cyrilzakka/clinical-trials huggingface dataset:
Pain Management During a Photodynamic Therapy Session on the Vertex for Actinic Keratosis: Tumescent Anesthesia Interest

This study focus on the efficacity of tumescent anesthesia in pain management during a photodynamic therapy on the vertex for treatment of actinic keratosis. To do this we carried out a prospective, randomized, controlled, open-ended study. Our aim is to show a 40% reduction in pain during photodynamic therapy session compared to a conventionally used analgesic method (paracetamol + cold water)


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18
* Diagnosis of clinical or histological actintic keratoses validated by a dermatologist
* More than 4 vertex actinic keratoses lesions that can be treated with a dynamic phototherapy session
* Free subject, without guardianship or curatorship or subordination
* Person affiliated or beneficiary of a social security plan
* Informed and signed consent by the patient after clear and fair information about the study

Exclusion Criteria:

* Known lidocaine hydrochlostate hypersensitivity, local amide-binding anesthetics or one of the excipients
* Hypersensitivity to paracetamol or one of the excipients
* Weight \< 50 kg
* Patients with an elongated TQ interval at the ECG (\>450 ms in men and \>470 ms in women)
* Patients with recurrent porphyria
* Severe hepato-cellular insufficient patients
* Patients who have received treatment for actinic keratoses in the last three months (cryotherapy, 5-fluorouracil, imiquinod, daylight-PTD)
* Patients who have already participated in this study
* People who do not have a social security plan or do not benefit from it through a third party.
* Persons with enhanced protection, namely minors, persons deprived of their liberty by judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and finally the sick in an emergency situation.
* Pregnant or lactating women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per bone, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy).
* Concurrent participation in another clinical research study.
Ultrasound Identification Automation Study

The overall aim of this study is to develop an automated spinal landmark identification system to improve patient safety and efficacy of neuraxial procedure needle insertion success.

This is a prospective cohort study to evaluate the accuracy of the automated spinal landmark identification technique using image processing system based on identification by experienced investigator using ultrasound in subjects requiring spinal anesthesia.

Neuraxial procedures are commonly performed with wide range of therapeutic and diagnostic indications. Applications include neuraxial anesthesia for surgery, epidural labour analgesia, epidural steroid injections and lumbar punctures. The current blind palpation landmark technique is known to be highly inaccurate and may increase the risk of multiple insertion attempts, patient suffering and complication rates such as spinal cord injury. A key challenge for neuraxial procedures is the correct identification of needle insertion site.

The ultrasound imaging technique has found its way to neuraxial procedures as an imaging method to detect the inner anatomical structure of the lumbar spine and is superior to the traditional palpation method. However, a full interpretation of ultrasound images requires professional training and experience.

The overall aim of this proposal is to develop an automated spinal landmark identification system to improve patient safety and efficacy of neuraxial procedure needle insertion success. The primary aim is to develop an automated spinal landmark identification algorithm using image processing system to achieve 90% 1st spinal needle success rate within 12 months. The investigators will recruit 100 subjects in a prospective cohort study to investigate the spinal needle success rate as a clinically relevant outcome.

Eligibility Criteria:
Inclusion Criteria:

* Age between 21-75 years old who required spinal anesthesia for surgical procedure;
* Weight of 40-90kg and height of 140-180cm;
* BMI less than 30.

Exclusion Criteria:

* History of scoliosis;
* History of spinal instrumentation;
* Drug allergy to ultrasound transmission gel;
* Visible wound or injury in the lumbar spine.
Implementation of Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery, a Randomized Controlled Trial

The aim of our study is to determine the effect of implementation of the ERAS (enhanced recovery after surgery) protocol in our institute and its impact on hospital length of stay and outcome of surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 60 years,
* Good nutrition,
* No systemic infection and
* Elective laparoscopic surgery

Exclusion Criteria:

* Age \>75 years,
* Malnutrition or an organ system infection
* Associated with obstruction, bleeding, emergency surgery or other surgical intervention
* Tumor with extensive metastasis
* Prior to surgery, patient was fasting, underwent gastrointestinal decompression and received nutritional support
* Previous history of abdominal surgery
* Patient have previously undergone gastrostomy
Ultrasound- Guided Continuous Serratus Anterior Plane Block Versus Ultrasound- Guided Continuous Thoracic Paravertebral Block in Multiple Traumatic Rib Fractures.

The aim of this study is to compare the analgesic efficacy of ultrasound guided continuous SAP block and ultrasound guided continuous TPVB in patients with multiple traumatic rib fractures.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either gender aged between 22-65 years with unilateral traumatic multiple fracture ribs (≥ 3 fractured ribs).

Exclusion Criteria:

* • Contraindications to regional block such as patient's refusal, coagulopathy, local infection at the site of the block, known allergy to local anesthetic drugs and spinal deformity.

  * Patients suffer from severe cardiovascular disease, hepatic or renal disease and patients with history of psychiatric illness.
  * Patients had indications for mechanical ventilation on admission or during the study period.
  * Patients had indications for immediate surgery for other associated injuries.
  * Patients with hemodynamic instability.
  * Patients having spine or pelvic fracture, traumatic brain injury, altered conscious level or spinal cord injury.
Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis

This multi-center observational Registry will collect long-term safety data on patients treated with celecoxib or non-selective nonsteroidal anti-inflammatory drugs (nsNSAIDs) as used in clinical practice for the treatment of Juvenile Idiopathic Arthritis (JIA).

None Study has been terminated early (LSLV = 09Jan2012) due to release of the postmarketing commitment by the US FDA. The study was stopped for futility/change in treatment paradigm that minimizes chronic NSAID use and not for safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 2 years but less than 18 years; JIA of any of the following subtypes: oligoarthritis, polyarthritis, or stable systemic disease;
* new treatment (started not more than 6 months prior) with one NSAID (celecoxib or nsNSAID).

Exclusion Criteria:

* Patients with the following JIA subtypes: active systemic disease, psoriatic Arthritis, enthesitis-related Arthritis, or undifferentiated arthritis;
* Patients with Reiter's syndrome; patients unlikely to complete 2 years of follow up;
* Patients who need to use multiple NSAIDs at the same time.
Telehealth Implementation of Brain-Computer Interface

Determine if Telehealth intervention can allow/empower a caregiver (who is untrained) to effectively implement and utilize a Brain-Computer Interface for communication with a participant who is "Locked in" following progression of Amyotrophic Lateral Sclerosis and other conditions.

People with Amyotrophic Lateral Sclerosis (ALS) or other conditions such as a pontine stroke may develop a condition called Locked In Syndrome (LIS) where they are unable to use alternative communication strategies such as eyegaze to allow for communication for social needs or instruction to caregivers. Brain-Computer Interface (BCI) devices have been shown in the laboratory to allow participants to effectively communicate needs and engage in social communication. However, translation of this research to the home environment has been limited. In order to be a functional option for people to utilize, BCI needs to be much easier to set up and operate.

This study is designed to determine if telehealth intervention is sufficient to allow an untrained caregiver to set up and maintain a BCI for a person with a long-term communication difficulty given LIS.

Participants will receive a computer and associated hardware to allow for set up of the BCI. Videoconference support will be provided by the research team to allow the client and caregiver to set up the device in their home. Participants will hopefully be able to use the device to generate novel communication related to their care and engage in social needs with caregivers and/or family members. Communication that is generated will be logged and times that the participant is engaged in use of the BCI when not under direct support by the researchers will also be monitored.

The hypothesis is that telehealth support will be sufficient to allow for setting up the computer. If this is true, this will make it much easier for a client to engage in use of a BCI to allow for that communication versus the current need of traveling to a clinic or other specialized setting.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis leading to severe communication impairment

Exclusion Criteria:

-
Effect of Bifidobacterium Lactis HN019 on Colonic Transit Time and Digestive Symptoms

The purpose of this study was to investigate the dose response effect of Bifidobacterium lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms.


Eligibility Criteria:
Inclusion Criteria:

* healthy males and females aged 25 to 65 years
* stool type 2-4 on the Bristol Stool Chart
* 1 to 3 bowel movements per week

Exclusion Criteria:

* use of any probiotic product intended to improve gastrointestinal function within the 2 weeks preceding study entry
* major chronic and uncontrolled systemic medical conditions
* severe gastrointestinal conditions known to prolong CTT
* lactose intolerance
* chronic diarrhea
* gastric bypass surgery or lap band insertion for weight loss
* regular laxative use
* pregnant or breast-feeding women
Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies

The study aims to obtain a local control rate in patients with lateral pelvic relapses of gynecologycal cancers previously irradiated. High LET (Linear Energy Transfer) particles as carbon ions can guarantee a biologic advantage compared to photons in radioresistant neoplasms, given to their higher biological efficacy (RBE).

Primary aim: estimate the effect, in terms of clinical response, of carbon ion treatment (CIRT) in patients with lateral pelvic recurrences of gynecological malignancies.

Secondary aims:

1. To describe the safety profile of carbon ion therapy.
2. To estimate the effect, in terms of survival, of carbon ion treatment

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* Karnofsky Index ≥ 70
* Histological or radiological diagnosis of pelvic and groin recurrence
* Contraindications for radical surgery
* No other distant progression or stable disease (SD) of known secondarisms (≥6 months)
* Previous radiation therapy on pelvis
* Distance ≥ 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated
* Possibility to perform a surgery to space the intestinal loops, in case of distance \< 10mm
* If needed, spacer in biocompatible material (silicon, goretex) or anatomical material (omentum, muscle patch), non-absorbable.
* DICOM (Digital Imaging and COmmunications in Medicine) images of the previous treatment plan availability
* Written informed consent
* Patient's ability to understand the characteristics and consequences of the clinical trial

Exclusion Criteria:

* Hip prosthesis, metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan

  * Intestinal infiltration
  * Bladder infiltration
  * Vessel infiltration
  * Previous therapy with anti-angiogenesis drugs
  * Psychic or other disorders that may prevent informed consent
  * Previous invasive tumor, with the exception of skin cancer (excluding melanoma) unless disease-free for at least 3 years
  * Spacer in absorbable material (i.e. vycril)
  * Distance \< 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated
  * Impossibility to assess MRI
Dynamic Balance, Flexibility and Agility as Predictors of Lower-extremity Injury in Football Players

This research investigates the reliability of tests to assess injury risk. Participants will be tested at the beginning of the survey and will be monitored for over 5 months. Participants will take 4 types of tests related to dynamic balance, flexibility, and agility. Subsequently, the relationship between test results and the incidence of injury in the subjects will be analyzed. If the tests prove reliable, they will be included in standard tests to assess the risk of injury to football players.

Too often, injuring athlete results in a large amount of money being spent on rehabilitation. In a world of sports where the speed of recovery means a lot, ways are sought first and foremost to minimize the frequency of non-contact injuries. To prevent certain things, it is important to know the initial state, therefore, to see if certain factors at the outset indicate to us that there is a certain imbalance that can result in the injury. Since we live in a country where sports clubs are unable to spend large amounts of money on rehabilitation, it would be of great benefit to find reliable tests that can help to prevent an injury. Studies have shown that tests of balance, flexibility, and agility can help to prevent injury to football players in other countries. The same tests will be applied to Premier League footballers in Bosnia and Herzegovina and their effectiveness in assessing the degree of risk of lower limb injuries will be tested. If they prove reliable, they can become a standard in the prevention of these injuries, that is, they will help in the development of injury prevention programs, which would be of great benefit to both clubs and football players.

The study aims to determine whether dynamic balance and flexibility tests can be used as reliable predictors of lower limb injuries in football players and whether reduced agility influences the increased risk of injury.

Eligibility Criteria:
Inclusion Criteria:

* Professional players
* Age above 18 years
* Voluntary access to research

Exclusion Criteria:

* Age under 18,
* Refusal to take the research,
* Remaining in the club until the end of the examination,
* Errors in keeping records of injuries by responsible persons,
* Injuries to the lower limbs in the last ten days,
* Vestibular disorders.
Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children

The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility Criteria:
Inclusion Criteria:

* A male or female child age 6 months to \< 18 years at the time of the vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
* Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
* Written informed consent obtained from the subject's parent/guardian; assent obtained in subjects \> 10 years.
* Female subjects of childbearing potential must agree to take a pregnancy test.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine, other than the study vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion.
* History of hypersensitivity to any vaccine.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrollment.
* History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
* Pregnant or lactating female.
* Receipt of an influenza vaccine outside of this study, during current (2006-07) flu season.
Effect of Metformin on Patients With Osteoarthritis

This randomized controlled trial aims to investigate if metformin has osteoarthritis protective effects among overweighted knee osteoarthritis patients. The co-primary outcomes are changes in tibiofemoral cartilage volume and Western Ontario and McMaster Universities Arthritis Index (WOMAC) from baseline to month 24. The secondary outcomes are changes in visual analog scale (VAS)-assessed knee pain, tibiofemoral cartilage defect, effusion-synovitis volume, and tibiofemoral bone marrow lesion maximum size from baseline to month 24.


Eligibility Criteria:
Inclusion Criteria:

1. Meet the American College of Rheumatology (ACR) criteria for symptomatic knee osteoarthritis assessed by a rheumatologist;
2. Age 50 to 75 years;
3. Body mass index ≥ 24 kg/m2;
4. Knee pain ≥ 20 on a 100 mm visual analogue scale (VAS);
5. Able to listen, speak, read and understand Chinese; capable of understanding the study requirements and willing to cooperate with the study instructions; able to provide written, informed consent.

Exclusion Criteria:

1. Severe radiographic knee OA as grade 3 joint space narrowing according to the Osteoarthritis Research Society International (OARSI) atlas;
2. Severe knee pain as knee pain ≥ 80 on a 100 mm VAS;
3. Planned knee or hip surgery (including arthroscopy, joint replacement, and joint open operation) within 2 years;
4. Severe knee trauma history (including arthroscopy, severe injury of knee ligament or meniscus);
5. Contraindication to MRI scanning (e.g. implanted pacemaker, artificial metal valve or cornea, aneurysm clipping surgery, arterial dissection, metal foreign bodies in the eyeball, claustrophobia);
6. Other forms of inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis);
7. Active malignant cancer or other life-threatening diseases;
8. Type 1 or type 2 diabetes mellitus;
9. Clinical manifestation of liver dysfunction or alanine aminotransferase/aspartate aminotransferase exceeding 2 times the upper limit of normal value;
10. Estimated glomerular filtration rate less than 60 ml/min/1.73 m2;
11. Hypoxic state (e.g. chronic heart insufficiency, acute myocardial infarction, heart failure, chronic obstructive pulmonary disease, cor pulmonale, peripheral vascular disease);
12. Alcoholism;
13. Pregnancy or lactation;
14. Allergic to metformin hydrochloride;
15. Conditions affecting the absorption of oral drugs (e.g. postgastrectomy and malabsorption syndrome);
16. Use of metformin in recent 30 days or plan to use metformin in the next 2 years;
17. Use of investigational drug in recent 30 days.
Randomized Study of Fetal Neurotransplantation for the Treatment of Parkinson's Disease

OBJECTIVES:

I. Assess the safety and efficacy of embryonic mesencephalic dopamine cell implants into the putamen of patients with Parkinson's disease.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are stratified by age (over and under 60). Patients are randomized to receive either sham surgery or tissue implantation.

Embryonic tissue is prepared. While patients are awake, but sedated, bilateral incisions are made in the skin and burr holes drilled in the skull. A cannula is inserted into the brain to the posterior putamen. Implant patients receive embryonic neural tissue or sham patients have no needles penetrate the brain. After 1 year, patients who receive the sham operation in the first operation may receive embryonic neural tissue in a second operation.

Patients are followed every 4 months during the first year and every 6 months thereafter.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Idiopathic Parkinson's disease for at least 7 years with rest tremor or bradykinesia and one of the following cardinal signs: Rigidity Flexed posture Loss of postural reflexes Freezing (motor blocks)
* Continuing response to levodopa
* Presence of at least one of the following intractable symptoms or signs: Intractable disabling fluctuations Intractable disabling dyskinesias Intractable "on" freezing (i.e., motor blocks that interfere with walking despite being "on"
* Bilateral parkinsonism when "off" (may be asymmetry between right and left sides)
* Decreased dopa uptake in the striatum

--Prior/Concurrent Therapy--

* No prior brain surgery

--Patient Characteristics--

* Cardiovascular: No severe cardiopulmonary disease
* Neurologic: No history of strokes No neuroleptics No encephalitis No oculogyric crisis No remission No cerebellar signs No dementia (Mini-Mental state score no greater than 22) No supranuclear gaze palsy No Babinski sign No orthostatic hypotension No hydrocephalus No brain tumor No occlusive cerebrovascular disease
* Pulmonary: Absolute standing pressure at least 90/60 mmHg
* Other: No diabetes mellitus No exposure to toxins No other severe medical disease Hamilton Depression Scale score of less than 20 points