cyrilzakka/clinical-trials huggingface dataset:
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV

To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of \>=35mmHg) by TTE.

The study design is a multi-center, prospective, non-randomized study of up to 70 implanted subjects (US) with no site representing more than 30% of the implanted subjects. The subjects will include those subjects who have previously undergone placement of a conduit between the right ventricle and pulmonary artery and now present with a dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation and/or RVOT conduit obstruction.

Eligibility Criteria:
Inclusion Criteria

1. Weight must be equal to or exceed 35 kilograms.
2. In situ conduit size of ≥ 16 mm and ≤ 24 mm in diameter.
3. Subject presents with moderate or severe pulmonary regurgitation defined as ≥3+ pulmonary regurgitation by TTE or RVOT conduit obstruction with a mean gradient of \>= 35 mmHg by TTE.
4. Subject is symptomatic as evidenced by cardiopulmonary exercise testing.
5. The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
6. The subject and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with protocol-required follow-up visits.
7. Catheterization is determined to be feasible by the treating physician.

Exclusion Criteria

1. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics)
2. Previously enrolled in this study.
3. Subject with pre-existing prosthetic heart valves in any position\*.
4. Severe chest wall deformity.
5. Leukopenia (WBC\<3000 mm3).
6. Acute or chronic anemia (Hb \<9 g/dL).
Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior

This study is designed to find out how smoking affects the way the brain responds to pleasure and how this impacts smokers' behavior. Participants will complete three sessions. The first session will be a screening and training visit to determine final eligibility. Eligible participants will work with a researcher to develop brief scripts about times when they smoke and do other activities. Next, participants will attend two magnetic resonance imaging (MRI) scans - one after abstaining from smoking for 24 hours and the other after smoking as usual. After the second MRI, participants will answer questions on their phone every day for two weeks.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* Right-handed
* Smoke \>= 10 cigarettes per day
* Smoking regularly for \>= 1 year
* Carbon Monoxide (CO) \> 8 at screening (or urinary cotinine \> 100)
* Own a compatible smartphone
* Able to read and understand English
* Able to identify at least 4 pleasurable activities they do not do concurrently with smoking or associate with smoking

Exclusion Criteria:

* Regular use of "roll your own" cigarettes
* Planning to quit smoking within the next 60 days
* Current or planned smoking cessation treatment
* Regular use of smokeless tobacco or other nicotine products
* Expired CO \> 80 parts per million
* Breath alcohol \> .000 at screening (re-attempts are allowed)
* Positive toxicology screen for exclusionary drugs
* Use of exclusionary medications
* Significant medical problems
* Currently breastfeeding, pregnant, or planning to become pregnant
* Enrollment in another study utilizing Spectrum cigarettes within the last 3 months
* Irregular slee-wake cycles (e.g. swing-shift work, unusual sleep patterns)
Dynamic Preload Parameters During Liver Transplantation

The arterial system compliance is compromised in liver cirrhotic patients. Dynamic preload variables are either pressure-based (e.g.pulse pressure variation; PPV), flow-based (e.g. stroke volume variation; SVV), or volume-based (plethysmographic variability index; PVI). It is not yet clear that dynamic preload parameters based on which mechanism will be accurate to predict fluid responsiveness in the cirrhotic patients. Therefore, this study aimed to claried which dynamic preload parameters would be more accurate during the liver transplantation.

Fluid management is crucial during liver transplantation. Patients with cirrhosis and portal hypertension have an altered blood volume distribution and pooling in the splanchnic circulation. Excess administration of intravenous fluid may increase portal hypertension due to splanchnic venous congestion and may also aggravate coagulopathy by dilution. On the other hand, fluid restriction may risk systemic and especially renal hypoperfusion. Traditional static fluid parameter, such as central venous pressure, pulmonary artery occlusion pressure, have been reported inaccurate to predict fluid responsiveness. In comparison, the recent developed dynamic fluid parameters based on heart-lung interaction were reported to be good preload indicators in a variety of different surgical settings. However, the validity of such dynamic fluid parameters is highly dependent on The arterial system compliance is compromised in liver cirrhotic patients. Dynamic preload variables are either pressure-based (e.g.pulse pressure variation; PPV), flow-based (e.g. stroke volume variation; SVV), or volume-based (plethysmographic variability index; PVI). It is not yet clear that dynamic preload parameters based on which mechanism will be accurate to predict fluid responsiveness in the cirrhotic patients. Therefore, this study aimed to claried which dynamic preload parameters would be more accurate during the liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* End stage liver disease patients scheduled for liver transplantation in National Taiwan University Hospital

Exclusion Criteria:

* Allergic reaction
* preexisting arrythmia
Stereotactic Radiosurgery (SRS) for Spine Metastases

This study will evaluate the most effective radiation dose. Patients will be randomized (like flipping a coin) to receive either low dose stereotactic radiotherapy (defined as "14 Gy") or high dose stereotactic radiotherapy (defined as 18 Gy).

This study will evaluate the pain control and the quality of life of patients with spinal metastases using stereotactic radiotherapy. Stereotactic radiotherapy is referred to as "targeted therapy". It uses special equipment to position the patient and guide the focused beams of radiation toward the cancer and away from normal surrounding tissue. This higher dose technique may work better to kill cancer cells with fewer side effects than standard radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Age greater than or equal to 18 years old.
* Prior histologically-proven, non-hematogenous malignancy (Specific exclusions are multiple myeloma and lymphoma).
* Radiographic evidence of one or two non-contiguous spinal metastases amenable to SRS.
* Metastatic disease must be symptomatic (causing either pain or neurologic symptoms).
* Maximum tumor size less than or equal to 5 cm.
* Zubrod performance status of less than or equal to 3.
* Life expectancy of greater than or equal to 3 months.
* Women/Men of childbearing potential must use effective contraception.

Exclusion Criteria:

* No prior radiation delivered to the involved area
* No evidence of spinal instability requiring urgent surgical intervention.
* No evidence of spinal cord compression requiring emergent surgical or radiotherapeutic intervention.
* No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) while on this protocol except at disease progression.Concomitant is defined as within 3 days before or after radiosurgery.
* No pregnant or lactating women.
* No active systemic infection.
* No evidence of myelopathy or cauda equina syndrome on clinical evaluation
Impact of OCT1 on Metformin Tolerance

Metformin is the first-line treatment for medical management of Type 2 Diabetes. Up to 25% of patients experience significant gastrointestinal symptoms and in approximate 5%, side-effects result in the discontinuation of metformin. It would be of great clinical significance if the underlying cause of this intolerance was identified.

Recent data has highlighted a metformin transporter in the gut - Organic Cation Transporter 1(OCT1) - as a potential culprit for the variability in metformin tolerance. Across a diabetic population, up to one in four people were shown to have a single reduced function allele for OCT1, with approximately 8% having two reduced function alleles. This may increase the risk of the individual experiencing metformin-associated side-effects, potentially due to accumulation within the cells lining the intestine. The investigators aim to show that loss of function of OCT1, either due to genetic variation or drug inhibition of OCT1, may lead to an increase in the symptoms associated with metformin intolerance.

The study is being undertaken at the Clinical Research Centre in Ninewells Hospital, Dundee. The investigators will recruit participants from the GoDARTS study (Genetics of Diabetes and Audit Research Tayside Study). The participants will be healthy controls, i.e. non-diabetic, and recruited according to their genotype of OCT1 (information from GoDARTS). The volunteers will then enter a matched cross-over study with two treatment periods. Metformin is taken during both treatment periods alongside either Omeprazole (a proton pump inhibitor used to prevent excess stomach acid, known to interact with OCT1) or placebo. The metformin dose is increased gradually during each period, to a maximum tolerated dose. The investigators expect to see a lower maximum tolerated dose in individuals with loss of function genotype, or in those taking concurrent omeprazole compared to placebo. The study will last approximately 9 weeks. Volunteers have 3 visits to the CRC, and weekly phone call interviews.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 - 80
* White European (to limit genetic variation as much as possible)
* Non-diabetic
* No previous treatment with metformin
* No known gastrointestinal pathology e.g. inflammatory bowel disease, IBS, coeliac
* No daily treatment with PPI, anti-spasmodic, or anti-motility drugs
* No daily OCT1 inhibiting drugs
* Able to complete the symptom severity score and Bristol stool chart independently i.e. no cognitive impairment or visual impairment
* Normal renal function - eGFR\>60
* Known OCT1 genotype - either normal ("wild type") or two reduced function alleles.

Exclusion Criteria:

* Does not meet inclusion criteria
* Heterozygous OCT1 genotype i.e. only one reduced function allele
* Recent involvement (\<30 days) in a CTIMP
* Pregnancy or planning to conceive
* Inability/unwillingness to comply with the protocol
Korean Coronary Bifurcation Stenting (COBIS) Registry II

The COBIS II registry is a multi-center, real-world registry of drug-eluting stenting in coronary bifurcation lesions in South Korea. From 18 major coronary intervention centers in Korea, a total of 2,873 patients were enrolled in this database between January 2003 and December 2009.

The aim of the study was to investigate long-term clinical results and predictors of adverse outcomes after percutaneous coronary intervention with drug-eluting stents for coronary bifurcation lesions in South Korea.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Any type of bifurcation lesion in major epicardial artery
* Side branch reference diameter \>= 2.3 mm and at least stentable with 2.5 mm stent
* Treated with drug-eluting stent

Exclusion Criteria:

* Protected left main disease previous CABG for LAD or LCX territory
* Cardiogenic Shock
* History of CPR in the same hospitalization
Rota China Registry

Rotational atherectomy (RA) facilitates percutaneous coronary intervention for complex de novo lesions with severe calcification. Some observational studies and a small randomized trial indicated that a strategy of routine RA did not conferred reduction in restenosis or MACE, but these studies are limited by missing follow-up, insufficient power to compare outcomes, and confounding factors in the RA group (long lesion length, etc.). With recent developments in medical therapy, advances in design and delivery of drug-eluting stents (DES), and advances in noninvasive and intravascular coronary imaging, the use of RA in current real-world practice remains to be well determined. We aimed to compile real-world clinical outcomes data for the RotablatorTM Rotational Atherectomy System in routine clinical practice in China.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Subject who is clinically indicated for PCI/stenting
* Written informed consent
* Subject is willing to comply with all protocol-required follow-up evaluation
* Subject must meet one of following angiographic/procedural inclusion criteria:

  * Target lesion is moderately to severely calcified by visual estimate
  * Unsuccessful balloon dilatation of the target lesion
  * Unsuccessful passage of device(s) (microcatheter, balloon, or stent) across the target lesion

Exclusion Criteria:

* Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI within 2 weeks
* Subject has any of the following angiographic findings:

  * Thrombus present in the target vessel (by visual estimate)
  * Significant dissection present in the target vessel (NHLBI types C-F)
  * Lesion angulation \> 60°(by visual estimate)
Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation

The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone a radical prostatectomy (should have unmeasurable PSA) or radiation therapy for prostate cancer and who have high risk disease as defined by one of the following:

  * Node positive disease post-operatively
  * Capsule involvement
  * Seminal Vesicles involvement
  * Gleason score ≥ 8
  * \>50% of core biopsies that are positive
  * Clinical Stage T2c and T3
  * Pre-op PSA \> 15 plus Gleason score of 7

    * Age greater than 18
    * ECOG Performance Status 0-1
    * Serum creatinine \<= 1.5 mg/dl
    * Granulocyte count \>= 1500/m3, Hemoglobin \> 8.0 g/dl, and platelet count \>= 100,000/m3
    * Total bilirubin \<= ULN
    * AST, ALT and Alkaline Phosphatase must be within the range allowing for eligibility.
    * Signed patient informed consent.
    * Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months thereafter.

Exclusion Criteria:

* Peripheral neuropathy \> grade 1
* History of severe hypersensitivity to Taxotere® or other drugs formulated with polysorbate 80.
* Patients who have received previous chemotherapy or are being treated on another clinical trial using an investigational agent.
* Active infection within 14 days of beginning treatment
* Patients with a serious illness or medical condition, history of significant neurologic or psychiatric or active infection.
* Patients with a current malignancy. Patients with prior a history of in situ lobular carcinoma of the breast, basal or squamous cell skin cancer, are eligible.
An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy

To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis

* To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis in the:

  * Improvement of pruritus
  * Improvement of psoriasis severity
  * Improvement of quality of life
  * Change of pruritus and psoriasis biological markers
  * Intake/application of treatments and skin care products for psoriasis and pruritus management, evaluated during a follow-up period
* To assess the time to pruritus relapse evaluated in subjects with pruritic plaque psoriasis, during the period following the Avène hydrotherapy (for the hydrotherapy group only)
* To assess the global efficacy of the Avène hydrotherapy in pruritic plaque psoriasis, according to subjects' and investigators' opinion (for the hydrotherapy group only)
* To assess the global cutaneous tolerance of the Avène hydrotherapy in subjects with pruritic plaque psoriasis (for the hydrotherapy group only)

Eligibility Criteria:
Inclusion Criteria:

* Subject with plaque psoriasis
* Subject with moderate to very severe chronic pruritus whose NRS score ≥ 4, (on a scale ranged from 0 to 10)
* Subject with chronic pruritus, i.e. for at least 6 weeks, due to plaque psoriasis

Exclusion Criteria:

* Subject with erythrodermic psoriasis, pustular psoriasis or palmoplantar keratoderma
* Subject with any other type of pruritus, not related to plaque psoriasis
* Subject with an acute, chronic or progressive disease other than plaque psoriasis which could be the origin of the pruritus
* Biotherapy, Phototherapy or PUVAtherapy treatment
* Psoriasis treatment by LASER
* Systemic or topical treatment taken/applied for psoriasis or pruritus management established or modified since the selection visit or planned to be established or modified between the inclusion visit and the end of the hydrotherapy
A Phase I Safety and Immunogenicity Trial of UBI SynVac (HIV-1 MN Octameric V3 Peptide Vaccine)

To determine the safety, immunogenicity, and optimal dose of rgp120/HIV-1MN octameric V3 peptide vaccine (SynVac) in healthy volunteers.

It is likely that the ultimate control of AIDS will depend on the development of safe and effective vaccines against HIV-1. SynVac is a synthetic candidate vaccine based on eight V3-derived peptides attached to a heptalysyl core to form radial octamers. In animal studies, the vaccine appears safe and demonstrates the capability for producing immune responses.

It is likely that the ultimate control of AIDS will depend on the development of safe and effective vaccines against HIV-1. SynVac is a synthetic candidate vaccine based on eight V3-derived peptides attached to a heptalysyl core to form radial octamers. In animal studies, the vaccine appears safe and demonstrates the capability for producing immune responses.

Twelve volunteers are entered at one of three dose levels of SynVac. At each dose level, 10 volunteers receive vaccine and two receive placebo. At least eight volunteers at each dose level must be monitored for 1 week before subsequent volunteers are entered at the next higher level. Intramuscular injections are given on day 0, 28, and 168. Approximately 12 clinic visits are required.

Eligibility Criteria:
Inclusion Criteria

Subjects must have:

* Normal history and physical exam.
* Negative for HIV by ELISA within 6 weeks of immunization.
* CD4 count \>= 400 cells/mm3.
* Normal urinalysis.

Exclusion Criteria

Co-existing Condition:

Subjects with the following conditions are excluded:

* Medical or psychiatric condition or occupational responsibilities that preclude compliance.
* Active syphilis (volunteers are eligible if serology is documented to be a false positive or due to a remote (\> 6 months) treated infection).
* Active tuberculosis (volunteers with a positive PPD and normal chest x-ray showing no evidence of TB and not requiring INH therapy are eligible).
* Hepatitis B surface antigenemia.

Subjects with the following prior conditions are excluded:

* History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
* History of anaphylaxis or other serious adverse reactions to vaccines.

Prior Medication:

Excluded:

* Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are permitted if received at least 2 weeks prior to first immunization.
* Experimental agents within the past 30 days.
* Prior HIV vaccines.

Prior Treatment:

Excluded:

* Blood products or immunoglobulin within the past 6 months.

Identifiable high-risk behavior for HIV infection, including history of injection drug use within the last 12 months prior to enrollment and higher or intermediate risk sexual behavior.
Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion

This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with either chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM) and scheduled to undergo tympanostomy tube insertion

Exclusion Criteria:

* History of sensitivity or reaction to anesthesia chosen for the procedure
* Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane
* Otitis externa
* Active acute otitis media
* Otitis media pathology requiring T-tubes
* Stenosed ear canal
* Anatomy that precludes sufficient visualization of and access to the tympanic membrane
* Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane