louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01998074: Evaluation of the Efficacy of a New Formula in Infants With Cow's Milk Protein Allergy
Official title: Evaluation of the Efficacy of a New Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Milk Hypersensitivity
Food Sensitivity
Protein Allergy
Keywords: Cow's Milk protein Allergy
Lead sponsor: United Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-11-28
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.


Eligibility criteria: Inclusion Criteria:

* Infants between 2 weeks and 6 months old
* In whom cow's Milk Protein Allergy has been proved by a food challenge performed during the previous month

Exclusion Criteria:

* Exclusively breast fed infants
* Preterm infants
* Infants already fed with an extensively hydrolyzed formula with no improvement of the symptoms.
* Infants fed an amino acid based formula
* Infants who had an anaphylactic reaction in the past

Primary outcomes:
measure: Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
timeFrame: at 4 weeks
Secondary outcomes:
measure: Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
timeFrame: at 3 months
measure: Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
timeFrame: at 6 months
measure: Growth (weight, height, head circumference)
timeFrame: 1 month
measure: Growth (weight, height, head circumference)
timeFrame: 3 months
measure: Growth (weight, height, head circumference)
timeFrame: 6 months
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis
Study officials:
References:
citation: Vandenplas Y, De Greef E, Hauser B; Paradice Study Group; Paradice Study Group. An extensively hydrolysed rice protein-based formula in the management of infants with cow's milk protein allergy: preliminary results after 1 month. Arch Dis Child. 2014 Oct;99(10):933-6. doi: 10.1136/archdischild-2013-304727. Epub 2014 Jun 9.
Clinical trial NCT05184374: Efficacy of Prolonged GnRH Test in Male Adolescents With Postoperative HH
Official title: Efficacy of Prolonged Gonadorelin Stimulation Test in Male Adolescents With Postoperative Hypogonadotropic Hypogonadism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypogonadotropic Hypogonadism
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Hypogonadotropic Hypogonadism(HH) could be caused by sellar lesions, sellar surgery or sellar radiotherapy. The incidence of HH after sellar surgery was higher in men than in women, and the therapy of HH was insufficient. Gonadotropin-releasing hormone(GnRH) stimulation test is used to evaluate the function of pituitary-gonadal axis. GnRH can be used to diagnose and treat fertility disorders and other endocrine disorders caused by HH. After a single injection of GnRH, the patients with poor response of luteinizing hormone and follicle stimulating hormone need to take extended provocation test, which is conducive to the formulation of the following treatment. GnRH pump can pulse subcutaneous injection of gonadorelin, which can be used as the extended provocation test.


Eligibility criteria: Inclusion Criteria:

* patients with HH after surgery of the saddle area
* sufficient therapy of the hypothalamic-pituitary-adrenal(HPA) and hypothalamic-pituitary-thyroid(HPT) axis

Exclusion Criteria:

* contradictions to gonadorelin
* androgen-dependent prostate cancer
* on the therapy of human chorionic gonadotropin(HCG) or testosterone

Primary outcomes:
measure: level of luteinizing hormone, follicle stimulating hormone and testosterone
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT02436174: Assessment Of Shivering With iSeismograph
Official title: Assessment Of Shivering With iSeismograph In Parturients Undergoing Surgical Procedures Under Epidural Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shivering
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: Shivering is a common side-effect of epidural anesthesia. In studies to date, the assessment of shivering has been based on a simple scale using descriptive words rather than actual measurements. We believe that we can assess shivering more scientifically by using a novel method to quantify arm movements during shivering.

Detailed description: This novel method will allow the investigators to quantitatively assess and measure shivering in obstetric parturients undergoing varying procedures under epidural anesthesia.

Eligibility criteria: Inclusion Criteria:

* pregnancy
* epidural in situ

Exclusion Criteria:

* non-cesarean delivery

Primary outcomes:
measure: Comparison between physician-reported shivering and measured shivering
timeFrame: During cesarean delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Simon Massey, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02934074: Relationship Between Gait Variability and Sensation
Official title: Investigating the Relationship Between Gait Variability and Related Factors in Individuals With Lower Limb Loss
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amputation, Traumatic
Keywords: Limb Loss
Gait Variability
Phantom Sensation
Phantom Pain
Peripheral Sensation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with traumatic lower limb loss

Brief summary: Twenty individuals who were referred to receive physiotherapy will be participants of the study. Participants with lower limb loss will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, year, side and level of limb loss will be recorded. Gait parameters (step length, variation of step length) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed.Phantom sensation and phantom pain will be asked as existence or not. Sensorial loss will evaluate with Semmes Weinstein Monofilaments

Detailed description: Twenty participants with lower limb loss who were referred to receive amputee rehabilitation at Hacettepe University, Faculty of Health Sciences, department of Physiotherapy and Rehabilitation, Prosthetics and Biomechanics unit, will be the subjects of this study.

Participants with lower limb loss will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, year, side and level of limb loss will be recorded. Gait parameters (step length, variation of step length) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed. To eliminate the learning effect, participants practiced at treadmill to determine appropriate gait speed. Once participants implied the preferred speed, they asked to walk at their self selected speed for 6 minutes. Data was recorded between the 2nd and 4th minutes at walk. Phantom sensation and phantom pain will be asked as existence or not. Sensorial loss will evaluate with Semmes Weinstein Monofilaments.

Eligibility criteria: Inclusion Criteria:

Individuals with unilateral lower limb loss Traumatic limb loss Age between 20-55 years Using conventional type socket design Dynamic foot using

Exclusion Criteria:

Have passive joint limitation at extremities Surgery at last 1 year Systemic problems such as neurologic disorders, rheumatoid disorders... Another orthopedic anomalies

Primary outcomes:
measure: Step length variability assesment while walking.
timeFrame: Initially evaluation at first minute
Secondary outcomes:
measure: Phantom sensation and phantom pain assessment
timeFrame: Initially evaluation at first minute
measure: Sensory test
timeFrame: Initially evaluation at first minute
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01814774: A Retrospective Chart Review of BOTOX® and Xeomin® for the Treatment of Cervical Dystonia and Blepharospasm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Dystonia
Blepharospasm
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-03-20
Enrollment: 48
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: Participants with cervical dystonia or blepharospasm previously treated with Xeomin® and BOTOX®.

Brief summary: This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice.


Eligibility criteria: Inclusion Criteria:

* confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at least 2 years
* treatment with Xeomin® and BOTOX® for at least 1 year each

Exclusion Criteria:

* having a neuromuscular junction transmission disorder or taking any medications that could affect neuromuscular junction transmission
* previous surgical procedure involving bone or muscle for the management of cervical dystonia or blepharospasm

Primary outcomes:
measure: Dose of Botulinum Toxin Used to Treat Cervical Dystonia
timeFrame: 2 Years
measure: Dose of Botulinum Toxin Used to Treat Blepharospasm
timeFrame: 2 Years
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 2 Years
measure: Botulinum Toxin Inter-injection Interval
timeFrame: 2 Years
Other outcomes:
Locations:
city: Bergen
country: Norway
city: Wakefield
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00993174: Surgery for Esotropia Under Topical Anesthesia
Official title: Amount of Surgery for Esotropia Under Topical Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esotropia
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
First posted: 2009-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adult patients requiring surgery for esotropia will be randomized to surgery under topical anesthesia or sub-Tenon's anesthesia. Amount of surgery required with the two anesthetic procedures will be compared. Motor and sensory outcome of the two treatment groups will also be compared.


