cyrilzakka/clinical-trials huggingface dataset:
DIabetic Retinopathy Candesartan Trials

The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with retinopathy.

The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate change in urinary albumin excretion rate (UAER).

This study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 1 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 37 - 75 years with type 2 diabetes diagnosed at age of 36 years or thereafter.
* Duration of diabetes for \> 1 year and \< 20 years with stable diabetic therapy within last 6 months.
* Patients with untreated resting mean sitting SBP \< 130 mmHg and mean sitting DBP \< 85 or treated resting mean SBP \< 160 mmHg and mean sitting DBP \< 90 mmHg with retinal photograph grading level \>20/10 up to \< 47/47 (on ETDRS severity scale).

Exclusion Criteria:

* Patients with the following conditions are excluded from participation in the study:
* Cataract or media opacity of a degree which precludes taking gradable retinal photographs
* Angle closure glaucoma, which precludes pharmacological dilatation of the pupil
* History of or presence of proliferative retinopathy
* History or presence of clinical significant macular oedema (CSME)
* History or evidence of photocoagulation of the retina
* Other retinal conditions which may mask assessment, eg, retinal vein occlusion
* Positive micral dipstick test
* Presence of secondary diabetes
* Pregnant or lactating women or women of child bearing potential not practicing an adequate method of contraception
* Need of treatment with ACE-inhibitor
* Haemodynamically significant aortic or mitral valve stenosis
* Known renal artery stenosis or kidney transplantation
* Hypersensitivity to study drug
* Severe concomitant disease which may interfere with the assessment of the patient, eg, malignancy, as judged by the investigator
Antihemostatic Therapy and Endoscopic Biliary Sphincterotomy Induced Bleeding

The aim of the study is to observe the effects of antihemostatic therapy including nonsteroidal antiinflammatory, anticoagulant and antiaggregant therapy and other patient and procedure related factors on the risk of endoscopic biliary sphincterotomy induced bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization
* Endoscopic sphincterotomy
* The patients whose warfarin treatment was stopped and INR was normalized prior to examination

Exclusion Criteria:

* The patients who had undergone endoscopic cholangiography with no sphincterotomy
* Outpatient procedures
Women With Epilepsy: Pregnancy Outcomes and Deliveries

This is a three-center prospective case-control study to examine the patterns of fertility among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy (WWoE).

This is a three-center prospective case-control study to examine the patterns of fertility among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy (WWoE). The investigators will determine if pregnancy rates differ in WWE compared to WWoE. Covariates of interest include proportion of ovulatory cycles, sexual activity, and type of anti-epileptic drug (AED). The investigators will compare seizure frequency during preconception to seizure frequency during pregnancy, with analysis of covariates of interest (AED type, AED ratio-to-target concentrations, and epilepsy syndrome). The investigators will also observe interactions between seizures/epilepsy, AEDs, and sex steroid hormones during this opportune time when women are not on birth control. Patterns of seizures will be evaluated for accepted catamenial patterns with consideration of ovulatory and anovulatory cycles, AED concentrations, and epilepsy type.

Eligibility Criteria:
Inclusion Criteria:

* between ages 18 and 40
* planning pregnancy
* stopped birth control or planning to stop birth control
* for women with epilepsy: receiving at least one AED (lamotrigine, levetiracetam, carbamazepine, phenytoin, oxcarbazepine, phenobarbital, topiramate, rufinamide). If on polytherapy, AEDs cannot include lamotrigine, levetiracetam or valproate.

Exclusion Criteria:

* Use of hormonal therapies for contraception
* demonstrated infertility with the same partner (more than 12 months of unprotected intercourse without achieving pregnancy)
* diagnosis of infertility
* Polycystic ovarian syndrome
* severe endometriosis
* currently breastfeeding
* male factor infertility
* surgical or medical menopause
* smokers who have more than 10 cigarettes per day
* untreated thyroid disease
* hyperprolactinemia or other pituitary disease
* recently trying to achieve pregnancy for more than 6 months with having regular vaginal sexual intercourse without contraception
A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications

Glaucoma is the second leading cause of visual impairment worldwide. Eye drop medications reduce vision loss from glaucoma by at least 60%, but eye drops must be taken every day to be effective. However, adherence to eye drop treatment is poor with only 50% of patients regularly taking their prescribed eye drops. The investigators are developing the Devers Drop Device (D3) eye drop monitor to accurately measure eye drop cap removal and to improve eye drop-taking behavior. The investigators will test eye drop adherence with the D3 device in a randomized, prospective clinical trial.

Universal Adherence is an emerging medical device company dedicated to improving adherence to ocular medications through innovative technical solutions. The Devers Drop Device (D3) will accurately track when a patient removes an eye drop bottle cap, communicate usage data wirelessly to a database that researchers can access, and send alerts to patients when a medication is due. In addition to helping patients maintain their dosing schedule, the D3 will also provide adherence information to researchers and eye care providers, which will help to understand poor treatment outcomes and to develop improved treatment strategies.The clinical benefits of the device in improving adherence will initially be assessed and targeted towards glaucoma, but the ability of the device to be attached to all FDA-approved eye drop bottle caps will make this device attractive to all patients that need consistent daily use of eye drops.

Randomized, prospective clinical trial: The investigators will enroll 50 participants (25 male, 25 female) into a prospective trial with duration of up to 50 days. The inclusion criteria are those who are prescribed latanoprost eye drop to be used once per day at bedtime, and own a functioning Android or Apple iphone smartphone (iOs) with Bluetooth and cellular connectivity. The investigators will exclude patients who currently use smartphone medication reminders and those with severe cognitive impairment limiting their ability to understand a questionnaire. The 50-day period is useful for glaucoma studies because patients revert to their normal dosing pattern within two weeks after their last visit. This study will include two stages: Stage 1) a 25-day period evaluating baseline patient adherence with the D3 device; and Stage 2) a subsequent 25-day period to determine the effect of no reminder versus daily reminder using the D3 app, which includes integrated audio and visual reminders.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are prescribed latanoprost eye drop to be used once per day at bedtime, and own a functioning smartphone and have a password-protected home wireless connection.

Exclusion Criteria:

* Patients who currently use smartphone medication reminders and those with severe cognitive impairment limiting their ability to understand a questionnaire.
Hospital Management of Hyperglycemia Study of Insulin Glargine Plus Insulin Lispro Versus Human Regular Insulin

The purpose of this study is to compare the use of insulin glargine plus insulin lispro to human regular insulin for treatment of hyperglycemia in the hospital setting in patients without known prior history of diabetes.

This study involves a comparison of 2 methods for administering subcutaneous insulin therapy to non-critically ill adult patients with hyperglycemia and without known history of diabetes who are admitted to non-intensive care unit (ICU) general medical hospital services. Basal-bolus therapy, considered the gold standard for glucose control in patients with known diabetes, will be compared with sliding scale insulin, a commonly used method of glucose control (prevailing standard practice) in hospitalized patients. In this study, basal-bolus therapy will consist of once-daily glargine plus lispro 3 to 4 times daily adjusted to achieve pre-meal capillary plasma glucose \<140 milligrams per deciliter (mg/dL) and bedtime capillary plasma glucose \<180 mg/dL for patients who are eating \[predose plasma glucose \<140 mg/dL for patients with nil per os (NPO) orders\]; sliding scale insulin will be administered using human regular insulin 4 times daily as needed adjusted to achieve predose capillary plasma glucose target \<140 mg/dL in patients who are eating or have NPO orders.

Eligibility Criteria:
Major Inclusion Criteria:

* No known history of diabetes
* Admission or pre-entry plasma glucose (PG) level between 140 and 400 mg/dL
* Non-critically ill and admitted to acute care medical services
* Have a body mass index greater than or equal to 18.5 kg/m\^2 and less than or equal to 45 kilograms per square meter (kg/m\^2)

Major Exclusion Criteria:

* Received any insulin/analog therapy for longer than 108 hours prior to study entry or intermediate- or long-acting insulin/analogs (neutral protamine Hagedorn, detemir, or glargine) in the 24 hours prior to randomization or any intravenous insulin therapy prior to randomization
* Laboratory evidence of diabetic ketoacidosis for patients with pre-randomization PG greater than 250 mg/dL
* Have taken any oral or injectable antihyperglycemic medications other than insulin within 3 months prior to study entry
* Have acute critical illness or are expected to require admission to an ICU or equivalent or be treated with glucocorticoid therapy during the hospital study period
* Expected hospitalization less than 24 hours post-randomization
Prospective Evaluation of the Clinical Utility of Endoscopically Placed Self-expandable Stents

The investigators' believe that it is important to medical practice to obtain information on how expandable metal stents work in a large group of patients who have metal stents placed in the gastrointestinal system. The purpose of this research study is to collect information on the stent placement in our facility and how the patients responded to the stent placement.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older.
2. Scheduled to undergo endoscopy with placement of self-expanding stent at the University of Florida, Gainesville, FL.
3. Subject must be able to give informed consent.

Exclusion Criteria:

1. Any contraindication to performing endoscopy.
2. Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
3. The subject is unable/unwilling to give informed consent.
Mulligan Mobilizations Versus Active Release Technique in Tension-type Headache.

Tension-type headaches, characterized by a dull, aching head pain, are one of the most prevalent forms of headache disorders worldwide. Although they are typically not associated with severe disability or neurological symptoms, they can significantly impact an individual's quality of life due to chronic pain and discomfort. Non-pharmacological interventions, such as manual therapy techniques, have gained prominence in headache management, offering potential relief and functional improvements for patients. This study aims to investigate the comparative effectiveness of two widely used manual therapy approaches, Mulligan mobilization and Active Release Technique (ART), in alleviating pain, reducing disability, and enhancing range of motion (ROM) in patients suffering from tension-type headaches. Understanding which technique offers superior outcomes is vital for optimizing headache management strategies.

This randomized controlled trial (RCT) will recruit adult participants diagnosed with tension-type headaches according to standardized criteria. Eligible individuals will be randomly assigned to one of three groups: The Mulligan mobilization group, the ART group, and the control group. Each group will undergo a specific manual therapy intervention protocol administered by trained therapists. The primary outcome measures will include assessments of pain intensity via VAS, disability levels via Headache disability index (HDI), Stress levels will be assessed by PSS (Perceived Stress Scale), and ROM of the cervical spine by using the Flexion rotation test. Secondary outcomes will encompass patient-reported measures of headache frequency, medication usage, and overall quality of life. Data will be collected at baseline, immediately post-intervention, and at follow-up intervals. Statistical analyses will be conducted to assess and compare the effects of the two interventions on the primary and secondary outcomes using ANOVA from SPSS software, thereby addressing the research question regarding their relative efficacy. This study holds the potential to enhance the evidence base for non-pharmacological headache management and guide clinicians and patients toward more effective treatment choices.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18-35 years.
* Diagnosis of chronic tension-type headache according to the International Classification of --Headache Disorders (ICHD-3) criteria.
* Baseline HDI from 10 and above, and NPRS score 3 and above.
* No prior exposure to any of the two interventions (ART and Mulligan Mobilization).

Exclusion Criteria:

* All other types of headaches.

  * Individuals taking medications for headaches.
  * Serious neurological or medical conditions that could affect the study outcomes.
  * History of psychiatric disorders.
  * Recent head or neck trauma or surgery.
  * Contraindications for any of the two interventions.
  * Participation in other headache management studies during the study period.
Assessment of the ACE Program for Rehabilitation in Hearing Loss

* Introduction: Hearing loss is a prevalent condition in elderly population. However, the low adherence to hearing aids is a fact, with an estimation of use of 50 per cent. In 2007 there was designed a rehabilitation program called ACE, which aims to improve rehabilitation directed to hearing aids users. The study hypothesis is that a counseling program will improve adherence to hearing aids in elderly population.
* Objective: To evaluate the utility of a standardized counselling program in patients with hearing loss.
* Material and Methods: A before/after trial will be carried out, approved by the Hospital ethics - committee. Patients with 65 years and older with hearing loss diagnosed by pure tone audiometry will be included. To assess adherence we will use the IOI-HA scale.

* Introduction: Hearing loss is a prevalent condition in elderly population. However, the low adherence to hearing aids is a fact, with an estimation of use of 50 per cent. In Chile, hearing aids are provided by the State for elderly population. In 2007 there was designed a rehabilitation program called Active Communication Education (ACE), that is a semistructured rehabilitation program for people with hearing loss, which aims to improve rehabilitation of hearing aids users by a strategy based on problem solution.
* The study hypothesis is that a counseling program will improve adherence to hearing aids in elderly population.
* Objective: To evaluate the utility of a standardized counseling program in patients with hearing loss.
* Material and Methods: A before/after clinical trial will be carried out, approved by the Hospital ethics - committee. Patients with 65 years and older diagnosed by pure tone audiometry who are beneficiaries of the Public GES hearing loss programme and receive a hearing aid will be included. The subjects will be randomized in two branches: Active branch, subject to the rehabilitation program; and passive branch, which was control, with usual management (no intervention). To assess adherence we will use the IOI-HA scale.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral hearing loss equal or higher than 40 decibels
* Age 65 years old or more
* Agree to be included in the study
* Have a relative to go to the intervention with the subject

Exclusion Criteria:

* Severe organic brain impairment
* Physical or mental incapacity to understand the study questionnaires
* Structural pathology of the ear that produces hearing loss as chronic otitis media, ear canal tumor, or tumor of the cerebellopontine angle
Processing and Effects of Cannabis

The purpose of this study is to investigate the processing of cannabis, and to investigate the occurrence of effects of cannabis on the cardiovascular system and the central nervous system; at higher levels of exposure.

In Europe, cannabis is the most illicit used drug, mainly for its psychoactive properties (becoming "high" or "stoned"). The active compound in cannabis is THC (tetrahydrocannabinol). In recent years the strength of cannabis (marihuana) available on the market in the Netherland has increased (especially "netherweed"). The THC-content has increased from on average 8.6% in 2000 to on average 20.3% in 2004. Experienced users adapt their habit of smoking to the strength of the cannabis sigaret (joint). However, there is also a group of people, mainly young ones, who intent to smoke the joint entirely, and can therefore be exposed to higher levels of THC. Information is lacking about the effects of cannabis at higher levels of exposure. Because of this, the Ministry of Health, Welfare, and Sports of the Netherlands ordered the investigators to perform a study to gain more insight in this issue.

Eligibility Criteria:
Inclusion Criteria:

* Cannabis users (2-9 joints per month)

Exclusion Criteria:

* Psychiatric illness
* Evidence of excessive alcohol abuse
* Use of other drugs
Effect of Functional Electrical Stimulation on Erectile Dysfunction

Objective: The aim of this study is to evaluate the FES effect on erectile function in men with erectile dysfunction.

Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.

Introduction: Erectile dysfunction (ED) affects approximately 150 million men worldwide. The application of functional electrical stimulation (FES) has been used due to the high regenerative capacity of smooth muscle cells. This approach can be beneficial in the treatment of which usually has the ultimate causes cavernous smooth muscle degeneration.

Objective: The aim of this study is to evaluate the FES effect on erectile function in men with erectile dysfunction.

Methods: Randomized Clinical Trial will be selected in which 30 patients with erectile dysfunction. The men included will be randomized into two groups. The intervention group will conduct therapy with FES (50Hz / 500us) for 15 minutes with intensity below the motor threshold and the control group will use FES placebo. Two sessions will be held weekly for four weeks. Erectile function will be assessed using the validated questionnaire IIEF-5. The instrument will be completed by blinded researcher and the technique is randomized and the treatment done randomly.

Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Male patient
* 40 to 65 years of age, with stable marital relationship (6 months)
* Diagnosis of erectile dysfunction (score of less than 22 IIEF5)
* Clinical history of ED for at least 6 months

Exclusion Criteria:

* A neurogenic (spinal cord injury, Parkinson's, MS, post prostatectomy)
* Hypogonadism (total testosterone \<300 ng / dl)
* Patient reporting use of inhibitors or 5PDE FIC in the last 60 days
* Diagnosis of coronary artery disease and / or cerebrovascular disease
* Impossibility of understanding the goals, technical study and informed consent cognitive impairment
ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)

After conventional induction treatment with R-CHOP (Rituximab, cyclophosphamide, adriamycin, vincristine and prednisone) the patients are randomized to:

A: Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg

B: Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months

The study will evaluate the benefit of consolidation treatment with 90Y Ibritumomab tiuxetan (Zevalin®) or maintenance with rituximab (MabThera®) in terms of progression free survival, after induction with chemotherapy and rituximab in folicular lymphoma patients no treated previously.

The other aims are, evaluate the global survival, event free survival, time until next treatment, response rate after consolidation or maintenance treatment, quality of life, security of two branches and relation cost-efectivity

Eligibility Criteria:
Inclusion Criteria:

* Folicular Lymphoma CD20-positive, grade 1, 2 or 3a, confirmed in previous 4 months.
* Patients no treated previously.
* Ann Arbor Stage II, III o IV.
* Symptoms or signes wich indicate necesary treatment (GELF criteria):

  * Ganglionar or extraganglionar mass
  * B Symptoms
  * LDH or B2-microglobuline increased
  * 3 ganglionar territory afected (\> 3 cm)
  * Esplenomegalia
  * Compresive syndrome
  * Pleural/peritoneal effusion
  * Secondary medular insufiency due to infiltration
* Age\> 18 years and \<75 years.
* ECOG \< 2
* Adecuate hematological function: Hemoglobin \> 8,0 g/dl (5,0 mmol/L); RAN \>1,5 x 109/L; platelets \> 100 x 109/L
* No pregnant women. Women and man should use an appropiate anticonceptive method during the study and one year after
* Informed consent

Exclusion Criteria:

* Transformation in high grade lymphoma
* FL grade 3b.
* Skin or gastro-intestinal primary lymphoma
* History of CNS diseases ( or CNS lymphoma)
* Previous treatment
* Regulary treatment with corticosteroids (permited \< 20 mg/day prednisone or equivalent).
* Previous cancer diseases
* Major surgery in 28 days before inclusion in study.
* Creatinine \> 2,0 mg/dl (197 mmol/L)
* Bilirubin \> 2,0 mg/dl (34 mmol/L), AST (SGOT) \> 3 x upper normal limit.
* HIV infection or active infection VHB o VHC \< 4 weeks before inclusion.
* Other complicated diseases

Criteria investigador:

* Life expectancy \< 6 months.
* Hipersensibility to Ibritumomab tiuxetan, rituximab, other murines proteins or any excipients.
* Treatment in other experimental study in previous 30 days
* Any medical o psicologycal condition that can modify the capacity to give the consent