cyrilzakka/clinical-trials huggingface dataset:
A Restylane Treatment Algorithm Approach for Participants With Appearance of Insufficient Bone Structure in the Lower Face Alone or in Combination With Facial Soft Tissue Deficiencies

The study's main purpose is to evaluate the overall aesthetic improvement of the treated areas by treatment group, as assessed by the Investigator.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing to comply with the requirements of the study including being photographed, following post-treatment care instructions, attending all study visits and providing a signed written informed consent.
* Males or non-pregnant, non-breastfeeding females, over the age of 18.
* Intent to receive treatment for temporary augmentation in the chin region.

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins and/or local anesthetics, e.g., lidocaine or other amide-type anesthetics
* Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
* Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from the lower orbital rim.
* Any previous aesthetic procedures or implants.
* Use of concomitant medication that have the potential to prolong bleeding times such as anticoagulants or inhibitors of platelet aggregation.
* Participation in any other interventional clinical study within 30 days (about 4 and a half weeks) before baseline.
* 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 of EXPAREL in Patients Undergoing Breast Augmentation

This is a Phase 4, prospective, open-label, non-randomized, sequential study with two treatment groups differing only in the technique used for EXPAREL administration (instillation or infiltration).

Each subject underwent bilateral augmentation mammoplasty and received the same dose of EXPAREL. This primary objective of this study was to assess the efficacy of EXPAREL when administered via infiltration versus instillation as part of bilateral augmentation mammoplasty. The secondary objectives were to further assess other efficacy measures and the safety profile of EXPAREL.

Eligibility Criteria:
Inclusion Criteria:

* Female, 18-75 years of age inclusive.
* American Society of Anesthesiologists (ASA) physical status 1-3.
* Undergoing bilateral augmentation mammoplasty without any concurrent surgical procedure(s).
* Physically and mentally able to participate in the study and complete all study assessments.
* Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the study components.

Exclusion Criteria:

* History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
* Any subject whose anatomy or surgical procedure might, in the opinion of the Investigator, preclude the potential successful local administration of EXPAREL.
* Subjects currently pregnant or who may become pregnant during the course of the study.
* Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.
* Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
Impact of COVID-19 on the Benefit of Cardiac Rehabilitation

The COVID-19 attack is polymorphic with otorhinolaryngological, pneumological, cardiac, digestive, neurological, muscular attacks with a higher mortality in subjects with comorbidity \[\> 70 years old, cardiovascular history in particular Arterial hypertension (hypertension ), heart disease...\]. This polymorphism is linked to vasculitis and the immune response.

Patients with cardiovascular disease are particularly at risk of decompensating, particularly due to the increased metabolism induced by viral infection and reduced cardiovascular capacities.

On the cardiovascular level, two sides can be considered. On the one hand, cardiovascular disease (hypertension, coronary artery disease) is a comorbid factor. On the other hand, the myocardial damage reflected by the increase in troponin or an alteration of the ejection fraction is a very clear risk factor for death or severe form.

Cardiovascular involvement is particularly high in hospitalized and deceased patients. The odds ratio calculated in a meta-analysis of severe forms of covid-19 with hypertension is 3 \[1.9; 3.1\], for cardiovascular pathologies of 2.93 \[1.73; 4.96\]. Recommendations were made for pulmonary rehabilitation but not for cardiovascular rehabilitation.

Cardiac rehabilitation is indicated in most cardiovascular pathologies (after acute coronary syndrome, after coronary angioplasty, in heart failure, after coronary or valve heart surgery, etc.).

It consists of a multidisciplinary approach combining therapeutic pharmacological adjustment, physical activity, therapeutic education in order to improve physical capacities for exertion and reduce morbidity and mortality. The physical exercises can be endurance or resistance type.

Capacity gain at the end of rehabilitation is measured by visual scales, quality of life questionnaires, and a stress test at the start and end of rehabilitation. Most often, rehabilitation centers only do the stress test and estimate through questioning for subjective improvement.

The hypothesis is that patients who contracted COVID-19 would have lower cardiac capacities after recovery from the infection than patients without COVID-19 or that their capacity for recovery would be less. There could be a difference in recovery after cardiac rehabilitation between the two populations regardless of whether the cardiac damage requiring rehabilitation was triggered by COVID-19 or was pre-existing.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 18 years
* Patient referred for outpatient cardiovascular rehabilitation in one of the participating centers between 02/01/2020 and 12/31/2020
* French-speaking patient

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under legal protection
* Patient objecting to the use of their data as part of this research
Droxidopa / Pyridostigmine in Orthostatic Hypotension

This study is being done to study the combination of pyridostigmine and low-dose Droxidopa for the treatment of orthostatic hypotension.


Eligibility Criteria:
Inclusion Criteria

1. The presence of OH (fall in systolic BP \>=30 mm Hg) is required for this study.
2. Autonomic testing and clinical evaluation demonstrates OH to be of neurogenic etiology.

Exclusion Criteria:

1. Pregnant or lactating females.
2. Chronic illnesses or the presence of other conditions that potentially involve the CNS or affect autonomic testing. These include congestive heart failure, recent (\<6 months) myocardial infarct, severe anemia, diabetes mellitus, alcoholism, malignant neoplasms, amyloidosis, hypothyroidism, sympathectomy, cerebrovascular accidents, and neurotoxins or neuroactive drug exposure.
3. Orthopedic problems or cardiopulmonary disease, sufficient to compromise mobility and activity of daily living.
4. Any known concurrent infection or severe liver or kidney disease.
5. Medications that could affect autonomic function are suspended prior to autonomic testing. Therapy with midodrine, alpha and beta adrenergic antagonists, or other medications that affect autonomic function will be withdrawn 48 hours prior to autonomic evaluations. Fludrocortisone doses up to 0.2 mg per day will be permitted. Stable doses of antidepressants (tricyclics, SSRIs, SNRIs) will also be permitted. The 48h medication withdrawal is reviewed on a case by case basis - if felt unsafe by the investigators, the withdrawal period may be shortened. This will be documented in the study documents.
6. Occasional use of a neuroleptic as an anti-emetic in the past is allowed, but none can have been used within 3 weeks prior to this study.
7. Use of methylphenidate, cinnarizine, reserpine, amphetamine, atypical antipsychotics such as risperidone, olanzapine, and quetiapine or a MAO-A inhibitor within 3 weeks prior to this study.
8. Dementia (DSM-IV criteria - Amer. Psych. Assoc., 1994). The score on the Mini-Mental State Examination must be \>24.
9. History of stroke (diagnosed on clinical grounds as an acute deterioration of neurological function typical of a stroke; confirmatory CT or MRI evidence of stroke will be useful but not necessary).
10. History of electroconvulsive therapy.
11. History of brain surgery for Parkinson's disease.
Hypercapnic Spontaneous Hyperpnoea and Recovery From Sevoflurane Anesthesia

The rate of elimination of inhalation agent is directly proportional to the degree of alveolar ventilation. Using Isocapnic Hyperpnoea (IH) device, it is possible to maintain constant end-tidal CO2 with increased minute ventilation. This is achieved by passively adding a flow of CO2 to the inspirate in proportion to increases in ventilation above the baseline. In animal and human studies IH shortens the time of awakening from isoflurane and sevoflurane anesthesia when manual positive pressure ventilation is applied. IH device could be used for spontaneous hyperpnoea as well. The investigators want to compare recovery times from sevoflurane anesthesia in patients with application of hypercapnic spontaneous hyperpnoea (HSH) versus the standard anesthesia protocol (controls). 44 patients ill be randomized to either HSH facilitated recovery, or conventional recovery (controls).The time intervals from the end of anesthesia (turning off the vaporizer) until recovery milestones will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* elective gynecological surgery
* age 18-80
* ASA I-III
* informed consent

Exclusion Criteria:

* ASA IV-V,
* contra-indications to sevoflurane anesthesia or other anesthetics included in the protocol
* history of cardiac or respiratory disease
* intracranial pathology
* alcohol or drug abuse
* psychiatric illness and/or medications
The Efficacy Study of the Evidence-Based Psychological Intervention for Improving Resilience and Preventing Burnout of Residents

There are few systematic studies on the working environment and mental health of residents who are at the forefront of Korean medical care. In particular, there is no scientific research on burnout prevention. Since preventing burnout of surgical residents is directly related not only to personal well-being but the health of the patients, it is necessary to care for the individual's psychological state at a social level. This psychological intervention program that is expected to improve recovery resilience in stressful situations of residents and prevent burnout is implemented, and its effectiveness is to be verified.


Eligibility Criteria:
Inclusion Criteria:

* Surgical trainees (residents and clinical fellows) at Bundang Seoul National University Hospital, who is 20 years of age or older, regardless of sex or race.

Exclusion Criteria:

* Subjects who do not consent to the study
* Subjects with meditation experience
Impact of Physiotherapy on Spasticity, Upper Limb Function, Daily Activities, and Kinesiophobia in Hemiplegic Patients

This study investigated the effects of rehabilitation exercises on spasticity levels, upper extremity functions, activities of daily living, and kinesiophobia in patients with hemiplegia following a stroke.

Hemiplegia is a neurological condition characterized by paresis and movement limitations on one side of the body due to functional loss in one hemisphere of the brain caused by a vascular event after a stroke. This study aims to evaluate the effects of a physiotherapy and rehabilitation program on spasticity levels, upper extremity functions, activities of daily living, and kinesiophobia in patients with post-stroke hemiplegia.

Participants' spasticity levels were assessed using the Modified Ashworth Scale, upper extremity functions with the Fugl-Meyer Upper Extremity Motor Assessment, activities of daily living with the Barthel Index, and kinesiophobia levels with the Tampa Scale of Kinesiophobia. The treatment program consisted of 24 sessions, with three sessions per week. Each session lasted 45 minutes and included Transcutaneous Electrical Nerve Stimulation (TENS), range of motion exercises for upper and lower extremities, balance and coordination exercises, and weight transfer exercises. Assessments were conducted before and after the treatment.

As a result of the treatment program, a significant decrease in spasticity levels was observed in joints other than the hip joint, along with significant improvements in upper extremity functions and activities of daily living, and a significant reduction in kinesiophobia levels.

Physiotherapy and rehabilitation programs have been found to be effective in reducing spasticity, improving upper extremity functions and activities of daily living, and reducing kinesiophobia in post-stroke hemiplegic patients. These findings can contribute to the development of post-stroke rehabilitation strategies. Future research should deepen these findings with larger sample groups and long-term follow-up studies.

Eligibility Criteria:
Inclusion Criteria:

* Being between 22-79 years of age
* Having been diagnosed with a stroke (SVO)
* Possessing adequate language and cognitive skills
* Willingness to participate voluntarily
* Not having any chronic diseases that could affect the study outcomes

Exclusion Criteria:

* No other neurological problems affecting functionality besides hemiplegia
* Having cognitive impairment
Standard vs Mini-PCNL for the Treatment of Stone Disease

Randomized comparison of patient outcomes following standard PCNL versus mini-PCNL.

This study is a randomized controlled trial which compares the operative outcomes and complications of mini-percutaneous nephrolithotomy (mini-PCNL) versus standard PCNL for renal stones. This study will be a multi-institutional, prospective randomized controlled clinical trial with patients who have already agreed to undergo PCNL. Patients will be randomized at a 1:1 ratio to receive either standard PCNL or mini-PCNL, defined as tract sizes of 30 and 16.5 to 18 French respectively. Patients will be asked to complete pre-operative, and post-operative quality of life questionnaires, and to allow collection of one additional vial of blood for measurement of factors associated with inflammation. The participating institutions are academic medical centers in the United States and Canada that are part of the EDGE research consortium.

Eligibility Criteria:
Inclusion Criteria:

* Patients planned for PCNL at participating institutions
* Age ≥ 18 years old
* Male and female patients
* Patients of all ethnic backgrounds
* Stone size 10-20mm

Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study.

Exclusion Criteria:

* Conversion to open procedure
* Multiple access tracts
* Anticoagulated or history of coagulopathy
* Preoperative ureteral stent or nephrostomy tube placement
* Technical problems/impossibility of localizing the stone on the day of intervention

Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.
A Self-Guided Intervention to Promote Condom Use Among African American Males

The Centers for Disease Control and Prevention has declared that AIDS is a "state of emergency" in the US for African Americans - young African American men are especially vulnerable in this epidemic. Thus, the development of effective interventions tailored to this population is a national priority. The investigators previous preliminary studies suggest that a brief, clinic-initiated, home-based, self-guided condom use program may effectively promote the acceptance of condom use and increase the quality and consistency of condom-protected sexual behaviors. This pilot study will (1) develop and test the feasibility of this program (Homework Intervention Strategy, HIS) for young African American men attending an urban STD clinic and (2) identify variables that may mediate the efficacy of the program. The HIS has the potential to be readily translated into widespread practice, while requiring only minimal resources. Unlike previously tested interventions, the HIS can be applied to all men who use condoms, regardless of the sex of their partners or their HIV/STI status. To develop the HIS to meet the needs of these high-risk men, the proposed study will include a formative phase during which the basic intervention "instructions" which will be delivered by DVD will be refined and tailored for this population.

One hundred young African American men recruited from an urban STD clinic will be randomized to each of two groups (HIS vs. "standard of care") in a randomized 2-arm trial with 5 assessment periods over the course of 6 months. Assessments will compare the groups on frequency of unprotected sex, quality of the condom use experience, experience of condom use errors and problems, attitudes regarding condom use, condom use acceptability, and condom use self-efficacy and confidence.


Eligibility Criteria:
Inclusion Criteria:

* African American men
* 15 to 24 years of age
* able to read, write and comprehend English
* have engaged penile-vaginal intercourse (PVI) or insertive penile-anal intercourse (PAI) with a partner at least once in the past 30 days
* willing to use a condom
* does not intend to get a partner pregnant in the next 6 months
* consent to participate in the study
* client of the Bell Flower Clinic in Indianapolis, IN in the past 12 months
* has maintained a cell-phone number for the past three months and is willing to use it for data collection and incur fees for voice communication or text messaging it they do not have unlimited plans
Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel

The primary objective is to evaluate the effectiveness of Benepali in participants with Rheumatoid Arthritis (RA) and axial spondyloarthritis (axSpA), including participants with Ankylosing Spondylitis (AS) and non-radiographic axSpA, following their transition from treatment with Enbrel.

The secondary objectives of this study are to describe clinical characteristics of patients transitioned from Enbrel® to Benepali® in routine practice, to evaluate safety during and following the transition from Enbrel to Benepali and to evaluate patient-reported outcomes during and following the transition from Enbrel to Benepali.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have been diagnosed with either rheumatoid arthritis or axial spondyloarthritis, according to local practice
* Transition from Enbrel to Benepali at the physician's (Investigator's) discretion prior to enrolment into the study
* Must have been treated with the same dose of Enbrel for at least 6 months prior to transition to Benepali and have at least 1 efficacy data value including but not restricted to DAS-28 or BASDAI during that period
* Must have a stable disease throughout the 2 month prior to enrolment based on the Investigator's judgement
* Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during Benepali therapy and for three weeks after discontinuation of therapy

Key Exclusion Criteria:

* Have any medical conditions that precludes administration of Benepali according to Summary of Product Characteristics (SmPC), such as the following:
* Hypersensitivity to the Benepali active substance, or to any of the associated excipients
* Sepsis, or risk of sepsis
* Active clinically significant local or chronic viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 2 months prior to enrollment
* Show any clinical sign or medical condition not allowing for treatment continuation (of etanercept) in the judgment of the Investigator
* Treatment with another biologic agent
* Are currently receiving or have previously received any therapies that would preclude administration of Benepali, such as the following:
* Immunizations with live or live-attenuated vaccines within the last 6 months prior to transition point and throughout the observation period
* Treatment with investigational agents within the last 6 months prior to transition point and during the period of observation.
* Any other unspecified reasons that would, in the opinion of the Investigator, make the patient unsuitable for enrollment.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Nutrition and Soccer for Pediatric Overweight and Obesity

This study will examine whether two months of youth soccer, combined with a single brief behavioral/nutritional intervention, can reduce BMI in 5th grade overweight or obese females.

Female overweight and obese public school students will be recruited during the summer of 2006 based on FitnessGram testing done by graduate students at MSU during their prior (4th grade) school year. After receiving informed consent from parent/child, the subjects will be checked for height/weight and other screening criteria, then exposed to 2005 My Pyramid for Kids, "Tips for Families" information, and watch a short 8 minute DVD that discusses the importance of exercise and fitness by way of interviewing two club level female soccer players of equivalent age. Subjects will then be randomly assigned to fall youth soccer in Starkville, or spring youth soccer, after first phase data collection occurs in November, 2006.

Eligibility Criteria:
Inclusion Criteria:

* obese or overweight 4th grade public school student in Starkville

Exclusion Criteria:

* unable to run or physical disease or disability
Endoprosthetic Replacement for Pathological Fractures of the Hip: A 35-year Update

This study will be based on a retrospective review of patients who received endoprosthetic reconstruction for pathologic fracture of the proximal femur. The objectives would be two-fold: (1) to compare rates ofambulation, pain, and survival to the historic cohort and (2) to identify predictors of ambulation in the current population.


Eligibility Criteria:
Inclusion Criteria:

* Participants have received endoprosthetic reconstruction for pathologic fracture of the proximal femur

Exclusion Criteria:

* Participants with fractures greater than 3mm from the lesser trochanter
* Participants without histopathologic confirmation of tumor