cyrilzakka/clinical-trials huggingface dataset:
Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation

Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding. The new generation of ultrathin strut sirolimus-eluting stent with bioabsorbable polymer allow for shorter antiplatelets regimens and could be a good option for this high-bleeding risk patients.

Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding. The new generation of ultrathin strut sirolimus-eluting stent with bioabsorbable polymer allow for shorter antiplatelets regimens and could be a good option for this high-bleeding risk patients.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all inclusion criteria:

* Patients with Signed informed consent and
* Patients with \>=18 years old and
* Patients with chronically receiving oral anticoagulation treatment with any type of anticoagulant for any reason and
* Patients with de novo Coronary artery disease requiring both elective or urgent percutaneous revascularization due to stable coronary artery disease or acute coronary syndrome with or without ST-segment elevation, and in which an ultrathin strut Sirolimus-eluting stent with bioabsorbable polymer has been used

Exclusion Criteria:

Patients do not have to meet any exclusion criteria

* Patients treated percutaneously with any type of stent other than the SupraFlex Cruz® in the 6 months prior to the index procedure in which he or she is included.
* Use in the same procedure or in a scheduled procedure of other stents different from the one evaluated for the treatment of another vessel(s).
* Patients treatment for restenosis or stent thrombosis.
* Patients presentation in cardiogenic shock or after cardiorespiratory arrest.
* Patients with allergy to any of the components of the stent to be used.
* Patients with impossibility for follow-up.
* Patients with life expectancy less than 1 year.
Obstructive Sleep Apnea - Patient Specific Factors, Success Rate and Compliance

Obstructive sleep apnea (OSA) is a condition where the patient's breathing cease during sleep due to collapse of the oro-pharynx. The consequences are reduced quality of sleep, increased risk for developing cardiovascular disease and increased risk of accidents caused by daytime sleepiness. Among Norwegians 30-65 yrs, the prevalence of OSA are estimated to 16%. The golden standard in OSA-treatment is Continuous Positive Airway Pressure (CPAP). This is effective and must be used for life. However, CPAP-treatment might be uncomfortable for the patient, with poor compliance as a result. An alternative is Mandibular Advancing Splints (MAS), which is perceived as less troublesome and may initiate higher compliance. Through mapping of patient characteristics, the researchers investigate which patient-type benefits most from two different treatment-devices. The aim of the study is to assess how the MAS treatment differ from the CPAP treatment in respect to efficacy, compliance and impact on health related quality of life among patient diagnosed with mild/moderate OSA. All OSA patients referred to the Ear- Nose- Throat-department (ENT) at University Hospital, Northern-Norway (UNN) and St.Olavs Hospital were invited to participate in the study. The sample size at completion of the study should be 140 patients. Participants in the trial were randomly allocated to the two treatment groups, and assessed after 4 and 12 months of treatment. Data were collected through anamnesis, clinical examination, clinical photos, radiographs and questionnaires concerning general health related quality of life (SF36), oral health, cognitive aspects (HADS), sleep quality (PSQI), daytime sleepiness (Epworth's Sleepiness scale) and compliance.


Eligibility Criteria:
Inclusion Criteria:

* 10 ≤ Apnea-Hypopnea-Index ≤ 30 at baseline
* Subjective symptoms of OSA
* Ability of at least 5mm protrusion of the mandible
* Accept randomization of treatment modality
* Accept to fill in the questionnaires
* Accept to attend at planned consultations

Exclusion Criteria:

* Primarily central sleep apnea
* Known temporomandibular dysfunction (TMD)
* Mental instability
* Drug abuse
* Extensive usage of sedative medication which disqualifies for OSA-treatment
* Extensive gag-reflex or claustrophobia
* Inadequate dental support (\< 10 teeth in lower jaw)
* Inadequate periodontal support (no tooth mobility \> Miller grade I)
* Anatomical abnormalities in the nasal cavity or oro-pharynx that disqualifies the use of CPAP and/or MAS
* Anatomical abnormalities which should be surgically corrected before treatment with CPAP and/or MAS
* Severely compromised general health condition
* Pregnancy
* General health issues that disqualifies the use of CPAP and or MAS
Effects of Dexamethasone on Common Bile Duct Cannulation Time

The main aim of this clinical trial is to evaluate the effects of dexamethasone on common bile duct cannulation time during endoscopic retrograde cholangiopancreatography (ERCP) in patients with biliary pathologies. The study will also study the effects of dexamethasone on total procedure time and total fluoroscopy time during ERCP.

Participants will be divided into two groups, treatment group and placebo group. Patients in treatment group will receive dexamethasone and those in placebo group will be given normal saline before undergoing ERCP. The results in both groups will be compared to determine the effects of dexamethasone.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years or above
* Both genders, male and female patients

Exclusion Criteria:

* Age younger than 18 years or below
* Pregnant females
* Pre existing stent in CBD or pancreatic duct
* Previous history of ERCP
* Patients with billroth II surgery
* Anatomical abnormalities
* Lack of competence in patients
* Roux en Y gastric bypass
* Patients with contra indications for steroids like DM
Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration

Primary Objective:

To evaluate the long-term safety and tolerability of SAR422459 in patients with Stargardt's Macular Degeneration.

Secondary Objective:

To assess:

* Safety
* Biological activity

Patients will be followed for 15 years after completion/early termination from the previous TDU13583 study (NCT01367444).

As the initial TDU13583 study is terminated - recruitment to this LTS13588 study is over with 27 patients enrolled.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet ALL of the following criteria:

1. Provide signed and dated written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act \[HIPAA\])
2. Must have been enrolled in protocol TDU13583 (SG1/001/10)
3. Must have received a subretinal injection of SAR422459
4. Must have completed protocol TDU13583 to Week 48 or undergone an early discontinuation visit.

Exclusion Criteria:

The following would exclude Patients from participation in the study:

1. Did not receive SAR422459 as part of the TDU13583 protocol.
Impact of Positive End Maximum Voluntary Ventilation and Dyspnea Index in Patients After Valvular Heart Surgery

Pulmonary mechanics are further disturbed after cardiothoracic surgery that manifests like restrictive pathology, which may persist for weeks to months postoperatively. This experimental aimed to investigate the efficacy of a positive end-expiratory pressure device on maximum expiratory pressure, maximum voluntary ventilation, and dyspnea index in patients who underwent valve surgery.

Thirty male and female adolescent patients who underwent valve surgery aged 12-18 years old, recruited from the national heart institute enrolled in this experimental. They were assigned into two matched groups: Experimental group consisted of 15 patients, received positive end-expiratory pressure (PEEP) with a mouthpiece in addition to routine chest physiotherapy (postural drainage, percussion, vibration, and deep breathing exercises). Control group consisted of 15 patients, received routine chest physiotherapy alone. The program continued for four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male patients
* underwent valve surgery (repair or replacement) for mitral valve stenosis;
* hemodynamically stable,
* ages ranged from 12 to 18 years old-
* BMI ranges from 18.5 to 24.9
* reduced MEP, MVV and complaining from shortness of breath with exertion.

Exclusion Criteria:

* Patients with previous cardiac surgery
* congenital heart disease
* neurological disorders
* type1 diabetes mellitus
* smoker
* pacemaker implantation
* atrial fibrillation
* utilization of mechanical ventilation longer than 24 hours.
The Effect of Spice Consumption on Postprandial Vascular Function

A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. After each diet period a meal test will be conducted. Participants will consume a meal with a spice content corresponding to the diet period they have just completed. Endothelial function will be measured at 2 and 4 hours after meal consumption. Blood samples will also be taken during the 4 hours after meal consumption for measurement of lipids, immune and inflammatory markers.

A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function, lipid levels, immune and inflammatory markers. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. At baseline and after each diet period a postprandial test will be conducted. Flow mediated dilation (FMD) will conducted in the fasting state and a catheter will be inserted for blood sampling. Participants will consume a control test meal containing low spice at baseline and after each diet period the test meal will contain a level of spice that corresponds to the amount of spice consumed during the diet period. Blood samples will be taken at 30, 60, 120, 180 and 240 minutes after meal consumption, and FMD will be performed at 120 and 240 minutes.

Eligibility Criteria:
Inclusion Criteria:

Men and postmenopausal women Overweight or obese (25-35kg/m2) Non-smoking Waist circumference \>= 94cm for men and \>=80cm for women

At least one other of the following:

* LDL- cholesterol \>130mg/dL
* CRP \>1mg/L
* Triglycerides \>=150mg/dL
* HDL \<40mg/dL for men or \<50mg/dL for women
* Systolic blood pressure \>= 130mmHg or diastolic \>= 85mmHg
* Fasting glucose \>=100mg/dL

Exclusion Criteria:

* Diabetes (fasting glucose \>126mg/dL)
* Hypertension (systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg)
* Prescribed anti-hypertensive or glucose lowering drugs
* Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease
* Use of cholesterol/lipid lowering medication or supplementation (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals
* Pregnancy or lactation
* Weight loss of \>=10% of body weight within the 6 months prior to enrolling in the study
* Vegetarianism
Epidemiology and Diagnosis of Haemoptysis: a Multicenter Study

Haemoptysis is the coughing up of blood originating from the respiratory tract. It is a common and worrying clinical symptom which can be due to different aetiologies including lung cancer, tuberculosis, COPD, bronchiectasis, pneumonia, acute bronchitis or unknown origin (cryptogenic haemoptysis). Epidemiology and optimal diagnostic approach are largely unclear. Aims of this study are to define current epidemiology and to provide the best diagnostic approach by providing a diagnostic algorithm.


Eligibility Criteria:
Inclusion Criteria:

* haemoptysis requiring a diagnosis

Exclusion Criteria:

* history of known bleeding lesions in the upper or lower airways
Novel Mediators of the Lipodystrophy and Metabolic Consequences of Cushing's Disease

This proposal will evaluate the glucocorticoid mediated changes in body fat distribution and metabolism that occur in patients with Cushing's disease. The objective is to identify the mechanisms that influence both the accumulation of lipodystrophic fat and also the changes in energy expenditure and metabolism that accompany them. The study is designed to determine if the high cortisol and AgRP levels in the blood of people living with Cushing's syndrome, either from taking steroid medications or from tumors, impact body fat and metabolism by turning off brown fat, which is a type of fat that increases one's metabolism.

Cushing's disease (CD) is a disorder of chronic glucocorticoid (GC) excess that gives rise to a constellation of metabolic comorbidities and to a distinct lipodystrophic body habitus characterized by central adiposity, extremity wasting, and the accumulation of supraclavicular (SC) and dorsocervical (DC) fat in the region where human brown and beige adipose tissue is known to be concentrated. In spite of the recognized thermogenic capacity of select cervical adipocytes, the potential impact of lipomatous alterations in this depot on energy balance and metabolism in CD is unknown. To our knowledge, the "buffalo hump" and the supraclavicular fat pads - which are a sensitive physical finding for CD, have never been phenotypically characterized and the mechanisms underlying the GC mediated development of fat in these depots and the associated metabolic complications have not been explored in humans. The proposed research will advance our understanding of Cushing's lipodystrophy and its metabolic complications. Furthermore, it may lead to the identification of novel mediators and targetable pathways to attenuate the adverse effects of hypercortisolism on body composition and metabolism in CD, as well as in the significant population of patients treated with chronic GCs for an array of other clinical conditions. These findings may have important implications not only for those with Cushing's disease, but for the millions of Americans who are treated with chronic glucocorticoids for an array of clinical conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-70 yrs
2. Body mass index (BMI) \<35 kg/m2
3. Urine free cortisol (UFC) ≥150ug/d
4. Pituitary tumor \>6mm on MRI or an inferior petrosal sinus sampling with central to peripheral plasma adrenocorticotropic hormone (ACTH) gradient
5. Normal renal and thyroid function
6. HbA1c ≤8.0.

