louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05370963: Dexmedetomidine or Hyalase : Which of Them Can Augment Lumbar Epidural Steroid Injection in Failed Back Surgery Patients. A Randomized Clinical Trial
Official title: Dexmedetomidine or Hyalase : Which of Them Can Augment Lumbar Epidural Steroid Injection in Failed Back Surgery Patients. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain, Chronic
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: hyalase and dexmedtemodine are well known adjuvants given epidurally to alleviate chronic back pain. Use in failed back surgery is an up to date field to hasten analgesia and py off recurrence .


Eligibility criteria: Inclusion Criteria:

* Age group. 25-75ys old
* Both sex.
* persistent (at least 6 month) pain and or disability following laminectomy with or without sensory-motor neurological deficits or any form of urinary or bowel incontinence
* Patients suffering from persistent (\> 6 months) back pain following laminectomy for spinal canal stenosis and/or discectomy for herniated nucleus pulposus documented by magnetic resonance imaging (MRI) were included for screening and enrollment.

Exclusion Criteria:

* Diabetic patients.
* Refusal to participate
* MRI with disc sequestration, concurrent sacro-ilitis, facet arthropathy .
* Coagulopathic patients
* Surgical induced discitis.

Primary outcomes:
measure: pain assesment
timeFrame: 6 months
Secondary outcomes:
measure: functional disability
timeFrame: 6 months
measure: acute complications
timeFrame: 6 hours
Other outcomes:
Locations:
city: ALMinya
country: Egypt
facility: Maher Maher
Study officials:
References:
Clinical trial NCT04438863: Daily Home Spirometry for Early Detection of Pulmonary Complications in Patients With COVID19
Official title: A Descriptive Pilot Study of Daily Home Spirometry for Early Detection of Pulmonary Complications in High Risk Patients With COVID19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID 19
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-06-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: confirmed COVID19 patients (hospitalized or not hospitalized) with mild to moderate symptoms.

(low grade fever, cough, anosmia, fatigue, discomfort, anorexia or other gastrointestinal symptoms)

Brief summary: The aim of this preliminary study is to describe the potential decline in forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by home spirometry in high-risk subjects infected with COVID-19. We hypothesize that the magnitude of such a decline in FEV1 and/or FVC may be associated with clinical deterioration and hospitalization. The study will ultimately inform a larger subsequent RCT that will evaluate the efficacy of home spirometry in the early detection (pre respiratory symptoms) of respiratory complications and therefore prompt early medical attention which is a key for improving outcome.


Eligibility criteria: Inclusion Criteria:

1. without dyspnea and with no evidence of pneumonia, ARDS, organ failure or requiring admission to ICU.
2. All patients ≥55 years age or ≥1 risk factor for disease complications (prior pulmonary, kidney or cardiovascular disease, diabetes mellitus, hypertension, bone merrow suppression, solid organ transplant, HIV with CD4\<250, heavy smoker, BMI \>30). All participants will sign a written informed consent.

Exclusion Criteria:

1. Patients unable to perform spirometry
2. contraindications for spirometry (hemoptysis, active tuberculosis, syncope associated with forced exhalation or increased risk for spirometry)
3. adhere to the follow-up protocol.

Primary outcomes:
measure: Hospitalization
timeFrame: number of participants hospitalized in a time frame of a year
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT02825563: A Phase I Study of Anlotinib on Pharmacokinetics to Assess the Effect of High Fat Diet in Advanced Cancer Patients
Official title: Phase I Additional Study of Anlotinib on Pharmacokinetics to Assess the Effect of High Fat Diet in Advanced Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to further study the pharmacokinetic characteristics of Anlotinib in Advanced Cancer Patients with High Fat Diet.


Eligibility criteria: Inclusion Criteria:

* Histological documentation of Advanced solid tumors( Non-small Cell Lung Cancer.Soft Tissue SarcomaMedullary. Thyroid Carcinoma)
* At least one measurable lesion (by RECIST1.1)
* Lack of the standard treatment or treatment failure
* 20≤BMI≤25
* 18-70 years,ECOG PS:0-1,Life expectancy of more than 3 months
* Main organs function is normal
* Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
* Patients should participate in the study voluntarily and sign informed consent

Exclusion Criteria:

* Clear allergies to the study drug or its ingredients
* Had the disease to affect drug absorption and metabolism
* Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
* Brain metastases patients with symptoms or symptoms controlled \< 1 months
* Used any drugs inhibit or induce hepatic drug metabolic enzymes in 30 days before the study
* Patients with drug abuse history and unable to get rid of or Patients with mental disorders
* Patients participated in other anticancer drug clinical trials within 4 weeks
* Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Primary outcomes:
measure: Pharmacokinetics of Anlotinib (in whole blood):Peak Plasma Concentration(Cmax)
timeFrame: up to 14 Days
measure: Pharmacokinetics of Anlotinib (in whole blood):Area under the plasma concentration versus time curve (AUC)
timeFrame: up to 14 Days
Secondary outcomes:
measure: Pharmacokinetics of Anlotinib (in whole blood):Peak time（Tmax）
timeFrame: up to 14 Days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT01680263: Kinesiotaping in Treatment of Pes Anserinus Tendino-bursitis
Official title: Kinesiotaping in Treatment of Pes Anserinus Tendino-bursitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pes Anserinus Tendinobursitis
Keywords: Kinesiotaping
pes anserinus tendino-bursitis
nonsteroidal anti-inflammatory drugs
physical therapy
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to determine the effects of kinesiotaping in comparison to NSAIDs and physical therapy in treatment of pes anserinus tendino-bursitis.

Detailed description: The treatment of pes anserinus tendino-bursitis includes refraining from aggravating activities, local modalities such as heat, ice, ultrasound (US), iontophoresis, phonophoresis, electrical stimulation (ES), nonsteroidal anti-inflammatory drugs (NSAIDs) and injections with either corticosteroids or local anesthetics. Another treatment that seems to have a significant effect on the improvement of the disease is kinesiotaping. Kinesiotaping is a cotton strip with an acrylic adhesive that is used for treating athletic injuries and a variety of physical conditions. The therapeutic effects of the tape is to relax the overused muscles and in rehabilitation to facilitate the underused muscles. Advocates claim that the wave pattern found on the kinesiotaping has a lifting effect on the skin which can diminish swelling and inflammation via improving circulation and reduce pain by removing pressure from pain receptors.

Eligibility criteria: Inclusion Criteria:

* Patients with clinical diagnosis of pes anserinus tendino-bursitis.

Exclusion Criteria:

* Previous history of trauma or surgery on the knee joint,
* History of NSAIDs induced acid-peptic disease
* Systemic and rheumatic diseases

Primary outcomes:
measure: Pain (VAS)and swelling scores
timeFrame: 3 weeks
Secondary outcomes:
measure: The number of participants with adverse events
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Kaynoosh Homayouni, M.D.
role: STUDY_CHAIR
affiliation: Shiraz University of Medical Sciences
name: Shima Foruzi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: Fereshte Kalhori, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Homayouni K, Foruzi S, Kalhori F. Effects of kinesiotaping versus non-steroidal anti-inflammatory drugs and physical therapy for treatment of pes anserinus tendino-bursitis: A randomized comparative clinical trial. Phys Sportsmed. 2016 Sep;44(3):252-6. doi: 10.1080/00913847.2016.1199251. Epub 2016 Jun 22.
Clinical trial NCT04640363: Combi-elastography Assessment of HCC Recurrence After Thermal Ablation Multi-center Study
Official title: Combi-elastography Assessment of HCC Recurrence After Thermal Ablation Multi-center Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HCC
Recurrence Tumor
Keywords: Thermal ablation
Elastography
Ultrasound
Recurrence
Predictive Cancer Model
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 300
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: patients who underwent thermal ablation of HCC will be observed and evaluate the predictive power of combined elastography for tumor recurrence.

Brief summary: Combined F index, A index,ATT index and spleen stiffness to predict tumor recurrence in different liver settings after thermal ablation of HCC.

Detailed description: Thermal ablation is one of the established method for HCC treatment. Postoperative recurrence of HCC is one of the major factors leading to poor prognosis of HCC patients. Most studies have shown that the risk factors of recurrence include tumor size, tumor number and intrahepatic spread, etc.

Besides, the carcinogenic effects of inflammatory activity and fibrosis in liver background caused by chronic hepatitis also be related to the recurrence. In the study, combi-elastography imaging technology , not only the F index which is related to liver fibrosis stage can be obtained, but also the A index which is related to inflammation activity can be measured, this may provide a more valuable method for tumor recurrence of early prediction.

Eligibility criteria: Inclusion Criteria:

* Aged 18 to 80 years of age, and gender not limited;Chronic hepatitis B patients;The lesions of liver have the histopathological diagnosis of HCC and within MiLan criteria;All lesions were performed thermal ablation surgery;Sign the informed consent.

Exclusion Criteria:

* Lesions that unrealized complete inactivation evaluation by the enhanced imaging;Merging other systems' serious illness that can't cooperate with elastic imaging checking(such as heart failure, renal failure, such as mental illness);After liver transplantation patients;Patients with pregnancy.

Primary outcomes:
measure: F index
timeFrame: baseline
measure: A index
timeFrame: baseline
measure: ATT index
timeFrame: baseline
measure: Spleen stiffness
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Ping Liang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05269563: Double Flap Technique for Macular Hole
Official title: Double Flap Technique Utilizing ERM and ILM for Macular Hole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Holes
Keywords: Double Flaps
Lead sponsor: Ibinsina Modern Eye and Retina Center
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Double flapping technique to close the macular hole.

Detailed description: Recently, it is agreed to close the macular hole with the retinal innermost layer; which is called internal limiting membrane (ILM), in most cases, the hole closes. But, sometimes the ILM single flap might displace resulting in a persistent hole.

Therefore, the investigators tried to make two flaps utilizing ILM, and sometimes certain patients have a very thin membrane over the retina; it is called epiretinal membrane (ERM). The investigators use the double flapping technique by utilizing ERM; therefore, the ILM remains and can be used if the hole resists closing with the first surgical interventions.

Here, the investigators did not use any new materials with unknown side effects on the human retina. Although the flap technique is well known; however, investigators are making a double flap to decrease the chance of persisting macular holes.

The visual recovery will be appeared in the post-operative period, whether it is the same, better, or worse.

Eligibility criteria: Inclusion Criteria:

* Full thickness macular hole

Exclusion Criteria:

* Partial-thickness macular hole
* Vitreomacular traction

Primary outcomes:
measure: Ocular coherence tomography
timeFrame: The fourth week post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Ibinsina Modern eye and retina center
Study officials:
affiliation: Ibinsina Modern Eye and Retina Center
name: Omer Abdullah, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04815135: Effect of Covid-19 Pandemic on Emergency Surgery Practice
Official title: The Impact Of The Covid-19 Pandamic On Emergency Surgery In A Tertiary Hospital In Jordan. A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 344
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were admitted to the surgical wards via the emergency department at our institution.

Brief summary: A retrospective study at a tertiary university hospital to determine the effect of the COVID-19 pandemic on the emergency surgery practice in the hospital.

Detailed description: The investigators conducted a retrospective review of all the patients who were admitted to the surgical wards through the emergency department at the Jordan University Hospital in the periods from March 2020 to May 2020. The records were compared to those of the patients who were admitted in the same period from the year 2019.

Data collection includes the number of admissions, the reason for admission, the average of symptoms duration until admission, the age of the patients admitted, gender, type of management, and the average length of stay before discharging the patients.

Eligibility criteria: Inclusion Criteria:

* All patients who were admitted to the surgical wards via the emergency department during the study periods

Exclusion Criteria:

-

Primary outcomes:
measure: Average duration of sx prior to admission in hours
timeFrame: 1 year
measure: Type of management (surgical vs conservative)
timeFrame: 1 year
measure: Length of stays in Days
timeFrame: 1 year
measure: Level of care (ICU vs floor)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Ibrahim Khrais
state: Please Select
Study officials:
References:
Clinical trial NCT04179435: Cognitive and Brain Development in Adolescents With Gilles de la Tourette Syndrome
Official title: Développement Cognitif et cérébral Chez Les Adolescents Souffrants d'un Syndrome de Gilles de la Tourette
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tourette Syndrome in Adolescence
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2019-11-27
Enrollment: 132
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between group comparison
Primary purpose: BASIC_SCIENCE

Brief summary: In children with neurodevelopmental disorders, adolescence is usually associated with a reshaping of the clinical picture and symptomatology. Tourette syndrome (TS) is a paradigmal neurodevelopmental syndrome characterised by involuntary paroxysmal movements (motor tics) and vocalisation (vocal tics) often associated with various psychiatric disorders. The neuronal and cognitive mechanisms associated with TS symptoms improvement during adolescence, or the persistence in adulthood remains unknown, and this is what we aim to address in this study.

Detailed description: Thus, the aims of the present project is threefold:

Aim 1: To evaluate the maturation of cognitive functions in adolescents with TS compared to typically developing adolescents.

To achieve this aim, three distinct cognitive dimensions will be assessed in all subjects (patients and controls): (i) reward sensitivity and habit formation; (ii) cognitive impulsivity and action control and (iii) self-agency.

Aim 2: To identify neuronal correlates of cognitive function and brain development in health and disease. To achieve this aim, we will use a combined behavioural (as described in Aim 1), (i) neuroimaging and (ii) TMS approaches.

Aim 3: To predict clinical outcome . In this part of the project we aim to identify behavioural, imaging or neurophysiological markers of clinical outcome in patients with TS.

Eligibility criteria: Inclusion Criteria:

* Tourette syndrome
* Ages 13 - 18
* Acceptance to perform the Brain MRI
* Acceptance to perform the cognitive testing
* Acceptance to perform the TMS measures

Exclusion Criteria:

* Learning disability
* Incompatibility with MRI procedure (metal body implants, pregnancy)

Primary outcomes:
measure: Behavioral test main outcome measures [1]
timeFrame: from 16 to 20 months
measure: Behavioral test main outcome measures [2]
timeFrame: from 16 to 20 months
measure: Behavioral test main outcome measures [3]
timeFrame: from 16 to 20 months
measure: Behavioral test main outcome measures [4]
timeFrame: from 16 to 20 months
measure: Brain MRI scan measures
timeFrame: from 16 to 20 months
measure: Transcranial magnetic stimulation
timeFrame: from 16 to 20 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Worbe Yulia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01760135: Nutritional Requirement for the Severe Trauma Patients
Official title: Nutritional Requirement for the Severe Trauma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Trauma
Keywords: trauma
nutrition
hyperglycemia
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: After severe trauma, high caloric nutrition supplement do harm on metabolic and immunologic aspects.


Eligibility criteria: Inclusion Criteria:

* ISS more than 15 score
* older than 20 years old
* patient who need parenteral nutrition more than 5 days

Exclusion Criteria:

* patients who have metabolic disease except for diabetes
* patients who cannot resuscitated
* very low body weight (\< 40kg)

Primary outcomes:
measure: Duration of antibiotics usage (days)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 week).
Secondary outcomes:
measure: Mortality
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 week
measure: Number of date when is showing hyperglycemia (more than 200mg/dL)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 week
measure: Hospitals stays
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 week
measure: ICU stays
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Suk-Kyung Hong, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: