cyrilzakka/clinical-trials huggingface dataset:
A Study of Neurofeedback for the Treatment of Parkinson's Disease

This study aims to reveal relationship between brain activities and the symptoms of Parkinson disease when a neurofeedback training was applied for them.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with age more than 20
* Subjects obtained the consent
* Subjects with Parkinson disease and healthy subjects

Exclusion Criteria:

* The subjects who can not conduct the tasks
* Subjects with severe illness
* Subjects whom the experimenter think as in appropriate
* Subjects with implantable devices such as pacemaker
Immune Responses in Prostate, Lung, Melanoma and Breast Cancer Patients Following Stereotactic Body Radiotherapy (SBRT), Intensity Modulated Radiotherapy (IMRT) or Brachytherapy

Success of cancer immunotherapy is limited by the ability of solid tumors to evade local and systemic antitumoral immune responses. Several mechanisms of tumor immune evasion have been identified, including low intratumor expression of antigens and elevated expression of inhibitory co-regulatory molecules. An effective immunotherapy is one which would induce necrotic cell death and accompanying proinflammatory cytokine induction. Stereotactic Body Radiotherapy (SBRT) or Intensity Modulated Radiotherapy (IMRT) or brachytherapy, which is capable of delivering high, conformal radiation doses (\>8 Gy) of tumor ablative radiation may be an effective means of conditioning a tumor bed to a state favorable to the initiation of robust antitumoral immune responses.


Eligibility Criteria:
Inclusion Criteria:

* Hormone Refractory, Metastatic Prostate Cancer, Lung Cancer, and Melanoma or Breast Cancer

Exclusion Criteria:

-Life expectancy of less than 3 months
10-year Follow-up After Aortic Valve Replacement Surgery

There is a lack of data on patients self-reported outcomes (PROMs) on health-related quality of life (HRQoL)and symptoms on anxiety and depression 10 years after Surgical After Aortic Valve Replacement (SAVR), and patient reported experiences with the health services (PREMS). In this 10-years follow-up study on patients alive from the study named "The Impact of 24/ 7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial (AVRre)" NCT02522663 we will repeat the survey on symtoms on anxiety and depresion using Hospital Anxiety and depression Scale (HADS), health-related quality of life (EQ-5D) and questions about experiences with the health services.

"The Impact of 24/ 7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial (AVRre) was a prospective, randomized controlled study (RSC) Including 286 patients after AVR from 2015 til 2017, NCT02522663. The results reported in international publications showed reduced symptoms on anxiety the first month after AVR.

Reduction of anxiety revealed to be an important aim for the intervention. We found that symptoms of anxiety in the early rehabilitation phase after discharge following surgical aortic valve replacement phase was significantly reduced.

There is a lack of data on patients self-reported outcome on symptoms on anxiety and depression 10 years after Surgical After Aortic Valve Replacement (SAVR), and patient reported experiences with health services. In this 10-years follow-up study on patients alive from the study named "The Impact of 24/ 7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial (AVRre)" NCT02522663 we will conduct a survey on symtoms of anxiety and depresion using Hospital Anxiety and depression Scale (HADS), quality of life (EQ-5D) and questions about experiences with health services.

The results of the planned 10-years follow-up may give guidance in how to allocate health resources and planning for and follow-up of patients after heart surgery.

Eligibility Criteria:
Inclusion Criteria:

Treatment with AVR (biological or mechanical) single, AVR (b or m)+aortocoronary bypass, AVR (b or m)+supra coronary tube graft Can understand, speak and write native Language (norwegian), and be able to fill in the questionnaires

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Exclusion Criteria:

Patients not alive after the AVRre study
The Effect of 0.05% CsA Eye Drops on Diabetic Patients with Dry Eye Disease

The objective of this study is to observe the effects of 0.05% cyclosporine eye drops combined with artificial tears on patients with diabetes-associated dry eye, and to monitor changes in ocular surface characteristics and inflammatory cytokines in tears before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

I. Age: 50 to 70 years old; II. Gender: No restriction; III. Meets the diagnostic criteria for dry eye: Refer to the 2020 Chinese Expert Consensus on Diagnostic Criteria for Dry Eye.

IV. Meets the diagnostic criteria for diabetes: History of type 2 diabetes with a course of ≥5 years; Diagnosis refers to the 1999 WHO Diagnostic Criteria for Diabetes.

V. Provision of written informed consent.

Exclusion Criteria:

I. active ocular infection, ocular inflammation, active ocular allergy, severe blepharitis or obvious inflammation of the eyelid margin.

II. Uncontrolled systemic disease. III.Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.

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Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia

The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Age between 18 to 64 years;
* Participants diagnosed with chronic insomnia defined by difficulty in initiating or maintaining sleep in the last 3 months for at least 3 nights a week according to DSM-V criteria and confirmed by polysomnography;
* Participants with difficulty in initiating or maintaining sleep parameters.

Exclusion Criteria:

* Participants with clinical or laboratory diagnose of non-treated hypothyroidism or hyperthyroidism, kidney or liver failure;
* Known hypersensitivity to any of the formula compounds;
* Participants with other sleep disorders according to the International Classification Sleep Disorders (3rd edition), example: sleep-relate breathing disorders, circadian rhythm sleep-wake disorders, parasomnias (including history of sleep-walking after hypnotic use) and sleep related movement disorders;
* Participants using sedatives or hypnotic medications;
* Participants with current diagnosis of depression or anxiety according to the Diagnostic and Statistical Manual of Mental Disorders;
* Participants with history of drug and alcohol abuse in the past 2 years;
* Participants with current smoking habits during the night period;
* Participants who treated insomnia in the last 3 months;
* Participants who are pregnant, breastfeeding or planning to get pregnant or female participants with the potential to become pregnant who are not using a reliable method of contraception;
* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Participants with current or medical history of cancer in the last 5 years;
* Participants who participated in other research protocol in the last 12 months, unless the investigator judges that there may be a direct benefit to it.
Epidemiology of Digital Nerve Injuries in the Stockholm County

This is a registry and medical record based epidemiological description of patients with digitial nerve injuies in the Stockholm County, Sweden

The primary aim of this study was to describe the epidemiology of patients with surgically repaired digital nerve injuries in a Swedish population during the period 2012 to 2018. Secondary aims included a description of the patient population, surgical treatment and rehabilitation regimens following digital nerve injury. Comparisons were made between groups consisting in patients with isolated nerve injuries and those with a concomitant flexor tendon injury.

METHODS

Patients In this cohort study, all patients treated with surgical repair of a digital nerve injury at the Department of Hand Surgery at Södersjukhuset, Stockholm, Sweden were included. Inclusion period was between 2012-01-01 and 2018-12-31. Patients were identified through the Swedish national quality registry for Hand surgery (HAKIR). Inclusion criteria were the diagnostic codes (ICD-10) for a digital nerve injury in the thumb (S64.3) or finger (S64.4) in combination with the surgical code (KKÅ97) Nomesco classification of surgical procedures for nerve repair (ACB29). A total of 1,329 patients were identified. Exclusion criteria were concomitant skeletal injury, amputations, severe soft tissue injuries, or if the injury needed microvascular reconstruction. Patients reciding outside the Stockholm region and children below 18 years of age were also excluded. A total of 1,004 patients were included for the final analysis. The study population was thereafter divided into two groups: patients with an isolated digital nerve injury and patients with a ditial nerve injry with a concomitant tendon injury. All clinical data was collected through search of medical records.

Eligibility Criteria:
Inclusion Criteria:

* diagnostic codes (ICD-10) for a digital nerve injury in the thumb (S64.3) or finger (S64.4) in combination with the surgical code (KKÅ97) Nomesco classification of surgical procedures for nerve repair (ACB29).

Exclusion Criteria:

* concomitant skeletal injury
* amputations
* severe soft tissue injuries
* injury needed microvascular reconstruction.
* Patients reciding outside the Stockholm region and
* patient age below 18 years of age
Evaluation of the Sleep Hygiene in the Lebanese Population During the COVID-19 Confinement Period.

The term "sleep hygiene" refers to a series of healthy sleep habits that can improve the ability to fall asleep. These habits are the most effective long-term treatment for people with chronic insomnia. The "Sleep Hygiene Index" is a 13-item questionnaire that evaluates these habits. We are in the process of validation of this questionnaire in the arabic language.

We will evaluate these habits in the Lebanese population during the COVID-19 confinement period.

The sleep hygiene will be evaluated during the COVID-19 confinement period. The "Sleep Hygiene Index" with other questions will be applied to the Lebanese population in english and arabic. It will be distributed by the means of WhatsApp and Facebook.

Eligibility Criteria:
Inclusion Criteria:

* Lebanese living in Lebanon, 18 YO and over, understanding written english or arabic.

Exclusion Criteria:

* Not having the inclusion criteria.
ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis

This is a novel preliminary study of biomarkers of pathologic pre-operative pulmonary vascular development, elevated pre-operative Pulmonary Vascular Resistance Index (PVRi), and complications associated with decreased post-operative pulmonary blood flow in single ventricle patients undergoing superior cavo-pulmonary anastomosis (SCPA). The study will utilize a combined targeted and untargeted approach to both optimize translation of a promising existing biomarker and efficiently identify novel biomarkers and potential therapeutic targets in this population.

Overall Hypothesis: Endothelin-1 (ET1) and associated dysregulation of key metabolic pathways decrease pre-operative pulmonary blood vessel development and increase post-operative pulmonary blood vessel resistance leading to decreased pulmonary blood flow in patients undergoing SCPA.

For enrolled patients, collected data will include:

* 3 mL blood sample (x2) at pre-SCPA catheterization.
* 3 mL blood samples at 2, 24, and 48 hours post-operative.
* Urine sample pre-operatively and post-operatively
* Collection of otherwise-discarded operative tissue sample from the pulmonary artery.
* Collection of clinical data, demographic data, and results of routine, post-operative hemodynamic monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Congenital heart disease patients undergoing catheterization for pre-SPCA evaluation or undergoing SCPA without plans for cardiac catheterization (utilizing data from a previously performed clinical catheterization).
* All patients will have age from 31 days to 2 years.

Exclusion Criteria:

* Patients who will remain post-op with a pulsatile source of pulmonary blood flow in addition to the cavo-pulmonary anastomosis (so called "1.5 ventricle" repair) will be excluded.
* Due to limitations in acceptable sample blood volumes for research, patients with weight \<4kg will be excluded.
* Patients will not be excluded on the basis of gender, ethnicity, genetic diagnosis, gestational age at birth, non-cardiac comorbidity, or pre-operative medication regimen.
Rescue Therapy for Helicobacter Pylori Infection

Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori.


Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with previous treatment experience

Exclusion Criteria:

* subjects naive to H. pylori treatment,
* under 18 or over 80 years old
* history of gastrectomy
* pregnant or lactating women
* Previous history of tuberculosis
* Allergy to any of the study drugs
* severe systemic diseases or malignancy
* administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
Haloperidol for the Treatment of Nausea and Vomiting in the ED

Single center, double-blind, randomized, controlled trial in patients who present to the emergency department (ED) with a chief complaint of nausea or vomiting. A total of 300 patients age 18-55 presenting to the emergency department with chief complaint of nausea or vomiting will be enrolled from February 2021 - February 2022. Patients will be randomized and symptom levels will be recorded at 30, 60, 90, minutes. Follow-up will be performed by telephone at 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* presenting to the emergency department with chief complaint of nausea or vomiting

Exclusion Criteria:

* abnormal blood pressure (\>200/100mmHg or \<90/40mmHg),
* fever (\>100.4F),
* acute trauma,
* QT \> 450ms on cardiac monitor,
* altered mental status (GCS \< 15),
* chest pain,
* known allergy to haloperidol or ondansetron,
* Parkinson's disease,
* pregnancy or lactation,
* use of any antiemetic in the previous 8 hours,
* nausea and vomiting associated with vertigo,
* prisoners or any wards of the state.
Rehabilitation Robot in Patients With Post-Coronavirus Disease (COVID-19) Fatigue Syndrome

The aim of the study is to compare the effectiveness of two models of rehabilitation:

* traditional neurological rehabilitation, and
* neurological rehabilitation combined with a rehabilitation robot (Luna by EGZOTech).

An additional goal is to test the qualitative diagnostic reference using the surface electromyogram of the Luna robot (certified as a Medical Device) for functional diagnostics based on standardized clinical tests.


Eligibility Criteria:
Inclusion Criteria:

- patients discharged from Intensive Care Units after undergone ventilator therapy due to COVID-19

Exclusion Criteria:

* active medical condition (infections; tumors; rheumatological, metabolic, endocrine, autoimmunological, cardiovascular diseases)
* bipolar disorder
* dementia
* nutritional disorders
* addiction to alcohol or psychoactive substances
* severe obesity
* overtraining
Comparison of Standard rapi̇d Sequential Intubation Protocol With Rocuronium in Emergency Department

Airway management and advanced airway management are the issues that are applied every day in emergency services and that the emergency physician should know best. Rapid sequential intubation is one of the most frequently used techniques in advanced airway management. However, anesthetic agents and paralytic agents have some concerns with some side effects. In our study, This study aimed to compare the effect of standard rapid sequential intubation protocol and application of rocuronium priming technique on the procedure time and hemodynamic profile.

This study is a prospective, observational and randomized study conducted between 15.07.2021 and 01.12.2021 in Ankara City Hospital Emergency Medicine Clinic, which is a third-level emergency department with approximately 450,000 patient admissions per year. Patients who applied to the emergency department and needed rapid sequential intubation were included in our study. Randomization was done according to the order of arrival of the cases. The demographic characteristics of the patients included in the study and the presence of diabetes mellitus were recorded. Routine rapid sequential intubation was performed in the standard group. In the priming group, 10% of the rocuronium dose was administered approximately 3 minutes before the induction agent. Intubation time, amount of drug used, vital signs before and after intubation, and end tidal carbon dioxide level to confirm intubation were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Be over the age of 18
* Need for advanced airway
* To give consent or consent to participate in the study consent of relatives of those who are unable to give

Exclusion Criteria:

* Have an indication of a crush (rescue) airway
* Have one of the difficult airway predictor Look, Evaluate, Obstruction, Neck mobility criteria
* maxillofacial anomaly or trauma
* detected during laryngoscopy with a cormack-lehane score of 3 and 4 patients
* Those who have inconveniences in applying ketamine to the clinic of the patient
* with a rocuronium or ketamine allergy
Investigation of Pharmacokinetic Drug-drug Interaction of BI 409306 and Donepezil in Healthy Male and Female Subjects

Part I:

To investigate whether and to what extent donepezil affects single dose pharmacokinetics of BI 409306

Part II:

To investigate whether and to what extent BI 409306 affects the single dose pharmacokinetics of donepezil


Eligibility Criteria:
Inclusion criteria:

* Healthy male/female subjects,
* age of 18 to 55 years,
* body mass index (BMI) of 18.5 to 29.9 kg/m2
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
* Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:
* Use of adequate contraception, e.g. any of the following methods plus condom:

intrauterine device (non-hormonal)

* Sexually abstinent
* A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
* Surgically sterilised (including hysterectomy)
* Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion criteria:

* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 60 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Chronic or relevant acute infections
* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
* Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
* Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
* Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication
* Smoker
* Alcohol abuse Further exclusion criteria apply