cyrilzakka/clinical-trials huggingface dataset:
OBSERVATIONAL STUDY OF COMPARISON EFFECTIVITY BETWEEN REMDESIVIR AND FAVIPIRAVIR IN SURABAYA, INDONESIA

In order to compare the effectiveness between Remdesivir and Favipiravir, an observational analytic study using a retrospective cohort design. Eighty-eight medical records of COVID-19 patients from January to August 2021

Coronavirus Disease 2019 (COVID-19) is an infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2). Antiviral therapies are considered to be one of the COVID-19 treatments. Remdesivir and favipiravir are the antivirals recommended by Indonesia's 3rd COVID-19 Management Guidelines. They have a similar mechanism to inhibit virus replication, specifically by inhibiting RNA-dependent RNA polymerase (RdRp) of the virus. Several studies reported that patients who received these antivirals had a lower duration of hospitalization. However, the effectiveness comparison of remdesivir and favipiravir remains unknown.

An observational analytic study using a retrospective cohort design. Eighty-eight medical records of COVID-19 patients from January to August 2021 are collected by consecutive sampling technique, and this research was carried out at Gotong Royong Hospital Surabaya.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (eighteen years old or above) with moderate to severe COVID-19 (categorized based on KEPUTUSAN MENTERI KESEHATAN REPUBLIK INDONESIA NOMOR HK. 01. 07/MENKES/413/2020);
* Admitted to Gotong Royong Hospital Surabaya from January 2021 to August 2021;
* Received remdesivir OR favipiravir with minimal five days of treatment
* Not in pregnancy and lactating condition

Exclusion Criteria:

* female patient with pregnancy and lactation
* patient whom was passed away or forced home during two-weeks observation period
Bile Leakage Test in Emergency Hydatid Liver Cyst Surgery Case Report

In liver cyst hydatid surgery, presence of cysto-biliary communication (CBC) is important for the prevention of postoperative morbidity. If cysto-biliary connections are not obvious, diagnosis is not easy. Intraoperative bile leakage test has been shown to reduce postoperative biliary complications by revealing occult CBCs. However, bile leakage testing in emergency conditions such as hydatid cyst perforation has not been experienced so far.

In liver cyst hydatid surgery, presence of cysto-biliary communication (CBC) is important for the prevention of postoperative morbidity. If cysto-biliary connections are not obvious, diagnosis is not easy. Intraoperative bile leakage test has been shown to reduce postoperative biliary complications by revealing occult CBCs. However, bile leakage testing in emergency conditions such as hydatid cyst perforation has not been experienced so far.

Here, a bile leakage test performed in a 23-year-old male patient undergoing emergency surgery due to the perforation of the hydatid liver cyst was presented. Following the treatment of perforated hydatid liver cyst and biliary peritonitis, a bile leakage test was performed. The common bile duct was cannulated with a 22 Gauge catheter, normal saline and parenteral lipid solution were given to demonstrate the CBCs, and leakage areas were suture ligated. The patient was discharged postoperatively without any problem.

The investigators recommend detection and treatment of the CBCs even in emergency hydatid liver cyst surgery for prevention of postoperative biliary complications.

Eligibility Criteria:
Inclusion Criteria:

* this study is a case report

Exclusion Criteria:

* this study is a case report
Comparison of Four Intensive Care Scores in Prediction of VA-ECMO Survival.

VA-ECMO is increasingly utilized in the setting of cardiogenic shock or cardiac arrest to restore hemodynamic stability and end organ function. VA-ECMO serves as a short-term ventricular assist device that can be rapidly placed at the bedside in the emergency room, intensive care unit, cardiac catheterization suite, or operating room. A bridge to decision approach allows for the assessment of neurologic status, renal and hepatic function, and subsequent recovery of cardiac function. Despite its life-saving potential, VA-ECMO is fraught with complications including vascular complications from cannulation. In addition, neurologic injury, renal failure, liver failure, and sepsis are all well described sequelae of the post-cardiogenic shock or cardiac arrest VA-ECMO patient. For these reasons, identifying early prognostic indicators and developing a score with regard to the outcome of this special patient population is of high interest. The proposed study aims to analyze 4 ICU scores/Survival prediction models \[APACHE-II (acute physiology and chronic health evaluation II), SAVE (Survival after VA ECMO) , SOFA (sequential organ failure assessment )and CASUS (Cardiac Surgery Score)\] and evaluate their performance in predicting survival after VA ECMO insertion. This will be a clinical retrospective study which will be conducted in the Cardiothoracic Intensive Care unit (CTICU) in the Department of Cardiothoracic Surgery, Heart Hospital, Doha. Patients admitted to the CTICU after institution of VA ECMO in the period between 1st January 2015 to 31st October 2022 will be screened retrospectively. Patients who stay for at least 12 hours in the CTICU would be eligible for inclusion in the study. All charts of patients who were admitted to CTICU after institution of VA ECMO during the afore mentioned period will be included in the review. All the risk scores would be calculated separately for all the enrolled patients and then subjected to statistical analysis to determine predictive accuracy for survival.


Eligibility Criteria:
* Inclusion criteria

  * Age more than18 years old.
  * Patients undergoing institution of VA ECMO
* Exclusion criteria

  * Patients staying \< 12 hours in the ICU
The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring.

The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been debated. Blood samples for s-clozapine monitoring should be drawn 12 hours post dose.

The scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine within the range of 10-14 hours after the last administration of clozapine .

Several factors can influence s-clozapine and thereby the occurence of dose-related adverse reactions and level of treatment response. The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been debated. Blood samples for s-clozapine monitoring are recommended to be drawn 12 hours post dose. Uncertainty regarding the timing of blood sampling and the individual pharmakokinetics for clozapine +/- 2 hours from the 12-hour timepoint, leads to uncertainty regarding the comparability of serum concentrations and the information hold within them.

The scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine within the range of 10-14 hours after the last administration of clozapine .

In addition we want to investigate if any of the following covariates might affect the change of s-clozapine and s-N-desmethyl-clozapine: Sex, age, BMI, co-medications, signs of infection, caffeine intake and smoking.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 \< 65
* Diagnosed with schizophrenia according to the criteria of ICD10 (International Classification of Diseases, World Health Organization) or the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, the American Psychiatric Association)
* Unchanged dose of clozapine for the last 30 days
* Usual time of clozapine evening-dose administration between 9 and 12 pm.

Exclusion Criteria:

* Significant drug or alcohol abuse that affects participation in this trial
* Non- or partial compliance of clozapine the day before the trial (assessed by interview)
* Unresponsive by telephone the evening before the trial
* Consumption of clozapine in the morning on the day of the trial
* Significant change in smoking habits within the last 30 days (assessed by interview)
* Significant change of caffeine intake within the last 7 days (assessed by interview)
* Modified use of other antipsychotics within the last 30 days
* Within the last 30 days (7 days for hormone based contraceptives) changes in the use of other medications that can affect s- clozapine during the trial : ( fluvoxamine, ciprofloxacin, hormone based contraceptives, carbamazepine , phenytoin , rifampicin, omeprazole )
* Females who are pregnant or breast-feeding
Effect of Dissecting of The Inferior Pulmonary Ligament on Postoperative Pulmonary Reexpansion and Recurrence

This subject analysis of the influence of the dissociating inferior pulmonary ligament on pulmonary reexpansion and recurrence in the treatment of primary spontaneous pneumothorax by video assisted thoracic surgery. All patients are randomly divided into two groups: group A and group B. Wedge resection(WR) will be performed for all patients. Investigators dissect the inferior pulmonary ligament(DIPL) for group A. Investigators do not dissect the inferior pulmonary ligament for group B. The pulmonary reexpansion and recurrence rate are observed between the two groups.

Wedge resection of the lung is usually used in the treatment of primary spontaneous pneumothorax. And the pleural treatment also might be used. But part of secondary pneumothorax patients who had undergone surgical, the bullae can be found especially in the apical of lung, even if the pleural have been treated in some way.This subject provides a new way of thinking and method to solve the problem of recurrent spontaneous pneumothorax.

Eligibility Criteria:
Inclusion Criteria:

1. The patients diagnosis pneumothorax with chest radiograph or computed tomography (CT)
2. The clinical and final pathological diagnosis for patient is PSP.
3. The patients with stable vital signs, no contraindication for operation and no communication barriers.
4. The patients,after informed of test content, significance and risk, who voluntarily enroll and sign informed consent.

Exclusion Criteria:

1. The patients who refuse to do a video assisted thoracic surgery.
2. The patients with pneumothorax with specific causes such as pulmonary hamartoangiomyomatosis, catamenial pneumothorax, and pneumothorax secondary to chronic obstructive pulmonary disease.
3. The patients who were older than 50 years
4. The patients with familial history of pneumothorax.
5. The patients with mental disorders, low Intelligence Quotient, can not objectively reflect the indicators of observation.
6. The patients who refuse to follow-up.
Topography-guided LASIK Surgery

The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism

The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism. The investigators will be monitoring changes in anterior segment optical coherence tomography epithelial thickness maps. The investigators will compare preoperative maps to postoperative maps at one, three, six and twelve months. In addition, the investigators will measure changes in epithelial maps from postoperative month through twelve months to help understand what is happening to the corneal epithelium to try to explain why UDVA and CDVA improves over time

Eligibility Criteria:
Inclusion Criteria:

* Subjects age 18 and older with healthy eyes. Nearsightedness between -0.50 diopters and -8.00 diopters.
* Subjects with up to 3.00 diopters of astigmatism.
* Subjects with a spherical equivalent of up to -9.00 diopters.

Exclusion Criteria:

* Subjects under the age of 18.
* Subjects with excessively thin corneas.
* Subjects with topographic evidence of keratoconus.
* Subjects with ectatic eye disorders.
* Subjects with autoimmune diseases.
* Subjects who are pregnant or nursing.
* Subjects with more than 3.00 diopters of astigmatism
Tongue Pressure Recording During Speech

This research is about tongue's pressure during speech, using a complete denture which allows respecting tongue and speech physiology at the best.

A strain gauge transducer is placed inside this prosthodontics device. During speech, the pressure and the sounds are recording. The analysis of the twos signals should explain what pressure is needed for what sound. The comparison between old complete denture wearers and new one is realized to provide informations about tongue adaptation's phenomenon.


Eligibility Criteria:
Inclusion Criteria:

new prosthodontics device or change of prosthodontics device male or female Age upper 18 French as native language

Exclusion Criteria:

-
Use of Black Cohosh and Red Clover for the Relief of Menopausal Symptoms

This Phase II study, a follow-up to a Phase I trial in normal volunteers, will determine the efficacy of black cohosh and red clover for the relief of menopausal symptoms. It will also assess the safety of chronic dosing (1 year) by evaluating uterine (endometrial biopsies), breast (mammography), and hematology parameters (CBC and chemistry lab values) at baseline and 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Menopausal women with intact uterus
* Must be experiencing hot flashes
* No menstrual periods for at least 6 months and no longer than 3 years
* Non-smoker
* Must have intact uterus (no hysterectomy)

Exclusion Criteria:

* Contraindications for hormone replacement therapy
* Diabetes mellitus
* Pregnancy or breast-feeding
* Obese (BMI \>35 excluded)
* History of endometrial hyperplasia/neoplasia/malignancy
* History of breast or reproductive cancer
* History of severe recurrent depression, or severe psychiatric disturbance
* History of stroke/CVA, severe varicose veins, sickle cell anemia, myocardial infarction (heart attack), or arrhythmia (rhythm disturbance of the heart)
* History of abnormal vaginal bleeding of unknown cause
* Untreated or uncontrolled high blood pressure/hypertension
* Use of any medication or supplement containing estrogen, progestin, SERM, St. John's Wort, bisphosphonates, or phytoestrogens
* History of hormone-associated migraines
* History of deep vein thrombosis (blood clots), thrombophlebitis, or thromboembolic disorders
* Participation in a clinical trial within 30 days
* Abnormal endometrial biopsy or mammogram
* Abnormal transvaginal ultrasound defined as \>7mm thickness
* Vegan
Parent Partnership Project

To evaluate the acceptability and feasibility of peers as interventionists in delivering family-based behavioral pediatric weight control intervention.

A new model of delivering family-based pediatric overweight treatment that decreases costs but sustains short- and long-term efficacy is needed. One possible opportunity for this is a peer intervention model in which families receiving professionally-led intervention then subsequently providing intervention to other families. In addition, peer interventionists' continued engagement in the behavior change process through providing intervention to others could improve their own long-term efficacy. The project begins with the standard approach of having professional interventionists provide family-based behavioral pediatric overweight treatment to overweight children and their parent (1st generation families; n=30). Subsequently, half of 1st generation families will be randomly assigned to serve as peer interventionists to other overweight parents and children (2nd generation families; n=30). The remaining 1st generation families will neither receive nor provide any additional treatment. This project aims to develop the peer intervention training and delivery and then to examine the feasibility and acceptability of the peer intervention. This project also aims to derive an estimate of the efficacy of peer intervention (receiving and providing) both at the end of receiving treatment and 6 months later, as well as the impact of providing intervention on peer interventionists' weight outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Child age: 7-11 years at time of enrollment
* Overweight child: at or above 85th percentile for age- and gender-specific BMI.
* At least one overweight parent (BMI≥ 25.0).
* Parent is willing and able to actively participate in treatment including willingness to serve as a peer interventionist following treatment.
* Must live within 50 miles of the treatment center.

Exclusion Criteria:

* Current enrollment in another weight control program for the participating child or parent.
* The participating parent is pregnant.
* Thought disorder, suicidality, or substance abuse disorder in either the participating parent or the participating child.
* Inability of the child to comprehend English at a 1st-grade level or participating parent to comprehend English at an 8th-grade level.
* Physical disability or illness in either the participating parent or the child that precludes moderate intensity physical activity.
* Medication regimen for the child that affects his or her weight.
* Conditions known to promote obesity in the participating child (e.g. Prader-Willi).
* Diagnosed eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder) in either parent (participating and nonparticipating) and/or the participating child.
Effect of GTN and Diamox Measured by BOLD-Response.

In healthy subjects different cerebral haemodynamic values wished to be determined after infusion of the NO donor Glyceryl trinitrate (GTN) and Diamox. The different values we wish to determine are:

* Blood-oxygenation-level-Dependent-signal (BOLD-signal) after visual stimulation.
* Changes in the diameter of a. cerebri media.
* Changes in the regional and global cerebral blodd flow (CBF) with the help of the arterial Spin labeling (ASL) method.

Experimental headache models give a unike opportunity to study pathophysiological mechanisms of prim. headache types such as migraine. Previous studies have used different methods that have had limitations and none of them have had the opportunity to study neuronal activation. But that is possible with the application of functional magnetic resonance (fMRI).

Before we apply fMRI to our experimental headache models it is needed to determine how the BOLD response is influenced and changed by the infusion of different drugs such as the NO donor Glyceryl Trinitrate (GTN) and Diamox (acetazolamide). It is known that GTN causes dilation of the cerebral arteries without having any effect on the regional cerebral blood flow. It is not known what effect GTN has on the BOLD response. Diamox (azetazolamide) increases the CBF but it is uncertain what effect the drug has on the BOLD response. Previous studies disagree gravely on this point.

In this study we will be giving infusion of GTN and Diamox in healty subjects to determine:

* Blood-oxygenation-level-Dependent-signal (BOLD-signal) after visual stimulation.
* Changes in the diameter of a. cerebri media.
* Changes in the regional and global cerebral blodd flow (CBF) with the help of the arterial Spin labeling (ASL) methode.

For the study we will be using a 3-Tesla MRI-scan.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* age 18-55 years
* weight 50-100 kg

Exclusion Criteria:

* Tension type headache more the once per month.
* other types of headache
* Daily use of medication other the birthcontrol pills.
* Pregnant or lactating women.
* headache on the examination date.
* contraindications to MRI-scan.
* hypotension or hypertension.
* mental illness og substance abuse.
* other significant conditions determined by the examining doctor.
AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection

The study is a prospective single-arm multicenter clinical trial. Adult patients will be consented and enrolled in an outpatient cardiology office or Arrhythmia Clinics.

The purpose of this study is to conduct clinical validation of the AIMIGo 12-lead Synthesis Software against a standard FDA-cleared 12-lead ECG system, based on quantitative and qualitative assessment of paired recordings from the same patient, in sinus rhythm or during episodes of symptomatic non-life-threatening arrhythmia. The study will provide the necessary data for an FDA 510(k) regulatory submission and develop experience for market access and integration into clinical workflows.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects over 18 years of age.
2. Referred to outpatient arrhythmia clinic with a history of one or more of the following conditions:

   1. Previous diagnosis of arrhythmia presenting to the clinic for routine follow-up evaluation.
   2. Patients with symptoms indicative of cardiac arrhythmias.
3. Able and willing to sign informed consent.

Exclusion Criteria:

1. Open chest wounds or recent (\<30 days) surgery to the chest or abdomen.
2. Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol.
Early Administration of Botox® in Neuropathic Pain Due to Thoracoscopy or Thoracotomy

Botulinum toxin type A has been reported to inhibit the release of various pain neurotransmitters (SP, CGRP, glutamate) responsible for neurogenic inflammation, a process that results from the sensitization of C-fiber nociceptors (peripheral sensitization). This action is probably responsible for the analgesic effect of botulinum toxin type A recently demonstrated in patients with neuropathic pain of peripheral origin.In those studies, patients had been suffering for years. The investigators can hypothesizes that earlier administration of Botox in the course of neuropathic pain might prevent central sensitization, that is secondary to peripheral sensitization. The investigators can hope to increase efficacy of Botulinum toxin type A injections and to prevent chronification of pain.


Eligibility Criteria:
Inclusion Criteria:

* daily pain, for 3 months, secondary to thoracoscopy or thoracotomy, of neuropathic origin (DN4 questionary)

Exclusion Criteria:

* contraindications for botulinum toxin
Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy

The purpose of this study is to determine the effect of lacosamide on mood and quality of life in people with epilepsy.

Lacosamide (LCM) was found in phase 3 studies to have good efficacy and tolerability as adjunctive treatment in adult patients with uncontrolled partial onset seizures, with or without secondary generalization. Dose-related adverse drug reactions (ADRs) included dizziness, headache and nausea, but the incidence of reported mood symptoms was similar to placebo. The very low incidence of such events, combined with LCM's unique mechanism of action, suggest that LCM has the potential to be among the few anti-epileptic drugs (AEDs) without clinically significant mood ADRs.

The effects of LCM on mood states (i.e., worsening or improvement) have not been examined with standardized measures. In addition, its effects on quality of life (QOL) have not been explored, although QOL is known to be affected by other AEDs.

The investigators propose to examine the effects of LCM on mood and QOL in a real-world population of adult patients with partial-onset seizures. To the knowledge of the investigators, the proposed study will be the first to examine these domains in a scientifically rigorous fashion in patients treated with LCM. Thus, study results will fill a current knowledge gap, and will provide important information to clinicians and patients when considering LCM treatment.

Eligibility Criteria:
Inclusion Criteria:

* At least 17 years old
* Have partial (focal) onset seizures that are not controlled with medication
* (LCM group only) LCM is being added to anti-epileptic drug regimen by treating physician

Exclusion Criteria:

* Have taken LCM in the past.
* Change in anti-epileptic drugs or their doses in the past 28 days.
* Have participated in another drug research study in the past 3 months.
* Have had epilepsy brain surgery, or plan to have epilepsy surgery in the next four months.
* Have a psychiatric or behavioral condition, which in the opinion of the investigator, could compromise patient's ability to participate in the study.
* Have a progressive (worsening) disease that affects patients brain and its functions.