cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure

The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.


Eligibility Criteria:
Inclusion Criteria

Patients eligible for inclusion in this study had to fulfill all of the following criteria:

1. Patients ≥ 18 years of age, male or female.
2. Patients with a diagnosis of chronic heart failure (NYHA

   Class II - IV):
   1. LVEF ≤ 35% at Visit 1 (local measurement, within the past 6 months assessed by echocardiography, multiple uptake gated acquisition scan (MUGA), computerized tomography(CT) scan, magnetic resonance imaging (MRI) or ventricular angiography)
   2. Elevated BNP or NT-proBNP at Visit 1:

   BNP ≥ 150 pg/mL (or BNP ≥ 100 pg/mL and unplanned hospitalization for HF within the last 12 months prior to Visit 1) (according to local measurement). OR NT-proBNP ≥ 600 pg/mL (or NT-proBNP ≥ 400 pg/mL and unplanned hospitalization for HF within the last 12 months prior to Visit 1) (according to local measurement).
3. Patients had to be treated with an ACEI at a stable dose enalapril 10 mg daily at least or any other ACEI, e.g. ramipril, quinapril, lisinopril, fosinopril, perindopril, trandolapril; based on equivalent doses, for at least 4 weeks prior to Visit 1
4. Patients had to be treated with a beta-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to visit 1 (for patients not on target dose, according to local guidelines, or in absence of that medication, the reason should be documented).
5. Written informed consent to participate in the study and ability to comply with all requirements.

Exclusion Criteria

Patients with any of the following were to be excluded from participation in the study:

1. History of hypersensitivity to any of the study drugs including history or allergy to ACEIs as well as known or suspected contraindications to the study drugs or previous history of intolerance to high doses of ACEIs during up- titration process.
2. Patients treated concomitantly with both an ARB and an aldosterone antagonist in addition to study drug at Visit 1.
3. Current acute decompensated HF (defined as an acute exacerbation of a chronic heart failure status manifested by typical signs and symptoms of HF like dyspnea, fatigue etc., that may require IV therapy with diuretics, vasodilators and/or inotropic drugs).
4. Symptomatic hypotension and/or less than 95 mmHg systolic blood pressure (SBP) at Visit 1 and/or less than 90 mmHg SBP at Visit 4.
5. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty, within the past 3 months prior to Visit 1.
6. Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after Visit 1.
7. Right heart failure due to severe pulmonary disease.
8. Patients with Diabetes Mellitus.
Real Life Weight Bearing After Tibial Fractures

In this prospective case series patients with a tibial fracture are monitored with smart biofeedback systems to document the healing progression and real life weight.

Ten patients treated with a large external fixator after tibial fracture will be enrolled for this prospective case series.

Patients will be equipped with the AO Fracture Monitor (a data logger device) attached post-operatively to a connection rod of the external fixator. The device continuously measures deformation of the fixator frame due to normal weight bearing for up to 12 months by means of a strain gauge. The strain signal is processed on-board and several parameters related to the loading characteristics of the fracture are stored.

Simultaneously, patients will be equipped with a fully integrated sensor insole (OpenGo Insole, Moticon GmbH, München). This product offers long-term weight bearing data (recording and storage) and allows non-invasive documentation of real life loading in patients without affecting the daily life activity of the patient. Recording of weight-bearing data will be obtained for a maximum of 4 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Diagnosis of tibial fracture (AO 41-43)
* External fracture fixation with large external fixator
* Capable of at least partial weight-bearing
* Bone segment transport (if applicable) must be completed
* Informed consent obtained, i.e.:

  * Ability to understand the content of the patient information/ Informed Consent Form (ICF)
  * Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
  * Signed and dated Ethics Committee (EC)

Exclusion Criteria:

* External fixation as temporary stabilization
* Bone fragment compression
* Joint-bridging external fixation
* Any not medically managed severe systemic disease
* Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
* Pregnancy or women planning to conceive within the study period
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population

The summary of this study is to know which HPV types are present in genital warts in Argentinean population.

This is a prospective study. Patients will be evaluated for the presence of external anogenital warts in our clinic. Biopsy will be performed if patients have genital lesions consistent with genital warts of the external genitalia or perianal area. All patients will be provided with an informed consent for the excision biopsy procedure, before performing the biopsy of the lesion. Biopsy specimens will be held in a formol 10% solution and will be sent to the pathologist. A portion of each sample will be processed for histological analysis, which will be performed by one pathologist. The remainder of each specimen will be saved to extract DNA for PCR analysis. All biopsies will be analyzed by the same pathologist who will confirm the histology of the lesion. A part of the specimen will be kept frozen and if the biopsy confirm genital warts by histology; then the specimen will be analyzed by PCR for the presence of DNA HPV 6 and 11. The PCR analysis will be done by microarrays. Detection is performed in a subtype of array platform system which detects the different types of virus. The reports will be as undetectable / detectable and type.

The study will be conducted in the Institute of Gynecology and Fertility (Institute affiliated with the School of Medicine - University of Buenos Aires).

Chronogram of activities: all activities will be done in a maximum of 60 days

1. st visit: detect external genital warts and firm informed consent and take the biopsy
2. nd visit: inform the result

Eligibility Criteria:
Inclusion Criteria:

* women between 15 and 45 years old, with External Genital Warts

Exclusion Criteria:

* women taking corticoid therapy, having an immunosuppressed disease, pregnancy, cancer related to HPV, VIN confirmed by histology, other sexually transmitted infection, HIV+ known
Propofol and Dexmedetomidin vs Midazolam Intraoperative Sedation and POCD

This study will examine the effect of intraoperative sedation with midazolam, propofol and dexemdetomidine on the occurrence of postoperative cognitive impairment in patients undergoing surgical treatment of pertrochanteric fracture of the femur.

Patients undergoing surgical treatment of pertrochanteric femoral fracture by intramedullary fixation will be included in the study. Patients will be older than 65 years and will belong to class I to III anesthesia risk according to the ASA classification. All patients included in the study will sign informed consent. Patients with dementia, mental illness, psychoorganically altered patients, and patients with a contraindication to dexmedetomidine, propofol, midazolam or with a contraindication to spinal anesthesia will be excluded from the study. All patients included in the study will have their blood taken for laboratory analysis of red blood cells, leukocytes, CRP, PCT, ChE and IL-6. Analyzes will be performed before the procedure, on the 1st, 3rd and 5th postoperative day. All patients will be tested for Mini mental state exame (MMSE) score before surgery to rule out pre-existing cognitive impairment, and those patients who have an MMSE value \<17 prior to surgery will be excluded from the study. In premedication, patients will be randomized using three envelopes selected by the blind researcher for the contents of each envelope. According to envelope patients will be divided into three groups: dexmedetomidine group (DS), propofol group (PS) and midazolam group (MS). Neuroaxial spinal block with intrathecal administration of 12.5 - 15 mg 0.5% levobupivacaine in the intervertebral space L3 / L4 or L4 / L5 will be the technique of anesthesia. After spinal block, patients in the DS group will receive a continuous infusion of dexmedetomidine at a dose of 0.5 mcg / kg / h, patients in the PS group will receive a continuous infusion of propofol at a dose of 25-75 mcg / kg / min, while patients in the MS group will receive 0.05-0.07 mg / kg bolus i.v. midazolam. The total dose administered and the duration of surgery will be recorded. The volume of intraoperatively administered crystalloids or blood products will be recorded in all patients included in the study. In the postoperative period, pain will be measured with a numerical rating scale (NRS) 4, 8, 12 and 24 hours after surgery. All patients will receive the usual postoperative analgesia with metamizole and tramadol according to the protocol of the Department. On the 1st, 3rd and 5th postoperative days in the morning between 8.00 and 10.00, all patients will be tested for MMSE and Digit Symbol Substitution Test (DSST) score. A researcher who will evaluate MMSE and DSST values in the postoperative period will be blind to the drug that patients received intraoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Pertrochanteric fracture surgery
* Informed consent signed

Exclusion Criteria:

* MMSE before surgery \< 17
* Allergy on midazolam, propofol or dexemdetomidine
* Contraindication for neuroaxial anesthesia
An Observational Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Non-myeloid Malignancy

This observational, prospective, multicenter study will evaluate the treatment response rate and the safety of NeoRecormon (epoetin beta) in anemic patients with non-myeloid malignancy. In addition to NeoRecormon, patients receive chemotherapy for their malignancy. Data will be collected for 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Presence of solid-tumor or non-myeloid malignancy
* Patients receiving chemotherapy
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
* Patients require NeoRecormon

Exclusion Criteria:

* Hypersensitivity to the drug
* Uncontrolled hypertension
* Female patients if pregnant and/or lactating
A Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer

This study is looking at the effects of Sirolimus (Rapamycin) on BCG-specific immunity during treatment of non-muscle invasive bladder cancer (NMIBC) with maintenance BCG.

This study will evaluate change from baseline in gamma-delta T cell numbers and function and Ag85 peptide-specific T cell responses following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis or T1) bladder cancer
* In their treating physician's opinion is a good candidate for BCG therapy
* Be able to give informed consent
* Be age 18 or older
* Not be in an immunosuppressed state (e.g. HIV, use of chronic steroids)
* Not have active, uncontrolled infections
* Not be on agents known to alter rapamycin metabolism significantly
* Not have a reported history of liver disease (e.g. cirrhosis)
* Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment except basal cell carcinoma or squamous cell carcinoma of the skin.
* Not pregnant, or taking effective contraception before rapamycin therapy, during therapy and for 12 weeks after discontinuation of therapy.

Exclusion Criteria:

* Have muscle-invasive (≥T2) bladder cancer
* Unable to give informed consent
* Age \< 18
* Immunosuppressed state (e.g. HIV, use of chronic steroids)
* Active, uncontrolled infections
* On agents known to alter rapamycin metabolism significantly
* Another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)
* Patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy.
* Individuals with a reported history of liver disease (e.g. cirrhosis)
* Individuals who are not a good candidate for BCG in their treating physician's opinion
Effects of Internet-based Storytelling Programs in Reducing Mental Illness Stigma With Mediation by Interactivity and Stigma Content

Mental illness stigma has been a concerning issue globally due to its adverse effects on the recovery of people with mental illness and may delay help-seeking for mental health out of the concern of being stigmatized. With technological advancement, Internet-based mental health stigma reduction interventions have been developed to combat mental illness stigma and the effects have been promising.

The present study aimed to examine the differential effects of Internet-based storytelling programs varied on level of interactivity and stigma content in reducing mental illness stigma.

In the present study, the investigator hypothesized that an Internet-based storytelling program with a combination of interactivity and stigma content would lead to the most significant reduction in public stigma, microaggression, and social distance from people with mental illnesses, followed by Internet-based storytelling program with stigma content-only and interactivity-only, compared with control. Secondly, the investigator hypothesized that the effects observed in stigma reduction would be mediated by perceived autonomy and immersiveness due to the presence of interactivity.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or above
* able to read and understand Chinese

Exclusion Criteria:

* less than 18 years of age
* unable to read or understand Chinese
The Asia Primary Tube Versus Trab (TVT) Study

Comparison of Ahmed Glaucoma Implant (AGI) against trabeculectomy with mitomycin C in patients with uncontrolled open angle glaucoma

The objective of the Asia Primary Tube versus Trab (TVT) study is to compare the efficacy and safety of placement of an Ahmed Glaucoma Implant (AGI) (New World Medical Inc., Rancho Cucamonga, CA, USA) against trabeculectomy with mitomycin C in patients with uncontrolled glaucoma, who may or may not have had previous clear corneal cataract surgery with intraocular lens implantation, over 5 years. Outcome discrimination between the two treatment groups will be made using following parameters:

1. Intraocular pressure
2. Need for supplemental medical therapy
3. Incidence of short and long term surgical complications and need for re-operation.
4. Visual function (Visual acuity and Visual field)

Hypothesis: Glaucoma drainage implants have better surgical outcomes in terms of IOP lowering efficacy compared to trabeculectomy with mitomycin-C over 5 years in Asian patients with medically uncontrolled glaucoma.

Eligibility Criteria:
Inclusion Criteria:

1. Open angle glaucoma including primary open angle glaucoma, pseudoexfoliative or pigmentary glaucoma.
2. IOP \> 18 mm Hg on 2 or more medications on at least 2 visits
3. Informed consent given and consent form signed.

