cyrilzakka/clinical-trials huggingface dataset:
Identify Coronavirus Disease by Chest X-ray

to identify the diagnostic accuracy of chest X-ray in diagnosis of Coronavirus disease19 .

The pandemic related to the coronavirus is now considered one of the deadliest epidemics. The numbers of cases exponentially increased with no specific treatment, creating havoc for the health and financial systems of the world \[1-6\]. Wuhan, the capital city of Hubei in China, reported the earliest cases that were treated as an unusual pneumonia. With the disease progression, the World Health Organization (WHO) announced the presence of several similar cases \[7, 8\]. Researchers revealed that a novel strain of the family Coronaviridae is the pathogen responsible for the respiratory illness of this disease and this is simulating two previous epidemics, namely MERS (Middle Eastern respiratory syndrome) and SARS (severe acute respiratory syndrome). The disease induced by SARS-CoV-2 was labelled as COVID-19 by the International Classification of Diseases (ICD) \[9\]. Chest radiographs are usually of limited value in the diagnosis of early stages especially in mild disease course; however, the CT findings may be present early even before the onset of the symptoms. Chest radiographs is very helpful in the intermediate to advanced stages of COVID-19 with features of acute respiratory distress syndrome (ARDS) as well as the follow-up \[10-11\]. This study to determine the COVID-19 disease course and severity using chest X-ray (CXR) scoring system and correlate these with patients' age, sex, and outcome.

Eligibility Criteria:
Inclusion Criteria:

* All individuals attending the Radiodiagnosis Department , who had paired posterior-anterior chest radiographs and RT-PCR nasopharyngeal swabs for COVID-19 at the time of initial attendance with moderate to advanced stage.
* The patients have positive finding in the posterior-anterior chest radiographs , multislice computer tomography and RT-PCR nasopharyngeal swabs for COVID-19.
* The patients with positive finding in the laboratory investigation (CBC, CRP ,ESR , S.Ferritin \& D-Dimmer) .
* Patients with positive chest-CT finding and laboratory finding despite of having negative PCR swab

Exclusion Criteria:

* Patients exceeding 30 days after positive RT-PCR .
* Patients diagnosed with mediastinal lymphadenopathy , masses ,Tree in bud appearance ,Pneumothorax. Or Cavitation.
Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin

This is a Phase 4, single center, open label, fixed-sequence, multiple dose, 2-way drug-drug interaction study.

This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.

Each subject will qualify for entry into the study not more than 30 days before admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. There will be 1 treatment period, with each subject receiving a once daily dose of pitavastatin 4 mg on Days 1 through 5 and Days 12 through 16 and a once daily dose of darunavir/ritonavir 800 mg/100 mg on Days 6 through 16. On Days 1 through 4, 6 through 10, and 12 through 15, study drug will be administered 30 minutes before a standard breakfast. On Days 5, 11, and 16, subjects will fast at least 8 hours before receiving study drug and remain fasted for 4 hours after dosing.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male or female volunteer aged 18 to 45 years, inclusive.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive.
* Subject has normal hematology, serum chemistry, and urinalysis test results
* Subject is able and willing to abstain from alcohol, grapefruit, caffeine or caffeine containing products, St John's wort, and herbal supplements for 4 days before Day 1 and until completion of the study
* Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug and until study completion.

Exclusion Criteria:

* Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption, distribution, metabolism, or excretion.
* Subject has had a previous allergy or intolerance to treatment with pitavastatin, darunavir, ritonavir, sulfonamides, or any drugs in these classes.
* Subject has a history of drug or alcohol abuse.
* Subject has had a clinically significant illness within 4 weeks before the first dose of study drug.
Evaluation of a Motorised Prosthetic Knee

The study will investigate the effect over time of the Power Knee (Össur) on performance during daily activities in people with a unilateral transfemoral amputation, will determine subjective feelings and gait kinematics over time during daily activities and will investigate the association between subjective feelings and objective outcomes of performing daily activities.

