cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Influence of Three Different α-antagonists and Placebo on the Extent of Weekly Phenylephrine-induced Mydriasis at Three Different Concentrations of Phenylephrine in Healthy Male Volunteers

The study was aimed to evaluate the pharmacological effect of different α-antagonists on phenylephrine induced pupil size in healthy male volunteers as pharmacological basis for Intraoperative floppy iris syndrome (IFIS)


Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* Age ≥ 21 and ≤ 55 years
* Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
* Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to seven days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on in-house trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
* Any laboratory value outside the clinically accepted reference range
* Excessive physical activities within the last week before the trial or during the trial

The following exclusion criteria are of special interest for this study:

* Hypersensitivity to any alpha agonist, or to phenylephrine
* Supine blood pressure at screening of systolic \< 110 mmHg and diastolic \< 60 mmHg
* Ophthalmological criteria:

  * Corrected visual acuity \< 0.5
  * Refractive Error with a spherical equivalent \> +6 or smaller - 6 D
  * Elevated intraocular pressure (higher than 22 mmHg)
  * Relevant anisocoria or pupil deformation
  * History of eye surgery apart from laser trabeculoplasty less than three months previously or extraocular surgery such as strabismus surgery
  * Topical ocular medication influencing IOP (intraocular pressure) or pupil size within 3 months prior to study-start
Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy

To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of vulvar and vaginal atrophy.


Eligibility Criteria:
Inclusion Criteria:

* postmenopausal female and otherwise healthy, 30 - 75 years of age.
* ≤ 5% superficial cells on vaginal smear cytology at Visit 1/Screening.
* vaginal pH \> 5.0 at Visit 1/Screening
* Have at least one self-assessed moderate to severe symptom of Vulvar and Vaginal Atrophy identified by the subject as being the most bothersome
* For women with an intact uterus, vaginal ultrasonography confirmation at Visit 1/Screening of an inactive endometrial lining with an endometrial thickness less than 4 mm.
* Systolic blood pressure no greater than 150 mm Hg and diastolic blood pressure no greater than 90 mm Hg at Visit 1/Screening and at Visit 2/Randomization

Exclusion Criteria:

* Undiagnosed vaginal bleeding or a history of significant risk factors for endometrial cancer.
* Known, suspected, or history of cancer of the breast or mammogram indicating any abnormalities or subject has a history of cervical cancer.
* Vaginal ultrasonography for all women with an intact uterus confirming endometrial thickness of 4mm or more
* History of hypersensitivity or allergy to estradiol or any of the other study medication ingredients.
* Known or suspected estrogen-dependent neoplasia.
* Has deep vein thrombosis, pulmonary embolism or history of these conditions.

  • Subject has active arterial thromboembolic disease (e. g. stroke, myocardial infarction) or history of these conditions.
* Known acute or chronic hepatic disease or dysfunction
Multicenter Trial for the Evaluation of a Fixed Dose Combined Tablet for the Treatment of Pulmonary Tuberculosis

The use of fixed-dose combined (FDC) drugs in the treatment of tuberculosis by National Tuberculosis Programmes has been recommended by both the International Union Against Tuberculosis and Lung Disease (The Union) and the World Health Organisation. The advantages of FDC drugs include preventing the emergence of drug resistance due to monotherapy, reducing the risk of incorrect dosage, simplifying procurement and prescribing practices, aiding adherence and facilitating directly observed treatment. Recent bioavailability studies of four-drug FDC tablets have demonstrated satisfactory results. In this study, we are testing the efficacy of this compound, when given in the initial intensive phase of treatment of patients with newly diagnosed smear positive pulmonary tuberculosis. This will be followed by four months treatment with a two-drug FDC of rifampicin and isoniazid.

This is a multiple country, multicenter study, using the parallel group open-label randomised trial design. The primary objective of this investigation is to assess the efficacy, acceptability and toxicity of a combined FDC regimen of chemotherapy in patients with newly diagnosed smear positive pulmonary tuberculosis in comparison with the standard regimen using separate drugs.

Patients will be allocated at random either :

* an initial intensive phase of eight weeks of daily ethambutol, isoniazid, rifampicin and pyrazinamide, in a fixed dose COMBINED tablet, followed by 18 weeks of rifampicin and isoniazid, in a fixed dose combined tablet three times a week (2COMB/4(RH)3) or
* the same drugs given in SEPARATE formulations in the initial intensive phase of eight weeks, followed by 18 weeks of rifampicin and isoniazid, in a fixed dose combined tablet, three times a week (2SEPA/4(RH)3)

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed pulmonary tuberculosis
* two sputum specimens positive for acid-fast bacilli on direct smear microscopy
* no previous anti-tuberculosis chemotherapy
* aged 18 years and over
* firm home address that is readily accessible for visiting for the duration of the trial (including follow up period)
* agree to participate in the study and to give a sample of blood for HIV test

Exclusion Criteria:

* patients in a moribund state,
* TB meningitis,
* pre-existing diseases: insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis,
* pregnancy or breast feeding,
* psychiatric illness
* alcoholism
* contraindication to any medications in the study regimens
American Cranberries to Prevent UTIs in Susceptible Women

The investigators pre-preliminary study showed that the urine from a portion of study participants had anti-adhesion activity. The investigators propose that UTI susceptible women can be divided into responders and non-responders depending on whether cranberry intake increase anti-adhesion activity of their urine. The overall objectives are to identify gut microbes and anti-adhesive urinary biomarkers which significantly contribute to the anti-adhesion of E. coli.

The American cranberries (Vaccinium macrocarpon) have been consumed for centuries to prevent urinary tract infections (UTI), which affect 50% of women in their lifetime. However, NIH-funded clinical trials of cranberries on UTI in the last 20 years yielded conflicting results but the reasons are unknown. About 90% of UTI are initiated by adhesion of uropathogenic E. coli on urinary tract epithelia. It was reported that human urine after cranberry intake inhibited the adhesion of E. coli. A-type procyanidins and xyloglucans are the presumed bioactives in cranberries; however, none of these compounds are absorbable in small intestine. They are degraded by microbes in colon.The pre-preliminary study showed that the urine from a portion of study participants had anti-adhesion activity, suggesting there are polymorphisms in human's ability to metabolize cranberry bioactives. Based on these observations, the investigators formulate a novel hypothesis that not all, but a fraction of women harbor specific gut microbes with the ability to catabolize cranberry bioactives to anti-adhesion metabolites in the urine; therefore, the variation of gut microbiome is the underlying mechanism for metabolic polymorphisms and disparity in UTI prevention. The investigators propose that UTI susceptible women can be divided into responders and non-responders depending on whether cranberry intake increase anti-adhesion activity of their urine. The overall objectives are to identify gut microbes and anti-adhesive urinary biomarkers which significantly contribute to the anti-adhesion of E. coli. The expected result will be to generate strong preliminary data showing the differences of gut microbiome between responders and non-responders in additional to correlations between gut microbes and candidate anti-adhesion biomarkers in the urine of UTI susceptible women.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women participants
* BMI 18.5-29.9 kg/m2
* At least 110 pounds in weight

Exclusion Criteria:

* BMI≥ 30 kg/m2
* Pregnancy and breast-feeding
* Smoking, frequent alcohol use
* History of any clinically important disorder that may interfere with interpretation of the results,
* Intake of medication that might influence the outcome of the study
Immunotherapy in Intractable Cryptogenic Epilepsy Patients With Autoimmune Antibody

The purpose of the study is to investigate effect of immunotherapy in intractable cryptogenic epilepsy patients with autoimmune antibody.

Cryptogenic epilepsy is an epilepsy of presumed symptomatic nature but the cause has not been identified. It account for at least 40% of adult-onset epilepsy. Autoimmune encephalitis including classic paraneoplastic syndrome and autoimmune synaptic encephalitis is a new category of immune-mediated disorders which often has favorable outcome. Recent studies reported that immunotherapy improves seizure outcome in medically intractable epilepsy patients with clinical and serological evidence of an autoimmune basis. Neural autoantibodies were detected in 22% of epilepsy due to unknown cause in a study, mostly from the antiepileptic drug(AED)-resistant epilepsy group. Of the patients who received immunotherapy, 75% archived \>50% reduction in seizure frequency.

Many patients with cryptogenic epilepsy are refractory to AED and significant percent of cryptogenic epilepsy harbor neural autoantibody. In those cases, immunotherapy is suggestive based on favorable outcome of immunotherapy in autoimmune encephalitis and autoimmune epilepsy. Investigators aim to investigate the response to immunotherapy in intractable cryptogenic epilepsy patients with neural autoantibodies.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of cryptogenic epilepsy according to the International League Against Epilepsy's Classification of Epilepsy.
* Intractable epilepsy: Complete seizure control is not achieved with trials of two appropriate antiepileptic drugs
* At least 1 seizure within the past 8 weeks
* Presence of autoimmune antibody (NMDAR, LGI1, CASPR2, AMPA1, AMPA2, GABAB-R, anti-Hu, -Yo, -Ri, -Ma2, -CV2/CRMP5, -amphiphysin, GAD) in serum or cerebrospinal fluid
* Written informed consent signed by the subject or legal guardian prior to entering the study

Exclusion Criteria:

* Clinical evidence of autoimmune encephalitis such as autoimmune limbic encephalitis
* History of severe head trauma
* Presence of structural abnormality which is thought to be epileptogenic in brain MRI
* Epilepsy of predominantly genetic or presumed genetic origin
* An active CNS infection, demyelinating disease, degenerative neurologic disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results History of immunotherapy
* A history of nonepileptic or psychogenic seizures within past 1 year
* Any clinically significant laboratory abnormality that in the opinion of the Investigator would exclude the subject from the study
* Any clinically significant psychiatric illness, psychological, or behavioral problems that, in the opinion of the Investigator, would interfere with the subject's ability to participate in the study
* Recent (within 4 weeks) change or dose adjustment of anti-epileptic drug (1 to 2 doses of rescue benzodiazepine is permitted)
* Refuse to participate in the study
Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease

A randomized, double-blind, placebo-controlled clinical study in non-homozygous human leukocyte antigen (HLA)-DQ.2.5+ adults with celiac disease (CeD).

A Phase 1, randomized,double-blind, placebo-controlled clinical study of Nexvax2, in adult subjects with confirmed CeD who, have been following a gluten free diet for at least 12 consecutive months prior to screening. The study will evaluate the safety and tolerability of Nexvax2 administered subcutaneously and will compare the bioavailability of subcutaneous versus intradermal administration. The study plan consists of 3 periods: a screening period of 3 to 5 weeks, a 46-day treatment period, and a 30-day post-treatment observational follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 to 70 years of age (inclusive)
* History of medically diagnosed Celiac Disease (CeD) that included duodenal biopsy.
* Maintenance of gluten free diet (GFD) for at least 12 consecutive months prior to screening.
* Willingness to consume a moderate amount of gluten on one occasion during screening.
* Able to read and understand English.

Exclusion Criteria:

* History of inflammatory bowel disease and/or microscopic colitis.
* Any medical condition or lab abnormality that in the opinion of the investigator may interfere with study conduct or would impact the immune response (other than CeD), confound interpretation of study results, or pose an increased risk to the subject.
* Use of immunomodulatory or immune-suppressing medical treatment during the 6 months prior to screening
* Use of oral or parenteral immunomodulatory corticosteroids, within the 6 weeks prior to screening. Topical or inhaled corticosteroids are acceptable.
* Receipt of any investigational drug or participation in another clinical study within 6 months prior to screening.
* Females who are lactating or pregnant
* Receipt of any vaccine within 1 week prior to planned first day of the treatment period.
Erector Spinae Plane Block for Postoperative Analgesia for Laparoscopic Cholecystectomy

Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented application of this blockade into practice at the clinic. Main purpose of this study is to evaluate the analgesic effect of ultrasound guided erector spinae block in laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* 25 - 75 years of age
* ASA I - II
* Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* obesity
* ASA III - IV
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
* recent use of analgesic drugs
Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures

Evaluated whether HA coated dynamic hip screws can improve fixation of the screw in trochanteric femoral fractures

Randomised study to determine the effect of HA coating on the stability of dynamic Hip screws used to stabilize femoral neck fractures. Stability of the screw will be determined by RSA measurements. Additionally the fracture stability will be evaluated by RSA measurements.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable intertrochanteric femoral fractures (Evans I, II, IV)
* able to speak Danish
* able to complete the postoperative controls
* written consent

Exclusion Criteria:

* unable to follow standard hip fracture regime
* were breastfeeding
* pregnant
* terminal disease
* in need of open fracture reduction
* in need of DHS plate with an angle different from 135 degrees
* insertion of fewer than 3 tantalum beads in the femoral head (for RSA)
* TAD \>20mm in two dimensions in the first postoperative x-ray
* fracture displacement \>20mm in two dimensions in the first postoperative x-ray
Evaluation of the Rate of Anterior Segment Retraction Using Two Types of Mechanics

The rate of anterior segment retraction in bi-maxillary protrusion cases was evaluated comparing the friction and friction-less mechanics. since, there has been a lack of clear cut guidelines for clinicians for the optimum method for retraction, this randomized clinical trial was done.

Thirty bi-maxillary protrusion female patients were randomly allocated into either intervention groups. In the Friction group, retraction was accomplished using elastomeric power chains extending from crimpable hooks distal to the lateral incisors, on 0.017x0.025-inch Stainless Steel wires, to the mini-screws . While in the friction-less group with retraction done using T- loop springs made of 0.017x0.025-inch titanium molybdenum wires. Retraction force was set to 160g per side in both intervention groups. Activation was done every four weeks. Rate of anterior segment retraction was evaluated via digital models.

Eligibility Criteria:
Inclusion Criteria:

* Female Subjects.
* Age 13-25 y of age.
* Skeletal Angle Class I malocclusion with Bimaxillary dentoalveolar protrusion in need of four 1st premolar extractions with maximum anchorage.
* Fully erupted permanent dentition without crowding.
* Good oral and general health.

Exclusion Criteria:

* Systemic Diseases or syndromes or on anti-inflammatory medication.
* Extracted or missing permanent teeth.
* History of previous Orthodontic Treatment.
* Parafunctional Habits.
* Badly decayed teeth.
The Metabolic Effects of Empagliflozin in Patients With High Risk of Heart Failure

The aim of this trial is to assess the effect of Empagliflozin on lipid and glucose metabolism as well as volume homeostasis and renal function in elderly and obese patients with increased risk of developing heart failure. No history of established heart failure or diabetes is allowed.

The primary hypotheses are that 6 months treatment with Empagliflozin 10 mg a day will: 1) decrease epicardial adipose tissue volume, and 2) reduce estimated extracellular volume compared with placebo.

The Empire Prevent: Metabolic is a part of the Empire Prevent Trial Program, which also comprises the Empire Prevent: Cardiac.

The Empire Prevent: Metabolic is designed to enroll at least 120 patients.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index \>28kg/m2
* Age 60-84 years
* Established risk factor for developing heart failure, defined as at least one of the following:
* hypertension
* ischemic heart disease
* stroke/transient cerebral ischemia
* chronic kidney disease (eGFR 30-45ml/min/1.73m2)

Exclusion Criteria:

* Diabetes mellitus type 1 or 2 (no medical history, no antidiabetic treatment)
* Heart failure with reduced ejection fraction (LVEF \<40%)
* Inability to perform exercise test
* Dementia
* Severe non-compliance
* Substance abuse
* Severe chronic obstructive pulmonary disease (FEV1\<50% expected value)
* Permanent atrial fibrillation
* GFR \<30 ml/min/1,73m2
* Severe peripheral artery disease
* Cancer treatment within one year beside prostate cancer and basal cell carcinoma
* Severe aortic or mitral valve disease
* Pregnancy or breastfeeding
* Acute hospital admission within 30 days
* Participation in other pharmacological study
Sexual Dysfunction in Palliative Care Patients: An Assessment of Patient's Perspective

To learn about the communications that Supportive Care patients receive about sexual well-being from their healthcare provider. Researchers also want to learn about your attitudes, beliefs, and feelings about sexual well-being.

Primary Objectives:

1. To determine the frequency of discussion about sexual dysfunction in palliative care patients.
2. To evaluate the impact of cancer diagnosis and treatment on patient's sexual life.

Secondary Objectives:

1. To evaluate patient self-reported severity of sexual dysfunction
2. To evaluate the proportion of patients suffering distress from body image concerns
3. To identify patient self-reported barriers that prevent discussion about sexual dysfunction
4. To evaluate patient self-reported impact of sexual dysfunction on their wellbeing

Eligibility Criteria:
Inclusion Criteria:

* All patients who are evaluated as follow-ups in the Supportive Care clinic, and able to voluntarily consent to participate in the study
* Patients must be able to understand, read, write, and speak English
* Diagnosis of cancer
* Patients who are 18 years of age or older

Exclusion criteria:

* New patients (consults)
* Patient who have declined to participate, or who are unable to consent
Limbs Range of Motion Exercises Along With Chest Physical Therapy After Correction of Congenital Heart Diseases in ICU

1. To determine the effect of limb ROMs along with chest Physical therapy on cardiopulmonary parameters after correction of congenital heart diseases in ICU
2. To determine the response of Inotropic drug in relation to Limb ROMs after Correction of Congenital heart diseases in ICU


Eligibility Criteria:
Inclusion Criteria:

* Patients below the age 5 years old that underwent congenital heart surgery.

Exclusion Criteria:

* Contraindications for exercise, mental retardation, unstable hemodynamics
Photoplethysmography Detects Changes in Vascular Tone

Changes in the vascular tone of anesthetized patients is common and cause hemodynamic problems. The monitoring of such changes in vascular resistance using simple and non-invasive tools is lacking. The present study was designed to determine if photoplethysmography can detect changes in the systemic vascular resistance using Doppler as the reference method.

This is a prospective and observational study designed to test the reliability of photoplethysmography to diagnose changes in the vascular resistance during anesthesia. The investigators will studied 50 mechanically ventilated patients undergoing general anesthesia. Photoplethysmography will be continuously recorded in the right thumb during anesthesia. Duplex color and power Doppler will measure flow in the radial artery of the right hand.The contour analysis of both, photoplethysmogram and radial artery flow will be analyzed, correlated and compared using the Bland-Altman plot.

Eligibility Criteria:
Inclusion Criteria:

* Written Inform Consent
* Programmed surgery
* Supine position

Exclusion Criteria:

* Emergency surgery
* Peripheral vascular diseases