cyrilzakka/clinical-trials huggingface dataset:
Pre-Hospital Cooling in Cardiac Arrest Patients

Type of study: Pilot prospective nonrandomized feasibility clinical study.

Aim of the study: To assess the feasibility of pre-hospital therapeutic mild hypothermia in patients successfully resuscitated from out-of-hospital cardiac arrest in the setting of prehospital and hospital care in Czech republic.

Evaluated hypothesis: Pre-hospital initiation of therapeutic mild hypothermia by rapid administration of intravenous bolus of cold crystalloids is simple, safe, effective and is a feasible procedure to significantly decrease body core temperature during patient's transport to the hospital in Czech republic.

The study is observational and does not evaluate any new drug, therapeutic procedure or diagnostic procedure. It is evaluating a known therapeutic procedure, therapeutic mild hypothermia, induced by known technique, cold crystalloid infusion, widely accepted in hospital-related postresuscitative care. However, even its prehospital usage has been published.


Eligibility Criteria:
Inclusion Criteria:

* patients resuscitated from out-of-hospital cardiac arrest
* remaining comatose and requiring mechanical ventilation

Exclusion Criteria:

* cardiac arrest of traumatic etiology
* patient conscious after short cardiopulmonary resuscitation
* coma of other origin than cardiac arrest (e.g., epileptic paroxysm, intoxication etc.)
* severe acute heart failure
* accidental hypothermia below 30°C
* bradycardia requiring transcutaneous cardiac pacing
* status Do Not Resuscitate or Do Not Intubate
* severe circulatory shock
* severe life threatening cardiac arrhythmias
* severe and life threatening bleeding
* severe sepsis
* any common opinion of intervening team of unfitness of induction of therapeutic mild hypothermia
Neoadjuvant Therapy of Icotinib in Epidermal Growth Factor Receptor Mutated NSCLC Patients

The purpose of this study is to evaluate the overall response rate and disease free survival for IIIAN2 non-small-cell lung cancer patients with EGFR 19 or 21 exon mutation.

Neoadjuvant therapy has been used for years to treat patients with non-small-cell lung cancer whose primary tumors are too large to allow for surgery. Reduction in size of the primary tumor with neoadjuvant therapy has made it possible for those patients. Moreover, the goals have expanded to include: determination of the sensitivity of the tumor so that subsequent therapy can be modified accordingly; to prolong disease free survival; to prolong survival.

Eligibility Criteria:
Inclusion Criteria:

* 1.The patients signed the written informed consent. 2.The patients present with operable IIIAN2 non-small-cell lung cancers with 19 or 21 exon mutation.

  3.The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, and surgical therapy.

  4.The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1. 5.The age of patient is ≥ 18 years old with a life expectancy longer than 3 months.

Exclusion Criteria:

* 1. Patients with unresected tumor. 2. Wild EGFR type. 3. Allergic to the study drug. 4. Patients have severe non-cancerous diseases. 5. Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials.
Survival and Prognostic Factors of Primary Retroperitoneal Sarcomas After Surgery: a Single-center Experience

he percentage of retroperitoneal sarcomas (RPS) among all soft tissue sarcomas ranges from 10%-15%. Surgery remains the gold standard for RPS. In this study, we analyzed the impact of surgical treatment for primary RPS on recurrence and overall mortality at a Chinese institution and identified and evaluated prognostic variables.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were as follows: (1) diagnosis of primary retroperitoneal sarcoma, (2) pathological conformity, (3) no prior surgical resection, (4) complete clinicopathological data, and (5) age of ≥18.

Exclusion Criteria:

* Patients with benign retroperitoneal tumors, gastrointestinal stromal tumors, Ewing, desmoid-type fibromatosis, pheochromocytomas/paragangliomas, or any other subtypes other than RPS were not included. The ethics committee of the Northern Jiangsu People's Hospital approved the study.
Use of Video Consultation in Follow-up Care for Patients With a Neuroendocrine Tumor: a Feasibility Study

Rationale: Patients with neuroendocrine tumors (NET) have a rare disease. Due to treating patients with a neuroendocrine tumor in 'NET knowledge centers' patients often have to travel long distances for follow-up visits at the outpatient clinic. Patients whose medical condition allows videoconsultation could save time by replacing outpatient clinic visits through videoconsultation for receiving follow-up care. Therefore, in this study we aim to introduce videoconsultation as a alternative for follow-up outpatient clinic visits in NET patients.

Objective: The primary objective is to assess if use of videoconsultation in follow-up care for NET patients is feasible. We hypothesize that videoconsultation is a suitable medium for providing follow-up care in NET patients. Secondary objectives are to explore the amount of time videoconsultation takes in comparison with outpatient clinic visits and the acceptability and satisfaction of physicians and patients with using videoconsultation in follow-up care.

Study design: The present study is a single-centre prospective feasibility study.

Study population: Adult NET patients under surveillance or treatment of the department Medical Oncology at the University Medical Centre Groningen (UMCG) whose medical condition allows videoconsultation will be invited to participate.

Intervention: Patient who give informed consent will participate in the study. Participants will receive follow-up care through videoconsultation instead of conventional visits at the outpatient clinic.

Main study parameters/endpoints: The main endpoint is the feasibility of videoconsultation for follow-up care in NET patients. We hypothesize that videoconsultation is a suitable medium for providing follow-up care.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age ≥ 18 yrs
* Grade I or II (low and intermediate grade) NET with any primary tumor type or disease stage
* Have access to required equipment/technology for performing videoconsultation

Exclusion Criteria:

* Newly referred NET patients, who are visiting the department of Medical Oncology at the UMCG for the first time
* Recently diagnosed NET patients, who are in the diagnostic phase of the disease
* NET patients who frequently require blood tests, consultation or physical examination
* A hearing or visual impairment, which would make videoconsultation difficult
Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia

Achalasia cardia is a primary oesophageal motility disorder of unknown etiology. Recently, peroral endoscopic myotomy (POEM) has gained widespread acceptance as an effective treatment modality for achalasia.

Major adverse events are uncommon with POEM. Since the operator works close to mediastinum during the POEM procedure, there is a potential for infectious complications. Therefore, intravenous antibiotics are universally used to prevent infection-related adverse events. There is no fixed protocol or duration of antibiotics for the same.

POEM is a novel minimally invasive treatment for achalasia, which emerged as an offshoot of natural orifice transluminal endoscopic surgery (NOTES). Major adverse events during POEM are rare and therefore, the procedure is considered safe.

Bacteremia can occur after endoscopic procedures like esophageal dilation, sclerotherapy of varices, and instrumentation of obstructed bile ducts. Bacteremia has been advocated as a surrogate marker for risk of infection-related complications. In POEM procedure, the endoscopist works in close proximity to mediastinum and peritoneal cavity. Therefore, the potential for infection-related complications is high. However, despite of different antibiotic protocols at different centers, the reported incidence of infection-related complications is very low. At present, prophylactic antibiotics are universally initiated before starting the POEM procedure and continued for a variable duration after POEM ranging from 1 day to 7 days.

Data from surgical studies indicate that prolonged administration of antibiotics for longer than 24 hours may not be beneficial. Prolonged use of antibiotics not only increases the costs and exposure to drug toxicity directly but also may be associated with an increased risk of acquired antibiotic resistance as well as infection with Clostridium difficile.

With this background, we planned a study to evaluate the difference in the infectious complications between short vs long duration antibiotic in patients with achalasia undergoing POEM.

Eligibility Criteria:
Inclusion Criteria:

* All the patient(aged 18-65) who underwent POEM for achalasia cardia.

Exclusion Criteria:

* Unwillingness to give written informed consent

  * Patients with multiple co morbidities.
  * Immunocompromised patients /on steroid therapy.
  * Patients with indications for antibiotic prophylaxis (infective endocarditis).
  * Patients who have received antibiotics in the last 1 week .
  * Patients who have possible signs of infection during preparation for POEM
Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica

The study will examine the efficacy of a single intramuscular injection of betamethasone dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml) as an induction therapy in patients with polymyalgia rheumatica. Twenty patients will be randomized to receive an injection of betamethasone or placebo (isotonic NaCl solution) immediately after diagnosis. Both groups will receive the standard-of-care steroid therapy, starting from 10 mg of prednisone every day (qd), tapered down by 2.5 mg monthly if the disease is not active (scheduled monthly follow-ups by a rheumatologist). Primary outcome measures: the total cumulative dose of glucocorticosteroids and disease duration.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of polymyalgia rheumatica

Exclusion Criteria:

* decompensated diabetes mellitus
* decompensated arterial hypertension
Observation Study for Prediction of Allograft Survival and Impact of Imaging in Kidney Transplant Recipients.

To further develop personalized medicine in kidney transplantation and improve transplant patient outcomes, attention has been given to define early surrogate endpoints that might aid therapeutic interventions, and help clinical decision-making.

To adequately predict transplant patients' individual risks of allograft loss and patients' complications, this would require a complex integration of data, including: donor data, recipient characteristics, transplant characteristics, biopsies results, immunosuppressive regimen, allograft infections, acute kidney injuries, recipient immune profiles, protocol and per cause biopsies and imaging (PET/CT imaging).

This project aims:

1. Assessed the usefulness of 18F-FDG PET/CT imaging in kidney transplantation recipients presenting with suspected acute rejection who underwent a transplant needle biopsy;
2. To develop a prognostic risk score to predict kidney allograft survival;
3. To evaluate the impact of corticoids withdrawal on long term outcomes (risk of rejection and impact on bone mineral density);
4. Evaluate the type and the frequencies of complications in our kidney transplant population

1. The detection of acute rejection in kidney transplant recipients, depends critically on assessments of serum creatinine, an insensitive measure of renal injury and the diagnosis relies on renal transplant needle biopsy which is an invasive procedure associated with a significant risk of bleeding and graft loss and is limited by sampling error and/or interobserver variability. Moreover, repeated biopsies to evaluate a renal graft's status pose challenges, including practicability and cost. Consequently, other sensitive and less invasive modalities, including gene expression profiling and omic analyses of blood and urine samples as well as in vivo imaging, are currently under investigation to reinforce our clinical armamentarium for acute rejection diagnosis. Likewise, it would be useful to non-invasively predict rejection in kidney transplant recipients with acute renal dysfunction and suspected acute rejection, thereby avoiding unnecessary transplant biopsy.
2. This study aims to generate a scoring system that predicts individual patients' risk of long-term kidney allograft failure.
3. Since 2007, the protocol in our institution is to withdraw the corticoids after 3 months after the protocol biopsy if no sign of rejection is demonstrated. We would like to evaluate the impact of such decision in the risk of rejection and the long-term allograft outcome in our patients. We are looking also to the impact on bone mineral density after corticoids withdrawal in those patients.
4. Evaluate the type and the frequencies of complications in our kidney transplant population to adapt our daily basis clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Kidney recipient transplanted after 2007
* Kidney recipient over 18 years of age
* Clinical, biological, immunological and follow up data available

Exclusion Criteria:

* Combined transplantation
A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder

A clinical study that will meaure how well SEP-363856 works and how safe it is in adults with Generalized Anixety Disorder. This study will be accepting both male and female subjects between the ages of 18 years and 65 years old. The study will be held in Approximately 50 global study centers and approximately 15 additional centers for a separate Japan population. Participation in the study can be up to approximately 12 weeks.

This is a multicenter, randomized, double-blind, parallel-group, flexible dose, outpatient study evaluating the efficacy and safety of SEP-363856 flexibly dosed (50 - 75 mg/day) versus placebo over an 8-week Treatment Period in subjects with GAD. This study is projected to randomize approximately 434 subjects to 2 treatment groups (SEP-363856 \[50 - 75 mg/day\] or placebo) in a 1:1 ratio.

Approximately 30 additional subjects (N = 15 per treatment group) are projected to enroll in the Japan Cohort. Treatment assignment will be stratified by country. Study drug will be taken at approximately the same time each evening at bedtime .

Eligibility Criteria:
Inclusion Criteria: (list is not all inclusive)

* Male or female subject between 18 to 65 years of age.
* Subject meets DSM-5 criteria for a diagnosis of Generalized Anxiety Disorder.
* Subject must be willing and able to comply with the study procedures and visit schedule and must be able to understand and follow verbal and written instructions.

Exclusion Criteria: (list is not all inclusive)

* Subject has DSM-5-based diagnosis of any disorder other than Generalized Anxiety Disorder that was the primary focus of treatment within 12 months before Screening.
* Subjects who report an inadequate response to more than 3 antidepressant treatments
* Subject is at significant risk of harming self or others based on Investigator's judgment.
* Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
* Female subject who is pregnant, lactating, or plans to get pregnant during the study.
Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy

Currently the main selection tool for Cardiac Resynchronisation Therapy (CRT) is the QRS duration on the surface echocardiography (ECG) which has been shown to be a poor predictor of response. We sought to evaluate the use of tissue Doppler (TDI) assessment of dyssynchrony in prediction of response to CRT.

The hypothesis is that the presence of mechanical dyssynchrony (measured using TDI echocardiography) successfully identifies heart failure patients who will respond to CRT. Conversely, the absence of mechanical dyssynchrony is associated with a low/no response to CRT.

This is a three arm study. Group 1 comprises patients with dyssynchrony on TDI who are implanted with a biventricular ICD whereas Group 2 patients comprise patients who have no dyssynchrony. Group 2 patients are randomised 1:1 to either receive a biventricular ICD (2a) or an ICD (2b). All patients undergo a NYHA class assessment, a cardiopulmonary exercise test, and an echocardiogram at baseline and at 6 months follow up. Baseline and 6 months findings will be compared in all three groups.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have an indication for ICD therapy
2. Heart failure of any aetiology with evidence of left ventricular (LV) systolic dysfunction with LV ejection fraction \< 35% and LV cavity dilatation (end diastolic dimension \> 55 mm)
3. NYHA Class III/IV symptoms of heart failure despite optimal medical therapy
4. QRS duration ≥120ms

Exclusion Criteria:

1. Reversible cause of heart failure such as ongoing ischaemia amenable to revascularisation or treatable valvular disease
2. Requirement for ventricular pacing due to atrioventricular block.
3. Limited life expectancy (\< 6 months)
Dietary Intervention Detection in the Small Intestine

Proof of concept study to validate the ability of a capsule device to gather samples from the small bowel for microbiome analysis in adults and to detect dietary changes from simultaneous ingestion of a probiotic.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 65 years old
2. Healthy
3. On no medication, or on stable doses of medications which will not be changed over the course of the study
4. Willingness to maintain their usual dietary habits and physical activity
5. Willing to discontinue consumption of fermented foods or probiotics (such as kombucha, yogurts with live, active cultures, or probiotic supplements) for the duration of the study.
6. Ability to understand and provide informed consent
7. Ability and willingness to meet the required schedule and study tasks and interventions
8. Willing to fast for at least 8 hours before the 2 intake visits (Visit 1 and Visit 2)

Exclusion Criteria:

1. History of a small intestine obstruction of symptoms of an intermittent small intestine obstruction (i.e., recurrent abdominal pain, distention, nausea and vomiting).
2. Pregnant or breastfeeding or planning on becoming pregnant during study timeline.
3. Use of other investigational product within 3 months of start of the study.
4. Suffering from immune disorders or with possible immune deficient status
5. Allergy to soy or milk.
6. Prior gastrointestinal surgery which has altered the anatomy of the esophagus, stomach or small or large intestine (exceptions include appendectomy or cholecystectomy more than 3 months prior to enrollment).
7. Use of any medications in the previous 7 days that could substantially alter gastrointestinal motor function (e.g. opioids, prokinetics, anticholinergics, laxatives), acidity (PPI, H2RA), or integrity (NSAIDs, oral steroids).
8. Body Mass Index (BMI) \> 38.
9. Previous history of gastric bezoar or gastroparesis.
10. Any abdominal or pelvic surgery within the past 3 months.
11. Known history of inflammatory bowel disease and/or Crohn's disease.
12. History of diverticulitis, diverticular stricture, or other intestinal strictures.
13. History of abdominal or pelvic radiotherapy.
14. History of dysphagia, eosinophilic esophagitis, esophageal stricture, or other swallowing disorder.
15. Cardiovascular, endocrine, renal or other chronic disease likely to affect motility.
16. Colon cleansing prep for 1 month before the first visit, or during the study.
17. Use of antibiotics, prebiotics, herbal supplements, or probiotics for 2 weeks before the first visit, or during the study.
18. \< 2 bowel movements per week.
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Anaplastic Astrocytoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have newly diagnosed anaplastic astrocytoma.

OBJECTIVES: I. Determine the efficacy of carmustine, cisplatin, and etoposide given prior to and during radiotherapy in patients with anaplastic astrocytoma. II. Assess the toxic effects associated with this regimen in these patients. III. Evaluate this regimen in terms of fatigue, depression, excessive daytime somnolence, and quality of life in these patients.

OUTLINE: Patients receive carmustine IV over 1 hour on days 1-3, oral etoposide on days 1-21 and 29-49, and cisplatin IV over 1-2 hours on days 1-3 and 29-31. Treatment repeats every 8 weeks for 3 courses. Patients receive radiotherapy concurrently with the third course of chemotherapy. Quality of life is assessed every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. Patients are followed every 3 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 20 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed, anaplastic astrocytoma No oligodendrogliomas or oligoastrocytomas

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3500/mm3 Platelet count at least 130,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 0.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled infection No concurrent malignant disease or major medical problem except superficial skin cancers

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 5 years since prior chemotherapy Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: At least 5 years since prior radiotherapy Surgery: Not specified