cyrilzakka/clinical-trials huggingface dataset:
Exploratory Study of Norepinephrine to Prevent Alopecia in Head and Neck Cancer Patients Treated With Radiotherapy

The study will evaluate the safety of topical norepinephrine in head and neck cancer patients who are receiving treatment with intensity modulated radiotherapy (IMRT).

The study will also provide information about whether topical norepinephrine can prevent or decrease the severity of the radiation-induced alopecia experienced by these patients.


Eligibility Criteria:
Inclusion Criteria:

* be ≥ 18 years of age with documented pathological diagnosis of H\&N (head and neck) cancer.
* planned to receive H\&N region IMRT treatment in which the mean dose to the dermis in the scalp risk zone (isodose plan) is estimated to be at least 20 Gy.
* have a palpable nuchal prominence (external occipital protuberance)
* have the ability to understand the informed consent document.
* be able to comply with protocol schedule.
* have a negative serum pregnancy test if a female of childbearing potential.
* consent to utilize medically acceptable methods of contraception throughout the study if of childbearing potential.
* be treated with IMRT alone or with concurrent platinum based chemotherapy
* receive definitive treatment for oropharyngeal squamous cell carcinoma

Exclusion Criteria:

* with clinical or radiographic evidence of adenopathy to the high level V posterior cervical nodes, post-auricular or occipital cervical nodal stations
* planned to receive H\&N region treatment in which the mean dose to the dermis in the scalp risk zone (isodose plan) is estimated to exceed 50Gy
* with underlying active untreated cardiac disease (e.g. arrhythmia)
* receiving concurrent chemotherapy other than single agent platinum based
* with generalized skin disorders that have required treatment within the past 6 months.
* with connective tissue disorders
* with unhealed wounds or scars in the study area
* with rashes, ulcerations, or poorly healed scars in the treatment area
* with a known allergy to norepinephrine
* with a known clinically significant abnormal ECG (electrocardiogram) within the past 6 months.
* taking MAO (monoamine oxidase) inhibitors or antidepressants of the triptyline or imipramine types
* taking β-blockers
* with NCI-CTCAE Version 4.0 grade 2 or higher hypertension at the time of study entry.
A Study to Determine the Pharmacokinetics of Cediranib in Chinese Patients With Advanced Solid Malignancies

This study is being carried out to see how single and multiple doses of cediranib are handled by the body (that is how they are absorbed, broken down and got rid of from the body) by measuring levels of drug in the blood in Chinese patients with advanced solid malignancies.

The study will also assess the tolerability of 20 or 30 mg cediranib in Chinese patients and how the tumour responds to treatment with cediranib.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Histological and/or cytological confirmed advanced solid malignancies
* Refractory to conventional therapeutic modalities, or for which no appropriate therapies exist

Exclusion Criteria:

* For the first question: Patients with a history of poorly controlled hypertension with resting blood pressure \>150/100 mmHg in the presence or absence of a stable regimen of antihypertensive therapy, or patients who are requiring maximal doses of calcium channel blockers to stabilize blood pressure.
* Significant haemorrhage (\>30 ml/bleeding episode in previous 3 months), haemoptysis (\>5 ml fresh blood in previous 4 weeks) or thrombotic event (including transient ischaemic attack) in the previous 12 months
* Recent(\<28 days) major thoracic and abdominal surgery prior to entry into the study, or a surgical incision that is not fully healed.
Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding

The aim of this study is to determine whether lactulose, L-ornithine L-aspartate, and rifaximin are effective in the prevention of the development of hepatic encephalopathy in cirrhotic patients with acute variceal bleeding


Eligibility Criteria:
Inclusion Criteria:

-Cirrhotic patients with acute variceal bleeding, without minimal or clinical hepatic encephalopathy according to PHES, CFF and West-Haven criteria

Exclusion Criteria:

* Age under 18 year-old or over 65 year-old, with any other neuropsychiatric disorder or dementia, presence of active bacterial or fungal infections, receiving antibiotics for any cause, previous diagnosis of hepatic encephalopathy and receiving therapy with lactulose, rifaximin, L-ornithine L-aspartate, source of bleeding different from variceal origin, serum creatinine greater than 2.0 mg/dl or with chronic renal failure. Therapy in the previous six months with any of the drugs that will be used in this clinical trial.
Aquatic Exercise and Reactive Balance

The present clinical trial aims to identify if skills acquired during aquatic exercise are more effectively transferred to a reactive balance task than land exercise. This study is designed as a double-blinded, randomized controlled clinical trial. Forty-four older adults aged 60 years or above who meet the eligibility criteria will be recruited and randomized into an aquatic exercise group or land exercise group. Each group will participate in the same balance training exercise during a single session that includes a ball throwing and catching task. A modified lean-and-release test will be implemented on land immediately before, after, and one week after the training session. The outcomes will include reaction time, rapid response accuracy, and mini-BESTest scores obtained from stepping and grasping reactions.

During the modified lean-and-release test, there are two possible settings: 1) the leg block is placed in front of both legs, and a safety handle is uncovered; or 2) the leg block is removed, and the safety handle is covered. The leg block and handle cover will be controlled via computer-triggered, servo motors. The testing session will be comprised of three blocks: 1) REACH (grasping a safety handle using their right hand while maintaining both feet fixed), 2) STEP (stepping forward using any leg), and 3) RANDOM (random variations of STEP and REACH).

Eligibility Criteria:
Inclusion Criteria:

* Ability to stand using a double-leg stance for one minute of time
* Ability to walk independently
* Normal or corrected to normal vision
* Normal or corrected to normal hearing based on a qualitative assessment

Exclusion Criteria:

* Any neurological or musculoskeletal disorders that may inhibit the participation in the training and testing protocols
* A concussion within the past one year before the participation
* Any cognitive deficiencies (e.g., memory, concentration, or attention disorder)
* One or more 'yes' answered on the Physical Activity Readiness Questionnaire (PAR-Q)
* Fear of water
Vaccination With Autologous, Lethally Irradiated Melanoma Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Granulocyte-Macrophage Stimulating Factor (GMSF)

The purpose of this study is to see if the proposed therapy will delay or stop the progression of the participants skin cancer. This study is being done because there are currently no treatments which have been shown convincing to treat disease which has progressed. This research study is designed to evaluate the immunologic effects and clinical side effects of giving vaccines to patients that are made from their own skin cancer cells.

* The vaccines created from the participants melanoma cells are scheduled to be given to the participants on days 1, 8, 15, 29 and every two weeks after until the supply of vaccine has run out. The amount of vaccine is dependent on the total amount of cells yielded when the tumor is processed and treated. It is hoped that participants will receive at least six vaccines.
* The vaccines will be administered in two injections that will be placed underneath the participants skin. The two injections will be given at the same place on the body.
* If tumor sample yields enough cells, participants will also receive an injection of non-transduced irradiated melanoma cells. The purpose of this is to measure the amount of reaction of the participants immune system occuring created by the vaccine.
* If either the vaccine site or DTH placement site has shown a reaction, a punch-biopsy will be taken. This will consist of a small piece of skin tissue removed under local anesthesia.
* With vaccine #5, participants will receive a second DTH injection. Two days after the vaccine and DTH injection, punch biopsies will be taken of both sites.
* At week 10 of treatment (or earlier if necessary), participants will undergo a chest, abdomen and pelvic CT scan. The physician may also have participants undergo a brain MRI if indicated at this time.

Eligibility Criteria:
Inclusion Criteria:

* Stage III patients must have: A) Histologically documented melanoma B) Lymphadenopathy of at least 2cm in greatest diameter by physical exam or CT scan in a region draining a known or suspected primary melanoma or in transit metastatic disease of at least 2cm in greatest diameter by physical exam or CT in a region draining a known primary melanoma C) refused, not eligible, or failed adjuvant therapy with high dose a-interferon D) must be able to have all measurable disease removed at time of tumor harvest
* Stage IV patients must have histologically documented metastatic melanoma
* ECOG Performance Status 0 or 1
* Estimated life expectancy of 6 months or greater
* 18 years of age or older
* Signed Informed Consent
* Greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic glucocorticoid therapy
* Greater than 6 months since bone marrow or peripheral blood stem cell transplant

Exclusion Criteria:

* Uncontrolled active infection
* Pregnancy or nursing mothers
* Evidence of infection with Human Immunodeficiency Virus, Hepatitis B or C
The Role of TVSG and HS in Determining Endometrial Pathologies

Although hysteroscopy (HS) and transvaginal ultrasonography (TVSG) are methods in the diagnosis of AUB, there is some suspicion about their efficacy. The aim of this study was to determine the efficacy and safety of HS and TVSG on diagnosing abnormal uterine bleeding(AUB) .216 women admitted to the investigators clinic (Sisli Ethal Training and Research Hospital, Obstetrics and Gynecology Department Obstetrics Service ) between 21-51 years of age. These patients were divided into two groups; menopause (71women) and pre-menopause (145 women). HS and endometrial sampling were performed both groups after TVSG.The success of these methods was assessed by kappa analysis


Eligibility Criteria:
Inclusion Criteria:

* patients who have no history of hysteroscopy and curettage,
* patients who have no history of ovulatory dysfunction
* women who have active vaginal bleeding.

Exclusion Criteria:

* presence of genital infections/PID
* presence of pregnancy
* presence of vaginal or cervical pathology causing vaginal bleeding
* women who are receiving hormonal treatment (COC/HRT)
* patients formerly diagnosed with endometrial pathology
* patients having coagulopathy
* women who are using intrauterine device.
Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.

Glutamate is fundamentally involved in learning and memory. Memory loss associated with mild cognitive impairment may be due to loss of glutamate receptors in the aging brain. There is evidence CX516 enhances brain activity by specifically targeting remaining glutamate receptors in the affected portions of the brain. This study will test the safety and efficacy of CX516 in the symptomatic treatment of participants with mild cognitive impairment.


Eligibility Criteria:
Inclusion criteria

* Clinical diagnosis of mild cognitive impairment
* Good general health with no additional diseases that would interfere with the study.

Exclusion criteria

* Any significant neurologic disease (other than suspected incipient Alzheimer's disease), such as Parkinson's disease, stroke, TIA's, multi-infarct dementia, Huntington's disease, head trauma, chronic CNS infection.
* History of major depression or another major psychiatric disorder within the past 6 months.
* History of schizophrenia, mania or recurrent psychotic episodes.
* History of alcohol or DSM IV-diagnosed substance abuse or dependence disorder within the past year.
* History of blackout, epilepsy or seizures, or an abnormal EEG as judged by the Investigator and considering the age of the participant.
* Any clinically significant hepatic, renal, cardiovascular, pulmonary, gastrointestinal or hematological illness or unstable medical condition which could interfere with drug safety, or absorption, distribution, metabolism and excretion, or lead to difficulty complying with the protocol.
Obstructive Sleep Apnea (OSA) Anesthesia and Positive Airway Pressure

To determine if autotitrating positive airway pressure (APAP) naïve patients with OSA can successfully use APAP following general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Obstructive Sleep Apna

Exclusion Criteria:

* non conformers
Pelvic Floor Contraction in Different Positions Among Women With and Without Stress Urinary Incontinence

Examination of pelvic floor contraction in different positions among women with and without stress urinary incontinence (SUI) will be conducted via diagnostic ultrasound. This will enable clinicians and researchers to establish an appropriate protocol for pelvic floor muscle examination and treatment.

The main goal of this study is to compare the ability of the pelvic floor muscles to contract in different positions among women suffering from SUI to healthy women. Secondary objectives: is to compare subjective reports of the difficulty to contract the pelvic floor muscles between the two groups, and to examine the connection between the severity of urinary leakage and the ability to contract pelvic floor muscles.

The study will include 50 female participants in the ages of 18-45. Research group will include 25 participants suffering from SUI in accordance with the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and 25 healthy participants (grade 0 on the ICIQ-SF questionnaire).

The examination will be performed with an abdominal ultrasound device in supine, sitting, standing and squatting. The Height of the bladder base will be measured during rest period and maximal contraction. The extent and direction of bladder base movement would indicate the quality of pelvic floor performance. Next, the length of contraction time will be measured. The participant would hold the maximal contraction as long as possible in order to examine muscular endurance. Rest will be given between tests. After finishing the tests in all four postures, the participants will be questioned about the degree of difficulty contracting the pelvic floor.

Significance of the study: The importance of the research is about granting the clinicians and researchers additional tools in order to help establishing a protocol for pelvic floor muscle activity examination and treatment.

Eligibility Criteria:
Inclusion Criteria (general):

* willing to participate in the study
* being able to squat for over 10 seconds.
* inclusion for study group - participants suffering from SUI that received a grade\>0 in sections 3+4 (how frequent does urinary leakage appear, the amount of urine leakage and does the participant use pads for leakage absorption) and a grade\>0 in section 5 (how much does SUI interrupt the participant's daily life) in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF).
* Inclusion for control group - healthy participants (grade 0 in the ICIQ- SF questionnaire).

Exclusion Criteria:

* Other types of urinary leakage
* receiving pelvic floor treatments in the past or present
* active urinary or vaginal infections
* neurological diseases
* urologic, gynecologic or abdominal surgery
* pelvic organ prolapse
* pregnancy
* chronic cough
* constipation
* unbalanced diabetes and the use of medication that affects urination
Optimal Dose of Acetylsalicylic Acid After Coronary Artery Bypass Grafting

This is a single-center, open-label, randomized controlled trial. Patients with stable angina pectoris without use of dual antiplatelet therapy or anticoagulation therapy scheduled for coronary artery bypass grafting (CABG) at Karolinska University Hospital in Stockholm, Sweden will be eligible.

This study investigates in patients having undergone CABG whether increasing the dose or the frequency of acetylsalicylic acid (ASA) treatment improves the efficacy of ASA regarding platelet inhibition compared to the standard dosing for cardiovascular prevention (75 mg once daily) in the first three months after surgery. Patients will be randomly assigned to postoperative ASA dose 75mg once daily, 75mg twice daily or 160 mg once daily. The study dose ASA will be started at hospital discharge and continued of three months. Blood samples for serum thromboxane B2 (TxB2) and other analyses will be taken before surgery, before discharge, and after one and three months. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.


Eligibility Criteria:
Inclusion Criteria:

* Stable coronary artery disease
* ≥18 years of age
* Scheduled to undergo elective CABG surgery
* Willing to participate and able to provide informed consent

Exclusion Criteria:

* Intake of drugs other than ASA that are known to influence platelet function, including nonsteroidal anti-inflammatory drugs (NSAIDs, including COX-2 selective anti-inflammatory drugs), GPIIbIIIa inhibitors, clopidogrel, dipyridamole, warfarin or acenocoumarol within 7 days of enrolment
* Hemorrhagic diathesis or known platelet dysfunction
* Chronic renal failure requiring dialysis
* Platelet count outside the 100 000 to 450 000/μL range
* Haemoglobin \< 8g/dl
DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy

This study is A Randomized, Double-blind, Placebo-controlled, Phase II Optimal Dose-finding Study to Determine the Safety and Efficacy of DWP450 in Subjects with Benign Masseteric Hypertrophy


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject over 18 years of age and written informed consent is obtained.
2. Subject with Benign Masseter Hypertrophy
3. Subject who has Bisymmetry of masseter at visual assessment.
4. Subjects who meets thickness of Masseter muscle by ultrasonography.
5. Subjects who can and will comply with the requirements of the protocol.

Exclusion Criteria:

1. Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
2. Subject who got any treatment, including double jaw surgery, laser, thread treatment etc. in 12 months.
3. Subject who had previously received botulinum toxin within 3 months prior to the study entry
4. Subject with known hypersensitivity to botulinum toxin
5. Subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study period.
6. Subjects who are not eligible for this study at the discretion of the investigator
Efficacy and Safety Curcumin in Depression

Antidepressants generally do not lead to an immediate relief of symptoms. Most people will not see a significant improvement for at least 4 weeks. Studies have generally shown that the full benefits of antidepressant therapy may take as long as 8 to 12 weeks. However, this timeline is variable among individuals.Curcumin is one of the main curcuminoids isolated from this perennial herb. It possesses a variety of pharmacological activities, including anti-inflammatory, antiproliferative, antioxidant, and neuroprotective effects. Curcumin has been found to possess antidepressant action in various animal models of depression. Chronic administration of curcumin has been reported to exert antidepressant-like action in olfactory bulbectomy model of depression in rats. Although the mechanism of the antidepressant effect of curcumin is not fully understood, it is hypothesized that it acts through inhibiting the monoamine oxidase enzyme and modulating the release of serotonin and dopamine.In randomized, double-blind, placebo-controlled study 40 patients will be randomized to receive either 500 mg/day of curcumin or placebo together with antidepressants for 6 weeks.


Eligibility Criteria:
Inclusion criteria:

Males and females in age 20-60 years

Major depressive episode according to DSM-IV

Clinical Global Impression Severity Scale scores more than 4

Hamilton Depression Rating Scale scores more than 21

Montgomery and Asberg Depression Rating Scale scores more than 22

Ability and willingness to sign informed consent

Exclusion Criteria:

Evidence of organic brain damage

Mental retardation

Alcohol or drug abuse

An unstable medical condition

Any significant medical or neurological illness

Patients with a known hypersensitivity to curcumin or other components of the product

Pregnant women or women who intend to become pregnant

Receiving any antidepressant and mood-stabilizers
Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD

This project explores the association between learning and cognitive flexibility by testing whether a cognitive behavioral intervention designed to improve flexibility in ASD changes learning and associated neural activation using model-based functional magnetic resonance imaging (m-fMRI). The study proposes that variability in learning mechanisms is associated with behavioral flexibility and explains differences in adaptive and treatment outcomes. The study employs a longitudinal case-controlled design in 60 14-18 year old youth with ASD at 3 time-points 8 months apart, each including m-fMRI during learning and behavioral measurement of executive and adaptive function. Aim 1 tests the hypothesis that individual variation in learning biases and their neural correlates predicts behavioral flexibility and is stable over time. Aim 2 tests plasticity of learning mechanisms induced by a cognitive-behavioral intervention for flexibility. Aim 3 tests hypothesis about intervention-induced plasticity of neural functional connectivity.


Eligibility Criteria:
Inclusion Criteria:

1. 14-18 years of age inclusive
2. Full scale IQ \> 80 on a standardized IQ test, either confirmed through educational testing within the last two years or confirmed by the Wechsler Abbreviated Scale of Intelligence (WASI-2) administered by research personnel. If current IQ testing (FSIQ) is not interpretable based on discrepancies between verbal and perceptual skills, we will use the best available verbal IQ estimate.
3. Broad ASD diagnosis according to Diagnostic Statistical Manual, fifth edition (DSM-5) criteria established by parent report of prior clinical diagnosis and confirmed by meeting cutoff criteria on the Social Communication Questionnaire (i.e., raw score \> 11) or the Autism Diagnostic Observation Schedule-2 (ADOS-2), Module 4 (total score ≥7).
4. Intact or corrected hearing and vision.
5. Parents/guardians speak and read English with sufficient fluency for completion of consent forms and informant questionnaires; youth participants will use/understand English as a primary or secondary language with sufficient fluency to engage effectively in executive function group therapy conducted in English, and for valid administration of neuropsychological and behavioral measures.

Exclusion Criteria:

1. Presence of a known medical condition in the participant that would interfere with his/her ability to participate in the study.
2. To preserve the integrity of the neuroimaging data, participants will be excluded if they have a history of neurological disorder, such as an established epilepsy diagnosis, significant brain trauma, hydrocephalus, central nervous system infection, or stroke.
3. Contraindications for MRI such as metal implants, dental braces, pregnancy (determined by parent or self-report).