louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00167661: Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation
Official title: Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Disorder Related to Renal Transplantation
Keywords: living or deceased donor renal transplant recipient
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Campath-1H induction and the associated lymphocyte depletion will permit long-term rejection-free renal allograft survival in the absence of ongoing corticosteroid administration.


Eligibility criteria: Inclusion Criteria:

* Participants must be a single-organ recipient (kidney only)
* Participants who are receiving their first living donor or deceased donor transplant

Exclusion Criteria:

* Participants who are recipients of HLA-identical living-donor renal transplants
* Participants with a PRA value \> 10% within 30 days prior to the transplant
* Participants who have received a multi-organ transplant
* Participants who are who are positive for hepatitis C, hepatitis B surface antigen or HIV
* Participants who have received an investigational drug within 6 weeks of study entry
* Participants who have a previous history of, or who currently have, malignancies and/or lymphoma
* Participants who have received corticosteroids within three months of transplantation
* Participants who are 3rd transplant recipients
* Female participants who are pregnant or lactating. Fertile female participants who are sexually active must agree to use an acceptable method of birth control during the study

Primary outcomes:
measure: Incidence of Graft Rejection
timeFrame: at 1, 3, 6, 12, and 24 months
measure: Participant Graft Survival
timeFrame: at 6, 12, and 24 months
Secondary outcomes:
measure: Estimated Glomerular Filtration Rate (EGFR)
timeFrame: at 1, 6, 12 and 24 months
measure: Number of Participants With Infection
timeFrame: up to 24 months
measure: Number of Participants With Malignancy
timeFrame: up to 24 months
measure: Growth Post-transplant Reported by Height Z Score
timeFrame: up to 24 months
measure: Number of Participants With Hypertension
timeFrame: up to 24 months
measure: Number of Participants With Hyperlipidemia
timeFrame: up to 24 months
measure: Participant Survival
timeFrame: at 6, 12, and 24 months
measure: Number of Participant With Diabetes Mellitus
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Sharon M Bartosh, MD
role: STUDY_CHAIR
affiliation: University of Wisconsin, Madison
name: Sharon M Bartosh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00760461: Domperidone in Refractory Gastroparesis
Official title: Domperidone in Refractory Gastroparesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gastroparesis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-09-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age 18 and older
* Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
* Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.
* Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

  * Increased prolactin levels
  * Breast changes
  * Extrapyramidal side effects
  * Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)

Exclusion Criteria:

* History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.
* Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc\>450 milliseconds for males, QTc\>470 milliseconds for females)
* Clinically significant electrolyte disorders. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.
* Gastrointestinal hemorrhage or obstruction.
* Presence of a prolactinoma (prolactin-releasing pituitary tumor).
* Pregnant or breast feedings female.
* Known allergy to domperidone

Primary outcomes:
measure: Gastroparesis Cardinal Symptom Index
timeFrame: upon study completion
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Digestive Diseases 40 Temple St, Suite 1A
state: Connecticut
Study officials:
affiliation: Yale University
name: Anish A Sheth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05088161: Prognostic Biomarkers of Pancreatic Cancer Based on Proteomics Techniques
Official title: Prognostic Biomarkers of Pancreatic Cancer Based on Proteomics Techniques
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects in this study were all patients with pathologically diagnosed pancreatic cancer.

Brief summary: In this study, we will use high-throughput proteomics techniques to search for biomarkers of post-operative prognosis of pancreatic cancer in samples of patients who have been diagnosed with pancreatic cancer through bioinformatics analysis.

Detailed description: This study plan from the affiliated hospital of Qingdao university collected 20 cases of patients with pancreatic cancer pathological tissue samples and clinical data, including clinical diagnostic information, laboratory tests, imaging examination results and other information data), through high-throughput proteomic technology in pancreatic cancer pathological finding biomarkers, the bioinformatics analysis to explore the prognosis biomarkers.

Eligibility criteria: Inclusion Criteria:

* Patients of Chinese nationality, age and gender are not limited.
* Pathologically confirmed pancreatic cancer patients.
* Pathological specimens were archived tumor tissue samples after a diagnosis of pancreatic cancer.
* Clinical diagnostic information was complete three months before sampling.

Exclusion Criteria:

* Patients with a second primary tumor.

Primary outcomes:
measure: Differentially expressed proteins in tumor and paracancer tissues
timeFrame: 180 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Phase I Clinical Research Center
state: Shandong
Study officials:
affiliation: the study director of phase I clinical research center
name: Yu Cao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04763161: Immuno-inflammation in the Acute Phase of an Ischaemic Cerebral Accident Managed by Decompressive Hemicraniectomy: a Case-control Study
Official title: Immuno-inflammation in the Acute Phase of an Ischaemic Cerebral Accident Managed by Decompressive Hemicraniectomy: a Case-control Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ischemic Cerebrovascular Accident
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-02-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population concerns patients suffering from malignant sylvian ischaemic cerebral accident and treated with decompressive hemicraniectomy. Eligibility will be assessed as soon as the first results of the MRI or brain scan carried out as part of the thrombolysis alert by the interventional neurologist or neuroradiologist triggering the treatment, in front of a large ischaemic cerebral accident (\>145 ml).

Brief summary: The objective of the NEUTROSURGERY study is to describe the local and locoregional immuno-inflammatory activity in patients suffering from malignant sylvian ischaemic cerebral accident and treated with decompressive hemicraniectomy compared to a control population of patients to be operated on in neurosurgery for another neurosurgical pathology.


Eligibility criteria: Inclusion Criteria Patients:

* Collegial indication given by a neurologist, a neuroreanimator and a neurosurgeon for HD in the context of a malignant sylvian AIC.

Inclusion Criteria Control:

- For neurosurgical operations in which cranial, meningeal, vascular (branch of the middle meningeal artery) or cerebral bone tissue is not preserved during the surgical approach.

Non-inclusion Criteria Patients:

* HD carried out in a context of acute cerebral haemorrhage
* Pre-existing neurological disability: modified Rankin score \> 2
* Patient benefiting from a legal protection measure

Non-inclusion Criteria Controls:

* Patient to be operated on for an acute vascular condition: meningeal haemorrhage, subdural or extradural haemorrhage, intra parenchymal haemorrhage.
* Patient operated on for an osteomeningeal pathology present at the approach site.
* Patient operated on for an infectious cranial or neuro-meningeal pathology.
* Patient to be operated on as a result of an intracranial traumatic condition

Primary outcomes:
measure: neutrophil polynuclear cells levels
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05534061: Motivation, Syringe Exchange, and COVID-19
Official title: Motivational Enhancement to Augment Contingency Management for SARS-CoV-2 Testing and Vaccination Utilization Among Syringe Exchange Clients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Pandemic
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-09-09
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: People who inject drugs (PWIDs) are highly vulnerable to SARS-CoV-2 infection and to the disease caused by SARS-CoV-2, coronavirus disease 2019 (COVID-19), however, rates of SARS-CoV-2 testing and vaccination uptake -vital to mitigating the spread of COVID-19 and achieving herd immunity - are lower among PWIDs compared to the general population. Building on our Phase I Rapid Acceleration of Diagnostics project, which found that contingency management (CM) increased testing utilization among PWIDs, the proposed project evaluates the comparative effectiveness of CM versus CM plus a brief motivational enhancement intervention on SARS-CoV-2 testing and vaccination uptake among PWIDs. This project has the potential to reduce COVID-19 health disparities among PWIDs and to decrease population level COVID-19 morbidity and mortality.

Detailed description: This study uses contingency management, specifically $10 financial incentives for participation in SARS-CoV-2 testing and $10 for participating in COVID-19 vaccination. It also uses a motivational enhancement intervention which is a brief conversation with clients to improve intrinsic motivation for testing and vaccination. Thus, the clinical trials portion of this study is a randomized control trial (N = 349) in which 177 participants will be assigned to contingency management plus the Connect2Test intervention and 172 will be assigned to the contingency management alone (i.e. services as usual). There will be a per site quota to ensure there are relatively equivalent numbers of participants per site to avoid site-specific biases. The data collection software (e.g., Qualtrics, PowerBI) will randomly assign individuals to condition in real time, after a participant consents to participate in the study.

Eligibility criteria: Inclusion Criteria:

* 18 and older, understand English

Exclusion Criteria:

* none

Primary outcomes:
measure: SARS-CoV-2 Testing
timeFrame: Immediate post intervention (i.e., same day)
measure: SARS-CoV-2 Testing
timeFrame: Up to 9-months after intervention
Secondary outcomes:
measure: COVID-19 Vaccination
timeFrame: Immediate post intervention (i.e., same day)
measure: COVID-19 Vaccination
timeFrame: Up to 9-months after intervention
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
References:
Clinical trial NCT04256161: Measurements of Sexual Steroids' Concentrations in Prostatic Tissue
Official title: Measurements of Sexual Steroids' Concentrations in Prostatic Tissue From Samples Taken by Biopsy Needle on Fresh Operating Parts : Measurements' Reliability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: Steroids' concentrations
Biopsy needle
Cystoprostatectomy
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 24
Sex: MALE
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: Adult male with a bladder cancer and expected to benefit from a total cystoctoectomy in the Urology Department of Foch Hospital.

Brief summary: In the investigators's previous work, measurements of intra-prostatic concentrations of sex steroids were determined on samples taken from the operating room using a punch.

In order to study the in-vivo intra-prostatic concentrations of sex steroid, it is necessary to validate a measurement technique performed on samples obtained by a biopsy needle used in standard care for prostate biopsy punctures allowing the diagnosis and follow-up of prostate cancer.

The aim of this project is to validate this measurement technique carried out on samples obtained by the biopsy needle and to define the optimal number of carrots obtained by biopsy offering dosage results comparable to the punch.


Eligibility criteria: Inclusion Criteria:

* Patient aged ≥ 18 years
* With a bladder cancer
* Should be operated by total cystoprostatectomy at Foch Hospital
* Affiliated to a health insurance scheme
* Having expressed the non-opposition for the participation to the study

Exclusion Criteria:

* Patient receiving or has received a treatment by analog or antagonist of Luteinizing Hormone Releasing Hormone (LHRH), antiandrogens (steroidal or non-steroidal), 5 alpha-reductase inhibitor, docetaxel or cabazitaxel chemotherapy, abiraterone acetate, enzalutamide or corticosteroids
* Patient who does not understand French
* Patient deprived of liberty or under guardianship

Primary outcomes:
measure: Intra-prostatic concentrations of sex steroids
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch, Suresnes
name: Yann NEUZILLET, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01990261: A Study to Assess the Survival of Non-small Cell Lung Cancer Patients Treated With Tarceva After Failed Chemotherapy Treatment
Official title: The Survival of Non-Small Cell Lung Carcinoma EGFR Non-mutated (Wild Type) Patients Treated With Erlotinib (TARceva) After the Failure of at Least One Chemotherapy Regimen
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-11-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult participants diagnosed with locally advanced, metastatic or recurrent non-small cell lung carcinoma with wild-type EGFR.

Brief summary: This study will evaluate the survival of non-small cell lung cancer (wild-type EGFR) participants treated with Tarceva after at least one failed chemotherapy treatment, and the impact of prior chemotherapy treatments.


Eligibility criteria: Inclusion Criteria:

* Adults \>/= 18 years
* Histologically documented locally advanced, metastatic, or recurrent non-small cell lung carcinoma with wild-type EGFR eligible for Tarceva treatment.
* At least one failed chemotherapy treatment.

Exclusion Criteria:

- Unknown EGFR mutation status

Primary outcomes:
measure: Survival Rate at Month 6
timeFrame: Month 6
measure: Survival Rate at Month 12
timeFrame: Month 12
measure: Progression Free Survival (PFS) at Month 6
timeFrame: From inclusion up to disease progression or death whichever occurs first (up to 6 months)
measure: Progression Free Survival (PFS) at Month 12
timeFrame: From inclusion up to disease progression or death whichever occurs first (up to 12 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 12 months
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to 12 months
measure: Overall Survival According to Prior Chemotherapy Treatment.
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Bucharest
country: Romania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06566261: ABA-101 in Participants With Progressive Multiple Sclerosis
Official title: A Phase 1 Open-label, Single Ascending Dose Study of ABA-101 in Participants With Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Progressive Multiple Sclerosis
Keywords: Progressive Multiple Sclerosis
Cell Therapy
Multiple Sclerosis
Treg
Regulatory T Cell
Lead sponsor: Abata Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-08-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential Escalating Dose Cohorts
Primary purpose: TREATMENT

Brief summary: This study will test the safety and effects of ABA-101 when given as a single dose to participants with progressive multiple sclerosis.

It is the first study of this treatment in humans. After safety is demonstrated with a low dose of ABA-101, a higher dose will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Is ≥18 years old at signing of consent.
* Has a diagnosis of MS per the 2017 revised McDonald criteria.
* Has documented evidence of progression of disability independent of MS relapse activity (clinical or radiographic).
* Expresses the HLA that matches the TCR restriction.
* Presence of a radiographic biomarker of CNS inflammation as identified by MRI.
* Meets Expanded Disability Status Scale (EDSS) criteria.
* Meets the nine-hole peg test (9HPT) criteria.

Exclusion Criteria:

* Presents with clinical or radiographic evidence of relapse within 24 months prior to or at Screening.
* Is considered by the Investigator to be immunocompromised.
* Current treatment with disease-modifying therapies (DMTs).

Primary outcomes:
measure: Incidence of adverse events (safety and tolerability)
timeFrame: Day of Treatment to End of DLT Evaluation Period (28 Days)
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: New Brunswick
country: United States
facility: Rutgers, Robert Wood Johnson Medical School
state: New Jersey
city: Cleveland
country: United States
facility: Cleveland Clinic Mellen Center
state: Ohio
Study officials:
References:
Clinical trial NCT05596461: New Techniques for Diagnosis and Treatment of Cognitive Impairment in Affective Disorder
Official title: Research on New Techniques for Diagnosis and Treatment of Neuropsychiatric Diseases - Research on New Techniques for Diagnosis and Treatment of Affective Disorders and Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Affective Disorder
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
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 explore the pathological mechanism of cognitive impairment in patients with affective disorder based on brain gut axis research, preliminarily verify the clinical efficacy of new neural regulation technology on cognitive impairment, and establish an evaluation model to predict the efficacy of physical therapy for affective disorder.


Eligibility criteria: Inclusion Criteria:

1. Age 16-65 years old, regardless of gender;
2. Meet DSM-V diagnostic criteria for depression or bipolar disorder;
3. Duration of stable period ≥ 3 months;
4. Young Mania Rating Scale (YMRS) ≤ 6 points;
5. Hamilton Depression Rating Scale 17 - item (HDRS-17) score ≤ 7;
6. The score of cognitive defects questionnaire (PDQ) ≥ 17;
7. Han nationality, right-handed;
8. More than 9 years of education.

Exclusion Criteria:

1. History of severe somatic or brain organic diseases and craniocerebral trauma;
2. Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination;
3. Those who do not cooperate or cannot effectively complete the experiment;
4. Drug, alcohol or other psychoactive substance abusers;
5. Pregnant, lactating or planned pregnancy.

Primary outcomes:
measure: Wechsler Memory Scale
timeFrame: 0-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References: