cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation

The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of MAA868 compared to apixaban in patients with atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥ 55 and \< 85 years old
* Body weight between 50 and 130 kg inclusive
* Atrial fibrillation or atrial flutter, as documented by electrocardiography
* CHA2DS2-VASc risk score ≥ 2 for male and female patients. Male patients with CHA2DS2VASc risk score of 1 can be included if anticoagulation therapy is warranted.
* Either anticoagulant-naïve or receiving a stable treatment of a recommended dose of a new oral anticoagulant (NOAC) over the 8 weeks prior to screening.

Exclusion Criteria:

* History of stroke, transient ischemic attack or systemic embolism
* History of major bleeding during treatment with an anticoagulant or antiplatelet therapy in the last 12 months
* History of traumatic or non-traumatic intracranial, intraspinal or intra-ocular bleeding
* Known bleeding diathesis or any known active bleeding site at screening or baseline
* Family history of bleeding disorder
* Known active GI lesions predisposing to bleeding events
* Myocardial infarction, unstable angina pectoris or coronary artery bypass graft (CABG) surgery within 12 months prior to the screening period
* Known hemodynamically significant valvular heart disease
* Uncontrolled hypertension defined as SBP/DBP ≥ 160/100 mmHg at the screening visit
* Heart failure NYHA class IV in the 3 months prior to the screening visit
* Dual antiplatelet therapy. Treatment with a P2Y12 inhibitor or low dose aspirin (≤ 100 mg/d) is allowed but not both.
* Severe renal impairment (creatinine clearance \< 30 mL/min) at the screening visit
Effect of Physiotherapy After Total Knee Replacement

Physiotherapy plays an important part in rehabilitation after total knee arthroplasty. Even if this is a common practice, few studies have been performed on this issue.

The prime aim of this study is to examine the effects of an ambulatory individualized task-oriented exercise program compared with current ambulatory physiotherapy(usual care)on activity performance and self efficacy beliefs in the time span 6 weeks to 3 months after total knee arthroplasty with a follow-up at twelve months.

HO:Task oriented physiotherapy has better effect than usual care on activity performance and self-efficacy beliefs in the time span 6 weeks to 3 months after total knee replacement.

A randomized controlled trial was performed with an experiment group having task oriented exercises in only weight-bearing 12 times from 6 weeks to 12 weeks after the operation, while the control group had usual physiotherapy care during the same time span. The primary outcome was walking measured by the six minutes walk test. Other performed and self reported measures of physical functioning were performed, at baseline, six weeks after the operation, immediately after the intervention at 12-14 weeks and with a follow-up nine months after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Primary gonarthrosis
* Good written and oral understanding of Norwegian
* Good cognitive function

Exclusion Criteria:

* Severe gonarthrosis in the other knee or coxarthrosis
* Neurological disorders or rheumatoid arthritis
Changed Serum Levels of Sirtuin1 and Sirtuin3 and Their Correlations With Sleep Quality and Cognitive Function in the Patients With Chronic Insomnia Disorder

The goal of this study is to explore whether mitochondrial dysfunction exists in patients with chronic insomnia disorder. The main questions it aims to answer are :

* Do serum mitochondrial markers change in patients with chronic insomnia?
* Is there a relationship between serum mitochondrial markers and sleep and cognition in patients with chronic insomnia disorder? The researchers will compare serum mitochondrial marker levels among participants in the chronic insomnia group with those in the healthy group, and analyze the relationship between the markers and sleep and cognition of the participants.

Participants will:

* Complete polysomnography, the Pittsburgh Sleep Quality Index (PSQI), the Chinese-BeiJing version of the Montreal cognitive assessment (MoCA-C), the Blue Velvet Arena Test (BVAT), the Nine Box Maze Test (NBMT) to assess sleep and cognition.
* The venous blood was drawn to detect mitochondrial marker levels.


Eligibility Criteria:
Inclusion Criteria:

* meet the diagnostic criteria of the third edition of the International Classification of Sleep Disorders,26 At the same time, meet the following requirements: ① Duration suffered form insomnia \> 6 months; ② 18-60 years old; ③ Receiving education ≥ 9 years of, without any understanding and hearing impairment; ④ The Pittsburgh Sleep Quality Index (PSQI) \> 7 sores, Hamilton Anxiety Scale-14 (HAMA-14) \< 14 scores, The Patient Health Questionnaire-9 (PHQ-9) \< 10 scores; ⑤ There was no history of any sedative and hypnotic drugs in the two weeks prior to the visit

Exclusion Criteria:

* patients during pregnancy or breastfeeding or patients who have taken sedative hypnotic drugs or any other drugs that may affect sleep, mood and cognitive function within two weeks were not eligible for the study.
Ocular Effects of Carotid Endarterectomy

All patients undergoing carotid endarterectomy in Shaare Zedek Medical Hospital, during about 1 year, will be offered to participate.

Retinal and choroidal structural changes will be assessed using swept-source OCT technology


Eligibility Criteria:
Inclusion Criteria:

* Carotid stenosis requiring surgical management

Exclusion Criteria:

* Ocular conditions: media opacities precluding fundus visualization, bilateral no-light perception
* Ocular surgery within 6 months prior to endarterectomy
Clinical Measures of Ovarian Reserve in Predicting IVF Success

The purpose of this study is to find out more about tests used to estimate the number of eggs a woman has remaining in her ovaries (her 'ovarian reserve'). It is thought that women who have a greater number of eggs or ovarian reserve may have a better chance of successful in vitro Fertilisation (IVF) treatment than those who have a smaller number of eggs. Accurately predicting the likely outcomes of IVF would be of great benefit for counselling patients before they go through expensive and demanding treatments such as IVF and IVF with Intracytoplasmic sperm injection (IVFICSI).

Over the past two decades, many endocrine and ultrasound markers have been designed and are now used as indicators of ovarian reserve. A number of screening tests are utilized to measure these markers, either by ultrasound scanning techniques or taking blood samples. However it is not yet known which, if any, best predict the outcome of IVF treatment. We would like to investigate these various measures of ovarian reserve to determine which are most accurate, particularly for predicting live birth rates, as up to now only poor to moderate quality evidence has been available for this outcome.

This will be a prospective cohort study of 300 women who already intend to undergo IVF/IVF-ICSI treatment. Study participants will have one extra blood sample and ultrasound examination, for the purposes of measuring markers of their ovarian reserve, at the start of their IVF/IVFICSI treatment cycle. No other interventions will be required and their treatment cycle will not be affected by their participation in the study.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Female, aged 18 years or above.
* First cycle of ovarian stimulation.
* Suitable for standard 'long protocol' IVF/IVF-ICSI cycle.

Exclusion Criteria:

* The participant does not understand the English language, or has special communication needs. This is because it is impractical to provide, for this small scale study, information sheets and consent forms in other languages except English.
* Patients unsuitable for standard 'long protocol' IVF/IVFICSI cycle

  * Presence of endometrioma or any other kind of ovarian cyst \> 20mm diameter.
  * Presence of Polycystic Ovarian Syndrome.
Clinical Study to Evaluate Clinical Impact of PGx-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures

The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) guided treatment when implemented into the pre-operative process for patients undergoing an elective spinal surgical procedure and requiring post-operative acute pain management, as compared to a group of subjects with the same attributes without the guidance of PGx testing for their post-surgery pain management. This study will also evaluate whether PGx testing can reduce narcotic consumption, opioid-related adverse effects, time to mobilization, medical visits and costs.

The incidence of opioid related adverse drug events can reach as high as 50% in surgical patients and poor pain management is a significant risk factor for early readmission. In addition, the rate of non- response to certain analgesics is double in patients who are poor metabolizers as demonstrated by mutations in both CPY26d alleles. Finally, there is a growing body of literature that ineffective acute pain management contributes significantly to the risk of chronic pain syndromes. Genetics and drug interactions can alter both the pharmacokinetics and pharmacodynamics of a multitude of drug compounds and in turn influence both the safety and efficacy of selected therapeutic regimens.

Pharmacogenetic-guided therapy selection can enhance patient response by facilitating the selection of the most appropriate medication at the most effective dose in the shortest possible time.

In this prospective, randomized, single-blind study, the investigators will evaluate the clinical impact of pharmacogenetics-guided treatment on the duration of the post-surgical hospital stay and on patient well-being as determined by post-op pain assessments. Additionally, the impact of PGx-guided treatment on narcotic consumption, number of adverse events, re-admission rates and costs will be evaluated during the study duration.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects over the age of 18;
* Patients undergoing an elective spine surgical procedures
* Willing and able to comply with study procedures
* Able to provide written informed consent
* Surgery timing - scheduled to occur after PGx testing and IDgenetix test report review (at least 4 days after Pre-Op visit)

Exclusion Criteria:

* Unwilling or unable to provide written informed consent and to comply with study procedures
* Any subject for whom providing a buccal swab sample would be contraindicated or not possible
* Subject with a history of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5)
* abnormal hepatic function within the last 2 years (INR \>1.2 not attributable to anticoagulant medications, AST/aspartate aminotransferase or ALT/alanine aminotransferase \>1.5x normal, or suspected cirrhosis)
* a history of malabsorption (short gut syndrome)
* any gastric or small bowel surgery less than 3 months prior to study enrollment
* Patients with a significant unstable medical condition or life threatening disease
* History of prior pharmacogenetic testing
Atrial Fibrillation After PFO Closure

An increased risk of atrial fibrillation (AF) after patent foramen ovale (PFO) closure was observed in randomized trials but systematic screening of AF was not performed in these studies. Purpose: The objective of this study was to evaluate incidence of AF in patients who underwent percutaneous PFO closure with serial 24-hours ambulatory ECG (AECG) monitoring during 6 months follow-up. Primary endpoint was incidence of AF on ECG monitoring. Secondary endpoints were clinical outcomes (symptoms, hospitalization from cardiovascular causes, ischemic stroke, or bleeding) up to 6 month follow-up.

This is a prospective, bicentric, observational cohort study which will be performed in University hospital center of Montpellier and Nîmes The study will include all consecutive patients, admitted for a percutaneous PFO closure after an ischemic stroke (IS) or a transient ischemic attack (TIA) of cryptogenic origin, or after the occurrence of a decompression illness during scuba diving. Patients eligible for the closure of a FOP in prevention of the recurrence of stroke or TIA of cryptogenic origin, was systematically evaluated for exclusion of supraventricular arrhythmia in accordance with international recommendations. This evaluation included a 12-lead ECG as well as an extended electrocardiographic monitoring lasting more than or equal to 24 hours (most frequently, performing a 72-hour ECG Holter). All patients previously has a transesophageal ultrasound (TEE) allowing to retain the diagnosis of PFO, to assess the presence or not of an atrial septum aneurysm (ASA) associated with PFO and to quantify the right to left shunt thanks to a contrast test potentiated by a Valsalva maneuver. Exclusion criteria included interatrial defect with left to right and others indications for PFO closure that cryptogenic stroke or decompression illness. Indication of PFO closure is always validated by a cardio neurological team.

The primary objective of the study was incidence of AF defined as an irregular rhythm without discernible P waves lasting at least 30 seconds on ECG monitoring during the 6-month follow-up. The secondary objectives were to evaluate the characteristics of the supra-ventricular arrhythmias (delay in onset, duration, recurrent nature), incidence of others arrhythmia, symptoms, and prognostic implications of AF (hospitalization , need of curative anticoagulation, need for cardioversion and occurrence of neurological accident documented by imagery (ischemic stroke or TIA). The investigators also evaluated risk factors for occurrence of arrhythmia.

A total of 100 patients included during 1 year is expected

Eligibility Criteria:
Inclusion Criteria:

* Men or women over the age of 18 to 60
* Benefiting from the closure of the FOP percutaneously after a cryptogenic ischemic stroke or a TIA (indication validated during a multidisciplinary meeting with neurologists and cardiologists)

Exclusion Criteria:

* Inability to perform a 24h ECG Holter
* Pregnant or lactating women
* Vulnerable people
Cardiovascular Risk Assessment for Patients With Rheumatoid Arthritis Arthritis:

One of the greatest success stories in rheumatology - the achievement of rheumatoid arthritis (RA) remission - is tempered by the fact that individuals with RA are dramatically under evaluated and under treated to reduce the risk for heart attacks and strokes. This project will build the foundation for an intervention that will test the hypothesis that the patient-centered intervention tailored to patients with RA to improve hyperlipidemia screening and treatment, thereby decreasing the risk for heart attacks and strokes.

The aims of this proposal are:

Aim 1: To identify patient and physician barriers to lower the risk for heart attacks and strokes in patients with RA.

Aim 2: To develop an intervention designed to optimize lipid screening and management in RA patients. This will consist of patient education and a decision support program to facilitate screening for hyperlipidemia (high cholesterol level) or initiation of medications to lower cholesterol (primary outcome) and self-efficacy (level of confidence in performing a task) in taking medications to lower cholesterol secondary outcome).

Aim 3: To pilot test the efficacy and feasibility of intervention developed in Aim 2. The investigators will apply methods related to clinical trials to test the feasibility of the newly developed intervention.


Eligibility Criteria:
Inclusion Criteria:

* Have RA
* Age between 40 and 75 years (inclusive)
* Provide a date of their next appointment with their rheumatologist or other physician on their care team
* Willing to work with a peer coach
* Speaks English
* Have a phone
* Has access to the internet
* Resides or lives in the US

Exclusion Criteria:

* Do not have rheumatoid arthritis
* Younger than age 40 or older than age 75
* Taking a statin
* No known history of diabetes
* No known history of CVD defined by:

  * Open heart surgery
  * Coronary angioplasty
  * History of heart failure
  * History of heart attack or stroke
Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients

To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe idiopathic RLS
* symptoms occur predominantly in the evening
* symptoms interfere with sleep onset or maintenance

Exclusion Criteria:

* Any secondary RLS
* require treatment for daytime RLS symptoms
* symptomatic neuropathies
Standardized Fecal Microbiota Transplantation for Crohn's Diseases

The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using fecal microbiota transplantation (FMT) for Ulcerative Colitis (UC), Crohn's diseases (CD), irritable bowel syndrome (IBS) and constipation have also met with some success. However, the results on CD is very limited. This marks the initial step in exploring the potential efficacy of fecal bacteriotherapy for CD. The investigators aim to evaluate the effectiveness, durability, and safety of FMT in a cohort of at least 500 patients with CD over a ten-year period

The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for CD (all age range,HBI\>4). We established a standard microbiota isolation from donated fresh stool in lab. The microbiota is then transplanted into the intestine via endoscopy or other established methods, such as mid-gut or colonic transendoscopic enteral tubing. Patients from multi-clinical centers in this study will be assigned to receive FMT or traditional treatments according to associated guidelines and follow-up for at least one year. Blood tests, imaging, endoscopy and questionnaire will be used to assess participants at study start and at study completion.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Crohn's disease, with the diagnosis remaining unchanged after at least three months of follow-up.

Willingness to undergo FMT (Fecal Microbiota Transplantation).

Exclusion Criteria:

Presence of serious conditions that made them unsuitable for inclusion (e.g., malignant neoplasms, cardiopulmonary failure, serious liver or kidney disease).
Tryptophan, Serotonin and Kynurenine in Septic Shock

Septic shock is a major cause of mortality and morbidity worldwide. Serotonin (5-HT) is released by activated platelets into the circulation, and is mediator of endothelial dysfunction. 5-HT metabolism is known in immune system via specific 5-HT receptor, also in effects on the peripheral nervous system. Kinetic of 5-HT, tryptophan, kynurenine, MAO activity and IDO activity in human septic shock was never investigated.


Eligibility Criteria:
Inclusion Criteria:

* Age above or equal to 18 years
* Strong presumption clinical sepsis
* Need for mechanical ventilation
* Body temperature above 38°C or below 36°C
* Heart rate above 90 bpm
* Systolic blood pressure of \<90mm Hg despite adequate fluid replacement or a need for vasopressors less than 3 hours
* Presence of at least one of the following criteria:

  * Ratio of arterial oxygen tension over inspired fraction of oxygen of less than 300 mm Hg
  * Urinary output below 0.5 mL per kg of bodyweight per h or below 30 mL/h (for at least 1 h)
  * Arterial lactate concentration above 2 mmol/L
* Consent signed

Exclusion Criteria:

* Age below 18 years
* Pregnancy
* Underlying disease with a poor prognosis, a life expectancy of less than 24 hours
* Depression or melancholy
* Neuropsychiatric diseases: Seizure, manic psychosis, Migraine, or Drug addiction
* Neuroendocrine tumors
* Obstructive cardiomyopathy or acute myocardial ischaemia
* Pulmonary embolism
* Advanced stage cancer, malignant haemopathy, or AIDS with a decision to withhold or withdraw aggressive therapies
* Inclusion in another clinical trial
* Patient who receive before inclusion one of the following treatment known to modify serotonin level: almotriptan, amitriptyline, amoxapine, citalopram, clomipramine, clozapine, desipramine, dihydroergotamine, dolasetron, dosulepin, doxepin, eletriptan, ergotamine, flunarizine, fluoxetine, fluvoxamine, granisetron, imipramine, indoramin, interferon Alfa, interferon alfacon-1, interferon beta, iproniazid, maprotiline, methysergide, mianserin, Milnacipran, mirtazapine, moclobemide, naratriptan, olanzapine, ondansetron, oxetorone, paroxetine, pizotifen, risperidone, sertraline, sumatriptan, tianeptine, trimipramine, tropisetron, venlafaxine,viloxazine, zolmitriptan.
* No consent
Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers?

The purpose of this study is to examine whether two clinically sensible dose regimen of fentanyl (low dose vs. high dose) lead to different pain scores as measured by the nonverbal rating scale (NRS) in healthy volunteers at 4.5 to 6.5 hours after fentanyl application. Pain modalities tested will include transdermal electrical stimulation and cold pressor pain.

The investigators hypothesize that the high dose fentanyl group will have an increase of approximately 20% in the NRS.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (ASA I-II) male volunteers
* Age \> 18 years
* BMI 18 - 25 kg/m2

Exclusion Criteria:

* Volunteers unable to give written informed consent
* Known drug allergies or intolerance to fentanyl
* Known drug allergies or intolerance to morphine and other opiates
* Recreational drug addiction or abuse
* Opiate use in the last month
* Volunteers taking confounding medication (analgesics, antihistamines, calcium or potassium channel blockers) in the last month
* History of motion sickness, neuropathy, chronic pain, neuromuscular or psychiatric disease
* Patients with renal failure (clearance \< 30 ml/min)
* obstructive sleep apnea syndrome (OSAS)
* Indication for Rapid Sequence Induction
* Patients not understanding German, French, Italian or English
Nonmyeloablative Stem Cell Transplant in Elderly

The study aimed to evaluate the efficacy of a nonmyeloablative conditioning consisting of fludarabine and total body irradiation in patients older than 60 years of age

A total of 35 patients with hematological malignancies were treated with fludarabine (30 mg/m2 x 3-5 days) and 200 cCy TBI followed by allogeneic hematopoietic stem cell transplantation (HSCT) from a matched-sibling donor.

Neutrophil recovery occurred in 89% of the patients at a median time of 15 days. On day +30, 10 patients had \> 95% donor chimerism, and 21 patients had mixed chimerism. The cumulative probabilities of grade II-IV acute GVHD and chronic GVHD were 51% and 84% respectively. Transplant-related mortality at 100 days and 1 year was 5% and 9% respectively. The probabilities of 1-year overall (OS) and progression-free survival (PFS) were 55% and 47% respectively. The estimated 1-year probability of OS and PFS for patients in early disease stages were 87% and 74% respectively , which were significantly higher than the survival and PFS estimates of 12% obtained in patients with advanced disease stages at the time of transplant

Eligibility Criteria:
Inclusion Criteria:

* patients with myeloid or lymphoid malignancy who were \> 60 years old potentially treatable with stem cell transplant

Exclusion Criteria:

* lack of an HLA-identical sibling donor