louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06753162: Oral Health and Endometriosis: A Cohort Study
Official title: Oral Health Perception Among 4,079 Women With Endometriosis: A Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: endometriosis
Oral Health
Periodontitis
Gengivitis
Lead sponsor: University of Bari Aldo Moro
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 4079
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women suffering from endometriosis

Brief summary: A survey has been conducted thanks to a questionnaire composed of 45 questions. The study group was composed of 4079 women affected by endometriosis, recruited from dedicated communities present on the social network Facebook. The questionnaire investigated about: the endometriosis status, the kind of therapy, the presence of any sign and symptoms in the oral cavity, the presence of periodontal problems, the self-perception of the oral health status, the presence of other autoimmune diseases and oral hygiene and the eating habits, physical activity practiced, the life quality.

Detailed description: The questions were structured thanks to the collaboration of expert health professionals: gynecologist, dentist, dental hygienist, physiotherapist, dietician, psychologist to obtain targeted information on endometriosis, on the type of therapy, on any signs and symptoms in the oral cavity (perception health status, presence of periodontal problems), to investigate oral hygiene and dietary habits, physical activity, quality of life, the presence of other immune-based diseases. In the final part of the questionnaire there was a section in which women were free to tell their stories.

Eligibility criteria: Inclusion Criteria:

* The only inclusion criterion was being at least 18 years old

Exclusion Criteria:

* • Pregnancy.

  * Administration of antibiotics in the last 15 days prior to entry into the study or indications for antibiotic prophylaxis.
  * Orthodontic Appliances.
  * Immunological diseases or use of drugs that can affect oral tissues (phenytoin, cyclosporine), nifedipine, chronic use of nonsteroidal anti-inflammatory drugs.
  * Refusal to participate in the study.

Primary outcomes:
measure: Response Patterns Based on Multiple Correspondence Analysis Dimensions
timeFrame: 1 year
measure: Epidemiological Analysis
timeFrame: 1 year
measure: Comparative Analysis of Oral Cavity Disorders Across Different Stages of Endometriosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: University of Bari Aldo Moro
Study officials:
affiliation: University of Bari Aldo Moro
name: Saverio Capodiferro, Professor
role: STUDY_DIRECTOR
affiliation: University of Bari Aldo Moro
name: Massimo Corsalini, Professor
role: STUDY_DIRECTOR
affiliation: University of Bari Aldo Moro
name: Giuseppe D'Albis
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bari Aldo Moro
name: Agneta Maria Teresa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04397991: Inhaled Furosemide for Transient Tachypnea of Newborn
Official title: Inhaled Furosemide for Transient Tachypnea of Newborn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Morbidity
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 64
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomized double blind clinical trial in which newborns with suspected Transient tachypnea of the newborn (TTN) will receive either furosemide or normal saline by nebulizer every 6 hours for 24 hours.


Eligibility criteria: Inclusion Criteria:

* Neonates with 34+0-39+0 gestational age
* on the first day of life
* with the clinical diagnosis of Transient Tachypnoea
* need for CPAP \>6 hours to obtain the oxygen saturation \>92%

Exclusion Criteria:

* Systemic infection
* Intubation and mechanical ventilation before Inclusion in the trail
* Malformation and any other disease with disturb of respiratory system

Primary outcomes:
measure: Percentage of patients with respiratory morbidity
timeFrame: 24 hours
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 15 days
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
affiliation: Makassed General Hospital
name: Mariam Rajab, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00647491: A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Eisai Limited
First posted: 2008-03-31
Enrollment: 352
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult Japanese subjects with RA


Eligibility criteria: Inclusion Criteria:

* Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits \>10 swollen joints, \>12 tender joints.
* Subjects must have failed prior treatment with one or more DMARDs.
* A negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration.
* Body weight less than or equal to 100 kg

Exclusion Criteria:

* A history of, or current, acute inflammatory joint disease of different origin from RA.
* Prior treatment with any TNF antagonist, including adalimumab.
* Any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics.
* Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.

Primary outcomes:
measure: ACR20
timeFrame: Week 24
Secondary outcomes:
measure: ACR20
timeFrame: Week12
measure: ACR50
timeFrame: Weeks 12 and 24
measure: ACR70
timeFrame: Weeks 12 and 24
Other outcomes:
Locations:
city: Aichi
country: Japan
city: Chiba
country: Japan
city: Ehime
country: Japan
city: Fukui
country: Japan
city: Fukuoka
country: Japan
city: Gunma
country: Japan
city: Hokkaido
country: Japan
city: Hyogo
country: Japan
city: Ibaraki
country: Japan
city: Ishikawa
country: Japan
city: Kagoshima
country: Japan
city: Kanagawa
country: Japan
city: Kyoto
country: Japan
city: Miyagi
country: Japan
city: Nagano
country: Japan
city: Nagasaki
country: Japan
city: Niigata
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Saitama
country: Japan
city: Shizuoka
country: Japan
city: Tochigi
country: Japan
city: Tokushima
country: Japan
city: Tokyo
country: Japan
city: Toyama
country: Japan
Study officials:
affiliation: Abbott
name: Shigeki Hashimoto, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
Clinical trial NCT01432691: Hemi Artificial Hipjoint Versus Total Artificial Hipjoint
Official title: Clinical and RSA Comparison of Hemi Versus Total Hip Arthroplasty After Displaced Femoral Neck Fracture. A Randomized Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Optimized Treatment
Keywords: Hip-fracture
RSA
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2011-09-13
Enrollment: 70
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Randomized Controlled Trial study comparing hemialloplastik versus total joint replacement.

Detailed description: Seventy patients over seventy years who are admitted in our hip fracture department with the indication for hemi joint replacement therapy, due to a Garden 3-4 femoral neck fracture or a fracture Garden 1-2 with over 20-degree posterior tilt are randomized to either hemialloplastik or total joint replacement. The patients are followed for 24 mouths with X-ray Stereo Photogrammetric Analysis (RSA) radiographs and clinical examinations.

Eligibility criteria: Inclusion Criteria:

* Patients over 70 years, admitted two our hip-fracture department with a 3-4 Garden femoral neck fracture or a fracture Garden 1-2 with over 20-degree posterior tilt.

  * Preoperative New Mobility Score ≥ 6th
* Patients must be able to speak and understand Danish.
* Patients must be able to give informed consent and be cognitively intact (Hindsøe score ≥ 6).
* Patients should be expected to be able to implement the postoperative controls. Patients should not be medically ill: ASA-score ≤ 3rd

Primary outcomes:
measure: Radiographic and clinical
timeFrame: Five years
Secondary outcomes:
measure: Clinical
timeFrame: Five years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital, Copenhagen
state: Hvidovre
Study officials:
References:
Clinical trial NCT01046591: Sleep and Behavior in Children With Cleft Palate
Official title: Sleep and Neurobehavioral Performance After Cleft Palate Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Palate
Keywords: Cleft Palate
Cleft Lip
Obstructive Sleep Apnea
Sleep-Disordered Breathing
Behavior
Learning
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-01-12
Enrollment: 82
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children will be recruited from cleft palate clinics

Brief summary: The purpose of this study is to determine whether cleft palate repair increases the risk for obstructive sleep apnea in children and whether sleep apnea could explain learning and behavior difficulties that are often observed.


Eligibility criteria: Inclusion Criteria:

* Previous cleft palate repair
* Age 6-15 years

Exclusion Criteria:

* Other condition that impacts the interpretation of PSG or neurobehavioral assessments
* Being treated for sleep apnea with CPAP

Primary outcomes:
measure: Severity of obstructive sleep apnea
timeFrame: Within 24 hours of enrollment.
Secondary outcomes:
measure: Hyperactivity scores
timeFrame: Within 24 hours of enrollment.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Louise M O'Brien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06932991: Cognitive Stimulation Therapy - Effects on Cognitive and Functional Domains in Dementia - A Retrospective Data Review
Official title: Cognitive Stimulation Therapy vs. Reality Orientation & Reminiscence Therapy: Effects on Cognitive and Functional Domains in Dementia - Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Keywords: older adults
dementia
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older people who are residence in a 24/7 care home

Brief summary: This retrospective, single-blind, parallel group study investigates the efficacy of Cognitive Stimulation Therapy (CST) compared to Reality Orientation and Reminiscence Therapy (RO\&RM) in enhancing cognitive and functional domains in older adults with mild to moderate dementia.

Detailed description: Through data review, this retrospective, single-blind, parallel group study investigates the efficacy of Cognitive Stimulation Therapy (CST) compared to Reality Orientation and Reminiscence Therapy (RO\&RM) in enhancing cognitive and functional domains in older adults with mild to moderate dementia.

Eligibility criteria: Inclusion Criteria:

* participants had to be 65 years old or above, live in Hong Kong and had a diagnosis for dementia in medical history

Exclusion Criteria:

* any major neurological illness other than dementia, any psychiatric disorder or a known history of substance abuse.

Primary outcomes:
measure: Kendrick Cognitive Test for the Elderly (KCTE).
timeFrame: Baseline line and six-month
Secondary outcomes:
measure: The Chinese Disability Assessment for Dementia (CDAD)
timeFrame: Baseline and 6-month after the start of the program
Other outcomes:
Locations:
city: UK
country: United Kingdom
facility: Northumbria University
Study officials:
References:
citation: Spector A, Thorgrimsen L, Woods B, Royan L, Davies S, Butterworth M, Orrell M. Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. Br J Psychiatry. 2003 Sep;183:248-54. doi: 10.1192/bjp.183.3.248.
citation: Mok CC, Siu AM, Chan WC, Yeung KM, Pan PC, Li SW. Functional disabilities profile of chinese elderly people with Alzheimer's disease - a validation study on the chinese version of the disability assessment for dementia. Dement Geriatr Cogn Disord. 2005;20(2-3):112-9. doi: 10.1159/000086612. Epub 2005 Jun 30.
Clinical trial NCT03541291: Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring
Official title: Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: We will test an ultrasound device that uses sound waves to detect the fetal heart beat, and use this device to tell the MRI scanner when to collect pictures of the fetal heart. This will help freeze motion of the fetal heart, to make MRI pictures sharper. This will be important for assessing human fetal heart disease, an active area of research at our institution.


Eligibility criteria: Inclusion Criteria:

* pregnant adults (age 18 and up) with fetus affected by congenital heart disease
* singleton pregnancy in their 2nd and 3rd trimesters
* scheduled for a clinical fetal ultrasound examination at the Fetal Echocardiography Clinic at SickKids

Exclusion Criteria:

* claustrophobia
* cardiac pacemaker
* non-MRI compatible implants
* non-singleton pregnancy
* obesity (BMI \> 30)

Primary outcomes:
measure: Comparison between fetal MRI and fetal echocardiography
timeFrame: within 2 weeks of participation in the study
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Mike Seed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000191: Carbamazepine Treatment for Cocaine Dependence - 5
Official title: Carbamazepine Treatment for Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: Cocaine Dependence
Carbamazepine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess carbamazepine as a pharmacotherapy for cocaine dependence.


Eligibility criteria: Please contact site for information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: James Cornish, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cornish JW, Maany I, Fudala PJ, Neal S, Poole SA, Volpicelli P, O'Brien CP. Carbamazepine treatment for cocaine dependence. Drug Alcohol Depend. 1995 Jun;38(3):221-7. doi: 10.1016/0376-8716(95)01102-5.
Clinical trial NCT00960791: Study to Assess the Absorption, Distribution, Metabolism and Excretion of AZD1656 in Type 2 Diabetes Mellitus (T2DM)
Official title: An Open, Single-centre, Single Group, Phase I Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of AZD1656 After Oral Administration of 14C-labelled AZD1656 to Type II Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type II Diabetes Mellitus
Keywords: Type II diabetes mellitus
absorption
distribution
metabolism
excretion
14C-labelled
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-08-18
Enrollment: 6
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the absorption, distribution, metabolism and excretion of AZD1656 after administration of a single oral dose of 14C-labelled AZD1656 solution in male Type 2 Diabetes Mellitus patients.


Eligibility criteria: Inclusion Criteria:

* Male type II diabetes patients diagnosed for more than 5 years and aged between 35 and 65 years.
* Subjects treated with metformin alone or metformin and one other oral anti-diabetic drug.
* Subjects should have FPG in the range of 6.0 to 11.0 mmol/L at screening and HbA1c less than 10% (HbA1c value according to international DCCT standard).

Exclusion Criteria:

* History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.
* Renal dysfunction.
* Use of insulin, glitazones, warfarin and amiodarone within 3 months before enrolment and use of potent CYP450 inhibitors, e.g., ketoconazole and macrolide antibiotics within 14 days before administration of IP.

Primary outcomes:
measure: Total recovery of radioactive dose, rate and routes of excretion of total radioactivity, metabolic pattern and metabolic profile, and PK variables of AZD1656 (AUC, Cmax, tmax, t1/2, Total Ae, CL/F and CLR)
timeFrame: One blood sample for analysis of plasma concentrations of AZD1656 taken on several days during the treatment period. A full PK profile for AZD1656 will also be taken on the last day of treatment
Secondary outcomes:
measure: Safety variables: Adverse Events (AEs), Blood pressure (BP), pulse, ECG and safety laboratory variables, glucose quick test
timeFrame: Frequent measurements during the study period
measure: Plasma Glucose
timeFrame: Plasma Glucose will be measured twice daily during residential period
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Research Site
state: California
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden
name: Klas Malmberg, MD, PhD, Prof.,
role: STUDY_DIRECTOR
affiliation: Clinical Pharmacology Unit (CPU)AstraZeneca R&D Alderley ParkMacclesfield, Cheshire SK10 4TG, UK
name: Emeline Ramos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06397391: Nonlinear Absorber in Essential Tremor Treatment
Official title: Nonlinear Absorber in Essential Tremor Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Keywords: Essential tremor
Passive treatment
Nonlinear absorber
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to develop a non linear absorber for patients with essential tremor (ET). It 's an extern passive medical device which should improve patients tremor.

Investigators will evaluate the impact of this medical device through one clinical scale (Fahn-Tolosa-Marin) and accelerometry record. Investigators focus on motor improvement.


Eligibility criteria: Inclusion Criteria:

* Adult man or woman between 20 and 90 years old
* Diagnosis of ET (Essential Tremor) established by a neurologist
* ET affecting the upper limbs, associated or not with head tremor
* Drug-resistant nature of ET (failure of beta-blockers, mysoline, benzodiazepine)
* Affiliate to a social security or similar system
* Having given written consent to participate in the study, free and informed.

Exclusion Criteria:

* Severe comorbidity
* ET affecting only the leader
* Wounds on the forearm
* Modification of treatment or surgery to manage ET, planned within 3 months following inclusion
* Cognitive disorder known or suspected by the investigator
* Pregnant or breastfeeding woman
* Persons placed under guardianship, curatorship or under judicial protection
* Persons deprived of liberty, subject to psychiatric care or admitted to a health or social establishment for purposes other than that of clinical investigation

Criteria for premature discharge

* MMSE (Mini-Mental State Examination) score\<24;
* ET of the patient with frequency range not between 4 to 6 Hz or 8 to 12 Hz and/or amplitudes of movement greater than 20°.
* modification of treatment for ET or performance of tremor surgery before the final visit;
* withdrawal of consent or refusal to continue visits.

Primary outcomes:
measure: Tremor improvement
timeFrame: 6 months maximum
Secondary outcomes:
measure: Tremor frequency
timeFrame: 6 months maximum
measure: Tolerance to wearing the device
timeFrame: 6 months maximum
measure: Patient satisfaction with the device measured by a specific multidimensional questionnaire
timeFrame: 6 months maximum
Other outcomes:
Locations:
city: Bron
country: France
facility: Service Pathologies du mouvement et neuromusculaire, Hopital neurologique Pierre Wertheimer
Study officials:
affiliation: Hopital neurologique Pierre Wertheimer
name: Stéphane THOBOIS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: