louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02008799: Intra Testicular Artery Injection of Bone Marrow Stem Cell in Management of Azoospermia
Official title: Intra Testicular Artery Injection of Bone Marrow Stem Cell in Management of Azoospermia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Azoospermia
Keywords: Stem cell, infertility, Azoospermia
Lead sponsor: Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 20
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Azoospermia due to low sperm production (non-obstructive azoospermia) affects approximately 1% of the male population and 10% of men who seek fertility evaluation. Testis biopsy reveals that these men have Sertoli cell-only pattern, maturation arrest, or hypospermatogenesis. Until recently, it was assumed that men with non-obstructive azoospermia were untreatable. Indeed, these patients were often referred to as being "sterile" or having "testicular failure." We start to use stem cell in treatment of such patients by injecting the stem cell at the testis and the testicular artery in one group and at the testis only in other group


Eligibility criteria: Inclusion Criteria:

- Azoospermia

Exclusion Criteria:

- Absent or surgical removed testes

Primary outcomes:
measure: Semen Analysis
timeFrame: Three to six months
Secondary outcomes:
measure: Inhibin B Hormone
timeFrame: Three to six months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Man Clinic
Study officials:
affiliation: Man Clinic
name: Khaled A Gadalla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00412399: Job Adaptation in Patients With Rheumatoid Arthritis
Official title: Job Adaptation in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Employment
Negative workplace events
Healthy controls
Fatigue
Physical activity
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2006-12-18
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY
Time perspective: PROSPECTIVE

Brief summary: The specific aim of this study is to compare the rate of negative work role events in individuals with rheumatoid arthritis compared to healthy controls.

Detailed description: Rheumatoid arthritis can cause multiple socio-medical disabilities, with work disability among the most marked. While a major focus has been documenting the rates of job loss and returning patients to the workforce, there is little information about how to foster job retention in those still employed. The goals of this study are to document negative workplace events over 1 year in 122 employed patients with rheumatoid arthritis, and to compare these to 122 healthy controls, who are included to account for the effects of socioeconomic status on employment. Events will be recorded with the work domain of the Psychiatric Epidemiology Research Life Events Scale. Additional goals are to compared fatigue, physical activity, functional status and sleep disturbances as covariates.

Eligibility criteria: Inclusion Criteria:

* Patients are eligible if they are:

  * over age 18;
  * meet American Rheumatism Association criteria for rheumatoid arthritis; and
  * are employed for salary or monetary reimbursement.
* Controls are eligible if they are:

  * over age 18;
  * have no major comorbidity; and
  * are employed for salary or monetary reimbursement.

Exclusion Criteria:

* Patients and controls are excluded if they:

  * have cognitive deficits and cannot provide informed consent;
  * do not speak English or Spanish; or
  * their physicians do not grant permission to enroll them.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Cornell Internal Medicine Associates
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Carol A Mancuso, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mancuso CA, Paget SA, Charlson ME. Adaptations made by rheumatoid arthritis patients to continue working: a pilot study of workplace challenges and successful adaptations. Arthritis Care Res. 2000 Apr;13(2):89-99.
Clinical trial NCT05834699: HER2 Expression of CTC to Predict Response in HER2-low Advanced Breast Cancer Patients Treated With ADC
Official title: An Exploratory Clinical Study of HER2 Expression of Circulating Tumor Cells : Predictive and Prognostic Value in HER2-low Advanced Breast Cancer Patients Treated With ADC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with HER2-low breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Brief summary: To evaluate the predictive and prognostic value of HER2 expression of circulating tumor cells in HER2-low advanced breast cancer patients treated with ADC


Eligibility criteria: Inclusion Criteria:

* Has pathologically documented breast cancer that:

  1. Is unresectable or metastatic
  2. Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
  3. Has progressed on, and would no longer benefit from, endocrine therapy
  4. Has been treated at least 1 prior line of chemotherapy in the metastatic setting
* Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
* Receives anti-HER2 ADC treatment
* Life expectancy \> 3 months
* Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before selection
* ECOG ≤2

Exclusion Criteria:

* Has breast cancer ever assessed with high-HER2 expression
* Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
* Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
* Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study

Primary outcomes:
measure: Progression free survival(PFS)
timeFrame: 3 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 2years
measure: Overall survival(OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of PLA General Hospital
state: Beijing
Study officials:
affiliation: Beijing 302 Hospital
name: Tao Wang
role: STUDY_DIRECTOR
References:
Clinical trial NCT02666599: Per-operating Use of a Probe for Detection of β+
Official title: Per-operating Use of a Probe for Detection of β+
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neoplasms
Keywords: F-18-FDG
neoplasm
probe
positron
diagnosis
surgery
radioguided surgery
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to evaluate the sensibility of the probe Forimtech to detect β+ emission in vivo in humans and its usefulness during elective surgical procedure Hypothesis:The probe Forimtech is able to allow per-surgery detection of tumoral lesions sensible to 18F-FDG and to help in the realization of guided biopsies, minimally invasive surgery or complement of resection of tumors.

The β+ emission detected by the probe Forimtech is correlated to the emission γ detected by the 18F-FDG.PET/CT

Detailed description: Patients with a malignant neoplasic lesion known or suspected for which a surgery is planned will be presented with the protocol. If inclusion/exclusion criteria are fulfilled all the procedures will be planned. A 18F-FDG PET/CT will be done. Surgery will be conducted within 3 hours after the I.V. injection of 18F-FDG according to the standard procedure applied in the visceral surgery department. During the surgery, emission of β+ from the lesion (s) seen during the PET/CT will be detected with the probe.

Resected pieces will be analysed histologically.

Eligibility criteria: Inclusion Criteria:

* Age \< 80 years old;
* Karnofsky index ≥80% ;
* Informed consent signed
* Patients with an indication of thoracic, visceral, or ENT surgery with the aim of a diagnostic biopsy, of an invasive minimal treatment, or an initial or complementary resection

Exclusion Criteria:

* Pregnancy
* Enable to sign informed consent

Primary outcomes:
measure: Sensibility of the probe β+ for detection per-surgery of hypermetabolic tumoral lesions
timeFrame: day 0
Secondary outcomes:
measure: PET/CT imaging results
timeFrame: day 0
measure: Sensibility of the probe β+ for detection per-surgery of hypermetabolic tumoral lesions
timeFrame: within 10 days after study procedure
measure: .Comparison of AUC of the imaging methods
timeFrame: within 10 days after study procedure
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaus
Study officials:
affiliation: Lausanne University Hospitals
name: John O Prior, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04688099: Synovial Fluid Sleep Study
Official title: A Single-center Observational Study of the Relationship Between Sleep, Synovial Fluid Cytokine Profiles, & Outcomes of ACL Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 20
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: Participants will be adults with acute ACL tear undergoing primary reconstruction with BPTB autograft

Brief summary: This is an observational study of the relationship between perioperative sleep time/quality, synovial fluid cytokine profiles, and clinical outcomes of primary ACL reconstruction with BPTB autograft in 50 subjects. Sleep during the week before and month after surgery will be assessed using Fitbit smartwatch and sleep diary. Synovial fluid sampled preoperatively, intraoperatively, and postoperatively will be analyzed for levels of pro- and anti-inflammatory cytokines. Postoperative knee pain and function will be assessed until 2 years post-op using validated questionnaires.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age
2. Undergoing primary ACL reconstruction with BPTB autograft for acute ACL tear, with or without concomitant meniscectomy
3. Presenting within 2 weeks of injury and undergoing reconstruction within 8 weeks of injury

Exclusion Criteria:

1. History of blood-borne diseases including HIV, HBV, HCV, HTLV, or syphilis
2. Pregnant
3. Multiligamentous knee injury
4. Concomitant meniscal repair, meniscal allograft transplantation, osteotomy, or repair of focal chondral defect (e.g., osteochondral autograft transfer system, osteochondral allograft, matrix-induced autologous chondrocyte implantation)
5. Prior ipsilateral knee surgeries or injuries
6. Primary sleep disorders including insomnia, sleep apnea, or restless legs syndrome
7. Uncontrolled psychiatric disorders with sleep disturbance
8. Night shift work
9. Travel with time zone change within three weeks of surgery
10. Systemic inflammatory disease
11. Autoimmune disease
12. Immunomodulatory drug use
13. Chemotherapy within a year before surgery
14. Intra-articular injection within 3 months before surgery

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Year 2
Secondary outcomes:
measure: Score on Lysholm Knee Scoring Scale
timeFrame: Year 2
measure: VAS Score for Anterior Knee Pain
timeFrame: Year 2
measure: Knee Range of Motion
timeFrame: Year 1
measure: Thigh Circumference
timeFrame: Year 1
measure: Concentration of Synovial Fluid Cytokines
timeFrame: Year 1
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Eric Strauss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05921799: A Novel Point-to-care Method for Fast Evaluation of Viscoelastic Hemostasis Analysis
Official title: A Novel Point-to-care Method for Fast Evaluation of Viscoelastic Hemostasis Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perioperative Period
Keywords: blood coagulation
blood coagulation tests
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 200
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: Participants for this study will be recruited at the Second Affiliated Hospital Zhejiang University School of Medicine. The study participants will be adult general anesthesia patients such that viscoelastic testing is performed to assess coagulopathy.

Brief summary: This study compares the results of the existing coagulation monitoring technology to the Ultrasound-based viscoelastic hemostasis analysis, a new method, using small amount of extra blood obtained during routine blood draws in surgery patients.

Detailed description: Ultrasound-based viscoelastic hemostasis analysis is a novel POC diagnostic method, which is suitable for use in surgical care settings.

The novel viscoelastic hemostasis analysis uses ultrasound guided waves to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis, which will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.

This single-center, prospective, observational pilot study will evaluate the analytical performance as well as compared to standard coagulation tests and comparable measures using conventional viscoelastic testing methods.

Eligibility criteria: Inclusion Criteria:

* Subject is scheduled for surgery with general surgery
* Subject is 18 years or order
* Subject requires routine TEG measurement

Exclusion Criteria:

* Subject is unwilling to participate
* Subject is unable to sign a consent form
* Subject is unsuitable for blood drawing
* Subject is unsuitable for this study in the opinion of the anesthesiologist

Primary outcomes:
measure: Comparison of the novel viscoelastic hemostasis analysis results to TEG results
timeFrame: 1 day
measure: Comparison of the novel viscoelastic hemostasis analysis results to standard coagulation test results
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University anesthesiology department
state: Zhejiang
Study officials:
References:
Clinical trial NCT02767999: Serotonin Selective Reuptake Inhibitor (SSRI) Effects on Cerebral Connectivity in Acute Ischemic Stroke
Official title: Resting State MRI Connectivity in Acute Ischemic Stroke: Serotonin Selective Reuptake Inhibitor (SSRI) in Enhancing Motor Recovery: a Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke
Keywords: Acute ischemic stroke
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients

Detailed description: In this placebo-controlled study, using functional resting state MRI, the investigators aim to investigate cerebral connectivity changes induced by fluoxetine given once a day for 90 days, in stroke patients with a moderate to severe motor deficit.

Eligibility criteria: Inclusion Criteria:

* First-ever ischemic stroke
* Cortical or subcortical stroke
* National Institute of Health Stroke Scale NIHSS\>12 or motor NIHSS\>6 at inclusion
* MRI-proved ischemic stroke

Exclusion Criteria:

* pregnant or breast-feeding women
* alcoholism
* ongoing Selective Serotonin Reuptake Inhibitor treatment or interruption \< 1 month
* allergic reaction after SSRI administration
* MRI contraindication
* NIHSS\>22
* Severe aphasia
* Coma

Primary outcomes:
measure: Intracerebral connectivity in the motor network between fluoxetine and placebo group.
timeFrame: 90 days
Secondary outcomes:
measure: Intracerebral connectivity in the motor network between good responders patients
timeFrame: 90 days
measure: Intracerebral connectivity in the motor network between non-responders patients
timeFrame: 90 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: François CHOLLET, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01386099: A PK-PD Study of PSN821 in Type 2 Diabetes Patients (T2DM)
Official title: A Phase IIa Study to Build an Understanding of the Pharmacokinetic-Pharmacodynamic Relationship of PSN821 in Type 2 Diabetes Patients (T2DM).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Prosidion Ltd.
Sponsor class: INDUSTRY
First posted: 2011-06-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 investigate the pharmacokinetics and pharmacodynamics of PSN821 in patients with type 2 diabetes.

Subjects will be assessed for beta-cell function using a hyperglycaemic clamp before the start of treatment and at the end of a 12 week treatment period as the primary endpoint. HbA1c, fasting plasma glucose and body weight are secondary endpoints.


Eligibility criteria: Inclusion Criteria:

* Patients with Type 2 diabetes according to the American Diabetes Association criteria, diagnosed at least 12 months prior to screening.
* Male or female, between 18 and 75 years of age, inclusive.
* Body Mass Index of 25 - 45 kg/m2, inclusive.
* Diabetes managed on a stable regimen of diet, exercise and metformin monotherapy (without dosage adjustments within 4 weeks prior to screening).
* Haemoglobin A1c (HbA1c) of 7.5 10% at screening.
* Fasting plasma glucose (FPG) of between 7 - 13.3 mmol/L at screening and Day -1.
* Males who are, and whose partners are able to comply with contraceptive advice.
* Females of non child-bearing potential.
* Willing to sign the written Informed Consent Form (ICF) to participate in the study and to abide by the study restrictions.

Exclusion Criteria:

* Patients with Type 1 diabetes or maturity onset diabetes of the young or secondary forms of diabetes, such as due to pancreatitis.
* Marked diabetic complications.
* Illness or medication that impacts on the scientific integrity of the study.

Primary outcomes:
measure: Beta-cell function
timeFrame: 12 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: 12 weeks
measure: Fasting plasma glucose
timeFrame: 12 weeks
measure: Body weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Pretoria
country: South Africa
facility: Synexus Clinical Research SA (Pty) Ltd
state: Gauteng
city: Bloemfontein
country: South Africa
facility: Parexel Bloemfontein
city: George
country: South Africa
facility: Parexel George
city: Port Elizabeth
country: South Africa
facility: Parexel Port Elizabeth
Study officials:
References:
Clinical trial NCT05067049: Evaluation of the Impact of a Connected Application on the Follow-up of Patients Treated for Glial Lesions Operated
Official title: Evaluation of the Impact of a Connected Application on the Follow-up of Patients Treated for Glial Lesions Operated: a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Phone Use, Cell
Glial Scar
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: Clairval Hospital
First posted: 2021-10-04
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is to evaluate the efficacy of a mobile app for monitoring the quality of life of patients but also on detection delay of side effects and/or complications linked to the therapeutic management. This allow to adapt their care more quickly, through a prospective randomized study. The impact of this connected monitoring of patients' anxiety will also be evaluated in this study as well as the time taken by the medical team to manage alerts generated by this application.


Eligibility criteria: Inclusion Criteria:

* Male or female over 18 years old without upper age limit.
* Subject operated for a non-recurrent glioma (grade II or III or IV glioma / glioblastoma) according to the WHO classification 2016;
* Subject with a connected support (smartphone,...) to download the connected tracking application.
* Unprotected adult within the meaning of the law
* Subject affiliated to a health insurance scheme
* Subject having signed an informed written consent

Exclusion Criteria:

* Minor subject, pregnant or breastfeeding woman;
* Subject under a measure of legal protection, guardianship or deprived of liberty by judicial or administrative decision;
* Antipsychotic treatment (neuroleptic or lithium)
* Subjects with documented cognitive disorders (Alzheimer, other dementia)
* Subject with a personal medical history of psychiatry
* Subject unable to complete a questionnaire on his own (inability to read French language , severe cognitive disorders)
* Medical contraindication to performing an MRI (pace-maker) or scanner;
* Subject refusing to sign informed consent.

Primary outcomes:
measure: Assessment of the impact of the connected mobile monitoring application on the quality of life, at 6 months, of patients treated for an operated glioma.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Clinique privée
Study officials:
References: