cyrilzakka/clinical-trials huggingface dataset:
Transvaginal Treatment of Symptomatic Cystocele Grade II-III

This observational study will evaluate treatment of symptomatic cystocele grade II-III with Cousin Biomesh and Allium Medical Endofast Reliant. Data about 100 patients will be collected. Follow-up till 3 years after the procedure. Primary endpoint is absence of recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a woman
* Patient is between 40 and 90 years old
* Patient has to sign the informed consent form prior to the procedure
* Patient has to agree with the scheduled follow-up visits on month 1, month 6, year 1, year 2 and year 3
* Patient has symptomatic anterior prolapse

Exclusion Criteria:

* Recurrence cystocele
* Patient is pregnant
* Patient has a wish to become pregnant
* Patient is taking Plavix, Sintrom, Marcoumar, Marevan, Brilique, Efient, Ticlid, Xarelto, Eliquis or Pradaxa. If intake is stopped prior to procedure, patient is allowed to be included.
* Patient is taking LMWH in a dose of more than 40 mg/day
* Patient has a life expectancy \< 1 year
* Patient has a known connective tissue disease
* Patient has a history of surgery of the anterior vaginal wall or pelvis
* A scheduled hysterectomy during the index-procedure
A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients

The purpose of this study is to determine if two dose levels of indinavir combined with two nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma viral load (level of HIV in the blood).

In this open-label study 350 seropositive HIV-1 men and women are first stratified according to baseline plasma viral RNA (less than 400 copies/mL vs negative plasma viral RNA result) then randomized into one of two arms:

Arm 1: Indinavir (800 mg, q8h) plus two pre-existing NRTIs. Arm 2: Indinavir (1,200 mg, q12h) plus two pre-existing NRTIs. Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week study.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documented HIV-1 seropositive status.
* CD4 count greater than 100 cells/mm3.
* Parental consent for patients under 18.
Feasibility of Slow-paced Respiration Therapy for Treatment of a Symptom Cluster in Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH) is a chronic illness characterized by increased pulmonary pressures resulting in right heart failure and premature death. Common symptoms that impair quality of life and functioning are dyspnea, fatigue and sleep disturbance. This trio of symptoms is highly prevalent and forms a symptom cluster (2 or more symptoms that co-occur) in PAH. From a biological, proinflammatory cytokines are implicated in dyspnea, fatigue and sleep disturbance; there is activation of the sympathetic nervous system (SNS) and an inherent inflammatory process in PAH that contributes to the pathophysiology, but the link to this symptom cluster has not been investigated. One novel, treatment for symptom clusters is slow-paced respiration therapy using the FDA-approved device, RESPeRATE. The device contains headphones and a sensor that attaches to the chest to detect inhalation and exhalation. Musical tones synchronize with the respiratory cycle to slowly guide the user to decrease respirations. RESPeRATE moderates effects of the SNS; lowers blood pressure; improves functional capacity and ejection fraction; and significantly decreases pulmonary pressures in left heart failure. The investigators will enroll 10 women with PAH to use the RESPeRATE device to perform slow-paced respiration for 15 minutes per day for 8 weeks to determine the feasibility and effects on the SNS and inflammatory activity and the symptom cluster. The investigator's overall hypothesis is that, as compared to baseline, after eight weeks of therapy women with PAH who receive slow-based respiration therapy will have lower SNS activity and inflammatory levels, and improved dyspnea, fatigue and sleep disturbance.


Eligibility Criteria:
Inclusion Criteria:

* Previous documentation of mean pulmonary artery pressure \> 25 mm Hg with a pulmonary capillary wedge pressure (or left ventricular end-diastolic pressure) \< 16 mm Hg and PVR \> 3 WU at any time before study entry.
* Women with WHO Group I PAH (idiopathic, heritable, or associated with connective tissue disease, congenital heart disease, anorexigens or HIV)
* Targeted PAH therapy at stable dose for 3 months
* Age \>21 years
* Ability to perform six minute walk testing without limitations in musculoskeletal function or coordination.
* Informed consent

Exclusion Criteria:

* Age \< 21
* Hypotension (blood pressure \< 90/60 mmHg)
* Pregnancy
* Chronic Fatigue Syndrome (current or history of)
* Known sleep disorder (obstructive sleep apnea, restless leg syndrome, narcolepsy, current or history of)
* Hospitalized or acutely ill
* Major Depression (current or history of)
* Lung transplant recipient
A Study On The Effect Of Vitano® On Physiological And Psychological Responses To Psychological Stress

A pilot investigation into the stress relieving properties of Vitano® which will assess the following hypotheses

Individuals exposed to Vitano® will demonstrate diminished blood pressure and heart rate responses to mental stress compared to individuals in the control condition

Physiological recovery (BP, HR and cortisol) from mental stress will be enhanced in individuals exposed to Vitano® compared to individuals in the control condition

Vitano® will have positive effects on cognitive functioning.

Subjective ratings of stress will be reduced in individuals exposed to Vitano® compared to individuals in the control condition

There will be a significant improvement in subjective well-being in individuals taking Vitano®.


Eligibility Criteria:
Inclusion Criteria:

* subject is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
* The subject has signed the ICF.
* Healthy male or female subjects aged 18-35 years inclusive. Attempts will be made to achieve an equal gender ratio through appropriate screening procedures, but a failure to do so will not preclude analysis of the final data set.
* A score above 30 on the Spielberger State-Trait Anxiety Inventory (STAI).
* The subject agrees to use suitable methods of contraception during the study and for 3 months afterwards.
* The subject is a non-smoker.
* The subject is, in the opinion of the Investigator, healthy on the basis of medical history, vital signs, and the results of routine laboratory tests.

Exclusion Criteria:

* The subject is pregnant or breast feeding.
* The subject consumes more than 5 caffeine-containing beverages per day.
* The subject is colour blind.
* Clinically significant hepatic or renal abnormality as determined by laboratory tests.
* BMI above 33.
* History of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence within the 12 months preceding Visit 1.
* Positive alcohol breath test at any visit. A repeat test will not be allowed. \[NOTE: subjects must be told to avoid consumption of alcoholic beverages for at least 24 hours prior to attending the Centre\].
* Use of any other medication which may interfere with study outcome and/or interfere with IMP within the 2 weeks or 5 half lives preceding the first treatment phase, with the exception of contraceptive pill, non-steroidal analgesics, and paracetamol. \[NOTE: Concomitant medications which do not influence study outcome and/or do not interfere with IMP may be allowed at the discretion of the Investigator\].
* Current participation in another clinical trial with an investigational or non-investigational drug or device, or participation in another clinical trial within the 3 months preceding Visit 1 (screening visit).
* Any condition that, in the Investigator's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.
* Moderate or severe anxiety\* \*If participants are found to have moderate or severe anxiety during the screening process then they will be referred to the University Counselling service.
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)

The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).

The study consists of a Screening Period (approximately 35 days), Period 1, Period 2, and a 20-week Follow-up Period. Period 1 is a 24-week randomized, double-blind, placebo-controlled, parallel-group period. Period 2 is the long-term period and starts at Week 24. To maintain the blind to the original treatment allocation, treatment at the Week 24 Visit is blinded: participants randomized to placebo receive blinded risankizumab 150 mg, and participants randomized to risankizumab receive blinded placebo. At Week 28 and for the remaining dosing visits (to Week 316), all participants receive open-label risankizumab 150 mg every 12 weeks. Participants remain blinded to the original randomization allocation for the duration of the study. The total study duration is 336 weeks including a telephone call 140 days (20 weeks) after last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at Screening Visit.
* Participant has active disease defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts) at both the Screening Visit and Baseline.
* Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter or nail changes consistent with psoriasis at Screening Visit.
* Participant has demonstrated an inadequate response or intolerance to biologic therapy(ies) or conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).

Exclusion Criteria:

* Participant is considered by investigator, for any reason, to be an unsuitable candidate for the study.
* Participant has a known hypersensitivity to risankizumab.
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

This trial is designed to assess the efficacy, tolerability, and safety of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in kidney transplant recipients.


Eligibility Criteria:
Inclusion criteria

1. Males and females aged 18 to 75 years.
2. Recipients of living related kidney transplant, treated with cyclosporine, with or without corticosteroids, as primary immunosuppression.
3. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to or at screening. Effective contraception must be used during the trial, and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
4. Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

Exclusion criteria:

1. Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney.
2. Patients with any known hypersensitivity to other components of the formulation (e.g. lactose).
3. Patients with low platelet count (\< 75,000/mm3), with an absolute neutrophil count of \< 1,500/mm3, and/or leukocytopenia (\< 2,500/mm3), and/or hemoglobin \< 6 g/dL at screening or baseline.
4. Patients who have received an investigational drug within four weeks prior to study entry.
5. Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
6. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.

Additional protocol-defined inclusion/exclusion criteria may apply
Compound to Control Presbyopia Symptoms

Low dose compose to control presbyopia symptoms

A los dose compound including pilocarpine, brimonidine and oxymetazoline was use to control presbyopia symptoms compared to pilocarpine and brimonidine in low doses.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* Presbyopic
* 40 - 59 years

Exclusion Criteria:

* Diabetics
* Previous eye surgery
* Previous eye disease
* \> 0.50 myopia
* \> 1.5 hyperopia or astigmatism
Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy 10 Days in the First Line Therapy

The investigators aimed to compare the eradication rates of sequential therapy for 10 days versus triple therapy for 14 days


Eligibility Criteria:
Inclusion Criteria:

* Patients are aged greater than 20 years who have H. pylori infection without prior eradication therapy and are willing to receive the sequential therapy will be eligible for enrollment.
* Written informed consents will be obtained from all patients prior to enrollment.

Exclusion Criteria:

Patients will be excluded from the study if any one of the following criteria is present:

* children and teenagers aged less than 20 years,
* history of gastrectomy,
* gastric malignancy, including adenocarcinoma and lymphoma,
* previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin, metronidazole) and prompt pump inhibitors (lansoprazole), - contraindication to treatment drugs,
* pregnant or lactating women,
* severe concurrent disease
* Patients who cannot give informed consent by himself or herself.
A Comparison of Two Surface Materials (Tantalum Versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty

The purpose of this study is to compare two surface materials (tantalum versus titanium fiber mesh) of acetabular components in hip arthroplasty.

In younger patients, acetabulum components are most often implanted without the use of cement. A direct ingrowth of bone to the implant is crucial to the attainment of good results in those cases where cement is not employed. A new implant material (tantalum) has shown better properties than the implant material which is in use today (titanium). The advantages of tantalum implants are greater porosity, reduced stiffness and a higher friction coefficient than with titanium implants.

Hypothetically, the higher porosity of tantalum should enhance bone ingrowth due to better osteoconductivity in terms of:

1. less migration of the acetabulum component, as evaluated by RSA;
2. increased BMD in the bone surrounding acetabulum components;
3. fewer postoperative complaints on the Harris Hip Score and visual analog scale scores.

The migration of acetabulum components will be evaluated by RSA. The follow-up RSA will be scheduled for week 1, as well as 3 months, 12 months and 2 years after surgery. Bone mineral density around the implanted femoral component will be examined by DEXA scan at week 1, as well as 1 year and 2 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary arthritis in the hip.
* Patients with sufficient bone density to allow uncemented implantation of a femoral component.
* Informed patient consent in writing.

Exclusion Criteria:

* Patients with neuromuscular or vascular disease in the affected leg.
* Patients found upon operation to be unsuited for uncemented acetabulum component.
* Patients who regularly take non-steroid anti-inflammatory drugs (NSAID) and cannot interrupt intake for the postoperative phase of the study.
* Patients with fracture sequelae.
* Female patients of childbearing capacity.
* Hip joint dysplasia.
* Sequelae to previous hip joint disorder in childhood.
the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections.

Pharmacological treatment of physiologic Gastro-esophageal Reflux disease (GERD) is excessive in France, as 65%-85% of children below 11 years are being treated, frequently with Proton Pump Inhibitors (PPIs) PPI have been associated, in adults, with an increase of infection rate but data in pediatry are scarce, especially in community medecine. Recently a study conducted in England brought up controversial results suggesting that the use of PPIs can be associated with a reduced risk of community acquired pneumonia.

Our study was aimed to assess, on a population-based database, the association between PPI prescription and community infections in children of 11 years or under.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 11 years or below with at least 2 consultations during the follow up

Exclusion Criteria:

* chronic pulmonary or cardiac
* muscoviscidosis
* immunodeficiency
* H. pylori infection
* Diabetes
* Denutrition
* known digestive upper tract malformation
Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae

There is an urgent need to control our current national outbreak of carbapenem-resistant Klebsiella pneumoniae (CRKP). The purpose of this study is to eradicate CRKP gastrointestinal carriage using selective digestive decontamination (SDD); with buccal and oral gentamicin and polymyxin E administration. This will reduce infections and hopefully mortality caused by CRKP.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized men and women with a positive rectal swab for CRKP
* Age 18 years or older

Exclusion Criteria:

* Age less than 18 years
* Pregnant women, lactating women
* A known allergy to the study drugs
Prospective Evaluation of PH-impedance Tracings According to the Wingate Consensus, and Influence on GERD Classification According to the Lyon Consensus

Commonly, in clinical practice an automated analysis of pH-MII tracings is obtained.

All pH-MII performed in UZ Brussel are already reviewed manually according to the Wingate con-sensus and interpreted according to the Lyon consensus. In this study, we will prospectively categorise the reasons for discarding reflux episodes identified by automated analysis during the manual review according to the Wingate consensus, as well as the impact on different parameters related to the interpretation of pH-MII. Based on comments received to our retrospective study, we will evaluate possible confounders to the interpretation, including the indication for referral for pH-MII, symptom severity, use of PPI during pH-MII.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 - 80 years old;
* pH-MII performed off PPI

Exclusion Criteria:

* Prior upper GI endoscopy indicative of structural disease (except for oesophagitis or hiatal hernia).
* Incomplete pH-MII (less than 21 hours recording);
* Ph-MII performed on PPI
* Suboptimal quality of the tracings preventing interpretation in clinical practice;
* Prior oesophageal (including anti-reflux intervention) or gastric surgery.
Prognostic Assessment of Different Pattern of Bifurcation Restenosis

The LATINA registry aims at assessing a new classification of bifurcation restenosis in the prediction of major adverse cardiac events in patients who have previously undergone a succesful percutaneous bifurcation intervention.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* restenosis involving a coronary bifurcation previously treated percutaneously

Exclusion Criteria:

* life expectancy \>1 year
Evaluation of Kidney Function by Multi-modal Magnetic Resonance Imaging and Spectroscopy

Multimodal functional magnetic resonance (MR) methods, including MR diffusion, Blood-Oxygenation Level Dependent (BOLD) imaging and MR spectroscopy may provide complementary information about the functional status of a kidney. The researchers hypothesize that these non-invasive methods correlate with histology as "gold standard" and compete favorably with conventional in part invasive evaluation methods, and thus provide specific and early detection of kidney diseases of various etiologies, drug toxicity, or renal allograft dysfunction.

Early and specific detection of dysfunction in kidney diseases and differential diagnosis of potential complications in the renal allograft are fundamental to initiate appropriate treatment. In addition, determination of renal function may reveal physiological mechanisms that may prove useful for future therapeutic procedures. Currently, used methods to access renal function like ultrasound, radionuclide imaging, and laboratory methods have several disadvantages, as they are nonspecific, require radioactive contrast agents or are limited in spatial information. Therefore, alternative non-invasive methods to detect early morphological and functional changes are required. Recently, a variety of very promising advanced magnetic resonance imaging (MRI) methods have evolved to obtain functional information of different organs. These methods include MR angiography, diffusion, perfusion and Blood-Oxygenation Level Dependent (BOLD) imaging. In addition to MRI, MR spectroscopy (MRS) provides renal functional information. In abdominal organs like the kidney, respiratory, and cardiac motion and susceptibility artifacts have limited the use of these functional MR methods for clinical applications. However, this may be overcome with the advent of greatly enhanced hardware, allowing very fast imaging times. Besides these in vivo techniques, novel processing algorithms for complex ex vivo MR spectra of body fluids have emerged recently. These methods, labeled "Metabonomics", access renal function by obtaining metabolic profiles that are indicative for renal dysfunction.

The researchers hypothesize that these non-invasive methods correlate with histology as "gold standard" and compete favorably with conventional in part invasive evaluation methods, and thus provide specific and early detection of kidney diseases of various etiologies, drug toxicity or renal allograft dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age 16 years
* Male or female
* Signed consensus report to the study

Exclusion Criteria:

* History of allergy to contrast media
* Pregnancy
* Contraindication for MR examination: Content of electronic devices in the body of the subject (i.e. pacemaker of heart, implanted insulin pump, nerve stimulator, or similar medical devices), content of metallic foreign bodies or metal-pieces (without amalgam filling), claustrophobia
* Back or other problems that don't allow motionless lying for 75 minutes
* Missing signed consensus report to the study
Dosing of Levetiracetam (Keppra) in Neonates

The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady state drug levels of levetiracetam in neonates.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age ≥ 32 weeks
* Postnatal age ≤ 30 days
* Birth weight ≥ 2000 grams
* Admitted to the Neonatal Intensive Care Unit at Cincinnati Children's Hospital
* Clinical or electrographic seizures of any etiology
* Seizures or seizure prophylaxis requiring treatment with levetiracetam
* Parental consent obtained

Exclusion Criteria:

* Infants with renal insufficiency indicated by serum creatinine \> 2.0 at any time
* Infants who have previously received levetiracetam
* Parents refuse consent
* Attending physician does not wish the infant to be enrolled in the study
* Infants who are currently receiving an investigational drug