cyrilzakka/clinical-trials huggingface dataset:
Measurement of Circulating Tumor Cells in Prostate Cancer

Can tumor cells and tumor DNA be sampled from blood samples from prostate cancer patients? Is it possible to understand the causal relationship between the occurrence of the tumor cells and the tumor DNA in the blood by reviewing the patient's medical records, including information about investigations, analytical reports or diagnoses? Can gene defects that may be useful in predicting the best treatment be detected by sequencing individual tumor cells or plasma from blood samples?

Prostate cancer is the most common form of cancer in men and the second most deadly. Today's diagnostic methods and treatments are therefore obviously not adequate. In this study we will evaluate a new diagnostic sampling and analysis method for prostate cancer, not try new treatments. The test sampling involves the rare tumor cells and tumor DNA found in the blood, and sequencing their DNA to determine which, if any, defective genes they contain that may explain the disease. There is currently no universally accepted diagnostic test of either tumor cells or tumor DNA in blood. We have access to new technology that one of us (CE) developed at the Karolinska Institute, which by all accounts can give access to the rare tumor cells in the blood so that we can sequence their DNA. In this study we want to try to see if it is possible in practical healthcare to apply the new technology for prostate cancer patients and if there are signs that it works equally well in the healthcare environment as in the laboratory.

Impact: If the sampling of tumor cells and tumor DNA from blood samples works within the healthcare system processes, it will be possible to understand the causal relationships behind their occurrence, and their gene defects, we can design follow-up studies that would take us closer to clinical use of the new technology to predict which treatment would be most effective and which treatment would produce the least side effects.

Ethical considerations: The risks of blood sampling are limited and known and can be managed within the healthcare system. Data is handled safely. The potential future benefit of a new cancer cell- and DNA-test is great.

The study is a collaboration between Region Sörmland, Karolinska Institutet and iCellate Medical AB. The data collection is expected to be completed in 2020 and the analyses in 2021.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with prostate cancer of moderate risk planned for prostatectomy with lymph node removal, or
* patients diagnosed with prostate cancer stage 3, or
* patients with diagnosed prostate cancer stage 4, or
* patients with diagnosed benign inflammatory prostatitis or other benign urological condition constituting age-matched, cancer free, controls

Exclusion Criteria:

* Patients undergoing prostate cancer treatment (no prostate cancer treatment should be given to the patient before blood collection)
* Patients with previous malignancy
Comparison Study of Two Iron Compounds for Treatment of Anemia in Hemodialysis Patients

Patients with end-stage kidney disease on maintenance hemodialysis frequently require iron supplementation to compensate for ongoing iron losses, and to maintain hemoglobin levels with or without additional use of erythropoiesis-stimulating agents (ESA).

The investigators aim to compare two different intravenous iron preparations, ferric carboxymaltose and iron sucrose in 140 hemodialysis patients. The investigators primary objective is to assess whether both agents are equally effective to maintain a target haemoglobin within 10-12 mg/dl. The investigators will also measure ferritin, transferrin, transferrin saturation, and how much ESA therapy is administered.

Patients will be randomly assigned to either treatment group and followed in parallel over an active study period of 40 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Male and female patients aged ≥ 18
* Patients with anemia and end stage kidney disease on dialysis
* Hemoglobin ≥ 8,5g/dl
* Ferritin \< 1000mg/dl
* TSAT \< 50%
* CRP \< 5mg/dl

Exclusion Criteria:

* Hemoglobin \< 8,5g/dl
* Pregnancy or Nursing
* Known allergic reaction to i.v. iron supplementation or to ingredients of Investigational Medicinal Product (IMP)
* Chronic infections (HIV, Hep B, Hep C)
* Acute infections (CRP\>5mg/dl; Antibiotic therapy except for prophylactic use)
* Malignant tumor disease
* Oral iron supplementation at study inclusion
* Participation in a different study at the same time
* Active bleeding issues
* Surgical intervention within the last 4 weeks before study inclusion
* Mental diseases
* Bronchial asthma
* Atopic allergy
* Eczema
* Receipt of red blood cell (RBC) concentrate within the last 4 weeks before study inclusion
The Effects of Diesel Exhaust Inhalation On Exercise Capacity In Patients With Stable Angina Pectoris

The purpose of this study is to determine whether exposure to diesel exhaust (air pollution) has a functional impact on patients with stable angina pectoris.

Air pollution is a major cause of cardiovascular morbidity and mortality. The mechanism and components of air pollution responsible for these cardiovascular effects are unknown but small combustion-derived particles are suspected to be the major cause. Using a unique exposure system in Umeå Sweden, we have demonstrated that healthy volunteers who inhale dilute diesel exhaust develop an impairment of two important, highly relevant and complementary aspects of vascular function: the regulation of vascular tone and endogenous fibrinolysis. We have recently extended these findings and have shown that brief exposure to dilute diesel exhaust promotes myocardial ischemia and inhibits endogenous fibrinolytic capacity in patients with stable asymptomatic coronary heart disease. We now wish to extend these findings to patients with chronic stable angina pectoris. In particular, we wish to determine the functional impact of diesel exhaust inhalation as well as describe the time course and minimum exposure that can induce these detrimental effects.

Eligibility Criteria:
Inclusion Criteria:

* Documented coronary heart disease
* Symptoms of stable angina pectoris

Exclusion Criteria:

* History of arrhythmia
* Severe 3 vessel coronary artery disease or left main stem stenosis that has not been revascularised
* Resting conduction abnormality
* Digoxin therapy
* Uncontrolled hypertension
* Renal or hepatic failure
* Patients with unstable disease (ACS or unstable symptoms within 3 months)
* Asthma
* Intercurrent illness
Long Term Results in Redo Mitral Valve Surgery After Mitral Valve Repair

The current gold standard for severe mitral regurgitation is mitral valve plasty (PLM). The surgery allows the repair of the mitral valve, therefore without the need for mitral valve replacement (SVM), which involves the implantation of a biological prosthesis or a mechanical prosthesis.

However, PLM has a rate of failure, between 1-4% per year in degenerative mitral pathologies. As a result, patients with PLM failure and severe residual regurgitation are increasingly presenting in recent years.

Generally these patients are re-operated to replace the mitral valve. Our aim is to investigate the differences in re-operation involving mitral valve replacement or re-repair in patients who underwent mitral valve re-operation (re-repair or replacement) in our center between 2003 and 2017.


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* failure of previous mitral valve repair which needed a new surgical treatment
* group Re-PLM: patients reoperated with a new mitral valve repair
* group Re-SVM: patients reoperated with a mitral valve replacement

Exclusion Criteria:

* urgent/emergent procedures
Utility of Novel BRAF Test for Melanoma

This primary purpose of this study is to obtain blood samples from participants with both early and later stages of melanoma (Stage II/III and Stage IV). The researchers hope to better understand an abnormal protein found in many melanoma tumors called the BRAFV600 mutation.

There will be two separate cohorts (groups) of participants on this study. You will be placed in one of the Groups.

Group 1-For participants with advanced melanoma: Your existing tumor tissue sample will be compared to the blood samples given in order to further analyze and to understand the BRAFV600E gene mutation.

Group 2-For participants with stage II/III melanoma: Following surgery, blood samples will be collected and analyzed.

Understanding the BRAFV600E gene mutation in melanoma will help the researchers better understand the disease, and help plan treatment options for people with melanoma of all stages in the future.

There will be no extra clinic visits for this study. These research blood samples will be drawn at the same time as your regularly scheduled blood draws that are part of standard care for melanoma.

About 2 to 4 teaspoons of blood will be drawn for each research sample.

Depending on which group you are in, you will have either a one time blood draw or ongoing blood work for 1-2 years.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven advanced (unresectable stage IIIC or stage IV)or high risk (stage II or stage III) malignant melanoma

Exclusion Criteria:

* History of a different malignancy except for the following circumstances: disease-free for at least 2 years and deemed by the investigator to be at low risk for recurrence; or non-metastatic prostate cancer, cervical cancer in situ and basal cell or squamous cell carcinoma
* Known history of a different BRAF mutant malignancy
Effect of Calling the Patient's Name on Recovery From General Anesthesia

The purpose of this study is to find if we can shorten the recovery time by calling the patient's name during anesthesia reversal.


Eligibility Criteria:
Inclusion Criteria:

* patient aged between 20-70
* patient receiving breast cancer surgery under general anesthesia with total intravenous anesthesia using remifentanil and propofol, and intubated with LMA

Exclusion Criteria:

* refusal of consent
* patients taking CNS stimulants
* general anesthesia with other agents than propofol and remifentanil
* intubated with other equipments than LMA
* chronic alcoholic patient
* patients with convulsive disorder
Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia

After dividing the patients into two groups, sedation is performed with propofol and remimazolam, respectively, after spinal anesthesia. Compare the patient's body temperature change after surgery.

Patients in the study were randomly assigned to the propofol group (Group P) and the remimazolam group (Group R) in a 1:1 ratio. Study drugs are prepared in the same 50 ml syringe, double-blind to group assignment. All patients are not given pre-anesthetic medication, and body temperature, blood pressure, and heart rate are measured in the recovery room after surgery at 10-minute intervals from just before anesthesia induction to surgery. If hypotension or bradycardia occurs during surgery and is not corrected even after rapid fluid infusion, ephedrine is increased by 10 mg or glycopyrrolate 0.2 mg or atropine 0.5 mg is administered.

If spinal anesthesia is successfully performed, check the patient's anesthesia height. When the appropriate level of anesthesia is confirmed, Group P receives propofol at 25-100ug/kg/min and maintains the BIS at 70-80. Group R receives remimazolam at 1-20ug/kg/min and maintains BIS between 70-80. Both groups apply a conventionally used air heating device, and the operating room temperature is kept at 20 °C. If shivering occurs during surgery, the elapsed time from induction and the shivering grades are recorded.

At the end of the surgery, record total anesthesia time and surgery time, fluid dose, and drug use. After moving to the recovery room, the patient's body temperature, systolic blood pressure, diastolic pressure, heart rate, the incidence of shivering, and the grade of shivering are checked. When shivering occurs, a forced air-warming device is applied first, and if shivering continues, administer meperidine in 5mg increments until the patient is comfortable and record the total dose.

Eligibility Criteria:
Inclusion Criteria:

* Those aged between 19 and under 65 who are undergoing surgery under spinal anesthesia at Wonkwang University Hospital.
* American Society of Anesthesiologists' physical status class (ASA) award class I-III.

Exclusion Criteria:

* Patients with fever before surgery
* Patients taking antipyretics before surgery
* Patients who are chronically using anti-inflammatory drugs
* High-risk patients with ASA class IV or higher
* Patient who refused sedation
* Patients with thyroid dysfunction.
To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax

Hepatic hydrothorax is defined with accumulation of transudate fluid (500 ml) in the pleural cavity in patients with decompensated liver cirrhosis but without cardiopulmonary and pleural diseases. The Prevalence is 5-12% The treatment for hydrothorax is diuretics, repeated thoracocentensis, TIPS and liver transplant.. Midodrine increases effective arterial blood volume and also increases renal perfusion.It has also been used in Refractory ascitis .It has been shown to mobilise ascitis. In patients who are ineligible for TIPS and Liver transplant there is no data on Midodrine and its effects on Hydrothorax in cirrhotics.There are also no guidelines on the use of albumin during Pleural fluid tapping and the dose to be used. This study is being done to assess the safety and efficacy of Midodrine in hydrothorax.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hepatic hydrothorax
* Patients with age from 18-75 years
* No evidence of Cardiac and pulmonary disease

Exclusion Criteria:

* Renal failure ( Creatinine\>2.5mg/dl)
* Gastrointestinal bleeding
* Spontaneous bacterial empyema/ Peritonitis
* Patients with urinary retention
* Intrinsic advanced pulmonary disease (CXR, HRCT thorax)
* Cardiovascular disease (Electrocardiogram, 2D Echo)
* Systemic arterial hypertension
* Presence of hepatocellular carcinoma or portal vein thrombosis, Budd chiari syndrome
* Patients with active untreated sepsis
* Pregnancy
* Patients with hepatic encephalopathy
* Patients eligible for TIPS
* No use of drugs affecting systemic hemodynamics prior to 7 day of enrollment
Virtual Therapy as a Method Supporting Treatment of Late-Life Depression

This study evaluates the addition of virtual therapy intervention in the treatment of depression in the elderly. Half of the participants will receive virtual reality treatment as an addition to physical exercises and psychoeducation, while the other half will receive physical exercises and psychoeducation alone.

Depressive disorders are frequent and can either first be manifested at a younger age and recurrent during later life or have an onset beyond 60 years (late-life depression). The multifactorial genesis of depression in old age includes psychosocial, vascular and metabolic factors and requires multimodal and multi-professional therapy including physical activity and psychosocial interventions. However, there is still a percentage of older people who do not show improvement in depressive symptoms.

In recent years, various types of virtual reality are gaining in popularity, primarily because of the availability and ease of use. A systematic review from 2018 concluded that VR treatment had moderate to large effects in anxiety and depression, compared to controls and it could be another effective choice available to clinicians and patients.

Therefore, the aim of this project was to evaluate the effectiveness of virtual therapy in the elderly, in whom the previous multimodal therapeutic program has not brought the expected results.

Eligibility Criteria:
Inclusion Criteria:

* GDS≥10 or HADS-A≥8 or HADS-D≥8

Exclusion Criteria:

* cognitive impairment (MMSE\<24) or aphasia and a serious loss of sight or hearing that makes it impossible to assess cognitive functions based on MMSE;
* contraindications for virtual therapy (epilepsy, vertigo, eyesight impairment);
* substance abuse;
* participation in another therapeutic project or individual psychotherapy;
* antidepressant treatment;
Efficacy and Safety of Monotherapy With Noradrenaline and Terlipressin in Patients of Cirrhosis With Septic Shock Admitted to Intensive Care Unit

The Patient evaluated in Emergency room since admission and detailed history and clinical examination done .The in hospital cases where sepsis is the culprit and shifted to Intensive Care Unit (ICU) in view of septic shock were included since onset of shock.

Initial fluid resuscitation done and if the patient were no fluid responsive they were randomized into arms noradrenaline or terlipressin and the dose escalated to achieve the primary objectives. At the same time the strict vitals monitoring and standard medical therapy for sepsis including antibiotics and other supportive therapy continued. The patients were followed up till discharge, death or up to 28days after enrollment into the protocol (whichever the longest). The detail methodology has been explained in column 14 later.


Eligibility Criteria:
Inclusion Criteria:

* Patient of cirrhosis or ACLF (Acute on Chronic Liver Failure) with septic shock (defined later).
* Age 18-70yrs
* An informed consent from the patient or relative

Exclusion Criteria:

* Pronounced cardiac dysfunction( valvular heart disease, coronary artery disease),
* Acute mesenteric ischemia (confirmed or suspected) or vasospastic diathesis (e.g. Reynaud's syndrome or related diseases).
* Pregnancy
* Previous history of transplantation on immunosuppressant.
* Acute gastrointestinal bleed.(defined later)
The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation

The aim of this study is to asses the effect of Bifidobacterium lactis and Inulin on functional constipation in children


Eligibility Criteria:
Inclusion Criteria:

* children with functional constipation over 3 years age
* below 18 years of age

Exclusion Criteria:

* Chronic gastrointestinal disease,
* hirschsprung disease,
* celiac disease,
* hypothyroids,
* neurological deficit,
* constipation treatment receiving children will be excluded
Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long term among clinically stable patients. The study will also assess the long term effectiveness of lurasidone as compared to an active comparator.


Eligibility Criteria:
Main Inclusion Criteria:

To be eligible to enter the study, each patient must comply with the following inclusion criteria:

* Subject is 18 to 75 years on the day of signing the consent form (age parameters may be restricted further per local requirements without protocol amendment).
* Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90), catatonic (295.20), or residual (295.60) or schizoaffective disorder (295.70) subtypes.
* Subject is not pregnant or nursing, and is not planning pregnancy within the projected duration of the study.
* Subject will comply with the study procedures and outpatient visit requirements in the opinion of the investigator.
* Subject voluntarily agrees to participate in the study by giving written informed consent.

Main Exclusion Criteria:

To be excluded from entering this study if they fulfil any of the criteria below:

* Subject has a chronic organic disease of the central nervous system (other than schizophrenia).
* Subject has current clinically significant or history of, alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
* In the opinion of the investigator, the subject has any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study.
* Subject has participated in a study with an investigational compound or device within 30 days of signing informed consent.
Effect of Acute ObeEnd Exposure on Factors Regulating Appetite

n Canada, over 60% of adults are classified as overweight and obese resulting in a public health crisis including increasing health care costs and negatively impacting the well-being of many Canadians. To overcome these barriers, the ObeEnd device, manufactured by WAT Medical Enterprise, is a new and innovative wellness technology that uses electrical pulses to stimulate acupressure point PC6 to help control appetite. PC6 stimulation could potentially modulate appetite and restore gastric dysfunction, which are important factors that contribute to obesity. If PC6 electrostimulation facilitates the normalization of appetite and restoration of gastric dysfunction in those with obesity, then the device could be a potentially helpful aid to weight loss.

To measure the change of appetite hormones and enzymes related to appetite regulation after using the ObeEnd device. The investigators hypothesize that, compared to placebo, acute electrostimulation of PC6 an acupuncture spot on the wrist for a 1 hour period will result in changes in enterogastric hormones in a direction that decreases appetite. This study will provide the first evidence of the acute effects of electrostimulation at PC6 on factors affecting body weight regulation providing insight into the utility of the ObeEnd device for weight control.


Eligibility Criteria:
Inclusion Criteria:

* People with obesity (BMI\>30kg/m2)
* Generally healthy
* Premenopausal females

Exclusion Criteria:

* Past (\<1 year) or present use of nicotine products
* History of chronic disease or metabolic conditions
* Females who are pregnant, less than 6 months postpartum, or breastfeeding
* Diagnosed hepatic disease, renal impairment, uncontrolled hypothyroidism
* Use of any medications that may affect study outcomes (e.g. hormone replacement therapy)
Studding the Implementation of ERAS Protocols in Pediatric Surgery

this is a retrospective cohort, descriptive study, investigating the role of ERAS protocols, in pediatric surgery and evaluate the feasibility and effectiveness of implementing these protocols


Eligibility Criteria:
Inclusion Criteria:

* all patients aged 6months -18 years, who underwent pediatric surgeries at a single tertiary institution

Exclusion Criteria:

* patients who had co-morbidities that might affect the outcome of the enhanced recovery and those who were younger than 6 months.