cyrilzakka/clinical-trials huggingface dataset:
Guanfacine Clinical Trial for Smoking Cessation

Adult daily smokers motivated to quit smoking will be randomized to extended-release guanfacine (6mg/day) or placebo and will enroll in an 8-week treatment period combining medication with brief behavioral support. The investigators hypothesize that the active dose of guanfacine compared to placebo will increase rates of prolonged smoking abstinence at the end of the 8-week treatment phase.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Able to read, write and comprehend English
* Smoker
* Able to take oral medications and willing to adhere to a medication regimen
* Provide evidence of a stable living residence in the last 2 months, have reasonable transportation to the study site, and have no plans to move within the next 3 months or unresolved legal problems

Exclusion Criteria:

* Any significant current medical conditions that would contraindicate smoking
* Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
* Positive test results at intake appointment on urine drug screen for illicit drugs
* Past 30 days use of any psychoactive drugs including anxiolytics and antidepressants
* Women who are pregnant or nursing
* Suicidal, homicidal or evidence of current mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders
* Meeting DSM-IV criteria for current attention deficit hyperactivity disorder (ADHD)
* Individuals who are currently taking medications known to be effective for smoking cessation or are regular users of other tobacco products in the past 30 days
* Only one member per household can participate in the study
* Specific exclusions for administration of guanfacine not already specified include:
* EKG evidence at baseline screening for any clinically significant conduction abnormalities or arrhythmias
* Known intolerance for guanfacine or any alpha blocker
* History of fainting, syncopal attacks
* Heart failure or myocardial infarction
* Impaired liver (as indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT) \>3x normal)
* Renal function (as indicated by estimated creatinine clearance \<60cc/min)
* Treatment with any antihypertensive drug or any alpha-adrenergic blocker
* Use of any central nervous system depressant (e.g., phenothiazines, barbiturates, benzodiazepines)
* Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole) or inducers (e.g., rifampin), or consumption of grapefruit juice
* Subjects may not have donated blood in the past 8 weeks or have been involved in other investigational studies that involve substantial blood draws or medications unknown to us
Evaluation of Three Non-invasive Analgesic Techniques in Pain Prevention During Injections

Injections are associated to a certain level of pain which tolerance can vary between individuals. As regards non-invasive pain control techniques in subcutaneous injections, scarce literature exists with adequate levels of evidence and design quality to support any specific analgesic method.

In this study, the investigators evaluated the effectivity of three non-invasive analgesic techniques (cold, anesthetic cream and vibration) when performing subcutaneous forehead injections, in a series of 100 healthy volunteers.

This study is a randomized, controlled, simple-blind clinical trial, and it has been approved by the Ethics Committee of the Medical Research Institute Hospital La Fe. The study included 100 healthy volunteered, and it was performed in the University and Polytechnic Hospital La Fe, Valencia.

The procedures of the study consisted in the sequential performance of four injections of 0,1mL of physiologic saline (0,9%NaCl) in the forehead of each subject, 2cm above the eyebrows, with a 29G needle, after applying any of the non-invasive anesthetic methods studied in the trial, except for the control zone. The anesthetic method utilized in each part of the forehead of each patient was randomized through simple randomization. Injections always started from the right side of the forehead to the left. The non-invasive analgesic methods utilized were:

* Control zone: None
* Vibration: Application of the vibrating device on the skin below the injection site, before and during injection.
* Cold: Application of a bag of 50mL of frozen physiologic saline covered with a plastic glove on the injection site for 50 seconds prior to performing the injection.
* Anesthetic cream: Application of a uniform thickness of 2mm of the anesthetic cream EMLA covered with an adhesive transparent plastic dressing for 30 minutes, before injection.

Eligibility Criteria:
Inclusion Criteria:

* Every subject who did not meet any of the exclusion criteria, and signed the informed consent, was included in the study

Exclusion Criteria:

* Subjects younger than 18
* Subjects that suffered from any local or systemic sensitivity alteration
* Subjects that suffered from any cognitive deficit
* Individuals allergic to any of the components of the anesthetic ointment EMLA (eutectic mixture of lidocaine 2,5% and prilocaine 2,5%).
Tooth Mousse and Fluoride in Dentin Hypersensitivity Treatment

GC Tooth Mousse, a complex containing amorphous calcium phosphate (ACP) and casein phosphopeptide (CPP), is recommended in dentin hypersensitivity reduction due to its ability to block opened dentinal tubules. It acts synergistically with fluorine in slowing caries progression. Whether CPP-ACP can act synergistically with fluorine in the dentin hypersensitivity treatment is unknown. The aim of this study was to assess the effect of CPP-ACP combined with fluoride varnish in cervical dentin hypersensitivity treatment.


Eligibility Criteria:
Inclusion Criteria:

* subjects with a minimum of three cervical hypersensitive teeth at both sides of the dental arch

Exclusion Criteria:

* dentin hypersensitivity caused by caries lesions
* fracture of restoration
* chipped teeth
* marginal gaps
* post-operative sensitivity
* cracked-tooth syndrome, and which were confirmed by periapical radiographs and teeth with cervical fillings
Serun Fluoride and Kidney Transplant

Our primary goal is to investigate any hidden burden upon the grafted kidney from the increase of serum fluoride resulted from sevoflurane, versus isoflurane.

Eighty patients with end stage renal failure undergoing living donor kidney transplant under general anesthesia were included in this study, by using an open (non-blinded) study design, patients were randomly assigned to two groups, 15 patients in each. Randomization was done through computer generated random tables. Isoflurane group; anesthesia was maintained with isoflurane 1-2%. Sevoflurane group; anesthesia was maintained with Sevoflurane 1-2%.

A peripheral intravenous access was secured in the hand opposite to the functioning fistula and induction of anesthesia was done with propofol 2mg/kg, neuromuscular blockade was maintained with atracurium 0.6mg/kg and all patients were intubated and ventilated to maintain end-tidal carbon dioxide (ETCO2) concentration between 30-40 mmHg. Anaesthesia was maintained with 1-2% isoflurane (isoflurane group) or 1-2% sevoflurane (sevoflurane group) with fresh gas flow of 2 L/min. In both groups inhalational anesthetic was delivered in an air-oxygen mixture of 1:1 ratio. Analgesia was maintained with fentanyl 1µg/kg/hr. Mannitol and sodium bicarbonate was given immediately before reperfusion (de-clamping of renal artery). Intraoperative monitoring included heart rate, noninvasive blood pressure, oxygen saturation, ETCO2, ECG and central venous line was placed in the right or left internal jugular vein depending upon the presence of dialysis catheter. Hemodynamic target include: mean arterial pressure of \> 80mmHg, CVP between 10-15 mm Hg to optimize cardiac output and renal blood flow.

Eligibility Criteria:
Inclusion Criteria:

* end stage renal disease

Exclusion Criteria:

-
Brief, High-dose rTMS for Depression

High frequency repetitive transcranial magnetic stimulation (rTMS) has been shown to be safe, feasible, and acceptable. Conventionally, rTMS investigations have relied on rational decision trees for dosage determination. The purpose of this study is to systematically examine an accelerated protocol of intermittent theta burst (iTBS). Study 1 aims to provide a quantifiable dose-response curve for iTBS and depressive symptom reduction in major depression. Study 2 aims to determine the role of individual variations of their functional networks compared to the site of stimulation and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* A negative urine pregnancy test, if female subject of childbearing potential.
* Able to speak English and complete study forms, adhere to treatment regimens, and be willing to return for regular visits.
* After full explanation of the study, willingness of participant is demonstrated by signing the informed consent form.

Exclusion Criteria:

* Clinically unstable medical disease:

  * cardiovascular
  * renal
  * gastrointestinal
  * pulmonary
  * metabolic
  * endocrine
  * other
* CNS disease deemed progressive
* Moderate or severe traumatic brain injury (TBI)
* Pregnant females or those currently breast-feeding.
* Current or history of schizophrenia or other psychotic disorder, except psychosis not otherwise specified (NOS) when the presence of sensory hallucinations is clearly related to the subject's trauma, Bipolar Type I disorder, or dementia:

  * vascular
  * Alzheimer's disease
  * other types
* Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) within 6 days of study entry, with the exception of alcohol use disorder, which, at the discretion of the study team, may be permitted.

See further explanation under protection from risk.

* Active participation or plan for enrollment in another evidence-based psychotherapeutic clinical trial
* Participation in other psychotherapeutic modalities must have been stable for 3 months prior to enrollment and must remain stable throughout participation.
* Currently taking medications that have short half-lives, lower the seizure threshold, and do not have evidence of antidepressant efficacy. These include:

  * high dose theophylline or stimulants such as methylphenidate patients taking bupropion must be on a stable dose and take less than or equal to 300 mg/day. Stable means the same dose for 5 half-lives.
* An implanted device in subject's head (shunt, cochlear implant) and/or metal in subject's head (other than dental implant).
* History of seizures or a seizure disorder.
ChOcolate COnsumption And Blood Pressure (COCOA-BP): A Wearable Devices Pilot Trial

The COCOA-BP Trial is designed to assess the impact of 50g daily dark chocolate intake on blood pressure and compare outcome data derived from wearable/digital health devices to data derived from standard methods. Additionally, the usability of the wearable technology will be evaluated.

The COCOA-BP Trial is a prospective, single-center, single-arm, Boston Scientific volunteer trial, designed to assess the impact of 50g daily dark chocolate intake on blood pressure and compare outcome data derived from wearable/digital health devices to data derived from standard methods. Additionally, the usability of the wearable technology will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age
* Subject has an iPhone (5 or higher)
* Subject is willing to comply with all trial requirements
* Subject understands the trial requirements and procedures and provides written informed consent before any trial-specific procedures are performed

Exclusion Criteria:

* Anyone part of the study execution team cannot be part of the trial
* Current smoker or history of smoking in the last 5 years (including E-cigarettes)
* Diabetes mellitus including those managed by diet alone
* Medically treated hypertension
* Diagnosed with persistent or frequent irregular heart beat (e.g. atrial flutter, atrial fibrillation)
* Permanent pacemaker or defibrillator implanted
* Subject is a women who is pregnant
* Known allergy to chocolate or cacao products
* Known allergy to skin adhesives
Risk Factors and the Effect of Plasma Exchange on Prognosis of Pregnancy-related Thrombotic Microangiopathies

Early identification of the risk factors of pregnancy-related thrombotic microangiopathies can help us reduce the complications of such patients and increase the survival rate of patients. In addition, it is still controversial whether patients with pregnancy-related thrombotic microvessels should receive plasma therapy.

"Objective: To evaluate the risk factors of pregnancy-related thrombotic microangiopathies and the effect of plasma exchange on the prognosis (recovery status of renal function, recovery status of platelets, survival or death within 28 days).

Design: A retrospective analysis of pregnant patients admitted to the ICU from 2015 to 2019. According to the outcome indicator of the occurrence of pregnancy-related thrombotic microangiopathies, they were divided into thrombotic microangiopathies group and non-thrombotic microangiopathies group. Patients in the pregnancy-related thrombotic microangiopathy group were divided into plasma exchange combined non-plasma exchange group according to whether they received plasma exchange. Collect the clinical data of the patients, and analyze the data using SPSS 1 7.0 statistical software package. The measurement data were compared by paired t test and one-way analysis of variance; the count data were compared by χ2 test. Compare the differences of the indicators between the two groups and analyze the risk factors of pregnancy-related thrombotic microangiopathies. Then compare whether there is a difference in the prognosis between the plasma exchange group and the non-plasma exchange group."

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients admitted to the Department of critical care medicine, the Third Hospital of Peking University from 2015 to 2019

Exclusion Criteria:

* NO
PENG Block Versus LP Block for THA Postop Pain

The purpose of this randomized, double blinded, prospective study is to compare the postoperative analgesia provided by the PENG block to that provided by the LPB for patients undergoing primary anterior approach THA.

Regional anesthesia procedures represent a common modality for postoperative analgesia after total hip arthroplasty surgeries (THA). The standard practice many years has been the Lumbar Plexus block (LPB), which anesthetizes the L1-L5 lumbar nerve roots1. While the LPB offers analgesia from the associated sensory block, it also blocks motor fibers, leading to lower extremity weakness that could potentially delay the patient's ability to participate in early physical therapy and may thereby delay discharge. In the past several years, newer regional anesthesia block approaches have been described and investigated in an attempt to provide patients with postoperative analgesia while avoiding associated muscle weakness, facilitating earlier physical therapy participation and discharge. One such nerve block is the peri-capsular nerve group (PENG) block, which anesthetizes the articular branches of the femoral, obturator, and accessory obturator nerves providing sensory innervation to the hip joint capsule without consistently causing lower extremity weakness2. Some institutions are utilizing the PENG block to provide postoperative analgesia and facilitate early mobilization. There are currently no prospective studies that directly compare the efficacy of LPB to PENG block for providing postoperative analgesia after THA.

Eligibility Criteria:
Inclusion Criteria:

* elective primary total hip arthroplasty surgery anterior approach
* provided informed consent
* no contraindications to medications used in providing the analgesic blocks

Exclusion Criteria:

* contraindications to regional anesthesia, such as an allergy to amide local anesthetics
* pre-existing coagulopathy or thrombocytopenia \<100,000
* refusal of analgesic block for pain management
* presence of an progressive lower extremity neurological deficit
* localized or systemic infection
* chronic use of high dose opioid analgesics (defined as daily use greater than 60 mg oxycodone equivalents)
* pregnant
* refusal of consent
Wound Dressing With Moisture Sensor

Explorative study of function of a moisture sensor on top of a superabsorbent wound dressing on exuding leg ulcers.

The function of a novel moisture sensor placed on a superabsorbent wound dressing has been evaluated in a small clinical investigation. Five patients with leg ulcers were included. The investigational device, Absorbest Fuktsensor, was placed on the dressing DryMax Extra Soft. Two variants of the study product were used, Variant A and Variant B. The difference between the variants were that Variant B had an extra layer of a nonwoven between the moisture sensor and the dressing in an attempt to delay the activation of the moisture sensor a little compared to Variant A which was not equipped with this nonwoven layer.

The overall aim was to observe the function of the sensor in clinical use and practical operation. Further the aim was to evaluate the two combinations of Absorbest Fuktsensor and DryMax Extra Soft and decide which combination would activate the sensor display in a satisfactory way related to the utilization of the dressings absorbing capacity while avoiding leakage and maceration.

The study was performed accordingly to ISO 14155 and the declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* Presence of moderate to highly exuding leg ulcer by clinician assessment
* Wound deemed suitable for treatment with study product
* Informed consent from the participants.

Exclusion Criteria:

* Pregnancy
* Prisoner
* Bleeding from the wound
* Known allergy to components
* Wound infection
* Mental illness
* Illness or treatment of an indication other than the wound and which, according to the study personnel, can affect the wound treatment, the study and/or the dressing.
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-97489 in Healthy Adult Participants

This study aims to evaluate the safety, tolerability, of CC-97489


Eligibility Criteria:
Inclusion Criteria:

* In good health, as determined by the investigator based on past medical history, physical examination, vital signs and clinical laboratory safety tests at screening.
* Body mass index (BMI) ≥ 18 and ≤ 33 kg/m\^2, inclusive. BMI = weight (kg)/(height \[m\])\^2

Exclusion Criteria:

• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, echocardiogram (ECG), or clinical laboratory determinations beyond what is consistent with healthy participants

Other protocol-defined inclusion/exclusion criteria apply
Early Goal-Directed Therapy Utilizing Transpulmonary Thermodilution and Severe Burn Injury

This study aimed to optimize fluid resuscitation with transpulmonary thermodilution (TPTD)-guided protocol and to lower the mortality rate of the severely burned.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \> 18 years).
* Major burn (as total burned surface area (TBSA) \> 20% with at least second degree burn depth).
* Admitted to the intensive care unit (ICU) of the Burn Center.

Exclusion Criteria:

* Patients younger than 18 years old.
* Patients with severe cardiopulmonary diseases, or associated with other major trauma.
* Patient with incomplete data.
Accuracy of Commercially Available Heart Rate Monitors

Over the last two decades, there has been a proliferation of commercially available heart rate monitors. Recognizing that elite athletes often use heart rate to monitor training and assess aerobic fitness, fitness companies have offered a variety of heart rate monitoring systems to the general public. Recently, there has been a move from monitors that rely on chest straps to measure electrical activity toward more convenient, wrist-worn monitors that employ optical sensing technology similar to that used for pulse oximetry. While the accuracy of chest strap monitors has been assessed in a variety of studies, there is no data concerning the accuracy of wrist-worn heart rate monitors. Assessment of the monitors' accuracy is important both for the subjects who rely upon these monitors to guide their athletic activity and for the physicians to whom these individuals report their heart rate readings.

Physicians have long-used heart rate as an index of aerobic fitness and cardiovascular health. Resting heart rate has been linked to longevity and freedom from cardiovascular morbidity, and heart rate during exercise serves as a measure of aerobic capacity. In addition, heart rate recovery after exercise carries implications for an individuals' health.

Like physicians, coaches and athletic trainers employ heart rate measurement on a daily basis. In the athletic setting, heart rate during exercise is used as an indication of aerobic exertion. Elite athletes and their coaches often design workouts based upon achieved and targeted heart rates.

Once the province of physicians and elite athletes, heart rate monitoring has become widespread among the general public. In the nineteen eighties, fitness companies added heart rate monitors to their product lines. Systems employing a chest strap to monitor electrical activity, telemetry and a wrist-borne receiver became popular, and several controlled, scientific studies confirmed their accuracy.

More recently, manufacturers have marketed a new class of heart rate monitors that consist solely of wristwatch-style devices. These heart rate monitors use optical sensing technology to measure heart rate. While they offer convenience, their accuracy, particularly during exercise, is uncertain. A recent article in USA Today suggests that these wrist-worn monitors fail to provide accurate readings during exercise; however, to date there has been no rigorous scientific inquiry addressing this question.

The purpose of this study is to assess the accuracy of four popular, commercially available wrist-worn heart rate monitors under conditions of varying physical exertion.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Able and willing to exercise (walk/jog) for a total of fifteen minutes

Exclusion Criteria:

* Health issues that preclude or contraindicate walking and/or jogging, including cardiovascular, orthopedic, pulmonary and other conditions
* Presence of a cardiac pacemaker
* Known cardiovascular disease
* Known heart rhythm disorders
* Use of Beta-blockers or antiarrhythmic medications
* Tattoos around the wrist area