cyrilzakka/clinical-trials huggingface dataset:
Mindfulness, Group Therapy and Psychosis; Training Decreases Anxiety and Depression

The objective of this non-randomized, within-group comparison was to evaluate the addition of mindfulness as a new technique in an outpatient group therapy program for participants diagnosed with a psychotic spectrum disorder, alongside of cognitive behavioral therapy.

Participants completed the Patient Health Questionnaire-9 (PHQ-9), and the Generalized Anxiety Disorder 7-item scale (GAD-7), at admission and discharge. The first experiment compared scores of those who received mindfulness training plus standard psychiatric treatment or treatment as usual (TAU) against those who received TAU. The second experiment compared age using matched scores from participants who received mindfulness training plus TAU. Participants attended group therapy for a five-week minimum, and were taught the mindfulness practices of breath, acceptance, observation, remaining non-judgmental, and letting go.

Eligibility Criteria:
Inclusion Criteria:

* All Diagnostic Statistical Manual, Fifth edition, (DSM-5) diagnoses that included a psychosis spectrum disorder

Exclusion Criteria:

* those lacking symptoms of psychosis
Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

Unblinded study of flibanserin for 8 weeks with responders randomized 1:1 to receive study medication alone vs. study medication and sex therapy for 12 additional weeks.

This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Subjects meeting inclusion and exclusion criteria will receive flibanserin for an 8-week run-in period to differentiate between responders and non-responders. Responders will be determined by a score of 1-3 on the Patient Global Impression of Improvement (PGI-I) at 8 weeks from baseline, and will be randomized 1:1 to receive study medication alone vs. study medication and sex therapy for an additional 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is willing and able to provide written informed consent and HIPAA authorization before any study procedures are conducted;
2. Subject is female;
3. Subject is ≥18 years old;
4. Subject has biologic-based HSDD as her primary sexual complaint;
5. Subject scores \<26 on FSFI and \<4.8 on desire domain of FSFI at screening;
6. Subject scores \>18 on FSDS-DAO;
7. Subject answers yes to questions 1-4 on the DSDS screener;
8. Subject is willing to use effective contraception during the study if pre-menopausal (oral contraceptives, barrier method, long acting reversible contraceptive, surgical sterilization);
9. Subject agrees to comply with the study procedures and visits.

Exclusion Criteria:

1. Subject has sexual pain;
2. Subject does not have generalized, acquired HSDD;
3. Subject has used flibanserin in the last 6 months;
4. Subject has history of alcohol or drug abuse;
5. Subject uses tobacco in any form;
6. Subject is currently using androgen therapy and unwilling to washout;
7. Subject is pregnant, nursing, or planning to become pregnant over the next 6 months;
8. Subject is taking a moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor;
9. Subject is taking a CYP3A4 inducer;
10. P-glycoprotein substrate;
11. Subject has a history of liver impairment;
12. Subject has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
13. Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.
Sleepiness in Parkinson's Patients With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation

Sleepiness is frequent in parkinsonian patients, increasing with the duration of disease. By patients with motor fluctuations, continuous dopaminergic delivery devices or deep brain stimulation are justified to improve the motor prognosis. Antiparkinsonian treatments, especially dopaminergic agonists, may worsen the sleepiness and thus affect the quality of life. The investigators aimed to monitor sleepiness in parkinsonian patients before and during treatment with continous dopaminergic delivery device or deep brain stimulation.


Eligibility Criteria:
Inclusion Criteria:

* patient with Parkinson's disease and motor fluctuations
* and indicated for a continuous dopaminergic delivery device or deep brain stimulation

Exclusion Criteria:

* age \< 18 years
* refusal for the continuous dopaminergic delivery device or deep brain stimulation
* wake-promoting drugs intake
* refusal to participate
* legal protection
* uncontrolled sleep apnea
Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent

To compare the clinical outcomes of P2Y12 antagonist monotherapy with aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with bioabsorbable polymer Everolimus-eluting stents (Synergy®)


Eligibility Criteria:
Inclusion Criteria:

1. Age 19+
2. Patients treated with a new generation of Evelorimus-eluting stents (Synergy®)
3. Patients who understand the content of the subject description and voluntarily sign the subject

Exclusion Criteria:

1. Age 86+
2. Hemodynamically unstable patient
3. Severe hypersensitivity reactions to aspirin, clopidogrel, ticagrelor, everolimus, contrast agent
4. Patients at high risk of bleeding, anemia, thrombocytopenia
5. Patients requiring oral anticoagulants
6. Pregnant women or women of childbearing age
7. Life expectancy is less than one year
8. Patients receiving a potent CYP3A4 inhibitor (eg, ketoconazole, clarithromycin, napjodone, ritonavir, atazanavir)
9. Patients with a history of intracranial hemorrhage
10. Patients with moderate to severe hepatic impairment
11. Patients underwent coronary intervention with stenting within 1 year
12. Patients with left-main lesions requiring coronary intervention
13. Patients with chronic stricture lesions requiring treatment
14. Patients with in-stent restenosis in a lesion requiring treatment
15. Patients with bifurcation lesions requiring stenting in lateral branches
16. Patients with lesions requiring more than 3 stents
Comparison of Video Laryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation During Pediatric Dental Surgery

Background and Objective: Airway control is a condition that should be evaluated primarily in anesthesia practice in the pediatric age group. Failed intubation or prolonged intubation duration can cause atelectasis and hypoxia in children. The aim of this study was to examine the effects of Macintosh laryngoscopy and McGrath videolaryngoscopy on hemodynamic parameters in pediatric patients who were scheduled to undergo elective dental surgery and required intubation for the application of general anesthesia.

Methods: Sixty-six patients were divided into two groups according to the procedure used during intubation, namely, direct laryngoscopy or video laryngoscopy. The Cormack-Lehane and Mallampati scores, intubation duration, heart rate at minutes 0, 1, 3 and 5 during intubation, mean arterial pressure, EtCO2and SpO2 values were recorded for all the patients.

Many techniques in the management of a difficult airway have been used in adult patients. In pediatric patients, awake fiberoptic intubation is difficult or even impossible . The video laryngoscope is a new tool produced by combining video technology and laryngoscope. Published studies on the video laryngoscope were mostly performed in adults . In this study, we used a Macintosh laryngoscope, which is a routinely used tool in anesthesiology, and a McGrath video laryngoscope, which is a type of a newly developed video laryngoscope that has not widely been used in the pediatric age group. The aim of this study was to examine the effects of Macintosh laryngoscopy and McGrath videolaryngoscopy on hemodynamic parameters in pediatric patients who were scheduled to undergo elective dental surgery and required intubation for the application of general anesthesia. We also evaluated whether Macintosh laryngoscopy and McGrath videolaryngoscopy improved the stress response and whether these approaches facilitated the intubation procedure.

Eligibility Criteria:
Inclusion Criteria:

Healthy children between the ages of 4-13

* Ordu University School of Medicine ,pediatric age group ,elective oral surgery 4-13 years and who were scheduled for elective oral surgery under general anesthesia with intubation If Patients with a Cormack -Lehane score 1,2 or 3 and if Mallampathy score of 1,2 or 3 were inccluded from the study

Exclusion Criteria:

1. With malignancy disease patients
2. with norological disorders
3. with congenital heart disease
4. with airway abnormality
5. with airway disease patients
6. Patients age Under 4 years , Above 13 years
7. If Patients with a Cormack -Lehane score 4 and if Mallampathy score of 4 were excluded from the study -
Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Have inadequate eyelashes due to chemotherapy treatment
* Treated for solid tumors such as breast or colorectal cancer in early stages where the cancer has not spread outside the primary organ (eg, stage 1, 2 or 3a for breast cancer)
* Have completed chemotherapy treatment for at least 4 weeks but not more than 24 weeks and all side effects related to chemotherapy are recovered, improved or maintained, with the exception of hair loss

Exclusion Criteria:

* Any disease/infection/abnormality of the eye or area around the eye
* Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
* Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
* Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
* Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
* Use of treatments which may affect hair growth (eg, minoxidil) within 6 months except for prior chemotherapy
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). A Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement.

The purpose of this study is to assess if 10 mg Bay 59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.


Eligibility Criteria:
Inclusion Criteria:- Male and female patients aged 18 years or above- Patients scheduled for elective total knee replacement Exclusion Criteria:- Active bleeding or high risk of bleeding contraindicating treatment with LMWH- Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)- Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)
Superiorly Based Pharyngeal Flap Versus Myomucosal Resection and Direct Closure

Patients were classified into two groups. Group (A) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. Group (B) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall

Patients were classified into two groups. Group (A) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. Group (B) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall

Eligibility Criteria:
Inclusion Criteria:

* - Patients have velopharyngeal insufficiency.
* Age range 4-10 years

Exclusion Criteria:

* - Syndromic patients.
Optoacoustic Detection of Inflammation Using MSOT Device

The purpose of this study is to evaluate the safety and potential of a new experimental imaging instrument called multispectral optoacoustic tomography (MSOT) to detect inflammation in patients with chronic graft versus host disease of the skin or GI tract, Crohn's disease, or Colitis disease.

This is a single arm, 3-cohort study that is designed to provide safety information regarding the use of the Acuity MSOT device in the clinical setting, and the ability of MSOT imaging data to correlate with clinical findings identified via pathology or radiology.

The device will be used to obtain images of the areas of inflammation in the above patients for investigational use only, to compare to clinical pathology and patient's medical record. Patients will go through standard care procedures prior to imaging. Medically established diagnostic procedures will be used to detect areas of inflammation associated with GVHD, Crohn's, or colitis. Images using the MSOT device will be obtained through intact skin. A second MSOT scan will be performed for all patients 4 weeks post treatment. The temperature of the patient's skin will also be measured prior to and after MSOT imaging.

MSOT imaging will be for research only and no treatment decisions will be based on the MSOT images obtained.

Eligibility Criteria:
Inclusion Criteria:

* Patients documented clinical/pathologic 1) acute or chronic colon or skin GVHD, 2) Crohn's disease, or 3) colitis
* Have acceptable hematologic status \[total hemoglobin (tHb) ≥ 7.0 mg/dL\]
* Patients ≥ 18 yrs of age
* Willing to comply with study procedures and be available for the duration of the study
* Patient has ability to understand and the willingness to provide a signed and dated IRB-approved informed consent document.

Exclusion Criteria:

* Patients with a tattoo over the area of inflammation
* Pregnant patients are not eligible for this trial. Eligible patients (if applicable) will be required to document the date of the first day of their last menstrual cycle, and provide a negative pregnancy test if sexually active and of childbearing potential
* Patients who are breastfeeding
* Any open wound (skin ulcerations or infections) at or near the site of imaging that would preclude MSOT imaging.
* Any febrile illness that precludes or delays participation preoperatively
Teleteaching on Clinical Procedural Skills

This study aims to develop a model of teleteaching and teleassessment for clinical procedural skills, consisted of teleteaching design making and teleteaching intervention was conducted in September 2020 - February 2021 at a tertiary center Dr. Cipto Mangunkusumo Hospital/ Faculty of Medicine Universitas Indonesia.

Six plastic surgery residents and 12 general practitioners voluntarily participated in 3 different workshops. Three workshops on different procedural skill sets were conducted by including surgical knotting skills, suturing techniques and basic laparoscopic hand-eye coordination skills. A group of participants learned the skills on site, while another group joined the workshop synchronously through the online multiscreen display teleconference platform. The teaching effectiveness was assessed using pre-post written test, OSATS, GRS and self-efficacy. Online skills teleassessment was also compared to the asynchronous assessment based on pre-recorded videos.

Eligibility Criteria:
Inclusion Criteria:

* Medical doctors (General Practitioners or Residents in Plastic Surgery Training) who volunteered to join the workhops

Exclusion Criteria:

* Participants who do not consent to join the workshops
Multifidus Plane Block Versus Caudal Block for Hypospadias

This study aims to evaluate the safety and efficacy of ultrasound-guided sacral multifidus plane block and compare its analgesic effect to ultrasound-guided caudal block in pediatric patients undergoing hypospadias surgery under general anesthesia

Peri-operative pain management in pediatric surgeries is considered a challenging issue for the anesthesiologists. The usage of regional anesthesia in association with general anesthesia (GA) is a simple intraoperative way that reduces (GA) requirements and side effects. Recently, paraspinal fascial plane block, the sacral multifidus plane block (MPB), was used successfully in infants. The study has been designed to determine the effect of MPB versus caudal epidural block to control peri-operative pain in hypospadias surgeries in children.

Eligibility Criteria:
Inclusion Criteria:

* ⦁ Children aged (1 -7) years old.

  * All patients will be of ASA classification I, II physical status

Exclusion Criteria:

* ⦁ Parents refusing to participate are excluded from the trial.

  * Children who had spinal anomalies, altered mental status.
  * A history of developmental delay.
  * Blood diseases: Coagulopathy or anaemia.
  * Infection at the site of injection.
  * Drug allergy.
Knowledge and Attitude of Dental Interns on Child Abuse

1. Knowledge and attitude of dental interns of the pediatric dental department regarding child abuse recognition and reporting will be assessed 2 times before and after attending one of 2 learning modules ( interactive lecture or online module ) assessment through a questionnaire
2. assessment of the learning experience through a written questionnaire

1. An introduction with the aim of the study will be given to all the interns of the pediatric dentistry department, Faculty of Dentistry, Cairo University during a regular scheduled seminar.
2. All interns willing to join the study will be asked to sign an informed consent.
3. A pre-test questionnaire on recognition and reporting of child abuse will be given to the participants
4. The participants will be randomly allocated to 2 study groups Online Group: (this group will receive the educational material through an online educational module ) Lecture Group: (this group will receive the educational material through an interactive lecture based educational module )
5. A post-test same as the pre-test will be used to assess the change in knowledge and attitude regarding child abuse recognition and reporting after the completion of the assigned educational module.
6. All participants that attended both educational modules will be asked to answer a small questionnaire about their perceptions regarding the learning experience.

Eligibility Criteria:
Inclusion Criteria:

* Dental Interns enrolled in the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University
* Participants of both genders
* Graduates of any dental school in Egypt

Exclusion Criteria:

* Participants who refused to sign the consent
* Participants who won't be able to have online access to the material
Comparison of Plant-based or Animal-based Protein on Anthropocentric and Metabolic Parameters in Obese Subjects

The investigators will try to evaluate the effects of substitution of dietary animal protein by black soybean milk (400 mL x 2) per day on anthropocentric and metabolic parameters in obese subjects.

According to the survey by the Ministry of Health and Welfare, the proportion of obese male adolescents in Taiwan has been increasing year by year. Obesity is associated with chronic low-grade inflammation. Obese people prefer to intake foods containing higher levels of advanced glycation end products (AGEs). High intake of dietary AGEs (dAGEs) results in abdominal obesity, and shows positive correlation with body mass index (BMI) and waist circumference. When a large amount of AGEs accumulates in the body, inflammation usually occurs. Therefore, reducing dAGEs intake prevents the incidence of obesity, chronic diseases and aging. Black beans are high in protein. The black bean coats contain high level of anthocyanins. Previous studies demonstrated the biological functions of anthocyanins on blood lipid regulation, inflammation, and also inhibition of AGEs formation. Compared with meat (beef, pork, lamb, chicken, and seafood), the plant protein source, soy milk, under the same protein content showed significantly lower dAGE. In this study, the investigators will try to eveluate the effects of substitution of dietary animal protein by black soybean milk (400 mL x 2) per day on anthropocentric and metabolic parameters in obese subjects. This will be a randomized crossover interventional trial for 16 weeks: 0 to 4 weeks will be run-in period, 4 to 8 weeks and 12 to 16 weeks will be the soy milk or meat intervention period, and the between of two interventions (8 to 12 weeks) will be washout period. The body composition, blood pressure and AGE level will be measured. The blood, urine and feces sample will be collected for biochemical analysis and gut microbiome. The investigators expect the results could support the promotion of plant protein as part of dietary protein source to improve abnormal anthropometric and metabolic parameters in obese subjects.

Eligibility Criteria:
Inclusion Criteria:

* 20 to 64 year male or female
* 27 \<= BMI \< 35 or waist circumference male \>= 90 cm/female \>= 80 cm
* fasting blood glucose: 100-125 mg/dL

Exclusion Criteria:

* Hypertension, cardiovascular disease, endocrine disease, acute and chronic liver and kidney disease, mental disease, binge or anorexia, or long-term drug use
* Consume probiotics, prebiotics, antibiotics or weight loss drugs regularly for the past month
* Try to lose weight and do resistance exercise regularly for the past month
* Allergic to soy products
Comparison of Sugammadex (MK-8616/Org 25969) With Neostigmine Administered at 1-2 Post-tetanic Counts (PTCs) After Administration of Rocuronium or Vecuronium (19.4.302/P05945/MK-8616-025)

The purpose of the trial is to demonstrate a faster recovery from neuromuscular block (NMB) induced with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by 70 μg/kg of neostigmine in combination with 14 μg/kg glycopyrrolate.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Class 1 to 4
* 18 years or older
* Scheduled to undergo an elective surgical procedure under general anesthesia requiring the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block
* Scheduled for surgery in supine position
* Given written informed consent

Exclusion Criteria:

* Participants in whom a difficult intubation is expected due to anatomical malformations
* Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction
* Known or suspected to have a (family) history of malignant hyperthermia
* Known or suspected to have an allergy to narcotics, muscle relaxants, or other medications used during surgery
* Receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics, and magnesium (Mg2+)
* Participants in whom the use of neostigmine and/or glycopyrrolate may be contraindicated
* Female participants who are pregnant or breast-feeding
* Females participants of childbearing potential not using an acceptable method of birth control \[condom or diaphragm with spermicide, vasectomized partner (\> 6 months), IUD, abstinence\]
* Participants who had already participated in an Org 25969 trial
* Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.302