cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of A Stigma Directed Interventional Program in Schizophrenia

randomized controlled study measuring the effectiveness of Stigma focused intervention in patients suffering from Schizophrenia

Effectiveness of A Stigma Directed Intervention Program in Schizophrenia

It is a Randomized Controlled trial that aims at:

* Assessment of the relationship between self- stigma and

  1. Family burden on the caregiver (Family member).
  2. Medication adherence by patients.
* Assessment of the effectiveness of the family incorporation in the process of psychoeducation delivered to the patients suffering from Schizophrenia on the self-stigma and family burden of patients with Schizophrenia patients.

The study will be held in Mansoura University hospital Psychiatry department and will include 80 Egyptian patients with Schizophrenia or Schizoaffective disorder will be recruited from Psychiatry department of Mansoura University Hospital

Eligibility Criteria:
Inclusion Criteria:

1. Patients meet the diagnosis of schizophrenia or schizoaffective disorder according to DSM5.The clinical condition is stabilized.
2. Age range between 18 to 50 years.
3. Male and female sexes are included.
4. Availability of close relative in direct contact with the patient.

Inclusion Criteria for the family members:

1. Primary caregiver and the family member share household with patient.
2. No history of receiving treatment of psychiatric disorders.
3. No history of serious head trauma.

Exclusion Criteria :

1. Co morbid substance abuse or dependence disorder.
2. Co morbid intellectual disability.
3. Co morbid chronic medical or neurological condition or history of serious head trauma.

Exclusion Criteria for family members:

-Sever physical illness that hinders their participation- -
Mobile Intervention Supervised Exercise Therapy Study 1

This is a randomized controlled trial evaluating the impact of the mobile phone delivered SVS SET Program on utilization, functional capacity, symptoms and quality of life.

This is a national randomized controlled study with approximately 10-15 sites enrolling patients with Rutherford II peripheral artery disease (PAD) in total. Patients will be randomized between the SVS SET Program and "usual care" for each site. The primary outcome will be to study the site-specific effect on utilization of exercise therapy. Secondary outcomes will be the effect on the 6-minute-walk test, passive activity and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of Age
* Rutherford Class I-II PAD (claudication)
* Ambulatory
* Exercise Therapy Naive (\>18 mo)
* Primary Owner of an Android or iOS device
* Willingness to participate (text, call, fill out surveys) via a mobile phone

Exclusion Criteria:

* Symptomatic coronary artery disease
* Oxygen dependent COPD
* Significant osteoarthritis limiting ambulation
SARS Cov 2 Vaccination in Adolescents With Juvenile Idiopathic Arthritis

Since june 2021, vaccination against the SARS-Cov2 virus is recommanded in France to all children from 12 to 18 years old. In the specific population of teenagers living with juvenile arthritis, the vaccine seems to be safe and well tolerated. It has been shown previously that this population has a vaccine coverage lower than the global population even though few datas are available on this topic The aim of this resarch is to study the vaccination coverage against the SARS-Cov2 virus and more specifically the reasons why adolescents were or were not vaccinated in the population of adolescents with juvenile arthitis followed up in Angers, Nantes and Rennes. For this purpose, a review of the medical record will be done and a questionnaire will be adressed to the family of patients in order to collect informations about the disease, the treatments, the motives or obstacles to vaccination. Secondaries end points are safety of the vaccination, consequences on the juvenile arthritis (such as changes in the medication, flare-up of the illness) and the occurence of covid infection after vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Patients from 12 to 18 years old, on January the 1st 2022
* Patients followed up from juvenile arthritis
* Patients followed up in 2021 and 2022

Exclusion Criteria:

* Patients under 12 years old.
Everyone Can Sing: A Feasibility Study of a Mental Health Promoting Intervention Among 0-3rd Grade Students

This study aims to explore the feasibility of implementing and evaluating a class-based intervention in three Danish primary schools. The intervention includes class choir among all students in 0 to 3rd grade as part of the regular school schedule.

Approximately every fifth child in Denmark experience mental health problems, mental illness, or low levels of school thriving before the age of ten, and 15% of Danish adolescent are diagnosed with a mental disorder before they turn 18. The experience of mental health problems, low school thriving and mental illness in childhood and adolescence is a severe risk factor for school segregation, low grades, school dropout and mental illness in youth and adulthood. There is therefore an urgent need for feasible and effective mental health promoting and preventive interventions from early childhood. High-quality music singing (e.g. choir singing) can promote well-being, social inclusion in school, and positive social relations among school-children, which are key prerequisites for strengthening children's mental health. However, the potential benefits of this type of intervention have not been evaluated in a Danish context. Therefore, we developed the Alle kan synge (AKS; in English: Everyone can sing) intervention as a prototype for implementation and dissemination.

The aim of this feasibility study is to explore the feasibility of implementing the AKS intervention in three Danish primary schools and assess feasibility of the evaluation design. Findings will provide knowledge on the critical aspects of the intervention, which may lead to a possible refinement of the AKS intervention, the implementation processes or evaluation design.

Eligibility Criteria:
Inclusion Criteria: All students in grades 0 to 3 (typically aged 5 to 10 years) in three different Danish elementary schools

Exclusion Criteria: None
Assessing Performance of the Testing Done Simple Covid 19 Antigen Test

This study will measure the sensitivity and specificity of the Testing Done Simple severe acute respiratory syndrome (SARS) CoV-2 antigen test in subjects with suspected Covid-19 that present throughout several urgent care clinics. The antigen test performance will be compared to a real-time polymerase chain reaction (RT-PCR) test.

The Testing Done Simple antigen test is a lateral flow immunoassay that detects the presence of the SARS CoV-2 nucleoprotein and is primarily intended for use in an at home setting. The antigen test will be compared to a traditional RT-PCR tested nasal swab specimens. The purpose of study is to measure the performance of the Testing Done Simple test via sensitivity and specificity when compared to the gold-standard RT-PCR test. The test will be administered in symptomatic and asymptomatic subjects and participants will report the days that has passed since their symptom onset. The RT-PCR test will be performed prior to the Testing Done Simple test.

Eligibility Criteria:
Inclusion Criteria:

* Subject was given a SARS CoV 2 PCR test for any of the following 4 reasons:

  1. Subject has Covid like symptoms that started within past (7) days
  2. Subject has been exposed to another individual with a known Covid diagnosis or probable Covid diagnosis
  3. Subject needs Covid test done for travel, school, work, etc
  4. Subject works in a high risk environment
* Subject can provide a nasal swab sample
* Subject is at least 18 years of age
* Subject was given a SARS CoV 2 PCR test on same day participating this study
* Subject provides informed consent

Exclusion Criteria:

* Subject is less than 18 years of age
* Subject does not provide consent
* Subject's Covid 19 related symptom(s) started greater than 7 days from visit
* Asymptomatic subjects whom have had symptom(s) within past (14) days
* Signs of local infection in the area of the face
* Subject was not given a SARS CoV 2 PCR test on same day as study
ACT-Measurement at Different Location During Left Atrial Ablation Procedures

Ablation of atrial fibrillation is standard therapy for symptomatic patients or patients with severely reduced systolic left ventricular ejection fraction. Complications of the procedure are ischemic thrombembolic stroke. Therefore periprocedural treatment with heparin is administered to acchieve a therapeutic anticoagulation. The efficacy of anticoagulation is measured by active-clotting time (ACT) which is measured with blood drawn mostly from the V. femoralis.

Despite controlled anticoagulation periprocedural stroke is published with an incidence of up to 2% and asymptomatic cerebral embolization from 2% to 15%.

The ACT-Trial has two aims:

1. Analysis of the influence of the localization of blood drawing on the measured ACT: blood from central venous line, from LA and from LAA.
2. Dependency of the ACT measured in the blood of the LAA with regard to anatomic und functional LAA-measurements.

Patients will be included scheduled for left atrial ablation procedure and will be divided in two groups: atrial fibrillation at time of procedure and sinus rhythm at time of procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 until 80 years with atrial fibrillation scheduled for left atrial ablation procedure (according to 20216 ESC Guidelines for the management of atrial fibrillation" and/or "2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation" 3. signed informed consent. 4. hemoglobin \>10 g/dl in Messungen up to 8 weeks before inclusion.

Exclusion criteria:

Incompliance or contraindication of oral anticoagulation prior to ablation procedure.
Expiratory Time Constant in Mechanically Ventilated Patients

Determining expiratory time constants in mechanically ventilated patients

Adult patients (n = 30) undergoing elective cardiac surgery with extracorporeal circulation (ECC) were included. Patients were excluded from the study if they had any known lung disease or had previous thoracic surgery. After the surgery, all patients were transferred to the intensive care unit (ICU) and connected to well-established Servo-U (Maquet, Getinge AB, Solna, Sweden) mechanical ventilator. First, the ventilation mode was set to mandatory volume-controlled ventilation (VCV) for 15 minutes. After that, mandatory pressure-controlled ventilation (PCV) for another 15 minutes was commenced. All patients were in supine position, sedated and paralyzed using continuous infusion of propofol and atracurium with no spontaneous breathing efforts. During VCV, an end-inspiratory pause (TPAUSE 10%) has been added to obtain inspiratory plateau pressure (P PLAT) under static conditions. Respiratory variables in VCV for all patients were as follows: PEEP 6 - 9 cmH 2 O depending on the local protocol, protective tidal volume (Vt) of 7 ml/kg/PBW, T PAUSE was set to 10%, I:E ratio of 1:2, rise time 5% and the respiratory rate was 14 breaths/min. After 15 minutes, VCV was changed to PCV with the same ventilator setting with inspiratory pressure set in the way to best match the Vt during the VCV. ARDSNet tables were used to determine PBW for all patients.

A novel device enabling data acquisition (Dr. Wave, Quadrus Medical Technologies, NY, White Plains, USA) has been connected to the Servo-U ventilator after admission to the ICU to record flow, pressure, and volume waveforms. All data in the study were derived from measurements and calculations from this device and included: Peak Inspiratory Pressure (PIP), PPLAT, PEEP, expiratory tidal volume (Vt) respiratory system compliance (C RS ), airway resistance (RTOT) and the peak expiratory flow rate (PEFR).

Based on obtained data of flow, volume and pressure during PCV and VCV, six different methods to determined expiratory time constant were examined

Eligibility Criteria:
Inclusion Criteria: cardiac surgery with extracorporeal circulation

-

Exclusion Criteria:

* known pulmonary disease
* previous thoracic surgery
* poor preoperative cardiac status
A Study to Assess CLn® BodyWash for Reducing Skin Fauna in Patients With Hand Eczema

The primary objective of this protocol is to acquire pilot data for a larger study to test the following hypothesis: Treatment of the hands of patients with chronic hand dermatitis/atopic dermatitis with CLn BodyWash, a novel gel wash cleanser currently marketed as a cosmetic product containing a dilute concentration of less than 0.01% sodium hypochlorite and less than 0.005% concentration as it is lathered, will result in a statistically significant reduction in the number of skin fauna present on the hands of these patients compared to treatment of such patients with traditional wash used clinically such as Cetaphil Daily Facial Cleanser.

Patients with Hand Eczema will be asked to wash with either a CLn BodyWash or Cetaphil Daily Facial Cleanser. Patients and study staff will be blinded. Hand swabs will be done prior to the wash and after 20 minutes. The average time spent in the study for each patient should be less than 2 hours unless an Adverse Event occurs.

Eligibility Criteria:
Inclusion Criteria:

* Seen by an OSU Dermatology provider at OSU Dermatology East after the date of approval of this protocol
* Ability to provide informed consent, or parent or legal guardian capable of providing consent for child or mentally handicapped individuals
* Willingness to participate in a research study.
* Diagnosis of chronic hand dermatitis

Exclusion Criteria:

* Inability to provide informed consent
* Allergy to any of the treatments used
Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait

Eradication of H. pylori reduces morbidity in patients with chronic gastritis and can prevent gastric cancer. We aimed to evaluate the efficacy of clarithromycin-based triple therapy and non-bismuth based quadruple therapy for eradicating H. pylori in patients with chronic gastritis in Kuwait.

Helicobacter pylori (H. pylori) induced chronic infection is associated with peptic ulcer, chronic gastritis, gastric cancer, and increasing antibiotic resistance. Eradication of H. pylori reduces morbidity in patients with chronic gastritis and can prevent gastric cancer in the high-risk population. We aimed to evaluate the efficacy of clarithromycin-based triple therapy and non-bismuth based quadruple therapy for eradicating H. pylori in patients with chronic gastritis in Kuwait. We enrolled treatment-naive dyspeptic patients with gastric biopsy-proven chronic gastritis secondary to H. pylori in a prospective, open-label, randomized study conducted at the gastroenterology outpatient clinics of Haya Habeeb gastroenterology center in Kuwait. Patients were randomized into two groups: the first group received the standard triple therapy (omeprazole, amoxicillin, and clarithromycin) for 14 days; and the second group received quadruple therapy (omeprazole, amoxicillin, clarithromycin, and metronidazole) for 14 days. All patients were tested for the eradication of H. pylori by carbon-13 urea breath test (13C-UBT) one month after completion of eradication therapy.

Eligibility Criteria:
Inclusion Criteria:

* Male and female dyspeptic subjects aged ≥18 years with any nationality
* Patients with gastric biopsy-proven H. pylori related chronic gastritis and no other abnormalities in the upper gastrointestinal tract upon endoscopy
* Patients who were naive to treatment for H. pylori infection.

Exclusion Criteria:

* Pregnant or breastfeeding females
* Patients who were previously treated for H. pylori infection
* Patients who received any antibiotics, bismuth or acid-suppressant drugs within the last month
Turkish Version of the Ankle Instability Instrument

This study aimed to translate the Ankle Instability Instrument into Turkish language, to perform a cultural adaptation study and to evaluate its validity and reliability in the Turkish population. Ankle Instability Instrument was developed to determine the ankle instability level of individuals with a history of ankle injury. Assessment of ankle instability is particularly useful in determining the complaints and functional levels of individuals with a history of functional or chronic ankle instability. It is anticipated that introducing this scale to our language will contribute to other studies in this field.


Eligibility Criteria:
Inclusion Criteria:

* History of ankle injury or sprain at least one time
* Aged between 18 to 40 years

Exclusion Criteria:

* Neurological or orthopedic disorders that may affect ankle instability.

Inclusion criteria for healthy population are; no history of ankle injury or sprain before and. aged between 18 to 40 years
Preoperative Portal and Splanchnic Flow Measurement Using MRI

This study aims to assess the alteration of portal and splanchnic flow using MRI after liver transplantation in patients with splenomegaly or splenic varix.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* And signed informed consent
* And planned either a) liver transplantation as a recipient; or b) liver transplantation as a donor

Exclusion Criteria:

* any absolute/relative contraindication of contrast-enhanced MRI
Comparison of Patient-reported Pain After Initial Archwire Placement

Three different types of 'archwires' can be used in Orthodontic treatment, wire choice is decided by treating Orthodontist based on professional preference since research shows that all types are equally effective.

It is possible that one type of wire engenders more patient discomfort. This study will compare the discomfort levels engendered by the three wire types to determine if there is one that induces the least amount.

Orthodontic treatment with fixed appliances has the potential to induce pain in patients. At the beginning of treatment, the orthodontist must determine which initial orthodontic archwire to insert. Among the more popular choices for initial leveling and aligning of the dental arches are small-sized, round-diameter nickel-titanium archwires. Various types of nickel-titanium (NiTi) archwires exist including stabilized martensitic wires (ie classic Nitinol), active austenitic wires (superelastic NiTi) and active martensitic wires (thermoelastic NiTi). The efficacy of these wire types has been heavily researched with no significant differences in the alignment timing of the dentition (treatment time to reach the final archwire). Pain differences from these wires has been inconclusive from conflicting past studies. It is of critical importance to determine whether one or more of these archwires leads to more discomfort for the patient than the others.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy, with no significant systemic diseases or complications or special needs
2. Requiring a minimum of 1 dental arch (first molar to first molar) labial fixed orthodontic appliance banded/bonded in 1 appointment
3. All banded/bonded teeth can be ligated to initial archwire (no severely displaced or blocked out teeth).
4. Any planned dental extractions that is part of the orthodontic treatment plan must be carried out at least 3 weeks prior to or after initial orthodontic appliance bonding.
5. Age 12 years or older

Exclusion Criteria:

1. Currently taking or recently taken sulfonamides, monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines
2. Currently taking physician-prescribed medical marijuana for the management of pain or recreational marijuana during the trial period
3. Metal-type (Nickel) allergies
4. Less than 12 years old
5. Same day use of analgesics prior to bonding
6. Treatment requiring dental extractions prior to or immediately after bonding of fixed appliance
The Efficacy of Oral Everolimus in Patients With Neovascular Age-related Macular Degeneration

The study will assess the safety and efficacy of Everolimus (RAD001) alone or in combination with Lucentis in patients with neo-vascular age related macular degeneration (AMD)


Eligibility Criteria:
Inclusion Criteria:

* Patients with neovascular Age-Related Macular Degeneration (AMD)
* Best corrected visual acuity ( BCVA) of 20/40 or worse in study eye
* Patients with predominantly classic, minimally classic, or occult choroidal neovascularization in the macula of one eye (the study eye) who have had an inadequate response to VEGF inhibitors in the study eye. Inadequate response is defined as a gain of less than one line of visual acuity and persistent macular edema (central sub-fiel thickness ≥ 300 μm as measured by Optical Coherence Tomography (OCT) despite a minimum of 3 treatments with Lucentis or Avastin

Exclusion Criteria:

* Any concurrent ocular condition in the study eye that may result in substantial change in vision during the study
* Uncontrolled medical conditions such as cancer, angina, diabetes, viral or fungal infections, impaired lung function, history of stroke
* Patients who have macular edema in the study eye that, in the judgment of the investigator, is unlikely to respond to treatment. Examples of features that may guide the investigator's judgment about unresponsiveness are large regions of geographic atrophy, retinal angiomatous proliferation, or large regions of sub-retinal fibrosis. The presence of one of these features excludes a patient only if the investigator judges the study eye to have irreversible macular edema.
* active bacterial, fungal or viral infections at the time of enrollment, e.g. hepatitis B or C infection. Patients with risk factors for hepatitis B should be tested for hepatitis B viral load and serological markers at screening (a positive HBV-DNA, HBsAg). Patients with risk factors for hepatitis C should be tested using HCVRNA-PCR at screening. A clinical history of hepatitis B or hepatitis C will exclude the patient from the study.

Other protocol-defined inclusion/exclusion criteria may apply
Effect of Low-calorie Diet on Serum Lipids, Adipokines, Insulin Resistance and Also Body Composition in Women With Metabolic Syndrome

The purpose of this study is to evaluate the effect of a hypocaloric diet on biomarkers associated with insulin resistance, metabolic profile and body composition in women with Metabolic Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* BMI of 30-34.9 kg/m2, diagnostic of metabolic syndrome based on National Cholesterol Education Panel ATPIII (2002)

Exclusion Criteria:

* Diabetes mellitus, non-treated thyroid disease, treatment with lipid-lowering drugs and glucocorticoids or weight loss treatment within the previous 3 months.