cyrilzakka/clinical-trials huggingface dataset:
Adapt Monorail Carotid Stent System: A Postmarket Clinical Follow-up Study

The purpose of this study is to get outcomes data for the Adapt Monorail Carotid System used in conjunction with the FilterWire Embolic protection system for treatment of patients that suffer from carotid artery stenosis and that cannot have surgery due to high risk factors.

According to the World Health Organization, 15 million people suffer stroke each year. Of these, 5 million die and another 5 million are permanently disabled. Predominant mechanism responsible for stroke is embolism from proximal rupture of atherosclerotic plaque and thrombus. 25-30% of stroke deaths related to the carotid stenosis. The primary therapy for carotid occlusive disease is the surgical removal of this atherosclerotic plaque from inside the artery. Another treatment option for subjects with significant surgical risk factors has been found: the carotid artery stenting is a non-surgical procedure which unblocks narrowing of the carotid artery lumen by inserting a small metal tube (stent) to keep the plaque against the wall of the artery to improve blood flow.

Eligibility Criteria:
Inclusion Criteria:

* High-risk for carotid endarterectomy due to anatomical or co-morbid conditions and either has neurological symptoms and ≥ 50% stenosis, via angiography or is asymptomatic and has ≥ 80% stenosis, via angiography
* Target lesion located in the common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation
* Arterial segment to be stented has a diameter between 4mm and 9mm
* Age ≥ 18 years
* Life expectancy \> 12 months from the date of the index procedure

Exclusion Criteria:

* Contraindication to percutaneous transluminal angioplasty (PTA)
* Severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system
* Lesions in the ostium of the common carotid artery
* Occlusion of the target vessel
* Evidence of intraluminal thrombus
* Known sensitivity to nickel-titanium
* Known allergy to heparin, aspirin or other anticoagulant/ antiplatelet therapies, or is unable or unwilling to tolerate such therapies
* Uncorrectable bleeding disorders, or will refuse blood transfusions
* History of prior life-threatening contrast media reaction
* Previous stent placement in the target vessel
* Evolving stroke or intracranial hemorrhage
* Previous intracranial hemorrhage or brain surgery within the past 12 months
* Clinical condition that makes endovascular therapy impossible or hazardous
Clinical Study in Post-operation Treatment of Cervical Cancer

The purpose of the research is to evaluate the effect of additional chemotherapy in postoperation therapy of cervical cancer patients with risk factors (big tumor, deep invasion or tumor thrombi in the vascular system).

Cervical cancer has a very high morbidity. Many patients need additional therapy after surgery in order to elevate the survival rate and life quality. In this research, we are going to give additional therapy to patients who have big tumor, deep invasion or tumor thrombi in the vascular system after surgery. randomized control method will be used in this research, in order to compare the survival rate and side effects between radiation therapy only, concurrent chemoradiotherapy, and concurrent chemoradiotherapy with additional chemotherapy. 3D-CRT and Topotecan will be used in this research.

Eligibility Criteria:
Inclusion Criteria:

1. patients who underwent the cervical cancer radical surgery in three months have higt risk factors which including deep stromal invasion,large primary tumour and/or lymphovascular spase invasion;
2. squamous carcinoma;
3. age\<70;
4. Gynecologic Oncology Group (GOG):0-2.

Exclusion Criteria:

1. negative nodes,surgical margin,and/or parametrium;
2. No serious damage to the liver and kidney function, no hypertension,diabetes and other effects of therapy complications.
Effects of Pitavastatin Treatments on the Plasma Lgi3 Level in the Patients With Dyslipidemia

Leucine-rich glioma inactivated 3(Lgi3) has been postulated to have a pro-inflammatory adipokine that inter-plays with other adipokines in adipogenesis and metabolic inflammation according to recent investigations. Thus, in this study, we sought to demonstrate that the treatment of statin can decrease Lgi3 level along with the decrease of the atherosclerosis to further evaluate the role of Lgi3 in atherosclerosis.

Patients who assigned to the pitavastatin treatment first group will be given the pitavastatin 4 mg qd treatment for 12 weeks after randomization, followed by wash-out period of 3 weeks and life-style modification treatment for 12 weeks. Similarly, patients who assigned to the life-style modification treatment first group, will be treated with life-style modification treatment for 12 weeks after randomization, followed by wash-out period of 3 weeks and pitavastatin treatment for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-80 years
* Patients with intermediate or low cardiovascular risks needing the statin treatment
* Patients with intermediate or low cardiovascular risks treating the statin treatment

Exclusion Criteria:

* Patients without signed informed consent
* Patients with myopathy
* Pregnant women or women with potential childbearing
* Patients with diabetes
* Patients with established coronary artery disease
* Patients with heart failure
* Life expectancy less than 1 year
Autistic Symptomatology and Sensory Profile in Children with Prader-Willi Syndrome

Prader-Willi Syndrome (PWS) is a rare neurodevelopmental disorder stemming from genetic damage in the 15q11-q13 region, leading to hypothalamic dysfunction. Individuals with PWS often exhibit social interaction challenges, intellectual deficits, significant eating disorders, mood disturbances, and sensory-related autistic features. Although PWS is recognized by DSM-5 as a genetic cause of Autism Spectrum Disorder (ASD), ASD diagnosis in PWS remains rare in France. The CASSPER study aims to investigate the distinct autistic and sensory profiles in children with PWS, also analyzing the potential impact of early oxytocin treatment on these manifestations, in line with recommendations for early and tailored intervention.

Prader-Willi syndrome (PWS) is a rare and complex neurodevelopmental disorder (NDD) with genetic origin linked to chromosomal damage in the 15q11-q13 region and characterised by hypothalamic dysfunction. At the psychiatric level, patients with PWS display difficulties in social interaction, mild to moderate intellectual deficit, major eating disorders, mood disorders and autistic manifestations, including hypo-/hyper-reactivity to sensory stimuli.

While the International Classification (DSM-5) lists PWS as one of the genetic causes of Autism Spectrum Disorder (ASD), little is known about the interaction between autistic traits, sensory features and PWS.

To date, assessment and diagnosis of ASD in PWS remains exceptional in standard care in France, despite the obvious importance of correct assessment for early identification and intervention.

In this context, the CASSPER study aims to identify the specificity of PWS in terms of autistic symptomatology and sensory characteristics. The CASSPER study is in line with the recommendations of the French National Health Authority (HAS) for early and appropriate guidance of children with PWS.

In addition, almost all children with PWS under the age of 5 have received early treatment with oxytocin (OT). As the neuromodulatory effect of OT treatment and the involvement of this neurohormone in the development of attachment, social interaction and sensory processing may explain a difference in autistic symptomatology, this parameter will be included in the analyses.

The CASSPER study aims to fill gaps in our knowledge of PWS and its care and could be useful more generally to improve our understanding of autistic manifestations in NDD of genetic origin.

Eligibility Criteria:
Inclusion Criteria:

* Child with genetically confirmed PWS and identification of genetic subtype;
* Child aged between 3 and 16 years;
* Hospitalisation or multidisciplinary consultation planned for the child's routine follow-up at one of the investigating centres;
* No parental/legal guardian objection.

Exclusion Criteria:

* Change in psychotropic treatment (start, change in dose or discontinuation) in the past 3 months;
* Inability to provide clear information to parents/legal guardian;
* Not covered by social security.
FF/UMEC/VI Inhaler: Qualitative Analysis and Subject Preference Survey

Three main classes of inhaled treatment exist for chronic obstructive pulmonary disease (COPD): Beta2-adrenergic agonists (which may be short (SABA) or long (LABA) acting), long-acting muscarinic acetylcholine receptor antagonists (LAMA), and inhaled corticosteroids (ICS). For subjects at higher risk of exacerbation, treatment with all these three classes of medication is recommended. This study aims to explore the potential utility of a device called single inhaler triple combination or fluticasone furoate/ umeclidinium/ vilanterol (FF/UMEC/VI) inhaler containing all three groups of compound. This is a mixed methods study with a qualitative phase and a quantitative Discrete Choice Experiment (DCE) phase and will be conducted in four stages: qualitative concept elicitation, DCE development, DCE piloting and testing, and conduct of the DCE. The study will conducted in the United Kingdom (UK), United States (US) and Germany and approximately 573 subjects with COPD will be included.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD, self-reported.
* Age: More than or equal to 40 years.
* Moderate to severe COPD, indicated by a COPD Assessment Test (CAT) score of greater than or equal to 10 or Modified Medical Research Council (MMRC) score of greater than or equal to 2.
* Currently prescribed and receiving one of the following treatment types: ICS/LABA; LABA/LAMA; ICS/LABA/LAMA (triple therapy); LAMA.
* Currently resident in the UK, US or Germany.
* Adequate written and oral fluency in language of country of residence.
* Willing and able to understand the study and provide informed consent.
* Has access to the internet (Cognitive interviews and DCE survey only).

Exclusion Criteria:

* Has taken part in any other stage of this study.
* Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).
* Any co-morbidity that would inhibit the ability to provide informed consent or allow participation in a telephone of face-to-face interview.
The Effects of a Single Session of Rhythmic Movement Program on Selected Biopsychological Parameters in PD Patients

The aim of the present study is to examine the acute effects of a specially designed musicokinetic (MSK) program for patients with Parkinson's disease (PD) on a) anxiety levels b) select kinematic and kinetic parameters, and c) frontal cortex hemodynamic responses, during gait initiation and steady-state walking.

This is a blind cross over randomized control trial (RCT) in which 13 volunteers with PD will attend a 45 min MSK program under the following conditions: a) synchronous learning format, b) asynchronous remote video- based, and c) control conditions. Changes in gait biomechanics and frontal cortex hemodynamic responses will be examined using a 10-camera 3D motion analysis (Vicon T-series, Oxford, UK), and a functional near-infrared spectroscopy (f-NIRS - Portalite, Artinis, NL) system, respectively, while anxiety levels will be evaluated using the Hamilton Anxiety Rating Scale.

Eligibility Criteria:
Inclusion Criteria:

* Hoehn and Yahr (H\&Y) Parkinson disease scale I-III
* No restriction on disease duration,
* No restriction on type of drug therapy
* Stable antiparkinsonian medication of at least 6 months
* Data collections will be "on" medication
* No participation to any other exercise program for at least 2 months
* 100% attendance of the session.

Exclusion Criteria:

* Dementia
* Deep brain stimulation,
* Cancer,
* Cardiovascular diseases
* Poor visual capability
* Poor or auditory capability
* Musculoskeletal problems
* No stable antiparkinsonian therapy
Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation

Researchers are trying to determine if an anti-diabetes medication, called Exenatide SR, is well tolerated in kidney transplant patients with elevated blood glucose levels, and if it's effective in preventing diabetes.

New diabetes can develop after transplant and may affect a transplanted kidney's health and a recipient's overall health. Currently, patients who are pre-diabetic are encouraged to exercise and lose weight. Researchers are planning to test whether an addition of this medication will lead to better results and more effectively prevent diabetes in patients who already have high blood sugars.

Exenatide SR is medication given by weekly injection. It increases insulin release in response to a meal and slows digestion. This medicine is already in use and approved by the US Food and Drug Administration (FDA) in patients with diabetes. However, it has not been approved for this indication; the FDA has allowed the use of this drug in this research study.

Eligibility Criteria:
Inclusion criteria:

* Recipients of solitary kidney transplants (i.e. not combined liver-kidney, pancreas-kidney etc.)
* At 4 months after transplantation: Prediabetes (fasting blood glucose 100-125 mg/dl; or 2 hr glucose 140-199 or HgbA1c 5.7-6.4%)

Exclusion criteria:

* Diabetes pre-transplantation
* Diabetes at 4 months
* \<18 years of age
* eGFR \<30 ml/min (estimated by MDRD equation from serum creatinine)
* Active acute cellular rejection including borderline (If treated and resolved, these patients can be included)
* BK nephropathy active
* History of pancreatitis, pre-existing moderate-to-severe gastroparesis, liver cirrhosis or family /personal history of multiple endocrine neoplasia 2 or medullary thyroid cancer
* Pregnant or breastfeeding women. Female Subject must be either:

  * Of non-child bearing potential: Post-menopausal (defined as at least 1 year without any menses) prior to screening , or documented surgically sterile or status post-hysterectomy
  * Or if childbearing potential, agree not to try and become pregnant during the study for at least 90 days after the final study drug administration. And have a negative serum or urine pregnancy test. And if heterosexually active, agree to consistently use two forms of highly effective birth control.
* Hypersensitivity to Exenatide
Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.

To compare the uptake of azithromycin in white cells relative to plasma concentrations in HIV-infected patients.

Patients are randomized to receive azithromycin orally or intravenously, with crossover to the alternate treatment after a 21-day wash-out period.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretroviral agents, provided regimen has been stable for at least 1 month.

Patients must have:

* HIV infection.
* CD4 count \<= 200 cells/mm3.
* No active opportunistic infection (pending discussion with Pfizer Clinician).

Prior Medication:

Allowed:

* Prior antiretroviral agents.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active intercurrent illness (pending discussion with the Pfizer Clinician).
* Allergies to macrolide antibiotics.
* Signs and symptoms of severe illness that would preclude treatment.

Patients with the following prior conditions are excluded:

* History of clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
* Clinically important change in baseline status within 4 weeks prior to study entry.
* Condition affecting drug absorption (e.g., ulcers, gastrectomy, HIV-associated enteropathies) within 4 weeks prior to study entry.

Prior Medication:

Excluded:

* Investigational drugs including treatment IND drugs within 4 weeks prior to study entry.

Known drug or alcohol dependence.
Same Day Discharge (SDD) After Implantable Cardioverter Defibrillator (ICD) Implant

The purpose of this study is to determine whether it is safe to send patients home from the hospital on the same day following an implantable cardioverter defibrillator (ICD) implant.

SDD for ICD is a prospective, randomized, multi-center study designed to show that SDD is safe in a defined patient population receiving an ICD implant and that this approach can be more cost effective for the hospital than the current NDD approach. Safety is to be demonstrated by showing that postoperative complications do not occur at a higher rate in the SDD group of patients when compared to the NDD group. Cost effectiveness is to be demonstrated by comparing health care utilization between the SDD and NDD groups for the first week post implantation. Patients who were implanted with a St. Jude Medical single or dual chamber ICD for primary prevention and who met all inclusion and exclusion criteria may be enrolled in the study. Patients areconsidered enrolled at the point of randomization.

Randomization is assigned in a 1:1 ratio between the NDD group and the SDD group. Patients will undergo study evaluations after implant, pre-discharge, 1-week and 6 months post implant.

Eligibility Criteria:
Inclusion Criteria:

* Patient has a St Jude Medical device that is compatible with Merlin.net (remote monitoring)
* Patient is receiving an implantable cardioverter defibrillator for primary prevention
* Patient lives within 50 miles of an emergency room or 24 hour urgent care
* Patient is able to sign informed consent

Exclusion Criteria:

* Patient experiences a complication during or 4 hours after implantable cardioverter defibrillator procedure
* Physician elects to keep the patient in over night due to a change in medical condition or a pre-existing condition that requires administration of continuous blood thinners
* Physician is unable to program the implantable cardioverter defibrillator to collect all required information remotely from device
* Patient is pregnant
ROX Index in Acute Respiratory Failure

evaluation of ROX index among ICU patients to evaluate the success of non invasive ventilation or the need for intubation


Eligibility Criteria:
Inclusion Criteria:

* Participants admitted to RICU with type I and type II respiratory failure requiring NIV support with one or more of the following :

  1. PaO2/FiO2 less than or equal to 300 mmHg despite supplying oxygen at a flow rate ≥ to 10 l/min for ≥ 15 min
  2. Patients requiring ventilatory support due to increased respiratory rate ≥ 25 breaths/min or using accessory muscles of respiration

Exclusion Criteria:

* 1. Absolute indication for intubation like coma, hemodynamic instability, or life-threatening arrhythmia.

  2. Contraindication to NIV like untreated pneumothorax, pneumothorax with air leak, widespread facial burn or trauma, tracheotomy,or active upper gastrointestinal bleeding.

  3. Resusal to participate in the study
Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran

This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal study participants following a single dose of BMT with or without a single 8 mg po dose of Zofran given 30 minutes before BMT dosing.

This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal study participants following a single dose of BMT with or without a single 8 mg po dose of Zofran given 30 minutes before BMT dosing. The study consists of a 21-day screening period for subject eligibility followed by a 1-day double-blind period in which all subjects receive a single open-label dose of 1.75 mg SC BMT after receiving a single blinded dose of Zofran (ondansetron) 8 mg or placebo. Approximately 228 subjects will be enrolled at up to two study sites in the United States. Safety and tolerability of BMT administration will be summarized and assessed.

Eligibility Criteria:
Key Inclusion Criteria:

1. Willing and able to provide written informed consent prior to participating in the study.
2. Female subjects ≥18 to 55 years of age (inclusive) and premenopausal as defined by the modified STRAW criteria (specifically, Stage -5 \[menses variable to regular\] through Stage 1 \[≥2 skipped cycles and an interval of amenorrhea ≥60 days\]).
3. Able to communicate clearly with the Principle Investigator (PI) and staff; able to read English, complete questionnaires, and understand study procedures.
4. Able to complete all screening period evaluations, stay in the clinic testing facility for minimum of 4 hours following dose of BMT.
5. In good general health, free from clinically significant medical or psychiatric illness or disease (as determined by medical/surgical history, physical examination, weight, 12-lead ECG, and clinical laboratory tests).

Key Exclusion Criteria:

1. Postmenopausal female, designated by having amenorrhea for ≥12 months.
2. Has current or recent (within 6 months) history of gastrointestinal disease, or any surgical or medical condition such as Crohn's disease or liver disease, that could potentially alter the absorption, metabolism, or excretion of the study drug.
3. Has any clinically significant medical condition, physical exam finding, or ECG abnormality, or clinically significant abnormal value for hematology, serology, clinical chemistry, or urinalysis at Screening, or at admission to the study center, as assessed by the PI.
4. Has any of the following:

   - History or current diagnosis of uncontrolled hypertension defined as: Two (2) sequential assessments (at least 5 minutes apart and no more than 15 minutes apart) at levels \>140 mmHg SBP or 90 mmHg DBP and/or treatment for hypertension that has been changed at least once in the 4 weeks before Screening.

   - Renal dysfunction (creatinine clearance \< 80 mL/min using Cockcroft Gault calculation).
5. History or presence of malignancy within the past 5 years, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma), which is allowed.
Comparison of Costoclavicular Brachial Plexus Block and Supraclavicular Brachial Plexus Block

The investigator will compare Costoclavicular approach of infraclavicular block and supraclavicular block. Especially, the incidence of phrenic nerve palsy and the quality of block.

Costoclavicular brachial plexus block is a recently developed approach of infraclavicular brachial plexus block. Using ultrasound, all of 3 cords are well visible in single plane. Compared to conventional infraclavicular block, it needs smaller amount of local anesthetics.

Supraclavicular brachial plexus block is known as spinal anesthesia of upper extremities. It provides fast and good quality of anesthesia and analgesia. But some studies showed that there are over 50% of phrenic nerve palsy in supraclavicular block.

In this study, the investigator will compare phrenic nerve palsy incidence and block quality between Costoclavicular block and supraclavicular block using ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* ASA I or II
* Scheduled for surgery of hand or forearm

Exclusion Criteria:

* Patient refusal
* Neuromuscular disease
* Pregnancy
* Previous history of surgery of periclavicular region
* Nerve injury history
* Bleeding tendency
* Allergy to local anesthetics
* Other contraindication of regional anesthesia