louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06794970: Tissue Study on the Chronic Active Humoral Rejection (cAMR) Population of Kidney Transplantation
Official title: Tissue Study on the Chronic Active Humoral Rejection (cAMR) Population of Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplant
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Based on the number of patients attending the Kidney Transplant Follow-up Outpatient Clinic of the Unit of Nephrology, Dialysis and Transplantation Prof. La Manna of the Policlinico di S. Orsola, about 50 patients will be enrolled, of whom about 25 have already been diagnosed and are undergoing treatment and about 25 new diagnoses are expected during the enrolment period in the prospective-only component.

Brief summary: The study is tissue-based, retrospective and prospective, single-centre, non-sponsored.

Primary objective: To examine patient and organ survival and eGFR variation in kidney transplant patients diagnosed histologically with cAMR.

Detailed description: At the kidney transplant follow-up clinic of the UO Nephrology, Dialysis and Transplantation Unit of the IRCCS AOUBO Policlinico di Sant'Orsola, directed by Prof. G. La Manna, all patients with a diagnosis of cAMR made since 01/01/2018 and patients with a new diagnosis of cAMR made after the approval of this protocol by the Ethics Committee will be enrolled.

The study will last 5 years and 6 months.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Kidney transplant recipients
* eGFR\>15 ml/min/1.73 sq m at the time of diagnosis of cAMR
* cAMR diagnosis defined on the basis of the 2018 Banff Classification (17), made after 1/1/2018.
* Obtaining Informed Consent to Participation.

Exclusion Criteria:

* Combined transplant patients (heart-kidney, liver-kidney or kidney-pancreas)
* Histological evidence of concomitant disease (e.g. recurrence of original nephropathy or diagnosis of 'de novo' nephropathy, acute cellular rejection, polyomavirus BK nephropathy, other)

Primary outcomes:
measure: Kidney survival post tranplant
timeFrame: 1 year, 2 years
measure: Change in eGFR
timeFrame: 1 year, 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Sant'Orsola University Hospital - Nephrology, Dialysis and Transplant Unit
state: BO
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Gaetano La Manna, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05185570: Prognosis of Elderly Patients With Acute Poisoning.
Official title: Evaluation of the Risk Factors Influencing the Prognosis of Elderly Patients With Acute Poisoning.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Poisoning
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: elderly patients with acute poisoning.

Brief summary: Acute poisoning is a major public health problem all over the world, it causes significant mortality and morbidity. It primarily involves younger populations, with less than 3% of the affected cases being in people aged 60 years or older in most studies. More than half of the intoxication events in the elderly over 65 years old were accidental.

Detailed description: The elderly are different from younger adults in many aspects. There are age related physiological changes. They have a higher incidence of comorbidities and use of many medications for chronic conditions, both of which make the elderly more susceptible to acute poisoning and its related consequences.

Although the elderly form a relatively small proportion of those admitted to hospital for acute self-poisoning, the poisoning in them is often more serious, complications are more frequent and a fatal outcome is more common.

The presence of multiple physical, social, and psychiatric problems, with possible difficulties in the diagnosis of poisoning make the management of the elderly more complicated than that of younger poisoned patients. There are three main difficulties in diagnosing acute poisoning in the elderly. At first, it may not be easily obvious that the patient has taken an overdose. Secondly, the presence of pre-existing diseases may obscure the clinical picture and finally, the drug may cause physical signs that similar to common problems of old age.

Eligibility criteria: Inclusion Criteria:

all patients more than 60 years will be included.

Exclusion Criteria:

younger than 60 years.

Primary outcomes:
measure: Change in Acute physiology and chronic health evaluation II score (APACHE II) in cases of elderly patients with acute poisoning.
timeFrame: 24 hours after admission to intensive care unit (ICU).
measure: Change in Poisoning Severity Score (PSS) in cases of elderly patients with acute poisoning.
timeFrame: 24 hours after admission to intensive care unit (ICU).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00197470: Cytokine Gene Polymorphisms in Gastric Diseases
Official title: Effects of Pro-Inflammatory and Anti-Inflammatory Cytokine Gene Polymorphism on the Development of Gastric Cancer and Peptic Ulcer in Japanese
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Ulcer
Duodenal Ulcer
Gastric Cancer
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
Collaborators: name: Yokoyama Foundation for Clinical Pharmacology
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Recently, cytokine polymorphisms are considered to play an important role in the pathogenesis of peptic ulcer and gastric cancer. We intended to clarify the association between polymorphisms of pro-inflammatory and anti-inflammatory cytokines, and the susceptibility to gastric cancer, gastric ulcer and duodenal ulcer in Japan, and to detect the individuals who have higher risks for gastrointestinal disease development.

Detailed description: H. pylori infection has close associations with the development of peptic ulcer diseases as well as gastric cancer, gastric adenoma, and gastric MALT lymphoma. The association of the host genetics with the susceptibility to various gastroduodenal disorders has been intensively investigated in the pathogenesis of peptic ulcer and gastric cancer by H. pylori infection .

In chronic active gastritis induced by H. pylori infection, activated neutrophils and mononuclear cells produce several pro-inflammatory and anti-inflammatory cytokines. In fact, levels of pro-inflammatory and anti-inflammatory cytokines are elevated in gastric mucosa infected with H. pylori.

Cytokine polymorphisms are associated with various inflammatory and autoimmune diseases. Recently, cytokine polymorphisms are considered to play an important role in the pathogenesis of peptic ulcer and gastric cancer. However, the roles of the IL-10 polymorphisms on the pathogenesis of H. pylori-related gastric cancer and peptic ulcer have not been fully elucidated.It is unclear whether pro-inflammatory and anti-inflammatory cytokines polymorphisms were associated with pathogenesis of peptic ulcer and gastric cancer in Japan. Then, we intended to clarify the association between polymorphisms of IL-10 and the susceptibility to gastric cancer, gastric ulcer and duodenal ulcer in Japan, and to detect the individuals who have higher risks for gastrointestinal disease development.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* patinets without H. pylori

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
Study officials:
affiliation: First department of medicine, Hamamatsu University School of medicine
name: MItsushige Sugimoto
role: STUDY_CHAIR
References:
Clinical trial NCT02974270: Analysis of Body Mass Index in Central Precocious Puberty Patients Treated With Leuprolide Acetate
Official title: Analysis of Body Mass Index in Central Precocious Puberty(CPP) Patients Treated With Leuprolide Acetate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Precocious Puberty, Central
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2016-11-28
Enrollment: 100
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Analysis of body mass index in Central Precocious Puberty patients treated with leuprolide acetate


Eligibility criteria: Inclusion Criteria:

1. Child diagnosed with CPP who has a peak-stimulated Lutenizing Hormone(LH) concentration over 5 IU/liter before initiation of therapy
2. Chronological age(CA) at the appearance of pubertal changes less than 8 years in girls and less than 9 years in boys.
3. Tanner stage ≥2
4. Advanced bone age (Bone Age/Chronological Age \>1.1)
5. Able to have the signed written informed consent provided by the patients' parents or legal guardians prior to any study-related procedures

Exclusion Criteria:

1. Patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion
2. Patient with a cerebral tumor requiring a neurosurgery or cerebral irradiation known chronic disease of underlying medical condition
3. Currently on or planning growth hormone treatment
4. Previous Gonadotropin-Releasing Hormone agonist treatment
5. Any patient who in opinion of the investigator should not participate in the study

Primary outcomes:
measure: Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Cheol Woo Ko
Study officials:
References:
Clinical trial NCT06076070: GENomic PROfilation for Therapeutic Purposes in SARComas and Molecular Tumor Board (MTB): Retrospective/Prospective Study in Referral Centers
Official title: GENomic PROfilation for Therapeutic Purposes in SARComas and Molecular Tumor Board (MTB): Retrospective/Prospective Study in Referral Centers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcoma
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Candiolo Cancer Institute - IRCCS
name: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
name: Istituto Oncologico Veneto IRCCS
name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Istituto Ortopedico Rizzoli
name: Ospedale Pediatrico Bambin Gesù
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Istituti Tumori Giovanni Paolo II
name: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
First posted: 2023-10-10
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multicenter noninterventional, translational study, retrospective/prospective designed in order to assess the aptitude to the use of genomic profiling methods for therapeutic purposes and evaluation by the institutional Molecular Tumor Board (MTB) of sarcoma patients with metastatic/locally advanced disease that is inoperable with no viable therapeutic alternatives or with histotypes known to be resistant to available in-label medical treatments and without already therapeutically validated driver mutations.

Brief summary: Multicenter noninterventional, translational study, retrospective/prospective designed in order to assess the aptitude to the use of genomic profiling methods for therapeutic purposes and evaluation by the institutional Molecular Tumor Board (MTB) of sarcoma patients with metastatic/locally advanced disease that is inoperable with no viable therapeutic alternatives or with histotypes known to be resistant to available in-label medical treatments and without already therapeutically validated driver mutations.


Eligibility criteria: Inclusion Criteria:

* Sarcoma patients of any age (inclusion of centers pediatric)
* Patients with any histotype of soft tissue sarcomas and bone
* Patients at any stage of the treatment pathway for disease that is localized or metastatic/inoperable
* Availability of follow-up data
* Written informed consent (prospective part/patients in follow-up)

Primary outcomes:
measure: Evaluate interest and feasibility in carrying out genomic profilingfor building two databases data collection
timeFrame: Baseline
measure: Extended molecular profile
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References:
Clinical trial NCT06105970: Chinese Community Sample of Hierarchical Model of Psychopathology
Official title: Chinese Community Sample of Hierarchical Model of Psychopathology : Validation and Analysis of Underline Trans-diagnostic Risk Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mental Health Issue
Adverse Childhood Experience
Keywords: Hierarchical Model of Psychopathology
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study aims to recruits partcipants across the whole regions of China, with the aim of collecting representative Chinese community sample.

Brief summary: By validating Hierarchy Model of psychopathology(HiTOP) in Chinese community samples, this study aims for illumating the problem of diagnostic heterogeneity and high comorbidity within existing psychiatric classification systems in Chinese culture. Concurrently, this study also focuses on exploring trans-diagonostic risk and proctective factors underline HiTOP dimensions.

the main questions it aims to answer are:

1. Explore HiTOP model cultural differences between western culture and eastern culture.
2. Understand the impact of different dimension of adverse childhood experience on HiTOP structure.
3. Investigate the relationship between individual unique psychological variables and psychopathological dimensions.

Participants will receive a detailed survey trying to measure their psychopathology symptoms, adverse childhood experience and psychological variables. This study expects to fallow up participants for 4 years to monitor the symptom changes.


Eligibility criteria: Inclusion Criteria:

1. Chinese citizens
2. Years of education \> =9 years.
3. age \>= 18 years old.

Exclusion Criteria:

(1)Subjects who have insufficient self-awareness, and are unable to obtain complete informed consent, such as: schizophrenia, manic episode of bipolar disorder, severe depression.

Primary outcomes:
measure: Chinese version of Hierarchy Model of psychopathology
timeFrame: 1 year
measure: Mapping different dimension of adverse childhood experience on Hierarchy Model of psychopathology structure
timeFrame: 1 year
Secondary outcomes:
measure: Investigate the relationship between individual unique psychological variables and psychopathological dimensions.
timeFrame: 4 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
affiliation: Shanghai Mental Health Center
name: Zhen Wang, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06039670: Percutaneous Transluminal Forceps Biopsy
Official title: Percutaneous Transluminal Forceps Biopsy Combined With Transhepatic Biliary Drainage in the Management of Patients With Obstructive Jaundice: Efficacy, Safety and Accuracy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Stricture
Biopsy Wound
Oncology
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with obstructive jaundice referred for percutaneous transhepatic biliary drainage without histological diagnosis

Brief summary: To evaluate during a 7 months period the efficacy, safety and accuracy of percutaneous transluminal forceps biopsy combined with transhepatic biliary drainage in patients with biliary stricture

Detailed description: Biological parameters of liver function, histopathology of specimens, comparison with others clinical and pathological data (imaging follow up, percutaneous biopsy, surgical biopsy, endoscopic biopsy) were recorded Comparison between pathological findings of surgery or endoscopy or percutaneous biopsy and specimens coming from biliary forceps biopsy follow up of the patient 12 months after biopsy Evaluation of complications, accuracy

Eligibility criteria: Inclusion Criteria:

* Patients with biliary strictures without histology available

Exclusion Criteria:

* Pregnant patients
* Children

Primary outcomes:
measure: Efficacy of PTBD
timeFrame: 7 days
measure: accuracy for percutaneous biliary biopsy (PTFB)
timeFrame: from baseline up to 1 month
measure: incidence of PTFB-related adverse events
timeFrame: up to 1 month after procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Caen UH
name: Audrey Fohlen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00844870: Exploring New Approaches in Reaching Behavior Post Stroke
Official title: Training With or Without Upper Body Restraint During Reaching in Individuals Post Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: rehabilitation, reaching, stroke
Lead sponsor: University of the Sciences in Philadelphia
Sponsor class: OTHER
First posted: 2009-02-16
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After 4 weeks of training the hypothesis that the more natural training program would yield greater functional changes was proven correct.

Detailed description: Analysis indicated that both methods improved reaching without trunk use Reaching performance scale (RPS), but the trunk -stabilized group led to more significant changes. Training under less restrictive conditions associated with Task-Related Training (TRT) (auditory feedback from trunk sensor) as compared to stabilized TRT, led to improved functional and impairment measure scores (WMFT, FM and shoulder flexion). Conclusion: Fading feedback with both training methods, during extended TRT reaching/grasping practice generally led to some improvements. However, as demonstrated by impairment and functional outcome measures, using TRT with an auditory feedback signals is a more effective approach than forcing the stabilization of the trunk during rehabilitation of the upper-limb.

Eligibility criteria: Inclusion Criteria:

* Individuals all scored between 20 and 44 on the Upper-Arm subsection of the Fugl-Meyer Scale (FM- Poole \& Whitney, 1988) and demonstrated some trunk movement during the pretest reaching performance scale measures (RPS, Levin 2006)

Exclusion Criteria:

* Individuals were referred if they had no receptive aphasia, apraxia or other cognitive deficits.

Primary outcomes:
measure: WMFT
timeFrame: 1 year
Secondary outcomes:
measure: FM and shoulder flexion
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University of the Sciences in Philadelphia
name: Gregory T Thielman, Ed.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06356870: Alveolar Cleft Reconstruction Using Bone Marrow Aspirate Concentrate and Allograft vs Iliac Cancellous Bone.
Official title: Alveolar Cleft Reconstruction Using BMAC and Allograft vs Iliac Cancellous Bone: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alveolar Cleft Grafting
Keywords: BMAC
alveolar cleft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment
Primary purpose: TREATMENT

Brief summary: radiographic and clinical assessment of alveolar cleft grafting using Allograft mixed with BMAC compared to the standard protocol of anterior iliac crest cancellous bone grafting

Detailed description: In the study group BMAC is collected after processing of bone marrow aspirated from anterior iliac crest using a stab incision and a specialized trocar with no surgical intervention at donor site. The BMAC will be mixed with allow graft and used for alveolar cleft grafting

In the control group the standard protocol for alveolar cleft grafting will be used which is surgical exposure of the anterior iliac crest and harvesting of cancellous bone particles.

Eligibility criteria: Inclusion Criteria:

* alveolar cleft patients at the mixed dentition phase

Exclusion Criteria:

* patients with previous alveolar grafting intervention

Primary outcomes:
measure: bone density
timeFrame: 6 months
Secondary outcomes:
measure: Bone gain
timeFrame: 6 months
measure: Postoperative donor site morbidity
timeFrame: 1 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References: