cyrilzakka/clinical-trials huggingface dataset:
Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced Hodgkin's lymphoma.

OBJECTIVES:

* Determine the feasibility of short term chemotherapy with the Stanford V regimen (mechlorethamine, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide) followed by, as indicated, consolidative radiotherapy in patients with stage IIB, IIIA, IIIB, or IV Hodgkin's lymphoma.
* Determine the initial response to 8 weeks of Stanford V chemotherapy in these patients.
* Assess the complete and partial response rate to 12 weeks of Stanford V chemotherapy in these patients.
* Determine the acute toxicity associated with this treatment.
* Determine the disease free interval and survival following Stanford V chemotherapy with or without consolidative radiotherapy in these patients.

OUTLINE: All patients are treated on Regimen A with the Stanford V Regimen; those with initial bulky, residual, or splenic disease who achieve a CR/PR proceed to Regimen B.

* Regimen A: Patients receive mechlorethamine IV on weeks 1, 5, and 9; doxorubicin and vinblastine IV on weeks 1, 3, 5, 7, 9, and 11; vincristine and bleomycin IV on weeks 2, 4, 6, 8, 10, and 12; etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3, 7, and 11; and prednisone orally every other day on days 1-84. Treatment continues for 8-12 weeks, depending on response, in the absence of disease progression or unacceptable toxicity.
* Regimen B: Patients begin radiotherapy 2-4 weeks after completion of Regimen A. Patients receive radiotherapy to lungs, pleura, and other extralymphatic sites for approximately 5 weeks.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 50 patients will be entered if at least 16 of the first 22 patients respond. As of 03/96, it is expected that a total of 45 patients each with stage III/IV disease and 40 with unfavorable stage II disease will be accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed Hodgkin's lymphoma of any histology
* Unfavorable disease required

  * Clinical stage IIIA, IIIB, IV, or IIB (non-bulky)
  * Locally extensive stage I or II with either of the following:

    * Mediastinal mass greater than 1/3 the maximum intrathoracic diameter
    * Two or more extranodal sites

PATIENT CHARACTERISTICS:

Age:

* 18 to 60

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No prior malignancy except nonmelanomatous skin cancer
* No significant concurrent illness that precludes protocol participation

PRIOR CONCURRENT THERAPY:

* No prior treatment for Hodgkin's lymphoma

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
The Effect of Hazelnut Flour on Blood Glucose

One of the factors affecting human health is nutrition. The effects of foods on blood glucose are still under investigation. The Glycemic Index (GI), which is associated with many diseases today, is a value that measures the rate at which carbohydrate-containing foods raise blood glucose. It is thought that the loaves of bread produced will be a product with low GI value and can be consumed by celiacs and diabetics. It is aimed to investigate the effect of adding different amounts of hazelnut flour to bread recipes using gluten-free corn flour on blood glucose.


Eligibility Criteria:
Inclusion Criteria:

* The study group consisted of volunteer individuals aged between 18 and 35 years.
* The first blood glucose measurement was taken after at least 8 hours of fasting and any of the bread types were given to the participants for consumption.
* During the measurements, the volunteers were observed to avoid water, coffee, and any food intake and to avoid excessive exercise.

Exclusion Criteria:

* Pregnant,
* lactating women
* patients with physician-diagnosed chronic diseases
Comparison of Surgical Versus Medical Termination of Pregnancy Between 13-20 Weeks of Gestation in Ethiopia

The purpose of the study is to determine the safety and effectiveness of dilation and evacuation for surgical abortion as compared to medical abortion

All patients with a gestational age between 13-20 weeks are fully counseled on the risks and benefits and given the option of medical or surgical abortion. Those who choose medical abortion receive mifepristone 200 mg on day 1 and are appointed to return to SPHMMC 24-48 hours later for admission and misoprostol administration. Those who chose surgical abortion are given mifepristone 200 mg with or without laminaria and appointed to return the next day for surgical abortion.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 13 - 20 weeks confirmed with ultrasound,
* Age at or more than18 years,
* Having a working phone and willingness to be contacted for a follow-up questionnaire 2 weeks after the procedure.

Exclusion criteria

* Inability to give consent
* complicated abortion (missed abortion, septic abortion)
Fastigial Nucleus Stimulation for Coronary Heart Disease

To observe the effects of fastigial nucleus stimulation on serum inflammation, oxidative stress related factors, cardiac autonomic function and prognosis in patients with coronary heart disease

In recent years, with the improvement of the material living standards of the investigators residents and the change of working lifestyle, the prevalence and mortality of coronary heart disease (CHD) in urban and rural residents in China have increased year by year. According to statistics, the number of patients with coronary heart disease in China is currently 11 million. Coronary heart disease has become a major health problem in China. At present, it is found that inflammatory reaction and oxidative stress factors are involved in the occurrence and development of coronary heart disease, and their indicators such as heart rate variability are related to the prognosis of coronary heart disease. Fastigial nucleus stimulation (FNS) has been widely used in the treatment of various diseases such as cerebrovascular disease, migraine, and eye diseases. The study found that FNS can reduce inflammatory cytokines and oxidative stress factors in ischemic myocardium and improve heart rate variability in rats with myocardial infarction. The aim of this study was to investigate whether FNS can improve the aforementioned indicators and clinical outcomes in patients with coronary heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Coronary angiography was performed after admission, and coronary heart disease was diagnosed (coronary angiography showed at least one coronary artery with a diameter reduction of ≥50% from more than two different angles)
* Patients and their families agreed and signed informed consent

Exclusion Criteria:

* Severe chronic heart failure, and LVEF \<30%
* Body temperature \> 38 ° C and / or combined with severe infection in any system
* Severe liver and kidney dysfunction
* Malignant tumor
* Autoimmune diseases
* High blood pressure and diabetes with severe comorbidities
* Use of implantable electronic devices
* Intracranial implanted vascular stents
* Surface treatment electrode conductive materials Allergic or mastoid skin lesions
Mobile Clinic - a Cross-sectional Epidemiological Survey

The aim of the study is to find out prevalence of aged-related macular degeneration (AMD) in Slovak Republic. The outcome of the project will be epidemiology survey, prevalence of wet form of AMD in relation to demographic data, patient´s anamnesis, nutrition, co-morbidities etc.

It´s cross-sectional epidemiological survey, multi-centric, non-interventional

1. Patients will fill a questionnaire with demography data, anamnesis, risk factors.
2. Patients will be assessed by using Amsler grid.
3. Patient´s back of the eye will be examined with fundus camera (searching for long-term back of the eye changes, retina vessels, macula and surrounding tissues) by retina specialist.
4. Patient undergoes optical coherent tomography (OCT) examination (cross-section of fovea and macula) by retina specialist.

The project actively screen patients with wAMD. All patients will sign an informed consent.

The process of screening will be held in certain timeframe (cca. 2 months) and selected areas of Slovak Republic.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (aged≥55 years) from selected areas in Slovak Republic
2. Patients with home base far than 35 km from the nearest center (centers: Bratislava, Nitra, Nové Zámky, Trenčín, Bojnice, Žilina, Martin, Ružomberok, Banská Bystrica, Zvolen, Poprad, Prešov, Košice, Trebišov)
3. Patient´s informed consent signed.

Exclusion Criteria:

* Patients who do not meet the inclusion criteria
Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/CT in Patients With Gastrointestinal Tumors and Compared With 18F-FDG PET/CT

To evaluate the potential usefulness of 18F-AlF-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in gastrointestinal tumors, and compared with 18F-FDG PET/CT.

Subjects with gastrointestinal tumors underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 18F-AlF-FAPI, 18F-FDG PET/CT were calculated and compared to evaluate the diagnostic accuracy.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (aged 18 years or order);
* patients with suspected or newly diagnosed or previously treated gastrointestinal tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
* patients who had scheduled both 18F-FDG and 18F-AlF-FAPI PET/CT scans;
* patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* patients with non-malignant lesions;
* patients with pregnancy;
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
SHAPE of Portal Hypertension in Children

Early diagnosis of portal hypertension is difficult as symptoms rarely manifest until the later stages of liver disease. Both cirrhotic and non-cirrhotic portal hypertension can result in life-threatening complications, the most frequent of which is bleeding from esophageal varices. In children, variceal bleeds are associated with mortality rates of 1-3 %, while life-threatening complications have been reported in up to 20 % of children with cirrhosis. Despite the high incidence of portal hypertension in children with liver disease, a noninvasive modality to monitor disease progression and risk of complications is currently lacking. Hence, this trial will investigate the safety and efficacy of subharmonic aided pressure estimation (SHAPE) as a noninvasive ultrasound technique for diagnosing portal hypertension in children.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of chronic liver disease without portal hypertension.
* Patients with a diagnosis of chronic liver disease with portal hypertension.

Exclusion Criteria:

* Subjects who are pregnant.
* Patients with known or suspected hypersensitivity to egg phosphatidyl serine or with a history of anaphylactic allergy to eggs or egg products.
* Subjects with allergy to egg products or other components of the ultrasound contrast agents will be excluded.
* History of allergic reaction to Lumason®, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)
* History of allergic reaction to Sonazoid
* Patients with biliary atresia with asplenia or polysplenia.
* Patients with prior liver transplant.
* Patients with cystic fibrosis.
* Patients with chronic lung disease.
* Patients with portal vein thrombosis, cavernous transformation of the portal vein or absent portal vein.
* Adults not competent/impaired.
* Patients with significant heart disease or severe congenital heart disease
Description of Immunologic, Enzymatic and Metabolic Biomarkers Associated to the Severity of COVID-19 (SARS-CoV-2) and Its Resolution

Prospective study to describe the immunological, metabolic and serologic profile in the acute and post acute phases of Coronavirus disease (COVID-19)


Eligibility Criteria:
Inclusion Criteria for patients:

* adult patient
* Patient with Covid-19 confirmed by RT-PCR, supported by Poitiers hospital
* Patient came for RT-PCR test at the drive of the hospital, or hospitalised in one of the Covid-19 departments of the Poitiers hospital (geriatry, infectious and tropical diseases, medical resuscitation and continuous care unit)
* informed consent signed by the patient or a trusted or immediate person after clear and loyal information on the study

Exclusion Criteria for patients:

* minor patient
* patient having had syptoms for more than 8 days
* patient already enrolled in another study regarding immunomodulators
* patient not benefiting from a Social Security scheme or not benefiting from it through a third party
* patient benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adult under legal protection

Inclusion Criteria for volunteers:

* adult patient
* subject wishing to be vaccinated with anti-COVID-19 BioNTech Pfizer vaccine
* informed consent signed by the volunteer after clear and loyal information on the study

Exclusion Criteria for volunteers:

* minor patient
* subject having had COVID-19 documented by a positive RT-PCR test or serology
* subject already vaccinated against COVID-19 (complete or partial vaccinal scheme)
* patient not benefiting from a Social Security scheme or not benefiting from it through a third party
* patient benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adult under legal protection
Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck

Severe acute and late dysphagia is now considered as a dose-limiting toxicity of radio(chemo)therapy for head and neck cancer that significantly affects patients' quality of life. We propose to preserve swallowing function by:

* adapting (individualizing) treatment (intensity-modulated radiotherapy: IMRT) to per-treatment changes occurring in the tumor and surrounding organs and tissues;
* reducing the volumes of elective neck, that may result in significant decrease of severe acute and late dysphagia.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
* Primary non-resected tumor and/or patients refused surgery
* Stage T1-4, N0-3; for cancer of the glottis T3-4 or T any N1-3
* Decision of curative radiotherapy or radiochemotherapy made by a Multidisciplinary Group of Head and Neck Tumors at UZ Gent and UZ Gasthuisberg Leuven
* Karnofsky performance status \>= 70 %
* Age \>= 18 years old
* Informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

* Treatment combined with brachytherapy
* Prior irradiation to the head and neck region
* Surgery of the primary tumor except lymph node dissection prior to radiotherapy
* induction chemotherapy
* history of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease at least 5 years
* Distant metastases
* Creatinine clearance (Cockroft-Gault) =\< 60 milliliter/minute before treatment or creatinine value \> 1,3 milligram/deciliter
* Known allergy to the CT-contrast agents
* Pregnant or lactating women
* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
* Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits and unlikely to complete the study
The Usage of Telemetric Prechamber Sensor Reservoir in Management of Normal Pressure Hydrocephalus. Comparisson of Benefit for Patients with Implanted Telemetric Prechamber Sensor Reservoir.

Normal pressure hydrocephalus (NPH) is a preventable and treatable cause of dementia. However, as a nosological entity, it is significantly underdiagnosed, often being mistakenly classified as presenile or senile dementia without further investigation. Ongoing management is crucial, currently relying mainly on indirect methods-clinical and imaging-based. Telemetry offers a real-time, online method to assess actual cerebrospinal fluid pressures, which are crucial for patient management. Telemetry allows for tailoring treatment to the individual patient. This project is planned as a pilot study before a more extensive research project.

Normal pressure hydrocephalus (NPH) is a preventable and treatable cause of dementia. However, as a nosological entity, it is significantly underdiagnosed, often being mistakenly classified as presenile or senile dementia without further investigation. Diagnosing NPH is not straightforward; it is based on a series of examinations, the results of which determine whether the patient is a responder and therefore a candidate for shunt surgery (implantation of a ventriculoperitoneal shunt). The medical literature identifies additional criteria that predict whether the implantation of the shunt will have a good or poor effect. However, treatment from a neurosurgical perspective does not end there. Ongoing management is crucial, currently relying mainly on indirect methods-clinical and imaging-based. Telemetry offers a real-time, online method to assess actual cerebrospinal fluid pressures, which are crucial for patient management. Telemetry allows for tailoring treatment to the individual patient. This project is planned as a pilot study before a more extensive research project.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosed communicating hydrocephalus
* mini-mental state examination test \> 10 points
* Absence of any structural lesion on MRI or CT
* Accepted Informed consent

Exclusion Criteria:

* Non-communicating hydrocephalus
* Structural lesion on MRI or CT (tumour, contusion, aneurysm)
* mini-mental state examination test \< 10 points
* Life-expectancy shorter than 1 year
* Pre-existing other type of dementia (m. Alzheimer, vascular dementia)
* Surgery lasting more than 120 minutes
* Blood loss more than 500 ml
* Adverse events during general anesthesia: mean arterial pressure \< 60 mm Hg more than 5 minutes, arrythmia with need for pharmacological treatment
A Randomized Phase II Study of Stereotactic Ablative Body Radiotherapy for Metastases to the Lung (TROG 13.01 SAFRON II)

The main purpose of this study is to determine the safety (defined as number of participants experiencing ≥ 5% toxicity at 12 months post treatment) of stereotactic ablative fractionated radiotherapy versus radiosurgery for oligometastatic neoplasia to the lung.

Stereotactic Ablative Body Radiotherapy (SABR) is an exciting novel radiotherapy technique that is delivered over very few sessions. In the case of limited pulmonary 'oligometastases', SABR can result in long-term survival. It is non-invasive and associated with high rates of tumour control and relatively low toxicity. Additionally, the large doses of precision radiotherapy involved may evoke a strong immune response to recognise and attack any remaining tumour cells. In the future, SABR may be an attractive alternative to invasive surgery. There are two SABR techniques emerging in Australia; fractionated and single fraction treatments. We aim to conduct the first clinical trial of SABR in patients with limited pulmonary metastases testing fractionated versus single fraction treatments.

The primary aim of this study is to evaluate the toxicity, Quality of Life, clinical efficacy and cost effectiveness of single fraction SABR compared to multi-fraction SABR in patients with oligometastases to the lung.

The secondary aim of this study is to assess the immune response evoked by both fractionated and single fraction SABR and its prognostic implications for patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. A maximum of three metastases to the lung from any non-haematological malignancy
2. Tumour diameter ≤5cm
3. Targets are located away from central structures (defined as 2cm beyond bifurcation of lobar bronchi and central airways). Targets in proximity to chest wall and mediastinum that meet these inclusion criteria are eligible.
4. Patients must be medically inoperable, technically high risk or have declined surgery.

Exclusion Criteria:

1. Previous high-dose thoracic radiotherapy.
2. Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are not excluded (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotrophin releasing hormone receptor modulators)
3. Targeted agents (such as sunitinib and tarceva) within 7 days of commencement of treatment, or concurrently with treatment.
Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker Against Respective Gold Standard References

Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.

Comparison study comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.

Specifically, continuous beat-by-beat blood pressure readings against arterial catheter readings and cardiac output (CO) and stroke volume (SV) measures against thermo-dilution measurements

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* able and willing to participate
* provide written consent

Exclusion Criteria:

* Unable to give written consent
* \<18 years of age
* No or poor finger pulse, as determined through visual inspection for ischemic hands
Advanced Characterization of Autosomal Dominant Optic Atrophy

The purpose of this study is to determine the anatomy of the retina and the optic nerve in patients with autosomal dominant optic atrophy (ADOA). Based on these findings the aim of the study is to determine why patients with the same type of genetic material, i.e. the same mutation, have such large variations of symptoms, spanning from unaffected subjects to blindness. The project requires examination of both healthy and affected family members.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with autosomal dominant optic atrophy

Exclusion Criteria:

* Age below 8 years old