cyrilzakka/clinical-trials huggingface dataset:
the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients

This study assess the safety, tolerability, and efficacy in reducing viral load and proviral DNA of UB-421 administered as an add-on to the ART in ART-experienced viremic HIV-1 subjects.


Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 seropositive
2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
3. have been receiving antiretroviral therapy (ART) for more than 2 years

Exclusion Criteria:

1. Any previous exposure to a mAb within 12 weeks prior to the first dose of UB-421 treatment.
2. Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined during the screening period, medical history, and/or physical examination that, in Investigator's opinion, would preclude the subject from participating in this study.
3. History of anaphylaxis to monoclonal antibodies.
4. Any vaccination within 8 weeks prior to the first dose of UB-421.
The Effect of Intravenous Lidocaine on Trigeminal Neuralgia

The aim of this randomized double blind, placebo controlled, crossover study is to investigate in a prospective way the effect of lidocaine in patients with trigeminal neuralgia. Included patients will undergo four weekly sessions, two of which with lidocaine (5mgs/kg) and two with placebo infusions administered over 60 minutes. Effect will be measured with pain diaries and visual analogue scales.


Eligibility Criteria:
Inclusion Criteria:

(1) confirmed diagnosis of TN according to IASP definition, (2) age equal to or greater than 18 years, (3) visual analogue scale (VAS) score equal to or greater than 3 (out of a maximum 10), (4) DN4 score equal to or greater than 4 (out of a maximum 10), (5) having received the recommended medications for TN (antiepileptics, spasmolytics, opioids, anti-inflammatory and simple analgesic drugs) for an adequate period without therapeutic results, (6) TN duration of at least 12 months, (8) no history of allergy to lidocaine, (9) no history of substance abuse, (10) absence of severe psychiatric diseases, (11) not being pregnant, (12) not lactating, (13) absence of severe cardiac, hepatic and renal decease, and (14) be willing to provide a written informed consent to undergo the experimental procedures.
Patients With Lumbar Spinal Stenosis With Balance Disorder

It is seen that patients with Lumbar Spinal Stenosis often experience balance problems. Although the relationship between muscle thickness and balance has been explained, there are insufficient studies investigating the relationship between balance problems and muscle thickness in patients with LSS. In addition, no study has been found comparing the difference in muscle thickness and cross-sectional area in LSS patients with poor and normal balance. In addition, in LSS, pain, disability and fear of falling in balance disorders are nor clear. The aim of our study is to examine the relationship between balance and biopsychosocial factors that can affect it.

The stability and balance of the lumbar spine depends on the paraspinal muscles surrounding it. In addition, the atrophy of the muscle in this area leads to deterioration of the body's stability. The multifidus muscle is important for the lumbar region due to its multiple connections. Today, morphological factors of paraspinal muscles are being investigated. The degeneration occurring in these muscles also causes a decrease in the thickness and cross-sectional areas of the muscle. This condition is associated with loss of balance in various populations. However, this relationship has not been adequately investigated in patients with lumbar spinal stenosis. At the same time, the intensity of pain affects balance and causes disruptions. Balance problems in older adults can lead to falls, leading to vertebral and femoral neck fractures. These injuries cause a decrease in quality of life. When the literature is examined, it is seen that patients with LSS often have balance problems. Parameters such as muscle mass, pain, disability and fear of falling affect this factor. However, although the relationship between muscle thickness and balance has been described in various populations, there are insufficient studies investigating the relationship between balance problems and muscle thickness in patients with LSS. In addition, no study has been found comparing the difference in muscle thickness and cross-sectional area in LSS patients with poor and normal balance. In addition, it is observed that biopsychosocial factors such as pain, disability and fear of falling in balance disorders are not adequately explained. In this context, our study aims to The aim of our study is to examine the relationship between balance and biopsychosocial factors that can affect it.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with L4/5 lumbar spinal stenosis by MRI,
* Patients who can stand independently
* Volunteering to participate in the study

Exclusion Criteria:

* Patients who did not agree to participate in the study,
* Having a history of serious neurological diseases such as Parkinson's, hemiplegia, multiple sclerosis,
* Having undergone a surgical operation on the lumbar region within the last year,
* Having severe joint disorders in the lower extremities,
* Having malignancy in the spine,
* Having had an operation on the lower extremity,
* Having vision and/or vestibular system problems,
* Those who do not cooperate well
Pediatric Enhanced Recovery After Cardiac Surgery

Identify our institution's current perioperative management strategies for pediatric cardiac surgery patients. Identify predictive factors for receiving perioperative care following P-ERACS strategies.

Compare outcomes between P-ERACS and non-P-ERACS patients

study aims to 1) assess our institution's current perioperative management strategies for pediatric cardiac surgery patients, 2) identify which patient population would be appropriate for inclusion in a pediatric ERACS (P-ERACS) program, and 3) compare the outcomes of patients whose perioperative care followed general consensus P-ERACS strategies (P-ERACS patients) and those whose perioperative care did not (non-P-ERACS patients). Results from this study will inform current efforts to establish a local P-ERACS protocol, and facilitate the initiation of a clinical trial to assess adherence to a P-ERACS pathway as well as the impact of such a pathway on patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* all pediatric patients (\&lt;18 years of age) who underwent elective cardiac surgery requiring cardiopulmonary bypass (CPB)

Exclusion Criteria:

* Emergency procedures and transplantation (heart, lung, heart and lung)
Validation of Kinocardiography, a New Technology Measuring Cardiac Mechanical Activity Via Accelerometers and Gyroscopes

Kinocardiographic measures mechanical and electrical function of the heart. The proposed solution is based on measurements of body vibrations. By measuring these movements on the surface of the body, it is possible to deduce, taking into account the individual's weight and size, the quality of the heartbeat that caused this vibration. The technique developed consists of a device measuring these vibrations at two places in the body: on the torso (Seismocardiography) and on the lower back (Ballistocardiography). The first measurement is a reflection of the local strength of the heartbeat as well as the transmission of blood to the body's main artery, the aorta. The second measurement, in the lower back, is the result of the contraction and movement of blood within the arterial system. Based on these two measurements, the energy produced by the heart and transmitted to the torso or the whole body is calculated. The energy over an entire cardiac cycle and the distribution of that energy within a heartbeat are used to characterize the mechanical function of the heart.

Clinical studies carried out previously have demonstrated the repeatability of kinocardiographic measurements (KCG) and their robustness with respect to the use of different sensors.

KCG measurements also showed a high sensitivity (\> 94%) to different hemodynamic states induced by the injection of active inotropic agents, i.e. dobutamine also used as a treatment for heart failure in an advanced stage. In a randomized, double-blind, cross-over study controlled by Placebo, these measurements showed a strong correlation (r = 0.8, p \<0.0001) with cardiac output measured by echocardiography. The technique has also demonstrated its ability to track changes in cardiac mechanical function during expiratory voluntary apnea.

KCG measurements were also evaluated during a micro-gravity simulation in Bedrest on 23 healthy volunteers. The measurements tracked cardiac deconditioning in the control group compared to the exercise group similarly to cardiac MRI measurements. Subsequently, KCG metrics showed an ability to distinguish reduced ejection fraction (HFrEF) heart failure patients from non-insufficient patients. These latest results also showed that the chest sensor alone was sufficient to separate HFrEF patients from normative patients, laying the foundation for possible use of the smartphone alone.

The prototype of a mobile application, named OKCARDIO, makes it possible to take measurements perfectly similar to the Kino thoracic sensor, but to date have never been used it in a clinical study. Such a tool would allow anyone with a smartphone-type mobile phone to measure their cardiac mechanical function themselves and make it available to the attending physician.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged above 18 years old.
* BMI (Body Mass Index) is below 50 kg/m2.
* Fit in one of the groups

Exclusion Criteria:

* Patients younger than 18 years old.
* BMI (Body Mass Index) higher than 50 kg/m2.
An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver.

Approximately 10 subjects from one clinic having sustained a burn injury covering 1-25% or the Total Body surface Area (TBSA)and assessed as superficial partial-thickness or superficial deep-partial-thickness. The subject will be assessed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. . The dressing Mepilex Transfer Ag will be used as wound contact layer and gauze rolls and compression as second dressing.

Approximately 10 subjects from one site will be evaluated provided they fulfill the inclusion criteria and none of the exclusion criteria and gives a signed and dated consent.

Subjects may have sustained a burn injury covering 1-25% of the Total Body Surface Area (TBSA)and assessed as superficial partial-thickness or superficial deep-partial thickness in dept. Each subject will be followed one time per week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. Healing is defined as ≥95% epithelialisation. Percent (%) healed epithelialization will be measured by photo analysing using the PictZar program. Dressing changes will be performed at each visit and in between if deemed necessary by the investigator.Gauze rolls and compression will be used as secondary dressing.All dressing changes will be registered in a log. Pain before, during and after removal will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Subject with a second degree (superficial, deep or mixed) partial thickness burn from 1-25% TBSA.
* One single, isolated burn area selected for study site Study site area should be between 1-15% BSA
* Male or female
* From 18 years and above
* Either in- or out-patient
* Thermal burn injury
* Signed Informed Consent/Assent Form

Exclusion Criteria:

* Electrical, chemical burn etiology
* If any full thickness areas are present, these should not be \> 5 %
* Burn greater than 36 hrs old
* Burns to face
* Use of chemical/enzymatic and biological debridement within 7 days of investigation start
* Presence of inflammation or infection in burn wounds
* Use of topical antibiotics, antiseptics, or antimicrobials in conjunction with study product.
* Subjects with lung injury or Subject being on a ventilator
* Subjects with dermatologic skin disorders or necrotizing processes
* Subjects with insulin dependent diabetes mellitus judged by the investigator to be a potential interference in the treatment
* Diagnosed underlying disease(s) (e.g HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment
* Subject not expected to follow the investigation procedures
* Subjects previously included in this investigation
* Subjects included in other ongoing clinical investigation at present or during the past 30 days
Fetal Cystoscopy Versus Vesico-amniotic Shunting in Severe Lower Urinary Tract Obstructions

There are two options of fetal treatment in cases of severe lower urinary tract obstructions: the vesico-amniotic shunting and fetal cystoscopy. There is no study confirming the effectiveness of these treatment, specially comparing both techniques. The present study aims to investigate the effectiveness of these treatments.

Objectives: To evaluate the effectiveness of fetal cystoscopy for the diagnosis and therapy of the posterior urethral valves and to compare with the results of vesicoamniotic shunting.

Outcomes: Accuracy of the prenatal cystoscopic diagnosis of posterior urethral valves, neonatal and infant survival (6 and 12 months), as well as normal renal function during the same ages.

Study design: Randomized controlled trial. Methods: Pregnant women whose fetuses have isolated and severe lower urinary tract obstruction (LUTO) with (oligohydramnios and severe hydronephrosis) will be invited to participate in the present study. Patients will be randomized into the fetal cystoscopic group (CYSTO) vs vesico-amniotic shunting (VAS). The investigators intend to enroll 30 patients in each group (a total of 60). All patients will be followed by fetal ultrasound each 15 days. Besides, these infants will be followed up to one year of age. Maternal and obstetrical complications are going to be evaluated as well as neonatal and infant survival and the renal function.

Eligibility Criteria:
Inclusion Criteria:

* single pregnancy
* male fetuses
* gestational age dating by ultrasound examination performed before 20 weeks
* confirmed severe LUTO (see details before)
* severe oligohydramnios (AFI\<5.0cm)
* no other structural anomalies by complete fetal anatomy ultrasound scan and fetal echocardiogram
* no abnormal karyotype
* 'favorable' urine analysis (urinary sodium \<100 mEq/L, chloride \<90 mEq/L, osmolarity \<200 mOsm/L) when gestational age \>20 weeks

Exclusion Criteria:

* presence of other anomalies diagnosed after fetal intervention
* maternal refusal to participate in the present protocol
Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma

Study of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in Combination with Bortezomib and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma.

Phase I Multicenter, Open-label, Dose-escalating Clinical and Pharmacokinetic Trial of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM), to determine the efficacy of the combination plitidepsin/bortezomib/dexamethasone, to evaluate the safety and tolerability of the combination in patients with relapsing and/or refractory MM and to study the pharmacokinetics (PK) and pharmacodynamics (PDy) of plitidepsin in combination with bortezomib and dexamethasone.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Prior autologous transplantation (HSCT) patients are allowed.
* Patients must have received at least one previous treatment line of induction, chemotherapy, chemotherapy and transplantation or previous treatment with bortezomib or another proteasome drug

Exclusion Criteria:

* Previous treatment with plitidepsin.
* Active or metastatic primary malignancy other than MM.
* Serious concomitant systemic disorders
* History of hypersensitivity reactions to bortezomib, polyoxyl 35 castor oil or mannitol
* Neuropathy
* Pregnant and/or lactating women
* HIV infection
* Active hepatitis B or C virus infection.
* Treatment with any Investigational Medicinal Product (IMP) in the 30 days before inclusion in the study
* Plasma cell leukemia at the time of study entry
* Contraindication for the use of steroids
Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch

This study aims to validate a proprietary cuffless blood pressure algorithm using measurements from a multi-modal chest-worn medical device, the Perin Health Patch (PHP).

The study will compare the performance of the PHP to an ambulatory blood pressure cuff across 85 subjects for a 10-minute monitoring period, followed by an optional cold pressor test and an additional 10-minute monitoring period. The study aims to confirm that the calibrated measurement from the wearable device meets AAMI performance standards.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older,
* Willing and able to provide informed consent,
* Able to comply with study procedure.

Exclusion Criteria:

* Any member defined under 'Special Population' in the AAMI standards (Pregnant, children, arm circumference \> 42 cm),
* Patient with a pacemaker,
* History of reactions to medical adhesives,
* Inability to comply with the study procedure,
* Non-English Speaker.
Cognitive Training in Obsessive Compulsive Disorder

This unique study will allow us to observe the neural correlates associated with working memory in an obsessive compulsive disorder (OCD) paradigm. We believe that developing working memory in participants suffering with OCD will reduce the severity of their symptomology. This will allow a greater understanding into the functioning of these participants which in turn presents with treatment possibilities.

It is currently unclear whether cognitive training using a working memory task, is effective in reducing obsessive-compulsive symptoms and neuropsychological deficits in patients with OCD. Two groups (OCD and control) will be recruited. Both groups will undergo an intervention consisting of 8 weeks of cognitive training. Working memory, neuropsychological functioning and OCD symptomatology will be assessed pre and post-treatment, in both groups. Furthermore neuroimaging using functional magnetic resonance imaging (fMRI) will be conducted at baseline as well as at the end of the 8 week period in both groups. The scan will serve to show any structural or functional changes in the frontostriatal area involved with working memory. To our knowledge, this is one of the first studies to date to examine whether cognitive training improves symptoms in OCD.

Eligibility Criteria:
Inclusion Criteria:

* A primary diagnosis of OCD, with a score \> 16 on the Yale-Brown Obsessive Compulsive Scale (YBOCS) (Goodman et al, 1989b, 1006-1011).
* Participants must be aged older than 18 and younger than 65 years.
* Right handed.
* If taking SSRI's the participant needs to be on a stable dose for at least 2 months.

Exclusion Criteria:

* Significant physical or neurological illnesses. An exception will be made for patients taking SSRI's (and not using any other drugs).
* Any significant current DSM disorder (in addition to OCD).
* Past history of significant substance or alcohol abuse.
* Pregnancy.
* Any metal pins/ prostheses or cardiac pacemakers.
* Sufferers of claustrophobia.
* Head injury
The Effects of Continuous Positive Airway Pressure (CPAP) on Sympathetic Activity in Different Sites of Activation

Recent evidences suggest that obstructive sleep apnea (OSA) can contribute to cardiovascular disease even in the absence of hypertension. However, there are few data regarding the impact of OSA on the sympathetic system in apparently normotensive patients with OSA as well as the impact of treatment with continuous positive airway pressure in different sites of activation (heart, peripheral nerves and circulating catecholamines)


Eligibility Criteria:
Inclusion Criteria:

* Severe OSA males

Exclusion Criteria:

* Smoking

  * Sustained Hypertension
  * Heart failure
  * Diabetes
  * Renal diseases
  * Under use of any medication
  * Under treatment for OSA
Cefixime Clinical Trial

This study aims to evaluate the efficacy of cefixime compared to benzathine penicillin G in the treatment of syphilis.

This will be a randomized, multisite, open-label, non-inferiority clinical trial to evaluate the effectiveness of cefixime (400mg orally, twice a day, for 10 days) compared to benzathine penicillin G (2.4 million units, intramuscularly) in patients with and without HIV infection. In total, 400 participants with early syphilis will be enrolled from 9 clinical sites in the U.S. and Peru. Participants will participate in follow-ups to monitor clinical outcomes and serological response (RPR titer) every 3 months for 9 months. Study findings may identify an efficacious alternative syphilis treatment to penicillin, effective for people living with HIV infection, to help address the crisis of penicillin shortages and offer options for those with penicillin allergy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment
* 18 years of age or older
* Able to provide informed consent
* Individuals with HIV infection must be on treatment for HIV infection and virologically suppressed (viral load \<200 copies/mL) or have a CD4 count ≥ 350 cells/mm3 according to most recent labs before study enrollment

Exclusion Criteria:

* Pregnancy or a positive pregnancy test on the day of enrollment
* Patients showing signs and symptoms of neurosyphilis
* Serofast RPR titer, defined as persistently positive RPR titer without more than 4-fold (2-titer level) change for 12 months or greater
* Recent (within the past 7 days) or concomitant antimicrobial therapy with activity against syphilis, namely azithromycin, doxycycline, ceftriaxone, or other beta-lactam antibiotics (e.g. amoxicillin)
* Individuals with HIV infection who report HIV treatment interruption for more than 4 weeks since their most recent viral load or CD4 test
* Self-reported allergy to cephalosporins or penicillin
* Unwilling or unable to attend follow-up visits