louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02143674: Muscle Strengthening Exercises and Global Stretching in Elderly
Official title: MUSCLE STRENGTHENING EXERCISES AND GLOBAL STRETCHING: IMPACT ON BALANCE, FEAR OF FALLING AND FUNCTIONAL CAPACITY OF ELDERLY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Senile Osteopenia
Keywords: Stretching exercise muscle
Elderly
Techniques and exercise
Physiotherapy
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Ciência e Tecnologia de Pernambuco
First posted: 2014-05-21
Enrollment: 59
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: The life expectancy and the number of people hitting the old age have increased in recent years. The aging process is accompanied by morphological and functional changes that contribute to reduced functional capacity, increase the number of falls and the appearance of physical limitations. Exercise promotes maintenance of functional autonomy, improving the physical ability of the elderly making it more independent.

Objective: To evaluate the effect of a program of muscle strengthening exercises associated with global stretching on balance, fear of falling and functional capacity in elderly women.

Methods: This was a non-randomized controlled trial, in which 12 volunteers aged over 60 years were divided into two groups: intervention group (IG, n = 7) submitted to muscle strengthening exercises and stretching, 2 times per week for 12 weeks, and the control group (CG, n = 5), not submitted to the protocol but were educated about physical exercises. Before and after the protocol were evaluated scores of Berg Balance Scale, the Falls Efficacy Scale International (FES-I) and Evaluation of Functional Autonomy Development Group for Latin American Maturity (GDLAM). Data were statistically analyzed within and between groups with a significance level of p \<0.05.


Eligibility criteria: Inclusion Criteria:

* women aged over 60 years,
* independent in locomotion,
* with ability to understand verbal commands to perform the tests and participation in the treatment program

Exclusion Criteria:

* execution of other physical activities or doing other types of physical therapy,
* had any prior neurological deficit (stroke, traumatic brain injury, Parkinson's disease) or
* musculoskeletal diseases which compromising performance and mobility,
* use of orthosis for locomotion,
* inability to perform the evaluation tests and/or participation in the intervention session

Primary outcomes:
measure: balance score
timeFrame: 12 weeks
Secondary outcomes:
measure: Fear of falling score
timeFrame: 12 weeks
measure: Functional Capacity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Laboratory of Kinesiotherapy and Manual Therapeutic Resources, Department of Physical Therapy, Federal University of Pernambuco (UFPE)
state: Pernambuco
Study officials:
References:
Clinical trial NCT04010474: Surgical APGAR Score and Modified Surgical APGAR Score
Official title: Comparison of Surgical APGAR Score and Modified Surgical APGAR Score in Predicting Possible Postoperative Complications in Major Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative/Postoperative Complications
Keywords: Complication
Mortality
Modified
Surgical Apgar Score
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 308
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 who underwent elective major surgery (Abdominal and Orthopedic surgery) were included (n=308)

After the operation modified SAS (mSAS) was calculated by adding the duration of the operation to data used in calculation of the SAS (Table 1.).

Observed complications and related conditions were also noted.

Table 1. Modified Surgical Apgar Score (mSAS)

mSAS 0 1 2 3 4

Estimated blood loss, ml \>1000 601-1000 101-600 ≤100 -

Lowest MAP\*, mmHg \<40 40-54 55-69 ≥70 -

Lowest HR\*\*, beats per min \>85 76-85 66-75 56-65 ≤55

Time -4 -3 -2 -1 0

Duration of operation (hour) \>8 7.01-8 5.01-7 3.01-5 0-3

\* MAP=Mean arterial pressure

Brief summary: In this study we aimed to define a new modified SAS is to predict the incidence of postoperative complication and mortality in major abdominal and orthopedic surgery. We also identify the effectivity of this modified scoring system composed of the duration of operation in addition to the three intraoperative parameters of SAS.


Eligibility criteria: Inclusion Criteria:

* Subject has major surgery
* More than 18 years

Exclusion Criteria:

* Pregnant
* Younger than 18

Primary outcomes:
measure: Comparison of Surgical APGAR Score and Modified Surgical APGAR Score in Predicting Possible Postoperative Complications in Major Surgery
timeFrame: 01.06.2017 - 30.09.2017
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Namigar Turgut
Study officials:
affiliation: University of Health Seciences, Okmeydani Training and Research Hospital
name: Namigar Turgut, Prof.Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT05103774: Thyroid Functions in Children With Congenital Heart Diseases
Official title: Thyroid Functions in Children With Congenital Heart Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Value of Thyroid Functions in Children With Congenital Heart Diseases
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Place of the study: Sohag University Hospital (pediatrics department -cardiology unit).
* Sample size the whole sample size will be at least 100 child diagnosed as CHD divided equally into two groups (group A and B) Group A: children exposed to any type of radiation or contrast Group B : children not exposed to an type of radiation or contrast

Brief summary: Thyroid hormone is critical for normal neurocognitive development in young infants, and even transient hypothyroidism can cause adverse neurodevelopmental outcomes. In a population of infants with CHD who already bear a high risk of long-term developmental delay, detection of hypothyroidism, even of a transient nature, may be even more consequential, and routine periodic monitoring of thyroid function may be necessary to reduce the risk of neurodevelopmental disabilities


Eligibility criteria: Inclusion Criteria:

* All children since birth up to age of 12 years old including both genders diagnosed to have CHD exposed to radiation, contrast or not.

Exclusion Criteria:

* above 12 years old

Primary outcomes:
measure: Assessment of thyroid function in children with congenital heart diseases at Sohag University hospital
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Hospital of Sohag University
Study officials:
References:
Clinical trial NCT06038474: Descartes-08 for Patients With Systemic Lupus Erythematosus
Official title: Descartes-08 for Patients With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus (SLE)
Keywords: Descartes-08
CART
CAR-T
Autoimmune
Auto-antibody
Auto antibody
chimeric antigen receptor
T cells
Lupus
SLE
Lupus Erythematosus
Systemic Lupus Erythematosus
LE
Lead sponsor: Cartesian Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-09-14
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: This is a Phase II study to evaluate the safety, tolerability and manufacturing feasibility of Descartes-08 CAR T-cells in patients with Systematic Lupus erythematosus (SLE).


Eligibility criteria: Inclusion Criteria:

* Patient must be at least 18 years of age.
* Patient must have systemic lupus erythematosus (SLE) at the time of screening.
* Active symptoms despite recent or ongoing immunosuppressive therapy with glucocorticoids and at least 2 other immunosuppressive medications being tried for at least 12 weeks within 24 months of screening.
* At least one of: anti-dsDNA, anti-histone, anti-chromatin, and/or anti-Sm antibodies detectable at screening as assessed by a CLIA-certified laboratory.

Exclusion Criteria:

* Active severe lupus nephritis, active severe CNS lupus, and/or neurological symptoms of SLE including headache, seizure, psychosis, and organic brain syndrome (a patient with an incidental headache, deemed unrelated to SLE, may re-screen by telephone upon resolution of the headache);
* Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient.
* Patient is pregnant or lactating.

Primary outcomes:
measure: Assess safety and tolerability of Descartes-08 in patients with systemic lupus erythematosus (SLE)
timeFrame: Day -59 to Day 50
Secondary outcomes:
measure: Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
timeFrame: Day -59 to Month 12
measure: Assess the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Responder Index (SRI)
timeFrame: Day -59 to Month 12
measure: Assess the clinical activity of Descartes-08 in patients with SLE using British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA)
timeFrame: Day -59 to Month 12
measure: Quantify the clinical activity of Descartes-08 in patients with SLE using Physician Global Assessment (PGA)
timeFrame: Day -59 to Month 12
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Profound Research LLC
state: California
Study officials:
References:
Clinical trial NCT03581474: Evaluation of BAL Procedure With Ambu aScope 3 Large in Patients in an ICU Setting
Official title: Evaluation of a Bronchoalveolar Lavage Procedure With a Flexible Disposable Bronchoscope, Ambu aScope 3 Large in Patients in an Intensive Care Unit Setting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atelectasis
Bronchoscopy
Lead sponsor: Ambu A/S
Sponsor class: INDUSTRY
First posted: 2018-07-10
Enrollment: 12
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: An Investigation to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung.

Detailed description: The purpose of this investigation it to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung. The hypothesis is that aScope 3 Large is able to manage the secretion and thereby facilitating the resolution of secretion in the lung.

Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years
* Clinical indication and eligible for a BAL procedure, as judged by the investigator
* Patients being admitted in the ICU at the investigational centre
* Provision of signed IC by subject, or subject's legal representative e.g. next of kin

Exclusion Criteria:

* Patients where BAL treatment cannot be clinically justified, judged by the investigator
* ETT \>7 mm and ≤8.5 mm in diameter
* Participating in other interventional clinical investigations or have previously participated in this investigation

Primary outcomes:
measure: Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment
timeFrame: 4 hours after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
Study officials:
affiliation: Ambu A/S
name: Anna Charlotte Lundgaard
role: STUDY_CHAIR
References:
Clinical trial NCT05562674: Impact of VVV Group for Veterans With SMI
Official title: Impact of Veteran Voices & Visions Peer Support Groups on Social Integration for Veterans With SMI/Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-10-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single arm trial evaluating the feasibility and acceptability of the manualized protocol the investigators develop.
Primary purpose: TREATMENT

Brief summary: Veterans with Serious Mental Illness (SMI) struggle with social integration - participation in work, housing, and citizenship - due to symptoms, stigma, and psychosocial challenges. Despite considerable VA efforts to provide mental health care to Veterans with SMI, programs that promote social integration are lacking. Veterans with SMI are at especially high risk for poor social integration and suicidal ideation during the COVID-19 pandemic. This project addresses this need with a group-based, peer specialist (PS) co-facilitated psychosocial intervention for Veterans with SMI, called "Veteran Voices and Visions" (VVV). VVV targets Veterans with SMI who experience psychosis, a group particularly in need of support with social integration. Virtual VVV groups are co-led by VA mental health clinicians (MHCs) and PSs via online video conference. The approach facilitates group cohesion around and normalization of the common psychotic symptoms of SMI: hallucinations, delusions, and social isolation. This intervention has the potential to create and foster a supportive community that improves the social integration of participants by reducing their distress and self-stigma, and increasing self-efficacy.


Eligibility criteria: Inclusion Criteria:

* DSM 5 diagnoses of schizophrenia, schizoaffective disorder, bipolar with psychosis, depression with psychosis, unspecified psychosis

Exclusion Criteria:

* Substance-induced psychosis,
* clinically significant neurological disease,
* history of serious head injury with loss of consciousness \> 1 hour.

Primary outcomes:
measure: The Psychotic Symptoms Rating Scale (PSYRATS-AHS)
timeFrame: 12 weeks after the initiation of the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Ippolytos A Kalofonos, MD PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02399774: Dental Support Device During Breastfeeding as a Mean for Pain Control
Official title: Dental Support Device During Breastfeeding as a Mean for Pain Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breastfeeding
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.

This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.

Detailed description: Dental support device is effective in increasing isometric force in different muscle contraction \[1-7\]. In 2009 an avant-garde study \[8\] found in a small cohort that dental support device during labor, can shorten the second stage and reduce obstetrical interventions such as operative delivery and cesarean section. In this stage the woman has to contract muscles in order to push the fetus through the birth canal.

Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.

This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.

Eligibility criteria: Inclusion Criteria:

1. Maternal age 18-45 years.
2. Normal vital signs.

Exclusion Criteria:

1. Contraindications for breastfeeding.
2. Significant systemic disease that cause pain or require chronic pain relief.

Primary outcomes:
measure: Rate of change in of the vas scores before and after using this device
timeFrame: 24 months
Secondary outcomes:
measure: Duration of breastfeeding
timeFrame: 24 months
measure: The rate of cessation of breastfeeding because of pain
timeFrame: 24 months
Other outcomes:
Locations:
city: Petah tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Director, Division of obstetrics and delivery
name: Yariv Yogev, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.
Clinical trial NCT03578874: SECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC
Official title: A Combination of Sorafenib, Capecitabine and Oxaliplatin (SECOX) as Neoadjuvant Therapy in Patients With Locally Advanced Hepatocellular Carcinoma: A Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 resectability after treatment with SECOX (sorafenib, capecitabine, oxaliplatin) as neoadjuvant therapy in patients with locally advanced hepatocellular carcinoma


Eligibility criteria: Inclusion Criteria:

* HCC confined to single lobe of non-cirrhotic liver (locally advanced) and not suitable for surgery or loco-regional therapies at the time of study entry, but can become resectable after treatment
* Diagnosis of HCC confirmed by histology
* Child-Pugh class A cirrhosis with adequate remnant liver parenchyma
* Measurable disease
* Fit enough to undergo surgery to resect the primary liver tumour

Exclusion Criteria:

* Prior systemic therapy for HCC
* Presence of extrahepatic metastasis
* History of liver transplantation
* Peripheral sensory neuropathy with functional impairment
* Uncontrolled hypertension/ cardiac disease

Primary outcomes:
measure: Resectability
timeFrame: At the end of Cycle 4 (each cycle is 14 days)
Secondary outcomes:
measure: Objective response rate
timeFrame: At the end of Cycle 4 (each cycle is 14 days)
measure: Progression-free survival
timeFrame: Approximately 18 months
measure: Overall survival
timeFrame: Approximately 33 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
References:
Clinical trial NCT01049074: A Random Controlled Test (RCT): Acupuncture Treatment on Nonspecific Low Back Pain (NLBP)
Official title: A Random Controlled Test (RCT): Acupuncture Treatment on Nonspecific Low Back Pain (NLBP) (ANLBP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Acupuncture
RCT
Lead sponsor: Beijing Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2010-01-14
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Acupuncture procedure of He's Santong Methods could be an option to treat nonspecific low back pain.

Detailed description: He's Santong Methods is a combined manipulated needling methods, including filiform needling, fire needling and bloodletting needling, which was created by Dr. He Puren who is one of the most famous TCM doctors in China.

Eligibility criteria: Inclusion Criteria:

* The patient who is suffering the Non-specific Low Back Pain which meets the diagnostic criterion of posterior ramus of lumbar spinal nerve syndrome.
* The patient who is from 18 to 79 years old.
* The patient who can comprehensively understand and fill in the questionnaires about the disease.
* The patient who suffered problems no less than 12 weeks.
* The patient who have not the other diseases which can result in back pain.
* The patient who received the clear examinations of X-ray, CT scan or MRI.
* The patient who wrote the informed consents.

Exclusion Criteria:

* The patient whose low back pain is the consequences of spondyloschisis, Spondylolysis, osteoarthritis, osteoporosis, internal disease, metastatic tumor.
* The patient who have the hemorrhagic disease such as hemophilia.
* The patient who have the spinal diseases which have not been diagnosed clearly.

Primary outcomes:
measure: Score of SF-36
timeFrame: 4 weeks, 8 weeks, 12 weeks, 24 weeks
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 4 weeks, 8 weeks, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing TCM Hospital
state: Beijing
city: Lasi
country: Romania
facility: Hospital CF Iasi, Clinic of Rehabilitation Medicine, Phys. Med., Balneoclimatology
Study officials:
affiliation: Beijing TCM Hospital
name: Linpeng Wang, M.D.
role: STUDY_CHAIR
affiliation: Hospital CF Iasi, Clinic of Rehabilitation Medicine, Phys. Med., Balneoclimatology
name: Stratulat Ioan Sorin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: