cyrilzakka/clinical-trials huggingface dataset:
Arabic Version of Identification of Functional Ankle Instability Questionnaire

Testing the validity and reliability of IdFAI

reliability \& validity of Identification Functional Ankle Instability Questionnaire (IdFAI) Arabic version were assessed in reference to Lower Extremity Functional Scale among repeated ankle sprains college students in Cairo. These college students were randomly selected from different colleges in Cairo University

Eligibility Criteria:
Inclusion Criteria:

* eighty six male and female college students will voluntarily participate in the study

Exclusion Criteria:

* Previous ankle surgery.
* History of any ankle surgery.
* History of fracture within the last 6 months.
* Been involved in any previous strengthening or athletic training program.
Causes of Kinesiophobia in Lymphedema

In this study, the reason for the fear of movement in patients with lymphedema will be investigated and recommendations will be given to the patients to eliminate it.


Eligibility Criteria:
Inclusion Criteria:

* Those between the ages of 18-65
* To be diagnosed with lymphedema in the unilateral lower extremity
* Volunteering to work
* Not having orthopedic disorders in the lower extremities

Exclusion Criteria:

* Not volunteering to participate in the research
* Having bilateral lower extremity lymphedema
* Having an active infection
* Having a mental cognitive disorder
* Being unable to communicate and cooperate
A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons

The primary objective of this research study is to assess if daily valacyclovir therapy for suppression of HSV-2 reactivation is associated with a decrease in mucosal HIV shedding in individuals co-infected with both HSV-2 and HIV.

Sexually transmitted diseases and genital ulcer disease (GUD) contribute significantly to the spread of HIV, as their presence is associated with higher rates of HIV acquisition in susceptible individuals. Herpes simplex virus-2 (HSV-2) is a major cause of GUD in developed and developing countries.

The primary objective of this research study is to assess if daily valacyclovir therapy for suppression of HSV-2 reactivation is associated with a decrease in mucosal HIV shedding in individuals co-infected with both HSV-2 and HIV.

This study is a randomized, double-blind, placebo-controlled, crossover trial. Sixty men who have sex with men (MSM) will be randomized to first receive either valacyclovir, 1 gram once a day, or matching placebo for 8 weeks. After a 2-week washout period during which all participants receive placebo, subjects then switch to the other treatment for the next 8 weeks.

At screening, informed consent is obtained and individuals will have blood drawn to test antibody status to HIV and HSV and well as to monitor CD4 count and plasma HIV RNA determination. At enrollment, oral, genital, and rectal specimens are obtained and additional blood is drawn. Participants are given a two-week supply of study medication and are instructed on the technique of collecting daily home samples and completing a diary. Following enrollment, they are asked to collect daily home oral and genital samples, as well as semen samples twice a week, for the full 18 weeks of the study. Participants return to the clinic three times per week for follow-up, for collection of oral and rectal specimens, and additional study medication. Rectal Biopsy is performed at weeks 8 and 18 for those individuals that signed the additional rectal biopsy consent form.

Eligibility Criteria:
Inclusion Criteria:

* HIV seropositive and HSV-2 seropositive
* MSM (men having sex with men)
* 18 years old or older

Exclusion Criteria:

* Known history of adverse reaction to acyclovir or valacyclovir
* Planned open label use of acyclovir, valacyclovir or famciclovir
Pain Management in Internal Medicine Department

The assessment of pain management in Internal medicine department.

The experimental procedure - A Literature review of the management of pain in internal departmnet and after that defining and identifying gaps between the pain management practice recommendations in the literatureareas to that of the departmnet.

Determining the educational processes for the medical team, in initiation treatment for pain and pain assessment. As well, obtain quality indicators to monitor pain management.

Assessment of attitudes, knowledge and tools for pain management team before the educational process and afterwards.

In patients with mild pain or above, a combination of quantitative and qualitative tools will assess the pain and its treatment along the hospitalization in the Internal medicine ward.

Eligibility Criteria:
Inclusion Criteria:

* All patient with mild pain and above

Exclusion Criteria:

* None
Totally Implantable Catheters in Pediatric Hematology-oncology: a Study on Infectious Complications

This is a retrospective analysis of infection on catheters of pediatric oncology patients.


Eligibility Criteria:
Inclusion Criteria:

* patients admitted between Jan/2008 and Dec/2009
A Trial of Routine Aspiration Thrombectomy With Percutaneous Coronary Intervention (PCI) Versus PCI Alone in Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Undergoing Primary PCI

This is an international, randomized, controlled, parallel group study in which patients with ST-Segment Elevation Myocardial Infarction (STEMI) will be allocated to one of the following: Manual aspiration thrombectomy with Percutaneous Coronary Intervention (PCI) or PCI alone.

The hypothesis for TOTAL is that the routine use of manual aspiration thrombectomy with an aspiration catheter (Export®) with PCI compared to PCI alone will reduce the incidence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure (HF) at 180 days in patients with STEMI undergoing primary PCI.

Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with:

   * Symptoms of myocardial ischemia lasting for ≥ 30 minutes AND
   * Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
2. Referred for primary PCI
3. Randomized within 12 hours of symptoms onset and prior to diagnostic angiography
4. Informed consent

Exclusion Criteria:

1. Age ≤ 18 years
2. Prior coronary artery bypass surgery (CABG)
3. Life expectancy less than six months due to non-cardiac condition
4. Treatment with fibrinolytic therapy for qualifying index STEMI event
The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma

The purpose of this study is to verify the role of adding cisplatin chemotherapy to the intensity-modulated radiotherapy (IMRT) for stage II nasopharyngeal carcinoma.

Clinical Stage II nasopharyngeal carcinoma consisted of T2N0M0, T1N1M0, T2N1M0 three subgroups, the data came from conventional radiotherapy era showed that the prognosis of this three subgroups were different, the N1 groups suffered more distant metastasis than N0 group, and some literature showed that combined chemotherapy with radiotherapy in stage II patients can improve the treatment results.

Intensity-modulated radiotherapy (IMRT)now is an widely used technique in the treatment of nasopharyngeal carcinoma, the preliminary results showed that IMRT can improve the quality of life in nasopharyngeal through salivary gland preservation.

Compared IMRT alone with IMRT plus cisplatin concurrent chemotherapy in the treatment of stageII nasopharyngeal carcinoma, we hope to confirm whether stage II (and which subgroup) nasopharyngeal carcinoma will be benefit from concurrent chemoradiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* pathological confirmed squamous cell carcinoma, WHO II-III type,
* clinical stage II (UICC 7th edition, 2009)
* Karnovsky performance score \> 70
* first course of radiotherapy, without radiotherapy and chemotherapy history for other head and neck cancer.
* anticipated life span more than 6 month
* Hemoglobin \> 120g/L, WBC \> 4.0x10\*9/L, Plt \> 100x10\*9/L
* liver and renal function under the 1.25 normal upper limit
* with written consent information

Exclusion Criteria:

* have other cancer history
* have chemotherapy history
* have radiotherapy history
* have head and neck surgery history(exclusion lymph node biopsy)
* evidence showed distant metastasis or other cancer
* other severe medical comorbidity
Feeding Patterns and Practices in Young Children With PKU During the First Two Years of Life

In this study the feeding patterns and practices at the introduction of a second stage phe-free protein substitute will be assessed in young children with PKU. This will be compared with the normal weaning process in healthy non-PKU age-matched children. In addition, tolerability and acceptability of the study product will be evaluated in a smaller group of subjects who have already been transferred onto a second stage protein substitute. The study is performed in 3 centers in the United Kingdom.

Part 1:

For subjects with PKU, the study product will be incorporated in the diet as the second stage protein substitute until the subjects are 2 years of age.

The healthy non-PKU age-matched subjects will not have the study product incorporated in their diet in order to be able to compare the weaning experience and nutritional intake of PKU subjects with non-PKU subjects. The healthy subjects will also be part of the study until the subjects are 2 years of age.

Part 2:

All PKU subjects will take the study product for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PKU identified on screening during the newborn period and requiring a phenylalanine free protein substitute
* Subjects who are about to commence weaning and require a concentrated phe-free protein substitute to meet their total protein requirements and are aged between 4 and 10 months (Part 1)
* Subjects aged under 5 years who have already been fully transferred onto a concentrated phe-free protein substitute and are willing to try the study product for 7 days (Part 2)
* Written informed consent obtained from subject or parents / caregiver
* May or may not have commenced weaning solids (i.e. using normal foods)

Exclusion Criteria:

* Presence of serious concurrent illness
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
* Any child who has not commenced a second stage protein substitute and is over the age of 10 months
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Any children having taken antibiotics over the previous 2 weeks leading up to the study
Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients

The study purpose is to evaluate whether early surgical fixation of upper arm fractures in elderly patients' age 65 years and older improves patient functional and psychological outcome scores compared to the standard of care with non-operative management.

A prospective cohort study following patients that are 65 years or older after they have suffered a humeral shaft fracture. Follow up will continue until 1 year post treatment to see functional and psychological outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Diaphyseal humeral shaft fracture (as defined as superior border of insertion of pectoralis major proximally, to the distal diaphysis)
2. Ambulatory (with or without the use of walking aides)

Exclusion Criteria:

1. Fractures with intra-articular extension
2. Ipsilateral upper extremity injury
3. Patients with vascular injury
4. Brachial plexus injury
5. Compartment syndrome
6. Pathological fractures
7. Open fractures
8. Periprosthetic fracture
9. BMI \&amp;gt;40
10. Dementia or cognitive impairment that inhibits the collection of outcome measures
11. Likely problems, in the judgement of the investigator, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged, patients without adequate support, etc.)
12. Inability to provide informed consent
Pilot Study to Evaluate 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography /Computed Tomography (PET/CT) in Prediction of Early Response to Chemotherapy in Ovarian Cancer.

We hypothesize that 18FDG Positron Emission Tomography (FDG PET) imaging, carried out after the first cycle of chemotherapy, will identify responders, thus permitting early termination of potential toxic therapy in non- responders leading to a significant decrease in morbidity and cost. The value of PET imaging as an early predictor of response to chemotherapy has been shown in other cancers.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven ovarian cancer at diagnosis of any stage.
* Patients with evidence of disease that is radiographically measurable (CT scan)
* Patients have planned to undergo standard chemotherapy. Dose and schedule will be determined per treating physician

Exclusion Criteria:

* Patients with any other malignancy active within 5 years except for non-melanoma skin cancer, or carcinoma in situ of the cervix.
* Patients with an active infection
* Patients of childbearing potential are excluded from this study.
* Patients who have expected survival \< 3 months.
* Patients not planning or able to receive the outlined chemotherapy regimen as part of standard practice.
* Patient unable to complete study
Mucociliary Clearance in Healthy Subjects: Comparison of Levalbuterol and Racemic Albuterol

The purpose of this study is to determine whether lung mucociliary clearance (MCC) can be significantly enhanced in healthy subjects by one week of inhalation of nebulized levalbuterol aerosol, as compared to racemic albuterol or placebo. Subjects will inhale one week of levalbuterol, one week of racemic albuterol, and one week of placebo, in a randomized order.

In healthy lungs, inhaled insoluble material such as bacteria, viruses, antigens, and toxins deposit in the tracheobronchial airway mucus and are removed from the lung in a matter of hours by mucociliary clearance (MCC). When MCC is overwhelmed or impaired, some mucus can be removed by mechanical or cough clearance (CC). Impairment of MCC typically leads to the accumulation of mucus in the airways, and this in turn is associated with acute infections, chronic bacterial colonization, and chronic inflammation.

Racemic albuterol has been shown to stimulate MCC in various patient populations. Inhaled and subcutaneous terbutaline has also been shown to stimulate MCC in healthy subjects. We hypothesize that levalbuterol will be more potent than racemic albuterol in enhancing MCC and CC in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* non-smoking males and non-pregnant females greater than or equal to 18 years of age
* forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) greater than or equal to 80% of predicted values
* normal systolic and diastolic blood pressures

Exclusion Criteria:

* history of heart disease, irregular heartbeat, hypertension
* history of diabetes, hyperthyroid
* history of pneumonia, tuberculosis
* history of seizure disorder, depression, hospitalization in the last month for non-elective purposes, cold or flu in the previous three months
Complications in Children With B- Thalassemia Major

Worldwide, there are more than 60,000 births annually of serious forms of thalassemia .The World Health Organization considers thalassemia to be a major health burden.

Beta- thalassemia is a group of recessively inherited disorders of hemoglobin synthesis characterized by reduced synthesis of the ß-globin chain caused by a mutation. The homozygous state results in severe anemia which needs regular blood transfusion.

Thalassemia is the most common monogenic disorder in the world .Thalassemia major (beta-thalassemia) affects a significant segment of the population in certain areas of the world. Alterations in migration patterns have changed the geographic distribution of this disease and made it a worldwide health problem with a high frequency in Africa, India, Southeast Asia and the Mediterranean area.

The combination of transfusion and chelation therapy has dramatically extended the life expectancy of these patients, thus transforming thalassemia from a rapidly fatal disease of childhood to a chronic illness compatible with a prolonged life. On the other hand, frequent blood transfusions leading to iron overload and the chronic nature of the disease have contributed to a whole new spectrum of complications in adolescents and young adults suffering from thalassemia major.

Complications associated with beta thalassemia, aside from the aforementioned anemia, are as follows

* Extramedullary hematopoiesis
* Asplenia secondary to splenectomy
* Medical complications from long-term transfusional therapy - Iron overload and transfusion-associated infections (eg, hepatitis) Increased risk for infections resulting from asplenia (eg, encapsulated organisms such as pneumococcus) or from iron overload (eg, Yersinia species))
* Cholelithiasis (eg, bilirubin stones) Study of the prevelance and risk fators responsible for thalassemia complication can help in adopting appropriating strategies for management of these complication.

Eligibility Criteria:
Inclusion Criteria

* All patient from 1 year up to 18 year (1year-18 year) admitted at Haematology unit at Assuit University Children Hospital who were diagnosed as Beta thalassemia major

Exclusion Criteria:

* Age less than 1 year( 1 ≤ year)
* Children who diagnosed as other types of thalassemia except Beta thalassemia major
AI-Assisted Facial Surgical Planning

Computer vision using deep learning architecture is broadly used in auto-recognition. In the research, the deep learning model which is trained by categorized single-eye images is applied to achieve the good performance of the model in blepharoptosis auto-diagnosis.

This auto-diagnosis system of blepharoptosis using machine learning architecture will assist in telemedicine, such as early screening of childhood ptosis for prompt referral and treatment. People could use this software via mobile devices to get a primitive diagnosis before they reach the physicians. Furthermore, in primary health care, where there is no oculoplastic surgeon, the software could assist primary care physicians or general ophthalmologists, in identifying the need for a referral.

Eligibility Criteria:
\[Inclusion Criteria\]

1. The participants who were 20-year-old or above,
2. Surgical informed consent was endorsed by the participants themselves,
3. Participants who have surgical indications of the oculofacial surgeries, and
4. The participants who agreed on photograph taking after explanation by the surgeon at outpatient clinics.

\[Exclusion Criteria\]

1. The participants who were 19-year-old or under,
2. The participants who don't have surgical indications of the oculofacial surgeries,
3. The participants who were designed for minimal invasive treatments, such as Botox or any kind of fillers injection,
4. The participants who refused photograph taking for any reason, and
5. The participants who are not available for standard quality of photograph taking, such as bedridden patients.
A Study to Assess Safety of Nivolumab in Routine Oncology Practice in China

The purpose of this study is to assess the safety of nivolumab in routine cancer practice in China. Part one of the study will investigate nivolumab for non-small cell lung cancer previously treated with platinum-based chemotherapy that has locally advanced or has spread. Part two will investigate nivolumab for post-platinum squamous cell carcinoma of head and neck that is recurrent or has spread. Part three will investigate nivolumab for locally advanced or metastatic non-small cell lung cancer. Part four will investigate nivolumab for recurrent or metastatic squamous cell carcinoma of head and neck.


Eligibility Criteria:
Inclusion Criteria:

Part 1

* Histologically or cytologically confirmed diagnosis of locally advanced/metastatic non-small cell lung cancer (NSCLC) participants
* Treatment with nivolumab per physician's prescription

Part 2

* Histologically or cytologically confirmed diagnosis of recurrent/metastatic squamous cell carcinoma of head and neck (SCCHN)
* Treatment with nivolumab for recurrent or metastatic SCCHN

Part 3

* Histologically or cytologically confirmed diagnosis of locally advanced/metastatic NSCLC
* Participants with at least one dose of nivolumab administered since June 2018

Part 4

* Histologically or cytologically confirmed diagnosis of recurrent/metastatic SCCHN
* Participants with at least one dose of nivolumab administered since September 2019

Exclusion Criteria:

* Prior participation in a clinical trial within the past 4 weeks
* Current or pending participation in a clinical trial
* Current or pending systemic treatment for cancer other than NSCLC for part 1 and SCCHN for part 2
* Previously treated with immune checkpoint inhibitors for part 3 and part 4
* Participants must not have any other concurrent primary tumor(s) for part 3 and part 4

Other protocol-defined inclusion/exclusion criteria apply
Augmentation of Depression Treatment by Gamified Network Retraining

Major depressive disorder (MDD) is a highly prevalent and debilitating mental disorder with a high lifetime prevalence of 16-20%. Particularly for people with low socio-economic status, the existing and effective treatment options are hard to reach and show weaker effectivities. There is a potential to ameliorate depressive symptoms and improve quality of life in persons with mild-to-moderate depression by providing access to stimulating computerized trainings. Single computerized trainings that target depressive symptoms have been tested in laboratory and clinical settings so far. To date, innovative market access and confirmatory studies are missing for a large-scale implementation of such trainings. Thereby, the present work will foster a digitalized training paradigm (Paced-Auditory Serial Addition Task; PASAT) which was previously shown to reduce depressive symptoms, but in a novel innovative and gamified form on a tablet-PC handed out to participants. Different versions of the same training paradigm that comprise additional game elements will be compared. The feasibility study will gather data on effect size estimates of symptom severity reduction, user experience and usage in an ecological valid setting.


Eligibility Criteria:
Inclusion Criteria:

* Full age (\> 18 years old)
* Consent
* German mother tongue
* Presence of mild-to-moderate depressive symptoms (MADRS \> 10 and \< 34 and confirmation of depressive symptoms in M.I.N.I. diagnostic interview)
* Stable or no medication with antidepressant drugs or other psychoactive agents (at least for 6 weeks)
* No or current psychotherapy

Exclusion Criteria:

* Presence of schizophrenia / psychotic disorder (according to M.I.N.I. diagnostic interview)
* Cognitive impairment
* Epilepsy
The Effect of Mandala Activity on Life Satisfaction

This study aimed to determine the effect of mandala activity on life satisfaction of women receiving chemotherapy for gynecological cancer.

Data will be collected using the descriptive information form and the Life Satisfaction Scale.

Eligibility Criteria:
Inclusion Criteria:

* Receiving chemotherapy
* No communication problems
* Having at least 6 months of cancer diagnosis
* Being in Stage 2 and Stage 3 of the disease

Exclusion Criteria:

* Having a medical device (IV catheter, etc.) or physical symptoms (vision problems, Parkinson's disease, etc.) that may prevent mandala drawing.
* Being in Stage 1 and Stage 4 of the disease.