cyrilzakka/clinical-trials huggingface dataset:
Pregnancy-related Changes in Melanocytic Nevi

This study is

* to analyze whether more changes in melanocytic nevi (MN) occur in women during and after pregnancy compared to non-pregnant women of the same age
* and to analyze psychological effects of total body mapping and dermoscopic examination assisted by artificial intelligence during pregnancy.

Melanocytic nevi (MN) are believed to undergo macroscopic and dermoscopic alterations during pregnancy. Possible changing features previously observed include color, pigment network, size, vascularization and the emerging of dots and globules. Recent studies have reported of melanoma being associated with increased mortality in pregnant women when compared to non-pregnant women. The new FotoFinder® ATBM master device provides the combination of total body mapping with deep learning-driven body scan algorithm which identifies all pigmented skin lesions of the body surface by pattern recognition software and supplies a risk assessment score (0.0-1.0; 0 indicating no suspicion for melanoma, 1 indicating a high suspicion for melanoma).

This study is

* to analyze whether more changes in melanocytic nevi (MN) occur in women during and after pregnancy compared to non-pregnant women of the same age
* and to analyze psychological effects of total body mapping and dermoscopic examination assisted by artificial intelligence during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant female participants beyond the 12th week of pregnancy
* Non-pregnant female participants

Exclusion Criteria:

* Fitzpatrick skin phototypes V and VI
* less than 15 MN (MN with a diameter less than 2mm will not be taken into account)
* insufficient knowledge of project language (German, English, French)
* inability to give consent.
Antifungal Potential of Moringa Olifera Against Otomycosis

patients with Otomycosis were recognized by an ENT specialist. 20 patients were distributed randomly into two groups. The first group will be treated with Nystatin ear drops twice daily. The second group will be treated with Moringa ear drops. patients will be examined endoscopically by the ENT specialist. patient's swabs will be isolated and analyzed by ELISA.

Inclusion criteria:

(1) Otomycosis .

Exclusion criteria:

1. tympanic membrane perforation;
2. concurrent immune suppression,
3. and concurrent bacterial infection.

Eligibility Criteria:
Inclusion Criteria:

1. Otomycosis
2. ear inflammation

Exclusion Criteria:

1. tympanic membrane perforation
2. concurrent immune suppression,
3. concurrent bacterial infection.
18F-fluorocholine PET/CT Imaging in Hyperparathyroidism

To assess the efficiency of 18F-fluorocholine PET/CT in localization of hyperfunctioning parathyroid tissue in hyperparathyroidism, thereby enabling minimally invasive surgical approaches with fewer complications and comparable success rates

Primary hyperparathyroidism is a common endocrine disorder for which the diagnosis is biochemical and therapy surgical in the vast majority of cases; in secondary and tertiary hyperparathyroidism, surgical treatment is usually chosen when conservative measures fail to control the condition. The previously used surgical approach of bilateral neck exploration is being replaced by minimally invasive procedures, whose advantage is shorter duration of operation and general anesthesia, lower morbidity and fewer complications with comparable success rates.

A prerequisite for minimally invasive surgery is successful localization of the offending parathyroid tissue. Most commonly used imaging modality for this purpose is parathyroid scintigraphy with 99mTc-sestaMIBI, usually supplemented by ultrasound of the neck. Overall, parathyroid scintigraphy is a sensitive method for localization of hyperfunctioning parathyroid tissue; however, its diagnostic performance is significantly lower in patients with multiple parathyroid lesions.

In comparison to conventional nuclear medicine imaging approaches for localization of the offending parathyroid tissue, positron emission tomography with computed tomography (PET/CT) offers superior image resolution with an additional advantage of attenuation correction and co-registration of functional and anatomical information. 18F-fluorocholine is a PET tracer which is commonly used for prostate cancer imaging. In contrast to 18F-fluorodeoxyglucose (18F-FDG), it is also taken up by well-differentiated neoplasms in which 18F-FDG uptake is unreliable. The investigators hypothesize that 18F-fluorocholine might be efficiently taken up by parathyroid adenomata and/or hyperplasia.

The aim of this study is to investigate the efficiency of localization of hyperfunctioning parathyroid tissue with 18F-fluorocholine PET/CT in patients with primary hyperparathyroidism and to compare its efficiency to conventional scintigraphic imaging methods for this purpose.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Biochemically proven hyperparathyroidism (elevated iPTH, elevated on normal Ca2+) or elevated Ca2+ and inadequately supressed iPTH

Exclusion Criteria:

* Age under 18 years
* Pregnancy
* Clinical history of oncological, inflammatory/infectious disease of the head and neck
Evaluation of Fanconi Syndrome and Cystinosis

OBJECTIVES:

I. Classify renal tubular defects using clinical and biochemical findings in patients with Fanconi syndrome and cystinosis.

PROTOCOL OUTLINE:

Patients receive a clinical and biochemical evaluation, including a psychometric assessment and molecular, renal, and thyroid studies.

Eligibility Criteria:
* Inherited renal tubular defects, i.e., Fanconi syndrome
* Fanconi syndrome due to cystinosis eligible
Effects of Thoracic Kinesio Taping on COPD Patients

The purpose of this study was to investigate the effect of kinseio taping on functional capacity, pulmonary functions, respiratory muscle strength, severity of dyspnea, severity of fatigue in Chronic Obstructive Pulmonary Disease (COPD). Assessment of patients was done baseline and 6th week.

Eligible patients for the study randomly allocated to Kinesio Taping Group (KTG), or Control Group (CG). Both groups received three different deep breathing exercises (diaphragmatic, thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30 seconds of rest between each set. KTG also received thoracic kinesio taping application.


Eligibility Criteria:
Inclusion Criteria:

* aged 40 years and older,
* having stage II-III COPD diagnosis according to GOLD system and BODE Index by chest physician,
* unwilling to participate in any kind of pulmonary rehabilitation program for COPD,
* able to read, write, and understand Turkish; and
* willing and able to attend the study.

Exclusion Criteria:

* being in COPD exacerbation period,
* having neurological or musculoskeletal problems that would affect physical mobility,
* having unstable, severe heart disease(s) (heart failure, unstable hypertension, previous angina pectoris or myocardial infarction, heart valve problems),
* having scar, lesion or incision in the area of kinesio tape application,
* previous use of kinesio tape,
* having skin sensitivity against kinesio tape,
* malignancy,
* having mental and cognitive disorders that would affect cooperation.
Methylprednisolone in COVID-19 Patients (Methyl19LGH)

In COVID-19 deep airway and alveolar destruction occurred due to inflammatory reaction resulting into severe pneumonia. In COVID-19, lung injury is not only due to viral damage to tissue, but it is also due to immune response that leads to activation of inflammatory cells and release of cytokines. In COVID-19 acute respiratory distress syndrome ARDS is produced due to mucinous or cellular fibromyxoid exudates, desquamation of pneumocytes and alveolar damage and hyaline membrane development and within 5-7 days disease become more aggressive due to pneumonia and respiratory failure. It is important to start the prompt and strengthen treatment for suppression of inflammatory response and cytokine storm. Methylprednisolone are the traditional immunosuppressive drugs. They are important and effective to delay the pneumonia progression and treating the ARDS.

Corticosteroids are broadly used as treatment for ARDS and there was an evidence for its efficacy for treating SARS and decreasing mortality of SARS in the past. However for COVID-19 corticosteroids efficacy and safety usage is still under clinical trials

All new decision and new interventions that are made for decreasing dependency of ventilator in patients and decreasing patients mortality would have played a great role on global public health. The aim of the study is to address the efficacy of methlyprednisolone for the treatment of COVID-19 patients and its clinical outcome at a tertriary care hospital.

Eligibility Criteria:
Inclusion Criteria:

* All patients of all ages, males, and females who will be diagnosed COVID-19 positive by RT-PCR with moderate illness.
* Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest.
* Respiratory rate \> 22/ min and \>50% of radiological involvement of lung with typical lesions.
* FiO2 remain static or improving, along with \> 30% deranged ≥ 2 biochemical markers CRP \> 20 mg/l, LDH \> 600 U/L, D.Dimer \> 0.5mg/l or 500 ng/ml, Serum Ferritin \< 500 ng/ml or mcg/l will be included in clinical trial.

Exclusion Criteria:

* Heart failure,
* Cardiac arrest
* Decompensated liver cirrhosis,
* Decompensated psychiatric disorder
* Contraindication for corticosteroids
* Leukopenia \<1000/mm or neutropenia \<500/mm
* Recent or history of bone marrow or solid organ transplantation
Symphony IL-6 Cutoff Establishment Study for Patients at Risk of Severe Sepsis Due to COVID-19

Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing. Symphony IL-6 comprises two components, the Symphony Fluorescence Immunoanalyzer and the Symphony IL-6 Cartridge. Whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. After 20 minutes a readout and printout are given with a quantitative IL-6 concentration. The used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. Given the nature of this device and its portability, there is potential for future deployment as a point-of-care (POC) device.

This study is to establish an interleukin-6 (IL-6) cutoff value using the Symphony IL-6 test for patients at high risk of severe sepsis caused by a COVID-19 infection.


Eligibility Criteria:
Inclusion Criteria:

* Whole-blood specimen collected in K2 EDTA anticoagulant tubes
* Subject is considered to have severe or critical illness per below:

Severe Illness

1. SpO2 \< 94% on room air at sea level;
2. Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \< 300 mmHg;
3. Respiratory frequency \> 30 breaths/min;
4. Or lung infiltrates \>50% Critical Illness

a) Respiratory failure; b) Septic shock; c) And/or multiple organ dysfunction d) At least one criterion of severe illness

* Subject confirmed to be COVID-19 positive by an EUA RT-PCR test
* Subject is 18+ years of age
* Minimum volume of 100µL for Symphony IL-6 testing
* Specimen is available for testing within 12 hours from collection

Exclusion Criteria:

* Subject is receiving an anti-IL-6 treatment
* Subject is receiving corticosteroids
* Hemolyzed specimens
Clinical Research for the Consistency Analysis of PD-L1 in Cancer Tissue and Plasma Exosome

The detection of tissue PD-L1 immunohistochemistry in Non-small cell lung cancer (NSCLC) has an important role in guiding for the treatment of immune detection point. At the same time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the information of tumor tissue,PD-L1 mRNA in plasma exosomes (pExo) is expected to be simple, rapid, non-invasive means of detection. The project is planned to explore the consistency analysis of PD-L1 expression level detected in cancer tissues and pExo.We have designed to detected the expression levels of PD-L1 mRNA and protein in cancer tissue and detected the expression levels of PD-L1 mRNA in pExo.By using variance analysis of repeated measures design information. Thus exploring the consistency analysis of PD-L1 expression level detected in tissues and pExo,guiding clinical practice of radiotherapy combining with immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological histology and/or cytology confirmed malignant tumor;
2. Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent.

Exclusion Criteria:

1. Vital organs (e.g., heart, liver, kidney) have serious dysfunction;
2. Patients with a history of autoimmune disease;
3. Patients with participating in other clinical trials at the same time;
4. Other cases that researchers believe that patients should not participate in the present trial.
CT Dose Simulation Study for Appendicitis

The study will explore CT radiation dose as low as reasonably achievable in diagnosing acute appendicitis, by using of dose simulation technique and iterative reconstruction.

Three sequential non-inferiority tests are planned. First, three readers will review the original 2-mSv images. Second, the readers will review the 75%-dose images. After the readers review the 75%-dose images and before the readers reviewed the 50%-dose images, the non-inferiority of 75% dose to the original dose will be tested. If the non-inferiority is not accepted, the study will be terminated with the conclusion of 2 mSv as the lowest acceptable dose. If the non-inferiority is accepted, the study will be continue to the next step. In the same manner, the readers will review the next lower-dose images (50% and then 25%), and then the noninferiority will be tested against the original dose.

Eligibility Criteria:
Inclusion Criteria:

* 18-44 years of age.
* Emergency department visit with suspected symptoms and signs of acute appendicitis
* Intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis

Exclusion Criteria:

* having contraindications of intravenous contrast agent
Continuous Passive Paracentesis for Intra-abdominal Hypertension

Liver cirrhosis patients in Intensive Care present intra-abdominal hypertension and this is an independent risk factor for increased organ disfunction and mortality.

Patients will be randomized into intermittent or continuous passive paracentesis and the clinical results of these two strategies for preventing and treating intra-abdominal hypertension will compared.

Intra-abdominal hypertension is an independent risk factors for increased mortality in Intensive Care patients and is highly prevalent in the critically ill cirrhotic patient. This study compares two strategies in minimizing intra-abdominal pressure and optimizing abdominal perfusion pressure in the prevention and treatment of intra-abdominal hypertension associated morbidity and mortality. Critically ill cirrhotic patients will be allocated into a standard-of-care large-volume paracentesis group (control) and a continuous passive paracentesis (intervention) group using randomization. Results will assess renal function and multi-organ function using standard clinical scales and vital outcomes.

Eligibility Criteria:
Inclusion Criteria:

* liver cirrhosis diagnosis with ascites
* ICU admission for medical reason

Exclusion Criteria:

* prior liver transplant
* haemorrhagic ascites
* extreme severity: CLIF-SOFA number of organ failures 5 or more
* less than 24 hours of ICU stay
* Any of the following conditions at 24 hours of ICU stay:

  i. Hemorrhagic shock with active uncontrolled bleeding ii. Refractory shock (MAP\<60mmHg) with multiple vasopressors iii. Predictably short ICU stay (\<72 hours) iv. Therapeutic futility determined by the medical staff
GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women

To examine the time to healing of genital lesion and duration of herpes simplex virus (HSV) shedding from genetic ulcer disease (GUD) among 90 HIV-negative African women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir 400mg orally three times daily or matching placebo three times daily for 5 days and who are followed for a total of 13 days.


Eligibility Criteria:
Inclusion Criteria:

* HIV negative as determined by concordant rapid testing
* HSV-2 seropositive (Focus HerpeSelect \>3.4)
* At least one prior occurrence of GUD
* 18-50 years of age

Exclusion Criteria:

* Current use, or use w/in past 7 days of acyclovir, valacyclovir, or famciclovir
* Prior hypersensitivity \&/or allergic reaction to acyclovir
* Use of probenicid
* Current use, or use within past 28 days, of an investigational agent
* Currently pregnant or nursing
* Currently plan to become pregnant during next 3 months
* Any condition that will interfere with successful completion of study procedures
Staccato Loxapine in Agitated Patients With Bipolar Disorder

Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.

This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adult patients with bipolar 1 disorder and acute agitation

Exclusion Criteria:

* Agitation caused primarily by acute intoxication
* History of drug or alcohol dependence
* Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration
A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America

The purpose of this post approval pragmatic clinical study is to see how well semaglutide lowers body weight compared to other medication on the market used to treat obesity, across three US-based employers. These employers represent employees of diverse demography and job functions including hospitality, clerical, administrative, housekeeping, maintenance, and specialised employees across a range of socioeconomic and educational backgrounds. The study will also look at how weight loss affects physical functioning, quality of life and ability to work. It will also gather information on how satisfied participants are with the medication they take. Participants will either receive semaglutide or one of 4 approved anti-obesity medication (Xenical/Qsymia/Contrave/Saxenda).


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) greater than equal to 30.0 kilogram per meter square (kg/m\^2).
* Employed at randomisation by one of the selected employers and expecting to be so for the duration of the study.

Exclusion Criteria:

* Known or suspected hypersensitivity or contraindications to Wegovy or related products according to the label.
* Known or suspected hypersensitivity or contraindications to all of the other Anti-Obesity Medications (AOMs) for chronic weight management (Xenical, Qsymia, Contrave, and Saxenda) or related products according to the labels.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
* History of type 1 or type 2 diabetes mellitus.
* Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion might jeopardise participant's safety or compliance with protocol.
Reliability and Validity of FIBSER, STAR-P, HEA Scale The Reliability and Validity of Chinese Version of FIBSER, STAR-P, HEA Scale in Depression Assessment

According to the survey of the World Health Organization, the number of patients with depression in the world has reached 350 million, has becoming the primary cause of disability and the main disease burden worldwide. In order to better dealing with adverse reactions, improving the doctor-patient relationship and optimizing the treatment cost, FIBSER, STAR-P and HEA Health Economics Follow-up Evaluation Scale are selected as simple and quick evaluation scales to evaluate the influence, doctor-patient relationship and social and economic benefits after drug treatment in clinical treatment. At present, the reliability and validity of FIBSER, STAR-P and HEA scales will be verified the reliability and validity of the above three scales in depressive disorder, aiming at enriching the treatment of depressive patients based on assessment, thus improving the compliance of medication for depressive disorder, improving the doctor-patient relationship and reducing the total burden of social diseases.

In this study, the reliability and validity of FIBSER Scale, Doctor-patient Relationship Scale-Patient Edition (STAR-P) and HEA in Chinese population will be verified to increase the diversity and selectivity of domestic assessment tools.

This study includes two steps.

1. baseline: demographic data, HAM-D, HAM-A, YMRS, drug side effects scale：FIBSER, TESS； doctor-patient relationship scale ：STAR-P, PDRQ-15；Health economics follow-up evaluation scale ：SDS and HEA were evaluated.
2. follow-up (4 weeks): HAM-D, HAM-A, YMRS, FIBSER, STAR-P and HEA scale in order to verify the reliability of retest.

Eligibility Criteria:
Inclusion Criteria:

* Case group:

  1. The subjects were psychiatric outpatients and inpatients who were able and willing to provide informed consent.
  2. Men or women aged between 18 and 65, with junior high school education or above.
  3. according to DSM-5 criteria, patients diagnosed with depressive disorder.
  4. The total score of Hamilton Depression Scale (HAM-D) was ≥7 and the total score of Young Mania Scale (YMRS) was ≤5.
  5. subjects were treated with antidepressants at least two weeks before the study visit, all of them were SSRIs.

Control group:

1）did not meet the diagnostic criteria of any axis I in DSM-5. 2）18-65 years old, with junior high school education or above. 3）Willing to participate in this study, and the subjects signed the informed consent form.

Exclusion Criteria:

- 1）severe drug allergy. 2）Suffering from some serious physical diseases adversely affects the validity of neuropsychological test data.

3）serious negative suicide concept.
Validation Study of a New Digital Treatment Test

Oculomotor behavior and cognitive processing of visual information are intimately connected. AD patients show ocular movement problems. Oculomotor deficits are broad consisting mainly of different saccade metrics, altered pupil responses. and smaller and irregular eye vergence movements. Here we test an interactive eye-tracking game to improve eye motion control and thereby training cognitive behavior


Eligibility Criteria:
Inclusion Criteria:

1) Clinical diagnosis of MCI or AD

Exclusion Criteria:

1. Severe cognitive deterioration
2. History of neurological disease with clinically relevant impact on cognition
3. Severe psychiatric disorder
4. Incidental structural brain findings with impact on cognitive impairment
5. Presence of relevant visual problems