cyrilzakka/clinical-trials huggingface dataset:
Drop in Gastroscopy - Experience After 9 Months

The capacity for endoscopical procedures in the Norwegian health system is low in comparison to demands from patients and family practitioners.

The studies aim is to evaluate the acceptance of a new concept: an open access gastroscopy clinic where patients can attend without a preceding appointment.

The investigators wish to evaluate:

1. Patient´s satisfaction.
2. General practitioner´s satisfaction.
3. Acceptance by the staff of the clinic.

The fact that access to specialized norwegian health care is characterized by a mismatch between system´s capacity and patient´s and refering physician´s demands, leads to delay of diagnostic investigations such as for example gastroscopies. Patients referred to gastroscopies have to wait 4 to 12 weeks to get an appointment. Consequence might be a delay in diagnosing of significant diseases such as ulcers or even malignancies. In addition the general practitioner is frequently forced to start a therapy by suspicion, and the patient has in numerable cases to stay off work.

In September 2008, the investigators started an open-access gastroscopy outpatient clinic, which allows the family practitioners in a defined area of the Telemark county to refer their patients to a gastroscopy without a preceding appointment. Patients from the other parts of the county and those, who need special service as i.e. interpreter, endocarditis prophylaxis etc. are referred conventionally and need an appointment.

Aim of the study is to evaluate the acceptance of both forms of outpatient clinics by both patients and general practitioners. In addition to that, the investigators will evaluate the acceptance of the open access clinic by the staff. Of special concern is the fear, that easier access might lead to a number of unnecessary procedures.

All patients from open access clinic and from the conventional clinic are asked to fill in a questionaire without any kind of personal identifying data such as name, age, date of the procedure etc., but with questions about their satisfaction with the procedure, the time from their first contact with their family practitioner to the procedure, the information prior and after the procedure. They will be asked if they did consume drugs against "ulcer-disease" or not.

In addition the referring practitioners are asked to fill in a questionnaire about their acceptance of the open access clinic, and to give the investigators some ideas about advantages and disadvantages from their point of view.

The staff is asked to give their experience especially according to the not calculable number of patients that attend to the clinic each day.

If the present study shows high acceptance of the open-access-offer by patients and health workers, the plan is to extend it to other patient groups and to perform studies to investigate the effects on the grade of diseases at the time of diagnosis and possible consequences for treatment and health economy.

Eligibility Criteria:
Inclusion Criteria:

* all patients from 18 years of age.

Exclusion Criteria:

* age \< 18,
* inability or unwillingness to cooperate.
Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema

This 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in preventing angioedema attacks in subjects with hereditary angioedema (HAE). In Part 1 of the study, eligible subjects will be randomized to receive oral BCX7353 or placebo for 4 weeks. Assuming successful completion of Part 1, additional subjects will be randomized in Part 2 to one of 2 lower doses of BCX7353 or placebo. Part 3 will enroll additional subjects into one of three doses of BCX7353 or placebo. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical and pharmacologic outcomes, and the safety and tolerability of each dose of BCX7353 compared to placebo.


Eligibility Criteria:
Key Inclusion Criteria:

* A clinical diagnosis of HAE type I or II
* Documented HAE attacks within a defined calendar period
* Access to acute attack medications
* Sexually active women of child-bearing potential and sexually active men must utilize effective contraception

Key Exclusion Criteria:

* Women who are pregnant or breast-feeding
* Any clinical condition or medical history that would interfere with the subject's safety or ability to participate in the study
* Use of C1INH, androgens or tranexamic acid for prophylaxis of HAE attacks
* History of or current alcohol or drug abuse
* Infection with hepatitis B, hepatitis C or HIV
* Participation in any other investigational drug study currently or within the last 30 days
Role Of Phosphorus And FGF 23 In Patients With Dent Disease

Patients with Dent disease have suppressed levels of FGF 23 which contributes to hypercalciuria, kidney stones, nephrocalcinosis and renal failure. Supplementation with phosphorus may reduce hypercalciuria.


Eligibility Criteria:
Inclusion Criteria:

Patients will be recruited from those in the RKSC Dent Registry

1. Diagnostic criteria for Dent disease Observational arm include:

   1. \<18 years old
   2. LMWP (at least 5 times above the upper limit of normal) and at least 1 of the following criteria: 1. Hypercalciuria, 2. Kidney stones, 3. Nephrocalcinosis, 4. Hypophosphatemia, 5. Renal phosphate leak, 6. Aminoaciduria, 7. Glucosuria without diabetes mellitus, 8. Hematuria, 9. Renal insufficiency, 10. Family history with x-linked inheritance or
   3. 1 of the above criteria (1-9) and confirmed genetic mutation of CLCN5 or OCRL1.
2. Diagnostic criteria for Dent disease Intervention arm include:

   1. \>18 years old
   2. LMWP (at least 5 times above the upper limit of normal) and at least 1 of the following criteria: 1. Hypercalciuria, 2. Kidney stones, 3. Nephrocalcinosis, 4. Hypophosphatemia, 5. Renal phosphate leak, 6. Aminoaciduria, 7. Glucosuria without diabetes mellitus, 8. Hematuria, 9. Renal insufficiency, 10. Family history with x-linked inheritance or
   3. 1 of the above criteria (1-9) and confirmed genetic mutation of CLCN5 or OCRL1.
3. Idiopathic calcium nephrolithiasis with renal phosphate leak

   1. Male patients \> 18 years old
   2. History of symptomatic calcium oxalate or calcium phosphate stone, hypercalciuria (\>250 mg/24 hrs), renal phosphate leak (TMP/GFR \<2.07 mg/dl)
4. Idiopathic calcium nephrolithiasis without renal phosphate leak

   1. Male patients \> 18 years old
   2. History of symptomatic calcium oxalate or calcium phosphate stone, hypercalciuria (\>250 mg/24 hrs), renal phosphate leak (TMP/GFR \<2.07 mg/dl)

Exclusion Criteria:

1. Exclusion for Dent disease include: primary or secondary hyperparathyroidism, hyperthyroidism, chronic diarrhea states; intake of thiazide diuretics, glucocorticoids, or estrogens within one month of the study.
2. Exclusion criteria for calcium stone formers include: primary or secondary hyperparathyroidism, hyperthyroidism, estimated GFR \<40 ml/mn/1.73m2, chronic diarrhea states; intake of thiazide diuretics, glucocorticoids, or estrogens within one month of the study.
3. Exclusion criteria include history of symptomatic or asymptomatic kidney stone disease; primary or secondary hyperparathyroidism; estimated GFR \<40 ml/min/1.73m2, chronic diarrhea states; intake of thiazide diuretics, glucocorticoids, or estrogens within one month of the study.
Effect of Different Sedation and Analgesia Strategies on Patients With Mechanical Ventilation

Most patients in ICU are treated with a combination of analgesics and sedatives in most cases. Due to the different mechanism of different sedative and analgesic drugs, different antagonistic or synergistic effects may occur when combined with drugs, resulting in different clinical effects, especially significant effects on ventilators for patients with assisted breathing. Therefore, this study hopes to compare the effects of different sedative and analgesic drug combinations on the duration of mechanical ventilation for patients with ventilators, so as to guide the clinical adoption of a more reasonable sedative and analgesic scheme.


Eligibility Criteria:
Inclusion Criteria:

* Adults who are treated with sedation and analgesia for invasive mechanical ventilation

Exclusion Criteria:

* they have baseline severe cognitive impairment; were pregnant or breast-feeding; were blind, deaf ; had second-degree or third-degree heart block or bradycardia requiring intervention; had an allergy to the experimental drugs; had an indication for benzodiazepines; were anticipated to have immediate discontinuation of mechanical ventilation; were expected to have neuromuscular blockade for more than 48 hours; were in a moribund state; or had received mechanical ventilation for more than 96 hours before meeting all inclusion criteria.
Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques

The aim of this clinical trial is to explore the optimal preventative treatment strategy for non-flow-limiting vulnerable plaques. The main question it aims to answer is:

Can interventional therapy further improve the outcome of non-flow-limiting vulnerable plaques on top of optimal pharmacologic therapy?

Researchers will randomly assign patients who meet the inclusion criteria to preventative intervention plus optimal drug therapy (experimental group) or optimal drug therapy alone (control group).

Participants will:

Assigned to the control group: optimized drug therapy consisting of lifestyle improvement and intensive drug therapy including anti-inflammatory therapy (colchicine 0.5 mg/day) while receiving high-dose statin or other therapy to achieve target levels (low-density lipoprotein cholesterol \<1.4 mmol/L). Lifestyle improvement and risk factor management included smoking cessation, nutritional optimization, physical activity, compliance with prescribed medications, and control of diabetes and hypertension.

Assigned to the experimental group: all non-flow-limiting vulnerable plaques were treated with conventional second-generation drug-eluting stents or drug balloons. After the procedure, participants received dual antiplatelet therapy for about 12 months as well as other medications in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-80, male or non-pregnant female
* Clinical diagnosis of ACS
* Willing and able to provide written informed consent
* At least one significant stenosis (\>50% diameter stenosis) with FFR or QFR \>0.8, meeting the following: OCT-defined thin-cap fibroatheroma (fibrous cap thickness \<65 μm and lipid arc \>90°)
* Reference vessel diameter: 2.5-4.0 mm
* Lesion length ≤ 40 mm

Exclusion Criteria:

* Contraindications to dual antiplatelet therapy or planned discontinuation within one year
* Severe comorbidities with a life expectancy of less than two years
* Planned cardiac or major non-cardiac surgery
* Pregnancy, breastfeeding, or planned pregnancy during the study
* Left ventricular ejection fraction \<35%
* Estimated glomerular filtration rate \<30 ml/min/1.73m²
* Allergy to contrast agents, drug-eluting stents, or DEB drugs
* Participation in other clinical studies
* Preferred treatment is CABG
* Severely calcified or angulated target lesion
* Target lesion requiring dual stent technique
* Left main disease
* Previously stented target lesion
* Target lesion in a graft vessel
One-Step Universal Adhesives: A 3-year Clinical Trial in Class II Composite Restorations

to evaluate and compare the clinical performance and periodontal responses of four commercially available one-step universal adhesives with different formulations in Class II composite restorations over a three-year period.

The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a split-mouth design. A total of forty-eight adult patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Outpatient clinic at Faculty of Dentistry, Mansoura University.

No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The protocol of the study was approved by Mansoura University's ethics committee before initiation

Eligibility Criteria:
Inclusion Criteria:

* Patients must present with at least four posterior primary compound proximal caries involving two surfaces, specifically occluso-mesial or occluso-distal cavities, with a corresponding International Caries Detection and Assessment System (ICDAS) score of 4 or 5.
* The buccolingual width of the lesion should be approximately less than two-thirds of the intercuspal distance.
* Teeth to be restored must be in normal occlusion with the natural antagonist teeth.
* Vital teeth with no signs of pulpal inflammation or pathological lesions.
* Normal periodontal status and good oral hygiene.
* Good likelihood of recall availability.

Exclusion Criteria:

* Patients with proximal cavities that extend beyond two surfaces or have a lesion buccolingual width greater than two-thirds of the intercuspal distance, or requiring cusp coverage.
* Partly erupted or endodontic treated teeth.
* Poor oral hygiene or severe periodontitis.
* Absence of neighboring or antagonist teeth.
* Patients with known allergy to any component of the study materials.
* Patients with unstable medical conditions.
* Patients with known unavailability to attend recall visits.
* Pregnant or lactating females.
* Patients with heavy para-functional habits, fractured, or visibly cracked teeth.
Mental Health of Men Before and After Testicular Cancer Treatment

This is a prospective observational study, that investigates men diagnosed with testicular cancer before and after treatment.

The patients are included at their visit at the Fertility clinic in Horsens, where they deposit semen for cryopreservation prior to surgery and potential systemic treatment. Here the patients, who want to participate will perform a cognitive test and afterwards complete a questioner (T1). After 9 month the patients will be invited to perform the cognitive test and complete the questionnaire again (T2).


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 - 45 years.
* Newly diagnosed testicular cancer and referred to the fertility clinic in Horsens fore cryopreservation of semen prior to further treatment.

Exclusion Criteria:

* Men, who cannot talk, read ore write Danish.
* Men who are not able to give informed consent.
Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes

DHA, a type of fatty acid, is important in early development, both in terms of reproductive physiology of gestation and in postnatal behavioral and cognitive function. In adults, DHA has been shown to lower triglycerides and is important to cardiovascular health and autonomic control, lowering heart rate and blood pressure and increasing heart variability. Little is known about how fatty acids impact cardiac control in infants, children or the fetus. Our hypothesis is that maternal DHA supplementation (600 mg/day) will lower fetal HR and increase fetal HRV.

We have observed that maternal DHA supplementation during pregnancy results in lower fetal heart rate (HR) and higher heart-rate variability (HRV). In another study, we found that infants on DHA supplemented formula have lower HR. Because DHA supplementation in infancy is associated with improved neurobehavioral outcomes and infants with lower HR and higher vagal control have been found to have improved developmental outcomes, the first aim is to conduct a randomized, placebo-controlled trial to determine whether maternal DHA supplementation during pregnancy results in lower HR and higher HRV in the fetal period. We will document other fetal neurobehaviors (body and breathing movements) as they are hallmarks of fetal well-being and influence HR and HRV.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant females 16.0-35.99 years of age who are 12 to 20 weeks gestation at the time of enrollment (by dates or ultrasound)
* Agree to consume study capsules from enrollment until delivery
* BMI \<40 at baseline or weight does not exceed 300 pounds
* No serious illnesses likely to confound study outcomes
* Available by phone

Exclusion Criteria:

* Less than 16 or greater than 35.99 years of age at enrollment
* BMI \>40 at baseline
* Any serious illness likely to confound primary study outcomes
* Expecting multiple infants
* Diabetes (Type I, II or gestational) at baseline
* Elevated blood pressure due to any cause (systolic BP \>= 140 mm Hg
* Gestational age at baseline \< 12 weeks or \> 20 weeks
* Unable to provide informed consent in English
A Study Evaluating Botulinum Toxin Type A in Subjects With Postherpetic Neuralgia

4-month study including a 30-day baseline phase


Eligibility Criteria:
Inclusion Criteria:

* Postherpetic neuralgia for more than 3 months after the healing of a herpes zoster skin rash.

Exclusion Criteria:

* Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype.
Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's Disease

Patient reported outcomes (PRO) have become an important endpoint assessed in clinical trials. It is important to understand the relationship between medication and patients' symptomatology, quality of life and well-being. We predict levodopa/carbidopa intestinal gel (LCIG; Duodopa) will significantly improve quality of life and emotional well-being compared to baseline in patients with advance Parkinson disease (APD) not well controlled with conventional treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced levodopa-responsive Parkinson's disease, with at least, 2 hours "off" time or 2 hours of dyskinesia based on clinician's/investigator's medical judgment
* Patients with advanced Parkinson's disease with severe motor fluctuations and dyskinesia when combination of conventional PD treatments was unable to satisfactory control symptoms.
* Patients with advanced Parkinson's disease who meet the criteria for use of Levodopa/Carbidopa Intestinal Gel (LCIG) established in the summary of product characteristics, Spanish Neurology Society (SEN) guidelines, local/regional directories (CCAA) or site's protocols for use of LCIG in common clinical practice.
* The decision to treat with LCIG is made by the physician prior to any decision to approach the patient to participate in this study.
* Patients with a cognitive level enough to complete the questionnaires, confirmed by a Mini-mental state examination (MMSE) score of at least 26 points, according to the recommendation of the Movement Disorder Society (MDS) task force on dementia in Parkinson's Disease (PD)

Exclusion Criteria:

* LCIG's contraindications included in the Summary of Product Characteristics (product label)
Effect of Atlas Cedarwood Essential Oil Aromatherapy on Sleep Quality Among Patients With Coronary Heart Disease

Sleep-wake disturbances were found to be a common problem among patients with CHD either earlier during hospitalization or/ and after discharge Although there is an evidence that sleep-wake disturbanes occur in high rate among patients with CHD little was found about assessment and management of this problem. This randomized controlled study will assess sleep quality of stable CHD patients who were admitted for undergoing coronary angiography electively. Then it will test the hypothesis that atlas cedar wood essential oil aromatherapy have a positive effect on sleep quality of CHD patients.

The primary aim is testing the effect of Atlas cedar wood essential oil aromatherapy on sleep quality of patients after CHD.

The secondary aim is estimating the prevalence of sleep-wake disturbances (difficulty falling asleep, staying asleep, inadequate sleep duration, dissatisfaction with a sleep and excessive daytime sleepiness) among recruited CHD patients.

- data were collected by two phase:

* phase one: sleep quality of recruited CHD patients, who were admitted for undergoing coronary angiography electively, were assessed using Pittsburg Sleep Quality Index (PSQI). CHD participants who were reported poor sleep quality (=\>5) in PSQI score will randomly allocated by toss either to intervention or control group.
* Phase two:

  1. Intervention group received an atlas cedar wood aromatherapy for five consecutive nights.
  2. Control group received no intervention.
  3. Sleep quality of both group participants re-assessed at second day and six day of recruitment, respectively, using PSQI.

Eligibility Criteria:
Inclusion Criteria:

1. stable CHD patients with history of myocardial infarction, stable angina, unstable angina or acute coronary syndrome who were admitted for elective coronary angiograph (cardiac catheterization) during the study period.
2. age of participants must be between 20-64 years old.
3. participants must have an ability to understand and communicate with the researchers.

Exclusion Criteria:

included CHD patient were excluded if they:

1. pregnant women or who has a plan for pregnancy as well as any patients who their care giver is pregnant
2. have a recent cardiac attack within 24-48 hours or had a history or risk of heart failure or cardiogenic shock were excluded.
3. have problems in smell sensations , history of breathing difficulties and disorders such as asthma, sleep apnea or allergies to plants and flowers parts were excluded, too.
4. have history of psychological disorders (i.e., depression) or psychiatric disorders (i.e., schizophrenia) were excluded
5. using prescribed sedatives drugs or other complementary therapy likes herbal remediates or even aromatherapy in recent one week were excluded
6. shift workers.