louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06189677: Creation of a Biobank of Fertile Men
Official title: Creation of a Biobank of Biological Samples From Fertile Men
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fertility
Keywords: Fertility
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 2000
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normospermic male individuals, naturally fertile men recruited on an outpatient and day-hospital basis.

Brief summary: Collection and conservation of human biological material from fertile subjects, i.e. men with previous parenthood (normospermic men, natural fathers).

Detailed description: The project aims to collect biological material derived both from surgical resections of the most common urological tumors and from peripheral blood or other biological fluids such as urine or seminal fluid when available. The objective of the study is to establish a biobank of human biological material, which will allow access to samples of extreme value for the pathophysiological study of the tumor, its origin, mechanisms and markers of progression, as well as the creation of this collection it will represent an extremely valuable tool for the study of individual response to therapies.

Eligibility criteria: Inclusion Criteria:

* Normospermic male individuals
* Naturally fertile male individuals
* Male individuals \> 18 years

Exclusion Criteria:

* Non-normospermic male individuals
* Male individuals who are not naturally fertile
* Male individuals \< 18 years

Primary outcomes:
measure: Prognostic role of the biological material
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Lombardy
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
Study officials:
References:
Clinical trial NCT02166177: Safety and Efficacy Study of Regulatory T Cell Therapy in Liver Transplant Patients
Official title: Pilot Study Evaluating the Safety and Efficacy Profile of Regulatory T Cell Therapy in Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: End-stage Liver Disease
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2014-06-18
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 'ThRIL' aims to explore the feasibility, safety and efficacy of TR002, a regulatory cell therapy, as adjunct immunosuppressive treatment in the context of liver transplantation

Detailed description: Stage I: To evaluate the safety of administering TR002 to liver transplant recipients.

Stage II: To evaluate the efficacy of TR002 administration in allowing for the discontinuation of immunosuppressive therapy in liver transplant recipients.

Eligibility criteria: Inclusion Criteria:

* Able to give informed consent
* adult patients with end-stage liver disease listed for primary liver transplant;
* calculated MELD score ≤ 25 at time of transplantation

Exclusion Criteria:

* HIV or RNA-positive Hepatitis C Virus infection;
* autoimmune liver disease
* previous organ transplant
* Ebstein Virus and/or Cytomegalovirus sero-negativity
* chronic use of systemic immunosuppressants
* hepatocellular carcinoma outside Milano criteria
* leukocytes \<1.5x10\^9/L and/or platelets \<50x10\^9/L.

Primary outcomes:
measure: Rate of dose limiting toxicities (DLTs)
timeFrame: 1 month after IMP administration
measure: Graft Loss
timeFrame: 24 months
Secondary outcomes:
measure: Immunosuppressive doses
timeFrame: 24 months
measure: Prevention of acute and chronic rejection
timeFrame: 24 months
measure: Acute and Chronic Toxicity
timeFrame: 24 months
measure: Liver histology
timeFrame: 12 months
measure: Rate of successful immunosuppressive drug withdrawal
timeFrame: 24 months
Other outcomes:
measure: Immunological biomarkers
timeFrame: 12 months
Locations:
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: King's College London
name: Giovanna Lombardi, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02527577: Analgesia by Transversus Abdominis Plane Nerve Block in Patients Undergoing Liver Resection.
Official title: Analgesia by Transversus Abdominis Plane Nerve Block in Patients Undergoing Liver Resection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Cancer, Adult
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 39
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 indications liver cancer surgery currently booming due to the increase in surgical techniques and instruments for a more secure resection of liver tissue with a significant reduction in bleeding or surgical complications. This allowed to expand surgical indications in the most fragile patients so assuming optimized anesthetic care.

So far, the technique of analgesia reference to this surgery remains administration of morphine analgesia via a device controlled by the patient (PCA) for epidural analgesia is against-indicated because of induced bleeding disorders by surgery.

Rafi then McDonnell in 2007 have described a new technique of loco regional anesthesia, the abdomen of the Transversus Abdominis Plane (TAP) nerve block(TAP), which allows selective anesthesia of the abdominal wall. But parietal pain related muscular and nervous sagging surgical approach represent a significant share of post operative pain.

This study proposes an evaluation of the abdomen transverse blocks in hepatectomy.


Eligibility criteria: Inclusion Criteria:

* hepatectomy or segmentectomy

Exclusion Criteria:

* Sepsis uncontrolled current
* Overdose in anticoagulant during general anesthesia
* Thrombocytopenia \<50 g / dl
* Severe renal impairment: Cockcroft \<30 ml / min
* history of ventricular arrhythmia serious unexplained .\*
* Allergy to local anesthetics of the amide
* Contraindication to remifentanil and morphine
* Hypovolemia

Primary outcomes:
measure: consumption of morphine over the first 48 hours postoperative.
timeFrame: at 48 hours postoperative
Secondary outcomes:
measure: pharmacokinetic of ropivacaine (plasma concentrations)
timeFrame: 1, 2, 3, 6, 10, 24, 36, 48 hours post-dose
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: carine.labruyere@chu-st-etienne.fr MOLLIEX, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02657577: REseArCH INteGration in Women, Infants, and Children
Official title: REseArCH INteGration in Women, Infants, and Children: REACHING WIC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Weight Changes
Keywords: Women
Infants and Children
Survey
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 628
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 1000 individuals will be identified at WIC clinics in Louisiana. Participants must be at least 18 years of age.

Brief summary: WIC is a governmental program that provides healthy foods, nutrition education and referrals to other health and social services. With the goal of applying for a future grant to expand the dissemination of SmartLoss® within the WIC program, feedback from WIC staff and WIC clients must be solicited to better understand the burden and barriers of integrating these kinds of programs and with WIC participants.

Detailed description: Participants will complete a 15 minute online survey. WIC Staff will be eligible to complete the WIC staff survey and WIC clients will be eligible to complete the WIC client survey. This is a qualitative research study designed to identify the receptiveness of implementing a weight management program in the WIC program and the barriers to weight management intervention as described by WIC staff and WIC clients.

Eligibility criteria: Inclusion Criteria:

* Individuals who are at least 18 years old
* Have been employed or volunteered at a WIC Clinic or DHH in Louisiana for at least 6 months in the past 2 years OR received WIC services during pregnancy or postpartum or have had a child who received WIC services in the past 2 years

Exclusion Criteria:

* Less than 18 years old

Primary outcomes:
measure: Receptiveness to Weight Management Interventions in the WIC Program
timeFrame: 1 day
measure: Barriers to WIC Appointments as Described by WIC Clients
timeFrame: 1 day
measure: Lack of Time at WIC Appointments as a Barrier to Implementing Weight Management Interventions as Described by WIC Staff
timeFrame: 1 day
measure: Lack of Staff at WIC Appointments as a Barrier to Implementing Weight Management Interventions as Described by WIC Staff
timeFrame: 1 day
measure: Lack of Training at WIC Appointments as a Barrier to Implementing Weight Management Interventions as Described by WIC Staff
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00134277: Trial Comparing Different Medical Devices for Infragenual Dilatation
Official title: Prospective Randomised Comparing Trial Between an Infragenual Dilatation (ID), an ID With Stenting, an ID With Cutting Balloon and Laser Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Angiopathies
Intermittent Claudication
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2005-08-24
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a comparison of different medical devices for infragenual dilatation.

Detailed description: Dilatation and recanalisation of the distal veins (infragenual popliteal artery, tibiofibular trunc, posterior tibial artery, anterior tibial artery) by classical balloon dilatation or cutting balloon with or without stenting or by endovascular laser. This intervention happens only once; the duration of the intervention depends on the procedure and the original injuries(30 - 120 minutes).

Eligibility criteria: Inclusion Criteria:

* Diabetes type I or II with diabetic angiopathy stage IIb to IV (Fontaine)
* Atherosclerotic patients with distal angiopathy stage IIb to IV (Fontaine)

Exclusion Criteria:

* Acute ischemia
* Multisegmentaric damage above the knee
* Sepsis: acute respiratory distress syndrome (ARDS), C-reactive protein (CRP) \> 30, white blood cell (WBC) \> 25,000
* Acute myocardial infarction (AMI) during the last 14 days
* Operative contraindication
* Life expectancy \< 2 years
* Blue toe syndrome (micro-embolisation)

Primary outcomes:
measure: Primary patency after 6 months
timeFrame: After 6 months
Secondary outcomes:
measure: Proving the superiority or non-superiority of one treatment procedure to another treatment procedure
timeFrame: After 6 months.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Caren Randon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03441477: Comparative Study of the NIDEK TONOREF III and the Haag-Streit Goldmann Manual Tonometer and Comparison of Pachymetry Values for NIDEK TONOREF III With the NIDEK CEM-530
Official title: Comparative Study of the NIDEK TONOREF III and the Haag-Streit Goldmann Manual Tonometer (Predicate) to Demonstrate Conformance to ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the Applicable Supplemental Information Sheet and Comparison of Pachymetry Values for NIDEK TONOREF III With the NIDEK CEM-530 (Predicate)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Intraocular Pressure
Lead sponsor: Nidek Co. LTD.
Sponsor class: INDUSTRY
First posted: 2018-02-22
Enrollment: 225
Sex: ALL
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 clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device. The secondary objective is to demonstrate that the test device is as safe as the predicate devices.


Eligibility criteria: Inclusion Criteria:

1. be at least 18 years of age of either sex and any race or ethnicity;
2. be willing and able to provide written informed consent prior to any study procedures being performed;
3. be willing and able to follow all instructions and attend all study visits;

Exclusion Criteria:

1. have only one functional eye;
2. have poor or eccentric fixation in either eye;
3. have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye;
4. have microphthalmos in either eye;
5. have buphthalmos in either eye;
6. be a contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months;
7. have dry eyes, meaning having been diagnosed by a physician with dry eyes and currently using a prescribed medication or daily use of artificial tears;
8. be a lid squeezer - blepharospasm;
9. have nystagmus in either eye;
10. have keratoconus in either eye;
11. have any other corneal or conjunctival pathology or infection in either eye;
12. have a condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.

Primary outcomes:
measure: Agreement of Intraocular Pressure
timeFrame: 1 day
measure: Agreement of Corneal Thickness
timeFrame: 1 day
Secondary outcomes:
measure: Number of Occurrences of Adverse Events
timeFrame: 1day
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References:
Clinical trial NCT02118077: Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Group Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Lead sponsor: Cancer Advances Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Compare the effect of G17DT with that of placebo on the survival of subjects with advanced pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

* Subjects with a histologically or cytologically confirmed diagnosis of pancreatic carcinoma, who were not eligible for tumor resection with curative intent (i.e., Stage II, III, or IV disease)
* Male or female subjects over 18 years of age
* Subjects with a life expectancy of at least 2 months
* KPS score of ≥60%
* Written informed consent

Exclusion Criteria:

* Previous, concomitant, or anticipated use (up to Week 12) of chemotherapy, radiotherapy, immunotherapy, or any other anticancer therapy
* Previous (during the 4 weeks before the study), concomitant, or anticipated use (up to Week 12) of immunosuppressants. However, for systemic \[i.e., oral or injected\] corticosteroids, previous use and concomitant use at study entry were prohibited, while introduction during the course of the study was permitted.)
* History of other malignant tumor within the previous 5 years, except nonmelanomatous skin cancer, and in situ carcinoma of the uterine cervix
* Known immunodeficiency
* Females who were pregnant, planning to become pregnant, or lactating (Women who, in the opinion of the investigator, were of childbearing potential were to have a negative pregnancy test before study drug administration.)
* Subjects taking part in another study involving an investigational or licensed drug or device in the 3 months preceding enrollment or up to Week 12 during this study
* Previous G17DT treatment
* Hematological indicators as follows:

  * Hemoglobin \<9.5 g/dL
  * Neutrophils \<2.0 × 109/L
  * Platelets \<100 × 109/L
* Any other condition or circumstance that might have the following results:

  * Worsen if the subject participated in the study
  * Reduce the subject's ability to comply with the protocol
  * Confound the interpretation of the study results

Primary outcomes:
measure: Patient Survival
timeFrame: Up to week 134
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: up to week 134
Secondary outcomes:
measure: Objective tumor response
timeFrame: Weeks 24 and 52
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00186277: Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer
Official title: Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Sanofi-Synthelabo
First posted: 2005-09-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To combine oxaliplatin and taxotere in patients who have had prior cisplatin therapy in bladder cancer.

Detailed description: To test the combination of oxaliplatin chemotherapy in combination with taxotere chemotherapy in patients with advanced bladder cancer who have failed one prior chemotherapy.

Eligibility criteria: * Patient Population Type: Advanced Muscle Invasive Bladder Cancer
* Prior Therapy: One prior therapy for advanced disease
* Disease: Measurable disease
* ECOG Performance: 0,1
* Indication: Histologically Proven Carcinoma of the bladder
* For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
* Allergies: No known allergy to one of the study drugs
* Patient Status:
* No CNS metastases
* No peripheral neuropathy \> grade1
* No other serious concomitant illness
* Fully recovered from any prior therapy
* Informed Consent: Patient and doctor have signed informed consent
* Lower Age Limit: Lower age limit \>18
* Upper Age Limit: Upper Age Limit \<70
* ANC: ANC \>1500/mm3 or WBC \> 3000/mm3
* Platelets: Platelets \>100,000/mm3
* Creatinine: Creatinine \<1.8mg/dL
* Bilirubin: Bilirubin \<=2.0 x ULN
* SGPT: SGPT (ALT) \<=1.5 x ULN (\<4xULN if liver metastases present)
* RBC: Hemoglobin \> 9.0g/dL
* Cardiovascular: No active congestive heart failure, no uncontrolled angina, no myocardial infarction within the past 6 months
* Patients with metastatic cancer of the urothelial tract (TCC, Adenocarcinoma)
* No prior exposure to Oxaliplatin
* No cytotoxics or radiation 4 weeks prior to enrolling on protocol
* PT/PTT normal

Primary outcomes:
measure: Tolerability of the this combination in patients with recurrent metastatic bladder cancer.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr. Sandy Srinivas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01410253: Effects of Cardiac Rehabilitation on Postoperatory of Coronary Artery Bypass Graft.
Official title: Evaluation of the Effects of Different Physical Therapy on Cardiac Rehabilitation in Post Operatory Period of Coronary Artery Bypass Graft: Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Complication of CABG
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2011-08-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized Clinical Trial to evaluate the use of different techniques of physical therapy on recovery of functional capacity, pulmonary function and respiratory muscle strength in the period of hospital stay after coronary artery bypass graft.


Eligibility criteria: Inclusion Criteria:

-Patients are recruited from the waiting list for a first CABG intervention at the Porto Alegre Clinical Hospital.

Exclusion Criteria:

* chronic renal failure,
* unstable angina,
* moderate or severe valve disease,
* complex cardiac arrhythmia,
* stroke,
* inability to exercise the lower limbs,
* subjects with forced expiratory volume in 1 second less than 70% of predicted

Primary outcomes:
measure: submaximal functional capacity
timeFrame: Change from Baseline in functional capacity at seven days and thirty days after surgery
Secondary outcomes:
measure: capacity functional
timeFrame: evaluated 40 days after surgery
measure: respiratory muscle strength
timeFrame: Change from Baseline in respiratory muscle strength at seven days and thirty days after surgery
measure: lung function
timeFrame: Change from Baseline in lung function at seven days and thirty days after surgery
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Porto Alegre Clinical Hospital
state: Rio Grande do Sul
Study officials:
References: