cyrilzakka/clinical-trials huggingface dataset:
NAD-supplementation in Drug naïve Parkinson's Disease

1. Primary objective: Determine if NR has an impact on the neurometabolic profile of patients with PD as measured by \[18F\]Fluorodeoxyglucose (FDG)-positron emission tomography (FDG-PET).
2. Secondary objective: Determine whether high dose oral NR improves motor symptoms associated with PD.
3. Tertiary objectives: determine whether high dose oral NR rectifies NAD metabolism and increases NAD levels in body fluids and muscle tissue.

Individuals with PD (n=30) will be recruited starting 14/02/2019 from the department of Neurology, Haukeland University Hospital. Only newly diagnosed and drug naïve PD patients are eligible for inclusion. After initial assessment at baseline, the participants will be randomly assigned (1:1) to one of two study groups (n = 15 per group): Nicotamide Riboside (NR) 500 mg x 2/day, or placebo. Participants and investigators will be masked to treatment group. Participants and investigators will be blinded (double blinded). The study will have a 4 week exposure period, during which patients will self-administer NR 500 mg x 2/day, or placebo per os. Patients will not be using any dopaminergic treatment during the study period. During baseline and 4 week follow-up, MDS-UPDRS will be performed as clinical measure. We will also collect blood, cerebral spinal fluid and muscle biopsy from all subjects at baseline and 4 week follow-up. Imaging will be performed using MRI, DAT Scan and FDG-PET at baseline and 4 week follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed with PD
2. Drug naïve with respect to dopaminergic treatment
3. Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for PD

Exclusion Criteria:

1. \[¹²³I\]FP-CIT single photon emission CT (DaTscan) does not show nigrostriatal degeneration.
2. Magnetic resonance imaging (MRI) suggestive of atypical parkinsonsism.
3. Dementia or other neurological disorder at baseline visit
4. Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit
BiPAP for Cardiomyopathy With Central Sleep Apnea

We investigated whether treatment of central sleep apnea-hypopnea with bilevel positive airway pressure (BiPAP) in patients with idiopathic dilated cardiomyopathy (IDCM) would improve LV function.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic dilated cardiomyopathy

Exclusion Criteria:

* a history of alcohol abuse, diabetes mellitus, endocrine disorders, hypertension, obstructive sleep apnea syndrome, and chronic obstructive pulmonary disease
Minimally-Invasive Cardiovascular Hemodynamic Optimization (MiCHO) Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock

Early intervention in the treatment of septic shock, including early goal-directed therapy (EGDT) in the first 6 hours of disease presentation, has been shown to significantly decrease mortality. However, this approach requires invasive hemodynamic monitoring, thus limiting its widespread application in the emergency department setting. A minimally invasive protocol utilizing esophageal Doppler monitoring (EDM) may be of benefit and practical if it is shown to result in similar outcome as EGDT.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>= 18 years old
* Source of infection
* Two or more of systemic inflammatory response syndrome criteria
* Systolic blood pressure \< 90 mmHg after a fluid bolus OR lactate \>= 4 mmol/L
* A central line has been placed for CVP/ScvO2 monitoring

Exclusion Criteria:

* Pregnancy
* Acute stroke
* Acute cardiogenic pulmonary edema
* Status asthmaticus
* Unstable cardiac dysrhythmia
* Active hemorrhage
* Acute seizure
* Drug overdose
* Trauma
* Requiring immediate surgery
* Do-not-resuscitate status
Evaluation of Early Relapse After Mandibular Lengthening Surgery

The goal of this study is to evaluate whether the use of a bone graft substitute at the osteotomy site will result in better stability and diminish early relapse after mandibular lengthening surgery.

The study focuses on the evaluation of the following hypothesis:

The use of bone graft substitute at the osteotomy site has an influence on:

* The 3-dimensional stability of the osteotomy site
* Early relapse based in the plasticity of the site

Bilateral sagittal split osteotomy (BSSO)of the mandible is a surgical procedure used to correct dentofacial discrepancies. Post-operative stability is of great concern for CMF (Cranio maxillo facial) surgeons as the goal is to achieve optimal functional outcomes, good aesthetic results and satisfaction of patients' concerns. Skeletal relapse is a known complication of mandibular lengthening surgery and is divided into two groups; short term or early relapse and long term or late relapse.

Short term relapse occurs within the first 6 to 8 weeks post-operatively and is due to intersegmental movement at the osteotomy site (osteotomy slippage) and osteosynthesis slippage. Late relapse is thought to be caused by progressive condylar resorption, a clinical entity affecting the temporomandibular joint.

The rationale to reconstruct the lateral cortical defect resulting from mandibular advancement with BSSO with a bone graft substitute lies in the prevention of an unaesthetic notching at the inferior border. The use of a self-hardening, space-occupying paste could add mechanical stability, thus increase 3D-stability at the osteotomy site and prevent early relapse.

The use of cone-beam computed tomography (CBCT) in the treatment planning and postoperative follow-up of orthognathic patients has provided the surgeons with a new three-dimensional imaging modality to evaluate the postoperative skeletal relapse and postoperative morphologic changes of the condyles. Skeletal relapse, as well as positional and dimensional changes of the condyles, can be quantified in three dimensions.

Eligibility Criteria:
Inclusion Criteria:

* Class II occlusion of non-syndromic origin, mandibular hypoplasia
* Availability of pre- and postoperative CBCT scans of sufficient quality
* Age: \>10years

Exclusion Criteria:

* Previous orthognathic surgical treatment
* Simultaneously performed genioplasty
* Plate osteosynthesis
* Buccal plate fracture during surgery
Prognostic Value Cardiac Dysfunction Assessed by Bedside Echocardiography in Critically Ill COPD Patients Requiring Mechanical Ventilation

Chronic obstructive lung disease (COPD) is a major cause of morbidity and mortality, and is a major reason for ICU admission. Cardiac function is often impaired in this disease but its association with clinical outcome has not been fully established. The study aims to investigate the association between cardiac dysfunction and clinclial outcomes.

This is a prospective observational study conducted in a 47-bed mixed ICU of tertiary academic teaching hospital. The study will be performed between January 2014 to December 2015. All patients meeting the diagnostic criteria of AECOPD and admitted to ICU are potentially eligible for the present study. Relevant demographics and laboratory measurements are obtained. Transthoracic echocardiography (TTE) is performed immediately after ICU admission by experienced intensivists. Cox proportional hazard regression model is fitted by using stepwise forward selection and backward elimination technique. If linear assumption is not satisfied, the linear spline function will be used.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients experiencing episode of exacerbation and require mechanical ventilation were admitted to ICU

Exclusion Criteria:

* COPD patients admitted to ICU due to other reasons (major surgery, ischemic heart disease, and renal failure)
* moribund and expected to die within 48 hours
* with Do-Not-Resuscitation order
Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease

OBJECTIVES: I. Phase II trial to determine surgical morbidity of decompression coring, including any adverse events in the perioperative period and the rate of secondary medical or surgical interventions.

II. Collect preliminary data to determine if decompression coring results in a substantial improvement in pain and mobility compared to conservative therapy in patients with avascular necrosis of the hip related to sickle cell disease.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage of avascular necrosis (I vs II vs III). Patients are randomized into one of two treatment arms.

Arm I: Patients undergo a core biopsy and decompression of the hip followed by a standardized program of touch down or nonweight bearing with appropriate equipment and regular physical therapy for 6 weeks and then full weight bearing if tolerated.

Arm II: Patients undergo the standardized ambulation and physical therapy program as in arm I. They do not undergo any surgical procedure.

For 1 week prior to the beginning of the standardized program and during the 6 weeks of touch down or nonweight bearing, all patients complete a weekly pain and medication diary.

Patients are followed at 3 months and 6 months, then every 6 months for 1.5 years, and then annually for up to 5 years.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of stage I, II, or III avascular necrosis (AVN) by MRI or plain film imaging that is related to sickle cell disease
* Clinically moderate to severe pain originating from the hip and/or limitation of movement of the affected hip
* AVN in the contralateral hip allowed, regardless of stage, if the primary hip is eligible If both hips eligible, most symptomatic hip enrolled

Exclusion criteria:

* Non-sickle cell arthropathies
* Concurrent chronic steroids
* Chronic transfusion therapy
* Alcoholism
A Single-Dose Study of the Safety and Tolerability of REGN475(SAR164877) in Healthy Subjects

This is a randomized, double-blind, placebo-controlled single-dose study of the safety and tolerability of intravenously administered REGN475 in healthy volunteers. The primary objective of the study is to assess the safety and tolerability of REGN475. The secondary objectives are to characterize the pharmacokinetic and immunogenicity profiles of REGN475.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female volunteers, in general good health and 21 to 65 years of age.
* Female volunteers must be post-menopausal for at least 1 year or surgically sterile.

Key Exclusion Criteria:

* Significant concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, GI, hepatic, metabolic or lymphatic disease that would adversely affect the subject's participation in this study or interpretation of safety/ PK data
* Participation in any clinical research study evaluating another investigational drug or therapy within 3 weeks or at least 5 half-lives of the investigational drug, whichever is longer, prior to the Screening Visit.
A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients

Researchers leading this study hope to learn about the safety of combining the study drug relugolix with another study drug called itraconazole or ritonavir in prostate cancer. This study is for individuals who have advanced prostate cancer and plans to have medical castration (the use of medications or chemicals to lower hormone production in the testicles). Your participation in this research will last up to 1 month.

The purpose of this research is to gather information on the safety and effectiveness of relugolix in combination with ritonavir or itraconazole. The goal of this research is to find out if combining two medications (relugolix and itraconazole or relugolix and ritonavir) could possibly lead to using less relugolix, which is an expensive drug.


Eligibility Criteria:
Inclusion Criteria:

* Must have histologically or cytologically confirmed prostate cancer with plans to start medical castration therapy.
* Age 18 or older. Because no dosing or adverse event data are currently available on the use of relugolix in combination with itraconazole or ritonavir in patients \<18 years of age, children are excluded from this study.
* Eastern Cooperative Oncology Group performance status ≤2 (Karnofsky ≥60%)
* Participants must satisfy the following laboratory criteria:
* Testosterone \> 200 ng/dl
* QTc within normal limits
* Aspartate Transferase (AST)/alanine transaminase (ALT) \< 3x upper limit of normal
* Ability to take oral medication and be willing to adhere to the medication regimen.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Need for combination systemic therapy for prostate cancer including docetaxel and/or second-generation androgen receptor pathway targeted agents (i.e. abiraterone, enzalutamide, apalutamide, darolutamide, etc).
* Concurrent therapy with strong interacting drugs with CYP3A4 and P-gp (See Appendix list of strong inhibitors or inducers) due to concerning possible drug-drug interactions with itraconazole, ritonavir and relugolix. Potential drug-drug interactions will also be reviewed by study investigators prior to enrollment.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to relugolix, itraconazole or ritonavir.
* Patients receiving treatment with another investigational drug or other intervention within 3 expected half-lives of the agent.
* Serious or uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
* New York Heart Association Class III of IV congestive heart failure
* Known gastrointestinal malabsorption.
* Active psychiatric illness/social situations that would limit compliance with protocol requirements.
Uterine Round Ligament Preservation Vs Resection in Laparoscopic Inguinal Hernia Repair in Women：A Multicenter,Stratified Randomized Controlled Trial

This study aims to compare the clinical effects of uterine round ligament preservation versus resection in laparoscopic inguinal hernia repair in women.The primary outcomes included Time required for patient surgery.The secondary outcomes included Inguinal hernia recurrence,quality of life assessment,Indicators of postoperative recovery,, et al.


Eligibility Criteria:
Inclusion Criteria:

* ►Age : Female patients over 18 years of age without a childbearing requirement

  * Diagnosis and basis : Female patients diagnosed with Unilateral inguinal hernia.
  * agreed to participate in this study and signed the informed consent form.

Exclusion Criteria:

* ►Combined with severe heart, liver, kidney and other diseases.

  * pregnant or lactating women.
  * those with surgical contraindications.
Trends and Satisfaction in Hypertensives Using Aktiia Optical BP Monitoring Device (SHINE)

The SHINE study aims to gather data on the evolution of participant's blood pressure and to correlate this with demographic, lifestyle and health factors in a hypertensive population as well as, to gather data on participants' perception of the device under test (Aktiia 24/7).


Eligibility Criteria:
Inclusion Criteria:

1. Adult participants aged 22 to 85 years old
2. A participant whose last blood pressure reading was within the last 12 months and was either:

   1. SBP ≥145
   2. or ≥DBP 90
3. People who use either an iOS or Android smartphone
4. People who have 2 arms
5. Able and willing to provide informed consent and to adhere to study procedures.

Exclusion Criteria:

1. Participants whose BP data submitted is \>180 mm Hg systolic OR \>120 mm Hg diastolic .
2. Participants with a self-reported known diagnosis of

   1. atrial fibrillation
   2. congestive heart failure
   3. heart valve disease
   4. pheochromocytoma
   5. Raynaud's disease
   6. arm lymphedema
3. Participants who take insulin
4. Participants who are on hemodialysis
5. Women who are self-reported to be pregnant
6. Participants whose arms shake uncontrollably or are paralyzed (cannot move)
7. Participants with upper arm circumference \<22 cm or \>42 cm
8. Participants with wrist circumference \>23cm
9. Participation in another interventional clinical study or use of investigational drugs in the last 30 days.
Spaso Versus Self-assisted Maneuver for Anterior Shoulder Dislocation

To compare the results and efficacy of the self-assisted Boss-Holzach-Matter maneuver for anterior shoulder dislocation and the Spaso method performed by a physician.

Introduction: There are many described maneuvers in literature describing how to reduce an anterior shoulder dislocation. Most of these maneuvers are performed by a trained physician, however, seldom are these taught to patients in case of recurrence or accidental dislocations that may occur far from a trained professional to treat. The Boss-Holzach-Matter maneuver is a simple, easy to understand and easy to perform self assisted method that has not been compared to any other method.

Hypothesis: The Boss-Holzach-Matter method is a less painful maneuver compared to the Spaso method assuming an equal success rate.

Objective: To determine whether the Boss-Holzach-Matter method is a less painful method for anterior shoulder dislocations compares to the Spaso method assuming equal success rate.

Methodology: Fifty six patients presenting acute anterior shoulder dislocation will be randomized, at the time of the admission , to either Spaso reduction method performed by a physician or the self-assisted Boss-Holzach-Matter method.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an acute anterior shoulder dislocation that are diagnosed in our hospital trauma area.

Exclusion Criteria:

* Fracture luxation of the same shoulder.
* Inability to cooperate due to mental or physical condition.
Ticagrelor Versus Clopidogrel in Left Ventricular Remodeling After ST-segment Elevation Myocardial Infarction

The purpose of the study is to evaluate the novel role of ticagrelor to improve long-term LV remodeling following ST-segment elevation myocardial infarction.

The investigators designed the HEALING-AMI study to compare the influence of ticagrelor (180 mg loading and 90 mg twice daily maintenance) vs. clopidogrel (600 mg loading and 75 mg daily maintenance) on long-term left ventricular (LV) remodeling measured by 3D echocardiography in STEMI patients undergoing primary PCI.

The primary objective of the HEALING-AMI study is to demonstrate the novel role of long-term ticagrelor therapy in reducing the risk of LV remodeling,. The secondary objectives are to reveal the cross-talk between platelet and inflammatory process in ST-segment elevation myocardial infarction (STEMI) patients. Moreover, this study will determine whether the high platelet inhibition by ticagrelor culminate the protection of infarcted myocardium.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older.
* First-time onset STEMI patients uneventfully treated with primary PCI within 12 hours of onset of symptom.
* Infarct-related artery with TIMI 0, 1, or 2 grade flow at the time of initial diagnostic angiography (before wire passage).
* proximal or mid-portion lesion of epicardial coronary artery.

Exclusion Criteria:

* Previous history of myocardial infarction.
* Left bundle branch block on ECG at the time of screening.
* Cardiogenic shock at the time of randomization.
* Refractory ventricular arrhythmias or atrial fibrillation.
* New York Heart Association class IV congestive heart failure.
* Severe or malignant hypertension (SBP\> 180 and/or DBP\> 120 mmHg).
* Fibrinolytic therapy.
* History of hemorrhagic stroke.
* Intracranial neoplasm, arteriovenous malformation, or aneurysm.
* Ischemic stroke within 3 months prior to screening.
* Platelet count \< 100,000/mm3 or hemoglobin \< 10 g/dL.
* A need for oral anticoagulation therapy that cannot be safely discontinued for the duration of the study.
* Women who are known to be pregnant, have given birth within the past 90 days, or are breast-feeding.
* Unable to cooperate with protocol requirements and follow-up procedures.
* A history of P2Y12 receptor inhibitor pretreatment (at least prior 1 month).
* An increased risk of bradycardia.
* Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer.
Remote Enhanced Assessment for Care At Home (REACH)

The goal of this single arm pilot clinical trial is to test the feasibility and acceptability of providing families of infants with kits of tele-peripheral devices to use during telemedicine visits with their usual primary care practice.

The main question it aims to answer are:

- the feasibility of providing families of infants with a kit to tele-peripheral devices to use during at-home, same-day live-interactive primary care telemedicine visits.

Participants will receive a kit with tele-peripheral devices which they will have the option to use during telemedicine visits with their primary care practice. Participants will be asked to consent to electronic record review and to complete surveys about their experiences receiving care.

The investigators will prospectively enroll 100 children (6 month 0 days to 8 months 30 days) in this one-arm pilot feasibility study. Enrolled participants will receive kits including pulse oximeters, thermometers, and tele-otoscopes as well as respiratory viral swab tests and will complete a test call with study team members to confirm ability to connect and use the devices.

After enrollment, families will continue to seek care based on their own preferences and primary care clinic guidance, but will have the ability to provide additional information to their primary care clinicians when primary care telemedicine visits occur.

The investigators will ask families to complete online surveys at 0, 30, and 180 days, and the investigators will perform chart reviews to capture visits (telemedicine and in-person to primary care, urgent care, and emergency department) and antibiotic receipt.

Eligibility Criteria:
Inclusion Criteria:

* Infants receiving care at study sites presenting for 6 mo well child visit
* Infants between 6m0d and 8m30d

Exclusion Criteria:

* Caregiver not able to consent in English or Spanish
* Child has chronic condition (prematurity \<33 weeks, congenital anomaly)
* Child is ward of the state
* Family lacks device and/or wifi plan to be able to participate in telemedicine visits
Impact of Hydroxocobalamine on Outcome of Smoke Inhalation Injury Admitted to the ICU

In Europe, hydroxocobalamin (cyanokit) has been used for suspicion of cyanide intoxication associated with the inhalation of fire smoke (1). However, the impact of hydroxocobalamin on outcome has never been thoroughly evaluated. While hydroxocobalamin has long been presented as being side-effect free, recent data suggest that in patients with severe burns, its use was associated with the occurrence of acute renal failure by intra tubular precipitation of oxalate crystals (2, 3). The purpose of this observational study is to investigate the association between use of hydroxocobalamin and outcome after smoke inhalation.

In Europe, hydroxocobalamin (cyanokit) is the antidote recommended by expert consensus in cases of suspicion of cyanide intoxication associated with the inhalation of fire smoke (1). However, cyanokit has never been evaluated in this indication. Clinical data suggest that in patients with severe burns, its use is associated with the occurrence of acute kidney injury by intra tubular precipitation of oxalate crystals (2, 3). The purpose of this observational study is to investigate the association between use of hydroxocobalamin and outcome after smoke inhalation. The results of this study should guide future research and advice on the benefit-risk ratio of hydroxocobalamin.

Eligibility Criteria:
Inclusion Criteria:

* Admission in ICU with smoke inhalation diagnosed

Exclusion Criteria:

* none