cyrilzakka/clinical-trials huggingface dataset:
Safety Study of HSV2 DNA Vaccine to Treat Patients With Recurrent Genital Herpes Caused by HSV-2

The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body and evaluate the effect it has on herpes outbreaks

Herpes simplex virus type 2 (HSV-2) infection is a serious public health problem, with up to 20% of the US population infected. Following primary infection, HSV-2 establishes a latent infection that can lead to recurrent disease when the virus reactivates. Genital lesions are often experienced with viral recurrence and these can be uncomfortable and painful, resulting in significant anxiety and social distress. There are no commercial vaccines available for therapy of HSV-2 infection.The aim of a therapeutic vaccine would be to enhance such natural responses by boosting the appropriate cellular immune response to HSV-2 in those latently infected individuals who experience frequent and unwanted reactivations. The purpose of this study is to evaluate the safety and tolerability profile of the pPJV7630 HSV-2 DNA vaccine as administered by Particle Mediated Epidermal Delivery (PMED )

Eligibility Criteria:
Otherwise healthy subjects with recurrent genital herpes due to HSV-2 infection
Effects of Two Anti-HIV Drug Regimens on Quality of Life and Health Care Use Among SMART Study Participants

The purpose of this study is to compare the effects of two different anti-HIV drug regimens on quality of life and health care utilization among SMART study participants.

Advances in antiretroviral therapy (ART) have dramatically reduced mortality and morbidity rates for HIV infected people. However, HIV infection is a costly disease to treat. With improvement in survival, quality of life and the long-term cost of HIV treatment have become increasingly important to the majority of individuals infected with HIV. Different HIV treatment regimens may lead to variations in quality of life and health care costs over the course of treatment. In the SMART study, participants were randomly assigned to one of two treatment groups:

* Group 1 participants followed a drug conservation (DC) regimen in which ART was stopped or deferred until CD4 cell count dropped below 250 cells/mm3, initiated until CD4 cell count was at least 350 cells/mm3, and then followed by episodic ART based on CD4 cell count.
* Group 2 participants followed a viral suppression (VS) regimen in which ART was continued to keep viral loads as low as possible, regardless of CD4 cell count.

The purpose of this study is to compare how the DC and VS regimens affect quality of life, symptom severity, health care utilization, and resulting costs among SMART study participants.

At baseline, participants will complete questionnaires regarding quality of life, symptoms, health care utilization, current insurance, and socioeconomic status. Body appearance and signs of HIV disease progression will also be assessed at this time. Follow-up evaluations on quality of life and symptoms will be repeated at Months 4, 8, and 12 and annually thereafter. Follow-up evaluations of all other baseline measures will occur once a year.

Eligibility Criteria:
Inclusion Criteria:

* Coenrollment in the SMART study
* Parent or guardian willing to provide informed consent, if applicable
Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)

This is a multinational, non-randomized, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability and anti-tumor efficacy of AZD4205 as monotherapy in patients with peripheral T cell lymphoma (PTCL), who have relapsed from or are refractory/intolerant to standard systemic treatment.

Phase 1 part:

Around 20\~40 patients will be subsequently enrolled into 2 different dose ascending cohorts. Additional 10\~20 patients may be enrolled to further explore a selected dose defined by dose escalation cohorts.

Phase 2 part:

After the recommended phase 2 dose (RP2D) is defined, a phase 2 single-arm open-label pivotal study will be conducted to assess anti-tumor efficacy and safety of AZD4205 at RP2D in patients with refractory or relapsed PTCL.


Eligibility Criteria:
Inclusion Criteria:

1. Obtained written informed consent
2. Patients must have histologically confirmed peripheral T-cell lymphoma according to the 2016 revision of the World Health Organization classiﬁcation of lymphoid neoplasms. Tumor samples are required for central pathology review to confirm the diagnosis.
3. Patients must have measurable disease according to the Lugano criteria.
4. Patients should be transplant-ineligible upon their entry into this study, and must have relapsed after or been refractory/intolerant to ≥ 1 (but not \> 3) prior systemic therapy(ies) for PTCL.
5. Adequate bone marrow reserve and organ system functions.

Exclusion Criteria:

1. Any unsolved toxicity \> Common Terminology Criteria for Adverse Events (CTCAE) grade 1 from previous anti-cancer therapy (except alopecia).
2. Active infections, active or latent tuberculosis.
3. Patients with severely decreased lung function.
4. History of heart failure or QT interval prolongation.
5. Central nervous system (CNS) or leptomeningeal lymphoma.
6. History of treatment with Janus kinase (JAK) or signal transducer and activator of transcription 3 (STAT3) inhibitor.
7. Patient has undergone an allogeneic stem cell transplant. Patient had autologous stem cell transplant within 6 months.
Plexa ICD Lead Registry

The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.


Eligibility Criteria:
Inclusion Criteria:

* Successfully implanted with a BIOTRONIK ICD or CRT-D compatible system along with the Plexa lead no more than 30 days prior to consent
* Able to understand the nature of the registry and provide informed consent
* Available for follow-up visits on a regular basis at the study site for the expected 5 years of follow-up
* Accepts BIOTRONIK Home Monitoring® concept
* Age greater than or equal to 18 years

Exclusion Criteria:

* Enrolled in any investigational cardiac device trial
* Enrolled in BIOTRONIK's QP ExCELs lead study
* Planned cardiac surgical procedures or interventional measures within the next 6 months
* Expected to receive heart transplantation or ventricular assist device within 1 year
* Life expectancy of less than 1 year
* Patients reporting pregnancy at the time of enrollment
randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure

The purpose of this randomized, actively controlled, double-blind study with prospective data collection was to assess differences between sacubitril/valsartan versus enalapril in increasing exercise capacity and non-sedentary physical activity in HFrEF patients. Physical activity was assessed by the 6 minute walk test, and daily physical activity was continuously measured by means of a wrist-worn accelerometry device from 2 weeks before until 12 weeks after start of study therapy (sacubitril/valsartan or enalapril).


Eligibility Criteria:
Key Inclusion Criteria:

* Written informed consent obtained before any study assessment is performed.
* Ambulatory ≥ 18 years of age with a diagnosis of chronic symptomatic HF (NYHA class ≥ II) with reduced ejection fraction, defined as known LVEF ≤ 40%

AND one of the following two criteria:

* Plasma NT-proBNP level of ≥ 300 pg/mL or BNP ≥ 100 pg/mL (measurement may be recorded no longer than past 12 months) OR
* Confirmation of a heart failure hospitalization last 12 months.
* Patients must be on stable HF medication for at least 4 weeks prior to Week - 2, where the minimal daily dose of current evidence based therapies is equivalent to at least 2.5 mg/d enalapril
* Willingness to wear the accelerometer wristband continuously for the duration of the trial.
* Patients must be living in a setting, allowing them to move about freely and where they are primarily self-responsible for scheduling their sleep and daily activities.

Key Exclusion Criteria:

* History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes
* Use of sacubitril/valsartan prior to week - 2.
* Bedridden patients, or patients with significantly impaired/limited physical activity and/or fatigue due to medical conditions other than HF, such as, but not limited to angina (chest pain at exertion), arthritis, gout, peripheral artery occlusive disease, obstructive or restrictive lung disease, malignant disease, neurological disorders (e.g. Parkinson's or Alzheimer's disease, central and peripheral neuroinflammatory and -degenerative disorders or functional central nervous lesions due to hemodynamic or traumatic incidents), injuries (incl. diabetic foot ulcers) or missing limbs
* Patients with palsy, tremor or rigor affecting the non-dominant arm.
* Patients with any skin or other condition of the non-dominant arm that would limit the ability to wear the actigraphy device continuously (24h/day) over 14 weeks.
* Patients fully depending on a mobility support system, e.g. wheelchair, scooter or walker. Patients are allowed to use a cane as long as this is not used with the non-dominant arm.
Prospective Registration of Patient Data and Quality of Life in Eye Melanoma Patients

PROQEM is a prospective cohort study among patients diagnosed with uveal melanoma to assess quality of life before and in the first five years after treatment.

PROQEM is a prospective observational cohort study wherein patients with uveal melanoma are registered at diagnosis and are requested to fill in an array of questionaires before treatment and at 3, 6, 12, 24, 36 and 60 months after treatment. A comprehensive overview of the impact of their disease and treatment on quality of life is obtained by systematic assessment of the psychological impact of the initial diagnosis, eye symptoms, physical, emotional, social and role functioning.

In addition, the PROQEM has a substudy called the PROQEM-pco (Preferences, Choices and Outcomes) for the subgroup of patients who are eligible for both proton therapy and enucleation. They are invited to participate in research on patient preferences and shared decision-making. The consultations wherein the treatment decision is made are audiotaped and data on perceived shared decision-making, preferences, decision satisfaction and -regret are collected by questionaires at baseline and in the first 36 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Clinical or pathological diagnosis of a melanoma of the choroid or ciliary body
* No signs of metastasis after staging procedures with at least an X-thorax, blood test and an ultrasound of the liver
* Treatment by brachytherapy, proton therapy or enucleation

Exclusion Criteria:

* None
Multivariate Analysis and Machine Learning Model Risk Prediction of Recurrent Pain After PLIF Surgery for Degenerative Lumbar Spine Disease At Long-term Follow-up

The study was a clinical retrospective study designed to investigate risk factors for long-term recurrent pain after PLIF in patients with lumbar degenerative disease and to improve patient outcomes


Eligibility Criteria:
Inclusion Criteria:

1. confirmed diagnosis of lumbar degenerative disease (spinal stenosis, disc herniation with lumbar instability, and lumbar spondylolisthesis), with no significant symptomatic relief after conservative treatment for more than 3 months, and in need of surgical intervention;
2. lumbar spinal fusion surgical treatment with PLIF;
3. grouping based on the presence or absence of a lumbar or limb pain with VAS ≥3 at the 12-18 month postoperative follow-up;
4. observational indicators including individual factors, surgical factors, spine-pelvis sagittal balance parameters, and paravertebral muscle parameters.

Exclusion Criteria:

(1) those with a history of lumbar spine trauma, inflammation, tumor, or surgery; (2) those with congenital or acquired severe lumbar vertebral deformity; (3) those with severe neurological dysfunction; (4) those with incomplete baseline and follow-up data.
Epinephrine and Cortisol in Depression

This study investigates the effects of two hormones called epinephrine and cortisol on how the brain processes emotional material using functional MRI to measure brain activity. The study hopes to learn how epinephrine and cortisol affect the brain differently in depressed and non-depressed individuals.


Eligibility Criteria:
Inclusion Criteria:

* Weight of less than 280 pounds
* HAM-D Score of greater than 7 for depression participants

Exclusion Criteria:

* Psychotropic medications
* Recent surgery
* Endocrine disorders
* Liver disease
* Kidney disease
* Thyroid disorder
* History of malaria
* Tuberculosis
* Osteoporosis
* Glaucoma or cataracts
* Chronic expressed infections (herpes, HIV, etc)
* History of congestive heart failure
* History of recurring seizures
* Stomach ulcers
* Comorbid psychosis
* Current use of illicit drugs
* Diabetes
* Any cardiovascular disease (angina, hypovolemia, coronary artery disease, low/high blood pressure, etc)
* Any pulmonary disease
* Any cerebrovascular disease
* Sulfate hypersensitivity
* Glaucoma
* Infection
* Pregnancy
* Parkinson's Disease
* Panic Disorder
* Over 280 pounds in weight
* In-dwelling ferrous metals
* Left handed
* Abnormal hearing
* Claustrophobic
* Head injury with loss of consciousness
* Active suicidal ideation
Reprieve System Pilot Study

The objective of the study is to evaluate the use of the Reprieve System to decongest subjects with acute decompensated heart failure.


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema/swelling) AND 1 sign (peripheral edema, ascites, jugular venous distension, pulmonary vascular congestion on chest radiography)
2. ≥10 lb. (4.5 kg) above dry weight either by historical weights or as estimated by health care provider.
3. Patients ≥ 18 years of age able to provide informed consent and comply with study procedures.

Exclusion Criteria:

1. Inability to place Foley catheter or IV catheter or other urologic issues that would predispose the patient to a high rate of urogenital trauma or infection with catheter placement.
2. Hemodynamic instability as defined by any of the following: systolic blood pressure \<90 mmHg, use of vasopressors, use of IV inotropes to treat hypotension (systolic blood pressure \<90 mm Hg) or suspected/confirmed low cardiac output/shock, mechanical circulatory support, uncontrolled arrhythmias, active severe bleeding, or confirmed or suspected cardiogenic shock. Note: In the absence of the above conditions, use of inotropes to augment diuresis is permitted.
3. Dyspnea due primarily to non-cardiac causes (e.g., severe chronic obstructive pulmonary disease or pneumonia).
4. Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count).
5. Estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy (RRT).
6. Significant left ventricular outflow obstruction, uncorrected complex congenital heart disease, known severe stenotic valvular disease, infiltrative or constrictive cardiomyopathy, acute myocarditis, type 1 acute myocardial infarction requiring treatment (within previous week), or any other pathology that, in the opinion of the investigator, would make aggressive diuresis poorly tolerated.
7. Inability to follow instructions or comply with follow-up procedures.
8. Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral, or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the protocol instructions or follow-up procedures.
9. Severe baseline electrolyte abnormalities (e.g., serum potassium \<3.0 mEq/L or magnesium \<1.3 mEq/L). Note: These are based on baseline/screening labs. Subjects whose electrolyte levels are repleted cannot be reassessed for inclusion in the trial.
10. Serum sodium \<135 mmol/L or history of severe hyponatremia
11. Poorly controlled diabetes
12. Enrollment in another interventional trial during the index hospitalization
13. Life expectancy less than 3 months
14. Women who are pregnant or intend to become pregnant.
Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA

The investigator's purpose is to study the population pharmacokinetics of paracatamol and ibuprofen in neonates with patent ductus arteriosus (PDA) and assess the feasibility of dosage individualization.

The investigator's purpose is to study the population pharmacokinetics of paracatamol and ibuprofen in neonates with patent ductus arteriosus (PDA) and assess the feasibility of dosage individualization. In this study, the investigator will detect drug concentration in plasma and other clinical test to construct population pharmacokinetic models.

Eligibility Criteria:
Inclusion Criteria:

* Patients have been diagnosed with PDA;
* Age: postnatal age ≤ 28 days;
* Paracetamol or ibuprofen used as part of regular treatment;
* Paracetamol or ibuprofen was administered orally.

Exclusion Criteria:

* Patients who die within the treatment cycle;
* Patients with other heart diseases;
* Other factors that the researcher considers unsuitable for inclusion.
PREgnancy and FERtility Registry

The PREgnancy and FERtility (PREFER) study is a comprehensive program aiming to optimize care and improve knowledge around the topics of fertility preservation and pregnancy issues in young breast cancer patients. The program was initiated at the National Institute for Cancer Research, IRCCS AOU San Martino - IST in Genova (Liguria Region, Italy) and then it has been spread to other Italian Institutions under the umbrella of the Gruppo Italiano Mammella (GIM) study group. It is composed of two distinctive studies, one assessing fertility (i.e. PREFER-FERTILITY) and the other pregnancy (PREFER-PREGNANCY) issues. Hence, two different study protocols were developed under the umbrella of the PREFER registry.

PREFER-FERTILITY aims to obtain and centralize data about the preferences and choices of young cancer patients on the fertility preservation strategies available in Italy. Furthermore, it aims to assess the outcomes of patients undergoing one or more strategies for fertility preservation in terms of success of the techniques (i.e. recovery of ovarian function, number of cryopreserved oocytes, post-treatment pregnancies) and safety (i.e. long-term survival outcomes).

PREFER-PREGNANCY has two main objectives: 1) to obtain and centralize data on the management of breast cancer diagnosed during pregnancy, the obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments, and the long-term survival outcomes of these patients; 2) to obtain and centralize data on the clinical outcomes of breast cancer survivors that achieve a pregnancy after prior diagnosis and treatment of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* breast cancer diagnosis
* age between18 and 45 years (only for PREFER-FERTILITY)
* have not received any radiation or chemotherapy for cancer before enrolment (only for PREFER-FERTILITY)
* absence of metastatic disease (only for PREFER-FERTILITY)
* diagnosis of breast cancer during pregnancy or within 1 year from the end of pregnancy or pregnancy after prior diagnosis and treatment for breast cancer (only for PREFER-PREGNANCY)
* informed consent

Exclusion Criteria:

* inability to provide written informed consent
* stage IV disease at diagnosis (only for PREFER-FERTILITY)
* serious psychiatric disorders
Adverse Effects of ALA-PDT for the Treatment of Moderate to Severe Acne Vulgaris: a Prospective Study

To understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ALA-PDT for moderate to severe acne vulgaris.

To understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ALA-PDT for moderate to severe acne vulgaris.

Eligibility Criteria:
Inclusion Criteria:

* (1) Patients diagnosed with moderate to severe acne and graded grade III-IV according to Investigator's Global Assessment (IGA) ;
* (2) Patients unsuitable for drug treatment owing to various reasons and who voluntarily participated and signed informed consent following information about other alternatives;
* (3) Patients who read the instructions and were willing to follow the program requirements.

Exclusion Criteria:

* (1) Patients who had a history of photosensitive diseases;
* (2) Patients who had Modified-PDT;
* (3) Patients who had oral isotretinoin in the past 3 months, used oral contraceptives or antibiotics and underwent local or facial surgery in the past 4 weeks;
* (4) Female patients who were pregnant or lactating.
Assessing the Effectiveness of a Stress Reduction Intervention in Inflammatory Bowel Disease (IBD)

The investigators have designed a guided, online, tri-component, stress reduction intervention for participants with inflammatory bowel diseases.

In a randomized controlled trial, the investigators assessed the impact of an online, 3-month stress reduction intervention (yoga, breathwork, and meditation). The primary outcome was the change in Cohen's Perceived Stress Scale (PSS) between the control and intervention arms. The following secondary outcomes were also assessed: anxiety, depression, IBD disease activity (e.g., changes in CRP, fecal calprotectin, medication, hospitalization, or surgery), serum inflammatory markers, serum and salivary markers of stress, stress-resilience, and health- related quality of life. Participant satisfaction and adherence to the intervention were also evaluated.

Eligibility Criteria:
Inclusion Criteria (RCT):

* Adults (≥18 years)
* with IBD in remission (UC - partial Mayo \<2 and fecal calprotectin \<250 μg/g; CD regular HBI \<5 or CRP \<8)
* on stable therapy for the past 3 months
* the last flare \<24 months prior to enrollment
* PSS-10 score ≥ 7 at time of screening

Inclusion Criteria (Substudy):

* Adults (≥18 years)
* IBD
* on stable therapy for the past 3 months.

Exclusion Criteria (RCT or Substudy):

* Major medical co-morbidity
* Steroid use in past 3 months
* Clostridium difficile infection in the last 3 months
* Unstable dose of psychiatric medications for the last 3 months
* Inability to provide informed written consent
* Severe psychiatric disorders (HADS scores \>10 or suicidal ideation)