cyrilzakka/clinical-trials huggingface dataset:
Dermacyd Silver Floral (Lactic Acid) - Photo Evaluation

Primary Objective:

To demonstrate the absence of photoirritation and potential photosensitization of the product Dermacyd Silver Floral.


Eligibility Criteria:
Inclusion criteria:

* Phototype Skin II and III Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion

Exclusion criteria:

* Lactation or pregnancy
* Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Concomitant use of photosensitivity drugs
* History of sensitivity or photosensitivity withr topic products
* Cutaneous active disease which can modify the study results
* History or activity of photodermatosis
* Personal or family antecedents of cutaneous neoplasia photo induced
* Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis
* Intense exposure solar in the test region
* Use of new drugs and/or cosmetics during the study
* Previous participation in studies using the same product in test
* Relevant history or confirmation of alcohol or other drugs abuse
* Intolerance detected or suspected for some component of the sample tested
* Medecin or sponsor employees or their close family.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Endoscopic Resection of Gastrointestinal Neoplasms

The study aims to retrospectively investigate the endoscopic resection procedures of cancerous and precancerous lesions of the upper and lower digestive tract in order to evaluate the efficacy and safety outcomes and to compare different resection techniques. In particular, the resection techniques investigated will be mucosectomy, en bloc and piecemeal, endoscopic submucosal dissection (ESD) and its variants, full-thickness resection. The anatomical districts involved will be the esophagus, stomach, duodenum, colon and rectum.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* all patients who have undergone endoscopic resection of an upper or lower digestive tract tumor

Exclusion Criteria:

* age under 18
* inability to provide informed consent
LOW CYCLO: Study Evaluating the Benefit of Two Doses of Ciclosporine in de Novo Cardiac Transplant

Primary Objective:

* Evaluation of the benefit on renal function of one year of a low dose of ciclosporine versus the usual dose

Secondary Objective:

* To evaluate the immunosuppressive efficacy and tolerance of the treatment

Study Duration:

Twelve months for each patient

Study Treatment: Ciclosporine

Group A: low dose \>= 130 µg/l \< T0 ciclosporinemia \< 200 µg/l; Group B: standard dose \>= 200 µg/l \< T0 ciclosporinemia \< 300 µg/l.

Study Visits:

One visit every 15 days, for the first three months; then 1 visit every month, for 6 months; and 1 visit at 9 and 12 months.

Associated Treatments:

* Mycophenolate (Cellcept®), 3g a day
* Corticoids, as used for transplanted patients

Randomization: Randomization will occur when it is decided that ciclosporine will be introduced.


Eligibility Criteria:
Inclusion Criteria:

Recipient:

* Males or females, ages \> 18 \< 65.
* First cardiac transplant.
* Negative pregnancy test for females of childbearing potential, at screening. Efficient method of contraception must be used during the study.
* Written informed consent.

Donor:

* Cold ischemia duration \< 6 hours

Exclusion Criteria:

Recipient:

* Unstable hemodynamic status at randomization.
* Patient with assisted circulation, considered unstable.
* Serum creatinine \> 250 µmol/l.
* Nursing or pregnant females.
* HIV positive.
* PCR hepatitis C virus (HCV) positive or hepatitis B surface (Hbs) antigen positive (within 6 months prior to study).
* Multi-organ graft or retransplant.
* History of cancer (evolving, or within 5 years, except for epidermoid or basocellular localised cutaneous carcinoma).
* Use of any investigational product and/or participation in another clinical research study within the last 30 days prior to study entry.
* Any substance abuse or any psychiatric disorder
* Contra-indication to study treatments.
* Unable to introduce ciclosporine within 4 days after transplant.

Donor:

* Known coronary pathology or cardiac disease.
* HBsAg positive or HCV positive
Melatonin for Sleep in Children With Autism

The purpose of this study is to determine if liquid supplemental melatonin is an effective treatment for children with autism who have sleep problems related to insomnia (difficulty falling asleep).

Sleep difficulties in children with autism spectrum disorders (ASD) are common reasons why parents seek medical intervention for their children. Identifying a safe and effective pharmacologic agent that promotes sleep in ASD would favorably impact the lives of these children and their families. In this study we plan to determine the dose-response, tolerability and any adverse effects of supplemental melatonin in 30 children with ASD.The melatonin dose levels are 1mg, 3mg, 6mg, and 9mg. After a 3 week baseline period, the child will begin melatonin at 1mg and will dose escalate every three weeks until he/she is falling asleep within 30 minutes of bedtime at least 5/7 nights per week. No child will take more than 9 mg of supplemental melatonin.

Eligibility Criteria:
Inclusion Criteria:

* Children with autism ages 4-10 years.
* Diagnosis of autism based on Autism Diagnostic Observation Schedule (ADOS).
* Time to fall asleep of 30 minutes or longer by parent report at least 3 nights/week in the last 3 months.
* Children may take seasonal allergy medications.
* Children may take the following medications for the same dose at least 3 months: Citalopram (Celexa), Escitalopram (Lexapro), Amphetamine-dextroamphetamine (Adderall), Atomoxetine (Strattera), Methylphenidate(Ritalin), Dextroamphetamine(Dexedrine), Risperidone (Risperdal.

Exclusion Criteria:

* Children taking medications other than those in the inclusion criteria.
* Children with primary sleep disorder other than insomnia (such as sleep-disordered breathing).
* Children with non-febrile unprovoked epileptic seizure within the last two years.
* Children with liver disease or high fat diets, as melatonin metabolism may be affected in these children.
* Children who are visually impaired (partially or completely blind) as light suppresses melatonin synthesis and these children may have altered diurnal melatonin rhythms.
* Children with known genetic syndromes co-morbid with autism including fragile X, Down syndrome, neurofibromatosis, or tuberous sclerosis.
* Children who have outside normal limits on blood work for complete blood count, liver and renal function and hormone levels of ACTH, cortisol, LH, FSH, prolactin, testosterone and estradiol.
* Tanner staging beyond level 1 at any time point in the study.
* Children whose assessment score does not place them on the autism spectrum.
Drug Concentration Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers

The purpose of this study is to assess the drug concentration of Micafungin amongst healthy volunteers having different weight groups.

This is a single center study. A total of 36 adult volunteers will be consented for the study. Volunteers will be admitted for an overnight stay. Half will be female and half male. Twelve volunteers will have a body mass index (BMI) less than 25 kg/m2, 12 will have a BMI 25-40 kg/m2, and 12 will have a BMI greater than 40 kg/m2. Volunteers will have height and weight measured after they have consented to participate. Exactly half the volunteers in each category will received a single dose of intravenous micafungin of 100 mg, while the other half will receive 300 mg as determined by a coin flip. The volunteers will have blood drawn via an intravenous catheter just prior to the dose, and then at 1, 4, 8, 12, 16, and 24h after the drug dose. The intravenous catheter is then removed after the 24h blood draw, and the volunteer discharged from the study. Compensation will be provided to the participants for their time.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects
* 18 years or older
* All racial and ethnic origins
* English or Spanish speaking

Exclusion Criteria:

* Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of micafungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of micafungin, so that the pregnancy and post-partum state would be a confounding variable.

  * Abnormal liver function tests: transaminases\>10 times upper limit of normal, Alkaline phosphatase\>5 times upper limit of normal, total bilirubin\>5 times upper limit of normal.
* Creatinine Clearance \< 70 ml/min as estimated by the Cockcroft-Gault equation
* History of allergies to echinocandins
* Echinocandins are contraindicated for any reason
* Volunteers unwilling to comply with study procedures.
* Suspected or documented systemic fungal infection.
Evaluation of Prophylactic Endotracheal Intubation

Upper gastrointestinal (GI) bleeding is defined as patients who either presented with hematemesis or presented with melena along with evidence of hemodynamic compromise. These patients have risk of aspiration of blood along with gastric content. The mortality rate can be 15% to 20% in the cases with variceal bleeding. From a practical standpoint, it is widely accepted that the best way to secure an airway during upper GI bleeding is prophylactic endotracheal intubation (PEI). The aim of this study is to determine the incidence of complications among critically ill patients with upper GI bleeding and received urgent endoscopy.

This is a prospective observational study. After IRB approval, consecutive patient with upper GI bleeding and undergoing urgent endoscopy will be enrolled to the study over 24 months period. Data pull will be requested from Parkland Office of Research Administration (ORA) regarding eligible subjects and protocol requiring data elements. The data pull will be requested at the end of the 24 months-period.

Primary endpoint:

The incidence of cardiovascular unplanned event within 48 hours of the upper gastrointestinal endoscopy procedure.

Secondary end points:

The incidence of pulmonary unplanned event within 48 hours of the upper gastrointestinal endoscopy procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Presence of upper gastrointestinal bleeding either presented with hematemesis or melena along with evidence of hemodynamic compromise.
* Received procedural (conscious) sedation
* Undergoing urgent upper gastrointestinal endoscopy procedures

Exclusion Criteria:

* Intubation other than airway protection
* Prior tracheostomy before onset of gastrointestinal bleeding
* Subjects intubated before transfer to gastrointestinal suite
* Subjects without hemodynamic instability
* Subjects with a diagnosis of pneumonia, acute respiratory distress syndrome, myocardial infarction, pulmonary edema, arrhythmia, or cardiac arrest before endoscopy
* Endoscopy done for other than upper gastrointestinal bleeding
* Pregnant subjects
Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis

The purpose of this study is to confirm the effect of ANT-1403 in the treatment of primary axillary hyperhidrosis.


Eligibility Criteria:
Inclusion Criteria:

* ages 18 - 70 years of age
* diagnosis of moderate to severe primary axillary hyperhidrosis
* ≥50 mg of sweat production/axilla in 5 minutes as measured gravimetrically
* HDSS score of ≥3

Exclusion Criteria:

* diagnosis of secondary hyperhidrosis
* skin affliction in the axilla requiring medical treatment
* 20% aluminum hydrochloride, e.g. Drysol®, in 2 weeks prior of Baseline
* oral anticholinergic treatment
* botulinum toxin treatment in the prior 9 months
* history of surgery for axillary hyperhidrosis
* present or history of neuromuscular disease
* female subjects who are pregnant or are nursing a child
Comparison of Episiotomy Scissors and BasIQ-4 Episiotomy Device in Mediolateral Episiotomy

Episiotomy is an obstetric intervention performed to facilitate, accelerate and / or prevent third and fourth degree perineal tears by cutting the vagina at the end of the second stage of labor. Postpartum perineal pain affects patients' lives significantly and causes negative effects on work life, social life and family relations. Median episiotomy is associated with 3-4 times increased anal sphincter injury as well as easy recovery. Therefore, mediolateral episiotomy is preferred in Europe. The common feature was that scissors are used in previous studies and the incision was made from the central to the distal. A randomized controlled clinical study is planned to compare the scissors and episiotomy device BasIQ-4, which carries scalpel, holding apparatus, and cuts from distal to the center in mediolateral episiotomy. This is the first study in humans in this field.

Pregnant women who applied to Ege University Gynecology and Obstetrics Department Delivery Room Service and had vaginal delivery will be included in the study after obtaining their consent. When the cases meeting the inclusion criteria will be taken to the delivery table for delivery, verbal consent will be obtained by the physician if the need for episiotomy is determined by the physician in the second stage of delivery. Following the administration of 10 ml of 1% lidocaine, mediolateral episiotomy will be opened with scissors or Basiq-4 according to computer generated randomization. The presence of shoulder dystocia during delivery, the number of moves for episiotomy incision, the duration of stage 2, fetal weight, the degree of perineal injury, any additional injury, and urethral injury will be recorded in the prepared case form. Then, the episiotomy incision will be continuously sutured with 2-0 slow dissolving polyglactin 910 suture material for all cases.

The length of episiotomy after suturing and the length of perineal injury, if any, will be measured with a sterile ruler and recorded on the case form. Postpartum discharge is carried out 48 hours after birth in accordance with the Ministry of Health Regulations. Participants will be reassessed during discharge in terms of pain with the Visual Pain Scale (VAS).

The cases will be evaluated by the study team again, and notes regarding episiotomy length, infection, pain, incision separation, fecal incontinence, rectovaginal fistula, and painful defecation will be recorded on the case form six months after delivery. Participants will be requested to fill FSFI forms to evaluate their sexual lives.

Eligibility Criteria:
Inclusion Criteria:

1. Nulliparous singleton pregnancies \> 37th gestational week
2. Estimated fetal weight between 3000-4000g
3. The need for an episiotomy in the second stage of labor
4. Vertex presentation

Exclusion Criteria:

1. Additional internal disease
2. Inability to communicate in Turkish and English
3. Multiple pregnancy
4. Episiotomies in emergency situations without crowning the baby's head
5. Using vacuum device at birth
Intraoperative Sedatives and Postoperative Pain

In this study, based on the hypothesis that dexmedetomidine administered intraoperatively for sedation can reduce postoperative pain than that of propofol, the investigators examined the ability of dexmedetomidine to reduce postoperative pain in in patients undergoing the total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total knee arthroplasty
* Age: 20 - 80 yrs

Exclusion Criteria:

* ASA classification ≥ 3
* Patient who do not want sedation during the surgery
* Patient who wants general anesthesia
* Cardiovascular disease
* Liver dysfunction
* Renal dysfunction
A New Insertion Technique for Laryngeal Mask Airway

A laryngeal mask airway ("LMA") is an airway device that is commonly used and placed under general anesthesia to facilitate ventilation of the patient's lungs while anesthetized. It is similar to an "endotracheal tube" (a breathing tube) but is less invasive. It is also placed as a backup when the Anesthesiologist is unable to pass a breathing tube and the patient is not adequately ventilating. Unfortunately, an LMA may lead to complications similar to those of breathing tube placement, such as sore throat and hoarse voice. Previous studies have examined several variables that may affect how often complications occur; these variables include giving anti-inflammatory medications and inflating the LMA to different pressures (the "working" end of the LMA, which rests in the patient's throat, has a cuff that is inflated to provide a seal). We are studying the effect of the PLACEMENT TECHNIQUE on postoperative sore throat, hoarse voice, and difficulty swallowing. We will be using 3 placement techniques - the traditional placement technique, a slightly different traditional placement technique, and a new technique, abbreviated the "ELLIA" method. The hypothesis of this study is that a new LMA insertion technique will have no difference in postoperative pharyngolaryngeal morbidity including sore throat, dysphagia and dysphonia.

The LMA will be inserted based on one of three methods randomly assigned to each patient. The ELLIA technique involves gently lifting the patient's laryngeal structures (throat) while placing the LMA to oppose the force of gravity. Whereas the traditional method of placement involves guiding the LMA through the pharynx with a finger inserted into the pharynx, the ELLIA method avoids this step. General anesthesia will be maintained at the discretion of the Anesthesiologist throughout the surgical procedure. At the end of the case, as would normally occur, the LMA will be removed from the patient's airway and the patient will be taken to the PACU, where he or she will be cared for as usual. At one and two hours postoperatively, blinded research assistants will assess the patient for sore throat, hoarse voice, and difficulty swallowing. Finally, at 24 hours the patient will receive a telephone call from a blinded research assistant assessing for the same outcomes. These data will be collected and presented.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists patient fitness category) I, II, III
* Age 18-90
* General anesthetic for where LMA (Laryngeal Mask Airway) placement is not contraindicated will be included

Exclusion Criteria:

* Small mouth opening
* Preoperative sore throat/dysphagia/dysphonia
* Patients at increased risk for aspiration
* Morbid obesity BMI \> 40
* Untreated chronic GERD
* Pregnancy
* Suspected supraglottic abnormalities
* N2O use
* Need for oral-pharyngeal suctioning
* Undergoing oral and nasal surgery
* Intubation or any oral instrumental manipulations other than
* LMA placements intraoperatively or postoperatively
The Superiority of Contralateral Oblique View for Mid-thoracic Epidural Assess

The aim of the present study is to compare contralateral oblique view with the lateral view for fluoroscopic guided mid-thoracic epidural assess.

A thoracic epidural assess (block or catheter insertion) is a widely used intervention to reduce pain in patients with postherpetic neuralgia or who underwent chest and upper abdominal surgery.

In order to achieve the correct procedure, accurate access to the thoracic epidural space is needed. However, a thoracic epidural assess is a relatively more difficult procedure than procedures used in other regions, because the spinous process of the thoracic vertebra is longer than that of the lumbar vertebra, and the area through which the needle can approach the epidural space is relatively smaller due to an acute angle and larger distance between the skin and the epidural space. The midthoracic region (T4-8) is the most difficult area when performing this procedure.

To overcome this issue, a method of approaching the thoracic epidural space through the contralateral oblique view (CLO view) has been introduced, however, unlike the cervical or lumbar spine, advantages of the CLO view over the lateral view or the optimal angle of the CLO view have not yet been studied. Therefore, we planned this study to investigate the advantages of the CLO view compared with the lateral view and to determine the optimal angles of the CLO view when fluoroscopic guided mid-thoracic epidural assess.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for mid thoracic (T4-T8) epidural block or catheter insertion
* 20 ≤ age \<80
* Presence of thoracic MRI or CT
* When obtaining informed consent voluntarily

Exclusion Criteria:

* Allergy to local anesthetics and contrast dye, and steroid
* Use of anticoagulants or antiplatelet medication, coagulopathy
* Infection at the insertion site
* Neurological or psychiatric disorders
* Prior spine instrumentation
* Pregnancy
Electrophysiologic Study of Perioperative Monitoring of the Recurrent Laryngeal Nerve: Impaired Vocal Cord Movement After Thyroidectomy

Paralysis of the recurrent (or inferior) laryngeal nerve (RLN or ILN) is one of the most common and most serious complications of thyroid surgery. Neuromonitoring of the inferior laryngeal nerve (ILN or recurrent) is a technique currently used during thyroidectomy to locate ILN during dissection. Detector electrodes are placed in contact with vocal muscle which is stimulated electrically at the location of ILN, producing an acoustic and visual signal. This is a basic electromyographic technique whose diagnostic and prognostic potential for the entire neuromuscular system has not yet been fully explored. The study of action potentials generated by the stimulation-detection of nerves ILN and vagal nerves at the beginning and end of dissection, notably the decrease in amplitude, could allow a diagnosis during the course of surgery making it possible to diagnose lesions of the nerve and guide the surgeon in his surgical decisions, thus avoiding the risk of bilateral recurrent paralysis. It could also enable the surgeon to give a prognosis for functional recovery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a total thyroidectomy or a thyroid lobectomy

Exclusion Criteria:

* History of mobility disorder of the vocal cords
First in Man Study With SLV341

First in man study with single and multiple rising doses with SLV341


Eligibility Criteria:
Inclusion Criteria healthy Exclusion Criteria not healthy