physical activity and dietary intake.

Detailed description: Goal setting has become an integral part of physical activity and dietary interventions; however, few studies have examined the theoretical constructs that drive goal-setting theory. To address the limitations and gaps in the literature, we designed an 8-week health behavior intervention for a racially and ethnically diverse sample of older adults. The primary aim of this study was to determine whether older adults randomized to a goal-setting intervention for physical activity or fruit and vegetable (F\&V) intake would make significant improvements in physical activity or F\&V intake. The secondary aim of this study was to determine whether participating in goal-setting interventions was associated with changes in theoretical constructs related to goal-setting. We hypothesized that older adults assigned to the physical activity condition would significantly increase metabolic minutes (MET-minutes) of physical activity from baseline to follow-up and that participants assigned to the F\&V intake condition would significantly increase mean servings of F\&V. In addition, we hypothesized that mean scores of goal specificity, difficulty, effort, commitment, persistence, barrier self-efficacy, and task self-efficacy would significantly increase from baseline to follow-up for both groups.

Eligibility criteria: Inclusion Criteria:

* must be 55 years or older,
* posses a telephone,
* able to give informed consent, and
* commit to a 10 week study.

Exclusion Criteria:

* currently enrolled in a study promoting physical activity or dietary intake,
* currently exceeding current recommendations for physical activity or F\&V intake at baseline, and
* medical conditions contraindicating physical activity or fruit and vegetable consumption.

Primary outcomes:
measure: Leisure Time Physical Activity
timeFrame: 8-weeks
Secondary outcomes:
measure: Goal specificity and difficulty
timeFrame: 8-weeks
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Cancer Research Center of Hawaii / University of Hawaii
state: Hawaii
Study officials:
affiliation: University of Hawaii Cancer Research Center
name: Raheem J Paxton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04188613: Use of High-Frequency Jet Ventilation During Percutaneous Tracheostomy
Official title: Use of High-Frequency Jet Ventilation During Percutaneous Tracheostomy as an Alternative to a Classic Mechanical Ventilation by Endotracheal Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheostomy Complication
High-frequency Jet Ventilation
Percutaneous Tracheostomy
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-12-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Percutaneous tracheostomy is the mouth opening of the tracheal ostium to the skin by creating an opening in the anterior wall of the trachea using Seldinger methods. This procedure is done using an endotracheal tube (ETT) or a laryngeal mask (LMA). High-frequency jet ventilation (HFJV) commonly used in oropharyngeal surgeries and creates an extra passage for the procedure. The investigators aimed to demonstrate the effective use of HFJV in percutaneous tracheostomy.

Detailed description: Seventy five patients between 18-80 years of age who were hospitalized in intensive care unit were included in the study. The number of patients will be finalized by power analysis. whose written consent cannot be obtained and who undergo surgical tracheostomy for any reason will be excluded from the study. In addition, patients with active infection in the area of the procedure, bleeding diathesis and pathologies that interfere with the procedure in the ultrasonographic evaluation (thyroid diseases, etc.) will be excluded from the study. Patients will be divided into three groups as those using classical ventilation (group 1), HFJV (group 2) and classical laryngeal mask (group 3). Age, gender, height, BMI, ASA scores, presence and type of additional diseases, tracheostomy day, pre- and post-procedure blood gas analysis, duration of procedure, duration of anesthesia, complications during the procedure (bleeding , desaturation, accidental extubation, malposition, bradycardia, hypotension, etc.) will be recorded. Patients will be observed for mortality in the first 30 days after the procedure. Mortality results will be recorded.

Eligibility criteria: Inclusion Criteria:

* percutaneous tracheostomy procedure

Exclusion Criteria:

* whose written consent cannot be obtained
* who undergo surgical tracheostomy for any reason
* patients with active infection in the area of the procedure,
* bleeding diathesis
* pathologies that interfere with the procedure in the ultrasonographic evaluation (thyroid diseases, etc.)

Primary outcomes:
measure: percutaneous tracheostomy time
timeFrame: during procedure
Secondary outcomes:
measure: complications rate
timeFrame: during procedure
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey
Study officials:
References:
Clinical trial NCT00964613: Pars Plana Surgical Capsulotomy for Posterior Capsular Opacification
Official title: Pars Plana Surgical Capsulotomy for Posterior Capsular Opacification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blindness
Keywords: Pars Plana
Surgical Capsulotomy
Posterior capsule opacification
visual outcome
Complications
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Pakistan Ministry of Health
First posted: 2009-08-25
Enrollment: 176
Sex: ALL
Minimum age (years): 1
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having posterior capsular opacification

Brief summary: Cataract is a leading cause of Global blindness. After cataract surgery nearly half of the people become blind due to posterior capsular opacification. The only solution for this problem is LASER capsulotomy. Laser machine is not available in remote areas especially in underdeveloped countries. The solution of this problem is surgical capsulotomy which can be performed any where.

Detailed description: posterior capsular opacification is treated by YAG laser capsulotomy. this require sophisticated technology ans specific environment which is not possible in underdeveloped countries. we describe a method in which posterior capsular opacification could be managed by using only a 27 Gauge needle through pars plana. opacified posterior capsule is under tension that is why a small puncture results in a large central opening

Eligibility criteria: Inclusion Criteria:

* Patients with Posterior capsular opacification
* Both Sexes
* All ages

Exclusion Criteria:

* Retinal disease
* Uncontrolled Glaucoma
* Corneal opacity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05339113: Comparison of [68Ga]GaFAPI-46 PET/CT and [18F]FDG PET/CT Findings in Breast Carcinoma
Official title: Comparison of [68Ga]GaFAPI-46 PET/CT and [18F]FDG PET/CT Findings in Breast Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Positron Emission Tomography
Fibroblast Activation Protein Inhibitor
Fluorodeoxyglucose F18
Lead sponsor: The National Center of Oncology, Azerbaijan
Sponsor class: OTHER_GOV
Collaborators: name: SOFIE INC
First posted: 2022-04-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare the diagnostic performance of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT in primary and metastatic lesions of breast cancer and to reveal the best diagnostic imaging time of 68Ga-FAPI-46 PET/CT.

Detailed description: Participants with breast carcinoma will undergo contemporaneous 18F-FDG and 68Ga-FAPI PET/CT. Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-FAPI PET/CT will be calculated and compared to evaluate the diagnostic efficacy. In addition, best diagnostic imaging time of 68Ga-FAPI-46 PET/CT will be evaluated at 10th, 30th and 60th minute scan time.

Eligibility criteria: Inclusion Criteria:

* adult participants (aged 18 years or order);
* participants with newly diagnosed breast carcinoma;
* pathology confirmed by lesion tru-cut biopsy;
* participants who were able to provide informed consent.

Exclusion Criteria:

* participants with non-malignant lesions;
* participants with pregnancy;
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Maximum standardised uptake value [SUVmax] for primary lesion
timeFrame: 2-3 days
measure: Best diagnostic imaging time of 68GaFAPI-46 PET/CT
timeFrame: 2-3 days
Secondary outcomes:
measure: Diagnostic efficacy for breast carcinomas
timeFrame: 2 days
measure: SUVmax for metastatic lymph nodes
timeFrame: 2 days
measure: Diagnostic efficacy for metastatic lymph nodes
timeFrame: 2 days
measure: Correlation between tumor SUVmax values and pathology grade
timeFrame: 2 days
Other outcomes:
Locations:
city: Baku
country: Azerbaijan
facility: National Centre of Oncology
Study officials:
References: