louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06906952: A Prospective Single-center Randomized Controlled Trial of Robotic Surgery with Transrectal Resection Specimens (NOSES-IV) and Traditional Assisted Robotic Surgery for the Treatment of High Rectal and Sigmoid Colon Cancer
Official title: A Prospective Single-center Randomized Controlled Trial of Robotic Surgery with Transrectal Resection Specimens (NOSES-IV) and Traditional Assisted Robotic Surgery for the Treatment of High Rectal and Sigmoid Colon Cancer
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Natural Orifice Specimen Extraction Surgery
Robotic Surgery
Short-term Outcomes
Lead sponsor: Nanchang University
Sponsor class: OTHER
First posted: 2025-04-02
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: This study aimed to compare the short-term efficacy of robotic radical resection of high rectal cancer and sigmoid colon cancer (NOSES-IV) with transrectal resection specimens and traditional robotic surgery in the treatment of high rectal cancer and sigmoid colon cancer. At the same time, the safety and advantages of robotic radical resection of high rectal cancer and sigmoid colon cancer (NOSES-IV) with transrectal resection specimens and traditional robotic surgery in the treatment of high rectal cancer and sigmoid colon cancer were compared.


Eligibility criteria: Inclusion Criteria:

* 1) The age is more than 18 years old and less than or equal to 85 years old 2) Eastern Cooperative Oncology Group score ≤2 3) Preoperative pathological diagnosis of rectal adenocarcinoma 4) cT1-3NxM0 rectal cancer defined by preoperative contrast-enhanced MRI 5) The maximum diameter of tumor ≤5cm on preoperative enhanced MRI 6) The body can tolerate the operation and sign the informed consent

Exclusion Criteria:

* 1) multiple primary colorectal cancer 2) recurrent rectal cancer 3) preoperative neoadjuvant chemoradiotherapy 4) complicated with intestinal obstruction or intestinal bleeding requiring emergency surgery 5) previous anal surgery history 6) BMI≥30kg/m2 7) severe mental illness

Primary outcomes:
measure: The rate of all complications
timeFrame: 1 months after surgery
measure: The rate of all complications (Clavien-Dindo grade ≥ III )
timeFrame: 1 months after surgery
Secondary outcomes:
measure: operative time
timeFrame: Intraoperative
measure: estimation of blood loss
timeFrame: Intraoperative
measure: postoperative hospital stay
timeFrame: 1 day after operation
measure: visual analogue pain score
timeFrame: 1 weeks after surgery
Other outcomes:
Locations:
city: NanChang
country: China
facility: the First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330000
Study officials:
References:
Clinical trial NCT05404152: Evaluation of Cognitive Impairment in the Elderly Admitted to Nursing Homes
Official title: Evaluation of Cognitive Impairment in the Elderly Admitted to Nursing Homes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurocognitive Disorder, Etiology of Neurocognitive Disorder
Keywords: Cognitive impairment, nursing home, neurocognitive disorder
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 390
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Elderly without cognitive assessment at admission
* Existence of doubts about the presence of IC

Brief summary: This research aims at analysing the profile of the elderly with cognitive impairment (IC) and inquiring about the mental illnesses that cause cognitive impairment of a population (elderly admitted to nursing homes with a high incidence).

Detailed description: The objectives of these studies are to determine the presence of IC and the profile of users who suffer from it in 8 nursing homes in the province of Pontevedra of new admission in 2017, as well as the identification of the frequency of underdiagnosis in the filiation of the mental pathology that causes IC and if that underdiagnosis is related to the presence of doctors or nurses specialists in geriatrics. Sociodemographic, clinical (with special relevance in cognitive assessment and the presence of mental disorders) and functional variables will be analyzed. In addition to providing information that can improve the DC early detection as well as the scarcity of studies in this field, the importance of this research is justified by developing treatment guidelines for people with IC in the future

Eligibility criteria: Inclusion Criteria:

* Vounteer
* Elderly Admitted to Nursing homes
* From 60 years old

Exclusion Criteria:

* Elderly without cognitive assessment at admission
* Existence of doubts about the presence of IC

Primary outcomes:
measure: Study of Evaluation of Cognitive Impairment. MEC o MMSE <24 points or diagnosis of Neurocognitive disorder
timeFrame: Two years
Secondary outcomes:
measure: Statistical correlation of CI with educational level.
timeFrame: Two years
Other outcomes:
measure: Causes underdiagnosis of IC affiliation and Mental illnesses that cause IC
timeFrame: Two years
Locations:
city: Murcia
country: Spain
facility: UMurcia
Study officials:
affiliation: Universidad de Murcia
name: MARIA ELENA MOSQUERA LOSADA, MSc in Nursing
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Murcia
name: ANTONIA GOMEZ-CONESA, PhD, PT
role: STUDY_DIRECTOR
affiliation: University of A Coruña
name: RAMON GONZALEZ CABANACH, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03155152: Decremental Exercise: a New Training Approach?
Official title: Decremental Exercise Protocol as a Training Stimulus: More or Less Efficient Than Traditional High-intensity Interval Training?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Performance of Fit Athletes
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Different types of high-intensity interval training (HIIT) sessions are used by athletes in order to improve their physical performance, but innovative approaches to training are lacking. Therefore, in Part A of this study the physiological response to a standard HIIT and a new decremental exercise training (DECT) will be compared in runners and cyclists. Next, in Part B the training effects of a 4-week block of the HIIT and DECT will be compared.


Eligibility criteria: Inclusion Criteria:

* Age: 18-40 years
* Healthy, i.e. normal physical and mental status (not taking any medication on a regular basis for more than a month, except contraceptive medication)
* Normal Body-Mass-Index (BMI): 18.5-24.9 kg·m-2
* Well-trained athletes: V̇O2max \> 55.1 ml·min-1·kg-1 for men and \> 50.1 ml·min-1·kg-1 for women
* Normal lung function
* Non-smoking
* Willing to adhere to the general study rules

Exclusion Criteria:

* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the study
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Previous enrolment into the same part (A or B) of the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Acute or chronic illness
* Intake of medications affecting performance or the respiratory, cardiovascular or neuromuscular system
* Insufficient training history (\<3 yrs of participation in competitive cycling/running) or training volume (\<40 km running/week or 150 km cycling/week) in the previous 6 months
* Recent (\<3 months) history of orthopaedic injury or participation in structured high-intensity training blocks

Primary outcomes:
measure: Change in exercise performance
timeFrame: measured before and after the 4-week training block, during a time-trial (40 km cycling or 10 km running)
Secondary outcomes:
measure: Change in maximal oxygen uptake
timeFrame: Measured during a maximal incremental exercise test before and after the 4-week training block
measure: Average oxygen uptake
timeFrame: The two training session are performed within one week
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
state: ZH
Study officials:
affiliation: ETH Zurich
name: Christina M Spengler, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05725759: Rehabilitation in SOD1 ALS Treated With Tofersen
Official title: The Effects of Rehabilitation on Functional Outcomes in Patients With SOD1 ALS Treated With Tofersen
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Amyotrophic Lateral Sclerosis
Lou Gehrig Disease
Familial Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Motor Neuron Disease, Familial
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with SOD1 ALS

Brief summary: The primary objective of this study is to document and describe the effects of a personalized rehabilitation program for patients with SOD1 ALS participating in the tofersen expanded access program. Participants currently receiving tofersen treatment will be referred to outpatient physical and/or occupational therapy. Participants will have an initial assessment performed and an individualized rehabilitation program will be prescribed. Each participant is encouraged to follow the prescribed recommendations that will include scheduled outpatient therapy sessions, functional assessments, and/or a home-based rehabilitation program. Functional assessments will be done at a minimum of every three months.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of ALS with an SOD1 mutation
* Current enrollment in the tofersen expanded access program
* Age greater than 18 years
* Medically able to participate in outpatient physical therapy and/or home-based rehabilitation, as determined by the treating health care provider

Exclusion Criteria:

* Any comorbidities or conditions that, in the opinion of the treating healthcare provider, would unacceptably increase the risk of participation in outpatient physical therapy and/or home-based rehabilitation

Primary outcomes:
measure: Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS)
timeFrame: 12 months
Secondary outcomes:
measure: 1. Change from baseline in Handheld Dynamometry (HHD)
timeFrame: 12 months
measure: 2. Change from baseline in Rasch-Built Overall Amyotrophic Lateral Sclerosis Functional Rating (ROADS)
timeFrame: 12 months
measure: 3. Change from baseline in ALS Assessment Questionnaire, 5-item (ALSAQ-5)
timeFrame: 12 months
measure: Change from baseline in motor Functional Independence Measure (motor FIM)
timeFrame: 12 months
measure: Change from baseline in Modified Ashworth Scale (MAS)
timeFrame: 12 months
measure: Change from baseline in Slow Vital Capacity (SVC)
timeFrame: 12 months
measure: Change from baseline in Maximal Inspiratory Pressure (MIP)
timeFrame: 12 months
measure: Change from baseline in Fatigue Severity Scale (FSS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT04896359: High Doses Vitamin C and Tissular Repair in Surgical Patients
Official title: Effect of High Doses of Vitamin C on the Tissular Reparation (Healing) in Patients Under Surgery in the "Hospital de Los Valles".
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tissue Damage
Lead sponsor: Universidad San Francisco de Quito
Sponsor class: OTHER
Collaborators: name: Biomolec Pharma
First posted: 2021-05-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective, randomize, double-blind, and placebo-controlled study to evaluate in patients with clinical criteria for any of the following open surgical procedure: (1) cesarean section; (2) aesthetic surgery like abdominoplasty; (3) orthopedic surgery; and (4) abdominal open surgery \[excluding laparoscopic procedures\] will be invited to receive either a high dose of vitamin C (12.5 g) three times (48 h pre-surgery, immediately before surgery and 48 h post-surgery) or its placebo, to evaluate the tissue repair process using an international validated instrument named Patient and Observer Scar Assessment Scale.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years.
* Susceptible for any of the following surgical procedures: (1) cesarean section; (2) aesthetic abdominal plastic surgery; (3) orthopedic prosthetic replacement surgery
* Voluntary consent to participate

Exclusion Criteria:

* Known allergy to the vitamin C
* Known problems with wounds healing
* Kidney disease (including lithiasis) or gout

Primary outcomes:
measure: Evaluation of linear scars
timeFrame: initial assessment, two weeks after surgery
measure: Evaluation of linear scars
timeFrame: second assessment, one month after surgery
measure: Evaluation of linear scars
timeFrame: third assessment, three months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Quito
country: Ecuador
facility: Hospital de los Valles
state: Pichincha
Study officials:
affiliation: Universidad San Francisco de Quito
name: Enrique Teran
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06457659: Effect of Early Prosthetic Fitting in Patients With Below-knee Amputation
Official title: Effect of Early Prosthetic Fitting in Patients With Below Knee Amputation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Amputation Stump
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A randomized control trial of 50 patients to identify the effect of early prosthetic fitting and physical rehabilitation. Previous studies show a significant impact of early induction of prosthetic rehabilitation of amputation. Delayed rehabilitation may cause severe physical complications like joint contracture, and muscle strength loss.

Detailed description: Along with physical complications delays in rehabilitation may also significantly affect psychological, economic, and quality of daily life. Pakistan is a low-income developed country and the major cause of amputation here is traumatic amputation, which affects mostly younger age people. After missing a precious body part if the amputee comes along with such kind of physical and Psychological complications, his/her whole daily life will be affected. There is a keen need for the implementation of global rules for physical rehabilitation of amputees and disabled including the duration of induction of prosthetics as well as overall physical rehabilitation after surgical and traumatic removal of limbs.

Eligibility criteria: Inclusion Criteria:

* Male and female below-knee amputees due to trauma and diabetes were included

Exclusion Criteria:

* patients with comorbidities and old users of prostheses were excluded

Primary outcomes:
measure: World Health Organization Quality of life (WHO QOL)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Dera Ismail Khan
country: Pakistan
facility: Mobility Rehab care, Islamabad Medical Center
state: Khyber Pakhtunkhwa
Study officials:
References:
Clinical trial NCT01205659: Allergy and Ashthma in Children Who Were Fed Supplemented Infant Formula
Official title: Allergy and Asthma in Children Who Were Fed Supplemented Infant Formula (3-7 Years of Age)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy and Asthma
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2010-09-20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children who participated in randomizaed trials of supplemented infant formula conducted by The Retina Foundation of the Southwest during infancy

Brief summary: Allergy and Asthma study of children (3 - 7 Years of age) who participated in randomized trials of supplemented infant formula during infancy conducted by The Retina Foundation of the Southwest .


Eligibility criteria: Inclusion Criteria:

* Children who participated in randomized trials of supplemented infant formula conducted by The Retina Foundation of the Southwest during infancy

Exclusion Criteria:

-

Primary outcomes:
measure: Prevalence of asthma and allergy related diagnosis in medical records for ages 3 - 7 years
Secondary outcomes:
measure: Prevalence of Serious Adverse Events in medical records
measure: Long-term growth
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The Retina Foundation of The Southwest
state: Texas
Study officials:
References:
Clinical trial NCT03540459: Central Apnea in Patients Receiving Ticagrelor
Official title: Central Apnea in Patients Receiving Ticagrelor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Lead sponsor: Les Grands Prés
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patient receiving ticagrelor 10 days to 2 years after an acute coronary syndrome will be included

Brief summary: all patients with a left ventricular ejection fraction superior or equal to 50% less than 2 years after an acute coronary event and receiving ticagrelor will undergo a sleep polygraphy

Detailed description: all patients with a left ventricular ejection fraction superior or equal to 50% less than 2 years after an acute coronary event and receiving ticagrelor will undergo a sleep polygraphy the main objective of the study will be to look for central sleep apnea

Eligibility criteria: Inclusion Criteria:

* patient receiving ticagrelor 10 days to 2 years after an acute coronary syndrome

Exclusion Criteria:

* left ventricular ejection fraction \< 50%
* patients refusal

Primary outcomes:
measure: central apnea index
timeFrame: at baseline
Secondary outcomes:
measure: global apnea hypopnea index
timeFrame: baseline
Other outcomes:
Locations:
city: Villeneuve Saint Denis
country: France
facility: Les Grands Prés
Study officials:
References:
citation: Meurin P, Ben Driss A, Defrance C, Dumaine R, Weber H, Renaud N, Bonnevie L, Mouram S, Tabet JY. Central sleep apnea after acute coronary syndrome and association with ticagrelor use. Sleep Med. 2021 Apr;80:39-45. doi: 10.1016/j.sleep.2021.01.026. Epub 2021 Jan 20.
Clinical trial NCT04091659: Use of Virtual Reality for Overdose Management Educational Trainings
Official title: Use of Virtual Reality for Overdose Management Educational Trainings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Overdose
Virtual Reality
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This cluster-randomized trial will compare changes in attitudes and knowledge on administering naloxone based on exposure to either a virtual reality educational training or the current standard educational trainings (e.g. on-line videos, printed information handouts) offered at local libraries. Individuals attending local library's naloxone training days will voluntarily complete an anonymous validated survey pre and post attending either the virtual reality or standard educational training.

Detailed description: This study will utilize a cluster-randomized trial design. Entire libraries will be randomized to either offer community members the virtual reality training or the standard educational offerings (e.g. handouts, online videos). Volunteers will be asked to complete the brief, anonymous, and validated Opioid Overdose Knowledge Scale prior to receiving an education intervention (pretest) and then again immediately after (posttest). Neither participants nor investigators will be blinded. Library patrons who do not participate in the study will be offered current standard training materials. Regardless of the library's randomization, to either virtual reality or standard training, all patrons completing pre and post test surveys will have the opportunity to view the virtual reality training or other public health department materials.

Eligibility criteria: Inclusion Criteria:

* Able to complete paper surveys independently
* Provide verbal consent

Exclusion Criteria:

* Unable to complete immediate post-training assessment
* Individuals under 18 years of age
* Individuals who cannot communicate in English and provide consent

Primary outcomes:
measure: Change in Opioid Overdose Knowledge Scale (OOKS) From Pre- to Post-training
timeFrame: Immediately Pre-Training and Within 1 Hour Post-training
Secondary outcomes:
measure: Change in Opioid Overdose Attitudes Scale (OOAS) From Pre- to Post-training
timeFrame: Immediately Pre-Training and Within 1 Hour Post-training
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Lecturer
name: Nicholas A Giordano
role: PRINCIPAL_INVESTIGATOR
References: