louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05205551: Prospera Test Evaluation in Cardiac Transplant (ProTECT)
Official title: Prospera Test Evaluation in Cardiac Transplant (ProTECT)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Transplant Rejection
Lead sponsor: Natera, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-25
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart Transplantation Patients

Brief summary: The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation.

Detailed description: The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera™ testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation. Patients who are enrolled in this study should have blood drawn for Prospera™ testing at regular intervals per routine clinical care. Prospera™ test results and results of surveillance endomyocardial biopsies, laboratory testing, echocardiograms, angiography and hemodynamic monitoring performed to monitor cardiac status and for signs of transplant rejection, as well as medications and post-transplant re-vascularization and surgical procedures will be recorded in the electronic case report form (eCRF). Patient management decisions, even those informed by the Prospera™ test result, are made based on the individual judgment of the healthcare providers participating in the study.

Eligibility criteria: Patients must meet all the following criteria to be eligible for the study:

1. Age 18 or older at the time of informed consent.
2. Enrolled within 60 days following heart transplantation.
3. Prospera™ testing is planned as part of standard clinical care to monitor for and assess transplant rejection.
4. Prospera™ testing is planned to be performed within 60 days (inclusive) following heart transplantation.
5. Selected by their healthcare provider to receive or continue receiving Prospera™ testing as part of their routine transplant management.
6. Willing and able to provide written informed consent.
7. Willing and able to comply with study procedures.

Patients are not eligible for the study if they meet any of the following criteria:

1. Pregnant at the time of signing informed consent.
2. Candidate for multiple solid organ or tissue transplant.
3. History of prior organ or cellular transplantation.
4. Ongoing testing with another allograft dd-cfDNA assessment is planned.

Primary outcomes:
measure: Primary Endpoints:
timeFrame: 3 years
Secondary outcomes:
measure: Secondary Endpoints
timeFrame: 3 years
Other outcomes:
Locations:
city: San Carlos
country: United States
facility: Natera
state: California
Study officials:
affiliation: Natera, Inc.
name: Michael Olymbios, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02966951: Use of Adipose Tissue Derived Mesenchymal Stem Cells for Knee Osteoarthrosis
Official title: Knee Osteoarthrosis (KOA) in Jordanian Patients: a Phase I Dose-finding Study Using Adipose Tissue Derived Mesenchymal Stem Cells (ATMSC) for Advanced Stage III and IV KOA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Knee Osteoarthrosis
Keywords: osteoarthrosis
knee
adipose tissue
stem cells
cell therapy
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 10
Sex: ALL
Minimum age (years): 42
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Adipose tissue derived Mesenchymal Stem cells (ATMSC) will be injected in patients diagnosed with Knee osteoarthrosis

Detailed description: Ten patients from both genders diagnosed with Knee osteoarthrosis, will be enrolled according to specific inclusion and exclusion criteria. These patients will be injected with Adipose Tissue derived Mesenchymal Stem Cells. Then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.

Eligibility criteria: Inclusion Criteria:

Severe KOA stage III or IV by Laurance \& Kellgren staging as judged by Posterioranterior (PA) Xray of the knee joint.

Willing to participate by signing the informed consent

Exclusion Criteria:

* Sublaxation beyond 20 degrees of the bones of the knee joint
* Oral anticoagulants or heparin therapy
* Heart failure or arrhythmia
* Body Mass Index \> 35
* Uncontrolled Diabetes Mellitus.
* Evidence of Infectious Diseases.
* Active infection
* Malignancy
* Pregnancy
* Anemia less than 11g/dl or thrombocytopenia less than 100,000 or leucopenia less than 3000.
* Unreliable patients
* Non-resident in Jordan

Primary outcomes:
measure: Evaluation of the safety and tolerability of the intra articular injection
timeFrame: Time Frame: 6 months
Secondary outcomes:
measure: Assessment of the efficacy of intra-articular injection of ATMSC
timeFrame: 12 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Cell Therapy Center
Study officials:
affiliation: Cell Therapy Center
name: Abdallah Awidi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00550251: Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients? Formal Study
Official title: Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients? Formal Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nausea
Vomiting
Keywords: Nausea
Vomiting
Emesis
Palliative
Terminal
Cancer
Lead sponsor: Sue Ryder Care
Sponsor class: OTHER
First posted: 2007-10-29
Enrollment: 58
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: Pilot study completed - power calculation performed. Now formal double blind randomized study comparing active with placebo wristbands for nausea in palliative care patients to be carried out.

Detailed description: Terminally ill hospice in-patients suffering with nausea will be randomized to active or placebo acupressure bands. The study will last 3 days and they will be allowed to continue regular or have PRN anti-emetics during the study.

Assessors and patients will both be blinded to whether they patients are receiving active or placebo bands.

Eligibility criteria: Inclusion Criteria:

1. Have a diagnosis of advanced cancer with an estimated prognosis of less than 1 year but more than 3 days.
2. Describe their nausea as at least moderate on a Likert scale OR at have had at least one vomit per day for the last three days.
3. Have an underlying cause for their nausea which is thought to be irreversible OR the patient has made an autonomous choice not to proceed with treatment for any potentially reversible cause (for example surgery for obstruction or drainage of ascites).
4. Can be male or female patients but must be over the age of 18.
5. Have signed a consent form prior to entering the study.
6. If patients are taking corticosteroids the dosage should be stable for 3 days before and during the trial.
7. Be thought to be well enough to complete the 3 day trial.

Exclusion criteria:

1. Arm lymphoedema.
2. Weakness, fatigue or confusion sufficient that patient is unable to take part.
3. Previous history of acupuncture/acupressure for nausea or vomiting, or history of use of acupressure by a close relative.
4. History of Parkinsonism or Parkinsonism on examination.
5. Patients will not be enrolled if they are sharing a room with another patient taking part in the study.
6. Patients who are unable to read or comprehend the questionnaire or Visual Analogue Scale.

Primary outcomes:
measure: Number of PRN Doses of anti-emetics needed
timeFrame: 3 days
Secondary outcomes:
measure: Visual Analogue Scale of nausea; duration of perceived nausea; number of vomits per 24 hours; volume of vomit per 24 hours; adverse effects of acupressure; measure of whether the patient felt the intervention helped.
timeFrame: 3 days
Other outcomes:
Locations:
city: Cheltenham
country: United Kingdom
facility: Sue Ryder Care Leckhampton Court Hospice
state: Gloucestershire
Study officials:
affiliation: Sue Ryder Care Leckhampton Court Hospice
name: Paul Perkins, MB Bch MRCP
role: STUDY_DIRECTOR
References:
Clinical trial NCT00971451: Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction
Official title: Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rupture of Anterior Cruciate Ligament
Keywords: Anterior cruciate ligament
ACL
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2009-09-03
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients who are diagnosed with an isolated tear of the anterior cruciate ligament and scheduled for arthroscopic reconstruction using bone-patellar tendon-bone autograft will be recruited to participate.

All subjects will be invited to participate in 2 weeks (2 supervised sessions per week) prior to their surgery. Each session will include supervised therapeutic exercises. Subjects will be randomly assigned to receive continuous transcutaneous electrical nerve stimulation (TENS) during each session or knee joint cryotherapy prior to each exercise session. The investigators will measure quadriceps function before and after this 2-week intervention (both sessions occur prior to reconstruction surgery). This study will also have a true control group that will not receive either exercise of modality intervention. The investigators will collect subjective and objective outcomes data at regularly scheduled post-operative visits.


Eligibility criteria: Inclusion Criteria:

1. Complete ACL rupture
2. Age 15-55

Exclusion Criteria:

1. Persons who cannot tolerate knee joint TENS.
2. Persons who have a known allergy to cryotherapy
3. Patients who are pregnant or who plan on getting pregnant during the 12-month follow-up period.

Primary outcomes:
measure: Quadriceps muscle strength and inhibition using the quadriceps central activation ratio
timeFrame: Day 15
Secondary outcomes:
measure: Quadriceps H-reflex testing
timeFrame: Day 15
measure: International Knee Documentation Committee Subjective Knee Joint Evaluation
timeFrame: Day 15
measure: Visual Analog Scale
timeFrame: Day 15
measure: Tegner Activity Rating
timeFrame: Day 15
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Joseph M Hart, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06071754: Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
Official title: Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Atrial Fibrillation
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2023-10-06
Enrollment: 365
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements


Eligibility criteria: Inclusion Criteria:

* Subject is 22 years of age or older
* Subject is comfortable to read and communicate in English\*
* Subject belongs to one of two groups:
* Subjects without any prior arrhythmia diagnosis presenting in normal sinus rhythm (Group1)
* Subjects with history of paroxysmal or persistent atrial fibrillation presenting in atrial fibrillation (Group 2) \*This is to ensure the subject can provide informed consent (as Masimo INVSENSOR00057 ECG study materials are currently available in English only) and can comply with study procedures.

Exclusion Criteria:

* Subjects who are physically unable to wear a wristwatch
* Subjects whose skin is not intact (e.g., has open wounds, has inflamed tattoos or piercings, has visible healing wounds) in or at the vicinity of the device placement site.
* Subjects with an implantable defibrillator or cardiac pacing device.
* Subjects with a skin condition which would preclude proper ECG electrode placement..
* Subjects with known allergic reactions to adhesive tapes or ECG gel.
* Subjects previously diagnosed with non-atrial fibrillation cardiac arrhythmia.
* Subjects not suitable for the investigation at the discretion of the investigator or the clinical team

Primary outcomes:
measure: Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
timeFrame: Approximately 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Clinical Lab
state: California
city: Laguna Hills
country: United States
facility: PCA Cardiology
state: California
city: Greensboro
country: United States
facility: Cone Health
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management
state: North Carolina
Study officials:
References:
Clinical trial NCT06435754: Hard and Soft Tissue Changes Following Vestibular Socket Preservation Versus Ice Cream Cone Technique for Management of Defective Fresh Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial
Official title: Hard and Soft Tissue Changes Following Vestibular Socket Preservation Versus Ice Cream Cone Technique for Management of Defective Fresh Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alveolar Ridge Preservation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of hard and soft tissue changes following vestibular socket preservation versus ice cream cone technique for management of defective fresh extraction sockets in the esthetic zone.

Detailed description: The aim of this randomized clinical trial is to assess the volumetric and radiographic ridge contour changes following alveolar ridge preservation using Vestibular socket preservation in patient with type II fresh extraction sockets, versus ice cream cone technique.

In patients needing extraction in anterior maxilla with type II sockets, there will be no difference between the Vestibular socket preservation and ice cream cone technique regarding the changes in alveolar ridge contour.

Eligibility criteria: Inclusion Criteria:

* Adults from the age of 18 - 40 years
* Patients with non-restorable maxillary teeth/tooth indicated for extraction in the area from 2nd premolar to 2nd premolar
* Type II sockets will be selected as revealed by Cone beam computed tomography (CBCT).
* Intact gingival tissue with at least 2mm keratinized tissue
* Absence of any systemic disease or drugs that contraindicate oral surgery using Modified
* Cornell Medical Index .
* Patients accepts to provide informed consent

Exclusion Criteria:

* Pregnant and lactating females.
* Smokers as smoking is a contraindication for any plastic periodontal surgery.
* Patients with BOP\>15%.
* Patients with periodontal diseases .
* Handicapped and mentally retarded patients.
* Patients undergoing radiotherapy.
* Presence of systemic disease that would affect wound healing.
* Presence of active infection with soft tissue communication.

Primary outcomes:
measure: Linear buccal distance (mm)
timeFrame: 6 months
Secondary outcomes:
measure: Changes in the height of the socket buccal and palatal ridges (mm)
timeFrame: 6 months
measure: Labiopalatal volumetric ridge contour analysis (mm)
timeFrame: 6 months
measure: Patient satisfaction (Yes/No)
timeFrame: 2 weeks
measure: Pain (1-10)
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01413854: Diclofenac add-on to Treatment as Usual for Suicidal Patients
Official title: "Antiinflammatoriska läkemedels Effekt för Att Minska Suicidalitet Hos Deprimerade Patienter Som Nyligen Har Gjort självmordsförsök"
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Depression Suicidal
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2011-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 determine whether diclofenac is effective in the treatment of depressed patients with a recent suicide attempt.

Detailed description: The study will start with a feasibility study including treatment of 10 patients with diclofenac.

Eligibility criteria: Inclusion Criteria:

* Depressive disorder
* Montgomery Asberg Rating Scale Score more than 20 p.
* Recent suicide attempt (Treated as inpatient due to a recent suicide attempt)
* Informed consent
* Competence to give informed consent

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Serious somatic disease e.g. serious heart, vascular, hepatic, kidney, pulmonary, intestinal, endocrine, haematological or neurological diseases
* Ongoing substance abuse
* Schizophrenia or other psychotic disorders
* Ongoing psychosis
* Risk factors for cardiovascular events
* Ulcer or gastrointestinal bleeding
* Ongoing Electroconvulsive therapy
* Previous allergic reaction to NSAID, acetylsalicylic acid, sulfonamides or the diclofenac or sugar pill content
* Galactose intolerance, lactase deficiency or glucose-galactose malabsorption
* Ongoing treatment with warfarin or other anticoagulants
* Ongoing treatment with ACE inhibitors or angiotensin II antagonists Ongoing treatment with drugs known to effect the immune system Ongoing treatment with rifampicin, carbamazepine or barbiturates

Primary outcomes:
measure: Suicide Assessment Scale (differences in scores before and after treatment)
timeFrame: four weeks of treatment
Secondary outcomes:
measure: Montgomery Asberg Rating Scale (differences in scores before and after treatment)
timeFrame: four weeks of treatment
measure: Barratt Impulsiveness Scale (differences in scores before and after treatment)
timeFrame: four weeks of treatment
measure: Montgomery Asberg depression Ratin scale (changes in suicidality item before and after treatment)
timeFrame: four weeks of treatment
measure: Montgomery Asberg Rating Scale (changes in concentration item before and after treatment)
timeFrame: four weeks of treatment
measure: Comprehensive Psychopathological Rating Scale (changes in aggressive feelings item before and after treatment)
timeFrame: four weeks of treatment
measure: Comprehensive Psychopthological Rating Scale (changes in fatigue item before and after treatment)
timeFrame: four weeks of treatment
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Psychiatry Skane
Study officials:
affiliation: Lund University
name: Åsa Westrin, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00831454: Identification of EGFR-TKIs Sensitivity or Resistance Markers in NSCLC May Help in Optimal Patient Selection
Official title: Relationship of Polymorphisms and Mutations of Epidermal Growth Factor Receptor and Tyrosine Kinase Inhibitors Responsiveness in Non-small-cell Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NON-SMALL-CELL LUNG CANCER
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2009-01-29
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NON-SMALL-CELL LUNG CANCER patients treated with EGFR-TKIs

Brief summary: The aim of this study was to retrospectively evaluate associations between EGFR and AKT DNA-polymorphisms involved in transcriptional regulation and overall survival in NSCLC patients treated with EGFR-TKIs.

Detailed description: DNA will be isolated from blood samples or paraffin-embedded tumor specimens and than a mutation analysis and SNPs genotyping will be done.

Eligibility criteria: Inclusion Criteria:

* Availability of tumor tissue or blood samples.
* Diagnosis of NSCLC
* At least one treatment with EGFR-TKIs inhibitors

Exclusion Criteria:

* Other than NSCLC primary diagnosis
* No treatment with EGFR-TKIs inhibitors
* No archival tissue available

Primary outcomes:
measure: to evaluate the presence of EGFR- and AKT-DNA polymorphisms.
timeFrame: At the end of enrollment
Secondary outcomes:
measure: to correlate the biological characteristics with clinical characteristics and survival data of patients.
timeFrame: At the end of enrollment
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinco Humanitas
state: Mialno
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: PRINCIPAL_INVESTIGATOR
References: