louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02669108: PET-MRI for Functional Imaging of the Testis: A Feasibility Study
Official title: PET-MRI for Functional Imaging of the Testis: A New Methodology for Evaluation of the Infertile Male
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infertility
Non-obstructive Azoospermia
Vasectomy
Keywords: testis
spermatogenesis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to explore feasibility of testis functionality assessment and testis imaging obtained from Positron Emissions Tomography (PET) /Magnetic Resonance Imagine (MRI). Using advanced MRI metrics, investigators will study the three-dimensional structure of normal testis, the levels of specific elements and compounds in the tissues (which can only be found via these imaging techniques), and the directionality (and alterations in directionality) of tissue structure. Investigators hope to develop hypothesis that will in turn suggest bio-markers to be explored in subsequent clinical trials.


Eligibility criteria: Inclusion Criteria:

* Men with proven paternity desiring vasectomy who are over 18 years of age.

Exclusion Criteria:

* Bilaterally absent testes, unilaterally or bilaterally undescended testes
* Patients who have proven azoospermia or no proven paternity
* Inability to tolerate MRI including conditions such as claustrophobia or inability to lay flat for \> 45 minutes.
* Presence of pacemaker/IImplantable Cardioverter Defibrillator (ICD) or perfusion pumps
* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants.
* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study
* All women are excluded as such patients do not have the relevant anatomy being considered in this study
* Anyone from a vulnerable population will be excluded from the study

Primary outcomes:
measure: Diffusion-weighted coefficient imaging of testis using PET/MRI fusion
timeFrame: 2 Months
measure: T2 relaxation time using PET/MRI fusion
timeFrame: 2 Months
measure: Metabolite concentration using PET/MRI fusion
timeFrame: 2 Months
measure: Spectroscopy of the testis using PET/MRI fusion
timeFrame: 2 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Joseph Alukal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01696708: Utilization of 31P-Nuclear Magnetic Resonance Spectroscopy to Monitor Brain Energy Deficit in Huntington Disease
Official title: Study of the Brain Energy Profile Evolution, Using 31Phosphorus-Nuclear Magnetic Resonance Spectroscopy, at Different Stages of Huntington Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Huntington Disease
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2012-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this project is to study brain energy profile evolution at different stages of the Huntington disease.


Eligibility criteria: Inclusion Criteria:

* UHDRS \< 50
* Age \> 18 years
* Ability to undergo MR scanning
* Covered by french social security

Exclusion Criteria:

* Evidence of psychiatric disorder
* Attendant neurological disorder
* Contraindications to MRI (claustrophobia, metallic or material implants)
* Severe head injury
* Unable to understand the protocol
* Pregnancy
* Failure to give informed consent
* Subjects with exclusion criteria required by french law (e.g. subjects who require a legally authorized representative to obtain consent)
* Unwillingness to be informed in case of abnormal MRI

Primary outcomes:
measure: Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr
timeFrame: 2 years
Secondary outcomes:
measure: Correlation between primary outcome measure and clinical parameters
timeFrame: 2 years
measure: Study of longitudinal changes in Pi/PCr ratio over time.
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Brain and Spine Institute (ICM)
Study officials:
affiliation: INSERM UMR S975 Institut du Cerveau et de la Moelle, AP-HP Département de Génétique, Université Pierre et Marie Curie, Paris France
name: Fanny Mochel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adanyeguh IM, Rinaldi D, Henry PG, Caillet S, Valabregue R, Durr A, Mochel F. Triheptanoin improves brain energy metabolism in patients with Huntington disease. Neurology. 2015 Feb 3;84(5):490-5. doi: 10.1212/WNL.0000000000001214. Epub 2015 Jan 7.
Clinical trial NCT05016323: A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Groups, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: IgA Nephropathy
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-23
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind, multicenter, placebo-controlled, parallel groups, Phase II clinical trial
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of HR19042 capsules compared to matching placebo for the treatment of primary IgA nephropathy, and explore the optimal dose for the treatment.


Eligibility criteria: Inclusion Criteria:

1. Female or male patients ≥18 years old；
2. Biopsy-confirmed primary IgA nephropathy；
3. Urine protein≥0.75 g/24hr or urine protein creatinine ratio (UPCR)≥0.5 g/g；
4. Estimated GFR (using the CKD-EPI2009 formula) ≥30mL/min/1.73 m2；
5. Willing and able to take adequate contraception during the trial;
6. Willing and able to give informed consent and follow the protocols during the trial.

Exclusion Criteria:

1. Systemic diseases which could lead to secondary IgA nephropathy；
2. Patients with severe chronic infection or active infection under systemic antibiotic therapy in previous 14 days；
3. Patients with severe cardiovascular diseases；
4. Patients diagnosed with malignancy within the past 5 years；
5. Patients with liver cirrhosis；
6. Patients received organ transplantation；
7. Patients with uncontrolled Type 1 or 2 diabetes；
8. Positive results in HIV-Ab/TP-Ab/ HBsAg/HCV-Ab tests；
9. Patients treated with any systemic immunosuppressive drugs (excluding corticosteroids) within the past 12 months before screening；
10. Patients treated with any systemic corticosteroids within the past 3 months before screening.

Primary outcomes:
measure: Change from baseline in urine protein creatinine ratio (UPCR)
timeFrame: 9 months
Secondary outcomes:
measure: Change from baseline in 24-hour proteinuria
timeFrame: 9 months
measure: Change from baseline in urine albumin creatinine ratio (UACR)
timeFrame: 9 months
measure: Change from baseline in estimated GFR
timeFrame: 9 months
measure: Change from baseline in estimated GFR
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: NanFang Hospital of Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT02626923: Study of Maraviroc (MVC) and Epzicom (ABC/3TC) Once-Daily in ART-Naive & First Switch Patients
Official title: Observational Study of the Safety and Efficacy of Nucleoside Reverse Transcriptase Inhibitor Backbones With Maraviroc (MVC) and Epzicom (ABC/3TC) Once-Daily in Antiretroviral Therapy-Naive Patients and First-Switch Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug-induced Hypotension
Lead sponsor: Southwest Infectious Disease Clinical Research, Inc.
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2015-12-10
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV impacted individual on therapy with once daily Maraviroc

Brief summary: Hypotension does not occur with Maraviroc at a dose of 600 mg/day

Detailed description: A qualitative description of orthostatic hypotension in patients receiving once daily Maraviroc at 600 mg with Epzicom measured by a validated questionnaire

Eligibility criteria: Inclusion Criteria:

* Epzicom Maraviroc once daily dosing

Exclusion Criteria:

* Maraviroc with any other back bone

Primary outcomes:
measure: Hypotension related to once daily Maraviroc dosing
timeFrame: 48 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Southwest Infectious Disease, PA
name: Nicholaos C Bellos, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02901223: The Impact of Oncoplastic Breast Surgery on the Oncological Safety and Patient Satisfaction
Official title: Oncoplastic Breast Surgery Allow Tumor Resection With More Oncological Safety Than Standard Quadrantectomy With Nice Cosmetic Results and Better Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Metastatic Breast Cancer
Keywords: Oncoplastic breast surgery
oncological safety
patient satisfaction
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 70
Sex: FEMALE
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to asses the oncological safety of oncoplastic breast surgery, its impact on patient satisfaction and is it worthy for general breast surgeon to learn different oncoplastic techniques.

Detailed description: This non randomized prospective trial was conducted on 70 female patients presented to our tertiary referral breast unit -Ain Shams University hospitals with non metastatic breast cancer during the period from September 2012 to September 2013. All of them signed an informed consent to share in this study that was approved in the ethical committee held on April 2012 - Ain Shams University. Our patients were divided into 2 equal groups: group A (35patients) who underwent standard quadrantectomy, group B (35 patients) who underwent oncoplastic surgery. In group A all quadrantectomies were done by general breast surgeons while in group B the oncoplastic procedures were done by well trained oncoplastic breast surgeons not assisted by plastic surgeons. The following data were reported in all cases including: age, family history, tumor size, volume and weight of the specimen, location of tumor, margin length, (primary tumor, regional nodes, metastasis) staging, molecular subtype and patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Stage 1, 2 breast cancer
* Non metastatic breast caner
* Singing informed consent

Exclusion Criteria:

* Metastatic breast cancer
* Stage 3, 4 breast cancer
* Inflammatory breast cancer
* Multicentric/multifocal disease
* Ductal carcinoma in situ
* Patients older than 60 years
* History of breast surgery in oncoplastic group
* Co-morbidity in oncoplastic group
* Patients more than 60 years old

Primary outcomes:
measure: Margins in all specimens measured in millimeters.
timeFrame: two years.
measure: Patient satisfaction assessed using questionnaire.
timeFrame: Two years.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Yasser mohamed abdel-samii El Ghamrini
Study officials:
References:
Clinical trial NCT00481923: Efficacy and Safety of Rimonabant With or Without Hypocaloric Diet in Obese Patients
Official title: A Randomized, Double-Bind, Placebo-Controlled, Parallel-Group, Fixed-Dose (20 mg/Day), 3-Month, Multicenter Study of the Energy Intake Effects and Safety of SR141716 With or Without Hypocaloric Diet in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: hypocaloric diet
energy intake
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-06-04
Enrollment: 156
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 primary objective of this study is to assess the effect of rimonabant on the energy intake (kcal/day/meal) from ad-libitum high-fat dinner (primary endpoint), pre- and post-ingestive responses, and the hedonic evaluation of food, and its effect on food choice, cravings and feelings of control.

The secondary objectives are to determine the effect of rimonabant on body weight with or without hypocaloric diet and its clinical and laboratory safety.


Eligibility criteria: Inclusion Criteria:

* Obese subjects with Body Mass Index ≥ 30 and \< 45 kg/m²

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Absolute change from baseline in energy intake during ad-libitum dinner of the high-fat probe day at Weeks 3/4 of double-blind treatment.
Secondary outcomes:
measure: Satiety, food choice, feeling of control, craving using a series of rating scales during the probe and/or "free-living" days
measure: Clinical Safety
Other outcomes:
Locations:
city: Guilford
country: United Kingdom
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: University of Leeds, United Kingdom
name: John Blundell, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02992223: Retrospective Analysis on Relapsed/Refractory Aggressive Non Hodgkin Lymphoma Treated With Z-BEAM Plus ASCT
Official title: Retrospective Collection of Data on Patient With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma Treated With Y90 Ibritumomab Tiuxetan Radioimmunotherapy Plus High-Dose Chemotherapy and Autologous Stem Cell Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractory B-Cell Non-Hodgkin Lymphoma
Recurrent B-Cell Non-Hodgkin Lymphoma
Keywords: Aggressive B-cell non-Hodgkin Lymphoma
Relapsed
Refractory
Zevalin
Y90 Ibritumomab Tiuxetan
Autologous stem cell transplant
BEAM
Recurrent
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma treated with Y90 Ibritumomab Tiuxetan Radioimmunotherapy Plus High-Dose Chemotherapy and Autologous Stem Cell Transplant

Brief summary: Evaluate if Y90 Ibritumomab Tiuxetan Radioimmunotherapy in addition to standard high dose chemotherapy followed by autologous stem cell transplant could improve prognosis in patients affected by relapsed/refractory aggressive non Hodgkin lymphoma


Eligibility criteria: Inclusion Criteria:

* High Risk Relapsed/refractory aggressive non-hodgkin lymphoma defined as:
* Progressive disease
* Early relapse (within 12 months from response)
* Recurrent relapse
* Treated with salvage chemotherapy followed by Y90 Ibritumomab Tiuxetan plus high-dose chemotherapy and Autologous stem cell transplant
* Age \> 18 years
* Previous treatment with Rituximab
* Written informed consent

Exclusion Criteria:

