louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06279832: Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer.
Official title: Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer ID: ROMANTIC STUDY
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Keywords: Radiomic
Ultrasound
MRI
Molecular sequencing
Radiogenomic
Omic analyses
molecular classification
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: As far as the sample size concerns, the number of images required for the analysis are a figure of at least 100 positive cases (15). We considered as positive patients with a favorable prognostic profile according to PORTEC-4a and also low and intermediate risk class according to ESGO/ESTRO/ESP 2020 recommendations.Therefore, we estimate to enroll at least 1000 patients in order to reach the 100 positive cases.
Primary purpose: DIAGNOSTIC

Brief summary: The aim is to develop radiogenomics models to stratify patients into three main risk categories (Favorable, Intermediate, and Unfavorable) according to the ProMisE model (9) and use these models to predict the most prognostically relevant EC histopathological features (i.e. FIGO stage, degree of tumor differentiation, histotype, LVSI status, myometrial and cervical invasion, lymph node metastases).

These models would support clinicians in personalizing surgical and adjuvant treatment choice among the options considered by the international guidelines.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed diagnosis of primary endometrial cancer (endometrioid, clear cell, serous, mixed, any grade)
* FIGO stage IA-IB
* Formalin-fixed, paraffin-embedded (FFPE) tissue at the diagnosis available - Availability of preoperative MRI scans in dicom (.dcm) format
* Availability of preoperative US images in dicom (.dcm) format
* Availability of preoperative CT-scan images in dicom (.dcm) format (optional)
* Available clinical information (e.g. baseline information, surgery, adjuvant therapy, median follow up period 24 months)

Exclusion Criteria:

* Metastatic cancer to the uterus (not primary EC)
* Uterine sarcoma
* Conservative surgery
* FIGO stage \> II
* Formalin-fixed, paraffin-embedded (FFPE) tissue at the diagnosis not available
* Patients without available MRI, US or CT-scan images on digital media
* Clinical information not available or incomplete
* Any other malignancy in the previous 5 years or synchronous
* Patients aged under 18 years

Primary outcomes:
measure: Predictive value of the model
timeFrame: up to one year
Secondary outcomes:
measure: Validity of the model
timeFrame: up to one year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Agostino Gemelli IRCSS
state: Lazio
Study officials:
References:
Clinical trial NCT06593132: Single Port Endoscopic Breast Conserving Surgery
Official title: Prospective Clinical Study of Single Port Endoscopic Breast Conserving Surgery or Open Breast Conserving Surgery for Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Conserving Surgery
Endoscopic Surgery
Keywords: breast conserving surgery
single port endoscopic
early breast cancer
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients aged 20-70 years who are eligible for breast-conserving surgery and are willing to undergo breast-conserving surgery.

Brief summary: The center plans to carry out a prospective clinical study of single hole total endoscopic breast conserving surgery for early breast cancer compared with open breast conserving surgery, to provide high-level evidence-based medical evidence for the development of endoscopic breast conserving surgery for early breast cancer.

Detailed description: Data show that breast cancer has surpassed lung cancer asthemost prevalent malignant tumor in the world, and traditional open surgery is highly invasive and has poor cosmetic results. This study investigates the results of endoscopic breast- conserving surgery(E-BCS) versus conventional breast-conserving surgery(C-BCS) in the treatment of patients with early-stage breast cancer and to compare the advantages and disadvantages of the two surgical procedures, so as to provide the best evidence for the rational choice of the procedure by both doctors and patients.

Eligibility criteria: Inclusion Criteria:

1. Breast cancer confirmed by pathology；
2. Tumor \<5 cm, TNM stage 0-II；
3. Single Port Endoscopic or traditional open surgery; (4)20 to 70 years old female patients.

Exclusion Criteria:

1. Bilateral breast cancer;
2. Reconstruction after breast conserving surgery ;
3. Basic information is not complete；
4. Breast conserving surgery was converted to modified radical resection or subcutaneous adenoidectomy.

Primary outcomes:
measure: Six months after operation SURVIVAL EFFECTS
timeFrame: From enrollment to the end of 6 months after surgery
Secondary outcomes:
measure: Intraoperative blood loss
timeFrame: From the beginning to the end of the operation
measure: Postoperative drainage volume in the first three days after breast conserving surgery
timeFrame: 3 days after surgery
measure: Length of surgical incision
timeFrame: 1 week after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: the First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
References:
Clinical trial NCT06772532: A Study in Healthy People to Compare How 3 Different Formulations of Survodutide Are Taken up in the Body
Official title: Relative Bioavailability of Three Different BI 456906 Formulations Following Subcutaneous Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Three-period, Three-sequence Crossover Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2025-01-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main objective of this trial is to investigate relative bioavailability of BI 456906 formulation B and BI 456906 formulation C vs. BI 456906 formulation A.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests.
* Age of 18 to 55 years (inclusive).
* Body mass index (BMI) of 20 to 29.9 kg/m² (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.

Further inclusion criteria apply.

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm).
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator.

Further exclusion criteria apply.

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: Up to 22 days
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: Up to 22 days
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: Up to 22 days
Other outcomes:
Locations:
city: Biberach/Riß
country: Germany
facility: Humanpharmakologisches Zentrum Biberach
Study officials:
References:
Clinical trial NCT05719532: Core Strength and Coordinative Skills
Official title: Correlation of Core Strength/Core Stability and Coordinative Skills in Healthy Adults - an Explorative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postural Balance
Core Strength
Core Stability
Physical Fitness
Lead sponsor: Johannes Kepler University of Linz
Sponsor class: OTHER
Collaborators: name: Kepler University Hospital
First posted: 2023-02-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy young adults between 18 and 35 years.

Brief summary: Evaluation of healthy young adults regarding balance, core strength/core stability and physical fitness. Correlation of primary outcome parameters and selected secondary parameters.


Eligibility criteria: Inclusion Criteria:

* Adequat cognitive and lingual competence
* Written informed consent

Exclusion Criteria:

* low back pain or other painful disorders regarding the spine during the last 6 weeks
* Previous spine surgery
* Neurologic disease or disease of the vestibular organ
* Previous arthroplasty of joints

Primary outcomes:
measure: Center of pressure track (COPT)
timeFrame: Baseline
measure: Area of sway (AOS)
timeFrame: Baseline
measure: Core stability test of the Swiss Olympic Medical Center
timeFrame: Baseline
Secondary outcomes:
measure: Baecke Questionnaire of Habitual Physical Activity (BQHPA)
timeFrame: Baseline
measure: Stability energy
timeFrame: Baseline
measure: Harmony index
timeFrame: Baseline
measure: Frequency of sway
timeFrame: Baseline
measure: Feedback
timeFrame: Baseline
measure: Movement control
timeFrame: Baseline
measure: Weight distribution index
timeFrame: Baseline
measure: Body mass index (BMI)
timeFrame: Baseline
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Department of Physical Medicine & Rehabilitation, Kepler University Hospital
Study officials:
affiliation: Kepler University Hospital
name: Christian Mittermaier, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05207332: The Effect of a Vegan Alginate Product on Athletes Recovery and Performance
Official title: The Effect of a Vegan Alginate Product on Athletes Recovery and Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletic Performance
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Future Food Innovation
First posted: 2022-01-26
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The feeding strategies during recovery are essential to optimize a subsequent performance. Carbohydrate is a major fuel source during exercise as it has been shown to maintain high rates of carbohydrate oxidation. Protein intake in combination with carbohydrate have been shown to increase Amino acid bioavailability and may alter physiologic responses during exercise, which may be relevant to endurance performance. The goal of this study is to assess the effect of a new developed vegan product on athletes recovery and subsequent performance.


Eligibility criteria: Inclusion Criteria:

* males between 18-50 years of age
* moderate to trained individuals with a VO2max \> 50 ml/min/kg

Exclusion Criteria:

* persons diagnosed with metabolic diseases (i.e. Type 2 Diabetes) which relates to the carbohydrate metabolism.
* persons ingesting prescribed drugs/medicin, supplements or a special diet (i.e. low carbohydrate), which might affect the glykogen synthesis and/or performance.

Primary outcomes:
measure: Performance
timeFrame: Aprox. 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
References:
Clinical trial NCT05819632: Clinical Comparison of Application of Curcumin Gel in Pain Management After Free Gingival Graft Harvesting
Official title: Clinical Comparison of Topical Application of Curcumin Gel Versus Gelatin Sponge in Pain Management and Wound Healing After Free Gingival Graft Harvesting: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Palate; Wound
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to compare the effect of using 2% curcumin gel versus gelatin sponge when applied to palatal donor site in pain management and wound healing after free gingival graft harvesting.


Eligibility criteria: Inclusion Criteria:

1. Systematically healthy patient (American Society of Anesthesiology class I and II).
2. Male or female
3. Patients with mucogingival defects scheduled for free gingival graft.
4. Patients with good oral hygiene.

Exclusion Criteria:

1. Patients with any uncontrolled local or systemic disease where periodontal plastic surgery might be contraindicated.
2. History of recent periodontal surgery at the donor site.
3. Smokers.
4. Pregnancy and lactation.
5. Patients allergic to the used agents,
6. Severe gagging reflex.
7. Inability or unwillingness to provide informed consent.

Primary outcomes:
measure: post-operative pain
timeFrame: one week post operative
Secondary outcomes:
measure: Soft tissue healing of the palatal wound
timeFrame: up to three weeks post-operative
measure: Re-epithelization of the palatal wound
timeFrame: up to three weeks post-operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
state: Manial
Study officials:
affiliation: master student
name: tansim k abdelrahman, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecture of oral medicine and periodontology, faculty of dentistry ,Cairo university
name: mohamed Atef, PHD
role: STUDY_DIRECTOR
affiliation: Professor of oral medicine and periodontology factuality of Dentistry,Cairo university
name: manal m hosny, phd
role: STUDY_CHAIR
References:
Clinical trial NCT01053832: Ventricular Pace Suppression Study
Official title: Ventricular Pace Suppression Study With the EVIA/ENTOVIS DR-T/DR Pacemaker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pacemaker Indication
Keywords: ventricular pace suppression
pacemaker
efficacy
safety
support of intrinsic heart rhythm
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2010-01-21
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.

Detailed description: The aim of this study is to investigate the percentage of reduction of ventricular pacing using the VpS feature of the EVIA/ENTOVIS pacemaker in a controlled clinical investigation.

Eligibility criteria: Inclusion Criteria:

* Paroxysmal AV block and/or Sinus Node Dysfunction
* DDD(R)-ADI(R)-Mode (VpS Algorithm) applicability

Exclusion Criteria:

* Permanent AV block III°
* Permanent Atrial Fibrillation/ Flutter
* Require mode other than DDD(R)-ADI(R) or DDD(R)
* Have a life expectancy of less than six months
* Expected to receive heart surgery within six months
* Enrolled in another cardiac investigation

Primary outcomes:
measure: Reduction of right ventricular pacing with the help of the VpS algorithm in the EVIA/ ENTOVIS pacemakers.
timeFrame: 6-8 months
Secondary outcomes:
measure: A Complication free rate >95%, with respect to the VpS feature of the implanted pacemaker.
timeFrame: 6-8 months
Other outcomes:
Locations:
city: Coburg
country: Germany
facility: Klinikum Coburg gGmbH
state: Bavaria
city: Kiel
country: Germany
facility: Abteilung für Elektrophysiologie, Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Kiel
name: Hendrik Bonnemeier, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03536832: Subcuticular Skin Closure at Cesarean Delivery
Official title: Comparison of Suture Materials for Subcuticular Skin Closure at Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section; Infection
Keywords: Cesarean Section; Complications
suture material
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Subcuticular skin closure with suture after cesarean has been shown to result in lower rates of wound complications than with staple closure. However, the optimal choice of suture material for subcuticular skin closure is unclear. Vicryl vs Prolen suture materials will be used for subcuticular closure of transverse skin incisions after cesarean section. Patients will be controlled for superficial surgical site infections 1 week after the cesarean section.

Detailed description: Cesarean section is the most common abdominal surgery worldwide. Subcuticular skin closure with suture after cesarean has been shown to result in lower rates of wound complications than with staple closure. However, the optimal choice of suture material for subcuticular skin closure is unclear. Vicryl vs Prolen suture materials will be used for subcuticular closure of transverse skin incisions after cesarean section. Patients will be controlled for superficial surgical site infections 1 week after the cesarean section.

Eligibility criteria: Inclusion Criteria:

* Age 18-40
* women undergoing cesarean section

Exclusion Criteria:

* body mass index\>30

Primary outcomes:
measure: surgical site infection
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni SSTRH
Study officials:
affiliation: KSSTRH
name: Berna Aslan A Çetin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00580632: Study Evaluating Workload, Clinical and Therapeutic Management of Psoriatic Arthritis
Official title: Workload, Clinical and Therapeutic Management of Psoriatic Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-27
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Psoriatic Arthritis Patients with a representative geographic sample

Brief summary: In Spain, there is little data available concerning the evolution and treatment of Psoriatic Arthritis by rheumatologists and dermatologists. This study is designed to obtain more data about the clinical and therapeutic management of Psoriatic Arthritis in Dermatology and Rheumatology Medical centers.


Eligibility criteria: Inclusion Criteria:

1. patients older than 18 years with a psoriatic arthritis diagnosis that go to dermatologic and/or rheumatologic centers or primary care centers.
2. patients that receive pharmacologic treatment for their condition
3. patients that give their written consent to participate

Primary outcomes:
measure: Determine diagnosis and evolution time of patients
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01117532: Brief Group Intervention Using EFT (Emotional Freedom Techniques) for Depression in College Students
Official title: Brief Group Intervention Using EFT (Emotional Freedom Techniques) for Depression in College Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Depression
Keywords: students,
depression,
group therapy,
EFT (Emotional Freedom Techniques),
energy psychology
Lead sponsor: Soul Medicine Institute
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Depression is an important mental health concern in college students. This study will recruit students who test positive for moderate to severe depression on the Beck Depression Inventory (BDI). Subjects will be randomly assigned to either a treatment or a control condition. Those in the treatment group will receive four 90 minute group classes using EFT (Emotional Freedom Techniques) to address traumatic memories and other self-identified causes of depression. It will compare them to a no treatment control group.


Eligibility criteria: Inclusion Criteria:

* A score of 19 or more on the Beck Depression Inventory
* Currently enrolled at the University of Santo Tomas
* Able to read, understand, and complete forms

Exclusion Criteria:

* None

Primary outcomes:
measure: Student scores on the Beck Depression Inventory (BDI)
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: College of Science, University of Santo Tomas
Study officials:
References:
citation: Church D, De Asis MA, Brooks AJ. Brief group intervention using emotional freedom techniques for depression in college students: a randomized controlled trial. Depress Res Treat. 2012;2012:257172. doi: 10.1155/2012/257172. Epub 2012 Jul 17.