louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05893667: Evaluation of Inflammatory Markers in LARC Patients
Official title: Evaluation of Pretreatment Inflammatory Markers in Predicting Response to nCRT and Prognosis in LARC Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced Rectal Cancer
Lead sponsor: Hospital Pedro Hispano
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: as in inclusion criteria

Brief summary: Introduction: In locally advanced rectal cancers (LARC), TNM staging is far from optimal. We aimed to investigate the value of previously described circulating biomarkers as predictors of prognosis.

Methods: Retrospective analysis of 245 LARC patients diagnosed between January 2010 and December 2022, who underwent neoadjuvant chemoradiotherapy and surgery at two centers. A Cox regression and Kaplan-Meier analysis were performed.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed pathologically with rectal adenocarcinomas, located within 12cm from the anal verge (measured by MRI), clinically staged T3-4 and/or N+ and treated with neoadjuvant chemoradiotherapy (nCRT) followed by radical surgery

Exclusion Criteria:

* evidence of distant metastasis at diagnosis, emergent or palliative surgery, local excision or "watch and wait" approach and evidence of inflammatory or hematological disorders

Primary outcomes:
measure: Overall survival Disease-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Pathological response through Ryan Tumor Regression Grade
timeFrame: at study completion, average of 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01959867: SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy
Official title: Clinical Study Comparing Two-Stage Breast Reconstruction Following Mastectomy With and Without the Use of SurgiMend® PRS Fetal Bovine Collagen Matrix in Patients With Pre-Mastectomy Radiation Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: mastectomy
breast reconstruction
bovine
ADM
breast cancer
breast implants
breast expanders
radiation therapy
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age
* Patient is female
* Patient is undergoing immediate, two-stage breast reconstruction following mastectomy with or without the use of SurgiMend® PRS
* Patient has previously undergone pre-mastectomy XRT for breast cancer, with lumpectomy or partial mastectomy, with the previously irradiated breast now being reconstructed (with or without contralateral mastectomy \& reconstruction)
* Patient utilized a textured expander only
* Patient utilized a smooth gel permanent implant only
* Patient has agreed and is able to comply with the study follow-up requirements
* Patient or guardian has provided consent for participation

Exclusion Criteria:

* Patient is undergoing single-stage breast reconstruction
* Patient is undergoing a delayed reconstruction
* Patient is undergoing reconstruction using a smooth tissue expander, textured gel breast implant or any saline breast implant.
* Patient is undergoing planned reconstruction using autologous tissue
* Patient has a known hypersensitivity to collagen or bovine derived materials
* Patient is currently pregnant, nursing, or planning a pregnancy during the course of the study
* Patient who has had pre-mastectomy XRT bilaterally for breast cancer (either at the same time or separated in time)

Primary outcomes:
measure: Capsular Contracture Rate
timeFrame: 12 months Post-Exchange
measure: Breast Q
timeFrame: 12 months Post-Exchange
Secondary outcomes:
measure: No. Capsule Procedures
timeFrame: 12 months Post-Exchange
measure: Cosmetic Assessment
timeFrame: 12 months Post-Exchange
measure: Time to Completion
timeFrame: 12 months Post-Exchange
measure: Total number of OR procedures
timeFrame: 12 month follow-up visit
measure: Total number of visits
timeFrame: 12 month follow up visit
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06628167: Community Support Program for Lung Cancer Screening Volume II
Official title: Community Support Program for Lung Cancer Screening Volume II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2024-10-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a West Philadelphia based community project to improve adherence to lung cancer screening. The overall objective of this project is to demonstrate the impact of a community support program (CSP) on improve adherence to LCS follow-up guidelines in an urban environment. The study will target individuals in the Penn Medicine healthcare system residing in Philadelphia with an upcoming or missed follow-up screening or orders placed but who have not yet scheduled their screenings by offering free transportation coordination to and from the appointment. The study team will also offer to connect those with placed but unscheduled low dose CT orders to connect with Penn Medicine's scheduling staff.


Eligibility criteria: Inclusion Criteria:

* Upcoming or missed low dose CT for lung cancer screening
* Philadelphia resident

Exclusion Criteria:

* Lives outside Philadelphia city limits

Primary outcomes:
measure: Measure the impact of the community support program in improving adherence to lung cancer screening follow-up
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Univeristy of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: farouk.dako@pennmedicine.upenn.edu
name: Farouk Dako, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05818267: Efficacy and Safety of Regorafenib Maintenance Therapy in Patients With Metastatic Colorectal Cancer (mCRC)
Official title: Efficacy and Safety of Regorafenib Maintenance Therapy in Patients With Metastatic Colorectal Cancer (mCRC) Without Imaging Progress Three Months After Second-Line Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Regorafenib in third-line treatment of metastatic colorectal cancer(mCRC) significantly prolongs the survival of patients, and its advancement has a sensitizing effect on postline chemotherapy and thus improves the prognosis of patients. Therefore, the present study was designed to include patients who achieved stable disease/partial response(SD/PR) after 3 months of second-line therapy and advance regorafenib to investigate the role of advance regorafenib in prolonging progression-free survival, prolonging the efficacy of overall survival, safety, and quality of life in patients with mCRC compared with standard second-line and third-line therapy.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically or cytologically confirmed metastatic colorectal cancer who have measurable metastatic disease according to the Resolute Efficacy Criteria for Solid Tumors (RECIST) version 1.1.
* Received standard second-line therapy, achieved stable disease(SD) and above by recist1.1 tumor assessment and maintained for 3 months.
* Eastern Oncology Collaborative Group(ECOG) physical status of 0 or 1 at trial entry and life expectancy ≥ 3 months.
* No bone marrow suppression and normal heart, lung, liver and kidney function.
* Voluntary participation in research.

Exclusion Criteria:

* Concurrent primary tumors of other types.
* MSI-H/dMMR type mCRC patients.
* Heart, liver, kidney, bone marrow insufficiency or mental abnormalities.
* Intolerant to treatment methods
* Concurrent participants in other clinical trials.
* Pregnant or lactating women.
* Patients deemed unsuitable for study participation by the remaining investigators.

Primary outcomes:
measure: duration of disease control(DDC)
timeFrame: 6 month
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: 3 years
measure: Quality-of-Life(QoL)
timeFrame: 3 years
measure: The incidence of adverse events
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Colorectal Surgery in Changhai Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT05433467: CT-guided Localization for Micro Hepatocellular Carcinoma Before Surgical Resection
Official title: The Feasibility of CT-guided Localization for Micro Hepatocellular Carcinoma Before Surgical Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cirrhosis, Liver
Hepatocellular Carcinoma
Keywords: Cirrhosis
hepatocellular carcinoma
localization needle
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 5
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: In this project, the preoperative anatomical location of micro hepatocellular carcinoma under the guidance of CT can provide guidance for accurate surgical resection. It may also shorten the operation time and reduce intraoperative bleeding.

Detailed description: General and basic information of the patients included in the study was collected. After preoperative preparation was completed, on the day of surgery, disposable pulmonary nodular localization needle (Ningbo Sonjiecang Biological Technology Co., LTD., Model: SS510-10) was used for the localization of micro hepatocellular carcinoma that could be found by preoperative CT enhancement or MRI. After the micro hepatocellular carcinoma was located under the guidance of CT, and then the patient was sent to the operating room. During the operation, the lesion was removed according to the tail line of the positioning needle and the position of the positioning needle.

Eligibility criteria: Inclusion Criteria:

1. Be at least 18 years old and give informed consent to participate in the study
2. A preoperative (clinical, radiological, or histological) diagnosis of cirrhosis of the liver due to any cause.
3. micro hepatocellular carcinoma (diameter less than 1cm).
4. Preoperative CT plain scan could not find the lesion, and preoperative B-ultrasound could not find the lesion.
5. Preoperative CT enhancement or MRI can detect the lesion.

Exclusion Criteria:

1. Child-Pugh grade C
2. Uncontrolled Hypertension
3. Severe lung dysfunction
4. Severe cardiac dysfunction

Primary outcomes:
measure: The position of the needle
timeFrame: During operation
Secondary outcomes:
measure: Operation time
timeFrame: During operation
measure: Intraoperative bleeding
timeFrame: During operation
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Clinical Medical College, Yangzhou University
state: Jiangsu
Study officials:
affiliation: Clinical Medical College, Yangzhou University
name: Guo-Qing Jiang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04813367: Twisted Fallopian Tubes
Official title: Long Term Follow-up of Twisted Fallopian Tubes Among Young Girl. International Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Twisted Fallopian Tube
Keywords: Twisted Fallopian Tube
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 100
Sex: FEMALE
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Girl younger than 18 with isolated tubal torsion. Girl above 18 and tubal torsion associated with ovary torsion are excluded.

Brief summary: Isolated tubal torsion is a very rare event already in adults (1: 1.5 million women), it remains exceptional in children without being able to find a prevalence in the literature. The causes can be malformative or idiopathic, but even that remains unknown.

Because of the scarcity, surgical treatment is not standardized and left to the good care of the surgeon in charge.


Eligibility criteria: Inclusion Criteria:

* Patient younger then 18 going through surgery for twisted fallopian tubes

Exclusion Criteria:

* Girl above 18 and tubal torsion associated with ovary torsion

Primary outcomes:
measure: Fallopian tube Surgery results
timeFrame: Evaluation 10 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: Centre Hospitalier Universitaire de Angers
city: Marseille
country: France
facility: APHM, Hôpital La Timone Enfants et Hôpital Nord
city: Paris
country: France
facility: Hopital NECKER Enfant Malades
city: Erice
country: Italy
facility: ASP Trapani - presidio ospedaliero "S. Antonio Abate
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
city: Siena
country: Italy
facility: AOU Siena, Ospedale le Scotte
city: Torino
country: Italy
facility: Ospedale infantile Regina Margherita
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health IRCCS G. Gaslini, Genova
city: Beirut
country: Lebanon
facility: Hôtel-Dieu de France Hospital
city: Iaşi
country: Romania
facility: Hospital d Urgences pour les enfants
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine Children's Hospital
Study officials:
References:
Clinical trial NCT03991767: Implementation and Evaluation of an Electronic Alert to Encourage Targeted Screening for HIV Infection at Foch Hospital According to Socio-demographic Criteria
Official title: Implementation and Evaluation of an Electronic Alert to Encourage Targeted Screening for HIV Infection at Foch Hospital According to Socio-demographic Criteria: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Testing
Keywords: medical practices
HIV
Electronic Alert
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: In 2013 in France, 29,000 people are reported to be unaware of their HIV status. HIV testing is a priority in France where one third of all diagnoses remain late despite 5 million annual tests. It is recommended to offer at least one HIV test to the general population, over the life course, when seeking care and more frequently to populations at risk. Several international and national articles have shown that emergency screening is feasible and well accepted. But also that during systematic screening few infections were discovered, and the majority of newly diagnosed people belonged to the most exposed groups.

Our hypothesis is that an electronic alert would identify people who are unaware of their HIV status. This alert would be based on two data: social data (French health coverage) and the country of birth. This alert is only relevant in high-prevalence regions, as is the case in the Ile de France region.


Eligibility criteria: Inclusion Criteria:

* Patient hospitalized at Foch Hospital over 18 years of age.
* Patient with AME or CMU and/or CMUc, or patient born in one of the following countries/regions: Sub-Saharan Africa, Haiti, South America, Asia, Eastern Europe, Guadeloupe, Martinique and Guyana

Exclusion Criteria:

* Patient whose vital prognosis at the time of admission does not allow him/her to indicate his/her non-opposition to an HIV test.
* Patient being followed for a known HIV infection.

Primary outcomes:
measure: Evaluation of HIV testing practices : screening proposal rate, patient acceptance rate and serological achievement rate
timeFrame: 18 months
Secondary outcomes:
measure: Study of the obstacles
timeFrame: 18 months
measure: Prospective data vs retrospective data : number of screening serologies performed
timeFrame: 18 months
measure: Newly HIV+
timeFrame: 18 months
measure: Positivity rate
timeFrame: 18 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: FOCH Hospital
name: David Zucman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04810767: Chronic Pain After CS in Egypt
Official title: Prevalence and Risk Factors for Chronic Pain After Cesarean Delivery in Upper Egypt: Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20-40 years old Women attending to Al Azhar assuit, Sohag and South valley universities hospitals for any reason in the duration from 1 May to 31 October 2021, and who underwent elective ceserean section under spinal anesthesia with horizontal lower abdominal surgical incision within last two years

Brief summary: This retrospective study will include Women who will attending to Azhar assuit, Sohag and South valley universities hospitals for any reason in the duration from 1 May to 31 October 2021, and who underwent elective CD under spinal anesthesia with horizontal lower abdominal surgical incision within last two years.

Exclusion criteria will be refusal to participate, age less than 18 years, recent CD (within 3 months), if the infant had died, and history of chronic pain medications or psychiatric disorder.

Data collection

Participants will be contacted personally by one of study authors. Data collected are consisted of:

* Participants' characteristics as Age, parity and ways of delivery, weight, height, residency, husband smoking status, work, previous abdominal surgery, history of diabetes mellitus and hypertension.
* Last CD related data which include presence of multiple pregnancies, if CD was in private/public facility, presence surgical wound infection.
* Pain experienced will be assessed by questionnaire described by Nikolajsen et al, 2004


Eligibility criteria: Inclusion Criteria:

* Women attending to Azhar assuit, Sohag and South valley universities hospitals for any reason in the duration from 1 May to 31 October 2021, and who underwent elective ceserean section under spinal anesthesia with horizontal lower abdominal surgical incision within last two years

Exclusion Criteria:

* refusal to participate, age less than 18 years, recent ceserean section (within 3 months), if the infant had died, and history of chronic pain medications or psychiatric disorder

Primary outcomes:
measure: Chronic pain
timeFrame: Three months after the last ceserean section
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lecturer of anesthesia and ICU
name: Kareem ElGebaly, Lecturer
role: STUDY_CHAIR
affiliation: Consultant of anesthesia and ICU Elhelal insurance hospital
name: Hossam Eldin Mostafa, Consultant
role: STUDY_DIRECTOR
References:
Clinical trial NCT01003067: Intraperitoneal Mesh-Implementation After Laparotomy
Official title: Intraperitoneal Mesh-Implementation After Laparotomy to Reduce Risk of Incisional Hernia: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Incisional Hernia
Lead sponsor: Kantonsspital Liestal
Sponsor class: OTHER
First posted: 2009-10-28
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study is to evaluate the risk reduction of intraperitoneal mesh-implementation after laparotomy (Group 1) in a randomized control trial compared with patients with standard abdominal closure (Everett-suture). This is the primary endpoint. Second endpoints are the feasibility of mesh-implementation even after colorectal surgery, find risk factors for wound infection and incisional hernia.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Median Laparotomy

Exclusion Criteria:

* Bowel perforation
* Pregnancy
* Palliative surgery
* Drug abuse
* Age under 18
* Mental disability
* Allergy to mesh components

Primary outcomes:
measure: Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy
timeFrame: 2 years
Secondary outcomes:
measure: Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia.
timeFrame: 5 Years
Other outcomes:
Locations:
city: Liestal
country: Switzerland
facility: Kantonsspital Liestal
state: BL
Study officials:
References:
citation: Glauser PM, Brosi P, Speich B, Kaser SA, Heigl A, Rosenberg R, Maurer CA. Prophylactic Intraperitoneal Onlay Mesh Following Midline Laparotomy-Long-Term Results of a Randomized Controlled Trial. World J Surg. 2019 Jul;43(7):1669-1675. doi: 10.1007/s00268-019-04964-6.
citation: Brosi P, Glauser PM, Speich B, Kaser SA, Maurer CA. Prophylactic Intraperitoneal Onlay Mesh Reinforcement Reduces the Risk of Incisional Hernia, Two-Year Results of a Randomized Clinical Trial. World J Surg. 2018 Jun;42(6):1687-1694. doi: 10.1007/s00268-017-4363-2.