Exclusion Criteria:

1. Smoking
2. Alcohol \>2 drinks/day
3. Uncontrolled hypertension
4. HIV given potential for lipodystrophic confounding
5. Pregnancy and nursing
6. Use of beta-blockers, β-adrenergic or diabetes medications other than insulin
7. History of claustrophobia or difficulty lying flat
8. In-dwelling metal hardware.
Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study

To evaluate the percentage of Korean dyslipidemic subjects in the total group and each cardiovascular risk group achieving LDL-C target as defined by NCEP ATP Ⅲ criteria at starting doses of 10mg, 20mg and 40mg of atorvastatin after 8 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Is a Korean , dyslipidemic outpatient
2. Is eligible for LDL-lowering drug therapy at screening and baseline as determined by the following LDL-cholesterol (LDL-C) cut-off points defined by NCEP ATP Ⅲ: 2. 1 LDL-C ≥ 190 mg/dL for subjects with 0 or 1 CHD risk factor 2. 2 LDL-C ≥ 160 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk \< 10 % 2. 3 LDL-C ≥ 130 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk 10-20 % 2. 4 LDL-C ≥ 100 mg/dL for subjects with documented CHD or CHD risk equivalents (10-year risk \> 20 %)
3. Has LDL-C ≤ 220mg/dL at baseline 4. Has triglyceride level ≤ 600mg/dL at baseline

Exclusion Criteria:

1. Is pregnant or lactating
2. Has present myopathy or history of myopathy or has personal or familial history of hereditary muscular disorders or any history of rhabdomyolysis
3. Has history of intolerance or hypersensitivity to atorvastatin or other statins
4. Uncontrolled hypertension (i.e. moderate hypertension, sitting systolic BP ≥ 160mmHg and/or diastolic BP ≥ 100mmHg)
5. Has HbAlc \> 10%
6. Has any severe disease of has had any major problem or surgical procedure within the 3 months prior to screening that is likely to jeopardize the planned termination of the study. (e.g., any carcinoma, coronary angioplasty, coronary artery bypass graft, cardiac infarct, severe or unstable angina pectoris)
Efficacy and Safety of Natamycin and Lactulose Vaginal Suppositories in Treatment of Vulvovaginal Candidiasis

The purpose is to study superior efficacy of combination of Natamycin and Lactulose (Natamycin 100 mg + Lactulose 300 mg vaginal suppositories) compared to Pimafucin (Natamycin 100 mg vaginal suppositories), or Lactulose 300 mg vaginal suppositories. The second objective of the study was to investigate the safety of the combination suppositories in the treatment of vulvovaginal candidiasis in non-pregnant adult females.


Eligibility Criteria:
Inclusion Criteria:

* two or more of the following signs and symptoms of vulvovaginal candidiasis: white or yellowish-white curd-like, thick or creamy vaginal discharge; vulvar itching, burning and pain; anogenital itching and burning; discomfort in the vulva; itching, burning, painful urination (dysuria);
* yeast cells in the vaginal swab specimen;
* vaginal pH ≤ 4.5.

Exclusion Criteria:

* a clinical and laboratory diagnosis of bacterial vaginosis; vulvovaginitis caused by specific pathogens such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae; chronic inflammatory, atrophic, or oncologic diseases of the female genital tract; previous surgery on external or internal genitalia within 6 months; childbirth and abortion within 6 months.
Patient Preference for Biopsy Notification

Effective communication between physician and patient is fundamental to effective care. The recent introduction of electronic patient on-line portals has the potential to change the communication landscape. The investigators surveyed patients to assess their preferred modality for biopsy notification at 3 institutions with differing patient access to on-line portals, to ascertain what patient preferences are currently and if it has changed from historical preferences. Our hypothesis is that as patients become more familiar with ln-line portals, their preferences will likely reflect familiarity with this modality.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were 18 years of age or older and English speaking were eligible to participate

Exclusion Criteria:

* Younger than 18, non-English speaking.
A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)

The primary objectives of the trial are to assess erythroid response to darbepoetin alfa, as determined by changes in hemoglobin and/or red blood cell (RBC) transfusion-dependence and to describe the safety profile of darbepoetin alfa in patients with MDS. The secondary objective is to assess bone marrow progenitor BFU-E growth before and after treatment with darbepoetin alfa.


Eligibility Criteria:
Inclusion Criteria:- Diagnosis:

* Bone marrow aspirate/biopsy-proven MDS for \> 2 months prior to enrollment.
* MDS French-American-British (FAB) subtypes refractory anemia (RA), RA with ringed sideroblasts (RARS), RA with excess blasts (RAEB), and non-proliferative chronic myelomonocytic leukemia (CMML) \[WBC \< 12,000/ml\].
* Patients must have an untransfused hemoglobin \< 10.0 g/dL and/or patients must be red cell transfusion-dependent for a period of at least 2 months prior to study entry.

  - Laboratory:
* Bilirubin \< or = to 2 mg/dL
* ALT/SGPT \< or = to 2.5 x the upper limit of normal (ULN)
* Normal renal function (Stanford: serum creatinine \< 1.2 mg/dL \[male\], \< 1.0 mg/dL \[female\]; Vanderbilt: \< 1.5 mg/dL).

  * Age: \> or = to 18
  * Other:
* ECOG performance status 0-2.
* Patients may receive standard supportive care, including transfusions and antibiotics as required.
* Patients must be r-HuEPO naive or must not have received prior treatment with r-HuEPO \> or = to 40,000 U/week for more than 4 weeks. Exclusion Criteria:- Patients with secondary MDS or prior allogeneic bone marrow transplant.
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

The objective of this study is to investigate the safety and efficacy of aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over a period of 52 weeks in subjects who complete a short-term treatment study of pediatric patients (aged 13-17 years) with schizophrenia (031-09-003 study).


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of schizophrenia (295.30, 295.10, 295.20, 295.90, 295.60), according to DSM-IV-TR
* Male and female patients aged 13-17 years
* Patients completing the 031-09-003 study
* Patients who, in addition to their legal guardian, provide written informed consent, having understood the details of this study
* Inpatient or outpatient status

Exclusion Criteria:

* Patients who have a diagnosis of any other disease except schizophrenia, according to DSM-IV-TR
* Patients who have been compulsorily admitted to hospital
* Patients with mental retardation
* Patients with thyroid disorder
* Patients who fall under a contraindication listed in the ABILIFY package insert
* Patients with a serious hepatic, renal, cardiac or hematopoietic disorder
* Patients with a history or a complication of organic brain disorder or convulsive disorder such as epilepsy
* Patients with a history or a complication of diabetes and patients who fall under any of the following: fasting blood glucose level ≧ 126 mg/dL, non-fasting blood glucose level ≧ 200 mg/dL, HbA1c ≧ 6.5%
* Patients with a history or a complication of suicide attempt, suicidal thought or self-harm
* Patients with a score of ≧2(mild) on PART1 evaluation of CGI-SS
* Patients with a history or a complication of malignant syndrome, tardive dyskinesia or paralytic ileus
* Patients in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition
* Patients with a history or a complication of water intoxication
* Patients with Parkinson's disease
* Pregnant women, parturient women, nursing women, women of childbearing potential who wish to become pregnant during this trial. However, women of childbearing potential who are practicing an appropriate method of contraception (refer to 8.6) and have a negative pregnancy test result are eligible for inclusion in this study.
* Study enrollment is otherwise judged to be inappropriate by the Investigator or Subinvestigator
Safety Study of Stemchymal® in Acute Liver Failure

To investigate the safety of Stemchymal® via intravenous (IV) infusion in acute liver failure (ALF) and acute on chronic liver failure (ACLF) patients.


Eligibility Criteria:
Inclusion Criteria:

1. ALF or ACLF patients.
2. Subjects are between 20 and 70 years of age.
3. MELD scores meet 17 ≤ MELD ≤ 26.
4. Subjects who had completed signing informed consent.

Exclusion Criteria:

1. Subjects who had been enrolled in any other cell therapy within six months.
2. Females with a positive pregnancy test result.
3. Subjects have contraindication for liver transplantation.
4. Subjects with psychiatric illnesses.
5. Subjects who are diagnosed as active tuberculosis (TB).
6. Subjects with immunological disorders (e.g. autoimmune hepatitis) or using immunosuppressive drugs (e.g. steroid for immunosuppression) within six months prior to screening visit.
7. Subjects with unstable illnesses or contraindication for this clinical trial according to investigator's judgment.