cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Effect of GDC-0449 on the QT/QTc Interval in Healthy Female Subjects

This is a Phase I, single-center, three-arm, randomized, double-blind, active- and placebo-controlled study to investigate the effect of GDC-0449 on the QT/QTc interval in healthy female subjects of non-childbearing potential.


Eligibility Criteria:
Inclusion Criteria:

* Female, over 45 years of age
* In good health, as determined by the absence of clinically significant findings from the screening visit
* Body mass index between 18 and 32 kg/m\^2 inclusive, with a body weight \> 45 kg
* Of non-childbearing potential

Exclusion Criteria:

* History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiac, vascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer; or cirrhosis
* Allergy to moxifloxacin or any quinolone antibiotics or any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
* Personal or family history of congenital long QT syndrome or family history of sudden death
* Participation in an investigational drug or device study with an investigational drug within the last 3 months or six times the elimination half-life, whichever is longer, prior to Day 1 of the study
Comparative Study of SMILE, ICL, and Wavelight Plus Alcon Technologies in Myopia Correction

Myopia is a prevalent refractive error with significant lifestyle impact. While traditional SMILE (Small Incision Lenticule Extraction) and ICL (Implantable Collamer Lens) surgeries are standard options, the advent of the Wavelight Plus Alcon system presents a promising new technique. This trial aims to evaluate the safety, efficacy, and patient satisfaction across these methods.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-40 years
* Spherical equivalent of -1.00 to -10.00 D
* Stable refraction for at least 12 months
* Informed consent provided

Exclusion Criteria:

* Other ocular pathologies
* Previous refractive surgery
* Pregnancy or nursing
* Autoimmune or connective tissue disorders
Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients

The aim of this study is to compare conventional neurorehabilitation with robot-assisted gait training program in terms of fatigue, anxiety, depression and quality of life.

Gait disturbances are common in Multiple Sclerosis (MS) patients. Nowadays, gait training with robot assisted technology is used for rehabilitation. In several studies conventional rehabilitation was compared with robot assisted rehabilitation program, and they found no superior effects of robot assisted walking program. In this study we aimed to compare these modalities in terms of fatigue, anxiety and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old Multiple Sclerosis patients
* EDSS score: 5.5-7.5
* Being oriented and cooperated
* Mini-mental score ≥24/30

Exclusion Criteria:

* Modified Ashworth \>3 in lower extremity muscles
* Cognitive impairment
* Botox injection within last 6-months
* Having another neurological disease
* Pregnancy or breast-feeding
Normal Values of Parameters of Thrombin Generation in Function of Different Tissue Factor Concentrations

The thrombin generation assay (TGA) is a good tool for measuring clot formation in plasma.TGA using Calibrated Automated Thrombography method, enables the quantification of thrombin concentrations in platelet-rich plasma (PRP) and in platelet-poor plasma (PPP).According to the clinical context, different TF(Tissue Factor) concentrations (1, 5 and 10 pM) can be used to trigger the coagulation cascade.The aim of the study is to determine the normal values of TG (Thrombin Generation) in fresh PRP and in PPP with different TF concentrations.

The thrombin generation assay (TGA) is a good tool for measuring clot formation in plasma. TGA using Calibrated Automated Thrombography method, enables the quantification of thrombin concentrations in platelet-rich plasma (PRP) and in platelet-poor plasma (PPP). The thrombin generation (TG) profile varies from patient to patient and depends on the activity of the pro and anti-coagulant factors. The TGA values depend on the analytical conditions such as Tissue Factor (TF) concentration and the plasma analyzed (PRP or PPP). According to the clinical context, different TF concentrations (1, 5 and 10 pM) can be used to trigger the coagulation cascade.

As a consequence, the reference values vary with the analytical conditions but also with the studied population (men or women). The reference values are not provided by the manufacturer and each laboratory has to establish the normal values according to the analytical conditions chosen for the pathology explored (hemorrhagic or thrombotic). Moreover, in PPP, the TG results can be different according to batch reagents. That is the reason why plasma will be frozen for a new determination in case of deviation of the result of the control plasma.

The aim of the study is to determine the normal values of TG in fresh PRP and in PPP with different TF concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Patient beneficiary or affiliated to Social security system
* Consent signed

Exclusion Criteria:

* Personal or family history (parents, brothers, sisters) of hemorrhage
* Personal or family history (parents, brothers, sisters) of thrombosis before 45 years old
* Taking an anti-inflammatory or an aspirin one week before the sampling
* Current take of an anticoagulant or antiaggregant treatment
* Surgery within previous month before the sampling
* Chronic pathology responsible of an inflammatory syndrome
* Episode of viral or bacterial infections
* Known HIV or Hepatitis C Virus (HCV) infection
* Participation in a therapeutic clinical trial
Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment

This study will evaluate the effectiveness of the rotigotine transdermal patch in reducing anxiety in people with Parkinson's disease.

Anxiety is a serious medical condition that worsens quality of life by negatively affecting peoples thoughts, feelings, and ability to function normally. Anxiety can affect anyone, but people with Parkinson's appear to be at a much higher risk with an estimated 40% or more suffering from anxiety. Parkinson's is a neurological disorder that causes tremor and other problems with normal movements. The disease symptoms are believed to be caused in large part by the loss of dopamine producing cells in the midbrain. Anxiety in Parkinson's may be associated with the loss of dopamine caused by the disease and therefore may respond to dopamine based treatments. This study will evaluate the effectiveness of the rotigotine transdermal patch, a dopamine replacement medication, in reducing symptoms of anxiety in people with Parkinson's disease.

Participants in this double-blind study will be randomly assigned to receive either rotigotine or a placebo patch for 8-weeks. All participants will be evaluated at the study site at baseline and weeks 2, 4, and 8. Psychiatric, cognitive, and movement assessments will be performed along with a review of anxiety symptoms. All participants will be offered continued routine psychiatric care with the study physician upon completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 Anxiety Disorder
* Stable medical history and general health
* On stable anti-parkinsonian therapy for 2 weeks before enrollment

Exclusion Criteria:

* Unstable medical disease of comorbid psychiatric disease
* Dementia
* Subjects with less than one year duration of Parkinson's
* Current treatment with a dopamine agonist
Integrated Treatment for Opioid Use Disorder and PTSD

This study will test a therapy intervention, HOPE, for individuals with opioid use disorder and posttraumatic stress disorder. Interested individuals will need to be taking medications for opioid use disorder (e.g., suboxone, naltrexone, methadone). Interested participants will complete a 10-12 week therapy, and be asked to complete surveys.

Up to half of individuals with OUD have PTSD, but to date, there are no established evidence-based behavioral interventions that concurrently address OUD and PTSD symptoms. The proposed study directly addresses this major clinical gap by testing whether augmenting medications for OUD by testing an adapted, trauma-focused, integrated behavioral treatment for substance use disorders and co-occurring PTSD (i.e., Helping Opioid Use and PTSD with Exposure; HOPE) will enhance clinical outcomes. The investigators will test HOPE combined with medications for OUD (MOUD) versus MOUD-only in a randomized clinical trial among 76 individuals with OUD and PTSD to evaluate feasibility and preliminary efficacy in reducing opioid use and PTSD severity. Both conditions will also complete ecological momentary assessments (EMA) to assess for daily opioid use, craving, and PTSD symptoms. EMA will allow for the assessment of the associations between daily PTSD symptoms and opioid craving and use, which may then inform treatment development.

Eligibility Criteria:
Inclusion Criteria:

* Any gender; any race or ethnicity; aged 18-70 years old.
* English-speaking
* Meet DSM-5 diagnostic criteria for OUD.
* Meet DSM-5 diagnostic criteria for PTSD and have some memory of their index traumatic event.
* Must be maintained on a stable dose of medication for OUD for at least 1 month.
* Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 1 month before study initiation.

Exclusion Criteria:

* Participants presenting with psychiatric contraindications (e.g., unmanaged psychosis or mania, or bipolar) will be excluded and referred clinically.
* Participants considered an immediate suicide risk, with current suicidal ideation and a plan of intent, or displaying other high-risk behaviors (i.e., MOUD refusal, risky fentanyl use, etc.), as determined by the PI and study team. These individuals will complete a safety plan and be referred for treatment.
* Participants meeting DSM-5 criteria for a concurrent, non-opioid, substance use disorder and who report that the other substance is their primary substance of use. These participants will be referred clinically for treatment.
* Participants enrolled in ongoing evidence-based psychotherapy for substance use disorders or PTSD outside of medications for OUD and standard psychotherapy groups in treatment programs.
* Medical problems requiring immediate and intensive treatment, such as unstable or symptomatic end stage liver disease.
Using Health-related Quality of Life (HRQL) in Routine Clinical Care

The objective of this study is to assess the effects of using HRQL measures in the clinical care of pre- and post-lung transplant patients.

The hypotheses are that the inclusion of HRQL measures, the Health Utilities Index System Mark 2(HUI2) and Mark 3 (HUI3), in routine clinical care of pre- and post-lung transplant patients, will: 1) improve patient-clinician communication;2) affect patient management; 3) improve patients' HRQL.

Recently there has been increasing interest in the use of health-related quality of life (HRQL) measures in routine clinical practice. Traditionally, patient care has been based on laboratory results, medical history, and signs and symptoms diagnosed by clinicians. The inclusion of HRQL measures in routine practice may provide important and often otherwise missing information, revealing the impact of the disease or its treatment on the patient's physical, emotional and social well-being, and may assist in patient management. HRQL assessments may assist in changing the medical paradigm from a disease-centered approach to a patient-centered one.

Several studies in mental health and oncology discuss the application of HRQL measures in clinical practice. Taenzer et al (2000) and Detmar et al. (2002) provide evidence that using HRQL measures improves patient-clinician communication. Velikova et al (2004) detected impacts on communication and the emotional well-being of patients.

Using a framework based on these previous studies and the methods for the health technology assessment of diagnostic technologies (Guyatt et al. 1986), we will assess the effects of including HRQL assessments in the routine clinical care of patients undergoing solid organ transplantation (lung).

We expect that the routine use of HRQL measures in clinical practice will affect patient-clinician communication, patient management, and patient outcome.

Lung transplantation trades a fatal disease (end-stage pulmonary disease) for a chance at prolonged survival and improved quality of life, albeit with immunosuppression. In this context, generic preference-based measures such as HUI2 and HUI3 are preferred to specific measures, because they measure a broader range of health dimensions, including pain, ambulation and emotional issues that are expected to be relevant. Preference-based measures provide scores on the conventional 0.00 (dead) to 1.00 (perfect health) scale that allows for the integration of morbidity and mortality effects and calculation of quality adjusted life years (QALYs) and health-adjusted life expectancy (HALE).

Eligibility Criteria:
Inclusion Criteria:

* pre-lung transplant:subjects who are included on the waiting list and are being seen at the out-patient clinic
* post-lung transplant subjects.

Exclusion Criteria:

* younger than 18 years of age
* diagnosed as being cognitively impaired
* unable to complete questionnaires in English
Sensor-augmented Pump Versus Multiple Daily Injections With Degludec as Basal Insulin for Insulin Therapy in Type 1 Diabetes

Several studies have shown that Continuous Subcutaneous Insulin Infusion together with Continuous Glucose Monitoring improves glycemic control in type 1 diabetes when compared to more traditional approaches; however, in available trials the basal insulin used in multi-injection therapy is typically glargine, which is associated with a higher hypoglycemic risk than degludec.

This study will assess the efficacy and safety of Continuous Subcutaneous Insulin infusion (CSII) combined with Continuous Glucose Monitoring (CGM), as compared to Multiple Daily Injections (MDI) of insulin analogues, using degludec as basal insulin, associated with traditional self-monitoring of capillary blood glucose (SMBG) in patients with type 1 diabetes. A crossover design was chosen in order to minimize study sample improving statistical power.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Duration of diabetes \> 2 years
* Current treatment with MDI, using insulin analogues as bolus and basal insulin
* HbA1c\<64 mmol/mol

Exclusion Criteria:

* HbA1c\>64 mmol/mol
* Pregnancy or lactation
Effects on Quality of Life Following Dysport Treatment in Post-stroke Spasticity of the Arm

The main purpose of this study is to assess the effect on Quality of Life of two cycles of Dysport treatment on post-stroke spasticity of the upper limb. The effect of treatment on spasticity and function will also be measured.


Eligibility Criteria:
Inclusion Criteria:

* The patient has suffered a stroke, as defined by the World Health Organisation (WHO) criteria, at least 6 months previously.
* The patient has a hemiparetic arm and meets minimum score requirements on the Modified Ashworth Scale.
* The patient has the cognitive and communication ability to participate in the study.

Exclusion Criteria:

* Patients who have received botulinum toxin treatment within the past 120 days.
* Contraindication to botulinum toxin treatment.
* Patients who are receiving oral anti-spasticity medication and who have had a change in dosage of this medication in the month prior to study entry.
* Patients who have previously been treated with phenol for their upper limb spasticity.
Light Therapy and Binge Eating Disorder Treatment (BED Light Study)

Binge Eating Disorder (BED) is the most widespread food behavior disorder, with prevalence three times higher than anorexia. Its pathophysiology remains poorly understood and the investigators have few therapeutic options. Following a review of the literature, the investigators hypothesize that luminotherapy could be an innovative treatment of BED by its favorable effect on triggers of hyperphagic access, circadian disturbances, attention and impulsivity. The study is prospective, interventional, randomized, double-blind, monocentric (HCL). 52 patients with BED will be randomized to an active arm with intensive luminotherapy (1 daily 30 min, 10,000 lux in the morning) versus a placebo arm (\<500 lux). Treatment will be delver every day during 30 days. Assessments will take place on D0, D30 and D60. The main objective is to compare the evolution of the number of hyperphagic access before and after treatment between the two groups. Secondary objectives are to compare characteristics of hyperphagic access, bodily concerns, food dependence and impulsivity, mood, anxiety, cognitive and attentional profiles (STROOP, Go / No Go, SST, BART, Prospective Time Estimation Task, Switching Task), liking / wanted for different food categories and carbohydrate metabolism (CRP, glucose, insulinemia, insulin resistance, profile of lipid abnormalities, 25-OH vitamin D3).


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 55 years old
* Binge eating disorders or other eating disorders according to DSM V criteria
* Patient with BES score (with " Bing Eating Scale " ) \> 18
* Patient with BMI \> 18.5 kg/m2
* Patient who agrees to be included in the study and who signs the informed consent form
* Patient affiliated to a healthcare insurance plan

Exclusion Criteria:

* Patients with other psychiatric comorbidities, including a disorder bipolar mood
* Unstabilized diabetic patient with or retinopathy
* Patient with sleep disorder (delay or phase inversion)
* Patient with psychotropic treatment unstabilized (except anxiolytic treatment)
* Recent eye surgery or eye problem preventing exposure to bright light.
* Medication making the skin more sensitive to light (eg. Tablets against malaria)
* Patient who does not understand French/is unable to give consent
* Mentally unbalanced patients, under supervision or guardianship
* Patient already included in a research study
* Pregnancy or desire to be pregnant during the study
Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease

This study is a proof of concept that will assess the Predictor's kit performances. The test will be performed by several technicians, in immunological laboratories of several sites in France.

In this study, "couples" of donor / recipient in the frame of a graft of CSH will be included.

The Hematopoietic Stem Cell (HSC) graft is the only curative treatment for lots of hematologic diseases, malignant or not, particularly leukemias.

The acute Graft versus Host (aGvH) reaction is the most frequent complication, and could concern until 50% of recipients. It is mainly linked to immune characteristics of the donor which will act versus the graft recipient.

There is a huge need of a technology that could predict the risk of aGvH, especially in order to select a donor in case of several possibilities, in order to reduce morbidity and mortality of graft.

The Predictor' kit allows to predict acute and severe forms of Graft versus Host disease before the graft of peripheral hematological stem cells, by the assesment of iNKT cells expansion.

Eligibility Criteria:
Main inclusion Criteria for Donors :

* Being a relative of the recipient patient, OR being registered on the National Registry of the volunteers for bone marrow donation
* Being candidate for a donation of Hematologic Stem Cells with a HLA compatibility 10/10

Main inclusion Criteria for Recipient :

* Being candidate for a donation of Hematologic Stem Cells with the following criteria:
* HLA compatibility 10/10 with the donor
* Suffering from malignant or non-malignant hemopathy in first remission
* Myeloablative or reducted intensity conditioning
* Classic scheme of immunosuppression decreasing

Main exclusion Criteria:

* Participation to a therapeutical protocol in the 30 last days
Assessing Response to Albuterol in Bronchiolitis

Bronchiolitis is a significant cause of morbidity and hospitalizations in children, accounting for more than 125,000 hospitalized children per year in the United States. Although treatment is largely supportive, bronchodilator medications such as albuterol are frequently used due to increased pulmonary resistance in this population.2-4 However, despite four decades of clinical trials, the efficacy of albuterol in the treatment of bronchiolitis has yet to be proven. This inconsistency is due in part to the lack of sufficiently sensitive methods for the evaluation of lung function and thus the response to albuterol in infants. Because of the difficulties in evaluating the response to therapy, healthcare providers are forced to rely on their physical examination skills or a clinical scoring system, both of which are highly subjective in this population. The investigators propose to conduct a prospective observational study of healthcare providers to determine the accuracy of clinical assessment as compared to that of pulmonary mechanics in a population of children intubated and mechanically ventilated for bronchiolitis.

We propose to conduct a prospective observational study of healthcare providers to determine the accuracy of clinical assessment as compared to the assessment of pulmonary mechanics in a population of children intubated and mechanically ventilated for bronchiolitis. Before and at 20 minutes following a routinely scheduled albuterol treatment, measurements of pulmonary mechanics obtained as part of the child's clinical care will be compared to a healthcare provider's simultaneous clinical assessment. Three healthcare providers (a nurse, physician, and respiratory therapist) will assess the child during these time periods. Data regarding their observations will be recorded using a data collection tool (attached). Healthcare providers will be blinded to each other's assessments and to the measurements of pulmonary mechanics. Using sensitivity and specificity analysis, the healthcare provider's assessment of response will be compared to the standard assessment of response according to the measurements of pulmonary mechanics. A precision of the estimate of sensitivity and specificity will be calculated. Clinical characteristics of the child will be recorded. Each child may be assessed on up to three occasions if that child receives greater than 1 dose of albuterol. However, no more than 3 providers will assess the child at one time.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization with a primary admission diagnosis of bronchiolitis
* Age between birth and 2 years
* Intubated with \< 1 cm H2O leak around endotracheal tube
* Receiving inhaled albuterol therapy

Exclusion Criteria:

- Not meeting inclusion criteria
Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy

The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing percutaneous nephrolithotomy for kidney stone disease

Exclusion Criteria:

* History of nonsteroidal antiinflammatory drug allergy
* Asthma
* History of long-term opioid use
* Intraoperative blood loss greater than 300 mL
* Postoperative hemodynamic instability
* Active peptic ulcer disease
* Advanced renal impairment (Creatinine \> 2.0 mg/dL)
* Bleeding diathesis
* Current use of probenecid
* Pregnancy