cyrilzakka/clinical-trials huggingface dataset:
Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors

This observational trial evaluates the use of Ommaya reservoir placed during a biopsy to collect biomarkers longitudinally in patients with brain tumor. A biomarker is a measurable indicator of the severity or presence of the disease state. An Ommaya reservoir is a small device that's implanted under the scalp. It allows the doctor to take samples of cerebrospinal fluid (CSF) in the future without doing a spinal tap. The identification of biomarkers in CSF is rapidly emerging as a promising minimally invasive approach for monitoring tumor growth and response to therapy. In the future, these biomarkers may be used to help determine what treatments could be most effective and how well a tumor has responded to prior therapy. Currently, limited long-term access to CSF has made it difficult for studies to learn if collecting CSF at different points in the treatment process is useful. Having an Ommaya reservoir placed during a biopsy may allow for longitudinal biomarker collection in patients with brain tumor.


Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiographic evidence suggesting a diagnosis of a brain tumor
* Planned biopsy for suspected or previously diagnosed brain tumor as part of routine clinical care at Mayo Clinic (Rochester, Minnesota \[MN\])
* Willingness of the patient to provide informed consent
* Patient is willing to have their Ommaya sampled on at least 2 future occasions
* Patients is willing to have CSF banked through the neuro-oncology biorepository (requires a separate signature)
* Adults lacking capacity to consent

Exclusion Criteria:

* Vulnerable populations including pregnant women, prisoners, and individuals \< 18 years old
* Patients who are not appropriate candidates for biopsy due to current or past medical history or uncontrolled current illness
* Prior history of any wound infection
* Any patient who the surgeon feels is not an optimal candidate for Ommaya reservoir placement. Such reasons may include, but will not be limited to, surgical anatomy, clinical evidence of immunosuppression, and/or elevated risk of wound infection due to diabetes, smoking history, morbid obesity, or any other concerns
Learning Effect of Computerized Balance Evaluation System

Thirty healthy individuals will be participants of the study. Participants will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, will be recorded. Postural sway and limits of stability parameters will evaluate with computerized balance evaluation system (BERTEC) for seven times .

Thirty healthy individuals will be participants of the study. Participants will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, will be recorded. Postural sway and limits of stability parameters will evaluate with computerized balance evaluation system (BERTEC) for seven times. Every seven evaluations will be repeated while participants in combination of the condition including eyes open, eyes closed, normal surface and perturbated surface.

Eligibility Criteria:
Inclusion Criteria:

* Want to participate

Exclusion Criteria:

* Have passive joint limitation at extremities
* Surgery at last 5 year
* Systemic problems such as neurologic disorders, rheumatoid disorders...
* Another orthopedic anomalies
One-year Cardiac Follow-up of Patients With COVID-19 Pneumonia

The primary objective of the study is to assess the cardiac status of COVID-19 pneumonia patients during 1 year after discharge

Although COVID-19 manifests in most cases with respiratory symptoms, cardiovascular abnormalities is common in hospitalized patients. Patients with cardiovascular risk factors or established disease appear to have a worse prognosis. Myocardial dysfunction could be a direct manifestation of COVID-19. The investigators hypothesize that subjects after COVID-19 pneumonia present myocardial and vascular remodeling during 1 year after discharge, even in the absence of prior cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

-Patients with documented COVID-19 pneumonia

Exclusion Criteria:

* Patients with cancer
* Impossible to follow up
ACRO Biocornea Clinical Trial in Taiwan

The goal of this clinical trial is to investigate the safety and clinical performance of ABCcolla Collagen Ophthalmic Matrix used for anterior lamellar keratoplasty in patients suffering from corneal ulcer.

Participants will undergo keratoplasty using the investigational product and be followed up for 24-week observation (total of 10 times).


Eligibility Criteria:
1. Inclusion criteria:

1. Male or female from 20 to 80 years old
2. Subject who has been diagnosed with corneal ulcer
3. The depth or the size of the ulcer increases or increased anterior chamber inflammation after treatment (clinic, hospitalization, or others...)
4. The corneal ulcer affects corneal stroma depth to 1/3 and infiltrates \>2 mm diameter, detected by OCT
5. Best corrected vision acuity \< 0.05
6. Subject who signs the informed consent form (ICF), and agrees to complete the treatment and follow-up

2. Exclusion criteria:

1. Accepted keratoplasty
2. Has a corneal perforation and expects to have vision
3. Has a severe dry eye
4. Experience s incomplete eyelid closure
5. H as liver function (ALT and AST) tests with the score as twofold or greater than that of the normal
6. Has renal function (Cr) levels greater than normal two folders
7. Has serum protein 10% low than normal
8. Has severe cardiovascular and cerebral vascular disease
9. Subject with uncontrolled diabetes
10. Subject with current malignancy
11. Known to be allergic to collagen
12. Has a systemic collagen connective tissue disease
13. Has a constitution prone to severe allergic reactions
14. Use s anticoagulants 5 days before studying keratoplasty
15. Use s injectable NSAID 3 days before studying keratoplasty
16. Cannot accept investigated material due to religious or cultural reason
17. Pregnant or breastfeeding women or childbearing-age women who plan to get pregnant
18. Participation in any drug or medical device clinical trial within 30 days prior to signing the informed consent form;
19. Not being considered suitable for this study by the investigator
Clinical Variables and Dyspnea and Fear of Movement in Chronic Obstructive Pulmonary Patients

Patients diagnosed with COPD who applied to the Pulmonary Diseases Department of Kırıkkale Yüksek İhtisas Hospital will be included in the study. The aim of our study: It is aimed to investigate the effect of fear of movement due to dyspnea on respiratory function, muscle strength, physical performance and balance in Chronic Obstructive Pulmonary Disease Patients.

At Kırıkkale Yüksek İhtisas Hospital, individuals with COPD who meet the inclusion and exclusion criteria and volunteer to participate in the study will be included. The number of patients to be included in our study will be determined by power analysis.

Sociodemographic information (Age, Gender, Body Mass Index, Smoking history) of the individuals included in the research will be recorded.

Regarding COPD symptoms:

Whether the cough is productive or non-productive, its frequency and period Presence of sputum, type, amount, color, presence of hemoptysis, Presence of chest pain, Presence of peripheral edema, You will be asked about the presence of resting and/or exertional dyspnea, orthopnea, paroxysmal nocturnal dyspnea (PND).

1. Respiratory Muscle Strength: It will be measured using an electronic, mobile, intraoral pressure measuring device.
2. Peripheral Muscle Strength Evaluation: Quadriceps muscle strength will be evaluated using a dynomometer.
3. Physical Performance: A 6-minute walk test will be used to determine the physical fitness levels of individuals.
4. Balance Level: Mini-BEST Test will be used to determine the balance level
5. Kinesiophobia Level Due to Dyspnea:

It will be evaluated with the Breathlessness Beliefs Questionnaire (BBQ). When the literature was examined, no study was found that examined all of these factors together in patients with COPD. Existing studies have shown that the effects of variables are different and it is stated that more studies are needed.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with COPD Be clinically stable for the last four weeks Not using antibiotics for the last four weeks being over 45 years old, Volunteering to participate in the study

Exclusion Criteria:

* Not being able to cooperate with the evaluations to be made, Having any physical disability that may affect walking and balance Having severe neuromuscular, musculoskeletal and rheumatological problems accompanying COPD
Chronic Pain After Shoulder Arthroplasty

Chronic pain is relatively common after different types of surgery. The investigators intend to study prevalence, characteristics and risk factors of chronic pain after shoulder arthroplasty, focusing on neuropathic pain characteristics, and risk factors such as preoperative pain, severe acute postoperative pain, age, gender, and pain elsewhere.


Eligibility Criteria:
Inclusion Criteria:

* Patients operated with any shoulder prosthesis between april 2011 and april 2012 in Denmark

Exclusion Criteria:

* Secondary prosthesis
* Bilateral prosthesis
* Age below 18
* Reoperated in the same shoulder after the prosthesis
Effect of Magnetic Current on Ulcer Healing

This study aims to evaluate the effectiveness of magnetic current in the management of DFUs as an alternative therapy on promoting the healing of chronic diabetic foot ulcers as compared with a control group.Twenty diabetic patients (n=40) affected with diabetic foot ulcer(s) will be recruited in the study and will be randomly allocated into two equal groups (20 patients in each group):

1- Group A: Pulsed electromagnetic field (PEMF) group. 2- Group B: Control group. Assessments of the healing of ulcers will be performed at the baseline, post-treatment evaluation (ie, after 14 treatment sessions), and 1-month follow-up.

:

This study aims to evaluate the effectiveness of magnetic current in the management of DFUs as an alternative therapy on promoting the healing of chronic diabetic foot ulcers as compared with a control group.Twenty diabetic patients (n=40) affected with diabetic foot ulcer(s) will be recruited in the study and will be randomly allocated into two equal groups (20 patients in each group):

1. Group A: Pulsed electromagnetic field (PEMF) group.
2. Group B: Control group. Assessments of the healing of ulcers will be performed at the baseline, post-treatment evaluation (ie, after 14 treatment sessions), and 1-month follow-up.

Outcome measures will include:

1. Wound closure.
2. Wound depth.
3. Microcirculation.

Eligibility Criteria:
Inclusion Criteria:

* 1. The ankle brachial index should fall between 0.9 and 1.2 to reassure that arterial insufficiency was not causing or contributing to the nonhealing wound.

  2. Patients diagnosed with diabetes with unsatisfactory healing of ulcer(s) in the preceding 4 weeks.

  3. Wagner grade 1 or 2 ulcers on the foot without exposure of bone, muscle, ligaments, or tendons.

Exclusion Criteria:

- 1- Ulcers secondary to non-diabetic etiology. 2- Poorly controlled diabetes. 3- Pregnancy. 4- Patients wearing a pacemaker or with malignancy or history of radiotherapy. 5- Patients who were taking medications that might affect their circulation or sensation and motor functioning and patients with any history of alcoholism were also excluded.

6- Patients who had clinical signs of infection or were taking antibiotics at the time of enrollment.
Risk Factors for Post ACL Reconstruction Pain

In 2006, approximately 130,000 arthroscopic anterior cruciate ligament reconstructions were performed in the United States, and the number is increasing each year. Despite being a minimally invasive procedure, pain is the most common postoperative problem after arthroscopic anterior cruciate ligament reconstruction associated with cost, postoperative opioid consumption, opioid-related side effects, quality of life, patient satisfaction, and delayed discharge. Over two-thirds of the patient receiving arthroscopic anterior cruciate ligament surgery have moderate to severe pain.

At present, multimodal analgesia is a successful mainstay treatment for arthroscopic anterior cruciate ligament surgery which range from opioid, paracetamol, non-steroidal anti-inflammatory agents (NSAIDs), local anesthetic agents, ketamine, corticosteroid, and cold compression therapy. Previous study showed femoral nerve block reduces pain score but also increases incidence of falling. Afterward, a study on adductor canal block showed equivalent postoperative analgesia while preserving quadriceps strength. Furthermore, a few studies were conducted to determine risk factors for postoperative pain after arthroscopic anterior cruciate ligament surgery, but results are contradictory. Previous research found risk factors for postoperative pain after arthroscopic anterior cruciate ligament surgery are female, young age, smoker, preoperative visual analog scale score ≥3, tourniquet time \> 50 minutes, and cartilage injury. In addition, evidence showed higher preoperative visual analog scale, and previous opioid use are associated with greater amount of opioid consumption. In contrary, some evidence showed no effect of age, sex, body mass index (BMI), tourniquet time, type of anesthesia on post postoperative pain after arthroscopic anterior cruciate ligament surgery.

Eligibility Criteria:
Patients undergoing primary unilateral arthroscopic anterior cruciate ligament reconstruction with or without unilateral cartilage/meniscus injury with or without other ligaments injury (posterior cruciate ligament/medial collateral ligament/lateral collateral ligament) Age ≥ 15 years
Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma

The aim of this study is the evaluate the feasibility and safety of chemotherapy induction treatment combined with cetuximab followed by chemoradiotherapy combined with cetuximab in the treatment of patients with non-metastatic esophageal cancer.

Patients with a locoregional carcinoma of the esophagus or gastro-esophageal junction have a low survival prognosis following surgical resection. In studies published to date no positive effect upon overall survival could be demonstrated for preoperative chemotherapy or chemoradiotherapy. However, patients with a complete remission following preoperative therapy show prolonged survival.

This study design is based upon decreasing primary tumour and preventing oder delaying micrometastases by means of a chemo induction therapy, increasing R0 resection rates and preventing local recurrence by means of preoperative chemoradiotherapy, increasing the radiosensitivity of tumour cells through treatment combination with cetuximab, surgical resection of the locoregional primary tumour or definitive radiochemotherapy in case the primary tumour is inoperable.

The aim of this study is therefore to evaluate the feasibility and safety of a 3-staged therapy approach including an EGFR antibody in the treatment of patients with potentially resectable esophageal cancer, as well as the evaluation of objective response rates to this preoperative therapy.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* histologically confirmed esophageal cancer (squamous cell carcinoma)
* measurable, non-metastatic disease (uT1-4)
* no previous cancer therapy (chemotherapy, radiotherapy or resection)
* life expectancy \> 3 months
* age \> 18 years
* WHO Status ≤ 2
* negative pregnancy test for women of child-bearing potential, and use of adequate contraception
* hematological status: neutrophiles ≥ 1,5x10E9/L, thrombocytes ≥ 100x10E9/L
* adequate renal function: serum creatinine ≤ 1,5 x ULN
* adequate liver function: alkaline phosphatase \< 2,5 x ULN, total bilirubin \< 1,5 x ULN

Exclusion Criteria:

* pregnant or nursing women
* women of child-bearing potential without adequate contraception
* concomitant anti-tumoral therapy except study mandated procedures
* cervical esophageal cancer or diagnosis of metastases
* participation in other clinical trials within the last 30 days
* history of malignant disease within the last 5 years
* peripheral neuropathy (NCI CTC ≥ grade 1)
* concurrent active and serious non-malignant diseases: uncontrolled heart insufficiency, angina pectoris, hypertension or arrhythmias, liver disease, significant neurological or psychiatric conditions
* active infections
Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects

The primary objective of this study is to characterize the steady state plasma

The primary objective of this study is to characterize the steady state plasma PK of rifaximin (550 mg BID) in subjects with severe hepatic impairment (MELD 19 to 25 and MELD \>25), as well as healthy subjects with normal hepatic function.

Eligibility Criteria:
Inclusion Criteria:

* Hepatically impaired subjects will be ≥18 years of age, have a diagnosis of liver cirrhosis and a MELD score of ≥19 at Screening. Note: At least 6 of the hepatically impaired subjects will have a MELD score of \>25.

Exclusion Criteria:

* Subject has known allergy to rifaximin, rifampin, or other rifamycins, excipients and/or vehicles used in the formulation, or any other clinically significant allergies.
* Subject has participated in an investigational drug or device study within 30 days prior to Day 1 (Baseline).
* Subject has any concurrent illness (other than liver cirrhosis), disability or circumstance that may affect the interpretation of clinical data, could cause noncompliance with treatment or visits or otherwise contraindicates participation in this study in the opinion of the investigator.
Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)

This is a clinical trial designed to assess the cardiovascular outcome of long-term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin in participants with type 2 diabetes mellitus (T2DM) having a history of cardiovascular (CV) disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.

Primary hypothesis A is that sitagliptin, when used as part of usual care, is non-inferior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint of Major Adverse Cardiovascular Event (MACE) plus. If hypothesis A is satisfied: hypothesis B is that sitagliptin, when used as part of usual care, is superior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Has T2DM
* Has HbA1c between 6.5% (48 mmol/mol) and 8.0% (64 mmol/mol) on stable dose(s) of antihyperglycemic agent(s), including insulin
* Has pre-existing cardiovascular disease

Exclusion Criteria:

* Has a history of type 1 diabetes mellitus or ketoacidosis.
* Is not able to take sitagliptin
Optimization Strategy of Carotid Artery Stenosis

The goal of this observational study is to learn about how to utilize multiple evaluation techniques in carotid artery stenosis patients for optimizing assessment of diagnosis and treatment strategy.

The main questions it aims to answer are:

* Identify best strategy that use multi-modal MRI and CT to assess patients' cerebral lesions and perfusion.
* Identify best strategy that use multi-modal MRI, PET-MRI ultrasound and CT to assess components and characters of patients' carotid plaques.

Participants will accept imaging examination before and after surgery. And doctors will collect basic characteristics, imaging results and biological samples of patients for analysis.


Eligibility Criteria:
Inclusion Criteria:

1. patients with severe stenosis (≥50%) or near-occlusion diagnosed by computed tomographic angiogram;
2. patients received carotid endarterectomy at Peking Union Medical College Hospital

Exclusion Criteria:

(1) Any contraindication to image examination; (3) refuse to sign the Informed consent.
Relationship Between Respiratory Muscle Strength, Balance, Trunk Control, Functional Capacity in Stroke Patients

The purpose of this study; To determine the relationship between respiratory muscle strength, balance, trunk control, functional capacity and motor functions in stroke patients and compare them with healthy individuals.

Stroke is one of the most important causes of chronic disability in adults. Hemiplegia and hemiparesis are common neurological conditions following stroke. Neurological findings associated with hemiplegia negatively affect posture, muscle tone, motor control, voluntary motor activation and trunk muscle synergy. The effect of stroke on the respiratory system depends on the structures affected by the lesion. The continuation of normal ventilation also depends on the influence of the neuromuscular system. The interference in trunk muscle synergies brings about loss of respiratory muscle function. Symptoms associated with respiratory problems, especially dyspnea, reduce exercise performance. On the other hand, motor control function losses; It disrupts the coordination of the respiratory muscles and changes the thickness of the diaphragm muscle, causing asymmetry between the affected and unaffected sides. Developing asymmetry can lead to progressive loss of strength in the respiratory muscles.

In the evaluation of stroke patients, measurements of the pulmonary system are rarely included. It is thought that the fact that patients do not have symptoms and/or diseases related to the pulmonary system before the development of stroke may explain the insufficient attention to respiratory evaluations. However, in a few studies, respiratory system evaluations were also made in stroke patients; It has been reported that there are effects related to pulmonary functions such as partial or total diaphragm on the affected side and weakening of intercostal and abdominal muscles.

Eligibility Criteria:
Inclusion Criteria:

* Stroke individuals over the age of 18

Exclusion Criteria:

* Patients with another neurological problem (Parkinson, Multiple sclerosis, etc.) that will affect functionality and balance other than stroke
* Patients with orthopedic problems (short limbs, spine and lower extremity surgery) with pulmonary disease
* Patients with cooperation and communication problems
Quality of Life in Managing Chronic Pain

This study evaluates the use of a health-related quality of life report based on the SPADE cluster (sleep disturbance, pain interference with activities, anxiety, depression, and low energy/fatigue) derived from the PROMIS-29 instrument in patients with chronic low back pain. Half of the participants will receive the report, while the other half will not.

The health-related quality of life report provides participants with an overall score on the SPADE cluster and scores on each of its five component scales. The recently released Federal Pain Research Strategy states that pain cannot be measured in isolation, but rather should be assessed in conjunction with other outcome measures in 'non-pain domains,' such as quality of life. It recognizes that pain may be affected by, and affect, such patient attributes as sleep, mood, cognition, function, and quality of life. Further, the report states that improvement in pain without concomitant improvement in other domains may not constitute a clinically meaningful outcome. This study aims to assess the utility of a health-related quality of life report in improving quality of life, back pain intensity, and back-related disability in participants with chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

Chronic Low Back Pain based on criteria established by the NIH Task Force on Research Standards for Chronic Low Back Pain AND SPADE Cluster Score ≥ 55

Exclusion Criteria:

Absence of Chronic Low Back Pain OR SPADE Cluster Score \< 55