cyrilzakka/clinical-trials huggingface dataset:
Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.

The regulation of clitoral vascularization by sex steroids is still under-investigated. We aimed to explore the effects of 6 months transdermal Testosterone (T) therapy on clitoral color Doppler ultrasound (CDU) parameters in pre- and postmenopausal women with female sexual dysfunction (FSD). In order to do that, we retrospectively recruited n=81 women with FSD, divided into 4 groups according to different treatments followed as per clinical practice, for 6 months: transdermal systemic 2% T gel; local estradiol ovules; local non-hormonal moisturizers; transdermal T plus local estrogens.

Our main hypothesis is that systemic T treatment is able to positively modulate clitoral blood flow in basal conditions, specifically to increase clitoral artery Peak systolic velocity (PSV).

Strong clinical evidence supports the use of transdermal systemic testosterone (T) treatment for Hypoactive Sexual Desire Disorder (HSDD) in menopausal women. According to preclinical studies, T is necessary to maintain the functional machinery underlying clitoral arousal response. In hypogonadal men with erectile dysfunction, T replacement therapy is able to improve penile vasodilation as assessed by using color Doppler ultrasound (CDU). On the other hand, the regulation of clitoral vascularization by sex steroids is still under-investigated.

We aimed to explore the effects of 6 months T therapy on clitoral CDU parameters and sexual function in pre- and postmenopausal women with female sexual dysfunction (FSD).

Adult heterosexual women attending our clinic for sexual concerns were retrospectively recruited. A subgroup of sexually active patients with FSD (n=81) was divided into 4 different groups according to different treatments followed as per clinical practice: women with Hypoactive Sexual Desire Disorder (HSDD) treated with off-label transdermal 2% T gel once daily (300 mcg T per day, n=23); women with dyspareunia due to moderate to severe vulvovaginal atrophy (VVA), treated with local estrogens (estradiol ovules) taken daily for 2 weeks and afterwards twice a week (n=12); women with dyspareunia due to mild to moderate VVA, treated with non-hormonal moisturizers every 2-3 days (n=37); women with HSDD reporting also significant dyspareunia due to moderate to severe VVA, treated with combined therapy (transdermal T and local estrogens) (n=9). Patients underwent physical, laboratory, uterine and genital (clitoral and uterine arteries) CDU examinations, and completed the Female Sexual Function Index (FSFI). at baseline and after 6 months.

Our main hypothesis is that systemic T treatment is able to positively modulate clitoral blood flow in basal conditions, specifically to increase clitoral artery Peak systolic velocity (PSV).

Eligibility Criteria:
Inclusion Criteria:

* being heterosexual.

Exclusion Criteria:

* history of drug or alcohol abuse
* a diagnosis of uncontrolled or unstable mental or organic disease.
LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery

After surgery on his penis, your child will probably have some pain. The investigators will give you a prescription for acetaminophen (Tylenol) with codeine, given by mouth (orally), for pain. In this study, the investigators want to see if a local anesthetic cream applied to the base of the shaft of the penis can reduce the need for oral medicine .

Your child will receive a general anesthetic for the surgery. After your child is asleep, he will receive a local anesthetic injection in the area of the tailbone (normal procedure for this surgery). At the end of the operation your child will go to the recovery room. At the time of discharge from the hospital, we will be give you the prescription for acetaminophen with codeine (standard medication given for children undergoing surgery on the penis), and a tube of cream. The tube will contain either a local anesthetic cream (LMX-4)® or a cream with no active medicine (a placebo). We want you to apply the cream to the base of your son's penis every six hours. Which kind of tube you get will be picked randomly (similar to drawing numbers out of a hat) by a computer. Thirty minutes after applying the study cream, or sooner if needed, if you think your child needs pain medication, you may give the oral pain medicine (Tylenol with codeine as prescribed on the bottle). You may continue to apply the cream and give oral medicine every six hours as long as you think your child needs pain medicine for a maximum of 7 days. The cream can also be re-applied when changing diapers to facilitate the continued use of the cream even if it is sooner than the suggested 6 hours.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 3 months to less than 3 years of age (at least 3 months old but not yet reached his 3rd birthday at the time of enrollment).
* Subject has presented with a clinical diagnosis of buried penis
* With the exception of the disease being studied, subject is in good health in the opinion of the investigator.
* Subject and parent(s) or legal guardian(s) must agree to the requirements and restrictions of the study and will appear for all required examinations.
* Subject's parent or legal guardian must sign a written, IRB-approved informed consent prior to admission into the study, and must be able to understand that consent form.

Exclusion Criteria:

* Subject has a known hypersensitivity to any component of the study medication.
* Subject has history or evidence of other conditions that would interfere with evaluation of the study medication.
* Subject has been treated with another investigational device or drug within 30 days prior to study enrollment, or is participating in a clinical trial at the time of enrollment or intends to participate in a clinical trial concurrent with this study.
"Program "Cerdanya on Fitness" to Improve the Lifestyle of People With Obesity in Cerdanya (CF).

To evaluate the effectiveness of an intervention program called "Cerdanya on fitness" based on the prescription of physical activity, healthy nutritional habits and the promotion of positive mental health, adapted to people with obesity to improve their lifestyle and psychoemotional wellbeing

Previous phase:Presentation of the protocol to doctors and nurses of the primary health care center.

Phase 1: After being informed about the study and the possible risks, all patients who give their written informed consent will undergo.

-1) 4 weeks of screening to determine eligibility to enter the study. Referral of patients who meet the inclusion/exclusion criteria to enter the Cerdanya on fitness program by the nursing consultation.

Phase I protocol data collection (physical activity scale, positive mental health scale, Mediterranean diet scale, sociodemographic variables will also be collected week 0) Patients who meet the eligibility requirements will be randomized in a non-blinded fashion. (control group and research group) (5 weeks)

weeks 1-2: Initial assessment of physical fitness and dietary habits in the intervention group (blood test- stress test- anthropometry)

week 3-39: Implementation of the intervention (nutritional, physical activity and psychosocial) to the intervention group. The control group will continue with the usual nursing controls in the primary care center.

40-41 week: Final evaluation of the physical condition and eating habits of the intervention group (blood test, stress test, anthropometry): Final data collection of the control and intervention group (physical activity scale, positive mental health scale, Mediterranean diet scale).

Translated with www.DeepL.com/Translator (free version)

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Body Mass Index 30-40

Exclusion Criteria:

* Serious cognitive impairment
* Serious mental disorder
* Impossibility of performing physical activity for medical diagnosis (IAM \< 3 months, hemorrhagic stroke \< 3 months, major surgery \< 3 months)
* Severe mobility difficulties (people with use of devices such as cane, walker, wheelchair..)
Heterologous Booster Study of COVID-19 Protein Subunit Recombinant Vaccine in Children 12-17 Years of Age

The goal of this clinical trial is to evaluate immune response and safety of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac) as a heterologous booster dose in healthy children 12-17 years of age.

Participants who had received complete primary doses of inactivated (Sinovac®) COVID-19 Vaccine will be given IndoVac as a booster dose.

This trial is open label prospective intervention study. In this study 150 subjects who had received complete primary doses of inactivated (Sinovac®) COVID-19 Vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial.

Subject will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac).

Eligibility Criteria:
Inclusion Criteria:

1. Clinically healthy children 12-17 years of age.
2. Subjects who have previously received complete primary series of inactivated (Sinovac®) COVID-19 vaccine with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion.
3. Parent/legal guardian and subject has been informed properly regarding the study, and signed the informed consent form (parent/legal guardian) and assent form (subject).
4. Parent and/or legal guardian will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial.
2. Subject who has received booster dose of COVID-19 vaccine.
3. Subject who has history of COVID-19 in the last 3 months (based on anamnesis or other examinations).
4. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
5. History of uncontrolled asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
6. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
7. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.
8. Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\> 2 weeks)).
9. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
10. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
11. Female who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
12. Subjects plan to move from the study area before the end of study period.
Comparison Between Functional Outcomes of Flexor Tendon Repair Under WALANT and Brachial Plexus Block

Although outcomes after flexor tendon repair have reportedly improved with modern treatment, complications are common. Early passive and active motion protocols have improved outcomes of flexor tendon repairs. One potential complication of early motion occurs when the forces produced by this motion exceed the strength of the repair, which leads to gap formation and inhibits healing. Wide Awake Local Anesthesia No Tournique (WALANT) is a new anesthesia technique that has gained popularity among plastic surgeons. It was developed by Dr. Lalonde in Canada, and it involves the use of Lidocaine and adrenaline in the surgical site to control bleeding without the need for a tourniquet. Peripheral nerve blocks are overall safe when performed correctly, there are rare but serious risks associated with them. Risks include block failure, bleeding, infection, damage to surrounding structures, permanent nerve injury, and intravascular uptake of local anesthetic resulting in systemic toxicity.

WALANT can be applied in both elective and emergency surgeries and is commonly used for procedures involving the hand, wrist, and fingers, such as root tunnels syndromes, trigger finger, and fractures. However, it has some limitations and contraindications, including patients with coagulopathy or on anticoagulant therapy, those with allergies to any of the anesthesia components, or patients with a history of psychiatric disorders or aggressive behavior. Infraclavicular brachial plexus block (ICBPB) is widely used for anesthesia or analgesia during surgery on the hand and forearm. Today, it is most frequently performed using a sagittal ultrasound scan at the lateral infraclavicular fossa (LICF), where the local anesthetic is injected deep to the pectoral muscles. Peripheral nerve blocks are overall safe when performed correctly, there are rare but serious risks associated with them. Risks include block failure, bleeding, infection, damage to surrounding structures, permanent nerve injury, and intravascular uptake of local anesthetic resulting in systemic toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Cooperative patients .
* age between 16-60 years.
* Acute flexor tendon injuries of the hand in both genders in medial four fingers.
* Sharp mechanism of injury.
* Single level injury zone 2.

Exclusion Criteria:

* Associated fractures close to the tendon injury.

  * Vascular injury requiring revascularization
  * Multiple level injury
  * Combined flexor and extensor laceration
  * Insufficient skin and soft tissue coverage
  * Tendon substance loss
  * Patients with coagulopathy or on anticoagulant therapy
  * Patients with allergies to any of the anesthesia components
A Study Evaluating Skin Irritation, Phototoxicity and Safety After Administration of LEO 90105 on Intact Skin of Healthy Japanese Male Subjects

The objective of the trial is to investigate skin irritation, phototoxicity and safety of LEO 90105 and its components by patchtest (48 hours closed patch test and photo patch test) in healthy Japanese male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese male subjects,
* Aged 20 to 40 years inclusive.
* Subjects without signs of skin irritation (erythema,dryness, roughness or scaling) on test sites.
* Subjects willing to follow the study procedures and complete the study Subjects having understood and signed a written informed consent.
* Subjects without abnormal in physiological test and clinical test in screening, and also judged as possible to participant the study by investigators.

Exclusion Criteria:

* Body mass Index (BMI ) (body weight (kg)/height(m)²) outside the range 18-25 kg/m2
* History of alcohol, chemical or drug abuse
* History of allergic reaction to drugs or history of skin reaction to the tape
* Any systemic or cutaneous disease that could in any way confound interpretation of the study results (e.g. atopic dermatitis, eczema, psoriasis)
* Known sensitivity to any component of any of the formulations being tested
* Known hepatic or renal disorders
* Use of systemic, locally injected or inhaled corticosteroids within 4 weeks of study start (Day 1)
* Use of systemic vitamin D analogues, vitamin D or calcium supplements within 4 weeks of study start(Day 1)
* Use of any drug (systemic or topical) within 2 weeks of study start (Day 1)
* Use of non-marketed/other investigational products one month prior to or 5 half lives (for those the half life is longer than one month) and during the trial is not permitted
* Any abnormality found at medical interview before administration of the test drug, which will affect the clinical study as judged by the investigator
* History of or active photo-induced or photoaggravated disease (abnormal response to the sun light)
* Exposure to excessive or chronic ultraviolet (UV)radiation (i.e., sunbathing, tanning salon use, phototherapy)within four weeks prior to inclusion (Day 1) or planned during the study period
* Scars, moles, sunburn, or other blemishes in the test area which would interfere with grading
* Subjects whose partner wishes to become pregnant but is unwilling to use birth control during the study
* Any condition which, in the opinion of the investigator, would place the subject at an unacceptable risk if he participated in the study
* Any disease which are contradictions for treatment of the investigation products or for which treatment with the investigation products needs to be carefully considered (Subjects with any of the following conditions present on the area(s) to be treated with study medication: viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers or wounds).
Mommio: Training in Vegetable Parenting

A 20 episode video game called Mommio simulates parent-child feeding interactions for parents of 3-5 year old children within a storyline addressing a problem commonly reported by parents (getting their 3-5 yo to taste a vegetable, which is often a first step toward eating the vegetable), thereby training parents in effective food parenting practices. This research evaluates whether the 20 episodes targeting barriers identified by parents across five levels of difficulty influences vegetable parenting practices and children's dietary intake. We had to discontinue the study since changes in commercial availability of game development software required reprogramming and available funding did not allow for completion of game programming. Thus, no game evaluation was possible.

Video games for parents that simulate interactions with a child using a narrative, offering feedback on performance and goal setting for changing practices in the real world, and addressing vegetable (V) feeding problems commonly reported by parents, may elicit desirable cognitive, affective, and behavioral outcomes.

The rationale for training parents of preschool children in effective V parenting practices is that: 1) parents have an important influence on young children's dietary intake; 2) child dietary intake tracks into the adult years; and 3) high V consumption protects against several chronic diseases later in life. Since parents of young children commonly complain about not getting their child to eat V, there should be broad interest in playing Mommio.

A pre-post randomized clinical trial with 110 parents of 3-5 year olds who report having difficulty getting their child to eat vegetables will be employed. The primary outcome will be parent report of children's dietary intake; the secondary outcome will be use of V parenting practices.

We had to discontinue the study since changes in commercial availability of game development software required reprogramming and available funding did not allow for completion of game programming. Thus, no game evaluation was possible.

Eligibility Criteria:
Inclusion Criteria:

* being a parent of a child 3-5 years old
* willing to complete all measures
* having an iPhone.

Exclusion Criteria:

* the parent not speaking English (since the games are in English alone, due to budget constraints);
* having a 3-5 year old child with a medical condition that influences diet; or
* a parent with an illness that impairs the ability to complete questionnaires
Bupivacaine Liposomal Injectable Suspension, Pain and Narcotic Use After Elective Orthognathic Surgery

This research is being done to determine quantitative and qualitative differences in patients' post-operative pain levels following elective orthognathic surgery after the local administration of a liposomal bupivacaine injection.

A primary objective is to determine whether using a liposomal bupivacaine injection placed locally at the conclusion of elective orthognathic surgery will decrease pain levels (as determined by VAS scores). A secondary objective is to examine whether using a long acting liposomal bupivacaine injection locally at the conclusion of elective orthognathic surgery leads to decreased use of narcotics post-operatively.

Participants in Group 1 (study group) will receive ExparelTM (133 mg/10 ml - 4 ml into the maxilla, and 6 ml into the mandible). This will be injected into the soft tissue and gingiva surrounding the surgical site at the time of wound closure. Participants in Group 2 (standard of care) will receive bupivacaine 0.5% (4 ml into the maxilla, and 6 ml into the mandible) injected into the soft tissue and gingiva surrounding the surgical site at the time of wound closure.

Post-operatively, all participants will be cared for utilizing the current standard post-operative pain management protocol for all patients undergoing elective orthognathic surgery at Boston Medical Center. This consists of acetaminophen 325 mg given every 4 hours as a scheduled medication; patients also receive an additional 325 mg of acetaminophen for a reported pain level of 1-3, 5 mg of oxycodone for a reported pain level of 4-6, and 10 mg of oxycodone for a reported pain level of 7-10. All participants will be provided the same methods of postoperative pain control following their elective orthognathic surgery.

Eligibility Criteria:
Inclusion Criteria:

* males and females 18-40 years of age undergoing elective double jaw orthognathic surgery

Exclusion Criteria:

* pregnancy
* known hypersensitivity to any local anesthetic
Assessing Circulating Tumor Cell as a Biomarker for Prostate Cancer Detection in Patients With Gray Zone PSA Level

Prostate cancer screening with PSA is plagued by high rate of unnecessary prostate biopsies, especially in the "gray zone" (4.00ng/ml e 10.99ng/ml). We introduce a new circulating-tumor-cell (CTC) biomarker for detection of prostate cancer in patients in the PSA "gray zone" level, with the clinically verified potential to substantially decrease the number of unnecessary prostate biopsies.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are willing to sign the informed consent and agree to comply with the study procedures.
* Age from 20 to 99 years old
* Subjects with a PSA 4.00- 10.99 ng/ml and will receive biopsy within 3 months

Exclusion Criteria:

* Age \< 20 years
* Refuse to sign the informed consent form
* Received regional anesthesia and general anesthesia within one month
* Previous cancer history
* Autoimmune diseases
* Chronic inflammatory diseases
* Diagnosed with colorectal polyps or adenomas
* Acute inflammatory or infectious diseases in three months
* Other diseases decided by PI