cyrilzakka/clinical-trials huggingface dataset:
Feeding Schedules After Surgery in Patients With Gynecologic Cancer

RATIONALE: Abdominal pain and nausea and vomiting may be lessened by waiting after surgery before eating foods by mouth. It is not yet known which feeding schedule is more effective in patients undergoing surgery.

PURPOSE: This randomized clinical trial is comparing two feeding schedules after laparotomy in patients with gynecologic cancer.

OBJECTIVES:

Primary

* To investigate the relationship between the different policies of realimentation (early oral feedings versus traditional feedings) and the length of hospital stay following a laparotomy in patients with gynecologic oncologic disease.
* To assess the degree of postoperative abdominal pain in these patients.
* To evaluate the incidence of ileus symptoms, including nausea and vomiting, and the postoperative recovery of intestinal activity in these patients.
* To determine the incidence of postoperative complications in these patients.
* To elucidate the global postoperative patient's satisfaction and the quality of life in both groups of patients.

OUTLINE: Patients are stratified according to laparotomy with or without intestinal resection (yes vs no), and presence of ovarian cancer (yes vs no). Patients are randomized to 1 of 2 groups at the end of surgery.

* Group 1 (early feeding): Patients are offered a liquid diet on day 1 for 24 hours following surgery. Beginning on day 2, patients who tolerate a liquid diet are offered a regular diet until hospital discharge.
* Group 2 (traditional feeding): Patients are offered nothing by mouth on days 1 and 2 following surgery. Beginning on day 3, patients are offered a liquid diet for 24 hours. Beginning on day 4, patients who tolerate a liquid diet (i.e., no nausea and vomiting) are offered a semi-solid diet for 24 hours. Beginning on day 5, patients who tolerate a semi-solid diet are offered a light regular diet until hospital discharge.

Data is collected through the Post-Operative Pain Questionnaire, Bowel Function Table, Global Postoperative Patient's Satisfaction Questionnaire, Postoperative Complication and Hospital Stay Questionnaire, and the Quality of Life Questionnaires EORTC OV-28 and EORTC QLQ-C30.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Preoperative diagnosis for probable gynecologic pathology

  * No benign pathology or final histopathology diagnosis confirmed as non-gynecologic disease
* Admitted to the European Institute of Oncology
* Elected to undergo laparotomic surgery

  * No total or anterior pelvic exenteration
  * No emergency laparotomy

PATIENT CHARACTERISTICS:

* No metabolic pathology (e.g., diabetes mellitus type I)
* No preoperative ASA score ≥ 4
* No preoperative infection
* No severe malnutrition (weight loss \> 10% within the past 3 months)
* No preoperative intestinal obstruction
* No postoperative admission to the intensive care unit (ICU) for more than 24 hours
* No severe concomitant medical condition

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior abdominal and/or pelvis radiotherapy
Effect of Virtual Video Reality Gaming on Fine Motor Skills in Children With Down's Syndrome

Down's syndrome is genetic disorder caused by trisomy 21. Children with Down's syndrome are characterized by awkward movements, gait, increased flexibility of joints, timing of mastering of basic skills, under development of fine motor skills.

Virtual Reality Therapy (VRT) is a technique that uses interactive games as a physical therapy resource and has shown positive results in cortical reorganization, improving functional mobility, and quality of movement.

This is an experimental study in which randomized controlled trials study design is being used.

Down's syndrome is a genetic disorder caused by trisomy 21. Down's syndrome is characterized by a variety of dysmorphic features, congenital malformations and other health problems and medical conditions. Not all of them are present in each affected individual. The impact of Down's syndrome for each person is variable some are more affected, some are mild affected and some are fully independent.Children with Down's syndrome are characterized by awkward movements, gait, increased flexibility of joints, timing of mastering of basic skills, under development of fine motor skills.

Virtual video gaming is a best method for development of fine motor skills in Down's syndrome children. Virtual Reality Therapy (VRT) is a technique that uses interactive games as a physical therapy resource and has shown positive results in cortical reorganization, improving functional mobility, and quality of movement.

This is an experimental study in which randomized controlled trials study design is being used. Data will be collected from rising sun institute within 6 months after the approval of synopsis. Randomized sampling method will be used. Sample size will be 16 children with Down's syndrome. One group is Control group (self-help skills) in which only self-help skills effect on fine motor skills in Down's syndrome children will be assessed. Other group is Experimental group (virtual video gaming) in which effect of virtual video gaming on fine motor skills will be assessed. ABILHAND-KIDS tool will be used for measurement of effectiveness of virtual video gaming in children with Down' s syndrome. The objective of study is to determine the effects of virtual reality video gaming on fine motor skills in children with Down' s syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Age group of patients ranged between 6 years to 10years.
* Both the gender will be considered.
* Subject who is able to follow the instruct

Exclusion Criteria:

* Patients with medical co-morbid.
* Gross deformity of upper /lower limb
* Epilepsy
Effects of Earplugs on Sleep and Sleep Apnea

The main goal of this study is to assess whether use of earplugs has any effect on sleep, sleep apnea, and daytime sleepiness in individuals who snore.


Eligibility Criteria:
Inclusion Criteria:

* Adults, ages 18 or older
* Scheduled at the University of Michigan Sleep Disorders Center for a diagnostic polysomnogram to evaluate for sleep-disordered breathing

Exclusion Criteria:

* Medical, psychiatric or other conditions that would interfere with interpretation of the results of the sleep studies or the subject's ability to complete the Stanford Sleepiness Scale
Treatment of Ocular Demodicosis by Cleansing the Eyelid Margins Combined With Tea Tree Oil Ointment

To investigate whether the cleaning of eyelid margins increases the effectiveness of traditional tea tree oil eyelid margins in treating mites. The investigators randomly divided 60 participants into two groups: Group A was treated with traditional tea tree oil eyelid margin, Group B was treated with traditional tea tree oil eyelid margin + eyelid cleansing, and participants were rechecked after 3 months of regular medication.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosisof ocular surface mite parasitism

Exclusion Criteria:

* any acute keratoconjunctivitis;c dacryocystitis
Effect of Irbesartan on Endothelial Function of the Retinal Vasculature in Patients With Hypercholesterolemia

The retinal vasculature is morphologically and functionally related to the cerebral vessels due to its common origin from the internal carotid artery. A recent study demonstrated that endothelium-dependent vasodilation of the retinal vasculature is impaired in patients with essential hypertension, which is a strong risk factor for stroke. Furthermore, AT1-receptor blockade was demonstrated to improve retinal endothelium-dependent vasodilation in these hypertensive patients. Hypercholesterolemia is also a risk factor for ischemic stroke and impairment of endothelial function has been observed in various vascular beds in hypercholesterolemic patients, including the coronary and the forearm vasculature. Whether endothelial function of the retinal vasculature is impaired in patients with hypercholesterolemia has not yet been investigated. In patients with stroke, AT1-receptor blockade and angiotensin-converting enzyme inhibition have beneficial effects on clinical outcome. Alterations of endothelial function of the cerebral vasculature might be one pathogenetic factor for the beneficial clinical outcome. To further address this issue, the present study was designed to test the hypothesis that endothelium-dependent vasodilation of the retinal vasculature is impaired in hypercholesterolemic patients and that endothelial function can be improved by AT1-receptor blockade.

see above

Eligibility Criteria:
Inclusion Criteria:

* Male patients aged 18-65 years with LDL-cholesterol \>= 130mg/dl
* Male healthy control subjects aged 18-65 years

Exclusion Criteria:

* All kinds of secondary hyperlipidemia.
* Advanced damage of vital organs (grades III and IV retinopathy)
* Lipid-lowering drugs (including lipid lowering dietary supplements or food additives) within the last 4 weeks
* History of serious hypersensitivity reaction to AT1-receptor blockers
* Actual or anamnestic alcohol- or drug abuse.
* Smokers or ex-smokers \< 1 year.
* Patients with Diabetes mellitus (oral medication or insulin).
* Patients with arterial fibrillation or AV-Block (II° or more).
* Patients with anamnestic myocardial infarction.
* Patients with instable angina pectoris including EcG-aberrations or cardiac insufficiency NYHA III or IV.
* History of malignancy (unless a documented disease-free period exceeding 10 years is present) with the exception of basal cell carcinoma of the skin
* History of allograft transplantation
* Patients with anaphylaxis or known therapy resistance of the used test matters
* Therapy with not approved concomitant medication, or participation in a clinical study within 4 weeks preceding treatment start.
* Disease which interfere with the pharmacodynamics and pharmacokinetics of the study drug.
* Liver or kidney disease with SGOT, GPT, g-GT, AP, bilirubin and creatinin above 200% of standard.
* Patients, who are not sufficiently compliant, or patients, who are not capable or willing to appear for controlling visits.
* Presumed risk of transmission of HIV or hepatitis via blood from the proband
AMAZE™ Asthma Implementation QI Study

The primary study objective is to generate evidence as to the feasibility, usability, perceived value, and potential benefits of implementing the AMAZE™ platform into clinical practice.

