cyrilzakka/clinical-trials huggingface dataset:
The Evaluation of the Safety and Effectiveness of a Novel Gel-type Sodium Hyaluronate for the Correction of Aging Mid-face

This study is to evaluate the safety and effectiveness for the correction of aging mid-face of treatment group compared with the negative control group.


Eligibility Criteria:
Inclusion Criteria:

1. Age 30 to 60 years of male or female
2. MidFace Volume Deficit Scale (MFVDS) of midface graded 2 to 5 by evaluator.

Exclusion Criteria:

1. Injection site with infection or other skin diseases present which may affect the evaluation
2. With medical history of chromatosis, discoloration, keloid formation, hypertrophic scarring at midface
3. With permanent implants or planning to receive permanent implants during the study period at the injection sites
4. Hyaluronate facial dermal implant injection or other impermanent dermal fillers injection at injection sites within the past 6 months
5. With under-eye facial Botox or fat injection within the past 6 months or planning to receive under-eye facial Botox or fat injection during the study period
6. With Major surgery 3 months before the start of the trial
7. With under-eye facial chemical or lasers peeling, non-invasive skin tightening, thermocool within the past 3 months or planning to receive these aesthetic procedures during the study period
8. With systemic immunosuppressive therapy or systemic corticosteroids within the past 2 months or planning to receive these therapies during the study period (subjects who have received inhaled/intranasal corticosteroids could be considered to include.)
9. With clinical meaningful coagulation disorders, underdoing anticoagulant treatment or within the past 10 days, or taking blood circulation promotion and blood stasis movement medications
10. With epilepsy or porphyria
11. With congenital or idiopathic methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency
12. With analgesic dependence, analgesics within the past 2 weeks or planning to receive analgesics during the study period
13. With history of hypersensitivity or allergy to lidocaine, amide anesthetics, hyaluronic acid or any component of the device; Gram-positive bacterial or Streptococcus proteins; other severe hypersensitivity history unsuitable for participating in the study
14. Planning to undergo any surgery which may cause significant body weight change (such as bariatric surgery) or take any medication which may cause significant body weight change
15. Pregnant, planning pregnancy or in breastfeeding females
16. Participated in clinical study of other device or drug and have not terminated within the past 30 days -Other circumstances which judged to be unsuitable for participating in the study by the investigator
Acceptance and Commitment Therapy with and Without Enhanced Mindfulness Training for Chronic Pain

As non-pharmacological alternatives, psychosocial treatments have been recommended for chronic pain management. One such treatment is Acceptance and Commitment Therapy (ACT). ACT is a cognitive behavior therapy based on Relational Frame Theory, a comprehensive theory about language and cognition. This treatment intends to help patients identify values ("what is truly meaningful to them") and to set goals and take action according to their values. ACT has research support in the treatment of several mental health problems. Moreover patients are taught mindfulness skills to increase acceptance of pain, thoughts and feelings so that these will have less impact on functioning and action. Among patients with chronic pain, several small clinical trials have shown that ACT is more effective than other treatments in terms of increasing function and improving mental health. ACT in combination with mindfulness training has not been tested so far. Further methodologically robust trials are required. This study will therefore examine whether ACT is more effective for chronic pain than an education program, and whether adding daily mindfulness training will improve the outcome, in a large sample of patients from four multidisciplinary pain centers.


Eligibility Criteria:
Inclusion Criteria:

* referred to one of the pain clinics in Oslo (200), Trondheim (200), Bergen (100) or Tromsø (100)
* primary diagnosis of chronic pain lasting for at least 6 months

Exclusion Criteria:

* severe somatic disease
* severe mental disorder (ongoing mania, psychosis, suicidal ideation, substance abuse/addiction
* not able to communicate in Norwegian
* needing 24-hour personal assistance
Frequency of Prostate-Specific Antigen Screening in African American Men in the San Francisco Area

RATIONALE: Screening may help doctors find prostate cancer sooner, when it may be easier to treat.

PURPOSE: This research study is looking at whether patients who are being screened for prostate cancer have been previously screened.

OBJECTIVES:

Primary

* To determine the degree to which patients who are being screened for prostate cancer have been previously screened.

OUTLINE: Participants complete questions on a survey about prior prostate-specific antigen blood tests done for the purpose of screening for prostate cancer and are asked about their pastor, church, and how they heard about the SELECT study to determine the degree to which African-American men in a church-going population have been previously screened.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets all of the following criteria:

  * African-American male
  * Age 35 years or older
  * Attends church on a regular basis
  * Resides in the San Francisco area

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
A Pilot Functional Performances Study of Two Synthetic Male Condom

Over the decades, male condoms had been widely commercialized and used to protect against unintended pregnancy and sexually transmitted infections (STI). While natural rubber latex (NRL) male condoms has majority proportion of male condoms in the market, synthetic male condoms (SMC) made from polyurethane or other synthetic materials remain new to the consumers. Notably, synthetic male condoms are found to be more durable, non-allergenic and have better compatibility with lubricants when compared to NRL male condoms. The SMCs that have FDA approval and commercially available are AvantiTM (polyisoprene condom), Trojan SupraTM (polyurethane condom) and eZ.onTM (polyurethane condom). Although the effectiveness of SMCs in the prevention of sexually transmitted infections has yet to be established, SMCs are believed to be comparable to NRL male condoms in both STI prevention and contraception protection. Notwithstanding, a recent literature had reported the shortfall on the quality of variant male condoms in the market, especially nonconforming volumetric capacity, burst pressure and freedom from holes. This warrant the current investigation, to evaluate the functional performances of two newly invented synthetic male condoms, branded as "WONDALEAF-CAP" (WLC) and "WONDALEAF-ON-MAN" (WLM). Apart from being made of polyurethane, the major feature of WLC and WLM are nonetheless their adhesive coating on the outer rim of the condom opening which by securely adhering to the foreskin, prevent slippage of condom and spillage of male ejaculate or secretions when the penis is flaccid, and thereby improve the user-friendliness of condom usage.


Eligibility Criteria:
Inclusion Criteria:

1. Their female sexual partners are not at risk of pregnancy (using alternate contraception);
2. They don't have known sexually transmitted infections, including HIV/AIDS;
3. They should be experienced condom users, minimum 10 male condoms used in the last 12 months;
4. They are between 18 to 45 years of age;
5. They are in a monogamous heterosexual relationship and agree to practice vaginal sex only using male condoms provided by the study.

Exclusion Criteria:

1. couples who work for the research team or who are close relatives of the research team;
2. men with known allergy to natural rubber latex;
3. men with known sensitivity to the residual chemicals used in the manufacture of natural rubber latex condoms or the test condom materials;
4. couples where one knowingly has a sexually transmitted infection.
5. couples who are pregnant in time of recruitment
The Collateral Impact of Bariatric Surgery on Families

This proposal is designed to examine the impact of bariatric surgery on the health of patients and their families. The shared environment of spouses/cohabitating partners suggests that patients' families are exposed to the extensive diet and lifestyle changes required of patients following bariatric surgery.

The specific aims of this proposal are to:

1. Collect clinical data (e.g., weight, blood pressure, body composition, blood sample), as well as monitor physical activity and eating patterns, before and after bariatric surgery (Adults Only).
2. Analyze clinical data, physical activity and eating patterns to determine how the health of patients and their families change after one family member completes bariatric surgery (Adults Only).
3. Determine the feasibility of recruiting patients, spouses/partners and their children.

Eligibility Criteria:
Inclusion Criteria:

* All patients who receive surgery have been cleared medically and psychosocially for surgery. Thus, surgical candidacy criteria will serve as eligibility criteria for the current study for surgical patients.
* Cohabitation with patients will be considered inclusion criteria for partners/spouses.
* Children between the ages of ≥5 - ≤ 16, who cohabitate with the patient the majority of the time will be asked to participate by providing assent.

Exclusion Criteria:

* Report current or planned use of weight loss medications (including OTC), or other weight loss strategy.
* Report pregnancy, lactation, or plans to become pregnant during study duration.
JETi Hong Kong Post Market Study (PMS)

The JETi Hong Kong PMS is a single-arm, multicenter study to collect real-world data on the safety, performance, and clinical benefits of the JETi System for the treatment of acute and subacute thrombosis in the peripheral vasculature. This is a post-market study that will register approximately 20 subjects at approximately 5 centers in Hong Kong. Subjects participating in this study will be followed for up to 30 days (in cases of prospective consent) after Day 0. Day 0 is defined as the day when the JETi catheter is introduced into the intended vasculature of the subject.

The JETi System is a hydro-mechanical aspiration system manufactured by Abbott Medical, consisting of a catheter, pump set, and accessories. The system is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature and to subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

This study will collect data on how the JETi System performs in the treatment of patients undergoing a percutaneous thrombectomy procedure for peripheral thrombosis. Subjects treated for arterial, venous, or arteriovenous thromboses, and subject with diagnoses such as acute limb ischemia (ALI), chronic limb ischemia/chronic limb threatening ischemia (CLI/CTLI), peripheral artery disease (PAD), deep vein thrombosis (DVT), hemodialysis access thrombosis, and others may be included.

Both prospective and retrospective consent (if all assessments needed for the primary endpoints are complete) are permitted. After index procedure, subjects will be evaluated at discharge and 30 days in cases of prospective consent. In cases of retrospective consent, duration of participation will vary. If consent occurs after the procedure and prior to 30 days, the subject will be asked to return for a 30-day visit. If consent occurs after 30 days, the subject will not need to return for a study visit. Relevant data will be collected from the medical record.

Eligibility Criteria:
Inclusion Criteria:

1. Subject was treated or is expected to be treated for acute/subacute thrombosis, as determined by investigator, in the peripheral vasculature with the JETi Hydrodynamic Thrombectomy System.
2. Subject or legally authorized representative must provide written informed consent
3. Subject must be ≥ 18 years of age and of Asian race.

Exclusion Criteria:

1. Subject has previously been registered in the JETi Hong Kong PMS in the last 12 months unless treated in the contralateral limb/different anatomy; patients treated in the contralateral limb/different anatomy within the last 12 months may re-enroll in the study.
2. Subject is currently participating in another drug or device clinical investigation.
3. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading infectious agent within the past 20 days.
Oxytocin Levels in Typically Developing Boys

Measuring basal levels of plasma oxytocin in individuals with typical development across childhood and adolescence using both extracted and unextracted EIA methods.

Measuring basal levels of plasma oxytocin in individuals with typical development across childhood and adolescence using both extracted and unextracted EIA methods. This study is necessary since there is great variability in reported plasma oxytocin in typically developing children from other studies as well as up to 1000 fold variability in such levels using different assay procedures. Further existing studies have not clearly described variation in levels with age. all samples will be taken in the afternoon.

Eligibility Criteria:
Inclusion Criteria:

* Between 3 and 17 years old, inclusive
* Consent of parent or guardian.

Exclusion Criteria:

* Exclusion Criteria for Healthy Control Participants:
* Female gender
* Evidence of a mental health diagnosis
* Evidence of significant medical condition (ie: renal, cardiovascular or genetic disease)
* First degree family member with an ASD diagnosis
Analysis of Three-dimensional Movements of the Head in Cervical Dystonia

This study addresses postures and range of motion in cervical dystonia (Spasmodic Torticollis). It uses 3D miniature and wireless motion captures sensors, and aims to increase the understanding of the biomechanics of the movement disorders of the cervical column in this pathology. In addition, the clinical state of cervical dystonia of the patients will be assessed, using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). The investigators will compare the results between control and study groups.


Eligibility Criteria:
Inclusion Criteria:

* Segmental cervical dystonia diagnosed by a neurological specialist in movement disorders

Exclusion Criteria:

* Neurological pathology other than cervical dystonia such as Parkinson's disease, head tremor, severe pain or cervical ailment, which would have required a treatment within the last six months
* Neuroleptic treatment in course
* Pregnancy
* breast feeding
Nursing Students & Positive Birth Perception & Simulation

The study aimed to investigate the impact of simulation-based training on nursing students' perception of positive birth and natural birthing approaches.

This study aimed to determine whether simulation-based training could improve the perception of positive birth and natural birthing approaches among fourth-year nursing students. The study used a randomized controlled quasi-experimental design with pre-test and post-test. The intervention group received hybrid simulation, while the other received video-modeling training. The study used several tools to assess the impact of the training, including the Demographic Information Form, Natural Birth Approach Questionnaire, Student Satisfaction and Confidence in Learning Scale, Satisfaction with Education Methods Questionnaire, and Natural Birth Approach Clinical Skills Guide.

Eligibility Criteria:
Inclusion Criteria:

* The voluntarily agree to participate in the study Not having experience with simulation Being a 4th year nursing undergraduate student not working as a nurse

Exclusion Criteria:

* During the study, participants must complete all forms, attend all theoretical training, and remain in the study until completion.
Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis

To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients with vernal keratoconjunctivitis

To give a chance of continuous use of 0.1% FK506 ophthalmic suspension to patients with vernal keratoconjunctivitis who were enrolled in the FJ-506D-AC09 study, long-term safety and efficacy were evaluated. Primary efficacy endpoint was the mean change from the baseline (before the treatment) in total score for objective clinical signs.

Eligibility Criteria:
Inclusion Criteria:

* Vernal keratoconjunctivitis patients who were enrolled in the FJ-506D-AC09 study
* Patients who wish to receive continuous administration of FK506 ophthalmic suspension

Exclusion Criteria:

* Subjects who needed prohibited concomitant therapy at the initiation of the study
* Subjects who needed to wear contact lenses during treatment period on a testing eye
* Subjects with complicating an eye infection
Assessing Outcomes After Surgery for Gastroesophageal Reflux Disorder

The purpose of this study is to review pre-operative studies and patient evaluation reports and compare those with the results of the post-operative studies, patient evaluation reports and subjective patients' outcomes following laparoscopic surgery for gastroesophageal reflux disorder. This will allow us to evaluate how patients have benefited from the procedure.

This study will include all patients who have laparoscopic surgery for gastroesophageal reflux disorder. Patients who participate will be asked to answer questionnaires regarding symptoms of reflux before and after surgery. In addition medical charts will be reviewed for relevant data.

Eligibility Criteria:
Inclusion Criteria:

* patients must have GERD and must plan to have laparoscopic surgery for GERD.
* patients must be at least 18 years of age
Ankle-foot Orthoses for Peripheral Artery Disease

The primary aim of this study is to investigate the effect of an ankle foot orthoses (AFO) on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD).

The investigators will test the hypothesis that PAD patients using an AFO during a graded exercise test will demonstrate a greater PWT compared to PWT assessed without the use of an AFO. Secondary hypotheses include evaluation of the effect of an AFO on: 1) calf muscle function, 2) claudication onset time, 3) functional ability, 4) peak oxygen consumption, and 5) patient-reported outcomes. We will also examine the effects of the AFO on outcomes following 12 weeks of community walking.

Eligibility Criteria:
Inclusion Criteria:

* Men and women diagnosed with atherosclerotic peripheral arterial disease (PAD).
* Patients who experience calf claudication
* ≥40 years of age
* An abnormal ankle-brachial index (ABI) of ≤.90.
* For patients with an ABI \>.90 and \<1.00, a post-exercise ABI drop of 15% or more compared to the resting ABI

Exclusion Criteria:

* Lower extremity amputation(s) which interfere(s) with walking.
* Critical limb ischemia (i.e., ischemic rest pain, ulcers/gangrene on the lower extremities).
* Non-atherosclerotic PAD (e.g., popliteal entrapment syndrome, Takayasu's arteritis)
* Major surgical procedures that are contraindicated to an exercise program (e.g., recent organ transplant) or coronary artery bypass graft within 6 months prior to screening.
* Primarily limitations to exercise due to chronic obstructive pulmonary disease, angina or heart failure.
* Myocardial infarction within 3 months prior to screening.
* Acute coronary syndrome symptoms diagnosed at time of screening.
* Significant ischemic changes (documented on the 12-lead electrocardiogram) with horizontal or down-sloping ST-segment depression ≥ 0.5mm at rest and \>1 mm with exercise in 3 beats for 2 contiguous leads, relative to the PR-segment (or ST-segment elevation ≥1mm).
* Transient ischemic attack or stroke 3 months prior to screening.
* New left bundle branch block or sustained ventricular tachycardia \>30 seconds during screening.
* Uncontrolled hypertension defined as ≥180 systolic or ≥100 diastolic resting blood pressure during screening.
* Women who are pregnant (women of childbearing potential, a pregnancy test will be performed at screening.
* Individuals currently incarcerated.
* Evidence of acute impairment from alcohol or other illicit drugs.
* Lack of diabetes control (glycated hemoglobin \>12%)
* Patients who are anemic (Hgb \<11 g/dL for women and \<10 g/dL for men).
* Any other clinically significant diseases (e.g., pulmonary, renal, psychiatric, immunological) that are not stabilized or may otherwise confound the results of the study.
Investigating the Effect of a Smartphone-based Serious Game on Depressive Symptoms.

The objective of the present project is to study the effect of a smartphone-based serious game intervention for depressive symptoms. The serious game is based on Cognitive Behavior Therapy CBT, being behavioural activation and the promotion of physical activity one of the most important components.

Due to the current COVID-19 pandemic and the effects of quarantine on people's daily lives, a dramatic increase in people suffering from symptoms of depression is expected; one of the most common mental disorders globally, the primary cause of suicide deaths in Europe and the major contributor to the overall global burden of disease.

Although there are effective treatments for depression, more than half of those affected worldwide (and more than 90% in many countries) do not receive these treatments. The dominant model of treatment delivery (individual face-to-face therapy) will not be enough to reach the majority of people who need treatment. Hence, one of the most important challenges within this scope is the design of new forms of treatment delivery to maximize the efficacy and dissemination of psychological treatment.

The use of the Information and Communication Technologies (ICTs) has allowed a new effective ways of treatment, endorsed by several studies; and the use of serious video games as a partial or complete form of treatment, whose own characteristics make them potentially effective for the treatment of mental health, has opened the possibility of a still very new field of study. The arrival of smartphones has increased the possibilities of designing online therapies for mental health and facilitated the use of games as therapy.

Therefore, the objective of the present project is to study the effect of a smartphone-based serious game intervention for depressive symptoms through a two armed pilot randomized control trial. A minimum of 40 participants diagnosed with mild to moderate depression symptoms will be randomly assigned to one of the two experimental conditions: a smartphone-based serious game condition, and a waiting list control condition. The researchers' hypothesis is that the smartphone-based serious game intervention will produce a significant improvement in depressive, anxious symptomatology and improved well-being after treatment compared to the waiting list control group.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Being able to read and understand Spanish
* Being able to use a smartphone
* Having an Android smartphone with internet connection
* Suffering from mild to moderate depressive symptoms (from 14 to 28 on the Beck Depression Inventory-II \[BDI-II\]

Exclusion Criteria:

* Suffering a severe mental disorder: bipolar disorder, alcohol and/ or substance dependence disorder, psychotic disorder, or dementia
* Having a high suicide risk (ideation or plan assessed by the MINI and item 9 of the BDI-II)
* Receiving another psychological treatment while the study is still ongoing.