* Patient with no complete data available for collection

Primary outcomes:
measure: Overall Survival
timeFrame: Date of last follow-up for at least 18 months (up to 78 months)
measure: Progression Free Survival
timeFrame: From first response to last follow-up for at least 18 month (up to 78 months)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: A.O.U. Città della Salute e della Scienza
name: Barbara Botto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05930223: Intravenous VAL-1221 Lafora Expanded Access Protocol
Official title: Intravenous VAL-1221 Lafora Expanded Access Protocol (LEAP)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Lafora Disease
Keywords: Glycogen Storage Diseases
Polyglucosan Disorders
Progressive Myoclonic Epilepsy
Lead sponsor: Parasail, LLC
Sponsor class: INDUSTRY
First posted: 2023-07-05
Sex: ALL
Minimum age (years): 12
Maximum age (years): 28
Standard ages: CHILD
ADULT

Brief summary: Only qualified physicians treating a Lafora Disease patient may request VAL-1221 Expanded Access treatment under the Parasail Lafora Expanded Access Protocol (LEAP). According to FDA guidance, this protocol can enroll up to 10 patients. However, individual patient inclusion will ultimately be dependent on protocol eligibility, site geography, treatment requirements, and available supply of the investigational therapy. Inquiring physicians can submit a request by contacting the Central Contact personnel listed below in Contacts/Locations.


Eligibility criteria: Inclusion Criteria:

* Documented genetic diagnosis of Lafora Disease (LD) based on likely pathogenic or pathogenic variants in both alleles of either the EPM2A or the EPM2B gene
* Mid-stage in evolution of LD between 12 and 28 years of age
* Able and willing to comply with the protocol, including travel to Protocol Center, procedures, measurements and visits, including:

  * Adequately supportive psychosocial circumstances, in the opinion of the Investigator
  * Caregiver/trial partner committed to facilitate patient's involvement in the study who is reliable, competent, at least 18 years of age

Exclusion Criteria:

* Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the participant unsafe for inclusion or could interfere with the participant participating in or completing the protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01922323: Metabolomics of Liver Regeneration Following Partial Hepatectomy in Healthy Living Liver Donors
Official title: Metabolomics of Liver Regeneration Following Partial Hepatectomy in Healthy Living Liver Donors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Insufficiency
Keywords: Living liver donor
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be comprised of living liver donors.

Brief summary: The PI will study metabolism during liver regeneration in living liver donors

Detailed description: Samples of blood and urine will be collected from study participants at defined timepoints. The samples will be evaluated to study the metabolism of the regenerating liver after a portion of the liver has been donated from a living donor.

Eligibility criteria: Inclusion Criteria:

1. Potential donor must be in excellent medical and psychological health.
2. Potential donor must be between the ages of 18 and 60.
3. Must have a compatible blood type to the recipient.
4. Must have health care coverage for non-donor related health issues that arise post donation
5. Recipient and donor must have compatible body size.
6. Donors Body Mass Index (BMI) must be less than 30.
7. All previous donor abdominal surgeries will be reviewed on a case by case basis by the surgeon.

Exclusion Criteria:

1. Positive blood test for Human Immunodeficiency Virus, Hepatitis C virus, Hepatitis B virus
2. The size of the donor liver is not large enough to safely resection and still retain enough volume to function normally after the surgery.
3. Liver biopsy show liver cirrhosis or early stages of HCC.

   -

   -

Primary outcomes:
measure: Characterized Metabolic Changes during liver regeneration
timeFrame: one year after donation
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Sammons Cancer Center, Baylor University Medical Center
name: Giuliano Testa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bottiglieri T, Wang X, Arning E, Fernandez H, Wall A, McKenna G, Ruiz R, Onaca N, Trotter J, Lawrence M, Naziruddin B, Asrani SK, Testa G. Longitudinal profiling of plasma and urine metabolites during liver regeneration in living liver donors. Clin Transplant. 2022 Jan;36(1):e14490. doi: 10.1111/ctr.14490. Epub 2021 Oct 1.