cyrilzakka/clinical-trials huggingface dataset:
Exercise With Individual Dosage Against the Best Current Practice in Lower Limb Tendinopathy (MaLaGa Trial)

This study compares the effect of a therapeutic physical exercise programme based on an individualized control of the exercise dose by monitoring the force-speed curves against the current best practice in the treatment of tendinopathies of the lower limb. Half of the participants will receive the experimental intervention, while the other half will receive the best current practice.

The current best practice is based on a progressive strength training sustained in the continuous model of tendinopathy proposed by Cook and Purdam (Cook \& Purdam, 2009), showing in the literature this methodology more effective than the wait and see approach or that the use of corticosteroid injections, accentuating the differences in long-term follow-up evaluations (Mellor et al., 2018). However, the current system lacks an objectification methodology for the severity of the pathology and objective criteria for the progression of the load, usually based on subjective feelings of discomfort or pre-established intensities.

Therefore, the investigators hypothesize that the development and introduction of a methodology for the quantification and progression of the loads, with an individual control and management of the exercise dose, as well as the execution of specific exercises for each one of them, could improve the clinica and functional results. Moreover, achieving neuromuscular adaptations based on the characteristics of the neuromuscular system, could improve the times and results of the intervention, as well as the rate of treatment failures, in the tendinopathies of the lower limbs.

Eligibility Criteria:
Inclusion Criteria:

1. People between 18 and 65 years with a clinical diagnosis of mid-portion Achilles, patellar, or gluteal tendinopathy;
2. Pain duration for at least one month.

Exclusion Criteria:

1. Corticosteroid injection in the studied tendon in the last 12 months;
2. Other injuries in the affected lower limb in the last 12 months;
3. Previous surgery for musculoskeletal causes of the affected lower limb in the last 12 months;
4. Tendinous rupture history in the affected lower limb;
5. Systemic diseases such as rheumatic arthritis or diabetes mellitus.
20110165: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms (Study 165)

The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) schizophrenia
* Total score on the PANSS Marder Negative Symptom Factor Scale (NSFS) ≥ 20
* Total score on the PANSS Marder Positive Symptom Factor Scale (PSFS) ≤ 30
* Receiving stable antipsychotic therapy for at least 8 weeks prior to screening
* Receiving a stable dose of other psychotropic agents for at least 8 weeks prior to screening
* Subject has had a stable residence or living arrangement for at least 8 weeks prior to screening and the residence or living arrangement is not anticipated to change for the duration of the study
* The subject or subject's legally acceptable representative has provided informed consent.

Exclusion Criteria:

* Current schizoaffective or bipolar disorder, panic disorder, obsessive compulsive disorder, evidence of mental retardation by history or clinical examination or known premorbid IQ ≤ 70
* Clinically significant suicidal ideation or suicide attempts, assaultive behavior or marked changes in mood within the 8 weeks prior to screening, or currently endorsing suicidal ideation in clinical exam
* Substance abuse (with the exception of nicotine or caffeine abuse) within the 8 weeks prior to screening, or during screening
* Substance dependence (with the exception of nicotine or caffeine dependence) within the 6 months prior to screening, or during screening
* Planning to initiate a smoking cessation therapy or otherwise substantially modify nicotine use during the study
* Positive urine drug test for substances of abuse (with the exception of positive screens for prescribed agents such as benzodiazepines).
* Other criteria may apply
The Effect of Adding Nalbuphine to Intrathecal Morphine on Analgesic Efficacy and Side Effects After Cesarean Section

The primary endpoint of this study is to investigate the effect of adding nalbuphine to intrathecal morphine on quality of postoperative analgesia and Morphine related side effects post- cesarean delivery.

The study will be performed in Assiut University Hospitals, after obtaining approval from the local ethics committee and written informed patient consent. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. All the patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous. Intrathecal block under strict aseptic conditions will be performed in sitting position at L3-4 or L4-5 inter-spinous space with 25G pencil-point spinal needle. All patients will receive intrathecal 10 mg of 0.5% hyperbaric bupivacaine.

