louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06035133: Treatment of Low Locally Advanced Rectal Cancer With Radiotherapy Removal TNT Plus Neoadjuvant Therapy
Official title: One Arm Exploratory Trial of Efficacy and Safety of TNT Plus Mode With Neoadjuvant Radiotherapy in the Treatment of Locally Advanced Medium-low Rectal Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: (1) To evaluate the oncological effects of Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT plus mode on TRG, Anal sphincter preservation surgery rate / rectal preservation surgery rate, cCR rate, pCR rate and other oncological effects in patients with middle and low LARC; (2) Evaluate the R0 resection rate, LARS score, urination function and sexual function score, local recurrence rate, and 3-year DFS and OS of Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT plus mode, resolve the current dispute about the Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT treatment mode of LARC, provide a new mode for LARC treatment, and hopefully rewrite the diagnosis and treatment guidelines for rectal cancer.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 70;
* Histologically confirmed adenocarcinoma of rectum;
* The distance from the lower edge of the tumor to the anus is ≤ 10cm;
* ECOG score ≤ 1;
* Have not received any anti-tumor treatment before;
* Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2; M0 chest and abdomen CT showed no obvious metastasis. (Note: PET-CT is recommended when small nodules can not be identified by liver or lung CT, and can still be included in the group when considering the possibility of metastasis)
* Hematological indicators and liver and kidney function within 7 days are within the normal range;
* Sign the informed consent form and be able to follow the research and /or follow-up procedures.

Exclusion Criteria:

* Have serious basic diseases, such as heart disease, renal failure, severe liver failure or liver failure, coagulation dysfunction, etc; Postoperative recurrence of colorectal cancer;
* The patient had a history of malignant tumor within 5 years;
* Pregnant or lactating women;
* The patient has a history of adjuvant radiotherapy for other system diseases, and surgical contraindications, so it is not suitable for surgery;
* The patient has had radiotherapy and chemotherapy records before this visit;
* Distant metastasis was found during operation;
* Patients with poor radiotherapy compliance and difficult cooperation;

Primary outcomes:
measure: tumor regression grading, TRG
timeFrame: one month after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02480933: Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens
Official title: Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Breast Cancer
Male Breast Cancer
Lead sponsor: Centro Hospitalar Lisboa Ocidental
Sponsor class: OTHER_GOV
Collaborators: name: Instituto Nacional de Medicina Legal e Ciências Forenses, Delegação do Sul
First posted: 2015-06-25
Enrollment: 768
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to define silent breast cancer prevalence in both sexes and will be held by biopsies performed in imaging suspicious areas of the breast (ecography and mammography) in cadavers without known breast cancer.

Detailed description: Cadavers of both sexes are going to be submitted to bilateral mastectomy. The specimens are going to be examined by palpation, ecography and mammography and all areas with (Breast Imaging Reporting and Data System) BI-RADS classification \>= 3 are going to be biopsied.

Biopsy specimens are going to be processed by the pathology department and cancers are going to be identified and classified by their molecular type.

The investigators intend to know which is the disease reservoir in various ages.

Eligibility criteria: Inclusion Criteria:

* Female and male cadavers above 40 years

Exclusion Criteria:

* Known breast cancer
* Breast tissue accidental damage

Primary outcomes:
measure: Silent breast cancer prevalence
timeFrame: 2 years
Secondary outcomes:
measure: Silent breast cancer prevalent molecular profile
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01515033: Aerobic Exercise on PETCO2 Response in Coronary Artery Disease Patients
Official title: Effect of Continuous and Interval Exercise Training on PETCO2 Response During Graded Exercise Test in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Exercise Addiction
Complication, Cardio-respiratory
Keywords: Coronary artery disease
Exercise
Ventilatory efficiency
Lead sponsor: Hospital TotalCor
Sponsor class: OTHER
First posted: 2012-01-23
Enrollment: 37
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study was to evaluate: 1) the effects of continuous exercise training and interval exercise training on end-tidal carbon dioxide pressure (PETCO2) response during graded exercise test in patients with coronary artery disease; and 2) examine the effects of exercise training modalities on the association among PETCO2 at ventilatory anaerobic threshold (VAT) and indicators of ventilatory efficiency and cardiorespiratory fitness in patients with coronary artery disease.

Detailed description: End-tidal carbon dioxide pressure (PETCO2) is a noninvasive index considered to be a good indicator in evaluating the ventilation/perfusion relationship in patients over a wide range conditions. Variations in PETCO2 have been shown to reflect changes in both cardiac output and pulmonary blood flow in animals and humans under constant ventilation. In this regard, it has been shown that patients with cardiac disease have an abnormally low PETCO2 during exercise, especially those with an impaired response of cardiac output during exercise

Eligibility criteria: Inclusion Criteria:

* was stable coronary artery disease diagnosed by coronary angiography

Exclusion Criteria:

* unstable angina pectoris,
* complex ventricular arrhythmias,
* pulmonary congestion and
* orthopaedic or neurological limitations to exercise

Primary outcomes:
measure: PetCO2 response during graded exercise test
timeFrame: before and after 3 months of the interventions
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital TotalCor
name: Danilo ML Prado, Prof.MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03021733: A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears
Official title: A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Full Thickness Rotator Cuff Tear
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to an orthopaedic clinic with full-thickness rotator cuff tears as determined by surgeon opinion and imaging

Brief summary: This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears.

Detailed description: This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears. Pragmatic or effectiveness clinical trials reflect real world settings and thus have greater external generalizability than efficacy trials. The evaluation component in this trial will be three-fold: first, the study team will compare the success of patients undergoing operative versus non-operative management and identify which variables predict success in each group; second, investigators will attempt to predict which patients end up choosing, along with their care giver(s), operative versus non-operative management by examining the predictive capability of a selection of variables; third, investigators will evaluate the clinical research site(s), personnel, and implementation processes for their capability to implement clinical trials with the intent of planning for a future large multi-site clinical trial building on the results of the present study.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age with full-thickness rotator cuff tears eligible for operative repair

Exclusion Criteria:

* less than 18 years old,
* non-operative rotator cuff tears,
* calcific tendonitis, fracture, adhesive capsulitis,
* severe osteoarthritis of the shoulder,
* no prior shoulder surgery

Primary outcomes:
measure: Veterans Rand VR-12 Quality of Life Score
timeFrame: baseline
measure: Veterans Rand VR-12 Quality of Life Score
timeFrame: 4 weeks
measure: Veterans Rand VR-12 Quality of Life Score
timeFrame: 8 weeks
measure: Veterans Rand VR-12 Quality of Life Score
timeFrame: 16 weeks
measure: Veterans Rand VR-12 Quality of Life Score
timeFrame: 32 weeks
measure: Veterans Rand VR-12 Quality of Life Score
timeFrame: 48 weeks
measure: Veterans Rand VR-12 Quality of Life Score
timeFrame: 64 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00699933: Diagnostic and Interventional Therapy in Acute Pancreatitis
Official title: Diagnostic and Interventional Therapy in Acute Pancreatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Pancreatitis
Keywords: acute pancreatitis
interventional therapy
CT-guided drainage therapy
percutaneous necrosectomy
Comparison of different diagnostic procedures: MRI, CT, Ultrasound
Evaluation of interventional therapy including percutaneous drainage techniques und necrosectomies
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2008-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 patients with acute pancreatitis

Brief summary: The study aims to evaluate the course of patients with acute pancreatitis. Thereby we analyze different diagnostics and compare ultrasound, MRI and CT-scan in detection of necrotic areas and evaluate interventional therapy methods like percutaneous drainage techniques regarding the outcome. Laboratory values were assessed as well.

Detailed description: For laboratory values different inflammation markers were measured and compared.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Acute pancreatitis
* Written formal consent

Exclusion Criteria:

* Pregnancy
* Missing formal consent
* Individual contraindications for CT-scan
* MRI or endoscopic ultrasound

Primary outcomes:
measure: Length of hospital stay
timeFrame: weekly
Secondary outcomes:
measure: time to surgery
timeFrame: weekly
measure: active necrosectomy
timeFrame: weekly
measure: ICU stay
timeFrame: weekly
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Department of Internal medicine I, University of Regensburg
Study officials:
affiliation: Director of Department of Internal Medicine I
name: Jürgen Schölmerich, Prof.
role: STUDY_DIRECTOR
affiliation: Director of Department of Radiology
name: Stefan Feuerbach, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06629233: Evaluation of a Novel Technique for the Discovery of New, Tumor-specific Targets for the Deployment of Innovative Immunotherapeutics Against Cancer.
Official title: Tn-Miner: Technology for the Discovery of Tumor-specific Glycopeptide Immunotherapy Targets.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Estrogen Receptor Positive Breast Cancer
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
name: Algemeen Ziekenhuis Maria Middelares
First posted: 2024-10-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this interventional, prospective research on human bodily material is to discover new, cancer-specific molecular structures (i.e. glycopeptides) within surgically removed, estrogen receptor positive breast cancer tumors.

The main goal it aims to achieve is:

To discover tumor-specific targets, that allow the use of very potent immunotherapeutic drugs as treatment for solid tumors, such as estrogen receptor positive breast cancer. These new targets are very specific for cancer cells, meaning that virtually no healthy cells should be attacked by the treatment, resulting in less side effects.

Participants will undergo standard of care treatment, comprising surgical removal of the breast tumor. Part of these tissues will be used for this clinical research.


Eligibility criteria: Inclusion Criteria:

* Female
* Minimally 18 years old
* Diagnosed with estrogen-receptor positive breast cancer
* This must be a primary tumor

Exclusion Criteria:

* Male
* Younger than 18 years old
* Previous history of other tumors

Primary outcomes:
measure: Discovery of new, tumor-specific, glycopeptide epitopes.
timeFrame: The patients are only involved during their standard of care surgery (one day). The discovered epitopes will not be shared with enrolled patients.
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: AZ Maria Middelares
state: East-Flanders
city: Ghent
country: Belgium
facility: University Hospital Ghent
state: East-Flanders
Study officials:
References:
Clinical trial NCT05529433: Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars
Official title: Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries in Children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 33
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the clinical trial is to assess pain during Atraumatic Restorative Treatment (ART), Smart Burs and Chemo-mechanical Caries Removal (CMCR) in primary molars.

Detailed description: The principles of the caries removal have changed greatly in the last decade. The use of local anesthesia with conventional techniques"high-speed hand piece" increase the fear and anxiety of the child. Minimally invasive techniques reduce the pain and anxiety of the child by eliminating the use of local anesthesia.

In ART, soft carious tissue is removed by hand instruments. Although this technique is very simple.

Moreover, Smart Burs are more efficient in removal of soft infected dentine than ART leaving the affected dentin intact; as when they touch hard dentin, they become dull.

Finally, the recent effective method of caries removal is CMCR. The chemical agent contains proteolytic enzyme which destructs partially degraded collagen, leaving the infected dentin soft and easy to be excavated.

Therefore, the aim of this study is to assess pain during Atraumatic Restorative treatment, Smart Burs and Chemo-Mechanical Caries Removal in primary molars.

Eligibility criteria: Inclusion Criteria:

* Caries in second primary molars within enamel/ dentin without pulp disease.
* There is a clear band of dentin coronal.
* Cooperative and healthy children.

Exclusion Criteria:

* Presence of signs and symptoms of necrosis.
* Root caries.
* History of spontaneous pain.

Primary outcomes:
measure: Pain assessment
timeFrame: at baseline
Secondary outcomes:
measure: Time taken for caries removal
timeFrame: at baseline
measure: Efficacy of caries removal
timeFrame: at baseline
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Rania Nasr, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Rasha Hatem, Associate Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Reham Mahmoud, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04102033: Eltrombopag in Chronic ITP
Official title: Efficacy of Eltrombopag in Chronic Immune Thrombocytopenia in Pediatrics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Immune Thrombocytopenia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of eltrombopag on the platelet count in pediatric patients with chronic immune thrombocytopenia.


Eligibility criteria: Inclusion Criteria:

1. Pediatric patients with chronic ITP aged 1 to 17 years.
2. Platelet count is less than 30×109 per liter.
3. Patients neither have had spontaneous resolution of the thrombocytopenia nor responded to corticosteroids and/or IV immunoglobulin.

Exclusion Criteria:

1. Patients with clinical and/or laboratory evidence of hepatotoxicity/liver decompensation (Hepatotoxicity due to eltrombopag is defined as increased serum alanine aminotransferase ≥3 times the upper limit of normal (ULN), aspartate aminotransferase ≥3 ULN, alkaline phosphatase \>1.5 ULN, total bilirubin \>1.5 ULN)
2. Patients with history of thrombotic/thromboembolic events.

Primary outcomes:
measure: Measuring the platelet count response to eltrombopag in pediatric chronic ITP
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Corman SL, Mohammad RA. Eltrombopag: a novel oral thrombopoietin receptor agonist. Ann Pharmacother. 2010 Jun;44(6):1072-9. doi: 10.1345/aph.1P042. Epub 2010 May 11.
citation: Bussel JB, de Miguel PG, Despotovic JM, Grainger JD, Sevilla J, Blanchette VS, Krishnamurti L, Connor P, David M, Boayue KB, Matthews DC, Lambert MP, Marcello LM, Iyengar M, Chan GW, Chagin KD, Theodore D, Bailey CK, Bakshi KK. Eltrombopag for the treatment of children with persistent and chronic immune thrombocytopenia (PETIT): a randomised, multicentre, placebo-controlled study. Lancet Haematol. 2015 Aug;2(8):e315-25. doi: 10.1016/S2352-3026(15)00114-3. Epub 2015 Jul 28.
Clinical trial NCT06882733: The Immediate Effect of Applying Transcutaneous Electrical Nerve Stimulation (TENS) on Sympathetic Ganglion and Gastrocnemius for Popliteal Blood Flow
Official title: The Immediate Effect of Applying Transcutaneous Electrical Nerve Stimulation (TENS) on Sympathetic Ganglion and Gastrocnemius for Popliteal Blood Flow
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Transcutaneous Electrical Nerve Stimulation (TENS)
Popliteal
Blood Flow
Sympathetic Ganglia
Keywords: transcutaneous electrical nerve stimulation (TENS)
blood flow
sympathetic ganglia
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the immediate hemodynamic effects of transcutaneous electrical nerve stimulation (TENS) on the popliteal artery and vein. Vascular issues like PAOD and DVT are common in patients with diabetes, obesity, or immobility due to increased resistance and reduced blood flow. Traditional treatments (medication or surgery) are not always feasible, prompting interest in TENS as an alternative. Although primarily used for pain relief, TENS may enhance blood flow. This research compares different stimulation frequencies (80 Hz vs. 4 Hz) and sites (gastrocnemius muscle vs. thoracolumbar sympathetic ganglia) to identify the most effective configuration.


Eligibility criteria: Inclusion Criteria:

1. Healthy people
2. Age: 18 years and above (inclusive)
3. Body mass index (BMI) between 18.5 and 24

Exclusion Criteria:

1. Unable to complete two interventions within a week
2. Have contraindications to electrotherapy (for example: metal implants in the body, open wounds, pregnancy, sensory loss)
3. Obvious varicose veins 4. Unable to lie down for about 1 to 2 hours 5. Taking drugs or nutritional supplements that affect autonomic nervous activity or vasodilation (for example: Ginkgo biloba) 6. Smoking 7. Ankle and Ankle Index (ABI) less than 0.9 or greater than 1.3

Primary outcomes:
measure: Doppler ultrasound measurement of changes in popliteal fossa blood flow
timeFrame: 45 minutes
Secondary outcomes:
measure: heart rate
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
References:
Clinical trial NCT03878433: Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity.
Official title: Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity. A Prospective Randomized Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melasma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Oxidative stress has been reported to play a role in melasma pathophysiology. The objective of the study is to compare oral superoxide dismutase (GLISODin) to placebo, in combination to sunscreen to decrease melasma severity.


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed melasma in adult patient
* signed inform consent

Exclusion Criteria:

* Pregnant women
* Other pigmentary disorder of the afce
* Use of depigmentant agent in the month before the inclusion
* Use of topical steroid, tretinoin, hydroquinone in the month before the inclusion
* Coeliac disease or allergy to gluten

Primary outcomes:
measure: Severity of melasma
timeFrame: At baseline and at 12 weeks
Secondary outcomes:
measure: Quality of life of patient: VAS (Visual Analog Scale)
timeFrame: At baseline and at 12 weeks
measure: Satisfaction of the patients: VAS (Visual Analog Scale)
timeFrame: At baseline and at 12 weeks
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Dermatology
state: Alpes-Maritime
Study officials:
affiliation: Dermatologie, CHU de Nice
name: Passeron Thierry, PhD
role: PRINCIPAL_INVESTIGATOR
References: