louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04019665: Self-screening of Cognitive Impairment in Primary Care
Official title: Self-screening of Cognitive Impairment in Primary Care: a Comparative Study Between a Test Based on SAGE at Home and MMSE at Doctor's Office in Picardie
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cognition Disorder
Alzheimer Disease
Keywords: Cognition Disorder
Alzheimer Disease
MMSE
SAGE
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: According to 2011 HAS recommendations, early detection of Alzheimer disease is the major objective in order to allow an earlier care and support. These recommendations strengthen general practitioner role, who plays a key role in the identification of cognitively impaired patients. HAS recommendations are the use of MMSE like test (Mini Mental State Examination) at general practitioner office. A self-screening test, without medical presence, would allow a self-administered cognitive assessment by the patient. A review of the literature about self-administered cognitive tests has been realized. The Self-Administered Gerocognitive Examination (SAGE) has been chosen. It is a brief, valid and reliable cognitive assessment tool, rated on 22 points, which allows an early detection of cognitive impairment, with a sensitivity close to the MMSE test. Nevertheless, SAGE has never been tested at home without medical supervision. In this study, the investigators will determine if SAGE scores at home correlates with MMSE scores at general practitioner office.

Patients with inclusion criteria will be recruited during the general practitioner consultation and will have a clinical assessment included MMSE and clinical data collection. Then, SAGE will be given to the patient in order to be completed at home without medical supervision and send to the general practitioner.


Eligibility criteria: Inclusion Criteria:

* Subjects from three Picard general practitioner's practice
* 60 years old or more
* patients who accept to complete the tests
* with ou without cognitive complaint
* patients able to read and write
* affiliated to social security system

Exclusion Criteria:

* major visual disorders
* legal safeguard
* diagnosis of neuro-cognitive disorder

Primary outcomes:
measure: MMSE Score at general or post emergency geriatric consultation
timeFrame: day 0
measure: Sage test done at home
timeFrame: 10 days
measure: Concordance between the MMSE test score done at consultation and the sage test core done at home
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Federspiel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montdidier
name: Deschamps, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hangest-en-Santerre
name: Briat-Lagache, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06120465: YOGA-CF (Yoga Outcomes Get Assessed in Cystic Fibrosis)
Official title: Yoga Outcomes Get Assessed in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Yoga
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 314
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate the effects of yoga participation for adults with cystic fibrosis.

The main question it aims to answer is: does participation in yoga affect health-related quality of life for adults with cystic fibrosis?

Researchers will compare a group completing a 12-week yoga programme alongside usual cystic fibrosis care, to a group completing usual care alone to see if the addition of yoga effects health-related quality of life.


Eligibility criteria: Inclusion Criteria:

Diagnosis of CF (confirmed by standard criteria; (Farrell et al. 2017))

Sixteen years of age or over

Home internet access

Ability to complete questionnaires in English

Stable CF disease as judged by the investigator, a senior CF clinician

Exclusion Criteria:

Inability to consent for treatment or measurement

Current participation in another interventional study

Current haemoptysis (greater than streaking in the sputum)

Known pregnancy at time of recruitment

Forced expiratory volume in 1 second (FEV1) below 30% predicted at baseline

Use of ambulatory oxygen therapy, long-term oxygen therapy (LTOT) or non-invasive ventilation

Current regular participation in yoga practice

Current neurological or musculoskeletal injury which would prevent completion of yoga

Diagnosis of osteoporosis (bone density Z score \<-2.5) or history of spontaneous spinal fractures

Uncontrolled gastroesophageal reflux

Acute pulmonary exacerbation within 28 days of screening

Primary outcomes:
measure: Respiratory Health- related quality of life - measured by the respiratory domain of the Cystic Fibrosis Questionnaire - Revised.
timeFrame: Baseline, 12 and 24-weeks
Secondary outcomes:
measure: Other Health-related quality of life domains - captured on the Cystic Fibrosis Questionnaire - Revised (CFQ-R)
timeFrame: Baseline, 12 and 24-weeks
measure: One Minute Sit to Stand Test
timeFrame: Baseline, 12 and 24-weeks
measure: Forced Expiratory Volume in 1 second
timeFrame: Baseline, 12 and 24-weeks
measure: Forced vital capacity (FVC)
timeFrame: Baseline, 12 and 24-weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal Brompton Hospital
state: Greater London
Study officials:
affiliation: Royal Brompton Hospital, Guys and St Thomas's Foundation Trust
name: Nicholas Simmonds
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05370365: Four or Six Weeks of Immobilization in the Conservative Treatment of Distal Radius Fractures in Elderly Population?
Official title: Four or Six Weeks of Immobilization in the Conservative Treatment of Distal Radius Fractures in Elderly Population?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 135
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective single-blinded randomised clinical trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare if there are differences in wrist function and pain after a distal radius fracture treated conservatively with immobilization for 4 or 6 weeks in elderly patients after six months of follow-up.


Eligibility criteria: Inclusion Criteria:

* Patients older than 65 years with a low energy distal radius fracture
* Intra or extraarticular distal radius fracture (A2, A3, C1, C2)
* Acceptable primary reduction (dorsal inclination \<10º, radial shortening \<3mm, articular gap \<2mm)

Exclusion criteria:

* History of ipsilateral fracture
* Bilateral fracture
* Open fracture
* Other concomitant fracture (except ulnar styloid fracture)
* Fracture AO B
* Previous surgeries in this area
* Dementia

Primary outcomes:
measure: Patient Rated Wrist Evaluation (PRWE)
timeFrame: 3 months
measure: Patient Rated Wrist Evaluation (PRWE)
timeFrame: 6 months
measure: Patient Rated Wrist Evaluation (PRWE)
timeFrame: 1 year
Secondary outcomes:
measure: Quick Disability of Arm and Shoulder (QuickDASH)
timeFrame: 3 months
measure: Quick Disability of Arm and Shoulder (QuickDASH)
timeFrame: 6 months
measure: Quick Disability of Arm and Shoulder (QuickDASH)
timeFrame: 1 year
measure: Visual Analogue Scale (VAS)
timeFrame: 3 months
measure: Visual Analogue Scale (VAS)
timeFrame: 6 months
measure: Visual Analogue Scale (VAS)
timeFrame: 1 year
measure: Range Of Movement (ROM)
timeFrame: 3 months
measure: Range Of Movement (ROM)
timeFrame: 6 months
measure: Range Of Movement (ROM)
timeFrame: 1 year
measure: Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
References:
Clinical trial NCT03776565: Comparison of Antrum Surface Between Women With Operative Hysteroscopy or Planned Caesarean Section
Official title: Gastric Ultrasound Before Planned Caesarean Section or Operative Hysteroscopy : How Much Pregnancy Changes Surface of Antrum of the Stomach ? Comparative Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2018-12-14
Enrollment: 137
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women comming to hospital/sites for a planned caesarean section or operative hysteroscopy.

Brief summary: Realization of a gastric ultrasound just before surgery, to measure the surface of antrum of stomach and compare if divergence sizes can be observed between women with a operative hysteroscopy and women with a planned caesarean section. To know if anaesthesia need to be adapted to the population.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 40
* Membership of a national insurance scheme
* Written consent
* Physical status score or American Society of Anesthesiologists (ASA) score = 1 or 2
* Planned caesarean section or operative hysteroscopy

Exclusion Criteria:

* Not able to give her written consent (not speaking French), under legal protection
* Insulin-dependant diabetes
* Hiatus hernia
* History of gastro-oesophageal surgery
* Contraindication to right lateral decubitus
* Treatments with anti-acids before ultrasounds.

Primary outcomes:
measure: Measure of antral surface
timeFrame: Just before anesthesia and surgery
Secondary outcomes:
measure: Measure of Perlas score
timeFrame: Before surgery
measure: Assessment of anxiety on gastric residue with a numeric scale
timeFrame: Before surgery
measure: Assessment of frequency of intraoperative inhalation
timeFrame: During surgery
measure: Incidence of fasting on gastric residue between the two populations
timeFrame: Before surgery
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hopital Béclère (APHP)
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Beclere (APHP)
name: Frederic Mercier, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06531265: Cryotechnique as a Diagnostic and Therapeutic Tool of Endobronchial Tumors
Official title: Cryotechnique as a Diagnostic and Therapeutic Tool of Endobronchial Tumors: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryotherapy Effect
Bronchial Neoplasms
Keywords: cryobiopsy
cryotherapy
endobronchial tumors
Lead sponsor: Sohag University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2024-07-31
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study was to assess the diagnostic yield and the safety of bronchoscopic cryotechniques in the management of endobronchial tumors.

Detailed description: Novel flexible cryoprobes were introduced for tissue sampling during bronchoscopy. Employing this approach, the sample is collected when frozen, with the tissue attached to the frozen end of the probe. This approach enables the retrieval of larger tissue samples from endobronchial lesionsEndobronchial cryotherapy is employed to treat individuals with obstructive central bronchial lung cancers. It has been demonstrated to effectively recanalize obstructed respiratory passages, alleviate symptoms, and improve the quality of life for patients in advanced stagesThis study aimed to assess the effectiveness and safety of using bronchoscopic cryotechniques for diagnosing and treating endobronchial malignancies.

Eligibility criteria: Inclusion Criteria:

* patients with radiologically suspected endobronchial masses

Exclusion Criteria:

* Patients with contraindications to bronchoscopy.
* uncorrected coagulopathy (if the international normalized ratio (INR) is more than 1.5).
* severe refractory hypoxemia (even after administering the highest possible dose of oxygen, the partial pressure of oxygen ("PaO2") stays below 70 mm Hg.
* hypoventilation with hypercapnia (type 2 respiratory failure).
* severe pulmonary hypertension \> 55 mmHg by echocardiography.
* hemodynamic instability.

Primary outcomes:
measure: Diagnostic yield
timeFrame: within 10 days
measure: Recanalization Success
timeFrame: one day following the procedure
Secondary outcomes:
measure: Degree of dyspnea improvement after the procedure
timeFrame: 2 weeks after the procedure
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Cairo University
name: Sabah Ahmed, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00353665: Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)
Official title: Phase 2-3 - Memantine for Disability in Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Amyotrophic Lateral Sclerosis
Keywords: amyotrophic lateral sclerosis
motor neuron disease
memantine
clinical trial
Lead sponsor: University of Lisbon
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2006-07-19
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study the effect of Memantine (uncompetitive, moderate affinity, NMDA receptor antagonist that binds to the NMDA receptor channel, and regulates the calcium influx into the neurons), a drug used to treat Alzheimer´s disease, on the progression of Amyotrophic Lateral Sclerosis (ALS). Memantine is added to riluzole (the single drug approved to treat ALS).

Detailed description: Phase 2/3 trial in ALS patients Double-blinded, parallel, randomized (2 blocs, bulbar/spinal onset)

Memantine + riluzole x Placebo + Memantine

Inclusion criteria:

* \< 75 years at disease onset
* \< 3 years of disease progression
* ALS-FRS \> 24
* FVC \> 60
* Probable or definite disease (revised El Escorial criteria)
* No other medical condition
* Normal blood tests
* Regular medication on riluzole \> 1 month
* Nerve conduction studies ruling out conduction block
* EMG with widespread loss of motor units (revised El Escorial criteria)
* At least one hand with ADM strength \> 2 on MRC scale

Duration - 2 years

Evaluation - every 3 months

Primary outcome - ALS-FRS Secondary -SF36, Hamilton depression scale, motor unit number estimation, neurophysiological index, strength (clinical evaluation); side-effects

Intention to treat analysis

60 patients

number estimated for 50% change in decline rate of ALS-FRS

Eligibility criteria: Inclusion Criteria:

* Definite or probable disease - revise El Escorial criteria
* Normal blood tests
* Riluzole treatment during 1 month or more
* EMG in accordance with El Escorial criteria

Exclusion Criteria:

* Other diseases (such as PNP)
* Both ADM muscles \< 3 on MRC scale
* Conduction block on nerve conduction tests
* Disease duration \> 3 years
* ALS-FRS \< 25
* Forced vital capacity - \<60%

Primary outcomes:
measure: ALS-FRS
timeFrame: 12 months
Secondary outcomes:
measure: QoL, depression scale, strength (clinical evaluation), forced vital capacity
timeFrame: 12 months
measure: neurophysiology (motor unit counting, neurophysiological index)
timeFrame: 12 months
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Department of Neurology - Hospital de Santa Maria
Study officials:
affiliation: Department of Neurology- Hospital de Santa Maria
name: Mamede de Carvalho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02949765: Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease
Official title: Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Celiac Disease
Iron Deficiency (Without Anemia)
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anemia and sideropenia are a common effect of untreated celiac disease. In a portion of patients a certain degree of hypoferritinemia persist after the diagnosis, despite a good compliance and clinical response to gluten-free diet. These patients are usually premenopausal women in whom the cyclic menstrual bleeding and the oral iron intake are not balanced.

The aim of the study is to compare the efficacy of a pharmacological therapy, frequently not tolerated, and a dietary approach through a iron-rich diet in this subset of patients.


Eligibility criteria: Inclusion Criteria:

* Celiac patients on gluten free diet since 1 year
* iron deficiency (ferritin \<15 ng/L or ferritin 15-20 + transferrin saturation \<15%)

Exclusion Criteria:

* allergy to iron supplementation
* anemia
* pregnancy or breastfeeding
* menopause
* organic or psychiatric diseases

Primary outcomes:
measure: Ferritin levels (ng/mL) increase > 95% compared to basal levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Hemoglobin levels (g/dL), compared to basal levels
timeFrame: 12 weeks
measure: Iron levels (mcd/dl), compared to basal levels
timeFrame: 12 weeks
measure: Transferrin saturation (%, ratio of serum iron and total iron-binding capacity), compared to basal levels
timeFrame: 12 weeks
Other outcomes:
measure: Number of participants with treatment-related adverse events assessed through NRS (number rating scales)
timeFrame: 12 weeks
measure: Degree of compliance to therapy assessed through telephone interviews (number of pills taken)
timeFrame: 12 weeks
measure: Degree of compliance to diet assessed through compliance questionnaires (mg of irons ingested)
timeFrame: 12 weeks
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Study officials:
affiliation: Gastroenterology and Endoscopy Unit Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Department of Pathophysiology and Transplantation Università degli Studi di Milano - Italy.
name: Francesca Francesca, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05285865: Scapular Mobilization on Inspiratory Capacity of Post-CABG Patients
Official title: Effects of Scapular Mobilization on Inspiratory Capacity of Post-CABG Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CABG
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine the effects of scapular mobilization on pulmonary functions of post-CABG patients.


Eligibility criteria: Inclusion Criteria:

* CAD patients undergone CABG surgery (Post-Op. Day#. 01).
* Both genders (male and female).
* Aged between 40 to 70 years .
* Patient having oxygen saturation (SPO2) of more than or equal to 90% with 25% of fraction of inspired oxygen (FiO2) - (possibly nasal cannula inserted).

Exclusion Criteria:

* Patients with low glasgow coma scale (GCS) score (less than 15).
* Patients having inspiratory capacity of 3500ml and above.
* Patients on ventilator.

Primary outcomes:
measure: Incentive Spirometer
timeFrame: 1 week
measure: Borg scale
timeFrame: 1 week
measure: Numeric pain rating scale
timeFrame: 1 week
measure: Digital Spirometer
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Rehman Medical Institute
state: KPK
Study officials:
affiliation: Riphah International University
name: Malik Muhammad Ali Awan, MSPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03942965: Registry Evaluation of a Double Balloon Accessory Device
Official title: Multi-center Prospective Registry Study Utilizing a Double Balloon Accessory Device to Facilitate Endoscopic Polypectomy in Large Intestine.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adenomatous Polyp of Colon
Lead sponsor: Lumendi, LLC
Sponsor class: INDUSTRY
First posted: 2019-05-08
Enrollment: 165
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: Investigator's practice

Brief summary: This study is collecting standard of care information pertaining to the use of the accessory device and patient outcomes when this double balloon accessory device is used during endoscopic procedures in the colon.


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for endoscopic removal of suspected adenomatous benign polyps(s)
2. Patients capable of giving informed consent in English
3. No medical contraindication to endoscopic mucosal resection or endoscopic submucosal disection

Exclusion Criteria:

1. No patients less than 18 years of age.
2. Any contraindication to colonoscopy with due to subject's colon anatomy (i.e. stricture)
3. History of open or laparoscopic colorectal surgery
4. History of Inflammatory Bowel Disease

Primary outcomes:
measure: Ability to perform the procedure safely and effectively with the study device.
timeFrame: Intraoperatively
Secondary outcomes:
measure: Time to reach target lesion
timeFrame: Intraoperatively
measure: Time to remove lesion after intervention begins
timeFrame: Intraoperatively
measure: Total time using study device during case
timeFrame: Intraoperatively
measure: Total case time
timeFrame: Intraoperatively
measure: Total defect closure time
timeFrame: Intraoperatively
measure: User feedback on device performance
timeFrame: Intraoperatively
measure: Number of Study Subjects with Treatment Related Adverse Events
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida - Division of Gastroenterology, Hepatology and Nutrition
state: Florida
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: University of Florida
name: Peter Draganov, MD
role: PRINCIPAL_INVESTIGATOR
References: