louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05474391: MammaPrint Value for Pre-menopausal Breast Cancer Patients
Official title: The Value of MammaPrint in Adjuvant Therapy Decision Among Pre-menopausal Breast Cancer Patients: a Survey Based on Clinical Staff
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 200
Sex: FEMALE
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer (according to ICD-10)

Brief summary: Nearly 200 cases are to be enrolled. The information of patient age, histologic grade, tumor size, ER and PR status, Ki-67 index, surgery mode should be provided. The adjuvant therapy regime (chemotherapy: none, TC\*4, TC\*6 or EC-T; endocrine therapy: TAM, OFS+TAM, OFS+AI) will be compared before and after MammaPrint testing. About 20 clinical staffs are enrolled to participate in this survey for the clinical decision making. Each case could be chosen five times at random.


Eligibility criteria: Inclusion Criteria:

1. pre-menopausal breast cancer patients aged less than 50 years old.
2. Pathology confirmed invasive dutal carcinoma or invasive lobular carcinoma.
3. receiving breast conserving surgery or mastectomy with/without reconstruction; sentinel lymph node biopsy or axillary lymph node dissection.
4. TNM staging: T1b-T2N0-1M0.
5. molecular subtype: ER positive/HER2 negative.
6. MammaPrint testing before initiation of adjuvant therapy.

Exclusion Criteria:

1. Incomplete medical history.
2. Pregnancy or lactation.
3. Contradiction of chemotherapy or ovarian function suppression.

Primary outcomes:
measure: Treatment decision survey
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03764891: Clinical Outcomes of Transvaginal Mesh Procedures for Cystocele Repair: Comparisons of Uphold and Perigee Systems
Official title: Far Eastern Memorial Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Surgical Mesh
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 152
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pelvic organ prolapse patients underwent Uphold or Perigee surgeries

Brief summary: Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women.

The aim of this study was to compare the clinical outcomes of Uphold system and Perigee system in treating women with cystocele.

Detailed description: Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women. Traditional vaginal surgery with native tissue is associated with high recurrence rate. Thus, synthetic meshes were introduced into POP surgery and became the mainstream. Several transvaginal mesh procedures, such as Uphold system (Boston Scientific) and Perigee system (American Medical Systems Inc), have been used for cystocele repair. Perigee system is a trans-obturator four-arm mesh device attached to proximal and distal arcus tendineus fasciae pelvis. Nonetheless, Uphold system, is a single incised, two-arm anterior sacrospinous mesh fixation system. Both systems can be used for cystocele repair, despite Uphold system can be used for concomitant repair of apical prolapse. The aim of this study was to compare the clinical outcomes of Uphold system and Perigee system in treating women with cystocele.

Eligibility criteria: Inclusion Criteria:

1. Vaginal anterior wall prolapse greater than or equal to second phase of POP-Q
2. Underwent Uphold or Perigee procedures

Exclusion Criteria:

* nil

Primary outcomes:
measure: Recurrence rate of pelvic organ prolapse
timeFrame: 10 year
Secondary outcomes:
measure: Complication rate
timeFrame: 10 years
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT05808491: Online Resilience Intervention in Older Adults
Official title: Effectiveness of Online Resilience Intervention in Older Adults: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Promotion Program
Keywords: resilience intervention
physical activity
well-being
older adult
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 63
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control group and experimental group
Primary purpose: PREVENTION

Brief summary: Resilience in older adults is important for Healthy aging. The purpose of this study was to examine the effectiveness of an on-line program of resilience interventions among older adults.

Detailed description: Healthy aging not only free from illness but also need to maintain healthy physical and mental function, be active in social life and contribute to society. Aging bring comprehensive impacts toward family, society and country, especially in individual. Resilience intervention can improve the intrinsic health and well-being for older adults. Good physical activity benefits to healthy aging. The purpose of this study was to examine the effectiveness of an on-line program of resilience interventions among older adults.

Eligibility criteria: Inclusion Criteria:

* able to read Chinese, and aged 65 years or older.

