louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06173154: Feasibility Assessment of Implementing a Care System to PREVENT Iatrogenic Dependency (ID)
Official title: Feasibility Assessment of Implementing a Care System to PREVENT Iatrogenic Dependency (ID) Related to Hospitalization in People Over 70 Years : Pilot Study. PREVENT-ID
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aged
Keywords: prevention
elderly
dependance
hospitalization
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 76
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the feasibility of a care system to prevent iatrogenic dependency during hospitalisation in people 70 years old and over. 2 cares units participate : one with routine care and the other with a care system to prevent ID. The caregivers of this unit receive training about iatrogenic dependency and how prevent it. They set up this prevention and the research compare evolution of dependence hospitalized patients.


Eligibility criteria: inclusion criteria:

* Patient hospitalized for at least 48 hours in the participating center
* Persons affiliated to a social security system,
* The patient, his trusted person or a relative present during his hospitalization have not expressed opposition to his participation in the research..

exclusion criteria:

* End of life situation,
* ADL at 0/6 for 15 days before hospitalization.
* Refusal to participate,
* Patient under judicial protection

Primary outcomes:
measure: number of participants with loss of independence
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Caroline BERBON
role: STUDY_DIRECTOR
References:
Clinical trial NCT03684954: Effect Of PRF Versus Xenograft In Closed Sinus Lift.
Official title: Prf Controlled, Randamized Clinical Trial of THE EFFECT OF PLATELET RICH FIBRIN( PRF ) VERSUS XENOGRAFT IN CLOSED SINUS LIFT AND IMLANT PLACEMENT ON IMPLANT STABILITY IN PATIENTS WITH MISSING MAXILLARY PREMOLAR.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Implant or Graft; Rejection
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patallel Assignment
Primary purpose: TREATMENT

Brief summary: Indirect sinus lift with used PRF as a graft material versus xenograft

Detailed description: Crestal incision and reflect the tissue until exposure of the bone, then use drilling to make osteotomy. Then use sutable osteotomes to elevate the sinus floor, then pack of Prf or bone graft in the osteotomy and implant placement . Then closed the flap and suturing.

Eligibility criteria: Inclusion Criteria:

* Edentulous area and bone high at least 5-6 mm below the maxillary sinus at maxillary premolar.
* Good oral hygiene.

Exclusion Criteria:

* bad oral hygiene.
* patient with systemic disease that may affect normal healing
* pregnant patients.
* patients with bone diseases and presence of periapical pathology affecting the neighboring teeth.
* Heavy smoker more than 20 cigarettes per day

Primary outcomes:
measure: Primary stability by ostell device
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03332654: Stress Urinary Incontinence in Women With Multiple Sclerosis
Official title: Prevalence and Risk Factors of Stress Urinary Incontinence in Women With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence, Stress
Multiple Sclerosis
Keywords: Urinary Incontinence, Stress
Multiple Sclerosis
Lower Urinary Tract Symptoms
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 363
Sex: FEMALE
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: All women aged \>18 years with multiple sclerosis, who had undergone a urodynamic test for lower urinary tract symptoms were included

Brief summary: Objective: To report the prevalence and risk factors of stress urinary incontinence (SUI) and the prevalence of intrinsic sphincter deficiency in women with multiple sclerosis (MS). Methods: A retrospective study was conducted among Female patients with MS, followed for lower urinary tract symptoms (LUTS) during a 15-year period. Demographic data, MS history, expanded disability status scale (EDSS) score at the urodynamic visit, obstetrical past, birth weight, LUTS, and urodynamic findings were collected. SUI was defined as incontinence during cough, or any effort. A maximum urethral closure pressure less than 30 cm H2O defined intrinsic sphincter deficiency. Results: In total 363 women with a mean age of 46.7±10.8 years and a mean disease duration of 12.9±8.7 years were included. The incidence of relapsing remitting MS, a secondary progressive form, and a primary progressive form was 60.6%, 32.8%, and 6.6%, respectively. The prevalence of SUI was 31.4%. The prevalence of intrinsic sphincter deficiency was 1.4% and 0.8% of these patients had a SUI (P=0.300). In a multivariate analysis, women with a SUI had significantly higher birth weight (P=0.030), a pelvic organ prolapse (P=0.021), urgent urinary incontinence (P=0.006), a lower EDSS score (P=0.019), and a weaker containing effort (P\<0.001). Conclusions: The prevalence of SUI in women with MS was 31.4%. This symptom could affect the quality of life of women with MS.


Eligibility criteria: Inclusion Criteria:

* Women aged \>18 years
* Multiple sclerosis
* Urodynamic test for lower urinary tract symptoms
* Followed in Saint Philibert Hospital between December 1999 to June 2014

Exclusion Criteria:

* Non confirmation of diagnosis of Multiple sclerosis

Primary outcomes:
measure: Stress urinary incontinence
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GHICL
name: Cecile Donzé, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05620654: A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
Official title: A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin in Patients With Advanced-stage Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Ovarian Cancer
Hyperthermic Intraperitoneal Chemotherapy
Paclitaxel
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Bayesian Optimal Interval Design
Primary purpose: TREATMENT

Brief summary: Primary objective of this trial is to identify the maximum tolerated dose (MTD) of paclitaxel combined with a fixed dose of cisplatin (75 mg/m2) delivered as hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with ovarian cancer.

In this single-center Phase I trial, Bayesian Optimal Interval Design (TITE-BOIN) was used. The starting dose for paclitaxel was 175 mg/m2, with escalation in 25 mg/m2 increments until the MTD was determined or the maximum dose level of 225 mg/m2 was reached. The target dose-limiting toxicity (DLT) rate was 25%, and the total sample size was 30 patients.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 65 years;
* adequate renal function (blood creatinine: 58-96 µmol/L), bone marrow function (hemoglobin ≥ 110 g/L, white cell count ≥ 4.0 ×109/L, neutrophil count ≥ 2.0 × 109/L, platelet count ≥ 100 × 109/L) and hepatic function \[bilirubin 3.4-22.2 µmol/L, alanine aminotransferase (ALT) 7-40 U/L, aspartate aminotransferase (AST) 13-35 U/L, AST/ALT≤ 1.5\].

Exclusion Criteria:

* Patients who had been treated with cisplatin OR paclitaxel for any reason within 3 weeks prior to HIPEC.
* A history of HIPEC treatment

Primary outcomes:
measure: Dose-Limiting Toxicity
timeFrame: within 3 weeks following HIPEC
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Other (Non U.s.)
Study officials:
References:
Clinical trial NCT00117754: Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Official title: Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tinea Capitis
Keywords: Terbinafine, Tinea capitis, pediatric, antifungal
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-07-08
Enrollment: 720
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs which can be associated with tinea capitis. The infection is caused by a relatively small group of dermatophytes in the genera Trichophyton and Microsporum.

Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study will evaluate the efficacy and safety of terbinafine in children with tinea capitis.


Eligibility criteria: Inclusion Criteria:

* Patients with clinical diagnosis of tinea capitis confirmed by positive KOH determined by the central mycology laboratory.
* Male or female patients who are at least 4 years old and no more than 12 years old.

Exclusion Criteria:

* Patients having a medical condition that alters the absorption and/or metabolism of terbinafine (e.g. liver, renal disease etc.)
* Patients receiving medication that may interfere with the evaluation of the drug's effect
* Patients who have kerions requiring immediate treatment or treatment with systemic corticosteroids and/or systemic antibiotics
* Patients with a history of liver disease or current/active liver disease or with elevation of livery enzymes outside of the normal range corresponding to their age
* Patients who have received recent systemic or topical treatment for tinea capitis within the specified time periods (e.g. systemic antifungals within 2 months of screening visit, topical treatments \[e.g. antifungals, corticosteroid preparations, zinc pyrithione or selenium sulfide or tar containing products\] within 1 week of screening).
* Patients with a history of systemic lupus erythematosus

Primary outcomes:
measure: Complete cure (negative mycology and clinical cure) rate at Week 10
Secondary outcomes:
measure: Clinical cure rate at Week 10
measure: Mycological cure rate at Week 10
measure: Safety of terbinafine
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
References:
Clinical trial NCT00949754: Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation
Official title: A Multi-Center, Randomized, Double Blind, Active-Controlled, Parallel Group Clinical Study to Evaluate the Dose Effect of Intradermal Injections of Apitox vs. Histamine in Subjects With Osteoarthritis Symptoms of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: honeybee venom
osteoarthritis
pain
knees
Lead sponsor: Apimeds, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-30
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation of osteoarthritis of the knee.


Eligibility criteria: Inclusion Criteria:

* osteoarthritis of one or both knees
* on stable NSAID or none due to intolerance
* women either post menopausal or on stable birth control
* no clinically significant disease or or abnormal laboratory values
* signed informed consent, communicate effectively, understand and comply with all study requirements

Exclusion Criteria:

* serious or unstable medical or psychological condition
* known sensitivity to honeybee venom, histamine or lidocaine
* history of asthma
* any clinically significant ECG abnormalities
* any clinically significant laboratory values OOR
* history of drug or alcohol abuse
* history of joint injury and forms of inflammatory arthritis

Primary outcomes:
measure: WOMAC
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pinellas Park
country: United States
facility: Radiant Research Inc.
state: Florida
city: Chicago
country: United States
facility: Radiant Research - Chicago
state: Illinois
city: Columbus
country: United States
facility: Radiant Research - Columbus
state: Ohio
city: San Antonio
country: United States
facility: Radiant Research - San Antonio
state: Texas
Study officials:
affiliation: Apimeds, CEO
name: Christopher MH Kim, M.D.
role: STUDY_CHAIR
affiliation: Apimeds, Inc, US Chief Operating Officer
name: Robert Brooks, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04481854: Cricoid Pressure Versus Paratracheal Pressure
Official title: Cricoid Pressure Versus Paratracheal Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cricoid Pressure During Tracheal Intubation
Keywords: cricoid pressure
paratracheal pressure
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients will be randomized to recieve cricoid pressure or left paratracheal pressure
Primary purpose: OTHER

Brief summary: Prospective randomized trial, including adult patients scheduled for orthopedic or abdominal surgery under general anesthesia and tracheal intubation. in this study the investigators will compare the classic cricoid pressure and the left paratracheal pressure regarding their impact on the intubation condition and the effectiveness.

Detailed description: Prospective randomized trial, including adult patients scheduled for orthopedic or abdominal surgery under general anesthesia and tracheal intubation. in this study the investigators will compare the classic cricoid pressure and the left paratracheal pressure regarding their impact on the intubation condition and the effectiveness.

During the laryngoscopy, the modification of the Cormack and Lehane grade before and after the application of the cricoid or paratracheal pressure will be noticed.

concerning the effectiveness of the procedure, a gastric tube will be introduced through the oesophagus during the procedure, under direct vision.

Eligibility criteria: Inclusion Criteria:

* adult patients with no criteria of difficult intubation or mask ventilation
* no criteria of full stomach requiring crush induction

Exclusion Criteria:

* Unexpected difficult laryngoscopy or mask ventilation

Primary outcomes:
measure: Modification of Cormack and Lehane grade
timeFrame: 3 minutes after induction of general anesthesia
Secondary outcomes:
measure: Effectiveness of the pressure
timeFrame: 5 minutes after induction of general anesthesia
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Mongi Slim Hospital
Study officials:
References:
Clinical trial NCT03790254: D Mannose for Prevention and Treatment of RUTIs
Official title: Oral D Mannose in the Prevention and Treatment of Recurrent Urinary Tract Infections: a Systematic Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Urinary Tract Infections
Antibiotic Prophylaxis
Antibiotic Resistance
Keywords: recurrent urinary tract infections
d mannose prophylaxis
antibiotic prophylaxis
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Search strategy and selection criteria Only publications with the text and/or the abstract written in the English language were considered. Additional papers cited in the references of the search manuscripts were further examined. Articles not addressing topics of interest were excluded, and the full text of the remaining articles was examined. Our literature search identified 15 articles pertaining to the search terms (Word variations have been searched). Further analysis of these articles resulted in 11 clinical trials which were deemed relevant to our review. The retrieved studies were assessed for their relevance based on the title and abstracts. Finally, studies references were screened in order to identify eventually unknown studies.

Brief summary: The aim of this review is to address clinical reliability, efficacy and safety of long-term treatment with oral D Mannose for the prevention of recurrent urinary tract infections (RUTIs) in females.

Detailed description: A comprehensive systematic MEDLINE, Embase, Cochrane search was performed for English language reports published before December 2018 using the term "recurrent urinary tract infections and d mannose." We searched Medline, Embase, and the Cochrane Register of Controlled Trials since January 2010 to December 2018. Eligible studies did not include non-oral therapy, local (vaginal) treatment in women with RUTIs.

Study eligibility criteria- We identified eligible original articles. The heterogeneity of the available studies, their different rationale and aim, the assumption of d mannose for prophylaxis or treatment of recurrent UTIs need to be taken into account.

Eligibility criteria: Inclusion Criteria:

recurrent urinary tract infections (RUTIs)

Exclusion Criteria:

Upper urinary tract infections, severe clinical symptoms, fever \> 37,5 with lumbar pain

Primary outcomes:
measure: research literature data on d mannose for prevention and treatment of recurrent urinary tract infections.
timeFrame: January 2010-December 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Urology Department Fondazione IRCCS Policlinico San Matteo
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo
name: Daniele Porru, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04578054: Benefit of the FLYing Transport of Patients Requiring Mobile Intensive Care Unit
Official title: Benefit of the FLYing Transport of Patients Requiring Mobile Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stress, Psychological
Emergency Medicine, Transport
Critical Care
Keywords: Stress, Psychological
emergency Medicine, transport
critical care
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France
First posted: 2020-10-08
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency Physician

Brief summary: Patient care who requires fast and intensive care by a mobile intensive care unit in a rescue helicopter is a common practice in Auvergne since more than 3 years. Indeed, a complete team (nurse and emergency physician) is on Dragon 63 and HeliSMUR 63 (SMUR = emergency medical services ). There are multiple fields of action, with a primary rescue activity (patient care directly at the site of the operation) but also secondary transport (transfer of patients from one hospital to another). This allows a reduction in transport time and therefore unavailability of the MICU team in general hospitals, which are in short supply of attending physicians. In addition, this allows patients to be repatriated to the Clermont-Ferrand University Hospital Center, which is the reference center for many pathologies and has the Level 3 adult and pediatric Trauma Center.

Detailed description: This is an observational study using a REDCap® questionnaire via an internet link, which will be distributed by any means (institution mailing lists via a referent, flash codes distributed to physicians, etc.).

The questionnaire will assess the type of medicalisation, the type of activity, the different hours of intervention, the age, the type and the severity of the patient's disease, the type of care practiced and the stress of the physician.

Eligibility criteria: Inclusion Criteria:

* Every Emergency Physician that participate to the Helicopter rescue

Exclusion Criteria:

* Every Emergency Physician non-voluntary to participate

Primary outcomes:
measure: Stress
timeFrame: Day 1
Secondary outcomes:
measure: Severity of the disease
timeFrame: Day 1
measure: Duration of the care
timeFrame: Day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
Study officials:
References:
Clinical trial NCT00801554: Autism Spectrum Disorders (ASD) Characterization Study
Official title: A Characterization Study of Individuals With Autism Spectrum Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorders
Keywords: Autism Spectrum Disorder
ASD
Autism
Asperger's Syndrome
PDD-NOS
Pervasive Developmental Disorders- Not Otherwise Specified
Adults
Children
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-12-03
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adults with ASDs.

Controls: healthy volunteers who have never been diagnosed with an Autism Spectrum Disorder.

Brief summary: The overarching aim of the study is to characterize children and adults with ASDs, and compare them with age-matched controls in relation to their functioning in family, academic, employment, and social spheres. Subjects will be comprehensively assessed in multiple non-overlapping domains of functioning, using psychiatric, cognitive, and psychosocial instruments.


Eligibility criteria: Inclusion Criteria:

* Age: 6-60 years old
* For subjects who have ASD: Meet DSM-IV PDD criteria based on clinical assessment including PDD module of structured interview
* For subjects who have ASD: One parent/guardian available for interviews about each subject. If a parent or guardian is not available, a reliable adult reporter identified by the subject available for an interview
* Full-scale IQ of above 80

Exclusion Criteria:

* Major sensorimotor handicaps (e.g. deafness, blindness)
* Any severely unstable psychiatric conditions including the following: psychosis, suicidality, bipolar disorder, substance use disorders (alcohol or drugs) that would require in-patient hospitalization.
* Inadequate command of the English language.

Primary outcomes:
measure: Overall level of functioning of children and adults with autism spectrum disorders (ASD) compared to individuals without ASD.
timeFrame: single time point
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joseph Biederman, MD
role: PRINCIPAL_INVESTIGATOR
References: