louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06057454: R-5280 in Newly Diagnosed Patients With Type 1 Diabetes
Official title: Evaluating the Safety and Tolerability of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Type 1 Diabetes
Type 1 Diabetes (Juvenile Onset)
Diabetes Mellitus, Type 1
Keywords: Type 1 Diabetes
Lead sponsor: Rise Therapeutics LLC
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 39
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double Blinided, placebo controlled, Phase 1B study.
Primary purpose: TREATMENT

Brief summary: Evaluating the adverse events and tolerance of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients

Detailed description: Double blinded, placebo controlled, Phase 1B study assessing the safety and efficacy of 12 weeks daily administrations of R-5280 in newly diagnosed Type 1 Diabetes adolescents

Eligibility criteria: Inclusion Criteria:

* Newly Diagnosed children (age 11-17 years old)
* BMI \<85%
* Diagnosed by ADA criteria with T1D within 2 years
* Accepted to adhere to a healthy diabetic diet as recommended by the ADA

Exclusion Criteria:

* Monogenic forms of diabetes or type 2 diabetes
* History of ongoing infection or antibiotic treatment within the past four (4) weeks
* History of immunocompromised, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past six (6) months
* History of chronic gastrointestinal disease, possible or confirmed celiac disease
* Pregnancy or possible pregnancy
* Allergy to corn (prebiotic), milk allergy, soy (present in the MMTT meal) or their products
* Participation in other intervention research trials within the past three (3) months
* Anticipated major change in diabetes management during the study (e.g., change from injections to insulin pump therapy or new continuous monitor usage, all known to significantly alter glycemia)
* Children consuming a high-fiber or vegetarian diet (consuming three (3) or more servings of high fiber foods on four (4) or more days per week) or any fiber supplements will be excluded (to be assessed at screening)
* Any COVID vaccines within 30 days prior to Day 1

Primary outcomes:
measure: Measurement of adverse events from the date of the first dose through 12 weeks of R-5280 tolerance
timeFrame: 12 Weeks
Secondary outcomes:
measure: Measurement of clinical activity and to determine the gut microbiome profile in youth with recently diagnosed Type 1 Diabetes
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Plantation
country: United States
facility: Edward Jenner Research Group LLC
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Dallas
country: United States
facility: UTSW Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT04786054: Genetic Association of Glucocorticoid Receptor Gene Polymorphisms With Binge Eating
Official title: Genetic Association of Glucocorticoid Receptor Gene Polymorphisms With Binge Eating Disorders in Type 2 Diabetic Obese Female Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge-Eating Disorder
Eating Disorders
Obesity
Diabetes Type 2
Adolescent Behavior
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 91
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of the present study was to specifically screen obese diabetic adolescent female individuals for BED, checking the variants of the GR gene (rs56149945; rs41423247) amongst identified individuals, and this led to assessing the impact of binge eating disorders on glycaemic control in obese diabetic adolescent females in Pakistan, South Asia.

Detailed description: Challenges in eating for diabetic adolescents can be categorized as eating disorders (ED) and disordered eating symptoms (DES). Binge-eating disorder (BED) is defined as recurrent episodes of binge eating at least once a week over a three-month time period and it is accompanied by feeling the lack of control and marked distress over one's eating behaviour. The aim of the present study was to specifically screen obese diabetic adolescent female individuals for BED, checking the variants of the GR gene (rs56149945; rs41423247) amongst identified individuals, and this led to assessing the impact of binge eating disorders on glycaemic control in obese diabetic adolescent females in Pakistan, South Asia.

Eligibility criteria: Inclusion Criteria:

* Unmarried females diagnosed with Type 2 diabetes \> 12 months
* Age 10-19 years
* Obesity class I and II (based on BMI range of 30 - 40).

Exclusion Criteria:

* Presence of psychosis, major psychiatric or neurocognitive disorder
* Substance use
* Untreated attention-deficit hyperactivity disorder
* Use of psychopharmacological medications or psychotherapy
* Class III obesity

Primary outcomes:
measure: BED
timeFrame: Baseline
Secondary outcomes:
measure: NR3C1 Presence of variants of the GR gene (rs56149945; rs41423247)
timeFrame: Six months into the study after identifying all individuals who scored high on the BEDS7 Questionnaire
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Zainab Khan
state: Punjab
Study officials:
References:
Clinical trial NCT00743054: microRNA Expression in Renal Cell Carcinoma
Official title: microRNA Expression in Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Keywords: Carcinoma, Renal Cell
MicroRNAs
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2008-08-28
Enrollment: 50
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: Inpatients in the department of Urology of 1st Affiliated Hospital, Sun Yat-Sen University

Brief summary: In this study, renal cell carcinoma (RCC) related miRNA and the target genes of related miRNA will be examined in order to investigate the role of miRNA in the formation of RCC and look for the biomarker of RCC.

Detailed description: Due to the lack of specific indicators for the early diagnosis of RCC, the RCC patients often have distant metastasis when diagnosed and their five-year survival rate is much low. Therefore, the biological markers of RCC are needed for early detection, early treatment and improvement of the survival rate of RCC patients.

MiRNA and tumor are closely related. MiRNA can control the important cancer-related genes and participate in the tumor cell proliferation, apoptosis, invasion and angiogenesis.

In this study, RCC related miRNA and the target genes of related miRNA will be examined,and the relationship between RCC related miRNA and the RCC pathological types, TNM (tumor-nodes-metastasis) stages and prognosis will be analyzed. The purpose of this study is to investigate the role of miRNA in the formation of RCC and look for the biomarker of RCC.

Eligibility criteria: Inclusion Criteria:

* Patients with primary renal cell carcinoma.
* Subjects who agree to participate in the study and sign the informed consent.

Exclusion Criteria:

* Patients with secondary renal cell carcinoma.
* Subjects who refuse to participate in the study and sign the informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: The 1st Affiliated Hospital, Sun Yet-sen University
state: Guangdong
Study officials:
affiliation: 1st Affiliated Hospital, Sun Yat-Sen University
name: Xueqing Yu, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02772354: Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes in Pediatric Population
Official title: Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes as a First-line Therapy in Pediatric Population Without Structural Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Ventricular Arrhythmia
Keywords: Pediatric population, ablation
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2016-05-13
Enrollment: 124
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness and safety of catheter ablation of frequent symptomatic PVCs in the pediatric population as first-line therapy compared with antiarrhythmic drugs.


Eligibility criteria: Inclusion Criteria:

* Symptomatic, frequent, premature ventricular complexes (more than 10,000 according to the 24 hour Holter ECG)

Exclusion Criteria:

* Antiarrhythmic therapy before inclusion Structural heart pathology requiring surgical correction; Premature ventricular complexes associated with structural heart disease; Previously performed radiofrequency ablation due to premature ventricular complexes.

Primary outcomes:
measure: The presence of premature ventricular complexes ≥ 300 according to the 24-hour Holter ECG monitoring
timeFrame: 12 months
Secondary outcomes:
measure: Complications
timeFrame: 12 months
measure: Left ventricle diameter
timeFrame: 12 months
measure: Right ventricle diameter
timeFrame: 12 months
measure: Premature ventricular complexes burden according to the 24- hour Holter ECG
timeFrame: 12 months
measure: Ventricular tachycardia according to the 24- hour Holter ECG
timeFrame: 12 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Research Clinical Institute of Pediatrics, N.I. Pirogov Russian National Research Medical University
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Study officials:
References:
Clinical trial NCT07022054: iCare IC1000 Alignment Study
Official title: iCare IC1000 Alignment Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraocular Pressure
Lead sponsor: Icare Finland Oy
Sponsor class: INDUSTRY
First posted: 2025-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective of this study is to evaluate the performance of the alignment feature of iCare IC1000 tonometer.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years

Exclusion Criteria:

1. Subjects with only one functional eye
2. Central corneal scarring
3. Microphthalmos
4. Buphthalmos
5. Contact lens use during measurement or hard lenses 24h prior to measurement
6. Dry eyes (clinically significant)
7. Nystagmus
8. Keratoconus
9. Any other corneal or conjunctival pathology or infection relevant to this study
10. Coloboma or other pupil deformation

Primary outcomes:
measure: Primary Objective
timeFrame: Through study completion, an average of 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Worth
country: United States
facility: Clear Vue Laser Eye Center
state: Florida
Study officials:
References:
Clinical trial NCT00203554: Percutaneous Vertebroplasty Versus Conservative Treatment of Pain
Official title: Percutaneous Vertebroplasty Versus Conservative Treatment of Pain: A Prospective, Randomized Controlled Study of Osteoporotic Fractures in the Spine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Osteoporosis
Fracture
Keywords: osteoporosis
vertebra
fracture
pain
percutaneous
vertebroplasty
polymethylmetacrylate
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of vertebroplasty with that of traditional medical treatment in the treatment of painful vertebral fractures in osteoporotic patients.

Detailed description: In vertebroplasty a bone cement is injected in one or more fractured vertebra. The indication is pain that needs high doses of analgesics.

The cement is a well known product called poly methyl metacrylate (PMMA) normally used fixate joint prosthesis.

Vertebroplasty is done in local anaesthesia. The treatment was introduced in 1984 in France and today thousands of patients have been treated worldwide, but so far no randomized controlled trials have been published.

Eligibility criteria: Inclusion Criteria:

* new pain in spine (within 6 months)
* x-ray verified low energy spinal fracture(s)

Exclusion Criteria:

* less than 20% or more than 90% reduction of the vertebral height
* lack of pain at fracture level
* no need for continuous analgesic treatment
* patient no able to communicate
* general anaesthesia contraindicated
* MRI not possible
* coagulopathy (not adjustable)
* spondylitis
* discitis
* spinal metastasis

Primary outcomes:
measure: Level of pain
timeFrame: before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.
Secondary outcomes:
measure: Needs for analgetics, number of days at hospital, level of ADL
timeFrame: before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dep of Neuroradiology, Aarhus University Hospital
Study officials:
name: Leif Sorensen, Consultant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01867554: Research and Characterization of New Genes Involved in Intellectual Disability
Official title: Recherche et caractérisation de Nouveaux gènes impliqués Dans la déficience Intellectuelle.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intellectual Disability
Keywords: Intellectual disability
Autism spectrum disorders
gene
Next generation sequencing
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2013-06-04
Enrollment: 8500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 2500 patients with intellectuel disability
* 5000 parents or unaffected sibs
* 1000 affected sibs

Brief summary: Intellectual disability (ID) occurs in 2 to 3 % of the general population but the cause is identified only in 30 to 60% of cases.

The purpose of this study is to indentify genes involved in ID with new genetics tools (SNP-arrays, next generation sequencing...) and establish genotype-phenotype correlations.


Eligibility criteria: Inclusion Criteria:

* for the patients: Clinical diagnosis of intellectual disbility
* for the unaffected sibs: to be aged at least 3 years
* informed consent

Exclusion Criteria:

* absence of informed consent

Primary outcomes:
measure: Number of participants with genetic cause identified
timeFrame: 5 years
Secondary outcomes:
measure: genotype-phenotype correlations
timeFrame: genotype-phenotype correlations (according to the genes identified in a period of 5 years)
Other outcomes:
Locations:
city: Paris
country: France
facility: CRICM - UPMC/Inserm UMR_S975/CNRS UMR7225, Groupe Hospitalier de la Pitié-Salpêtrière,
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Alexis Brice, MD
role: STUDY_DIRECTOR
References:
citation: Nava C, Lamari F, Heron D, Mignot C, Rastetter A, Keren B, Cohen D, Faudet A, Bouteiller D, Gilleron M, Jacquette A, Whalen S, Afenjar A, Perisse D, Laurent C, Dupuits C, Gautier C, Gerard M, Huguet G, Caillet S, Leheup B, Leboyer M, Gillberg C, Delorme R, Bourgeron T, Brice A, Depienne C. Analysis of the chromosome X exome in patients with autism spectrum disorders identified novel candidate genes, including TMLHE. Transl Psychiatry. 2012 Oct 23;2(10):e179. doi: 10.1038/tp.2012.102.
Clinical trial NCT00996554: Randomized Study Comparing Two Established Gastrointestinal Suture Techniques - One-layer-continuous Versus Double-layer-continuous Suture
Official title: Randomized Trial to Compare Two Gastrointestinal Anastomosis Techniques - Single Layer Continuous Versus Double Layer Continuous
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Colo-colonic Anastomoses
Ileo-colonic Anastomoses
Keywords: Hand-sutured colo-colonic and ileo-colonic anastomoses in elective surgery
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2009-10-16
Enrollment: 252
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: The purpose of this study is to examine the frequency of postoperative complications depending on the number of suture layers in colo-colonic and ileo-colonic anastomoses Hypothesis: double-layer suture has less anastomotic leakages compared to single-layer suture.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old,
* planned for elective surgery
* at least one hand-sutured ileo-colonic or colo-colonic anastomosis

Exclusion Criteria:

* ASA-Score \> 3,
* missing written consent of the informed patient
* no existing choice between suture-techniques according to the surgeon
* patient not able to cooperate/non-compliance
* rectal anastomoses

Primary outcomes:
measure: Frequency of clinical anastomostic leaks
timeFrame: 3 months
Secondary outcomes:
measure: death of any cause within 3 months post-operatively
timeFrame: 3 months
measure: postoperative morbidity
timeFrame: 30 days
measure: Duration of anastomosis (min)
timeFrame: 1-3 hours
measure: Frequency of anastomotic strictures
timeFrame: 3 months
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Medical Center Mannheim, Surgical Department
Study officials:
affiliation: University Medical Center Mannheim, Germany, Surgical Department
name: Stefan Post, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herrle F, Diener MK, Freudenberg S, Willeke F, Kienle P, Boenninghoff R, Weiss C, Partecke LI, Schuld J, Post S. Single-Layer Continuous Versus Double-Layer Continuous Suture in Colonic Anastomoses-a Randomized Multicentre Trial (ANATECH Trial). J Gastrointest Surg. 2016 Feb;20(2):421-30. doi: 10.1007/s11605-015-3003-0. Epub 2015 Nov 2.
Clinical trial NCT03450954: Long Term Results of Amniotic Membrane Transplant in Bullous Keratopathy Patients
Official title: Amniotic Membrane Transplant in Symptomatic Bullous Keratopathy Patients: Confocal Microscopy & AS-OCT Long Term Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bullous Keratopathy
Lead sponsor: Prince of Wales Hospital, Shatin, Hong Kong
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases who have undergone amniotic membrane transplant in our unit up till 2016 and controls who had bullous keratopathy awaiting endothelial keratoplasty

Brief summary: A retrospective study including 22 patients who have undergone amniotic membrane transplant in our unit up till 2016. Confocal microscopy and anterior segment optical coherence tomography (ASOCT) were performed to assess the retention of amniotic membrane and to detect any corneal structural changes. Comparison was made with 5 controls who had bullous keratopathy awaiting endothelial keratoplasty.

Detailed description: This retrospective cohort study (CREC Ref No.: CRE-2013.687) was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee. All patients who had AMT done due to symptomatic bullous keratopathy at the Prince of Wales Hospital and Alice Ho Miu Ling Nethersole Hospital (from 1998 onwards till June 2016) were invited back for confocal microscopy and anterior segment optical coherence tomography (ASOCT) at the clinic by the principal investigator (GS) from October to November 2016.

Eligibility criteria: Inclusion Criteria:

* All patients who have undergone amniotic membrane transplant in our cluster up till 2016.
* Patients who have bullous keratopathy on conservative treatment such as lubricants, bandage contact lens

Exclusion Criteria:

* patients who refuse to participate in the study, have passed away or cannot return for the clinical assessment will be excluded.

Primary outcomes:
measure: Amniotic membrane retention
timeFrame: from date of operation till 2016
Secondary outcomes:
measure: Pain
timeFrame: from date of operation till 2016
Other outcomes:
Locations:
Study officials:
affiliation: The Prince of Wales Hospital
name: Gillian DJ Siu, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00139854: A Multicenter, Open-Label, Randomized Crossover Trial to Assess Subject Preference for Alprazolam Orally Disintegrating Tablets Compared to Conventional Alprazolam Tablets in Subjects With Anxiety
Official title: A Multicenter, Open-Label, Randomized Crossover Trial to Assess Subject Preference for Alprazolam Orally Disintegrating Tablets Compared to Conventional Alprazolam Tablets in Subjects With Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ANXIETY
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This was a multicenter, open-label, randomized crossover trial comparing two treatments, Alprazolam ODT versus conventional alprazolam tablets, in subjects who were already taking conventional immediate-release alprazolam tablets for anxiety. The trial included five study visits (four periods of 7 3 -day duration): Screening (Visit 1), Treatment Period 1 (Visit 2), Treatment Period 2 (Visit 3), Final Visit (Visit 4), and Follow-up (Visit 5 \[telephone visit\]). At Visit 1, following screening, eligible subjects continued to take their own conventional alprazolam as prescribed by their physician. At Visit 2, eligible subjects were randomized in approximately equal numbers to one of two treatment sequences: Alprazolam ODT/ conventional alprazolam or conventional alprazolam/ Alprazolam ODT. Subjects continued taking alprazolam in accordance with the treatment sequence to which they were assigned, at the same dose regimen as their own prescribed alprazolam. At Visit 3, subjects crossed over to the alternate treatment until Visit 4. At Visit 4, subjects completed the Subject Preference Questionnaire, and a physical examination and clinical laboratory tests were performed. At the end of Visit 4, subjects resumed taking their own conventional alprazolam. The site made a follow-up telephone call 7 - 3 days after Visit 4 to assess the subject's health status.

Detailed description: See approved Package Insert for Adverse Event information.

Eligibility criteria: Inclusion Criteria:

* Currently being treated with conventional alprazolam

Exclusion Criteria:

* Dose of greater than 10 mg

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Schwarz
state: Wisconsin
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: