cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies

To assess the feasibility of using rhBMP-2/CPM in OWO as a surgical model for pharmacodynamic studies, with assessment of the following parameters:

* Injecting the desired volume of rhBMP-2/CPM within the defect
* Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence of rhBMP-2/CPM.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 45 to 70 years of age
* Within 96 hours prior to dosing, the subject underwent a successful open wedge tibial osteotomy to correct medial compartment OA of the knee.
* Female subjects of childbearing potential must have a negative pregnancy test (hospital acceptable test), upon hospitalization for OWO and agree to use medically approved contraception for the duration of the study.

Other inclusion applies.

Exclusion Criteria:

* Subjects with pre-existing conditions of the knee or tibia that would confound an interpretation of results.
* Subjects for whom surgery in the opposite knee is planned during the 6 months of follow-up.
* Subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy within the past 5 years, except subjects with a history of basal skin carcinoma.

Other exclusion applies.
Staging Candidiasis in ICU Patients

Our primary objective is to evaluate the relevance of the early determination of Candida infection status among non-neutropenic patients hospitalized over 48 hours in ICUs.


Eligibility Criteria:
Inclusion Criteria:

* Polynuclear neutrophils \> 500/mm\^3
* Hospitalized for \> 48 hours in participating ICUs

Exclusion Criteria:

* Patients discharged from ICU in \< 48h
* Patient diagnosed with invasive candidosis before entry to ICU
* Patient is taking an anti-fungal treatment
* polynuclear neutrophils \< 500/mm\^3
* patient transferred to another ICU
* patient included in the Abmidex protocole
Exploratory Study on the Role of Somatic Modulation in Hyperacusis

This study focuses on patients with a primary complaint of hyperacusis. Hyperacusis has been defined as 'abnormally reduced tolerance to sound' and is commonly associated with tinnitus. The effects of somatic modulation upon tinnitus have been studied, but not so for hyperacusis.. The effect of 9 somatic modulations (i.e. 3 jaw modulations and 6 cervical spine modulations) and 1 control movement (i.e. without any somatic modulation effect) in random order on the sound tolerance of a 1 kilohertz (kHz) broadband noise sound and the tinnitus experience will be investigated. More specifically, the perceived loudness and intrusiveness of this sound and the tinnitus sound will be evaluated before somatic modulation and during the somatic modulation.


Eligibility Criteria:
Inclusion Criteria:

* Primary complaint of hyperacusis

Exclusion Criteria:

* Primary complaint of tinnitus
Effects of Resisted Versus Balance Exercises on Cognitive And Motor Function In Patients With Mild Cognitive Impairment

Mild cognitive impairment affects older adults and it includes memory and attentions deficits, and problem-solving difficulties in activities of daily living. Resisted exercises is considered a viable strategy to improve balance and motor function in older population. Balance exercises comprises proprioceptive, visual and motor learning to a larger degree and has positive effects on memory and spatial cognition and improves balance and motor function. This study aims to determine the effects of resisted and balance exercises on cognition and motor function in patients with mild cognitive impairment.

This randomized clinical trial will be conducted at Aziz Bhatti Shaheed Teaching Hospital Gujrat in seven months after approval of synopsis. The sample size for this trial is 78 patients with MCI. The participants will be randomly allocated into two groups using Online Randomization tool. Group A will receive resisted exercises for 30 minutes and Group B will receive balance exercises for 30 minutes. Participants will receive 3 sessions on alternate days per week for 12 weeks.Montreal Cognitive Assessment (MoCA) and Computerized battery test will be used to assess cognitive impairment, Mini-besTest and Time Up and Go Test (TUG) for balance and motor function.Data will be entered and analysed by using SPSS 26 software.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Mild Cognitive Impairment. (Having score between 18 - 24) on MoCA.
2. Participants with Both Genders will be included .
3. The Age limit for the participants will be 60 to 75 years.
4. Patients having Independence of life (ability to walk independently without any walking aid).

Exclusion Criteria:

1. Previous and current History Cardiovascular, neurological, psychiatric and motor disorders like (fractures, diagnosis of Osteoporosis)
2. Patients taking any medication for mild cognition.
3. Depressive symptoms, acute and chronic conditions that would preclude exercise, regular exercise (\>30 min/day, \>3days/week).
4. Patients having estrogen replacement therapy.
5. Simultaneous participation in other studies.
6. Regular physical activity (once a week during the last 3 months); physio therapeutic treatment in the last 3 months.
7. Diseases that promote incapacity; severe visual deficiency; recurrent vertigo; and uncontrolled systemic arterial hypertension.
SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following mRNA COVID-19 Vaccination

A novel zoonotic coronavirus was discovered in Wuhan (Hubei Province, China) mid-December 2019 and was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus rapidly spread to the rest of the world, including Europe and explicitly affects the respiratory system, generating Coronavirus disease 2019 (COVID-19).

This study is a monocentric interventional prospective and retrospective cohort study. After signing a written informed consent, participants will be recruited for questionnaire completion and blood sampling. Sample storage and analysis will be performed at the laboratory of microbiology of the UZ Brussel.

To document SARS-CoV-2 seroprevalence and seroconversion among employees of the UZ Brussel after mRNA vaccination for SARS-CoV-2, namely at 8 weeks after first vaccination, 6 months after first vaccination and 12 months after first vaccination.

A novel zoonotic coronavirus was discovered in Wuhan (Hubei Province, China) mid-December 2019 and was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus rapidly spread to the rest of the world, including Europe and explicitly affects the respiratory system, generating Coronavirus disease 2019 (COVID-19).

UZ Brussel employees presenting symptoms suggestive of COVID-19 are offered to be tested with real-time PCR on nasopharyngeal swabs. As asymptomatic infections have been described and as the PCR can be negative when taken late after onset of symptoms, serologic tests can be performed. The SARS-CoV 2003 epidemic demonstrated that serological assays were a useful diagnostic tool of non-acute infections. Although it is still uncertain whether convalescing patients have a risk of re-infection, recent data suggest that SARS-CoV-2 antibodies could protect at least for some time from subsequent viral exposures.

As the COVID-19 pandemic had devastating medical, economic and social consequences, safe and effective prophylactic vaccines were urgently needed. And thus several candidate vaccines against SARS-CoV-2 have been developed. During the first weeks of the vaccination campaign, the health care workers of the UZ Brussel, were invited to receive the BNT162b2 (Pfizer) vaccine.

Consequently, the investigators aim to prospectively document the SARS-CoV-2 seroprevalence and seroconversion among vaccinated employees of the UZ Brussel, at three different time points, namely 6 weeks (+/- 2 weeks; T1), 6 months (+/- 1 month; T2) and 12 months (+/- 1 month; T3) after the second vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Any adult employee of the UZ Brussel at T1 who has been vaccinated at the UZ Brussel with mRNA COVID-19 vaccine (Comirnaty®) between the 19th of January and the 5th of February 2021 after participating to phase 4 of the COVEMUZ study (with a maximum of 5 days difference between blood drawel and vaccination) and has provided a signed informed consent.

Exclusion Criteria:

* UZ Brussel employees not active during the inclusion period (T1).
Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study

The purpose of the study is to evaluate the efficacy of exogenous melatonin in improving sleep quality in HD gene carriers.


Eligibility Criteria:
Inclusion Criteria:

* Verified HD mutation carriers.
* Patients who report sleep disturbance as measured by a score ≥5 on the Pittsburgh Sleep Quality Index (PSQI);
* Stable concomitant medication (no change of medication during last 30 days prior to inclusion);
* Written informed consent by prospective study participant before conduct of any trial-related procedure;
* Participant must be able to make an informed decision of whether or not to participate in the study.

Exclusion Criteria:

* Pregnant or nursing women;
* Woman of childbearing potential, not using highly effective methods of contraception such as oral, topical or injected contraception, intrauterine device (IUD), contraceptive vaginal ring, or double barrier method such as diaphragm and condom with spermicide) or not surgically sterile (via hysterectomy, ovariectomy or bilateral tubal ligation) or not at least one year post menopausal;
* Presence of any medically not controllable disease (e.g. uncontrolled arterial hypertension or diabetes mellitus);
* Use of benzodiazepines, sedating antidepressants (mirtazapine or trazodone) or sedating antipsychotics (olanzapine and quetiapine) in the previous four weeks;
* Severe cognitive disorders defined as a score \< 18 on the MOCA;
* Participation in another investigative drug trial within 2 months;
* Subjects who are unlikely to be compliant and attend scheduled clinic visits as required as determined by the Investigator.
Ketamine As an Adjunctive Therapy for Major Depression (2)

Pragmatic, randomised, controlled, parallel-group, superiority trial of ketamine vs. midazolam as an adjunctive therapy for depression. The main purpose of the trial is to assess the mood-rating score difference between ketamine and midazolam from before the first infusion to 24 hours after the final infusion, supplemented by a 95% confidence interval. There will also be a 24-week follow-up after the final infusion session.

Pragmatic, randomised, controlled, parallel-group, superiority trial. Trial participants will be patients admitted to St Patrick's University Hospital for treatment of a major depressive episode. The investigators aim to recruit up to 104 participants who will be eligible for this study and randomly allocate 52 patients to each group. Both participants and assessors will be blind to treatment allocation. Eligible consented participants will be randomly allocated in a 1:1 ratio to a course of up to eight infusions of either ketamine or midazolam twice weekly over up to four weeks. Block randomisation will be independently performed. Physical, psychotomimetic and cognitive outcomes will be monitored before, during and after infusions. During the allocated infusions and follow-up period patients will be monitored for treatment-related adverse events relating to both mental and physical health. Participants will also be followed-up for 24 weeks after the end of the initial randomised treatment and assessment period lasting up to four weeks, in order to identify if and when relapse occurs. During the trial, both groups will continue usual inpatient care as prescribed by their treating team.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old.
* Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 20 at screening and start of the first infusion.
* Voluntary admission for treatment of an acute depressive episode
* Meet DSM-5 criteria for a major depressive disorder or bipolar affective disorder (current episode depression). Diagnosis of a major depressive disorder or bipolar affective disorder (DSM-5) will be confirmed by the structured diagnostic Mini International Neuropsychiatric Interview (MINI; updated Version 7 for DSM-5).

Exclusion Criteria:

* Current involuntary admission.
* Medical condition rendering unfit for ketamine/midazolam.
* Currently taking any of the contraindicated medications that may alter the pharmacokinetics of ketamine.
* Active suicidal intention.
* Dementia.
* Lifetime history of schizophrenia or schizoaffective disorder; active anorexia nervosa or bulimia nervosa in the past 12 months; alcohol or other substance use disorder (with the exception of nicotine) in the previous six months; any DSM-5 disorder other than a major depressive episode (unipolar or bipolar) as the primary presenting problem.
* Electroconvulsive Therapy (ECT) administered within the last two months.
* Pregnancy, breastfeeding or considering becoming pregnancy whilst on the trial for up to 12 weeks after last dose or inability to confirm use of adequate contraception during the trial.
* Breastfeeding women.
A Study to Define the Distribution of Type of Hypertension in Asia by Blood Pressure Monitoring at Home (Asia BP@Home)

Blood pressure variability (BPV) is being increasingly recognized as an important influence on hypertension outcomes as well as a risk factor for other cardiovascular (CV) events. However, in Asia there is a current lack of awareness of BPV and its significance on patient outcomes. Furthermore, there is ongoing debate on the role of home blood pressure (HBP) monitoring in managing hypertension patients and uncertainty on how best to integrate it into clinical practice.

Therefore, we conduct Asia BP@Home study to assess HBP control status in each Asian country and develop an Asian consensus and Asia-specific treatment for hypertension.

Blood pressure variability (BPV) is being increasingly recognized as an important influence on hypertension outcomes as well as a risk factor for other cardiovascular (CV) events. However, in Asia there is a current lack of awareness of BPV and its significance on patient outcomes. Furthermore, there is ongoing debate on the role of home blood pressure (HBP) monitoring in managing hypertension patients and uncertainty on how best to integrate it into clinical practice.

The main purpose of this study is to:

* Assess HBP control status in each Asian country
* Develop an Asian consensus and Asia-specific treatment for hypertension
* Improve the management of hypertension in Asia by encouraging patients to monitor HBP

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 20 years
2. Subjects with stable medication (\> 3 months) diagnosed as hypertension
3. Asian
4. Subjects have been thoroughly informed about this registry and signed an Informed Consent Form.

Exclusion Criteria:

-
Effect of Family Member's Massage Therapy on the Vital Signs and Glasgow Coma Scale Score

The effect of family member's massage therapy on the Vital signs and Glasgow Coma Scale Score of hospitalized patients in Intensive Care Unit: A Triple-blinded Randomized controlled Clinical Trial Study

Aims and objectives: To determine the effects of family member's massage therapy on the Vital signs and Glasgow Coma Scale Score of hospitalized patients in Intensive Care Unit.

Background: Unalleviated complications related to hospitalization including stress, anxiety, pain, and fear can easily impacts on different systems including brain and stimulates sympatric nerves and as a result causes instabilities in vital signs and deterioration in consciousness level. Alternative and complementary therapies including therapeutic massage have been used to decrease the mentioned side effects.

Design: A Triple-blinded Randomized controlled Clinical Trial Methods: All prolonged hospitalized patients and their families (45 patients and 45 family members in each group) were selected consecutively among the patients admitted in ICU. Data collection tool consisted of two parts. The first part included demographic data (age, mar¬ital status and Body Max Index) and the second part included a checklist to record the patient's vital signs (systolic blood pressure, diastolic blood pressure, respiratory rate, and pulse rate). All measurements were conducted in same time in both groups as follow: before the intervention (the whole massage therapy), one hour, two hours, three hours, and four hours. Collected data was analyzed using descriptive and analytical statistics utilizing SPSS 11.5 software.

Keywords: Family member's massage therapy; Vital signs; Glasgow coma scale; Intensive care unit; Randomized controlled Clinical Trial; Iran.

Eligibility Criteria:
Inclusion Criteria:

* more than 10-day hospitalization, hemodynamic stability, having the Glasgow coma scale score between 7 to 12, intra cranial pressure less than 20 mmHg, no limitation or contraindication for changing in body position (including active bleeding or flail chest) and body massage (such as advanced burn degrees, severe dyspnea, fever, etc) and willing to participate in the study

Exclusion Criteria:

* Any factors which violate inclusion criteria
Effect of Polyphenols on Peripheral Vascular Disease.

Peripheral arterial disease (PAD) is a clinical setting characterized by an exceptionally high risk for cardiovascular events. Oxidative stress seems to play a role in impairing flow-mediated dilation (FMD) and contributing to atherosclerosis in patients with PAD. Cocoa seems to exert artery dilatation via oxidative stress inhibition.

OBJECTIVES: To investigate whether in PAD patients, dark chocolate elicits artery dilatation via down-regulation of NOX2, the catalytic core of NADPH oxidase.

Atherosclerosis represents the major cause of worldwide death; it is a complex phenomenon that encompasses the intricate interplay of classic cardiovascular risk factors, oxidative stress and inflammation.

Peripheral artery disease (PAD) is a clinical setting that well represents the model of widespread atherosclerosis. PAD affects 20% of patients over the age of 75. Furthermore, PAD patients are at an exceptionally high risk for cardiovascular events and the majority will eventually die of a cardiac or cerebrovascular etiology.

Polyphenol could represent a novel therapeutic strategy to counteract atherosclerosis. During the last decades, a growing interest in polyphenols resulted from prospective and epidemiological studies that showed the beneficial effects of these substances on human health. In particular, polyphenols exert their beneficial effect by inhibition of NADPH oxidase (NOX2), an enzyme directly involved in atherosclerosis; thus, the activation of this enzyme leads to an enhanced production of oxidative stress and inflammatory processes.

The objective of this study is to evaluate the effect of polyphenols on oxidative stress and inflammation and on surrogate markers of atherosclerosis in PAD patients. Polyphenols, inhibiting NOX2-mediated oxidative stress and immune-mediated process, could represent a novel therapy to reduce the high risk of cardiovascular events in PAD.

Eligibility Criteria:
Inclusion Criteria:

Every PAD patient to be enrolled in the study had:

1. claudication (defined as leg pain on walking, disappearing within 10 minutes of standing, of presumed atherosclerotic origin) and
2. ankle/brachial index (ABI), that was assessed as ankle/arm systolic blood pressure ratio by Doppler ultrasonography \<0.90 on the worst leg at rest.

Patients had to be in stable conditions without abrupt changes of ABI (\>20%) in the last month before the enrolment.

Exclusion Criteria:

Subjects were excluded from the study if they had liver insufficiency, serious renal disorders (serum creatinine\>2.8 mg/dL), acute stroke, acute myocardial infarction, deep venous thrombosis or if they were current smokers or were taking antioxidants.
Neurally Targeted Cognitive Training to Augment CBT Outcomes in Pediatric Anxiety

This study will assign participants with anxiety to cognitive behavioral therapy (CBT) with computerized cognitive training (CCT). In addition, the study will have a control group and enroll age- and gender-matched anxious children assigned to CBT.

The hypothesis of this trial is that CCT with CBT will further increase task control network (TCN) activation and connectivity.

Both groups will have one CBT therapy session each week for 12 weeks. However, for participants in the CCT arm plus CBT they will also receive up to 4 weeks of at home CCT to complete during the two weeks prior to the first CBT session and during the two weeks after the first CBT session. CCT is to be done at home for approximately 30 minutes per day, 5 days per week. Additionally, participants in the CCT arm plus CBT will receive CCT for 30 minutes just prior to CBT sessions 4-12.

Each group will also have pre and post therapy functional magnetic resonance imaging (fMRI) and be asked to complete anxiety severity interviews and questionnaires throughout the study as well as after the treatment.

Update as of 4/7/2020: Enrollment and in-person-only interactions/interventions are temporarily paused due to COVID-19 and are expected to resume in the future. This is not a suspension of IRB approval.

Update as of 7/20/2020: Enrollment and in-person-only interactions/interventions are resumed.


Eligibility Criteria:
Inclusion Criteria:

* Parent or guardian willing to give informed consent, and children willing to give informed assent to participate in the study
* Must be actively enrolled and maintain eligibility in Dimensional Brain Behavior Predictors of CBT Outcomes in Pediatric Anxiety (HUM00118950; P.I. Fitzgerald) to participate in the study.

Exclusion Criteria:

* Color blindness
Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices

The investigators are providing MRI in patients with non-MRI approved CIED's (Cardiac Implanted Electronic Devices)

At Saint Luke's Hospital, despite growing evidence to the contrary, there is extremely limited data and experience with performing MRIs on patient with abandoned and epicardial leads in patients with non-approved ICDs and PMs. There is a limited mechanism to discuss this issue with the patient, screen the patient and assess their device beforehand, monitor them during the MRI examination, keep track of pulse sequences used, assess their devices after (and if necessary, resume prior programming before any changes), and to maintain that experience. The objective of this study is to create a protocol for an MRI at the commonly used magnetic strength of 1.5 T in patients that do not have conditional pacemakers and/or defibrillators and have abandoned or epicardial leads and maintain a registry of participants, devices involved, MRI examinations and pulse sequences used, and to keep records of any follow up events.

Eligibility Criteria:
Inclusion Criteria:

* Anyone with a cardiac device

Exclusion Criteria:

* Anyone who cannot consent for themselves or who don't have a durable power of attorney