louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05920031: Cross-Education and Mirror Therapy for Upper Limb in Post-Stroke Patients
Official title: Combining Cross-Education and Mirror Therapy for Upper Limb Rehabilitation in Post-Stroke Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial will investigate the potential synergistic effects of combining cross-education training with mirror therapy on strength and motor function in the more affected upper limb of post-stroke patients.


Eligibility criteria: Inclusion Criteria:

* Post-stroke patients with upper limb motor impairments
* Aged 30 years to 60 years old
* At least 3 months post-stroke
* Able to participate in the intervention

Exclusion Criteria:

* Severe cognitive impairments
* Visual impairments
* Any contraindications to the intervention

Primary outcomes:
measure: Changes in Upper limb strength
timeFrame: Changes in Upper limb strength at baseline, 8 weeks, 16 weeks
measure: Changes in motor function
timeFrame: Changes in motor function at baseline, 8 weeks, 16 weeks
Secondary outcomes:
measure: Changes in Quality of life
timeFrame: Changes in Quality of life at baseline, 8 weeks, 16 weeks
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_DIRECTOR
References:
Clinical trial NCT01831531: Study of S-1 in Combination With Radiotherapy in Esophageal Cancer
Official title: Phase II Study of S-1 in Combination With Radiotherapy in Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 105
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 trial aims to study the safety, the local control, and the overall survival of S-1 combined with radiotherapy for patients with esophageal squamous cell carcinoma. 105 patients will be recruited into this trial.


Eligibility criteria: Inclusion Criteria:

* Joined the study voluntarily and signed informed consent form;
* Age \>75 or age 18-75 who are intolerant of or reject intravenous chemotherapy
* Both genders
* Esophageal squamous cell carcinoma confirmed by pathology
* Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a, AJCC 6th)
* No radiotherapy, chemotherapy or other treatments prior to enrollment
* PS ECOG 0-2
* Life expectancy of more than 3 months
* Hemoglobin（Hb）≥9 g/dL
* WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L
* platelet count (Pt) ≥100x 109/L
* Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\<1.5 x ULN
* Renal function: creatinine \< 1.5 x ULN
* No immuno-deficiency
* Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

* Complete esophageal obstruction
* Deep esophageal ulcer
* Esophageal perforation
* Haematemesis
* After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy
* Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
* Participation in other interventional clinical trials within 30 days
* Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
* Drug addiction
* Alcoholism or AIDS
* Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
* Patient who has metastasis such as lung, liver metastasis

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 1 years
measure: 3-yr local control rate
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Kuaile Zhao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen Y, Zhu Z, Zhao W, Liu Q, Zhang J, Deng J, Ai D, Lu S, Jiang L, Tseng I, Jia H, Zhao K. Long-Term Results of a Phase 2 Study of Definitive Chemoradiation Therapy Using S-1 for Esophageal Squamous Cell Carcinoma Patients Who Were Elderly or With Serious Comorbidities. Front Oncol. 2022 Apr 5;12:839765. doi: 10.3389/fonc.2022.839765. eCollection 2022.
Clinical trial NCT00603031: Effect of GLP-1 and GIP on Insulin Secretion in Type-1 Diabetes Mellitus
Official title: Effect of GLP-1 and GIP on the Maximal Insulin Secretory Capacity in Type-1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type-1 Diabetes Mellitus
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2008-01-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: study hypothesis: treatment with GLP-1 and/or GIP is able to potentiate the maximal stimulated insulin secretion even in c-peptide negative type-1 diabetic patients classified as having no residual beta cell function left.


Eligibility criteria: Inclusion Criteria:

* Age 18-60 years
* Type-1 diabetes diagnosed between 5-40 years of age
* Normal weight(BMI 18-27),
* Insulin treatment from time of diagnosis.

Exclusion Criteria:

* Severe complications to diabetes
* Abnormal liver or kidney function
* Haemoglobin below the lower limit
* Macroalbuminuria
* Systemic disease
* Pregnancy.

Primary outcomes:
measure: phase insulin response and phase insulin response measured as incremental area under the curve from 0-10 minutes and incremental area under the curve from 10-45 minutes respectively after iv glucose
timeFrame: 2 hours
Secondary outcomes:
measure: maximal insulin response defined as mean insulin at time 47 and 49 minutes (2 and 4 minutes after infusion of L-Arginine)
timeFrame: 2 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. of Endocrinology, Hvidovre Hospital
Study officials:
affiliation: unafilliated
name: Urd Kielgast, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06453031: Gastric Ischemic Preconditioning Before Esophagectomy
Official title: Short-term Outcomes of Gastric Ischemic Preconditioning Before Esophagectomy With Preoperative Embolization of the Left Gastric Artery: A Prospective Single-Center Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Operable Esophageal Cancer
Embolization of the Left Gastric Artery Prior to Surgery
Lead sponsor: CHU Rennes - Hopital Pontchaillou
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with operable esophageal cancer who underwent embolization of the left gastric artery prior to surgery.

Brief summary: The aim of the study is to investigate the impact of left gastric artery embolization before esophagectomy on postoperative complications, particularly anastomotic leaks and necrosis of the gastric conduit.


Eligibility criteria: Inclusion Criteria:

Patient with operable esophageal cancer who underwent embolization of the left gastric artery prior to surgery.

Exclusion Criteria:

Patient with no operable esophageal cancer

Primary outcomes:
measure: Anastomotic leak
timeFrame: 6 months
measure: Anastomotic stenosis
timeFrame: 6 months
measure: Gastric conduit necrosis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Livin
state: Bretagne
Study officials:
References:
Clinical trial NCT03000231: Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency
Official title: Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency: a Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Insufficiency
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2016-12-22
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary or secondary Adrenal Insufficiency age 18 and older and healthy matched control subjects

Brief summary: The purpose of this study is to compare cardio-metabolic risk, glucose tolerance, and night time blood pressure between healthy control subjects and patients with adrenal insufficiency. No intervention will be administered and the study is observational only.

Detailed description: We propose to use a case control design to test the main hypothesis that as compared to healthy control subjects matched for sex, age, adiposity and race/ethnicity, patients with adrenal insufficiency, whether primary or secondary, have disturbances of the circadian system that are associated with high day to day variability of sleep time as well as elevated markers of cardio-metabolic risk, including abnormal oral glucose tolerance and reduced nocturnal blood pressure dipping.

A secondary hypothesis of the study is that adrenal insufficiency patients on a replacement regimen (as part of their standard of care ongoing treatment) that results in daytime cortisol profiles approximating the normal diurnal variation will have better cardio-metabolic function than adrenal insufficiency patients who have grossly abnormal cortisol profiles.

Eligibility criteria: Inclusion Criteria:

* Primary or secondary adrenal insufficiency, Healthy matched controls, acute or unstable health conditions age 18 or older

Exclusion Criteria:

* Diabetes, Tertiary adrenal insufficiency

Primary outcomes:
measure: day to day variability of sleep timing over 1 week of recording
timeFrame: day 1 to day 7
Secondary outcomes:
measure: nocturnal blood pressure dipping
timeFrame: day 8 to 9
measure: oral glucose tolerance
timeFrame: day 11 to 12
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Eve Van Cauter, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05520931: Pain-related Long Covid in Covid-19 Survivors
Official title: Pain-related Long Covid in Covid-19 Survivors
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: COVID-19
Pain, Chronic
Keywords: Covid-19
Coronavirus
Chronic Pain
Persistant pain
Long Covid
SARS-CoV-2
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 600000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital group: All patients aged 18 or above that has been admittet to a hospitals in Denmark between 1st of Mach 2020 and 31st of December 2021.

PCR+ group: All persons aged 18 or above that between 1st March 2020 and 31st of December 2021 have tested positive in a PCR test without hospital admission.

Brief summary: The exploratory project aims to investigate the presence of pain as a long Covid-19 symptom in previously hospitalised patients and in non-hospitalised persons previously tested positive in a PCR test.

Detailed description: The main objectives investigated will be to determine the general prevalence of pain symptoms In Covid-19 survivors, correlating and analysing the role of previously comorbidities in the development of pain symptom in Covid-19 survivors, and to understand the prevalence of pain related long Covid-19 symptoms for future characterisations. Hence, the projects main outcome will be to try to understand why som Covid-19 survivors develop persistant pain and others don't. Furthermore, the project plan to analyse gender and age differences, and data between Covid-19 waves as well as any possible association between pain prevalence and time after positive PCR-test.

Eligibility criteria: Inclusion Criteria:

* Previously infected with SARS-CoV-2 virus

Exclusion Criteria:

* Participants under the age of 18
* Hidden/secret address/name
* No access to digital mail (the channel of data collection)

Primary outcomes:
measure: Persistent pain in Covid-19 survivors
timeFrame: Above six months after a SARS-CoV-2 infection
Secondary outcomes:
measure: The role of comorbidities in the development of persistent pain in Covid-19 survivors
timeFrame: Above six months after a SARS-CoV-2 infection
measure: The role of comorbidities in the development of persistent pain in Covid-19 survivors II
timeFrame: Above six months after a SARS-CoV-2 infection
measure: The role of socio-economic impact on the development of persistent pain in Covid-19 survivors
timeFrame: Above six months after a SARS-CoV-2 infection
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: The North Denmark Region
Study officials:
affiliation: North Denmark Region
name: Lars Arendt-Nielsen, Dr.med, PhD
role: STUDY_DIRECTOR
affiliation: North Denmark Region
name: Brian D Ebbesen, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03347331: [18F]-F13640 as a New Brain Radiopharmaceutical
Official title: First-in-man Study of [18F]-F13640, a PET Radiopharmaceutical for Functional 5-HT1A Receptor Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Neurological Pathology
Healthy Subjects
Keywords: PET imaging- Serotonin-Radiotracer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This clinical assay is designed to validate that \[18F\]F13640 as a radiotracer of 5-HT1A functional receptors. A first group of healthy subjects underwent a PET scan with arterial blood sampling to determine the kinetic model of the tracer. A second group of healthy subjects underwent a classical test-retest study (i.e two distant PET scans) to determine the reproducibility of measures.


Eligibility criteria: Inclusion Criteria:

* Healthy Subjects
* Weight between 50 kg and 90 kg
* Affiliated to a social security or similar scheme
* Not subject to any legal protection measures

Exclusion Criteria:

Subjects with neurologic or psychiatric disease including all substance addictions

* Daily smokers
* Active infectious disease
* MRI contraindications
* PET contraindications determined with FDG injection
* Subjects deprived of their liberty by judicial or administrative decision
* Subjects unable to sign written consent for participation in the study.
* Severe and progressive medical pathology
* Volunteer who has exceeded the annual amount of compensation authorized for participation in research protocols

Primary outcomes:
measure: Binding potentials
timeFrame: 180 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Scheiber Christian
role: STUDY_CHAIR
References:
Clinical trial NCT03632031: Treatment of Wounds Using Oasis® ECM
Official title: Treatment of Wounds Using Oasis® Extracellular Matrix in the Community Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-healing Wound
Keywords: partial and full-thickness wounds
pressure ulcer
venous ulcer
chronic vascular ulcer
diabetic ulcer
Lead sponsor: Cook Biotech Incorporated
Sponsor class: INDUSTRY
First posted: 2018-08-15
Enrollment: 40
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 with non-healing ulcer (any etiology) present for at least 1 month and treated in the ambulatory clinic or home healthcare setting

Brief summary: The purpose of this clinical study is to gather post-market clinical evidence on the use of Oasis ECM as a treatment for different types of chronic wounds in the community setting in the United Kingdom.


Eligibility criteria: Inclusion Criteria:

1. Non-healing ulcer (any etiology) present for at least 1 month and treated in the ambulatory clinic or home healthcare setting

Exclusion Criteria:

1. Age \< 18 years
2. Unable or unwilling to provide informed consent
3. Unable or unwilling to comply with the study follow-up schedule, and procedures
4. Simultaneously participating in another investigational drug or device study
5. Target wound area is \< 2 cm2 or \> 140 cm2 after baseline debridement
6. Target wound has reduced in area by \> 40% with 4 weeks of documented standard of care therapy
7. Known allergy to pig or porcine products
8. Systemic infection
9. Infection of the target wound as determined by the collection of pus
10. Osteomyelitis
11. ABI/TBI \< 0.6 obtained within 3 months prior to the screening visit
12. Other exclusions may apply

Primary outcomes:
measure: Wound healing
timeFrame: 12 weeks
Secondary outcomes:
measure: Wound closure- Percentage
timeFrame: up to 12 weeks
measure: Wound closure- Mean number of weeks
timeFrame: up to 12 weeks
measure: Wound closure- Mean Percentage
timeFrame: up to 12 weeks
measure: Patient reported Quality of Life measurement
timeFrame: up to 12 weeks
measure: Adverse Events
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Ashington
country: United Kingdom
facility: Nursery Park Health Centre
city: Wakefield
country: United Kingdom
facility: Pinderfields Hospital
Study officials:
affiliation: Mid Yorkshire Teaching NHS Trust
name: Leanne Atkin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02517931: Sphenopalatine Ganglion Block for Postdural Puncture Headache in the Emergency Department
Official title: Sphenopalatine Ganglion Block for Treatment of Postdural Puncture Headache in the Emergency Department: A Prospective, Randomized, Double-Blind Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postdural Puncture Headache
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study evaluates sphenopalatine ganglion block (SPGB) for the treatment of postdural puncture headache (PDPH) in the emergency department (ED). Half of the patients will receive a true nerve block with lidocaine and bupivacaine. The other half will receive a placebo nerve block.

Detailed description: Postdural puncture headaches (PDPH) are a common consequence of diagnostic lumbar puncture. The gold standard treatment for a PDPH is currently an autologous epidural blood patch (AEBP), which involves placing a needle into the epidural space of the spine and then injecting 20 ml of the patients own blood through the needle and into the epidural space to form a clot over the tear in the tissue layer that causes the headache. This is an invasive procedure that carries risks of pain, bleeding, infection, and in rare cases, neurological complications. We want to test the efficacy of using a less invasive procedure, called a sphenopalatine ganglion block (SPGB), for treatment of PDPH. SPGB has been used for many years in the treatment of migraines and cluster headaches, and there are several case reports of its use to successfully treat PDPH as well. SPGB simply involves applying a local anesthetic to the mucosa in the back of each nostril to numb the nerves that cause the headache. We hope that the SPGB will reduce the number of PDPH patients that require an AEBP.

Eligibility criteria: Inclusion Criteria:

* Active postdural puncture headache within 7 days after diagnostic lumbar puncture
* Age ≥ 18 years.
* American Society of Anesthesiologists (ASA) physical status ≤ 3

Exclusion Criteria:

* Known coagulopathy
* Known nasal septal deviation or abnormalities
* Medical conditions contraindicated to lidocaine or bupivacaine

Primary outcomes:
measure: Pain level with Verbal Rating Scale
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Carly Eastin, MD
role: PRINCIPAL_INVESTIGATOR
References: