cyrilzakka/clinical-trials huggingface dataset:
COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)

A study to evaluate the effect of the 12-week treatment with timolol/dorzolamide combination eyedrops (COSOPT) on decrease in intraocular pressure (IOP) at 2 hours after the study drug administration


Eligibility Criteria:
Inclusion Criteria:

* Patients who have not been treated with a glaucoma medication within 6 weeks prior to study participation after diagnosis with primary open-angle glaucoma
* Patients with primary open-angle glaucoma based on gonioscopy
* Patients with normal tension glaucoma diagnosed based on accompanying optic disc cupping and reappearance of visual field defect corresponding to retinal nerve fiber layer defect.
* Subjects with \< 22 mm Hg of diurnal IOP measured using Goldmann applanation tonometer (every two hours between 9 a.m. and 5 p.m.)

Exclusion Criteria:

* Patients with another type of glaucoma but primary open-angle glaucoma
* Patients treated with other glaucoma medications within 6 weeks prior to study participation
* Patients with a history of chronic ocular inflammation or recurrent ocular inflammation
* Patients using contact lenses
* Patients who are allergic to timolol or dorzolamide
* Patients with a history of any of the following COSOPT (timolol/dorzolamide combination) contraindications:

  * Reactive airway diseases
  * Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock
  * Severe renal impairment
* Patients with a history of significant ocular trauma or intraocular surgery within 6 months before participating the study, or intraocular laser surgery within 3 months before the participating the study
* Patients with a history of a corneal disease
* Patients who are using steroid or used the drug for more than 2 weeks within 12 months before participating the study
* Pregnant women
Anodal and Cathodal Transcranial Direct Current Stimulation in Stroke Recovery

The purpose of this study will to compare the long-term effect of anodal versus cathodal transcranial direct current stimulation (tDCS) on motor recovery in subacute stroke patients. Forty patients with subacute ischemic stroke will randomly assigned to one of three groups: Anodal, Cathodal and Sham. Each group will receive tDCS at an intensity of 2mA for 25 minutes daily for 6 consecutive days over the affected (Anodal, Sham) or unaffected (Cathodal) motor cortex. Patients will be assessed with National Institutes of Health Stroke Scale (NIHSS), the Barthel index (BI) and the Medical Research Council (MRC) muscle strength scale at baseline, after end of the 6th tDCS session, and then 1, 2 and 3 months later. Motor cortical excitability will be measured at baseline and after the 6th session in both hemispheres.


Eligibility Criteria:
Inclusion Criteria:

* acute hemiparesis with single thromboembolic non-hemorrhagic infarction documented by magnetic resonance imaging (MRI)
* Accept to participate in the study

Exclusion Criteria:

* extensive infarction (taking all territories of middle cerebral artery)
* severe flaccid hemiplegia
* head injury
* Any other neurological disease other than stroke
* previous administration of tranquilizer
* patients who are unable to give informed consent because of severe aphasia, or cognitive deficit.
* Patients with no motor evoked response recorded from First Dorsal Interosseus (FDI) muscle of the affected hand
Body Weight-Based Interval Training in Sedentary Overweight and Obese Adults

Body-weight based interval training (IT) performed 3 times per week will lead to reductions in abdominal adiposity and reduce overall body fat percentage in overweight and obese sedentary adults more effectively than moderate intensity continuous training (MICT). Body-weight interval training will improve exercise capacity (peak VO2) in overweight/obese adults.

Participants will be randomly assigned to one of the two home-based exercise groups.

The MICT group is the standard care group and will be instructed to walk for 30 minutes, 5 days per week at a moderate intensity. The goal is to accumulate 150 minutes of continuous aerobic exercise each week. Participants will be instructed on the use of the Rating of Perceived Exertion (RPE) scale during baseline testing and will be instructed to reach an RPE of 12-16. A heart rate monitor will be worn to monitor exercise intensity. Heart rate should reach \~70% of maximal heart rate.

The IT group will perform 5 body-weight exercises in three progressive phases. During the first 2 weeks the circuit will be completed twice, 30 second intervals, 90 seconds of rest. The exercises will be performed on 3 days of the week with at least one day of rest between exercise days (ideally Monday, Wednesday, Friday). The number of repetitions will increase to a maximum of 4 while the interval and rest periods increase to a maximum of 45 seconds each. The total time spent performing intervals by week 8 will be 15 minutes. A 2 minute warm up and 3 minute cool down will be performed, such as jumping jacks or simply walking. A heart rate monitor will be used to measure exercise intensity. Heart rate should reach approximately 90% of heart rate max during the intervals. Participants will be instructed on the use of the Rating of Perceived Exertion scale during baseline testing and will be instructed to reach an RPE of ≥17 during the high intensity intervals.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-65 years of age
* Willing and able to provide informed consent
* Sedentary, overweight and obese adults (\<90 minutes of moderate intensity exercise)
* BMI 25≤35
* Able to safely begin an exercise program
* Have a smartphone, and willing and able to download and use the Fitbit app

Exclusion Criteria:

* Unable to provide informed consent.
* Known cardiovascular disease, or uncontrolled hypertension,
* Diagnosed type 1 or 2 diabetes
* Women who are pregnant or plan to become pregnant in the next 3-4 months
* Orthopedic injury/limitation or any other contraindications to exercise.
* Medications that cause weight gain (steroids, HIV-related medications, etc.), or glucose lowering medications
Pregablin for Anxiety-comorbidity in Patients With Schizophrenia

The PACS study aims to investigate the efficacy and tolerability of pregabalin for schizophrenic patients that suffer from comorbid anxiety.

The study design is an 8 week flexible dosage, randomized placebo controlled.

The study population is patients diagnosed with ICD-10 schizophrenia and age 18-65. Patients are recruited from outpatient clinics from entire Denmark.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-65 years
* An ICD-10 schizophrenia diagnosis F20.0-20.3 or F20.9
* Stable dosage of psychotropic 4 weeks before inclusion
* Hamilton Anxiety Scale total score \> 15
* Positive and Negative Syndrome Scale for Schizophrenia total score \< 70
* The Calgary Depression Scale for Schizophrenia total score \< 10
* Fertile women: Contraception during the trial
* S-creatinin within normal reference range
* Signed informed consent and power of attorney

Exclusion Criteria:

* Significant substance abuse
* QTc \> 480 milliseconds
* Severe dysregulated diabetes
* For women: Pregnancy or breast-feeding
* Confinement in accordance with the Danish Law of Psychiatry
* Concrete suicidally
* Known hypersensitivity or allergic reaction to the active ingredient of the drug
Vitamin D, C-reactive Protein and Insulin Resistance

Randomized, double blind, placebo-controlled clinical trial of vitamin D supplementation (cholecalciferol, 4,000 IU/day for 6 months, in 104 postmenopausal women with type 2 diabetes mellitus.

The objective was to evaluate the effect of vitamin D supplementation on C-reactive protein (CRP) and insulin resistance in women with type 2 diabetes mellitus (T2DM).

The trial was conducted from March to October 2008 at the Hospital of the Mexican Social Security in Cuernavaca, Mexico.

Methods. Randomized, double blind, placebo-controlled clinical trial. We selected 104 postmenopausal women, ages 45 to 65, with uncomplicated T2DM and BMI ≥25. Women with history of kidney or liver disease, BMI\>40, autoimmune disease or cancer were not included in the study.

Participants were randomly assigned to receive either a capsule containing 4,000 IU of vitamin D3 (cholecalciferol, n=52) or placebo (n=52), once a day during 6 months.

Outcome variables were serum CRP, measured with a high-sensitivity assay (nephelometry), and HOMA-IR. Serum vitamin D (25-OH-D) was measured by HPLC. Outcome variables were measured at baseline, and 3 and 6 months thereafter. All participants received diet and physical activity counseling, and visited the clinic for medical check-up once a month.

Baseline Results. Mean age was 56.8 ± 5.1 y. Baseline BMI was 30.7 ± 3.9. Median CRP concentration was 5.0 mg/L (Interquartile range: 1.0, 8.5). HOMA index at baseline was 7.13 ± 3.8. Serum 25-OH-D concentration at baseline was 54.5 ± 15.7 nmol/L (\~22 ng/mL). Almost 94% of patients had baseline serum 25-OH-D levels \<80 nmol/L, and 25% were below 40 nmol/L. No one had levels \<20 nmol/L. There were no statistical differences on important variables by treatment group at the onset of study.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus w/ \< 10 yrs of diagnosis
* Postmenopausal
* Overweight or obesity (BMI \>=25)
* Treated with metformin

Exclusion Criteria:

* BMI \>=40
* Liver or kidney disease
* Other important chronic disease: i.e. cancer, autoimmune.
* Receiving insulin
Drowning Incidents Treated by the Danish SAR Helicopters

Improving oxygenation and ventilation in drowning patients early in the field is critical and may be lifesaving. This may be achieved by helicopter emergency medical services (HEMS) such as the Danish Air Ambulance, or the Royal Danish Air Force's Search And Rescue (SAR) helicopters. The SAR operates in all weather conditions and is equipped with a hoist system, able to hoist patients from the sea or small ships without helipads. This study aimed to estimate the incidence of drowning missions attended by the Royal Danish Air Force's SAR helicopter and describe patient characteristics and prehospital interventions.

The national Danish Drowning Cohort contains data on all fatal and non-fatal drowning patients treated by the Emergency Medical Services. However, data on drowning patients treated by the SAR helicopters is reported in a separate system.

