cyrilzakka/clinical-trials huggingface dataset:
Postoperative Hyperthyroidism

The purpose of this study is to evaluate the frequency and the clinical course of postoperative hyperthyroidism following surgery of tertiary hyperparathyroidism (THP) and to determine the diagnostic value of thyroglobulin in this setting.


Eligibility Criteria:
Inclusion Criteria:

* patients with tertiary hyperparathyroidism undergoing surgery for this reason
* dialysis treatment

Exclusion Criteria:

* patients wish
The Effect of Listening to Music and Stress Ball Application on Patients' Anxiety Level and Hemodynamic Parameters During PCI

In this study, it was aimed to determine the effects of listening to music and applying a stress ball on patients' anxiety level and hemodynamic parameters during percutaneous coronary intervention (PCI).

Percutaneous coronary intervention causes patients to experience anxiety and change their hemodynamic parameters. In this study, it was aimed to determine the effects of listening to music and applying a stress ball on patients' anxiety level and hemodynamic parameters during percutaneous coronary intervention.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older,
* Literate,
* Able to communicate verbally,
* Turkish speaking,
* No hearing or vision loss,
* No sensory or motor deficits in the hand or arm,
* Percutaneous coronary intervention will be applied,
* intervention from the femoral artery,
* Voluntarily participated in the research,
* Patients signing the informed consent form will be included.

Exclusion Criteria:

* Under the age of 18,
* Not signing the informed consent form,
* Illiterate,
* Unable to speak Turkish,
* Unable to communicate verbally
* Those who have a neurological or psychiatric disease that prevents communication,
* Hearing and sight impaired,
* Those who have had a mastectomy
* Those with arterio-venous fistula
* Percutaneous coronary intervention has been performed in the last 2 years,
* Restricted special groups (pregnant women, criminal convicts, etc.),
* Emergency cases where communication cannot be established,
* Those with equipment problems such as monitors and cuffs,
* Those who will be given sedatives during the procedure,
* Those who will be taking cardiovascular system medications other than routine practices during the procedure,
* Those who will be given oxygen during the procedure,
* Patients who are treated from a different artery other than the femoral artery will not be accepted.

Criteria for exclusion from follow-up:

* Those who want to quit working,
* Those who give up listening to music,
* Those who give up using the stress ball,
* Those who were given cardiovascular system medications other than routine practices during the procedure,
* Those who underwent intervention from a different artery instead of the femoral artery,
* Those who do not want to wear headphones because they cannot hear the doctor's questions
* Those whose second measurements could not be taken because they were quickly removed from the interventional room,
* Those who underwent carotid artery angiography in addition to coronary artery,
* Those who give incorrect PCI history,
* Those who cannot listen to music or whose music is interrupted due to connection problems,
* Those whose intervention cannot be performed at the planned time due to urgent patient arrival,
Cross-Sectional Study to Define and Validate "Doctor/Pharmacy Shopping" as Outcomes Suggestive of Abuse and/or Addiction

The purpose of this study is to formulate definitions of doctor/pharmacy shopping and evaluate its association with abuse/addiction

Based on a review of the literature, the Food and Drug Administration (FDA) concluded that more data are needed regarding the serious risks of misuse, abuse, addiction, overdose, and death associated with the long-term use of extended release/long acting (ER/LA) opioid analgesics. Thus, the FDA is requiring that ER/LA opioid analgesic drug sponsors conduct post-marketing studies to assess these risks. The four observational post-marketing requirement (PMR) studies are labeled Study #2065-1, Study #2065-2, Study #2065-3, and Study #2065-4.

The objective of PMR Study #2065-4 is to define and validate "doctor/pharmacy shopping" as outcomes suggestive of misuse, abuse and/or addiction.

Study #2065-4 consists of three sub-studies, Study 4A, Study 4B, and Study 4C. In the current study (#2065 sub-study, Study 4A), the IMS® LRx database, a longitudinal pharmacy database that captures both third-party and self-pay transactions, will be linked to the PharMetrics Plus™ database, which contains provider, facility and pharmacy claims. From these databases, patients with shopping behavior will be identified and evaluated against an algorithm for abuse/addiction that will be developed and validated in PMR Study #2065-3B. Study #2065-3B will review the literature for health information suggestive of abuse/addiction in medical charts and medical claims. Then, through iterative processes that involve experts reviewing claims profiles and medical charts, text searches of medical records using natural language processing and supervised machine learning will identify and create a compilation of codes and health information with the best specificity and sensitivity to identify patients with opioid abuse/addiction. The compilation of codes and health information will be used to develop the algorithm that Study 4A will apply to define abuse/addiction. Restricting the validation of shopping behavior to only patients with diagnoses related to abuse would ignore the population with undiagnosed abuse. By supplementing ICD-9 codes with other information available on claims (e.g., addiction treatments, emergency visits) to define abuse/addiction, the measurement bias will be decreased and the estimates of the association of shopping behavior with abuse/addiction will be more valid. Categories of doctor shopping will be derived from the population distributions of the multiple variables analyzed for opioid users. The 4 categories will range from no shopping behavior (lowest level) to extensive shopping behavior (most extreme). The specifics of how the categories will be defined will be driven by the data.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Minimum of two dispensings for IR or ER/LA opioids or two or more diuretic dispensings

Exclusion Criteria:

N/A
A Study of RO6811135 in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Metformin

This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety and tolerability of RO6811135 in Type 2 diabetic patients treated with a stable dose of metformin.


Eligibility Criteria:
Inclusion Criteria:

* Adults between the age of 18 and 65
* Have been diagnosed with diabetes for at least 3 months and treated with a stable dose of metformin for at least 8 weeks
* Hemoglobin A1c between 7.2 and 10.5%
* Fasting plasma glucose less than 250 mg/dL
* C-peptide greater than 1.5 ng/mL
* Body mass index (BMI) between 27 and 44

Exclusion Criteria:

* Pregnant or lactating women
* Type 1 diabetes
* Had undergone weight loss surgery or weight loss procedure involving the gastrointestinal tract, such as gastric bypass, gastric stapling, or gastric banding
* Uncontrolled hypertension or other significant cardiovascular disease as determined by investigator
* Significant kidney or liver disease as determined by the investigator
Intraoperative OCT Guidance of Intraocular Surgery II

The overall five-year goals of the project are to develop novel technology to provide actionable new information through provision of live volumetric imaging during surgery, improving surgical practice and outcomes. The investigators believe this technology will enable novel ophthalmic and other microsurgeries not possible due to current limitations in surgical visualization.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy controls: Healthy eyes without known disease: refractive error including myopia and non-significant cataract is allowed. For selected testing pseudophakia is allowed.
2. Surgeons as research subjects: Adult (≥18 years old)
3. Surgical patients (vitreoretinal surgery): Patients undergoing examination under anesthesia or surgery for vitreoretinal diseases
4. Surgical patients (anterior segment surgery-glaucoma, ocular surface or strabismus requiring extraocular muscle surgery): Include both adults and children. Patient undergoing primary, elective minimally invasive glaucoma surgery, ocular surface surgery, or strabismus surgery.

Exclusion Criteria:

1. Healthy controls: Any ocular disease that restricts the ability to perform OCT scanning. Conflict of interest with investigators/study personnel, e.g. a student in the lab of an investigator.
2. Surgeons as research subjects: no specific exclusion criteria.
3. Surgical patients (vitreoretinal surgery): Neonates (\< 4 weeks of age) and patients with any ocular disease that restricts the ability to perform OCT scanning.
4. Surgical patients (anterior segment surgery-corneal and cataract diseases): Pediatric patients: The cornea and cataract surgery studies will be restricted to adults (≥ 18 years). Children do not have cataract surgery typically by residents and therefore would not fit our study design. Similarly pediatric corneal transplants are very rare.
Beer for Endurance Exercise Recovery

Athletes who are participating in the Keys100 Ultramarathon event in Key West, FL are eligible, based on inclusion criteria, to participate in this research study that is seeking to determine whether supplementation of beer (alcohol) immediately following a long distance ultramarathon race can positively impact exercise-associated hyponatremia \[EAH\].


Eligibility Criteria:
Inclusion Criteria:

* Completed informed consent
* Ability to read and speak English language
* Age 21 years or older
* Not considered a vulnerable population, such as pregnant (by history) or cognitively impaired.
* Able to tolerate needle exposure for blood draw
* Willing to drink alcoholic or nonalcoholic beer
* Willing not to eat or drink other than the study fluid during 1 hour study period
* Participating in 100 mile or 50 mile race
* To participate in the controlled part of the study the individual must have fully completed either the 100 mile or the 50 mile race.

Exclusion Criteria:

* Under age 21 years
* Vulnerable population, such as pregnant (by history) or cognitively impaired
* Subjects who are alcohol-naive (i.e first exposure to alcohol)
* Subjects with known familial and/or genetic backgrounds at higher risk for the development of alcohol dependence
* Subjects should not be seeking treatment for alcohol or drug abuse
* Subjects who are in general high risk for abuse such as those completing or participating in alcohol or drug abuse programs
* Subjects who have had a sustained period of abstinence, with history of heavy drinking problems, while living in the community
Promoting Long-term Behavior Change to Reduce CVD Risk

Once intervention class or staff contact is removed, obese adults participating in behavioral weight-loss programs often give up healthy eating habits and regain weight. We examined whether taste-based goal setting, which minimizes perceived deprivation by promoting taste and moderation, would sustain long-term reductions in saturated fat and body mass index (BMI).

Once intervention class or staff contact is removed, obese adults participating in behavioral weight-loss programs often give up healthy eating habits and regain weight. We examined whether taste-based goal setting, which minimizes perceived deprivation by promoting taste and moderation, would sustain long-term reductions in saturated fat and body mass index (BMI). Participants were randomized to Taste-Based Choices (taste-based goal setting + a standard 6-month behavioral weight-loss intervention), Smart Consumers (a standard 6-month intervention alone) or Community Access (access to commercial/community-based behavioral weight-loss programs) and followed over 18 months. To test our hypotheses, we examined a set of orthogonal contrasts (TBC and SC vs. CA; TBC vs. SC) on reductions in saturated fat (Block FFQ) and clinic-measured BMI.

Eligibility Criteria:
Inclusion Criteria:- Body mass index between 27-37

* Physically inactive
* Able to participate in physical activity
* Percentage of daily calories from total fat 30% or more
* Free of diagnosed heart disease
* Stable on medications for 3 months or more Exclusion Criteria:- Diabetic
* Dysphoric (Beck Depression Inventory score greater than 18)
* Binge eating or bulimic (Eating Disorder Diagnostic Scale)
mTORC1 and Autophagy in Human Brown Adipocytes

The long term goal is to identify the potential therapeutic targets for the treatment of obesity and its associated disorders by studying the driving factors of activation of brown adipose tissue (BAT) in human adults. Whereas activation of brown adipose tissue (BAT) in human adults has been considered as a potential therapeutic target to battle obesity since it was identified in 2009, the underlying mechanisms of beige adipocytes appearance in human adults is unclear. The objective of this proposal is to investigate the role of autophagy in mediating the inhibitory effect of mammalian target of rapamycin complex 1 (mTORC1) in regulating human brown adipocytes. The central hypothesis is that autophagy plays a critical role in regulating browning of white adipose tissue and mediates the beneficial effect of mTORC1 inhibition on thermogenesis in human brown adipocytes.

Specific Aim 1: To investigate the role of mTORC1 and autophagy in regulating thermogenesis in human brown adipocytes. The working hypothesis is that inhibition of mTORC1 or activation of autophagy improves thermogenesis in human brown adipocytes. It will be first determined if the mTORC1/autophagy signaling modulates thermogenic gene expression and beige markers by collecting human brown fat from lean non-diabetic subjects. The brown fat during the anterior cervical spine surgery or thyroidectomy from lean subjects with a BMI \<25, or obese participants who have a BMI \>30, will be harvested and then be used to determine: 1) whether mTORC1 signaling, autophagy and thermogenic gene expression, and the fraction of various types of immune cells in human brown fat are different from those in rodents;2) whether rapamycin treatment enhances basal or CL-induced thermogenic gene expression and O2 consumption in primary human brown adipocytes; and 3) whether inhibition of autophagy by 3-methyladenine (3-MA) suppresses thermogenic gene expression induced by CL316,243, a β3-adrenoceptor agonist that mimics cold stress in vivo in human brown adipocytes.

Overall, this study will lead to the identification of mTORC1 as a key regulator of thermogenesis in human adipose tissue and reveal promising new anti-obesity drug targets. In addition, this study will further investigate the role of rapamycin administration in obesity in human adults near the future. These studies are designed to be a proof-of-principle. If the results are promising, then future drug development could focus on designing new inhibitors of mTORC1.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* age 18-60
* able to give informed consent
* non-diabetic
* scheduled for anterior cervical spine, thyroidectomy, or parathyroidectomy surgery at UNMHSC
* BMI \<25 (lean) or \>30 (obese)
* English or Spanish speaking

Exclusion Criteria:

* has diabetes mellitus (type I or II)
* currently on any study medication (including sedatives or analgesics, coagulopathy (INR of 1.5 or greater, platelet count of \<50,000/microliter), or anticoagulant)
* pregnant
* incarcerated
Alterations of Gut Microbiome, Function, and Its Intervention After Defunctioning Ileostomy

This study focused on the alterations of gut microbiome and function during defunctioning ileostomy, and observed the effects of probiotic intervention on intestinal microbiome and function. The investigators looked forward to find the specific intestinal maladjusted flora from this work, which could provide a new scheme for the subsequent treatment of the damaged intestinal function and the reduction of the incidence of postoperative complication.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with primary rectal cancer received total mesolectal resection combined with defunctioning ileostomy.
2. Patients voluntarily sign informed consent.

Exclusion Criteria:

1. Disease progression or death after surgery.
2. Patients with inflammatory bowl disease.
3. Patients need to be on antibiotics/other probiotics for a long time.
Effect of Auricular Vagus Nerve Stimulation in Women With Migraine Disease

The aim of the study was to investigate the effectiveness of non-invasive auricular vagus nerve stimulation on pain and pulse variability in women aged 18-55 years with migraine. It is also aimed to see the effects of vagus nerve stimulation from all directions by making pain, pulse, blood pressure and autonomic measurements.

Migraine, a neurological disorder that causes severe disability, is characterized by recurrent moderate to severe attacks associated with vegetative symptoms. Patients with frequent attacks may overuse drugs, which can lead to migraine chronization and headache. In the last decade, neuromodulatory approaches have been developed for the treatment of headaches that do not respond adequately to treatment. Non-invasive neuromodulation techniques are an evolving field in migraine research and treatment. Non-invasive vagus nerve stimulation is one of the non-invasive neuromodulation techniques. Promising findings on vagus nerve stimulation in people with chronic pain, including migraine and cluster headaches, are slowly being recognized. Stimulation of the vagus nerve provides a way of regulating autonomic tone. Auricular vagus nerve stimulation regulates abnormal sympatho-vagal balance while activating the parasympathetic system, including anti-inflammatory pathways (cholinergic anti-inflammatory pathway and hypothalamic-pituitary adrenal axis). It is aimed to evaluate the effect on pain and pulse variability after vagus nerve stimulation in women with migraine disease and to learn how the vagus nerve crosses according to the pulse measurements taken from the right and left index fingers.

Eligibility Criteria:
Inclusion Criteria:

* People between the ages of 18-55 with migraine disease
* Having a definite diagnosis of migraine by a neurologist
* Absence of any orthopedic, neurological, etc. diseases that will prevent physical activity
* Not using drugs continuously except for migraine attacks
* Willingness to participate in the study
* Having signed the informed consent form

Exclusion Criteria:

* Cases do not want to continue the study.
* Not signing the informed consent form
* Being on medication for migraine prophylaxis
* Having a communication problem that does not allow evaluation
* Having a history of additional chronic disease that interferes with physical activity,
* Pregnancy
Infrared Thermography for the Diagnosis of Musculoskeletal Pain

This study sought to evaluate the vasomotor response in the pain referral area of healthy individuals, performing the same procedure with and without the experience of delayed onset muscle soreness.

Validity of infrared thermography for properly diagnosing musculoskeletal pain and their clinical applicability is lacking. This study investigates temperature changes on the upper extremity before and after a suprathreshold stimulation (painful stimulus) with a digital algometer over the infraspinatus muscle. The same procedure is performed in two consecutive days, 24 hours apart (Day-1 and Day-2). At the end of Day-1, an eccentric exercise is performed in order to to induce delayed onset muscle soreness on the external rotators of the shoulder.

Eligibility Criteria:
Inclusion Criteria:

* Being healthy and free from any pain specific to the upper limbs and/or in general.

Exclusion Criteria:

* Previous history of chronic pain.
* Any systemic diseases or regional pathology which can interfere with the outcome measures.
Curosurf® in Adult Acute Respiratory Distress Syndrome Due to COVID-19

Surfactant replacement therapy (SRT) improves oxygenation and survival in NRDS and some infant ARDS. SRT was tried in adult ARDS with conflicting results. Research by Filoche and Grotberg helped to understand the failure of previous clinical trials and yielded a strong scientific rationale for SRT success, now allowing to design a new administration protocol for SRT in adults, to be tested by this clinical trial in COVID-19 adult ARDS patients.

Patients will be randomized to receive either a bronchial fibroscopy alone (with aspiration of secretions) or a bronchial fibroscopy with administration of 3 mL/kg of a solution of poractant alpha diluted to 16 mg/mL and distributed into each of the 5 lobar bronchi.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years
* Intensive care unit admission.
* Intubation and mechanical ventilation since less than 72h.
* Positive end-expiratory pressure ≥ 5 cmH2O.
* Acute respiratory distress syndrome following Berlin definition.
* COVID-19
* PaO2/FiO2 ratio \< 150 mmHg during at least 3 hours despite PEP trial.
* Compliance of the respiratory system \< 50 mL/cmH2O

Exclusion Criteria:

* Contraindication to prone position.
* Pregnancy.
* Weight \< 40 kg
* height \< 140 cm or height \> 190 cm.
* Profuse bronchorrhea (at least 1 succion per hour during 3 hours).
* Other significant cause than ARDS to the respiratory failure.
* Decision to limit active therapies.
* No arterial line in place.
* Obesity with weight / height ratio \> 1 kg / cm.
* Impossible to give neuromuscular blockers (e.g. drug unavailable owing to global pandemia).
* Severe chronic respiratory failure with oxygen at home.
* Other severe acute or chronic organ faillure (eg severe liver cirrhosis, severe chronic cardiac failure).
* History of pneumonectomy or pulmonary lobectomy.
* Patient scheduled for extracorporeal membrane oxygenation.
* Known hypersensibility to Curosurf.
* Contraindication to bronchial fibroscopy.
* Person under legal protection.
Package of Interventions After Recovering From Moderate Acute Malnutrition

Children who recover from moderate acute malnutrition in Malawi remain at high risk for relapse or death in the year following recovery. This cluster-randomized trial will evaluate a package of affordable, safe, proven interventions specifically targeted to this population of children in an attempt to decrease their risk of relapse or death following recovery from moderate acute malnutrition. These children will be followed for a year following recovery to assess rates of relapse and mortality.


Eligibility Criteria:
Inclusion Criteria:

* recovered from moderate acute malnutrition, as defined by mid-upper arm circumference (MUAC) of 11.5-12.4 cm

Exclusion Criteria:

* not permanent resident in vicinity of site
* severe chronic illness
* receiving other supplementary food or participating in other research