cyrilzakka/clinical-trials huggingface dataset:
the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males

The purpose of this study is to evaluate the diagnostic value of Rigiscan (nocturnal penile tumescence and rigidity, NPTR ) test in erectile dysfunction of Chinese males.

The Rigiscan test is used to evaluate the NPTR parameters. The "normal" NPTR parameter is provided by the Rigiscan manufacturer based on a clinical study on 500 American males. Original studies of NPTR parameters on Chinese males are warranted. On the other hand, during the past decades, several new NPTR parameters have been developed, like tip TAU (tip tumescence activity units), tip RAU (tip rigidity activity units), base TAU (base tumescence activity units), base RAU (base rigidity activity units), but their diagnostic values have been less evaluated. Basd on the these background, we determined to observe the clinical manifestation of these new parameters and to establish the "normal criteria" of NPTR parameters in Chinese males. This could be clinically beneficial in the differential diagnosis of organic and psychological erectile dysfunction.

Eligibility Criteria:
Inclusion Criteria:

1. patients in a stable and heterosexual partnership with a fixed sexual partner for more than 6 months;
2. age≥20 year;
3. complete the validated International Index of Erectile Function (IIEF-5) questionnaire.

Exclusion Criteria:

1. advanced age (≥65);
2. pelvic trauma
3. thyroid diseases
4. metabolic diseases
5. hypogonadism and other hormonal disorders
6. sleep disorders
7. penile deformities
8. taking drugs that may interfere with erectile function.
Comparative Study on the Effects of Epidural Dexmedetomidine on Heart Rate Variability During General Anesthesia in Patients Undergoing Gastrectomy

The use of epidural dexmedetomidine decreases the anaesthetic requirements and improved postoperative pain. Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist and has sympatholytic effect. Power spectral analysis of heart rate variability(HRV) is a useful tool to assess cardiac autonomic activity. We investigated whether preemptive epidural dexmedetomidine can develop hemodynamic change and it could be identify patients by HRV.


Eligibility Criteria:
Inclusion Criteria:

* Patients consented to spinal anesthesia were enrolled
* Patients aged 40\~70 years olds undergoing gastrectomy
* No contraindication of epidural analgesia
* ASA class I and II
* Patients consented to epidural anesthesia were enrolled

Exclusion Criteria:

* Patients with hypovolemia, coagulation disorders, local infection at the site of operation, history of headache, heart diseases, and history of allergy, chronic alcohol use or abuse, anemia, congenital heart diseases, bundle block, congestive heart failure or arrythmias
* patients who had recently received sedative drugs or were under antidepressant treatment were not included in the study
A Study Evaluating the Safety and Efficacy of Treating Sinus Infection With Levofloxacin 750 mg for 5 Days.

The purpose of this study is to evaluate the effectiveness and safety of a once-daily administration of 750 milligrams levofloxacin (an antibiotic) for five days, in treating bacterial sinus infections.

Acute bacterial sinusitis is a common diagnosis for which an antibiotic is prescribed in outpatients. Some types of bacteria that cause sinusitis are resistant to penicillin and certain other classes of antibiotics, but may be treatable with the antibiotic levofloxacin. This will be an open-label, multi-center, non-comparative clinical trial involving outpatients with protocol-defined acute bacterial sinusitis suitable for treatment with oral antibiotics. At the Preliminary Visit, a sinus radiograph will be obtained to confirm the clinical diagnosis of sinusitis, and the Investigator will perform a nasal exam. Sinus puncture and placement of an indwelling sinus catheter into an affected maxillary sinus will be performed on all eligible patients at the first visit. Patients meeting the study criteria will receive 750 milligrams levofloxacin tablets once daily for 5 days. The primary objective is to establish the rate and extent of bacteriological eradication, defined as eradication of pathogens from the maxillary sinus, and to establish the effectiveness and safety of once-daily 750 milligrams levofloxacin for the treatment of acute bacterial sinusitis in adults.

Levofloxacin 750 milligram tablet orally once a day for 5 days

Eligibility Criteria:
Inclusion Criteria:

* Clinical signs and symptoms of acute maxillary sinusitis for 5 to 28 days
* Visible nasal purulence evident on physical examination
* CT scan or standard sinus x-ray (Waters' projections) performed within 5 days prior to the first dose of study drug, showing total sinus opacification or an air-fluid level
* Agree to a maxillary sinus puncture and catheter placement
* If female, using birth control

Exclusion Criteria:

* Chronic sinusitis
* Need for hospitalization or intravenous antibiotics
* History of head, neck, or nasal cancer or surgery
* Previous allergy, serious adverse reaction to, or failed therapy with, levofloxacin or any other member of the quinolone class
* Presence or history of serious complications of sinusitis
* Previous antimicrobial therapy within 7 days of Study Entry
Early Antiviral Therapy for Critically Ill HIV Infected Patients

The aim of the study is to verify the effect of HAART in critically ill HIV infected patients. The current practice is to begin antiviral therapy after ICU discharge, when the condition of the patient is more stable. The investigators hypothesis is that the investigators can improve outcome of these patients with earlier antiviral therapy in the ICU. The investigators just have retrospective studies in this scenario. After admission to ICU, patients are assigned to one of two arms: early HAART (within 5 days of ICU admission) or conventional therapy (initiation of HAART after ICU discharge). The following data will be collected: demographic variables, CD4 count, viral load, drug toxicity, opportunistic infection, hemodialysis, mechanical ventilation and vasoactive drug. The patients will be followed to determine ICU mortality, hospital mortality and 6-month mortality.


Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* CD4 cell count less than 350 cells/mm3 within 3 months prior to study entry OR CD4 cell count between 350 cells/mm3 and 500 cells/mm3 if age \> 55 years, coinfection with HBV or HCV, neoplasia, viral load \> 100,000 copies/ml or elevated cardiovascular risk OR AIDS-defining illness

Exclusion Criteria:

* Regular use of HAART
* Pregnant
Anovo™ Surgical System - Registry Study

To collect Real-World Data (RWD) on the ongoing safety and effectiveness of the anovo Surgical system in transvaginal gynecological laparoscopic surgical procedures and to obtain information on the impact of the anovo Skills Development Pathway on user behavior and performance (where performance is measured by the learning curve of the surgeons and procedure outcomes).

Specific Aims:

1. To collect RWD from surgeons with varying experience and expertise on their learning curve and time to achieve competency, and as such assess the success of the Skills Development Pathway.
2. Collect safety information and analyze the causality between type and frequency of adverse events to surgeons' experience.
3. Evaluate the effectiveness of the device while minimizing bias by enrolling "all comers", which will represent the general patient population.

Eligibility Criteria:
All patients receiving gynecological surgical procedure with the anovo Surgical System by their surgeon will be offered to participate in the registry.

Inclusion Criteria:

* patients must understand and sign the informed consent form, including data privacy authorization, indicating their consent to participate in the registry study.
* willing to complete post-operative questionnaire

Exclusion Criteria:

-none
Ability to Cope With Type 1 Diabetes

The purpose of this study is to learn about the relationship that exists between coping skills and blood glucose control. In addition to this, we will study the effect of Type 1 diabetes on coping skills in different age groups, genders, ethnicities, socioeconomic groups, and the duration of diabetes.

Coping with type 1 diabetes can be very difficult. Type 1 diabetes is a very unique chronic disease because it requires constant attention to several responsibilities such as daily glucose monitoring, multiple daily insulin doses, and strict diet and exercise. Several studies have shown that increased rates of poorer glucose control are a result of struggling to cope with type 1 diabetes. This may be due to the fact that many type 1 diabetics experience a feeling of exhaustion, or "burnout," after a certain period of time due to an overwhelming amount of responsibility.

In our study we would like to determine how children's ability to cope with diabetes affects glucose control. By completing several questionnaires, we can analyze different kinds of coping skills through a complex scoring system. These scores will then be analyzed in comparison to your glucose control using HbA1c.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be type 1 diabetic
* English/Spanish speaking
* The legal guardian must be present

Exclusion Criteria:

* Non-cognitive or mentally ill
* Under the age of 8.0 years
Bone Marrow vs Liver as Site for Islet Transplantation

The goal of this study is to evaluate safety and efficacy of bone marrow (BM) as site for pancreatic islet transplantationin humans. Our hypothesis is that BM represents a better site than liver (currently the location of choice for this procedure) thanks to its potential capacity to favor islet engraftment. To address our hypothesis we propose herein a randomized phase II trial to compare BM and liver as sites for islet transplantation in T1D patients.

The study is a phase II, single center, open label, pilot study. We will recruit 12 patients with T1D to be randomly (1:1) assigned to receive islet either into the liver through the portal venous circulation (standard procedure; arm A, n=6) or directly into the BM at the level of the iliac crest (arm B, n=6). Patients will be selected from those eligible for islet Tx based on local practice and guidelines.

Eligibility Criteria:
Inclusion Criteria:

* diabetic patients eligible for pancreatic islet transplantation based on local accepted practice and guidelines. This includes at least: a)clinical history compatible with T1D with insulin-dependence for \>5 years; b) undetectable stimulated (arginine or MMTT) C-peptide levels (\<0.3 ng/mL) in the 12 months before transplant c)presence of severe hypoglycaemic events

Exclusion Criteria:

* presence of hematologic disease
Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

To analyze the efficacy of beraprost and sildenafil for treatment of pulmonary hypertension in children with left to right shunt.

analyze the efficacy and side effects.

Eligibility criteria:

Inclusion:

1. children aged 1-17 years with left to right shunt, diagnosed as pulmonary hypertension.
2. free from chronic pulmonary disease
3. never performed any cardiac surgical
4. never got any treatment for PH
5. agree to enroll in this study. Exclusion

1. suffer from portal hypertension, HIV and connective tissue disease 2. under interferon therapy.

Outcome measure:

Pulmonary artery pressure

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as pulmonary hypertension with left to right shunt CHD (VSD, ASD, PDA and combination)
* agree to enroll in this study

Exclusion Criteria:

* suffer from chronic lung disease
* suffer from soft tissue tumor, HIV/AIDS
* under interferon therapy
* already performed any cardiac surgery
* already got anti-PH remedy
Lung Cancer and Idiopathic Pulmonary Fibrosis : Pathological and Molecular Characterization

Retrospective inclusion of lung cancers developed in a context of idiopathic pulmonary fibrosis, diagnosed and / or treated in participating centers. The cases are recovered retrospectively from the records of the pulmonology and pathology departments of our various partners.

Primary objective:

Characterize altered molecular pathways in lung cancer in patients with IPF versus lung cancer in non-IPF patients.

Secondary objectives:

Identify specific therapeutic targets Describe a cohort of lung cancers on IPF (clinical / radiological and pathological data) To study the relationship between neoplastic / preneoplastic lesions and pulmonary parenchyma reshaped by fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Lung carcinoma
* Idiopathic pulmonary fibrosis

Exclusion Criteria:

- No tumor sample available
Registry of BrentuximabVedotinin Patients With R/R Anaplastic Large Cell Lymphoma or Classical HL

In case of relapsed or refractory ALK-negative ALCL patients, high-dosage chemotherapy/ stem cell transplantation is a universal salvage option for patients with sensitivity to anti-cancer treatment and a relatively successful salvage rate can be expected.

Recently, there has been a report of successful stem cell transplantation with full response to BrentuximabVedotin induced before stem cell transplantation and BrentuximabVedotin's role as a bridge therapy before stem cell transplantation has also been suggested.

Hodgkin lymphoma is a type of curable blood cancer with unique tissues and clinical characteristics. Based on the 2008 WHO classification, Hodgkin lymphoma has two types-nodular lymphocyte predominant type and classical type-and the classical type is further classified into four types, nodular sclerosis, mixed cellularity, lymphocyte depletion and lymphocyte-rich type.

Recently, immune checkpoint inhibitor is reported as a very effective treatment for relapsed Hodgkin lymphoma and more active treatment such as stem cell transplantation is considered for younger patients.

Treatment with Brentuximabvedotin targeting CD30+ is also very effective for the treatment of relapsed Hodgkin lymphoma and considered a good option for patients who are not suitable for stem cell transplantation or aged patients.

It shows consistent response to anti-CD30 antibody treatment in relation to relapsed anaplastic large cell lymphoma or Hodgkin lymphoma. The effect of Brentuximabvedotin (BV) has been proven for relapsed or intractable ALCL targeting CD30 as an antibody-chemical adhesive in the recent phase-2 study.

As Korea currently lacks real-world evidence in relation to BV, this study was conducted to address BV's effect as salvage therapy for patients with relapsed/refractoryanaplastic large cell lymphoma or Hodgkin lymphoma. This study identified the clinical results for treatment patterns and patients using the collected data and derived critical evidence for treatment decisions.


Eligibility Criteria:
Inclusion Criteria:

Any patient subject to one of the following at the start of treatment with BrentuximabVedotin:

1. Any patient planning to administer BrentuximabVedotin to treat the target disease;
2. Any patient administering BrentuximabVedotin to treat the target disease;
3. Any patient tracing BrentuximabVedotin after treating the target disease; or
4. Any patient administering another salvage option for cancer as the target disease has relapsed after terminating treatment using BrentuximabVedotin.

Exclusion Criteria:

1. If conditions for target diseases are not met.
2. If conditions for target patients are not met.
3. If patients do not give written consent to participate in study.
Natural Dendritic Cell Vaccines in Metastatic Melanoma Patients

Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As such they are currently used in clinical vaccination protocols in cancer patients, and both immunological and clinical responses have been observed. Several subsets of dendritic cells have been characterized in the peripheral blood. One such subset is referred to as plasmacytoid dendritic cells (PDC), another as myeloid dendritic cells (myDC). To date PDC and myDC have not been evaluated for their capability to induce anti-tumor immune responses in patients. For this reason the investigators will perform a safety and efficacy study with PDC and myDC in stage IV melanoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Stage IV melanoma according to the 2001 AJCC criteria. Limited tumor burden; LDH \< 2x upper limit of normal
* Histological proof of cutaneous melanoma
* Melanoma expressing tyrosinase and/or gp100 (approximately 20% of cells or more determined by immunohistochemistry staining)
* HLA Type A2
* WBC \> 3.0 \* 10E9/l, lymphocytes \> 0.8 \* 10E9/l, platelets \> 100 \* 10E9/l, serum creatinine \< 150 umol/l, serum bilirubin \< 25 umol/l, normal liver function
* Expected adequacy of follow up
* Written informed consent

Exclusion Criteria:

* autoimmune disorders, concomitant use of immunosuppressive drugs
* serious concomitant disease, serious active infections, other malignancy in the past 5 years with the exception of curatively treated carcinoma in-situ of the cervix/squamous cell carcinoma of the skin
* known allergy to shell fish (vaccine contains KLH)
* pregnancy or lactation
* clinical signs of CNS metastases, in patients with a clinical suspicion of CNS metastases, a CT scan of the brain should be performed to exclude this
* prior chemotherapy, immunotherapy, or radiotherapy within three months before planned vaccination is allowed
The Effects of Glucocorticoids on Mortality and Renal Function in Patients With Acute Decompensated Heart Failure

Evidence showed that glucocorticoids could induce potent diuretic actions and improve renal functions in patients with decompensated congestive heart failure. Thus we design this study to determine the efficacy of glucocorticoids on cardiovascular mortality in the 30 days following randomization.

Newly emerging clinical evidence showed glucocorticoids, when added to best conventional therapy, could produce potent diuretic effects, and improve renal functions in patients with decompensated congestive heart failure. It holds ture even in the patients who failed to respond to high dose of furosemide (\>200mg/day). The present study is to confirm the clinical efficacy of glucocorticoids on cardiovascular mortality in patients with decompensated congestive heart failure who are on best conventional therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with dyspnea at rest due to acutely decompensated CHF requiring hospitalization and intravenous therapy. The cardiac etiology for acutely decompensated CHF was established by echocardiogram and/or a chest x-ray film and 2 of the following:

  1. \>2-pillow orthopnea before study entry
  2. Jugular venous distention and/or abdominal discomfort due to mesenteric congestion.

Patients may have had acute decompensation of chronic heart failure, gradual worsening of chronic heart failure, or new onset of acutely decompensated CHF. Patients who were receiving intravenous therapy i.e. Inotropic and/or vasodilator but who otherwise met entry criteria were also permitted into the study. Patients with signs of cardiac shock were also permitted into the study.

Exclusion Criteria:

* Patient refusal
* Any signs of infection
* any condition that would contraindicate a glucocorticoids use
* Poor controlled hypertension
* Poor controlled diabetes mellitus
* Active myocarditis
* Malignancy or other terminal illness
PC001- A Study to Evaluate the Usability of PointCheck

This a study about the usability of PointCheck a novel non-invasive technology for monitoring chemotherapy-induced neutropenia.

The study will include patients with cancer visiting the outpatient hematology clinic for their standard of care chemotherapy administration. A final sample size of 90 oncologic outpatients will be enrolled and studied with the technology.

The main objective is to evaluate the usability of PointCheck. Secondary outcomes include a preliminary assessment of PointCheck diagnostic accuracy and precision.

For this, study subjects will be tested twice with PointCheck during the same session and the usability in an at-home simulated environment by naïve users will be evaluated


Eligibility Criteria:
Inclusion Criteria:

1. Able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
2. Male or Female aged 18 years or above.
3. Diagnosed with a hematological (e.g., lymphoma, myeloma) or breast cancer.
4. Scheduled active treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia.
5. Able (in the Investigators opinion) and willing to comply with all study requirements

Exclusion Criteria

1. Participants with amputations, congenital malformations, or any severe abnormalities of the hands as determined by the investigator.
2. Participants with a history of vasculitis, Raynaud syndrome, scleroderma, mixed connective tissue disease or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold.
3. Participants with circulating tumour cells in previous or current lab determinations.
4. Participants with leukemia.
5. Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
6. Inadequately medically controlled hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg).
7. Participants whose gold standard blood differential was obtained more than 120 minutes after the last evaluation with the medical device.
8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
9. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.