Exclusion Criteria:

1. Unwilling or unable to give consent, unwilling to accept randomisation, or unable to return for scheduled protocol visits.
2. Pregnant or nursing women
3. No light perception vision
4. Previous incisional intraocular surgery, other than uncomplicated clear corneal cataract surgery
5. Previous ocular laser in study eye (keratorefractive surgery and cyclodestructive procedure), except for laser trabeculoplasty procedures (Argon Laser and Selective Laser Trabeculoplasty)
6. Iris neovascularisation or proliferative retinopathy
7. Primary angle closure or primary angle closure glaucoma
8. Iridocorneal endothelial syndrome or anterior segment dysgenesis
9. Epithelial or fibrous downgrowth
10. Aphakia
11. Chronic or recurrent uveitis
12. Severe posterior blepharitis
13. Unwilling to discontinue contact lens use after surgery
14. Glaucoma secondary to penetrating keratoplasty, trauma, steroids, retinal disease/surgery or neovascular disease
15. Conjunctival scarring from prior ocular surgery, trauma or cicatrizing disease precluding a superior trabeculectomy
16. Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for urgent additional ocular surgery
17. Advanced glaucoma with MD \<-20dB
Neuropsychological Prognosis Factors of Smoking Cessation

The low overall effectiveness of available smoking cessation treatment so far, indicate the need for new and more efficacious ways to help smokers maintain abstinence. Smokers are a highly heterogeneous population. Identification of individual characteristics that predict success in smoking cessation is highly desirable to allow designing more specific strategies in order to enhance success in quitting tobacco.The main objective of this study is to assess whether the presence of certain neuropsychological deficits found before the initiation of smoking cessation is associated with a greater relapse rate.The secondary objectives concern how neuropsychological performance are involved in motivation and craving in the whole sample of smokers or in subsample. Long-term perspective is to define clinical or neuropsychological factors associated with agood or poor prognosis for success and provived more specific and therefore more effective care.

This is a prospective multicenter study. Patients will be recruited to anti tobacco consultations in the Montpellier and Clermont-Ferrand University Hospitals. The initial assessment includes a clinical assessment of smoking history, Axis I disorders history, motivation to quit and craving, a neuropsychological assessment : NART, RVIP task, trail Making Test, Stroop, Iowa gambling task, Hayling test, N back, verbal fluency. Then patients will be reviewed 3 times in 6 months. These visits include: CO level and cigarette consumption since the last visit, cessation strategy (medication, observance ... ), tobacco craving questionnary, withdrawal symptoms, abstinence.

The primary endpoint will be smoking abstinence objectified by the rate of carbon monoxide measured at each visit. Subjects who emerge from the study prematurely, especially patients lost to follow will be considered as failures in the statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-60 years old
* Patient applying for withdrawal regardless of the number of P / A, the length of smoking.
* Patient with nicotine dependence (Fagerstrom Test score \> or = 3)
* Patient able to understand the nature, purpose and methodology of the study
* Patient who gave written informed consent to participate in the study
* Patient agree to cooperate in the clinical and neuropsychological evaluation
* Patient affiliated to a French social security system

Exclusion Criteria:

* Patient with a physical disease being able to interact with the cognitive performances: dysthyroidies, pituitary adenomas, neurodegenerative diseases, Parkinson's disease, neoplastic diseases with intellectual location, the central neurological disorders, the cranial traumas.
* Patient in the incapacity to answer at neuropsychological tests
* Patient who can't go back at visits in 6 months
* Pregnancy women
The Use of Water Jet for Initial Treatment FOR Peri-Implant Disease

The aim of this study was to evaluate the effect of a dental water jet on initial peri-implant disease resolution.

Peri-implant disease is becoming more frequent during the last decade. Till today, there is no effective evidence-based treatment. The use of water-jet might improve those situations and reduce morbidity and implant loss.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated Informed Consent Form.
* Patient suffer from peri- implant disease
* Age Eligible for study: 18 year old and older
* Genders Eligible for study: Both

Exclusion Criteria:

* Patient substantially fails to comply with the study schedule, or treatment program as described in this Protocol.
Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB)

The purpose of the study is to determine whether glycemic control (HbA1c) is linked to chromosomal damage in type 2 Diabetes patients


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes (T2DM)
* Sex: female
* Age: \> 30years
* Medication: oral anti-diabetics and/or Insulin therapy
* Constant nutritional behavior, constant physical activity, constant weight for the last 4 weeks
* Non-smoking for at least 1 year

Exclusion Criteria:

* Patients with type 1 DM
* Age: \< 30years
* Pregnant or lactating women
* Participation in another clinical trial
* Change of medication in regard to metabolic parameters within the last 4 weeks
* Significant cardiovascular damage with NYHA \> III
* Liver disease with three-times higher transaminase values
* Chronic kidney disease with serum creatinine \> 2 mg/dl
* Dialysis
* HIV positive
* History of chronic alcohol abuse in the last two years
* History of cancer, stroke, organ transplantation
* Male