cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Early Morning Blood Pressure and Central Arterial Pressure

The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran) with nifedipine controlled-release tablets (Adalat）in the treatment of Early Morning Blood Pressure and Central Arterial Pressure.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily participate and must sign informed consent form
* Mild to moderate essential hypertension (SBP 140-179 mmHg and/or DBP 90-109 mmHg)
* The mean morning blood press of one week \>135/85 mmHg

Exclusion Criteria:

* Secondary hypertension and malignant hypertension
* Pregnant or nursing women, or patients that cannot guarantee to take effective contraception measures
* Baseline SBP≥180 mmHg or DBP≥110 mmHg, or patients with cerebral, cardiac or renal complications
* Have following complications: cerebrovascular accident within 6 months, myocardial infarction or cardiac failure, macroaneurysm or dissecting aneurysm, definite angina, A-V block of grade 2 or higher, sick sinus syndrome, atrial fibrillation or other malignant arrhythmia
* Clinical significant diseases of heart, lung, liver, kidney and hematologic system or malignant tumors, HIV infection, uncontrolled diabetes (fasting blood glucose ≥7.0 mmol/L, 2-hour postprandial blood glucose ≥7.8 mmol/L)
* Kock pouch
* Sever gastrointestinal stenosis
* Abnormal laboratory values with clinical significance, including serum potassium \<3.5 or \>5.5 mmol/L, glutamic-pyruvic transaminase (ALT) or glutamic oxalacetic transaminase (AST) \>2-fold upper limit of normal (ULN), Cr \>ULN
* Gastrointestinal abnormalities or surgery that may interfere with drug absorption
* Hyperthyroidism or hypothyroidism
* Allergic to any ingredient or metabolite of investigational drug or drugs of similar structure
* Psychological diseases, acrasia, cannot express explicitly
* Patients whose mood may be affected by variations in blood pressure, which in turn increases blood pressure
* Anxiety disorders, depression or cannot follow study protocol
* BMI \>30
* Night shift, irregular sleep patterns or insomnia
* participate in other clinical trials within 3 months
* other conditions that investigators consider unsuitable for participation
Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of topotecan in treating patients who have advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer.

OBJECTIVES:

* Determine the maximum tolerated dose and duration of prolonged topotecan as maintenance in patients with advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer with complete clinical response after platinum-based chemotherapy.
* Determine the safety of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral topotecan twice daily for 21 days. Treatment repeats every 28 days for up to 6 months in the absence of unacceptable toxicity or disease progression.

Patients who tolerate course 1 may receive an escalated dose of topotecan for subsequent courses. The maximum tolerated dose is defined as the dose tolerated by the majority of the patients.

Patients are followed every 2 months for at least 6 months.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal serous cancer

  * Stage IIIB, IIIC, or IV
  * Surgically staged and debulked
* Complete clinical response after first-line platinum-based chemotherapy (cisplatin or carboplatin) defined by all of the following criteria:

  * No evidence of cancer by history or physical examination
  * CA 125 no greater than 35 units/mL
  * No evidence of residual cancer on CT scan of the abdomen/pelvis and chest x-ray
* Must have received at least 5 courses of first-line chemotherapy

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* Granulocyte count at least 1,200/mm\^3
* Platelet count at least 90,000/mm\^3

Hepatic

* Bilirubin normal
* ALT and AST less than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase less than 1.5 ULN

Renal

* Creatinine clearance at least 60 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No concurrent immunotherapy

Chemotherapy

* See Disease Characteristics
* At least 3 weeks since prior first-line chemotherapy
* At least 3 years since other prior chemotherapy (other than first-line chemotherapy for ovarian, fallopian tube, or primary peritoneal cancer)
* No other concurrent chemotherapy

Endocrine therapy

* No concurrent hormonal therapy

Radiotherapy

* No prior abdominopelvic radiotherapy
* No concurrent radiotherapy

Surgery

* See Disease Characteristics
* No concurrent surgery

Other

* No other concurrent antitumor therapy
Comparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status and Strength Parameters in Patients With Fibromyalgia.

In this study, it was aimed to examine the effects of aerobic exercise and balance-proprioception exercises on pain, functionality and strength parameters of fibromyalgia patients and to compare the two exercise types.

In the study planned to evaluate the effect of aerobic and balance-proprioception exercises on the symptoms of the disease and the superiority of the two exercise models in patients with fibromyalgia syndrom (FMS), 62 women who meet the inclusion criteria will be randomly divided into two groups. Aerobic exercise group (n = 26) and balance-proprioception exercise group (n = 26) will be applied for 3 weeks a week, 6 days a week under the supervision of a physiotherapist in the exercise laboratory of the Istanbul Medical Faculty Sports Medicine Department. Pain (VAS), functional status (FİQ) and knee extension muscle strength (Cybex isokinetic dynamometer) will be evaluated before and after the program. Cognitive status will be evaluated with standardized Mini Mental Test only before the program.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18 and 60,
* Symptoms lasting longer than 3 months,
* According to the 2013 ACR criteria, the Pain Settlement Score (PLI) is ≥17,
* According to the 2013 ACR criteria, the Symptomatic Impact Scoring (SIQR) is ≥21,
* Acceptance of treatment that will continue 3 days a week for 6 weeks,
* The possibility of any change in medical treatment due to FMS during the study is not foreseen.

Exclusion Criteria:

* Known central or peripheral nervous system disease, progressive neurological damage,
* Any serious cardiovascular pathology,
* Sense, loss of sense of position, unhealed fracture or a surgical wound,
* Presence of uncontrolled hypertension,
* Failure to understand or perform simple commands.
A Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy

Mechanical diagnosis and treatment (MDT) and Manual Therapy (MT) have both demonstrated efficacy in the management of CLBP. The use of a Point of Care (POC) design in this study will allow for comparison of these two treatment modalities in a clinical setting. The purpose of this study is to demonstrate the feasibility of recruiting, enrolling and collecting outcome data on CLBP patients utilizing the POC methodology.

20 new patients entering the chiropractic clinic who meet inclusion criteria including demonstrating a directional preference upon physical examination during their initial evaluation will be recruited. Patients will be queried as to interest and those interested will be consented. Patients will then be randomized utilizing a computer generated randomization chart to receive either MDT or MT delivered in a pragmatic manner. Outcomes will include: Pain (PEG), Quality of Life (PROMIS Global Health Survey (GHS)), psychosocial questions and Self Efficacy (2 Question). Outcomes will be collected at baseline, 4 weeks and 8 weeks post baseline.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Lower back pain (CLBP) (\>12 weeks)
* Veteran
* At least 18 years of age
* Directional preference on physical examination

Exclusion Criteria:

* Non Veteran
* \>89 years of age
* Non Mechanical Cause of LBP
* Unable to identify directional preference on physical examination
* Contraindications to manual therapy (cauda equina syndrome, spinal neoplasia or metastatic disease, destructive joint pathology such as rheumatoid arthritis, bowel/bladder dysfunction (associated with the back pain), peripheral neuropathy or progressive lumbosacral radiculopathy, progressive myelopathy or neurogenic claudication or any absolute contraindications to MT such as acute fracture of the lumbar spine)
* Open Worker's compensation case
Acute Respiratory Failure and COVID-19 in Real Life

In December 2019 a new kind of virus was identified in China as the responsible of severe acute respiratory syndrome (SARS) and interstitial pneumonia. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quickly spread around the world and in February 2020 became a pandemia in Europe.

No pharmacological treatment is actually licensed for the SARS-CoV2 infection and at the current state of art there is a lack of data about the clinical management of the coronavirus 2019 disease (COVID-19).

The aim of this observational study is to collect the data and the outcomes of COVID-19 patients admitted in the H. Sacco Respiratory Unit treated according to the Standard Operating Procedures and the Good Clinical Practice.

All consecutive adult COVID-19 patients admitted to our Respiratory Unit will be enrolled. All demographic, anthropometric, laboratory, radiological, clinical and microbiological data will be collected and analyzed according to the primary and secondary outcomes (see the dedicated section).

During the hospitalization, patients will be treated according to the standard operating procedure of our Respiratory Unit, such as arterial gas analysis, Rx, pharmacological treatment, ventilation. This study is purely observational and no randomization will be performed.

After discharge, patients a 7 days, 30 days and 6 months follow up will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients that can give written or oral informed consent
* patients with microbiological diagnosis (i.e. rhinopharyngeal swab) of SARS-CoV2 infection

Exclusion Criteria:

* severe cognitive impairment
* absolute contraindication to non invasive ventilation or cpap therapy
* rhinopharyngeal swab negative for SARS-CoV2
Platelet and Autotransfusion Device in Cardiac Surgery

Cardiac surgery is a bleeding-risk surgery and frequently requires blood transfusion. Intraoperative autotransfusion devices are used to aspirate, process and retransfuse patients' blood. These devices are effective in recovering red blood cells and limiting the need for transfusion of packed red blood cells. Some devices, such as I-SEP's SAME®, can also be used to recover platelets, but their effectiveness has not yet been evaluated in real-life situations. The aim of this study is therefore to investigate the evolution of platelet counts following the use of an intraoperative recovery device in adult patients undergoing standard cardiac surgery


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Having undergone standard cardiac surgery (excluding redux surgery, dissection, endocarditis, circulatory assist and transplants)
* Treated with an autotransfusion device during the surgery
* Subject having expressed their consent to the study

Exclusion Criteria:

* Anemia less than 7 g/dL
* Pregnant women
* Redux surgery, dissection, endocarditis, circulatory assistance, and transplants
* Contraindication to the use of an autotransfusion device
* Impossibility of giving the subject informed information
Nova Max Creatinine and EGFR Meter System

To assess the performance of the Nova Max Creatinine and eGFR assay in the hands of CLIA-Waived Point-of-Care users in at least three (3) distinct Point-of-Care clinical settings on venous, and capillary blood and compare the performance characteristics to a traceable laboratory reference method (the Siemens EXL creatinine determination).

To assess the Ease of Use of the Nova Max Creatinine and eGFR Meter System in the hands of the intended CLIA-Waived Point-of-Care users.

This study is designed to evaluate the performance of the NM Meter when used by CLIAW operators in terms of both accuracy to an established reference method and precision. CLIAW operators will receive no training or prompting on how to use the NM Creatinine and eGFR Meter, operating only using the instructions found in printed labeling materials (IFU, QRG, packaging).

In determining the accuracy of the device, subjects will be tested using the NM Creatinine and eGFR Meter alongside a central laboratory reference method and the results will be compared to one another. This portion of the study is referred to as Method Comparison.

In determining the precision of the device, multiple creatinine determinations will be made with the NM Creatinine and eGFR meter using both stabilized control materials (testing over the course of 20 days) and venous whole blood specimens (tested over the course of a single day). The difference between the multiple test results will determine the device's level of precision. This portion of the study is referred to as Precision.

Eligibility Criteria:
Inclusion Criteria:

1. Adult males or females (≥ 18 years of age)
2. CKD Stage 1 (healthy)
3. CKD Stages 2-4
4. Subjects willing and able to consent to participating in the study.
5. Subjects whose pre-screen creatinine and eGFR value, if performed, is deemed valuable to the study.

Exclusion Criteria:

1. Subjects unable to consent to participating in the study.
2. Subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study.
Thermotherapy Against Persistent Bacterial LUNG Infections

The aim of this study is to determine whether an intervention with frequent thermotherapy will be able to reduce the amount of colonizing bacteria in the bronchoalveolar lavage sample and eradicate the colonizing bacteria.

Normally, bacterial lung infections are acute such as community-acquired pneumonia and typically resolve after antibiotic therapy without leaving much lasting damage on the lungs. However, a great amount of persons with disrupted clearance of mucus and/or lung immune system get persistent lung infections, which can be life-long, usually do not resolve even with antibiotics, and can greatly increase morbidity and mortality. IThese persistent lung infections are thus characterized by stable periods with exacerbations inbetween, akin to chronic lung diseases such as asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis. In addition, it has not been thoroughly investigated whether antibiotic regimens have an effect on disease control, as biofilm formation prevents antibiotics from killing the bacteria.

This is a randomized, controlled, multi-center, superiority trial evaluating the effect of a thermotherapy intervention, consisting of min. 7 minutes stay in min. 85℃ environment at least 4 times a week for 6 months, in persons with persistent bacterial lung infection, defined as min. 2 positive cultures during the last 24 months for one of the following bacteria: Pseudomonas aeruginosa, Achromobacter xylosoxidans, Stenotrophomonas maltophilia, Klebsiella oxytoca, Klebsiella pneumoniae, Haemophilus influenzae or Staphylococcus aureus, incl. 1 positive culture after attempted eradication therapy. The aim of the study is to investigate whether thermotherapy may offer a valid proposal for treatment of chronic lung infections.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Competent and capable
* FEV1\>1,0 L
* Have had a positive culture from sputum or BAL min. 2 times in the last 24 months for bacteria of the species: Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Staphylococcus aureus, Haemophilus influenzae, Achromobacter xylosoxidans, Klebsiella oxytoca or Klebsiella pneumoniae. In addition, min. 1 positive culture after treatment with antibiotics
* Willing to go to a sauna (min. temperature of 85℃ for at least 7 minutes) four times weekly for six months or avoid going to a sauna for six months

Exclusion Criteria:

* Allergy to lidocaine and/or midazolam
* Contraindications to bronchoscopy
* Previous severe laryngospasm (intubation requiring)
* Pregnancy/breastfeeding
* Severe linguistic problems or inability to give informed consent
* Severe mental illness that is not controlled with medication. NB: Patients with controlled mental illness can be included and will be asked on an equal footing as others
Effects of Hiit Associated With Emotional Regulation on Negative Emotions

Despite the benefits of physical exercise, the population does not adhere to the recommended levels of physical activity. The reported difficulties in starting and maintaining a physical exercise program are attributed to personal barriers and lack of motivation. Thus, there is an urgent need for efficient intervention proposals to increase engagement in daily physical exercise. High-intensity interval training (HIIT) is a promising and economical method, aiming at the development of efforts at high, maximum or supramaximal intensity, based on several methods: calisthenics (using the body's own strength) resistance (heavy objects, bars or devices for high-repetition resistance activities) and traditional (exercise modalities such as running and cycling). Emotional regulation (ER) is essential for the psychosocial well-being of human beings and is defined as the ability to influence, experience and express emotions, being an action, conscious or not, that directly modulates emotions and alters their nature as the intensity and duration. Regular physical exercise has been attributed to a reduction in depression symptoms, an increase in emotional well-being and a reduction in negative feelings. In addition to physical exercise, the use of cognitive reassessment to regulate emotions was positively associated with a decrease in negative affect in psychopathological diagnoses.

Main goal

To evaluate the effects of high-intensity interval training (HIIT) associated with a cognitive reassessment strategy on negative emotions in sedentary women.

Specific objectives

Evaluate and compare the positive and negative affective of women in three moments; Evaluate and compare the intensity and valence of emotions in three moments; Investigate possible associations between emotion dysregulation and emotion regulation strategies in positive and negative affect; Investigate and compare HIIT intensity and emotion regulation strategy in pleasure and displeasure during physical exercise during practice.

Eligibility Criteria:
Inclusion criteria:

• No psychiatric or neurological disorder

Exclusion criteria:

* Using mood-altering medications
* Joint problems
* Practicing physical activity for six months
Seroepidemiological Study of SARS-CoV-2 (COVID-19) Infection in Population Subgroups in the State of São Paulo

Seroepidemiological Study of SARS-CoV-2 Infection in Population Subgroups in the State of São Paulo

This is a cross-sectional study to estimate the prevalence of antibodies against SARS-CoV-2 is different population subgroups in the State of São Paulo

Eligibility Criteria:
Inclusion Criteria:

* All potential volunteers invited to participate in the study.

Exclusion Criteria:

* All potential eligible participants, but who do not show interest in participating in the study.
Effect of the Stellate Ganglion Block on the Retinal Microcirculation

Surges in the sympathetic nervous system occur at the ictus of a variety of neurological critical illnesses including intracranial hemorrhage and ischemic stroke. It is hypothesized that these exaggerated increases in sympathetic nervous activity produce maladaptations that promote secondary brain injury. One of these possible mechanisms include diffuse vasospasm that cause cerebral ischemia. Hence, methods to abrogate the sympathetic nervous system in this context are under active investigation. One possible method is the regional anesthesia technique of the stellate ganglion nerve block, which is ordinarily used for complex regional pain syndrome, but has been shown to reduce cerebral sympathetic activity and reduces vasospasm in patients with subarachnoid hemorrhage. However, its effect on the microcirculation is not clear. Hence, we propose to study patients receiving the stellate ganglion nerve block as part of their standard medical care and to image their retinal microcirculation before and after the procedure using Optical Coherence Tomography Angiography (OCTA).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patients receiving the stellate ganglion nerve block for an approved indication, e.g. complex regional pain syndrome

Exclusion Criteria:

* Pregnancy
* Non-English speaking
* Temporary or permanent physical limitation that renders the patient unable to sit up and look inside OCTA device
Comparing Oxygen Saturation in Post Anesthesia Care Unit After Different Methods of Pain Relief

To determine the which method of pain relief is better after current anesthesia care.

We hypothesized that in children, the current anesthesia care (combined light general anesthesia and caudal analgesia) may decrease incidence of intra and or postoperative de-saturation( SaO2 \< %95), the need of oxygen during child's transport to the PACU and during his stay in the recovery room, compared with children who receive intravenous narcotics for intra and postoperative pain relief.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children
* ASA physical status 1 or 2
* 1-6 yr old
* Scheduled for elective uni or bilateral orchidopexy

Exclusion Criteria:

* Children with compromised pulmonary, cardiac, neurological, hematological, renal condition, with history of prematurely or are obese will be excluded.
A Deep Learning Framework for Pediatric TLE Detection Using 18F-FDG-PET Imaging

This study aims to use radiomics analysis and deep learning approaches for seizure focus detection in pediatric patients with temporal lobe epilepsy (TLE). Ten positron emission tomograph (PET) radiomics features related to pediatric temporal bole epilepsy are extracted and modelled, and the Siamese network is trained to automatically locate epileptogenic zones for assistance of diagnosis.

Purpose:The key to successful epilepsy control involves locating epileptogenic focus before treatment. 18F-FDG PET has been considered as a powerful neuroimaging technology used by physicians to assess patients for epilepsy. However, imaging quality, viewing angles, and experiences may easily degrade the consistency in epilepsy diagnosis. In this work, the investigators develop a framework that combines radiomics analysis and deep learning techniques to a computer-assisted diagnosis (CAD) method to detect epileptic foci of pediatric patients with temporal lobe epilepsy (TLE) using PET images.

Methods:Ten PET radiomics features related to pediatric temporal bole epilepsy are first extracted and modelled. Then a neural network called Siamese network is trained to quanti-fy the asymmetricity and automatically locate epileptic focus for diagnosis.The performance of the proposed framework was tested and compared with both the state-of-art clinician software tool and human physicians with different levels of experiences to validate the accuracy and consistency.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of temporal lobe epilepsy.
2. Age range from six to eighteen years old.
3. Underwent PET, EEG, computed tomography (CT) and MRI.

Exclusion Criteria:

1. Image quality is unsatisfactory (e.g. severe image artifacts due to head movement).
2. 18F-FDG PEG examination is negative.
3. Clinical data is incomplete.
4. EEG or MRI report is missing.