louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06152159: Postpartum Experience by the Second Parent
Official title: Postpartum Experience by the Second Parent
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postpartum Experience
Keywords: postpartum experience
second parent
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The second parent of a child born since minimum 3 months and maximum 6 months.

Brief summary: Many studies have been performed on mothers and their postnatal experiences. Unfortunately, studies about the second parent are very rare. Second parent is yet an essential figure in the parent-child triad and a real support for the mother.

The postpartum period is a time of intense restructuring and upheaval, both physically and psychologically. Studies have shown that almost 13% of fathers suffer from depression.

Detailed description: The main objective is to describe the postpartum experience of the second parent.

Eligibility criteria: Inclusion Criteria:

* Males and females
* Second parent of a child born living for at least 3 months and at most 6 months
* Major
* Agreeing to participate in the study

Exclusion Criteria:

* Minors
* Protected by law (guardianship, curatorship, safeguarding of justice)
* Not agreeing to participate in this study
* Parents of stillborn children
* Refusing to participate in the study

Primary outcomes:
measure: Experience of the postpartum by the second parent
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Ufr Medecine Urca
city: Reims
country: France
facility: Université de Reims Champagne Ardenne
Study officials:
References:
Clinical trial NCT02003859: Predictive Value of pCLE Findings in Pediatric IBD
Official title: Predictive Value of pCLE Findings in Pediatric IBD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Keywords: IBD
Pediatrics
pCLE
Lead sponsor: Scientific Center of Children's Health RAMS
Sponsor class: OTHER
Collaborators: name: University of Alberta
name: Harvard Medical School (HMS and HSDM)
First posted: 2013-12-06
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients with IBD from all over Russia, treated from IBD in our Center

Brief summary: Studies over the past two decades have convincingly demonstrated the role of barrier dysfunction in the pathogenesis of inflammatory bowel disease. It previously shown that optical biopsy with probe-based confocal laser endomicroscopy (pCLE) could be used to assess mucosal barrier function. Furthermore, mucosal barrier dysfunction on pCLE was shown to be predictive of disease relapse in adult IBD patients. The purpose of the current study is to determine the predictive value of pCLE findings in pediatric IBD patients.


Eligibility criteria: Inclusion Criteria:

* signed informed consent
* patients with established IBD

Exclusion Criteria:

* Any kind of allergy
* Bronchial asthma
* Liver or kidney disease
* Inability to sign informed consent

Primary outcomes:
measure: Primary study end-point was moderate to severe flare requiring hospitalization after pCLE
timeFrame: follow up period was a median of 18 months (range 4 to 33)
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: The Scientific Center of Children's Health
Study officials:
affiliation: The Scientififc Center of Children's Health
name: Andrey A Shavrov, M.D.
role: STUDY_CHAIR
References:
citation: Shavrov A, Kharitonova AY, Davis EM, Claggett B, Morozov DA, Brown DK, Shavrov AA, Liu JJ. A Pilot Study of Confocal Laser Endomicroscopy to Predict Barrier Dysfunction and Relapse in Pediatric Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):873-8. doi: 10.1097/MPG.0000000000001022.
Clinical trial NCT05240859: Real World Study of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis
Official title: A Multicenter, Prospective, Observational Real World Study For the Efficacy and Safety of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: RA patients who start Geleli treatment

Brief summary: The purpose of this multicenter, prospective, Observational study is to assess the Efficacy and Safety of an Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis in the real world setting.


Eligibility criteria: Inclusion Criteria:

* Participants who fulfilled the 1987 revised American College of Rheumatology (ACR) or 2010 ACR/EULAR classification criteria for RA.
* Participants for whom the rheumatologists have decided to initiate Geleli treatment.
* Participants who provide a written informed consent form of participating in this study.

Exclusion Criteria:

* Current active or chronic infections, or previous history of active TB infection.
* History of malignancy.
* Congestive heart failure with NYHA class III or IV.
* Females of childbearing or breastfeeding.
* Participate in other clinical trial within 3 months.
* Allergic to the drugs involved in the study.
* The investigator believes that the patient is not suitable to participate in this study.

Primary outcomes:
measure: Proportion of Participants Achieving American College of Rheumatology (ACR) 20
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Who Were on Geleli for a Period of 24 Weeks
timeFrame: Week 24
measure: Remission rate According to Boolean Criteria
timeFrame: Week 12 and Week 24
measure: Remission rate According to Clinical Disease Activity Index (CDAI)
timeFrame: Week 12 and Week 24
measure: Proportion of Participants Achieving American College of Rheumatology (ACR) 20
timeFrame: Week 4 and Week 12
measure: Proportion of Participants Achieving American College of Rheumatology (ACR) 50
timeFrame: Week 4, Week 12 and Week 24
measure: Proportion of Participants Achieving American College of Rheumatology (ACR) 70
timeFrame: Week 4, Week 12 and Week 24
measure: Change From Baseline in Disease Activity Score 28 (DAS28)-ESR
timeFrame: Baseline, Week 4, Week12 and Week 24
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Baseline, Week 4, Week12 and Week 24
measure: Assessment of Safety Based on Adverse Events that Occur During the Study.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Department of Rheumatology and Immunology, Peking University People's Hospital
name: Zhanguo Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06020859: MCE-new for Detection of Gastric Lesions
Official title: New MCE System for Detection of Gastric Lesions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Capsule Endoscopy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Clinical application of magnetically controlled capsule endoscopy : a prospective self-controlled trial

Detailed description: The aim of this study is to investigate the effectiveness and safety of using a new MCE system for routine gastric examination and automatic scanning. This study is a prospective, self controlled clinical trail, which includes adult patients who plan to undergo MCE examination. Patients will undergo three different tests during the experiment: NaviEC-2000Pro Gastro Scan, NaviEC-2000Pro routine gastric examination, NaviEC-1000 routine gastric examination.

Eligibility criteria: Inclusion Criteria:

* underwent gastric examination;
* At least 18 years old；
* Be able to provide informed consent.

Exclusion Criteria:

* With swallowing obstruction or disorders;
* With known or suspected gastrointestinal obstruction, stenosis and fistula;
* Have no conditions for surgery or refuse to undergo any abdominal surgery;
* Be allergic to or have other known contraindication or intolerance to the drug used in the study;
* With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies;
* Women during pregnancy;
* Currently enrolled in another clinical trial of a drug or device;
* Other conditions determined by the investigator to be inappropriate for enrollment.

Primary outcomes:
measure: the degree of gastric mucosal visualization
timeFrame: 2 weeks
Secondary outcomes:
measure: The time of gastric examination
timeFrame: 2 weeks
measure: detection of lesions
timeFrame: 2 weeks
measure: Equipment operation evaluation
timeFrame: 2 weeks
measure: Safety Assessment
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11.
citation: Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.
Clinical trial NCT01266759: Efficacy of Combined Contraceptive Vaginal Ring(NuvaRing)in Women With Idiopathic Menorrhagia
Official title: Combined Contraceptive Vaginal Ring or Norethisterone for Treatment of Idiopathic Menorrhagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menorrhagia
Keywords: Menorrhagia
Vaginal ring
Norethisterone Acetate
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2010-12-24
Enrollment: 95
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile age


Eligibility criteria: Inclusion Criteria:

* Women with heavy menstrual bleeding based on PBAC score over 185 (mean of two control cycles)and desire contraception

Exclusion Criteria:

* Menorrhagia of endocrine or systemic origin
* other pathology e.g. patients with fibroids of any size, adenomyosis, endometriosis, pelvic inflammatory disease.

Primary outcomes:
measure: Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart.
Secondary outcomes:
measure: Haemoglobin and serum ferritin at the end of study (cycle 3)
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals,OB/GYN department
state: Dakahlia Governorate
Study officials:
affiliation: Mansoura University Hospital
name: Hatem Abu Hashim, MD MRCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University Hospital
name: Waleed El-Sherbini, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University Hospital
name: Mohamed Bazeed, MD
role: STUDY_CHAIR
References:
citation: Matteson KA, Boardman LA, Munro MG, Clark MA. Abnormal uterine bleeding: a review of patient-based outcome measures. Fertil Steril. 2009 Jul;92(1):205-16. doi: 10.1016/j.fertnstert.2008.04.023. Epub 2008 Jul 16.
citation: Oddsson K, Leifels-Fischer B, Wiel-Masson D, de Melo NR, Benedetto C, Verhoeven CH, Dieben TO. Superior cycle control with a contraceptive vaginal ring compared with an oral contraceptive containing 30 microg ethinylestradiol and 150 microg levonorgestrel: a randomized trial. Hum Reprod. 2005 Feb;20(2):557-62. doi: 10.1093/humrep/deh604. Epub 2004 Nov 11.
Clinical trial NCT04056559: Normative Assessment of Adaptable Mouthguards.
Official title: Normative Assessment of Adaptable Mouthguards.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Manifestations
Keywords: Prototype
Adaptable mouthguards
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The aim of this study is to the validate adaptable mouthguards prototypes, patented by Bordeaux University and Bordeaux University Hospital.

Detailed description: The current state of knowledge in the areas of mouthguards shows that type II (adaptable) models account for 90% of the mouthguards of the sporting population. But a majority of these devices do not appear to comply with the European Directive 89/686 / European Economic Community.

A previous work consisted of the production of prototypes of mouthguards meeting the essential requirements of the directive. These prototypes were the subject of a patent filed by the Bordeaux University and the Bordeaux University Hospital.

The aim of this study is to the validate the prototypes for a future launch on the market.

Eligibility criteria: Inclusion Criteria:

* Subject aged 18 to 35,
* Subject affiliated to a social security,
* Subject who has signed the free and informed consent form.

Exclusion Criteria:

* Subject with a pathology incompatible with the performance of the test, namely: Recent infarction,Threat syndrome, blood pressure resting\> 200/120 mmHg, uncompensated cardiac insufficiency, atrioventricular block 3rd degree acquired, Myocarditis, Pericarditis, Endocarditis, Aortic Dissection, Intracardiac Tumor or Thrombus, Deep Vein Thrombosis, Pulmonary Embolism,
* Subject under B-mimetic drug treatment,
* Subject under safeguard of justice,
* Subject participating in another search,
* Subject during pregnancy.

Primary outcomes:
measure: Impact on ventilatory flow rate by minute
timeFrame: At Week 51
measure: Impact on O2 consumption
timeFrame: At Week 51
measure: Impact on respiratory rate
timeFrame: At Week 51
measure: Impact on current volume
timeFrame: At Week 51
measure: Impact on CO2 production
timeFrame: At Week 51
measure: Impact on comfort according an analogical visual scale for 11 criteria
timeFrame: At Week 51
measure: Impact on electromyographic recording
timeFrame: At Week 52
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Philippe POISSON, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03897959: COMPARISON OF KOHLI AND FOLEY CATHETERS IN SUPRAPUBIC CATHETER PATIENTS
Official title: FOLEY VERSUS KOHLI FOR SUPRAPUBIC CATHETER ASSOCIATED PROBLEMS STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Catheter Infection
Complications; Catheter
Keywords: suprapubic, urinary catheter
Lead sponsor: Nellie Medical, LLC
Sponsor class: INDUSTRY
First posted: 2019-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will utilize existing urinary drainage catheter for 30 days and then switch to alternative for 30 days. Patient will repeat this cycle once more.
Primary purpose: PREVENTION

Brief summary: The purpose of this medical research study is to compare two different urinary drainage catheters to see which has fewer problems with blockages and pain. The study involves completing 16 weekly 3-question surveys either online or by phone. The new catheters are FDA-approved and will be provided for FREE. No medications will be given.

Detailed description: The purpose of this study is to see if a redesign of the catheter to remove the extended tip of the conventional urinary catheter will reduce problems with catheter blockage or catheter-associated discomfort. By eliminating the extended tip, the bladder wall will no longer be subject to the tip rubbing on the bladder wall. This could lead to fewer problems with blockages and less irritation and trauma to the bladder lining. A reduction in trauma to the bladder wall could reduce pain, bladder inflammation/irritation and the risk of urinary tract infections.

Eligibility criteria: Inclusion Criteria:

* Indwelling suprapubic Foley urinary catheter for at least 30 days prior to entry with anticipation for continued indwelling urinary catheterization for at least 30 days after entry into the study.
* Catheter associated discomfort or difficulty with mucous plugging of the catheter.

Exclusion Criteria:

* Inability to provide informed consent
* No catheter associated discomfort or problems with mucous plugging

Primary outcomes:
measure: Suprapubic catheter blockage - failure to drain
timeFrame: 1 year
Secondary outcomes:
measure: Suprapubic catheter pain
timeFrame: 1 year
measure: Suprapubic catheter urinary tract infection (UTI)
timeFrame: 1 year
Other outcomes:
Locations:
city: Wellesley
country: United States
facility: Boston Urogynecology
state: Massachusetts
Study officials:
References:
Clinical trial NCT03675659: Intra-articular Magnesium Sulfate for Tmj Dysfunction
Official title: Effect of Magnesium Sulfate on Pain and Clicking Sound on Patients With Temporomandibular Joint Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Temporomandibular Joint Disorders
Temporomandibular Sprain
Keywords: tmj pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: mixing the magnesium sulfate with dextrose for management of tmj pain will be studied using intra-articular injection of the solution


Eligibility criteria: Inclusion Criteria:

* healthy females-no treatment received within the last 6 months-accept treatment protocol

Exclusion Criteria:

* unco-operative patients-patients with auto-immune diseases-patients diagnosed with arthritis

Primary outcomes:
measure: estimation of pain: Visual Analog Scale
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Atef
Study officials:
References:
Clinical trial NCT01118559: A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150
Official title: Pharmacokinetic Study of YM150 - A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Pharmacokinetics of YM150
Keywords: YM150
Food effect
Healthy volunteer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-05-06
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy male adult subjects.

Detailed description: To evaluate the effect of food on the pharmacokinetics of YM150 in healthy non-elderly adult male subjects using a 2×2 crossover design. Also, to evaluate the safety of YM150.

Eligibility criteria: Inclusion Criteria:

* Body weight: ≥50.0 kg, \<80.0 kg
* BMI: ≥17.6, \<26.4
* Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests

Exclusion Criteria:

* Received any investigational drugs within 120 days before the study
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
* Received medication within 7 days before the study
* A deviation from the assessment criteria of physical examinations or laboratory tests
* A deviation from the normal reference range of coagulation test \[PT or aPTT\]
* History of drug allergies
* Upper gastrointestinal disease within 7 days before the study
* Concurrent or previous hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
* Concurrent or previous malignant tumor
* Previous treatment with YM150

Primary outcomes:
measure: Plasma concentration of YM150 and its metabolites
timeFrame: for 3 days after drug administration
Secondary outcomes:
measure: Safety assessed by AEs, vital signs, 12-lead ECG and lab tests
timeFrame: for 3 days after drug administration
measure: PT (prothrombin time)
timeFrame: for 3 days after drug administration
measure: aPTT (activated partial thromboplastin time)
timeFrame: for 2 days after drug administration
measure: FXa (factor Xa) activity
timeFrame: for 1 days after drug administration
Other outcomes:
Locations:
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: