cyrilzakka/clinical-trials huggingface dataset:
The Effect of Newborn Massage on Comfort Level and Vital Signs

This study was planned as a randomized, controlled, experimental study to examine the effect of neonatal massage on the comfort level and vital signs of newborn babies.An answer to the question "Does massage applied to infants in the neonatal period have an effect on vital signs and comfort level?" will be sought.

The sample of the study consisted of a total of 60 infants, 30 in the experimental group and 30 in the control group, who were hospitalized in the Neonatal Intensive Care Unit of a City Hospital between December 2022 and April 2023, whose parents' written and verbal consent was obtained for participation in the study after being informed, and who met the inclusion criteria. "Data Collection Form", 'Life Findings Assessment Form' and 'Newborn Comfort Behaviors Scale' prepared by the researchers were used as data collection tools. Newborns in the experimental group were massaged twice a day for 15 minutes 30 minutes after feeding and routine care for 4 days. The data obtained in the study will be analyzed using SPSS (Statistical Package for Social Sciences) for Windows 22.0 program.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 37-42 weeks,
* Birth weight of 2500 grams and above,
* The infant was hospitalized in the Neonatal Intensive Care Unit during data collection,
* Completion of 24 hours after birth

Exclusion Criteria:

* Gestational age below 37 weeks,
* Birth weight below 2500 grams,
* Refusal of the parent to participate in the study,
* The baby is on mechanical ventilation
A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion

This study is being done to see if reflux of stomach fluid might be a cause of chronic fluid in the ears. Our hypothesis is that treatment with an anti-reflux medication (lansoprazole) will increase the rate of resolution of chronic middle ear fluid in children.

This study is being done to see if reflux of stomach fluid might be a cause of fluid in the ears. Earlier studies have found pepsin or pepsinogen, a component of stomach fluid, in the middle ear fluid of many children with chronic middle ear fluid. Anti-reflux medicines called proton pump inhibitors (PPI) reduce the acidity of the contents of the stomach and the activity of pepsin or pepsinogen. We are studying the effectiveness of a PPI called lansoprazole (Prevacid™) in reducing fluid in the ears. If lansoprazole is able to reduce the fluid in the middle ear, this tells us that the reflux of gastric acid into the esophagus and into the ear canal may be causing middle ear fluid.

Eligibility Criteria:
Inclusion Criteria:

* History of chronic otitis media with effusion meeting clinical indications for tympanostomy tubes placement, defined as the presence of middle ear fluid on physical exam for at least 3 months, in at least one ear.

Exclusion Criteria:

* Past medical history or concurrent conditions known to increase the incidence of either recurrent otitis media or otitis media with effusion or gastroesophageal reflux disease, including cleft palate, neurological delay, cerebral palsy, Down syndrome, velocardiofacial syndrome, and primary ciliary dyskinesia.
* Children with structural abnormalities of the tympanic membranes, such as cholesteatoma, deep retraction pockets, and atelectasis of the tympanic membrane. These abnormalities would require placement of tympanostomy tubes in standard clinical practice.
* Children weighing less than 10 kilograms, due to the lower weight limit for standard Prevacid™ dosing
Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations

clarithromycin may reduce the exacerbations in middle-aged and elderly patients with non-CF bronchiectasis.

The study is aimed to (A) investigate the etiologies and clinical features of patients with bronchiectasis, (B) compare the effect of clarithromycin 250mg daily on the frequency of exacerbations, quality of life and lung function, stratified according to the degree of bronchiectasis severity.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50 years or older
* At least 2 or more exacerbation requiring antibiotic treatment in the past year Clinically stable for at least 4 weeks prior to enrollment (defined as no symptoms of exacerbation, no requirement for supplemental antibiotic therapy)
* Diagnosis of bronchiectasis defined by high-resolution computed tomography (CT) scan

Exclusion Criteria:

* History of cystic fibrosis; hypogammaglobulinemia; allergic bronchopulmonary aspergilosis,
* Cigarette smoking within 6 months
* A positive culture of non-tuberculosis mycobacteria in the past 2 years or at screening
* Macrolide treatment for more than 3 months in the past 6 months
* Oral or intravenous courses of corticosteroids within 30 days of screening
* Any antimicrobial treatment for lower respiratory tract infection in the last 2 weeks
* Unstable arrhythmia
* History of coronary artery disease, or symptoms of heart disease
* Known allergy or intolerance to macrolides
* Patients with liver disease or with elevated transaminanse (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels equal to or greater than the upper limit of the normal)
* Concurrent medication: Colchicine, calcium channel blocker, statins, amiodarone, amitriptyline, trazodone, citalopram, disopyramide, itraconazole, saquinavir, ritaonavir, atazanavir, sildenafil, tadalafil, vardenafil, theophylline, carbamazepine.
MMF Influence on HCV Viral Evolution After Liver Transplantation

Samples from a large clinical trial comparing three immunosuppression regimens, two of which contained MMF, are used to identify the HCV viral quasispecies behaviour after liver transplantation


Eligibility Criteria:
All patients enrolled into - An Open Randomized, Prospective Multicenter Study to Compare the Efficacy and Safety Among Three Immunosuppressant Treatment Regimens in Patients Receiving a Liver Transplant for End-Stage Liver Disease Caused by Chronic Hepatitis C Infection
Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy

PREVENDO is a prospective, multicenter, pilot, and randomized study in 2 parallel arms and single blind, evaluating the proportion of endometrial synechiae 6 weeks after surgery in patients undergoing abdominal myomectomy or polymyomectomy, according to the application or not of an anti-adhesion gel (HYALOBARRIER® GEL ENDO)

Myomas are a common pathology affecting a large population of women of reproductive age. Depending on their location and the patient's symptoms, surgical removal of fibroids may be indicated.

Interstitial or subserous myomas are accessible through the abdominal route (laparotomy or minimally invasive surgery).

The impact of this surgery on the endometrial cavity and the risk of post-surgery synechiae is poorly understood, although it is essential, especially in a population of women wishing to preserve their fertility. In order to reduce and prevent endometrial synechia formation, we suggest PREVENDO study which consist in the systematic intracavitary placement of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) immediately after surgery in patients undergoing abdominal myomectomy or polymyomectomy (laparotomy, laparoscopy, robot-assisted laparoscopy) and the evaluation of the proportion of endometrial synechiae 6 weeks after surgery in patients during diagnostic hysteroscopy performed 6 weeks after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. Of childbearing age
3. Indication of myomectomy / polymyomectomy by laparotomy / laparoscopy / robot-assisted laparoscopy
4. FIGO 2 to 6 classification myomas

Exclusion Criteria:

1. History of intra uterine synechia treatment
2. Uterine malformation
3. Patients under legal protection measure (guardianship or curatorship) or under security measure
4. Pregnant or breastfeeding women
5. Absence of health insurance; or patient with AME
6. Absence of free, informed and written consent
7. Endometrial synechia before operation (grade 1-3) (assessed by systematic diagnostic hysteroscopy)
8. Patient with upper genital infection
9. Hypersensibility to hyaluronic acid
Pranayama for Posttraumatic Stress Disorder

This study aims to investigate the effect of pranayama (yoga-breathing techniques) on post-traumatic symptom severity in patients with post-traumatic stress disorder undergoing standard, out-patient, trauma-focused psychotherapy. Therefore, short pranayama sessions of 5-10 minutes will be provided to the patients directly at the begin of each of psychotherapy unit, while the control group will receive standard, trauma-focused psychotherapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed PTSD according to ICD-10 F43.1
* PCL-5 Score of at least 33 points
* Undergoing outpatient standard trauma-focused psychotherapy (Cognitive Behavioral Therapy, Psychodynamic Psychotherapy, or Systemic Psychotherapy)

Exclusion Criteria:

* Pre-existing mental or somatic conditions that are unlikely to result in correct or safe performance of pranayama:

  1. Substance dependence current use (ICD-10 F10.X, F11.X).
  2. Dementia (ICD-10 F00-F03)
  3. Somatoform Disorder (ICD F45.X) of moderate or severe degree according to DSM-5 300.82: ≥ 2 reactions (cognitive, emotional, or behavioral) to somatic symptoms (≥ 2 criterion-B)
  4. Severe cardiovascular disease: presence of cardiac or vascular implants or grafts, e.g., pacemaker (ICD-10 Z95.X), condition after organ or tissue transplantation (ICD-10 Z94.X)
  5. Acute adverse events occurring during pranayama at baseline (including neck pain, subjective sensation of pressure in the lungs, anxiety / panic)
* Cancer diagnosis in the past 5 years (ICD-10 C00-C97, D37-48)
* Pregnancy / breastfeeding
* Regular pranayama practice in the last 12 months
Evaluation of Outcomes Following Surf Therapy

The current study evaluates psychological and physical health outcomes for active-duty service members following participation in an established surf therapy program. Participants complete assessments before and after the surf therapy program, as well as brief assessments before and after each surf therapy session.

The proposed study would evaluate whether an existing surf therapy program that is part of the Wounded, Ill, and Injured (WII) Wellness Program at Naval Medical Center San Diego (NMCSD), significantly reduces both psychological symptoms (e.g., PTSD, depression, anxiety, negative affect, lack of positive affect) and physical symptoms (e.g., pain, sleep) among active-duty service members. Psychological and physical symptoms will be assessed before beginning the surf program and at program completion. In addition, brief assessments of mood and symptoms will be completed before and after each individual surf therapy session.

Eligibility Criteria:
Inclusion Criteria:

* Active-duty military service members seeking surf therapy at NMCSD and have been medically cleared to participate
* Diagnosis of either a psychological (e.g., PTSD, depression) or physical (e.g., amputated limb; traumatic brain injury) condition that served as a reason for referral

Exclusion Criteria:

* Service members who cannot receive medical clearance to participate in the NMCSD surf therapy program
* Service members who have previously participated in the NMCSD surf therapy program
The Efficacy of Traditional Chinese Medicine in Olfactory Dysfunction

Studies have demonstrated that patients with olfactory dysfunction could improve the olfactory function after olfactory training. But the efficacy of Traditional Chinese Medicine is unknown.The purpose of this study is to evaluate its efficacy in olfactory dysfunction.

A recent meta-analysis found significant positive effects of olfactory training on the individual subcomponents of odor threshold, discrimination, identification, and the composite TDI score. In addition to the evidenced improvement in olfactory function after olfactory training, this form of treatment carries very little risk of adverse effects, is cheap, and can be administered by the patient. For these collective reasons, olfactory training is an attractive treatment modality. Chinese experts consensus on diagnosis and treatment of olfactory dysfunction in 2017 shown that some evidences proved that Traditional Chinese Medicine treatment would benefit olfactory dysfunction but the evidences is not adequate. Until now, the efficacy of Traditional Chinese Medicine is controversial. This study investigate the efficacy and the safety of Traditional Chinese Medicine and olfactory training as a treatment for patients with olfactory dysfunction.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Olfactory dysfunction;
2. 18 ≤ age ≤ 55 years old;
3. No active infection, such as uncontrolled pneumonia;
4. Women with reproductive potential and sexually active men agree to use acceptable and effective contraceptive methods.

Exclusion Criteria:

1. Refuse to sign informed consent;
2. With other diseases that affect the result, such as severe hepatic and renal dysfunction and the investigators believes will interfere with the treatment;
3. Pregnant or lactating women;
4. Without personal freedom and independent civil capacity;
5. Enrolled in other intervention clinical trials;
6. Autoimmune diseases;
7. Other situations that the investigators think are not suitable for the trial.
A Study Evaluating An Integrated Pharmacy Digital Diary and Delivery Strategy to Increase PrEP Use Among MSM and TGW

The PrEP 3D randomized controlled trial (RCT) will study the effectiveness of the PrEP-3D app compared to standard of care for starting pre-exposure prophylaxis (PrEP), continuing PrEP, and adherence to PrEP.

The investigators will be testing a pharmacist-led model of PrEP delivery combined with mobile app-based PrEP support developed by the investigator's team to improve PrEP initiation and persistence. Alto Pharmacy is a full-service online pharmacy already using mobile and web apps to communicate with patients, providers, laboratories, and insurers to provide timely medication delivery. Alto can provide PrEP prescriptions, order laboratory tests, and perform clinical referrals through a collaborative practice agreement (CPA) with SFDPH that allows transfer of these responsibilities. The investigators have integrated online tools with Alto Pharmacy's technology platform to create PrEP-3D: Digital Diary and Delivery, combining a tailored online support tool with the personalized service of a community pharmacy and the convenience of medication delivery. By removing the requirement for initiation and quarterly visits with a primary care physician for PrEP, the PrEP-3D model will expand access to PrEP visits (including for persons who choose not to go to their primary care provider for PrEP) and reduce burden on the health care system.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Assigned male at birth who reports sex with persons assigned male at birth
* Willing and able to provide written informed consent
* HIV-uninfected by negative 4th generation HIV test during screening
* Owns a smartphone and has private access to the internet
* Able to understand, read, and speak English or Spanish
* Lives in California
* Self-reported evidence of being at-risk for HIV acquisition, including at least one of the following in the past 6 months:

  * ≥ 1 episode of anal/vaginal sex with a male or transgender female partner;
  * Diagnosed with a bacterial sexually transmitted infection (STI).
* Interested in taking daily TDF/FTC or TAF/FTC PrEP
* Willing and able to receive PrEP prescriptions through Alto Pharmacy (e.g., no specific pharmacy required by health plan, such as Kaiser HMO)
* Creatinine clearance \>30 mL/min
* No contraindications to TDF/FTC or TAF/FTC use

Exclusion Criteria:

* Repeatedly reactive HIV test at screening or enrollment
* Signs or symptoms of acute HIV infection at screening or enrollment
* Currently enrolled in another HIV intervention study.
* Unable to commit to study participation for the duration of the study
* Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Pharmacokinetics of Valacyclovir Oral Solution in Children

Valacyclovir has replaced acyclovir in many clinical scenarios. Pharmacokinetic data support the use of oral valacyclovir in children, but practical problems exist in children having to take adult-dose tablets. A formulation with acceptable palatability, good pharmaceutical quality and possibility of flexible dosing is developed. Pharmacokinetic data of this formulation is missing.

The present study investigates the pharmacokinetics of valacyclovir oral solution in children by determine the area under the curve (AUC0-12), time above critical concentration (Ccrit), Cmax and Tmax of acyclovir.

Secondary, the safety profile of a single dose of valacyclovir oral solution will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in the age of 2-12 years.
* Subject has an indication for (val)acyclovir prophylaxis and are planned to receive valacyclovir oral solution.
* Subject is managed with a central venous catheter (CVC/Port-a-Cath).
* Subject's parents have signed the Informed Consent Form prior to screening evaluations.
* Subject is willing to participate after study procedures are explained in comprehensible language for the child.

Exclusion Criteria:

* Severe anemia (\<6.0 mmol/L).
* Full dose has not been taken.
SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction

SAVE PACe is a large, prospective, single-blinded, randomized clinical trial with the main objective to study the effect of unnecessary right ventricular apical pacing on the clinical outcome of time to development of persistent AF.

Conventional dual-chamber pacing maintains atrioventricular synchrony but results in high percentages of ventricular pacing, which causes ventricular desynchronization and has been linked to an increased risk of atrial fibrillation in patients with sinus-node disease.

Patients with sinus-node disease and intact atrioventricular conduction are randomly assigned to receive conventional dual-chamber pacing or dual-chamber minimal ventricular pacing with the use of new Medtronic pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization. The primary end point was time to persistent atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Willing and able to give informed consent
* Willing and able to comply with the study follow-up schedule
* Class I/ClassII indications for dual chamber pacing
* Initial implant of a Kappa 700, Kappa 900, EnPulse, or EnRhythm dual chamber IPG
* Demonstrate 1 to 1 conduction and a QRS interval of \< 120ms at 100 beats per minutes for a period of nine seconds while atrial pacing

Exclusion Criteria:

* Less than 18 years of age
* Unwilling or unable to give informed consent
* Unwilling or unable to commit to follow-up schedule
* Medical conditions that would preclude the testing required by the protocol or limit study participation
* Enrolled or intend to participate in another clinical trial during the course of this study
* A life expectancy of less than 2 years
* History of continuous atrial fibrillation for the 6 months prior to screen visit
* Two or more cardioversions, chemical or electrical, within the past 6 months prior to screen
* History of persistent second or third degree atrioventricular block
* A prior implant of pacemaker or defibrillator device
* A baseline, pre-paced QRS \>120 ms on surface ECG
* Failure of the 1 to 1 atrioventricular conduction test
* Anticipated major cardiac surgery within the course of the study
Ischemic Preconditioning in Endurance Athletes

The aim of this study is to investigate the effect of remote ischemic preconditioning on biochemical and functional indices of cardiac function induced by a 30 km run in healthy trained long distance runners.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Healthy
* Age between 18 and 65 years
* Endurance-trained (two or more training sessions per week)

Exclusion Criteria:

* Not applicable
Predictive Model in EEG for Induction and Emergence in Pediatric With Propofol

Anesthesia is essential to control pain and produce unconsciousness during surgery and other procedures during childhood. The anesthetic deepness is measured indirectly through changes in blood pressure and heart rate or can be inferred according to estimated or measured concentrations of anesthetics.

In adults, anesthetic dosing, using patterns based on electroencephalogram (EEG) analysis, has shown clinical advantages compared to traditional monitoring. These advantages include lower consumption of hypnotics, less post-operative cognitive deterioration and decreased intraoperative awakening.

The maturation of the brain and Central Nervous System (CNS) that occurs in childhood affects the response of anesthetics. Additionally, the EEG changes with age and its dominant frequency is lower in children. This explains why brain monitoring methods developed in adults do not work well in children. However, these patterns cannot be extrapolated to the pediatric population. Therefore, it is necessary to develop indexes based on EEG with pediatric data to improve the dosage of hypnotics in this population.

The appearance of alpha wave in frontal EEG has been successfully used as a marker of unconsciousness during general anesthesia with GABAergic hypnotics in adults (sevoflurane, propofol). However, in children, the alpha wave appears since 4 months of age in anesthetics with sevoflurane, so studying the characterization of this wave during the loss and recovery of secondary consciousness anesthetic agents such as propofol has not been studied yet.

Research question:

Is it possible to use the alpha wave as an indicator of loss and recovery of consciousness in anesthesia with propofol in children?

Hypothesis:

The appearance and disappearance of frontal alpha wave is a good indicator of loss and recovery of consciousness in anesthesia with propofol in children.

Eligibility Criteria:
Inclusion Criteria:

* ASA I - II
* Indications of phimosis surgery, cryptorchid and/or inguinal hernia surgery

Exclusion Criteria:

* Anatomical limitations for installing the EEG cap.
* Congenital or genetic malformations that influence his/her brain development.
* Neurological or cardiovascular disease
* Use of drugs with effect in the CNS in the last 24 hrs.
* Preterm newborn less than 32 weeks.
A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)

The purpose of this study is to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women with Hypoactive Sexual Desire Disorder(with or without Decreased Arousal).


Eligibility Criteria:
\[Main Inclusion Criteria\]

* Has met diagnostic criteria for HSDD for at least 6 months
* Is willing and able to understand and comply with all study requirements
* Has a normal pelvic examination at screening

\[Main Exclusion Criteria\]

* Subjects should be generally healthy premenopausal females with no psychological, gynecological or urological conditions which might contribute to the sexual dysfunction, compromise study participation, or confound interpretation of the study results
* Not currently under treatment for the sexual dysfunction and willing to forego other treatments through the course of the clinical trial