cyrilzakka/clinical-trials huggingface dataset:
A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure

This was a dose-finding study to evaluate the efficacy, safety and tolerability of 3 different doses of LIK066 compared to placebo or empagliflozin in T2DM patients with heart failure

The study was prematurely discontinued on 04-May-2018 due to slow enrollment that would preclude obtaining study results in a timely manner.

Eligibility Criteria:
Key Inclusion Criteria:

* BMI ≥ 22kg/m\^2
* Type 2 diabetes with HbA1c between 6.5% and 10.0%
* Documented symptomatic chronic heart failure (NYHA II-IV)
* Plasma NT-proBNP \> 300pg/ml
* eGFR ≥ 45ml/min/1.73m\^2 (calculated by MDRD)

Key Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
* History of ketoacidosis, lactic acidosis, or hyperosmolar coma
* Symptomatic genital infection or UTI within 4 weeks of screening
* Myocardial infarction, stroke, surgery for heart disease, percutaneous coronary intervention within 3 months of randomization
* Unstable angina within 3 months of screening
* Isolated right HF due to pulmonary disease
* Patients with a mean sitting systolic blood pressure ≤ 100mmHg, at randomization
* History of lower limb amputation
* Diabetic foot ulcer at screening
A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A

The main aim of this study is to check for long-term side effects from ADYNOVI/ADYNOVATE prophylaxis in participants with haemophilia A when used under standard clinical practice in the real-world clinical setting.


Eligibility Criteria:
Inclusion Criteria

* Signed informed consent obtained from participant and/or legally authorised representative before any study related activities (any procedure related to recording of data according to the protocol).
* Participant at any age with haemophilia A prescribed ADYNOVI/ADYNOVATE prophylaxis.
* Negative factor VIII (FVIII) inhibitor test at study entry.
* Decision to initiate treatment with commercially available ADYNOVI/ADYNOVATE has been made by the participant and/or legally authorised representative and the treating physician before and independently from the decision to include the participant in this study.

Exclusion Criteria

* Previous participation in this study. Participation is defined as signed informed consent.
* Known or suspected hypersensitivity to ADYNOVI/ADYNOVATE or related products.
* Mental incapacity, unwillingness or other barriers precluding adequate understanding or cooperation.
A Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer

To examine the efficacy of a 10-week multimodal lifestyle program, versus waitlist control, on cardiorespiratory fitness capacity and body weight in survivors of cancer.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent before any trial-related activities
* History of any malignancy
* Completion of cancer-directed therapy (e.g., surgery, chemotherapy, and radiotherapy) prior to enrollment (patients receiving ongoing endocrine or targeted therapy are eligible to participate)
* No evidence of residual or recurrent cancer under active treatment
* Age ≥18 years
* Body mass index (BMI) ≥30 kg/m2 or BMI ≥27 kg/m2 with one or more treated or untreated weight-related coexisting conditions
* Willing to be randomized
* Allow the collection and storage of biospecimens and data for future use

Exclusion Criteria:

* Engaging in ≥3 purposeful exercise sessions per week, on average, over the past 12 weeks
* Significant purposeful weight loss (\>11 kg) within the past 12 weeks
* Current use of medications or devices for the purpose of weight loss
* Metabolic or bariatric surgery within the last year
* Cardiovascular, respiratory, or musculoskeletal disease that would prohibit participation in an exercise and weight loss program
* Currently pregnant, breastfeeding, or planning to become pregnant with the next 12 weeks
* Psychiatric disorders or conditions that would preclude participation in the study intervention
* Any other condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the study
VistaCare® in the Treatment of Wounds of the Lower Extremity

Assessment of the safety and performance of the VistaCare® medical device in current medical practice in the treatment of acute and chronic lower limb wounds.

The study is an open-label, prospective, multicenter, post-CE mark (European Conformity assessment indicating marketing approval in Europe) study to assess the safety and performance of the VistaCare® device in the treatment of wounds. The duration of patient follow-up is up to 30 days, with intermediate visits at 3, 7, 15 and 30 days following initiation of treatment with the device.

Up to 30 patients will be recruited in the trial. Assessments will include clinical status, wound status, standardized photography, TcPO2 (trans-cutaneous oxygen pressure assessment) in a study sub-population, visual analogy scales to assess pain and comfort and adverse events monitoring.

Eligibility Criteria:
Inclusion Criteria:

* male or female consenting and able patients aged 18 or more affiliated to social security
* presenting with acute or chronic traumatic or surgical lower limb wounds (excluding tumoral excision)
* presenting with no intercurrent pathology which in the opinion of the investigator may interfere with the capacity for wound healing
* patients whose wound is compatible in terms of location with VistaCare treatment
* patient whose wound has a minimal surface of 10 cm2
* patient whose wound does not need surgical Peterson after inclusion (if needed should be performed prior to inclusion)

Exclusion Criteria:

* Female patients pregnant, lactating, or of childbearing age and not using adequate contraception (pregnancy test mandatory)
* patients incapable of making an informed decision about participation
* patients presenting a condition that interferes with adequate wound healing capacity (uncontrolled diabetes, heavy smokers, auto-immune disease)
* concurrent treatment or treatment within one month prior to inclusion with local or systemic corticosteroids, immunosuppresseurs, chemotherapy or radiotherapy
* wound location incompatible with VistaCare
* general infection signs at the time of inclusion (fever, lymphangitis, pus ...)
* patients presenting with important uncontrolled hemorrhage at the time of inclusion
* patients previously recruited into this trial or any other trial within 1 month, or currently in the exclusion timeframe of another trial
* patients with a wound surface less than 10 cm2
* patient with a would previously treated with hyperbaric chamber
* legally incapacitated, under guardianship or psychiatric patients
* emergency condition prohibiting adequate patient consent prior to inclusion
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* HCV RNA \> 10\^4 IU/mL at screening
* Chronic HCV infection (≥ 6 months)
* Confirmed CPT class B (7-9) at screening

Exclusion Criteria:

* Current or prior history of solid organ transplantation, significant pulmonary disease, significant cardiac disease, or porphyria
* Inability to exclude hepatocellular carcinoma (HCC) by imaging within 6 months of baseline/Day 1
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Screening ECG with clinically significant abnormalities
* Prior exposure to SOF or any other nucleotide analogue HCV nonstructural protein 5B (NS5B) inhibitor or any HCV NS5A inhibitor
* Laboratory results outside of acceptable ranges at screening
Ultrasound Image Collection for the Development of an AI Software

This study is designed to collect ultrasound images from healthy volunteers in the U.S.

The goal of this study is to create an ultrasound image dataset of healthy volunteers from the U.S. population. This dataset will be used for development of an AI software which will assist anesthesiologists in detection of key anatomical structures on the ultrasound image for peripheral nerve block applications. These blocks are:

* Interscalene Brachial Plexus
* Supraclavicular Brachial Plexus
* Infraclavicular Brachial Plexus
* Cervical Plexus
* Axillary Brachial Plexus
* PECS I \& II
* Transversus Abdominis Plane (TAP)
* Rectus Sheath
* Femoral Nerve
* Adductor Canal
* Popliteal Sciatic
* Erector Spinae Plane (ESP)

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* At least 18 years of age and older
* Stated willingness to comply with all study procedures and availability for the duration of the study
* In good general health

Exclusion Criteria:

* Pregnancy
* Inability to lie to flat
* Any complaint or anatomical deformity on the regions to be scanned
Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial

The purpose of the study is to investigate new therapies to alleviate pain on neuropathic chronic pain. At this time, the main purpose is to complete a feasibility or pilot study with 60 participants suffering from neuropathic chronic pain. Participants will be randomized to (1) Ketamine (Hydrochloride) HCL; (2) psychotherapy (using Cognitive Behavioral Therapy); or (3) a combination of Ketamine HL and psychotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age
2. Diagnosis of chronic neuropathic pain as determined by a pain specialist with moderate-to-severe neuropathic pain as per ID pain questionnaire, with mean pain scores \> 3 on a numeric rating scale (NRS), in the 7 days preceding inclusion
3. For participants of childbearing potential, use highly effective or double-barrier methods of contraception. Abstinence is acceptable if it is the preferred and usual lifestyle of the participant
4. Capacity to provide informed consent

Exclusion Criteria:

1. Patients less than 18 years of age
2. Current or lifetime history of schizophrenia, psychotic disorder, bipolar disorder, or borderline personality disorder
3. Known history of hypersensitivity or allergy to Ketamine-HCL
4. Current history of dissociative disorders
5. Current concomitant use of theophylline or aminophylline
6. Current elevated intracranial pressure
7. Pregnancy or ongoing breastfeeding in female participants
8. Concomitant active substance use in the 6 months preceding enrolment (amphetamines, alcohol, and ketamine)
9. Contraindication to receiving Ketamine-HCL (e.g. current or lifetime history of cerebrovascular accident; current significant hypertension \[systolic blood pressure higher than 160 mmHg and/or diastolic blood pressure higher than 100 mmHg\]; current severe cardiac decompensation \[e.g. presence of dyspnea, peripheral edema, elevated jugular venous pressure, hepatomegaly, pulmonary rales, pleural effusions\])
BIOtinidase Test In Optic-Neuropathy

Biotinidase is an enzyme that recycles biotin, a water-soluble vitamin essential as a coenzyme for four carboxylases that are involved in gluconeogenesis, fatty acid synthesis, and in the catabolism of several branch-chain amino acids. Biotinidase deficiency (BD) is an autosomal recessively inherited disorder. Patients with profound BD (\<10% of mean normal serum biotinidase activity) presents, usually during early childhood, with neurological (seizures, hypotonia, ataxia, developmental delay, vision problems, and/or hearing loss) and non-neurological findings (metabolic acidosis, respiratory difficulties, alopecia and/or skin rash) that may progress to coma or death if untreated.

Three cases of adult-onset biotinidase deficiency with reversible optic neuropathy have recently been described in France, where there is no neonatal screening of BP. Once treated with Biotin, patients' vision was fully restored.

This study aims to assess the prevalence of BP among a population of patients with idiopathic optic neuropathy, and to assess the efficacy of Biotin supplementation on visual impairment in these patients.


Eligibility Criteria:
Inclusion Criteria:

* patient with bilateral optic neuropathy
* symptoms beginning before 50 years old
* diagnosed for more than 1 months
* etiology unknown

Exclusion Criteria:

* none
Development and Accuracy Evaluation of Gram Staining Analysis AI

The investigators use Gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of Gram staining analysis AI


Eligibility Criteria:
Inclusion Criteria:

* Patients in whom a Gram stain test was ordered

Exclusion Criteria:

* No exclusion criteria
Changes in Cerebral Oxygenation Related to Intraoperative Position Changes

This is a prospective, observational study. This study will assess the effect of temporary changes in body position (supine, head of bed elevated 30 degrees, head of bed elevated 60 degrees) in anesthetized patients. Tissue oxygenation will be assessed non-invasively using near infrared spectroscopy (NIRS) by a device that is used in our operating rooms and the ICU setting to assess cerebral and tissue oxygenation.


Eligibility Criteria:
Inclusion Criteria:

* Patients 10-21 years of age undergoing posterior spinal fusion, requiring neurophysiologic monitoring and an arterial cannula

Exclusion Criteria:

* Patients in whom an arterial cannula is not indicated for the surgical procedure
* Patients with comorbid conditions that may impact cerebral blood flow, cerebral perfusion or place them at risk for cerebral hypoperfusion
* Patients in whom an invasive arterial cannula cannot be placed
Study to Assess the Reliability of PASI Scoring Using Digital-Based Images

This is an open-labeled study to evaluate the reliability of digital photographs for the remote assessment of the disease severity of plaque psoriasis.

This study is being conducted to evaluate the reliability of digital photography for the remote assessment of psoriasis disease severity using the Psoriasis Area and Severity Index (PASI) compared to in-person evaluations. Approximately 30 adult subjects will undergo in-person assessments of the severity of the disease and have digital photographs taken for comparative remote evaluations.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects aged 18 to 75 years, inclusive, at the time of consent.
2. Subject has at least a 6-month history of plaque psoriasis prior to screening visit (information obtained from medical chart or subject's physician, or directly from the subject).
3. Subject has plaque psoriasis covering at least 0.5% his/her total BSA at screening/Day 1 visit.
4. Subject has a PGA score ≥2 at screening/Day 1 visit.

Exclusion Criteria:

1. Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
Femoral frACturEs and COVID-19.

Retrospective cohort study comparing the early prognosis after surgically-treated proximal femur fragility fractures in patients affected and not affected by COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥45 years
* Admitted to IRCCS Orthopaedic Institute Galeazzi for proximal femur fractures from march 2020 to april 2020.
* Tested for COVID-19 through naso-pharyngeal swab analized with RT-PCR

Exclusion Criteria:

* Age \<45 years
* Not tested for SARS-CoV-2
* Other fractures (including bilateral proximal femur fractures)
A Safety and Efficacy Study of NAC in Patients With TA-TMA

HSCT associated thrombotic microangiopathy(TA-TMA) is a heterogeneous, fatal disorder seen within 100 days post-transplant and presents with thrombocytopenia, hemolysis, acute renal failure, mental status changes and involvement of other organs. N-Acetylcysteine (NAC) is a small, simple molecule that began as a generic drug almost 40 years ago. It has since been approved by the FDA for many indications. The investigators conducted an prospective clinical trial to evaluate the safety and efficiency of NAC in patients with TA-TMA.

Hematopoietic stem cell transplantation (HSCT) has been commonly used as a potentially curative option in the treatment of various hematological malignancies. However, it may end up with serious complications in various systems, including the hemostatic system. HSCT associated thrombotic microangiopathy(TA-TMA) is a heterogeneous, fatal disorder seen within 100 days post-transplant and presents with thrombocytopenia, hemolysis, acute renal failure, mental status changes and involvement of other organs. Since the pathophysiology has not been clarified, there are no established treatments for TA-TMA several agents seem to have successful results. N-Acetylcysteine (NAC) is a small, simple molecule that began as a generic drug almost 40 years ago. It has since been approved by the FDA for many indications. Studies showed NAC reduce plasma VWF multimers and VWF multimeric size without an effect on the bleeding time in vitro and in vivo, thus proposed as a possible supplementary treatment for TTP. The investigators conducted an prospective clinical trial to evaluate the safety and efficiency of NAC in patients with TA-TMA.

Eligibility Criteria:
Inclusion Criteria:

1. Patients be scheduled to undergo HSCT;
2. Not received decitabine 6 month ago;
3. Without severe organ damage;
4. ECOG 0-2;
5. Informed consent were obtained.

Exclusion Criteria:

1. Be sensitive to NAC;
2. Bronchial asthma；
3. Peptic ulcer；
4. Severe organ damage；
5. Pregnancy and breastfeeding women；
The Effectiveness and Safety of Topiramate on Prevention of Chronic Migraine

The purpose of this study is to evaluate the safety and effectiveness of individualized doses (50 to 200 milligrams) of topiramate tablets compared against placebo for the prevention of chronic migraine headaches over a period of 16 weeks.

Previous studies have shown that topiramate is effective in preventing chronic migraine headaches. This study will start with a 4-week baseline period in which no treatment is given, followed by a 12-week period in which each patient's dose is adjusted and then kept stable for the last 4 weeks of the 16-week double-blind phase. The individualized dose will start at 25 milligrams of topiramate per day and will be increased 25 milligrams per day once weekly and then raised to either the target--100 milligrams per day--or the maximum dose that is well tolerated up to 200 milligrams per day. Patients who are randomized to receive topiramate will remain on the optimized dose. The comparison phase of the study is a 16-week period in which the change in migraine days of patients on topiramate (taking at least 50 milligrams per day) is compared with the change in migraine days for patients on the placebo. Also studied will be the patients' health-related quality of life as assessed by questionnaires filled out at specific visits as well as the patients' views of the safety and tolerability of topiramate. The study hypothesis is that the number of migraine days, periods, and attacks from the baseline period to the last 4 weeks in the double-blind period is reduced more in the topiramate group than the placebo group. During the 16-week comparison period, patients will take by mouth a dose of 50 milligrams to 200 milligrams of topiramate daily.

Eligibility Criteria:
Inclusion Criteria:

* History of migraine for \>= 1 year
* Headache type meets HIS (International Headache Society) criteria for migraine
* History reflects "chronic" headache--an average of \>= 15 migraine days per month in the 3 months preceding trial entry
* History of chronic migraine for \>=1 year\>=15 headaches per month with an average duration of 4 hours if not treated
* Patient is otherwise neurologically and physically healthy on a pre-trial exam.

Exclusion Criteria:

* Any other type of chronic headache (besides migraine) from section 2 to 13 of the International Headache Society classification or headache resulting directly resulting some other factor (except for medication overuse)
* Onset of migraine after age 50
* Use of an anticonvulsant drug in the month prior to trial entry
* Use of an antidepressant unless dose has been used at a stable dose for \>=3 months
* Use of migraine prevention medicine in the 3 months prior to trial entry unless the drug has been used for at least 3 months and used at a stable dose for at least a month
* Use of a carbonic anhydrase inhibitor such as acetazolamide (used to treat high blood pressure, glaucoma and seizures) or triamterene (a "water pill" for swelling and high blood pressure).
A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)

The objective of this post marketing observational registry is to evaluate clinical outcomes (safety and performance) in an all-comers population with coronary artery disease (CAD) treated with the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR and planned for an abbreviated (≤ 3 months) dual antiplatelet therapy (DAPT) regimen.

This study is a prospective, observational, multi-country, multi-Centre, single-arm registry designed to evaluate the clinical safety and performance of VIVO ISAR, Polymer Free Sirolimus Eluting Coronary Stent System. The study population is made up of subjects who have undergone PCI using VIVO ISAR and are receiving standard of care short DAPT treatment (≤ 3 months) . Subjects will be screened by site teams and offered the opportunity to participate in the registry after their procedure. Rationale for this study is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent in real world CAD patients with follow-up at 1 month, 3 months and 12 months.

All medications and procedures to be used/ performed in this registry are commonly used/performed for clinical indications as part of standard of care and have well-defined safety profiles.

The study does not influence the choice of device utilized nor does it alter the routine standard of care. After a patient has been treated with the Vivo ISAR, informed consent will be requested and the eligible patient will be registered in the study.

Baseline data will be completed using medical notes. All recruited subjects will then be followed as per routine practice together with telephonic follow-up at 30 days, 3 months and 12 months from the baseline PCI procedure date.

The 30 day, 3 months and 12 month telephonic follow up will consist of a verbally report of the DAPT anticoagulation medications continued, about any lab assessments that might have happened, recording of any adverse events, and any interventional treatment that has occurred since previous contact.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent.
2. Treated only with the VIVO ISAR stent system.
3. ≥ 18 years old.
4. Male or non-pregnant female patient.
5. Intended for treatment with ≤ 3 months DAPT after PCI as per standard of care.

Exclusion Criteria:

1. Patients having any of the following conditions will not be considered (enrolled) for the study Concurrent participation in an interventional study.
2. Cardiogenic shock/hemodynamic instability around the time of the index procedure.
3. Concurrent medical condition with a life expectancy of less than 12 months.
4. Allergy or contraindication to antiplatelet therapy, cobalt chromium, sirolimus or any known hypersensitivity to the planned anti-platelet drugs.
5. History of cerebrovascular accident in the last 6 months.
6. Pregnant female.
7. PCI performed within the previous 3 months from the date of index procedure
8. Treated with another stent type during the index procedure in addition to the VIVO ISAR stent system