cyrilzakka/clinical-trials huggingface dataset:
Plasma Exosome RNA to Diagnose Prostate Cancer

The aim of the present study is to investigate a RNA combination to diagnose prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Blood prostate-specific antigen PSA\&gt;4ng/dl;
2. Patients suspected of having prostate cancer through clinical symptoms, digital rectal examination, ultrasound examination, magnetic resonance imaging, and PSMA PET/CT examination.
3. The patient is willing to undergo prostate biopsy.

Exclusion Criteria:

1. Previous diagnosis of prostate cancer through prostate biopsy;
2. History of other malignant tumors in the past two years;
3. According to the research physician\&#39;s judgment, serious complications may occur and affect the normal conduct of the experiment
The Tilt Test-Induced REsponse in Closed-loop Stimulation (TIRECS) Study

Multicentre, prospective, double blinded, randomized study designed as an intrapatient comparison to evaluate the effects of the Biotronik Closed-loop Stimulation algorithm on prevalence and timing of haemodynamic variations and clinical prodromes induced by head-up tilt test in patients underwent pacemaker implantation for refractory cardioinhibitory vasovagal syncope.

A total of 30 patients with refractory cardioinhibitory vasovagal syncope receiving a Biotronik pacemaker with Closed-loop Stimulation (CLS) algorithm will be enrolled in the study. Two head-up tilt test (HUTT), one during DDD 60/min pacing with CLS algorith turned off (CLS-OFF) and the other during DDD-CLS pacing (CLS-ON), will be performed one week apart; patients will be randomly and blindly assigned to group A (n=15, first HUTT in CLS-ON mode) or B (n=15, first HUTT in CLS-OFF mode). During HUTT heart rate, blood pressure, and the incidence of clinical prodromes and syncope wil be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Refractory cardioinhibitory vasovagal syncope treated with permanent pacemaker;
* Pacemaker Biotronik with Closed-loop Stimulation algorithm
* Ability to perform a head up tilt test
* Completion of the 18th year of age

Exclusion Criteria:

* Contraindications to head up tilt test
Investigating the Effect of Ryzodeg® in Adult Patients With Type 2 Diabetes in Lebanon

The study is investigating Ryzodeg®,a medication prescribed to patients with type 2 diabetes mellitus.The study is being carried out to investigate the effect of Ryzodeg® on the change of glycated haemoglobin levels and other diabetes indicators. Participants participation will not affect their medical care. In this retrospective study, the study doctor will collect data from the participants patient files available at the study site. Participants will need to sign the informed consent form during a single visit. Participants files will be reviewed and data relevant to the study will be extracted, within 26 weeks before and after Ryzodeg® treatment initiation (total of 52 weeks). Chart review for all patients is expected to take approximately 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male or female, age above or equal to 18 years at the time of signing the informed consent.
* Patients diagnosed with Type 2 Diabetes Mellitus (T2DM).
* Patients who were not achieving optimal glycaemic control and who required intensification of antidiabetic treatment and Ryzodeg was the treatment of choice.
* Available and documented HbA1c value at less or equal to 12 weeks prior to initiation of Ryzodeg® treatment and end of study within the study windows.
* Available and documented follow up time of at least 52 weeks with 26 weeks follow-up prior to and after initiation of Ryzodeg®.
* The decision to initiate treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as signed informed consent.
* Participation in any clinical study of an approved or non-approved investigational medicinal product within 26 weeks before and after initiation of treatment with Ryzodeg®.
* Having been previously treated with Ryzodeg® prior to study start.
* Female who were pregnant or breast-feeding during the study.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Treating Earthquake in Nepal Trauma (TENT) Trial 2016

The purpose of this study is to determine whether two types of short-term trauma-focused therapies (individual Narrative Exposure Therapy and group-based Control-Focused Behavioural Treatment) are effective in the treatment of chronic PTSD in earthquake survivors of Nepal.

Background: Post-traumatic stress disorder (PTSD) is a common mental health disorder after natural disasters. Without treatment survivors of earthquake would continue suffering from PTSD for many years. There are not many short-term trauma-focused psychosocial therapies that have been examined after natural disasters in developing countries. This study investigates the effectiveness of a 4-session revised narrative exposure therapy (NET-R), and 2-session group-based control-focused behavioural treatment (CFBT-R) delivered by non-specialists with minimum supervision.

Methods/Design: Participants would be identified and recruited through a door-to-door survey of families severely affected by the 2015 earthquake in Bhaktpur municipality of Nepal. PTSD Checklist for DSM-5 (PCL-5) will be used to screen all adult survivors (aged 18 and above) for the possible presence of PTSD, and the CAPS-5 interview will be used for the diagnosis of current PTSD. Investigators aim to include 240 consenting participants in a single blind randomised controlled clinical trial. All participants will be randomly allocated to one of three treatment conditions (N = 80 each): 4-session revised narrative exposure therapy (NET-R), 2-session group-based control-focused behavioural treatment (CFBT-R) involving instructions to conduct self-exposure, or a 3-month waiting list. In both NET-R and CFBT-R interventions, treatment sessions will last 90 minutes; NET-R will be delivered within a week while CFBT-R will be done over 2 weeks. All participants will be subjected to blind assessments for PTSD symptom severity with CAPS-5 and Fear and Avoidance questionnaire at pre-treatment (T0) and 3-month post-treatment (T1).

Discussion: The results from the post-treatment measurement would provide strong empirical reference of the safety and effectiveness of trauma-focused short-term therapies (NET-R and CFBT-R) for mass trauma survivors in developing countries like Nepal. It may also provide information on who may benefit most from which type of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Must have a diagnosis of PTSD according to DSM-5 criteria with a Clinically-Administered PTSD Scale (CAPS-5); during the screening, participants will be asked to report on traumatic events that fulfil DSM-5 criterion 'A'.
* The PTSD symptoms must be a result of the Nepal earthquake in April 2015

Exclusion Criteria:

* High suicidality (Yes to the question "Have you recently had thoughts of ending your life and made any plans to this effect?)
* People with severe degree of prolonged grief (Grief Score of 25 or more on the Grief Assessment Scale, adapted from Prigerson et al., 1999)
* Severe intellectual impairment, being unable to communicate and dependent on others for daily living (i.e. suffering from severe Learning disability)
Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure

This clinical study aims to assess the efficacy of TOTUM-854, a mix of 6 plant extracts, consumed twice a day on automated office blood pressure in subjects with moderately elevated blood pressure. The hypothesis is that TOTUM-854 is superior to placebo for decrease of automated office blood pressure after 12 weeks of consumption.


Eligibility Criteria:
Main Inclusion Criteria:

* Office Systolic Blood Pressure between 130 and 159 mmHg and Diastolic Blood Pressure \< 100 mmHg
* Body Mass Index (BMI) between 18.5 and 35 kg/m²
* Weight stable within ± 5 % in the last three months
* No significant change in food habits or in physical activity in the 3 months before the randomization and agreeing to keep them unchanged throughout the study

Main Exclusion Criteria:

* Known or suspected secondary hypertension
* Subjects with a very high Cardio Vascular risk SCORE2 or SCORE2-OP according to their risk regions: (Subjects \<50 years old: ≥7.5%; Subjects between 50 and 69 years old: ≥10%; Subjects ≥70 years old: ≥15%)
* Known hypertensive retinopathy and/or hypertensive encephalopathy
* History of spontaneous or drug-induced angioedema
* Clinically significant valvular heart disease or severe aortic stenosis
* History of an acute coronary syndrome (non-ST elevation myocardial infarction, ST-elevation myocardial infarction, and unstable angina pectoris), stroke, or transient ischemic attack within 6 months prior to inclusion
* Newly diagnosed or suffering from a non-treated or uncontrolled metabolic disorder such as diabetes, dyslipidemia, thyroidal dysfunction or other metabolic disorder
* Suffering from a severe chronic disease or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator
A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis

The purpose of this study is to demonstrate the efficacy and safety of Certolizumab Pegol (CZP) in the treatment of moderate to severe chronic plaque Psoriasis (PSO) in Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female, \>= 20 years of age.
* Institutional Review Board-approved written informed consent form is signed and dated by the subject.
* Other protocol-defined inclusion criteria may apply.

For subjects with moderate to severe chronic plaque psoriasis (PSO)

* Chronic plaque psoriasis for at least 6 months.
* Baseline Psoriasis Activity and Severity Index (PASI) \>=12 and Body Surface Area (BSA) affected by PSO \>=10% and Physician's Global Assessment (PGA) score of 3 or higher.
* Candidates for systemic PSO therapy and/or phototherapy and/or chemophototherapy.

For subjects with generalized pustular PSO or erythrodermic PSO

* Diagnosis of generalized pustular PSO or erythrodermic PSO at Screening.
* History of plaque-type PSO if subjects have a diagnosis of erythrodermic PSO.
* Baseline BSA affected by PSO \>=80% if subjects have a diagnosis of erythrodermic PSO.

Exclusion Criteria:

* Female subject who is breastfeeding, pregnant, or plans to become pregnant during the study or within 5 months following last dose of study drug. Male subject who is planning a partner pregnancy during the study or within 5 months following the last dose of study drug.
* Subject has guttate psoriasis or drug-induced psoriasis. For subjects with moderate to severe plaque psoriasis, erythrodermic or pustular forms of psoriasis also are excluded.
* History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol. Also, subjects with a high risk of infection in the Investigator's opinion.
* History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
* History of other malignancy or concurrent malignancy as described in the protocol.
* Class III or IV congestive heart failure
* History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis).
* Subject has any other condition which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study.
* Concurrent medication restrictions as described in the protocol.
* Subject with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or with untreated latent tuberculosis infection (LTBI) or current or history of nontuberculous mycobacterial (NTMB) infection.
* Subject has any protocol defined clinically significant laboratory abnormalities at the screening
* Other protocol-defined exclusion criteria may apply.
Pregnancy-Related Hypertension: Adherence to a New Type of Monitoring

A large segment of our patient population is diagnosed with hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia. New guidelines from the American College of Obstetricians and Gynecologists recommend postpartum monitoring of blood pressures via blood pressure checks on day 3 postpartum and between days 7-10 postpartum. Our purpose is to compare the effectiveness of using a Bluetooth-enabled home blood pressure monitoring platform to the standard postpartum office-based blood pressure monitoring in performing the recommended postpartum follow-up for patients with hypertensive disorders of pregnancy.

While inpatient during the postpartum period, patients will be identified who were diagnosed with hypertensive disorders of pregnancy antepartum, intrapartum, or postpartum. These patients will be recruited prior to discharge home. This will be a randomized control trial, non-blinded. The study group will receive a mobile app for postpartum education and an integrated Wi-Fi connected blood pressure cuff for at-home monitoring for 16 days postpartum. The home BP monitoring will occur twice a day and study team will check the BPs twice a day and intervene by phone or text if necessary. The control group will be scheduled for blood pressure checks at the clinic between days 7-10. These groups will be compared with regard to adherence to guidelines from the American College of Obstetricians and Gynecologists for blood pressure monitoring, antihypertensive initiation after discharge, unscheduled visits, readmission, and attendance of postpartum visit.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have delivered an infant either at Greenville Memorial Hospital or MUSC and be willing and able to follow-up with her respective institution.
* Patient must have been diagnosed with a hypertensive disorder of pregnancy in the antepartum, intrapartum, or postpartum period.

Exclusion Criteria:

* \<18 years of age
* BMI \>50 (due to limitations in blood pressure cuff size through BabyScripts)
* non English-speaking
* not able to receive phone calls and unlimited texts on cell phone
* not able to download and use Babyscripts phone application
Continuous Adductor Canal Block for Total Knee Arthroplasty Analgesia

The purpose of the study is to determine whether the association of sciatic nerve block to continuous adductor canal block is effective in the treatment of total knee arthroplasty post operative pain .


Eligibility Criteria:
Inclusion Criteria:

* Elective unilateral TKA,
* Planned continuous spinal anesthesia ,
* Ability to follow study protocol,
* American Society of Anesthesiologists class 1 to 3.

Exclusion Criteria:

* Contraindication for neuraxial anesthetic,
* Chronic opioid use (defined as daily or almost daily use of opioids for \>3 months),
* Hypersensitivity and/or allergies to any of the study medications,
* Intraoperative use of volatile anesthetics,
* Preexisting neuropathy on the operative limb,
* Contraindications to a femoral, adductor canal or Tibial nerve block.
Community-Based Health Education Programs for the Early Detection of, and Vaccination Against, COVID-19 and the Adoption of Self-Protective Measures of Hong Kong Residents

This study evaluates the community-based health education program in improving early testing for COVID-19, increasing vaccination acceptability and enhancing emergency preparedness and self-protection measures against COVID-19 in HK. We established a partnership with several local community stakeholders and they will be responsible for recruiting participants and implementing educational programs. Half of the community collaborators will receive the core intervention package, and use it as education material. The other half will be encouraged to self-collect and send health information to the participants.

This health education program is based on a Community-based Participants Research (CBPR) approach, which is a partnership approach that equitably involves community members and researchers in all aspects of the research process. Given the different cultural, professional or living background of Hong Kong residents, we think this simple, flexible and sustainable approach will effectively mitigate the COVID-19 risk in HK society,

An academic-community collaboration platform with several nongovernmental organizations (NGOs), companies and schools will be established before this study. They will work together to recruit participants, design and implement a series of educational programs aimed at controlling the spread of COVID-19 in the community.

Eligibility Criteria:
For participants recruited by NGOs and companies, the Inclusion Criteria will be:

* HK resident aged 18 years or above;
* Agreement to participate in the study and provide written informed consent.

The Exclusion Criteria will be:

* Cognitive impairment that inhibits communication with the investigators;
* Inability or unwillingness to provide written informed consent.

For participants recruited by schools, the Inclusion Criteria will be:

* HK students aged 12 to 18 years and their parents.

The Exclusion Criteria will be:

* Cannot provide written informed consent (or assent for the younger students).
Study of Valproate in Young Patients Suffering From Epilepsy

Main objective: Therapeutic follow-up study Evaluate the clinical and biological safety of valproate administered as microgranules, under standard prescription conditions, with therapeutic follow-up and individual dosage adjustment, using valproate plasma concentrations and antiepileptic comedication as well as biological assays.

Secondary objectives: Ancillary population kinetics study

* Estimate the pharmacokinetic parameters of valproate administered as microgranules under standard therapeutic conditions within the population studied, from the therapeutic follow-up data.
* Evaluate the influence of individual characteristics on the pharmacokinetic parameters.
* Describe the relationship between plasma concentrations and adverse events for valproate and the main anti-epileptic comedications.


Eligibility Criteria:
Inclusion Criteria:

* Children aged between 6 months and 15 years.
* Suffering from any type of epilepsy.
* Receiving at the time of inclusion valproate in the form Micropakine® SR 20 to 30 mg/kg/d by oral route, in 2 daily administrations and at most two other antiepileptic drugs (an antiepileptic benzodiazepine treatment taken daily or on demand more than 2 times weekly, must be considered as an antiepileptic treatment).
* Followed by hospital paediatricians or neuropaediatricians.
* For whom the consent has been signed by the parents or the holders of parental authority and if possible by the child him/herself.
* For whom the parents or legal guardian do not have any language or cultural obstacle for understanding the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Comparison Between Individualized PEEP Ventilation Guided by Driving Pressure and Conventional Lung Protective Strategy in Obese Patients Undergoing Laparoscopic Bariatric Surgery

this study to compare the ventilation in obese patients either using Driving pressure ventilation technique or conventional protective lung strategy all by using Lung ultrasound score


Eligibility Criteria:
Inclusion Criteria:

1. patients who have a BMI 30-40 kg/m2
2. American Society of Anesthesiologists (ASA) physical status II or III
3. patients aged between 18 and 60 years,
4. patients scheduled to undergo laparoscopic bariatric surgeries.

Exclusion Criteria:

1. patients' refusal to participate in the study,
2. previous history of thoracic surgery,
3. Patients with a history of chest disease (COPD, emphysema, or pneumothorax),
4. Patients with abnormal pre-operative chest radiographs, such as pneumonia and pleural effusion,
5. Patients with right-side heart failure or impending failure,
6. Patients with known hypovolemia, and Patients with increased intracranial pressure.
The Effect of Tennis Ball on Balance and Quality of Life in Cancer Patients With Neuropathy.

This research; It was aimed to evaluate the effect of myofascial release using a tennis ball on balance and quality of life in cancer patients who developed peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Complaints of peripheral neuropathy among patients who have completed the standard chemotherapy treatment protocol due to colorectal cancer, entered the follow-up process and come to the outpatient clinic for routine control.
* Registered to Selçuk University Faculty of Medicine Hospital Medical Oncology Polyclinic
* Karnofsky Performance Scale must be 80 or above
* Over 25 years old, under 65 years old
* Presence of grade 2 or higher peripheral neuropathy,
* Being conscious and cooperative
* Verbal and written approval to participate in the study after an explanation about the study is made.

Exclusion Criteria:

* Having any skin sensitivity on hands and feet before
* Refused to participate in the study after making a statement about the study
* Development of peripheral neuropathy due to reasons other than chemotherapy \[tumor compression, nutritional disorders, infections or major systemic disease (diabetes mellitus, etc.)\]
* Bone or spine metastases
Trial of Alternating Current Stimulation in Optic Neuropathy

Non-invasive brain stimulation can increase cortical excitability in the visual system, but it is not known if this is of clinical value. The investigators now assessed if repetitive, transcranial alternating current stimulation (rtACS) can improve visual field size in patients with optic nerve damage. The investigators hypothesized that rtACS would improve visual functions within the defective visual field sectors of the visual field (primary outcome measure).

In a prospective, double-blind, randomized, placebo-controlled clinical trial 22 patients with optic nerve damage were randomly assigned to a rtACS- (n=12) or placebo-group (n=10). Visual field measures, visual acuity and EEG-recordings were collected before and after a daily 20-40min treatment for 10-days and at a 2-months-follow-up. Primary outcome measure was detection accuracy (DA) in defective visual field sectors of computer-based high resolution perimetry (HRP). Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.

Eligibility Criteria:
Inclusion Criteria

* patients with optic nerve lesion
* stable visual field defect with residual vision
* lesion age at least 6 months

Exclusion Criteria

* heart pacemakers and any metal artefacts in head and truncus
* epileptic seizure within the last 3 years
* photosensitive epilepsy as determined by EEG
* mental diseases (schizophrenia etc.)
* unstable diabetes, diabetes causing diabetic retinopathy
* macular degeneration, maculopathy with decimal visual acuity below 0.4
* high blood pressure
* instable or high level of intraocular pressure (i.e. \>27 mmHg)
* presence of an un-operated tumor anywhere in the body
* total blindness
* primary or secondary glaucoma
* pathological nystagmus