louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02114086: IORT-Boost-Study, Prospective Observational Study for Intraoperative Radiotherapy of the Breast as a Boost
Official title: Prospective Observational Study for Intraoperative Radiotherapy (IORT) of the Breast as a Boost
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Adverse Effect of Radiation Therapy
Keywords: Observational Study
intraoperative Radiation of Breast Cancer
early and late effects of radiation
cosmesis and quality of life
Lead sponsor: Kantonsspital Münsterlingen
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 163
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with breast cancer breast-conserving therapy

Brief summary: In this study the investigators observe the investigation, whether the new method for Boost-Irradiation with the Intrabeam Device of Zeiss Germany influences local recurrence, acute and late effects of Radiotherapy, overall survival, quality of life and cosmesis.


Eligibility criteria: Inclusion Criteria:

* women with histologically proven unifocal ductal-invasive or other histology of breast-cancer, size of tumor \< or = 3.5 cm
* written informed consent
* ability to cooperate
* full legal capability

Exclusion Criteria:

* missing written informed consent
* lack of compliance

Primary outcomes:
measure: number of Participants with local recurrence histologically proven
timeFrame: up to 10 years
Secondary outcomes:
measure: observation of acute and late effects of Radiotherapy
timeFrame: up to 10 years
measure: Overall survival
timeFrame: up to 10 years
measure: Quality of life
timeFrame: up to 10 years
measure: Cosmesis
timeFrame: up to 10 years
Other outcomes:
measure: observation of influence of smoking
timeFrame: up to 10 years
Locations:
city: Münsterlingen
country: Switzerland
facility: KMünsterlingen
state: Thurgau
Study officials:
affiliation: Kantonsspital Münsterlingen
name: Christiane Reuter, Dr. med.
role: STUDY_DIRECTOR
References:
citation: Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Warlam-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. doi: 10.1200/JCO.2007.11.4991. Epub 2007 Jun 18.
Clinical trial NCT03323086: Women SHARE Study: Reducing Sexual Risk
Official title: Reducing Alcohol-related HIV/STI Risk for Women in Reproductive Health Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol and Substance-Related Mental Disorders
Sexually Transmitted Diseases
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Planned Parenthood of Southern New England
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2017-10-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate whether BI and technology extenders are feasible and acceptable for female patients at a reproductive health center (ages 18-29).

Detailed description: This study will assess the feasibility and acceptability, and obtain initial evidence of the efficacy, of the BI and technology extenders. At-risk women drinkers (N = 50) recruited from a reproductive health care clinic will be assessed, randomly assigned to the integrated BI or control (a Centers for Disease Control and Prevention-produced brochure with information about alcohol and women's health), and reassessed at 3 months to determine impact on alcohol use, condom use, and number of partners as well as hypothesized mediators.

Eligibility criteria: Inclusion Criteria:

* Female
* Age 18-29 years
* Meeting NIAAA definition of "at-risk" drinking (\>3 drinks on any day in the last 3 months18 and/or \>7 drinks per week)
* Sexual risk behavior (i.e., last 3 months: vaginal/anal intercourse with \>1 partner; vaginal/anal intercourse with a partner who has other partners; inconsistent condom use; new relationship (under 3 months))
* English speaking
* Absence of acute intoxication, depression, or suicidal ideation
* No plans for relocation

Exclusion Criteria:

* Male
* Under 18 years old or older than 29 years old
* Non-English speaking
* Suicidal Ideation
* Relocating
* Clinic provider advising against recruitment in the study
* Unwilling or unable to provide consent

Primary outcomes:
measure: Feasibility of Providing Intervention
timeFrame: Immediately following intervention session (post-intervention), up to 30 minutes
Secondary outcomes:
measure: Session Evaluation Questionnaire
timeFrame: Immediately following intervention session (post-intervention), up to 30 minutes
measure: Number of Sexual Partners
timeFrame: 3-month Follow-up
measure: Condomless Sex
timeFrame: 3-month Follow-up
measure: Alcohol Use Quantity
timeFrame: 3-month Follow-up
measure: Alcohol Use Binge Frequency
timeFrame: 3-month Follow-up
Other outcomes:
Locations:
city: Providence
country: United States
facility: Planned Parenthood of Southern New England
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Michael P Carey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05202886: "LiverColor": Machine Learning in Liver Photographs
Official title: "LiverColor": AN ALGORITHM QUANTIFICATION OF LIVER GRAFT STEATOSIS USING MACHINE LEARNING AND COLOR IMAGE PROCESSING
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Death
Liver Steatosis
Keywords: machine learning
liver donor (DBD)
liver steatosis
liver pictures
liver pool
Lead sponsor: Hospital Vall d'Hebron
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 246
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Liver from deceased donors
Primary purpose: DIAGNOSTIC

Brief summary: The main goal of this project is to create a machine learning model in order to quantify liver steatosis in liver donor faster, more objective and reliable than histological analysis and surgeons point-of-view.

Detailed description: Surgeons (junior and senior operators) from the HBP \& Transplantation Unit took the pictures. They were taken after the laparotomy and before any type of surgical procedure. For each deceased donor case, a total of 5 pictures were taken: one for the left lobe and another for the right one before undergoing a surgical biopsy, two more (one for the left and one for the right lobe) after the histological analysis, near to the site of the surgical biopsy, and finally, one picture after liver perfusion.

Eligibility criteria: Inclusion Criteria:

* Livers from donor donor brain death with informed consent before inclusion in the study was obtained from all participants or families.

Exclusion Criteria:

* Age \< 18 years old
* Donor after cardiac death
* Split
* Cholestasis due to a biliary obstruction
* Total bilirubin levels above 2,5 mg/dL
* Glutamic oxaloacetic transaminase (SGOT)/ serum glutamatepyruvate transaminase (SGPT) levels and gamma-glutamyl transaminase (GGT) levels above 400 U/L
* Cirrhotic livers

Primary outcomes:
measure: The main goal of this project is to create a machine learning model in order to quantify liver steatosis in liver donor faster, more objective and reliable than histological analysis and surgeons point-of-view.
timeFrame: 4 weeks
Secondary outcomes:
measure: To build an image dataset to evaluate postransplant liver function.
timeFrame: 1 week
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Concepción Gómez-Gavara
Study officials:
affiliation: Vall D´Hebron University Hospital
name: Concepcion Gómez-Gavara, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01937286: Single Center Experience Over a Decade in Living Donor Liver Transplantation for Egyptian Patients With Hepatocellular Carcinoma: Stretching the Limits
Official title: Single Center Experience Over a Decade in Living Donor Liver Transplantation for Egyptian Patients With Hepatocellular Carcinoma: Stretching the Limits
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrence of HCC After LDLT
Keywords: LDLT,HCC, Microvascular invasion
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2013-09-09
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptien Patient with HCC who underwent LDLT

Brief summary: Within community with high incidence of HCC, stretching the limits could be justified based on tumor characters and its biological behavior

Detailed description: 590 Egyptian patients underwent LDLT; of them, 172 (32%) patients were transplanted for HCC. Twenty six cases (15.1%) were excluded due to early postoperative mortality (n=22) or due to non HCC related mortality (n=4). One hundred forty six patients were retrospectively reviewed to determine prognostic factors for recurrence.

Eligibility criteria: Inclusion Criteria:

* Egyptien Patients with HCC
* Patients within Milan Criteria
* Patients beyond Milan criteria are selected on a case by case basis until 2005. From 2005 , patients beyond Milan criteria are subjected to down staging protocol and then reassessed (pre transplantation local ablative therapy either with RFA or TACE according to the size and the site of the lesion and we wait for 12 weeks after ablation ,only those with well ablated lesions, decreased AFP and no denovo lesions were transplanted).

Exclusion Criteria:

* • Evidence of macro vascular invasion by CT portography and/or US duplex.

  * Metastatic HCC
  * General contraindications for LT (ongoing sepsis, other major co morbidities,...).
  * Early postoperative mortality (first1 month).
  * Post transplant mortality during the period of follow up due to any cause other than recurrent HCC (e.g. sepsis, rejection, cardiological or cerebrovascular complications...)

Primary outcomes:
measure: Recurrence of Hepatocellular carcinoma after LDLT
timeFrame: at least 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo,
country: Egypt
facility: Ain Shams Center For Organ Transplantation (ASCOT),Ain Shams university
Study officials:
References:
Clinical trial NCT04603586: Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses
Official title: A Prospective Phase Ⅱ Clinical Study of Stereotactic Radiotherapy Combined With Chemotherapy With Different Biological Effective Doses (60-70gy vs. >70Gy) in Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment
Keywords: SBRT
Locally Advanced Pancreatic Cancer
Biological Effective Dose
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the safety and efficacy of SBRT in LAPC with different biological effective dose (BED) (60-70Gy Vs.\>70Gy ) , to identify a dose range that could achieve better survival benefit and minimize the toxicity of radiotherapy.


Eligibility criteria: Inclusion Criteria:

* 18≤Age≤75 years
* Cytologically or histologically verified pancreatic adenocarcinoma or clinically diagnosed as pancreatic cancer by multidisciplinary consultation
* locally advanced pancreatic cancer (LAPC)
* SBRT was not preceded by any targeted antitumor therapy
* ECOG 0-1
* Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures

Exclusion Criteria:

* Patients who have previously received related treatment because of pancreatic adenocarcinoma, such as radiotherapy, chemotherapy or focal treatment
* Patients with severe liver or kidney dysfunction
* Patients with obstructive jaundice
* Patients with mass ascites
* Patients participated in other clinical trials for less than three months
* Patients with other malignancies, or acute or other severe infections, with ulcerative colitis, inflammatory bowel disease, ect
* Unsuitable to participate in this clinical trial judged by the investigator

Primary outcomes:
measure: 1-year Disease Progression-Free-Survival (DPFS)
timeFrame: 1-year
Secondary outcomes:
measure: The Probability of gastrointestinal (GI) Toxicity
timeFrame: 1-year
measure: 1-year Local Control Rate
timeFrame: 1-year
measure: Overall Survival
timeFrame: 1-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
Study officials:
References:
citation: Ye Y, Zhu X, Zhao X, Jiang L, Cao Y, Zhang H. Biologically effective doses of 60-70Gy versus >70Gy of stereotactic body radiotherapy (SBRT) combined with chemotherapy in locally advanced pancreatic cancer: protocol of a single-centre, phase II clinical trial. BMJ Open. 2022 Aug 29;12(8):e049382. doi: 10.1136/bmjopen-2021-049382.
Clinical trial NCT05079763: Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis
Official title: Bacterial Cellulose-monolaurin Hydrogel for Preventing Therapy-induced High-grade Acute Dermatitis Among Filipinos With Breast Adenocarcinoma: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Radiation Dermatitis
Keywords: ARD
postmastectomy
breast cancer
breast adenocarcinoma
Lead sponsor: University of the Philippines
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Acute radiation dermatitis (ARD) is almost universally experienced by patients with cancer during or after radiation therapy. This condition potebtxallt leads to detrimental clinical outcomes as it adversely affects adherence to prescribed subsequent management and further worsens quality of life. Nevertheless, there remains no consensus on the appropriate intervention for ARD. This pilot two parallel-group randomized trial aims to clinically assess the potential of bacterial cellulose-monolaurin hydrogel, compared to placebo cream, to prevent high-grade ARD among Filipinos with breast cancer up to four weeks after last radiotherapy session.


Eligibility criteria: Inclusion Criteria:

* Female sex at birth
* Age at least 18 years at the time of invitation
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of either 0 or 1
* With histopathologic diagnosis of breast carcinoma
* Already completed prescribed mastectomy and chemotherapy (adjuvant or neoadjuvant) interventions
* Scheduled to receive hypo fractionated postmastectomy-postchemotherapy radiation therapy

Exclusion Criteria:

* Pregnant or lactating
* With concurrent or previous history of any malignancy
* With history of mediastinal or thoracic irradiation
* With current bilateral synchronous breast carcinoma
* With diagnosis of metastases from any form of breast cancer
* With any skin lesion in the planned radiation field deemed deramtologically and/or radiotherapeutically relevant
* With concomitant disease states deemed clinically significant (connective tissue diseases, infections, uncontrolled chronic disorders, renal failure, hepatic dysfunction, etc.)
* With known history of hypersensitivities and/or reactions against any component of either experimental or comparator interventions
* Inability to personally provide informed consent or to personally comply with skin care instructions

Primary outcomes:
measure: Incidence of high grade acute radiation dermatitis
timeFrame: Baseline to Week 4 post-radiotherapy
Secondary outcomes:
measure: Distribution of participants in terms of ARD CTCAE grades
timeFrame: Baseline to Week 4 post-radiotherapy
measure: Patient-reported quality of life
timeFrame: Baseline to Week 4 post-radiotherapy
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Philippine General Hospital
Study officials:
References:
Clinical trial NCT05923463: Precision Feedback to Improve Health Care Quality
Official title: A Scalable Service to Improve Health Care Quality Through Precision Audit and Feedback: A Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anesthesia Care Quality
Keywords: Audit and feedback
Anesthesiology
Learning health system
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2023-06-28
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This cluster-randomized trial will assess the effectiveness of a precision feedback service on anesthesia provider performance. The precision feedback service enhances a standard audit and feedback (A\&F) email with a brief message and visual display about high-value performance information. The control arm will receive a standard "one size fits most" A\&F email that is currently sent to anesthesia providers each month. Hypothesis: Providers receiving precision feedback will increase a) care quality for improvable measures and b) email engagement (click-through and dashboard login rates) when compared with providers receiving standard A\&F emails. The study investigators will assess unintended consequences in a mixed-methods process evaluation.


Eligibility criteria: Inclusion Criteria (assessed before interventional period):

* Participation in the Multicenter Perioperative Outcomes Group (MPOG) provider feedback email program.

Exclusion Criteria (assessed after interventional period):

* Ended participation in the MPOG provider feedback email program for any reason during the study period
* Changed professional roles (e.g. transitioned from resident to attending) before the end of the intervention period
* Changed institutions during the study period
* Had no institution-selected quality measures in common between the pre-intervention and intervention period
* Were not candidates to receive a precision feedback email for the majority of the trial.

Primary outcomes:
measure: Measure success rate (M) for operative cases of anesthesia care providers
timeFrame: Up to 1 year
Secondary outcomes:
measure: Average email click-through rate (CTR)
timeFrame: Up to 6 months
measure: Average dashboard login rate (L)
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Zach Landis-Lewis
role: PRINCIPAL_INVESTIGATOR
References:
citation: Landis-Lewis Z, Flynn A, Janda A, Shah N. A Scalable Service to Improve Health Care Quality Through Precision Audit and Feedback: Proposal for a Randomized Controlled Trial. JMIR Res Protoc. 2022 May 10;11(5):e34990. doi: 10.2196/34990.
Clinical trial NCT06824363: ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma w/ARID1a Mu
Official title: Proof of Principle Study Evaluating Single Dose Dual Immune Checkpoint Inhibitors to Increase Intra-tumoral T Cells in Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinomas With ARID1A Mutations: ESR-22-22082
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Solid Tumor, Adult
Malignant Solid Tumor
Stomach Adenocarcinoma
Esophageal Adenocarcinoma
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a proof of principle clinical trial determining efficacy of single dose dualimmune checkpoint inhibitors to increase intra-tumoral T cells in esophageal, gastroesophageal junction, and gastric adenocarcinomas. These are subjects who have not previously been treated for their disease, who are willing to undergo biopsy procedures, who's disease has not spread to other parts of the body, who's tumors have ARID1A mutations.


Eligibility criteria: Inclusion Criteria:

* Non metastatic GEC including locally advanced unresectable
* Treatment naïve
* Histologically proven adenocarcinoma of the esophagus or the stomach with ARID1a mutation either by liquid biopsy (ctDNA) or tissue NGS/WES
* MSI-Stable or pMMR
* Age ≥ 18 years
* Body weight \> 66 pounds
* ECOG ≤ 2
* Repeat biopsy feasible
* No clinically significant autoimmune disease

Exclusion Criteria:

* Patients with known metastatic disease
* Prior systemic treatment for esophagus, GEJ, or the stomach adenocarcinoma
* Patients with uncontrolled autoimmune disease per investigator discretion
* Inability or refusal to undergo biopsy procedures to obtain tissue samples

Primary outcomes:
measure: Percentage of Subjects Completing Study Treatment
timeFrame: 2 Years
measure: Percentage of Subjects Completing Post-Treatment Biopsy
timeFrame: 2 Years
Secondary outcomes:
measure: Percent Change in the Proportion of Intra Tumoral Effector T-cells
timeFrame: 2 years
measure: Assessment of effects on circulating cytokines in a 96-cytokine-discovery assay.
timeFrame: 2 years
measure: Number of Patients who received one dose of Tremelimumab and Durvalumab with reported Adverse Events
timeFrame: 2 years
measure: Comparison of T-Cell Infiltration in Various Tumor Mutations
timeFrame: 2 years
Other outcomes:
Locations:
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center, University of California, Irvine
state: California
Study officials:
affiliation: Chao Family Comprehensive Cancer Center
name: Farshid Dayyani
role: PRINCIPAL_INVESTIGATOR
References: