cyrilzakka/clinical-trials huggingface dataset:
Positron Emission Tomography for the Diagnosis of Immune Checkpoint Inhibitor-Related Myocarditis

This study evaluates positron emission tomography for the diagnosis of immune checkpoint inhibitor-related myocarditis. Immune checkpoint inhibitors have shown promising results in various malignancies however, several immune related adverse events have been described of which myocarditis carries the highest reported mortality. Diagnostic procedures, such as positron emission tomography, help find and diagnose myocarditis and provide functional or disease activity information as opposed to the largely structural/anatomic information.

PRIMARY OBJECTIVE:

I. To prospectively evaluate the sensitivity, specificity, positive predictive value, and negative predictive value of fludeoxyglucose F-18 (18 fluorodeoxyglucose) positive emission tomography computed tomography (PET CT) for the diagnosis of immune checkpoint inhibitor (ICI) related myocarditis.

SECONDARY OBJECTIVES:

I. To explore the clinical presentation and disease course of ICI-related myocarditis which include presenting symptoms (chest pain, dyspnea, fatigue), time from ICI initiation to symptom onset, hospitalization duration, time to peak troponin levels, and peak troponin levels.

II. To evaluate biomarkers, including peak troponin, peak no probnp, admission troponin level, and admission nt probnp level, and imaging modalities of ICI-related myocarditis which include sensitivity, specificity, positive predictive value, and negative predictive value of cardiac magnetic resonance imaging (MRI).

III. To determine the response to various treatments of ICI-related myocarditis which include time to resolution of symptoms, hospitalization duration, and peak troponin value stratified by treatment.

IV. To observe the long-term outcomes, including late decline in left ventricular ejection fraction (LVEF) to \< 50%, and survival after ICI related myocarditis, and monitoring of ICI-related myocarditis.

V. To assess differences in PET CT imaging results between patients on steroid therapy versus not on steroid therapy for myocarditis.

OUTLINE:

Patients receive a low carbohydrate and high fat diet for 48-72 hours. Patients receive 18 fluorodeoxyglucose (FDG) then undergo PET CT.

Eligibility Criteria:
Inclusion Criteria:

* Patients of age \>= 18 years
* Patients must be able to understand and be willing to sign a written informed consent document. Surrogate decision-makers of patients will be allowed to consent patients for this study
* Patients must be receiving or have a history of receiving any ICI therapy in monotherapy or combination therapy
* Patients must have a suspicion of ICI-related myocarditis either by clinical presentation, biomarkers, or other diagnostic modalities

Exclusion Criteria:

* Pregnant or lactating patients will be excluded
Aromatherapy With Lavender Essential Oil in Patients With Multiple Sclerosis

The study was conducted with patients with Multiple Sclerosis (MS) who applied to the Neurology Outpatient Clinic of Atatürk University Research Hospital, met the inclusion criteria and agreed to participate in the study. At the time of the study, 96 patients were interviewed. 26 patients were excluded from the study because they did not meet the research criteria, and 70 multiple sclerosis patients constituted the research sample. 1 person from the control group and 1 person from the experimental group did not continue to work and 1 person developed a lavender allergy. The study was completed with 63 multiple sclerosis patients.

Patient Description, Fatigue Severity Scale and Pittsburgh Sleep Quality Index were applied to the patients at the first interview. Lavender oil in 15 ml opaque dark colored bottles closed with metal caps to prevent volatility to the venture group (Oleum Lavandula Angustifolia/ HACCP, Halal Food, ISO 22000:2005, ISO 14001:2015, ISO 9001:2015, ISO 45001:2018) certificates) and 40 2×2 cotton pads were delivered. Studies have reported that the most common use of aromatherapy is three drops, three days a week. Patients were asked to apply lavender oil 30 minutes before going to bed. Deep breathing increases the concentration of aromatic substances in the body. The time it takes for essential oils to be absorbed into the blood circulatory system is about 30 minutes for complete absorption by the body.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older,
* Having been diagnosed with MS at least 1 year ago,
* Verbal communication (hearing and speaking)
* No problem with sense of smell,
* Not having an allergy to lavender,
* Having fatigue and sleep problems for the last 3 months,
* Not applying an intervention that helps to fall asleep,
* Pittsburgh Sleep Quality Index ≥5,
* Fatigue Severity Scale ≥4.

Exclusion Criteria:

* Having had an attack in the last month,
* Having DSM-IV Axis I disorder,
* Pregnancy,
* Using sleeping pills,
* Breastfeeding
Questionnaires in Assessing Attitudes About Legalization of Marijuana Use in Participants With Cancer

This trial studies attitudes about legalization of marijuana use in participants with cancer. Questionnaires may help doctors to learn about and compare the attitudes that patients in non-legalized and legalized states have towards the legalization of medical marijuana.

PRIMARY OBJECTIVES:

I. To compare the proportion of cancer patients' who have a positive attitude about legalizing marijuana for medical purposes between those in a legalized versus (vs.) a non-legalized state.

SECONDARY OBJECTIVES:

I. To evaluate the association of cancer patients' belief in the usefulness of medical marijuana in their state of residency (Texas versus Arizona).

II. To examine the association of demographic, physical and psychosocial characteristics of patients and their perception of medical marijuana.

III. To examine the preference of patients for treatment of pain, anxiety and depression between medical marijuana vs. opioids, anti-anxiety and anti-depressant medications.

IV. To examine the association of media to perception of use of medical marijuana.

V. To evaluate the association of cancer patients' attitude about legalizing marijuana for medical purposes vs. recreational purposes.

VI. To examine the association of patients who have used marijuana for certain medical conditions/symptoms and their belief of how it has affected that condition/symptom.

VII. To compare demographic, physical and psychosocial characteristics of patients who have used marijuana for medical purposes.

VIII. To compare demographic, physical and psychosocial characteristics of patients who have used marijuana for non-medical purposes. IX. To compare demographic, physical and psychosocial characteristics of patients who believe marijuana is useful for medical reasons.

OUTLINE:

Participants complete 5 questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Patients (inpatient or outpatient) seen by the Palliative Care team at Banner MD Anderson or UT MD Anderson
* Patients able to speak and read English
* Patients enrolled in each site must be a resident of the state where that site is located (e.g. if a patient is enrolled at UT MD Anderson Cancer Center \[MDACC\], they should be resident of the state of Texas)
* Patients should have a cancer diagnosis

Exclusion Criteria:

* Patients who are not able to speak or read English
* Altered mental status as determined by the interviewer based on the ability to understand the nature of the study and consent process
Historical Case Record Survey of Visual Acuity Data From Patients With Leber's Hereditary Optic Neuropathy (LHON)

The purpose of this survey is to collect visual acuity data from patients with LHON in order to establish the clinical course (natural history) and visual acuity outcomes in patients with a genetically confirmed diagnosis of LHON. In addition, this survey will generate data that will serve as comparator for the open-label study SNT-IV-006.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 12 years
2. the onset of symptoms is dated after 1999 and is well documented (at least month of onset of symptoms is known for each eye)
3. at least two VA assessments are available within 5 years of onset of symptoms and prior to idebenone use
4. have a genetic diagnosis for LHON for one of the following mitochondrial DNA (mtDNA) mutations: G11778A, G3460A, T14484C

Exclusion Criteria:

1. any participation in an interventional clinical trial after the onset of symptoms
2. any other cause of visual impairment (e.g. glaucoma, diabetic retinopathy, AIDS related visual impairment, cataract, macular degeneration, etc.) or any active ocular disorder (uveitis, infections, inflammatory retinal disease, thyroid eye disease, etc.) during the data collection period
Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section

This retrospective study aims to evaluate the fate of children born by cesarean section under spinal anesthesia with or without norepinephrine as vasopressor support for anesthesia. The main objective is to compare the initial Apgar score. The records of patients who received norepinephrine are compared to those without norepinephrine. To limit the biases of this type of study, the investigators will apply a propensity score that will include as a variable: age, ASA score, comorbidity, urgency. The patients analysed correspond to the period 2016-2017.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* Spinal Anesthesia for Cesarean Section

Exclusion Criteria:

* sub epidural cesarean section
* contraindication to spinal anesthesia (allergy, severe heart disease, coagulopathy)
A Study of Glucose Control in Participants With Type 1 and Type 2 Diabetes

The main purpose of this study is to determine whether combining meal, glucose and insulin data in a web-based system will improve management of type 1 (T1D) and type 2 diabetes (T2D). No study drug will be given. The study will last about 18 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with type 1 or type 2 diabetes for \>3 years by clinical diagnosis who use basal insulin, in addition to at least one injection of meal time insulin per day
* Insulin pen use for at least 3 months
* Current use of or willingness to use Dexcom G6 at least 6 out of 7 days per week
* A1c 6.5-9.5%

Exclusion Criteria:

* Currently using any form of insulin pump, including hybrid closed-loop system (e.g., Medtronic 670G)
* Individuals requiring single insulin boluses of \>40 units
* Individuals planning to follow a specific diet plan for weight loss
* Inability to consume regular, consistent meals
* Individuals who have had severe hypoglycemia with seizure or coma within the past 6 months
* Individuals who have been hospitalized for diabetic ketoacidosis (DKA) within the past 6 months
A Safety, Efficacy and Pharmacokinetic Study of BTCT4465A (Mosunetuzumab) as a Single Agent and Combined With Atezolizumab in Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

This is a Phase 1/2 dose-escalation study of BTCT4465A (Mosunetuzumab) administered as a single agent and in combination with atezolizumab in participants with relapsed or refractory B-cell NHL and CLL. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.


Eligibility Criteria:
Key Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* B-cell hematologic malignancies expected to express the cluster of differentiation 20 (CD20) antigen who have relapsed after or failed to respond to at least one prior treatment regimen and for whom there is no available therapy expected to improve survival
* Adequate hepatic, hematologic, and renal function

Key Exclusion Criteria:

* Pregnant or lactating women
* Monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, chemotherapy, or other investigational anti-cancer agent within 4 weeks prior to study drug
* Treatment with radiotherapy within 2 weeks prior to the first BTCT4465A (Mosunetuzumab) administration
* Systemic immunosuppressive medication within 2 weeks prior to study drug
* Autologous stem cell transplantation (SCT) within 100 days prior to study drug, or any prior allogeneic SCT or solid organ transplantation
* Autoimmune disease with the exception of controlled/treated hypothyroidism, disease-related immune thrombocytopenic purpura, or hemolytic anemia
* History of central nervous system (CNS) lymphoma or other CNS disease
* Significant cardiovascular or pulmonary disease
* Hepatitis B or C or human immunodeficiency virus (HIV)
* Receipt of a live attenuated vaccine within 4 weeks prior to study drug
* Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days before first BTCT4465A (Mosunetuzumab) administration
Borderline of CME/D3 Dissection for Local Advanced Right-sided Colon Cancer

The study was conducted on patients with advanced right-sided colon cancer, and the clinical pathological and prognostic data of the patients were compared between the two groups of patients who were randomly divided into those undergoing SMV and SMA left resection, with the aim of resolving the controversy over the left resection boundary of CME/D3 lymph node dissection through this study, and to clarify whether SMA left resection is superior to SMV left resection.


Eligibility Criteria:
Inclusion Criteria:

* right side colon cancer(The primary lesion is located in the ileocecal region, ascending colon, hepatic flexure of colon, or proximal transverse colon)
* T3-4 and/or N1-2M0
* Colonoscopy and pathological biopsy confirmed colon adenocarcinoma

Exclusion Criteria:

* T1-2N0M0
* Cannot undergo curative resection
* Simultaneous multiple primary colorectal cancer or other diseases requiring segmental resection
* Distant metastasis
* Tumor invades surrounding organs, requiring joint organ resection
* Emergency surgery is required for complications such as intestinal obstruction, perforation, and bleeding
* Patients who have received neoadjuvant therapy before surgery
* Pregnant or lactating women
* Patients who are not suitable or unable to tolerate surgery
Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension

This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill combination in patients with uncomplicated essential hypertension not adequately controlled (MSDBP ≥90 mmHg and \<110 mmHg) on valsartan 160 mg alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients must give written informed consent
* Male or female ages 18 or older and less than 86 years
* Diagnosed as having essential diastolic hypertension, as follows:

  * Visit 2/Single-blind run-in entry, all participants MUST have a MSDBP ≥ 95 mmHg and \< 100 mmHg
  * At Visit 3/Core double-blind treatment period entry, all patients MUST have a MSDBP \>=90 mmHg and \<110 mmHg

Exclusion Criteria:

* Severe hypertension
* Evidence of secondary form of hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma or polycystic kidney disease )
* Malignant hypertension
* Administration of any agent indicated for the treatment of hypertension after Visit 1
* Known moderate or malignant retinopathy.
* Known or suspected contraindications, including history of allergy or hypersensitivity to Angiotensin II Receptor Blockers (ARBs), Calcium Channel Blockers (CCBs), or to drugs with similar chemical structures
* History of hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack, myocardial infarction or all types of revascularization, angina pectoris of any type, including unstable angina
* History of heart failure Grade II-IV according to New York Heart Association (NYHA) classification
* Second of third degree heart block regardless of the use of a pacemaker, concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia

Other protocol-defined inclusion/exclusion criteria may apply
Types of Upper Limb and Hand in Patients With Cerebral Palsy

Cerebral palsy (CP) has been defined as "a group of permanent disorders of the development of movement and posture causing activity limitation(s) that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain".

Investigators previously developed two classification systems, one for the upper limb and one for the hand, based on 100 films of patients with cerebral palsy. Separate classifications were developed following an initial study in which investigators found no correlations between upper limb and hand patterns, meaning that specific upper limb patterns are not always associated with specific hand patterns. Thumb patterns were not included in these classifications since robust classifications already exist, moreover thumb patterns are independent from hand patterns.

The aim is to evaluate the inter- and intra-rater reliability of two previously developed classifications of upper limb and hand patterns.


Eligibility Criteria:
Inclusion Criteria:

* cerebral palsy

Exclusion Criteria:

* none
Swiss Atrial Fibrillation Pulmonary Vein Isolation Registry

Registry of patients with atrial fibrillation undergoing catheter-based ablation of atrial fibrillation (pulmonary vein isolation) to determine long-term success rates of catheter-based ablation of atrial fibrillation (pulmonary vein isolation) and to evaluate factors associated with long-term success of catheter-based ablation of atrial fibrillation (pulmonary vein isolation).


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing catheter-based ablation of atrial fibrillation (pulmonary vein isolation)

Exclusion Criteria:

* Patients not able or willing to participate in this study
Pilot Study of Continuing Aspirin Versus Switching to Clopidogrel After Stroke or Transient Ischemic Attack

Pilot study of continuing aspirin versus switching to clopidogrel after stroke or transient ischemic attack.

Pilot study of continuing aspirin versus switching to clopidogrel after stroke or transient ischemic attack.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older.
* Stroke or transient ischemic attack (TIA) while taking aspirin within one week of consent.
* Women of child-bearing potential will be included only if there is a negative pregnancy test and they agree to birth control during the treatment period.

Exclusion Criteria:

* Any medical indication for a specific antiplatelet agent (aspirin, clopidogrel, ticlopidine, aggrenox), or an indication for a combination of antiplatelet agents.
* Any medical indication for anticoagulation, except subcutaneous heparin for deep vein thrombosis prophylaxis.
* Allergy to aspirin or clopidogrel.
Endovascular Procedures With Computer Assistance in the Chronic Occlusive Arthritis of the Lower Limbs on the Femoro-popliteal Stage.

Pilot study to assess the feasibility of creation of a bone and arterial panorama by 2D-2D registration technique during endovascular femoro-popliteal procedures with a mobile C-arm X-ray system using EndoNaut® software.

The aim of this study is to show that it is possible to give a complete image of the area to be operated by the surgeon by creating a complete bone and arterial panorama of the femoro-popliteal axis with 2D-2D registration techniques. This study should have a clinical impact for the patient and caregiver. With this technique, we expect a reduction in the irradiation of the patient and the caregivers, a decrease in the volume of injected contrast product and a decrease in operating time.

Eligibility Criteria:
Inclusion Criteria:

* Patients with peripheral arterial disease of the lower limbs, all clinical stages, lesions of the femoro-popliteal stage and candidates for endovascular treatment of these lesions.
* Major patients
* Patients not opposed to their participation in the study

Exclusion Criteria:

* Patients requiring conventional surgical revascularization.
* Patient under legal protection (guardianship, safeguard of justice).
* Pregnant or lactating women
Low Intensity Extracorporeal Shock Wave Therapy (Li-ESWT) for Erectile Dysfunction

Low-intensity extracorporeal shock wave therapy (Li-ESWT) has shown promise as a novel treatment for erectile dysfunction (ED), though the the mechanism of action and optimal protocol for administration has not been well-established. The aim of this study is to assess for subjective and objective improvements in erectile function following treatment with Li-ESWT.

Eligible patients will be enrolled as outlined below. Prior to initiation of Li-ESWT treatments, patients will complete validated questionnaires to assess erectile function. In addition, patients will undergo induction of artificial erection in clinic with assessment of penile blood flow using penile Doppler. Intracavernosal pressure measurements will be obtained. A corporal aspirate will be drawn and examined for levels of neuronal nitric oxide synthase, endothelial nitric oxide synthase, brain-derived neurotropic factor and vascular endothelial growth factor. Patients will then receive twice-weekly Li-ESWT treatments of 0.2mJ/mm\^2 over 3 treatment sites along the dorsal penile shaft, 1500 shocks per treatment (500 shocks per treatment site), for a total of 3000 shocks per week, for 6 weeks of treatment (totally 18,000 shocks). Following Li-ESWT treatments, patients will complete the same validated questionnaires, penile Doppler studies, corporal aspirates and measurement of intracavernosal pressures immediately following the final Li-ESWT treatment, 4-6 weeks following completion of treatment, and again at 3 and 6 months following completion of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male veterans between 40 and 80 years of age
* Known or suspected vasculogenic erectile dysfunction based on clinical history
* In an active sexual relationship with a minimum of 2 sexual attempts per month for at least one month prior to enrollment
* Suffering from ED for at least 6 months
* International Index of Erectile Function - EF domain score between 17-25, Erection Hardness Score score ≥ 1
* Testosterone level between 300-1000ng/dL within one month prior to enrollment
* Hgb A1c ≤ 8% within one month prior to enrollment
* Able to consent to study participation

Exclusion Criteria:

* Erectile dysfunction due to radical prostatectomy, prior pelvic surgery, or radiation therapy to the pelvis within 12 months prior to enrollment.
* Men with known neurogenic or psychogenic ED
* Anatomic malformations of the penis including Peyronie's disease
* Testosterone \< 300ng/dL or \>1000ng/dL
* Hgb A1c \> 8%
* International Normalized Ratio \> 2.5, and men on any blood thinners other than 81mg aspirin

Participants will be required to discontinue all erectogenic medications for 1 months prior to initiation of treatment and will not be permitted to use erectogenic medications for the duration of the treatment study.
Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)

This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.


Eligibility Criteria:
Inclusion Criteria:

* Participants with chronic asthma who actively smoke at least 0.5 to no more than 2 packs of cigarettes a day

Exclusion Criteria:

* Participant cannot have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.