AstraZeneca has developed the AMAZE™ disease management platform to be used across multiple disease indications to provide a unified experience for the management of patients throughout their patient care journey. AMAZE™ integrates multiple systems, including a patient mobile application where patients can enter daily symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials. Implementation of AMAZE™ within clinical practice has not yet been evaluated. The results from this study will be used to inform any changes or modifications that need to be made to the technology platform, its implementation process, and explore impact on clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age at the time of enrollment
* Clinically confirmed diagnosis of asthma
* Access to a smartphone with internet access with the following requirements: iOS (Operating System iOS 13 or newer and Devices iPhone 8 or newer) or Android (Operating System 8.0 or newer)
* Able to understand and speak English sufficiently to be able to use the AMAZE™ patient App
* Willingness to participate in a telephone interview and be audio-recorded
* Consenting to participate in the study

Exclusion Criteria:

* Current diagnosis of active chronic obstructive pulmonary disease (COPD) or any pulmonary diagnosis other than asthma;
* Has a cognitive impairment, hearing difficulty, acute psychopathology, medical condition, or insufficient knowledge of the English language that, in the opinion of the investigator, would interfere with his or her ability to agree to participate and/or complete the ACT™
A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities for Overweight and Obese People

The aim of this study was to validate functions for estimating energy expenditure in controlled and free-living conditions. This method was based on accelerometry data acquired from smartphones worn in a trouser pocket. The developed functions have been compared to the estimations provided by three research devices named Fitmate, Armband and Actiheart.

There is a growing interest in evaluating physical activity and energy expenditure (EE) to provide feedback to the user. The use of mass-market sensors such as accelerometers offers a promising solution for the general public due to the growing smartphone market over the last decade.

Two previous studies allowed to propose a function named PredEE, which has been tested on normal-weighted volunteers.

This EE estimation function has been tested and improved with data collected from 43 overweight volunteers equipped with smartphones and two or three research sensors (Fitmate, Armband and Actiheart in controlled conditions, and Armband and Actiheart in free-living conditions). Research sensors' data serves as reference during the evaluation and improvement of the proposed function.

This EE estimation function using the smartphone technology is dedicated to light- and moderate-intensity activities, and the investigators believe it can be a new way to help people controlling their daily physical activity level.

Eligibility Criteria:
Inclusion Criteria:

* men and women
* age: 18-60 years
* BMI between 28 and 42 kg/m²
* subject considered as healthy after clinical examination and medical questionnaire
* no pregnant women
* subject with normal rest electrocardiogram (validated by a cardiologist)
* certificate of non-indication against the practice of exercise stress testing delivered by a physician
* subject with normal blood pressure (\<140/90 mm Hg) with or without medical treatment
* subject with no foot pad problem
* subject giving his/her written informed consent
* subject willing to comply with study procedures
* affiliated to National Health Insurance

Exclusion Criteria:

* respiratory failure or cardiovascular problem
* non-indication against the practice of exercise stress testing
* known cardiac decompensation or myocardial infarction
* surgery made less than 6 months before the study beginning
* pregnant women and nursing mother
* current infectious pathology
* abnormal electrocardiogram
* not affiliated to national health insurance people
* under legal guardianship
* refusal to sign informed consent
* refusal to be registered on the national volunteers data file
* currently participating or who having got 4500€ in this year before to have participated in another clinical trial
A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

The purpose of this study is to assess the long-term safety, tolerability and clinical efficacy of treatment with rozanolixizumab.


Eligibility Criteria:
Inclusion Criteria:

* Study participant completed TP0003 \[NCT04200456\] or TP0006 \[NCT04224688\] until Visit 27 (Week 25) and, in the opinion of the investigator, has been compliant with the TP0003 or TP0006 study assessments
* The study participant is considered reliable and capable of adhering to the protocol, visit schedule, or medication intake according to the judgment of the investigator
* Study participants may be male or female:

  1. A male participant must agree to use contraception during the Treatment Period and for at least 3 months after the final dose of study treatment and refrain from donating sperm during this period
  2. A female participant is eligible to participate if she is not pregnant as confirmed by a negative urine pregnancy test and not planning to get pregnant during the participation in the study, not breastfeeding, and at least one of the following conditions applies:

Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 3 months after the final dose of study treatment

Exclusion Criteria:

* Study participant has any ongoing investigational medicinal product (IMP)-related serious adverse event (SAE) or ongoing severe IMP-related treatment-emergent adverse event (TEAE) experienced during TP0003 or TP0006
* Study participant has, at last available assessment of TP0003 or TP0006, 3.0x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP)
Enemas Before Elective Cesarean Section

Enemas are not anymore used routinely before vaginal deliveries.The intention of this study is to elucidate whether there is a benefit in routine use of enema before cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Cesarean Section, Elective
An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients

The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are receiving a Nucleus® CI512, CI522, or CI532 electrodes
* 18 years and older
* Postlingual onset of hearing loss (onset of hearing loss \>two years of age)
* Individuals who qualify for cochlear implantation using the clinics current CI candidacy criteria
* Individuals who have recently been implanted but not yet had their external device activated
* Willingness to participate in a study and comply with all study requirements
* Fluent in spoken English

Exclusion Criteria:

* Ossification or any other cochlear anomaly that might prevent insertion of less than 10 electrodes of the electrode array
* Diagnosis of retro-cochlear pathology
* Diagnosis of auditory neuropathy
* Subject considering an acoustic component in the implanted ear
* Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
* Unwillingness or inability to comply with all investigational requirements
* Severe-profound sensorineural hearing loss \>30 years
* Previous cochlear implant in the contralateral ear. Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the investigator
Factors Affecting Quality of Life in Patient With Chronic Musculoskeletal Pain

This study included patients who applied to the physical therapy and rehabilitation outpatient clinic and were diagnosed with chronic low back pain and osteoarthrosis and met the criteria for participation in the study.

Demografik datas, pain , Functional Limitations and Quality of Life wa evaluated.

When treating diseases, clinicians traditionally aim for pain reduction and functional recovery. This is also true for chronic musculoskeletal diseases. However, the psychosocial support required to improve the general health perception of patients is becoming increasingly important. In clinical practice, it is essential to evaluate the quality of life and general well-being and to evaluate the patient completely biopsychosocially . Determining the factors affecting the quality of life is important in terms of contributing to the rehabilitation processes and treatment plans of CMP patients. In this direction, our study aims to examine the factors affecting the quality of life.

When treating diseases, clinicians traditionally aim for pain reduction and functional recovery. This is also true for chronic musculoskeletal diseases. However, the psychosocial support required to improve the general health perception of patients is becoming increasingly important. In clinical practice, it is essential to evaluate the quality of life and general well-being and to evaluate the patient completely biopsychosocially . Determining the factors affecting the quality of life is important in terms of contributing to the rehabilitation processes and treatment plans of CMP patients. In this direction, our study aims to examine the factors affecting the quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65 years old
* Clinical diagnosis of spondilosis and gonarthrosis-
* Must not be surgical indication

Exclusion Criteria:

* History of knee or back surgery
* Detection of muscle weakness on physical examination
* Presence of additional neurological disease that will affect the patient's mobilization and cognitive level
* Presence of Cognitive impairment
* Presence of Chronic pain of nonmusculoskeletal origin (gynocological, retroperitoneal, abdominal)
* Being treated for depression
Incentive-based Smoking Cessation for Methadone Patients

The prevalence of cigarette smoking among patients receiving opioid agonist treatment, such as methadone or buprenorphine maintenance, is more than three-fold that of the general population and is associated with increased morbidity and mortality. The overarching goal of this project is to systematically develop a voucher-based contingency-management (CM) intervention for promoting initial and longer-term abstinence from cigarette smoking in patients receiving methadone or buprenorphine treatment for their opioid abuse.

The prevalence of cigarette smoking among patients receiving opioid agonist treatment, such as methadone or buprenorphine maintenance, is more than three-fold that of the general population and is associated with increased morbidity and mortality. Despite these statistics, little is known about how to effectively help opioid-maintained patients to quit smoking. We believe a treatment that successfully promotes smoking cessation in these patients would offer exciting potential for dissemination. First, these treatment modalities are uniquely situated to offer an ideal setting for implementing smoking-cessation interventions. Many patients achieve significant periods of stability and drug abstinence and remain engaged in treatment for long periods of time, which can promote the frequent and prolonged clinical contact to enable success with smoking cessation. Second, opioid treatment programs often adhere to a uniform set of state and federal regulations, which could support the dissemination of an effective intervention throughout clinics across the country. Therefore, the overarching goal of this Behavior Therapy Development project is to systematically develop a voucher-based contingency-management (CM) intervention for promoting initial and longer-term abstinence from cigarette smoking in patients receiving methadone or buprenorphine treatment for their opioid abuse. Our first aim is to develop a CM treatment that will promote initial smoking abstinence in these patients using an intensive but brief 2-week intervention (Study 1). Our second aim will then be to integrate procedures for establishing initial abstinence with those designed for maintaining abstinence with the overarching goal of promoting smoking cessation that is sustained after the incentive program is discontinued (Study 2).

Eligibility Criteria:
Inclusion Criteria:

* For inclusion in the proposed study, subjects must report smoking 10 or more cigarettes per day and have smoked at least that amount for the past year. Subjects must be maintained on a stable methadone or buprenorphine dose for the month before study intake, with no evidence of regular illicit-drug abuse (\<30% positive specimens for illicit drugs in the past 30 days).

Exclusion Criteria:

* Participants will be excluded if they are currently pregnant and/or nursing or if they report regular THC use and are unwilling to stop before beginning the study (THC use will confound CO values when we aim to monitor smoking status).