Eligibility criteria: Inclusion Criteria:

* Esotropia deviation angle equal to or lower than 45 prism dioptres (requiring one or two-muscle surgery)
* Visual acuity at least 20/40 in each eye
* Cooperation for topical anesthesia

Exclusion Criteria:

* Paretic or restrictive strabismus
* Previous eye muscle surgery
* Significant eye disease other than strabismus

Primary outcomes:
measure: Amount of surgery required in mm and mm/degree of deviation angle
timeFrame: Immediate
Secondary outcomes:
measure: Motor (deviation angle) and stereoacuity outcome
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Univ Ramón y Cajal
Study officials:
affiliation: Hospital Universitario Ramon y Cajal
name: Jaime Tejedor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01384474: Impact of Crew Resource Management Training to Improve the Effectiveness of Surgical Safety Checklist (IDILIC)
Official title: Impact of Crew Resource Management Training to Improve the Effectiveness of Surgical Safety Checklist
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: Crew Resource Management
Surgical safety checklist
Postoperative complications
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2011-06-29
Enrollment: 23056
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients needing a surgery who are hospitalized in one of the 31 departments.

Brief summary: This multicenter cluster-randomized trial will evaluate the impact of Crew Resource Management training on the occurrence of postoperative complications and the adherence to a surgical safety checklist, among a large sample of French surgical departments.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Hospitalization ≥ 24 hours
* Available medical file

Exclusion Criteria:

* Patient refusal

Primary outcomes:
measure: Occurrence of any major postoperative complication during hospitalization
timeFrame: during the two phases of the study : 18 months
Secondary outcomes:
measure: Team's adherence to the items of surgical safety checklist
timeFrame: During the two phases of the study : 18 months
measure: Occurrence of any postoperative death during hospitalization
timeFrame: During the two phases of the study : 18 months
measure: Healthcare workers' attitude regarding the patient safety culture
timeFrame: Twice during the study : the 4th and the 17th month after the beginning of the study
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon - Pôle Imer - 162 Avenue Lacassagne - 69003 LYON
name: Cyrille COLIN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sens F, Viprey M, Piriou V, Peix JL, Herquelot E, Occelli P, Bourdy S, Gawande AA, Carty Mj MJ, Michel P, Lifante JC, Colin C, Duclos A; IDILIC Study Group. Safety Attitude of Operating Room Personnel Associated With Accurate Completion of a Surgical Checklist: A Cross-sectional Observational Study. J Patient Saf. 2022 Aug 1;18(5):449-456. doi: 10.1097/PTS.0000000000000954. Epub 2021 Dec 17.
citation: Duclos A, Peix JL, Piriou V, Occelli P, Denis A, Bourdy S, Carty MJ, Gawande AA, Debouck F, Vacca C, Lifante JC, Colin C; IDILIC Study Group. Cluster randomized trial to evaluate the impact of team training on surgical outcomes. Br J Surg. 2016 Dec;103(13):1804-1814. doi: 10.1002/bjs.10295. Epub 2016 Sep 19.
Clinical trial NCT03351374: Web Platform to Integrate Behavioral Health
Official title: Web Platform to Integrate Behavioral Health
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Integrating Behavioral Health
Keywords: behavioral health
software
integration
Lead sponsor: Medical Decision Logic, Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-22
Enrollment: 16000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that enter the health system through primary care clinics, academic medical and behavioral health centers, hospitals, or rural health clinics.

Brief summary: Under this Small Business Innovation Research (SBIR) Phase II project, Research Topic 155, the Contractor will create an integrated multi-module system of web software tools to aid in behavioral health screening, prevention, triage, and tracking in medical, school, and mental health settings.

Detailed description: Health care systems experience problems with lack of tools, lack of knowledge, process variation, and system fragmentation in addressing behavioral health. As an ongoing science-based process for improving care and lowering costs, robust increases in translational capability are needed to re-tool health delivery systems for behavioral health integration. A logic linking translational capability to behavioral health integration as an ongoing shared information process, founded on the core belief that enabling human action with new information technology tools can grow knowledge, is the most powerful way to solve problems and improve health care.