Eligibility Criteria:
Inclusion Criteria:

* Female patients
* age between 16 to 40 years
* ASA physical status I - II

Exclusion Criteria:

* Infection at the site of injection.
* Coagulopathy or other bleeding diathesis.
* Preexisting neurologic deficits.
* History of hypersensitivity to any of the given the drugs.
* Inability to communicate with the investigator and the hospital staff.
* History of chronic opioid us
Assessment of Anterior Teeth Restored With Ultra-translucent Multilayer Zirconia vs Lithium Disilicate Laminate Veneers

The aim of the present study is to assess the clinical performance of multilayered translucent zirconia laminate veneers versus lithium disilicate laminate veneers in terms of modified USPHS criteria for assessment of dental restorations (retention, restoration integrity, color match and marginal adaptation)

inferior mechanical properties of glass ceramics necessities the continuous development and modification for materials suitable for all clinical situations

multilayered translucent zirconia provides the advantages of high mechanical properties than all glass ceramic in addition to the improved translucency in the new generations.

Therefore, the purpose of the present study is to evaluate the clinical performance of newly introduced multilayered translucent zirconia as a monolithic laminate veneer in comparison with lithium disilicate laminate veneer to determine the clinical functional and structural integrity of the restoration

Eligibility Criteria:
Inclusion Criteria:

* sufficient sound enamel thickness
* Presence of one adjacent natural teeth that doesn't need laminate to compare shade
* age range 20 to 40 years old
* non smokers
* diastema less than 2mm
* tooth fracture not exceeding incisal one third
* normal occlusion
* vital teeth
* healthy periodontal tissues

Exclusion Criteria:

* -insufficient enamel thickness
* restoration more than 40 % of tooth surface
* parafunctional habits
* deep discoloration
* sever teeth rotation
* edge to edge or deep bite
* abnormal occlusion
* bad oral hygiene
Study to Evaluate the Safety and Efficacy of Sirolimus, in Subject With Refractory Solid Tumors

This study is a single arm, pilot study of sirolimus in patient with Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway aberration Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.

sirolimus 1mg will be administered orally daily. To investigate the efficacy and safety of sirolimus in patient with Refractory solid tumor.


Eligibility Criteria:
Inclusion Criteria:

* Provision of fully informed consent prior to study specific procedures.
* Patients must be \>= 19 years of age
* Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway aberration( H1047R, E542K, E545K, PTEN LOSS) Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
* ECOG Performance status0-2
* Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
* Adequate Organ Function Laboratory values

  * Absolute neutrophil count \>= 1.5 x 109/L, Hemoglobin \>= 9g/dL, Platelets\>=75 x 109/L Bilirubin \<= 1.5 x upper limit of normal AST/ALT \<= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine\<= 1.5 X UNL
* Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
* Adequate heart function

Exclusion Criteria:

* Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for \<= 5 years.
* Has known active central nervous system(CNS) metastases
* Has an active infection requiring systemic therapy
* Pregnancy or breast feeding
* Patients with cardiac problem
* Any previous treatment with sirolimus
Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis

Aortic valve pathology is the third most common cardiovascular disease after coronary artery disease and hypertension, which is responsible for severe morbidity and mortality in elderly patients and requires surgical treatment in its most severe form of progression. The purpose of this study is to find a link between arterial stiffness and degenerative aortic stenosis. If this link is established, arterial stiffness may become a medical therapeutic target in order to delay the evolution of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age, without legal protection (guardianship or curatorship),
* Stable hemodynamic status.
* Affiliation to a social security scheme

Exclusion Criteria:

* Hemodynamically unstable patients: Systolic PA \<10 cmHg, rapid peripheral pulse and spinning, mottling, obnubilation, oliguria, sweating, coma
* History of significant valvulopathy other than an aortic stenosis,
* Pregnancy.
* Patient under tutelage or curatelle or deprived of public right.
A Comparison of Electrical Pudendal Nerve Stimulation and Transvaginal Electrical Stimulation for Urge Incontinence

The purpose of this study is to determine whether electrical pudendal nerve stimulation is more effective than transvaginal electrical stimulation in treating urge urinary incontinence (UUI).

Electrical neuromodulation can be used to treat UUI refractory to medication. Electrical neuromodulation therapies include transvaginal or transanal electrical stimulation (TES), percutaneous tibial nerve stimulation (PTNS), sacral neuromodulation (SNM), and pudendal neuromodulation (PNM). TES is easily applicable but is sometimes intolerable for many patients due to discomfort, mucosal injury, and high-intensity stimulation necessary to obtain acceptable outcome. SNM with the InterStim device differs from TES by its continuous stimulation and close nerve contact. It has a high rate of success, but symptoms appear to recur almost immediately after discontinuation of the stimulation, and at least 20 % of patients initially tested do not respond to a test procedure. Its disadvantages included invasiveness, high cost of treatment, high surgical revision rate, device replacement required when battery runs out, and adverse events. PNM with the Interstim device or the Bion device can be used to treat UUI refractory to SNM, but this therapy also has the disadvantages similar to those of SNM. PTNS with needle electrodes is minimally invasive, demonstrates efficacy, and is easily applicable and well tolerated, but PTNS effects diminish over time after the end of treatment.

By combining the advantages of PTNS and PNM and incorporating the technique of deep insertion of long acupuncture needles, the investigators developed electrical pudendal nerve stimulation (EPNS). In EPNS, long acupuncture needles of 0.40 Х 100 or 125 mm were deeply inserted into four sacral points and electrified to stimulate the pudendal nerves (PN). CT transverse plane at the coccygeal apex has showed that the position of the lower needle tip is similar to where (adjacent to PN at Alcock's canal) the Bion device is implanted for chronic PN stimulation. Besides the radiographic evidence, simultaneous records of perineal ultrasonographic pelvic floor muscle contraction, vaginal pressure and pelvic floor surface electromyogram in our previous study have proved that EPNS can exactly excite PN. The purpose of this study is to compare the efficacies of EPNS versus TES in treating female UUI.

Eligibility Criteria:
Inclusion Criteria:

* UUI history
* Positive pad test result
* Urodynamic study: A decrease in bladder capacity at the first desire for urination; a decrease in maximum bladder capacity; low compliance bladder

Exclusion Criteria:

* UUI that can be relieved by drugs
* Neurogenic or non-neurogenic UUI
* Other types of incontinence such as stress incontinence and overflow incontinence
Intra-operative Assessment of Cavernosal Nerve Stimulus Threshold

Erectile dysfunction persists in approximately 80% of men 1 year after prostatectomy. Various erectile rehabilitation strategies have not provided benefit. Electrical stimulation has been demonstrated to benefit neuroregeneration and the functional recovery of neuromuscular systems. Therefore, electrical stimulation of the cavernosal nerves during radical prostatectomy is being investigated for its potential development into a treatment aimed at improving recovery of erectile function after prostatectomy. This pilot study is intended to determine the threshold of electrical stimulation that results in penile erection, as defined by persistent intracavernosal pressure increase, such that future studies of sub-threshold stimulation may be pursued.

Objective:

To determine the cavernosal nerve electrical stimulation amplitude thresholds at which an erection, as indicated by persistent increases in intracavernosal pressure, occurs for various stimuli of fixed frequency and fixed pulse-width.

Study Design:

This is a prospective pilot study used to determine a threshold range of cavernosal nerve electrical stimulation parameters that result in penile erection. Assignment to the order of stimulation paradigms will be randomized. No placebos are used. No blinding is used.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have prostate cancer being treated via radical prostatectomy by a single surgeon (primary investigator) with planned intraoperative nerve sparing.
* Subjects must have intact preoperative erectile function, sufficient for penetrative intercourse without medication nor assistive device, as defined by a Sexual Health Inventory for Men (SHIM) / International Index of Erectile Function (IIEF-2) score 22 or higher, which is collected as part of routine care.
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Baseline erectile dysfunction, as defined by the use of medications or devices to assist erection, lack of baseline erections, or a SHIM / IIEF-2 21 or lower, which is collected as part of routine care.
* Lack of successful intraoperative nerve sparing.
* Neurologic, metabolic, or vascular diseases that may negatively impact erectile function, such as: diabetes mellitus, peripheral vascular disease, coronary artery disease, stroke, multiple sclerosis, parkinson's disease, multiple systems atrophy, epilepsy, or spinal cord injury.
* Inability to provide a fully informed consent.
A Peer-based Mobile-health Intervention to Increase Access & Adherence to Hepatitis C Treatment & HIV Viral Suppression

The purpose of this study is to test an intervention designed to train persons who inject drugs (PWID) and are infected with hepatitis C (HCV) and HIV in communication skills to 1) promote new HCV treatment and care 2) risk reduction and 3) recruit their social network members for HIV and HCV testing and linkage to care.

The investigators propose recruiting 300 HIV/HCV co-infected PWID (i.e. Index participants). Half will be randomly assigned to the experimental condition and half to the equal attention comparison. The experimental intervention will include 8 group sessions that focus on communication to social network members, medical adherence and risk reduction skills, 2 dyad sessions with network members, monthly booster sessions for 6 months, and mHealth cuing of behavior for 6 months. These Index participants will be followed for 24 months (3, 6, 12, 18, \& 24 month assessments). Participants who test positive for HCV will be linked to the Johns Hopkins Viral Hepatitis clinic to assess liver function and HCV chronicity and if applicable offered HCV treatment. Additionally, 450 network members will be recruited and will be tested for HIV and HCV and followed longitudinally to examine the social diffusion and social network factors associated with adherence among the Index participants.

Eligibility Criteria:
Inclusion Criteria:

* HCV antibody positive
* HIV antibody positive
* lifetime history of injection drug use
* interrupted HIV care:\>3 months since HIV care or detectable viral load
* willingness to participate in group sessions and have conversations with social network members

Exclusion Criteria:

- participated in a behavioral intervention in prior 2 years
Baker Gordon Syndrome Natural History Study

The goal of this study is to conduct a prospective, longitudinal assessment of the natural clinical progression of children and adults with Synaptotagmin1-Associated Neurodevelopmental Disorder also known as Baker Gordon Syndrome (BAGOS). This will be performed by acquiring baseline measurements and developing effective outcome measures and diagnostic tools for the disorder, to prepare the healthcare system for future clinical trials.

The current natural history study is being conducted in anticipation of future treatments for patients with confirmed BAGOS. The study is an important avenue of investigation that will increase the understanding of the disorder and lead to important diagnostic and therapeutic advances. Its purpose is to identify demographic, genetic, environmental, and treatment modalities and concomitant medications that correlate with the disease's development and outcomes. This study will use standard scales and questionnaires for the assessment of global development, language, memory, and motor function, and by collecting sleep and seizure diaries. A small blood sample will be collected for whole genome sequencing and proteomic analysis. Brain imaging (MRI) and electroencephalography (EEG) recordings will be collected to identify disease biomarkers. The investigators will also be asking participants to provide a small skin sample for the development of patient specific stem cells which will be used to further understand the impact of Synaptotagmin1 mutations on neurodevelopment and as a potential screen for future therapies.

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed diagnosis of Baker Gordon syndrome.
* 0-99 years
* Ability to send medical records and diagnostic test results.
* Ability to complete tests and questionnaires.

Exclusion Criteria:

• The presence of another condition or co-morbidity unrelated to Baker Gordon syndrome, that affects neurodevelopment.

In this study, the primary caregivers/LAR for each participant diagnosed Baker Gordon Syndrome will be also considered participants.

Caregivers/LAR will have to meet the following inclusion criteria:

* \>18 years.
* Legal caregiver of the patient diagnosed with a Baker Gordon Syndrome.
* Willingness to follow study procedures, as assessed by the research team.
* Willingness to sign the consent form.
* Ability to understand all the information regarding the study, as assessed by the research team.

Caregivers/LAR Exclusion Criteria:

• Less than 18 years old.
Effects of a Whole Body Vibration Training in Patients After Lung Transplantation

Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in patients following lung transplantation. Exercise training has been shown to be a cornerstone of an inpatient rehabilitation program to reduce muscle dysfunction and improve exercise performance. In our study we will investigate the benefit of a whole body vibration training in addition to a standard pulmonary rehabilitation program that includes endurance and strength training. We will include a total of 140 patients (70 patients \< 1 year after lung Transplantation and 70 patients \> 1 year after lung Transplantation). Our hypothesis is that an addtitional whole body vibration training produces a greater benefit to exercise capacity in lung transplantat patients (LTx).


Eligibility Criteria:
Inclusion Criteria:

* participation in an inpatient rehabilitation program
* double or single lung transplantation due to chronic obstructive pulmonary disease, Alpha-1-antitrypsine deficiency, interstitial lung disease

Exclusion Criteria:

* severe exacerbation in the last 4 weeks with the necessity of delivering antibiotics/ corticosteroids
* non-compliance
O2 Tension During TAVI

Hyperoxemia can produce various complications including oxidative stress and myocardial injury. We hypothesized that the normoxic group would have lower myocardial injury compared to hyperoxic group after transcatheter aortic valve replacement.

Hyperoxemia can produce various complications, such as excessive oxidative stress, hyperoxia-induced vasoconstriction, increased perfusion heterogeneity, and resultant myocardial injury. Previous studies have been observed higher mortality in patient group maintained with supranormal oxygenation after resuscitation from cardiac arrest. However, the effect of hyperoxia vs. normoxia on myocardial injury during transcatheter aortic valve replacement (TAVR) has not been well investigated. We hypothesized that the normoxic group would have lower myocardial injury compared to hyperoxic group after TAVR.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for transcatheter aortic valve replacement due to aortic stenosis

Exclusion Criteria:

* Transapical approach
* Pre-procedural PaO2 \< 65 mmHg or oxygen support therapy
* Pre-procedural severe kidney injury (end-stage renal disease)
* Pre-procedural chronic pulmonary disease, symptomatic asthma
* Pre-procedural Tb-destroyed lung
* Lung cancer
* History of acute coronary syndrome within 6 months
* Pre-procedural elevated Troponin I or CKMB
* History of stroke or transient ischemic attack within 6 months
* Refuse to participate
* Pregnant
18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation

The investigators will evaluate the detection of cardiac sarcoidosis or inflammation using 18F-FSPG PET/MRI (or PET/CT for participants with metal implants).

PET/MRI scans will be performed with a whole-body PET/MR imaging system capable of simultaneous PET and MR imaging (SIGNA, GE Healthcare, Milwaukee, WI). Approximately 45-60 minutes after IV injection of 8 mCi of 18F-FSPG, PET emission scanning and MRI acquisition T1 weighted scanning will begin imaging both whole body and the heart.

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years old at the time of the scan
* Patient with known or suspected cardiac sarcoidosis.
* Patient is capable of complying with study procedures
* Patient can remain still for duration of imaging procedure

Exclusion Criteria:

* Patient is pregnant or nursing
* Metallic implants (contraindicated for MRI)
* History of renal insufficiency (only for MRI contrast administration)