cyrilzakka/clinical-trials huggingface dataset:
Investigation of the Efficacy of Treatments With Backup Device in Spine Pathologies

Our aim in this study is to examine the effectiveness of the Backup spine health device in spinal problems and compare it with traditional physical therapy methods.

The investigators study was planned as a randomized controlled study. Participants will be divided into 2 groups as conventional physiotherapy and Backup group by simple randomized method. Participants will be taken to a treatment program for 12 weeks, 3 days a week. Parameters such as pain, posture, sleep quality, quality of life, muscle shortening at the beginning and end of the study. The results will be analyzed statistically.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 20-60
* sick individuals with spinal problems
* Persons who have filled out the consent form

Exclusion Criteria:

* People with spinal pathology for whom physiotherapy is contraindicated
* Having a neurological problem
A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium Enhancement

This is a prospective trial investigating the effectiveness of a modified MRI preparatory pulse sequence to improve pulmonary vein isolation visualization.


Eligibility Criteria:
Inclusion Criteria:

* Men or non-pregnant women
* A diagnosis of symptomatic paroxysmal or recently persistent atrial fibrillation with a documented successful cardioversion within 4 months of the procedure
* Documented treatment failure or intolerance of at least 1 anti-arrhythmic medication used to control atrial fibrillation.

Exclusion Criteria:

* Contraindication to MRI, such as implanted incompatible metal prosthesis, or subject size exceeds bore or table limits
* Allergy to gadolinium-based contrast agent
* Previous atrial fibrillation ablation
* Renal dysfunction (estimated GFR \<60 mL/min/1.73m2) within 6 months
* Unwilling to provide informed consent for this protocol
Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

The purpose of this clinical study is to compare the visual outcomes of the AcrySof IQ PanOptix Multifocal Intraocular Lens (IOL) Model TFNT00 against that of a monofocal lens, the AcrySof Monofocal IOL Model SN60AT, in order to demonstrate comparable distance vision and superior near and intermediate vision.

Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 10 study visits over a 7-month period. Of these 10 visits, 1 is preoperative, 2 are operative, and the remaining 7 are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision
* Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures
* Clear intraocular media other than cataract in both eyes.
* Preoperative keratometric astigmatism of less than 1.0 diopter (D) in both operative eyes.

Exclusion Criteria:

* Clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema
* Previous refractive surgery or refractive surgery procedures (including, but not limited to LASIK, astigmatic keratotomy, and limbal relaxing incisions)
* Glaucoma (uncontrolled or controlled with medication)
* Degenerative eye disorders (e.g. macular degeneration or other retinal disorders)
* Pregnant or lactating
* Expected to require a second surgical intervention or retinal laser treatment.
Observationa Study is a Prospective and Multi-institutional Observational Study.

This observational study is a prospective, multi-institutional non intervention study to examine the prescription patterns, corresponding treatment effects and safety in routine clinical practice for patients prescribed for the treatment of gastroesophageal reflux disease.

The present observational study is designed to check effect and safety for patients who have been prescribed JAQBO for the treatment of erosive gastroesophageal reflux disease.

Eligibility Criteria:
Inclusion Criteria:

1. An adult over 19 years of age
2. A person who voluntarily provides written informed consent

Exclusion Criteria:

1. A pregnant woman or a nursing woman
2. A person who is deemed unsuitable for the subject of the study
Automated Detection and Triage of Large Vessel Occlusions Using Artificial Intelligence for Early and Rapid Treatment (ALERT)

Post Market, Prospective, Randomized, Controlled, multi center data collection study to evaluate the use of Viz versus the standard of care in stroke workflow and clinical outcome parameters.

This study will be a multicenter, multi arm, prospective randomized study to evaluate the use of Viz. The study will enroll all subjects that present at all participating centers that meet the study inclusion/exclusion during the period of study evaluation. All subject imaging (CT) data will be pushed to Viz and evaluated by Viz. Randomization will occur at the time of image processing by Viz that indicates the subject is positive for LVO per the software criteria (anterior location). Subjects randomized to the standard of care arm of the study will not receive any information via an automated notification from Viz. Subjects that are randomized to the Viz arm of the study will have an automated message sent to the enrolling center contacts. Subjects will be followed for 90 days post treatment. Data evaluation may occur at regular intervals throughout the study and at the completion of the study period.

Eligibility Criteria:
Inclusion Criteria:

A subject must meet all of the following inclusion criteria to be included in the study:

1. Age of 18 years or greater.
2. Signs and symptoms consistent with the diagnosis of a stroke.
3. Stroke protocol imaging (CTA) with a confirmed presence of anterior LVO via Viz.

Exclusion Criteria:

A subject may not be included in the study if any of the following exclusion criteria are met:

1. Poor or incomplete CTA imaging data.
2. Disagreement between neuroradiologist and stroke specialist or neurointerventionalist relative to presence of a stroke.
3. Other serious, advanced, or terminal illness (investigator judgment) requiring treatment that significantly delays initiating transfer and/or treatment for stroke.
The Effectiveness of Intravitreal Avastin Injection for CRVO

to determine the effectivness of intravitreal avastin injection on visual acuity on people that suffer from central retinal vein occlusion


Eligibility Criteria:
Inclusion Criteria:

* patients above 18 years old
* suffer from CRVO
* maximal visual acuity 6/15

Exclusion Criteria:

* VA of LP
* retinal disease other than CRVO
* incomplete medical record
* follow up less than 6 months
A Study of LY2334737 in Participants With Cancer That is Advanced and/or Has Spread

The purpose of this study is to evaluate two different dosing regimens of LY2334737 in participants with cancer that is advanced and/or has spread to other parts of the body. Information about side effects will be collected.

This study will consist of a Dose Escalation Phase (Arms A and B) followed by a Dose Confirmation Phase.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced and/or metastatic cancer (including lymphoma) for which no treatment of higher priority exists
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Estimated life expectancy of more than 12 weeks
* Have discontinued all previous therapies for cancer for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) and recovered from acute effects of therapy
* Have discontinued radiotherapy more than one week before enrolling in the study and have recovered from the acute effects of therapy
* Have adequate organ function
* Follow your doctor's directions and live close enough to the study site so you can continue to go to the clinic for follow-up
* Are willing and able to swallow capsules and follow study procedures
* Have given written informed consent prior to any study-specific procedures
* Males and females with reproductive potential should use medically approved contraceptive precautions during the study and for 6 months following the last dose of study drug
* Females with child-bearing potential must have had a negative urine or serum pregnancy test 7 days prior to the first dose of study drug

Exclusion Criteria:

* Have gastrointestinal diseases or prior surgery that may interfere with the absorption of medication taken by mouth
* Females who are pregnant or lactating
* Symptomatic central nervous system malignancy or metastasis
* Known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb)
* Liver cirrhosis or chronic hepatitis
* Acute or chronic leukemia
* Are currently receiving treatment with valproic acid (VPA) and its derivatives, or if you have a history of intolerance to VPA
* Known hypersensitivity to gemcitabine
The Effect of Recognition and Expression of Emotions Program Applied to Schizophrenia Patients

As a result of the positive and negative symptoms that occur in schizophrenia, patients with schizophrenia may experience negative emotions more frequently than individuals with other mental problems. Since these emotions can trigger psychotic symptoms, there is a need to develop effective emotion regulation strategies to be applied to patients with schizophrenia.

Aim: In this study, it was aimed to examine the effect of emotion recognition and expression program on alexithymia and emotion expression in patients with schizophrenia.

Method: Fifty schizophrenic patients who regularly receive outpatient treatment at Sinop Community Mental Health Center will form the universe of the study. Individuals over the age of 18 who have schizophrenia, do not have mental retardation, have no comprehension and hearing problems, have insight, and are in remission will be included in the study. Individuals who meet the study criteria will be divided into experimental and control groups as 22 experimental and 22 control groups. The emotion recognition and expression program prepared by the researchers in line with the literature will be applied to the experimental group for 8 weeks. Personal Information Form, Expression of Emotions Scale, Positive and Negative Syndrome Scale and Toronto Alexithymia Scale were planned to be applied to the experimental and control groups in the pre-test, post-test and follow-up. Follow-up will take place one month after the last session of the study. Psychosocial interventions applied to patients with schizophrenia help patients to increase their level of well-being and quality of life, to decrease negative and positive symptoms by increasing social functionality, to participate in social life, to be an autonomous individual and to prevent stigma. In line with psychosocial interventions, it is thought that the this program to be applied to the patients in this study will basically contribute to the individual patients' ability to recognize their emotions, discuss their emotions, regulate their emotion intensities, and express their emotions. Due to the impact that this program will have on the individual, it is believed that it will have positive results not only for schizophrenia patients, but also for the individuals with whom the patients interact, their relatives and even the society.

Eligibility Criteria:
Inclusion Criteria:

* Patient who had received a diagnosis of schizophrenia and comes to the Community Mental Health Center regularly,
* Being able to read and communicate
* Being 18 years of age or older,
* Not having mental retardation,
* Not having insight, understanding, hearing problems,
* Being in remission,
* Volunteering to study

Exclusion Criteria:

* Not diagnosed with clinical schizophrenia,
* Being under the age of 18,
* Having mental retardation,
* Having no insight,
* Not understanding and hearing,
* Not in remission
* Refusing to participate in the study
* Stop studying at any stage of the study
Mild Intraoperative Hyperventilation to Decrease Post-op. Shoulder Pain After LSG

Shoulder pain is common after laparoscopic surgeries. multiple maneuvers are in use to decrease its incidence with variable results. This study aims to investigate the effect of mild hyperventilation to an End-tidal CO2 level of 30-32 mmHg on the occurrence of postoperative shoulder pain. This is carried out through a comparison of the incidence of postoperative shoulder pain an intervention group to that in a control one with a normal End Tidal CO2 35-40 mmHg). controlling for all other variables.

This novel technique is based on the theory that shoulder pain is caused by diaphragmatic irritation by CO2 during laparoscopic surgery. The investigators postulate that lowering the CO2 level in the plasma, will lower tissue CO2 level in the diaphragm and decrease the hypothesized irritation. In this study, patients will be divided into an interventional group which will receive mild intraoperative hyperventilation determined by an End-Tidal CO2 level of 30-32 mm Hg and a control group in which End Tidal CO2 is kept at normal levels (35-40 mmHg). All other intraoperative factors will be standardized for all patients. Patients will be followed up postoperatively and asked whether the participants developed shoulder pain as a primary study outcome. The pain will be recorded in terms of severity, site, and position, and any associations (Nausea and vomiting). Appropriate statistical tests will be used to check for any significant effects of the technique.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* No mental illnesses
* American Society of Anesthesiologists (ASA) class I\&II,
* Patients undergoing laparoscopic sleeve gastrectomy.
* No previous intrabdominal surgeries.

Exclusion Criteria:

* ASA class \>II,
* previous abdominal surgeries.
* mental illnesses.
Absolute Myocardial Perfusion Measurement in the Transplanted Heart

The goal of this study is to detect AR and CR in the transplanted heart by quantitative assessment of myocardial blood flow and its constituents by myocardial contrast echocardiography (MCE). Further we investigate the collateral circulation in these patients.

Heart transplantation has become an accepted therapy for end-stage heart failure. Acute allograft rejection (AR) remains a major cause of mortality in heart transplant recipients. Chronic rejection (CR) determines the long-term prognosis after cardiac transplantation and is responsible for more than one third of late deaths. Different non-invasive methods have been evaluated for the detection of AR, but the gold standard remains endomyocardial biopsy (EMB).

Very little is known about the impact of CR on the collateral circulation in transplant patients. Since the collateral circulation of the heart is mainly part of the microcirculation, it can be hypothesized that it is less developed than in "normal" coronary atherosclerosis without microvascular lesions.

The quantification of CR with non-invasive techniques has remained difficult. In this context, there is a need for a reliable non-invasive test to avoid regularly invasive evaluation.

Based on the above considerations we propose that both AR and CR can be accurately detected and differentiated using non-invasive quantitative myocardial contrast echocardiography (MCE).

Eligibility Criteria:
Inclusion Criteria:

* Patients with heart transplantation, age 18-82 years
* EMB or EMB and coronary angiography
* Written informed consent to participate in the study

Exclusion Criteria:

* Known adverse reaction to adenosine or echo contrast (SonoVueâ)
* Second or third degree AV block, unprotected sick sinus syndrome, atrial fibrillation with uncontrolled ventricular rate
* Asthma, severe pulmonary arterial hypertension (systolic pulmonary artery pressure \>50mmHg assessed by echocardiography)
* Severe obstructive pulmonary disease
Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients

The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.

A total dose of 40.05Gy in 15 fractions was delivered to the tumor bed for each eligible breast cancer patients. The endpoints including loco-regional recurrence, cosmetic outcomes, and toxicities, were evaluated after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age≥ 50 years
* Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
* Negative surgical margins
* Pathologically confirmed invasive breast cancer
* A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2-
* Tumor bed is labeled with Titanium clips
* Received adjuvant hormonal treatment
* No adjuvant chemotherapy
* ECOG:0-1
* Written informed consent.

Exclusion Criteria:

* Age\<50 years
* KPS\<70
* Treated with neoadjuvant chemotherapy
* Treated or being treated with chemotherapy
* With severe comorbidity
* Previous breast cancer or other malignant tumor history
* Previous radiotherapy for breast or thorax
* Medical contraindication for radiotherapy
* Pregnant or nursing
Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction

A prospective study will be conducted to assess the outcomes of patients who underwent concurrent robotic-assisted mastectomy and robotic-assisted free DIEP flap harvest for breast reconstruction between March 2020 and June 25, 2023. Demographic data, including age, body mass index (BMI), and medical history, were collected, along with surgical time and perioperative parameters. The incidence of acute and chronic complications was documented.


Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction

Exclusion Criteria:

* None
Evaluation of Symptoms Improvement in NSCLC Patients With First-Line Therapy of EGFR Tyrosine Kinase Inhibitor

This is an open-label, non-interventional, single-arm, multicenter study in a real-world population to assess the clinically symptom improvement and quality of life (QoL) in patients with locally advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as the first-line treatment.

The Primary Objective is to estimate symptom improvement rates in patients with locally advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as the first-line treatment. A clinically meaningful improvement is defined as an increase from baseline of 2 or more points for LCS (Lung Cancer Scales) at Week 4.

The Secondary Objectives are:

1. To estimate symptom improvement rates at weeks 2 and 12
2. To estimate mean change from baseline in overall QoL scores using the FACT-L instrument and LCS score at Week 2, 4 and 12.
3. To estimate the proportion of patients exhibiting an LCS change of 7 points or more at weeks 2, 4 and 12.
4. Subgroup information of symptom improvement rate, QoL and disease-related symptom scores by gender, smoking status, smoking pattern, WHO performance, number of metastatic sites, female/never smokers and patients with COPD at week 2, week 4 and week 12.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with symptomatic, locally advanced or metastatic (stage IIIb/IV) NSCLC.
* Patients who are positive for EGFR mutation
* Patients with a prescription of EGFR-TKI as their first-line treatment

Exclusion Criteria:

- Involvement in any planning and/or conduct of the clinical trial.
Actual Use Trial of Ibuprofen 400 mg

This is an open label, multicenter, 30 day study designed to mimic an OTC like environment in which subjects will use the product after making a purchase decision about ibuprofen 400 mg caplets based only on their reading of the Drug Facts Label (DFL) and other information on the package.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age (19 years of age in Alabama)
* Subject reports taking over-the-counter (OTC) analgesics for pain or fever relief

Exclusion Criteria:

* Current government-issued identification (ID)
* Pregnant or breastfeeding females
Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease

This study is to research two questions. First, is vitamin D3 more effective than vitamin D2 in raising 25-hydroxyvitamin D \[25(OH)D\] levels in chronic kidney disease (CKD) patients? And secondly, what are the differential effects of vitamin D2 and vitamin D3 on other mineral metabolism parameters?

Vitamin D helps form and strengthens bones by allowing the body to absorb calcium. Vitamin D helps the immune system fight infection as well as helps keep muscles strong. Without enough vitamin D, bones can become weak, thin and brittle.

Vitamin D is useful in people with various types of health issues. Patients with CKD exhibit an unusually high rate of vitamin D deficiency, which may contribute to some of the poor clinical outcomes in this group.

This study will randomize patients with CKD and low vitamin D levels to two groups; one group will be treated with vitamin D2 (ergocalciferol) and the other group will be treated with vitamin D3 (cholecalciferol). The purpose of this study is to compare the effects of the two different forms of vitamin D specifically in patients chronic kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Chronic kidney disease with an estimated glomerular filtration rate (GFR) between 15-60 ml/min (CKD stage III-IV)
* Vitamin D insufficiency (25-hydroxyvitamin D level \< 30 ng/mL) that has not been treated with vitamin D replacement since the acquisition of this level

Exclusion Criteria:

* Current treatment with cholestyramine
* Presence of GI disorders such as short bowel, history of gastrectomy, colectomy, gastric bypass, inflammatory bowel disease, celiac disease, disorders of fat absorption, chronic diarrhea.
* Liver cirrhosis
* Known current substance abuse
* Current treatment with immunosuppressant medications
* Presence of chronic infection
* History of chronic inflammatory disease (i.e. - lupus, active rheumatoid arthritis, Crohns disease)
* Currently receiving high-dose vitamin D replacement (avg dose of ≥ 3,000 U per day) or "active" vitamin D analogue (e.g., calcitriol, which is 1,25-dihydroxyvitamin vitamin D).
Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS)

This research focuses on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in very young children. The medication being used is methylphenidate (Ritalin); it is being studied to determine its safety and how well it works to treat ADHD in preschool-age children (3-5.5 year olds).

Young children age 3-5.5 years will be studied. The study includes treatment with different doses of methylphenidate and placebo; all children will receive active medication during the study. Prior to treatment, each child will receive a thorough psychiatric evaluation and each guardian will complete a 10-week workshop (2 hours/week). Throughout the study, parents and teachers will complete forms that report on the child's behavior and possible side effects. Participants will be monitored by regular visits with a study physician. Most participants will be involved in the study for up to 16 months to ensure optimal evaluation, dosing, and monitoring

Eligibility Criteria:
Boys and girls who are:

* Between the ages of 3-5.5 years
* Qualified as having ADHD by our diagnostic evaluations and clinical staff
* Otherwise generally healthy
* Willing, and have parents that are willing, to attend all visits required by the study
* Enrolled in some type of day-program: day care, preschool, nursery school, kindergarten, for at least 2 half days/week
* In classrooms with teachers that are willing to participate by completing rating scale