louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05340517: Prospective Study of Video-assisted Rib Planting in Chest Wall Stabilization
Official title: Prospective Study of Video-assisted Rib Planting in Chest Wall Stabilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rib Fractures
Rib Fracture Multiple
Keywords: internal fixation
video-assisted
chest wall stabilization
prospective study
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the advantages and disadvantages of video-assisted rib planting and traditional internal fixation of rib fractures in chest wall stabilization.

The investigators design a new surgical method of video-assisted thoracoscopic surgery for rib fractures, evaluate the advantages and disadvantages of the new surgical techniques with a prospective study.


Eligibility criteria: Inclusion Criteria:

-≥3 unilateral rib displacement fractures

* 18-70 years old
* ASA score I-II
* Preoperative arterial oxygen partial pressure \>60mmHg
* Carbon dioxide partial pressure \<50mmHg

Exclusion Criteria:

* The distance from the broken end of the posterior rib fracture to the spine is less than 2cm
* Airway stenosis
* Abnormal coagulation system
* History of peptic ulcer or bleeding
* History of allergy to anesthesia related drugs
* History of asthma or chronic obstructive pulmonary emphysema
* Pregnant women

Primary outcomes:
measure: The pain score after operation
timeFrame: 6 hours after operation
measure: The pain score after operation
timeFrame: 12 hours after operation
measure: The pain score after operation
timeFrame: 24 hours after operation
Secondary outcomes:
measure: The postoperative drainage
timeFrame: 7 days at most
Other outcomes:
measure: The operation time
timeFrame: During surgery
measure: The length of incision
timeFrame: During surgery
measure: The intraoperative bleeding
timeFrame: During surgery
measure: The treatment costs
timeFrame: from the date of hospitalization to the date of leave hospital,assessed up to 100 months
measure: Days of stay hospital
timeFrame: from the date of hospitalization to the date of leave hospital,assessed up to 100 months
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Study officials:
affiliation: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Weigang Zhao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03458117: T-VEC in Non-melanoma Skin Cancer
Official title: A Phase I, Open Label, Single Arm, Single Centre Study to Evaluate Mechanism of Action of Talimogene Laherparepvec (T-VEC) in Locally Advanced Non-melanoma Skin Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-melanoma Skin Cancer
Basal Cell Carcinoma
Squamous Cell Carcinoma
Cutaneous Lymphoma
Merkel Cell Carcinoma
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 26
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: Evaluation of the mechanism of Action of talimogene laherparepvec (T-VEC) in patients with locally advanced non-melanoma skin cancer.

Detailed description: This study evaluates the administration of T-VEC in non-melanoma skin cancer. The aim is to evaluate the effectiveness, safety and tolerability of T-VEC in patients with non-melanoma skin cancer through determination of local immune effects after repeated T-VEC injections.

Eligibility criteria: Inclusion Criteria:

* Subjects Age ≥ 18 years
* histologically confirmed diagnosis of locally advanced squamous cell carcinoma, basal cell, carcinoma, Merkel cell carcinoma or cutaneous T cell lymphoma
* at least 1 injectable cutaneous lesion ≥ 20 mm in longest Diameter or multiple injectable lesions that in Aggregate have a longest Diameter of ≥ 50 mm
* Eastern Cooperative Oncology Group-Status (ECOG Status) 0 or 1
* Adequate organ functions

Exclusion Criteria:

* Hypersensitivity to T-VEC or any of ist components
* Presence of organ and lymph node metastases
* history or evidence of active autoimmune disease that requires systemic Treatment
* Evidence of clinically significant immunosuppression
* active herpetic skin lesions or prior complications hereof
* pregnancy, breast feeding
* requires intermittent or chronic systemic Treatment with an antiherpetic drug
* acute or chronic active Hepatitis B or C infection or HIV infection

Primary outcomes:
measure: Change from Baseline local immune effects after repeated T-VEC injections
timeFrame: at baseline, after 3 injections (week 6) and optionally after 6 injections (week 12)
Secondary outcomes:
measure: Detection of Tumor Regression using World Health Organization (WHO) response criteria
timeFrame: at baseline and at week 22
measure: Systemic immune response
timeFrame: at baseline and week 6, optionally also at week 12
measure: Analysis of Adverse events
timeFrame: At week 1, 4, 6, 8, 10, 12, 14, 16, 18, 22
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Dermatology, University Hospital Zurich
Study officials:
affiliation: vice-director dermatology
name: Reinhard Dummer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02598817: Acceptability and Gastrointestinal Tolerance of a High-Sn-2 Infant Formula
Official title: Acceptability of "High Sn-2" Infant Formula in Non-Breast Fed Healthy Term Infants Regarding Gastrointestinal Tolerability by Both Parents and Pediatrician. An Open Label Pilot Study Evaluation in the Gulf Cooperation Council (GCC) Countries.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant Term Birth
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-11-06
Enrollment: 276
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 healthy, full-term, formula fed infants

Brief summary: The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal (GI) Tolerance.

Detailed description: This is a multicenter, open label, observation study; 500 formula fed infants are planned to be enrolled from a network of general pediatricians in the Gulf countries (UAE, Kuwait, Qatar, and KSA). Eligible infants will consume a high sn-2 palmitate infant formula for 12 weeks. All enrolled infants will be evaluated at enrollment and at 4 weeks and 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Formula fed healthy full term infants with normal birth weight (2500g 4000g)
* Partially breast and formula fed infants who drink at least 2 formula feedings per day; each to be at least 30ml
* Infants of both genders at age of 2 weeks to 12 weeks
* Infants of parents providing written informed consent before any study related activities are carried out

Exclusion Criteria:

* Preterm or IUGR babies
* Contraindication of standard infant formula
* Infants who have allergy of cow's milk protein
* Infants with Serious medical or surgical GI disease
* Infants with multiple congenital anomalies
* Infants with suspected chromosomal or metabolic disorder
* Infants of mothers with a health condition or socioeconomic problems that may interfere with their ability to take care of their infants
* Infants of parents who refuse to participate in the study

Primary outcomes:
measure: Infant Stool Form Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes from baseline to 12 weeks in Height centile
timeFrame: 12 weeks
measure: Changes from baseline to 12 weeks in Weight centile
timeFrame: 12 weeks
measure: Changes from baseline to 12 weeks in Head Circumference centile
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Al Jubayl
country: Saudi Arabia
facility: Almana Hospital
city: Dammam
country: Saudi Arabia
facility: Tadawi General Hospital
city: Riyadh
country: Saudi Arabia
facility: Al Mouasat Hospital
city: Abou Dabi
country: United Arab Emirates
facility: Sheikh Khalifa Medical City
city: Dubai
country: United Arab Emirates
facility: Al Garhoud Private Hospital
Study officials:
affiliation: Pediatric Gastroenterologist
name: Islam Tawfiq Al Baroudi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01333917: Curcumin Biomarkers
Official title: Curcumin Chemoprevention of Colorectal Neoplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colorectal Cancer
Keywords: Curcumin
Colorectal Cancer
GWAS
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2011-04-12
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Colorectal cancer is a major problem in the United States and other developed countries. A safe and effective chemopreventive agent could reduce the burden of colorectal neoplasia. Curcumin, is a product that is derived from Curcuma longa. It has been used for thousands of years as a traditional remedy. Curcumin blocks a number of targets involved in tumor initiation, promotion, and progression, and is considered a promising chemopreventive agent. The investigators propose to enroll 40 patients after screening colonoscopy who will have rectal biopsies at baseline and after 4 weeks of curcumin 4 grams per day. The investigators will use microarray analysis to identify genes that are modified by curcumin that could be used as biomarkers in future chemoprevention studies. The study will also evaluate tolerability and toxicity.


Eligibility criteria: Inclusion Criteria:

1. Age 40 - 80.
2. A willingness to follow the study protocol, as indicated by provision of informed consent to participate
3. Good general health

Exclusion Criteria:

1. Familial colorectal cancer syndromes (e.g. Hereditary Non-Polyposis Colon Cancer, Familial Adenomatous Polyposis)
2. Ulcerative colitis or Crohn's disease.
3. History of large bowel resection for any reason
4. Diagnosed narcotic or alcohol dependence
5. Unwillingness to forgo curcumin/turmeric-containing supplements during the trial or consumption of curry/turmeric at meals \> 3 times a week.
6. Allergy to turmeric/curcumin.
7. Women with childbearing potential who do not agree to practice effective birth control.
8. Individuals with creatinine, AST or ALT above 1.5 times the upper limit of normal at baseline.
9. Personal or inherited bleeding disorders or therapeutic anti-coagulation with warfarin.
10. Women who are pregnant or nursing.
11. Individuals who have taken antibiotics within the three months prior to enrollment.

Primary outcomes:
measure: Gene expression
timeFrame: 30 days
measure: Ribonucleic acid (RNA) level
timeFrame: 30 days
measure: Apoptosis
timeFrame: 30 days
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Department of Family Medicine
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Gary N Asher, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06394817: Beijing Disability Risk and Ageing Monitoring Study
Official title: Beijing Disability Risk and Ageing Monitoring Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Age Problem
Disability
Death
Keywords: Disability, Ageing, Cohort
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community residents aged 60 years or older in China

Brief summary: This is a community-based prospective cohort study in Beijing, China. The study has been initialized in 2023 and enrolled older residents. This study aims to develop disability risk assessment standards and an early warning model for older adults.

Detailed description: This is a community-based prospective cohort study. Individuals who aged 60 years or older, lived in the communities for more than 1 year, and signed the informed consent form were enrolled in the present study. The study has been initialized in 2023 and aimed to develop an early warning model and a series of disability risk assessment methods for older adults. This work consists of three steps as following. First, we will build a community-based cohort and thus set up a database. Second, an intelligence model for disability risk assessment will be developed using the database. Third, a series of procedures will be established according to the risk assessment model.

Eligibility criteria: Inclusion Criteria:

* Aged 60 years or older
* Lived in the community for more than 1 year
* Signed the informed consent form

Exclusion Criteria:

* Cannot complete the survey

Primary outcomes:
measure: The prevalence and incidence of functional disability using a population-based survey
timeFrame: An average of 1 to 2 years
measure: The prevalence and incidence of mild cognitive impairment using a population-based survey
timeFrame: An average of 1 to 2 years
measure: The prevalence and incidence of dementia using a population-based survey
timeFrame: An average of 1 to 2 years
measure: The conversion rate of normal to mild cognitive impairment
timeFrame: An average of 1 to 2 years
measure: The conversion rate of mild cognitive impairment to dementia
timeFrame: An average of 1 to 2 years
measure: The genetic and environmental factors for mild cognitive impairment and dementia at genomic and expression levels
timeFrame: An average of 1 to 2 years
measure: The biomarkers for normal, mild cognitive impairment, and dementia diagnosis
timeFrame: An average of 1 to 2 years
measure: The prevalence and incidence of movement disorder using a population-based survey
timeFrame: An average of 1 to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Yi Tang, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00498017: Infections After Renal Transplantation: Diseases Pattern in Hong Kong
Official title: Infections After Renal Transplantation: Diseases Pattern in Hong Kong
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Infection
Keywords: Infections
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2007-07-09
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Over a period of 4.5 years, between 1/1/2000 and 30/6/2005, there were totally 58 new cases in our renal transplantation clinic. 36 of them were male, 22 of them were female (Male to female ratio is 1.64:1). All were single-organ recipients. Majority of them (57/58 or 98.3%) were receiving their first renal transplantation, the only exception was a women receiving her second renal transplantation during the study period. Majority (57/48 or 98.3%) of them were cadaveric renal transplantation (CRT). One living-related renal transplantation (LDRT) had been performed in Hong Kong during the study period. Majority of the renal transplantation were performed in Mainland China (48/58 or 82.8%), whilst the remaining 10 operations (17.2%) were performed in Hong Kong.

Brief summary: Infections are the most feared complications developing in patient who had had kidney transplantation. The aim of this study is to document the local disease pattern among this group of patients.


Eligibility criteria: Inclusion Criteria:

* All living-related or cadaveric renal transplantation episodes (including preemptive ones) performed in the Hong Kong Special Administration Region (HKSAR), Mainland China or overseas during the period 1/1/2000 to 30/6/2005

Exclusion Criteria:

* multiple organ recipients, incomplete records and lost to follow-up, including those cases who have been taken over by other renal centres

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Caritas Medical Centre
city: Hong Kong
country: China
facility: Princess Margaret Hospital
Study officials:
affiliation: Department of Medicine & Geriatrics, ICU, Caritas Medical Centre
name: Sze Kit Yuen, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06804317: Effectiveness of a Supervised Multicomponent Exercise-Based Telerehabilitation Intervention on Physical Performance in Older Patients with Multiple Chronic Conditions in Colombia
Official title: Effectiveness of a Supervised Multicomponent Exercise-Based Telerehabilitation Intervention on Physical Performance in Older Patients with Multiple Chronic Conditions in Colombia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Communicable Chronic Diseases
Keywords: Exercise Therapy
elderly
telerehabilitation
Lead sponsor: Fundacion Universitaria Maria Cano
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 41
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Currently, the older adult population faces an increase in the prevalence of cardiopulmonary diseases, which negatively impact their quality of life by limiting their ability to perform daily activities and affecting their physical and emotional well-being. In particular, cardiovascular and respiratory diseases are among the leading causes of morbidity and mortality among older adults in Colombia. Despite advances in pharmacological treatment and medical care, physical rehabilitation remains an essential component in the management of these diseases, with physical exercise serving as one of its fundamental pillars. However, access to physical rehabilitation programs for the older adult population, particularly in rural or hard-to-reach areas, continues to pose a significant challenge. Telemedicine and Information and Communication Technologies (ICT) have emerged as viable solutions to overcome this barrier, enabling the remote prescription and monitoring of physical exercises, facilitating the inclusion of more patients in rehabilitation programs, and improving their quality of life. Therefore, this study aims to evaluate the effectiveness of a multicomponent ICT-mediated intervention in terms of improving physical condition, reducing frailty, adherence, satisfaction, and quality of life in older adults with cardiopulmonary diseases.


Eligibility criteria: Inclusion Criteria

* Diagnosis of a non-communicable disease.
* Ability to communicate verbally or in writing.
* Stable disease status confirmed by clinical history.
* Condition present for at least three months to qualify as chronic.
* For patients with type II diabetes mellitus: glucose levels below 200 mg/dL during tele-rehabilitation sessions.

Exclusion Criteria

* Requirement for assistance with walking.
* History of disease exacerbation within the past six months.

Primary outcomes:
measure: Short Physical Performance Battery
timeFrame: Baseline and at 1 month postest
Secondary outcomes:
measure: Six-minute walk test
timeFrame: Baseline and at 1 month postest
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Fundación universitaria María Cano
Study officials:
References:
Clinical trial NCT04651517: Pilot Study of the ACE System in Lung Procedures
Official title: Pilot Study of the XACT Robotics ACE System for Image Guided Percutaneous Procedures in the Lung
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Lead sponsor: Xact Robotics Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects 18 years of age or older who are undergoing CT guided, minimally invasive percutaneous procedures of the lung.
Primary purpose: OTHER

Brief summary: To evaluate the XACT ACE Robotic System in lung procedures.

Detailed description: The XACT ACE Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous lung procedures. The system is used for trajectory planning and is intended to assist the physician in the positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking. This study will evaluate safety and accuracy of the XACT ACE Robotic System in subjects undergoing CT guided, minimally invasive percutaneous procedures of the lung in the interventional radiology suite.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age
2. Subjects undergoing CT-guided, minimally invasive percutaneous lung procedures in the interventional radiology suite, e.g., core biopsy, fine needle aspiration (FNA), tumor ablation, etc.
3. Following planning and registration CT scans, subject is found eligible to undergo CT-guided, minimally invasive percutaneous procedure
4. Subject is willing to sign informed consent
5. Subject is capable of adhering to study procedures

Exclusion Criteria:

1. Subjects in whom the target is within 1 cm of a major blood vessel, major nerve or heart
2. Subject with significant coagulopathy
3. Subject with preexisting or unstable medical condition(s), which in the opinion of the investigator, might interfere with the conduct of the study
4. Subjects who are pregnant or nursing
5. Following planning and registration CT scans, required clinical trajectory to target is beyond system workspace limits (e.g., entry angle is too sharp)

Primary outcomes:
measure: Adverse Events
timeFrame: 30 days
Secondary outcomes:
measure: Secondary Performance Evaluation - Clinical Accuracy
timeFrame: 1 hour
measure: Secondary Performance Evaluation - System Accuracy
timeFrame: 1 hour
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
Study officials:
affiliation: Lahey Hospital & Medical Center
name: Sebastian Flacke, MD
role: PRINCIPAL_INVESTIGATOR
References: