cyrilzakka/clinical-trials huggingface dataset:
Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition

This study is designed to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition

A randomized, evaluator-blinded, parallel group, no treatment controlled, multicenter study to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition in Canada

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults willing to comply with the requirements of the study and providing a signed written informed consent
* Consent the use of facial images for marketing purposes and educational material
* Subject with moderate to very severe (Grade 2 to 4) on the GJS
* Subject is willing to abstain from any other facial, submental, and/or neck aesthetic procedure(s) or implant
* Female of childbearing potential with a negative urine pregnancy test before treatment

Exclusion Criteria:

* Subjects presenting with known/previous allergy or hypersensitivity to hyaluronic acid (HA) filler, lidocaine or other amide-type local anesthetics
* Subjects presenting with known/previous allergy or hypersensitivity to streptococcal proteins
* Subject with bleeding disorders or taking thrombolytics or anticoagulants
* Prior surgical procedure in the treatment area
* History of other facial treatment/procedure in the previous 6 months HA in or near the intended treatment site
* Presence of any disease or lesions near or on the area to be treated
* Presence of any condition, in the opinion of the Treating Investigator, makes the subject unable to complete the study per protocol
* Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period
* Study site personnel, close relatives of the study site personnel, employees, or close relatives of employees at the Sponsor Company
* Participation in any other interventional clinical study within 30 days before treatment
Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.

Resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's also found in Polygonum cuspidatum. There is evidence that resveratrol consumption has beneficial effects on glucose and lipids metabolism, blood pressure and body weight.

The aim of this study was to evaluate the effect of resveratrol on metabolic syndrome, insulin sensitivity and insulin secretion.

The investigators hypothesis was that the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric were evaluated after a 75 g of dextrose load.

12 received resveratrol, 500 mg, three times per day (1500 mg) before meals during 3 months.

The remaining 12 patients received placebo with the same prescription.

Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.

Results are presented as mean and standard deviation. Intra and inter group differences were tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Patients both sexes
* Age between 30 and 50 years
* Metabolic Syndrome according to the IDF criteria
* Waist circumference
* Man ≥90 cm
* Woman ≥80 cm
* And two of the following criteria:
* High density lipoprotein
* Man ≤40 mg/dL
* Woman ≤50 mg/dL
* Fasting glucose ≥100 mg/dL
* Triglycerides ≥150 mg/dL
* Blood pressure ≥130/85 mmHg
* Informed consent signed

Exclusion Criteria:

* Women with confirmed or suspected pregnancy
* Women under lactation and/or puerperium
* Hypersensibility to resveratrol
* Physical impossibility for taking pills
* Known uncontrolled renal, hepatic, heart or thyroid diseased
* Previous treatment for the metabolic syndrome components
* Body Mass Index ≥39.9 kg/m2
* Fasting glucose ≥126 mg/dL
* Triglycerides ≥500 mg/dL
* Total cholesterol ≥240 mg/dL
* Low density lipoprotein (c-LDL) ≥190 mg/dL
* Blood Pressure ≥140/90 mmHg
The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity

The purpose of this study is to assess the impact of scheduled fresh frozen plasma (FFP) administration on extracorporeal membrane oxygenation (ECMO) pump longevity in critically ill pediatric and neonatal patients. Almost all ECMO patients receive multiple FFP transfusions during their ECMO course. The investigator proposes that scheduled FFP may maintain pro and anticoagulation balance thus mitigating the need for expensive and dangerous ECMO pump changes. In addition, this may lead to less overall transfusion with all products (red blood cells, platelets, and FFP) if coagulation homeostasis is maintained. The subjects will be neonatal and pediatric patients requiring ECMO support for any reason in the pediatric and pediatric cardiac critical care units. Subjects will be randomized to receive every other day FFP infusions or FFP administration per current standard of care. ECMO pump longevity (hours) and FFP use will be compared between the two groups There is a small risk that study subjects may receive more FFP transfusions and therefore have the increased associated risks however it is also possible that these subjects may benefit from less ECMO circuit changes and/or fewer transfusions of all blood products.


Eligibility Criteria:
Inclusion Criteria:

* All patients \< 18 years receiving ECMO

Exclusion Criteria:

1. Planned withdrawal of life sustaining therapy in the next 48 hours
2. Previous enrollment in the study
3. Patients who cannot be consented within 48 hours
4. Pregnant patients
Effects of a 2-week Relaxing Music Intervention on Anxiety, Stress, and Gut Symptoms in Aerobic Exercisers

The objective of the study is to determine the impacts of a 2-week relaxing music intervention on stress, anxiety, and gut symptoms in individuals who regularly perform structured aerobic exercise. Gut symptoms like bloating, reflux, cramping, nausea, etc. are relatively common during prolonged aerobic exercise. In addition, previous research has established that levels of anxiety and stress are associated with a higher occurrence of these gut symptoms. Relaxing music has reduced anxiety in certain populations, but currently, no studies are available on its effects on anxiety, stress, and gut symptoms in people who regularly do aerobic exercise.


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age
* do 120+ minutes per week of planned/structured aerobic exercise of at least moderate intensity
* have had at least mild anxiety over the past 2 weeks (GAD-7 score of 5 or more)
* not currently on a psychotropic medication, or if they are on one, they must have been on a stable dose for the past three months
* not currently listening to music for relaxation purposes regularly (\>60 minutes per week)
* have at least sometimes experienced gut symptoms (nausea, gas, bloating, cramping, side stitching, urge to defecate, etc.) during aerobic exercise sessions over the last month
* have access to the internet

Exclusion Criteria:

* not at least 18 years of age
* don't do 120+ minutes per week of planned/structured aerobic exercise of at least moderate intensity
* haven't had at least mild anxiety over the past 2 weeks (GAD-7 score of 5 or more)
* have recently started taking a psychotropic medication (within past 3 months)
* currently listening to music for relaxation purposes regularly (\>60 minutes per week)
* have never or rarely experienced gut symptoms (nausea, gas, bloating, cramping, side stitching, urge to defecate, etc.) during aerobic exercise sessions over the last month
* don't have internet access
A Randomized Trial of Vitamin D to Reduce Respiratory Infection

The goal of this study is to assess the effectiveness of vitamin D in reducing laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly vitamin D supplements or placebo. Participants who develop acute respiratory infection over a 12-month period, will be tested for influenza, the co-primary outcome, and other respiratory viruses, the other co-primary outcome, by RT-PCR.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 3 and 17
* Residing in Thanh Liem District, Ha Nam Province, Vietnam

Exclusion Criteria:

* Born prematurely at less than 32 weeks gestation
* Any chronic illness (except asthma)
* Currently using medication known to interfere with vitamin D metabolism
* Children with a sibling participating in the study
MY-ENDO -- Mind Your ENDOmetriosis: a Digital Mindfulness- and Acceptance-based Endometriosis Self-management Program

The purpose of the study is to assess the effect of a digital mindfulness- and acceptance-based psychological intervention on quality of life, work ability, pain experience and physical and mental health in participants experiencing chronic pain, fatigue and/or reduced quality of life due to endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old.
* Signed informed consent.
* Endometriosis diagnosed by a gynecologist based on the medical case history, ultrasound, laparoscopy, or MRI (all self-reported).
* Moderate to severe symptoms (pelvic pain and/or fatigue measured on an 11-point numeric rating scale (NRS) from 0 = no pain/fatigue to 10 = worst imaginable pain/fatigue symptom) or reduced endometriosis-related quality of life (measured by the EHP-30):
* Moderate to severe endometriosis-related chronic pelvic pain (NRS \> 2) or
* Moderate to severe endometriosis-related fatigue (NRS \> 2) or
* Low endometriosis-related quality of life (one or more EHP-30 subscale mean scores ≥ 40.00).
* Relevant clinical and/or surgical treatment according to the European Society of Human Reproduction and Embryology (ESHRE) guidelines for endometriosis has been attempted.
* Willingness to practice mindfulness and yoga at home for 30-45 minutes 5-7 days a week during the treatment period.

Exclusion Criteria:

* Under 18 years old.
* Severe psychiatric diagnosis made by a psychiatrist and/or ongoing psychiatric treatment.
* Pregnancy or planned pregnancy during the study period.
* An estimated lack of capacity or surplus energy to enter into a digital mindfulness treatment, for instance, because of:
* major life events taking place at the same time (e.g., divorce, loss of a close relative, etc.)
* linguistic or cultural barriers
Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer

The purposes of this study are to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good and bad) this combination has on patients with cancer of bile duct or gallbladder. Bevacizumab has been shown to slow or stop cell growth in tumors by decreasing the blood supply to the tumors.

* The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
* Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
* The following tests and procedures will be performed on day 1 and day 15 or each cycle: physical examination; medical history; blood work; and urine test. A PET scan will be repeated at the end of cycle 2 and CT scans will be repeated once every 8 weeks.
* Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, locally unresectable or metastatic biliary tract or gallbladder adenocarcinoma. Patients must have at least one measurable lesion outside prior radiation field.
* Zero to one prior chemotherapy for biliary tract or gallbladder cancer
* Age \> 18 years
* ECOG performance status 0-2
* Life expectancy \> 12 weeks
* Adequate organ and bone marrow function

Exclusion Criteria:

* Chemotherapy within past 3 weeks of initiation of therapy
* Pregnant or lactating women
* Clinically apparent central nervous system metastases or carcinomatous meningitis
* Biliary obstruction with inadequate drainage and total bilirubin \> 2.5 mg/dL
* Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Uncontrolled serious medical or psychiatric illness
* Pre-existing peripheral neuropathy of grade 2 or greater severity according to the Common Terminology Criteria of the NCI (version 3.0)
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
* Blood pressure of \> 150/100 mmHg
* Unstable angina
* NYHA Grade II or greater congestive heart failure
* History of myocardial infarction or stroke within 6 months
* Clinically significant peripheral vascular disease
* Evidence of bleeding diathesis or coagulopathy
* Major surgical procedure, open biopsy, or significant traumatic injury with 28 days prior to Day 1, anticipation of need for major surgical procedure during the course of the study
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1
* Serious, non-healing wound, ulcer, or bone fracture
Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution

This is a double-masked, placebo-controlled study which will determine the action of NCX 470 ophthalmic solution, 0.1% on aqueous humor dynamic parameters in healthy volunteers or subjects with OHT.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age
2. Either gender
3. Subjects without glaucoma
4. Qualifying IOP at Screening Visit

Exclusion Criteria:

1. Narrow anterior chamber angles or disqualifying central corneal thickness in either eye
2. Clinically significant ocular disease in either eye
3. Uncontrolled systemic disease
4. Serious hypersensitivity to topical anesthetic eye drops
5. Subjects with a known hypersensitivity or contraindications to any of the ingredients in the study medications
Endovascular treatmenT for Acute Ischemic Stroke in China (DETECT2-China)

This is a prospective real world registry study, aiming to explore the effectiveness and safety of endovascular treatment of acute ischemic stroke in a Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18;
* Ischemic stroke confirmed by head CT or MRI;
* Patients receiving endovascular treatment;
* First ever stroke or pre-stroke mRS≤2;
* signed informed consent.

Exclusion Criteria:

* Prestroke mRS≥3;
* Other serious illness that would confound the clinical outcome at 90 days;
* Unavailable neuroimaging data;
* Other unsuitable conditions judged by the investigator
Pulmonary Hypertension Observational Study

The purpose of this study is to establish the large PH cohort and biological database in China, aiming for precision medicine to optimize diagnosis and treatment choices.


Eligibility Criteria:
Inclusion Criteria:

* PH group: When the mean pulmonary artery pressure is greater than 25mmHg at rest or greater than 30mmHg during exercise.
* Signed informed consent obtained prior to participations with the ability to comply with protocol and be available for study visits over 5 years.

Exclusion Criteria:

* Acute exacerbation in the past 3 months Having other respiratory diseases with massive lung tissue destruction such as severe bronchiectasis and tuberculosis, etc.
* Serious uncontrolled diseases thoracic or abdominal surgery in the last 3 months.
* Eye surgery in the last three months.
* Retinal detachment myocardial infarction in the last 3 months.
* Admission to hospital for any cardiac condition in the last month.
* Heart rate over 120 beats per minute.
* Antibacterial chemotherapy for tuberculosis pregnant or breast feeding.
Observational Study of Effectiveness and Tolerability of Gliclazide MR 60mg in Diabetic Patients Fasting During RAMADAN

The purpose of this observational study is to assess effectiveness and tolerability of gliclazide MR 60mg during RAMADAN in a real world setting in 9 countries from Asia Pacific and Middle East/North Africa


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities
* Male or female type 2 diabetic patients aged \>18 years
* Patients with controlled or suboptimal controlled type 2 diabetes
* Patients with experience in SMBG controlling using glucometer
* Patients who are willing to fast during Ramadan
* Patients already treated with Gliclazide MR 60mg

Exclusion Criteria:

* Insulin therapy requirement
* Severe liver or renal failure
* HbA1c ≥ 9%
* Contraindication to gliclazide according to SmPC
* Pregnancy or breast feeding
* Previous experience of severe or repeated hypoglycemia events without triggered factor within the previous year
Digital Care Chains in Health Care - a Study of Care Consumption, Care Quality, Work Environment and Well-being

Digital healthcare has developed rapidly to meet demands for accessible healthcare, streamline care and meet future challenges with increasing healthcare needs and reduced labour force in Sweden. Developers and stakeholders in Sweden want to exchange the praxis of phone triage to digital or semi-digital triaging tools, to relieve staff's workload and utilize better resource use that would benefit all patient groups. However, previous studies have showed demographic differences in utilization rate and an increase of simpler care matters when digital healthcare options are offered. Also, little is known of medical accuracy of digital triage tools and of the work environment in digital healthcare. More research is needed on this, as well as on care consumption, care quality and of patients' experiences of digital healthcare. The overall aim of the research project is to study a new digital healthcare platform being introduced in 2021/2022 in the County of Gävleborg, Sweden. The studies will focus on care consumption, healthcare outcomes, care quality and patient safety as well as explore the digital work environment in the digital healthcare platform. Data will be collected before and after the introduction of the digital healthcare platform, using register data and questionnaires. The data from the two time periods will be analyzed with descriptive and inference statistics, to explore if the digital healthcare platform has brought differences on group levels in care consumption, healthcare outcomes, care quality and patient safety as well as in work environment aspects such as the staffs' well-being.


Eligibility Criteria:
Inclusion Criteria in the patient study:

* severe depression
* has received inpatient care in the County of Gavleborg during two given time-periods

Exclusion Criteria in the patient study:

* stress-related exhaustion disorder
* substance use disorder
* neuropsychiatric disorder
* psychosis
* postpartum depression.

Inclusion Criteria in the staff study:

* healthcare staff from all clinical areas in the County of Gavleborg
* staff with permanent employment

Exclusion Criteria in the staff study:

* administrative staff
* managers
* staff on long term leave
* staff on long term sick leave
* staff on parent leave
* staff expected to retire or resign within a year
Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix

The purpose of this study is to compare the effectiveness of two methods of treating cancer of the cervix. Half the patients will receive gemcitabine plus cisplatin while undergoing radiation therapy, followed by adjuvant gemcitabine and cisplatin and the other half will receive cisplatin along with radiation therapy without adjuvant therapy.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with cancer of cervix
* tumor that can be measured
* no previous treatment with chemotherapy or radiation for this cancer
* Karnofsky Performance Status Score \>=70
* able to give written consent
* willing and able to participate in the study, both during the active treatment and the follow-up period.

Exclusion Criteria:

* impairment such as hearing loss from prior cisplatin therapy
* damage to nerves such as being unable to distinguish hot and cold to touch
* used other experimental medication in past 30 days
* lab test results are not within the limits required for this study
* pregnancy or breast-feeding or possibility of becoming pregnant during this study and not using an approved method of birth control.
Intravenous Voriconazole in Patients With Renal Compromise

The purpose of this study is to determine whether patients with compromised renal function (CrCl \< 50mL/min) receiving intravenous voriconazole experienced any adverse effects related to serum chemistries or other imaging studies of the kidney due to the potential accumulation of the vehicle cyclodextran.

The purpose of this study is to determine whether patients with compromised renal function (CrCl \< 50mL/min) receiving intravenous voriconazole experienced any adverse effects related to serum chemistries or other imaging studies of the kidney due to the potential accumulation of the vehicle cyclodextran. t has been previously shown by a large multi-centered, prospective, randomized study that voriconazole is superior to the then gold standard amphotericin B in the treatment of patients with invasive aspergillosis - a disease with significant morbidity and mortality. In patients with these infections who have severe renal insufficiency may be denied the best therapy due to the accumulation of a diluent with unknown clinical consequences. Qualifying and or quantifying these consequences are important to these patients so that potentially life-threatening therapy should not be unduly denied.

Eligibility Criteria:
Inclusion Criteria:

- Patients \> 18 years old receiving voriconazole with a serum creatinine of \> 2mg/dl (a proxy marker for Creatinine clearance \< 50ml/min). Control group in this study will have serum creatinine \< 1.5mg/dl. Solid organ transplant patient. Patient that received at least 2 doses of voriconazole.

Exclusion Criteria:

* None