cyrilzakka/clinical-trials huggingface dataset:
Adaptation Among Adolescents and Adults With Klinefelter Syndrome

This study aims to understand the impact of living with Klinefelter syndrome (KS) and the factors that contribute to adaptation in adolescents and adults. Individuals with KS may have variable symptoms, including hypogonadism, gynecomastia, learning disabilities, and delay and underdevelopment of secondary sexual characteristics. Perhaps the most challenging symptom of KS is infertility, which seems to be a universal symptom. It is not fully understood how males with KS conceptualize their condition, cope with their diagnosis, and adapt to living with this condition. In this study, Lazarus and Folkman s Transactional Model of Stress and Coping provides a framework for examining coping and adaptation in males with KS. A cross-sectional research design using a quantitative survey will be utilized to examine the relationships among appraisals (illness perceptions and perceived stigma), time elapsed since learning of diagnosis, coping, and adaptation. Adolescents and adults with KS will be recruited from national KS support networks via website postings, email listservs, and printed newsletter postings. Adolescents will also be recruited from a private practice. Participants will have the option to complete an online or paper version of the survey. The main outcome variable is adaptation to living with a KS diagnosis.

This study aims to understand the impact of living with Klinefelter syndrome (KS) and the factors that contribute to adaptation in adolescents and adults. Individuals with KS may have variable symptoms, including hypogonadism, gynecomastia, learning disabilities, and delay and underdevelopment of secondary sexual characteristics. Perhaps the most challenging symptom of KS is infertility, which seems to be a universal symptom. It is not fully understood how males with KS conceptualize their condition, cope with their diagnosis, and adapt to living with this condition. In this study, Lazarus and Folkman s Transactional Model of Stress and Coping provides a framework for examining coping and adaptation in males with KS. A cross-sectional research design using a quantitative survey will be utilized to examine the relationships among appraisals (illness perceptions and perceived stigma), time elapsed since learning of diagnosis, coping, and adaptation. Adolescents and adults with KS will be recruited from national KS support networks via website postings, email listservs, and printed newsletter postings. Adolescents will also be recruited from a private practice. Participants will have the option to complete an online or paper version of the survey. The main outcome variable is adaptation to living with a KS diagnosis.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. Must have Klinefelter syndrome (47,XXY) by self-report.
  2. Must be 14 years or older.
Decision Support System for Anesthetists

The balanced anesthesia process contains three main parts: the control of hypnosis, analgesia, and neuromuscular blockade. For the induction phase, the anesthesiologist performs protocols based on prior planning specific to each patient and usually performs these controls by monitoring the classic vital signs and other clinical signs for the maintenance phase.

In a way, this professional is the controller in a control system that acts on the plant (the patient) through the infusion of hypnotic drugs, analgesics and neuromuscular blockers. In addition, the anesthesiologist estimates the state of consciousness, the level of analgesia and the level of neuromuscular blockage through other indirect measures, as well as a state observer.

There are different techniques for direct monitoring of these three anesthesia variables (DoA, NMB and NoL), such as BIS and Narcotrend, but all have some disadvantages, especially when the anesthesia process combines different drugs. This work proposes a new way of evaluating DoA, NMB and NoL using data fusion techniques to combine classical clinical signs with advanced EEG monitoring techniques to provide a decision support system for the anesthesiologist.

The balanced anesthesia process contains three main parts: the control of hypnosis, the analgesia and neuromuscular blockade. For the induction phase, the anesthesiologist performs protocols based on prior planning specific to each patient. Normally, the anesthesiologist controls the process by monitoring the classical vital signs and other clinical most common signs during the maintenance phase. In a way, this professional is the controller in a control system that acts on the plant (the patient) through the infusion of hypnotic and analgesic drugs and neuromuscular blockers.

In addition, the anesthesiologist estimates the the level of consciousness, of nociception and the level of neuromuscular blockade through these indirect measurements, just as a state observer in a control system would do.

There are different techniques for the direct monitoring of these three variables of anesthesia (DoA, NMB and NoL), such as BIS and Narcotrend, but all of them present a few disadvantages and mis-measurements, especially when the anesthesia process combines different drugs.

This work proposes a new way of evaluating DoA, NMB and NoL, using techniques to combine classical clinical signs with advanced EEG monitoring, to provide a decision support system for the anesthesiologist.

For this, we will perform data acquisition from the equipment usually used in surgical procedures with general anesthesia, such as ECG, EEG, blood pressure, mechanical ventilation, among others.

In short, all data of the patient's vital signs during the procedure and the actions taken by the anesthesiologist and surgeons.

The data will be concentrated on a specific equipment, and will be analyzed together with the data of other patients to improve the mathematical models involved in the process.

Eligibility Criteria:
Inclusion Criteria:

* Patients under general anesthesia

Exclusion Criteria:

* Cerebral Palsy patients
Exercise Program for ITB Syndrome

Patients with diagnosed iliotibial band (ITB) syndrome indicated for non-operative management will be randomized to individualized exercise program or standard physical therapy over the course of 3 months to determine any possible difference in clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ITB syndrome
* Age 18-65
* Ability to comply with a standardized physical therapy protocol
* Willing and able to provide consent

Exclusion Criteria:

* Patients at any increased risk of falls or at increased risk from harm due to falling, including issues with vertigo, osteoporosis, or a history of past falls
* Patient otherwise deemed at increased risk from this investigational rehabilitation program by their referring surgeon or physical therapist
* Patients who are pregnant
Drug Use Investigation for HEPSERA (Adefovir) Tablet

This post-marketing surveillance (PMS) is conducted to collect safety and efficacy data among subjects with chronic hepatitis B and hepatic cirrhosis B who is treated with adefovir tablets.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with chronic hepatitis B or hepatic cirrhosis B
* Subjects treated with adefovir tablets

Exclusion Criteria:

* None
Duloxetine in the Treatment of Stress Urinary Incontinence.

The purpose of this study is to monitor the long term safety of duloxetine in the treatment of stress urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Women with predominant stress urinary incontinence.
* 7 or more incontinence episodes per week.

Exclusion Criteria:

* Use of monoamine inhibitors.
Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild, Moderate and Severe Renal Impairment

Primary Objective:

* To study effect of mild, moderate and severe renal impairment on the pharmacokinetics of Otamixaban.

Secondary Objective:

* To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.

The study period for one subject is broken down as follows:

* 2 to 28 days of screening,
* 1 day of treatment,
* 8 to 11 days of follow-up after start of infusion.

There are 5 days in the unit starting the day before the start of infusion.

Eligibility Criteria:
Inclusion criteria:

* Subject with renal impairment:

  * Mild, moderate or severe renal impairment defined as Creatinine Clearance (CrCl) from 50 to 80, 30 to 50 and \< 30 mL/min respectively, based on the Cockcroft-Gault formula,
  * Body weight between 50.0 kg and 115.0 kg inclusive if male, between 40.0 kg and 95.0 kg inclusive if female, Body Mass Index between 18.0 and 34.9 kg/m2 inclusive.
  * Stable chronic renal impairment as defined by Cockcroft-Gault formula,
  * Vital signs, cardiac function and laboratory parameters within the acceptable range.
* Or matched subject (by age, gender and body weight) with normal renal function (defined as CrCl \>80 mL/min) and certified as healthy by physical examination, medical history and laboratory findings.
* If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.

Exclusion criteria:

* Uncontrolled clinically relevant cardiovascular, pulmonary, gastro-intestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness.
* Active hepatitis, hepatic insufficiency.
* Acute renal failure, nephrotic syndrome.
* History of or current hematuria of urologic origin.
* Subject requiring dialysis during the study.
* History or presence of drug or alcohol abuse within two years before inclusion.
* Smoking more than 15 cigarettes or equivalent per day.
* Any significant change in chronic treatment medication within 14-days before inclusion.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Bioequivalence Study to Compare the Pharmacokinetics (PK) Of Marketed Product TobraDex® To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin And Dexamethasone In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery

Each patient will be randomized to receive one dose of the test article in one eye and one dose of the reference formulations in the contralateral eye. One eye will be selected as the initial eye for cataract surgery and aqueous humor collection and hence will be dosed and operated on first. Followed by the second eye which will be dosed no early than a week followed by aqueous humor collection as per specified time points and no later than 35 days following the first eye again prior to the cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Be male or female 18 years of age and above
* Presence of visually significant cataracts in both eyes
* Have a chief complaint consistent with visually significant cataracts
* Be able to communicate effectively with the study personnel and be able to understand and follow directions
* Be medically fit with clinically acceptable laboratory profiles and ECG
* Be willing to carry out the required pre op directions and post op care and be able to make the scheduled appointment
* Have given the written informed consent for participation in the study
* In addition, female patients of child bearing potential age must have a negative urine pregnancy test

Exclusion Criteria:

* Participation in any ophthalmic indicative bioavailability/ bioequivalence/ Pharmacokinetic study or received an ophthalmic indicative investigational drug within a period of three months prior to screening
* Presence or history of recent viral corneal disorder or active corneal condition which is contraindicated.
* Presence or history of uveitis or uveitis
* Presence of retinal disorders
* Ocular trauma within three months of the trial
* Patients who had received topical and or systemic/ oral steroids
* Uncontrolled diabetes
* History of any allergies
* Known hypersensitivity or allergy to TobraDex® in combination or its components
* Clinical laboratory test values outside the acceptable reference range and when confirmed on re-examination deemed to be clinically significant as determined by the investigator(s)
* Clinically significant illness during 3 weeks prior to Visit 1 (as determined by the investigators)
* Presence of a clinically significant systemic disorder
Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR

The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations.

Studies with a limited number of patients have shown that a value of FFR (Fractional Flow Reserve) above 0.80 identify a low risk of events in case of not performing revascularization in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been found equivalent to FFR The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions could have an important clinical impact and justify its systematic use for the treatment decision in these high-risk patients.

The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations. In the case of intermediate stenoses (25-60%), invasive imaging tests, intravascular ultrasound (IVUS) or optical coherence tomography (OCT) or functional by determining the Fractional Flow Reserve (FFR), have been proposed to identify those patients who could benefit from revascularization.

Studies with a limited number of patients have shown that a value of FFR above 0.80 identify a low risk of events in case of not performing revascularization in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been found equivalent to FFR in assessing the prognosis of patients with intermediate lesions, the validation of the prognostic power of this index in patients with intermediate LMCA lesions has not been demonstrated, although it is used in clinical practice assuming the results in other locations of the lesions.

The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions could have an important clinical impact and justify its systematic use for the treatment decision in these high-risk patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with intermediate lesion in the LMCA (25-60% angiographic stenosis) by visual estimation) in which the realization of a study with guide of pressure for the determination of the iFR.
* Patients aged ≥18 years.
* Patients able of giving informed consent.

Exclusion Criteria:

* Patients with indication for coronary surgery regardless of the significance of the LMCA lesion.
* Patients with a LMCA lesion presenting with ulceration, dissection or thrombus.
* Patients with previous arterial or venous graft lesion functioning in the territory irrigated by the LMCA (LMCA protected).
* Patients with ACS (Acute Coronary Syndrome) with a potentially guilty lesion in the LMCA.
* Patients unable to obtain informed consent.
* Patients with known terminal illness that conditions a life expectancy less than 1 year.
* Patients with hemodynamic instability with Killip III or IV class.
Microperimetry in Macular Edema

In uveitic patients with fluorescein angiographically proven macular edema, a fundus related microperimetry is performed and results are correlated with foveal thickness as measured with optical coherence tomography (OCT).


Eligibility Criteria:
Inclusion Criteria:

* Patients with noninfectious uveitis, macular edema

Exclusion Criteria:

* Pregnancy, fluorescein allergy
Beneficial Effects of an Integrated Program of Multicomponent Physical Exercise. Cohort Study

The study has been designed to analyze the possible positive effects of a multicomponent physical exercise program monitored with an integrated electronic device system in dwelling-community frailty older adults.

The study will assess changes in physical, nutritional, cognitive, and psychological aspects after program finishes at six months.

Information will be collected by researchers at baseline, monthly and after study finishes.

The aging process is associated with physiological changes that determine a decrease in functional reserve and limit the ability to respond to external factors.

Likewise, aging is associated with a deterioration of the regulatory processes that maintain the functional integration of the different organs and systems. A direct consequence of this phenomenon is the atypical presentation of highly prevalent diseases in the elderly. This atypical presentation of diseases in the elderly is responsible for the so-called geriatric syndromes, considered as specific nosological entities with a high frequency of presentation in the elderly, being included within the prevention, diagnosis and treatment strategies of geriatric medicine.

These syndromes can generate greater morbidity and consequences, sometimes more serious than the disease that produces them. Its systematic detection should be included in the anamnesis of the clinical history of the elderly. Geriatric syndromes are a group of conditions usually caused by the conjunction of diseases with a high prevalence in the elderly and which are the frequent origin of functional or social disability in the population. They are the manifestation of many diseases, but they are also the beginning of many other problems that we must take into account from their detection to establish a good prevention of them.

The hypothesis of this work is that in frail and pre-frail older adults who participate in an integrated program of multicomponent physical exercise tutored by means of an app will improve their functional situation and reverse their diagnoses of pre and frailty.

Eligibility Criteria:
Inclusion Criteria:

* Frailty
* Informed consent signature

Exclusion Criteria:

* Life expectancy less than 6 months
* Acute Ischemic coronariopathy event during the last three months
* Active cancer treatment (chemoteraphy or radiotherapy) during the last three months
* Major surgery during the last six months
Respiratory Tract Inflammation in Children With Inflammatory Bowel Disease (IBD)

The purpose of this study is to determine whether inflammatory bowel disease in children involve the respiratory tract as expressed by increased levels of the Fraction of exhaled Nitric Oxide (FeNO) and spirometry.

Inflammatory bowel disease, Crohn's disease (CD) and Ulcerative colitis (UC) are chronic inflammatory diseases with remissions and exacerbations. CD and UC are associated with a variety of systemic (extra-intestinal) manifestations. In some studies, clinical and subclinical pulmonary abnormalities are described in active IBD as well as in the stable situation.

Nitric oxide (NO) is an important mediator of inflammation in several pathological conditions.Patients with lung diseases, like asthma, have higher levels of the Fraction of exhaled Nitric Oxide (FeNO) in active disease in comparison with healthy volunteers. One study in adult IBD patients showed increase in FeNO levels in those patients, with positive correlation with the disease activity and negative correlation between the disease activity and pulmonary functions.

We hypothesised that respiratory tract inflammation as expressed by FeNO and spirometry in pediatric IBD patients will correlate to the activity of the primary disease.

Methods: FeNO levels and spirometry will be assess for 40 patients with CD or UC (age 4-18 years) during remissions and exacerbations, calculated by the Pediatrics Crohn's Disease Activity Index (PCDAI) and the Pediatrics Ulcerative Colitis Activity Index (PUCAI), respectively.

Two aged matched groups, the first of healthy children and the second of chronic abdominal pain will serve a controls.

Eligibility Criteria:
Inclusion Criteria:

1. 4-18 years old children diagnosed with IBD:

   * Histological diagnosis of Crohn's disease
   * Histological diagnosis of Ulcerative colitis
2. Negative stool cultures

Exclusion Criteria:

1. Respiratory tract infection during the 6 weeks prior to enrollment
2. Diagnosis of asthma
3. Current treatment with steroids
4. Smoking
Reconstruction of Complex Proximal Humeral Fractures.

The purpose of this study is to evaluate the accuracy of shoulder replacement surgery in realization a computer assisted 3D planning compared to conventional 2D planning.


Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis or complexe proximal humeral fracture and indication for shoulder arthroplasty
* patients \> 18years

Exclusion Criteria:

* contraindication for computertomography
* pregnancy
* previous fracture or shoulder replacement of the contralateral side in case of a complexe proximal humeral fracture
A Study to Evaluate ASP8232 as Add-On Therapy to Angiotensin Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) in Reducing Albuminuria in Patients With Type 2 Diabetes and Chronic Kidney Disease

The purpose of this study is to evaluate the efficacy of ASP8232 in reducing Urinary Albumin to Creatinine Ratio (UACR) in subjects with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD) at 12 weeks compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have an estimated glomerular filtration rate (eGFR) ) \>=25 and \<75 ml/min/1.73m2.
* Subject must have a documented diagnosis of T2DM and received anti-diabetic medication (oral and/or parenteral) for at least 1 year prior to screening
* Subject's glycated hemoglobin (HbA1c) level is \< 11.0% (\<97 mmol/mol) at screening.
* Subject is on a stable therapy with an angiotensin-converting-enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB) for at least 3 months prior to screening.
* Subject who receives anti-hypertensive treatment, non-insulin anti-diabetic agents and/or vitamin D receptor activators at screening needs to be on stable therapy for at least 3 months prior to screening. Subjects on insulin therapy may have the insulin type/dose/schedule adjusted even during the 3 months prior to screening.
* If the subject has been subjected to specific dietary interventions then this has to be stable over the past 3 months prior to screening visit.
* Subject's UACR is ≥ 200 and ≤ 3000 mg/g in a first morning void (FMV) sample at screening AND the geometric mean UACR of all FMV samples at visit 4 and at visit 5 is ≥ 200 and ≤ 3000 mg/g AND the UACR in at least 3 FMV samples at visit 4 and visit 5 is ≥ 200 mg/g.

Exclusion Criteria:

* Subject is on, or previously received, renal replacement therapy (e.g. dialysis or kidney transplantation).
* Subject has obstructive uropathy or other causes of renal impairment not related to parenchymal renal disorder and/or disease of the kidney; or subject currently has or has had in the past renal disease secondary to malignancy.
* Subject's renal impairment and/or albuminuria is considered to be of other origin than Diabetic Kidney Disease.
* Subject has known (auto-) immune disorder and/or received immunosuppression for more than 2 weeks, cumulatively, within 12 weeks prior to screening or anticipated need for immuno-suppressive therapy during the study.
* Subject has active urinary tract infection which requires treatment or clinically significant infection at the time of screening or randomization
* Subject is diagnosed with type 1 diabetes mellitus or diabetes mellitus with unclear etiology.
* Subject has a sitting systolic blood pressure (SBP) \<90 or \>160 mmHg and/or a diastolic blood pressure (DBP) \>90 mmHg at screening.