cyrilzakka/clinical-trials huggingface dataset:
COVid-19: Awake Proning and High-flow Nasal Cannula in respiratorY DistrEss

Prone positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality.

Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19, either confirmed by SARS-CoV-2 assay, or clinically suspected, with results of the assay pending;
* Lung infiltrates documented on chest X-ray or chest CT-scan;
* Significant respiratory distress that requires treatment with HFNO.

Exclusion Criteria:

* Unable to consent;
* Unable to prone;
* Indication for immediate endotracheal intubation and mechanical ventilation;
* Contraindication to prone positioning (severe obesity, abdominal wound, pregnancy, unstable pelvic/spinal lesions, vomiting, etc.);
* Comfort care or imminent expectation of death.
Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy

The purpose of this study is to determine the role of ivabradine in cardiac resynchronization recipients with an unsatisfactory percentage biventricular pacing.

The study protocol 60 patients with heart failure NYHA (New York Heart Association) II-IV treated with optimal medical therapy as clinically indicated who received CRT-D device more than 3 months ago. Patients with biventricular pacing \<95% will and heart rate \<70 at rest and \>50% of heart rate in device memory \>70 will receive ivabradine. The minimal follow-up of patients in the study will be at least six months.

Approximately 30% of CRT recipients do not respond to therapy. One of the causes ot that is unsatisfactory percentage of biventricular pacing. Patients may loose biventricular pacing because of inadequate sinus tachycardia.

Ivabradine may prevent inadequate sinus tachycardia and improve quality of live of CRT recipients.

According to current guidelines ivabradine is recommended in patients with symptomatic heart failure with heart rate at rest \>70.

The hypothesis of this study is that ivabradine may increase percentage of biventricular pacing in CRT recipients who have unsatisfactory percentage of biventricular pacing and \>50% of heart rate in device memory \>70.

Eligibility Criteria:
Inclusion Criteria:

* heart failure NYHA II-IV
* left ventricular ejection fraction =\<35%
* CRT-D implanted over 3 months ago
* optimal CRT-D parameters
* biventricular pacing \<95% despite the optimal parameters of the device
* optimal pharmacotherapy with the highest well-tolerated beta-adrenolytic dosage
* heart rate at rest below 70 bpm
* over 50% of heart rhythm over 70 bpm at interrogation with the device

Exclusion Criteria:

* persistent atrial fibrillation/flutter
* device associated ineffective resynchronization
* contraindications to ivabradine
Iron Substitution After Total Knee Arthroplasty

Hemoboost is a registered natural product containing specially processed haemolysed haemoglobin and iron dextran. It is marketed for human use on the basis of many years' use and documented effect in veterinary medicine. Iron dextran was introduced for use in human medicine in 1954.

Krauterblut is a registered natural product made from a number of herbs where the active substance is ferrous gluconate. Both drugs have been available for a number of years and have become increasingly popular among patients and healthcare staff due to a reduction in adverse effects.

The objective of this study is to determine the effect and adverse effects of the natural products Hemoboost and Kräuterblut compared with the usually administered ferrous sulphate in knee arthroplasty.

Hip and knee arthroplasties are performed with increasing frequency in the western world, and in Denmark approximately 12,000 operations are performed annually (2/1000/year). The perioperative and postoperative blood loss generally constitutes ½ -1½ litres which is frequently associated with symptom-producing anaemia which obstructs mobilisation and increases the risk of complications.

Postoperative iron supplementation for a period of up to 12 weeks is therefore a frequently adopted practice. However, there is no consensus or evidence that support postoperative iron supplementation and the effects of iron deficiency are unclear. It is well-known that iron supplementation causes gastrointestinal adverse effects in up to 25% of cases.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* ASA group I-II

Exclusion Criteria:

* malignant disorder
* chronic renal insufficiency
* urinary tract infection
* haemorrhagic diathesis
* haemoglobin \< 7 mmol/l
* dementia or mental disorder incompatible with survey participation
TachoSil Paediatric Liver Trial (TC-019-IN)

The overall objective is to assess the haemostatic efficacy and safety of TachoSil for control of local bleeding in paediatric patients undergoing surgical resection of the liver with our without segmental liver transplantation.


Eligibility Criteria:
Inclusion criteria:

1. Has the parent(s)/legal guardian given informed consent according to local requirements before any trial related activities?
2. Is the child above 4 weeks and below 6 years of age?
3. Has at least segmental resection (anatomical/non-anatomical) of the liver and primary haemostatic treatment been performed? or Has resection of the liver and placement of a segmental liver graft and primary haemostatic treatment been performed?
4. Is only minor, i.e. oozing, or moderate haemorrhage persisting after primary surgical haemostatic procedures of the major vessels (no pulsating arterial haemorrhage and/or major venous bleeding)?

All inclusion criteria must be answered "yes" for a child to participate in the study.

Exclusion criteria:

1. Was the child retransplanted or had liver transplantation in combination with other organs?
2. Was there anamnestic or laboratory evidence of congenital coagulation disorders including Haemophilia A or B and von Willebrand disease?
3. Has the child a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
4. Has the child fulminant hepatic failure, portal vein thrombosis or anamnestic or clinical evidence of cirrhotic condition of the liver, including cirrhosis due to genetic deficiency of a1 - Antitrypsin?
5. Did the child undergo an emergency operation?
6. Does the child participate in another clinical trial during the intra-operative phase?
7. Has any serious surgical complication occurred?
8. Has any fibrin glue haemostatic (including TachoSil ® ) been used on the target wound before the planned application of TachoSil ® ? To participate in the study all exclusion criteria must be answered "No" for a child having segmental resection. For a child having total hepatectomy and placement of a segmental liver transplant criteria 4 and 5 can be answered "Yes".
Dorsovolar Kinesiotape in Carpal Tunnel Syndrome

This study aimed to compare the short- and medium-term efficacy of dorso-volar kinesiotape (KT) added to home exercises (HE) with sham-KT and HE alone in the treatment of mild or moderate carpal tunnel syndrome (CTS) in terms of pain, symptom severity, function, grip strength, and electrophysiological parameters.


Eligibility Criteria:
Inclusion Criteria:

* pain or numbness radiating to the palm for at least 6 weeks,
* at least one positive Tinel's, Phalen's, or carpal compression test on physical examination, and
* mild/moderate CTS on EMG examination.

Exclusion Criteria:

* Metabolic disease (diabetes, rheumatoid arthritis, thyroid disease),
* systemic or malignant disease, history of trauma, fracture or surgery to the wrist,
* physical therapy programs, surgical procedures, injections or KT applications to the wrist for CTS treatment in the past year,
* severe thenar atrophy,
* C6-C7 radiculopathy among CTS differential diagnoses,
* cervical spondylosis, thoracic outlet syndrome, entrapment of the median nerve above the wrist,
* polyneuropathy or traumatic injury to the median nerve,
* rashes or open wounds on the skin of the wrist and forearm that could prevent treatment with kinesiology taping
Development of a Diagnostic Kit for FLT3-ITD in Acute Myeloid Leukemia

FLT3 overexpression in acute myeloid leukemia (AML) is often caused by mutations in this gene. These mutations cause constitutive phosphorylation of FLT3 proteins leading to increased proliferation and survival, decreased apoptosis and resistance to chemotherapeutic agents in AML cells. There are two major types of FLT3 mutations- internal tandem duplication (ITD) and point mutation at 835th amino residue. AMLs with FLT3 mutations have worse prognosis and are often resistant to conventional chemotherapy. Several small molecule compounds targeting FLT3 have been in the market or in clinical trials. Therefore, identification of these mutations at the time of diagnosis will provide a better prognostic prediction, might guide the treatment selection and follow-up strategies. In this study, the investigators will develop a sensitive molecular assay to detect FLT3 mutations for future clinical application. The investigators will collect 100 AML samples with at least 20 samples with known FLT3 mutations. The investigators will compare this assay with commonly used methods and standardize the procedure to meet the requirement of clinical pathology laboratory with reasonable cost.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of acute myeloid leukemia

Exclusion Criteria:

* non
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

To determine the short term therapeutic efficacies of Gufoni maneuver and mastoid oscillation in apogeotropic type of benign paroxysmal positional vertigo (BPPV) involving the horizontal semicircular canal (HC-BPPV), a randomized, prospective, sham-controlled study was conducted.

The apogeotropic type of benign paroxysmal positional vertigo involving the horizontal canal (HC-BPPV) is likely due to otolithic debris in the anterior arm of the canal (canalithiasis) or the debris attached to the cupula (cupulolithiasis). It is important to seek the method to convert treatment-resistant apogeotropic form to the more treatment-responsive geotropic form in HC-BPPV. Recent randomized trials demonstrated that head shaking maneuver was more effective than the modified Semont maneuver and the Gufoni and head shaking maneuvers showed similar efficacy in treating apogeotropic HC-BPPV. Moreover, new repositioning maneuver using mastoid vibration showed good efficacies in patients with apogeotropic HC-BPPV in recent study. So we tried to compare the short term therapeutic efficacies of Gufoni maneuver and mastoid oscillation in apogeotropic HC-BPPV with a randomized, prospective, sham-controlled study.

Eligibility Criteria:
Inclusion Criteria:

1. history of vertigo associated with changes in head position
2. direction-changing horizontal nystagmus beating toward the uppermost ear (apogeotropic nystagmus) in both turning positions detected with Frenzel glasses or videoculography in the Head turning test
3. vertigo associated with the elicited nystagmus
4. symptom within 2 weeks
5. put one's signature on consent

Exclusion Criteria:

1. patients with identifiable central nervous system disorders that could explain the positional vertigo and nystagmus
2. the patients with apogeotropic form which was transited from geotropic after previous therapeutic maneuvers
3. the patients who transited from apogeotropic from vertical canal BPPV during study
4. patients who had possible cause of secondary BPPV such as Meniere's disease, migraine or recent trauma history
5. patients whose affected ear cannot be identified
6. patients with multiple canal atypical positional nystagmus or who were treated previously with repositioning maneuvers were excluded.
7. patients with cervical or lumbar spine problem
Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy

The purpose of this study is to determine the effectiveness \& safety of pirfenidone in type 2 diabetic patients with diabetic nephropathy


Eligibility Criteria:
Inclusion Criteria:

* Diabetic Nephropathy Stage 3 (eGFR 30-59 mL/min/1.73m2) Type 2 Diabetes HbA1c \<7.5% Patient taking ACEi/ARB for at least 3 months BP \<140/90

Exclusion Criteria:

* History of photosensitivity rash History of decompensated liver or cardiac disease History of urinary tract infection Pregnancy or lactation History of nephrotoxic drugs or hakeem medication Polycystic kidney disease History of autoimmune disease History of hypersensitivity to study drugs
Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts

The purpose of this study is to investigate the safety of different doses of sublingual tablets of house dust mite allergen extracts in adults with house dust mite-associated allergic asthma.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Male or female patient from 18 to 50 years.
* Diagnosed asthma with medical history consistent with HDM-induced allergic asthma.
* Positive SPT to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kU/L.
* Stable asthma treatments.
* Spirometry with best FEV1 \> 70% of the predicted value.
* Spirometry with reversibility of FEV1 of ≥ 12% and ≥ 200 mL.
* Asthma Control Test™ (ACT) score ≥ 20.

Exclusion Criteria:

* Current smoker or former smoker with \> 10 pack/year history.
* Co-sensitisation to any allergen possibly leading to clinically relevant respiratory allergy likely to significantly change the symptoms of the patient throughout the treatment period.
* Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or the outcome of this study.
* Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
* Female patient pregnant or breast-feeding/lactating.
* Female patient of childbearing potential not using a medically accepted contraceptive method.
* Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
* Patient who received allergen immunotherapy for HDM in the last 10 years.
* Ongoing treatment by immunotherapy with another allergen.
Comparison of Thrust Manipulation of Sacroiliac Joint and Pelvic Stabilization Exercises in Post Partum Low Back Pain

compare the effectiveness of SI joint thrust manipulation and pelvic stabilization exercises on Modified OSWESTRY Low Back pain Index (ODI) and Numeric Pain Rating Scale (NPRS) in patients with post-partum lower back pain.

Patients fulfilling the inclusion criteria will be divided into 2 groups i.e. Group A and Group B. Patients in Group A will receive thrust manipulation technique and Group B will receive pelvic stabilization exercises, heating pad will be given to both groups. Patients will be treated 3 times per week for 4 consecutive weeks. Patient will be evaluated at baseline, midline and at end of 4th week. Pain, functional status and disability will be evaluated after every 3 sessions.

Eligibility Criteria:
Inclusion Criteria:

* age 20-40 years
* Postpartum women (after 6 weeks)(3, 12)
* Postpartum LBP patient
* Patient pain increased by provocation test i.e. Faber test, High thrust test and Gaenslen test

Exclusion Criteria:

* C-section
* inflammatory or malignant type of pain
* Neurological deficit
* Severe trauma
* Pelvic fracture
* Osteoporosis, spinal stenosis, spondylolysis, spondoloesthesisi
Analgesic Efficacy of Fascia Iliaca Compartment Block

The aim of this study is to evaluate the analgesic efficacy of fascia iliaca compartment block using bupivacaine versus bupivacaine with dexamethasone or magnesium sulphate for dynamic hip screw surgery under spinal anesthesia.

The primary outcome will be the duration of effective analgesia from FICB till the first analgesic dose is required,the secondary outcomes will be the severity of postoperative pain as will be assessed by the visual analogue scale and the total dose of pethidin for rescue analgesia.

Different modes of analgesia are given prior to neuraxial blockade for pain relief like non-steroidal anti-inflammatory drugs (NSAID), opioids and peripheral nerve blocks such as, femoral nerve block, 3 in 1 block or fascia iliaca compartment block (FICB).

FICB is believed to be most beneficial compared to other procedures because of its safety and efficacy . FICB provides blockage of at least two of the three major nerves that supply the medial, anterior and lateral thigh with one simple injection, namely the femoral and lateral femoral cutaneous nerves.

FICB is an anterior approach to the lumbar plexus. The pop technique using fascial click had a low success rate of 35% - 47% .However, as the FICB was performed under real-time ultrasound guidance, the success rate was increased up to 82- 87%, leading to an increased interest in FICB as a postoperative analgesia option for hip and knee surgical procedures .

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology physical status (ASA) I \& II of both sex.
* Age between 20 and 70 years.
* Patients with traumatic hip fracture presenting for elective or emergency dynamic hip screw (DHS) fixation under spinal anesthesia.

Exclusion Criteria:

* Patient refused to give consent
* Patients with history of allergy to dexamethasone, magnesium sulphate or bupivacaine.
* Patients with contraindications to spinal anesthesia.
* Previous surgery in the affected hip, infection at the injection site, multiple fractures.
* Peripheral neuropathy.
* Use of analgesics within 8 hours before the spinal block.
* Inguinal hernia, and femoral artery graft.
Multicenter Cohort of STEMI Patients

Ischemic heart disease is the leading cause of mortality with 7.2 million of death in industrialized countries (WHO data). Myocardial infarction corresponding to acute occlusion of a coronary artery is the most brutal form and the more severe ischemic myocardial disease. Every year in France, about 60,000 Myocardial infarctions hospitalized, 30,000 are diagnosed remotely and 30,000 are revealed by an inaugural sudden death. Although mortality from myocardial decreased by 30% over the past decade, the prognosis is pejorative and difficult to assess precisely. The management of the patient depends on these factors, and justifies an active search on these topics, including the mechanisms of the deleterious ventricular remodeling, myocardial inflammation, reperfusion injury which determines in particular the evolution to heart failure. Cohorts of patients with myocardial infarction are rare but can be very valuable by their clinical, laboratory and imaging well documented. They are the source of new hypotheses for research or interventions as well as the quality of care assessment tool.

The main objective of this project is to identify new markers: biological and imaging, treatment response and prognosis after acute myocardial infarction.

Secondary objectives of the HIBISCUS-STEMI cohort to establish a clinical database, completed by biological samples and by imaging data that can be used in the following areas:

* Descriptive epidemiology of myocardial infarction and myocardial reperfusion
* Pharmacoepidemiology and treatments observatory: safety, efficacy, indication of treatment in real life, costs
* Assessment of the long-term effect of the treatment on the occurrence of heart failure and sudden death
* Quality of life and personal consequences, family, professional and social myocardial infarction
* Research of new diagnostic and prognostic biomarkers
* Research projects (e.g. risk of developing kidney failure or stroke in patients with myocardial infarction compared to the general population).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG.
* Primary Percutaneous coronary intervention (PCI)

Exclusion Criteria:

* Diagnosis of STEMI not confirmed by angiography
* Refusal to participate in the study or to sign the consent
* Impossibility to give information to the subject about the study
* Lack of medical social coverage
* Obvious contraindication to magnetic resonance imaging (claustrophobia, pacemaker, defibrillator, renal insufficiency, known allergy to a contrast agent)
* Deprivation of civil rights
* participating to another interventional study
Multimodal Imaging in Pre-surgical Evaluation of Epilepsy

Epilepsy is the most common chronic neurological disorder in the world, affecting more than 50 million people worldwide. Approximately 35% of patients with epilepsy are refractory to all available antiepileptic drugs. Drug-resistant epilepsies are often partial or focal. Patients with drug-resistant focal epilepsy suffer from an increased risk of death, primarily due to seizure-related fatalities, in comparison with the general population. The only therapeutic option for this form of epilepsy is the surgical removal of the region of the brain responsible for seizures, called the epileptogenic zone (EZ). This requires the precise localization of the EZ based on a comprehensive pre-surgical evaluation of patients.

Today the gold standard for localizing the EZ and validating a non-invasive technique for localization of the EZ remains intracerebral stereo-EEG (stereo-electroencephalography or SEEG) recordings of spontaneous seizures. The implementation strategy of the intracerebral depth electrodes is guided by clinical and neuroimaging data, including anatomical Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) with FDG (fluoro-Deoxy-Glucose) and MagnetoEncephaloGraphy (MEG). Although the contribution of each technique in the pre-surgical localization of the EZ has already been shown, no wide-scale study has examined the cumulative contribution of these three techniques.

The purpose of this study is (i) to evaluate rigorously the diagnostic value of multimodal imaging for non-invasive localization of the EZ and (ii) to better target the indications for intracerebral recordings (SEEG).

Eligibility Criteria:
Inclusion Criteria:

* Patient with drug-resistant focal epilepsy
* Candidates for pre-surgical evaluation including FDG PET, MRI, MEG and SEEG recordings.
* Age 18-65 years
* EEG-confirmed focal epilepsy for \>2 years
* Signed informed consent form.

Exclusion Criteria:

* Age \<18 years and \>65 years
* Contraindication to the MRI
* Pregnant woman
* Head size incompatible with MEG recordings
* Adult subject to legal protection measure.