louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04392206: AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
Official title: A Phase I, Open Label Study of Allogeneic Adipose Derived Mesenchymal Stem Cells in Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: End Stage Renal Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Researchers are evaluating the safety of allogeneic Adipose Derived Mesenchymal Stem Cells (AMSC) use during hemodialysis arteriovenous fistula and arterial bypass creation and its efficacy on improving access maturation and primary anastomotic patency.


Eligibility criteria: Inclusion Criteria:

* Patient between 18 and 85 years old
* Patient currently planned for creation of an upper extremity AV fistula with suitable anatomy
* Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
* Life expectancy of at least 24 months
* If female, must be post-menopausal or not able to have children. Post-menopausal/non-child bearing status must be clearly documented in the medical record. If documentation of post-menopausal/non-child bearing status is not available then a pregnancy test must be performed.

Exclusion Criteria:

* Malignancy or treatment for malignancy within the previous 6 months
* Immunodeficiency including AIDS / HIV or Active autoimmune disease
* Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events
* Treatment with any investigational drug/ device within 60 days prior to study entry or Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of AMSCs and the AVF
* History of failed organ transplant on immunosuppression.
* Subjects with known active infection (infection which is being treated)

Primary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Houssam Farres, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05367206: Neoadjuvant Chemotherapy Followed by Chemoradiation Versus Chemoradiation for Stage IIIC Cervical Cancer Patients: A Randomized Phase III Trial
Official title: Department of Radiation, Sun Yat-sen University
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cervical Cancer
Neoadjuvant Chemotherapy
Bulky Neoplasm
Keywords: cervical cancer
neoadjuvant chemotherapy
bulky neoplasm
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy and safety of neoadjuvant chemotherapy (NAC) with albumin-bound paclitaxel and carboplatin followed by chemoradiation therapy (CRT) for stage IIIC cervical cancer patients with carcinoma \>4 cm in greatest dimension and/or lymph node \>2cm in short axis.

Detailed description: in this phase III tiral , stage IIIC cervical cancer patients with carcinoma \>4 cm in greatest dimension and/or lymph node \>2cm in short axis will be randomly assigned to two circles of NAC with albumin-bound paclitaxel and carboplatin followed by standard CRT with weekly cisplatin plus pelvic radiotherapy or to standard CRT alone.

The primary end point was 3-year progression-free survival (PFS). Secondary end points were response rate, 3-year locoregional control, 3-year overall survival (OS), safety, and quality of life.

Eligibility criteria: Inclusion Criteria:

1. pathologically comfirmed : squamous cell, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix；
2. FIGO (2018 International Federation of Gynecology and Obstetrics) stage IIIC with carcinoma \>4 cm in greatest dimension and/or lymph node \>2 cm in short axis at initial diagnosis.
3. age 18 to 70 years；
4. Eastern Cooperative Oncology Group performance status 0 to 2；
5. adequate organ function.

Exclusion Criteria:

1. not at initial diagnosis; 2. with other kind of tumor.

-

Primary outcomes:
measure: 3-year progression-free survival ratio
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdone
Study officials:
References:
Clinical trial NCT00363506: American Migraine Prevention Study
Official title: Nutritional Based Protocol to Balance Serotonin for the Prevention or Reduced Frequency/Duration/Intensity of Migraines
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Migraine Disorders
Keywords: nutritional
C10.228.140.546.399.750
Lead sponsor: Dynamic Health Resources
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the use of nutritional supplementation and dietary management for the reduction in frequency, duration, and intensity of migraine headache pain.

Detailed description: AMPS, the American Migraine Prevention Study Program is a home based nutritional study for migraine prevention. It is designed to evaluate a nutritional supplement along with proper diet, and trigger management that may prevent migraines or reduce the frequency, duration and intensity of migraine headache pain.

The AMPS Program is availalbe nationwide. It is a home based study program.

During the three month study period, participants will be asked to take a daily nutritional supplement and follow a recommended diet to avoid potential migraine triggers. Participants will be asked to maintain a headache log and submit headache questionnaires at the beginning and end of the study. Participants do not have to travel and can participate from their current location.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of migraines
* Ages 18-72
* Migraines more than once per month
* Diagnosed migraines for more than one year

Exclusion Criteria:

* Pregnant/nursing

Primary outcomes:
measure: Migraine Impact and Disability Survey (MIDAS) - symptoms measured at study beginning and at 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chesapeake
country: United States
facility: Nationwide home based study program
state: Virginia
Study officials:
affiliation: Dynamic Health Resources
name: John J Carvalho, MBA
role: STUDY_CHAIR
References:
Clinical trial NCT03908606: Serum Hs-CRP in Periodontitis Patients With or Without Diabetes
Official title: Prognostic Value of Serum Hs-CRP in Periodontitis Patients With or Without Type 2 Diabetes Following Non-surgical Periodontal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Disease
Diabetes Mellitus, Type 2
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: the aim of this study was to assess serum levels of high sensitivity c reactive protein in periodontitis patients with and without type 2 diabetes in a trial to analyze its prognostic effect following non-surgical periodontal therapy.

Detailed description: Periodontitis and diabetes are chronic disorders with a two-way correlation as they can both stimulate an inflammatory response with subsequent formation of inflammatory mediators and cytokines. C reactive protein is an inflammatory plasma marker having a role in the systemic reaction to inflammation. thus, our aim in the current study was to evaluate serum levels of high sensitivity c reactive protein in periodontitis patients with and without type 2 diabetes in a trial to analyze its prognostic effect following non-surgical periodontal therapy. A total of 60 patients were enrolled in this study. ELISA was used for determination of hs- CRP. Non- surgical periodontal therapy was carried out for all periodontitis patients.

Eligibility criteria: Inclusion Criteria:

1. Diabetic patients type 2
2. Periodontitis patients

Exclusion Criteria:

1. Smokers
2. Pregnant females

Primary outcomes:
measure: clinical attachment level
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Gihane Madkour, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT04103606: A Mobile-App Training to Reduce Body Image Disorder Symptoms and Associated Features in Female University Students
Official title: A Mobile-App Training to Reduce Body Image Disorder Symptoms and Associated Psychological Features in Female University Students: a Randomized Controlled Pilot Study with Crossover Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Image Disorder
Body Dysmorphic Disorders
Eating Disorders
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Body dissatisfaction represents a prevalent condition in young women, and it is associated with low self-esteem, depression, and symptoms of Body Dysmorphic Disorder (BDD) and Eating Disorders (EDs). The aim of the trial is to test the effect of a mobile health application called "GGBI: Positive Body Image" in reducing body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated psychological features in female university students considered at high-risk of developing Body Image Disorders (BIDs).

Hypothesis: Participants using "GGBI: Positive Body Image" immediately following baseline assessment (Time 0; T0) (immediate-use App group: iApp) would exhibit greater reduction in body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated psychological features than participants who did not use "GGBI: Positive Body Image" in this phase of the study (delayed-use App group: dApp). Following crossover (Time 1; T1), the investigators expect that participants gains in the iApp group would be maintained at follow-up (Time 2; T2).


Eligibility criteria: Inclusion Criteria:

* Presence of Body Image Disorder symptoms

Exclusion Criteria:

* Presence of a full-blown Body Image Disorder
* Presence of a psychotic/schizophrenic disorder
* Current treatment for a Body Image Disorder

Primary outcomes:
measure: Change of body dissatisfaction and body dysmorphic disorder symptoms
timeFrame: 16 days
measure: Change of eating attitudes and behaviors
timeFrame: 16 days
Secondary outcomes:
measure: Change of self-esteem
timeFrame: 16 days
measure: Change in social anxiety symptoms
timeFrame: 16 days
Other outcomes:
Locations:
city: Padua
country: Italy
facility: University of Padua
state: PD
Study officials:
References:
Clinical trial NCT03703206: The Analgesic Efficacy of Protocol for Primary Total Knee Arthroplasty (TKA)
Official title: The Analgesic Efficacy of Adding the IPACK Block to a Multimodal Analgesia Protocol for Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Arthroplasty, Total
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups
Primary purpose: TREATMENT

Brief summary: This is a perspective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups to assess the analgesic efficacy of adding the iPACK (injection between the popliteal artery and the capsule of the knee) in addition to the adductor canal block (ACB) for Total Knee Arthoplasty patients (TKA).


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for total knee arthroplasty
* American Society Anesthesiologists (ASA) physical status I- III.
* Mentally competent and able to give consent for enrollment in the study.

Exclusion Criteria:

* Patient refusal,
* allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3).
* Revision surgery will be excluded.
* Impaired kidney functions
* patient with coagulopathy will be also excluded.
* Chronic pain syndromes and patients with chronic opioid use in excess of a daily morphine equivalent dose (MED) of 40mg or greater for the past 3 months prior to the surgery.
* BMI of 45 or more

Primary outcomes:
measure: Percentage of Patients Presenting With Pain in the Back of the Knee 6 Hours After Surgery
timeFrame: Six hours after surgery
Secondary outcomes:
measure: Pain Score Measurement Reported by Patients
timeFrame: 24 hours after surgery
measure: Quality of Recovery (QoR) Score
timeFrame: one week, measurements are obtained at 24 hours, 48 hours, and one week
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Taras Grosh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04667806: Health Related Quality of Life in Lung Transplantation in Strasbourg
Official title: Study of the Quality of Life in Surviving Lung Transplant Patients Between 2008 and 2018 by SF36 and St Georges's Questionnaires
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Transplantation
Keywords: Health related quality of life
Lung transplantation
SF36
St Georges's Respiratory
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 1000
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: Transplants survivors in Strasbourg hospital between 2008 et 2018

Brief summary: The aim of this study is to study the quality of life in lung transplant patients. The cohort includes all of the surviving and transplanted patients at the New Civil Hospital in Strasbourg between 2008 and 2018. The main objective is to assess the quality of life of this cohort by two questionnaires which are the SF36 (generic score) and the saint Georges's questionnaire (specific score).

The secondary objectives are the measurement of survival after lung transplantation, the comparison of the quality of life of these patients with that of the general population by the SF36 questionnaire, the search for perioperative factors influencing the quality of life and finally the search for an association between quality of life and socio-professional life.


Eligibility criteria: Inclusion Criteria:

* Transplants survivors in Strasbourg hospital between 2008 et 2018
* Patient able to answer a questionnaire in french

Exclusion Criteria:

* Pregnancy
* Vulnerability
* Safeguard of justice, curatorship or tutorship
* Emergency situation
* Difficilty in understanding

Primary outcomes:
measure: Health related quality of life
timeFrame: 12 month
measure: Health related quality of life
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT04739306: Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
Official title: A Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Macular Edema (DME)
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2021-02-04
Enrollment: 348
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: This is a Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P42 in comparison with Eylea in Patients with Diabetic Macular Edema


Eligibility criteria: Inclusion Criteria:

* Male or female patient aged ≥18 years.
* Patient with DME secondary to DM involving the center of the macula (defined as the Optical Coherence Tomography \[OCT\] central subfield) in the study eye.

Exclusion Criteria:

* Patient who has only one functional eye.
* Patient who currently has, or has a history (where indicated) of active proliferative diabetic retinopathy

Primary outcomes:
measure: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Mean Change From Baseline in BCVA at Week 52
timeFrame: Baseline and Week 52
measure: Proportion of Subjects Who Gained ≥15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52
timeFrame: Baseline and Week 52
measure: Proportion of Subjects With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Central Subfield Thickness (CST) at Week 52 as Assessed on Optical Coherence Tomography (OCT)
timeFrame: Baseline and Week 52
Other outcomes:
Locations:
city: Banska Bystrica
country: Slovakia
facility: II. Ocna klinika SZU, F.D.Roosevelt Hospital
Study officials:
References:
Clinical trial NCT01069406: The Association Between Uterine Artery Notch and First Trimester Bleeding
Official title: The Association Between Uterine Artery Notch and First Trimester Bleeding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Artery Notch
First Trimester Bleeding
Keywords: notch
uterine
first
bleeding
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2010-02-17
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with abnormal uterine artery Doppler at second trimester. pregnant women with eather: elevated HCG and/or aFP at triple test, patients with history of pre eclampsia, IUGR, APD, and patients with thrombophilia.

Brief summary: The purpose of the present study is to evaluate the occurrence of first trimester bleeding among patients with abnormal uterine artery Doppler.

A prospective study is designed and two groups will be studied; patients with abnormal uterine artery Doppler at second trimester (study group) and patient with normal uterine artery Doppler at second trimester (control group).The patients will be asked, as part of the routine history taken before the US about having first trimester bleeding during the current pregnancy.

Detailed description: The purpose of the present study is to evaluate the occurrence of first trimester bleeding among patients with abnormal uterine artery Doppler.

A prospective study is designed and two groups will be studied; patients with abnormal uterine artery Doppler at second trimester (study group) and patient with normal uterine artery Doppler at second trimester (control group). Both the study group and the control group represent high risk pregnant patients and the Doppler flows are done as part of the patient's predictive risk for placental associated abnormalities. The patients will be asked, as part of the routine history taken before the US about having first trimester bleeding during the current pregnancy.

Eligibility criteria: Inclusion Criteria:

* Patients with abnormal uterine artery Doppler at second trimester

Exclusion Criteria:

* Multi fetal pregnancies
* Patients without known gestational age (according to last month period or first trimester ultrasound
* Pregnancies with congenital structural or chromosomal anomalies
* Lack of prenatal care

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Soroka medical center
country: Israel
facility: Us unit
state: Beer sheva
Study officials:
References: