cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline

To demonstrate the effectiveness and safety of Radiesse (+) following deep (subdermal and/or supraperiosteal) injection to improve the contour of jawline by adding volume to the jawline.


Eligibility Criteria:
Inclusion Criteria:

1. Has right and left jawline ratings of 2 or 3 (moderate or severe) on the Merz Jawline Assessment Scale (MJAS).
2. Has the same MJAS score on both jawlines (that is, jawlines are symmetrical).
3. Is greater than or equal to (\>=) 22 and less than or equal to (\<=) 65 years of age.

Exclusion Criteria:

1. Ever been treated with fat injections or permanent fillers (example, silicone, polymethylmethacrylate (PMMA)) in the lower face and/or jawline area or plans to receive such treatments during participation in the study.
2. Been treated with semi-permanent dermal fillers (example, poly L-lactic acid) in the lower face and/or jawline area in the past 5 years or plans to receive such treatments during participation in the study.
Data Registry of Intensive Care Unit (ICU) Siamitra and Intensive Care Unit (ICU) Salad-Samung

As a general surgical intensive care units of the biggest tertiary referral university of Thailand with more than 1,000 admissions/year, recently, more complicated perioperative care surgical patients were accepted with high complications, morbidities, mortality and resource utilization. Good data registration was needed to provide information for quality improvement and resource allocation. This prospective observational (crosssectional) study was designed to register patient \> 18 years who will be admitted to these ICUs to explore the adequacy of these ICUs services, resource utilization (ICU length of stay and ventilator day), ICU complications, adverse outcome /ICU readmission within 72 hours after discharging from ICU. In addition, severe hemodynamic, respiratory, or neurological disturbance or complication intra and early postoperative (within 7 days after operation) that lead to ICU admission eg, intraoperative hypotension, intraoperative cardiac arrest, perioperative pulmonary aspirtaion will also be studied.

This prospective obseverational study wae ans will be done in all surgical patient (age . 18 yeras) admitted to the general surgical ICU (ICU Siammitra and ICU Salad-sumang) of the Department of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol UNiversity, Bangkok, Thailand. After approval by the IRB of Siriaj Hospital, all information of the patients admiited to the ICUs were carefully recorded included patient demographic data, comorbidities, type of anesthesia, type of surgery, complication associated with anesthesia and surgery, type of ICU admission and course in ICU including outcome as Iresouce utilization (cost in ICU, ventilator day, ICU and hosital length of stay. Morbidity occcuring in ICU, 28 and 90 days mortality also recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Surgical patients

Exclusion Criteria:

* Patient undergoing cardiothoracic surgery, traumatic surgery, neurosurgery
What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

To improve the clinical care of women with pelvic pain and abnormal uterine bleeding due to benign uterine conditions including leiomyomas (uterine fibroids) and adenomyosis by evaluating the accuracy of radiology diagnostic exams (MRI(magnetic resonance imaging), ultrasound and ultrasound with elastography).

Currently benign conditions of the uterus are frequently underdiagnosed or misdiagnosed. This project will help determine which diagnostic radiology exams are most helpful to the clinician in providing accurate diagnosis. In addition, this study will evaluate which exam (MRI vs. Ultrasound) patients prefer over another exam.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Pelvic pain and/or abnormal uterine bleeding. (this is specific for Arm. 1 of this study)
3. If you have had or are scheduled to have both a pelvic MRI (magnetic resonance imaging) and a pelvic ultrasound with 6 months of the time of enrollment. (this is specific to Arm 2 of this study).

   -

Exclusion Criteria:

1. If you are post-menopausal(have not had a period in at least one year's time).
2. If you have been diagnosed with gynecological malignancy such as uterine, endometrial, cervical or ovarian cancer.
3. If you are unable or unwilling to sign the informed consents
4. If you are unable to undergo the research study exams -
Application of Thrombin Gel Matrix for the Prevention of Lymphocele in Patients With Endometrial Cancer.

To compare the incidence of lymphocele in Endometrial cancer patients with thrombin gel matrix used and not used during pelvic lymph node dissection.

Pelvic lymph node dissection is the most accurate staging tool to determine lymph node involvement in endometrial cancer. Lymphoceles developed after surgery can cause serious morbidity, additional costs and delays in chemotherapy or radiotherapy. In this study, conventional pelvic lymphadenectomy will be compared with thrombin gel matrix application after pelvic lymphadenectomy. Our goal is to prospectively assess the lymphostatic effect of thrombin gel matrix in endometrial cancer patients undergoing pelvic lymph node dissection.

Eligibility Criteria:
Inclusion Criteria:

* Endometrial cancer patients who need laparotomic bilateral PLND
* Patients suitable for surgery

Exclusion Criteria:

* Previous pelvic surgery
* Previous Chemotherapy or Radiotherapy
* Patients who undergo only lymph node sampling
* Patients who have not signed Informed Consent
Correlation Between Optic Nerve Vessel Anomalies, Serum Angiogenic Factors and Renal Anomalies in Down Syndrome Children

In approximately half of individuals with Down syndrome, an higher than normal number of vessels cross the optic disc margin. Investigator hypothesize that early retinal vessel branching occurs due to inhibition of angiogenesis by triplet overexpression of endostatin, an angiogenesis inhibitor encoded on chromosome 21. Since angiogenesis is critical in the development of eyes and other organs angiogenesis depended (specially kidney, brain, and recently described lungs and heart), early branching of retinal vessels at the level of the optic disc would also likely result in abnormal renal and other organs development in these individuals. Investigator wish to determine whether observation of optic disc vessels may serve as an indicator of elevated endostatin levels and other angiogenesis-dependent organs anomalies.

Investigator will measure the serum levels of endostatin as well as others angiogenetic factors in Down syndrome children versus control group 1 constituted by the patient mothers.

Investigator will also perform renal and low urinary tract Doppler ultrasound with measurement of renal dimension in order to determine if the kidneys of patients with high level of serum of endostatin are smaller than those of patients with normal level of endostatin. Data observed in Down syndrome children will be compared to control group 2age constituted by sex and age matched healthy children Urine microalbuminuria and urine microalbuminuria/creatinuria from the first urine in the morning will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Provision of personally signed and dated informed consent document by adult subject or parents
* When capable of providing assent, provision of personally signed and dated informed assent document by children
* Subjects and/or their caregivers/parents are willing and able to comply with scheduled laboratory tests, and other required study procedures.

Exclusion Criteria:

• Inability to cooperate with study related examination

For "Study Group" subjects

* Known chronic diseases unrelated to their triallelic condition For "Control Group n°1" \& "Control Group n°3"
* General disease in which the level of endostatin may be modified such as leukemia, cancers, inflammatory diseases (e.g.: rheumatoid arthritis, Crohn's disease, psoriasis)
* Any condition that may cause a hypoxia
* Pregnancy

For "Control Group n°2":

* Healthy children except benign ophthalmological refraction anomalies
* Any known renal or low urinary tract diseases.
Effect of Paroxetine on Smokers' Cardiovascular Response to Stress - 1

Smokers report that they often smoke cigarettes during stressful times. The combined effect of smoking and exposure to stress leads to exaggerated increases in blood pressure, heart rate and other measures of stress response. This combination may result in greater cardiovascular harm than either smoking or stress alone. The purpose of this study is to determine the effects of paroxetine on the response to stress after smoking.

Smokers report that they often smoke cigarettes during stressful times. Smoking and stress produce similar physiological responses such as increases in heart rate, blood pressure, and adrenaline levels. The combination of smoking and stress results in greater increases in these physiological responses compared to smoking or stress alone. Such increases are thought to be harmful to cardiovascular health. Additionally, smokers with exaggerated responses to stress may be more likely to relapse following a smoking cessation attempt. The purpose of this study is to assess the effects of paroxetine, a selective serotonin reuptake inhibitor (SSRI), on the cardiovascular response to stress after smoking.

Participants in this double-blind, placebo-controlled study will receive 1 month of paroxetine and 1 month of placebo with the order of which is taken during the first month randomly assigned. Paroxetine will be administered at a daily dose of 10 mg for the first week and increased to a daily dose of 20 mg for the remainder of the study. After one month of medication, participants will abstain from smoking for one night and then undergo mental stress testing the following day. Immediately prior to the mental stress testing, participants will smoke a cigarette. Mental stressors will include speaking and math tasks. Physiological measures of stress (e.g., blood pressure, heart rate, and plasma catecholamine concentrations) and subjective measures of stress will be evaluated. Following the second month of medication, participants will again undergo the procedure for mental stress testing and evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Smokes an average of at least 10 cigarettes per day during the year prior to enrollment

Exclusion Criteria:

* Interested in quitting smoking within the 3 months following enrollment
* Current unstable medical condition
* Substance abuse within the year prior to enrollment
* Current use of any medications (e.g., psychoactive medications, antihypertensives) that, in the opinion of the investigators, might interfere with study measures or that would be expected to interact with paroxetine (e.g., CYP2D6 substrates)
* Smoking cessation therapy within the 3 months prior to enrollment
* Regular use of any form of tobacco other than cigarettes
* Significant psychiatric disorders as assessed by the PRIME-MD and verified by a clinician
* History of hypersensitivity to any selective serotonin reuptake inhibitor
* Pregnancy or breastfeeding
Low Carbohydrate and Conventional Diets Associated to Resistance Training on Muscle Fitness and Health Markers

The purpose of this study was to compare the effects of two different diets (low carbohydrate - LCD and conventional - CONV) on body composition, strength performance, muscle mass and biomarkers of health in overweight adults submitted to resistance training (RT). It has been hypothesized that LCD would produce higher rates of weight loss and that both diets would be useful to maintain muscle mass and strength and biomarkers of health.

Overweight and obesity prevalence has increased worldwide. Current guidelines recommend health behavior modifications, including better eating habits and regular physical activity (including resistance training - RT) as a strategy to control and prevent the problem. Traditionally, diets poor in energy and fat (conventional diets - CONV) have been recommended to promote losses in body and fat masses; however, there has been recently a growing interest in the academic community to investigate the effects of low carbohydrate diet (LCD) on health outcomes, since this kind of diet appears to be more effective for reducing body mass as compared to CONV. Nevertheless, evidences are scarce regarding the effects of LCD associated to RT on body composition, strength performance, blood lipids, endothelium function and other markers of health, demanding the development of clinical trials aiming to determine the combined health effects of these interventions.

Eligibility Criteria:
Inclusion Criteria:

* BMI equal or over 25 kg/m2
* resistance trained at least 12 weeks

Exclusion Criteria:

* upper or lower limbs injury
* pregnancy
* diabetes
* use of ergogenics, stimulants or drugs
* history of dislipidemias
* arterial hypertension
Effect of Topical Application of Iodex® Balm on Local Surface Temperature

The rationale of this study is to map out changes in temperature distribution brought about by topical application of our test product, and use this physiological phenomenon to visualize the onset of action involved in overall mechanism of action of the product.


Eligibility Criteria:
Inclusion Criteria:

* Participants suffering from chronic osteoarthritis of knee joint (as per American College of Rheumatology criteria) for \> 3 months
* Participants in good general and mental health with no clinically significant and relevant abnormalities of medical history or physical examination

Exclusion Criteria:

* Women of child bearing potential, pregnant and lactating women
* Intolerance/hypersensitivity to study material/ingredient
* Recent history of alcohol or drug abuse
* Participants receiving topical non-steroidal antiinflammatory drugs (NSAIDs), other topical analgesics/counterirritants/mineral oils, or other medication, which might interfere with study results
* Participants having psoriasis/active atopic dermatitis/eczema/skin infected lesions/burn/wound at the site of application
A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors

This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS - human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV), either as a monotherapy or in combination with pembrolizumab in patients with metastatic or advanced solid tumors.

CF33-hNIS, a novel chimeric orthopoxvirus, will be administered as a monotherapy or in combination with pembrolizumab to assess the safety and efficacy of the treatment regimens as well as immunological changes in the tumour microenvironment.

Patients eligible for treatment include those with any metastatic or advanced solid tumor who have documented radiological progression per RECIST following at least two prior lines of therapy which may have included treatment with an Immune Checkpoint Inhibitor.

All enrolled patients will be treated with CF33-hNIS on Day 1 and 8 of Cycle 1 and then on Day 1 of each cycle thereafter. Patients treated with the combination regimen will also received pembrolizumab beginning on Day 1 of each cycle beginning with Cycle 2.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from patient or legally authorized representative
* Age ≥ 18 years old on the date of consent
* Any metastatic or advanced solid tumor with documented radiological progression following at least two prior lines of treatment (which may have included prior immune checkpoint inhibitor treatment)
* ECOG performance status 0 - 2
* At least one measurable lesion
* Adequate renal function
* Adequate liver function
* Adequate hematologic function
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

* Prior treatment with a poxvirus based oncolytic virus.
* Continuous systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
* Prior radiotherapy within 2 weeks of start of study treatment.
* Active autoimmune disease
* Prior allogenic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state
* Inadequate pulmonary function per Investigator assessment.
* Uncontrolled brain or other central nervous system (CNS) metastases.
* History of documented congestive heart failure (New York Heart Association \[NYHA\] class III - IV), unstable angina, poorly controlled hypertension, clinically significant valvular heart disease or high-risk uncontrolled arrhythmias
Robotic Intervention Framework for Children With Autism Spectrum Disorder to Enhance Social Engagement and Participation

This study will develop and test a Robotic Intervention Framework for Children with ASD in the real context. The first part of this study will focus on the identification and initial testing of core elements of effective robotic intervention programs to form a practice framework. Pat II will use a randomized control trial to test the efficacy of the robotic intervention programs that incorporated all elements of the framework. Part III will use a qualitative approach to examine the qualitative outcomes of the program with reference to the elements of the practice framework. With a framework that is built upon evidence and tested sufficiently, practice guidelines and intervention protocol will be delineated to ensure success of robotic intervention programs.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of autism spectrum disorder
* aged between 5-11
* normal intelligence

Exclusion Criteria:

* with self-injurious or aggressive behavior
* with hearing or visual impairment
Survival and Success of MIS C1 Implants- a Field Study

The aim of the present study is to evaluate the 1-year and 3-year survival and success of MIS® C1 implants with a length of 10-15mm.

Specific Aims

1. To study 1-year and 3-year implant survival rate C1 implants
2. To study 1-year and 3-year implant bone level changes of C1 implants

10 implants will be allocated to each of the twelve dentists, for a total of 120 implants. One test implant per patient will be allowed into the study for a total of 120 patients.

The following data will be collected for each patient/implant:

1. Patient data including birthdate, health, surgery date.
2. Implant length, diameter
3. Insertion torque
4. Periapical radiographs (at insertion, and twelve months post surgery).
5. Post operative complications and adverse events.
6. Periodontal data around Ramfjord teeth (16, 21, 24, 36, 41, 44) : Plaque index, Gingival Index, Probing depth in six sites and Bleeding on probing in six sites, at baseline and twelve months post surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-75.
2. Patient expresses his wish to restore the missing tooth/teeth with implant therapy.
3. Partial edentulism with available bone height for dental implants ≥ 10mm mm.

Exclusion Criteria:

1. Contraindicating medical conditions such as uncontrolled diabetes, untreated malignancies, pregnancy, previous/current bisphosphonate therapy.
2. Untreated periodontal disease, untreated caries, periapical pathology in contact with the location of the perspective implant.
3. Major bone augmentation in conjunction with implant placement. Localised bone augmentation in conjunction with implant placement, of up to 3 mm on 1-2 aspects of the implant will be allowed.
4. One stage immediate loading/restoration.
Patch Study (Patch-augmented Rotator Cuff Repair)

This single-center, prospective, randomized controlled study will compare patients allocated to two treatment arms who are undergoing surgery to repair rotator cuff tears: (1) arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch, and (2) arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch. The primary objective is to compare complications (primarily retear rates) and the secondary objective is to compare mid- and long-term clinical and radiological outcomes using standard orthopedic assessments, such as the subjective shoulder value and the Constant-Murley score.

This single-center, prospective, randomized controlled study will compare patients allocated to two treatment arms who are undergoing surgery to repair rotator cuff tears: (1) arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch, and (2) arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch. The primary objective is to compare complications (primarily retear rates) and the secondary objective is to compare mid- and long-term clinical and radiological outcomes using standard orthopedic assessments, such as the subjective shoulder value and the Constant-Murley score.

The Pitch-Patch is a single-use synthetic polyester patch (Pitch-Patch, neoligamentsTM, Leeds, UK) intended to reinforce the rotator cuff following or during repair by sutures or suture anchors where weakness exists in the soft tissue. The surgical group will be randomly assigned, and each group will include 150 patients. After surgery, patients will be followed for two years and undergo clinical and radiological assessments.

The main research question to be answered by this investigation is whether synthetic patch augmentation can significantly improve outcomes in patients with rotator cuff tears from either degenerative or traumatic origins versus patients with no patch augmentation.

Eligibility Criteria:
Inclusion Criteria:

* Adults with massive rotator cuff tear
* Tear must affect at least two tendons
* Primary surgery only
* Origin of tear can be either degenerative or traumatic
* German language speaking

Exclusion Criteria:

* Fatty infiltration grade 4 (according to Goutallier)
* Bilateral tears
* Cases of arthritis or severe osteoarthritis
* Structural or pathological condition of the bone or soft tissue that could impair healing
* Unable or unwilling to restrict activities to prescribed levels or follow rehabilitation guidelines
* Unable or unwilling to give consent (language barrier or cognitive impairment)
* Unwilling or unable to be assessed at 1- and 2-year follow-up assessment visits