cyrilzakka/clinical-trials huggingface dataset:
A Randomized Trial of Base-in Prism Reading Glasses Convergence Insufficiency in Children

This study is designed to compare the use of special prism glasses to placebo treatment for children with symptomatic convergence insufficiency.

The Base-in for Convergence Insufficiency Treatment Trial (BI-CITT) is a multi-center, placebo-controlled, masked, clinical trial designed to compare the benefits of base-in prism for patients with convergence insufficiency (CI).

The goals of this clinical trial are:

* To compare the effectiveness of Base-in prism and Placebo eyeglasses for the treatment of CI in children
* To study the long-term effect of these treatments for CI
* To identify factors that may be associated with successful treatment of CI with base-in prism

Eligibility Criteria:
Inclusion Criteria:

* Age: 9 to \<19 years.
* Best corrected visual acuity of ≥20/25 in each eye at distance and near
* Willingness to wear eyeglasses or contact lenses to correct refractive error, if necessary
* Willingness to wear glasses for reading and other near work
* Exophoria at near at least 4 greater than at far
* Insufficient positive fusional convergence (fails Sheard's criterion)
* Receded near point of convergence of  6 cm break
* Random dot stereopsis appreciation using a 500 seconds of arc target.
* CI Symptom Survey score  16

Exclusion Criteria:

* Amblyopia (\> 2 line difference in best corrected visual acuity between the two eyes).
* Constant strabismus
* History of strabismus surgery.
* Anisometropia  2D in any meridian between the eyes.
* Prior refractive surgery.
* Vertical heterophoria greater than 1 .
* Systemic diseases known to affect accommodation, vergence and ocular motility such as: multiple sclerosis, Graves thyroid disease, myasthenia gravis, diabetes, Parkinson disease.
* Any ocular or systemic medication known to affect accommodation or vergence (Anti-anxiety agents (Librium or Valium), Anti-arrhythmic agents (Cifenline or Cibenzoline), Anticholinergics (Motion sickness patch (scopolamine), Bladder spasmolytic drugs (Propiverine), Chloroquine, Phenothiazines (Compazine, Mellaril, or Thorazine), Tricyclic antidepressants (Elavil, Nortriptyline, or Tofranil)
* Accommodative amplitude \<5 D in either eye as measured by the Donder's push-up method.
* Manifest or latent nystagmus.
* Developmental disability, mental retardation, attention deficit hyperactivity disorder (ADHD), or learning disability diagnosis in children that in the investigator's discretion would interfere with treatment.
* Household member or sibling already enrolled in the BI-CITT.
* Any eye care professional, ophthalmic technician, ophthalmology or optometry resident or optometry student.
ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)

Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of typical GERD
* well controlled on a standard clinical symptoms controlled dose of PPI treatment
* body mass index ≤32 kg/m2

Exclusion Criteria:

* exclusively atypical symptoms of GERD
* symptoms that have been shown not to be associated with GERD
* erosive oesophagitis
* hiatus hernia \> 3 cm
* current diagnosis of co-existing psychiatric disease
* known clinically significant allergy or known hypersensitivity to drugs
* pregnant or breast-feeding
* has received sodium valproate or topiramate within 30 days of Screening
* has a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study
mHealth Biometrics for Sedentary People (MotivateLJMU)

The investigators aim to undertake a feasibility randomised controlled trial (RCT) to investigate whether mHealth technology, allowing biometric informed feedback and coaching on exercise and PA, can be effective in previously sedentary individuals. The overall objective is to have an evidence-based exercise and PA intervention ready to evaluate in a future RCT.

Participants will be recruited from Liverpool John Moores University, and other local office-based businesses. Participants will be randomised to either online exercise resources only (n=50) or exercise counselling + mHealth (n=50).This is a pilot parallel group, randomised controlled trial whereby consenting participants will complete baseline testing (T1) before starting a 12-week exercise intervention supported by online resources only (online resources intervention) or online resources and a programme of exercise counselling enhanced with mobile health (mHealth) technology (mHealth intervention). Participants will repeat baseline assessments (i) 6-weeks into the intervention (T2) and, (ii) immediately post-intervention (T3). Testing at baseline and following the 12-week intervention will include changes in physical activity, blood pressure, body composition and glycaemia control (n=20).

Both groups will have access to online resources throughout the 12-week programme. The intervention group will be provided with exercise counselling and to support this they will also be provide with a wristwatch that can monitor everyday activity and their heart rate, a smartphone app and access to a website. The intervention group will also participate in 4 consultations with an exercise specialist to plan their exercise programme and be updated on their progress towards physical activity targets. Weekly text message updates will also provide feedback to the intervention group with participants able to respond to these updates.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 18-75
* No known cardiovascular or metabolic disorder (e.g. heart failure, diabetes, previous myocardial infarction etc.)
* Able to exercise safely as deemed by completion of the PAR-Q+.
* Not currently meeting the recommended exercise guidelines (150 minutes moderate or 75 minutes of vigorous intensity physical activity per week), as assessed during screening questions related to the participants previous activity levels.

Exclusion Criteria:

* Aged \<18 or \>75
* Pregnancy or planning to become pregnant in the next 3 months
* \<6 months postpartum or stopped breastfeeding \<1 month before recruitment
* Not owning a smartphone with a data plan or access to WiFi
Double Filtration Plasmapheresis (DFPP) and Lipid Metabolism

Little clinic trials showed that Double Filtration Plasmapheresis (DFPP) could improve lipid metabolism, however, whether DFPP can improve platelet function and recover Endothelial function is unknown. In this study, we try to confirm the hypothesis that DFPP can improve endothelial function in hyperlipidemia patients.


Eligibility Criteria:
Inclusion Criteria:

1. hyperlipidemia

Exclusion Criteria:

1. Severe liver and kidney dysfunction
2. Severe cardiopulmonary insufficiency
3. tumor
4. pregnancy
Nicotinic Receptors and Schizophrenia

The investigators hypothesize that sustained-release DMXB-A-SR (3-2,4 dimethoxybenzylidene anabaseine sustained release) will provide clinical improvement in cognition in patients with schizophrenia who are smokers and who are non-smokers. The study drug may also maintain abstinence from cigarette smoking and improve other symptoms in patients with schizophrenia.

Patients with schizophrenia will be screened then enrolled for one week placebo trial in addition to their existing antipsychotic medication. If pill compliance is greater than 80%, then they will receive baseline clinical, cognitive, and brain imaging and all clinical laboratory examinations and a physical examination, vital signs, and cardiogram. Then patients will receive in a randomized double blind trial either DMXB-A-SR (3-2,4 dimethoxybenzylidene anabaseine sustained release) or placebo comparator in addition to their existing antipsychotic medication. After one month patients will receive repeat clinical, cognitive, and brain imaging testing and all clinical laboratory examinations and a physical examination, vital signs, and cardiogram.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be selected to be 18 to 65 years old and in good general health.
* Subjects who fulfill Diagnostic and Statistical Manual -IV-Text Revision (DSM-IV-TR) criteria for schizophrenia or schizoaffective disorder.
* Smokers will smoke at least 20 cigarettes per day.
* Non-smokers will also be enrolled.
* Subjects will have normal:

  * vital signs,
  * hematology,
  * serum chemistries,
  * EKG, and
  * urinalysis with a negative drug screen before entry into the study.
* Subjects will be fluent in English.
* Smoking subjects will be interested in stopping smoking in the near future and not interested in nicotine replacement therapy.

Exclusion Criteria:

* Subjects with histories of:

  * neurological illness,
  * liver disease,
  * severe hypertension (cut-off blood pressure 160/100) or
  * cardiac disease, or
  * renal failure (cut-off creatinine above 1.4).
* Subjects who currently meet DSM-IV-TR criteria for substance dependence other than nicotine, cannabis, or alcohol will be excluded.
* Women who are capable of pregnancy and not on acceptable forms of birth control will be excluded.
* Subjects being treated with Clozapine will be excluded.
Attention Control Training for PTSD Related to Combat or Interpersonal Violence

Participants will complete a pre and post training psychological assessment. Participants will be assigned to attention control training or the comparison stimuli computer task in a double-blind randomized control trial design. Both computerized dot probe tasks display two stimuli on a computer screen, one above the other, followed by a small right or left arrow appearing in the location vacated by one of the stimuli. Participants are required to respond as quickly as they can by pressing the indicated right or left arrow on their computer keyboard without compromising accuracy. Participants complete 6 training sessions.


Eligibility Criteria:
Inclusion Criteria:

* military veteran or woman exposed to interpersonal violence (e.g. domestic or sexual violence).
* significant symptoms of PTSD

Exclusion Criteria:

* bipolar disorder, schizophrenia, OCD, unable to attend sessions sober.
Hemodynamic Changes After Anesthesia With Propofol: Study of Biomarkers

The purpose of this study is to evaluate biomarkers affecting the hemodynamic responses to propofol. Particularly, the investigators will assess the effects of polymorphisms in NOS3 and PRKCA genes on hemodynamic responses to propofol and the effects of these polymorphisms on biomarkers related to nitric oxide after propofol anesthesia. In addition, the investigators will evaluate the effects of propofol anesthesia on biomarkers related to nitric oxide in hypertensive patients chronically treated with angiotensin-converting enzyme inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* ASA I or II
* BMI lower 30 kg/m2

Exclusion Criteria:

* Severe hypertension
* Previous stroke
* Previous infarction
* Uncontrolled respiratory, renal, hepatic and hematological diseases.
CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

This is an open-label, single arm, dose escalation study in patients with relapsed or refractory CLL. Treatment will be administered on an outpatient basis and all patients will receive CYC065 over 4-hour infusion once every 2 weeks on Day 1 and Day 15 in combination with venetoclax. One treatment cycle is 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* CLL that is relapsed or refractory to BTK inhibitors and is on a stable dose of venetoclax
* ECOG 0-2
* Adequate bone marrow function
* Adequate renal function
* Adequate liver function
* INR \<=1.2 in patients not receiving chronic anticoagulation
* At least 4 weeks from prior cytotoxic chemotherapy
* At least 4 weeks from major surgery
* Agree to practice effective contraception

Exclusion Criteria:

* Known CLL involvement in CNS that is symptomatic and active
* currently receiving radiotherapy, biological therapy, or any other investigational agents
* Uncontrolled intercurrent illness
* Pregnant or lactating
* Known to be HIV-positive
* Known active hepatitis B and/or hepatitis C infection
Patients Treated in Real Life With VEnetoclax for WAldenström Macroglobulinemia

Waldenström macroglobulinemia (WM) is an incurable disease. BCL2 antagonist, an important anti-apoptosys molecule, is already approved for the treatment of chronic lymphocytic leukemia (CLL) and acute myeloid leukemia. Recently, a clinical trial including 32 patients with WM treated with Venetoclax showed an overall response rates of 84% and a major response rate of 81%. However, there is no in real life data, in the french population, of the efficiency of Venetoclax in WM. The aim of our multicentric retrospective study is to evaluate the efficiency and tolerance of Venetoclax in WM.


Eligibility Criteria:
Inclusion Criteria:

* Waldenstrom's macroglobulinemia
* Treatment with Venetoclax
* Non opposition

Exclusion Criteria: none
Regular Insulin vs Rapid Insulin Delivered by V-Go

The purpose of the study is to collect data about how well U-100 Regular Human Insulin can be used in the V-Go Insulin Delivery Device compared to U-100 Rapid Acting Insulin in the V-Go Insulin Delivery Device. The data collected will be used to see how much subjects' blood sugar levels change over time after they switch from using U-100 Rapid Acting Insulin to U-100 Regular Human Insulin within their V-Go Insulin Delivery Device.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 21 years at time of study enrollment
2. Diagnosed with T2D for at least 6 months prior to screening
3. Screening visit A1C ≥ 7.0% and ≤ 12.5%
4. Prescribed a stable (less than 20% change in the past 30 days) of rapid acting U-100 insulin delivered via V-Go insulin delivery device
5. Ability to read and understand English
6. Willing to complete all study related activities
7. Willing and able to understand and sign a written ICF indicating that they agree to participate and have been informed of all pertinent aspects of the study
8. Must be willing to take and record 7 glucose measurements per time period (pre-morning meal (fasting), pre-midday meal, pre-evening meal, and 2-hours after the start of the morning, midday, and evening meals, and at bedtime) three times throughout the study (prior to Visit 2, 3, and 4).
9. Completed a 7-point glucose profile prior to Visit 2
10. Able (by insurance or financial means) to cover the initial investment and ongoing cost of the V-Go insulin delivery device, insulin (current rapid acting insulin or potential new regular human insulin), personal glucometer and supplies for the length of the study.

Exclusion Criteria:

1. Subject with confirmed Type 1 diabetes
2. More than 1 episode of severe hypoglycemia (defined as requiring third party assistance) within 3 months of study entry
3. History of hypoglycemia unawareness
4. Require supplemental insulin in addition to V-Go therapy
5. Woman of child-bearing potential who has a positive pregnancy test at screening or plans to become pregnant during the course of the study. Women of childbearing potential are defined as any female who has experienced menarche and who it NOT permanently sterile of postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without and alternative medical cause.
6. Woman who are lactating.
7. Use of any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
8. A recipient of a solid organ transplant
9. Current use of U-100 RHI in V-Go within 90 days of screening
10. Current use of U-500 RHI in V-Go within 90 days of screening
11. Currently on dialysis
12. Medical or other problems which in the opinion of the investigator will render study participation unsafe.
A Study of Genetic Based Chemotherapy Dosing for Breast Cancer Patients

Epirubicin is a common chemotherapy medication used in the treatment of breast cancer. However, chemotherapy dosing is calculated based on people's height and weight, which may not be the most accurate way. The purpose of this study is to see if epirubicin dosing based on people's genetic profiles is better than the usual methods.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients with histologically confirmed non-metastatic invasive breast cancer who are scheduled to receive at least three cycles of FEC100 in the adjuvant or neoadjuvant setting
2. Documented pathological evaluation of the breast cancer for hormone receptor (estrogen receptor \[ER\], progesterone receptor \[PR\] and HER-2 status
3. Eastern Cooperative Oncology (ECOG) performance status of ≤ 2
4. A Left Ventricular Ejection Fraction (LVEF) ≥ 50%.

Exclusion Criteria:

1. Uncontrolled congestive heart failure (CHF) or angina, history of myocardial infarction within 2 months before study enrollment, or cardiac functional capacity Class III or IV as defined by the New York Heart Association Classification.
2. Psychiatric disorder(s) that would interfere with consent, study participation, or follow up.
A Comparative Study of Temporalis Fascia Graft and Periosteal Graft in Myringoplasty

A Comparative Study of Temporalis Fascia Graft and Periosteal Graft in Myringoplasty

The aim of this clinical trials is to asses and compare the surgical outcomes of Temporalis fascia graft and periosteal graft in myringoplasty in terms of graft intake and audiological improvement

Eligibility Criteria:
Inclusion Criteria:

age 12years to 40 years Small to moderate sized perforation . Dry tubotympanic chronic suppurative otitis media For more than 6 weeks .

Exclusion Criteria:

Active discharge or superimposed otomycosis . Patients with sensorineural hearing loss. Patients with considerable nasal pathology.
Strengthening Equilibrium and Educational Support in Preventing Falls in the Thermal Center

Preventing falls among people 65 years of age or older is a priority to promote healthy aging and reduce the number of hospitalizations, institutionalizations and years lived with disability. A preliminary study carried out at the Balaruc-les-Bains Thermal Center showed that one-third of people aged 65 are at significant risk of falling. Thermal establishments could therefore play a role in initiating measures to prevent falls among people aged 65 and over screened at risk.The main objective is to evaluate the impact on the incidence of falls at 12 months (M12) to add to the usual care (control group) a program combining, during the treatment, adapted physical activities (APA) and a Therapeutic patient education (FTE) followed by an educational follow-up for 12 months (intervention group) for people aged 65 and over who were at risk of falling on arrival at the Thermal


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 65 and over,
* Presence of at least one chronic pathology justifying treatment and cure
* Subject having a history of fall in the last year (at least one fall)
* Subject having at least one risk factor of falling among the following 3: balance disorder, decreased muscle strength or gait disorder

Exclusion Criteria:

* Subject considered by the investigators as not being able to participate in the program (inability to answer questionnaires, to perform tests, for example).
* Patient under the protection of justice, under guardianship or curatorship
Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes

The primary objective of this study is to determine whether intermittent use of continuous glucose monitor will facilitate weight loss in individuals who are overweight/obese with prediabetes.

Continuous glucose monitoring (CGM) has revolutionized the treatment of patients on intensive insulin therapy and its utility can also be harnessed to help individuals with prediabetes make healthful lifestyle changes. Successful weight loss requires adherence to lower calories, regular exercise, and self-monitoring. This proposal will test the hypothesis that intermittent CGM will facilitate all of these components for successful weight loss by functioning as a continuous self-monitor and guiding healthful food choices and physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese (BMI 25-40 kg/m2)
* Prediabetes (fasting glucose 100-125 mg/dL and/or HbA1c 5.7-6.4%)

Exclusion Criteria:

* On glucose-lowering medications (e.g., metformin)
* On weight-loss medications
Inflammatory Mediator Profiles During Heart Valve Replacement Surgery

The study aims at the comparative examination of pre-, intra- and post-operative release profiles of inflammatory and vasoactive mediators in patients undergoing heart valve surgery under cardiopulmonary bypass (CPB) due to either infectious endocarditis or degenerative valvular heart disease. Specific attention will focus on the distinction between mediator release associated with infection and that resulting from CPB. Concomitantly identification and characterization of infectious pathogens in the circulation and in valvular samples will be carried out, together with the search for resistance-coding transcripts.

Exaggerated release of inflammatory mediators and endogenous vasoactive substances resulting from the coincident infection and surgical stress plays a role in post-operative organ failure and altered immune defense, thus contributing to unfavorable post-operative outcome.

Cardiopulmonary bypass (CPB) itself, even in the absence of IE, has been shown to modify cytokine and vasoactive mediator release and may cause organ failure. Tracing of release profiles of inflammatory cytokines and vasoactive mediators and their correlation with postoperative organ dysfunction in cardiac surgery for IE or non-IE patients aims at the assessment of the prognostic validity of these biomarkers and the evaluation of measures for their pro-active clearance during the surgical intervention.

Induction of inflammatory mediators and their temporal release profile may vary depending on the involved pathogens, which cannot be always identified by conventional techniques (blood culture). Since it is conceivable that identification of the involved pathogen could explain differences in cytokine secretory patterns in IE, use of advanced molecular technologies (NGS) will support the clarification of such relations. Analysis of transcripts encoding inflammatory and vasoactive mediators in blood cells will enable the surveillance of temporal oscillations in their profiles during the observation time frame. Transcriptome analysis of identified putative pathogens can also disclose features of antibiotic resistance.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* age \> 18
* confirmed diagnosis of infective endocarditis or valvular heart disease
* scheduled surgical Intervention with CPB use

Exclusion Criteria:

* glucocorticoid dosage above Cushing threshold
* severe neutropenia (below 1000/mm3)
* immunosuppression or immunomodulatory therapy
* pregnancy