louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04516590: The Diagnostic Value of Autoimmune Antibody Detection in Newly Onset and Chronic Epilepsy
Official title: The Diagnostic Value of Autoimmune Antibody Detection in Newly Onset and Chronic Epilepsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Keywords: epilepsy
autoimmune antibody
diagnose
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: General Hospital of Ningxia Medical University
name: LanZhou University
name: First Affiliated Hospital, Sun Yat-Sen University
name: Henan Provincial People's Hospital
name: The Affiliated Hospital of Inner Mongolia Medical University
name: First Affiliated Hospital of Zhejiang University
name: Wulumuqi General Hospital of Lanzhou Military Command
name: Xuanwu Hospital, Beijing
name: Xiangya Hospital of Central South University
name: West China Hospital
name: Affiliated Hospital of Qinghai University
First posted: 2020-08-18
Enrollment: 130
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with newly onset or chronic epilepsy

Brief summary: multi-central and prospectively study the diagnostic value of autoimmune antibody detection in new and chronic epilepsy, and provide reference for clinical practice

Detailed description: multi-centrally recruit patients with newly onset or chronic epilepsy and hoping to find whether there exist an autoimmune cause. whether the patients receive immune therapy or not will depend on the type and titter of the autoimmune antibody as well as the severity of the symptom. At 3 and 6 months later, all patients will be followed-up, and the positive autoimmune antibody will be redetected. the clinical manifest, clinical data, medication and treatment outcome will be recorded and analyzed, to study the diagnostic value of autoimmune antibody detection in new and chronic epilepsy

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with epilepsy according to the diagnostic criteria of International League Against Epilepsy (ILAE) 2017
* Age from 16 to 70 years old
* The etiology of patients with epilepsy is unknown
* The patient or guardian signs an informed consent and can cooperate with the inspection and follow-up for six months

Exclusion Criteria:

* Patients with hereditary, infectious, and metabolic epilepsy
* The investigation and follow-up cannot be completed due to vision, hearing, language expression, disturbance of consciousness, and impaired understanding, and the guardian cannot replace the completed
* Patients with other progressive or systemic diseases

Primary outcomes:
measure: change of the seizure frequency
timeFrame: at six months after the patients being enrolled
measure: change of the autoimmune antigen
timeFrame: at six months after the patients being enrolled
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00919490: A Study of Single Dose of ABT-333 in Healthy Male Adults
Official title: A Double-blind, Randomized, Placebo-controlled Phase 1 Study in Healthy Male Adults to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single Dose of ABT-333
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HCV Infections
Keywords: Healthy Volunteers
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Abbott Japan Co.,Ltd
First posted: 2009-06-12
Enrollment: 39
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this study is to assess the safety, tolerability, and pharmacokinetics of blind, escalating, single, oral doses of ABT-333 under nonfasting conditions in healthy male adult in Japan.


Eligibility criteria: Inclusion Criteria:

* Subject has provided written consent.
* Subject is in general good health.

Exclusion Criteria:

* See above for main selection criteria.

Primary outcomes:
measure: To assess single dose safety and tolerability of an ABT-333 tablet formulation relative to placebo by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring
timeFrame: Daily assessment for 5 days then day 30 or more frequently as needed
measure: To evaluate single dose pharmacokinetics of an ABT-333 tablet formulation
timeFrame: Day 1-3
Secondary outcomes:
Other outcomes:
Locations:
city: Kagoshima
country: Japan
facility: Site Reference ID/Investigator# 19102
Study officials:
affiliation: Abbott
name: Yutaka Yamamura
role: STUDY_DIRECTOR
References:
Clinical trial NCT00108290: Chemotherapy, Hormone Therapy, and Surgery to Remove the Prostate Gland in Patients With High Risk Prostate Cancer
Official title: Chemohormone Therapy Prior to Prostatectomy in High Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate cancer
chemotherapy
hormone therapy
surgery
PSA
Gleason score
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-04-15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In men with prostate cancer who do not have evidence of spread to bone or other sites on computed axial tomography (CAT) scan/bone scan but are still at significant risk of failing treatment with surgery or radiation alone, a combination of chemotherapy and hormone therapy is being given for 6 months followed by surgery to remove the prostate.


Eligibility criteria: Inclusion Criteria:

* High risk prostate cancer without evidence of bone metastasis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: VA Maryland Health Care System
state: Maryland
Study officials:
References:
Clinical trial NCT04656990: SKIPping With PAX: An Integrated Gross Motor and Social-Emotional Skill Intervention
Official title: SKIPping With PAX: An Integrated Gross Motor and Social-Emotional Skill Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gross Motor Development Delay
Social Skills
Social Behavior
Sedentary Behavior
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 277
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to test the effects of an integrated intervention on the gross motor and social-emotional development of rural preschool boys and girls. A secondary purpose was to examine intervention effects on physical activity and sedentary behavior. An exploratory aim was to examine the role of executive functioning skills on intervention outcomes. This study featured a repeated measures (baseline, six-month posttest, three month retention \[nine-month follow-up\]), control group, experimental design. Classrooms were randomly assigned to either the experimental or control groups. Experimental participants received intervention while control participants received business as usual curricula.


Eligibility criteria: Inclusion Criteria:

* Enrolled in the early childhood center, aged 4-5 years

Exclusion Criteria:

* Enrolled in special education classroom

Primary outcomes:
measure: Test of Gross Motor Development, Third Edition
timeFrame: Baseline
measure: Test of Gross Motor Development, Third Edition
timeFrame: six-month posttest
measure: Test of Gross Motor Development, Third Edition
timeFrame: three-month follow-up
measure: Social Skills Improvement System Rating Scales
timeFrame: Baseline
measure: Social Skills Improvement System Rating Scales
timeFrame: six-month posttest
measure: Social Skills Improvement System Rating Scales
timeFrame: three-month follow-up
Secondary outcomes:
measure: Physical Activity From Accelerometer
timeFrame: Baseline
Other outcomes:
Locations:
city: Swansea
country: United States
facility: Lexington 4 Early Childhood Center
state: South Carolina
Study officials:
References:
Clinical trial NCT03945708: Does Whole Blood Adsorber During CPB Reduce Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery?
Official title: Does Whole Blood Adsorber During CPB Reduce the Amount of Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery? -a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infective Endocarditis
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: CytoSorbents, Inc
First posted: 2019-05-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to investigate the effect of addition of an adsorber during cardio pulmonary bypassin patients with infective endocarditis undergoing valve surgery, and if it will decrease the use of vasoactive drugs postoperatively.


Eligibility criteria: Inclusion Criteria:

1. Infected endocarditis patients undergoing heart valve surgery.
2. Age over 18 years.

Exclusion Criteria:

1 Declines participation

Primary outcomes:
measure: Use of vasoactive substances
timeFrame: 48 hours
Secondary outcomes:
measure: Milrinone use
timeFrame: 48 hours
measure: Chest tube bleeding
timeFrame: 48 hours
measure: Blood transfusions
timeFrame: 48 hours
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Emma Hansson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06080308: Liver Ischemia-reperfusion Injury and Clinical Data Analysis
Official title: Research on the Molecular Mechanisms of Liver Ischemia-reperfusion Injury and Clinical Data Analysis: an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Injury
Keywords: Hepatic ischemia; Reperfusion injury
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Criteria for liver ischemia-reperfusion injury patients: patients undergoing elective liver resection surgery with hepatic pedicle occlusion and reperfusion during the procedure.

Brief summary: Searching for new targets for the diagnosis and treatment of liver ischemia-reperfusion injury.

Detailed description: Through the analysis of serological data during liver resection elective surgery with hepatic pedicle occlusion and reperfusion, as well as the analysis of patient-related data, we aim to identify key target points that affect reperfusion injury and explore their underlying mechanisms.

Eligibility criteria: Inclusion Criteria:

1. Willingness to participate in the study and has signed an informed consent form. 2) Age ≥ 18 years and ≤ 70 years. 3) ASA classification ≤ III. 4) Criteria for liver ischemia-reperfusion injury patients: patients undergoing elective liver resection surgery with hepatic pedicle occlusion and reperfusion during the procedure.

Exclusion Criteria:

1) Patients with adverse events during surgery. 2) Patients in the end stage of disease with liver failure. 3) Liver tumor metastasis with concomitant severe heart failure or chronic renal insufficiency, etc. 4) Deemed unsuitable for participation in the study based on the judgment of the researchers.

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Primary outcomes:
measure: Length of hospital stay
timeFrame: 7days
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT02883608: Cap Assisted Forward-Viewing Endoscope vs Side-Viewing Endoscope for Examination of Major Duodenal Papilla
Official title: Cap Assisted Forward-Viewing Endoscope vs Side-Viewing Endoscope for Examination of Major Duodenal Papilla
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duodenal Papilla, Major
Keywords: Papilla
major duodenal papilla
ampulla of vater
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Examination of major duodenal papilla (MDP) using a standard forward-viewing esophagogastroduodenoscopy (S-EGD) is limited. Until now, side-viewing duodenoscope is the modality of choice to examine the MDP. Cap assisted esophagogastroduodenoscopy (CA-EGD) uses a cap fitted to the tip of the scope that can depress the mucosal folds and thus improve visualization and examination of MDP. The aim of this study is to compare CA-EGD to side\*viewing duodenoscope for complete examination of MDP.


Eligibility criteria: Inclusion Criteria:

* indication for elective upper endoscopy
* age over 18 years
* ability to provide informed consent

Exclusion Criteria:

* surgically altered upper gastrointestinal tract
* known or suspected upper gastrointestinal strictures
* upper gastrointestinal bleeding
* biliary stent
* planned endoscopic intervention
* American Society of Anesthesiologists class III or higher
* contraindication for or refusal of sedation with Propofol
* inability to give informed consent

Primary outcomes:
measure: Rate of complete visualisation of papilla duodeni major
timeFrame: within 5 minutes after intubation of the esophagus
Secondary outcomes:
measure: Duration needed to localize the papilla
timeFrame: within 5 minutes after intubation of the esophagus
Other outcomes:
Locations:
city: Munich
country: Germany
facility: II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
state: Bayern
Study officials:
References:
citation: Abdelhafez M, Phillip V, Hapfelmeier A, Sturm V, Elnegouly M, Dollhopf M, Kassem A, Klare P, Nennstiel S, Schmid RM, von Delius S, Eckel F. Comparison of cap-assisted endoscopy vs. side-viewing endoscopy for examination of the major duodenal papilla: a randomized, controlled, noninferiority crossover study. Endoscopy. 2019 May;51(5):419-426. doi: 10.1055/a-0662-5445. Epub 2018 Sep 10.
Clinical trial NCT02862808: Molecular Diagnosis of Syndromic or Isolated Severe Intellectual Disability Using Whole Exome Sequencing : a Pilot Study
Official title: Molecular Diagnosis of Syndromic or Isolated Severe Intellectual Disability Using Whole Exome Sequencing : a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Intellectual Disability
Keywords: Whole exome sequencing
Molecular diagnostic
Genetic counselling
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospectively included patients presenting severe intellectual disability without a molecular diagnosis, born from consanguineous parents and / or with intra-familial recurrence, whose parents are requesting for molecular diagnosis, in a context of deadlock with conventional techniques

Brief summary: Evaluation of diagnostic whole exome sequencing in patients with syndromic or isolated severe intellectual disability without a molecular diagnostic, with suspected autosomal recessive inheritance, allowing accurate genetic counseling in this high risk of recurrence group of diseases


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of syndromic or isolated severe intellectual disability (IQ \<50) without a molecular diagnosis
* Recurrence in siblings (multiplex families) suggesting autosomal recessive inheritance (with or without parental consanguinity) or sporadic cases from a consanguineous union
* Conventional genetic tests performed (including array-CGH) and MRI/CT-scan available
* DNA samples from parents and from both unaffected or affected siblings available, for parental segregation and confirmation of candidate variations identified.
* Availability of a signed informed consent
* To be affiliated or beneficiary of French social security/healthcare system

Exclusion Criteria:

* Parents in the exclusion period of another study or as provided by the national register of volunteers
* High-probability diagnostic hypothesis for which a molecular test is available at lower cost than exome sequencing

Primary outcomes:
measure: Number of patients with a molecular diagnostic and diagnostic yield
timeFrame: up to 12 months
Secondary outcomes:
measure: Cost/diagnostic ratio in comparison with conventional techniques
timeFrame: up to 12 months
measure: Reporting time in comparison with conventional techniques
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Besancon
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Paul Kuentz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02328508: Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life
Official title: Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Foot Ulcer
Diabetes
Keywords: hyperbaric oxygen therapy
diabetic foot ulcer
wound healing
inflammation
glycemic control
amputation
bacterial infection
quality of life
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: I-Shou University
First posted: 2014-12-31
Enrollment: 38
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: This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with diabetes.

Detailed description: OBJECTIVE - This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with diabetes.

RESEARCH DESIGN AND METHODS - This study was a randomized, single-center clinical trial. The effects of HBOT on patients in the experimental group were compared with the control group received only routine care. HBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions). Data were collected at 4 segments: pre-treatment (before first administration of HBOT; T1), during treatment (at the tenth administration of HBOT; T2), post-treatment (at the twentieth administration of HBOT; T3), and treatment follow-up (two weeks after the last therapy ended; T4).

Eligibility criteria: Inclusion Criteria:

* over 20 years of age
* a history of diabetes and a diagnosis of diabetic foot
* a wound classification of Grade 3 or below
* clear conscious and willing to participate in this study
* a signed consent form

Exclusion Criteria:

* less than 20 years of age, unwilling to participate

Primary outcomes:
measure: wound healing
timeFrame: 4 weeks
Secondary outcomes:
measure: inflammation index
timeFrame: 4 weeks
measure: amputation rate
timeFrame: 4 weeks
measure: survival rate of tissue in the affected limb
timeFrame: 4 weeks
measure: bacteriological wound cultures
timeFrame: 4 weeks
measure: glycemic control
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chen-Yu Chen, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05594108: Ultrasound-guided IUD Insertion During Family Medicine Residency Training
Official title: Ultrasound-guided Intrauterine Device Insertion During Family Medicine Residency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IUD Insertion Complication
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group=non ultrasound guided IUD insertion Experimental group=ultrasound guided IUD insertion
Primary purpose: OTHER

Brief summary: The objective of this pilot study is to test that hypothesis that ultrasound guided IUD placement by family medicine residents improves patient pain scores, procedure completion time, and procedure complication rates. The secondary objective is to test the hypothesis that ultrasound guided IUD placement improves resident confidence in performing the procedure. A prospective, randomized controlled pilot study will be conducted in the Department of Academic Family Medicine at the University of Saskatchewan. All women undergoing IUD placement (hormonal or non-hormonal) at West Winds Primary Care Center from Mar 1, 2020- Mar 1, 2021 will be invited to participate. Informed consent will be obtained from each patient and the resident inserting the IUD prior to initiating study procedures. The control group will comprise 20 women undergoing non-ultrasound guided IUD placement. The experimental group will comprise 20 women undergoing transabdominal ultrasound guided IUD placement. Patient pain scores and resident confidence scores will be tabulated using likert scales and compared between control and experimental groups using independent sample t-tests. Procedure completion time (minutes) will be compared between groups using t-tests. Procedure complications rates will be categorized as: a) inability to penetrate the cervix, b) improper location, c) inability to release the IUD from the insertion device, d) perforation, e) vasovagal reactions, and f) post-procedure infection; outcomes will be compared between groups using Chi-square analyses.


Eligibility criteria: Inclusion Criteria:

* all women of pre or perimenopausal age undergoing IUD (hormonal or non-hormonal) placement at West Winds Primary Care Center from Mar1, 2020 to Mar1, 2021

Exclusion Criteria:

* pregnancy, \< 6 weeks postpartum

Primary outcomes:
measure: post procedure pain score
timeFrame: 3 years
Secondary outcomes:
measure: procedure completion time
timeFrame: 3 years
measure: procedure complications
timeFrame: 3 years
measure: residency confidence with procedure
timeFrame: 3 years
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: West Winds Primary Care Center
state: Saskatchewan
Study officials:
References: