cyrilzakka/clinical-trials huggingface dataset:
Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds (OPreNBiS)

Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS (Bioresorbable Vascular Scaffold).

Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly reduced. This is expected to result in better short- and long-term outcomes.

Study design:

Following pre-dilatation a BVS will be implanted and optical coherence tomography (OCT) will be performed in all patients. After OCT post-dilatation with non-compliant balloons might be performed if this is considered necessary by the treating interventionist. Final OCT will be performed in all patients. 1:1 Randomization of two strategies before the implantation of bioresorbable scaffolds:

* OPN strategy (study group): pre-dilatation with OPN NC ® Super High Pressure PTCA (Percutaneous Transluminal Coronary Angioplasty) balloons
* standard strategy (control group): pre-dilatation with a standard (compliant) balloon

Enrolment:

Randomization of 50 patients

* 25 in the OPN strategy (study group)
* 25 in the standard strategy (control group)

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Able and willing to give informed consent.
* Willing to comply with specified follow-up evaluations.
* Clinical manifestation of coronary artery disease: stable angina, unstable angina or non-ST-elevation myocardial infarction.
* De novo lesion.
* Angiographic diameter stenosis \> 70 % and/or fractional flow reserve \<0.80.
* Vessel diameter between 2.5 and 4.0 mm.
* One- or two vessel disease (defined as diameter stenosis \> 70 % in vessels with a diameter \> 2.5 mm).
* Up to two lesions in one or two vessels can be treated

Exclusion Criteria:

* Patient characteristics

  * Pregnant or nursing patient or planned pregnancy in the period up to 1 year following the index procedure.
  * Patient with contraindication for 12 months of dual antiplatelet therapy.
  * ST-elevation myocardial infarction.
  * Any contraindication to the implantation of BVS. Lesion characteristics
  * Visible thrombus in coronary angiography
  * Chronic total occlusion
Current Treatment Methods of Idiopathic Intracranial Hypertension

Aim of the study :

1. to determine the response to each treatment plan.
2. to determine when to choose specific treatment method.
3. to determine complication of each type of treatment method

Idiopathic intracranial hypertension (IIH) is caused by an elevation of intracranial pressure (ICP). The condition mainly affects obese young women of childbearing age.

In a recent study in the United Kingdom University of Kentucky urokinase, the estimated annual incidence was 4.7 % which represents a growth of 108% in 14 years, and parallels the growth of obesity prevalence .

The combination of raised intracranial pressure, without hydrocephalus or mass lesion, normal cerebrospinal fluid (CSF) composition and where no underlying aetiology is found are accepted criteria for the diagnosis of IIH.

The two most prominent symptoms of IIH are progressive visual deterioration and chronic headache, although additional symptoms including cranial nerve palsies, cognitive deficits, tinnitus and olfactory dysfunction are frequently also part of the clinical presentation. While the visual dysfunction is known to largely result from a pressure-induced papilledema, the origin of the IIH-related headache is less clear and therapeutic approaches are less investigated.

The conventional treatment for IIH involves weight loss, steroids, diuretics, and serial lumbar punctures and surgical treatment.

Surgical intervention should be conducted as soon as medical treatment fails. It is not acceptable to delay the intervention for patient with sever visual deterioration . Therefore surgery is indicated once visual loss continues despite optimum medical therapy .

Medical treatment with acetazolamide and serial lumbar punctures represent the initial management, in such cases preserving surgery to non-responding cases and those who cannot tolerate medical treatment.

Surgical treatment include lumboperitoneal shunt insertion , navigation guided ventriculo-peritoneal shunt ,endovascular stenting of sinuses in cases of sinus thrombosis and stenosis .

Eligibility Criteria:
Inclusion Criteria:

* patient has symptoms of increased intracranial pressure with :-

  * papilledema,
  * normal neurological examination,(except 6th nerve palsy),
  * elevated opening pressure( \>=25 cm) csf,
  * normal csf content

Exclusion Criteria:

* Any patient diagnosed with increased intracranial pressure due to:

  * sinus thrombosis or stenosis will be excluded from this study and .accordingly endovascular stenting as a method of treatment will be excluded from this study.
A Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer

The purpose of this trial is to compare the severity of ISRs (Injection Site Reactions) following degarelix subcutaneous (s.c.) administrations with two different injection techniques and intramuscular (i.m.) administration in patients with hormone dependent prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years with a diagnosis of adenocarcinoma of the prostate (Gleason graded, all stages) where endocrine treatment is indicated.
* Caucasian origin.
* Able to provide written Informed Consent and willing and able to comply with trial procedures.
* Body mass index (BMI) between 18.5-30 kg/m2.
* Has a life expectancy of at least one year.

Exclusion Criteria:

* Current hormonal management of prostate cancer.
* Previous endocrine therapy for prostate cancer within 3 months prior to the screening visit.
* Any medical injection therapy that might interfere with degarelix injections.
* Patients with advanced muscle atrophy or cachexia which in the Investigator's opinion would preclude or pose risks of complications following ventrogluteal i.m. injection of degarelix.
* Any medical condition that could be aggravated or may cause extreme discomfort during the trial period or could cause a moderate risk to a patient (significant heart, renal or liver disease).
* Chronic pain syndrome or any continuous pain reported by the patient that, according to the judgement of the Investigator, could limit the evaluation of injection related pain.
Measurement of the Efficacy of MORPHINE in the Early Management of Dyspnea in COVID-19 Positive Patients

Morphine is used in the treatment of dyspnea and polypnea with a proven benefit on the improvement of these symptoms, both etiologically and symptomatically. This medication is used in particular in palliative care for this type of symptom.

The Sars CoV2 viral pneumonia table can lead to respiratory distress. In patients with moderate to severe impairment without goal of resuscitation (level of care 3 and 4), the introduction of morphine may sometimes be necessary to relieve respiratory symptoms. These also lead to major exhaustion which can worsen the clinical picture. However, the prescription of morphine is not systematic in front of a respiratory distress table.

The investigators hypothesized that early treatment with morphine lead to a better management of dyspnea, quality of live and survival in COVID-19 positive participants patients when there is not resuscitation objective management (level of care 3 and 4).

The objective is to measure the efficacy of morphine in the early management of dyspnea, quality of life and survival in COVID-19 positive participants patients treated in the Hospices Civils of Lyon during COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years.
* Having had a Covid-19 respiratory disease confirmed by PCR or TDM or anamnestic criterion for patients living in communities for the elderly (respiratory symptomatology suggestive and at least 3 cases confirmed in the living environment).
* Having had respiratory severity criteria: respiratory distress syndrome including FR\> 25 / min and oxygen-demand\> 4 L / min to maintain a SpO2\> 90% at inclusion.
* Having had a defined level of care after collegial discussion notified in the file rejecting the external cardiac massage and admission to the intensive care unit (Level 3 and 4 on the protocols of the Hospices Civils de Lyon).
* Collection of non-opposition

Exclusion Criteria:

-
Postoperative Muscular Pain, ETOIMS (Electrical Twitch Obstructive Intramuscular Stimulation)

Pancreaticoduodenectomy is inevitably an operation requiring extensive skin and muscle incision, resulting in postoperative pain resulting in limitation of the patient's early exercise and function. ETOIMS(Electrical Twitch Obstructive Intramuscular Stimulation) is used to relieve muscle pain and relax muscles. ETOIMS is a method to relieve pain by stimulating muscle in myofascial pain syndrome. ETOIMS as an effective new treatment for pain after pylorus preserving pancreaticoduodenectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing pancreatoduodenectomy in Gangnam Severance Hospital, Seoul, Korea
* Patients who are able to perform daily activities before surgery and were able to walk independently.
* Adults over 20

Exclusion Criteria:

* Patients with history of previous open surgery

  * Patients who are not able to exercise due to severe musculoskeletal pain except surgery-related diseases
  * Patients who can not walk because of difficulty breathing related to myalgia
  * Patients who can not exercise due to severe musculoskeletal pain
  * Patients who had a limb defect before surgery and were unable to walk without assistive devices and others
  * Pregnant / lactating mothers
  * Patients who have cognitive impairment and can not answer the questionnaire
  * Patients with Pacemaker
  * Patients who can not read the consent form
Real Time In-Vivo Body Surface Dosimetry for External Beam Radiation Therapy

This is an observational study. This protocol will determine the feasibility of using a novel nano-material based fiber-optic dosimeter (nanoFOD) device, with dimensions less than 1 mm wide, to measure real-time, pin-point, in-vivo radiation dose given during external beam delivery of radiation therapy treatments.This new protocol is similiar in design to Pro00050297 with the significant difference being the monitoring will be performed during external baem radiotherapy.

The device is currently in use in an ongoing IRB approved protocol Pro00050297 "Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy". Brachytherapy is an integral part of the management of many gynecological cancers, which uses radioactive isotopes to deliver radiation treatment in close proximity to the target. The protocol uses the device in the setting of gynecologic brachytherapy to monitor real time doses, with a primary endpoint of feasibility and accuracy. Accrual is ongoing, however, the device has initially given consistent results, within 3% of the expected values. This initial experience is intentionally designed with the simplest geometry and positioning. This protocol has a similar design to the initial brachytherapy trial, but with the significant difference that the monitoring will be performed during external beam radiotherapy. Calibration procedures are different in this scenario, and the considerations of when and where dose monitoring will be useful are distinct from these considerations in brachytherapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented neoplasm of the pelvis (including gynecologic, gastrointestinal, and genitourinary origin).
* Planned external beam radiotherapy as part of standard of care treatment
* The radiotherapy plan involves the body surface
* Age \> 18 years
* Able to provide and execute informed consent

Exclusion Criteria:

* Allergy or previous intolerance of skin adhesives
* Any clinical scenario in which the nanoFOD placement or reading would compromise the treatment efficacy, or endanger the patient in any way.
Database for Predicting Clinical Outcomes of Critically Ill Patients

Australian and New Zealand Intensive Care Society (ANZICS) has built a Center of Outcome and Resource Evaluation (CORE) adult patients database (APD) of adult critically ill patients. ANZICS CORE APD has built an international collaboration of ICU database. National Taiwan University Hospital has joined this international collaboration and built the data according to the APD data dictionary with same value domain attributes and data element attributes. We retrospectively collected the data of patients discharged from the March 1, 2019 to June 30, 2022. Data of this database are permitted to study clinical problems and predict the clinical outcomes of these critically ill patients using statistical methods and machine learning techniques.

Data of this database are permitted to study the following clinical issues: including delirium, sepsis, acute kidney injury, acute respiratory distress syndrome, disseminated intravascular coagulation, multiple organ injuries, nutrition, survival status, number of days on ventilators, need for renal replacement therapy, length of stays in intensive care unit, length of stay in hospital, and other relevant clinical outcomes. It is also planned to analyze the clinical prognosis of special disease subgroups and establish a prediction model according to the type of patient's disease.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients admitted to intensive care units

Exclusion Criteria:

* patients aged less than 18 years
Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation

This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of pulsed field ablation (PFA) in patients with persistent atrial fibrillation (PeAF). We will compare three distinct substrate ablation strategies: anatomical guided ablation (ANAT group), electrogram guided ablation (EGM group), and extensive electro-anatomical guided ablation (EXT group). The study seeks to identify which ablation strategy yields the highest efficacy and safety profiles to potentially guide future clinical practice in the management of PeAF.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18-80 years diagnosed with persistent atrial fibrillation.
2. Ineffectiveness or intolerance to at least one Class I or III anti-arrhythmic drug.

Exclusion Criteria:

1. Major valvular diseases needing surgical intervention.
2. Presence of a left atrial thrombus on recent imaging.
3. Recent myocardial infarction or severe heart failure (LVEF ≤ 30%).
4. Current Severe Infection.
Mistletoe Extract in Early or Advanced Breast Cancer, A Feasibility Study

The purpose of this feasibility study is to identify appropriate surrogate parameters for a randomized study to examine the efficacy of a complementary therapy with an extract of viscum album (Iscador P) in patients with breast cancer.

The study consists of three parts. Part 1 is a prospective non-randomized feasibility study in patients with breast cancer after primary surgery during chemotherapy or endocrine therapy comparing blood count, lymphocytes, quality of life and local and general side effects between the groups Part 2 is a prospective randomized feasibility study with a waiting list for three months comparing changes in quality of life, depression, diurnal cortisol profile and expression of zeta-chains in T- and NK-cells after three months of treatment or waiting in patients of two different strata (early breast cancer UICC I/II and metastatic breast cancer) Part 3 consists of two follow-up periods of 12 months respective. Patients may choose to continue, quit or restart mistletoe treatment upon their own decision, endpoints from part 2 are evaluated every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* breast cancer
* desire for additional therapy with mistletoe extracts

Exclusion Criteria:

* contraindication for a therapy with mistletoe extracts(allergy, tuberculosis, hyperthyreosis, acute infectious disease, intracranial pressure in case of tumors or metastasis)
* current medication with glucocorticoids or other immunosuppressive therapies
* other concomitant complementary therapies
* prior therapy with mistletoe extracts \> 2 years or during the last 6 months
* karnofsky-Index \<60
Classification and Characterization of Physical Strains During Sorting Series: Physiological Aspects

2 young candidates have tragically died during army pre-recruitment sorting series in 2006. As part of the classification and characterization of the physical aspects of the training, this experiment was requested.

We aim at determining the characteristics of physical strains in sorting series, by objective and subjective parameters and evaluating the difficulty levels and intensity of those strains.

each subject will perform the following 3 days experiment protocol, consisting of army training exercises:

1. sack carrying exercise; the subjects will go up and down through a steep slope with sand sack on their back (path length is 200 meters,10 repetitions).

   the first day will also include recruitment and medical examination, in addition to the exercise.
2. crawling exercise; the subjects will crawl with knee's protectors back and forth (path length is 20 meters,15 repetitions).
3. combined exercise: sprints session (path length 600 meter, 3 repetitions),15 min break, sack carrying session (same protocol as first day), 45 min break and crawling session (same protocol as the second day).

during all exercises heart rate, core temperature, lactic acid and CPK levels will be monitored continuously.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-22 years.
* Healthy civilian volunteers.
* without skeleton-muscle illnesses.
* without Infectious disease 2 weeks prior to the experiment.

Exclusion Criteria:

* any physical condition.
* physician decition.
Cryotherapy in Breast B3 Lesions

To determine the feasibility of cryotherapy for B3 fibroepithelial lesions


Eligibility Criteria:
Inclusion Criteria:

* lesion seen on ultrasound
* core biopsy revealed FEL of B3
* lesion \</+3.5cm
* keen for cryotherapy instead of surgery
* has other breast lesions for followup

Exclusion Criteria:

* cancer patients
* patients with bleeding diathesis
* lesions causing visible breast deformity
Effect of the Olive Leaf Tea Ingestion in Post-prandial Glycemic Response (OLIFTEA)

This study tests the effect of Olive Tea Ingestion in ameliorating glycemic response after a high-glycemic meal

This study is a double-blinded, randomized, placebo-controlled clinical trial with cross-over design.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* currently taking drugs interfering with glucose regulation
LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian Carcinoma

The ultimate clinical aim of this proposed phase I trial is to evaluate the toxicity and determine the recommended phase II dose of combining the effect of LDFWART following administration of docetaxel for 6 cycles in patients with recurrent platinum-resistant ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients must have platinum-resistant disease relapsing within 6 months or less from the date of their last cycle of initial adjuvant chemotherapy recurrent adenocarcinoma from a primary ovarian, tubal, or peritoneal cancer following first-line chemotherapy for metastatic disease. There is no limit on prior number of chemotherapy regimens. Patients who have received prior systemic docetaxel and platinum-based chemotherapy are eligible
* 1.1 Patients must have ≥ 1cm measurable disease on imaging studies independent of patients having an optional surgical salvage procedure.
* 2. Patients must have a life expectancy of at least 6 months.
* 3. Patients must have Karnofsky performance status of ≥ 60 or Gynecology Oncology (GOG) performance status of ≤ 2 (see www.GOG.org website).
* 4. Age 18 - 80 years old
* 5. Patients must have an adequate bone marrow, renal, and hepatic function:

  * 5.1 WBC: ≥ 3,000 /mcl
  * 5.2 ANC: ≥ 1,500 /mcl
  * 5.3 Platelets: ≥ 100,000 /mcl
  * 5.4 Creatinine: \< 2.0 mg/dcl
  * 5.5 Bilirubin: \< 1.5x institutional normal value
  * 5.6 LDH, GGT, SGPT (ALT), SGOT (AST), and ALK Phos:\< 3x institutional normal value.
* 6. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* 1. Patients who have received prior radiotherapy to the chest, whole abdomen, or lower extremities above the knees.
* 2. Patients who have received prior radiation therapy to the head, neck, or lower extremities below the knees if greater than 3 years prior to study entry.
* 3. Evidence of extra-abdominal extension of disease (such as groin nodes, lung, supraclavicular nodes, and pleural fluid).
* 4. Patients may not be receiving any other investigational agents within 4 weeks preceding the start of study treatment) or chemotherapy for at least 3 weeks preceding the start of study treatment.
* 5. Patients who have been diagnosed with another prior malignant tumor within 3 years of study entry, excluding non-melanoma skin cancer and carcinoma in situ of the cervix.
* 6. Patients with prior history of a severe hypersensitivity reaction to paclitaxel (polysorbate 80-Cremophor).
* 7. Patients with current history of uncontrolled hypertension, angina pectoris, heart failure, cardiac dysrhythmias, pericardial disease, cardiomyopathy, or active infection.
* 8. Presence of any medical condition that in the opinion of the investigator deems the patient unable to participate.
* 9. Females of child-bearing potential. It is expected that ovarian cancer patients would have had a hysterectomy and/or oophorectomy as part of the original standard of care.
* 10. Patients that are \< 18 yrs. of age or \> 80 yrs. of age.
Digestive Tract Cancer and CIPN

According to the incidence rate of cancer, the digestive tract cancer accounts for two of the top ten cancers. It also accounts for half of the top ten causes of cancer death. Chemotherapy remains one of the most common forms of cancer treatment, and chemotherapy-induced peripheral neuropathy (CIPN) is one of the common adverse effects of cancer treatment in cancer survivors. To date, there is no exercise guideline established for patients with CIPN; therefore, CIPN remains quite threatening to cancer survivors. Due to limited studies on effects of exercise on improvement of CIPN symptoms in patients with digestive tract cancers, this study aims to investigate the effects of exercise and different intervention delivery modes (remote home exercise and exercise under supervision) at different time points on the CIPN symptoms, body inflammatory index, physical function, and quality of life of gastrointestinal cancer survivors with chemotherapy-induced peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

1. Age 20 and above;
2. Diagnosed by a physician with gastrointestinal cancer and has undergone chemotherapy or is currently undergoing chemotherapy;
3. Diagnosed by a physician with chemotherapy-induced peripheral neuropathy.

Exclusion Criteria:

1. Cognitive impairment or inability to cooperate with verbal instructions;
2. Neurological, muscular, skeletal, or cardiovascular issues preventing participation in exercise training;
3. Age 80 or above;
4. Refusal to engage in exercise intervention or participate in data collection.