cyrilzakka/clinical-trials huggingface dataset:
Respiratory Support in Severe Chronic Obstructive Pulmonary Disease Exacerbation

Preliminary studies have shown that NPPV can avoid tracheal intubation in 40% to 60% patients who have severe exacerbation of COPD. Recently, large-scale comparative effectiveness research (CER) also found that compared with invasive ventilation, NPPV can reduce mortality rates. But there's no high-quality clinical studies which can confirm this. Therefore, investigators believe that NPPV can avoid intubation in patients with severe exacerbation of COPD in ICU with perfect monitoring conditions and reasonable human resource allocation, in order to reduce IMV-related complications and improve patients' outcomes.

In part of the patients who were AECOPD with pH \<7.25 , preliminary studies have shown that NPPV can avoid tracheal intubation in 40% to 60% patients, and also reduce the incidence of VAP. Recently, large-scale comparative effectiveness research (CER) also found that compared with invasive ventilation, NPPV can reduce mortality rates. At present, there's no high-quality clinical studies which can confirm this, and clinical guidelines do not have a recommendation on the use of NPPV in these patients. Therefore, investigators believe that NPPV can avoid intubation in patients with severe exacerbation of COPD in ICU with perfect monitoring conditions and reasonable human resource allocation, as well as the progress of medical technology in NPPV in recent years, in order to reduce IMV-related complications and improve patients' outcomes.

Eligibility Criteria:
Inclusion Criteria:

* AECOPD;

Exclusion Criteria:

* refuse to engage in the study;
* have been included in other study.
Prophylactic Treatment With Atorvastatin for Chronic Migraine (ChronicStatinMig)

The main objective of this study is to see whether the favorable preventative effect of Atorvastatin 40mg per day in episodic migraine, that was found previously in three smaller randomized controlled cross-over studies, can be confirmed in a larger, multicenter, randomized controlled parallel group study. In addition it will be investigated whether 1) the favorable side effect profile, seen in previous studies, can be confirmed, and whether it is even better with the smaller dose, and 2) estimating the cost of Atorvastatin treatment, considering cost of medicine, cost of acute attack medicine, and cost of lost worktime.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 64 years
2. Signed informed consent
3. Chronic migraine according to ICHD-3 criteria (32)
4. At inclusion, patients should retrospectively have at least 15 headache days per month wheof at least 8 migraine days during the last 3 months. This frequency must be confirmed in the headache diary before randomisation to treatment (See below).
5. Debut of migraine at least one year prior to inclusion based on information in the patient record or by careful examination of previous headache history
6. Start of migraine before age 50 years.
7. No use of other migraine prophylactics during the study
8. For women of child-bearing potential (WOCBP, see below) there must be no pregnancy or planned pregnancy during the study period, and use of highly effective contraception (See below).

After the baseline period, just before randomisation to the study drug, inclusion criteria will be evaluated once more, and the headache diary will be evaluated. If there are, according to the headache diary, fewer migraine days than 8 per month, the baseline period can be extended to 8 weeks.

Exclusion Criteria:

1. Medication overuse headache requiring detoxification from acute medication (triptans, opioids). Exception could be made for those fulfilling A and B:

   A. Have tried a withdrawal period of at least 2 months without impact on headache frequency B: Use of opioids (of any type) ≤ 8 days /months.
2. Pregnancy, planning to get pregnant, inability to use contraceptives (See inclusion criteria, point 8), and lactating
3. Clinical information on or signs of cholestasis or decreased hepatic or renal function.
4. High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator
5. Hypersensitivity to statins or previous use of statins
6. History of angioneurotic oedema
7. Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study
8. Current use of antiviral treatment agaist hepatitis C
9. Significant psychiatric illness
10. Alcohol or illicit drug dependence.
11. Inability to understand study procedures and to comply with them for the entire length of the study
12. Treatment for hypothyroidism
13. Lactose intolerance
Postoperative Pain Management Following Laparoscopic Cholecystectomy

Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated Vortioxetine as an adjuvant to standard care for postoperative pain management in patients undergoing LC

Postoperative pain is a main challenge for delayed hospital discharge in Laparoscopic cholecystectomy. . Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. Vortioxetine (VO) is a multimodal serotonergic antidepressant with a unique mechanism of action that is effective in treating neuropathic pain. The purpose of this study is evaluating the efficacy and tolerability of preoperative oral administration of Vortioxetine on postoperative pain control in patients undergoing LC

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to undergo elective LC.
* Adults (males and/or females) between the ages of 18-70 years old.

Exclusion Criteria:

* Chronic pain other than cholelithiasis.
* Patients who received analgesics or sedatives 24 h before scheduled surgery.
* Severe hepatic (Child Pugh Class B and C) and renal dysfunction (CrCl \<30ml/min)
* Previous allergic response to vortioxetine.
* Pregnancy and lactation
* Patients with communication problems, cognitive dysfunction, or psychological disorders
* Daily corticosteroid use
Capsule Endoscopy Delivery at sCale Through Enhanced AI anaLysis Study

The CESCAIL study tests the use of Artificial Intelligence (AI) on a video taken from a minimally-invasive imaging device, to improve efficiency and accuracy of the detection of polyps, which are little outgrowths within the lining of the bowel.

Participants will be continuing to follow their standard care pathway, and there are no additional requirements of the participants other than providing consent for their pseudonymised capsule video and data to be used to test the AI system.

The participant's final diagnosis will only be determined by the clinician's standard analysis pathway and not influenced by the AI enabled analysis pathway. All data is de-identified before a video is created and re-identified only once the standard final report is signed-off by the referring clinician. Therefore, the risk of patient harm due to exposed data is minimised.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over
* Patients who have been selected by overseeing clinician meeting NHS England criteria to undergo colon capsule endoscopy as part of their standard of care

Exclusion Criteria:

* Patients unable to provide consent to take part in the study
Registry of Arterial Hypertension

The problem of the quality of primary health care medical system for patients with arterial hypertension is acute for the investigator's country, as these diseases are the most common and cause the high mortality of the population.

The concept of "quality of primary health care medical system" includes its timeliness, accessibility and provision of medical care to the patient at the modern level, which is determined by the degree of performance by doctors of medical and diagnostic measures corresponding current clinical recommendations.

The system of cardiovascular desease registries, established in the Federal State Clinical Hospital of the Russian Federation Ministry of Public Health with the automated analysis of data on examination and treatment, in comparison with clinical Recommendations. It makes possibility to identify shortcomings and develop approaches to improving the provision of medical care to patients in real clinical practice.

Comparative analysis of the quality of examination and treatment in different samples of patients with cardiovascular desease, observed in 2018-2020, compared with results of previous years will identify ptrends in the provision of medical care to patients with cardiovascular desease.

The study will be conducted using the arterial hypertension registry method, which is a computer program with remote access that allows online collection medical data from medical primary care system. To minimize operator errors, doctors was trained before the work with the arterial hypertension registry. User's guide was developed and the rights of users was determined. Data of examination and treatment of patients from 18 years and older with an established diagnosis of hypertension will be added from outpatient cards into the registry of the arterial hypertension. The information is received by the Institution in an impersonal form through a certified dedicated security channel. Patients sign an informed consent for entering their medical data into the registry of arterial hypertension

Eligibility Criteria:
Inclusion Criteria: The diagnosis of arterial hypertension -

Exclusion Criteria: No diagnosis of arterial hypertension

-
Empowering New Mothers: Exploring the Effect of Breastfeeding Health Educational Program on Practices and Feeding Self-Efficacy of Primigravida in Saudi Arabia

Being pregnant causes a mother and her child to form a maternal tie, and the birth of the child fills the mother with an immense amount of love and happiness. Breastfeeding is how a mother and infant make their initial touch. Breastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby.

This study will be done to evaluate the primigravida mother's breastfeeding's knowledge, attitude and corrective technique through the implementation of an educational program and to ascertain the efficacy of such a program.

Eligibility Criteria:
Inclusion Criteria:

* Primigravida mothers who regularly visit maternity hospitals at Hail and Bisha City.
* Primigravida mothers during last three trimester and 1 month after delivery
* No problems during pregnant and have a healthy baby
* Primigravida mothers who are not contraindicated to breastfeeding

Exclusion Criteria:

* Multigravida mothers and pregnant women during first and second trimester
Regenerative Stem Cell Therapy for Stroke in Europe

Stroke is the second leading cause of death in the world population. When not fatal, stroke often results in disability, and secondary health problems affecting not only patients but also their families. Building on emerging preclinical and pilot clinical evidences, RESSTORE will focus on the clinical assessment of regenerative cell therapy to improve stroke recovery and patients quality of life.

RESSTORE European multicentre randomised phase IIb will explore the efficacy (functional recovery) and safety of intravenous infusion of allogenic adipose tissue derived mesenchymal stem cells (ADSC) in 400 stroke patients. Therapeutic effects of ADSCs will be assessed and monitored in patients using clinical rating scales, multimodal MRI and blood biomarkers.

The European regenerative therapy capacities (France, Spain, Finland, United Kingdom and Czech Republic), developed in RESSTORE will cover the full value chain in the field (large scale GMP cell production, clinical testing, biomarkers discovery, understanding of the restoring mechanisms, biobanking...).

Eligibility Criteria:
Inclusion Criteria:

* Hemispheric ischemic stroke (\>1.5cm)
* Inclusion from 1 to 4 days post-stroke
* NIHSS \> or = 7
* No craniectomy
* Able to follow a rehabilitation program
* Modified Rankin scale = 0 before stroke onset

Exclusion Criteria:

* Coma
* Severe leucoariosis
* Previous stroke
* Active endocarditis, pneumonia, AIDS, active hepatic disease due to HBV or HCV
* History of cancer
* Pregnancy, breast feeding
Platelet Rich Plasma Injection Versus Surgical and Medical Treatment of Mild-moderate Carpel Tunnel Syndrome.

to evaluate the therapeutic efficacy of single ultrasound guided Platelet Rich Plasma injection of the carpal tunnel Vs. surgical procedures and medical treatment and hand support in patients with mild-moderate carpal tunnel syndrome regarding pain relief and function improvement during a follow up period of 6 months.

Carpal tunnel syndrome (CTS) accounts for approximately 90% of peripheral entrapment neuropathy cases. Existing evidence based treatments for carpal tunnel syndrome, splinting, corticosteroid injection and surgery, are not 100% effective and alternative treatments are worth exploring .Surgery indicated in Patients with persistent numbness and pain, motor dysfunction with diminished grip or pinch grasping, or thenar eminence flattening. Empirical evidence indicates that many patients with CTS have self-limiting symptoms and respond to splinting and anti-inflammatory medications. Recently major attention has been drawn to platelet-rich plasma for its possible effects on axon regeneration and neurological recovery.

Eligibility Criteria:
Inclusion Criteria:

* patients with signs and symptoms of CTS and a confirmed diagnosis of mild and moderate CTS based on clinical and electrophysiological studies were included.

Exclusion Criteria:

1. pregnancy.
2. history of underlying metabolic diseases (such as diabetes mellitus, thyroid diseases, rheumatoid arthritis and etc.).
3. history of local corticosteroid injection in the past 3 months.
4. atrophy of thenar muscles.
5. previous carpal tunnel release surgery and evidence of concomitant neuropathy or radiculopathy.
6. Patients with autoimmune or hematologic disorders, NSAID consumption 2 days prior to injection, treatment with antiplatelet and anticoagulant agents, Hb level under 12 g/dl, and platelet count under 150,000 in ml.
Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus

The purpose of the study was to assess the effect of LIK066 on intestinal glucose absorption immediately after a single dose (immediate effect) and 6 hours following the dose (after multiple daily doses; sustained effect) in patients with type 2 diabetes mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* Patients, age 18-65 years, must have been diagnosed with T2DM at least 6 months prior to screening with HbA1c 6.5 to 10.0%, inclusive, at screening.
* Fasting plasma glucose ≤250mg/dL at screening.
* If treated with metformin, patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study.

Exclusion Criteria:

* Patients with type 1 diabetes mellitus.
* Patients with history of acute diabetic complications within the 6 months prior to screening.
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential unless they are using effective methods of contraception during dosing of study treatment.
* Patients with signs or symptoms of significant diabetic complications.
* Patients treated with certain blood pressure or lipid lowering medications unless patients have been on stable doses for the 12 weeks prior to dosing.
* History of drug or alcohol abuse within the 12 months prior to dosing.
* Any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study.

Other protocol-defined inclusion/exclusion criteria may apply
Clinical Validation of Breath Analyser Tests for Diagnosis of COVID-19.

The Sponsor has developed a rapid screening tool intended to determine if the subject tested is COVID-19-free (Negative to COVID-19).

Within this proposed project, the NHS will collect two diagnostic or screening tests per participant. One sample will be used by NHS and be run through regular diagnostics. The second, will be breath sample which will be tested using the BioSafety Technologies Ltd, rapid screening tool. This will use a pre-defined protocol. These tests would then be compared to assess the diagnostic efficacy including sensitivity and specificities. We will be aiming to achieve a significant comparison to ensure certainty and to exploit the information for proposing a novel diagnostic system to enhance capabilities to scale up the testing of patients. The proposed activity involves clinical validation of BioSafety Testing, to enhance the performance of detection along with clinicians.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Requiring a diagnostic or screening RT-PCR test for COVID-19

Exclusion Criteria:

* Subjects under general anaesthesia
* The inability to personally sign the consent form.
* The inability to exhale breath
Ambulatory Blood Pressure Monitoring in Rivaroxaban Therapy

One in ten patients on rivaroxaban therapy have dizziness and reductions in blood pressure. The investigators intend to monitor the ambulatory blood pressure of such patients in order to assess whether this is a true haemodynamic effect.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years
* Able to provide written, informed consent
* Taking rivaroxaban for any indication within the license of the drug, both once daily and twice daily dosing can be included
* Have measurable rivaroxaban levels on at least one occasion (this will be in line with standard of care, there will be no extra blood samples for the study)
* Not taking concomitant medication that can affect rivaroxaban metabolism (including amiodarone, dronedarone, -azole antifungals, protease inhibitors)
* On no antihypertensive or vasoactive medication
* Have a baseline BP recording taken in clinic

Exclusion Criteria:

* Unable to provide written, informed consent
* Presence of concomitant medication that may alter rivaroxaban levels and confound results (see above)
* Unwilling to undergo ambulatory blood pressure monitoring
* Contraindication to ambulatory blood pressure monitoring
Combined Retinoic Acid,Arsenic Trioxide and Chemo for Newly-diagnosed APL

In this prospective randomized study for patients with newly diagnosed acute promyelocytic leukemia, patients will be randomized (1:1) into two groups which receive retinoic acid and arsenic trioxide based treatment versus retinoic acid and chemotherapy based regimen.

The study is carried out based on Sanz risk stratification of newly-diagnosed APL patients into low-, intermediate- and high-risk groups, and all of them will receive ATRA and ATO as induction therapy (ATRA 25 mg/m2 per day orally + ATO 0.16mg/kg intravenously daily). Anthracycline is added to both high-risk groups or intermediate-risk group with hyperleukocytosis developed during induction therapy but not in low-risk groups.

After achieving CR, patients enter into consolidation therapy. Low-risk patients receive either 2 courses of ATRA plus ATO (Experimental group) or 2 courses of ATRA plus anthracycline chemotherapy (Control group). Intermediate-risk patients receive either 3 courses of ATRA plus ATO (Experimental group) or 2 courses of ATRA plus anthracycline chemotherapy (Control group). Patients of high-risk disease receive 2 courses of ATRA plus ATO and anthracycline and 1 course of ATRA plus ATO treatment (Experimental group) or 2 courses of ATRA plus anthracycline and cytarabine and 1 course of ATRA plus mid-dose cytarabine (Control group).

After consolidation therapy, patients with molecular complete remission (mCR) enter into maintenance therapy. Low- and intermediate-risk patients receive 3 cycles of ATRA and ATO sequential treatment, while those of high-risk receive 5 cycles of ATRA, ATO and methotrexate (MTX) treatment.

For low- and intermediate-risk patients who fail to achieve mCR after consolidation therapy, 3 courses of consolidation therapy of high-risk group will be given with cross-over (i.e. patients in Experimental group received the therapy of Control group, and patients in Control group received the therapy of Experimental group). If patients still fail to achieve mCR, together with high-risk group who fail to achieve mCR after consolidation therapy will be withdrawn from the study and proceed to salvage treatment.

Eligibility Criteria:
Inclusion Criteria:

* Newly-diagnosed patients with acute promyelocytic leukemia via cytogenetics and molecular assay
* Age: 18-65
* Hepatic/renal function: Bil≤35μmol/L，AST/ALT less than 2Xnormal range, Cr 150μmol/L
* Normal cardial function
* ECOG：0-4
* Informed consent

Exclusion Criteria:

* QTC interval \>450ms
* Pregnant or breast feeding patients
* Patients with drug addiction or mental illness
* Patients documented of CNS infiltration at diagnosis
* Patients with severe heart disease (acute myocardial infarction or heart failure)
* Patients with concurrent active malignancy, tuberculosis or HIV infection
* Patients with contraindication or allergy to anthracyclines or other agent in the protocol
* Patients enrolled in other clinical trials
* Patients not apply to the study protocol
An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy

In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with histologically or cytologically confirmed extensive stage disease SCLC
* Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Subjects with symptomatic Central Nervous System (CNS) metastases
* Subjects receiving consolidative chest radiation
* Subjects with active, known, or suspected autoimmune disease are excluded
* All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline

Other protocol-defined inclusion/exclusion criteria apply