cyrilzakka/clinical-trials huggingface dataset:
Acupoint Focused Ultrasound Versus Laserpuncture In Mechanical Neck Pain

this study will be conducted to compare the effect of Acupoint focused ultrasound and Laser puncture on pain intensity level, neck range of motion, and neck function in patient with chronic mechanical neck pain

Neck pain is a musculoskeletal condition with a high prevalence that may affect the physical, social, and psychological aspects of the individual, contributing to the increase in costs in society and business. Neck pain was significantly associated with repetitive movement, activities that require lifting and moving loads, and being in sitting and leaning positions.Non specific neck pain is a multifactorial and very common condition in adult individuals, traditional acupuncture (TA) and laser puncture (LP) may be treatment options for certain individuals in such a condition. The laser will be placed at the specific acupuncture points: Tianzhu, Fengchi, Jianjing, and Jianzhongshu . Because ultrasound can deliver vibration energy to soft tissues noninvasively, ultrasound has been applied to diagnostic imaging and therapeutic applications. To use ultrasound for acupoint stimulation, a stimulation device was developed using focused ultrasound. The application of an ultrasound stimulus to the acupuncture meridian system has been found safe and effective in many common clinical entities. The Sonicator head is applied to the chosen location as in standard ultrasound therapy, with a gentle circular motion. forty five patients will be assigned randomly to three groups; experimental group 1 will receive acupoint focused ultrasound, experimental group 2 will receive laserpuncture and the control group will receive conventional treatment three times a week for four weeks.

Eligibility Criteria:
Inclusion Criteria:

All subjects will be referred by the orthopedist. Cervical pain is episodic chronic, having occurred and recurred over regular or irregular intervals of time over at least the last 3 months.

The subject is willing and able to refrain from non-study procedure therapies for the management of neck pain throughout study participation.

Age ranged from 30-60 years BMI ranged from (25-30kg/m2)

Exclusion Criteria:

Cervical pain is undiagnosed or has been diagnosed as being other than of benign musculoskeletal origin.

Tension myositis syndrome. Osteoporosis with compression fractures. Congenital deformity of spine. Current active chronic pain disease. Cancer or cancer treatment in the past 6 months. Use of the following analgesics within 7 days of study onset - paracetamol, acetominophen, non-steroidal anti-inflammatory drugs (NSAIDs), compound analgesics, topical analgesics.

Use of the following muscle relaxants within the prior 30 days of study onset - cyclobenzaprine, diazepam, meprobamate.
Efficacy and Safety of iStent Inject and Inject W in the Management of Primary Open-angle Glaucoma

Primary open-angle glaucoma (POAG) is a chronic eye disease in which the only validated treatment is to lower intraocular pressure (IOP). It is the 2nd leading cause of blindness worldwide. The iStent® inject and inject W is an implantable device that is part of a new entity of so-called minimally invasive glaucoma surgery whose goal is to lower IOP with minimal tissue disruption in order to avoid the complications of conventional glaucoma surgery. This surgery is used in conjunction with cataract surgery in France. The primary objective is to study the 1-year efficacy and safety of combined cataract and iStent inject and inject W in the management of POAG in an observational, retrospective, controlled study of a cohort of POAG patients undergoing cataract surgery only.


Eligibility Criteria:
Inclusion Criteria:

* patient who have undergone combined phacoemulsification surgery and insertion of at least one iStent® for chronic open-angle glaucoma in the ophthalmology department of the Amiens University Hospital or the Saint-Quentin University Hospital (iStent® group).
* patient who have undergone simple phacoemulsification surgery in a patient with chronic open-angle glaucoma in the ophthalmology department of the Amiens University Hospital (control group).
* patient with Chronic open-angle glaucoma confirmed by gonioscopic examination, visual field, optical coherence tomography of the optic nerve, fundus examination, pachymetry and intraocular air pressure and/or applanation.

Exclusion Criteria:

* acute angle closure glaucoma,
* chronic angle closure glaucoma,
* uveitic glaucoma,
* traumatic glaucoma,
* exfoliative glaucoma.
* Previous filtering surgery on the operated eye.
* Intraoperative complication.
A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older

A phase III, randomized, observer-blind, active-controlled, parallel-group, multi-center study to evaluate immunogenicity and safety of a preventive COVID-19 vaccine EuCorVac-19 in healthy adults aged 18 years and older


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 years and older who voluntarily decide to participate in this study and provide written informed consent
* Female of childbearing potential who agree to use medically allowed methods of contraception during the study period
* Individuals who agrees not to perform blood donation and transfusion during the study period

Exclusion Criteria:

* Individual being considered to be confirmed COVID-19
* Direct contact with COVID-19 infected person within 14 days prior to the 1st dose of the IP
* Individuals at high risk of exposure to SARS-CoV-2
* Individuals with clinically significant abnormalities in clinical laboratory tests, ECGs, and chest X-ray during screening
* Individuals with fever within 72 hours prior to the 1st dose of the IP or suspected other infectious disease or symptoms associated with other infectious disease
* Individuals with serious medical or psychiatric disease
* History of SARS-CoV or MERS-CoV infection
* History of allergic reaction or hypersensitivity reactions to any of components of the IP
* History of serious adverse events, serious allergic reaction or serious hypersensitivity reactions to vaccination
* History of receiving organ or bone marrow transplant
* Suspected or history of drug abuse or alcohol abuse within 6 months prior to vaccination
* History of vaccination against SARS-CoV, MERS-CoV, or SARS-CoV-2
* History of vaccination with test vaccine substance
* Treatment with immunosuppressants or immune modifying drugs
* History of treatment with antipsychotics or opioid dependence
* Pregnant or lactating women
* Other reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator
Catequentinib in Patients Who Have Completed an Advenchen Study (A Compassionate Use Trial)

Catequentinib (AL3818, Anlotinib) has been developed in a variety of clinical studies as single agents or in combination with others. This trial is designed to offer patients who completed an Advenchen sponsored AL3818 related study without progression the opportunity to continue to receive this investigational product in this Post-Trial Access study (a compassionate use trial), if the Investigator believes the patients can benefit from such a treatment and the patients have signed the Informed Consent Form.

This is an open label trial and is designed to offer patients who are in a completed Advenchen sponsored AL3818 study without progression the opportunity to continue to receive AL3818. Qualified patients will continue therapy on their regimen established in the approved parent AL3818 clinical study until disease progression, physician decision, patient withdrawal, or sponsor discontinuation of the study. Dose modifications will be based on the suggestions in the approved parent AL3818 clinical study. Patients may be required to come to the site to receive AL3818. For patients who cannot come to the site to receive AL3818, the Site may mail the drug to the patient. The exact dispersing methods will be based on the Investigator's discretion.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be currently receiving treatment with AL3818 on a previously approved parent protocol, including drug crossover patients.
* Patients must have achieved stable disease, partial response or complete response based on the most recent tumor assessment. If progressive disease on the most recent tumor assessment, the Investigator believes the patient can clinically benefit from continuing to receive AL3818.
* Female patients of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception throughout the study period and for 4 months after the last dose of either study drug.
* Patient is willing and able to sign a new informed consent.
* Patients for whom the Investigator believes can benefit from continuing to receive AL3818

Exclusion Criteria:

* Patient has been discontinued from their previous AL3818 trial treatment greater than 3 weeks (one cycle) prior to entering the compassionate use trial.
* Patient progressed while receiving therapy with AL3818 during their participation in their immediate previous trial unless the Investigator believes the patient can clinically benefit from continuing to receive AL3818.
The Effects of Behavioral Activation and Physical Exercise on Depression

The purpose of this study is to compare an internet-based behavioral activation program with a physical activation program, as treatments for mild to moderate depression. The added effect of rationale and motivational interviewing will also be studied, as well as the effects of relapse prevention program.

BACKGROUND:

Despite their potential as low-threshold, low-cost and high-flexibility treatments of depression, behavioural activation and physical exercise have not yet been directly compared. This study will examine the effects of these interventions, administered via the Internet. The added effect of providing a treatment rationale will also be studied, as well as a relapse prevention program featuring cognitive behavioural therapy components.

METHODS/DESIGN:

This randomised controlled trial will include 500 participants meeting the diagnostic criteria for major depression, recruited in multiple cycles and randomised to either a waiting list control group with delayed treatment, or one of the four treatment groups: (1) physical exercise without a clear treatment rationale; (2) physical exercise with treatment rationale; (3) behavioural activation with treatment rationale; or (4) behavioural activation without a clear treatment rationale. Post treatment, half of the participants will be offered a relapse prevention program. Primary outcome measure will be the Patient Health Questionnaire 9-item. Secondary measures include diagnostic criteria for depression, as well as self-reported anxiety, physical activity and quality of life. Measurements - done via telephone and the Internet - will be collected pre-treatment, weekly during treatment period, immediately post treatment and then monthly during a 24-month follow-up period.

DISCUSSION:

The results of this study will constitute an important contribution to the body of knowledge of the respective interventions.

Eligibility Criteria:
Inclusion Criteria:

* Satisfy DSM-IV (or DSM-V) criteria for depression, with depression being primary diagnosis
* Scoring within the interval 15-35 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
* Living in Sweden and being able to read Swedish
* Access to computer with internet connection

Exclusion Criteria:

* Currently receiving other psychological treatment
* Non-stable use of psychoactive medication
* Deemed to suffer from a too severe depression
* Deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.
Bupivacaine Versus Lidocaine Local Anesthesia

The use of local anesthetics has become an important aspect of pain management in surgical settings and is currently recommended in pain management guidelines.

Elective outpatient hand surgeries, such as carpal tunnel or trigger finger release, cause minimum tissue disruption and are short in duration. As a result, these local anesthetic agents are a major component in post-operative pain control. The most commonly used local anesthetic agents are Lidocaine and Bupivacaine. Lidocaine acts faster (within 2-5 minutes of injection) and for this reason is often favored in outpatient setting for pre-incisional injection. However its effects only last up to 2 hours, without epinephrine, and 3 hours, with epinephrine. On the other hand, Bupivacaine, has a slower onset of action (about 5-10 minutes after injection) but its effects last much longer, for about 4-8 hours. The delay in onset of action makes it a less popular option as a primary source of local anesthesia in outpatient hand surgery.

Given the longer duration of anesthesia offered by Bupivacaine, the investigators believe that by giving it pre-operatively in elective outpatient hand surgeries will offer more effective post operative pain control compared to using Lidocaine only. There is limited published data confirming the effectiveness of use of pre-operative Bupivicaine in improved postoperative pain control and decreased consumption of narcotics. Therefore, the aim in this study is to compare the postoperative pain experienced by patients undergoing either elective carpal tunnel release or trigger finger release as well as their use of pain medications when the incision site is infiltrated preemptively with Lidocaine versus Bupivacaine.

The investigators believe that adequate post surgical pain control is essential for patients' full functional recovery. Poorly controlled post surgical pain increases incidence of surgery related complications and thus increased health care costs. It can also reduce patients' mobility, delay their return to full function,. If poorly controlled, post surgical pain may progress to chronic pain and rarely complex regional pain syndromes may ensue.

Subjects will be randomized to receive either 10ml of 0.5% Bupivacaine with 1:200,000 Epinephrine or 10 ml of 1% Lidocaine with 1:100,000 Epinephrine.

In the case of a single digit surgery such as the trigger finger release, the dose will be adjusted to 5ml of 0.5% Bupivacaine with 1:200,000 Epinephrine or 5ml of 1% Lidocaine with 1:100,000 Epinephrine.

An additional 5ml of study drug will be prepared in a separate syringe and administered when needed.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 90 year old
* Able to provide informed consent
* Consent to participate
* Carpal tunnel release surgery or Trigger finger release surgery
* Single procedure

Exclusion Criteria:

* Unable to consent
* Do not consent to participate
* Known Lidocaine or Bupivacaine allergy
* Known Epinephrine allergy or contra indication
* Known Codeine allergy
* Pregnant
* More than one procedure is being performed at the same setting
Effect of PEEP Titration on the EELV Measured by the Nitrogen Dilution Technique in ARDS

Mechanical ventilation of the patient with acute respiratory distress syndrome is one of the first therapies.

The application of positive end expiratory pressure is recommended but the question remains "How to set the best positive end-expiratory pressure (PEEP) level for each patient? ". Different titration techniques have been studied on oxygenation and respiratory mechanics parameters without reaching a consensus. Currently we have a module that is connected to the ventilator to collect the patient's lung volume. It will therefore allow us to optimize the settings of the ventilator and to set the best level of positive end-expiratory pressure "best peep" in order to individualize our treatment for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to intensive care with a diagnosis of moderate to severe ARDS in accordance with the Berlin criteria, i.e. a PAFI \<200 and PEEP \>5cm H20 ratio
* Diagnosis of ARDS made within 72 hours
* Age over 18 years
* Informed consent of the patient and/or trusted person where applicable

Exclusion Criteria:

* Start of mechanical ventilation more than 72 hours prior to inclusion.
* SDRA evolving for more than 72 hours
* Presence of major hemodynamic instability with mean blood pressure \<60mmhg, and/or heart rate \<45 bpm or \>150bpm with an increase in vasopressor amine dosage of more than 20% over the last 6 hours.
* Intracranial hypertension with CPP\<60mmhg
* Massive hemoptysis requiring immediate surgical or interventional radiology procedure
* Tracheal surgery (except intensive care tracheotomy) or sternotomy within the previous 15 days
* Trauma or surgery of the face in the previous 15 days.
* Deep vein thrombosis treated for less than 2 days
* Pacemaker implantation in the last 2 days
* Unstable fracture (spine, femur or pelvis)
* Respiratory reasons
* use of extracorporeal oxygenation
* nitric oxide
* pleural drainage system with bronchopleural gap
* pulmonary transplantation
* Poor respiratory tolerance per procedure with desaturation Spo2\<85%.
* Poor hemodynamic tolerability per procedure combining hypotension with MAP\<65mmhg and a 20% increase in norepinephrine dosage.
* Lack of patient consent to proceed
* minor patient
* lack of consent
G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer

This is a study to investigate the potential clinical benefit of G1T48 as an oral selective estrogen receptor degrader (SERD) alone and in combination with palbociclib, a cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, in patients with estrogen receptor-positive, HER2-negative metastatic breast cancer.

The study is an open-label design, consisting of 3 parts: dose-finding portion including food effect (Part 1), G1T48 monotherapy expansion portion (Part 2), and G1T48 in combination with palbociclib expansion portion (Part 3). All parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 184 patients may be enrolled in the study.


Eligibility Criteria:
Inclusion Criteria:

* For Part 1, postmenopausal women only
* For Parts 2 and 3, any menopausal status
* Confirmed diagnosis of ER-positive, HER2-negative advanced breast cancer, not amenable to curative therapy
* For Part 1, prior treatment with less than 4 prior lines of chemotherapy
* For Part 2, prior treatment with less than 2 prior line of chemotherapy
* For Part 3, prior treatment with no more than 1 prior line of chemotherapy
* For Parts 1 and 2, prior treatment with less than 4 prior endocrine therapies for metastatic breast cancer
* For Part 3, prior treatment with no more than 1 prior line of endocrine therapies for metastatic breast cancer
* For Parts 1 and 2, patients must satisfy 1 of the following criteria for prior therapy:

  * Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor
  * Progressed after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer
* For Part 3, patients must satisfy 1 of the following criteria for prior therapy:

  * Received ≥ 24 months of endocrine therapy in the adjuvant setting prior to recurrence or progression
  * Received ≥ 6 months of endocrine therapy in the advanced/metastatic setting prior to progression
* For Part 1, evaluable or measurable disease
* For Parts 2 and 3, evaluable (approximately 25%) or measurable disease (approximately 75%) as defined by RECIST, Version 1.1 including bone-only disease
* ECOG performance status 0 to 1
* Adequate organ function

Exclusion Criteria:

* For Part 3, prior treatment with CDK4/6 inhibitor, investigational oral SERDs or SERCAs in any setting
* Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
* Anticancer therapy within 14 days of first G1T48 dose or within 28 days for antibody-based therapy
* Concurrent radiotherapy, radiotherapy within 14 days of first G1T48 dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to \> 25% of bone marrow
* Prior hematopoietic stem cell or bone marrow transplantation
An Observational Study for Evaluation of for the Prevalence of Cerebrotendinous Xanthomatosis (CTX) Disease

The prevalence of CTX in our country is estimated to be 1 / 50.000. The aim of this study is to screen more volunteers by conducting a larger screening from neurology and pediatric metabolism clinics in Turkey.

This observational study was designed retrospectively and prospectively in two stages. In the retrospective section, the patient database and / or patient files will be screened in the neurology and pediatric metabolism clinics and the patients aged 40 and below in the neurology clinics with at least two of the following will be enrolled to the study:

* Ataxia and / or spasticity
* Bilateral cataract (except senile cataract)
* Intellectual limitation
* Non-enhancing hyperintensity on T2 sections in MR imaging of dentate nuclei
* Autosomal recessive transition pattern. (Ex: Relative Marriage)

In the pediatric metabolism centers, cases suspected of CTX and planned to apply the Mignarri Index according to the investigator's opinion will be identified.


Eligibility Criteria:
Inclusion Criteria:

I-1. Giving written informed consent

I-2. Patients in neurology clinics should have been identified with at least two of the following:

* Ataxia and / or spasticity
* Bilateral cataract (except senile cataract)
* Intellectual limitation
* Nonintensitive hyperintensity in T2 sections on MRI of the dentate nucleus
* Forming an autosomal recessive transition pattern. (Ex: Relative Marriage)

I-3. In the pediatric metabolism centers, cases suspected of CTX and planned to apply the Mignarri Index according to the investigator's opinion.

I-4. On the day the patient signed the Informed Consent Form, the patient did not get older than 41 years of age (subjects aged 40 and under will be included in the study)

Exclusion Criteria:

E-1. The patient's ataxia and / or spasticity, cataract, intellectual limitation, and non-contrasted hyperintensity of T2 sections in MR imaging of dentate nuclei with typical MRI findings are due to a known cause other than CTX or other underlying disease.

E-2. The patient has participated in an interventional clinical study in the last 30 days,

E-3. The patient and / or his / her legal representative does not give consent to participate in the study,

E-4. In the opinion of the investigator, the patient is not able to fulfill the working requirements appropriately,

E-5. Pregnancy and / or lactation

E-6. If the patient was 41 years old when included in the study.