cyrilzakka/clinical-trials huggingface dataset:
Assessmet of Patients With PAH Right Ventricular Volume

The primary endpoint of this study is the percent difference between the VentriPoint Medical System (VMS) and cMRI for estimating the end diastolic and end systolic right ventricular volumes (RVEDV and RVESV) in subjects with Pulmonary Arterial Hypertension (PAH). The trial will be defined as positive if the mean VMS-cMRI percent difference is \<10% and \>-10% at a 1-sided 0.025 statistical significance level for RVEDV and for RVESV, with no safety concerns for the VMS procedure.

The objective of this study is: The comparison of the VMS and MRI values for EDV, ESV, and EF using 75 subjects.

Secondary objectives are:

The determination of VMS inter-observer and intra-observer variability of these quantities using 30 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Group 1 Pulmonary Arterial Hypertension
* IPAH
* HPAH
* APAH-CTD
* APAH-HIV
* APAH-PoPH
* APAH-Drugs/Toxins
* APAH-CHD repaired simple systemic to pulmonary shunts, i.e. ASD, VSD and/or PDA
* APAH-CHD unrepaired simple systemic to pulmonary shunts, i.e. ASD, VSD and/or PDA Patients who can be expected to lie motionless during imagine Males and females 12 years of age and older

Exclusion Criteria:

* Lack of informed consent (and assent as appropriate)
* Other forms of PH not included in inclusion criteria
* Left heart disease including clinically significant valvular disease, ,i.e. moderate or greater mitral regurgitation or stenosis or mild or greater aortic insufficiency or stenosis, pericardial disease, LV systolic dysfunction, i.e. LVEF \<40% or LVSF \<22%, and/or clinically significant LVDD
* Known/detected arrhythmia that interferes with image acquisition
* Implanted cardiac defibrillator, pacemaker, or other devices containing ferromagnetic materials
* Pregnant or breast-feeding females
* Contraindications for MRI (for those patient that undergo MRI)
* Clinically significant obstructive or restrictive lung disease
* Subjects with known HIV infection who have any clinical or laboratory evidence of any opportunistic pulmonary disease (e.g., tuberculosis, Pneumocystis carinii pneumonia, or other pneumonias)
* PAH associated with thyroid disorders, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders or splenectomy
* Any subjects with congenital heart disease other than the simple congenital to systemic shunts specified in the inclusion criteria
* PAH associated with significant venous or capillary involvement (PCWP ˃ 15 mmHg), known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis
* Clinically significant cardiac ischemic disease
* Systemic hypertension defined as SBP ˃ 160 mmHg and/or DBP ˃ 95 mmHg (treated or untreated)
* Moderate or severe hepatic impairment, i.e., Child-Pugh Class B or C
* Any subject with obstructive sleep apnea or who requires the use of CPAP or BiPAP device
Therapeutic Drug Monitoring of Secukinumab in Psoriasis Patients.

Biologics such as secukinumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a'one dose fits all' dosing regimen, leading to potential over-and undertreatment. In this study we aim to investigate the predictive value of early serum trough levels of secukinumab and determine the therapeutic window of secukinumab in psoriasis patients.

Patients will be included after signing informed consent. After inclusion, patients will continue on standard dosing schedule of secukinumab (i.e. subcutaneous injections once a week for 5 weeks (300 mg) followed by subcutaneous injections every 4 weeks). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards secukinumab. In addition, Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
2. Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

1. Participants who have currently a predominant nonplaque form of psoriasis
2. Participants who are pregnant, nursing or planning a pregnancy
3. Participants who are unable or unwilling to undergo multiple venapunctures
4. Participants who are treated according to a different dosing schedule than standard dosing of secukinumab
Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus"

The purpose of this survey is to evaluate the long-term safety and efficacy of trelagliptin tablets in patients with type 2 diabetes mellitus in the routine clinical setting.

The drug being tested in this survey is called trelagliptin tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus.

This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the trelagliptin tablet in the routine clinical setting. The planned number of observed patients will be approximately 3000.

This multi-center observational trial will be conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus patients

Exclusion Criteria:

1. Have severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
2. Have severe infection, perioperative status, or serious trauma
3. Have severe renal impairment or on dialysis due to end-stage renal disease
4. Have a history of hypersensitivity to any ingredients of this drug
Efficacy of Ear Acupuncture in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients

Chemotherapy is a cancer therapy performed on advanced cancer with quite good success, but this therapy has quite a lot of side effects. Chemotherapy induced nausea and vomiting or commonly known as CINV, is a condition of nausea and vomiting experienced by cancer patients undergoing chemotherapy, with a prevalence of around 80% of all patients undergoing chemotherapy, and 40% has the potential to become severe. This study aims to determine the efficacy of a new acupuncture modality, namely the press needle, in preventing CINV symptoms in pediatric patients with cancer undergoing chemotherapy.

The study was conducted using a randomized controlled clinical trial (RCT) design in 64 pediatric cancer patients undergoing chemotherapy who were randomized into 2 groups, namely: (1) standard medical therapy as the control group; and (2) a combination of standard therapy with press needle acupuncture as the treatment group. The ear acupuncture points used are Shenmen and Stomach, and one body acupuncture point is PC6. Outcome measurements were carried out in the form of the RINVR questionnaire to assess the intensity of nausea and vomiting measured at 4 times: (1) 12 hours before chemotherapy; (2) 12 hours after chemotherapy; (3) 3 days after chemotherapy; (4) 7 days after chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with cancer who are undergoing chemotherapy.
* Age 6 - 18 years.
* Patients with platelet counts \> 20,000/μL and neutrophil values \> 1,000/μL.
* Willing to follow the research.

Exclusion Criteria:

* Patients with local infection in the puncture area.
* Patients with anatomic abnormalities in the auricle.
* Did not complete the acupuncture therapy until it was finished (three days after chemotherapy).
Phase 1 Study of SK3530 to Investigate of the Effect of Food

This study was designed to investigate the food effect of SK3530 on the pharmacokinetics (PKs).

The PDE5 inhibitor, SK3530, is expected to be taken concomitantly with food. The food interaction studies of other PDE5 inhibitors (Viagra, Levitra and cialis) have already accomplished and the results have provided useful information to the patients. The objective of this study is to compare the pharmacokinetics (PKs) of SK3530 and its metabolite (SK3541) under the fasted and fed (low-fat meal and high-fat meal) conditions.

Eligibility Criteria:
Inclusion Criteria:

* ages 19 to 50
* body weight of (IBM) ± 20%

Exclusion Criteria:

* cardiovascular disease
* color-blindness or weakness
Brain Dynamics in Different Stages of Arousal and Anesthesia

The principle aim of this project is to characterize the changes in relative stability of the intrinsic brain dynamics during onset of sleep and induction of general anesthesia. The investigators hypothesize that brain dynamics in the awake state are critical akin to physical systems close to a second order phase transition and that during loss of consciousness the dynamics move away from the critical point.

1. Once the electrode array is placed during the first surgery (on the day of admission) we will record brain activity as subjects are waking up from anesthesia
2. While subjects are staying at New York Presbyterian hospital before the second surgery we will record brain activity. Most of the recordings will be performed as subjects are going to sleep naturally, but other recordings will be acquired during waking hours. This will not interfere with normal monitoring of seizure activity.
3. Final recording session is immediately before the second operation as general anesthesia is gradually induced. During this time subjects may be asked to follow simple commands like: "Open your eyes" in order to determine the level of consciousness. Also during this session, if arterial line is placed by the anesthesiologist for real-time blood pressure monitoring we will collect several small (\~1 ml) blood samples to determine blood concentration of anesthetics. Approximately 1 teaspoon of blood will be obtained in total. No additional venipuncture will be necessary.

No additional invasive procedures will be performed for the purposes of the study. We will use the same electrode array as is typically used for monitoring and mapping of epilepsy. Subjects will receive the same anesthetic agent as is commonly used for induction of anesthesia for this surgery (propofol). Subjects will be monitored in the same way as is normally done during surgical procedures and during your stay at New York Presbyterian hospital.

As a part of the study subjects may be asked simple questions as they go under anesthesia.

We may collect several small blood samples (described above) to determine the concentration of anesthetic agents.

Eligibility Criteria:
Inclusion Criteria:

1.Patients referred for epilepsy resection surgery with Dr. Theodore Schwartz

Exclusion Criteria:

1. Patient refusal.
2. Patients requiring rapid sequence induction because of concerns about delayed gastric emptying as a result of diabetes or other medical conditions.
3. Age less than 15 or greater than 65 years old.
4. Pregnant or nursing.
5. Inability to follow simple commands such as "Open your eyes" and "Squeeze my hand" for any reason.
6. Severe mental disability.
7. Allergy to propofol or any components of the formulation.
8. Poor suitability for propofol infusion because of other medical concerns such as severe heart disease.
9. Patients deemed to have a difficult airway thus necessitating awake fiberoptic intubation.
10. Patients with severe sleep apnea requiring CPAP/BiPAP.
Electroencephalographic Patterns of Septic Patients and Its Correlation With Cognitive Outcomes

The investigators evaluated the electroencephalographic pattern by the Sinek and Young scales during ICU stay and its correlation with cognitive impairment determined by the Montreal Cognitive Assessment (MOCA) in septic patients after 3 months of ICU discharge..

The investigators prospectively evaluate patients with sepsis and septic shock expected to stay in the intensive care unit (ICU) for at least 4 days. We used Sinek and Young scales to classify electroencephalographic patterns during ICU stay (in the first 24 hours after admission and in the third ICU day) and correlate with cognitive outcome evaluated with MOCA score 3 months after ICU discharge. The investigators evaluate as primary outcome the association between electroencephalographic abnormalities and cognitive dysfunction measured by the Montreal Cognitive Assessment (MoCA) 3 months after ICU discharge and secondary outcomes as association between electroencephalographic patterns and 28 days mortality, Quality of Life (SF-36) after 3 months of discharge, ventilator free days, vasoactive drug free days and Glasgow outcome scale.

Eligibility Criteria:
Inclusion Criteria:

Included were patients aged above 18 years, who were expected to stay in the ICU for at least 4 days, between November 2021 and November 2022.

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Exclusion Criteria:

* CNS infections,
* Structural abnormalities of the CNS, known
* Liver or uremic encephalopathy,
* Advanced dementia (Mini mental \< 9),
* Psychiatric disorder
* Epilepsy.
Mapping Genes for Type 2 (Non-Insulin Dependent) Diabetes Mellitus

The aim of the project is to positionally clone susceptibility genes for NIDDM. Patients will be ascertained in Finland from previous health surveys and hospital discharge records. Approximately 400 affected sib pairs will be collected. Families will be chosen who have, at most, one parent with NIDDM no history of IDDM. A clinical examination will be undertaken on family members and blood drawn for DNA isolation. Covariates such as body weight, blood pressure, lipid levels and urinary albumin will also be measured. The unaffected spouse and children of a subset of probands will be invited to undergo a frequently-sampled intravenous glucose tolerance test (FSIGT) to measure parameters of pancreatic function and peripheral insulin resistance (IR). A number of unrelated elderly non-diabetic subjects will also be identified to conduct a population-based association analysis.

The FSIGT analysis will be performed in Los Angeles. The DNA will be shipped to Bethesda where a total genomic scan will be performed using semi-automated fluorescence-based genotyping technology. Data from Bethesda, Los Angeles and Finland will be sent to Ann Arbor where parametric and non-parametric methods will be used to analyse both discrete traits such as NIDDM and intermediate traits like IR....

The Finland-United States investigation of NIDDM (FUSION) study is a long-term effort to

identify susceptibility genes for Type 2 diabetes (T2D) and associated quantitative traits. This

involves the phenotyping and DNA analysis of thousands of individuals living in Finland, utilizing a study design that was originally based on affected sib pairs. The majority of these samples have already been subjected to a genome scan using microsatellite markers and the original FUSION samples. Additionally, thousands of other northern European cases and controls have been subjected to genome-wide association (GWA) analysis and/or fine mapping as part of the FUSION study. More recently, the opportunity provided by the lowered sequencing costs have allowed targeted and/or whole genome sequencing of many of these individuals.

Eligibility Criteria:
* No eligibility criteria listed.
Deep Repetitive Transcranial Magnetic Stimulation for Cannabis Use Disorder

There is a credible basis for lateral prefrontal cortex and insula deep repetitive transcranial magnetic stimulation (dTMS) stimulation as a treatment for cannabis use disorder (CUD), but no studies to date have examined this. Evidence of benefit could expand the treatment options available for CUD but require randomized controlled trials (RCTs) to evaluate its efficacy. Toward an RCT of this intervention, the proposed study is a phase 1 open-label pilot trial of dTMS for adults with CUD. This study will establish the viability of an H4 protocol constituting an active arm of a future double-blind RCT.

Deep repetitive transcranial magnetic stimulation (dTMS) is a technique that stimulates areas of the brain using magnetic pulses and is an approved treatment for several mental health and substance use disorders. The treatment uses head coils to deliver the magnetic pulses. A dTMS coil called the H4 coil stimulates the lateral prefrontal cortex and insula, and has been approved for the treatment of tobacco use disorder. No studies have been conducted on the H4 coil for treat cannabis use disorder. The purpose of this pilot study is to determine feasibility and tolerability of a dTMS H4 protocol. The goal is to lay the foundation for randomized controlled trials of dTMS as a treatment for adults with moderate-to-severe cannabis use disorder.

Eligibility Criteria:
Inclusion Criteria:

* Adult, age 25-65
* DSM-5 CUD, moderate or higher (4+ DSM-5 symptoms)
* 4 or more days of cannabis use per week
* Reports inhalation as one route of administration
* Treatment-seeking (i.e., self-reported readiness to change of 5 or greater on a 0-10 readiness ruler)
* Stable domicile and reliable transportation, and willingness to attend in-person visits at SJHH Hamilton.

Exclusion Criteria:

* Current psychotic symptoms, history of schizophrenia-spectrum disorders or bipolar disorder, or current PTSD
* Active suicidality (past 3 months) or history of severe suicidality (i.e., requiring hospitalization)
* Any other mental health condition deemed incompatible by the team
* High risk alcohol involvement and/or 4+ symptoms of alcohol use disorder
* Unstable management of an existing mental health condition or anticipation of a change to the treatment over the next 3 months
* Current unstable medical condition (e.g., diabetes)
* rTMS Contraindications: intracranial or metal implants in the head or nearby regions that cannot be safely removed; history of epilepsy or seizures; pregnancy (female participants only); pacemaker and/or implantable cardioverter-defibrillators).
* Medication contraindications (e.g., bupropion \>300 mg/day due to risk of seizures, benzodiazepine equivalent dose to lorazepam \>2 mg/day).
* History of recurrent headache or migraine (past year)
* Significant literacy, visual, or hearing problems
* Co-enrollment in a clinical drug trial
The Effect of Regional Anaesthesia and Genetic Factors in the Development of Chronic Pain Following Total Knee Arthroplasty

The study aims to assess the effect of spinal anaesthesia against a general anaesthesia with a femoral block, with respect to the incidence of chronic pain following a total knee replacement.

It will also focus on genetic factors and their influence on chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* patients able to undergo a total knee arthroplasty

Exclusion Criteria:

* age more than 75 years
* known case of chronic pain syndromes
* arthroplasty not due to osteoarthritis
* sensitivity to any drugs used in protocol
The Anchor Study: Digitally Delivered Intervention for Reducing Problematic Substance Use

This study aims to validate W-SUDs as a digitally-delivered substance use disorder program through a fully-powered randomized control trial that will test the comparative efficacy of the mobile-app based substance use disorder program (W-SUDs) to reduce substance use relative to a psychoeducation control condition, which has no cognitive behavioral therapy and the content is not delivered through a conversational user interface.

Phase II will evaluate the efficacy of W-SUDs in a large scale RCT relative to a psychoeducation control condition. Primary outcomes will be measures of the quantity and frequency of substance use including number of substance use occasions, heavy drinking days (if applicable) and percent reduction in substance use occasions. Additionally, Phase II will evaluate whether W-SUDs results in a greater reduction in substance-related problems compared to a psychoeducation control group and explore if engagement with W-SUDs, relative to psychoeducation control,

1. improves symptoms of depression and anxiety;
2. improves work productivity (i.e. reduce presenteeism/absenteeism);
3. reduces cravings;
4. improves situational confidence to resist substance use.

Eligibility Criteria:
Inclusion Criteria:

1. Have a smartphone
2. Endorse a substance use concern
3. Be between 18 and 65 years of age
4. Be available and committed to engage with the Woebot app
5. Be literate in English. (This is required for inclusion because all materials will be in English).

Exclusion Criteria:

1. Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
2. Suicide attempt within the past year (12 months)
3. Symptoms of severe drug/alcohol history: History of delirium tremens; Experiencing hypertension, drenching sweats, seizures or confusion after stopping alcohol or drugs; Liver trouble (cirrhosis or hepatitis); Convulsions or GI bleeding due to drug/alcohol use
4. Opioid overdose within the past year (12 months)
5. Opioid misuse without medication-assisted treatment
6. Not residing in the U.S.
7. Previous Woebot use
Sectional Versus Full Glass Ceramic Laminate Veneers

The aim of the study is to assess the marginal adaptation, color stability and clinical performance of glass ceramic sectional veneers compared to full laminate veneers There's two null hypotheses , the first is that there is no difference in the marginal adaptation of sectional and full glass ceramic laminate veneers.

the Second is that there is no apparent change in color stability and clinical performance of sectional and full glass ceramic laminate veneers.

Although seeking for more minimally invasive treatment modalities with the use of the new advancements in ceramics and adhesive materials, however there is insufficient clinical studies assessing the ultraconservative sectional veneers has been published although there are many published case reports proving their success .

Hence the aim of this study is to assess the sectional veneers compared to laminate veneer regarding marginal adaptation, color stability and clinical performance

Eligibility Criteria:
Inclusion Criteria:

* Patients seeking for esthetics with the following criteria
* Male or female patients age range above 18 years old
* Minor esthetic defects in anterior region
* Multiple spacing
* diastemas
* Incisal fracture
* Initial proximal caries
* Patients able physically and psychologically to tolerate restorative procedures
* Patients willing to return for follow-up examinations and evaluation
* Class I occlusion

Exclusion Criteria:

* Patients free of:
* Tempromandibular disorders
* Para-functional habits
* Cracked teeth
* Moderate or deep caries
* Heavily discolored teeth
* Heavy smokers
* Enamel defects compromising bonding
* Active periodontal disease
* Pulpal disease
* Mobility
* Occlusal disturbances
* Class II and III occlusion