cyrilzakka/clinical-trials huggingface dataset:
Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors

This early phase I trial studies how well hyperpolarized carbon C 13 pyruvate magnetic resonance imaging works in detecting lactate and bicarbonate in participants with central nervous system tumors. Hyperpolarized carbon C 13 pyruvate magnetic resonance imaging may be used to measure the metabolic state of malignant brain tumors.

PRIMARY OBJECTIVES:

I. To assess the safety of intravenous (IV) injection of hyperpolarized carbon C 13 pyruvate (hyperpolarized \[1-13C\] pyruvate) for magnetic resonance imaging (MRI).

II. To assess the frequency and sensitivity with which lactate and bicarbonate signals can be detected in malignant brain tumors after IV injection of hyperpolarized \[1-13C\] pyruvate.

OUTLINE:

Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo magnetic resonance spectroscopic imaging (MRSI) over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).

After completion of study, participants are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a known diagnosis of central nervous system (CNS) malignancy, including metastases, with known enhancement on magnetic resonance (MR) who are otherwise eligible to undergo MRI
* Glomerular filtration rate (GFR) \> 30 ml/min
* No allergy to gadolinium
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Refusal to have an IV placed for injection
* Acute major illness (e.g., unstable angina, etc.) or other condition that makes participation unsafe, per the investigator?s judgement
* Total bilirubin \> 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2.5 x ULN
* Gamma-glutamyltransferase (GGT) \> 2.5 x ULN
* Pregnant or breast-feeding
* Cardiovascular risk, including:

  * Poorly controlled hypertension, defined as either systolic \> 170 or diastolic \> 110
  * Congestive heart failure
  * Myocardial infarction within the past year
  * QT prolongation, defined as pretreatment corrected QT interval (QTc) \> 440 msec in males or \> 460 msec in females
YKL-40 and Complications in Type 2 Diabetes

In this study, the investigators plan to establish the relationship between plasma concentration of YKL-40 with various vascular complications in the patients of type 2 diabetes.

It is well recognized now that diabetes mellitus is a systemic vasculopathy and causes various micro- and macrovascular complications. Vascular damage and endothelium dysfunction in diabetes mellitus involve a chronic inflammatory process via a complicated mechanism.

YKL-40 is a 40 kD lectin molecule. It is secreted by various cells, including macrophages, vascular smooth muscle cells and giant cells, and the level of YKL-40 is found elevated in both acute (eg. infection) and chronic (eg. rheumatoid arthritis, systemic lupus erythematosus or cirrhosis of the liver) inflammatory processes. The plasma concentration of YKL-40 is elevated in the patients of type 2 diabetes mellitus compared with non-diabetic controls, and is associated with insulin resistance, fasting plasma glucose and plasma IL-6 concentrations. Furthermore, the concentration of YKL-40 is elevated and is associated with the severity of albuminuria in the patients of type 1 diabetes.

The objective of this study is to establish the relationship between plasma concentration of YKL-40 with various vascular complications in the patients of type 2 diabetes, and to evaluate its potential as a biomarker for the vascular diabetic complications in patients with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Clear consciousness
* type 2 diabetic patient
A Study of RO4995819 in Healthy Elderly Volunteers

This study will evaluate the safety, tolerability and pharmacokinetics of RO4995819 in healthy elderly volunteers. Volunteers will be randomized to receive once daily doses of RO4995819 or matching placebo. The anticipated time on study treatment is 14 days.


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy volunteer, 65-85 years of age
* Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive and a total body weight \>50 kg (110 lbs)
* Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria:

* Any history or suspicion of drug or alcohol abuse
* Clinically significant or unstable cardiovascular or bronchopulmonary diseases, or any type of cancer
* History of liver disease
* Significant past or present neurological disorder
* History of psychiatric disorders
* Participation in an investigational drug or device study within 12 weeks prior to screening
* Donation of blood over 500 mL within three months prior to screening
Comparison Between Bupivacaine-Dexmedetomidine Versus Bupivacaine-Dexamethasone in Pericapsular Nerve Group (PENG) Block

The aim of this work is to compare the effectiveness of bupivacaine- dexmedetomidine mixture versus bupivacaine-dexamethasone mixture in PENG Block as Post-operative Analgesia in Hip surgeries


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years.
2. Sex: Both sexes.
3. American Society of Anaesthesiologists (ASA) Physical Status Class I and II.
4. Scheduled for hip surgeries under spinal anaesthesia.

Exclusion Criteria:

1. Declining to give written informed consent.
2. History of allergy to the medications used in the study.
3. Contraindications to regional anesthesia (including patient refusal, coagulopathy and local infection).
4. Psychiatric disorder.
5. American Society of Anesthesiologists (ASA) Physical Status Class III and IV.
POA Prospective Repository

This repository is a multi-center, outcomes study designed to collect data on the demographics, presentation, diagnosis, treatment, cost of associated care, quality of life, and outcomes of subjects utilizing Caris Molecular Intelligence® (CMI) Services for the treatment of cancer.

This repository is a multi-center, outcomes study designed to collect data on the demographics, presentation, diagnosis, treatment, cost of associated care, quality of life, and outcomes of subjects utilizing Caris Molecular Intelligence® (CMI) Services for the treatment of cancer. Prior to enrolling a subject, the subject's physician will have made the independent decision whether or not to utilize the drug associations provided by CMI and made clinical treatment choices as appropriate. Thus, data captured and reported provides a "real world" perspective on diagnosis, treatment, cost, and outcomes.

Prospective data will be obtained only from consented patients or patients who have died or have been lost to follow-up. Lost to follow-up is defined as a subject who has not returned for continued care or evaluation (e.g., disability, relocation or unresponsiveness). Site coordinators are required attempt to contact the subject 3 times before deeming them lost to follow up. Data collection and the protection of privacy are discussed in the Methods section below.

In addition to treatment and response data, initial diagnosis and staging results will be recorded as well as any recurrence information. As the investigators are capturing the subject's cancer treatment as a whole, results from pertinent cancer-related tests performed by outside entities for eligible subjects will need to be collected by the site coordinator and maintained at the site accordingly for reporting and monitoring purposes.

Eligibility Criteria:
Inclusion Criteria:

* Subject's age must be greater than or equal to 18 years and must have received CMI testing

Exclusion Criteria:

* Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoners-patients shall not be approached for participation.
Comparison of Low-intensity Laser and ESWT in Carpal Tunnel Syndrome

Carpal tunnel syndrome is the most common neuropathy of the median nerve. Conservative methods are used in mild and moderate CTS in the treatment. In this study, we aimed to compare the effectiveness of low-intensity laser and ESWT treatments in patients with mild and moderate carpal tunnel syndrome diagnosed with EMG.

Carpal tunnel syndrome is the most common neuropathy of the median nerve. Its incidence increases between the ages of 40-60. Its prevalence is 4-5%, and incidence is 2.7%. It is more common in women than men. The vast majority of cases are idiopathic.The first symptoms usually start at night. The patient wakes up with a feeling of swelling without any visible swelling and symptoms such as burning, numbness and tingling in the median nerve region.In severe cases, hand weakness and thenar atrophy develop. Provocative tests such as phalen, reverse phalen, tinel, carpal compression test, tourniquet test can be used in the examination.The diagnosis of carpal tunnel syndrome is made by nerve conduction studies and electromyography. Conservative methods are used in mild and moderate CTS in the treatment. Surgical methods are recommended in severe cases and in cases unresponsive to conservative treatment.One of the methods used in the treatment is Laser (Light Amplification by Stimulated Emission of Radiation).There are low and high intensity laser applications according to their energy densities. The basic mechanism of action is tissue stimulation. ESWT (Extracorporeal Shock Wave Therapy), another treatment method, shows therapeutic properties by focusing high-amplitude sound waves on the desired area of the body. Apart from the mechanical effect, it also has an effect at the cellular level.In previous studies, both low-intensity laser and ESWT application were found to be effective in the treatment of carpal tunnel syndrome. However, as far as we know, there is no study comparing the efficacy of low-intensity laser therapy and ESWT therapy in carpal tunnel syndrome. In this study, we aimed to compare the effectiveness of low-intensity laser and ESWT treatments in patients with mild and moderate carpal tunnel syndrome diagnosed with EMG.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* Having a clinic compatible with carpal tunnel syndrome,
* Patients with electrophysiological data compatible with mild and moderate carpal tunnel syndrome

Exclusion Criteria:

* Cervical radiculopathy , polyneuropathy , brachial plexopathy , thoracic outlet syndrome
* Regular use of oral steroids or nsaii in the last 3 months
* Systemic disease (DM, hypothyroidism, RA, gout, acromegaly, CKD, dialysis)
* Severe carpal tunnel syndrome (kts)
APOLLO(Aromatase Inhibitor Patient cOmpLiance Program With qoL Questionaire)

To describe patients' compliance of taking Aromatase Inhibitor as an adjuvant treatment in the postmenopausal, early breast cancer as seen under current practice


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Patients with early breast cancer who are scheduled to receive first-line adjuvant endocrine therapy with aromatase inhibitor under the routine clinical practice
* Histologically or cytologically proven to be HR+(ER or PR +)
* Postmenopausal woman, defined as a woman fulfilling any of the following criteria(by the local guideline):

  * Age \>= 50 years
  * Age \< 50 years with amenorrhoea \> 12 months and an intact uterus
  * FSH levels within postmenopausal range (over 30-40 IU/ml), or
  * Having undergone a bilateral oophorectomy.
  * No other concomitant endocrine therapy such as estrogen therapy or selective estrogen receptor modulators

Exclusion Criteria:

* Recurrence of breast cancer
* Known hypersensitivity to aromatase inhibitor or to any of the excipients
* Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial protocol
* Previous inclusion in the present study
* Participation in a clinical study during the last 30 days
Sleep and Resistance Exercise

Introduction: Despite the awareness of the importance of sleep in our lives, especially for athletes, the consequences of poor rest on sports performance are not well understood. Furthermore, the interaction between complete and partial sleep deprivation over one night and sleeping the usual hours for each person remains unclear.

Objectives: The aim of this study is to evaluate the effects of sleep deprivation on the production of strength, power, and muscular endurance according to sex (men vs. women) and type of exercise (bench press vs. squat). Additionally, the study will analyze the effects of sleep deprivation on perceived fatigue, mood, dietary habits, electrical activity, resting metabolic rate (RMR), and maximal fat oxidation (MFO).


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 35 years.
* Body Mass Index (BMI) \&lt; 25 kg/m².
* Resistance-trained individuals (more than 2 years of structured training).
* Healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from exercising.
* Participants must be able to perform the tests described in the following section.

Exclusion Criteria:

* History of neuromuscular diseases, heart disease, or conditions that may affect liver or muscle metabolism.
* Use of drugs, stimulants, or sports supplements that could interfere with the dietary supplement used in the study.
* Sedentary habits (less than 150 minutes/week of moderate exercise).
* Having undergone prolonged periods of physical inactivity in the 6 months prior to the study.
* Engaging in strenuous exercise within 48 hours prior to the tests.
* Failure to replicate the same food intake on both experimental days.
* Consumption of caffeine or any other stimulant the day before the tests.
A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in combination with a topical corticosteroids in Japanese participants with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Have chronic Atopic Dermatitis (AD) that has been present for ≥1 year before the screening.
* Have moderate-to-severe AD, including all of the following:

  * EASI score ≥16 at the baseline
  * IGA score ≥3 (scale of 0 to 4) at the baseline
  * AD involvement on ≥10% of Body Surface Area (BSA) at the baseline
* Have a documented history provided by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening as defined by at least 1 of the following:

  * Inability to achieve good disease control, defined as mild disease or better (for example, IGA ≤2) after use of at least a medium-potency topical corticosteroids (TCS) for at least 4 weeks, or for the maximum duration recommended by the product prescribing information (for example, 14 days for super-potent TCS), whichever is shorter. Topical corticosteroids may be used with or without Topical calcineurin inhibitors (TCI) and/or topical Janus Kinase (JAK) inhibitors.
  * Participants who failed systemic therapies intended to treat AD within 6 months preceding screening, such as cyclosporine, methotrexate (MTX), azathioprine, and mycophenolate mofetil (MMF), will also be considered as surrogates for having inadequate response to topical therapy.
* Body weight ≥40 kilogram (kg)

Exclusion Criteria:

* Have a history of anaphylaxis
* Have uncontrolled chronic disease that might require bursts of oral corticosteroids for example, comorbid severe uncontrolled asthma within the past 12 months requiring systemic corticosteroid treatment or hospitalization for \>24 hours at baseline.
* Have an active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline or superficial skin infections within 1 week before the baseline.
* Evidence of acute or chronic hepatitis or known liver cirrhosis.
* Have a history of pneumocystis pneumonia (PCP) or a positive beta-D-glucan test at screening and a confirmed diagnosis of PCP.
* Have a history of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
* Have presence of skin comorbidities (for example, sclerosis, psoriasis, or lupus erythematosus) that may interfere with study assessments.
* Have presence of significant uncontrolled neuropsychiatric disorder.
* Have been exposed to a live vaccine within 12 weeks prior to baseline or are expected to need/receive a live vaccine during the study or up to 125 days after the last dose of study drug.
Evaluation of the Quantra QStat System in Obstetric Patients

This pilot study will assess the performance of the Quantra System with the QStat Cartridge versus standard of care coagulation testing in bleeding pregnant women at delivery.

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies including fibrinolytic defects. These patients include the tobstetric hemorrhage population. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system.

This single-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to standard of care coagulation testing in bleeding pregnant women at delivery.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \> 18 years.
* Subject is pregnant or at least 24 h postpartum
* Subject is fluent in English language.
* Subject is experiencing significant bleeding resulting in activation of the stage 2 OB hemorrhage protocol as defined by blood loss ≥1500ml at delivery or within the first 24 hours after delivery, and/or is hemodynamically unstable and/or is experiencing increased abnormal bleeding not responsive to OB stage 1 hemorrhage resuscitation.
* Subject or subject's legally authorized representative (LAR) is willing to provide informed consent, either prospectively or by deferred consent.

Exclusion Criteria:

* Subject is incarcerated at the time of the study.
* Subject is currently enrolled in a distinct study that might confound the results of the proposed study
* Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks
Bio Equivalence Study of Torrent Pharmaceutical Ltd's Rosuvastatin Calcium Tablets Under Fasting Condition.

Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium Tablets 40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA. Dosing periods of studies were separated by a washout period of 7 days.

An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Rosuvastatin Calcium Tablets containing Rosuvastatin Calcium 40 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Crestor® 40 mg Tablets containing Rosuvastatin Calcium 40 mg (Reference , AstraZeneca Pharmaceuticals LP, USA) in Healthy Human Volunteers Under Fasting Condition.

Eligibility Criteria:
Inclusion Criteria:

* Sex: male
* Age: 18-45 years
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day.

Exclusion Criteria:

* The volunteers were excluded from the study based on the following criteria:
* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute. Oral temperature less than 95°P or more than 98.6°P.
* Respiratory rate less than 12/minute or more than 20/minute
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse
* Positive breath alcohol test
* Recent history of kidney or liver dysfunction.
* History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of heart failure.
* HIV, HCV, HBsAg positive volunteers.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder.
* Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
An Evaluation of Motivational Interviewing to Increase Compliance in a Probation Setting

The purpose of this study is to examine the effects of Motivational Interviewing (MI) on probationer progress over a 6-month period, using probation officers as the MI providers.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be on felony probation.
2. Participants must be English speaking.
3. Participants must be classified as medium or high-risk.
4. Participants must be placed on a non-specialized caseload.
5. Participants must be at least 18 years of age.

Exclusion Criteria:

1. Does not speak English.
2. Is less than 18 years old.
3. Is not on felony probation.
4. Is not classified as medium or high-risk.
5. Is placed on a specialized caseload.