cyrilzakka/clinical-trials huggingface dataset:
Soliton Planar Acoustic Wave Device System for Dermal Tattoo Clearing Human Trial Protocol

To further evaluate accelerated fading resulting from additional treatment sessions of Soliton AWD as accessory to laser in tattoo reduction treatment.

To further evaluate accelerated fading resulting from additional treatment sessions of multi-pass Q-Switched laser with the Soliton Planar Acoustic Wave Device System (AWD) as an accessory to Q-Switched laser in tattoo reduction treatment.

Eligibility Criteria:
Inclusion Criteria:

* Range of Fitzpatrick skin color scores I to III
* The identical tattoo located on the arms, legs, and torso treated by Q-Switched laser and Laser + AWD during Soliton's previous 2016-001 clinical trial
* Black ink only. Other ink colors may be present, but areas of black only tattoo should meet inclusion criteria
* Approximately 1" x 3" tattoo with at least 30-50% of the treatment area containing black tattoo ink

Exclusion Criteria:

* Subject is pregnant or planning to become pregnant during the duration of the study
* Medical disorder that would hinder the wound healing or immune response (no blood disorder, diabetes, inflammatory disease, etc.)
* Skin disorders (skin infections or rashes, scarring, moles,birthmarks, psoriasis, etc.)
* Any surgical procedure in the prior 3 months, or planned during the duration of the study
* Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, etc.
* Moderate to heavy tanning on and around the tattoo to be treated as determined by the Principle Investigator.
Acute Effects of the Two Alternative Sweeteners D-allulose and Erythritol on Metabolism

The aim of this project is to investigate the effect of intragastric (ig) D-allulose on metabolic parameters in general and to investigate the effect of sweet taste receptor blockade on GI hormone responses, glycemic control, gastric emptying (GE) rates and appetite-related sensations to ig administration of erythritol and D-allulose.

Erythritol (natural non-caloric sweetener) could be an ideal candidate substitute for sugar as it may reduce caloric intake without compensatory overeating or earlier return of hunger. Moreover, it may serve as a physiological tool to disentangle the effects of gastrointestinal (GI) sweet taste receptor stimulation, (an)orexigenic hormone secretion, and glucose metabolism/caloric content on food intake regulation in vivo in humans. However, its effects on appetite, satiation, and satiety have not been studied systematically. Moreover, the mechanisms underlying erythritol-induced anorexigenic GI hormone release have not been investigated so far.

D-allulose is a sugar substitute with almost zero calories and is naturally occurring in small quantities. Apart from its use as sugar replacement, D-allulose seems to favorably affect glycemic control and metabolism as could be shown in animal trials and in a few human trials. However, to date the effects of D-allulose on GI hormone secretion, appetite-related sensations and glycemic control, are not or insufficiently studied in humans.

The aim of this project is therefore to investigate the effect of intragastric (ig) D-allulose on metabolic parameters in general and to investigate the effect of sweet taste receptor blockade on GI hormone responses, glycemic control, gastric emptying (GE) rates and appetite-related sensations to ig administration of erythritol and D-allulose.

Eligibility Criteria:
Inclusion Criteria:

* Healthy normal weight subjects with a body-mass index of 19.0-24.9
* Normal eating habits (no diets; no dietary changes)
* Age 18-55 years
* Stable body weight for at least three months
* Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion Criteria:

* Pre-existing consumption of erythritol or D-allulose on a regular basis (usage of erythritol or D-allulose as sugar replacement; in contrast, erythritol-containing toothpaste is allowed)
* Substance abuse
* Regular intake of medications, except anticonceptives
* Chronic or clinically relevant acute infections
* Pregnancy: although no contraindication, pregnancy might influence metabolic state. Women who are pregnant or have the intention to become pregnant during the course of the study are excluded. In female participants a urine pregnancy test is carried out upon screening.
* Participation in another study with investigational drug within the 30 days preceding and during the present study.
IW-6463 Safety Study in Healthy Elderly Subjects

This is a randomized, double-blind, placebo-controlled, 2-way cross-over study in healthy male and female elderly participants.

Participants will receive up to a total of 30 daily doses of study drug (15 days of daily IW-6463, only; 15 days of daily placebo, only) administered across two 15-day dosing periods (Period 1 and Period 2). The dosing periods will be separated by a 27-day washout. Participants will be randomized to a sequence of receiving IW-6463 for Period 1 and then placebo for Period 2, or vice versa.

Eligibility Criteria:
Inclusion Criteria:

* Subject is an ambulatory adult at least 65 years old at the screening visit
* Subject is in good health and has no clinically significant findings on physical examination
* Female participants must be postmenopausal. A postmenopausal state is defined as no menses for ≥12 consecutive months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level at screening (\>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state.
* Male participants who have not been surgically sterilized by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) must agree contraceptive use per protocol
* Men must also agree to not donate sperm throughout the study and for 3 months after the final dose of study drug
* Other inclusion criteria per protocol

Exclusion Criteria:

* Any active or unstable clinically significant medical condition
* Other exclusion criteria per protocol
Cost Effectiveness Of Sunitinib In Central America And Caribbean

Primary Hypothesis: The therapy with Sunitinib represents better cost-effectiveness than IFN-α in first-line treatment for metastatic Renal Cell Carcinoma (mRCC) in Central America and Caribbean countries

This study was terminated on 03Feb2011 due to the fact that the anticipated number of patients expected was not reached. The date of cessation of the drug was January 27, 2011. There was no intervention in the treatment or administration of the drug; the study only observed the treatment and collected data. As the study was dependent on the arrival of new patients with metastatic renal cancer, which was of a very low incidence, the study was terminated. Efficacy, adverse events or other safety issues were not factors in terminating the study. Lack of patients was the only reason.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of a personally signed (or legally acceptable representative) and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
* Adult (18 years old or older) men and women with confirmed diagnosis of mRCC treated with Sutent, IFN-α or Bevacizumab + IFN ; on the selected institutions.

Exclusion Criteria:

* Adult men or women with RCCm treated with any other medication that is not Sutent, IFN-α or Bevacizumab + IFN.
* Adult men or women with mRCC with palliative care.
* Adult men or women with RCC without metastasis.
The Evaluation of Banana Flower Stamens Extract on Prevention of Benign Prostatic Hyperplasia in Adults

To assess the evaluation of banana flower stamens extract on prevention of benign prostatic hyperplasia in adults

This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of benign prostatic hyperplasia (BPH) is evaluated by the doctor. The questionnaires are collected at every visit of the trial.

Eligibility Criteria:
Inclusion Criteria:

1. Male aged 40-80 years old
2. 7 ≤ IPSS score \<19
3. The subject did not take α-blocker or anticholinergic agents in the last 8 weeks. The subject did not take 5α-reductase inhibitor or androgen suppression agents in the last 16 weeks (depending on medical history).
4. The subject isn't diagnosed with cancer
5. The subject is able to read and finish the information on the questionnaire.
6. The subject must read and sign the informed consent form after the study has been fully explained.

Exclusion criteria:

1. The subject has a history of epilepsy or convulsions, liver and kidney disease, cancer, endocrine disease, mental illness, alcohol or drug abuse, and other major organic diseases (depending on medical history).
2. The lower urinary tract urination symptoms of the subject are not related to prostatic hypertrophy (depending on medical history).
3. Residual urine volume \> 250 mL (depending on medical history)
4. Subjects have had pelvic radiation therapy or pelvic surgery (including prostate or bladder surgery, but those who only have had a prostate slice can participate in the trial).
5. Subjects have taken sexual hormone preparations including LHRH agonists, anti-androgens, feminine, or Penta-reductase inhibitors (Proscar and Avodart) 16 weeks prior to the trial.
6. Subjects have participated in other clinical trials 12 weeks prior to the trial.
Analysis of the Reliability and Validity of the Chinese Version of CC-QoL

At present, there is no research scale designed for the quality of life of children with chronic cough in China, most of them use the cough scale designed for adults to evaluate the quality of life of children. In China, more and more attention has been paid to evaluate and improve the quality of life of children with chronic cough, but cough specific quality of life measurement tools for adults and parents are mostly used, and the Chinese translation version of CQLQ and LCQ is still the main method. There is still no cough specific quality of life measurement tool for children with chronic cough in China. Cc-qol, a specific scale for chronic cough in children, has not been promoted, and no relevant verification of the applicability, validity and reliability of the Chinese version has been found. Therefore, this study aims to verify and compare the applicability, reliability and validity of CC-QOL Chinese version in China through questionnaire survey and follow-up of children with chronic cough.

Descriptive Score: CC-QOL, CET,VAS, Peds-QOL,SCAS and Verbal category Score (VCD); descriptive score: DESCRIPTIVE score; descriptive score: DESCRIPTIVE score; descriptive score: DESCRIPTIVE score; To evaluate the reliability and validity of Cc-QOL in evaluating children's quality of life in China, Compare and analyze Leicester cough questionnaire(LCQ) and child chronic cough-specific quality of life measure Cc-qol was used to evaluate the quality of life in children with chronic cough.

Eligibility Criteria:
Inclusion Criteria:

* 1.Age 7-14；
* 2.Disease duration \> 4 weeks；
* 3.Spontaneous cough as the main or only clinical symptom。

Exclusion Criteria:

* Chest X-ray was unremarkable, excluding cystic fibrosis, typical asthma or dyspnea, and other underlying diseases.
Local Metabolic Effects of Ghrelin in Skeletal Muscle and Adipose Tissue

The metabolic effects of ghrelin is investigated by microdialysis technique. Subjects are healthy young men. End points are interstitial concentrations of glucose, lactate, and glycerol.


Eligibility Criteria:
Inclusion Criteria:

* healthy male
* age 18-65 years (included)
* Body mass index 20-25 (included)

Exclusion Criteria:

* alcohol abuse
* malignant disease
* use of any medicine except otc painkillers
* any disease recognized
* participation in a trial using radioactive isotopes within the last 6 months
Comparison of CNB and Surgical Specimens for ER, PgR, HER2 Status and Ki67 Index in Invasive Breast Cancer.

* This is a prospective, single-center, non-randomized, non-controlled study.
* The estrogen receptor (ER), progesterone receptor (PgR), HER2 status and Ki67 index of CNB specimen are critical biomarkers for making neoadjuvant therapy strategy in invasive breast cancer. The concordance of these biomarkers between CNB and surgical specimen was varied in previous retrospective reports. The aim of this study is to determine the discordance of these biomarkers between CNB and surgical specimen and the influence of making treatment strategy by the discordance.


Eligibility Criteria:
Inclusion Criteria:

* • histologically confirmed primary invasive breast cancer by core needle biopsy

Exclusion Criteria:

* • pathological diagnosed ductal carcinoma in situ or microinvasive breast cancer by core needle biopsy

  * patient plans to receive neo-adjuvant system therapy
Role of Nitric Oxide in Cirrhosis: Relationship With Systemic Hemodynamics, Renal Function, Vasoactive Systems and Endotoxemia

This study is to determine whether a compound, nitric oxide, made within the body, is the factor responsible for the changes in blood pressure and renal (kidney) functions that may occur during the course of cirrhosis. Patients with cirrhosis (liver scarring which causes poor liver function) will be eligible to participate. A group of healthy subjects will also be studied to compare the effects of the treatment to patients with cirrhosis and to confirm safety. A total number of 30 patients with cirrhosis and 10 healthy subjects will be enrolled in the study.

Upon admission, the patients will be physically examined and started on a special diet that will continue throughout the study. During the first four days of the study, the weight, heart rate and blood pressure of the patients will be measured every morning and 24-hour urine will be collected. On day 5, intravenous lines will be inserted in the patient's arms. One line will be used to draw blood samples and the other line will be used to infuse medications. Blood samples will be taken to measure liver and kidney function, nitric oxide, and other hormones that participate in the regulation of body fluids and blood pressure. Inulin and paraaminohippurate infusions (substances used routinely in the study of kidney function) will be started and blood and urine samples will then be taken at periodic intervals. Ninety minutes after the initiation of inulin and PAH infusions, L-NMMA (an investigational drug expected to increase the blood pressure and improve the kidney functions) will be infused. Blood and urine samples will be collected every 30 minutes. These procedures will take 4 hours. A total amount of about 10 tablespoons of blood will be drawn during the study. The patients will be discharged from the GCRC the next morning and restarted on their regular medications.

Eligibility Criteria:
Inclusion Criteria:

* Patients with compensated cirrhosis without previous history of ascites or edema
* Cirrhotic patient with ascites without renal failure
* Cirrhotic patients with ascites with functional renal failure
* Age and sex-matched healthy subjects
Medication Therapy Management (MTM) for a Medicaid Managed Care Population Within Patient-Centered Medical Homes

The primary objective of this project is to determine the estimated cost avoidance (ECA) resulting from medication therapy management (MTM) interventions in a patient-centered medical home (PCMH). The secondary objective of this study is to quantify the number and types of MTM interventions recommended by pharmacists and accepted by physicians within a PCMH.

CareSource™, the largest Medicaid managed care provider in Ohio, pays for pharmacist-provided MTM using the OutcomesMTM™ platform for claims submissions. In May of 2013, pharmacists at three PCMHs affiliated with a large academic medical center began providing MTM to patients with CareSourceTM through the OutcomesMTMTM platform. A retrospective chart review of the OutcomesMTM™ platform was performed for all patients who received MTM services between May 2013 and October 2014. The number and type of MTM interventions was tracked. For each intervention, the ECA level submitted to and accepted by the third party reviewer was collected. The ECA will be calculated using the cost associated to the CareSource™ managed care provider for each ECA level.

Eligibility Criteria:
Inclusion Criteria:

* Patient of a primary care doctor within The Ohio State University Division of General Internal Medicine
* CareSource™ Medicaid managed care as the insurance provider

Exclusion Criteria:

* n/a
Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers

Bioavailability study comparing two new nilotinib tablet formulations to an established nilotinib capsule formulation in healthy volunteers


Eligibility Criteria:
Inclusion

1. Healthy adult male (18 - 55 yrs) and sterile or post menopausal female subjects
2. Body weight must be ≥50 kg and \<100 kg, with a body mass index (BMI) \>18 but \<33.
3. Laboratory parameter values must fall within the normal range

Exclusion

1. Female who is pregnant or breast feeding.
2. Contraindication to receiving nilotinib.
3. Smokers or user of tobacco products
4. A past medical history of clinically significant Electrocardiogram abnormalities, or a history/family history of long QT-interval syndrome.

Other protocol-defined inclusion/exclusion criteria may apply
Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children

The purpose of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, pain and vital signs (blood pressure, heart rate and saturation) among children planned to undergone surgical intervention.

Lavender oil has sedative properties. Dental anxiety is one of the most common obstacles to dental care, especially for children ranges from 3% to 43% in different populations. To the best of our knowledge, this is the first study to investigate the use of lavender oil inhalation and to assess the correlation of anxiety and vital signs among children during a stressful surgical dental intervention. This study design was constructed according to the vital sign evaluations, anxiety and pain scores. Primary hypothesis was that of lavender oil inhalation prior to surgical dental interventions would affect vital signs and consequently reduce anxiety and perception of pain in children.

Eligibility Criteria:
Inclusion Criteria:

* being between 6 and 12 years of age
* children who are determined as Frankl 2, 3 or 4
* intellectually sufficient to complete the anxiety scale
* volunteer to take part in the study
* whose parents were willing to participate into the study

Exclusion Criteria:

* aged under 6
* has cognitive, cooperation (i.ex. Frankl 1) or systemic problems
* common allergies or dental pain
Different Doses of Dexmedetomidine Combined With Esketamine in Women Undergoing Cesarean Delivery

Esketamine is a commonly used analgesic during cesarean delivery, but may produce transient neuropsychiatric symptoms. Dexmedetomidine has both sedative and analgesic effects. When used in combination with esketamine, dexmedetomidine can reduce esketamine related neuropsychiatric effects after general anesthesia. The investigator speculate that combining low-dose dexmedetomidine with esketamine may also reduce neuropsychiatric adverse effects of esketamine in women undergoing cesarean section. This pilot trial is designed to determine the minimum dose of dexmedetomidine that can effectively prevent neuropsychiatric side effects of antidepressive dose esketamine (0.2mg/kg) in women undergoing cesarean delivery.

Esketamine is a commonly used anesthetic and analgesic drug during the perioperative period. Recent studies found that low-dose esketamine has rapid onset antidepressant effects and reduces postpartum depression when administered during cesarean delivery. However, even low-dose esketamine produces transient neuropsychiatric symptoms.

Dexmedetomidine is a high selective alpha2-adrenoceptor agonist and has both sedative and analgesic effects. When used in combination with esketamine, dexmedetomidine reduces esketamine related neuropsychiatric adverse reactions in patients undergoing general anesthesia.

The investigator speculate that combining low-dose dexmedetomidine with esketamine may also reduce neuropsychiatric adverse effects of esketamine in women undergoing cesarean delivery. The purpose of this pilot trial is to determine the minimum dose of dexmedetomidine that can effectively prevent neuropsychiatric side effects of antidepressve dose esketamine (0.2mg/kg) in women undergoing cesarean delivery.

Eligibility Criteria:
Inclusion criteria:

* Pregnant women aged ≥18 years.
* Scheduled for elective or emergency cesarean delivery under neuraxial anesthesia.

Exclusion criteria:

* A previous history of schizophrenia;
* Severe complications of pregnancy, such as pre-eclampsia, placenta accreta spectrum, or HELLP (intravascular haemolysis, elevated liver enzymes, and low platelet count) syndrome; or American Society of Anesthesiologists classification III or higher;
* Any contraindications to ketamine or esketamine, such as refractory hypertension, severe cardiovascular disease, or hyperthyroidism;
* Any contraindications to dexmedetomidine, such as sick sinus syndrome, severe sinus bradycardia (\<50 beats per minute), or second-degree or above atrioventricular block without pacemaker;
* Other conditions that are considered unsuitable for study participation.
Can Minimally Invasive Decompression Surgery Restore Sagittal Balance in a Patient Population With Sagittal Imbalance and Lumbar Spinal Stenosis

From adulthood onwards, the aging process manifests itself in the spine through loss of disc height and kyphotic deformity. As the general population ages, the prevalence of lumbar degenerative diseases and sagittal imbalance increases. Sagittal balance is a physiological alignment resulting from the effective muscular and ligamentary forces that place patients' heads harmoniously in line with their pelvis. Roussouly first classified this alignment by differentiating four types of balance in an asymptomatic population. He established a link between the varieties of sagittal balance of the spine, the sacral slope and the position of the pelvis in space. He went on to explain sagittal imbalance in the aging population suffering from degenerative diseases.

One of the most common lumbar degenerative diseases is lumbar spinal canal stenosis. Stenosis of the lumbar spinal canal is frequently associated with sagittal imbalance of the spine. Lumbar canal stenosis causes lumbar pain, leg pain, neurogenic intermittent claudication and bladder and rectal disorders. The severity of clinical symptoms increases linearly with progressive sagittal imbalance \[8\]. We represent the sagittal imbalance of the spine by a positive sagittal vertical axis (SVA) presented by patients to reduce the pressure exerted by the yellow ligament, which is hypertrophied in degenerative disease . Many have shown that this forward-flexing posture can be improved by simple decompression, and that this deformity corresponds to an analgesic position and not to a structural deformity. Little is known about the factors that influence alignment after lumbar canal decompression and short segment fusion.

This study therefore aims to elucidate some of the clinical and radiological factors likely to affect postoperative sagittal balance in patients undergoing simple minimally invasive decompression surgery and short segment fusion (1 or 2 levels).


Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥ 18 years
* French-speaking patients
* Patients undergoing minimally invasive lumbar decompression with or without one- or two-level arthrodesis
* Patients with preoperative sagittal imbalance measured on EOS images (sagittal vertebral axis \> 50 mm)

Exclusion Criteria:

* Patients under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of his or her data for this study
* Revision surgery