louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01127555: Salvage mFOLFOX in BTC After Failure of Gemcitabine
Official title: Phase II Study of Salvage mFOLFOX(5-fluorouracil, Leucovorin, Oxaliplatin) in Patients With Unresectable Biliary Tract Cancer (BTC) Who Had Failed Gemcitabine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Unresectable Biliary Tract Cancer
Keywords: Biliary Tract Cancer
Salvage therapy
FOLFOX
Lead sponsor: Chung-Ang University
Sponsor class: OTHER
Collaborators: name: Gyeongsang National University Hospital
name: Dong-A University Hospital
name: Samsung Medical Center
First posted: 2010-05-21
Enrollment: 30
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: The purpose of this study is to evaluate the efficacy and safety of mFOLFOX (5-fluorouracil, leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer who had failed gemcitabine.


Eligibility criteria: Inclusion Criteria:

1. Age : older than 18
2. Histologically confirmed adenocarcinoma of the biliary tract
3. Metastatic or unresectable biliary cancer
4. Prior exposure to gemcitabine chemotherapy for biliary cancer
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
6. A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral Computed Tomography (CT) or multidetector CT
7. Adequate bone marrow, liver, renal function

Exclusion Criteria:

1. Pregnancy and breast-feeding.
2. Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).
3. Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
4. Symptomatic or uncontrolled brain metastasis

Primary outcomes:
measure: Response rate
timeFrame: 1 year
Secondary outcomes:
measure: To evaluate the safety
timeFrame: 1 year
measure: To estimate the time to progression
timeFrame: 1 year
measure: To estimate overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Yongsan
country: Korea, Republic of
facility: Chung-Ang University Yongsan Hospital
state: Seoul
Study officials:
affiliation: Chung-Ang University Yongsan Hospital
name: In Gyu Hwang, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06815055: State of Play of Physiotherapy in the Postoperative Management of Prostate Cancer : Prospective, Monocentric, National Survey, Aiming to Explore the Technics of Physiotherapy (PREduKiné)
Official title: PREduKiné State of Play of Physiotherapy in the Postoperative Management of Prostate Cancer : Prospective, Monocentric, National Survey, Aiming to Explore the Technics of Physiotherapy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Radical Prostatectomies
Rehabilitation Outcome
Prostate Cancer
Prostate Cancer Surgery
Rehabilitation Exercise
Keywords: radical prostatectomy
rehabilitation
continence
quality of life
Lead sponsor: Centre Hospitalier de Roubaix
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 510
Sex: MALE
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: The population concerned by the study is national french territory. Subjects must have an postoperative follow up performing by an urologist.

Brief summary: In France, a considerable number of radical prostactectomy for cancer is carried out every year.This number was estimated at 20.000 in 2016.This surgery may have negative impact on the continence's subjects and their quality of life. The rehabilitation, preoperative or postoperative, practiced by a physiotherapist, can reduced those side effects. The rehabilitation techniques are many and their efficacy may differ.

No study where found about the clasification and evaluation of those rehabilitation techniques.

Detailed description: Investigator aim to create homogeneous clusters of subjects according to the rehabilitation techniques they have received during the preoperative or postoperative period, using a survey replied 6 months after the surgery.

To achieve that goal, invesgator will call subjects conduct two interviews. The first interview will take place around one month after the radical prostatectomy and the second around 6 month after the surgery.

During those interviews, investigator will question subjects about the rehabilitation techniques practiced on them, about their continence and quality of life. To evaluate the continence investigator will use the survey ICIQ-SF. To evaluate the quality of life, investagator will use the survey KHQ-HR Qol.

Eligibility criteria: Inclusion Criteria:

* men who has undergone a radical prostactectomy to treat a prostatic adenocarcinoma
* having a follow up postoperative consultation between one and two month after the surgery
* being able to answer to respond the questions during the interviews
* agreeing to participate by signing informed consent form

Exclusion Criteria:

* undergoing an adjuvant therapy as radiotherpy, chemotherapy and hormone therapy
* Refusing to take part in the study

Primary outcomes:
measure: Set up homogeneous groups of subjects (clusters)
timeFrame: It will take place around six months after the surgery.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06991855: Effects of Nutritional Supplementation of Leucine and Polyunsaturated Fatty Acids on Muscle Health in the Elderly
Official title: Explore the Effects of Nutritional Supplementation of Leucine and Polyunsaturated Fatty Acids on Muscle Health in the Elderly
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Sarcopenia in Elderly
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Chang Gung University
First posted: 2025-05-28
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Population aging has become a significant global concern, and Taiwan is set to officially enter the "super-aged society" in 2025. As individuals age, various physiological functions gradually decline, including a reduction in muscle mass, which is a key aspect of the aging process.

This interventional study aims to investigate the effects of leucine-rich protein combined with polyunsaturated fatty acid supplementation on middle-aged and elderly individuals (aged 50 and above) who are at high risk for sarcopenia.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 50 years
* ASMI \< 7 kg/m2 in men
* ASMI \< 5.7 kg/m2 in women
* Grip strength \< 28 kg in men
* Grip strength \< 18 kg in women
* Walk speed \< 1 m/s

Exclusion Criteria:

* People who are allergic to supplements
* cancer
* heart failure
* kidney disease
* autoimmune disease
* neurodegenerative disease

Primary outcomes:
measure: muscle mass
timeFrame: baseline, 12 weeks
measure: muscle function
timeFrame: baseline, 12 weeks
measure: physical function
timeFrame: baseline, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Linkou
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT03176355: Intraoperative Mitomycin C in Lacrimal Sac Mucocele
Official title: Evaluation of Intraoperative Mitomycin C in Surgical Management of Lacrimal Sac Mucocele
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lacrimal Mucocele
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 30 patients had lacrimal sac mucocele and dacryocystorhinostomy was done for them with intraoperative mitomycin C was added to decrease postoperative fibrosis and recurrence.


Eligibility criteria: Inclusion Criteria:

* Lacrimal sac mucocele

Exclusion Criteria:

* Paediatric patients (less than 16 years old).
* Previous lacrimal passage procedure.
* Neoplasms as secondary causes of obstruction.

Primary outcomes:
measure: Disappearance of the watering of the eye reported by the patients and by fluorescein disappearance test
timeFrame: 1 month
measure: Disappearance of lacrimal sac swelling
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06184555: Primary Tumor Sidedness Associated With Clinical Characteristic and Postoperative Outcomes in Colon Cancer: a Propensity Score Matching Study
Official title: Primary Tumor Sidedness Associated With Clinical Characteristic and Postoperative Outcomes in Colon Cancer: a Propensity Score Matching Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 24436
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: colon cancer patients

Brief summary: Background: Recent investigations have suggested that sidedness is associated with the prognosis of colon cancer patients. The role of sidedness in surgical outcome is unclear. The aim of this study was to investigate the different clinical characteristics and associated postoperative outcomes of sidedness in colon cancer.

Materials and methods: This is a retrospective study using the multi-institutional, nationally validated database of the American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) from 2009 to 2013. Sidedness groups including right sided and left sided colon cancer were created according to the associated diagnosis and procedure codes. Postoperative mortality, morbidity, overall complication, and length of total hospital stay were analyzed after using a propensity score matching method.


Eligibility criteria: Inclusion Criteria:

* colon cancer S/P colectomy

Exclusion Criteria:

-

Primary outcomes:
measure: postoperative complication
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04237155: French Source-monitoring Task
Official title: Development of a Source-monitoring Task in French Adapted to Neuroimaging Protocols
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: Sorce-monitoring
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For step 1, two populations of participants: 30 healthy volunteers and 30 patients with schizophrenia will have to complete a verbal material scoring questionnaire. For step 2, two populations of participants: 30 healthy volunteers and 30 patients with schizophrenia will have to complete the source-monitoring task which will be created from step 1 as well as the task of reference (Brunelin et al., 2008).
Primary purpose: OTHER

Brief summary: Source-monitoring is a cognitive process that refers to the ability to remember the source of an information. Source-monitoring processes are usually studied using experimental behavioral tasks. These tasks, which are very heterogeneous, are not all available in French and, for the most part, cannot be used in neuroimaging protocols.

The aim of this project is to develop an experimental task which allows the measurement of source-monitoring performances, and which is adapted to neuroimaging protocols in a French-speaking population.

Detailed description: The study will include 2 steps: 1) validation of the verbal material necessary for the creation of the source-monitoring task and 2) testing the task.

Eligibility criteria: Inclusion Criteria:

* Men and Women aged between 18 and 45
* Having given their written informed consent
* Native French speakers
* Normal or corrected-to-normal vision
* Education level greater than or equal to 8 (in years)
* For the healthy control group, no history of previous diagnosed psychiatric disorders (according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - DSM5), absence of first-degree relatives diagnosed with spectrum disorder schizophrenia and bipolar disorder (DSM).
* For the schizophrenia patients group, meeting the DSM5 criteria for schizophrenia.

Exclusion Criteria:

* Do not consent to be included in the study
* History of hearing impairments
* People who cannot read
* Presence of neurological or somatic diseases
* Being under tutorship or curatorship

Primary outcomes:
measure: Source-monitoring performances
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre Hospitalier le Vinatier
Study officials:
References:
Clinical trial NCT05971914: Alveolar Cleft Hard- and Soft Tissue Reconstruction With an Autogenous Tooth Derived Particulate Graft
Official title: Alveolar Cleft Hard- and Soft Tissue Reconstruction With an Autogenous Tooth Derived Particulate Graft
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cleft Lip and Palate
Keywords: cleft lip and palate
split thickness flap
autogenous tooth bone graft
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 8
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Eight patients aged 8-12 years exhibiting uni- or bilateral alveolar cleft defects and oronasal fistulas underwent supra-, subgingival scaling and received individual oral hygiene instructions prior to surgery at the Department of Periodontology, Semmelweis University, Budapest, Hungary. Surgeries will be performed at the I. Department of Paediatrics, Semmelweis University, Budapest, Hungary between January 2021 and November 2021. The study was approved by the Semmelweis University Regional and Institutional Committee of Science and Research Ethics (Approval Number SE TUKEB x/2020). Patients is treated in accordance with the World Medical Association Declaration of Helsinki (version 2008). Surgical interventions are undertaken with the understanding and written consent of each subject's caregiver
Primary purpose: TREATMENT

Brief summary: The present study aims at clinical and radiographic evaluation of the safety and efficacy of Bonmaker ATB powder combined with a novel split thickness papilla curtain flap in the treatment of alveolar cleft defects.


Eligibility criteria: Inclusion Criteria:

* children with alveolar cleft
* patient presented at least three deciduous teeth scheduled for extraction.

Exclusion Criteria:

* major relevant clinical diseases,
* systemic use of steroids,
* current or previous intravenous bisphosphonate treatment,
* acute infection at the operation site.

Primary outcomes:
measure: Radiological volumetric measurements
timeFrame: 6 months
Secondary outcomes:
measure: soft tissue healing
timeFrame: during the 6 months postoperatively
measure: complications
timeFrame: 1, 14, 30 days and 3 and 6 months after surgeries.
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Department of Periodontology
Study officials:
References:
Clinical trial NCT04176614: Cereal-based Products Fortified With Legumes and Effects on Body Weight Management
Official title: Functional Cereal-based Products Fortified With Legumes for Satiety and Weight Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: cereal-based snack fortified with legumes
body weight reduction
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2019-11-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Overweight/obese non diabetic subjects will follow an energy-restricted diet and supplemented with a cereal-based snack fortified with legumes (intervention group) or a common cereal snack (control group) for 12 weeks. Body weight, anthropometric, clinical and biochemical characteristics will be evaluated at the beginning and at the end of the study.
Primary purpose: TREATMENT

Brief summary: Legumes are high nutritional quality foods and constitute a rich source of proteins and dietary fibers which have been associated with appetite regulation and body weight management. The purpose of the study is to investigate the effects of regular consumption of a cereal-based snack fortified with legumes on body weight reduction.

Detailed description: Overweight/obese, non-diabetic subjects will participate in the study. Subjects will follow a 12-week energy-restricted dietary intervention supplemented with a certain amount of a cereal-based snack fortified with legumes daily. The effects of dietary intervention on body weight reduction will be examined.

Eligibility criteria: Inclusion Criteria:

* normal exercise and dietary habits
* weight stable for at least 3 months before enrollment

Exclusion Criteria:

* diabetes
* pregnancy
* chronic medical illness
* use of nutritional supplements
* regular intense exercise
* alcohol consumption \> 2 drinks/day

Primary outcomes:
measure: Change in body weight
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens
state: Attiki
Study officials:
affiliation: Harokopio University
name: Amalia Yanni, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: National and Kapodistrian University of Athens
name: Alexander Kokkinos, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01317914: Prospective Study of Undiagnosed Celiac Disease
Official title: Epidemiology of Celiac Disease: A Prospective Study of Undiagnosed Celiac Disease in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 31
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Direct benefits to the participants, who are diagnosed with celiac disease may be substantial and could include lessening or prevention of GI symptoms, correction of biochemical abnormalities and reduction in risk for malignancies or bone disease which are most common in untreated celiac disease. However, the precise benefit is unknown and the motivation for this proposed study. If these individuals have a positive celiac serology test at the present time there is a high likelihood that they may have celiac disease.


Eligibility criteria: Inclusion Criteria:

* At least 60 years old
* Male and female

Retrospective testing for celiac disease was done on previously stored serum. Contacting specific individuals for inclusion into study

Primary outcomes:
measure: Understanding the impact of undiagnosed celiac disease and the potential benefits of diagnosis
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Joseph Murray, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03958214: Promoting Self-Regulation Skills and Healthy Eating Habits in Early Head Start
Official title: Promoting Self-Regulation Skills and Healthy Eating Habits in Early Head Start
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poverty
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Penn State University
First posted: 2019-05-21
Enrollment: 244
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Families are blocked within home visitor caseload and randomly assigned to receive the new curriculum or usual practice Early Head Start home visits for 12 weeks.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the effectiveness of a new curriculum on toddlers' self-regulation skills and healthy eating habits. The curriculum is being delivered as part of Early Head Start home visits and compared to the effectiveness of usual practice Early Head Start home visits.


Eligibility criteria: Inclusion Criteria:

* Children must be receiving Early Head Start home visits and be at least 2 years old at the beginning of the study.

Exclusion Criteria:

-

Primary outcomes:
measure: Change in children's healthy eating habits: Body mass index
timeFrame: Baseline / up to 18 months
measure: Change in children's healthy eating habits: Food diaries
timeFrame: Baseline / up to 18 months
measure: Change in children's healthy eating habits: Parent reports
timeFrame: Baseline / up to 18 months
measure: Change in children's self-control skills: Direct testing
timeFrame: Baseline / up to 18 months
measure: Change in children's self-control skills: Video interactions
timeFrame: Baseline / up to 18 months
measure: Change in children's self-control skills: Parent ratings
timeFrame: Baseline / up to 18 months
measure: Change in parents' sensitive/responsiveness: Video interactions
timeFrame: Baseline / up to 18 months
measure: Change in parents' sensitive/responsiveness: Parent ratings
timeFrame: Baseline / up to 18 months
Secondary outcomes:
measure: Change in children's sleep habits: Parent reports
timeFrame: Baseline / up to 18 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Robert Nix, PhD
role: PRINCIPAL_INVESTIGATOR
References: