cyrilzakka/clinical-trials huggingface dataset:
[18F]F-DOPA Imaging in Patients with Autonomic Failure

Alpha-synucleinopathies refer to age-related neurodegenerative and dementing disorders, characterized by the accumulation of alpha-synuclein in neurons and/or glia. The anatomical location of alpha-synuclein inclusions (Lewy Bodies) and the pattern of progressive neuronal death (e.g. caudal to rostral brainstem) give rise to distinct neurological phenotypes, including Parkinson's disease (PD), Multiple System Atrophy (MSA), Dementia with Lewy Bodies (DLB). Common to these disorders are the involvement of the central and peripheral autonomic nervous system, where Pure Autonomic Failure (PAF) is thought (a) to be restricted to the peripheral autonomic system, and (b) a clinical risk factor for the development of a central synucleinopathy, and (c) an ideal model to assess biomarkers that predict phenoconversion to PD, MSA, or DLB. Such biomarkers would aid in clinical trial inclusion criteria to ensure assessments of disease- modifying strategies to, delay, or halt, the neurodegenerative process. One of these biomarkers may be related to the neurotransmitter dopamine (DA) and related changes in the substantia nigra (SN) and brainstem. \[18F\]F-DOPA is a radiolabeled substrate for aromatic amino acid decarboxylase (AAADC), an enzyme involved in the production of dopamine. Use of this radiolabeled substrate in positron emission tomography (PET) may provide insight to changes in monoamine production and how they relate to specific phenoconversions in PAF patients. Overall, this study aims to identify changes in dopamine production in key regions including the SN, locus coeruleus, and brainstem to distinguish between patients with PD, MSA, and DLB, which may provide vital information to predict conversion from peripheral to central nervous system disease.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis if pure autonomic failure
2. Patients with autonomic failure and possible PD, MSA, or DLB
3. Healthy adults aged 18 and above
4. Clinical exam confirming clinical designation

Exclusion Criteria:

* Subjects who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.), because such devices may be displaced or malfunction.
* Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced.
* Subjects who have cerebral aneurysm clips.
* Subjects who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes).
* Subjects who are pregnant, because the effects of high field MRI on fetuses are not yet known.
* Minors (younger than 18 years)

Also excluded are subjects incapable of giving informed written consent:

* Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher.
* Subjects who have limited mental ability to give informed consent, mentally retarded, altered mental status, mental disability, confusion, or psychiatric disorders.
* Prisoners
The Impact of Meditation on Anxiety and Post-Operative Pain in Pediatric Patients Undergoing Urological Surgery

1. The aim of this study is to assess anxiety in pediatric patients preoperatively, perioperatively, and postoperatively and whether meditation reduces anxiety in the days before, during, and after the surgery.
2. The second aim of this study is to see if longitudinal meditation is associated with decreased postoperative pain by examining whether the group prescribed meditation has reduced pain medication intake, measured by the frequency of liquid analgesic medicine intake.

Up to 70% of pediatric patients experience preoperative and perioperative anxiety. The anxiety level of their parents or guardians also affects the anxiety levels of pediatric patients themselves. Anxiety levels often peak during the time of anesthesia induction, suggesting the unfamiliar physical environment plays a role in increasing anxiety levels. Pediatric anxiety often manifests in various ways such as strong emotions, physical noncompliance, and regression. Pre-operative anxiety has been shown to increase the risk of cardiovascular events during the operation, increase difficulty gaining access to intubation, and increase anesthetic requirements. The effects of pre-operative anxiety do not end once the operation is complete. Rather, there have been suggestions that preoperative anxiety has a positive association with postoperative pain and prolonged hospital stay. Thirteen percent of pediatric surgical patients have postoperative pain that interferes with their daily activities or sleep patterns. In addition, 25-63% of pediatric patients who undergo urological surgeries experience moderate to severe pain on postoperative day 1 and the pain decreases but persists for 2 days on average. Therefore, it is worthwhile to explore noninvasive and adaptable methods to decrease preoperative anxiety among the patient and their guardians'.

Mindfulness is turning one's awareness of past and future events inward to focus on the present time. The practice provides an opportunity for people to reflect on their current internal conditions in a space and time that is not pressured, which can improve their ability to healthily and effectively respond to those conditions. One such study proposed that trait mindfulness and perceived anxiety have an inverse relationship. While another showed those with higher levels of trait mindfulness have increased resistance to stress and psychological flexibility. By embracing the entire spectrum of emotions one may encounter in the present or about a future event, people may be able to feel relief instead of increased anxiety or worry.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-18
* Pediatric urology patients at Children's Healthcare of Georgia in Augusta, GA; scheduled for any urological surgery
* Otherwise, healthy patients
* Must record any medical history and medications
* Must record prior attempts of meditation therapy
* Children must provide assent

Exclusion Criteria:

* History of any prior surgeries
* History of anxiety or anxiety-related disorders
* Diagnosis of developmental delay
Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty

Feasibility, acceptability, and preliminary efficacy of combined transcranial direct current stimulation and mindfulness for pain after total knee arthroplasty

The project is to assess the preliminary feasibility, acceptability, and efficacy of self-administered preoperative tDCS+MBI in older adults (50+) undergoing TKR. And to determine the effects of 5, 20-minute preoperative self-administered tDCS sessions combined with brief MBI on analgesic medication consumption following TKR.

Eligibility Criteria:
Inclusion Criteria:

* elective unilateral knee total replacement
* mentally capable of reading, giving consent and following instructions
* being able to answer questions in English
* not pregnant

Exclusion Criteria:

* history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
* systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia
* alcohol/substance abuse
* current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists
* hospitalization within the preceding year for psychiatric illness
* no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision
A Family-Based Approach To Reduce Smoking in Vietnamese Men

The goals of the study are to develop smoking cessation intervention using lay health worker (LHW) outreach and family involvement targeting Vietnamese Americans ages 18 and above in Santa Clara County, CA, to evaluate efficacy of the proposed intervention. The study is a two-arm randomized controlled trial targeting a total of 18 lay health workers (LHW) and 108 dyads of a smoker and a family member from the same household. The hypotheses are:

H. At 6-month post initiation of the intervention, Vietnamese male daily smokers who receive the proposed -Quit Smoking For a Healthy Family Intervention, a Family-based Intervention (FI), will be more likely to achieve biochemically verified 7-day point prevalence of smoking abstinence when compared to those receiving an attention control intervention (CI).

H2. At 6-month, FI participants we be more likely to report making at least one 24-hour quit attempt than those in CI.

H3. At 6-month, FI participants will be more likely to report using a recommended evidence-based smoking cessation resource (quitline, FDA-approved smoking cessation medications, advice from health professionals) than those in CI


Eligibility Criteria:
Inclusion Criteria:

* self-identified as Vietnamese, Vietnamese-American, or Vietnamese-Chinese;
* Vietnamese speaking;
* reside in the Santa Clara County, California
* plan to stay in the area (Santa Clara County, California) for the next 6 months
* for the smoker participants, they must be male and have smoked at least 1 cigarette daily in the past 7 days.
* for family member participants, the participant must live in the same household as the smoker participant to form a dyad.
* provide a valid contact telephone number for pre- and post-intervention assessments.

Exclusion Criteria:

- For smoker participants, currently engaging in assisted smoking cessation efforts
Validation of the Accuracy of a Novel POCT Dry Blood Gas Analyzer in Acute Care Settings

The goal of this observational study is to validate the performance of the novel POCT dry blood gas analyzer EG-i30, against the currently widely used traditional wet blood gas analyzer, Radiometer ABL90, in acute care settings. The main questions it aims to answer are:

1. How consistent are the results between EG-i30 and ABL90 in acute care settings, including outliers, correlation, linearity, and bias?
2. Whether EG-i30 can be considered a suitable alternative to ABL90 in acute care settings.

Participants will be patients in the emergency department who will undergo simultaneous testing with EG-i30 and ABL90 during their emergency care to assess the performance of EG-i30.

This observational study aims to compare the performance of two blood gas analyzers, the EG-i30 dry blood gas analyzer and the ABL90 wet blood gas analyzer, in an emergency department (ED) or emergency intensive care unit (ICU) setting. The study will evaluate the consistency, correlation, and bias between the two analyzers for various blood gas and biochemical parameters, such as Potential of hydrogen (pH), Partial pressure of oxygen (PaO2), Partial pressure of carbon dioxide (PaCO2), Sodium (Na+), Potassium (K+), Chloride (Cl-), Ionized calcium (iCa2+), Lactate (Lac), Glucose (Glu), and Hematocrit (Hct). The study design is observational, with no intervention or treatment assigned to the participants. The comparison will be made using residual blood samples collected as part of routine care, following standard clinical procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to undergo arterial blood gas analysis in the emergency department (ED) or emergency intensive care unit (EICU).

Exclusion Criteria:

* Patients with a confirmed history of infectious diseases such as hepatitis B, syphilis, HIV/AIDS, etc.
* Patients whose residual blood samples are not tested within the specified time frame after collection.
* Other patients deemed ineligible by the investigator (e.g., samples with contamination or other factors affecting sample quality).
Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015)

The purpose of this study is to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP) therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female and is at least 18 years old and less than 65 years old
* Patient must have a diagnosis of Obstructive Sleep Apnea/Hypopnea Syndrome
* Patient has been using nCPAP treatment for at least 2 months prior to Visit 1
* Patient is willing to stay at a sleep laboratory for 4 full days and nights for observation and assessments
* Patient is willing to refrain from napping for the duration of the study

Exclusion Criteria:

* Patient is pregnant, breastfeeding, or planning to become pregnant within the next 4 months
* Patient is or has participated in a study with an investigational compound or device within 30 days of signing the informed consent
* Patient has had asthma-related visit to the emergency room or hospitalization within 6 months of Visit 1
* Patient has donated or received blood products within 8 weeks of signing consent or is planning on doing either for the duration of the study
NES Gel-1, To Evaluate Nestorone Gel in Combination With Testosterone Gel

The purpose of this study is to determine the usefulness of two transdermal gels to be used in the future development for a male contraceptive.

The success of hormonal male contraception depends on the near complete suppression of spermatogenesis without producing any untoward effects on libido or other androgen-dependent functions or any other adverse events. The treatment with androgen alone has geen shown to be highly effective in Asian men but less effective in non-Asian men in clinical trials. To increase the efficacy of androgen alone treatment on spermatogenesis, combined regimens of a progestin and an androgen have shown promising results. The steady-state delivery of a progestin and an androgen by transdermal gel application would be a user-friendly delivery method as compared to injectable or implant approaches. Nestorone (NES) is a synthetic progestin that does not have any androgenic and estrogenic activity and is not expected to have some of the undesirable side effects of other drugs.

We propose to evaluate whether NES gel alone or in combination with T gel applied transdermally will result in more effective suppression of gonadotropins than NES or T gel applied alone in healthy men. Fifty healthy male subjects, age 18-50 will be enrolled at each center (2 sites).

Eligibility Criteria:
Inclusion Criteria:

* Healthy men
* Aged 18-50 years
* With normal clinical chemistry, serum levels of testosterone, PSA, gonadotropins within normal limits, and sperm concentration greater than 20 million/mL
* Subject or his partner willing to use a recognized effective method of contraception

Exclusion Criteria:

* Men not living in area of clinics
* Clinically significant abnormal findings at screening
* Elevated PSA greater than 4
* Partners who are pregnant
* Abnormal laboratory values, liver or kidney dysfunction
* Sperm counts below 20 million/mL.
* Use of androgens or body building substances within 6 months of enrollment,
* Blood pressure greater than 140/90, history of hypertension, including hypertension controlled with treatment
* History of primary testicular disease or disorder of the hypothalamic-pituitary axis
* Hypersensitivity of progestins
* History of venous thromboembolism
* Benign or malignant liver tumors
* Active liver disease, history of reproductive dysfunction including vasectomy or infertility
* History of active or chronic cardiac, renal, hepatic or prostatic disease
* Diabetes mellitus or morbid obesity (body weight greater than 120% of ideal body weight)
* Known or suspected alcoholism or drug abuse
* Known dermatitis or severe skin disorder

Men desiring fertility within 6 months or participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine will be advised of the relative and temporary hazards that participating in this study may have for their fertility or sporting status.
Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction

Acute myocardial infarction is characterized by an intense inflammatory response.

The degree of the response influences clinical outcome, with 'more' inflammation promoting heart failure. In this study we plan to determine whether treatment with plasma derived alpha-1 antitrypsin will quench the inflammatory response in patients with acute ST-segment elevation myocardial infarction (STEMI).


Eligibility Criteria:
Inclusion Criteria:

* Acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours and ECG evidence of ST segment elevation (\>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new
* Planned or completed coronary angiogram for potential intervention
* Age\>21

Exclusion Criteria:

* Inability to give informed consent
* Hemodynamic instability as defined as need for inotropic or vasoactive agents, or need for mechanical support devices (including intra-aortic balloon pump)
* Pregnancy
* Preexisting congestive heart failure (American Heart Association/American College of Cardiology class C-D, New York Heart Association III-IV)
* Preexisting severe left ventricular dysfunction (EF\<20%)
* Preexisting severe valvular heart disease
* Known active infections (acute or chronic)
* Recent (\<14 days) or active use of anti-inflammatory drugs (not including NSAIDs or corticosteroids used for IV dye allergy only)
* Known chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)
* Known active malignancy of any type, or prior diagnosis in the past 10 years
* Anticipated need for cardiac or major surgery
* Known active cancer (or prior diagnosis of cancer within the past 10 years)
* Known Immunoglobulin A (IgA) deficiency
Surgical Pleth Index (SPI) Guided Analgesia During Sevoflurane Anesthesia

The aim of the present study was to compare SPI guided analgesia with standard clinical practise during general anesthesia using a balanced setting of sevoflurane and sufentanil anesthesia. It was to be tested whether SPI guided analgesia leads to more cardiovascular stability, less use of analgetics and shorter recovery from anesthesia.

General anesthesia can be considered as a combination of hypnosis, antinociception, and immobility. The monitoring of hypnosis and immobility has been established in clinical practise, however for the evaluation of antinociception a valid monitoring is missing.

The Surgical Pleth Index (SPI; former named Surgical Stress Index-SSI) is a multivariate index derived non invasively from finger plethysmographic signal. It has been demonstrated to correlate with surgical stress intensity. In the setting of total intravenous anesthesia TIVA our group could show beneficial effects of SPI guided analgesia in terms of remifentanil consumption, hemodynamic stability and incidence of unwanted events.

Therefore, we wanted examine whether these beneficial effects of SPI guided anesthesia can be transferred to a setting of balanced anesthesia using a volatile anesthetic sevoflurane and the opioid sufentanil.

The following hypotheses have been made:

1. SPI guided analgesia will result in less sufentanil consumption
2. SPI guided analgesia will result in more hemodynamic stability and faster recovery of the patient after anesthesia, and less opioid use in post operative period

Eligibility Criteria:
Inclusion Criteria:

* age between 18 - 65 years
* ASA physical status I or II
* elective surgery under general anesthesia of 1-2 hours
* written informed consent

Exclusion Criteria:

* pregnancy
* history of cardiac arrhythmia
* presence of any neuromuscular opr neurologic disease
* use of CNS active medication or alcohol/illicit drug abuse -
Pharmacology of Immunosuppressants Following Heart Transplantation

The ongoing success of transplantation is largely due to the development of drugs to stop the patient's body from rejecting the new organ. In addition to steroids, two main types of drug are used to suppress the immune system following heart transplantation: calcineurin inhibitors (Ciclosporin-A or Tacrolimus) and mycophenolate. However, different patients respond in different ways to these drugs, with the same dose leading to different levels of the drug in the blood. This varies due to genetic and other factors such as age, kidney function and the use of other drugs. Therefore, the levels of immunosuppressive drugs in the blood are routinely measured and the dose adjusted accordingly. However, some patients still experience episodes of rejection despite apparently acceptable levels. In this study, the investigators will measure levels of the drugs (in the blood, in a type of white blood cell called T-cells and in the heart muscle) and the effectiveness of the drugs on T-cells. The investigators will compare these levels with patient genetic factors and the amount of rejection measured on heart biopsies. This will enable us to better understand how the blood and tissue levels of these drugs change with genetic and other factors in order to optimise immunosuppressive therapy and further improve outcomes from heart transplantation.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing heart transplantation

Exclusion Criteria:

* Decline participation
* Previous transplantation of another organ and already receiving chronic immunosuppressive therapy
Linguistically-Tailored Mobile Intervention for the Improvement of Follow Up for Abnormal Pap Test Results

This clinical trial evaluates the feasibility of a linguistically-tailored mobile intervention, called CervixChat in improving the follow-up of patients with abnormal Papanicolaou (pap) test results. A text messaging program, such as CervixChat may support patients who need a colposcopy.

PRIMARY OBJECTIVE:

I. To evaluate the feasibility of CervixChat intervention in a mix method design, through participants consent rate and the study completion rate.

SECONDARY OBJECTIVE:

I. To evaluate the acceptability of CervixChat intervention using a validated Likert-scale participant satisfaction questionnaire, as well as participant's interview data.

EXPLORATORY OBJECTIVE:

I. To evaluate the preliminary impact of CervixChat intervention, by comparing the colposcopy appointment adherence rate in the study cohort against a 1:1 matched control sample selected based on matching age, race and ethnicity, from participants at Jefferson Obstetrics and Gynecology (Ob-Gyn) department scheduled for a colposcopy in 2019.

OUTLINE:

Patients receive text messages for 1-2 months before scheduled appointment. Patients also complete a survey at baseline and after standard of care colposcopy and an interview after standard of care colposcopy.

After completion of study, patients are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

* Female, aged 21 to 65 years of age
* Had received an abnormal Pap smear result
* Scheduled colposcopy
* Able to communicate with ease in English or Spanish
* Have a cell phone with text (TXT) ability
* Competent to give consent

Exclusion Criteria:

* Are pregnant at the time of recruitment
* Display current evidence of positive invasive carcinoma of the cervix