louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01546779: The Use of Visual Feedback in Airway Clearance
Official title: The Immediate Effect of Resistive Expiration Via "Volumetric Incentive Spirometer" on Lung Function in Patients With Cystic Fibrosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cystic Fibrosis (CF) patients perform airway clearance incorporating various breathing strategies, to clear secretions from their lungs. Hand held devices may aid mucus expectoration, and also motivate the patient to manage by themselves. Our aims was to study if resistive expiration through "volumetric incentive spirometer" (VISex) can improve lung function in the short term in Cystic Fibrosis (CF) patients.


Eligibility criteria: Inclusion Criteria:

* cystic fibrosis patients

Exclusion Criteria:

* i.v. antibiotic therapy during the experiment day

Primary outcomes:
measure: lung function
timeFrame: fifteen minutes after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: The Pediatric Pulmonary Unit the Edmond and LiliSafraChildrens Hospital, Sheba Medical Center
Study officials:
References:
Clinical trial NCT01366079: Dynamic Position Change in Colonic Adenoma Detection
Official title: Dynamic Position Change in Colonic Adenoma Detection: a Prospective, Randomized, Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Position
Colonoscopy
Adenoma
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 1072
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: There was an only single operator study reporting dynamic position change during colonoscopy withdrawal significantly improved polyp and adenoma detection. So we designed a prospective, randomized multicenter study to verify the effect of dynamic position change in colonic adenoma detection. We think position change improve luminal distension and has the potential to improve adenoma detection rate.


Eligibility criteria: Inclusion Criteria:

* patient aged over 45 years who will be performed colonoscopy for the first time

Exclusion Criteria:

* polyposis syndrome
* musculoskeletal problem
* Inflammatory bowel disease
* previous bowel operation

Primary outcomes:
measure: Adenoma detection
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon, Daejeon, Bucheon, Seoul
country: Korea, Republic of
facility: Catholic University of Korea
Study officials:
References:
Clinical trial NCT00214279: MMF Monotherapy and Immune Regulation in Kidney Transplant Recipients: Part 1 Steroid Withdrawal
Official title: MMF Monotherapy and Immune Regulation in Kidney Transplant Recipients: Part 1 Steroid Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Transplantation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 32
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Part 1 of the study is to gradually withdraw steroids in a group of 50 older renal transplant recipients, converting then from the 3 drug regimen to a 2 drug regimen (cyclosporine and MMF), while carefully monitoring their graft function. 25 subjects would serve as control patients in the study and would remain on the 3 drug regimen (steroids, cyclosporine and MMF). Immunologic status will be determined before and after IS withdrawal using a delayed-type hypersensitivity (DTH) transfer test previously described in the original submission. Both the steroid withdrawal subjects and the control subjects will undergo the DTH testing throughout the 3 years of study participation.


Eligibility criteria: Inclusion Criteria:

* Patient who have received a kidney transplant during the "MMF era"
* Patients who have stable graft function indicated by a serum creatinine of \< 1.8 mg/dl, or a calculated creatinine clearance of \> 50 ml/minute

Exclusion Criteria:

* Patients who have had \> 1 rejection episode,
* Patients who have had a rejection episode within the past year;
* Patients who are steroid dependent due to pre-existing disease (for example, RA or SLE

Primary outcomes:
measure: Incidence of Allograft rejection
timeFrame: 3 years
Secondary outcomes:
measure: Renal function as determined by serum creatinine
timeFrame: measure after 36 months
measure: Allograft Survival
timeFrame: 3 years
measure: Immunological function as determined by Trans-vivo delayed hypersensitivity assay (TV-DTH)
timeFrame: Day 0 (pre-transplant)
Other outcomes:
Locations:
city: Madison
country: United States
facility: Unversity of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Hans Sollinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00475579: Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage
Official title: Influence of an Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage on Ventilator-Associated Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mechanical Ventilation
Keywords: ventilator-associated pneumonia
endotracheal tube
polyurethane cuff
polyvinyl cuff
subglottic secretion drainage
Lead sponsor: Hospital Universitario de Canarias
Sponsor class: OTHER
First posted: 2007-05-21
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients mechanically ventilated using an endotracheal tube with a subglottic secretion drainage lumen and a polyurethane cuff may develop lower ventilator-associated pneumonia than using a conventional endotracheal tube

Detailed description: Subglottic secretions accumulated above the endotracheal cuff may progress, descending along the channels within folds of the cuff wall, to the lower respiratory tract causing VAP. Subglottic secretion drainage (SSD) appears to be effective in preventing VAP, primarily by reducing early-onset pneumonia; but it may not prevent late-onset pneumonia. We set out the hypothesis that using an endotracheal tube incorporating, besides of a subglottic secretion drainage lumen, a polyurethane cuff (which reduces channel formation and fluids leakage from the subglottic area) it should be also possible to reduce the incidence of late-onset VAP.

Eligibility criteria: Inclusion Criteria:

* Patients expected to require mechanical ventilation for more than 24 hours

Exclusion Criteria:

* Age \<18 years,
* Pregnancy,
* HIV,
* Blood leukocytes counts \<1000 cells/mm3,
* Solid or haematological tumour,
* Immunosuppressive therapy

Primary outcomes:
measure: Ventilator-associated pneumonia
timeFrame: 8 months
Secondary outcomes:
measure: Late-onset ventilator-associated pneumonia
timeFrame: 8 months
Other outcomes:
Locations:
Study officials:
affiliation: Intensive care unit
name: Leonardo Lorente, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lorente L, Lecuona M, Jimenez A, Mora ML, Sierra A. Influence of an endotracheal tube with polyurethane cuff and subglottic secretion drainage on pneumonia. Am J Respir Crit Care Med. 2007 Dec 1;176(11):1079-83. doi: 10.1164/rccm.200705-761OC. Epub 2007 Sep 13.
Clinical trial NCT00141479: To Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox
Official title: A Single-center Safety and Tolerability Study to Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Treatment interruption on reinitiation
Schizophrenia
Schizoaffective disorder
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-09-01
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate a safe treatment interruption interval(s) for re-initiation of bifeprunox at a therapeutic dose. The study duration is approximately 7 to 10 weeks.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Schizophrenia or Schizoaffective disorder
* 18-55 years

Exclusion Criteria:

* Subjects who are acutely psychotic
* Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia
* Subjects at significant risk of suicide
* Subjects with a seizure disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Site 1
state: Kansas
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT01592279: GLP-1 Analogue Treatment in Uncontrolled Type 1 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Uncontrolled Type 1 Diabetic Patients
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-05-07
Enrollment: 124
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 new incretin-based therapies offer appealing advantages over existing drugs. Aside from glucose dependent insulin secretion and a proven glucose lowering efficacy, they have other concomitant beneficial effects, such as low risk of hypoglycemia, inhibition of the glucagon secretion with maintenance of counter-regulatory mechanism, promotion of weight loss, and possible cardiovascular benefits (improvement of lipid profile, blood pressure, endothelial and myocardial function). The glucose lowering effects resulting from the inhibition of glucagon secretion and the gastric emptying rate could be of clinical importance in type 1 diabetes.

The rationale behind the use of GLP-1 analogues in the treatment of type 1 diabetes relies on the assumption that these drugs, in addition to their action on insulin secretion and glucose regulation, may be effective in preserving and even expanding the β-cell mass. This class of drugs may represent an entirely new approach to the treatment of type 1 diabetes, focused on protection and preservation of β-cells. These therapies have the opportunity to interfere with the disease progression if used as an early intervention, when enough β-cell mass/ function can still be preserved or restored.

Hypothesis:

GLP-1 analogue (liraglutide) will improve glycemic control as measured by HbA1c in uncontrolled type 1 diabetic patients. The investigators expect a reduction of 1% in HbA1C from baseline.


Eligibility criteria: Inclusion Criteria:

1. HbA1C ≥ 8 at screening and at qualification
2. Not treated with GLP-1 analogue

Exclusion Criteria:

1. Moderate and sever hypoglycemia
2. Creatinin \> 2
3. amylase or lipase \> 3xULN
4. Calcitonin \> 10 pg/ml or Stimulated Calcitonin \> 50 pg/ml in women or 80 pg/ml in men
5. ALT or AST \> 3X ULN

Primary outcomes:
measure: The primary end point is the change in HbA1C relative to baseline after 3 months treatment with liraglutide in uncontrolled type 1 diabetic patients. The expected change is 1% reduction from baseline.
timeFrame: the change in HbA1C relative to baseline after 3 months treatment with liraglutide in uncontrolled type 1 diabetic patients.
Secondary outcomes:
measure: Endogenous insulin secretion and residual β-cell function estimated by the value of C-peptide
timeFrame: the change in C-peptide relative to baseline after 3 months treatment with liraglutide in uncontrolled type 1 diabetic patients
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06023979: Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.
Official title: Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles. A Single Blinded Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Operative Treatment After Unstable Malleolar Fractures
Keywords: malleolar fractures
postoperative treatment protocol
full weight bearing
partial weight bearing
bio-feedback insoles
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the postoperative results after ORIF (Open Reduction Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing protocol. But in addition, we will measure every patient's actual load by the means of walker integrated bio-feedback insoles for the first six postoperative weeks to record the adherence to the protocol.

Detailed description: This study aims to compare the postoperative results after PWB (partial weight bearing) and early FWB (full weight bearing) and to show, that documented early protected weight-bearing after surgical fixation of unstable ankle fractures leads to an improved early clinical outcome and a faster return to work compared to PWB. It also aims to show, that an early FWB is safe in terms of complication rate.

Eligibility criteria: Inclusion Criteria:

* patients with surgically stabilized unstable ankle fractures
* signed informed consent
* closed tibial and fibular epiphysis
* age 18 or older

Exclusion Criteria:

* dementia and other known cognitive impairment or incapacity of judgement
* polytrauma
* bilateral injury of the lower extremities
* additional injury of the ipsilateral lower extremity which prevents full weight bearing
* associated injury of one or both upper extremities
* open fractures grade II° and III°
* chronic loss of sensation on plantar aspect of the feet due to known distal neuropathy
* open epiphysis
* pregnancy

Primary outcomes:
measure: Manchester Oxford Foot and Ankle Questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: other PROMs (patient reported outcome measures)
timeFrame: 1 year
measure: Range of Motion
timeFrame: 1 year
measure: Secondary dislocation of fracture
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Saint Gallen
country: Switzerland
facility: Canton Hospital St. Gallen
Study officials:
References:
Clinical trial NCT03066479: Comparing Fitbit® Quality of Measured Sleep to Sleep Measured by Polysomnography in the Sleep Lab
Official title: Comparing Fitbit® Quality of Measured Sleep to Sleep Measured by Polysomnography in the Sleep Lab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is to evaluate a commercial tool on the market (Fitbit®) that also quantifies sleep. No one has studied how pediatric patients perform with it and how accurate it is in measuring their quality of sleep. This study will use the obstructive sleep apnea (OSA) questionnaire completed by parents and Fitbit® together and evaluate how they perform against the polysomnography (PSG).


Eligibility criteria: Inclusion Criteria:

* Patients who consent/assent to wearing Fitbit® band over wrist overnight during sleep study and parents who consent to answering questionnaire.

Exclusion Criteria:

* None

Primary outcomes:
measure: Total sleep time
timeFrame: At the end of the sleep study - average 6 hrs.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT05994079: Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy
Official title: Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Gastrostomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 86
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to evaluate the therapeutic effect of High intensity focused ultrasound in treatment of abdominal skin laxity post sleeve gastrectomy.

Detailed description: Lax skin is a common consequence of bariatric weight loss, and it may require one or more plastic interventions.

This study carried out to investigate the effectiveness of High-intensity focused ultrasound (HIFU) in treatment of abdominal skin laxity post sleeve gastrectomy.

Eligibility criteria: Inclusion Criteria:

The subject selection will be according to the following criteria:

* Age range between 30-45 years.
* Female patients will participate in the study.
* All patients will have post sleeve gastrectomy abdominal skin laxity mild to moderate degree according to skin laxity scale Randomized images were evaluated by three clinical specialists for the degree of skin laxity (0-3 scale; 0 = no laxity, 1 = mild, 2 = moderate, 3 = severe).
* All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

The potential participants will be excluded if they meet one of the following criteria:

* Age more than 45 years or less than 30 years.
* Patients have acute viral diseases, acute tuberculosis, mental disorders
* Older people with more extensive photo-aging, severe skin laxity.
* Open skin lesions at the target area.
* Severe or cystic acne.
* Metallic implants in the treatment area.
* Genetic disease
* Skin infectious diseases.
* Sociological diseases.
* Pregnant.

Primary outcomes:
measure: Assessment othe change in skin laxity
timeFrame: at baseline and after 4 weeks of intervention
measure: Assessment the change in abdominal skin laxity
timeFrame: at baseline and after 4 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Outpatient clinic faculty of physical therapy cairo university
Study officials:
affiliation: Cairo University
name: Rania Elhawary
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00952679: Computed Tomography (CT) Based Lymphatic Mapping and Localization of Sentinel Lymph Node in Breast Cancer Patients
Official title: Computed Tomography (CT) Based Lymphatic Mapping and Localization of Sentinel Lymph Node in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: The investigators evaluated the new method by comparing lymph nodes defined by CT and traditional ways.
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Breast cancer patients who diagnosed by core needle biopsy or excisional biopsy underwent CT scan to locate the sentinel lymph node (SLN) before SLN biopsy (SLNB) at the same day of surgery. When CT examination performed, those patients were in supine position, with the arms stretched upward but bent at the elbow with the hands at the side of the cranium which similar to the surgical position. After local anesthesia, 2mL of iopamidol was injected subcutaneously to the peritumoral and peri-areolar areas followed by gentle massage for about 1 minute. Contiguous 2-mm-thick CT images that included the breast and axilla were obtained prior to administration of the contrast agent. After 3D CT reconstruction, the SLN was identified as the most inferiorly visible nodule in the axilla connected to the lymphatic vessel on the CT imaging monitor. A professional intervention doctor punctured the defined lymph node guided by the CT monitor using the Breast Lesion Localization Needles (interv). The needle would stay in the patient's axilla until the surgery. All the lymph nodes including the CT defined one and which marked by methylene blue dye or 99mTc-sulfur colloid tracers were removed, which then would be tested by touch imprint cytology for the intraoperative diagnosis. Patients who had positive SLN would receive axillary dissection. The investigators evaluated the new method by comparing lymph nodes defined by CT and traditional ways.


Eligibility criteria: Inclusion Criteria:

* Breast cancer patients（T1-T2N0）
* Age 18-70
* Accept of SLNB
* Accept our protocol in the informed consent

Exclusion Criteria:

* LABC patients
* Age \< 18
* History of epilepsy
* History of thyrotoxicosis
* Pregnant women

Primary outcomes:
measure: all cause mortality
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00960479: Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Fasting Conditions
Official title: A Relative Bioavailability Study of Ribavirin (Geneva Pharmaceutical Technology Corporation, N.J., U.S.A.) 200 Capsules and Rebetol (Schering Corporation, N.J., U.S.A.) 200 mg Capsules in Females Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-08-17
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the relative bioavailability of Ribavirin 200 capsules and Rebetol 200 mg capsules in females under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Allied Clinical Research
name: Piyush Patel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: