cyrilzakka/clinical-trials huggingface dataset:
OSCA - Olaparib Standard of CAre Study

This study will be carried out as a retrospective, non-interventional observational review of medical records for patients in multiple countries with platinum-sensitive recurrent serous ovarian cancer. The objectives are to describe in a real-world population, treatment patterns, BRCA mutation testing and results, overall survival, health care utilization and also to estimate rates of selected treatment- and/or disease-related side effects


Eligibility Criteria:
Inclusion Criteria:

1. First determined to have platinum-sensitive recurrent serous ovarian cancer between January 1, 2009, and December 31, 2013 (study entry period), as defined by no evidence of disease progression for at least 6 months after completion of a first-line platinum-based chemotherapy regimen; the first date of platinum-sensitive recurrence between January 1, 2009 and December 31, 2013 will define the study index date.
2. At least 18 years of age on the index date.
3. Fully documented medical history related to the patient's ovarian cancer treatment beginning with initial diagnosis of serous ovarian cancer.
4. Patients can be either alive or deceased at the time of medical record abstraction.

Exclusion Criteria:

1. Ever taken an investigational product as part of an interventional clinical trial for ovarian cancer.
Prospective Analysis of Morbi-mortality of Patients With Cancers in Active Phase of Treatment Suspected or Diagnosed of a SARS-CoV-2 Infection

National multicentre epidemiological study to describe retrospectively and prospectively the clinical outcomes of patients with a suspected coronavirus infection (either confirmed or not) while receiving a medical treatment for the underlying cancer


Eligibility Criteria:
Inclusion Criteria:

I1. Confirmed diagnosis of any type of solid or hematologic tumor;

I2. Ongoing anticancer treatment (cytotoxic, targeted therapy, immunotherapy or loco regional procedure, including radiotherapy, surgery or interventional radiology procedure) at the time of inclusion or within the last 3 months prior to inclusion (last treatment administration or last loco regional procedure) ;

I3. Patient with suspicion of COVID-19 (clinical symptoms of COVID-19 including fever (\>38°C) and/or respiratory tract symptoms), either confirmed or not.

Note 1: Patients must have underwent diagnostic procedures: diagnostic test (positive or negative) and/or chest imaging. Note 2: Patients will be eligible regardless of the presence of a neutropenia (either febrile or not) ;

I4. Patient and/or family did not decline data collection after complete information.
INTEGRAL Study: A Longitudinal Study of Surgeries and Lasers in Glaucoma

The aim of this study is to create a large-scale register of all glaucoma patients diagnosed, followed and treated in a large tertiary centre specialising in glaucoma, in order to analyse whether specific factors influence the progression of the disease or guide our choice of treatment. This should lead to a better understanding of the disease and the factors to be taken into account when choosing the best treatment option for each patient, leading to safer, more effective and patient-centred care.

Glaucoma encompasses a group of chronic diseases characterized by progressive retinal nerve fibre loss and a concomitant pattern of visual field damage, eventually leading to blindness. To date, it is still considered the first cause of irreversible blindness worldwide. In recent years, treatment options for glaucoma have soared, and ophthalmologists can resort to a wide selection of drops, laser procedures and surgical techniques to reduce intraocular pressure, and slow the progression of the disease. The choice of the technique, however, often depends on personal preferences and it is still unclear if a specific technique is more efficient or safe, or if any patient-depending factors should guide the choice of treatment. The aim of this study is to create a large-scale register of all glaucomatous patients diagnosed, followed-up and treated in a large glaucoma-specialised tertiary centre, to analyse if any specific factor influence the progression of the disease or guide our treatment choice. This should lead to a better understanding of the disease itself and of the factors that should be considered when choosing the best treatment option for each patient, leading to safer, more efficient and more patient-centered care. This registry is thus of great importance for both patients and clinicians in the diagnosis and treatment of glaucoma.

The study is an observational analysis of patients' medical data recorded in a large-scale register, both retrospective and prospective.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of glaucoma (open-angle, closed-angle, primary or secondary) or ocular hypertension (IOP \> 24 mmHg, medicated or not)
* Patients who received treatment (medical, laser or surgical) at the Glaucoma Centre, Montchoisi Clinic and Swiss Visio Montchoisi
* Age: 18 years old or older
* Able and willing to provide informed written or verbal consent

Exclusion Criteria:

* Patients who are unable to understand the implications of their inclusion in the study or who are unable or unwilling to give informed consent
Impact of Neurostimulation on Patterns of Brain Electrical Activity in Patients With Tinnitus

Relating the electroencephalogram findings of patients with tinnitus before and after a therapeutic modality is still scarce in the literature, especially with neuromodulatory methods, more specifically with Transcranial Direct Current Stimulation - tDCS. This study is a double blind, sham-controlled clinical trial aiming investigate the impact of tDCS on patterns of brain electrical activity in patients with chronic tinnitus. 36 volunteers with tinnitus will be allocated randomly in 2 groups: the first (n = 18) will receive anodic tDCS in the temporoparietal left area and cathode in the right dorsolateral prefrontal cortex and the second group (n = 18) correspond to the sham group. In addition, healthy individuals (n = 18) will be recruited for comparative purposes of brain electrical activity with and without tinnitus, totaling 54 participants. Patients with tinnitus will receive transcranial direct current stimulation for 20 minutes for 5 consecutive days (1 week) and will be assessed before and after intervention by electroencephalogram, Acuphenometry, Visual Analogue Scale - VAS and questionnaire Tinnitus Handicap Inventory- THI. Follow-up of volunteers will also be performed after 1 month of the end of treatment with tDCS.


Eligibility Criteria:
Inclusion Criteria:

* Age of at least 18 years;
* Chronic tinnitus for at least 6 months.
* Age-adjusted normal (sensorineural) hearing

Exclusion Criteria:

* Pregnancy and/or lactation;
* Concurrent treatment for tinnitus;
* Prior exposure to transcranial direct current stimulation (tDCS);
* History of epilepsy and/or seizures;
* Electronic implants or metallic objects in body;
* Skin conditions where electrodes will be applied;
* Major neurological co-morbidities.
The Difference of Microparticles in Patients With Psoriasis Vulgaris Who Received Stelara(Ustekinumab)

Background: Psoriasis, a common inflammatory disease, is associated with atherosclerotic vascular diseases, including stroke, myocardial infarction, and impaired microcirculations, among which circulating microparticles play an important role. In severe psoriasis, there are increased endothelial- and platelet- microparticles that are reduced by TNF-α blockers in parallel with clinical improvement. However, whether Stelara(ustekinumab) treatment would decrease the level of microparticles remains unknown.

Objective: The investigators will evaluate the level of microparticles among normal control, severe psoriasis before and 4 months after ustekinumab treatment.

Methods: The investigators will recruit 50 patients with severe psoriasis who received ustekinumab and 50 control subjects without psoriasis from August 2014 to July 2016. Concentrations of microparticles with expression for surface markers (Annexin V, CD31, and CD41a) will be measured in peripheral blood using flow cytometry.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe psoriasis who receive ustekinumab treatment.
* Patients in the control group are examined thoroughly to make sure no psoriatic lesions by two dermatologists. Age, sex, lipid profiles, and blood pressure are recorded for all subjects.

Exclusion Criteria:

* The psoriatic patients and healthy controls who have pregnancy or infection (such as tuberculosis or sepsis) are excluded.
Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II

Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing totally occluded femoropopliteal arteries.

The purpose of this clinical study is to evaluate the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing chronic total occlusions (CTOs) in femoropopliteal arteries. The Ocelot Catheter is a minimally invasive percutaneous device that is designed to traverse arterial occlusions through the use of spiral wedges contained in the distal tip of the device. The device is also equipped with an OCT (optical coherence tomography) imaging fiber that provides directional orientation and an intravascular view of the vessel wall and target lesion. The Ocelot Catheter is used in conjunction with standard endovascular devices and as an adjunct to fluoroscopic guidance.

Eligibility Criteria:
Inclusion Criteria:

* Patient is willing and able to provide informed consent
* Patient is willing and able to comply with the study protocol
* Patient is \> 18 years old
* Patient has peripheral arterial disease requiring revascularization as evidenced by CTA, MRA or angiography
* Patient has an occluded femoropopliteal artery that is 99-100% stenosed and is ≥ 1 cm and ≤ 30 cm in length by visual estimate
* Target vessel is ≥ 3.0 mm in diameter
* Patient has Rutherford Classification of 2-5
* Lesion is recalcitrant to guidewire crossing

Exclusion Criteria:

* Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated
* Patient has a known sensitivity or allergy to aspirin, heparin or anti-platelet medications
* Patient is pregnant or lactating
* Patient has a co-existing disease or medical condition contraindicating percutaneous intervention
* Target vessel is severely calcified as evidenced by angiography
* Target lesion is in a bypass graft
* Target lesion is in a stent (i.e., in-stent restenosis)
* Patient has had a procedure on the target limb within 7 days
* Patient has had a procedure on the target limb within the past 30 days and is unstable
* Patient has a planned surgical or interventional procedure within 30 days after the study procedure
* Patient is simultaneously participating in an investigational device study for treatment of peripheral vascular disease
* Patient has a planned amputation of the target limb
* Patient has a history of bleeding diathesis, coagulopathy or will refuse blood transfusion in cases of emergency
Resilience, Grit, and Stress in Medical Students

The incidence of burnout and mental ill-health begins very early in medical school and continues to be high throughout training. Medical students are under high amounts of stress, which often becomes chronic, and can lead to both physical and psychological issues as a student, resident, and physician. Chronic stress and burnout in medical students are not a new phenomenon, but recent research has highlighted the worsening mental health of medical students, with as high as three-quarters of students reporting mental ill-health. It is vital that ways are found to reduce burnout and assist in improving the mental health of medical students. This quasi-experimental study is an ongoing study which is enrolling cohorts of students as they enter medical school.

The investigators will assess the effects of a year-long small process group intervention, led by a psychiatrist, which aims to improve self-awareness, mindfulness, and resilience in first and second-year medical students. Students self-select into the process group, and a similar number are randomly recruited as controls from the rest of the preclinical student body. The psychiatrist is blinded to student participation in the study. Students in the process and control groups will be surveyed with the Perceived Stress Scale, the Connor-Davidson Resilience Scale, and the Grit Scale in September 2023, and again after nine months and 25 sessions, in May 2024, after the academic year. Statistical analysis will be done with R Studio. Bandura's theory of self-efficacy was used to conceptualize the study. Recruitment is done by email, as is data collection. The intervention includes guided exploration of the psychodynamic process, group dynamic theory, cognitive behavioral therapy, dialectical behavioral therapy, boundaries, and empathy.

Eligibility Criteria:
Inclusion Criteria:

1. The participant must be an enrolled student at the College of Osteopathic Medicine of the Pacific-NW
2. Participant must be in their first or second year of medical school
3. Participant must be at least 18 years of age
4. Participant must self-select into either the intervention group or control group
5. Participant must sign informed consent

Exclusion Criteria:

1. Data will be excluded if a student goes on a LOA during the course of the year
2. Data will be excluded if a student does not attend a minimum of 12 out of 25 small group sessions
3. Student does not give informed consent
4. Student withdraws consent at any time
OptiLUTS Part C: the Development of a Symptom Assessment Tool in Sacral Neuromodulation.

Sacral neuromodulation (SNM) is a two-staged 2nd-line therapy for therapy-resistant LUTS and fecal incontinence. Currently, the assessment of symptoms at baseline and after stage I is directed towards a discipline related evaluation. The OptiLUTS trial strives for a more holistic approach, taking all pelvic floor dysfunctions into account.

A holistic assessment tool will be developed and SNM-care pathway will be set-up.

A prospective single centre trial is set up. Patients planned for the two-staged tined lead procedure are enrolled.

Bladder and bowel diaries and patient reported outcome measures (PROMS) will be collected at baseline and in between stage I and stage II, and PROMS at one month, 6 months and 12 months after definitive implant.

Phase I Step 1: The current implant rate, true success rate, outcomes and false positive rate will be measured.

Step 2: Development of a holistic symptom assessment tool. Phase II Implementation of the SNM care pathway.

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 years presenting with one or more of the following indications: Urinary urgency frequency with or without urinary incontinence (OAB dry or wet), non-obstructive urinary retention, dysfunctional voiding with post void residual volume, faecal incontinence and mixed incontinence
* Refractory to conservative treatment (i.e. Lifestyle changes, behavioural modification, pelvic floor muscle training, biofeedback) and refractory to pharmacological treatment.

Exclusion Criteria:

* Neurogenic bladder.
* Anal sphincter damage more than 120
* Abnormal sacral anatomy
* Mentally or physically disabled patients not capable to handle a patient programmer device.
* Pregnant patients
Establishment of Regional Severe Trauma Management System

To evaluate the effects of trauma treatment team establishment on the treatment of patients with severe trauma.

This is a national multi-center, cluster-randomized controlled trial. This cluster-randomized controlled trial will be performed, with counties as the randomization units. The included counties will be randomized into an experimental group and a control group. A trauma treatment team will be only established in the experimental group. The in-hospital mortality rate will be compared between the experimental and control groups to investigate the effects of trauma treatment team establishment on the treatment of patients with severe trauma.

Eligibility Criteria:
In this study, three-level subjects (counties, hospitals, and trauma patients) will be included according to the following inclusion and exclusion criteria:

* inclusion:
* Inclusion criteria of counties:

  * National counties and county-level administrative regions;
  * Local government and health management department have the desire and requirements to establish a standardized trauma emergency treatment system;
  * More than 500,000 people;
  * With pre-hospital emergency treatment system;
  * Trauma first aid needs: No less than 20 patients with severe trauma (ISS ≥ 16) throughout the county;
* Inclusion criteria of hospitals:

  * With the most advanced regional treatment resources during the entire period from trauma recovery to rehabilitation for third-grade class A hospitals;
  * With basic trauma treatment resources for second-grade class A hospitals;
  * Trauma doctors are on call 24 hours a day and can participate in the early treatment of patients with trauma;
* Inclusion criteria of patients:

  * Patients with acute trauma occurring within 48 hours;
  * Patients are transferred to trauma treatment center hospital or trauma treatment non-center hospitals;
  * Patients themselves go to or are transferred by their family members to the trauma treatment center hospital or trauma treatment non-center hospita;
* Exclusion:
* Exclusion criteria of counties:

  ○ All second-grade class A or third-grade class A hospitals in the county cannot establish a trauma treatment team because of various reasons;
* Exclusion criteria of hospitals:

  ○ Hospitals can not establish a trauma treatment team because of various reasons;
* Exclusion criteria of patients:

  * Patients with trauma from regions not included in this study.
Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects

The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with hepatic impairment. The results of this study will support treatment and dosing decisions for patients with varying degrees of hepatic impairment.


Eligibility Criteria:
All subjects:

Inclusions Criteria:

* Subjects must weight at least 50 kg, with a BMI within the range of 18 to 38 kg/m2
* Must be willing to remain in the clinical research unit as required by the protocol

Exclusion Criteria:

* Use of other study drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations
* History of hypersensitivity to the study treatment or to drugs of similar chemical classes
* Pregnant or nursing women
* Women of child-bearing potential

Healthy Volunteers:

Inclusion Criteria:

- In good health as determined by past medical history, physical examination, ECG, laboratory tests, and urinalysis at Screening.

Exclusion Criteria:

* Liver disease or liver injury
* Chronic infection with Hepatitis B or Hepatitis C
* History or presence of impaired renal function

Hepatically Impaired Subjects:

Inclusion Criteria:

- Hepatic impairment as defined by the Child-Pugh classification for severity of liver disease

Exclusion Criteria:

* Severe complications of liver disease within the preceding 3 months
* Emergency room visit or hospitalization due to liver disease within the preceding 3 months for mildly and moderately hepatically impaired subjects, and within the preceding 1 month for severely hepatically impaired subjects
* Subject has received liver transplant at any time in the past and is on immunosuppressant therapy
* Acute Hepatitis B or Hepatitis C infection

Other protocol-defined inclusion/exclusion criteria may apply.
Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy

The intention of research is to establish a multimodal prehabilitation protocol in patients who undergo neoadjuvant chemotherapy prior to gastrectomy, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, fitness and long-term prognosis.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥18 years;
2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2；
3. Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma；
4. The feasibility of neoadjuvant therapy was suggested by MDT, and the feasibility of radical gastrectomy was re-evaluated after neoadjuvant therapy;
5. Blood routine, liver function, kidney function, heart function and lung function were normal before neoadjuvant therapy, and there was no contraindication of chemotherapy and surgery;
6. The pregnancy test was negative within 1 month, and she was not pregnant or breastfeeding;
7. Informed consent and ability to comply with research protocols.

Exclusion Criteria:

1. metastasis;
2. End-stage cardiac insufficiency (LVEF\<30% or NYHA class IV), liver cirrhosis (Child-Pugh classification C), End-stage renal failure (receives chronic dialysis), or ASA grade IV;
3. Cerebral hemorrhage, cerebral infarction, TIA or central nervous system disease or mental illness within 6 months, could not cooperate with the completion of neoadjuvant therapy and pre-rehabilitation exercise;
4. Patients have severe infections (such as MODS, etc.) or have allergic reactions to chemotherapy drugs and metabolic disorders;
5. Concurrent tumors or other diseases requiring simultaneous surgery (except laparoscopic gallbladder surgery);
6. Emergency surgery is required due to tumor complications (e.g., bleeding, perforation, obstruction);
7. Patients participating in other clinical trials.
An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice

This prospective, multi-center, observational study will evaluate factors influencing the use of tocilizumab (RoActemra/Actemra) as monotherapy in rheumatoid arthritis patients in real life setting. Data will be collected from participants for 12 months following initiation of tocilizumab treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Patients with rheumatoid arthritis for whom the rheumatologist decides to start tocilizumab in combination with DMARD or as monotherapy

Exclusion Criteria:

* Current participation in a clinical trial in rheumatoid arthritis