cyrilzakka/clinical-trials huggingface dataset:
Fluorine F 18 FEQA in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer and in Healthy Participants

RATIONALE: Fluorine F 18 FEQA may be an effective radioactive drug to use with positron emission tomography (PET) scans.

PURPOSE: This clinical trial is studying the use of fluorine F 18 FEQA in patients with stage III or stage IV non-small cell lung cancer and in healthy participants.

OBJECTIVES:

* Determine the biodistribution of fluorine F 18 FEQA in patients with stage III or IV non-small cell lung cancer (NSCLC) and in healthy participants.
* Determine whether fluorine F 18 FEQA can be used as an imaging agent with positron emission tomography in patients with stage III or IV NSCLC.

OUTLINE: This is a pilot study.

Patients and healthy participants receive fluorine F 18 FEQA IV and then undergo whole-body dynamic scans comprising positron emission tomography.

Blood is collected during and after imaging to measure radioactivity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Must meet 1 of the following criteria:
* Diagnosis of non-small cell lung cancer by CT scan, bone scan, or biopsy

  * Stage III or IV disease
  * Clinically assessed with
* Healthy participant

Exclusion Criteria:
Efficacy and Safety of Hepatitis B Vaccine in Chronic Kidney Disease Patients

This is an open label clinical study designed to evaluate the safety and immunogenicity of Sci-B-Vac Hepatitis B Vaccine compared to Engerix-B Hepatitis B Vaccine in dialysis patients. The study hypothesis is that vaccination with Sci B Vac will achieve a higher seroprotection rate and a higher anti-Hepatitis B surface antibody serum titer level than vaccination with Engerix-B Dialysis patients will be categorized as "naïve" or "previously vaccinated" and each group will be randomized to treatment. Naïve patients randomized to Sci-B-Vac Hepatitis B vaccine will receive vaccination in three doses, 10 μg each, at 0, 1, and 6 months, or Engerix-B Hepatitis B vaccine given in four doses, 40 μg each, at 0, 1, 2, and 6 months. Previously vaccinated patients randomized to Sci-B-Vac Hepatitis B vaccine will receive vaccination in three doses, 20 μg each, at 0, 1, and 6 months, or Engerix-B Hepatitis B vaccine given in four doses, 40 μg each, at 0, 1, 2, and 6 months. All vaccines will be administered via intra-muscular injection to the deltoid muscle. The study will consist of three periods: a screening period of up to four weeks, a 24-week open-label treatment period, and a 24-week safety follow-up period. The total expected duration of the study per subject is 52 weeks as follows: Screening period: approximately 4 weeks; treatment period: 24 weeks; and follow up period: 24 weeks. The primary endpoint is the by-vaccine difference in the proportion of subjects attaining seroprotective immune response (anti-Hepatitis B surface antibody ≥ 10 IU/mL) 4 weeks after the last vaccination with either Sci-B-Vac or Engerix-B. Secondary endpoints include anti-Hepatitis B surface antibody geometric mean concentrations calculated for all subjects upon last active dose; the proportion of subjects with anti-Hepatitis B surface antibody concentrations equal to or above 10 IU/mL for all subjects at 12 weeks following the first vaccine dose; the by-treatment difference in serum titer levels of anti-Hepatitis B surface antibodies at 12, 24 and 52 weeks following the first vaccination. A by-vaccine comparison of adverse events will also be performed.


Eligibility Criteria:
Inclusion Criteria:

* Three months dialysis treatment for Chronic Kidney Disease; anti-Hepatitis B surface antibody titer levels \< 10 IU/ml

Exclusion Criteria:

* anti-Hepatitis B surface antibody titer levels \> 10 IU/ml
* Hepatitis B surface antigen positive
Clinical Study to Investigate Safety and Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of ACT-334441

The aim of the study is to investigate the safety of the concomitant administration of ACT-334441 with cardiovascular drugs.

The study will consist of two parts: a pilot part (Part A) that will be completed prior to the start of the main part (Part B). The Subjects who will participate in Part A are excluded from Part B.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening.
* Women of childbearing potential must have a negative pregnancy test and they must use reliable methods of contraception
* Healthy on the basis of physical examination,cardiovascular assessments and laboratory tests

Exclusion Criteria:

* Pregnant or lactating women
* Any contraindication to the study drugs
* History or presence of any disease or condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study drugs
* Any clinically significant abnormalities in laboratory tests, vital signs, ECG variables and pulmonary variables
* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol
Impedance Measurements in Heart Failure Patients

The purpose of this study is to measure impedance during inpatient treatment.


Eligibility Criteria:
Inclusion Criteria:

* patients admitted to hospital for symptoms of congestive heart failure
* patients older than 18 years
* patients willing and able to give informed consent

Exclusion Criteria:

* patients who will require adrenergic or positive inotropic medications
* patients enrolled in a concurrent study that may confound the results of this study
* patients unable or unwilling to participate in study procedures
* patients who are pregnant
* patients who are mentally handicapped or legal incompetent
* patients who are dependent on investigator or sponsor
Evaluation of Clinical Decision Support System for Brain Metastasis Using Brain MR Images

BT-M01 is a software that has been pre-learned based on a brain metastasis detection model using brain MR images, and clinical decision support system for brain metastasis by automatically analyzing brain MR images by assisting the medical team.

The specific aims of this study are to evaluate efficacy of BT-M01 for brain metastasis compared to the sensitivity and false positive rates of radiologists group.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 19 years old
* Brain MR acquired
* Positive group: A patient diagnosed with brain metastasis after a brain MR
* Negative group: A normal person or a patient not diagnosed with brain metastasis after a brain MR

Exclusion Criteria:

* Poor or incomplete brain MR image quality
* A patient with other pathological lesion in brain
* A patients with a history of primary brain tumors
Assessment of Endocan Serum Levels in Patients With Behcet Disease

The aim of our study was to assess serum endocan levels in patients with Behcet disease and to correlate it with various disease clinical and laboratory parameters of disease activity as well as carotid intima media thickness.

This study will be carried out on two groups:

• Group (I): Forty two patients diagnosed to have Behcets disease fulfilling the International Criteria for BD .

Group (II): including 42 age and sex matching healthy volunteers as control group.

(A) Clinical evaluation

1. Complete history taking.
2. Thorough clinical examination including opthalmologic evaluation .
3. Disease activity using The Behcet's disease current activity form (BD-DAF) . (B) Laboratory assessment:

All patients will be subjected to the following measurements:

1. ESR
2. CRP
3. CBC
4. liver and kidney function tests

d) Serum Endocan level e)triglycrides f) cholestrol C) carotid intima media thickness

Eligibility Criteria:
Inclusion Criteria:

* patients with Behcets disease fulfilling the International Criteria for BD .

Exclusion Criteria:

* infection
* malignancy
* other connective tissue disease
* chronic liver disease
* chronic kidney disease
* Diabetes mellitus
* hypertension
* hyperlipidemia
Voice Telerehabilitation

The aim of the study was to determine functional results of telerehabilitation (TR) in subjects affected by iatrogenic unilateral vocal fold paralysis (UVFP) during the COVID-19 pandemic outbreak. 40 patients with iatrogenic unilateral vocal fold paralysis underwent voice teletherapy with a synchronous approach. A multidimensional assessment by means of videolaryngostroboscopy, acoustic and perceptual analysis and patient self-assessment was carried out before, at the end of teletherapy and six months later.


Eligibility Criteria:
Inclusion Criteria:

* age between 18-75 years
* onset of UVFP less than 1 month before
* internet access
* availability and ability to use a computer with an internal or external webcam.

Exclusion Criteria:

* previous history of laryngeal pulmonary or gastric surgery
* current or previous pulmonary diseases
* hearing loss, neurological or motor deficits
* reading difficulties
* dysphagia
* unavailability of a computer and a webcam.
The Effects of Telerehabilitation on Muscle Function, Physical Activity and Sleep in Cystic Fibrosis During Pandemic

The aim of this study is to evaluate the peripheral muscle function, sleep disorders and physical activity level in children with cystic fibrosis who are physically inactive at home due to social isolation and to examine the effect of the 6-week online exercise protocol.

Considering the new coronavirus (COVID-19) pandemic global information, some patient populations have been identified at higher risk of this pandemic like older age, hypertension, cardiovascular and respiratory diseases. Self- isolation is recommended for preventive strategy in cystic fibrosis patients. Long-term social isolation and school closure can have negative effects on childrens' physical and mental health. Due to social isolation childrens are less physical active, have longer screen exposure and irregular sleep patterns.

There is no study to evaluate the the peripheral muscle function, sleep disorders and physical activity level and examine the effects of exercise training in children with cystic fibrosis in social isolation due the COVID-19 pandemic.

This study will be included children with cystic fibrosis who had stabile conditions Patients' peripheral muscle function, sleep quality and physical activity level will be assess and record at beginning, after the twelve and eighteen session.

Eligibility Criteria:
Inclusion Criteria:

* People who diagnosed cystic fibrosis disease at stabile conditions.
* Volunteering to participate in the study,
* Having a social isolation due to COVID-19 pandemic
* Having forced expiratory volume at one second (FEV1) %\> 40 % at last pulmonary function test.

Exclusion Criteria:

* Being diagnosed with acute pulmonary exacerbation at the time of study and / or within the last month.
* having a diagnosed with COVID-19 before or during the study
* Being physically or perceptually competent to exercise
* Patients with allergic bronchopulmonary aspergillosis (ABPA) who were treated with systemic steroid therapy
* Patients who were not complete the exercise training ability.
* Having FEV1 %\< 40% at pulmonary function test.
Comparison of Vascular Effects After Therapy With Irbesartan and Atorvastatin.

Vascular responses to angiotensin II and histamine are compared before and after 30 days of systemic treatment with either irbesartan 150 mg or atorvastatin 20 mg.

Vascular responses to angiotensin II and histamine are compared before and after 30 days of systemic treatment with either irbesartan 150 mg or atorvastatin 20 mg.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* no relevant disease
* amendment: hypercholesterolaemic subjects

Exclusion Criteria:

* any relevant disease
Intensified Treatment Regimens for TB Meningitis: PK, PD and Tolerability Study

Tuberculous meningitis (TBM) is the most lethal form of tuberculosis infection, and is diagnosed in approximately 5-10% of TB patients. The incidence of TBM has increased considerably during the last decade, partly due to the HIV epidemic. Without treatment, virtually all patients with TB meningitis will die. With the current treatment regimens, TBM is fatal in approximately 30-50% of cases, and responsible for severe disability in a similar proportion of survivors.

Worldwide, Indonesia the third highest case load of tuberculosis with an estimated 500,000 new patients / year. Representative data are lacking, but it is clear that TBM is a growing problem. For instance, in Hasan Sadikin Hospital, the top-referral hospital for West Java Province (population 40 million), Indonesia, 40-50 cases of TBM were treated yearly in the late 90's compared to approximately 100 in recent years.

There is very little evidence for the current treatment regimen for TBM, which dates back to the late 60's. Therefore, there is an urgent need to evaluate intensified treatment of TBM in randomized trials. We hypothesize that higher dose rifampicin, moxifloxacin (possibly also at high dose), or both will improve outcome of TBM. To determine the experimental regimen(s) which should be compared with current regimen in phase 3 trials, we want to evaluate pharmacokinetic aspects and toxicity of candidate regimens in a phase 2 clinical trial in 60 patients with TBM in Indonesia.


Eligibility Criteria:
Inclusion Criteria:

* Tuberculous meningitis, diagnosed based on clinical and/or CSF criteria
* Age 15 years old or more
* Hospitalized for the treatment

Exclusion Criteria:

* Pregnancy/lactation
* On TB treatment within 7 days before inclusion
* Elevated liver enzyme (\> 5x than normal values)
* Known hypersensitivity/intolerance to rifampicin or moxifloxacin
* Prolonged QTc interval in ECG or other detectable cardiac arrythmias, in the absence of hypokalemia
* Refusal to be included in the study
Study Evaluating IMA-638 in Healthy Japanese

The purpose of this study is to evaluate the safety and drug levels for single, ascending doses of IMA-638 in healthy Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* First generation healthy Japanese men and women of non-childbearing potential.
Concurrent Docetaxel Plus Cisplatin or Cisplatin Alone With IMRT in High Risk Nasopharyngeal Carcinoma

The investigators aim to evaluate the efficiency and toxicities of concurrent docetaxel and cisplatin with intensity-modulated radiotherapy in high risk locoregionally advanced nasopharyngeal carcinoma.

Eligible patients are randomly assigned to receive intensity-modulated radiotherapy (IMRT) with concurrent chemotherapy of docetaxel plus cisplatin or cisplatin alone. IMRT is delivered with a total dose of 68 Gy or higher in 33 fractions to the primary tumor. Concurrent chemotherapy in the experimental arm consists of docetaxel 60 mg/m², D1 and cisplatin 25 mg/m², D1-3 every 3 weeks for 3 cycles. Concurrent chemotherapy in the control arm consists of cisplatin 100 mg/m², D1 every 3 weeks for 3 cycles.The primary endpoint is overall survival (OS), defined as time from randomization to the day of death from any cause. Secondary end points include failure-free survival (FFS), locoregional relapse-free survival (LRFS), distant metastasis-free survival (DMFS) and the incidence of grade 3 or higher acute toxicities. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Eligibility Criteria:
Inclusion Criteria:

* Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma.
* Tumor staged as T1N3M0, T2-3N2-3M0 or T4N0-3M0 (the 2010 UICC/AJCC staging system).
* Pretreatment EBV DNA ≥ 1500 copies/mL.
* Karnofsky scale (KPS) ≥ 70.
* Adequate marrow: leucocyte count ≥ 4×10E9/L, hemoglobin ≥ 110g/L and platelet count ≥ 100×10E9/L.
* Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and bilirubin ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN.
* Adequate renal function: creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5×ULN.
* Patients must give written informed consent.

Exclusion Criteria:

* Prior malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
* Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
* History of previous radiotherapy (except for non-melanomatous skin cancers outside intended radiotherapy volume).
* Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
Validity and Reliability of Thai Version of Barthel Index for Hip Fracture Patients

Since an increasing in population age, there was an increasing in geriatric patients. Most of elderly patients needed rehabilitation programs to regain their quality of life during their medical treatments. Barthel index is a functional measurement to evaluate rehabilitation improvement in chronically-ill patients and also used for evaluation of patient's self-care.

Barthel index had been translated into many languages and validated in many medical conditions such as spinal cord injury, congestive heart failure, pneumonia, etc. However, Barthel index had not been translated into Thai language and validated to use in hip fracture patients.

The purposes of this study were to translate the Barthel index into Thai language and to assess validity and reliability of Thai version Barthel index in hip fracture patients.

Since an increasing in population age, there was an increasing in geriatric patients. Most of elderly patients needed rehabilitation programs to regain their quality of life during their medical treatments. Barthel index is a functional measurement to evaluate rehabilitation improvement in chronically-ill patients and also used for evaluation of patient's self-care. This index had initially developed to evaluate the self-care of stroke patients which comprised of 10 questions about their basic activity of daily living. Barthel index had been well-accepted and widely used. Barthel index had been translated into many languages and validated in many medical conditions such as spinal cord injury, congestive heart failure, pneumonia, etc. However, Barthel index had not been translated into Thai language and validated to use in hip fracture patients.

Hip fractures was usually occured in geriatric patients and there was a trend to increase every year. Most of the hip fractures were treated by surgical methods which needed postoperative rehabilitation programs to regain their functions. Less than half of the patients with hip fracture could regain their functions to preoperative level. Therefore, these patients needed a specific questionnaire to evaluate their functions. Barthel index is an uncomplicated questionnaire and can be used to evaluate treatment outcome of the patients.

The purposes of this study were to translate the Barthel index into Thai language and to assess validity and reliability of Thai version Barthel index in hip fracture patients.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 50 years old
* Hip fractures within 2 weeks since injury

Exclusion Criteria:

* incommunicable patients
* pathological fractures
* multiple fractures or multiple trauma
* postoperative complications which change postoperative rehabilitation protocols
Characterization of Bacterial and Mycosis Skin Flora in Seborrheic Macular Hypopigmentation - Microbiome

Hypopigmented skin changes are commonly encountered by dermatologists. A new dermatological entity was identified as scattered, hypopigmented oval-shaped macules and patches distributed mostly in seborrheic area of the face and of the trunk in dark skinned individuals. This patterned presentation of hypopigmentation was first described in the literature under the name of hypochromic vitiligo or vitiligo minor. Nerveless, histopathological patient's specimens analyzed by Krueger et al. clearly highlight that there is no tangible causal correlation with a diagnosis of vitiligo. They propose to rename this entity to Seborrheic Macular Hypopigmentation (SMH). The etiopathology of this dermatosis is still unknown preventing to propose any satisfactory treatment for this disfiguring affection.The objective of this study is to analyze the bacterial and fungal skin microbiome on hypochromic lesions of SMH compared to the surrounding non-lesional skin of the same patients and to healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

1. Female and male patients ≥ 18 years of age
2. Clinical diagnosis of SMH with lesion of the face
3. Written informed consent obtained before any assessment is performed
4. Affiliation with a social security scheme
5. Physical and psychological ability to participate

Exclusion Criteria:

1. Use of systemic antibiotics or any systemic antifungal treatments within 4 weeks before the inclusion visit
2. Use of topical antibiotics or any topical antifungal treatments on the face within 2 weeks before the inclusion visit
3. Use of any topical cream, gel, serum or ointment within 2 days before the inclusion visit
4. Laser, radiofrequency, peeling or any other procedure on the face in the past 3 months before the inclusion visit
5. Vulnerable patients: minors, patients under guardianship or curatorship, pregnant or breast-feeding women
The Life Paths That Lead Teenagers to Attempted Suicide:Trajectories of Proximal Adversity

Suicidal behaviors seriously alter the vital and functional prognosis of adolescents. Although the literature has lighted out a considerable number of risk factors for suicide attempts in youth, theoretical models - among which bio-psycho-social models - still lack empirical evidence. More specifically, the way adverse life events dynamically interact together and with the individual's diathesis to precipitate suicidal attempts remains unclear. Studies of life trajectories have opened an alternative approach to traditional linear epidemiological analysis to capture such a complex process. To date, adverse trajectories approaches never have been applied to the period immediately preceding the occurrence of the suicidal gesture (proximal adverse trajectories).


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for cases
* Youth aged 15-24 inclusive
* Who stayed at the hospital or in the emergency room for less than 15 days after a first suicide attempt
* Who were discharged less than 15 days ago
* Who gave their informed consent for majors, or whose parents gave their informed consent for minors Inclusion criteria for controls
* Youth aged 15-24 inclusive
* Who have never experienced any suicidal ideation or suicide attempt
* Who gave their informed consent for majors, or whose parents gave their informed consent for minors Inclusion criteria for informants
* Close relatives of the participant
* Who are major
* Who lived in the same household as the participant or have interacted with him/her for more than half the weeks of the year preceding the index suicide attempt

Exclusion Criteria:

* No consent or consent withdrawal for majors and/or their parents for minors
* Neurological or psychiatric condition altering the capacity to understand