cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM

The trial is performed to assess efficacy and safety of Beltavac with polymerized extract of house dust mites in allergic Rhinoconjunctivitis associated or not with asthma


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent, signed and duly dated.
* Man or woman between 12 and 65 years old (both included).
* Patient with moderate or severe symptoms of persistent rhinitis according to the ARIA Guide, associated or not with well or partially controlled asthma according to the GEMA 5.0 Guide.
* Confirmation of sensitization to DPT or DF with a positive prick test (mean papule diameter greater than or equal to 3 mm) with a commercial standardized allergenic extract and a serum extract-specific IgE value of class 3 or higher (\> 3.5 kU / L) within the 6 months prior to the study.
* Negative pregnancy test.
* Nasal symptom and medication combined scale score ≥ 1.5 during the screening phase.

Exclusion Criteria:

* Concomitant sensitization to allergens other than dust mites if clinically relevant symptoms are anticipated that may interfere with study evaluation periods at the discretion of the investigator.
* Poorly controlled asthma according to the GEMA 5.0 guideline
* Severe asthma, that is, those who during the last months have controlled their asthma according to therapeutic step 5-6 of the GEMA 5.0 guideline.
* Autoimmune diseases or immunodeficiency.
* Malignant neoplasms, serious cardiovascular disease, serious mental illness or other relevant chronic diseases that may interfere with the results of the study.
* Clinical history of anaphylaxis with cardio / respiratory symptoms.
* Hypersensitivity to any of the excipients of the investigational product.
* Immunosuppressive medication during the last 6 months before the inclusion of patients and until the end of the study.
* Treatment with beta-blockers during the study.
* Patients who have previously received immunotherapy with allergenic dust mite extract or other extracts and have failed within the last 5 years.
* Patients with immunotherapy with allergens other than dust mites during the study period.
* Patients who receive any other vaccine one week before the start of treatment or awaiting the second dose of vaccine against COVID-19.
* Pregnant or nursing patients.
To Better Understand the Most Important Factors for Patients When They Decide on the Type of Treatment They Receive for Muscle Invasive Bladder Cancer (MIBC).

Through our study, we aim to understand the most important factors for patients when they decide on the type of treatment they receive for MIBC. Our study consists of a discrete choice experiment (DCE): a type of questionnaire used to elicit preferences in the absence of data. DCEs are frequently used in oncological research to elicit preferences from participants without directly asking them to state their preferred options. Participants undertaking our DCE questionnaire will presented with a series of alternative hypothetical scenarios containing several variables or "attributes" (5), each of which may have a number of variations or "levels".

The study will be conducted using validated and established protocols for undertaking DCEs. A literature review was undertaken to assess what the most important considerations where for patients when making decisions about the treatment they receive for MIBC. Using this literature search as a starting point, discussion groups with relevant healthcare professionals and service users were undertaken to decide on the final attribute and levels for the questions. Five attributes were selected through an iterative process - Body image, Life expectancy, Side-effects from treatment, Living as bladder cancer survivor, and Sexual wellbeing

The study is divided into three stages:

1. Interviews with experienced healthcare professionals and service users to finalise attributes and levels to be used for the questionnaire
2. A representative sample of patients (\~10) will be asked to complete the questionnaire in addition to a brief unstructured interview to assess understanding (e.g. readability and ease of completing the questionnaire)
3. Necessary changes based on feedback from the pilot study will be applied before the main study is carried out

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with MIBC cancer and currently undergoing treatment or have previously completed treatment for MIBC

Exclusion Criteria:

* Any of other type of bladder cancer (unknown, metastatic, or non muscle invasive bladder cancer)
Feasibility of Process-based Therapy in a Naturalistic Setting

The main objective is to explore the feasibility of Process-based Therapy in a natural mental health care setting delivered by practitioners.

In the naturalistic setting of mental health care, treatment decisions of psychotherapists are often based on theories or experience related to treatment approaches. An alternative approach to treatment decision is suggested by Process-based Therapy (PBT), which emphasizes empirical and rational criteria for the selection of intervention. It utilizes ecological momentary assessment (EMA) data, incorporates feedback from dynamic network analysis, and supports interventions based on individual network models and empirical evidence from research related to change processes. Currently, there are no data on the feasibility and acceptability of PBT in practice. The present study investigates in a naturalistic setting, whether PBT can be implemented by psychotherapists in mental health care. Furthermore, the investigators explore the acceptability and efficacy of PBT as compared to psychotherapy delivered in routine practice (r-PT).

Eligibility Criteria:
Inclusion Criteria:

* A primary DSM-5 diagnosis of a depressive or anxiety disorder
* Age 18-65 years
* Sufficient knowledge of the German language
* Participating patients are not required to discontinue medication, but to keep medication constant over the treatment period

Exclusion Criteria:

* Increased suicidality
* Substance abuse or dependency
* Diagnose of a cluster A or B (DSM-5) personality disorder
* Pervasive developmental disorder
* Psychotic disorder
* Eating disorder
* Bipolar disorder
* Severe physical illness
Sacral Neuromodulation With InterStim® Therapy for Intractable Urinary Voiding Dysfunctions (SOUNDS): an Observational Study

The purpose of this study is to document the safety, the effectiveness, the continued performance at mid and long term, the morbidity and the percent of surgical revisions of the Interstim® therapy for up to 5 years in a representative sample of French centers under real-life conditions of use.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years old;
* Patient signed the Patient Data Release Form;
* Patient suffering from retention or Over Active Bladder;
* Patient is eligible for Interstim® system therapy.

Exclusion Criteria:

* Difficulty of collecting follow up patient data;
* Patient not affiliated to social security.
Metabolic Effects of Switching Kaletra to Boosted Reyataz

To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat in HIV-infected patients.

The primary objective of this study is to determine tissue specific glucose trafficking in patients before and after switching from a regimen containing Lopinavir/ritonavir (LPV/r) to one containing atazanavir/ritonavir (ATV/r). Secondary outcome measures of interest will include insulin sensitivity determined by clamp testing, and lipid metabolism and hepatic glucose production assessed using stable isotope techniques. We hypothesize that switching protease inhibitor (PI) to ATV/r from LPV/r will result in direct increases in glucose uptake in muscle and visceral adipose tissue in association with improvements in overall whole body insulin sensitivity compared to remaining on LPV/r. We will complete a prospective randomized trial of Human Immunodeficiency Virus (HIV) infected patients who have been on a stable antiretroviral (ARV) regimen containing LPV/r for at least 6 months and who will be randomized to either switch to a regimen containing ATV/r or remain on LPV/r for 6 months. Each subject will complete Positron Emission Tomography (PET) 18-fluorodeoxyglucose (FDG) imaging during a hyperinsulinemic clamp study at baseline and 6 months after randomization.

Eligibility Criteria:
Inclusion Criteria:

1. Previously diagnosed HIV infection
2. Age between 18-65 years
3. Stable antiviral regimen containing at least 2 nucleoside reverse transcriptase inhibitors (NRTI's) and LPV/r for ³ 6 mos
4. CD4 count \> 400 cell/mm3
5. Metabolic complication as indicated by one or more of hyperinsulinemia (fasting insulin \>= 15 mIU/ml), hypercholesteremia (fasting total cholesterol \>= 200 mg/dL), hypertriglyceridemia (fasting triglycerides \>= 150 mg/dL), or treatment with a lipid lowering medication.

Exclusion Criteria:

1. Hemoglobin \< 11.0 g/dL
2. History of Diabetes Mellitus
3. Currently on medication for Diabetes
4. Therapy with glucocorticoid, growth hormone or other anabolic agents currently or within the past 3 months
5. Current substance abuse, including alcohol, cocaine and/or heroin
6. Any contraindication to ATV/r or known allergy to ATV
7. Concurrent therapy with: Bepridil; cisapride; ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine); indinavir; irinotecan; lovastatin; midazolam; pimozide; proton pump inhibitors (esomeprazole, lansoprazole, omeprazole); rifampin; simvastatin; St John's wort; or triazolam
8. New or serious opportunistic infection in the past 3 months
9. Pregnancy
Exploring New Approaches in Reaching Behavior Post Stroke

After 4 weeks of training the hypothesis that the more natural training program would yield greater functional changes was proven correct.

Analysis indicated that both methods improved reaching without trunk use Reaching performance scale (RPS), but the trunk -stabilized group led to more significant changes. Training under less restrictive conditions associated with Task-Related Training (TRT) (auditory feedback from trunk sensor) as compared to stabilized TRT, led to improved functional and impairment measure scores (WMFT, FM and shoulder flexion). Conclusion: Fading feedback with both training methods, during extended TRT reaching/grasping practice generally led to some improvements. However, as demonstrated by impairment and functional outcome measures, using TRT with an auditory feedback signals is a more effective approach than forcing the stabilization of the trunk during rehabilitation of the upper-limb.

Eligibility Criteria:
Inclusion Criteria:

* Individuals all scored between 20 and 44 on the Upper-Arm subsection of the Fugl-Meyer Scale (FM- Poole \& Whitney, 1988) and demonstrated some trunk movement during the pretest reaching performance scale measures (RPS, Levin 2006)

Exclusion Criteria:

* Individuals were referred if they had no receptive aphasia, apraxia or other cognitive deficits.
Screening for Coronary Artery Disease USing Primary Evaluation With Coronary CTA in Aviation Medicine (SUSPECT)

SUSPECT is a prospective, single-center, cohort study of 250 military aircrew at the Center for Man in Aviation, Royal Netherlands Air Force. All asymptomatic aircrew (≥40 years) are asked to undergo a coronary CT scan on a voluntary basis, following the exercise electrocardiograms performed at their routine aeromedical examination. Coronary Artery Calcium score (CACS) and CCTA findings are reported.


