cyrilzakka/clinical-trials huggingface dataset:
Preoperative Risk Assessment in the Elderly

PrepTAB aims to determine whether elderly patients are able to complete 4 preoperative risk assessment questionnaires within a web-based survey.

Elderly patients are the most rapidly increasing group among surgical admissions. They are prone to a higher risk, because of predisposing risk factors. A comprehensive preoperative risk assessment is recommended by the European Society of Anaesthesiologists guideline, but time-consuming and usually not performed at present. A telemedical approach would enable an out-of hospital risk assessment before hospital admission and provide important information without the need for additional in-hospital resources. The feasibility of the completion of a web-based questionnaire by elderly patients, within a controlled in-hospital setting is required, as a base for a telemedical approach.

Eligibility Criteria:
Inclusion Criteria:

* Legally competent patients
* Written informed consent
* Age ≥ 65, male, female, diverse
* Multimorbid patients (≥ 2 comorbidities (according to the Charlson Comorbidity Index)
* Major elective surgery (such as total abdominal hysterectomy, endoscopic resection of prostate, lumbar discectomy, thyroidectomy, total joint replacement, lung operations, colon resection, radical neck dissection etc.)

Exclusion Criteria:

* Blind or deaf patients
* Patient/ Proxy not able to use electronic devices e.g. computer, tablet or smart phone
* Non-fluency in local language
* Alcohol and/ or drugs abuse
* Ambulatory surgery
* Repeated surgery, with previous participation
* Patients with severe neurological or psychiatric disorder
* Refusal of study participation by the patient
BDNF Level and val66met Polymorphism of Brain Derived Neurotropic Factor Gene in Patients With T2DM and Depression

This study aimed to evaluate the relation between the levels of (Brain Derived Neurotropic Factor) BDNF and val66met polymorphism of BDNF gene, and the presence of depression in type 2 diabetes. In addition to studying the relationship between BDNF level and val66met polymorphism of its gene and assessing relation between BDNF level and obesity.

The study included 88 type 2 diabetic patients, which are further divided into two groups; depressed and non-depressed. Depression was assessed by Hamilton Depression Rating Scale (HAM-D) and structured clinical interview for DSM-IV Axis disorder (SCID-I) for diagnosing depression and exclusion of other psychiatric disorders. Genotyping was performed by using Real Time-PCR (TaqMan probes).

Eligibility Criteria:
Adult patients who have type two diabetes with or without depression.
Investigation of Inter-rater and Test-retest Reliability of Y Balance Test in Individuals With Pes Planus

Pes Planus is characterized by the descent of the medial longitudinal arch, eversion of the hindfoot, and dorsiflexion and abduction of the midfoot. Disorders in the bones of the foot, dysfunction of the tibialis posterior muscle, shortness of the Achilles tendon or weakness in the muscles may pose a risk for pes planus.

In a study in which 80 female participants aged 65 and over participated voluntarily, it was shown that 90% of the deformities seen in the foot were pes planus. In another study conducted with adults aged 18-21 years, pes planus was found with a rate of 13.6%. In a study in a group of 500 people aged 18-25 years, this rate was found to be 29%.

Since exercise, physical activity and walking for a long time will cause foot and leg pain in people with pes planus, the level of physical activity of these people may be limited. There are studies examining the relationship between pes planus and different physical parameters. It has been determined as a result of some studies that the balance, which is one of these parameters, is negatively affected by the presence of pes planus.

According to the literature, many studies have used the Y test in the evaluation of dynamic balance in individuals with pes planus. However the reliability of the Y Balance Test, which is a valid and reliable method for assessing balance in healthy individuals, has not been found in individuals with pes planus.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study,
* Being between the ages of 18-40,
* Having pes planus.

Exclusion Criteria:

* Having had lower extremity or spine surgery,
* Having a neurological or rheumatic disease,
* Having a problem with vision and hearing,
* Having suffered a lower extremity injury in the last 1 year,
* Presence of acute or chronic pain,
* Regular participation in sports activities,
* Being pregnant,
* Ambulation with an assistive device,
* Active participation in treatment,
* Presence of lower extremity inequality.
The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]

This protocol is a molecular screening protocol only. No drug intervention study will be included in this protocol. Based on the molecular profiling, patients may be eligible for drug intervention study of SUKSES trial.

This procedure can be performed during or after the first-line treatment. DNA will be extracted from the archived or fresh tissue and blood. NGS-based cancer panel and Nanostring CNV will be tested with DNA from tissue and/or blood.

Immunohistochemistry and FISH will be done by pathologists using archived or fresh tissue.

Tumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring CNV, immunohistochemistry and/or FISH.

Specific methods of each molecular tests will be defined with standard laboratory manual developed by pathologists.

This protocol is a molecular screening protocol only. No drug intervention study will be included in this protocol. Based on the molecular profiling, patients may be eligible for drug intervention study of SUKSES trial.

This procedure (molecular profiling) can be performed before, during, or after the initial treatment.

DNA will be extracted from the archived or fresh tissue and blood. NGS-based cancer panel and Nanostring CNV will be tested with DNA from tissue and/or blood.

Immunohistochemistry and FISH will be done by pathologists using archived or fresh tissue.

In addition, blood collection will be conducted at Baseline (initial), three weeks, six weeks, twelve weeks, and subsequent imaging.

Tumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring CNV, immunohistochemistry and/or FISH. Specific methods of each molecular tests will be defined with standard laboratory manual developed by pathologists.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of fully informed consent prior to any study specific procedures.
2. Patients must be ≥20 years of age.
3. Histologically or cytologically confirmed Small cell lung cancers
4. ECOG performance status of 0 to 2
5. Patients who are being treated or were treated with platinum-based chemotherapy as a first-line treatment
6. Patients with available archival tissues for molecular analysis or patients who agreed with biopsy for molecular analysis

Exclusion Criteria:

1. More than two prior chemotherapy regimen for the treatment of small cell lung cancer
2. Pregnant or nursing women (women of reproductive potential have to agree to use an effective contraceptive method)
3. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤2 years.
Increlex Treatment of Children With Chronic Liver Disease and Short Stature

A major consequence of chronic liver disease in childhood is growth failure. This is because a chemical essential for growth called growth factor is created in the liver. Lack of response to growth hormone in people with chronic liver disease is characterized by high levels of growth hormone and low levels of growth factors. This growth hormone resistance is reflected in a variety of factors including insulin resistance and low nutritional intake. Unfortunately, growth hormone therapy has no effect for children with liver disease. In addition, failure of normal growth or malnutrition makes liver disease even worse in children, and growth hormone therapy is not likely to reverse this. A lack of proper nutrition is associated with hospitalizations and frequent complications. Poor growth is a predictor of poor outcomes after liver transplantation. Thus the management of children with liver disease remains a challenge. Children who have successful orthotopic liver transplants (OLT) show much improvement in some aspects of growth, including skin fold thickness, mid-arm circumference, and normalization of growth factor levels. However, some studies have recently reported that the growth of 15-20% of children remains poor even after a liver transplant. This can be explained by persistent abnormalities in growth factors after transplant.

Growth factor was found to be a good tool for prognosis in patients with chronic liver disease. Studies showed that patients with liver cirrhosis and growth factor levels below normal values showed lower long-term survival rates compared with patients who had above normal values. This suggests that growth factor can be a good predictor of survival and early marker of poor liver function. In this case, aggressive feeding may modestly improve growth factor levels leading to improved growth but it is unlikely that effects will be optimal. The investigators propose that growth factor administration may have a positive effect that leads to better growth which is a major predictor of good outcome. To date, no reports study the use of growth factor in children with chronic liver disease. This study proposes to examine the effect of growth factor therapy in childhood chronic liver disease.


Eligibility Criteria:
Inclusion Criteria:

Pre liver transplant patients with:

* Chronic liver disease
* Short stature (\< 5%)
* Low IGF-1 (\<-1SDS for age)
* Chronologic age 4-18 and bone age \< 14 for boys and \< 12 for girls (pre-pubertal)

Exclusion Criteria:

* Status post transplant
* Evidence of malignancy
* Diabetes mellitus
* Participation in other clinical trials involving investigational products
* Treatment with growth hormone within 3 months
* Pregnancy
* Significant abnormality in clinical results
* Hypoglycemic at baseline
* Allergic to benzyl alcohol
Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation

The purpose of this study is to establish a new treatment (repetitive transcranial stimulation (rTMS)) for Veterans with stimulant use disorder (SUD). Despite the large public health burden imposed by SUD, there is currently no FDA-approved or widely recognized effective somatic treatment. rTMS may be a promising treatment option for SUD. In this study, we will demonstrate the feasibility of applying rTMS to Veterans with SUD, examine the efficacy of rTMS in the treatment of SUD, and explore biomarkers that may guide patient selection for rTMS treatment and predict treatment response.


Eligibility Criteria:
Inclusion Criteria:

* SCID confirmed diagnosis of SUD, severe
* Last use of stimulants \>1 and \<6 weeks
* Stable medication regimen (no change in dose or agents between 2 weeks prior to the start of and throughout the treatment phase of the study)
* Stable social environment and housing to enable regular attendance at clinic visits.
* Ability to undergo cognitive testing, fMRI scans, and rTMS (no contraindications)
* IQ \> 80
* Stable medical health
* Veteran at Palo Alto VA's Addiction Treatment Services

Exclusion Criteria:

* Pregnant or lactating female
* History of prior adverse reaction to TMS
* On medications thought to significantly lower seizure threshold, e.g.:

  * clozapine
  * chlorpromazine
  * clomipramine
  * bupropion \> 400 mg/day
* Use of direct dopaminergic antagonists or agonists
* History of seizures or conditions known to substantially increase risk for seizures
* Implants or medical devices incompatible with TMS
* Acute or unstable chronic medical illness that would affect participation or compliance with study procedures, e.g. unstable angina
* Unstable psychiatric symptoms that precludes consistent participation in the study, e.g.:

  * active current suicidal intent or plan
  * severe psychosis
* Inability to undergo fMRI scan, e.g. claustrophobia, presence of ferromagnetic objects in subject's body
* Other substance use disorder not in sustained remission
* Chronic or recurring Axis I psychiatric condition preceding SUD other than PTSD
Post-Market Clinical Follow-Up Study to Confirm Clinical Performance and Safety of the Codman Enterprise® 2 Vascular Reconstruction Device in the Endovascular Treatment of Intracranial Aneurysms

The objective of this Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of the Codman Enterprise® 2 when used in conjunction with endovascular coil embolization of ruptured or non-ruptured intracranial aneurysms.


Eligibility Criteria:
Inclusion Criteria:

1. Subject ≥ 18 years old.
2. Subjects with non-ruptured or ruptured intracranial aneurysm that is referred for endovascular treatment.
3. Parent vessel with a diameter of ≥ 2.0 mm and ≤ 4 mm.
4. Subject understands the nature of the procedure and provides voluntary written informed consent in accordance with the requirements of this study protocol.
5. Subject is willing to participate in the telephone follow-ups and to return to the investigational site for the post-procedure follow-up evaluations.

Exclusion Criteria:

1. Angiogram demonstrating that the aneurysm is not appropriate for endovascular treatment (i.e.: severe intracranial vessel tortuosity, stenosis, intracranial vasospasm not responsive to medical therapy).
2. Mycotic or traumatic aneurysm.
3. Arteriovenous malformation (AVM) in the territory of the target aneurysm.
4. Two or more aneurysms (\>2mm) in associated distribution.
5. Hunt and Hess Scale (HHS) of IV or V at inclusion for subject with ruptured aneurysms.
6. Life expectancy of less than 6 months as determined by the treating physician.
7. A planned staged procedure (i.e. a procedure where entire treatment with the devices (e.g. coils/stents) is completed over separate sessions).
8. Previous neuro-interventional or neuro-surgical procedure of any kind within 30 days prior to the study procedure.
9. Intracranial mass (tumor, abscess, or other infection), or undergoing radiation therapy for carcinoma or sarcoma of the head or neck region.
10. Unsuitable for the antithrombotic and/or anticoagulant therapies
11. Serum creatinine level \> 2.5 mg/dl within 7 days prior to index procedure
12. Known hypersensitivity or allergies to cobalt, nitinol metal, nickel, or sensitivity to contrast media,
13. Evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure.
14. Uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
15. Subject is pregnant
Imaging Study to Compare Effects of Darolutamide and Enzalutamide With Respect to Placebo on the Blood Flow in the Brain in Healthy Male Volunteers.

The current study would investigate the effects of a single dose of darolutamide and enzalutamide compared with placebo and compared to each other on human brain blood flow using arterial spin labeling magnetic resonance imaging (ASL-MRI), a non-invasive MRI technique. The change in cerebral blood flow was an indirect measure of brain penetration.

The risk of drug-associated CNS-related adverse events was likely to be correlated with the concentration of the drug in the brain. In contrast to enzalutamide, preclinical studies of darolutamide indicate that its brain penetration was much lower.

The aim of this study was to determine whether there was a difference between darolutamide and enzalutamide compared to placebo in cerebral blood flow and thus in brain penetration.

The primary objective was to investigate drug-induced changes in grey matter cerebral blood flow during single-dose treatment with darolutamide or enzalutamide as compared to placebo using voxel-wise quantification of the grey matter for the entire brain.

The secondary objective was to investigate drug-induced changes in regional cerebral blood flow in brain areas related to cognitive function after single-dose treatment.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are healthy as determined by medical history, physical examination, laboratory tests, and cardiac monitoring.

Exclusion Criteria:

* Existing or recent relevant diseases of vital organs (eg, liver diseases, heart diseases, renal disease, lung disease), central nervous system or other organs (eg, Diabetes mellitus, myasthenia gravis).
* Known contraindication to magnetic resonance imaging.
* Any structural variants or pathological abnormalities on structural brain MRI during screening.
* Any history of seizures including a febrile seizure in childhood, loss of consciousness, transient ischemic attack, or any condition that may pre-dispose to seizure.
* Participant with any type of neurological problems or history of psychiatric disorder, especially mood disorders including medical history with suicidal ideation and/or suicide attempts, which may disable the participant to consent to the study.
* Participants who use prescription or oral over the counter medications which might influence the study objectives, dietary/nutritional supplements, (including vitamins, natural and herbal remedies, eg, St. John's wort) within 2 weeks prior to first study intervention administration or during the study.
Effect of Mulligan's Mobilization on Shoulder Joint Range of Motion and Subacromial Space in Paraplegic Patients

The aim of the study is to determine the effect of mulligan's mobilization on shoulder range of motion and subacromial joint space in paraplegic patients with subacromial impingement so, thirty patients will be randomly assigned to two groups group (A) and Group (B)

30 patients will be randomly assigned to two groups Group (A): will receive Mulligan's mobilization plus steroid injection for rotator cuff tendinopathy Group (B): will receive Steroid injection for rotator cuff tendinopathy only

Outcome measures will be:

* shoulder joint range of motion will be measured by laser goniometer
* Subacromial joint space will be measured by 3D ultrasonography

Eligibility Criteria:
Inclusion Criteria:

* More than one year after traumatic spinal cord injury
* The injury is at the second thoracic level or below.
* No cognitive impairment
* Relying on manual wheelchair for main movement.

Exclusion Criteria:

* No frozen shoulder
* No subluxation
Immunogenicity and Safety of a 1-dose Regimen of a Zoster Vaccine Versus Different 2-dose Regimens in Participants ≥ 70 Years of Age. (V211-043)

Primary objective:

Immunogenicity To demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a 0-1 month schedule or as a 0-3 month schedule in subjects ≥70 years of age as measured at 4 weeks post-vaccination

Secondary objectives Immunogenicity

* To summarise the VZV antibody titres at 4 weeks post-vaccination after a 1-dose regimen and 4 weeks post-vaccination after each dose of each 2-doses regimen of ZOSTAVAX®.
* To compare the VZV antibody titres at 12 months after completion of a 1-dose regimen with the VZV antibody titres at 12 months after completion of each 2-doses regimen of ZOSTAVAX®
* To summarise the VZV antibody titres at 24 and 36 months after completion of a 1-dose regimen and at 24 and 36 months after completion of each 2-doses regimen of ZOSTAVAX®


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 70 years
2. Varicella history-positive or residence for \> 30 years in a country with endemic VZV infection
3. Signed informed consent form prior to any study procedure

Exclusion Criteria:

1. Febrile illness within the last 72 hours before the first vaccination
2. Prior herpes-zoster episode clinically diagnosed by a physician
3. Prior receipt of varicella or zoster vaccine
4. Exposure to varicella or herpes-zoster within the 4 weeks prior to the first vaccination
5. Significant underlying illness preventing completion of the study vaccination schedules,
6. Known active tuberculosis,
7. Immune deficiency disorder, including active neoplastic disease within the prior 5 years,
8. Immune function impairment caused by medical condition or immunosuppressive therapy, or any other cause,
9. Receipt of any inactivated vaccine within the 2 weeks prior to the first vaccination,
10. Receipt of any other live vaccine within the 4 weeks prior to the first vaccination,
11. Receipt of immunoglobulins or blood-derived products within the 5 months prior to the first vaccination,
12. Concomitant use of non-topical antiviral therapy
Establishment of Social Skills Training Group in Adolescents With Autism Spectrum Disorder and Effectiveness Analysis

Autism spectrum disorders (ASD) is a neurodevelopmental disorder characterized by persistent deficits in social communication and social interaction across multiple contexts, and the presence of restricted, repetitive behavior and interests, affecting 1 in 68 children. Although atypical social deficits onset in early childhood, their social relationships with peers may remain a challenge or even worsen for individuals with ASD throughout the school years and beyond, as social contexts increase in complexity and pose higher social expectations.


Eligibility Criteria:
Inclusion Criteria:

* aged 11-20 years, currently enrolled in school between the sixth grade of elementary school and the third year of high school
* with a clinical diagnosis of ASD from a licensed mental health or medical professional based on DSM-5
* experiencing social difficulties as reported by parents in a structured intake interview
* scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD
* demonstrating verbal fluency in Chinese
* with a full-scale IQ \> 70 on WAIS-IV
* with motivation to participate in the intervention;
* with a caregiver who was fluent in Chinese and willing to participate as a social coach in the study.

Exclusion Criteria:

* a history of major mental illness (e.g., bipolar affective disorder, schizophrenia, or psychosis) or neurological diseases that might hinder participation in the treatment
* visual impairment and/or hearing impairment that would preclude participation in group-based social activities.