louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04615221: Immunological Mechanisms of Rejection in Uterine Transplantation
Official title: Immunological Mechanisms of Rejection in Uterine Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transplant Rejection
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to understand the mechanisms of rejection in uterine transplantation and to search for non-invasive markers of rejection. The biological samples necessary for our research have been or will be collected during procedures (biopsies, smears, vaginal swab, blood tests) carried out as part of the scheduled follow-up of patients. These will be samples whose collection is minimally or not invasive

Detailed description: In the context of uterine transplantation, non-invasive rejection markers will be sought by different approaches, including transcriptomics on a prospective cohort of patients with different types of samples: blood, smear and biopsy. A microbiota study will also be carried out. 3 groups will be studied: 1 group of 10 patients benefiting or having benefited from a uterine transplant, 1 second group made up of their 10 donors, 1 group of 10 control women

Eligibility criteria: Inclusion Criteria:

* Patient going to or having received a uterine transplant OR Patient going to or having donated a uterus for a recipient included in the study OR Premenopausal woman to undergo gynecological surgery under general anesthesia: for 4 of them it was a hysterectomy and they must be under 45 years old, the other 6 must be under 38 years old.

Exclusion Criteria (For witness):

* Pregnancy in progress
* Current infection
* Cervical dysplasia
* History of transplant or transfusion
* Cancer or history of cancer
* Menopause
* Patient aged 38 or over for the 6 controls without hysterectomy, patient aged 45 or over for the 4 patients with hysterectomy.
* Endometriosis

Primary outcomes:
measure: presence of new markers associated with transplant rejection
timeFrame: 8 years
Secondary outcomes:
measure: incidence of pregnancy on transplant immunology
timeFrame: 8 years
measure: microbiota in uterine transplant
timeFrame: 8 years
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Jean-Marc Ayoubi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00139321: Biomechanical Parameters of Gait in Patients With Parkinson's Disease and Parkinsonian Syndromes
Official title: Biomechanical Parameters of Gait in Patients With Parkinson's Disease and Parkinsonian Syndromes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gait Disorders, Neurologic
Keywords: Gait disorders
Postural instability
parkinsonian syndrome
Gait initiation
Parkinson's disease
Adults
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2005-08-31
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Gait disorders and falls are frequent in patients with parkinsonian syndromes. In patients with Parkinson's disease (PD), these signs occurred later during the course of the disease in comparison to patients with other degenerative parkinsonian disorders. The pathophysiology of these symptoms are still not fully understood. Gait initiation challenges the balance control system as the body moves from an upright stable static posture to a continuously unstable gait. The aim of this study is to analyse the gait initiation process in patients with parkinsonian disorders.


Eligibility criteria: Inclusion Criteria:

* Patients able to walk without assistance
* Patients with Parkinson's disease or other degenerative parkinsonian syndromes (progressive supranuclear palsy \[PSP\], multiple system atrophy \[MSA\], corticobasal degeneration \[CBD\], etc.)

Exclusion Criteria:

* Other parkinsonian syndromes
* Dementia
* Neuroleptic treatment

Primary outcomes:
measure: Biomechanical gait initiation parameters
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
Study officials:
affiliation: CIC-Pitié-Salpêtrière
name: Yves Agid, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06921421: Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging
Official title: Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging (SFDI): An Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Burn
Burn Injury
Keywords: SFDI
Spatial Frequency Domain Imaging
Burn depth
Burn injury assessment
Lead sponsor: The Metis Foundation
Sponsor class: OTHER
Collaborators: name: The United States Institute of Surgical Research
name: Modulated Imaging Inc.
First posted: 2025-04-10
Enrollment: 15
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: Patients receiving care at the US Army Institute of Surgical Research (USAISR) Burn Center with thermal burn injuries will be considered for enrollment into this study

Brief summary: The goal of this pilot clinical study is to evaluate the feasibility of collecting Spatial Frequency Domain Imaging (SFDI) data in patients with circulatory compromise due to thermal burns using the FDA-cleared Clarifi Imaging System and the next generation handheld m-Clarifi. Accurate assessment of burn depth and assessment at the point of care is an essential input for clinicians to plan proper treatment and management. SFDI has been shown to be a promising method to evaluate burn depth and extent within 24 hours in pre-clinical studies. The two feasibility goals of this study are as follows: 1) Do the values obtained with a commercial SFDI system provide utility in assessing burn depth in a clinical setting? And 2) Do Clarifi and m-Clarifi provide equivalent data when assessing subjects with burn injuries (biomarker imaging values, clinical workflow).


Eligibility criteria: Inclusion Criteria:

1. Patients 18 years of age or older
2. Thermal burns of any depth (superficial, deep partial thickness, or full thickness).

Exclusion Criteria:

1. Patients less than 18 years of age
2. Pregnant or breastfeeding women

Primary outcomes:
measure: Mean SFDI Scattering Parameter (mm-¹) at Burn Injury Sites Using Clarifi and m-Clarifi Imaging Systems
timeFrame: From enrollment to 21 days
Secondary outcomes:
measure: Correlation Between SFDI Scattering Parameter and Clinician-Determined Burn Depth
timeFrame: From enrollment to 21 days
Other outcomes:
measure: Agreement Between Clarifi and m-Clarifi Devices in Measuring SFDI Scattering Parameter
timeFrame: From enrollment to 21 days
Locations:
city: Fort Sam Houston
country: United States
facility: The United States Army Institute of Surgical Resarch
state: Texas
Study officials:
affiliation: The Metis Foundation
name: Rodney Chan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018421: Effects of Exercise on Patients With Hemiparetic Stroke
Official title: Effects of Exercise on Patients With Hemiparetic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiplegia
Cardiovascular Disease
Keywords: Cerebrovascular Disorders
Exercise
Rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized trial investigates the hypothesis that regular aerobic exercise training using a task specific gait training modality will improve cardiovascular fitness, functional mobility, and reduce risk factors for recurrent cardiovascular events in chronic hemiparetic stroke patients, when compared to matched controls performing just stretching.

Detailed description: The aims are to determine whether 6 months progressive graded treadmill training: 1) improves cardiovascular fitness levels and reduces the excessive energy demands of hemiparetic gait, as defined by oxygen consumption levels based on open circuit spirometry during peak and submaximal exercise ambulation tasks; 2) increases free living physical activity measured by portable kinematic recording devices and quantitative in vivo determination of energy expenditure using stable isotopes; and, 3) improves the cardiovascular-metabolic risk factor profile including measures of key endogenous fibrinolysis regulatory enzymes \[plasma tissue plasminogen activator (t-PA) and its main circulating inhibitor (PAI-1)\], fasting lipoprotein lipid profiles, blood pressure, and oral glucose tolerance and insulin responses. Measurements of body composition at baseline and after training will further determine the effects of aerobic exercise training on muscle mass and central obesity.

Eligibility criteria: Males or Females Ages 40 yrs to 80 yrs who are chronic hemiparetic stroke patients.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: VA Maryland Health Care System
state: Maryland
Study officials:
References:
Clinical trial NCT01952821: Validity and Reliability of Outcome Measures in Patients With Cancer of the Head and Neck
Official title: The Validity and Reliability of the Six-Minute Walk Test, Ten-Meter Walk Test, 30 Second Chair Stand, Linear Analog Scale of Function, and the Modified Brief Fatigue Inventory in Patients With Cancer of the Head and Neck
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer
Physical function
Cancer Related Fatigue
Gait Speed
6MWT
10-Meter Walk Test
30-Second Chair Stand
Linear Analog Scale of Function
Modified Brief Fatigue Inventory
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Nova Southeastern University
First posted: 2013-09-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community-dwelling patients with a new or recurrent diagnosis of head and neck cancer.

Brief summary: The purpose of this study is to establish the Six-Minute Walk Test, 10-Meter Walk Test, 30 Second Chair Stand, Linear Analog Scale of Function, and the Modifed Brief Fatigue Inventory as reliable and valid outcome measurements for patients with head and neck cancer.

Detailed description: This study will be looking at the test-retest reliability and validity of various outcome measures in patients with cancer of the head and neck. Testing will occur in 2 visits within one week.

Eligibility criteria: Inclusion Criteria:

* Age 18-85
* Within 3 months of surgery, or are currently undergoing radiation and/or chemotherapy for a diagnosis of head and neck cancer
* Community dwelling
* Able to provide informed consent, answer relevant questionnaires,follow instructions provided during testing

Exclusion Criteria:

* Vulnerable populations (minors, prisoners)
* Medical comorbidities which limit the safe completion of the 6MWT, gait speed, and strength testing
* Inability to return for a second day of testing within one week

Primary outcomes:
measure: Six-Minute Walk Test
timeFrame: Baseline - 1 week
measure: 10-Meter Walk Test
timeFrame: Baseline - 1 week
measure: 30-Second Chair Stand
timeFrame: Baseline - 1 week
measure: Linear Analog Scale of Function
timeFrame: Baseline - 1 week
measure: Modified Brief Fatigue Inventory
timeFrame: Baseline - 1 week
Secondary outcomes:
measure: FACIT-Fatigue
timeFrame: Baseline - 1 week
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Melissa M. Eden, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02107521: IMSI in Couples With Previous Implantation Failures
Official title: The Effect of the Intracytoplasmic Morphologically Selected Sperm Injection in Couples With Previous Implantation Failure After Intracytoplasmic Sperm Injection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Male Infertility
Female Infertility
Keywords: sperm morphology
ICSI
IMSI
implantation
pregnancy
Lead sponsor: Sapientiae Institute
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 25
Sex: FEMALE
Maximum age (years): 38
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is a lack of clarity regarding the justification to instruct the couple to shift from intracytoplasmic sperm injection (ICSI) to intracytoplasmic morphologically selected sperm injection (IMSI). In this study, we aim at evaluating the efficacy of IMSI in couples with previous implantation failure with ICSI.


Eligibility criteria: Inclusion Criteria:

* Patients with ICSI indication, who have previously underwent \>= 1 ICSI attempt in which at least 2 blastocysts were transferred, with no implantation.
* Regular menstrual cycles every 25-35 days.
* Body Mass Index less than 35 as calculated according to the following formula: body weight (kg) / height x height (m2)
* Presence of both ovaries.
* No pelvic and / or clinically significant uterine anomalies.
* Normal cervical cytology.
* Serum follicle stimulating hormone (FSH) within normal limits.

Exclusion Criteria:

* Clinically significant systemic disease.
* Infection by the human immunodeficiency virus (HIV).
* Infection by the by the hepatitis C virus
* Positive test for surface antigens of hepatitis B.
* Endometriosis stages III - IV (classification of the American Society for Reproductive Medicine).
* Hydrosalpinx, unilateral or bilateral.
* Abnormal gynecological bleeding, undiagnosed.
* Allergy or hypersensitivity to human gonadotropin preparations or any other related to the study medication.

-Simultaneous participation in another clinical trial. -

Primary outcomes:
measure: Implantation
timeFrame: 4-5 weeks' gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Fertility - Centro de Fertilização Assistida
Study officials:
affiliation: Sapientiae Institute
name: Edson Borges, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03030521: The Roles of Intraluminal Pressure and the Dilation of Tunica Media in the Development of Aortic Dissection
Official title: The Roles of Intraluminal Pressure and the Dilation of Tunica Media in the Development of Aortic Dissection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Dissection
Lead sponsor: Wuhan Asia Heart Hospital
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese adult patients with aortic repair surgery

Brief summary: Aortic dissection is defined as the separation of aortic medial lamellae. It is unknown why some aortic dissection are limited in extent while other aortic dissection extend extensively. The investigators hypothesize that the medial layers are separated as a result of the uneven dilation and dislocation of the inner and outer layers, and if this hypothesis is ture, dilation is necessary to the development of aortic dissection. In this study, an in vitro experiment was performed to test whether dilation is essential to the development of aortic dissection.

Participants will be recruited from patients with aortic repair surgery in Wuhan Asian Heart Hospital. A piece of aortic wall will be dissected to reconstruct aorta during operation. Firstly, the dissected aortic wall is sampled for routine pathological examination. Secondly, the remaining tissue is cut into a 2cm by 2cm sheet, then an incision was made on the inner surface of the tissue sheet. The outer 0.5mm media will not be incised. Thirdly, the tissue sheet is used to seal a hole in a syringe with the incision faced inside, and tissue sheet of the experimental group was bound by a band to restrict its dilation in the next step. Fourthly, the syringe is filled with blue stain, and a mechanical test is performed. Fifthly, for the experimental group, the band is removed, and the syringe is filled with red stain. The mechanical test is performed again. Finally, the tissue sheet is released and cut into several parts to show whether the inner and outer media layers are separated by the blue stain or the red stain.

Detailed description: The mechanical test: the syringe's pressure will increase gradually to a target level, and then decrease gradually to 0 Mpa, and this process is repeated for about 60 times.

Eligibility criteria: Inclusion Criteria:

* patients with aortic repair surgery.

Exclusion Criteria:

* the dissected aortic wall is not big enough to be cut into a 2cm by 2cm sheet after routine pathological examination.

Primary outcomes:
measure: The number of patients with a positive result of the aortic delamination test
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
Study officials:
affiliation: Wuhan Asia Heart Hospital
name: Zhenlu Zhang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04476121: Use of PRF in Treatment of Dry Socket.
Official title: Evaluation of Platelet Rich Fibrin Use in the Treatment of Dry Socket.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Osteitis
Keywords: dry socket
PRF
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The first medicine was applied, if dry socket was diagnosed following a tooth extraction. In case of subsequent extraction of homonymous tooth in the same patient and reoccurrence of dry socket, patients were treated with PRF application.
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the influence of PRF application in case of alveolar osteitis.

Detailed description: The main objective was to compare the effects of using two different methods in the treatment of dry socket (alveolar osteitis), which is a postoperative complication of dental extraction. The first was Nipas, applied, if dry socket was diagnosed following a tooth extraction. In case of subsequent extraction of homonymous tooth and reoccurrence of dry socket, patients were treated with application of PRF.

Eligibility criteria: Inclusion Criteria:

* no known medical history of abnormal platelet counts,
* patients with symmetric teeth qualified for extraction,

Exclusion Criteria:

* patients treated previously for existing dry socket,
* patients allergic to acetylsalicylic acid ,
* systemic diseases,
* pregnancy,
* lactation,
* drugs known to affect the number or function of platelets,
* abnormal platelet counts,

Primary outcomes:
measure: Intensity of pain vs. PRF and Nipas application
timeFrame: 24 hours
measure: Influence of treatment on bacteria levels in wounds
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Oral Surgery
Study officials:
affiliation: Medical University of Lodz
name: Anna Janas-Naze, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00621621: CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
Official title: CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tachycardia, Atrioventricular Nodal Reentry
Keywords: atrioventricular nodal reentrant tachycardia
AVNRT
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this post approval study of heart block is to gather additional information regarding how often patients develop heart block (atrioventricular block) after having standard ablation procedure using cryotherapy with the Freezor™ catheter.

Detailed description: Due to the lack of enrollments for the trial. The FDA and Medtronic discussed the inclusion of data found from from published literature (external studies) to corroborate study endpoint. The FDA allowed this data and the study was closed.

Eligibility criteria: Inclusion Criteria:

Some inclusion criteria can only be established during the electrophysiologic study (EPS); thus there are two groups of inclusion criteria.

For inclusion in the study subjects must fulfill ALL of the following criteria:

Pre-EPS inclusion criteria:

1. Patients with a clinical history of AVNRT who are referred for ablation.
2. Patients willing to provide written informed consent.

Post-EPS inclusion criteria:

1. Patients with EPS-documented AVNRT

Exclusion Criteria:

ANY of the following is regarded as a criterion for excluding a subject from the study:

1. Patients with any pre-existing AV block.
2. Patients with known cryoglobulinemia

Primary outcomes:
measure: Device or Procedure Related AV Block Persistent Through Discharge From Hospital.
timeFrame: After 250 subjects have been enrolled.
Secondary outcomes:
measure: AV Block That Requires the Insertion of a Permanent Pacemaker: Defined as the Insertion of a Permanent Pacemaker, as Assessed During Defined Study Follow up.
timeFrame: After 250 subjects have been enrolled.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Columbia University Medical Center and the New York Presbyterian Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Lehmann Consulting
name: John Lehmann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Friedman PL, Dubuc M, Green MS, Jackman WM, Keane DT, Marinchak RA, Nazari J, Packer DL, Skanes A, Steinberg JS, Stevenson WG, Tchou PJ, Wilber DJ, Worley SJ. Catheter cryoablation of supraventricular tachycardia: results of the multicenter prospective "frosty" trial. Heart Rhythm. 2004 Jul;1(2):129-38. doi: 10.1016/j.hrthm.2004.02.022.