louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05791162: Interest of Follicular Helper Lymphocytes / Regulatory Follicular Helper Lymphocytes Ratio in IgA Nephropathy
Official title: Interest of Follicular Helper Lymphocytes / Regulatory Follicular Helper Lymphocytes Ratio to Characterize and Predict Poor Prognosis Forms in IgA Nephropathy: an Exploratory Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glomerulonephritis, IGA
Keywords: Follicular helper T cells
Follicular regulatory T cells
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate the relevance of the Tfh/Tfr (Follicular helper T cells/ Follicular regulatory T cells) ratio in patients with IgA nephropathy:

* To identify a differential expression of the Tfh/Tfr ratio in patients considered stable or progressive
* To predict, at diagnosis, the clinical evolution of the disease (progressive or stable form) in the first year.


Eligibility criteria: Inclusion Criteria:

* IgA nephropathy histologically proven on renal biopsy according to KDIGO criteria, with 8 permeable glomeruli (patients diagnosed from 2009 with a minimum follow-up for their nephropathy of 5 years (arm 1) or patients diagnosed during the study (arm 2))

Control patients: Lupus or ANCA-associated vasculitis or polycystic kidney disease (arm 3)

Exclusion Criteria:

* Legal incapacity or limited legal capacity
* Subjects with no social security coverage.
* Pregnancy / No effective contraceptive method

Primary outcomes:
measure: Form of IgA nephropathy exhibited by the patient (progressive or stable)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
Study officials:
affiliation: Nephrology, CHU Besançon
name: Melchior Chabannes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01623362: Evaluation of a Low Fluoride Dentifrice for Caries Control
Official title: Low-fluoride Acidic Liquid Dentifrice in Non-fluoridated Communities: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Caries
Keywords: Dentifrices
Dental Caries
Fluorides
Nails
pH
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 212
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this randomized clinical trial is to evaluate the effect of pH and fluoride concentration in liquid dentifrices in the control of dental caries in early childhood, in non-fluoridated area. This study also aims to assess the effect of the consistency of liquid dentifrices in the fluoride uptake in the plaque and the fluoride concentration in the toenails, to estimate the fluoride intake from these formulations.

Detailed description: The study was carried out with schoolchildren living in a non-fluoridated area, with (A) or without (I) active caries lesions, were randomly allocated into 3 groups according to the LD used over 12 months: Group 1 (n=39-A/38-I): 550µgF/g-pH4.5, Group 2 (n=33-A/35-I) 1100µgF/g-pH7.0, Group 3 (n=33-A/34-I): 550µgF/g-pH7.0.

Eligibility criteria: Inclusion Criteria:

* Age 2 to 4 years;
* Not having participated in any other clinical study within 3 months prior to selection;
* Not having very large carious lesions or dentin sensitivity during the study;
* Signature of informed consent by the parents.

Exclusion Criteria:

* Using orthodontic appliances

Primary outcomes:
measure: Evaluation of the concentration of fluoride incorporated into the biofilm and nails 6 months after initiation of dentifrices use in non-fluoridated communities
timeFrame: 6 months
Secondary outcomes:
measure: New caries diagnostic criteria: caries progression/regression in caries-active children and caries progression in caries-inactive children after 12 months according to the type of dentifrice used in non-fluoridated communities
timeFrame: 12 months
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Paraíba Federal University
state: Paraíba
Study officials:
affiliation: Paraíba Federal University
name: Fábio Sampaio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01957462: Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy
Official title: Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Colostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the current investigation is to develop new soft and more flexible 1-piece convex ostomy products.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent and signed letter of authority.
2. Are at least 18 years of age and have full legal capacity.
3. Have had their ostomy (ileo- or colostomy) for at least 3 months.
4. Have used a 1-piece convex ostomy product during the last month.
5. Are willing and able to comply with investigation procedures.
6. Have a ostomy with a diameter of 33 mm or less.

Exclusion Criteria:

1. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
2. Currently receiving or have within the past 2 month received radio- and/or chemotherapy.
3. Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment.
4. Are pregnant or breastfeeding.
5. Have a loop ostomy (also called double-barrel or ostomy with two outlets).
6. Known hypersensitivity toward any of the test products.
7. Use irrigation during the investigation (flush the stoma with water).
8. Participating in other interventional clinical investigations or have previously participated in this investigation.

Primary outcomes:
measure: Degree of Leakage
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Coloplast A/S
name: Birte P Jakobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00543491: MK0767 and Sulfonylurea Combination Study (0767-027)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 129
Sex: ALL
Minimum age (years): 21
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess MK0767's ability vs. placebo to control blood glucose in patients with type 2 diabetes and to gauge whether fasting blood glucose is lowered, blood fats are improved, and insulin levels are impacted.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes with inadequate glycemic control
* On Sulfonylurea monotherapy
* Male or non-pregnant Females
* Age 21 to 78 years, inclusive
* On a stable dose of sulfonylurea for at least 2 weeks prior to Visit 2/Week-6

Exclusion Criteria:

* History of Type 1 diabetes
* Patient is currently on insulin (monotherapy or in combination with oral agent), Rosiglitazone or pioglitazone or other PPAR-y agonists, Metformin agents
* Patients with history of or intolerance of PPAR-y agonists

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01576991: Telomeres and Reproduction in Women
Official title: Telomeres and Reproduction in Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: InVitro Fertilization
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2012-04-13
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: InVItro Fertilization patients undergoing therapy

Brief summary: The purpose of the study is to describe the relationship between leukocyte, granulose cell and polar body telomere length, telomere injury foci (TIFs), polarized light microscopy of oocyte spindles and their frequency in the eggs from older women and associations with aneuploidy.

Detailed description: The chances of conception decrease and miscarriage increase with a women's age, and the locus of reproductive aging is the egg (1). Egg dysfunction affects most women beginning by their late '30's and for many women age related egg dysfunction represents a major cause of infertility. The cause of age related egg dysfunction is poorly understood, but telomere dysfunction may play an important role. Our group has demonstrated that genetic or pharmacologic shortening of telomeres in the eggs of mice, which normally do not exhibit age related egg dysfunction, mimics reproductive aging in women, with cell cycle arrest, apoptosis, spindle dysmorphologies and chromosomal abnormalities (1,2). Moreover, a pilot study the investigators conducted five years ago suggested that telomere length of spare human eggs may predict the outcome of womens' InVitro Fertilization (IVF) cycles (3). Subsequently, other investigators have demonstrated that telomere length of circulating leukocytes predicts miscarriages (4).

Eligibility criteria: Inclusion Criteria:

* Ages 18 to 48
* Undergoing InVitro Fertilization
* Willing to donate spare eggs, granulosa cells and blood
* Willing to give written informed consent

Exclusion Criteria:

* Not undergoing InVitro Fertilization
* Not willing to donate spare eggs, granulosa cells or blood
* Not willing to give written informed consent
* Previously donated spare eggs, granulosa cells or blood for this research project

Primary outcomes:
measure: Telomere length
timeFrame: 1 year
Secondary outcomes:
measure: Frequency of telomeres
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University of South Florida
name: Celso Silva, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03820791: Poster on Dysphagia-specific Food Procedures: Usability and Impact
Official title: Using a Visual Poster Communicating Dysphagia-specific Food Procedures as a Complementary Means of Information to Caregivers in Inpatient Care: Usability and Impact
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysphagia
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 60
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 aim of this study is to evaluate the use of a poster containing information on dysphagia-specific food procedures at two levels: utility from the point of view of patients' caregivers, and impact on patients' health. Half the patients will have the poster placed in their room, whereas the other half will not.

Detailed description: Dysphagia is a swallowing disorder that can be associated with clinically relevant complications, and caregivers can play a fundamental role in this process, namely because they feed the patient. However, studies show a lack of professional-caregiver communication in dysphagia, and caregivers' need for more information. Communicating dysphagia-specific food procedures through a visual poster might bridge professional-caregiver communication gaps, with consequences for the patient's health.

Eligibility criteria: Inclusion Criteria:

* Patients with post-acute dysphagia (lesion occurring at least six weeks prior, approximately),
* remaining in inpatient care for at least one month after the first moment of data collection,
* 18 years of age or older,
* receiving regular visits from their family members or caregivers.

Exclusion Criteria:

* Failing to meet inclusion criteria

Primary outcomes:
measure: Change in patients' aspiration risk before and after placement of the poster in their rooms
timeFrame: 1 month
measure: Change in patients' capacity for oral intake before and after placement of the poster in their rooms
timeFrame: 1 month
measure: Change in patients' oral health before and after placement of the poster in their rooms
timeFrame: 1 month
measure: Change in patients' nutritional health before and after placement of the poster in their rooms
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: CINTESIS - Faculty of Medicine of the University of Porto
Study officials:
affiliation: Universidade do Porto
name: Irene P Carvalho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00556491: Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery
Official title: Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Acute
Acute Kidney Insufficiency
Keywords: renal
kidney
injury
acute
bypass
cardiac
minocycline
prevention
Acute Kidney Failure
Lead sponsor: St. Louis University
Sponsor class: OTHER
Collaborators: name: Satellite Healthcare
name: Triax Pharmaceuticals
First posted: 2007-11-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study proposes to investigate whether treatment with minocycline pre-operatively in patients with mild to moderate chronic kidney disease undergoing cardiac surgery will reduce the occurence of kidney injury.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* planned CABG or valvular surgery with cardiopulmonary bypass
* Serum creatinine available (within 30 days)
* Estimated GFR 15-90ml/min using the abbreviated MDRD formula (CKD stages 2-4)

Exclusion Criteria:

* Emergent or urgent surgery (to be performed within the next 36 hours)
* End stage renal disease, or GFR \< 15ml/min (CKD stage 5)
* Estimated GFR\>90ml/min (CKD stage 1 or no CKD)
* Ongoing infection by positive blood, urine or sputum cultures or pneumonia on CXR
* Allergy to minocycline or tetracyclines
* inability to take oral medications
* use of preoperative vasopressor agents at therapeutic doses
* Pregnant or lactating females
* Advanced liver disease by history or exam(cirrhosis, ascitis, jaundice)
* Rising creatinine meeting the definition of acute kidney injury prior to surgery
* Neurologic signs or symptoms or history of increased intracranial pressure
* current participation in another research study involving an investigational drug or device

Primary outcomes:
measure: Development of Post-operative Acute Kidney Injury
timeFrame: up to 5 days post cardiac surgery
Secondary outcomes:
measure: Post Operative Hospital Days
timeFrame: 30 days post-operative
measure: On Vent >48 Hours
timeFrame: 30 days post op
measure: Infections Post Operative
timeFrame: 30 days post operative
measure: Stroke Post Operative
timeFrame: 30 days post op
measure: Re-operation
timeFrame: 30 days post-operative
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: St. Louis University
name: Tarek M El-Achkar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Golestaneh L, Lindsey K, Malhotra P, Kargoli F, Farkas E, Barner H, Qazi R, Schmidt A, Rauchman M, Al-Aly Z, Johnson R, Martin K, Dagher P, Friedman A, El-Achkar TM. Acute kidney injury after cardiac surgery: is minocycline protective? J Nephrol. 2015 Apr;28(2):193-9. doi: 10.1007/s40620-014-0152-2. Epub 2014 Oct 28.
Clinical trial NCT06667791: Computer Guided Visco Supplementation in the Management of Internal Derangement of Temporomandibular Joint
Official title: Evaluation of Computer-guided Visco Supplementation in the Management of Internal Derangement of Temporomandibular Joint (a Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: The intra-articular injection is considered the first line of minimally invasive treatment in TMJ-ID patients who do not respond to conservative treatment. Image-guided puncture technique has emerged to add safety, reliability, convenience, and decrease the need for correcting the puncture point.

Aim of the study: To evaluate the feasibility and clinical outcomes of computer-guided superior joint space injection of sodium hyaluronate in the treatment of temporomandibular joint disorder (TMJ-ID) compared with conventional injection


Eligibility criteria: Inclusion Criteria:

* 1. Patients diagnosed with internal derangement according to Wilkins stage I and II.
* Patients who would not respond to conservative treatment as a first line of treatment.

Exclusion Criteria:

* Patients with Wilkins stage III, IV, V.
* History of mandibular fracture.
* Lactating, pregnant or planning pregnancy women.
* Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.

Primary outcomes:
measure: Change in TMJ dysfunction
timeFrame: Baseline, 1 month, and 3 months
measure: change in pain score
timeFrame: Baseline,1 months, and 3 months
Secondary outcomes:
measure: Duration of operation
timeFrame: Baseline
measure: Number of Needle Relocation
timeFrame: Baseline
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient clinic of Oral and Maxillofacial Surgery
Study officials:
References:
Clinical trial NCT02082691: Continued Administration of G-202 for One Patient With Advanced Hepatocellular Carcinoma
Official title: Single Patient IND: Continued Administration of G-202 to a Patient With Advanced Hepatocellular Carcinoma Previously Treated With G-202 and Receiving Clinical Benefit
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Hepatocellular Carcinoma
Keywords: G-202
Hepatocellular
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: GenSpera, Inc.
First posted: 2014-03-10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Patient with advanced liver cancer (cancer that has spread to other parts of the body) continues to receive the study drug (G-202) even though patient no longer meets the criteria to be a part of the main treatment study. Patient's cancer responded well to receiving G-202 in the main study and will receive G-202 at the same dose given in the main study.


Eligibility criteria: Inclusion Criteria:

* History of hepatocellular carcinoma
* Participation in prior research study where G-202 was administered
* Tolerance of G-202 treatment
* Demonstration of stable disease

Exclusion Criteria:

* Disease progression
* Occurrence of unacceptable toxicity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Devalingam Mahalingam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02129491: National Egyptian Network Pediatric Stroke and Hemiplegia Registry
Official title: National Egyptian Network Pediatric Stroke and Hemiplegia Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke With Hemiparesis
Perinatal Stroke
Focal Neurologic Deficits
Keywords: stroke
Congenital stroke
neonatal
hemiplegia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-05-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children from birth to 18 years of age with acute stroke presented by focal neurological signs confirmed by neuroradiology CT or MRI. All children with hemiplegia till the age of 18 years.

Brief summary: Our aim is to establish multi-center national Egyptian database of information about cerebrovascular stroke and hemiplegia in infants and children from 0 to 18 years of age.

Detailed description: Aims: An open-ended multi-center, national Egyptian study to collect and analyze data for children with cerebrovascular stroke and hemiplegia .

Participants: Eligible infants and children with stroke and hemiplegia.

DESIGN: This study is a prospective cohort study.

Primary outcome measure: Initial acute stroke clinical and radiological presentation, recurrent stroke, mortality, and neurologic deficits in the acute stage, participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Eligibility criteria: Inclusion Criteria:

* Focal neurological deficit of acute onset lasting greater than 20 minutes. And CT or MRI showing infarct in location consistent with neurological signs and symptoms
* Hemiplegia

Exclusion Criteria:

1. Cerebral haemorrhage not associated with ischemic infarct.
2. Hypoxic ischemic event with diffuse or bilateral infarction alone.

Primary outcomes:
measure: Survival or neurologic deficit after acute cerebrovascular stroke.
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Secondary outcomes:
measure: Long term neurological deficit
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
state: Abassia
Study officials:
affiliation: Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
name: Sahar MA Hassanein, MD, PhD
role: STUDY_CHAIR
References: