cyrilzakka/clinical-trials huggingface dataset:
Efficacy Safety Score in Postoperative Management

The primary aim of this project is to determine whether postoperative patients may benefit from the Efficacy Safety Score (ESS) as a tool for postoperative clinical decision support, with a special focus on the first 24 hours after discharge from the postoperative care unit.


Eligibility Criteria:
Inclusion Criteria:

* undergoing surgery
* expectedly to be treated and observed in hospital for more than 24 hours postoperatively

Exclusion Criteria:

* refusal of participation
* poor communication capabilities
Comparison of Pilates Exercises Verses Muscle Energy Techniques Along With Kinesio Taping in Non-Specific Low Back Pain

To Compare the effects of Pilates Excercises versus muscle energy technique along with kinesiotaping in non specific low back pain.

This study will help to compare the effects of pilates Exercises with kinesiotaping and on other hand the effects of muscle energy technique with kinesiotaping for improving pain, disability and Range of Motion in patient with non specific low back pain. By combining these interventions, time consumption for treatment and disability among community due to low back pain will be reduced. This treatment will be effective for participants for improving function, movement of joints and muscle to manage and treat low back pain. The combination of treatment will be more effective to relief non specific low back pain. The targeted population of 18-40 years old and most of them are having occupational related low back pain or due to bad posture, study will have an impact in improving and managing the low back pain in such population.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both genders should present with non-specific low back pain and between 18 and 40 years of age.(21)
* Could maintain their standing posture independently for _\>30s.
* Patient having enough physical autonomy to participate in the physical activities required by the study.
* The patient having a visual analog scale (VAS) score of equal to or \>3 will be included.(16).

Exclusion Criteria:

* A history of spinal surgery, compression fracture, spondylolisthesis, or sciatica, ongoing pregnancy, experiencing hypertension, cardiovascular disease, diabetes mellitus, liver disease, renal disease, rheumatoid arthritis, or other rheumatologically related pathologies (8).
* Those taking corticosteroids 2 weeks before recruitment.
* Hypersensitivity to the tape(6).
Treatment Response to Rehabilitation in Patients With Schizophrenia

This study will examine the ways in which schizophrenia-related symptoms affect response to a rehabilitation program for people with schizophrenia.

Patients with schizophrenia often suffer neurocognitive impairment and psychosocial and vocational difficulties. This study will help identify those patients most likely to benefit from existing behavioral treatments and provide clues for how to modify treatments for those who do not benefit.

Two studies will be conducted. The first will investigate the relationship of symptoms and neurocognitive variables at study entry to psychosocial and vocational status 2 years later. The second study will investigate the relationship of symptoms and neurocognitive variables at study entry to treatment response in patients assigned to either a cognitive remediation track or a computer skills track as part of their rehabilitation treatment.

Both the cognitive remediation and computer skills training programs will last 4 to 6 months. Participants will be assessed pre- and post-treatment. Neuropsychological, psychosocial and vocational status will be measured.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for schizophrenia or schizoaffective disorder
* In need of intensive outpatient care
* Treatment with atypical antipsychotic medication for a minimum of 6 months prior to study entry

Exclusion Criteria:

* Auditory or visual impairment
* Mental retardation (IQ less than 70)
* Traumatic brain injury with loss of consciousness
* Presence or history of any neurological illness that may affect brain physiology
* Lack of proficiency in English
* Concurrent substance abuse and/or dependence
Comparison of Analgesic Effect of Volatile Anesthetics

The purpose of this clinical trial is to compare analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index.

Volatile anesthetics vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different bispectral index values. However, the difference between analgesic effects of volatile anesthetics have not yet been investigated. The purpose of this clinical trial is to compare analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index-guided remifentanil infusion.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing balanced general anesthesia using volatile anesthetics and remifentanil
* patients with american society of anesthesiologist physical status I, II
* patients aged 19-65 years
* patients obtaining written informed consent

Exclusion Criteria:

* patients with a history of any psychiatric or neurological disease
* patients who had received any medication affecting the central nervous system
* patients who had received medication affecting the sympathetic or parasympathetic nervous systems
* patients undergoing tracheal intubation for airway management
* pregnant women
Methods for Effective Disposal of Surplus Analgesics to Facilitate Elimination

The primary objective is to evaluate the difference in outcomes for mail-in vs. in-home disposal methods for leftover prescription opioids after discharge from surgery.


Eligibility Criteria:
Inclusion Criteria:

* Anticipated to be prescribed and use an opioid medication to treat acute pain after elective outpatient surgery
* Opioid-naive

Exclusion Criteria:

* Inability to receive email and/or phone calls for follow up assessment
A Study to Assess Dystrophin Levels in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD) Who Have Been Treated With Ataluren

This study is designed to generate additional data on the effect of ataluren for producing dystrophin protein in nonsense mutation nmDMD participants. This study will evaluate dystrophin levels from participants with nmDMD who currently have been receiving ataluren for ≥9 months.

The study will have a single visit (Visit 1).


Eligibility Criteria:
Inclusion Criteria:

* Evidence of signed and dated informed consent/assent document(s) indicating that the participant (and/or his parent/legal guardian) has been informed of all pertinent aspects of the trial.
* Ambulatory (10 meters walk/run in less than \[\<\] 30 seconds) and functional grade on the Brooke Upper Extremity Scale of a 1 or a 2.
* Currently being treated with ataluren 10, 10, 20 mg/kg for \>=9 months, with no gap in treatment of greater than (\>) 1 month, in an ongoing PTC-sponsored nmDMD clinical trial prior to study entry.
* Phenotypic evidence of duchenne muscular dystrophy (DMD) based on the onset of characteristic clinical symptoms or signs (for example, proximal muscle weakness, waddling gait, and Gowers' maneuver) by 6 years of age and an elevated serum creatine kinase (CK). Medical documentation of phenotypic evidence of DMD needs to be provided upon request by the medical monitor.
* Willing to undergo muscle biopsy.

Exclusion Criteria:

* Known contra-indication to muscle biopsy (such as bleeding or clotting disorders).
* Exposure to another investigational drug within 2 months prior to study enrollment or ongoing participation in any non-ataluren interventional clinical trial.
* Requirement for daytime ventilator assistance or any use of invasive mechanical ventilation via tracheostomy. Note: Evening non-invasive mechanical ventilation such as use of bilevel positive airway pressure (Bi-PAP) therapy is allowed.
* Prior or ongoing medical condition (for example, concomitant illness, psychiatric condition, behavioral disorder), medical history, physical findings or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the participant, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
Feasibility of Addressing Sexual Dysfunction in Women with Breast and Gynecologic Cancers with a Novel Mobile Application

The purpose of this study is to identify breast and gynecologic cancer patients with sexual dysfunction, to measure sexual dysfunction with the Female Sexual Function Index (FSFI) and to provide Patients with the opportunity during this six-month period to follow up with a healthcare provider to discuss the sexual dysfunction needs and to see if a medical intervention can be of aid.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a current or historic diagnosis of breast cancer or gynecologic cancer (uterine ovarian, fallopian tube, peritoneal, cervical, vulva, or vaginal cancers)
* Agree to participate in the study with completion of survey and use of ROSY mobile application

Exclusion Criteria:

* Currently pregnant
* Non-English speaking (ROSY is currently is only available is in English).
Biomarkers And Neurological Outcome in Neonates 2

Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies and a preliminary human study.

Follow-Up on neuro-developmental status of Study participants of BANON1. BANON1 (ClinicalTrials.gov ID: NCT03357250): The aim of the study is to validate the application of combinations of several laboratory parameters in early postnatal blood samples, for identification of infants, who will suffer from early abnormal neonatal neurological outcome, in a population at risk. The population at risk is defined as term and late preterm (\>36 weeks of gestation) human infants following perinatal hypoxia-ischemia with or without postnatal resuscitation, and where the combination of laboratory parameters is derived from a preliminary study performed in Turkey (AAMBI) using a metabolomics approach.

Eligibility Criteria:
Inclusion Criteria:

* Infants previously enrolled in BANON study

Exclusion Criteria:

* Missing valid written informed parental consent
Neural Bases of the Check Process

Effective exploration of the environment, check for information to improve one's own performance, are fundamental abilities of human cognition. These abilities are dependent on the process of cognitive control.

However, they are clearly impaired and uncontrollable in certain behavioral disorders such as obsessive-compulsive disorder (OCD). Compulsive checks of these patients, spontaneously associated with a feeling of intense uncertainty, suggest disturbances of evaluative and metacognitive functions. However, no biological observations have yet been able to feed these hypotheses.

The evaluation of decisions and actions involves the middle cingulate cortex (MCC) (which belongs to a cortico-subcortical network structurally and functionally altered in OCD patients). Cingulotomy has long been used as a therapy in severe OCD, with However, the precise part of the cingulate cortex that contributes to check (and its pathological forms) remains to be discovered.

The purpose of this research campaign is to determine, through functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) in healthy human subjects:

1. the location and role of the MCC region involved in normal check decision processes,
2. determine the identity of the entire network involved


Eligibility Criteria:
Inclusion Criteria:

* adults age range 20-45 years
* being able to provide a written consent form
* having a social insurance
* have a normal vision (with or without corrections)
* Right-handed

Exclusion Criteria:

* Subjects with MRI contraindications (e.g. pacemaker, claustrophobia, metal in the body, etc...).
* Pregnant subjects
* Subjects with neurological history
* Subjects must be willing to be advise in case of discovery of brain abnormality.
Pharmacokinetics and Safety of Transdermal Megestrol Acetate

Rationale: Megestrol acetate (Megace®) is a progestin analog that is FDA approved for the palliative treatment of breast and endometrial carcinoma. It is also commonly used as an appetite stimulant, particularly in HIV and cancer patients with poor appetite from their primary disease and/or their therapy. Megace is well absorbed orally, however, many patients, particularly younger ones have difficulty taking oral medications. Transdermal progestins are available and are FDA approved. For example, Ortho EvraTM is a transdermal contraceptive patch containing an estrogen (ethinyl estradiol) and a progestin (norelgestromin).

Key Objectives: Compare the pharmacokinetics of orally administered vs. transdermal Megace and determine if there are any local side effects of the transdermal route.

Study Population: Patients of any age who are already receiving oral Megace as an appetite stimulant. Patients must have an indwelling IV catheter in order to draw drug levels.

Major Inclusion \& Exclusion Criteria: Known hypersensitivity to the transdermal vehicle. Taking any other medicine that would interfere with the Megace assay. Weight less than 10 kg.

Allocation to Groups: Patients will serve as their own controls.

Summary of Procedures: Patients will be on a stable dose of oral Megace. To determine the steady state peak level and half-life for each patient, blood (2cc) will be drawn for a level in clinic 3 hours after an oral dose, then daily for 1-3 days. Patients may then resume their oral Megace, but must stop the medicine at least 5 half-lives prior to the transdermal dose. The transdermal dose will be applied as a gel under a transparent patch in clinic, and blood will be collected prior to, 10, 30, 60, 90, and 120 minutes, and 4 hours after the dose. The patch will be removed after the 4 hour blood level. The patient will return the following day for a 24 hour level, and the patient will be examined briefly for any local effects of the drug or vehicle, and then may resume the oral dose.

Major Risks \& Discomforts: Patients will need to be in clinic for 3-5 separate days, one of which will last at least 4 hours, for drug levels to be drawn. There may be mild skin reaction to the transdermal vehicle or the Megace.

Eligibility Criteria:
Inclusion Criteria:

* Patients of any age who are already receiving oral Megace as an appetite stimulant.
* Patients must have an indwelling IV catheter in order to draw drug levels.

Exclusion Criteria:

* Known hypersensitivity to the transdermal vehicle.
* Taking any other medicine that would interfere with the Megace assay.
* Weight less than 10 kg.
Validation of New Virtual Reality Treatment for Children With Lazy Eye Using the Vedea Amblyopia Therapy (VAT)

The purpose of this clinical study is to validate the effectiveness of the Vedea Amblyopia Therapy (VAT) as a treatment for children with lazy eye.

The main question it aims to answer is to prove that the VAT is as effective or more effective than the current gold standard for treating children with lazy eye. This is occlusion therapy by patching the dominant eye.

Participants will play VR-games specifically designed for children with lazy eye for 30 minutes per day, 5 days per week for 16 weeks. This group of children will be compared to children that undergo regular occlusion therapy to see how both treatments options compare.


Eligibility Criteria:
Inclusion Criteria:

* wearing the full corrected refraction for ≥14 weeks to adapt to the glasses
* diagnosed with an unilateral anisometropic, strabismic and/or deprivation amblyopia.

Amblyopia was defined as an intraocular difference (IOD) in visual acuity (VA) of 0.2 log MAR (2 lines) or more. Angle of strabismus ≤ 10 prism diopters at near and distance fixation. Current clear media (in case of deprivation amblyopia after successful surgery).

* currently under treatment or starting treatment for unilateral amblyopia
* participants must have easy access to an Android device equal to or higher than a Samsung Galaxy S8
* written informed consent by parents or legal guardians

Exclusion Criteria:

* current treatment with atropine penalisation
* documented history of severe negative side effects that occur with exposure to VR usage (eg. seizures or epileptic spasms)
* photosensitivity
* no developmental delay
* coexisting ocular pathology or systemic diseases
Achieving Sustained Early Child Development Impacts at Scale: A Test in Kenya

An estimated 43% of children under age 5 in low- and middle-income countries (LMICs) experience compromised development due to poverty, poor nutrition, and inadequate psychosocial stimulation. Numerous early childhood development (ECD) parenting interventions have been shown to be effective at improving ECD outcomes, at least in the short-term, but they are a) still too expensive to implement at scale in low-resource and rural settings, and b) their early impacts tend to fade over time in the absence of continued support. New ways to deliver effective ECD parenting interventions are sorely needed that are both low-cost to be potentially scalable, while also able to sustain impacts long-term.

The rapid growth and low cost of mobile communications in LMIC settings presents a potentially promising solution to the competing problems of scalability and sustainability. Yet there is no rigorous research on mobile-health (mHealth) interventions for ECD outcomes in LMIC settings. Study investigators recently showed that an 8-month ECD parenting intervention featuring fortnightly group meetings delivered by Community Health Workers (CHWs) from Kenya's rural health care system significantly improved child cognitive, language, and socioemotional development as well as parenting practices, and a group-based delivery model was more cost-effective than previous ECD interventions. Yet it is still too expensive for scaling in a rural LMIC setting such as rural Kenya, particularly if interventions are needed that can be extended for longer periods of time to increase their ability to sustain impacts. This study will experimentally test a traditional in-person group-based delivery model for an ECD parenting intervention against an mHealth-based delivery model that partially substitutes remote delivery for in-person group meetings. The relative effectiveness and costs of this hybrid-delivery model will be assessed against a purely in-person group model, and the interventions will extend over two years to increase their ability to sustain changes in child outcomes longer-term. The evaluation design is a clustered Randomized Control Trial across 90 CHWs and their associated villages and 1200 households. The central hypothesis is that a hybrid ECD intervention will be lower cost, but remote delivery may be an inferior substitute for in-person visits, leaving open the question of the most cost-effective program.


Eligibility Criteria:
Inclusion Criteria:

* mothers or other primary caretakers aged 18 years or older
* able to read English or Swahili at a level sufficient to understand the SMS messages
* with a child aged 6-18 months at recruitment without signs of severe mental or physical impairments (youngest child if more than one eligible for a given mother)

Exclusion Criteria:

* mothers/households without children
* households with children that are outside the age range of 6-18 months at baseline
* mothers who lack basic literacy so as not to understand SMS messages
The Effect of Continuous Accompanying Support in the Active Phase on Labor Pain, Duration and Satisfaction

This study was planned to determine the effect of continuous accompanying support during the active phase on labor pain, duration and satisfaction.

Participants who comes into childbirth needs the support of people around her in order to cope with the stress, anxiety and labor pain she experiences. This support is the continuous birth support given from the time the participants comes to the hospital until the birth of the baby. Having someone who supports the woman during the birth process will provide a positive birth experience for pregnant women. At the same time, the feeling of pain of the supported woman will be reduced and the delivery time will be shortened.

This randomized controlled study was planned to be performed on primiparous pregnant women between January 2023 and January 2024. The data of the study will be collected with "Personal Information Form", "Visual Analog Scale".

The study was divided into two groups as experimental and control groups. 55 participants in the experiment -55 participants will be randomized to the control group. Participants meeting the inclusion criteria will be asked to rate their pain and satisfaction from 0 to 10 with the VAS 4 cm, 6 cm, 8 cm and fully open. While both groups receive routine midwife support, when the experimental group reaches 4 cm, a person they want will be taken with them and continuous support will be given until there is a dilation of 10 cm.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 years old
* Being literate
* Fluent and speaking Turkish
* Primiparous
* Spontaneous vaginal delivery planned
* At the beginning of the active phase (dilatation 4 cm)
* Pregnant women who agreed to participate in the research

Exclusion Criteria:

* Presence of a health problem in the mother during pregnancy
* At risk of fetal anomaly
* Having multiple pregnancy
* Administering analgesic medication during labor
Randomized Clinical Trial: Nasoenteric Catheter or Jejunostomy

Curative treatment of upper gastrointestinal tract neoplasms is complex and associated with high morbidity and mortality. In general, the patients are already malnourished, and early postoperative enteral nutrition is recommended. However, there is no consensus concerning the best enteral access route in these cases.

A prospective randomized trial with patients undergoing esophagectomy, total gastrectomy or pancreaticoduodenectomy to asses the outcomes of either jejunostomy placement or catheter placement

Eligibility Criteria:
Inclusion Criteria:

* age over 18,
* gastrointestinal resections

Exclusion Criteria:

* age under 18,
* no gastrointestinal procedure