Given these connected and interacting issues and obstacles, the Contractor has developed a solution strategy, building on four tiers of prior innovation and validation:

* The Behavioral Health Screen (BHS);
* BH-Works: the web software delivery of the BHS and new production features from Phase I;
* BH-Works Portal: new production software features from Phase I; and
* BH-Works Services: expertise and professional services to help primary care providers and healthcare systems integrate behavioral health into their organizations and workflows.

Eligibility criteria: Inclusion Criteria:

* Potential Mental Health issue

Exclusion Criteria:

* Not Willing to be Screened for mental health issues

Primary outcomes:
measure: Increase Provider Integration
timeFrame: 2 Years
Secondary outcomes:
measure: Increase Screening
timeFrame: 2 Years
measure: Increase Referrals
timeFrame: 2 Years
Other outcomes:
Locations:
city: Connersville
country: United States
facility: Fayette Regional
state: Indiana
city: Philadelphia
country: United States
facility: Port Richmond Family Medicine
state: Pennsylvania
Study officials:
affiliation: Medical Decision Logic, Inc.
name: Allen Tien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06814574: Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement
Official title: Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement - Single Center Experience
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AV Block Complete
Tricuspid Regurgitation (TR)
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include every patient with a transcatheter tricuspid valve replacement in the study period.

Brief summary: Transcatheter tricuspid valve replacement (TTVR) is associated with a high risk of third-degree atrioventricular block (AVB). However, the optimal pacemaker management following TTVR remains unclear. This study aims to identify an optimal therapeutic approach for pacemaker implantation in patients undergoing TTVR.


Eligibility criteria: Inclusion Criteria:

* Transcatheter Tricuspid Valve Replacement

Exclusion Criteria:

* no defined exclusion criteria

Primary outcomes:
measure: Success
timeFrame: at the time of surgery
measure: Feasibility
timeFrame: at the time of surgery
measure: Safety
timeFrame: through study completion (an average of 6 Months)
Secondary outcomes:
measure: Type of Pacemaker Implantation
timeFrame: at the time of surgery
measure: Pacemaker Implantation - Procedural Details
timeFrame: at the time of surgery
measure: Electric Performance
timeFrame: at the time of surgery, through study completion (an average of 6 Months)
Other outcomes:
Locations:
city: München
country: Germany
facility: Deutsches Herzzentrum München
state: Bayern
Study officials:
References:
Clinical trial NCT01887574: Renal Mass Registry
Official title: Renal Mass Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Cell Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Collect valuable risk factor and quality of life data from Renal Cell Carcinoma patients and harness the latest technology to organize and analyze data.

Detailed description: RCC is a cancer that is poorly understood. The increase in both incidence and mortality rates for RCC, coupled with the lack of effective therapies for RCC beyond surgical excision, underscore the need for a better understanding of RCC tumor biology, immunology, and epidemiology. Such improved understanding could then be directly translated into new prevention strategies as well as improved patient care. Recently, the National Cancer Institute's Kidney Cancer Progress Review Group identified as top priorities for future research the need to better understand the mechanisms underlying known risk factors for kidney cancer; and examine tumor tissue to identify predictors of patient outcome and targets for therapy. In addition, the review group stressed that the leaders in renal cancer research over the next decade would be those institutions that could enroll large numbers of patients, collect valuable risk factor and quality of life data from these patients and harness the latest technology to organize and analyze data.

Eligibility criteria: Inclusion:

* Patients with a renal mass or a suspected metastatic lesion from a renal primary who have been treated or are going to be studied and or treated surgically at Mayo Clinic Arizona
* Patients must be 18 years of age or older
* Patients must be capable of and willing to sign an informed consent

Exclusion:

None

Primary outcomes:
measure: Evidence of Renal Mass Risk Factors as determined by patient questionnaire post surgery
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Erik Castle, MD
role: PRINCIPAL_INVESTIGATOR
References: