louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03987828: Noncurative Endoscopic Resection of Colorectal Adenocarcinoma
Official title: Long-term Outcomes After Noncurative Endoscopic Resection of Colorectal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Noncurative Resection
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 500
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: Patients who underwent a non-curative colorectal endoscopic submucosal dissection (ESD). Curative resection was defined as follows: en bloc resection (tumor removal in one piece without fragmentation) and R0 resection (negative horizontal and vertical resected margins) of a neoplastic (adenocarcinoma) lesion with no lymphovascular infiltration (LVI), no budding, no undifferentiated tumor (G3), no deep invasion (T1 sm3 or deeper).

Patients are required to meet none of the exclusion criteria.

Brief summary: Patients with noncurative resection after ESD for CRC were considered for additional surgical treatment. Then, they either underwent surgery with curative intent or did not, according to patients choice and surgeons indication / contraindication.

We performed a retrospective revision of outcome data by clinical report review or phone calls.

Detailed description: Patients with noncurative resection after ESD for CRC were considered for additional surgical treatment. Then, they either underwent surgery with curative intent or did not, according to patients choice and surgeons indication / contraindication.

We performed a retrospective revision of outcome data by clinical report review or phone calls.

Eligibility criteria: Inclusion Criteria:

- undergoing non-curative colorectal endoscopic submucosal dissection (ESD).

Exclusion Criteria:

* Histology other than cancer (adenocarcinoma).
* History of inflammatory bowel disease (IBD).
* Genetic conditions predisposing to CR.
* Lost to follow up or less than 6 months of follow up.

Primary outcomes:
measure: Survival
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Endoscopy Unit, Humanitas Research Hospital
state: Milano
Study officials:
References:
Clinical trial NCT01097928: Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: PERFECT
Official title: Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: The PERFECT Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Adventist Midwest Health
name: Weill Medical College of Cornell University
name: Memorial Hospital of South Bend
name: Northside Hospital, Inc.
name: Universidad de Zaragoza
First posted: 2010-04-02
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any adult patient who has developed a pulmonary embolism, and who will be undergoing catheter directed debulking of the embolus.

Brief summary: A prospective observational study to evaluate the safety and effectiveness data of catheter-directed therapy (CDT) including percutaneous mechanical thrombectomy (PMT) for treatment of acute pulmonary embolism (PE)

Detailed description: The primary objective of this study is to capture high quality patient safety and effectiveness data on CDT for acute PE. The goal will be achieved by capturing a concise set of immediate and short-term functional and clinical outcome data for PE patients undergoing CDT.

Secondary study objectives include the following:

- To assess and benchmark clinical practice patterns (patient selection, optimal technique, use of procedure worldwide)

These objectives will be achieved through the capture of selected process data for patients included in the registry. Data collected in this study may also be used to develop and refine standards of care for use of CDT for PE and to facilitate the design of randomized clinical trials

Eligibility criteria: Inclusion Criteria:

* Must be Age greater than or equal to 18
* Obtain informed written consent.
* Diagnosed with acute pulmonary embolism (PE) (\< 14 days)
* Catheter-directed therapy (CDT) was performed to treat acute PE

Primary outcomes:
measure: Resolution of hypoxia
timeFrame: Post-procedure and 3 months
measure: Survival from acute PE
timeFrame: Post-procedure and 3 months
measure: Stabilization of hemodynamics
timeFrame: Post-procedure and 3 months
Secondary outcomes:
measure: Clinical practice patterns across centers
timeFrame: 5yrs
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: William T Kuo MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuo WT, Banerjee A, Kim PS, DeMarco FJ Jr, Levy JR, Facchini FR, Unver K, Bertini MJ, Sista AK, Hall MJ, Rosenberg JK, De Gregorio MA. Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry. Chest. 2015 Sep;148(3):667-673. doi: 10.1378/chest.15-0119.
Clinical trial NCT02070328: Registry Study for Proton Therapy Clinical Outcomes and Long-Term Follow-up
Official title: Registry Study for Proton Therapy Clinical Outcomes and Long-Term Follow-up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Proton Therapy
Registry
Lead sponsor: Center for Biomedical Research, LLC
Sponsor class: OTHER
Collaborators: name: Provision Center for Proton Therapy
First posted: 2014-02-25
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are seen/treated at proton therapy centers

Brief summary: Proton therapy is a limited medical resource that is more expensive than conventional x-ray therapy. To correctly measure the success of proton therapy in treating different conditions, it is important to check a patient's health status after their treatment is finished. Checking on the progress of patients over many years (called long-term follow-up) is needed because the long-term effects of proton therapy are not well known.

Detailed description: The objective of this research protocol is the development of a national Proton Therapy Center Registry for the purpose of:

1. Performing retrospective research studies on diseases treated with proton therapy throughout the United States.
2. Maintaining regular, lifetime contact with subjects in order to obtain current identification , contact information, and self/parent-reported health status in order to obtain a better understanding of overall treatment strategies and patient benefits of treatment.
3. Permitting review of medical record information contained within the Registry to identify subjects who may be eligible for participation in future research studies conducted at the Proton Therapy Institution where the participant was treated. Obtaining the permission of Research Registry participants to be contacted to ascertain their interest in participating in future research studies being conducted at their participating Proton Therapy Institution for which it appears (i.e., based on medical information contained within the Research Registry) they may be eligible.

Eligibility criteria: Inclusion Criteria:

* All subjects who are receiving or seeking medical care at the participating Proton Therapy Center will be invited to participate in the Research Registry.

Exclusion Criteria:

* Subjects who do not agree to participate

Primary outcomes:
measure: Long-term follow-up
timeFrame: 6 months
Secondary outcomes:
measure: Future Research Possibilities
timeFrame: 12 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Ackerman Cancer Center
state: Florida
city: Franklin
country: United States
facility: Provision CARES Proton Therapy Nashville
state: Tennessee
city: Irving
country: United States
facility: Texas Center for Proton Therapy
state: Texas
Study officials:
affiliation: Provision Center for Proton Therapy
name: James R Gray, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03090828: Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease
Official title: Economic Evaluation of an Interactive Community-based Patient Education Platform Kidney Dialysis and Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End-stage Renal Disease
Dialysis
Kidney Transplantation
Keywords: economic evaluation
e health
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Centre Leon Berard
name: Université Montpellier
name: Telecom Bretagne
name: Paris School of Economics
name: Ministry of Health, France
First posted: 2017-03-27
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 1600 patients with severe, end stage renal disease or post transplant will be randomised 1:1:1 to either standard therapeutic education; or education using a specific app; or the enhanced interactive app using feedback messages.

The total follow up duration is 18 months. Primary endpoint is the cost utility of using app-based therapeutic intervention, secondary endpoints are: compliance with treatment guidelines, app use (professionals and patients), budget impact analysis


Eligibility criteria: Inclusion Criteria:

* severe end-stage renal disease Internet, literacy informed consent

Exclusion Criteria:

* did not fill the screening questionnaire

Primary outcomes:
measure: cost utility, efficiency, budget impact
timeFrame: 18 months
Secondary outcomes:
measure: overall survival
timeFrame: 18 months
measure: compliance and persistence
timeFrame: 18 months
measure: disease knowledge
timeFrame: 18 months
measure: lifestyle
timeFrame: 18 months
measure: app utilization by professionals and patients
timeFrame: 18 months
measure: health care delivery organization
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06521528: A Pilot Clinical Study to Evaluate the Feasibility of Using the SPC Test
Official title: A Pilot Clinical Study to Evaluate the Feasibility of Using the Single Patient Classifier as a Prognostic Test in Stage II-III Gastric Cancer Patients.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastric Cancer
Lead sponsor: Novomics. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-26
Enrollment: 237
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: histologically confirmed diagnosis of stage II or III AGC

Brief summary: Precision medicine approaches emphasize the importance of reliable prognostic tools for guiding individualized therapy decisions. In this study, we evaluated the clinical feasibility of the Single Patient Classifier (SPC) test, a new clinical-grade prognostic assay, in stage II-III gastric cancer patients.

Detailed description: A prospective multicenter study was conducted, involving 237 patients who underwent gastrectomy between September 2019 and August 2020 across nine hospitals. The SPC test was employed to stratify patients into risk groups, and its feasibility and performance were evaluated. The primary endpoint was the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment. Furthermore, 3-year disease-free survivals of risk groups were analyzed.

Eligibility criteria: Inclusion Criteria:

* being ≥19 years of age
* having a histologically confirmed diagnosis of stage II or III AGC according to the American Joint Committee on Cancer (AJCC) staging system (sixth edition)
* underwent radical gastrectomy without prior neo-adjuvant chemoradiotherapy and did not receive adjuvant chemotherapy
* having no visually or microscopically detectable residual tumors.

Exclusion Criteria:

-Those with insufficient quantity or quality of ribonucleic acid (RNA) for analysis were excluded from the study.

Primary outcomes:
measure: Timely delivered proportion
timeFrame: 14 days
Secondary outcomes:
measure: 3-year disease free survival of the enrolled patients.
timeFrame: 3-years after the enrollment completion
measure: 5-year overall survival of the enrolled patients.
timeFrame: 5-years after the enrollment completion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Novomics. Co., Ltd.
Study officials:
affiliation: National Cancer Center
name: Young-Woo Kim, MD., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03967028: Indication of Ceaseran Section in Primigravida According to Robson's Classification
Official title: Indication of Ceaseran Section in Primigravida According to Robson's Classification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CESAREAN SECTION
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women admitted to women health hospital

Brief summary: Rate of caesarean section surgery are rising worldwide,but the determinant of this increase,especially in low-income and middle-income countries, are controversial.In 1985,The world Health organization (WHO) stated;(There is no justification for any region to have a ceasearan section rate higher than 10-15%). Despite the lack of scientific evidence indicating any substantial maternal and perinatal benefits from increasing cs rates,and some studies showing that higher rates could be linked to negative consequences in maternal and child health, CS continue to increase world wide


Eligibility criteria: Inclusion Criteria:

* Nullipara
* Single fetus .
* More than 37 weeks .
* Patients who pass into spontaneous
* Patient who induced labour

Exclusion Criteria:

* Non cephalic presentation.
* Abnormal lie

Primary outcomes:
measure: The prevalence of etiologies of cesarean section
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT06388928: Effect of Menstrual Cycle on the Manual Dexterity of Female Dentists
Official title: Effect of Menstrual Cycle on the Manual Dexterity of Female Dentists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstrual Cycle
Manual Dexterity
Keywords: Menstrual Cycle
Manual Dexterity
Female Dentists
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 45
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Forty-five nulliparous female dentists, with at least one year of practice of the manual work, participated in this study. They were recruited from the outpatient clinic of the Faculty of Dentistry, Horus University, and from private dental clinics.

Brief summary: The aim of this observational study was to investigate the effect of the menstrual cycle on the manual dexterity of female dentists.

This study was conducted to answer the following question:

- Is there any effect of the menstrual cycle on the manual dexterity of female dentists?


Eligibility criteria: Inclusion Criteria:

* All participants were nulliparous female dentists having a regular menstrual cycle which was confirmed by using a calendar of three consecutive menstrual cycles.
* Their ages ranged from 25 to 35 years old.
* Their BMI was within the normal range (18.5 to 24.9 kg/m²).

Exclusion Criteria:

* Pregnant female dentists.
* Irregular menstrual cycle and any type of hormonal therapy that may affect normal hormonal level fluctuation.
* History of either orthopedic or neurologic diseases causing functional defects of hand strength such as fracture, carpal tunnel syndrome, or De-Quervain's syndrome.
* Upper limb or hand surgery.
* History of systemic diseases like diabetes mellitus.

Primary outcomes:
measure: Manual dexterity assessment
timeFrame: Assessment of the female dentists' manual dexterity was performed from July 2023 to December 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Horus University
Study officials:
affiliation: Cairo University
name: Amira I Hassanein
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03813628: Evaluation of Patient Satisfaction and Color Difference Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Celtra Press Treated With Different Surface Finishing Protocols
Official title: Evaluation of Patient Satisfaction and Color Difference Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Zirconia Reinforced Lithium Silicate Ceramics "Celtra Press" Treated With Different Surface Finishing Protocols.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Natural Optical Properties
Keywords: celtra press
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: investigating the effect of glazing and polishing on the color difference between natural teeth and all ceramic crowns made from celtra press (zirconia reinforced lithium silicate ceramic).

Detailed description: Two groups of patients will be selected according to special inclusion criteria N=5 in each group total of 10 patients, one of the two groups will receive a glazed zirconia reinforced lithium silicate ''celtra press'' crowns and the other group will receive a polished ones of the same material , after crowns delivery color difference (ΔE) between the natural teeth and the celtra press crown will be measured by a spectrophotometer device (intra oral) and patient satisfaction will be recorded.

Eligibility criteria: Inclusion Criteria:

* Age range of the patients from 20-45 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
* Patients able physically and psychologically to tolerate conventional restorative procedures.
* Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
* Patients with teeth problems indicated for full coverage restoration ( coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
* Patients with root canal treated teeth requiring full coverage restorations with contralatral tooth not filled or fractured.
* Patients willing to return for follow-up examinations and evaluation.

Exclusion Criteria:

* Patients in the growth stage with partially erupted teeth.
* Patients with poor oral hygiene and motivation.
* Pregnant women's to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution.
* Patients with psychiatric problems or unrealistic expectation
* Deep discoloration of abutment .

Primary outcomes:
measure: color match
timeFrame: immediately after crown delivery
Secondary outcomes:
measure: Color difference
timeFrame: immediately after crown delivery
Other outcomes:
measure: patient satisfaction
timeFrame: immediately after crown delivery
Locations:
Study officials:
References:
Clinical trial NCT04730128: Translation and Validation of a Disease-specific Questionnaire for Hirschsprung's Disease in Danish Patients
Official title: Translation and Validation of the Hirschsprung and Anorectal Malformation Quality of Life (HAQL) Questionnaire in a Danish Hirschsprung Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hirschsprung Disease
Keywords: Hirschsprung Disease
Quality of Life
Translation and validation
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2021-01-29
Enrollment: 173
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Based on the ICD-10 code for Hirschsprung's disease, all patients with Hirschsprung's disease diagnosed in Odense University Hospital will be offered to participate in the study. The diagnosis must be registered between the years 1985-2014 and the patient must be \> 7 years at the study initiation.

Brief summary: The Hirschsprung and anorectal malformation quality of life (HAQL) questionnaire is a disease-specific quality of life questionnaire with 5 different elements (3 questionnaires for patients (categories: age 8-11, 12-16, and \>17 years) and two questionnaires for parents of patients (categories: patients aged 8-11 and 12-16 years).

In the first part of this study, the questionnaires will be translated via forward-backward-translation, culturally adapted and evaluated for content validity.

In the second part of the study, the questionnaires will be validated in a cohort of all eligible Hirschsprung patients from Odense University Hospital from 1985-2014.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Hirschsprung's Disease between the years 1985-2014
* Age \> 7 years
* Good Danish comprehension
* Signed informed consent

Exclusion Criteria:

* Inability to follow the procedures of the study, e.g. due to language problems, severe psychological disorders, dementia, etc.

Primary outcomes:
measure: Internal Consistency (IC) assessed by Cronbach's Alpha
timeFrame: Day 1
Secondary outcomes:
measure: Test-retest reliability assessed by intraclass-correlations coefficient
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Region Syddanmark
Study officials:
References: