cyrilzakka/clinical-trials huggingface dataset:
Validation of the Blood Pressure Monitoring Function

High blood pressure is a major risk factor for cardiovascular diseases, stroke, and kidney disorders. Accurate blood pressure monitoring is crucial for the diagnosis, treatment, and prevention of complications related to high blood pressure. In recent years, due to the rapid development of wearable devices and mobile technology, wearable blood pressure monitors have gradually become a non-invasive and convenient method for blood pressure monitoring. However, the accuracy of these devices has not been fully established. This study aims to validate the performance of RadiHeart (an application program) in blood pressure measurement.

Following the ISO 81060-2:2018 standard, the accuracy of RadiHeart will be evaluated by comparing the blood pressure values obtained by the device with those measured by a conventional mercury sphygmomanometer. This research is expected to recruit 170 adults aged 20 and above. All participants will undergo blood pressure measurements using both RadiHeart and a mercury sphygmomanometer. Participants will operate RadiHeart under the guidance of the testing personnel, while the mercury sphygmomanometer will be operated by trained healthcare professionals. The blood pressure measurement results from both devices will be recorded simultaneously, and the consistency between the blood pressure values measured by RadiHeart and the traditional mercury sphygmomanometer will be compared to validate the accuracy of the blood pressure application.

Eligibility Criteria:
Inclusion Criteria:

The subjects should be aged 20 or older, with an equal gender distribution of 50% male and 50% female. From this group, 85 subjects with reasonable data values will be selected, with a requirement that at least 30% of them are male and at least 30% are female. Additionally, they must meet the following blood pressure conditions:

1. At least 5% (5 individuals) of the participants should have reference systolic blood pressure readings ≥ 160 mmHg (21.33 kPa).
2. At least 20% (17 individuals) of the participants should have reference systolic blood pressure readings ≥ 140 mmHg (18.66 kPa).
3. At least 5% (5 individuals) of the participants should have reference systolic blood pressure readings ≤ 100 mmHg (13.33 kPa).
4. At least 5% (5 individuals) of the participants should have reference diastolic blood pressure readings ≤ 60 mmHg (8.0 kPa).
5. At least 20% (17 individuals) of the participants should have reference diastolic blood pressure readings ≥ 85 mmHg (11.33 kPa).
6. At least 5% (5 individuals) of the participants should have reference diastolic blood pressure readings ≥ 100 mmHg (13.33 kPa).

Exclusion Criteria:

1. Pregnant.
2. Having any of the following conditions:

   * Arrhythmia
   * Medical assessment indicates that poor blood circulation would affect the blood pressure data collection.
   * Involuntary hand movements that would affect the blood pressure data collector.
   * Nail polish on the light sensor area of the fingertip oximeter.
   * Other conditions as determined by a physician that make the individual unsuitable for participation in the trial.
Adjuvant Effect of Chloroquine on Gemcitabine

The purpose of this study is to evaluate the safety by defining the maximum tolerated dose (MTD) of Choloroquine when combined with Gemcitabine, and to evaluate preliminary efficacy of combined systemic Gemcitabine and Chloroquine. In addition, the influence of the treatment on the anti-cancer immunity and the value of GOLPH2 as serum marker for pancreatic cancer will be assessed within a translational objective.

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

* Histologically or cytologically confirmed non-resectable locally advanced or metastatic adenocarcinoma of the pancreas. Assessment is done within 21 days before enrolment.
* Age = 18 years
* Adequate liver function or kidney function tests, including any of the following: Bilirubin \< 2 x ULN, Alanin-Aminotransferase (ALT) \< 5 x ULN, Alcaline phosphatase \< 5 x ULN, Estimated creatinine clearance \> 40 ml/min (using the Cockroft formula)
* Adequate haematological values: Haemoglobin \> 80 g/L, Leukocytes \>3.00 g/L, Neutrophils \> 1.00 g/L, Platelets \> 100 g/L
* Written informed consent
* Biliary decompression is mandatory before inclusion into the study in case of bilirubin levels \> 50 µmol/L.
* Women who are not breastfeeding and are using effective contraception if sexually active, who are not pregnant and agree not to become pregnant during the 12 months thereafter. A negative pregnancy test before inclusion into the trial is required for women of childbearing potential, defined as having not reached the menopause, last menstrual period occurred less than 12 months ago, no surgical sterilization performed, and fallopian tubes and/or uterus have been not surgically removed.
* Men who agree not to father a child during participation in the trial or during the 12 months thereafter.

Patient compliance and geographic proximity allow proper staging and follow-up. Patient not eligible for FOLFIRINOX treatment. WHO PS 0-2

Exclusion criteria:

* Life expectancy \< 3 months
* Severe medical or psychiatric co-morbidity prohibiting the planned treatment or the giving of informed consent
* Any prior chemotherapy for pancreatic cancer, including adjuvant chemotherapy.
* Any prior radiotherapy or combined radio-chemotherapy for pancreatic cancer if completed less than 12 months prior to study inclusion.
* Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs.
* Known glucose-6-phosphate dehydrogenase deficiency.
* Concurrent use of other experimental drugs, treatment within a clinical trial within 30 days prior to trial entry.
* Active heart disease defined as congestive heart failure \> NYHA class 2
* Past or current history (within the last 2 years prior to treatment start) of other malignancies except basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
* Inability or unwillingness to comply with the study protocol
* No understanding of the german language
Sciatic Nerve Blockade by Subgluteal Access 12.5 ml of 1% Lidocaine: US Guidance Versus US Guidance With Electrical Stimulation of Peripheral Nerves (Influence of the Sciatic Nerve Blockade on the Effectiveness of Small Doses of Local Anesthetic.).

In modern anesthesiology, peripheral nerve blocks are performed using ultrasound control and electrical stimulation of peripheral nerves (PEN), or only ultrasound control or only EPN. The most effective methods are with the use of ultrasound control. Until now, the effectiveness of the sciatic nerve blockade by the subgluteal approach, performed only under ultrasound control without EPN, in comparison with the blockade of the sciatic nerve performed under ultrasound control with EPN, has not been established.

There is no data on how the effectiveness of the blockade of the sciatic nerve with small doses of lidocaine is influenced by the method of performing the blockade: under ultrasound control versus ultrasound control with electrostimulation of the nerve.

Research hypothesis: the blockade of the sciatic nerve by the subgluteal approach (12.5 ml 1%lidocaine -Minimum Effective Dose - previously established ) performed only under ultrasound control has the same effectiveness as the blockade performed under the ultrasound control with EPN.


Eligibility Criteria:
Inclusion Criteria:

* indication requiring anesthesia maintenance;
* patient's written consent about the type of anesthesia and possible complications of regional anesthesia

Exclusion Criteria:

* patient's refusal of application for the proposed form of anesthesia;
* patients younger than 18 years;
* patients weighing less than 50 kg;
* a physical status score of more than 3 determined by the American Society of Anesthesiologists (ASA);
* a history of allergic reactions to the drugs used;
* coagulopathies;
* infections of the skin at the injection site;
* neurological or neuromuscular diseases;
* severe liver diseases or kidney failures;
* an inability to cooperate with the patient.
Prediction of Leg Length Discrepancy After Unilateral Total Knee Replacement in Varus Deformity

To What degree total knee replacement (TKA) affects leg length discrepancy in patients with varus deformity? Varus deformity, the most commonly encountered deformity in patients undergoing TKA is associated with limb alignment and varying degrees of contractures of medial soft tissue structures, laxity of the lateral soft tissue structures, flexion deformity and medial bone erosion at the knee joint .The challenges in performing TKA in a varus arthritic knee include restoration of limb alignment, balancing the medial and lateral soft tissue tension, equalizing flexion and extension gaps and restoring medial bone loss

Limb length discrepancy (LLD)less than 2cm is usually not noticeable and does not require treatment. LLD over 2cm is usually noticed by the individual affected leading to self compensation by walking on the ball of the foot (toe down) or by tilting the pelvis and curving the spine.Untreated LLD can lead to lower back pain and long leg arthritis of the hip LLD and its effects on patient function have been discussed in depth in the literature with respect to hip arthroplasty but there are few studies that have examined the effect on function of limb length discrepancy following TKA.

Improved surgical techniques and rehabilitation protocols have resulted in excellent knee function and range of motion following TKA.

The investigators are aiming from the study to improve functional outcome in patients with knee osteoarthritis undergoing TKA.

Eligibility Criteria:
Inclusion Criteria:

- 1-Cases of osteoarthritis of the knee with varus deformity undergoing unilateral TKA.

2-Cases with previous unilateral TKA undergoing TKA of the other side.

Exclusion Criteria:

* 1-Cases of osteoarthritis of the knee with valgus deformity. 2-Revision total knee replacement cases. 3-Patients with total hip replacement. 4-Extra-articular lower limb deformities. 5-Cases of bilateral TKA done at same setting. 6-Patients with previous knee surgery. 7-Patients with complicated inrta-operative TKA .
Directly Observed Antiretroviral Therapy Among Active Drug Users

The goal of this randomized, controlled trial is to compare the effectiveness of a community-based program of providing supervised antiretroviral therapy to HIV-positive drug users, compared to having the patients take the medicines on their own.

Highly active antiretroviral therapy (HAART) has dramatically reduced morbidity and mortality from HIV disease, but these benefits have not been conferred equally among all patient populations. Injection drug users (IDUs) have shown particularly less favorable outcomes, with HIV progression remaining at high levels, and IDU remains a significant risk behavior for the spread of HIV worldwide, with explosive epidemics in Eastern Europe, Russia, and Southeast Asia. It is therefore essential to develop and test strategies of HIV treatment that optimize outcomes for this population, in order to reduce morbidity and mortality and to curb secondary transmission.

Directly observed therapy (DOT) for tuberculosis has resulted in impressive improvements in adherence and clinical response and marked reductions in the development of resistance. The time-limited treatment of tuberculosis, the inherently different transmission patterns of tuberculosis and HIV, and the complexity of antiretroviral therapy have raised concerns about translating the DOT model to HIV. Successful, but non-comparative demonstration programs of directly administered antiretroviral therapy (DAART) have been implemented in methadone maintenance programs, community-based settings, skilled nursing facilities, and in prisons. None of these, however, have targeted active drug users or used a prospective, randomized controlled trial (RCT) design to rigorously determine the efficacy of DAART as an intervention to improve HIV outcomes among active drug users. One RCT of DAART recently failed to demonstrate an impact on virological outcomes among low-income HIV+ patients, but these results are unlikely to be applicable to IDUs or other populations with demonstrated problematic adherence.

We therefore conducted the first randomized controlled trial to address this question, consisting of six months of DAART versus self-administered therapy (SAT) among active drug users in a community setting. The objective was to determine the potential efficacy of a six-month DAART program on HIV infection, using surrogate markers of HIV- RNA levels and CD4+ T lymphocyte counts.

Eligibility Criteria:
Inclusion Criteria:

1. being HIV seropositive;
2. being eligible for and/or being prescribed HAART
3. living within the city of New Haven
4. actively using heroin and/or cocaine in the previous six months
5. receiving no more than a twice-daily regimen

Exclusion Criteria:

Not meeting inclusion criteria
Changes in Sensitivity, Taste and Smell in Stroke Patients

This study evaluates changes in swallowing using endoscopic swallowing studies and measuring of pharyngeal sensitivity, taste and smell in stroke patients. Younger (\<60 years) and older (\>60 years) volunteers will serve as control.

Stroke is the second leading cause of death. At least 50% of stroke patients develop dysphagia, leading to aspiration pneumonia, which is the main cause of death in stroke \[2\].

It is assumed that normal sensitivity is vital for aspiration-free swallowing and for the triggering of the swallowing reflex.

Ali et al. demonstrated aspiration-free swallowing in healthy volunteers who underwent local anaesthesia of oral and pharyngeal structures \[1\]. Power et al. showed a reduced sensitivity of pharyngeal structures in stroke patients prone to aspiration \[3\].

By combining measuring sensitivity and flexible endoscopic swallowing studies, this study further investigates the role of sensitivity in swallowing Neuropsychological deficits of swallowing, such as swallowing apraxia or buccal hemineglect, is assessed by neuropsychological testing.

Additionally, there is no systematic research investigating the change in smell and taste in correlation with changes in stroke patients

Eligibility Criteria:
Inclusion Criteria:

Volunteers:

* informed consent

Stroke patients:

* informed consent
* new supratentorial stroke (\<72 hours old) confirmed by CT (computed tomography) or MRI (magnetic resonance imaging)

Exclusion Criteria:

* pre-existing stroke oder dysphagia
* extensive white matter lesions in CT- or MRI-scan
* allergies to odorous substances or flavoring
* contraindications for FEES (flexible endoscopic evaluation of swallowing), CT or MRI (stroke patients only)
Adversity, Brain and Opioid Use Study

The way people process and remember information may be related to adverse childhood experiences and Opioid Use Disorder symptoms. The purpose of this project is to examine brain function and performance during learning and memory tasks in adults. The study will compare measures of learning and memory across three groups of participants: those with an Opioid Use Disorder (OUD) that take buprenorphine for opioid replacement therapy, adults without an Opioid Use Disorder taking buprenorphine, and healthy adults that do not have an Opioid Use Disorder and are not taking buprenorphine.


Eligibility Criteria:
Inclusion Criteria for all groups:

* Right handed
* Able to give informed consent
* Normal/corrected-to-normal vision and hearing

Inclusion Criteria for Opioid Use Disorder (OUD) group:

* Diagnosis of OUD
* Be actively receiving buprenorphine (BUP) for opioid agonist therapy
* Be free from illicit substance use for at least 2 weeks
* The study will allow stable dose (\> 3 months) of commonly prescribed psychiatric medications and some sleep aids (per protocol)

Inclusion Criteria for the BUP control group:

* Taking BUP for chronic pain
* No Substance Use Disorder (including OUD)
* The study will allow stable dose (\> 3 months) of commonly prescribed psychiatric medications and some sleep aids (per protocol)

Inclusion Criteria for Healthy participant group:

* Not taking BUP
* Free of any psychiatric or major medical conditions

Exclusion Criteria for all groups:

* Significant medical or neurologic conditions (e.g., stroke, seizures, multiple sclerosis)
* Actively suicidal
* Contraindication for MRI
* Inability to tolerate small, enclosed spaces without anxiety
* Life history of schizophrenia, bipolar disorder, learning disability, attention deficit disorder, or pervasive developmental disorder
* Use of substances or prescription medications that could interfere with measures of interest (per protocol)
* Unable to provide informed consent
* Participants who have completed other studies in our lab involving learning and memory assessments with the same/similar tasks used here (HUM00230585, HUM00121812) will not be eligible to complete the current study, due to possible learning/practice effects
* Unable to fit comfortably in the MRI scanner due to body size (typically men over 6 feet tall that weigh more than 250 lbs, men under 6 feet tall that weigh over 220 lbs, women over 5'11" tall that weigh more than 220 lbs, or women under 5'10" tall that weigh more than 200 lbs).
FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS

To analyse false positives in breast cancer screening with tomosynthesis versus 2D mammography. The Avellino Breast Tomosynthesis Screening Trial is a observational population-based study that analyze souspicious findings in tomosynthesis slice images.

This study is based on two years screening and tomosynthesis was analzyed by two expert breast radiologists.


Eligibility Criteria:
Inclusion Criteria:

* breast cancer screening population

Exclusion Criteria:

* previous cancer
* breast prostheses
Alzheimer's in Long-Term Care--Treatment for Agitation

The purpose of this study is to see if a medication called prazosin is useful in the treatment of agitation and aggression in persons with Alzheimer's disease (AD) and other types of dementia in late life.

Although the occurrence of disruptive agitation behaviors likely are influenced by environmental/ interpersonal factors, it is also likely that behaviorally relevant neurobiologic abnormalities lower the threshold for the expression of such behavior in Alzheimer's disease. Because of the success prazosin has had in the treatment of Posttraumatic Stress Disorder, it is thought that it could be used similarly with disruptive agitation. Originally designed to evaluate Alzheimer's disease patients in nursing homes, the study now includes outpatients. It is a 9-week placebo-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* No age limit
* probable/possible Alzheimer's disease diagnosis
* disruptive agitated behaviors (e.g., irritability, aggression, uncooperativeness, pacing)
* no hypotension
* no concurrent use of alpha-1-blockers
* no delirium, schizophrenia, mania, psychotic symptoms.

Exclusion Criteria:

* Cardiovascular: unstable angina, recent myocardial infarction, second or third degree atrioventricular (AV) block, preexisting hypotension (systolic blood pressure less than 110) or orthostatic hypotension
* Other medical exclusions: chronic renal or hepatic failure, or any unstable medical condition
* Exclusionary medications: current treatment with prazosin, other alpha-1-blockers
* Current enrollment in a separate investigational drug trial
* Psychoactive medications: subjects may be psychoactive medication-free or be partial responders (by subjective assessment of referring health care professional) to one psychoactive medication from any of the following classes: antipsychotics, anticonvulsants, mood stabilizers, antidepressants, benzodiazepines, or buspirone. Partial response is defined as some improvement in agitated behavior but persistence of agitated behaviors severe enough to cause patient distress and/or difficulty with caregiving. Although not formally rated, this improvement is equivalent to a Clinical Global Impression of Change (CGIC) rating of no more than minimal improvement (improvement is noticed by not enough to improve patient function or caregiver's practical management of the patient).
* Psychiatric/behavioral: lifetime schizophrenia; current delirium, mania, depression, or uncontrolled persistent distressing psychotic symptoms (hallucinations, delusions), substance abuse, panic disorder, or any behavior which poses an immediate danger to patient or others or which results in the patient being too uncooperative to meet the requirements of study participation.
A Post-market Registry of the MARIS-stent (Invatec) Implanted in the Superficial Femoral Artery

The MARIS Register is a prospective, multicenter registry of implantation in the superficial femoral artery (SFA) with a CE marked stent (Maris / Invatec) intended to capture initial angiographic success, complication rate and symptomatic related revascularization by following the clinical process and duplex examinations at 6 and 12 month.

Recent data suggest that there is some evidence for a reduced restenosis rate for the implantation of a self expanding nitinol stent in the superficial femoral artery (SFA) compared to implantation of balloon expandable stents or single balloon inflation (ABSOLUTE study/FAST study).

The purpose of the Maris Register is to evaluate the primary nitinol stent implantation in an all comer population with diseased SFA.

The MARIS Register is a prospective, multicenter registry of the implantation of at least one at most five nitinol stents (Maris / Invatec) in the SFA without limitations for stenosis or occlusion length.

The registry includes 998 patients from 13 German investigational sites. Clinical data are captured on electronic case report forms

The primary endpoint is the target lesion revascularization after 12 month

Secondary endpoints are :

* Restenosis rate \> 50% according to ultrasound criteria
* Restenosis rate \> 70% according to ultrasound criteria
* Location of restenosis (proximal, middle, distal AFS)
* Number of stent fractures (grading according to FESTO criteria)
* Procedure related complication rate
* Vascular complication rate within 12 month
* Amputations within 12 month
* Deaths within 12 month

In order to measure the restenosis the peak systolic velocity (PSV) is to be measured in two sections during the duplex ultrasound examinations at 6 and 12 month. First measurement is performed 2cm proximal to the first stent, second measurement at the location where the maximum peak velocity over all lesions/all implanted stents is measured.

The clinical status includes the patient´s Fontaine classification.

Eligibility Criteria:
Inclusion criteria

* stent implantation in SFA is possible
* existing SFA stenosis 70-100 % (visual estimation)
* absence of homodynamically relevant stenosis in A. poplitea
* at least one lower limb run off vessel

Exclusion criteria

* pregnancy
* life expectancy less than 1 year
* coagulation disorder
* chronic anticoagulation therapy
* active gastrointestinal bleeding
* thrombolytic therapy within 72 hours before intervention
* hyperthyreosis
* severe contrast agent allergy
* allergy to concomittant medication
* severe liver disease
* thrombus in target lesion
* target lesion extend into A. poplitea
* severe calcification of target vessel, where no successful pre-dilatation is feasible