louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05745649: Restoration of Physical Function in Patients Following Total Knee Replacement: Comparison Between Resistive Strength Training Exercises & Ankle Weights
Official title: Restoration of Physical Function in Patients Following Total Knee Replacement: Comparison Between Resistive Strength Training Exercises & Ankle Weights
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Neuro Counsel Hospital, Pakistan
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single blind RCT in which two groups were formulated. One as Control and other as an experimental
Primary purpose: OTHER

Brief summary: Techniques used to restore the physical functions in TKR patients

Detailed description: to restore the physical functions in TKR patients by the use of ankle weights and resistance exercises. Total 40 patients were included in this study and two groups had been formulated one as experimental and other as control. 2 sessions were given to each group for 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Age of patients above 40 years with total knee arthroplasty
* 4-6 weeks following TKR

Exclusion Criteria:

* Age less than 40 patients
* Concurrent medical disease that could affect the progress (e.g., uncontrolled hypertension, advanced malignancy, decompensated cardiovascular disease.
* Pain score more than 6/10

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 6 weeks
measure: Short form 36 Quality of life
timeFrame: 6 week
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Rawal General & Dental Hospital
state: Federal
Study officials:
References:
Clinical trial NCT06933849: PartnerED Care: Coordinated Emergency Department Transitions for Assisted Living Patients With Alzheimer's Disease and Related Dementias
Official title: PartnerED Care: Coordinated Emergency Department Transitions for Assisted Living Patients With Alzheimer's Disease and Related Dementias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease or Associated Disorder
Keywords: case management
emergency department
feasibility
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-04-18
Enrollment: 1989
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this observational study is to learn the feasibility, acceptability, appropriateness, and adherence to a case management intervention. PartnerED is a case management intervention that aims to reduce unnecessary hospital admissions by providing real-time, structured information and discharge support to emergency department providers via phone and fax. The intervention is led by chronic care managers employed by Bluestone Accountable Care Organization, a physician group primarily serving patients in assisted living centers.


Eligibility criteria: Inclusion Criteria:

* Bluestone Accountable Care Organization patient
* Registration in emergency department between November 1, 2023 and June 30, 2024, as recorded in electronic admission, discharge, and transfer notifications

Exclusion Criteria:

* None

Primary outcomes:
measure: Percent of eligible emergency department visits with completed outreach
timeFrame: Within 1-3 hours of emergency department registration
Secondary outcomes:
measure: Percent of successful outreach conversations in which staff reported avoidance of an unnecessary hospitalization
timeFrame: Within 24 hours of emergency department registration
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Bluestone Accountable Care Organization
state: Nebraska
Study officials:
affiliation: Brown University
name: Ellen McCreedy, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00332449: Early Breast Feeding and Glucose Levels in High Risk Newborns
Official title: Does Early Breast Feeding Prevents Neonatal Hypoglycemia in High Risk Newborns
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Hypoglycemia
Keywords: early breast feeding
hypoglycemia
newborn
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary clinic clinic

Brief summary: Early breast feeding has shown to be important to mother-infant bonding and is associated with longer duration of breast feeding. However, little data is available regarding its contribution to glucose levels in the newborn infants. Newborns that are at risk to develop hypoglycemia may benefit from early breast feeding if this appears to prevent post-partum hypoglycemia.

Detailed description: Mothers will be encouraged to breast feed early after delivery (at the delivery room). Data of high risk babies for developing post partum hypoglycemia (Infants of diabetic mothers, infants of hypertensive mothers, infants with birth weight more than 4 Kg or less than 2.5 Kg and infants with meconium stained amniotic fluid)will be recorded including maternal breast feeding times and quality of feeding. Glucose levels shall be routinely monitored and recorded at the neonatal department. A comparison of all data will be made between those newborns that breast feed after labor and those who were not.

Eligibility criteria: Inclusion Criteria:

* Newborns to diabetic mothers
* Newborns to hypertensive mothers
* Newborns with birth weight greater than 4 Kg or less than 2.5 Kg
* Newborns with meconium stained amniotic fluid

Exclusion Criteria:

* Newborns with major congenital malformation
* Preterm babies
* Newborns with post-birth distress

Primary outcomes:
measure: normal neonatal glucose levels
timeFrame: 2 days
Secondary outcomes:
measure: Hypoglycemia prevention
timeFrame: 2 days
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center - Neonatal Department
state: Tel-Hashomer
Study officials:
affiliation: Sheba Medical Center
name: Ayala Maayan-Metzger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01822249: Phase 2 Study of EPI-743 for Treatment of Rett Syndrome
Official title: A Phase 2A Randomized, Placebo Controlled Trial of EPI-743 in Children With Rett Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rett Syndrome
Keywords: Rett syndrome
EPI-743
Edison
Lead sponsor: Edison Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2013-04-02
Enrollment: 24
Sex: FEMALE
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rett syndrome is a severe neurodevelopmental disorder that primarily affects female children. Rett syndrome is characterized by significant elevation in blood markers of oxidative stress. EPI-743 is a novel therapeutic with demonstrated efficacy and safety in the treatment of disorders characterized by oxidative stress. The purpose of this study is to examine the safety and efficacy of EPI-743 in a population of children with Rett syndrome.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Rett syndrome with disease stage 1-2
* Abnormality of at least two disease biomarker levels
* Confirmed MeCP2 mutation
* Patient or patient's guardian able to consent and comply with protocol requirements
* Abstention from use of Coenzyme Q10, vitamin E and Idebenone two weeks prior to enrollment into the study

Exclusion Criteria:

* Any condition, which in the opinion of the investigator could compromise the subject's safety or adherence to treatment with EPI-743.
* Clinically significant allergy or hypersensitivity to EPI-743 or to any of the excipients of with EPI-743 (eg., sesame oil).
* Clinically significant allergy or hypersensitivity to Vitamin E
* Lack of confirmation of MeCP2 mutation
* Clinical history of bleeding or abnormal baseline PT/PTT
* Diagnosis of any other concurrent inborn error of metabolism
* Hepatic insufficiency with LFTs greater than 3 times upper limit of normal
* Renal insufficiency requiring dialysis
* End stage cardiac failure
* Fat malabsorption syndromes precluding drug absorption

Primary outcomes:
measure: Rett Syndrome Clinical Severity Sore
timeFrame: Change at six months from baseline
Secondary outcomes:
measure: Oxidative Stress Biomarkers
timeFrame: Change at six months from baseline
measure: Head circumference
timeFrame: Change at six months from baseline
measure: Rett syndrome behavioral questionnaire
timeFrame: Change at six months from baseline
measure: PedsQL
timeFrame: Change at six months from baseline
measure: Number of Drug-related adverse and serious adverse events
timeFrame: Six months
measure: Respiratory Disturbance Index (RDI)
timeFrame: Change at six months from baseline
Other outcomes:
Locations:
city: Siena
country: Italy
facility: University of Siena
Study officials:
References:
Clinical trial NCT00801749: Sleep and Daytime Activity in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Lead sponsor: Nagoya University
Sponsor class: OTHER
First posted: 2008-12-03
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: Sleep relate to cognitive function.


Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05472649: Long-Term Follow-Up of Patients Who Received Gene-Modified Cell Therapy
Official title: Long-Term Follow-Up Study of Patients Who Have Received Gene-Modified Cell Therapy or Gene Therapy in Trials Sponsored By Sorrento Therapeutics, INC.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Long-term Follow-up
Keywords: long-term follow up
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-25
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were exposed to gene-modified cell therapy produced by ex vivo transduction of immune cells expressing viral or non-viral vectors in studies sponsored by Sorrento Therapeutics, Inc.

Brief summary: Observational long-term follow-up study of patients who have been exposed to a gene-modified cell therapy produced by ex vivo transduction of immune cells expressing viral or non-viral vectors in studies sponsored by Sorrento Therapeutics, Inc.

Detailed description: Study CGT-LTFU-35 is an observational study of patients who have been exposed to a gene-modified cell therapy (GMCT) produced by ex vivo transduction of immune cells expressing viral and/or non-viral vectors in studies sponsored by Sorrento Therapeutics, Inc. Patients are to be followed for up to 15 years after exposure to a GMCT agent for the possible development of long-term adverse events and efficacy outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients must have received any amount of a CGT in a study sponsored by Sorrento Therapeutics, Inc.

Exclusion Criteria:

* Unable or unwilling to provide written informed consent and/or comply with study requirements.

Primary outcomes:
measure: Long-term safety of previous treatment with gene-modified cells
timeFrame: Baseline through end of study (approximately 15 years)
Secondary outcomes:
measure: Long-term durability of clinical effect of previous treatment with gene-modified cells
timeFrame: Baseline through end of study (approximately 15 years)
measure: Long-term durability of previous treatment with gene modified cells
timeFrame: Baseline through end of study (approximately 15 years)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center Clinical Research Unit, University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Sorrento Therapeutics, Inc.
name: Mike Royal, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04180449: DYsphagiA in interMedIate Care UnitS
Official title: DYsphagiA in interMedIate Care UnitS - a Retrospective Analysis of Available Data
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dysphagia
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 1400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intermediate Care unit patients

Brief summary: Retrospective study in intermediate care unit patients on the incidence, Risk factors, and effects on mortality of dysphagia. During a 6-month observational period, routine data will be collected and analysed.


Eligibility criteria: Inclusion Criteria:

* Intermediate care unit patients admitted within the observational period

Exclusion Criteria:

* documented refusal to General Consent

Primary outcomes:
measure: Incidence of positive screening (first screening) for dysphagia in neurosurgical intermediate care unit patients
timeFrame: within 8 hours from intermediate care unit admission
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dept of Intensive Care Medicine
Study officials:
References:
citation: Zuercher P, Moret CS, Dziewas R, Schefold JC. Dysphagia in the intensive care unit: epidemiology, mechanisms, and clinical management. Crit Care. 2019 Mar 28;23(1):103. doi: 10.1186/s13054-019-2400-2.
citation: Schefold JC, Berger D, Zurcher P, Lensch M, Perren A, Jakob SM, Parviainen I, Takala J. Dysphagia in Mechanically Ventilated ICU Patients (DYnAMICS): A Prospective Observational Trial. Crit Care Med. 2017 Dec;45(12):2061-2069. doi: 10.1097/CCM.0000000000002765.
Clinical trial NCT04188249: Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis
Official title: A Prospective Multicenter Registry of Golimumab in Chinese Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthritis, Rheumatoid
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This multicenter (12 centers), prospective program will register 200 RA patients routinely receiving golimumab treatment. Doctor will record the disease evaluation, concomitant drug, adverse events and laboratory tests based on patient's visit till they withdraw from clinical visit.

Brief summary: This will be a prospective, observational, single-arm, registry study based on data received from Chinese Registry of rheumatoid arthritis (CREDIT) database to register 200 Chinese RA patients treated with golimumab in one year. Patient characteristic, clinical effectiveness and drug adherence of golimumab will be evaluated.

Detailed description: This multicenter (12 centers), prospective program will register 200 RA patients routinely receiving golimumab treatment. Doctor will record the disease evaluation, concomitant drug, adverse events and laboratory tests based on patient's visit till they withdraw from clinical visit. Doctor will still collect above information whether patient interrupt or stop golimumab till the end of program or patient withdraw permanently.

Eligibility criteria: Inclusion Criteria:

* - 18 years and older
* Fulfil the ACR/EULAR classification criteria for RA in 2010
* Patients able to understand and complete self-evaluation questionnaires.

Exclusion Criteria:

* - Contraindications for golimumab
* Prior exposure to TNFi/JAKi

Primary outcomes:
measure: Percentage of low disease activity (CDAI) at week 12
timeFrame: At week 12
measure: Percentage of remission (CDAI) at week 12
timeFrame: At week 12
Secondary outcomes:
measure: Percentage of low disease activity (DAS28-CRP) at week 12
timeFrame: March 1, 2021
measure: Patient disease activity assessment (VAS) at week 12
timeFrame: at week 12
measure: Patient Pain Global assessment (VAS) at week 12
timeFrame: at week 12
measure: Function evaluation at week 12
timeFrame: at week 12
measure: Medication possession rate (MPR) at week 12
timeFrame: at week 12
measure: Medication possession rate (MPR) at week 24
timeFrame: at week 24
measure: Medication possession rate (MPR) at week 48
timeFrame: at week 48
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xiaofeng Zeng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05371249: Vonoprazan-Based Triple Therapy in Comparison With Extended Sequential Therapy
Official title: Seven-Day Vonoprazan-Based Triple Therapy With High-Dose Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial in Taiwan
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Helicobacter Pylori
Keywords: Proton Pump Inhibitors
Lead sponsor: Fu Jen Catholic University Hospital
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 628
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the efficacy of the current standard first-line anti-helicobacter pylori regimen, extended proton pump inhibitor-based sequential therapy, with that of vonoprazan-based triple therapy, through a randomized controlled trial.

Detailed description: Helicobacter pylori infection is a well-established risk factor for peptic ulcer disease and gastric cancer. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Extended proton pump inhibitor (PPI)-based sequential therapy as one of the most commonly used first-line regimens provides a satisfactory eradication rate of 90.7% (95% CI, 87.4% - 94.0%). Nevertheless, its complexity of the "sequential" usage is sometimes confusing to the patients and may lead to treatment failure. The emerging new regimen - vonoprazan-based triple therapy, on the other hand, is another appealing choice with simplicity, short treatment duration, and low pill burden. However, there's still no evidence regarding the use of vonoprazan-based triple therapy with high-dose amoxicillin (1000mg twice daily) as the first-line regimen. This study aimed to compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based triple therapy with high-dose Amoxicillin.

Eligibility criteria: Inclusion Criteria:

* Patients with H.pylori infection who was over 20 years old and agree to participate in the trial will be recruited.

Exclusion Criteria:

* Who had received helicobacter pylori eradication before
* Who are known to be allergic to any drug used in this trial
* Pregnant women
* Who are refuse to participate in the trial for any reason

Primary outcomes:
measure: Eradication rate of helicobacter pylori
timeFrame: Assessed at least 6 weeks after the therapy
Secondary outcomes:
measure: Adverse effects of the drugs
timeFrame: After patients completed the therapy (For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy)
measure: Compliance
timeFrame: After patients completed the therapy ((For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy)
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital
Study officials:
affiliation: Fu Jen Catholic University Hospital
name: Yu-tse Chiu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05147649: Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome
Official title: Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome, With and Without CPAP, During Wakefulness - Impact on Cognitive Functions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The obstructive sleep apnea syndrome (OSAS) involves recurrent sleep-related upper airways (UA) collapse. UA mechanical properties and neural control are altered, imposing a mechanical load on inspiration. UA collapse does not occur during wakefulness, hence arousal-dependent compensation. Experimental inspiratory loading in normal subjects elicits respiratory-related cortical activity during wakefulness. The objective of this study is to test whether awake OSAS patients would exhibit a similar cortical activity. Whether or not such cortical compensatory mechanisms have cognitive consequences would be also analyze.


Eligibility criteria: Inclusion criteria :

1. OSAS patients

   * severe OSAS with an Apnea-Hypopnea Index (AHI) \> 30/h
   * without CPAP treatment
2. Non-OSAS patients

   * absence of OSAS (AHI \< 15/h and absence of excessive daytime sleepiness with Epworth score \<11)

Non-inclusion criteria :

* \< 18 years old
* \>75 years old
* left-handed
* BMI\> 40 kg/m²
* another sleep disorder
* central component of sleep apnea syndrome (central apnea index\> 5 / h)
* current or past neurological pathology
* respiratory pathology (obstructive ventilatory disorder, restrictive ventilatory disorder, hypercapnia)
* MRI contraindication (metallic foreign body, claustrophobia, pregnant woman, etc.)
* taking drugs that can modify the BOLD signal on MRI (psychotropic drugs, vasodilators, vasoconstrictors, etc.),
* uncorrected sensory impairment (vision or hearing)
* protected by law.

Exclusion criteria :

* pregnant woman according to the positive beta-hCG test result
* left-handed following the laterality questionnaire
* MINI results showing:

  * a current mood episode
  * a current disorder of the use of psychoactive substances or in the last 6 months (excluding tobacco)
  * an eating disorder
  * a diagnosis of bipolar disorder, current or past schizophrenia

Primary outcomes:
measure: Premotor cortex activation in OSAS patients without CPAP
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References: