cyrilzakka/clinical-trials huggingface dataset:
Does Boredom Affect Mechanical Pain Thresholds

The purpose of this study is to investigate if the feeling of boredom could influence mechanical pain thresholds.

Participants will be randomized into 3 different groups watching different short video-clips (2.30 min). The boredom group will watch a boring video about ploughing, the distraction control group will watch a positively valenced video, the control group will just wait for 2.30 min, without any instructions about what to think about. Pressure pain thresholds will be measured with an algometer before and after the video-clip interventions.

Eligibility Criteria:
Inclusion Criteria:

* No pain at the test session
* Swedish fluency.

Exclusion Criteria:

* Pain anywhere in the body during the test session
* known neurological disease.
Cesarean Trial of Staples vs. Sutures

To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.

Despite this large number of cesareans performed annually, there is a paucity of data to suggest which technique is superior for closure of the skin incision with regards to wound complications, including wound separation and infection. As the morbidity associated with a cesarean delivery is usually related to wound complications, especially infection, we feel that it is important to examine this outcome by comparing the current skin closure techniques: staples versus suture.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing cesarean delivery for pregnancy greater than 23 weeks gestation.

Exclusion Criteria:

* Poorly controlled diabetes (defined as ≥ 50% of fasting or 2 hour postprandial glucose levels \> 95 and 120 respectively within the week prior to delivery),
* Vertical skin incisions
* Chronic steroid use
* Active lupus flare
* HIV/AIDS
* Current treatment for cancer or a history of radiation to the abdomen/pelvis
* Current treatment with immunosuppressant medications secondary to history of transplantation
* Emergency cesarean(precluding informed consent prior to surgery)
* Lack of access to a phone
* Allergy to suture or staple material
Multilevel Interventions to Increase Adherence to Lung Cancer Screening

Screening for lung cancer has the potential for a profound public health benefit. Repeat annual screening is necessary for early detection of lung cancer. The investigators will test two interventions which include patient education and reminders to improve adherence to lung cancer screening.

Screening for lung cancer has the potential for a profound public health benefit.

Successful population-based screening requires continuous monitoring to adherence repeat screening in high risk adults to achieve similar results. Repeat annual screening is necessary for early detection of lung cancer. Baseline or first LDCT scans detect prevalent lung cancer, when subsequent screening detects new nodules. However, adherence to screening is low, ranging at 28-38% from centers nationally.

The investigators developed two novel, patient-centered interventions to address patient education and offering reminders for on-time screening. To address these goals, the specific aims are to: 1) Compare effectiveness of two multilevel interventions relative to usual care in improving (a) rates of adherence to lung cancer screening, (b) patient-centered outcomes; and (c) clinic outcomes; and 2) Determine the patient-, clinician-, and system-level factors that influence changes in adherence to inform lung cancer screening programs.

Eligibility Criteria:
Inclusion Criteria:

* KPWA members
* Aged 50-78 years
* Have a negative screening LDCT scan
* Speak English or Spanish
* Meet US Preventive Services Task Force guidelines

Exclusion Criteria:

* Patients who were previously diagnosed with lung cancer,
* Patients who have a positive scan,
* Patients who have an indicator for interpreter services, except for Spanish
Ultrasound Features of Endometriosis of the Uterosacral Ligaments

Ultrasound features most indicative of endometriosis of the uterosacral ligaments, which connect the cervix to the sacrum and are part of the uterus support structures, and verify the actual presence of endometriosis of these ligaments during surgery

It is estimated that 1 in 10 women of childbearing age is affected by endometriosis. Objective examination alone is not sufficient to frame the pathology as the anatomic-clinical correspondence is relatively low: symptoms are not lesion specific and there may be asymptomatic women with pictures of severe endometriosis. Accurate diagnosis of all endometriosis by transvaginal ultrasound at the preoperative stage is therefore essential to discriminate patients who need surgery from those who can benefit from medical therapy alone, but also to be able to select a surgeon with adequate experience for this type of surgery. In recent years, moreover, it has been highlighted that ureteral endometriosis is associated with ipsilateral LUS injury. Ureteral damage has a nuanced symptomatology and cases in which the patient manifests signs and symptoms suggestive of renal resentment are rare (flank pain, renal colic, hypertension). Ureteral involvement can therefore lead to a silent loss of renal function, which in some cases requires nephrectomy. Several studies have already shown that there is a correlation between ureteral endometriosis and uterosacral ligaments (LUS) endometriosis, and that the likelihood of ureteral involvement increases with increasing nodule size. In light of this evidence and in order to improve the diagnostic power of the ultrasound method, it is therefore important to find the best combination of ultrasound parameters to predict endometriosis in LUS with sufficient accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Women with a clinical and/or ultrasound diagnosis of endometriosis who are candidates for surgery;
* Age between 18 and 50 years;
* Signature of informed consent to the study

Exclusion Criteria:

* Post-menopausal women (spontaneous or iatrogenic);
* Virgo patients;
* Hysterectomised patients;
* Pregnant patients;
* Patients undergoing pelvic/vaginal radiotherapy;
* Previous LUS surgery;
* Clinical diagnosis of pelvic organ prolapse;
* Preoperative ultrasound more than 60 days prior to surgery;
* Failure at surgery and any subsequent histopathological examination to find pelvic endometriosis
Non-Nicotine Agents for Smoking Cessation

The primary objective of this study is to determine which is the better approach to smoking cessation in veterans: bupropion combined with transdermal nicotine or high dose nicotine replacement therapy (NRT) using transdermal nicotine combined with nicotine inhaler.

This study is a two-arm open-label, randomized controlled trial of bupropion combined with transdermal nicotine versus high dose NRT (transdermal nicotine and nicotine inhaler) with all subjects receiving a behavioral counseling program for smoking cessation.

Eligibility Criteria:
Inclusion Criteria:

* Readiness to set a quit date in the next two weeks,
* Current smoking of at least 15 cigarettes a day

Exclusion Criteria:

* Current untreated depression or receiving treatment for depression,
* History of seizures, major head injury, or other predisposition for seizures
Inflammatory Mediators in Early Sepsis

Sepsis is still a challenge for clinicians since the detailed pathomechanism are still unknown and until now early markers for sepsis are not defined yet. Immunological pathways and new mediators defined in animal models are not yet investigated in patients with sepsis. Therefore the investigators will measure new mediators in patients with septic shock.

Semaphorins 1 to 7 will be determined in Blood of patients with early septic shock. Concentration will be compared with blood concentration of postoperative patients suffering systemic inflammatory response syndrome (SIRS).

Eligibility Criteria:
Inclusion Criteria:

* Septic Shock

Exclusion Criteria:

* Age \< 18 \> 85
* no consent of caregiver
* Trauma patients
* Burn patients
* Immunosuppression
* Pregnancy
* HIV- hepatitis infection
Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat

The purpose of this study is to evaluate the Efficacy and Safety of MT921 in Subjects with Moderate to Severe Submental fat compared with Placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Adults 19\~65 years of age
2. CA-SMFRS and PA-SMFRS score of 2 or 3
3. Satisfaction level is 3points or less
4. Voluntarily provide informed consent

Exclusion Criteria:

1. Following history that can affect the efficacy and safety evaluation in the chin or neck area as judged by the investigator

   * Scars or skin lesion on the study treatment region
   * Liposuction or lipolytic material treatment to decrease submental fat
   * Permanent filler, synthetic implantation and autologous fat grafting
   * Within 1 year of screening visit, semi-permanent filler (Calcium Hydroxyapatite, collagen-stimulator, etc.), radio-frequency treatment, HIFU, thread, laser procedure and chemical peeling procedure over medium-depth
   * Within 6 months of screening visit, temporary filler (Hyaluronic acid, etc.) procedure on the chin or neck, injection of botulinum toxin, radio-frequency treatment, HIFU, thread, laser procedure and chemical peeling procedure over medium-depth
2. BMI over 35.0 kg/m\^2
3. Submandibular enlargement due to causes other than localized subcutaneous fat (hyperthyroidism, cervical lymphadenopathy, etc.)
4. Current or past dysphagia
5. Judged difficult to measure submandibular fat due to sagging skin on the chin and neck or wide platysmal bands on the neck
6. Bleeding or taking anticoagulant drugs (except for patients taking anticoagulant drugs, those who can discontinue administration from 3 days before injection to 24 hours after injection of the IP)
7. Skin disease or would infection on the study treatment region
8. Hypersensitivity to Lidocaine, Benzocaine, Procaine or the IP
9. Pregnancy or breast feeding or female of child-bearing potential who has not agreed to use of medically acceptable contraception during the study period

   * All women of childbearing age have negative pregnancy test results can be enrolled in parallel with surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or menopause (amenorrhea for more than 12 months).
   * Medically acceptable contraception: Intrauterine device, Intrauterine system, vasectomy, tubal ligation, condom, Cervical cap, Contraceptive diaphragm, contraceptive sponges, spermicide, oral contraceptive pill and etc.
10. Experience of other clinical trials within 30 days before screening
11. Any other clinically meaningful conditions that are considered ineligible for the study in the medical judgement of principal investigator or sub-investigator
Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients

The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary embolism (PE) in Japanese patients with acute symptomatic DVT without symptomatic PE.

The general design of the trial is open label between the Rivaroxaban and the reference arm. However, there are two groups in the Rivaroxaban arm only for the initial 3 weeks. Between these two groups and in this initial period, the study is blinded.

Eligibility Criteria:
Inclusion Criteria:

* Men and women \>/= 20 years of age in patients with confirmed acute symptomatic proximal deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE)

Exclusion Criteria:

* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
* More than 48 hours pre-randomization treatment with therapeutic dosages of anti-coagulant treatment or more than a single dose of warfarin from the onset of the current episode of DVT to randomization
* Calculated creatinine clearance (CLCR) \< 30 mL/min
* Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
* Active bleeding or high risk for bleeding contraindicating treatment with unfractioned Heparin (UFH) or warfarin
* Systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg
Shortened Preoperative Fasts in ICU

Randomized controlled trial assessing the safety and benefits of shortening preoperative fasts on intubated ICU patients undergoing tracheotomy.

Patients undergoing bedside tracheotomy in an ICU are enrolled and randomized into two groups. Arm A receive a standard fast of at least 6 hours. Arm B receive a shortened fast of only 45 minutes, just before the surgery begins. Patients will be monitored for aspiration, pneumonia and our ability to delivery better nutrition as a result of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* intubated ICU patient undergoing tracheotomy, receiving enteral nutrition, adult, proxy available for consent

Exclusion Criteria:

* pregnant, \<18yo, cannot tolerate enteral feeding
Clinical Safety for the Inspiratory Muscle Training

The aim of this study is evaluate the clinical, hemodynamic and electrocardiographic responses during an inspiratory muscle training session during a single cardiopulmonary rehabilitation session program. An electrocardiogram will be continuously recorded and the heart rate (HR) and blood pressure (BP) will be evaluated before, during and immediately after a single inspiratory muscle training (IMT) session, consisting of two series of 15 cycles, with one-minute intervals between sets and an initial load of at least 30% of the initial maximal inspiratory pressure (MIP).


Eligibility Criteria:
Inclusion Criteria:

* Patients regularly attending a supervised exercise program
* Patients were already performing the IMT in their usual supervisioned exercise sessions

Exclusion Criteria:

* cognitive impairment
Acute Health Effects of Low Temperature Exposure

This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of low temperature exposure and the underlying mechanisms.

The investigators will conduct a randomized controlled human exposure crossover study among about 50 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the low temperature (16#) and once to the moderate temperature (22#) in a chamber for about 2-2.5 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted immediately prior to exposure (within 1 hour before the exposure session), during the period of exposure, and after exposure (within 2 hours after the exposure session). Health examinations include spirometry, Holter monitoring, blood pressure tests, cognitive function tests, symptom questionnaires, and magnetic resonance imaging. Investigators plan to collect blood, urine, exhaled breath condensate, and oropharyngeal swabs samples.

Eligibility Criteria:
Inclusion Criteria:

* Living in Shanghai during the study period;
* Body mass index \> 18.5 and ≤ 28;
* Right-handed;
* Receiving or having received higher education;
* With the ability to read and understand Chinese smoothly.

Exclusion Criteria:

* Smoking and alcohol abuse;
* Current drug and dietary supplements intake;
* Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy;
* Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension;
* Subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
* Subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease;
* Subjects who have a history of major surgery due to cardiovascular, cerebrovascular, respiratory, or neurological diseases;
* Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and schizophrenia;
* Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
* Subjects with color vision disabilities.
Buspirone in Parkinson's Disease

Anxiety is highly prevalent in Parkinson's disease and negatively impacts quality of life yet it frequently remains untreated and there have been no clinical trials dedicated to evaluating the pharmacological treatment of anxiety in Parkinson's disease. Buspirone is effective for the treatment of generalized anxiety disorder in the general and elderly population. It is not known if it is effective for the treatment of anxiety in Parkinson's disease. This is a single-center, placebo-controlled, double-blind design with participants randomized with a 4:1 allocation ratio to flexible dosage buspirone (maximum dosage 30 mg twice daily) or placebo for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic PD by UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
* Significant anxiety as determined by the self-rated Parkinson Anxiety Scale (score ≥ 14)
* Able to provide written informed consent
* At least 18 years of age

Exclusion Criteria:

* Diagnosis of atypical or secondary parkinsonism
* Concomitant treatment with an MAO inhibitor within the 14 days prior to screening visit
* Significant renal or hepatic impairment
* Significant cognitive impairment defined as MOCA score \< 23
* On-going depression with suicidal or homicidal ideation and concern for patient safety based on clinical determination by the investigator
* Allergy or intolerance to study drug, matching placebo, or their formulations
* History of prior exposure to study drug
* Lactating or pregnant woman
* Concomitant treatment with a disallowed medication (detailed in section 6.2)
* Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
* Concomitant treatment with an anxiolytic or antidepressant will be allowed however potential participants who had dosage changes in the 30 days prior to the screening visit will be excluded
* Use of an investigational drug within 30 days prior to screening visit
* Any medical or psychiatric comorbidity that, in the opinion of the investigator, would compromise study participation
* Dysphagia defined as a score of ≥ 2 on MDS-UPDRS Item 2.3 Chewing and Swallowing
Evaluation of Energy Drink Consumption on ECG and Hemodynamic Parameters in Young Healthy Volunteers

This study is designed as a safety assessment to determine the cardiac and hemodynamic effects of overuse of energy drinks in healthy individuals through ECG, heart rate (HR) and blood pressure measurements. It will evaluate the use of a consumer available product that is classified as a dietary supplement by the FDA.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female, active duty military service members or DoD beneficiaries, who are eligible to receive care at DGMC.
* Ages 18-40 years old
* Participants must be willing to refrain from caffeine and energy drink use 48 hours prior to study days 1 and 8. They must also refrain from consuming additional caffeine or energy drinks during the 24-hour observation time on days 1-2 and 8-9.

Exclusion Criteria:

* Cardiovascular risk factors: Heart rhythm other than normal sinus, history of atrial or ventricular arrhythmia, family history of premature sudden cardiac death before the age of 60, left ventricular hypertrophy, atherosclerosis, hypertension, palpitations, T-wave abnormalities, baseline corrected QT (QTc) interval greater than 440 milliseconds(ms). This will be determined on the ECG obtained during initial screening appointment, and reviewed by cardiologist and through the questionnaire responses of the participant.
* Blood pressure at initial screening appointment or at baseline on study Day 1 greater than 140/90
* Presence of any known medical condition, confirmed through participant interview. Examples of these are:
* Hypertension
* Thyroid disease
* Type 1 or 2 diabetes mellitus
* Recurrent headaches
* Depression, currently receiving treatment (due to possible drug interactions)
* Any psychiatric condition or neurological disorder
* History of alcohol or drug abuse in the previous 5 years
* Ever been diagnosed or told they have or had renal or hepatic dysfunction
* Concurrent use of ANY medication taken on a daily basis, to include herbal products or supplements. Daily basis is defined as greater than 2 days per week.
* Pregnant or lactating females will be excluded from participation with urine dipstick tests used to confirm pregnancy (pregnancy test performed before each treatment session, days 1 and 8)
* All non-English speaking / writing subjects and those that do not understand the study or consent process will be excluded from the study due to unavailability of medical qualified translator at all times during the study.
* If the subject refuses to sign the informed consent document or HIPAA Authorization, they will be excluded as well
Comparison of the Nociception Monitoring Devices During Cardiac Surgery.

The purpose of this study is to compare the values of Surgical Pleth Index (SPI) and Nociception Level Index (NOL) measured simultaneously during cardiac surgery.

Participants are given oral and written information about the course of the trial, associated risks and benefits and about the handling of the personal data on the day before the surgery by one of the investigators. Participants are also given written information about patient's rights and insurance, the aim of the trial and its course. 40 adult cardiac surgery patients will be recruited for the study. NOL and SPI values will be measured during the cardiac surgery procedure. All patients receive oral premedication and standardized anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* coronary artery disease of heart valve disorder qualified for the surgical treatment
* participant understands the course of the trial and its aim
* participant has given informed written consent

Exclusion Criteria:

* participant has not given consent
* neurological or psychical disorders (psychiatric medication)
* dementia
* alcohol or substance abuse
* central nervous system medication (medication for epilepsy or neuropathic pain)