Exclusion Criteria:

* with a psychiatric diagnosis and who had a neoplasm

Primary outcomes:
measure: the changes from baseline to 1, 3 month of resilience
timeFrame: baseline, 1, 3 month
measure: the changes from baseline to 1, 3 month of physical activity
timeFrame: baseline, 1, 3 month
measure: the changes from baseline to 1, 3 month of well-being
timeFrame: baseline, 1, 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang Ming University
Study officials:
References:
Clinical trial NCT05762991: Application of Artificial Intelligence on the Diagnosis of Helicobacter Pylori Infection and Premalignant Gastric Lesion
Official title: Application of Artificial Intelligence on the Diagnosis of Helicobacter Pylori Infection and Premalignant Gastric Lesion: A Multihospital Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Helicobacter Pylori Infection
Premalignant Lesion
Keywords: Helicobacter, Artificial Intelligence, Telemedicine
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will invite patients who need to undergo urea breath test, upper gastrointestinal endoscopy and histology examination.

Brief summary: The aim of this diagnostic accuracy study is to evaluate the application of artificial intelligence on the diagnosis of Helicobacter pylori infection and premalignant gastric lesions based on upper endoscopic images. We use techniques of artificial intelligence to analyze the correlation between endoscopic images and urea breath test results/histopathological results.

Detailed description: This study had invited patients to undergo urea breath test, upper gastrointestinal endoscopy, and histology examination. The study will collect their tests results, upper gastrointestinal endoscopy images, and histopathological results. Artificial intelligence techniques will be used to analyze the correlation between endoscopic images and urea breath test results/histopathological results. We aim to establish a telemedicine system to assist clinicians in diagnosing Helicobacter pylori infection and detecting premalignant gastric lesion using upper endoscopic images. The system will be implemented as a telemedicine service system in the rural areas, for example Matsu Islands. The baseline histological predictions will be linked to the newly incident gastric cancer.

Eligibility criteria: Inclusion Criteria:

1. Age 20-80
2. Scheduled urea breath test and endoscopy

Exclusion Criteria:

1. History of gastric surgery

Primary outcomes:
measure: Sensitivity to detect premalignant gastric lesions
timeFrame: Up to 5 years
Secondary outcomes:
measure: Specificity to exclude premalignant gastric conditions
timeFrame: Up to 5 years
Other outcomes:
measure: Areas under the ROC curves
timeFrame: Up to 5 years
measure: Gastric cancer incidence
timeFrame: Up to 10 years
Locations:
city: Taipei
country: Taiwan
facility: Yi-Chia Lee
Study officials:
affiliation: National Taiwan University Hospital
name: Tsung-Hsien Chiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02509091: Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis
Official title: Clinical Efficacy and Safety of Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis:An Open-label Randomized Parallel Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bronchiectasis
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2015-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The therapy of bronchoalveolar lavage and local amikacin injection as one of the treatment of bronchiectasis developed in recent years.this study is aim to evaluate the Clinical Efficacy and Safety of Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients with Acute Exacerbation of Bronchiectasis.

Detailed description: The aim of this study was to evaluate the efficacy and safety of The therapy of bronchoalveolar lavage and local amikacin injection through the observation of a large sample of clinical cases. During the observation, study visits will occur at the end of 30days, 60days, 90days.all the participants will be required to check the various efficacy and safety indicators.

Eligibility criteria: Inclusion Criteria:

1. Age≥18 years and ≤80 years;
2. Patients with non-cystic fibrosis bronchiectasis diagnosed by high-resolution CT;
3. Are sensitive to amikacin;
4. Acute exacerbation of bronchiectasis;
5. Capable of the completion of bronchoscopy, alveolar lavage, pulmonary function testing etc;
6. Willing to join in and sign the informed consent form.

Exclusion Criteria:

1. Active bleeding without control；
2. Receiving nasal or facial surgery recently；
3. With severe cardio-pulmonary dysfunction, such as left heart failure, unstable arrhythmia, etc.
4. With other respiratory diseases: such as active pulmonary tuberculosis, non-tuberculosis mycobacteria (NTM) pulmonary disease, pulmonary aspergillosis, etc.
5. Be allergic to amikacin

Primary outcomes:
measure: Improvement of Sputum volume and properties
timeFrame: 90 days
Secondary outcomes:
measure: changes in lung function (including Forced expiratory volume in one second (FEV1) ,forced vital capacity(FVC) and forced vital capacity rate of one second(FEV1/FVC))
timeFrame: 90 days
measure: Dyspnea score according by Modified Medical Research Center(MMRC)
timeFrame: 90 days
measure: Cough score according by Leicester Cough Questionnaire(LCQ)
timeFrame: 90 days
measure: Life quality: assessed by St. George respiratory questionnaire (SGRQ)
timeFrame: 90 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Jin-Fu Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03124394: Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study
Official title: Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peritoneal Carcinomatosis
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 100
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: Patients with peritoneal carcinomatosis

Brief summary: Evaluation of clinical outcome and economical aspects in the treatment of patients with peritoneal carcinomatosis.

Detailed description: Peritoneal carcinomatosis is a dooming finding with no hope for cure and a steadily decrease in quality of life. Cytoreductive surgery with intraperitoneal chemotherapy (CRS HIPEC) offers a small but proven chance for cure. The implementation of a CRS HIPEC and PIPAC programme in a Swiss tertiary care hospital is evaluated.

When a patient is deemed non resectable, pressurized intraperitoneal aerosol chemotherapy (PIPAC) administered laparoscopically may confer effective palliation.

Eligibility criteria: Inclusion Criteria:

* Men and Women \>18 years
* Tumour board decision for CRS and intraoperative chemotherapy

Exclusion Criteria:

* Missing Tumour board decision for CRS and intraoperative chemotherapy
* Pregnancy
* Age \<18 years

Primary outcomes:
measure: Postoperative surgical complications
timeFrame: 90 days
measure: Rehospitalisation
timeFrame: 90 days
measure: Disease-free survival
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 years
Secondary outcomes:
measure: Measurement of quality of life
timeFrame: 5 years
measure: Cost
timeFrame: 90 days
measure: Revenues
timeFrame: 90 days
measure: Cost-utility analysis
timeFrame: 90 days
measure: Cost-effectiveness
timeFrame: 90 days
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zürich
Study officials:
affiliation: Kantonsspital Winterthur KSW
name: Michel Adamina, Prof/MD/MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04655794: Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment
Official title: Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adverse Reaction to Drug
3HP
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The newly identified LTBI subjects who wanted to receive LTBI preventive therapy with 3HP were eligible for enrolment.

Brief summary: The treatment of latent TB with 3HP is an important issue for the prevention of active TB. However, significant proportion of subjects receiving 3HP had adverse reaction. The main purpose of this observation study is to identify subjects who have higher risk to develop adverse reaction. Clinical characteristics and biomarker will be used to predict adverse reaction.


Eligibility criteria: Inclusion Criteria:

* close contact with active TB patients
* patients with autoimmune diseases preceding biological therapy
* health-care workers
* other clinical conditions, which increased the risk of LTBI. LTBI was confirmed by QuantiFERON-TB Gold In-Tube test (QFT-GIT; Qiagen, Valencia, CA, USA) with a cut-off value of 0.35 IU/ml.

Exclusion Criteria:

* age less than 20 years
* pregnant women
* active TB or suspected active TB in the clinical evaluation
* severe liver disease
* ESRD
* organ transplantation
* close contact with a multidrug-resistant TB patient
* obesity (BMI\>30 Kgw/m2) and other conditions inappropriate for participation in this study as judged by the investigators.

Primary outcomes:
measure: sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
timeFrame: Change from Baseline sTREM1 at 2 weeks
measure: sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
timeFrame: Change from Baseline sTREM1 at SARs
measure: sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
timeFrame: Change from Baseline sTREM1 at 2 weeks
measure: sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
timeFrame: Change from Baseline sTREM1 at SARs
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Institutional Review Board Chang Gung Medical Foundation
Study officials:
References:
citation: Wang TY, Feng JY, Shu CC, Lee SS, Chen CY, Wei YF, Lin CB, Huang WC, Su WJ, Lin SM. Plasma Concentrations of sTREM-1 as Markers for Systemic Adverse Reactions in Subjects Treated With Weekly Rifapentine and Isoniazid for Latent Tuberculosis Infection. Front Microbiol. 2022 Mar 3;13:821066. doi: 10.3389/fmicb.2022.821066. eCollection 2022.
Clinical trial NCT02466594: Impact of Active Thermoregulation on the Microcirculation of Free Flaps
Official title: Impact of Active Thermoregulation on the Microcirculation of Free Flaps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microcirculation
Thermoregulation
Free Flap
Lead sponsor: Klinik Bogenhausen
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the impact of active thermoregulation on free flap microcirculation following free flap transfer. Thermoregulation is performed by passive warming, active warming (water circulation based device) and active cooling. Changes in microcirculation are assessed using combined laser Doppler flowmetry and remission spectroscopy.

Detailed description: Measurements are conducted at the day of the operation as well as the first three days following the operation. Tissue temperature is assessed by a temperature measurement probe that is placed 8 mm underneath the skin. The microcirculation parameters of free perforator flaps are assessed using combined laser Doppler flowmetry and remission spectroscopy (O2C®). This allows non-invasive measurement of blood flow, capillary venous oxygen saturation and relative postcapillary filling pressure using a fiber optic probe that is placed on the flap surface. Controlled Thermoregulation (between 10 and 38°C) is enabled using a water circulation based system (Hilotherm Clinic®).

Eligibility criteria: Inclusion Criteria:

Patients receiving free perforator flaps with a skin island not less than 4x4 cm

Exclusion Criteria:

* non-compliance,
* non-consent,
* history of cardiac disease,
* arterial hypo- or hypertension,
* intake of vasoactive drugs,
* peripheral arterial occlusive disease,
* chronic kidney and liver disease,
* vasculitis

Primary outcomes:
measure: Blood Flow (AU) measured by Doppler flowmetry and remission spectroscopy (Oxygen to See, O2C®, Lea Medizintechnik, Giessen, Germany)
timeFrame: Measurements were conducted at the day of the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Munich 81925, Germany
state: Bavaria
Study officials:
affiliation: Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Munich 81925, Germany
name: Ulf Dornseifer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06046794: Efficacy of First-Line Gemcitabine Chemotherapy in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients
Official title: Phase IV Study Assessing Efficacy of First-Line Chemotherapy With Gemcitabine in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients Ineligible to FOLFIRINOX Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Of Pancreas
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 100
Sex: ALL
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 study is to learn about the efficacy of first-line chemotherapy with Gemcitabine in metastatic pancreatic adenocarcinoma patients expressing the GemCore signature in their tumor. The main question it aims to answer is to assess efficacy of Gemcitabine (tumor response, survival rate) in the population of patient bearing the GemCore signature.

Participants will start the chemotherapy with Gemcitabine as usually performed in standard care of their center. They will consent to a genomic analyze of their tumor to know if it bears the GemCore signature. The center will manage the participant's follow up as usually realized in standard care.


Eligibility criteria: Inclusion Criteria:

* Metastatic pancreatic adenocarcinoma histological proved
* FOLFIRINOX chemotherapy-ineligible patient and going to receive first-line metastatic chemotherapy with gemcitabine monotherapy
* Tumor material allowing assessment of GEMCore status (i.e. FFPE block with tumor cellularity ≥ 10%);
* Life expectancy \> 2 months;
* Measurable target according to RECIST 1.1 criteria;
* No previous treatment in metastatic situation;
* Age ≥ 18 years;
* Patient not opposed to study participation;
* Affiliation to a social security system, or beneficiary of such a scheme.

Exclusion Criteria:

* Contraindication to Gemcitabine treatment;
* ECOG performance status ≥ 3;
* Person in emergency situation or unable to express non-opposition;
* Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice);
* Unable to undergo medical follow-up for geographical, social or psychological reasons.

Primary outcomes:
measure: Percentage of alive GemCore+ patients treated with Gemcitabine
timeFrame: 12 months
Secondary outcomes:
measure: Overall survival
timeFrame: 24 months
measure: Tumor response rate
timeFrame: 24 months
measure: Progression-free survival
timeFrame: 24 months
Other outcomes:
measure: Overall survival of GemCore- patients
timeFrame: 24 months
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
References: