cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Leish-111f + MPL-SE Vaccine in Healthy Adults Not Previously Exposed to Leishmania Parasite

This study will evaluate the safety and immunogenicity of the Leish-111f + MPL-SE vaccine in adult subjects who have no evidence of previous exposure to the Leishmania parasite.

Cutaneous leishmaniasis is a disfiguring disease that can progress to mucosal leishmaniasis, a more serious and possibly fatal form of Leishmania disease. All available medical therapies require weeks of treatment and cause significant toxicity.

It appears that Leishmania infections can be eliminated or prevented by T helper 1 immune responses. These findings argue that a vaccine that generates a T helper 1 response against the parasite will prevent the infection and disease. This is a phase 2, randomized, double blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity in Montenegro skin test (MST)-negative healthy adults of an investigational vaccine being developed for the prophylaxis of cutaneous leishmaniasis. The vaccine, identified as Leish-111f + MPL-SE, consists of a recombinant three-antigen Leishmania polyprotein (Leish-111f, 10 μg) together with the adjuvant MPL-SE (25 μg). In addition, the safety and immunogenicity of the vaccine will be compared to that of the Leish-111f protein (10 μg) given alone. The vaccine, Leish-111f protein alone or placebo will be given to each study subject three times at 4 week intervals.

Eligibility Criteria:
Inclusion Criteria:

* Must have negative Montenegro skin test (0 mm)
* Must be in good general health with normal lab values
* Negative for HIV, hepatitis B and C

Exclusion Criteria:

* History of leishmaniasis or exposure to Leishmania vaccine or MPL-SE
* Nursing or pregnant female
Low-intensity Focused Ultrasound Pulsation (LIFUP) for Treatment of Temporal Lobe Epilepsy

We intend to use focused ultrasound to stimulate or suppress brain activity in patients with epilepsy. We hypothesize that focused ultrasound is capable of brain stimulation or suppression visible with functional MRI, and will not cause tissue damage.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with clinical evidence from their diagnostic evaluations of unilateral hippocampal dysfunction and epileptogenicity.
* Subjects with seizures that have been refractory to treatment with at least three currently marketed antiepileptic drugs.
* Subjects with epilepsy who would clearly benefit from surgical intervention.
* Subjects who have been offered a non-dominant anterior-mesial temporal lobe resection as treatment for medication refractory epilepsy.

Exclusion Criteria:

* Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with the testing.
* Subjects with dementia, delirium and psychotic symptoms. - Subjects with ferromagnetic materials in the head.
* Subjects with severe cardiac disease, increased intracranial pressure, or a TENS unit.
* Subjects who exhibit primary generalized seizures or pseudoseizures.
* Subjects who have seizures secondary to drugs, alcohol, metabolic illness or progressive degenerative disease.
* Subjects who have experienced status epilepticus during the 3-week baseline period prior to the operation.
* Subjects (females) who are pregnant.
Validation of Predictive Scale of Chronic Postsurgical Pain

To asses the precision of a score to predict chronic post surgical pain in patients undergoing inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy. Prospective multicenter cohort study in 21 hospital in spain.


Eligibility Criteria:
Inclusion Criteria:

* Patients with given inform consent, aged mor than 18 years, who undergo scheduled surgery of one of the following types: inguinal hernia (men), abdominal hysterectomy, vaginal hysterectomy and thoracotomy (men)

Exclusion Criteria:

* Patients aged less than 18 years,
* Patients requiring reoperation because of surgical complications.
Pain Assessment During Less-Invasive-Surfactant-Administration

Primary aims of the study are to evaluate the feasibility of Skin conductance (SC) measurements and its correlation to Neonatal Pain and Distress Scale (N-PASS) - scores during the Less-Invasive-Surfactant-Administration (LISA)-procedure in preterm infants. Secondary aims are to evaluate the effect of LISA on the general stress-level in preterm infants with respiratory distress syndrome.

The assessment of pain and stress with SC measurement in addition to the subjective assessment with N-PASS may provide more conclusive data on the sensation of pain or stress during the LISA procedure and therefore the necessity of analgosedation. Therefore, this study might help to identify those infants in need for analgosedation, which would allow an individualized approach in the future.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants ≥27 0/7 weeks of gestation at birth
* Need for surfactant therapy via LISA according to the local standard operating procedure
* ≥27 0/7 weeks of gestation,
* within first 48 hours of life
* FiO2 ≥0.30 to maintain SpO2 ≥90% for 15 min,
* non-invasive respiratory support with PEEP 6-8 cmH2O
* consent of attending NICU staff for videorecording

Exclusion Criteria:

* Primary intubation in the delivery room
* Severe congenital malformation or other conditions requiring immediate endotracheal intubation
* Insufficient language skills (German or English) of the parents to understand and consent the participation in the study.
M. Hailey-Hailey: hSPCA1 Expression and Skin Structure Upon Laser Therapy

Hailey-Hailey disease is a genetic acantholytic dermatosis characterized by continuous erosion of the skin that results in a burning, painful sensation and restricts the patient in daily life. This disorder results from a genetic defect in a calcium pump, i.e. the hSPCA1 pump. Calcium pumps are crucial for the processing of cell-cell adhesion proteins such as E-cadherin, part of desmosomes, the major glue between keratinocytes in skin epidermis. Today therapy is mainly focussed on symptom relief and prevention of secondary infection.

Ablative laser therapy is known to result in a speedy healing of the affected skin site within 2 weeks following laser therapy. The fact that the treated skin site remains clear from this acantholytic disorder in the months/years following ablation, regardless the existence of a germline mutation, suggests that an epigenetic modification occurs in the process of wound healing.

Objective: to (1) study the expression of hSPCA1 in keratinocytes before and after laser therapy and (2) verify the loss of acantholysis by immunohistochemistry and electron microscopy of cell-cell adhesions before and after laser therapy


Eligibility Criteria:
1.Inclusion criteria

1.1.Hailey-Hailey patients

Inclusion Criteria:

* Clinically diagnosed M. Hailey-Hailey as confirmed by histopathology and/or genetic analysis.
* Indication for ablative laser therapy
* \>18 years old
* Informed consent

1.2. Patients without Hailey-Hailey disease

* \>18 years old
* Clinically no symptoms of M. Hailey-Hailey
* Informed consent

Exclusion Criteria:

* \<18 years old
* Treatment with tetracyclines, topical hormones or oral retinoids within the last 30 days preceding participation
* Lack of informed consent
Therapeutic Effects of Line Dancing in People With MS

The objective of this study is to analyze the effects of line dancing on balance, anxiety, depression and quality of life for people with multiple sclerosis (PwMS).

Purpose: The objective of this study is to analyze the effects of line dancing on balance, anxiety, depression and quality of life for people with multiple sclerosis (PwMS).

Methods: This study was conducted prospective parallel-group design study. 31 PwMS were randomized two groups. The dance group undertook 60-minute sessions twice a week for four weeks and the control group did not do any particular training during this period. The outcome were measured using the Berg Balance Scale (BBS), Hospital Anxiety and Depression Scale (HADS), and Multiple Sclerosis Quality of Life-54 (MSQoL-54) by an evaluator blinded to the study.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-65 years,
* EDSS \[22\]\<6,
* Mini-Mental State Examination score \>24.

Exclusion Criteria:

* exacerbations within the previous three months,
* have other physical, neurological problems,
* changeable health status.
* havig a cardiovascular disorder
Assessing the Bite Counter

This study is designed to test the usability of the Bite Counter in an attempt to reduce participants' daily bites while also increasing their daily steps.

Self-monitoring is an important component of behavioral management of obesity. The Bite Counter is a wrist-worn device which detects the motions characteristic of taking a bite of food or a drink of liquid, to provide the wearer with a cumulative count of bites and sips over the day. In earlier studies the method was shown to accurately count bites across a wide variety of foods, utensils and subject demographics, and to provide an unbiased intake measurement. The proposed work will continue to improve the bite counting method by adapting to varying eating rates, develop a self-managed bite count-based weight loss protocol, and perform an independent test of the protocol. An improved Bite Counter device will also measure activity (steps).

Eligibility Criteria:
Inclusion Criteria:

* Participants must be between the ages of 18 and 70 (inclusive)
* Participants must have a BMI between 27 and 35
* Participants must have regular and reliable access to a Windows-based computer with an internet connection with USB connectivity
* Participants must be currently consuming at least 1400 calories per day
* Participants must demonstrate adequate compliance with using Bite Counter and uploading data during the two-week baseline period

Exclusion Criteria:

* Participants must have no history of any eating disorder
* Participants must not have participated in a weight loss program within the month prior to baseline
Long Term Beta Thalassemia Treatment: Findings From The Extension Period

The project, titled "Long Term Beta Thalassemia Treatment: Findings From The Extension Period Of Phase 2 Clinical Trial," aims to compare the efficacy and safety of combination therapy (thalidomide and hydroxyurea) versus thalidomide alone. The study, lasting three years, is a Phase 2 single-center, open-label interventional study with a sample size of 30 participants aged 8-35 years. It includes specific inclusion and exclusion criteria for participant selection. Data will be collected through clinical interviews and medical records and analyzed using(Statistical Package for the Social Sciences. This project aims to enhance beta thalassemia treatment strategies, focusing on reducing transfusion dependency and improving patient quality of life.

Study titled Long Term Beta Thalassemia Treatment: Findings From The Extension Period Of Phase 2 Clinical Trial, conducted at the National Institute of Blood Disease \& Bone Marrow Transplantation (NIBD \& BMT).

This study focuses on the long-term comparison of combination therapy (thalidomide and hydroxyurea) versus thalidomide alone in treating beta thalassemia. The objective is to evaluate the efficacy and safety of the combination therapy compared to thalidomide alone, with the hypothesis that the combination will be more effective. Beta thalassemia is defined as an autosomal recessive disorder affecting beta-globin production, influenced by genetic modifiers. Key variables include hemoglobin, red blood cells, leukocyte count, reticulocyte count, platelets, lactate dehydrogenase, nucleated red blood cells, ferritin, bilirubin, Serum Glutamate Pyruvate Transaminase, creatinine, transfusion frequency, spleen and liver size, hemoglobin subunit beta \[ Homo sapiens (human) \] mutation, and certain polymorphism in gamma globin gene . The study took place at NIBD hospital over three years, designed as a Phase 2 single-center, two-arm open-label interventional study with a sample size of 30 participants using simple randomized sampling. Inclusion criteria are beta thalassemia major/intermediate patients aged 8-35 years, while exclusion criteria include patients with liver dysfunction, married patients, lactating mothers, and those with a history of thrombosis and fits. Data will be collected through clinical interviews and medical record reviews and analyzed using (Statistical Package for the Social Sciences.

Eligibility Criteria:
Inclusion Criteria:

* Known case of beta thalassemia major/intermediate (transfusion dependent)
* Willing to give informed consent

Exclusion Criteria

* Patients with comorbidities such as liver dysfunction
* Married patients
* Lactating mothers
* History of thrombosis and fits
Poor Quality of Life Associated With Traditional Chinese Medicine Constitution in HIV-infected Men Who Have Sex With Men

This study explores the pathological constitution as it relates to low quality of life with HIV- infected MSM patients, as a reference for clinical treatment.

Introduction :This study explores the pathological constitution as it relates to low quality of life with HIV- infected MSM patients, as a reference for clinical treatment.

Methods :It has a cross-sectional research design using structured questionnaires to collect data,including patient's basic case data, CD4+, CD4+/CD8+ ratio, Wang Qi constitution and WHOQOL-BREF -Taiwan version questionnaires. We consider the association between the constitutions and quality of life for HIV-infected MSM patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with HIV infected.
* Age greater than 20 years old (including) and less than 60 years old.
* Conscious clear and voluntary to attend the project with agreement.
* Willing to fill out the informed consent form.

Exclusion Criteria:

* conscious unclear
* Patients had histories of severe psychiatric disorders ( ex: schizophrenia) or if they met the criteria of Diagnostic and Statistical Manual of Mental Disorders ( ex: dementia)
* Age \< 20 years old.
* The patient does not want to fill out the informed consent form for any reason.
Atherosclerosis-Progression in Coronary Arteries Compared to Periphery Vessels

The study is a prospective-observational, explorative single-centre cohort study aimed to examine the atherosclerosis progression in coronary arteries compared to peripheral vessels (carotids, femoral arteries). Atherosclerotic alterations in peripheral vessels (IMT, plaque volume, plaque morphology) will be measured with ultrasound (IMT measurements and 3D quantitative plaque volumetry), whereas atherosclerotic alterations in coronary arteries will be tested with cardiac computertomography (CT) (coronary artery calcium score, calcium volume score, plaque morphology).

A total of 55 patients without prior known established vascular diseases will be tested. Cardiac CT and ultrasonography will be performed initially. After 2 years follow-up CT and ultrasound examination will be performed to assess the changes in atherosclerotic burden. Initially and after two years plasma samples will be collected and tested for traditional and novel cardiovascular risk factors.

The primary endpoint of the planned study will be the correlation of the atherosclerotic progression between coronary arteries and peripheral arteries (carotids, femoral arteries).

Secondary endpoints will include the correlation of atherosclerotic progression with established (hypertension, smoking, diabetes, dyslipidemia) and novel risk factors (hsCRP, P-selectin, cholesteryl ester transfer protein (CETP), intercellular adhesion molecule-1 (ICAM-1), CETP TaqIb polymorphism), with cardiovascular event rate, and the additional predictive value of atherosclerotic progression compared to an established risk score (SCORE Card, FRS). Also plaque morphology will be compared between coronary arteries and peripheral vessels.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-85 years, no prior established vascular diseases (CAD, PAD, cerebrovascular disease) no diabetes

Exclusion Criteria:

* Prior myocardial revascularisation therapy (aortocoronary bypass, PCI with stent implantation), coronary artery disease (CAD), peripheral artery disease (PAD), cerebrovascular disease (e.g.stroke), diabetes, pregnancy, lactation period, chronic renal insufficiency IIIB or lower (GFR \<45ml/min), manifest hyperthyreosis
Vets Helping Vets Pilot Study

The overall goal of this study is to evaluate the feasibility of a veteran patient navigator and social work counseling intervention in veterans with advanced stage cancer at the Denver VA Medical Center. This is a tiered intervention: patients first receive the veteran patient navigator component of the intervention, and then if additional patient needs are present they receive the social work counseling component of the intervention. The overall intervention will help veterans communicate their care preferences with their providers.This is a study of behavioral and care strategy interventions and involves no investigational drugs or devices.

Many patients with advanced cancer suffer from multiple symptoms including pain and fatigue and high rates of depression and anxiety. Many also experience end of life care that is inconsistent with their preferences.

Recent studies of palliative care find that symptoms, depression, and end of life care quality improved in patients with advanced cancer with multidisciplinary, specialist palliative care compared to usual care. However, these palliative care interventions are personnel-intensive and require multiple specialist providers. Because of the costs and limited availability of specialist palliative care providers, these interventions cannot be spread to the large population of patients with advanced cancer. Thus, there is a need for scalable interventions to improve symptoms, depression, and end of life care in this patient population.

Patient navigators, who often belong to the community they serve, have improved rates of cancer screening, follow up on abnormal diagnostic tests, and adherence to chemotherapy regimens. There has been increasing recognition that palliative care is an important part of patient navigation. However, to the best of our knowledge, there have been no studies outside our research program that have examined the effects of a peer navigation intervention to improve palliative care outcomes.

While patient navigators hold promise for improving outcomes in patients with advanced cancer, both psychosocial care needs and documenting future care preferences and goals may be complex. Therefore, the proposed intervention will supplement veteran patient navigators with a social work psychosocial intervention. The goal of the proposed study is to evaluate the feasibility of a stepped care intervention including a veteran patient navigator and social worker.

Eligibility Criteria:
Inclusion Criteria:

* Adult (over 18 years of age)
* Patient has an oncology provider within the VA ECHCS
* English is patient's primary language
* Has a reliable telephone
* Diagnosis of cancer deemed as incurable by oncology provider
* Oncology provider answers "no" to the question, "Would you be surprised if this patient dies in the next year?"

Exclusion Criteria:

* Already receiving specialist palliative care or receiving hospice care
TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN

To describe the clinical response rate in two groups (Docetaxel plus cisplatin plus 5-FU, versus Cisplatin plus 5-FU) after 3 cycle of neoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven squamous cell carcinoma of the head and neck with locally advanced inoperable disease.
* Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx , larynx or nasopharynx.
* Patients are required to have at least one (bi-or uni-dimensionally) measurable lesion.
* WHO performance status 0 or 1.
* Adequate bone marrow, hepatic and renal functions.

Exclusion Criteria:

* Pregnant and lactating women
* Previous chemotherapy
* Previous radiotherapy for H\&N
* Previous surgery for H\&N

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Ephedrine, Phenylephrine and Metaraminol Effects on Maternal Cardiac Output, Uterine Blood Flow and Fetal Circulation

It is a prospective clinical trial with random distribution that intends to investigate maternal and fetal effects of ephedrine, phenylephrine and metaraminol during cesarean delivery in patients with pre-eclampsia.

Spinal anesthesia has become the main anesthetic technique for cesarean delivery due to avoidance of failed tracheal intubation risk, improvement of post-operative analgesia and promotion of early mother-neonate bonding. Spinal anesthesia should be safe and comfortable for mother and child when referring to the side effects, including hypotension. The choice of the best vasopressor in this context is approaching to a resolution, favoring phenylephrine use. However, studies on high-risk pregnancies are still required, such as uteroplacental insufficiency, preeclampsia and intra-uterine growth restriction cases. The purpose of this study is to compare the effects of the vasopressors ephedrine, phenylephrine and metaraminol on maternal cardiac output, uteroplacental and cerebral fetal blood flow in patients with preeclampsia under spinal anesthesia for cesarean delivery. Sixty pregnant patients will be recruited and randomly assigned to receive either ephedrine, phenylephrine or metaraminol, making a total of three groups with 20 patients each. Variables to be analyzed are uterine arterial pulsatility index, umbilical arterial pulsatility index, fetus middle cerebral artery pulsatility index, maternal cardiac output, maternal cardiac frequency, maternal mean arterial blood pressure and maternal peripheral vascular resistance. These variables will be recorded in three moments: before the spinal anesthesia with the patient in dorsal recumbent and left displacement of the uterus, after spinal anesthesia in dorsal recumbent and after vasopressor bolus. Averages will be calculated in these intervals and then compared to the alteration caused by spinal anesthesia and the return to basal levels after drug intervention.

Eligibility Criteria:
Inclusion Criteria:

* Preeclampsia patients
* After 34 weeks pregnant

Exclusion Criteria:

* Patients' refusal
* Obstetric Emergency
* Contraindications to spinal anesthesia
* Obesity
Inspiratory Muscle Training in Children With Beta Thalasemia

respiratory complications are very prevalent in children with beta thalasemia major (BTM), so choosing inspiratory muscle trianing to decrease of prevent it and to improve pulmoanry funntions is important

children patients with BTM accounted 40 children will assigned to a group of inspiratory muscle training or waiting list group. the group will contain twenty children. the group of training will receive two session per day of training by threshold inspiratory muscle trainer ( for six day per week for 12 weeks)

Eligibility Criteria:
Inclusion Criteria:

* 40 beta thalassemia major children
* boys and girls

Exclusion Criteria:

* respiratory diseases
* cardiac diseases renal diseases liver diseases muscle and joint disease