cyrilzakka/clinical-trials huggingface dataset:
PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients with Glioblastoma

This phase III trial compares pH weighted chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI)-based surgical resections to standard of care surgical resections for the treatment of patients with glioblastoma. Standard of care therapy for glioblastoma is surgery to remove tumor tissue that enhances on standard MRI imaging, however, it has been shown that significant tumor burden exists in the region around the tumor tissue that does not enhance with standard MRI. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and tumor tissue. CEST MRI is a technique that uses differences in the tissue environment, like protein concentration or intracellular pH, to generate contrast differences. CEST MRI may identify tumor tissue that does not enhance with standard of care MRI. PH weighted CEST MRI based surgical resection may be more effective compared to standard of care surgical resection in treating patients with glioblastoma.

PRIMARY OBJECTIVE:

I. To assess the efficacy of potential of hydrogen (pH) sensitive MRI based resections of glioblastoma.

SECONDARY OBJECTIVE:

I. To find surgical and adjuvant therapies to treat infiltrating glioblastoma cells.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo surgical resection with standard intraoperative guidance using contrast-enhanced MRI. Patients also undergo post operative standard of care radiation therapy over 30 fractions and receive standard of care temozolomide orally (PO) for 6 weeks. Additionally, patients undergo MRI during follow up.

GROUP II: Patients undergo surgical resection with intraoperative guidance using CEST MRI. Patients also undergo post operative standard of care radiation therapy over 30 fractions and receive standard of care temozolomide PO for 6 weeks. Additionally, patients undergo MRI during follow up.

After completion of study treatment, patients are followed up at months 3, 6, 12, and 24.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Documentation of a newly diagnosed World Health Organization (WHO) grade IV glioblastoma as evidenced by clinical features and imaging data
* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion Criteria:

* Male or female \< 18 years of age
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
* Not medically cleared for surgery
* Previous treatment (any chemotherapy, molecular therapy, immunotherapy, or radiation therapy)
Relationship Between Potential Predictors and Mortality in COVID-19 Patients ın Turkey

In this study, the investigators planned to examine the laboratory characteristics of patients hospitalized with the diagnosis of Covid-19 and to investigate their relationship with mortality.

SARS-CoV-2 infection is effective in many countries and has caused pandemics. It is observed that it affects patients in a wide spectrum in terms of their clinical features worldwide. It is known that age, gender, and comorbidity play an important role in the course of the disease. Although mortality rates vary from country to country, there is no clear information due to the fact that the pandemic has not yet ended. In this study, the investigators planned to examine the laboratory characteristics of patients hospitalized with the diagnosis of Covid-19 and to investigate their relationship with mortality in Istanbul city which is the most affected by the pandemic in Turkey

Eligibility Criteria:
Inclusion Criteria:

* All patients who are 18 years of age and older, positive for SARS-CoV-2 PCR test and / or Covid-19 disease findings on CT will be included in the study.

Exclusion Criteria:

* Patients with negative SARS-CoV-2 PCR test, pneumonia on CT but not given Covid-19 treatment by not considering Covid-19 by their doctor will not be included.
A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC).


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 18 and 65 years of age, inclusive
* Healthy subjects and subjects with documented OIC on stable opioid regimen
* Willingness to stop all laxatives throughout the OIC screening and treatment period

Exclusion Criteria:

* Any clinically significant finding in healthy subjects
* Have participated in another clinical trial of an investigational drug 30 days prior to screening
* History of chronic constipation prior to opioid therapy in OIC subjects
* Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects
Study of the Natural History and Genotype-Phenotype Correlations of Hereditary Hemorrhagic Telangiectasia Patients

OBJECTIVES: I. Collect data regarding the natural history of hereditary hemorrhagic telangiectasia (HHT).

II. Establish genotype-phenotype correlations in HHT. III. Create a database of information for researchers throughout the world.

PROTOCOL OUTLINE: Patients complete a self-administered natural history questionnaire in a multiple choice format. Questionnaire is completed by a population consisting of males and females of all ages and ethnic backgrounds.

Data are collected and made available to all researchers.

Eligibility Criteria:
* Diagnosed hereditary hemorrhagic telangiectasia (Osler-Rendu-Weber disease) with recurrent epistaxis, telangiectases, and visceral vascular anomalies
Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25 and 50 mg) compared to placebo for the acute treatment of a single migraine attack.


Eligibility Criteria:
Inclusion Criteria:

* At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition, beta version
* Migraine onset before age 50
* History of migraines typically lasting between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom
* History of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the previous 3 months.

Exclusion Criteria:

* Difficulty distinguishing migraine headache from tension-type other headaches
* Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs \[NSAIDs\], triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per month in the previous 3 months
* Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine
* Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
* Required hospital treatment of a migraine attack 3 or more times in the previous 6 months
* Has a chronic non-headache pain condition requiring daily pain medication
* Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
* Has a history of any prior gastrointestinal conditions (eg, diarrhoea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded
* Has a history of hepatitis within previous 6 months.
Effect of Therapeutic Ultrasound Versus Anti-inflammatory Drugs in the Treatment of Trigger Finger

to determine the effect of US on pain intensity in TF patients 2) to determine the effect of US on number of daily finger triggering in TF patients.

Trigger finger (T.F) is a disorder characterized by snapping or locking of a finger. Painful popping or clicking sound is elicited by flexion and extension of the involved digit . It is a multifactorial disease. The common mechanism of triggering is that there is a mismatch of diameter between flexors tendons and the annular pulley (retinacular sheath) of the finger. Some studies found inflammatory cells as a part of the pathology, hence anti-inflammatory drugs are the first line of treatment .

Therapeutic ultrasound (US) is a form of acoustic energy which is often used in physical therapy. When US enters the body, it can affect the cells and tissues through thermal and non-thermal mechanisms. While a thermal mechanism has a direct heating effect which promotes anti-inflammatory response with increase blood flow, evidence indicates, however, that non thermal mechanisms are thought to play a primary role in producing a therapeutically significant biological effect (i.e. the stimulation of tissue regeneration) . So my question is in T.F patients does therapeutic ultrasound decrease pain more than anti-inflammatory drugs?

Eligibility Criteria:
Inclusion Criteria:

1 - patients will be included to this study if they are trigger finger patients ( clinically evaluated and refereed by orthopedist).

Exclusion Criteria:

1 - complete locked finger. 2-Ages below 18 y. 3-Patients with any other hand pathology .
Nutritional Counseling in Systemic Immunoglobulin Light-chain Amyloidosis

Poor nutritional status is common in patients with systemic immunoglobulin light-chain (AL) amyloidosis and has been associated with mortality and impaired quality of life (QoL). We investigated whether nutritional counseling is beneficial to the maintenance of nutritional status and QoL in AL outpatients.


Eligibility Criteria:
Inclusion Criteria:

* Treatment naïve patients with with systemic immunoglobulin light-chain amyloidosis
* Availability to planned measurements and to written informed consent

Exclusion Criteria:

* Age \< 18 years
* Indication to organ transplantation
* Indication to autologous stem cell transplantation
* Need to start or ongoing dialysis
* Ascites or massive edema
* Need to start or ongoing artificial nutrition
Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of single and multiple doses of ARO-HSD in healthy adult volunteers and in patients with NASH or suspected NASH.


Eligibility Criteria:
Inclusion Criteria:

* Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
* Willing to provide written informed consent and to comply with study requirements
* On a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study
* Normal electrocardiogram (ECG) at Screening
* No abnormal finding of clinical relevance (other than NASH, suspected NASH in patients) at Screening that could adversely impact subject safety during the study or adversely impact study results.

Exclusion Criteria:

* Clinically significant health concerns (other than NASH, suspected NASH in patients)
* Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B Virus (HBV), seropositive for Hepatitis C Virus (HCV)
* Uncontrolled hypertension
* Excessive use of alcohol within three months prior to Screening
* Use of illicit drugs within 1 year prior to Screening, or positive urine drug screen at Screening
* Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study

NOTE: additional inclusion/exclusion criteria may apply, per protocol

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Conformal Sphincter-Preservation Operation Versus InterSphincteric Resection on Anal Function in Low Rectal Cancer

In this clinical trial, the investigators compared anal function, genitourinary function, quality of life, perioperative safety, and oncological prognosis after CSPO for patients with low rectal cancer, using ISR as a control, to provide high-level evidence-based medical evidence for the choice of anorectal preservation surgical approaches for patients with low rectal cancer.

The CSPO surgical approach is a series of targeted improvements designed primarily on the basis of analyzing the causes of poor postoperative function of the ISR, while building on research on the ultrastructure of the pelvic floor anal canal. For these reasons, the investigators designed the present study to compare anal function, quality of life, perioperative safety, and oncologic prognosis after CSPO for patients with low rectal cancer, using ISR surgery as a control, and to provide high-level evidence-based medical evidence for the choice of anorectal preservation surgical modalities for patients with low rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-75 years;
2. Pathologically confirmed: moderately \& well-differentiated rectal cancer;
3. Low rectal cancer: lower edge of tumor ≦5cm from anal verge or ≦2cm from dentate line;
4. Tumor diameter: ≤3cm or \<1/3 bowel circumference;
5. Tumor infiltration depth: cT1-2, Bordeaux/Rullier classification: type II-III;
6. Locally progressive rectal cancer (cT1-4N0-2M0): significant tumor downstaging and downgrading after preoperative neoadjuvant therapy, meeting the above criteria;
7. ASA score: I-III and ECOG score: 0-1;
8. Undergo elective TME for colorectal or colorectal-anal canal anastomosis;
9. Normal preoperative anal function: Wexner score \<10, LARS score \<20;
10. Agree to participate in the clinical trial and sign an informed consent form.

Exclusion Criteria:

1. Combination of synchronous or metachronous (within 5 years) malignant tumors;
2. Combined distant metastasis of the tumor;
3. Combined intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery;
4. Combined psychiatric disorders that do not allow them to understand and participate in the study;
5. Combined systemic diseases that cannot tolerate surgery;
6. Women who are pregnant or breastfeeding;
7. Other reasons, judged by the investigator, for not being suitable for participation in this clinical trial.
Estimation of Intrinsic Positive End-Expiratory Pressure (PEEP) in Acute Respiratory Distress Syndrome (ARDS)

ARDS (Acute Respiratory Distress Syndrome) is a condition of severe inflammation and excess fluids in the lungs that impairs their function of oxygen uptake to the point of needing a ventilator (breathing machine) to help them obtain enough oxygen into the body. Because of the high amounts of gas that the ventilator has to give to these patients, high pressures may develop deep into the lungs and produce complications for the patient. However, physicians sometimes cannot recognize it because it requires special equipment to measure pressure deep in the lungs. The goal of this study is to determine if the amount of this pressure can be calculated using mathematical formulas and the routine numbers provided by ventilators. The study consists on making the conventional measurement of this deep pressure and at the same time calculate this same pressure from other measurements that the ventilator routinely provides, to see if the calculated value can replace the more complicated conventional measurement. The measurements will be done by:

1. placing a small device along the tubing connecting the patient to the ventilator;
2. giving medicines to relax the muscles (if the patient is not already receiving them); and
3. making the ventilator hold the patient's breath for a few seconds to take measurements.

This is repeated after the breathing rate of the ventilator is increased or decreased mildly. Risks related to the medicine to be used and the measuring maneuvers are rare but include transient narrowing of windpipes, transiently low heart rate, blood pressure or blood oxygen, and allergic reactions. This is not a treatment. The information obtained during the study will be shared with the treating doctors who may find it useful to make adjustments to the ventilator. The patient may receive no direct benefit from being in this study; however, the findings may contribute to better care for this kind of patients in the future.

Intrinsic PEEP (Positive-End Expiratory Pressure) was measured by end-expiratory occlusion method and estimated using formulas derived from measured expiratory flows and a postulated linear pressure-flow relationship during expiration in passive ARDS patients. Agreement between measured and estimated intrinsic PEEP was analyzed by Bland and Altman's method.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older with diagnosis of ARDS, as defined by the American- European Consensus Conference 4
* Receiving mechanical ventilation.
* Presence of autoPEEP by inspection of flow-time waveforms displayed by the mechanical ventilator.

Exclusion Criteria:

* Known or suspected diagnosis of COPD or airflow limitation.
* Next of kin not available to consent.
* Contraindication to receive a muscle relaxant when measurements may be inaccurate without its administration.
* Pregnancy
Predictors of Post-COVID-19 Clinical and Cognitive Consequences

The CDC describes Post-acute sequelae of SARS-COV-2 infection (PASC) for the wide range of physical and mental health consequences experienced by some patients. These sequelae may be present four or more weeks after SARS-COV-2 infection, including patients who had initial mild or asymptomatic acute infection. However, there is complete absence of data whether chronic sleep changes due to COVID-19 infection may influence these physical and mental health consequences. While fatigue is one of the common post-COVID conditions, there are no systematic examinations of sleep disturbances in COVID-19 survivors. This will be a pilot observational retrospective and prospective cohort study, to systematically assess if sleep disturbances and severity of sleep apnea comprise a modifiable facet of PASC as well as the short-term and longer-term effects of COVID-19 infection itself on sleep, cognitive function, exercise capacity and lung function.

This pilot study will systematically collect data to assess if sleep disturbances and severity of sleep apnea comprises a modifiable facet of PASC. This study will be the first step towards collecting preliminary data for a larger, longer-duration and more comprehensive study regarding the relationships between long-COVID and sleep disturbances which can inform future healthcare strategies and clinical decision-making. The study will also explore whether inflammatory biomarkers levels during acute COVID infection predict severity and duration of long-COVID or PASC and sleep fragmentation post-COVID.

Objectives: The overall goal of this project is to determine the associations between chronic post-COVID fatigue and sleep duration and sleep quality in patients after recovery from SARS-CoV-2 infection. The investigators have adopted the CDC definition for Post-COVID Conditions which persist for four or more weeks after SARS-CoV-2 infection and also is known as Post-Acute Sequelae of SARS-COV-2 infection (PASC).

Specific Aim 1: Determine associations between sleep duration and sleep quality on PASC-related fatigue symptoms, cognitive function, biomarker levels and vigilance.

Specific Aim 2. Determine if presence of obstructive sleep apnea (OSA) and level of PAP adherence during and prior to COVID-9 infection in patients with OSA predicts PASC- related fatigue, cognitive function and quality of life (QoL).

Exploratory Aim: Determine whether partial or full/booster vaccinations with COVID-19 mRNA vaccine vs. no vaccination has an impact on chronic post-COVID fatigue and sleep disturbances.

Eligibility Criteria:
Inclusion Criteria:

* All individuals 18 years or older, with prior history of COVID-19 infection diagnosis
* Both genders including all racial and ethnic groups
* Patients with OSA (apnea hypopnea index of 5/hour on polysomnography) with history of COVID-19 infection will be eligible with prior history of COVID-19 infection and without COVID-19 for Aim 2

Exclusion Criteria:

* Inability to give consent
* Active suicidal symptoms
* Children of all ages
* Pregnant women
Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation Lead

The purpose of this study is to determine the safety and efficacy of the implant of a ICD lead of defibrillation in the septum of the right ventricle

The rate of success at implant and the positive clinical outcomes for the patients implanted with a lead of defibrillation at the septal site would make it possible to recommend this site as a "new standard" for implant of the defibrillation lead in the RV for ICD.

Eligibility Criteria:
Inclusion Criteria:

* ICD indication according to current Guidelines

Exclusion Criteria:

* Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular rhythm, pacemaker dependency
Grape Polyphenol Kinetics in Humans

The objectives of this study are the following: 1) to confirm that the administration of grape juice, resveratrol, and grape seed polyphenol extract results in a similar plasma and urinary metabolic profile in aged humans compared to rats, 2) to confirm that a combined administration of grape juice, resveratrol, and grape seed polyphenol extract result in a similar plasma and urinary metabolic profile in adults with tendencies toward metabolic syndrome compared to non-obese healthy humans, and 3) to identify the anti-inflammatory effects of the combined administration of grape juice, resveratrol, and grape seed polyphenol extract.


Eligibility Criteria:
Inclusion Criteria:

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Exclusion Criteria:

* Age \<60 years at beginning of study
* Fasting glucose \> 126 mg/dl
* Blood pressure \> 160/100
* Fasting total blood cholesterol \> 280 mg/dl
* Fasting triglycerides \> 300 mg/dl
* Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
* Presence of type 2 diabetes requiring the use of oral antidiabetic agents or insulin
* History of bariatric or certain other surgeries related to weight control
* Smokers or other tobacco users (during 6 months prior to the start of the study)
* Consumption of more than 3 servings of tea, wine, or grape juice per day
* Use of supplements containing grape extracts or products
* Use of antibiotics during the intervention or for 3 weeks prior to the intervention period
* History of eating disorders, dietary patterns, or supplement use which will interfere with the goal of the intervention
* Volunteers who have lost 10% of body weight within the last 4 months
* Volunteers who are unable or unwilling to give informed consent or communicate with study staff
* Volunteers who self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol