cyrilzakka/clinical-trials huggingface dataset:
Prevenar (PCV-7) Post-Licensure Safety Study In Russia

This study is planned to monitor the local and/or systemic reactions and compatibility of PCV-7 with routine vaccines in the Russian National immunization schedule. Consistent with the observational nature of this protocol, Prevenar will be administered as standard of care.

The aim of this study is to estimate the incidence of febrile reactions more than 38.0 degrees Celsius, specifically (≥38 to \< 39 degrees C; \> 39 to \< 40 degrees C and \> 40 degrees C, and the frequency of other local or systemic reactions following vaccination with Prevenar (PCV-7) co-administered with other routine childhood vaccines under the conditions of routine daily use in the Russian Federation.


Eligibility Criteria:
Inclusion Criteria:

* Infants eligible for Prevenar vaccination according to the Regulatory approved terms of the marketing authorization in the Russian Federation:
* Infants from 3 months up to 23 months of age who may benefit from active immunization against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media).
* Parents or legal guardians willing and able to complete the diary cards.

Exclusion Criteria:

* Hypersensitivity to the active substances or to any of the excipients;
* Hypersensitivity to diphtheria toxoid;
* Age less than 3 months or greater than or equal to 2 years at enrollment;
* Contraindications as listed in the Package Insert / Russian SmPC for either Prevenar or for any concomitantly used other vaccines;
* Previously vaccinated with 23-valent pneumococcal polysaccharide vaccine;
* Prophylactic use of non-steroidal anti-inflammatory medications and/or acetaminophen (e.g., paracetamol). However, acetaminophen/paracetamol may be administered for treatment of fever, pain, etc.
Recurrent Urinary Tract Infections and the Microbiome

The primary objective is to determine if polymerase chain reaction (PCR) (UTIP™) is more sensitive in identifying urinary tract infections (UTI's) than standard urine cultures.


Eligibility Criteria:
Inclusion Criteria:

* 18 y/o-90 y/o
* Able to consent
* Female
* Group A only: Recurrent UTI (2 UTIs in 6 months)
* Group B only: No history of recurrent UTIs

Exclusion Criteria:

* Pregnant
* Pelvic radiation
* Urinary retention (\>200 ml residual)
* Greater than Stage 2 prolapse
* Renal calculi
* Immunosuppressed
* Neurologic disorder with significant bladder impairment
* No current UTI via dip stick
Study by 2D-strain of the Ventricular Wall Motion During Postnatal Adaptation

The left ventricular torsion during systole and diastole is a normal dynamic mechanism which participates in the ejection and the filling of the left ventricle. Postnatal hemodynamic modifications are major and probably affect this mechanism. The aim of this study is to compare the left ventricular twist in healthy newborns, between their first days of life and their third month of life, using the 2D-speckle tracking echocardiography.

The left ventricular torsion during systole and diastole is a normal dynamic mechanism which participates in the ejection and the filling of the left ventricle. Postnatal hemodynamic modifications are major and probably affect this mechanism.

The main objective is to compare the left ventricular twist mechanism in healthy newborns, at birth and at their third month of life, using the peak LV twist as primary endpoint. Secondarily, we compare other LV rotation and deformation parameters during the same period: peak LV torsion, peak LV twist rate, peak LV untwist rate, circumferential strain and radial strain. Finally, we compare the endo- and epicardial LV deformation, using the inner and outer circumferential strain as endpoints.

This is a longitudinal, prospective and monocentric study in the Grenoble-Alpes University Hospital between April 2018 and September 2018.

The number of required subjects is 30 with a statistical power of 80% and a p-value of 0,05

Eligibility Criteria:
Inclusion Criteria:

* Newborn hospitalized in the Grenoble University Hospital Maternity Unit
* Aged between 2 and 5 day of life at the first echocardiography
* Social security affiliation
* Signature of the consent document by both parents

Exclusion Criteria:

* Birth before 37 weeks gestation
* Birth weight \< 2,5kg or \> 4,5kg
* Gestational Diabetes Mellitus during pregnancy
* Fetal heart disease
PEEP Levels on Intraabdominal Pressure and Hemodynamics in Critically Ill Patients

In this study, it was aimed to compare the effects of three different PEEP levels (0-4, 5-8, 9-12 cmH2O) on intraabdominal pressure and hemodynamic parameters of patients in intensive care unit.

Patients between 18-80 years old whom were mechanically ventilated without any spontaneous respiratory efforts on supine position were included into the study. Bladder pressure measurement as a practical and frequently preferred method was used in order to measure intra-abdominal pressure. 100 ml isotonic fluid was given during the measurement. Level of symphysis pubis was chosen for zeroing the pressure transducer to measure the intra-abdominal pressure.

Three patient groups, each containing 22 cases, totally 66 patients were planned in this study. All patients were mechanically ventilated with various PEEP levels. The patients with 0-4 cmH2O PEEP levels were named Group 4; the patients with 5-8 cmH2O PEEP levels were named Group 8; the patients with 9-12 cmH2O PEEP levels were named Group 12. The levels of patients' PEEP levels were arranged by the responsible intensive care physician regarding to the patients' clinic.

Intraabdominal, central venous, arterial blood pressures, pulse rates, peripheric oxygen saturation, body temperature, instant fluid balances and amounts of urine (in ml/kg/hour unit) of the patients were measured on the 0. 6. 12. 18. and 24. hours and recorded.

Eligibility Criteria:
Inclusion Criteria:

* age between 18-80,
* connected to mechanical ventilator in intensive care,
* had not undergone surgery of the abdomen,
* patients followed at the same PEEP levels for at least 24 hours

Exclusion Criteria:

* The consent for the study,
* initial intrabdominal pressure level is over 12 cmH2O,
* undergoing abdominal surgery or bladder surgery,
* neurogenic bladder,
* morbid obesity,
* Chronic Obstructive Pulmonary Disease Patients were excluded from the study.
Proper Dietary Management, Follow-up, and Lactase Enzyme Supplementation for Lactose Intolerance

Lactose intolerance (LI) is considered the clinical syndrome caused by lactose malabsorption (LM).

It is possible to identify four causes of lactase deficiency defining four different types of LM: primary (genetic), secondary (acquired), congenital (alactasia), and developmental (in premature infants, so reversible).

The aim of this protocol is to investigate through an anonymous online survey the knowledge of the Italian population on clinical, pathophysiological, diagnostic and therapeutic issues of lactose intolerance. Data collected will be divulgated through a publication for both people with IL and nutritionists, enriched with tables and flow charts, to improve the knowledge on lactose intolerance and to support people suffering from this condition. The results of this survey will guide subjects suspected of suffering from lactose intolerance towards a correct diagnosis and a better management.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be adults (≥18 years of age)
* Willingness to complete the online survey

Exclusion Criteria:

* Subjects \<18 years of age
* Subjects not available to answer the online survey
Preliminary Study for Identification of Calcium-Binding Proteins in the Serum in Various Metabolic Bone Disorders

The purpose of this study is to determine whether the serum levels of certain calcium-binding proteins may be helpful in the diagnosis and management of metabolic bone diseases.

Osteoporosis is an important and costly health issue. The diagnosis of the disease is based on measurement of bone mineral density or the occurrence of characteristic fractures. Currently it is not possible to predict fractures in individual patients, and the ability to monitor the response to treatment is limited as well.

We have synthesized and characterized a novel photoreactive Ca2+-analog reagent, Azido ruthenium (AzRu) that binds covalently to Ca2+-binding sites in proteins. The specificity of AzRu for Ca2+-binding proteins, its photoactivation and its radioactive labeling pave the way for a wide use of AzRu as a powerful tool to assess Ca2+-dependent cellular processes, both in vitro and in vivo. Using radiolabeled AzRu, it will be possible to identify Ca2+-binding proteins in a biological sample such as whole cell, isolated mitochondria, ER or other protein containing fractions. Protein bound \[103Ru\]AzRu in biological sample can be separated by SDS gel electrophoresis, followed by Coomassie staining and exposure of the dried gel to X-ray film (autoradiography). This allows the identification of the \[103Ru\] radiolabeled proteins. The labeled protein bands can be cut from the gel and subjected to MALADI-TOF analysis and the identity of the protein can be determined by a sequence homology search.

These would allow detection of Ca2+-binding proteins in the serum of various diseases and disorders, potentially leading to identification of novel biomarkers for disease diagnostics.

We would like to use blood samples to carry out the procedure described above for identification of Ca2+ binding proteins appearing or their level is increased in disease or under pathogenic conditions. Since Ca2+ binding proteins play an important role in bone metabolism, we chose to test their occurrence in the serum of patients with osteoporosis and other metabolic bone diseases.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of a metabolic bone disorder

Exclusion Criteria:

* none
Uterine Niche After Cesarean Section

In the past decade several articles have described a defect that can be seen on ultrasound at the site of cesarean delivery scar, known as a 'niche' .An incompletely healed scar is a long-term complication of cesarean delivery and is associated with symptoms such as postmenstual spotting, dysmenorrhoea, chronic pelvic pain dyspareunia and subfertility. This study aimes to evaluate the prevalence of niche in a large cohort study after long term follow up since operation, and characterize the risk factors for its development and for symptoms to appear.

As the rate of cesarean deliveries continues to increase, concern regarding the association between delivery by cesarean section and long-term maternal morbidity has been growing . In the past decade several articles have described a defect that can be seen on ultrasound at the site of the cesarean delivery scar, known as a 'niche' .A 'niche' describes the presence of a hypoechoic area within the myometrium of the lower uterine segment, reflecting a discontinuation of the myometrium at the site of a previous cesarean delivery . An incompletely healed scar is a long-term complication of cesarean delivery and is associated with symptoms such as postmenstual spotting, dysmenorrhoea, chronic pelvic pain dyspareunia and subfertility.

The reported prevalence of a niche in non-pregnant women varies depending on the criteria used to define a niche, the time of evaluation since operation, method of detection, and study population. Osser et al. used the definition 'any visible defect' , Bij de Vaate et al. used 'any indentation of at least 1 mm and van der Voet used a cut-off level of 2 mm, however, consensus on the exact cut-off levels is lacking. As approximate evaluation to the operation, the prevalence reported is higher, as early scanning may facilitate the recognition of the location of the caesarean delivery scar in the uterine wall due to incomplete scar healing, with no definition of the most appropriate time since operation. Commonly used methods to evaluate the presence of a niche are trans vaginal ultrasound, sonohysterography and hysteroscopy with detection rate of approximately \~50% of women with previous cesarean section in all methods with no definition of the gold standard.

The aim of this study in to evaluate the prevalence of niche in a large cohort study after long term follow up since operation and characterize the risk factors for its development and for symptoms to appear.

Eligibility Criteria:
Inclusion Criteria:

* Women after cesarean delivery
* Minimum interval of 3 months since operation

Exclusion Criteria:

* Uterine scar other than low segment cesarean section ( s/p myomectomy, S/p T scar)
* Morbidly adherent placenta during pregnancy
* Cesarean hysterectomy
* Uterine anomaly
A Safety and Activity Study of NS2 in Subjects With Allergic Conjunctivitis

This is a randomized, parallel, single center, double masked, vehicle controlled study. The purpose of this study is to determine the activity and safety of NS2 in patients with grass, tree or ragweed-pollen induced seasonal allergic conjunctivitis . Subjects will be randomized 1:1 to receive multiple doses of NS2 Ophthalmic Drops (0.5%) or NS2 Ophthalmic Drops Vehicle (0.0%).

Free aldehydes are thought to be related to inflammatory conditions such as allergic conjunctivitis. NS2, a small molecule aldehyde trap, is being evaluated to determine whether it may decrease inflammation by lowering aldehyde levels.


Eligibility Criteria:
Inclusion Criteria:

* Graded conjunctival redness in at least one region (nasal or temporal) in each eye at any one time point (not necessarily the same time point) post-CAPT (Conjunctival Allergen Provocation Test) of \>2
* Graded ocular itching at any one time point
* Visual acuity of at least 20/50 in each eye
* At least 2 year history of moderate to severe allergic conjunctivitis.
* Positive skin prick test to ragweed, grass and/or tree pollen within one year of Screening Visit (Visit 1).
* Ability to avoid any topical or systemic ocular medications during the entire study period.

Exclusion Criteria:

* Subjects must not have an ocular itching score \>0 or a conjunctival redness score \>1 prior to CAPT in either eye in any region (nasal or temporal) at Visits 2-4. I
* History of glaucoma, or Intraocular Pressure (IOP) over 25mmHg at the screening visit, or a history of elevated IOP within the past 1 year.
* Ocular surgery, including laser procedures, within the past 12 months of Visit 1.
* Use of glaucoma medications, antibiotics, antivirals, or topical cyclosporine within 1 month of the screening visit.
* History of dry eye syndrome, blepharitis, herpes simplex keratitis or herpes zoster keratitis.
* History of uveitis in the past 3 years.
* Presence of any ocular infection or active ocular inflammation (e.g. follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to start of study (Visit 1).
* History of moderate to severe asthma or allergy induced asthma to the allergen that will be used in CAPT.
* Use of oral corticosteroids within 30 days of screening and throughout the study period; use of intranasal or inhaled corticosteroids within 14 days of screening and throughout the study period.
* Use of antihistamines (ocular, nasal, topical or oral) within 7 days prior to screening (Visit 1) and throughout the study period. Non-medicated artificial tears are allowed up to 72 hours before screening (Visit 1) and throughout the study period.
Evaluation and Development of Playing Skills for Parents With Children With Special Needs

Children with special needs; experiences physical, behavioral, social, cognitive and emotional limitations. These limitations affect the child's play skills. They need to be supported and encouraged by their parents to enable them to participate in the game. Parental playing skills creativity, self-efficacy and active participation are important factors in this regard.

In current studies, parents with special needs children; It is supported that there is a relationship between play, acting and parental self-efficacy. In this study, it was aimed to improve the skills of parents with special needs children to play games with their children multidimensionally and to develop these skills with individual-specific techniques.

Detailed assessments will be carried out in order to determine the functional, cognitive and psychosocial skills of the parents.

After the evaluation phase is completed, the scores of each parent will be analyzed and interpreted according to Occupational Therapy Models. Playing training will be given individually according to parameters such as strong and weak features, strong sensory system, personality traits, predisposition and defensive approaches.


Eligibility Criteria:
Inclusion Criteria:

* Being a mother of a special needs child
* The age of her child is 2-6 years
* Being able to speak Turkish
* Volunteer to participate in the study

Exclusion Criteria:

* Have training in play therapy
* Having a psychiatric or neurological disease that significantly affects cognitive status
A Study of Herceptin (Trastuzumab) in Combination With Xeloda (Capecitabine) in Patients With Metastatic or Recurrent HER2-positive Breast Cancer After First-Line or (Neo)Adjuvant Therapy.

This single arm. open-label study will assess the efficacy and safety of Herceptin (trastuzumab) in combination with Xeloda (capecitabine) in patients with metastatic or recurrent HER2-positive breast cancer, refractory to or relapsing after chemotherapy with Herceptin and taxanes. Patients will receive Xeloda 900mg/m2 twice daily orally on days 1-14 of each 3-week cycle and Herceptin 8mg/kg intravenously (iv) on day 1 of the first cycle followed by 6mg/kg iv every 3 weeks. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Female patients, 18-65 years of age
* Histologically confirmed HER2-positive breast cancer with measurable lesions (according to RECIST criteria)
* Metastatic disease after first-line therapy or recurrent disease after (neo)adjuvant therapy with Herceptin and taxanes
* ECOG performance status 0-2

Exclusion Criteria:

* CNS metastases which are not well controlled
* Simultaneous treatment with sorivudine
* History of another malignancy within the last 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in-situ of the uterine cervix
* Pregnant or lactating women
Clinical Research Study to Evaluate the Stain Removal Efficacy

The objective of this clinical research study is to evaluate the stain removal efficacy of a toothpaste containing stannous fluoride as compared to negative control toothpaste in adults.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Good general health
* Male and female subjects, aged 21-70, inclusive
* Present 12 scoreable natural anterior teeth
* A minimum mean Composite Lobene Index score of 1 or greater
* Available for the duration of the study
* Clinical evidence of a tendency to form extrinsic stain on anterior teeth

Exclusion Criteria:

* Presence of orthodontic bands
* Presence of partial removable dentures
* Tumor(s) of the soft or hard tissues of the oral cavity
* Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone)
* Five or more carious lesions requiring immediate restorative treatment
* Use of antibiotics or stain inducing medications any time during the one month prior to entry into the study
* Participation in any other clinical study or test panel within the one month prior to entry into the study
* Self-reported pregnancy and/or women who are breast feeding
* Dental prophylaxis received in the past four weeks prior to baseline examinations
* History of allergies to oral care/personal care consumer products or their ingredients, including allergies to hydrogen peroxide
* On any prescription medicines that might interfere with the study outcome
* History of alcohol and/or drug abuse
* Exposed to a tooth whitening procedure during the last 3 months
Application of Different Modes of Esketamine Administration in Pediatric Day Circumcision

To explore the application of different administration modes of esketamine in pediatric day circumcision, in order to find an anesthesia scheme more suitable for day pediatric circumcision.

The current clinical study believes that esketamine is suitable for pediatric anesthesia because of its advantages of light respiratory depression, low secretions, low incidence of psychomotor reactions and fast recovery of anesthesia, but there are few related studies on its administration mode and timing in clinical application, this study aims to explore the application of different administration methods of esketamine in pediatric day circumcision, and find an anesthesia scheme more suitable for day circumcision, in order to provide new ideas for anesthesia for pediatric day circumcision.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) class I and II children
* Age 5-12 years
* Foreskin cerclage is proposed
* No history of upper respiratory tract infection in the past two weeks
* Obtain the consent of the child's family

Exclusion Criteria:

* Hepatic and renal insufficiency, coagulation dysfunction
* Those who are allergic to esketamine
* History of cognitive impairment
* epilepsy
* other psychiatric and neurological disorders
Effects of Urocortins on Forearm Arterial Blood Flow in Healthy Volunteers (Protocol 3)

Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem with a poor prognosis and the search for novel treatments remains an important area of research.

Urocortins are proteins that appear to increase blood flow and heart pumping activity. There has been particular interest in the role of Urocortins 2 \& 3 (subtypes of Urocortins) in heart failure.

In this study, we will examine the effects and mechanisms of Urocortins 2 \& 3 on forearm blood flow and release of natural blood clot dissolving factors in the forearm circulation of healthy volunteers. In particular, we look at the endothelial mechanisms of vasodilatation of Urocortin 2 and 3.

In this study, we will look at the role of the lining of the blood vessel (endothelium) in response to urocortin types 2 and 3. We hypothesise that urocortins 2 \& 3 act via the endothelium to cause dilatation of the blood vessels and release of tissue-plasminogen activating factor (blood clot dissolving factor). We also hypothesise that urocortins have a role in maintaining the normal baseline level of blood flow in forearm arteries. In addition to the above, we will also look at the effect of temporarily blocking the effect of urocortins, using a specially designed blocker drug (Astressin 2B).

Utilising the well-established technique of 'forearm venous occlusion plethysmography', we will be able to focus on the local effects of urocortins on arterial blood flow in forearm vessels, without affecting this system in the body as a whole.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers between 18 - 65 years (inclusive)

Exclusion Criteria:

* Lack of informed consent- Age \<18 years \> 65 years
* Current involvement in a clinical trial
* Severe or significant co-morbidity including bleeding diathesis, renal or hepatic failure
* Smoker
* History of anaemia
* Recent infective/inflammatory condition
* Recent blood donation (prior 3 months)
* Positive baseline urine test for drugs of abuse (including cannabinoids, benzodiazepines, opiates, cocaine and amphetamines)
* History of allergy to Aspirin
Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences

The purpose of this study is to assess the long term urinary, sexual, cosmetic and psycho-social outcomes of adult patients operated for hypospadias during childhood


Eligibility Criteria:
Inclusion Criteria:

* Patients operated for hypospadias during childhood (before the age of 15) at the University Hospital of Besançon (France)

Exclusion Criteria:

* Patients with a non-operated hypospadias
* Opposition to participate
* Legal incapacity