The population of drowning patients treated by the SAR helicopters has never been described, thus contributing to the potential underreporting of the most critically ill drowning patients in Denmark. Given the rarity of drowning, registry-based studies are needed to provide patient characteristics and evaluate critical care interventions performed on this group of patients.

This study aims to identify and describe a national cohort of drowning patients at sea treated by the Royal Danish Air Force's SAR helicopters from 2014 to 2023.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated by the Danish SAR helicopters AND
* Drowning as defined by the WHO (the process of experiencing respiratory impairment from submersion or immersion in liquid)

Exclusion Criteria:

* Patients who have not been immersed or submersed.
* Duplets.
* Interhospital transfers.
Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI

The Physiological Study of Haemodynamic and Microcirculatory Evolution before/after Transcatheter Aortic Valve Replacement (TAVI) aims to investigate the physiological changes induced by the implantation of a prosthetic aortic valve on blood vessels in patients with severe aortic stenosis. The hypothesis of the study is that adaptive microcirculatory phenomena occur during TAVI implantation. The results of preoperative assessment of microcirculatory functional reserve differ according to whether or not organ dysfunction occurs after TAVI. There is a progressive adaptation of the microcirculation to the new cardiovascular load conditions after TAVI. Early features of this adaptation are associated with the occurrence of short- and medium-term complications.

This is a prospective, physiologic, monocentric, pilot cohort study carried out at the University Hospitals of Geneva on the initiative of the investigator. We are investigating the adaptive mechanisms at work in the blood vessels and their potential impact on clinical outcomes in the month following surgery. In addition to the usual perioperative monitoring, patients enrolled in the study will benefit from vascular monitoring, which consists of a series of additional non-invasive and painless examinations performed before, a few hours after and on the day after surgery. The clinical outcome of the aortic valve implantation will be monitored by a questionnaire on the day after the procedure, a 6-minute walk test during the usual consultation with the cardiologist on the 6th day after the procedure, and a review of patient health events one month after the valve implantation.

Eligibility Criteria:
Inclusion Criteria:

* All major patients undergoing a femoral TAVI procedure for severe aortic stenosis,

Exclusion Criteria:

* Non-femoral approach for TAVI implantation,
* Presence of other concomitant severe valve disease,
* Planned procedure under general anesthesia,
* Anticipated inability to perform a 6-minute walk test post-operatively (physical handicap),
* Heart failure with left ventricular ejection fraction \<40%,
* Chronic end-stage renal failure,
* Chronic lung disease with home oxygen therapy,
* Acquired changes in serum VEGF levels: recent myocardial infarction or stroke, recent vascular intervention (\< 3 months), active cancer, anti-angiogenic immunotherapy,
* Patients with known or identified cognitive disorders,
* Persons deprived of their liberty, persons under protective supervision,
* Pregnant or breast-feeding.
The Effects of Riboflavin/ Ultraviolet-A Corneal Cross-linking on the Signs and Symptoms of Bullous Keratopathy

Recently, riboflavin (0.1%) and ultraviolet-A (UVA) collagen cross-linking (C3R) has shown potential to improve the signs and symptoms of bullous keratopathy .The objective of this study is to demonstrate the effects of C3R to treat bullous keratopathy.


Eligibility Criteria:
Inclusion Criteria:

* patients with bollous keratopathy

Exclusion Criteria:

* corneal scarring or contemporary eye disease affecting VA were excluded.
Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Hexafocon A

This will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the other eye. Data from the first four weeks of Test and Control lens exposure will be used for the FDA 510 (k) submission.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to sign the informed consent form
* Aged ≥18 years old
* Experienced wearer of rigid gas permeable contact lenses
* Subject's habitual contact lenses must be made of Boston XO (hexafocon A) material
* Subjects must have owned spectacles or contact lenses prior to enrolment for this trial
* Spherical power between -10.00 D and +10.00 D (at vertex distance 0 mm)
* Corneal astigmatism ≤2.00 D

Exclusion Criteria:

* Eye injury or surgery within 3 months immediately prior to enrolment for this trial
* Pre-existing ocular irritation that would preclude contact lens fitting
* Currently enrolled in an ophthalmic clinical trial
* Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator
* Any use of medications for which contact lens wear could be contradicted, as determined by the investigator
* Current extended-wear users (sleep-in overnight)
* Current monovision lens wearers
* Current wearers of multifocal contact lenses
* Current wearers of toric contact lenses (front surface design)
* Current wearers of astigmatic contact lenses (posterior surface design)
* Has a reported "Strong" comfort or vision preference between each eye with their habitual RGP lenses
* Unacceptable fit of habitual lenses
* Pregnant women and nursing mothers
* Best-corrected visual acuity worse than 6/9 (LogMAR: +0.20; Snellen decimal: 0.63)
Photodynamic Therapy With Verteporfin for Corneal Neovascularization

Purpose: To investigate the efficacy of photodynamic therapy with verteporfin for the treatment of patients with corneal neovascularization.

Design: Prospective, non-comparative case series. Participants: Eighteen eyes of 18 patients with stable corneal neovascularization who were refractory to conventional treatment.

Methods: The patients were treated with photodynamic therapy with verteporfin (6 mg/m2). Five patients were treated following penetrating keratoplasty, and 2 patients were treated before penetrating keratoplasty. Best corrected visual acuity and anterior segment photography were performed before and after treatment. The length of cumulative blood vessels and area of corneal neovascularization were measured.

Main outcome measures: Vascular occlusion, best corrected visual acuity, cumulative blood vessel length, and corneal neovascularization area.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically stable corneal neovascularization who were not improved after treatment with 1% prednisolone acetate eyedrops instilled 4 times a day for at least 1 month

Exclusion Criteria:

* Individuals who had active keratitis with vessel proliferation, uncontrolled inflammation, active hepatitis or clinically significant liver disease, or porphyria or other porphyrin sensitivity
Interscalene Block Alone Versus Interscalene Block With Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia

The aim of this study is to compare the effectiveness of interscalene brachial plexus block alone versus interscalene brachial plexus block +Erector spinae plane block in anesthesia for shoulder arthroscopy.

Regional anesthetic techniques can control pain effectively, both at rest and on movement, allowing earlier mobilization without the adverse effects of opioids . Among the various types of regional anesthetic techniques, the interscalene brachial plexus block is a gold standard used nerve block technique for postoperative analgesia in patients undergoing shoulder surgery, as it has consistently been shown to significantly control.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years
* Both genders,
* BMI \< 40 kg/m2
* American Society of Anesthesiologists (ASA) physical status I-II
* Scheduled for elective shoulder arthroscopy.

Exclusion Criteria:

* Known allergy to local anesthetics,
* allergy to all opioid medications, diagnostic shoulder arthroscopic procedures,
* patients with chronic opioids,
* patients who converted to general anesthesia use and coagulopathy
Effects on Hemostasis, Lipids, Carbohydrate Metabolism, Adrenal & Thyroid Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG-EE (292004)(COMPLETED)(P05764)

The primary purpose of this study is to evaluate the effects of the combined oral contraceptive (COC) NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal function, and thyroid function.


Eligibility Criteria:
Inclusion Criteria:

* Sexually active women, at risk for pregnancy and not planning to use during trial medication use;
* Women in need for contraception and willing to use an oral contraceptive (OC) for 6 months (6 cycles);
* At least 18 but not older than 50 years of age at the time of screening;
* Body mass index = 17 and = 29 kg/m\^2;
* Good physical and mental health;
* Willing to give informed consent in writing

Exclusion Criteria:

* Present use or use within 2 months prior to screening of any other hormonal treatment including sex hormones (other than contraceptives), insulin, thyroid and corticosteroid hormones (with the exception for local dermatological use);
* Contraindications for contraceptive steroids
* Presence or history (within 1 year before screening) of alcohol or drug abuse as judged by the (sub)investigator.
* An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia \[CIN\], SIL, carcinoma in situ, invasive carcinoma) at screening or documentation of an abnormal smear performed within 6 months before screening;
* Clinically relevant abnormal laboratory result at screening as judged by the (sub) investigator;
* Use of an injectable hormonal method of contraception prior to screening; within 6 months of an injection with a 3 -month duration, within 4 months to screening of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;
* Before spontaneous menstruation has occurred following a delivery or abortion;
* Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication;
* Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, lipid-lowering drugs, anticoagulants and herbal remedies containing Hypericum perforatum (St John's Wort);
* Use of pharmacological agents which affect the hemostatic system during the pretreatment blood sampling: vitamin K (only prohibited within two weeks prior to sampling), nonsteroidal anti-inflammatory drugs (NSAIDS) and aspirin (both only prohibited during the week prior to sampling);
* Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
Evaluation of Clinical Utility of Non-invasive Hemodynamic Monitoring Device

In patients undergoing surgery under general anesthesia, the clinical utility of non-invasive hemodynamic status monitoring equipment using HemoVista is compared with invasive hemodynamic status monitoring equipment FloTrac.

For patients who are scheduled to monitor invasive blood pressure, invasive hemodynamic monitoring using FloTrac and additional HemoVista sensors are attached and output data are obtained at the same time during general anesthesia. FloTrac is used to conduct conventional anesthesia and fluid therapy, and the accuracy of HemoVista, a non-invasive hemodynamic monitoring equipment, is compared through prospective observational studies.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 20 or older who undergo surgery under general anesthesia for more than two hours
* invasive close hemodynamic monitoring with FloTrac is needed

Exclusion Criteria:

* problems in site where HemoVista is attached