cyrilzakka/clinical-trials huggingface dataset:
Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia

Methodologies and approaches have been implemented with differing degrees of success to prevent neuraxial hypotension. Currently utilized approaches to prevent hypotension during spinal anesthetic administration consist of physical precautions such as leg restraints and compression hosiery, as well as sympathomimetic medications Through a competitive inhibition of noradrenaline uptake, heptaminol hydrochloride prevented orthostatic hypotension and increased the plasma concentration of noradrenaline. This inhibitory effect might account for a portion of the antihypotensive effect After thorough research of the literature, studies evaluating the role of preoperative oral heptaminol hydrochloride in preventing hypotension after spinal anesthesia in lower limb surgeries with tourniquets are lacking.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 50 years old.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I-II.
* Undergoing elective orthopedic lower limb operations with a tourniquet or plastic surgeries under spinal anesthesia.

Exclusion Criteria:

* Patient refusal.
* History of hypertension, cardiovascular \[disorders of the heart and blood vessels and including coronary heart disease, rheumatic heart disease and other conditions\], and cerebrovascular diseases \[conditions that affect blood flow and the blood vessels in the brain. Problems with blood flow may occur from blood vessel narrowing (stenosis), clot formation (thrombosis), artery blockage (embolism), or blood vessel rupture (hemorrhage)\].
* Baseline SBP \>160 mm Hg before administration of the drug.
* Any contraindications to spinal anesthesia such as coagulopathy, local skin infection, swelling, trauma, or deformity.
* Medical conditions, which release vasoconstrictors such as pheochromocytoma.
* Patients taking vasoconstrictors or uncorrected tachyarrhythmia.
* History of drug allergy.
* Psychiatric, neuromuscular disorder, major systemic diseases.
* Pregnancy or lactating women.
* Inadequate effect of spinal anesthesia or supplemented with other types of anesthesia.
High Dose Influenza Vaccine in Nursing Home - Pilot Study

The purpose of this pilot evaluation is to help determine the feasibility and power needed to prospectively evaluate relative effectiveness of high-dose influenza vaccine in preventing influenza mortality and hospitalization in a nursing home population in the U.S., compared to the standard-dose influenza vaccine.

Influenza remains the most common preventable respiratory viral infection of older adults. Older adults incur more than 90% of the disease burden, and those residing in nursing homes are the most affected subset given their immune senescence, multi-morbidity, and close living quarters. Each year, the majority of influenza-related hospitalizations occur during the period with the greatest influenza activity.

Influenza vaccination has been associated with reduced hospitalization, strokes, heart attacks and death in non-institutional older adult populations, but the benefit of influenza vaccine for the oldest population has been questioned. The new high-dose influenza vaccine is considerably more immunogenic in older adults, and has recently been approved for use in individuals aged 65 years and older. No clinical data yet confirm whether the improved immunogenicity translates into added clinical benefit, such as further reduction in hospitalization or death. Estimating the benefit of influenza vaccination among older adults in long-term care settings using randomized controlled trials requires extensive effort and is costly. Instead, a pragmatic RCT in a nursing home population has several advantages as a model for comparing therapeutic approaches.

This clinical trial aims to test the feasibility of our protocol for a subsequent larger study. We aim to demonstrate that we can recruit and enroll facilities; randomly assign and coordinate vaccine delivery; collect data; conduct site audits for data validation; create outcomes using multiple data sources; and conduct analyses.

Eligibility Criteria:
Inclusion Criteria:

* Long-term care facilities in one of the 122 cities that serve as Center for Disease Control and Prevention (CDC) surveillance sites

Exclusion Criteria:

* Facilities already systematically administering HD vaccine to their residents
* Facilities for whom over half the residents are on Medicare (short-stay)
* Facilities in which over half the residents are on Medicare Part A (SNF)
* Facilities having fewer than 50 long-stay residents
* Hospital-based facilities
* Facilities with more than 20% of the population under age 65
* Facilities with mandated (employment-dependent) seasonal influenza vaccination
* Facilities not submitting MDS data
Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome

The purpose of this study is to study the effect of a commonly used antibiotic, doxycycline, on the production of ovarian hormones and menstrual cycles in women with Polycystic Ovarian Syndrome (PCOS).

Polycystic ovarian syndrome (PCOS) is one of the leading causes of female infertility, affecting 5-10% of reproductive-age women . This heterogeneous disorder is characterized by anovulatory infertility, androgen excess, an increase in the ratio of LH to FSH, and morphologic polycystic changes to the ovaries. Obesity and insulin resistance are also metabolic factors associated with PCOS that further increase the morbidity in these patients. Inducing fertility in patients with PCOS can be a challenge, as it most often involves ovulation induction that can lead to ovarian enlargement, hyperstimulation, and multiple-birth pregnancies. This study is designed to determine novel effective strategies to promote normal cycling in this patient population.

Eligibility Criteria:
Inclusion Criteria:

1. Women between 18 and 40 years of age.
2. History of PCOS with \< 8 periods the proceeding year
3. Clinical or biochemical evidence of androgen excess
4. BMI \<40
5. Willingness to sign consent for study including participation with collection of blood specimens
6. Willingness to discontinue OCP for duration of study period up to 36 weeks

Exclusion Criteria:

1. Pregnancy
2. Hypersensitivity to doxycycline or tetracycline
3. History of Cushing's syndrome
4. History of hyperprolactinemia
5. History of congenital adrenal hyperplasia
6. Significant hepatic impairment, including serum AST or ALT \>1.5 times upper limits of normal.
7. Significant renal impairment, GFR \<60 ml/min
8. Current use of metformin, statins, glucocorticoids, spironolactone and/or anti-estrogens.
Evaluation of the Association of Polymorphisms in the Innate Immune System With the Risk for Blastomycosis Dermatitidis Infection in Patients Not Infected With HIV and Complications Associated With Blastomycosis Dermatitidis Infection

Innate immunity plays an important role for fungal recognition and initiation of fungicidal activity. We hypothesize that subtle differences in different molecules of innate immunity may contribute to either the predisposition or clinical course of infection with Blastomycosis dermatitidis. To test this hypothesis, we propose to analyze the allelic frequencies of 15 different genes (mannose binding lectin, Fc-gamma receptor IIa and IIb, Fc-gamma receptors IIIa and IIIb, myeloperoxidase, tumor necrosis factor-alpha and -beta, interleukin 1A and 1B, interleukin-1 receptor antagonist, interleukin-10, NRAMP-1, chitotriosidase, and chemokine receptor 5) and their intragenic polymorphic forms and to compare this data to the incidence and severity of Blastomycosis dermatitidis infection. With this study we hope to identify a group of molecules of innate immunity which influence the risk and severity of invasive Blastomycosis dermatitidis infection.

Innate immunity plays an important role for fungal recognition and initiation of fungicidal activity. We hypothesize that subtle differences in different molecules of innate immunity may contribute to either the predisposition or clinical course of infection with Blastomycosis Dermatitidis. To test this hypothesis, we propose to analyze the allelic frequencies of 15 different genes (mannose binding lectin, Fc-gamma receptor Ila and IIb, Fc-gamma receptors IIIa and IIIb, myeloperoxidase, tumor necrosis factor-alpha and -beta, interleukin 1A and 1B, interleukin-1 receptor antagonist, interleukin-10, NRAMP-1, chitotriosidase, and chemokine receptor 5) and their intragenic polymorphic forms and to compare this data to the incidence and severity of Blastomycosis Dermatitidis infection. With this study we hope to identify a group of molecules of innate immunity which influence the risk and severity of invasive Blastomycosis Dermatitidis infection.

Eligibility Criteria:
* INCLUSION CRITERIA:

Patients in the database have been confirmed with a diagnosis of Blastomycosis dermatitides infection by a combination of isolation of the yeast form in a diagnostic microbiology laboratory and/or an elevated cryptococcal antigen titer (which is commercially available).

Only patients diagnosed and treated in the United States and Canada will be included in this analysis.

Only patients who are not co-infected with HIV will be included in the study.

Patient samples will be collected and clinical data will be evaluated only after signed consent has been obtained.
Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer That Has Been Removed With Surgery

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.

PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients with stage III or stage IV kidney cancer that has been removed by surgery.

OBJECTIVES: I. Determine the disease free survival and overall survival of patients with resected stage III or IV renal cancer treated with interleukin-2. II. Measure the degree of rebound lymphocytosis generated by this regimen in these patients.

OUTLINE: This is an open label study. Patients receive interleukin-2 IV over 15-30 minutes on 3 consecutive days weekly for 6 weeks, followed by 2 weeks of rest. Patients receive 2 treatment courses, each 8 weeks in duration. Patients are followed every 6 months until death.

PROJECTED ACCRUAL: A total of 20 patients will be accrued within 1 to 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven stage III or IV renal cancer that has been completely resected and is at high risk for recurrence, including at least one of the following: Tumor invades adrenal gland or perinephric tissues but not beyond Gerota's fascia (T3a) OR Tumor extending into renal vein, vena cava (T3b) OR Tumor grossly extends into vena cava above diaphragm (T3c) OR Tumor invades beyond Gerota's fascia (T4) OR Any lymph node involvement totally resected (N1-3) OR Completely resected metastases of all sites No brain metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin less than 3 times upper limit of normal (ULN) AST or ALT less than 3 times ULN Renal: Creatinine no greater than 1.9 mg/dL Cardiovascular: No prior myocardial infarction within 6 months No LVEF less than 35% No primary cardiac arrhythmias beyond occasional PVCs No angina No uncontrolled congestive heart failure No cerebrovascular accident Pulmonary: No dyspnea at rest or requirement for supplemental oxygen Oxygen saturation greater than 90% for patients with symptomatic lung disease Other: Not pregnant or nursing Negative pregnancy test Fetile patients must use effective contraception Temperatures greater than 100.5 degrees F must have occult infection excluded No psychiatric disorders

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent cyclosporine or methotrexate Endocrine therapy: At least 3 weeks since prior corticosteroids No concurrent corticosteroids Radiotherapy: Not specified Surgery: At least 2 weeks since prior surgery Other: At least 3 weeks since prior immunosuppressive medications No concurrent immunosuppressive medications
Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation

This study was designed to compare 3 immunosuppression regimens: sirolimus and tacrolimus versus everolimus and tacrolimus versus mycophenolate and tacrolimus.

The primary outcome is the incidence of cytomegalovirus infection / disease, a relevant medical need in the absence of pharmacological prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

1. Recipients, adults of the first living or deceased donor kidney transplant;
2. Patients who agreed to participate in the study and signed the informed consent form

Exclusion Criteria:

1. Receptors with a medical history of nephrotic syndrome or focal and segmental glomerulosclerosis confirmed as the etiology of end-stage renal disease;
2. Receptors with poor understanding about chronic kidney disease and its treatment alternatives;
3. Receptors with early history of non compliance to treatment with immunosuppressive drugs;
4. Retransplantation;
5. Multi-organ recipients;
6. Recipients with BMI\> 30 kg / m2;
7. KDPI\> 80%;
8. Cold ischemia time greater than 24 hours;
9. Receptors with a percentage of anti-HLA antibodies above 50%, either class I or Class II;
10. Women of childbearing potential who do not undertake contraceptive methods (condoms or oral contraceptives).
11. Patients receiving immunosuppressive therapy prior to transplantation, except low dose of prednisone;
12. Patients with severe uncontrolled dyslipidemia;
13. Patients who have a known contraindication for administration of any of the immunosuppressive drugs provided for in this study;
Transition to Adulthood Through Coaching and Empowerment in Rheumatology

TRACER is a study aiming to investigate the feasibility of transition coaching sessions for patients moving from paediatric to adult rheumatology care.

TRACER is a feasibility study investigating transition coaching for patients with rheumatic disease transferring from paediatric to adult rheumatology care. This is a vulnerable time in the patients' care and life as they are assuming more responsibility for their health and undergoing significant life transitions. There is risk for increased morbidity and mortality around this time if the patient are not well supported and if they do not stay engaged with care. This intervention aim to provide self-efficacy, self-management, coping skills and support to patients making the transition. This study aims to assess the feasibility of conducting a multi-centre randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* Patient with pediatic-onset rheumatic disease
* At their last paediatric rheumatology appointment prior to transferring to adult rheumatology care
* Able to communicate in English
* Have a phone or device capable of participating in video conference
* Available over the next 8 months

Exclusion Criteria:

* Cognitive impairment preventing participation in individualized education sessions (as determined by medical staff)
A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease

This is a multi-center, double-blind trial to assess the safety and efficacy of taliglucerase alfa in untreated subjects (2 to \<18 years old) with Gaucher disease randomly assigned to treatment with one of two doses, 30 or 60 units/kg. Subjects will receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The total duration of treatment will be 12 months. At the end of the 12-month treatment period eligible subjects will be offered enrollment in an open-label extension study if taliglucerase alfa is not commercially available.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 2 to \<18 years old.
* Diagnosis of Gaucher disease with leukocyte acid β-glucosidase activity ≤30% of the mean of the reference range for healthy subjects.
* Subjects who have not received enzyme replacement therapy (ERT) in the past or who have not received ERT in the past 12 months and have a negative anti-glucocerebrosidase antibody assay.
* Subjects who have not received substrate reduction therapy (SRT) in the past 12 months.
* Subjects whose clinical condition, in the opinion of the investigator, requires treatment with enzyme replacement therapy (ERT).

Exclusion Criteria:

* Currently taking another investigational drug for any condition.
* Presence of neurological signs and symptoms characteristic of Gaucher disease with complex neuronopathic features other than longstanding oculomotor gaze palsy.
* Presence of unresolved anemia due to iron, folic acid, or vitamin B12 deficiency
* Previous hypersensitivity reaction to Cerezyme® (imiglucerase) or Ceredase® (alglucerase).
* History of allergy to carrots.
* Presence of HIV, HBsAg or hepatitis C infections.
* Subject's parent(s) or legal guardian(s) are unable to understand the nature, scope and possible consequences of the study.
* Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the subject's compliance with the requirements of the study.
Relationship Education:Project Harmony

The purpose of this study is to evaluate the effectiveness of relationship education (RE) for individuals and couples participating in Project Harmony.

Although considerable research supports the positive effects of relationship education (RE) on relationship satisfaction and communication skills, the majority of existing research designs have favored pre/post or quasi-experimental designs. Furthermore, gaps in the empirical bases for RE remain regarding programmatic moderators that influence change. Consequently, there has been less emphasis on understanding which program elements contribute to positive change within couple relationships. To this end, Project Harmony seeks to conduct an impact local evaluation design utilizing a randomized control trial (RCT) to assess the effectiveness of relationship education between low income, ethnically diverse individuals and couples in the treatment group compared to the wait-list control group. Secondary research questions are focused on investigating mechanisms and moderators of change for the target population. Participants (individuals and couples) in Project Harmony will be randomly assigned to either the treatment or wait-list control group.

Eligibility Criteria:
Inclusion Criteria:

* Individuals and couples who are at least 18 years of age.

Exclusion Criteria:

* Does not meet the inclusion criteria
Stress Levels and Mental Well-Being Among Students During e-Learning

Introducing restrictions on human contact has been effective in preventing the uncontrolled spread of COVID-19, however, it appears to have negatively impacted mental health. Psychological problems in different age groups occur with different intensity and duration of the pandemic. This study was aimed to assess the impact of introducing distance learning (e-Learning) on the stress levels and mental well-being among Polish, Slovak and Lithuanian Students.

The COVID-19 pandemic has had the effect of accelerating changes in educational processes around the world. It resulted in a rapid conversion from face-to-face to online classes. This has disrupted the regular pattern of education and standard practices that have been followed for many years. It is a big organizational challenge for the academics but most importantly for the students. Remote learning has resulted in long-term social isolation and limitations in interaction with peers. It has also been noted that about 30% of students have symptoms of depression and increased levels of perceived stress, which during the COVID-19 pandemic affects about 50% of young people. Many factors have an impact on this condition, besides the epidemic situation, the social mood and the numerous restrictions, the prolonged time spent online and the reduced level of physical activity have an additional negative impact on their mental health. Due to the dynamic situation of the pandemic, there is a lack of current studies on the mental state of young people especially in the context of ongoing e-learning. Therefore, it was decided to investigate what is the prevalence of depressive disorders and the level of perceived stress during the ongoing remote learning in the group of students of 8 European Universities among Poland, Slovakia and Lithuania.

Eligibility Criteria:
Inclusion Criteria:

* Students attending the course cycle

Exclusion Criteria:

* Inability to self-complete the research questionnaires;
* Psychiatric or psychological treatment, likewise taking medications that affect the psyche during the research project;
Local Anesthetic Infiltration VS Trasversalis Fascia Block VS Spinal Anesthesia

Propose to comparison effectiveness of blind local anesthetic infiltration with ultrasound guided Transversals Fascia Block and Spinal Anesthesia in patients undergoing to inguinal hernia repair surgery. The effectiveness is defined as pain control during intraoperative and time need to reach hospital discharge criteria in the post-operative period.


Eligibility Criteria:
Inclusion Criteria:

* age\> 18 years;
* ASA score I - II - III;
* patients undergoing elective inguinal hernia repair;
* signed informed consent;

Exclusion Criteria:

* chronic therapy with opioids/ antidepressants;
* urgent/emergent surgery;
* postoperative transfer to the intensive care unit;
* known allergy to any drug medication;
* local skin infection;
* epilepsy;
* alcohol or drug abuse;
Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis

Study to evaluate the efficacy and safety of JTE-451 administered for 16 weeks in subjects with moderate to severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Have had a history of moderate to severe plaque psoriasis for at least 6 months prior to Visit 1;
* Subjects with moderate to severe plaque psoriasis covering ≥10% body surface area (BSA), with a psoriasis area and severity index (PASI) ≥12 and static Physician's Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2

Exclusion Criteria:

* History of discontinuation of biologic therapies (including marketed and investigational drugs) directly targeting Interleukin (IL)-17A, IL-17A/F, IL-17 receptor A, IL-12/IL-23p40 or IL-23p19 due to lack of efficacy, according to the Investigator's judgment;
* Prior exposure to retinoid-related orphan receptor (ROR)-γ inhibitors;
* Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions (e.g., clinically-significant eczema or severe acne) at Visit 1;
* History or presence of itch due to underlying conditions other than plaque psoriasis which cause or influence pruritus of the skin within 12 months prior to Visit 1.