Participants will visit the lab 6 times over a period of 5 weeks. The study includes a familiarisation phase (3 measuring moments) followed by the experimental phase (3 measuring moments). During the measuring sessions, participants will perform four tasks with their current prosthesis and with the Power Knee (Össur). The order in which the devices will be tested, will be reversed on each measuring moment to control for possible order effects and fatigue.

The experimental protocol will entail an L-test and slope walking test that will each be performed 3 times, followed by a 6 minutes of hallway walking (6MWT), 10 min rest and a dual-task 6MWT.

The slope walking test assesses the participants' ability to ascend and descend a 6 m long ramp of 10% inclination as fast as possible. For safety reasons bilateral handrails are warranted. Participants start the test in an upright position in front of the ramp and are asked to ascend the ramp, turn around on the platform, descend the ramp and return to the starting position.

The L-test, requires higher physical activity of the user. During the L-test, participants are asked to rise from a chair, walk 7 meters, turn 90 degrees, walk 3 meters, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter is covered.

The 6MWT will be performed on a hallway at a self-selected walking speed, which closely relates to the most efficient walking speed.

The dual-task 6MWT will be compiled out of conducting a 6MWT while performing a cognitive task, i.e. serial subtractions. Serial subtraction is mental arithmetic task that tests attention and working memory. Participants will be asked to continually subtract sevens from a random selected 3-digit number as long as the duration of the test.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral transfemoral (above knee) amputation
* Healthy subject
* Medicare Functional Classification Level: K3-4

Exclusion Criteria:

* Any neurological disease
* Upper limb or bilateral amputation
* Stump pain or bad fit of the socket
Longitudinal Multimodal Response Assessment During Neoadjuvant Treatment of Rectal Cancer

This pilot study aims to trial multimodal early response assessment to enable therapy adaptions in the context of non-operative therapy strategies of locally advanced rectal cancer (LARC) for development of a non-invasive response prediction model.

Patients with LARC, receiving neoadjuvant chemoradiotherapy (CRT) are followed by at least 4 multiparametric MRI-scans (diffusion weighted imaging and hypoxia-sensitive sequences) as well as repeated blood samples in order to analyse circulating tumour cells (CTCs). A standard pelvis radiotherapy (RT, 5040 cGy) will be performed in combination with a 5-Fluorouracil / Oxaliplatin regimen in all patients (planned: N = 50), succeeded by consolidation CTx (FOLFOX4) if feasible. Additional histologic markers, such as tumour-infiltrating lymphocytes (TILs) or PD-L1 status will be analysed before and after CRT. Resection is standard after completion of preoperative treatment. In case of complete regression and patient's request, a non-operative management ("watch and wait") is offered alternatively. The primary endpoint is response, defined by tumor regression grading, secondary endpoints comprise longitudinal changes in MRI as well as in CTCs and TILs.

Eligibility Criteria:
Inclusion Criteria:

* locally advanced rectal cancer (LARC): UICC Stage II/III
* no severe cardiac or lung disease
* no severe hepatic disorders (liver enzymes \<2.5 NR) or restrictions of renal function (GFR \> 30ml/min)
* no severe cytopenia (Neutrocytes \>= 3 Gpt/l; Thrombocytes \>= 100 Gpt/l; Hemoglobin \>6mmol/l)
* no homozygotic DPD deficiency
* no other neoplasms requiring therapy
* no earlier radiotherapy of the pelvis or earlier chemotherapy
* no contraindications for MRI
Quality of Life in Pediatric Transplant Patients

The goal of this study is to compare parent and child perceptions of wellness and vulnerability in children who have undergone solid organ transplant. It is hypothesized that there will be significant differences between parent and child perceptions.

There are numerous studies that report on the quality of life in solid organ transplant recipients. However, very few studies target quality of life parameters for these children and their families across all solid organ transplantation. Furthermore, no literature directly addresses a comparison of perceptions and wellness, impact on family, and vulnerability in a comparative format by these distinct, but definitely related populations.

The goal of this study is to compare parent and child perceptions of wellness and vulnerability in children who have undergone solid organ transplant. It is hypothesized that there will be significant differences between parent and child perceptions. Outcomes will be measured by using five different instruments:

1. Pediatric Quality of Life Inventory (PedsQL)
2. PedsQL Family Impact Module
3. PedsQL Family Information Form
4. Functional Status II-R
5. Child Vulnerability Scale (CVS)

Patients will be enrolled at the time of transplant listing, or after transplant. Patients and families will complete the survey once every 6 months while the patient is active on the respective transplant waiting list. After transplant, the patients and families will be asked to complete the survey once every 6 months for the first two years and annually thereafter.

This study may provide us with an improved understanding of parent and child perceptions in wellness, impact on family, and vulnerability within each transplant group. The results may also indicate trend differences between these three populations. These differences may help to provide insight into family perspectives allowing for greater anticipatory guidance and targeted interventions.

Eligibility Criteria:
Inclusion Criteria:

* between newborn and 21 years old
* parent/child pairs of patients listed for or who have received a liver transplant, kidney transplant, or heart transplant

Exclusion Criteria:

* unwilling or unable to participate
* not in one of the above transplant groups
* non-English speaking
M-ROSE Combined With mNGS in Severe Hospital-acquired Pneumonia

The purpose of this study is to determine the value of M-ROSE（microbiological rapid on-site evaluation）in severe hospital-acquired pneumonia.

Severe hospital acquired pneumonia (SHAP) is the critical risk factor leading to the death of nosocomial infection patients. Rapid identification of pathogens, guidance of individualized treatment and rational application of antibiotics can not only improve the administration of antibiotics, but also reduce the production of multi drug resistant bacteria. Metagenomic second-generation sequencing (mNGS) is an important tool to quickly identify the pathogen in ICU. However, due to the low qualified rate of lower respiratory tract specimens in patients with SHAP, easily polluted, and the difficulty to determine whether microorganisms are infectious, colonizated or polluted, the value of mNGS was limited in the etiological diagnosis of SHAP. The bedside M-ROSE system established by our research team can determine whether the lower respiratory tract specimen is qualified, whether infection exists and the pathogen of infection within half an hour. Based on the previous work, this project plans to conduct a prospective multicenter, single blind, randomized controlled study under the guidance of M-ROSE and mNGS in the individualized anti-infection strategy of SHAP, to reduce the mortality of patients with SHAP; Combined with the third-generation sequencing, the standard analysis framework for the traceability and prevention and control of drug-resistant bacteria was established to clarify the transmission route of drug-resistant bacteria, so as to provide a new solution for the prevention and control of clinical multidrug-resistant bacteria.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of severe hospital-acquired pneumonia
* Must have undergone bronchoalveolar lavage

Exclusion Criteria:

* BALF samples were not sent for mNGS examination
* Age \< 18 years old
* The hospitalization days ≤ 3
* The clinical data are incomplete
* Mechanical ventilation time \> 60 days
Vitamin K Supplementation in Patients on Hemodialysis

The purpose of this study is to determine whether vitamin K supplementation will improve anticoagulation control in patients on hemodialysis taking warfarin for atrial fibrillation. Patients who participate will receive vitamin K1 three times a week on dialysis days for a period of four months. INR levels collected during this period will be compared to the four month period prior to receiving the vitamin K1 to determine if vitamin K improves the standard deviation of INRs and time in therapeutic range.

Patients on hemodialysis with atrial fibrillation are at increased risk of stroke. These patients often take warfarin to reduce this risk. Warfarin is a drug that is used to prevent clots in the bloodstream. The dose of warfarin varies from person to person, and its effect is measured using a blood test called the international normalized ratio (INR). In most patients with atrial fibrillation the goal is to keep the INR between 2 and 3. Patients on hemodialysis often have unstable INR levels. Vitamin K supplementation has been shown to improve INR control in patients on warfarin but has not yet been studied in hemodialysis patients.

In this study, patients on hemodialysis receiving warfarin for atrial fibrillation will receive vitamin K 400 mcg orally three times a week on dialysis days for 4 months. INR levels in the four months before and the four months while receiving vitamin K will be reviewed.

The primary end point will look at INR stability and be measured by calculating the standard deviation of INR values before and after receiving vitamin K. The goal of this study is to determine whether vitamin K supplementation improves INR control in patients on hemodialysis taking warfarin for atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

* greater than 18 years of age
* Receiving in-house hemodialysis for at least 6 months
* Previously diagnosed with atrial fibrillation
* On warfarin for at least 6 months with a target INR of 2-3

Exclusion Criteria:

* are unable to provide informed consent
* have a mechanical heart valve
* are receiving supplements containing vitamin K
* have a known hypersensitivity to vitamin K
Heart Failure in Adult Patients With a History of Congenital Heart Disease

In today's world of advanced surgery, children born with congenital heart disease (CHD) are surviving into adulthood. However, the surgical procedures these children undergo do not cure the underlying problem and this these children develop other heart problems later in life. Heart failure is the one of the most common heart problems effecting these patients. This heart failure can be seen in both lower pumping chambers of the heart, however, sometimes only one side of the heart is affected. Since there are several congenital heart defects that are now seen in the adult population, an understanding of what causes heart failure in this patient population can help physicians develop better treatments for this condition. The goal of this study is to review the medical records of 350 adult patients with congenital heart disease that has developed heart failure. During this review, we plan to collect information regarding the various treatments utilized in these patients and to determine if there are any common elements regarding the development of heart failure in adult patients with CHD.

In today's world of advanced surgery, children born with congenital heart disease (CHD) are surviving into adulthood. However, the surgical procedures these children undergo do not cure the underlying problem and this these children develop other heart problems later in life. Heart failure is the one of the most common heart problems effecting these patients. This heart failure can be seen in both lower pumping chambers of the heart, however, sometimes only one side of the heart is affected. Since there are several congenital heart defects that are now seen in the adult population, an understanding of what causes heart failure in this patient population can help physicians develop better treatments for this condition. The goal of this study is to review the medical records of 350 adult patients with congenital heart disease that has developed heart failure. During this review, we plan to collect information regarding the various treatments utilized in these patients and to determine if there are any common elements regarding the development of heart failure in adult patients with CHD.

Eligibility Criteria:
Inclusion Criteria:

* Adults who have a history of congenital heart defects
Efficacy and Safety Study of Haporine-S for Treatment of Moderate to Severe Dry Eye Syndromes

The purpose of this study is to determine efficacy and safety of Haporine-S eye drop for the patients with moderate to severe dry eye disease in a multicenter phase III clinical trial.

This study is to compare the efficacy and the safety of topical Haposine-S and Restasis® eye drop 0.05% for the patients with moderate to severe dry eye disease in a multicenter, investigator(assessor) blind, parallel design, non-inferiority phase III trial.

Primary outcome is the change of corneal staining score(Oxford scheme) at 12 weeks from baseline.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 20 or over
* Patients with moderate to severe dry eye(DEWS Level II or over)
* Be informed of the nature of the study and will give written informed consent

Exclusion Criteria:

* Being treated with steroidal eye drop or non-steroidal anti-inflammatory eye drop for dry eye
* Being treated with systemic steroid or immunosuppressive
* History of eyeball surgical operation within 6 months
* Wearing contact lenses during participation of the study
* Pregnancy or breastfeeding
* Use of cyclosporine eye drop within 2 weeks
* Intraocular pressure(IOP)\> 25 mmHg
* History of punctal occlusion within 1 month or during participation of the study
* Hypersensitivity to the investigational products or be suspicious to them
* Patients whom the investigator considers inappropriate to participate in the study
TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis

TNF alfa blockers are widely used for treatment of severe psoriasis. These biologics are well-tolerated with few side effects.

Unfortunately not all patients respond adequately to treatment with tnf alfa blockers. Some do not respond at all while others respond initially but gradually lose effect despite increased dose and more frequent administration.

The cause of treatment failure is largely unknown and it may be production of tnf-alfa neutralizing antibodies. This has been demonstrated in patients with rheumatoid arthritis and inflammatory bowel disease who lost response after treatment with tnf-alfa blockers.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age above 18
* Psoriasis
* Indication for treatment with tnf alfa blocking drug
* Written informed consent obtained

Exclusion Criteria:

* Severe psychiatric disorder
* No indication for treatment with tnf-alfa blocking drug
* Pregnancy
* Breastfeeding
* No written informed consent
Efficacy of Roflumilast in the Treatment of Psoriasis

Roflumilast (Daxas®), a selective, long-acting inhibitor of the enzyme phosphodiesterase-4 (PDE4), is used for severe chronic obstructive pulmonary disease. Recent research suggest roflumilast is effective in treating psoriasis. The aim of this investigator-initiated trial is to study the efficacy of oral roflumilast in patients with plaque psoriasis. This has not previously been done.

Aim: To investigate the efficacy of roflumilast in the treatment of psoriasis.

Design: Multicentre, double-blinded, randomised, placebo-controlled, clinical trial.

Participants: Patients ≥18 years with plaque psoriasis.

Method: Twelve weeks treatment with either roflumilast or placebo tablets. Both groups continue for an additional 12 weeks open-label treatment.

Primary endpoint: Proportion of patients achieving at least 75% reduction from baseline psoriasis area and severity index (PASI75) at week 12.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Chronic stable plaque psoriasis (min duration 6 months)
* PASI \>8
* Body mass index (BMI) \> 20 kg/m2
* Candidate for systemic treatment of psoriasis
* Negative pregnancy test (only women)
* Safe anticonception during entire study and at least 1 week after end of treatment (\~5 times plasma half-life of roflumilast) (only applying for fertile women)

Exclusion Criteria:

* Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis
* Current tuberculosis
* Current viral hepatitis
* Heart failure (NYHA III-IV)
* Moderate or severe liver failure (Child-Pugh B-C)
* Current or former malignancy (basal cell carcinoma excluded)
* Current or former depression with suicidal ideation
* Topical therapy for psoriasis during within 2 of randomization or during study
* Systemic therapy for psoriasis or psoriatic arthritis within 4 weeks of randomization or during study
* Treatment with theophylline, phenobarbital, carbamazepine, or phenytoin
* Confirmed pregnancy
* Planned pregnancy within 6 months
* Breast feeding
* Blood donation during study
* Inability to complete study
Effects Of Nadroparin In Patients With Lung, Pancreas Or Prostate Cancer

This study will evaluate the effects of nadroparin on survival and disease progression in patients with hormone-refractory prostate cancer (HRPC), locally advanced pancreatic cancer or non-small-cell lung carcinoma (NSCLC).


Eligibility Criteria:
Inclusion criteria:

* Hormone refractory prostate cancer within 6 months of diagnosis, OR locally advanced (non-metastasized) pancreatic cancer within 3 months of diagnosis, OR non-small-cell lung cancer within 3 months of stage IIIB.

Exclusion criteria:

* Life expectancy of \<3 months.
* Poor performance status (Karnofsky \<60).
* Need to be on anticoagulants.
* Use of nadroparin (a low molecular weight heparin) for any reason including a history of heparin-induced thrombocytopenia.
* Have brain metastasis.
* At a high risk of bleeding or have a platelet count \<50,000/mm3.
* Have very poor kidney function.