Eligibility Criteria:
Inclusion Criteria:

* Military aircrew of the Royal Netherlands Air Force
* ≥ 40 years old
* Required to undergo cardiac screening (per military aviation regulations)

Exclusion Criteria:

* Typical angina
* Prior myocardial infarction
* Prior revascularization therapy (i.e. percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG))
* Left ventricular ejection fraction \<35%
* Does not comprehend study requirements, and/or is unwilling or unable to comply to study procedures
* CT-related contra-indications

  * Allergic to iodine contrast.
  * Renal insufficiency (GFR \<60 ml/min/1.73m2, calculated with the Modification of Diet in Renal Disease (MDRD) calculator: http://nephron.org/mdrd_gfr_si.
  * Severe claustrophobia.
  * Uncontrolled irregular heart rhythm or tachycardia unresponsive to beta blockade
  * Pregnancy
Dermacyd Silver Floral (Lactic Acid) - Acceptability.

Primary Objective:

To prove the safety of the gynaecological formulation in normal conditions of use.


Eligibility Criteria:
Inclusion criteria:

* Integral vaginal mucosa in the product analysis region
* Use the same category of cosmetics products
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time

Exclusion criteria:

* Use of Anti-inflammatory, immunossupression or antihistaminics drugs
* Allergic or atopic history to cosmetics products
* Cutaneous active disease (local and/or general) in the evaluated area
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Endocrinology pathology such as thyroid gland, ovary and adrenal gland
* Intensive solar exposure until 15 days before evaluation
* Gynecological treatment until four weeks before the study
* Other reason considered by the investigator as a reason for not being included.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
HPV Vaccination Study in Postpartum Women

The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States (U.S.) and is responsible for a wide range of conditions, including cancers within the anogenital tract and the oropharynx. In just the U.S. alone, it's estimated that HPV causes 330,000 cases of precancerous cervical dysplasia and 12,000 cases of cervical cancer. The investigators propose a 2-dose HPV vaccination study in women seeking postpartum care at Johns Hopkins University. The investigators will measure the immunogenicity and acceptability of the vaccine in the postpartum setting.

This is a pilot, non-inferiority clinical trial using historical controls. Participants will have whole blood drawn at 0 months, 6 months, and 7 months and receive the HPV vaccine at 0 months, 6 months, and 12 months. Each blood draw will consist of one 15mL red top tube to measure HPV serologies and hormone levels. All blood samples collected will be analyzed at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants biologically born as females between the ages of 15 through 45 who have delivered a live born baby within the past 72 hours.

Exclusion Criteria:

* Pregnancy
* Severe allergic reaction to vaccine components
* Prior receipt of an HPV vaccine dose
* Fetal demise or stillbirth
* Allergy to latex or yeast
* Moderate or severe acute illness (deemed by the investigator to exclude)
* Immunosuppression (e.g., HIV, solid organ transplant).
Endothelin-Receptor Blockade in Coronary Heart Disease

Endothelin is a hormon that causes acute and chronic narrowing of heart vessels. The purpose of this study is to assess whether suppression of this activity by using two types of receptor antagonists can reduce this effect and thus improve blood supply of the heart muscle.

Endothelin (ET) is the most potent vasoconstrictor known and plays a major role in the development of coronary artery disease as well as in acute vasoconstriction. This effect is mainly mediated by the vascular ET-A receptor, whereas the ET-B receptor mediates vasodilation and cleavage of ET. Currently, there are both selective ET-A antagonists and non-selective ET-A and ET-B antagonists under investigation. The aim of the study is to test the effect of ET-receptor blockade on the vasoreagibility of epicardial and intramyocardial coronary arteries in patients undergoing cardiac catheterization. We randomly use the selective ET-A receptor BQ-123 (Group A) and the combination of BQ-123 and the ET-B receptor antagonist BQ-788 (Group B). The tested infusion will be applied selectively into the assessed coronary artery by a special infusion catheter. To evaluate the morphometric changes we use quantitative coronary angiography to measure the diameter of the coronary artery before and after intracoronary infusion of the tested substances. Furthermore we will use Pressure Wire to measure the hemodynamic conditions before and after infusion, thus evaluating the epicardial and the intramyocardial blood perfusion.

Comparison: Coronary artery diameter as measured by quantitative angiography (minimal lumen diameter) and parameters indicative of epicardial and intramyocardial blood flow as determined by Pressure Wire (fractional flow reserver, coronary flow reserve, intramyocardial resistance) before and after ET-antagonist infusion will be compared.

Eligibility Criteria:
Inclusion Criteria:

* coronary artey disease
* stable angina pectoris
* male and post-menopausal female patients
* age above 19 years
* able and willing to conform to the requirements of the study
* provided written informed consent

Exclusion Criteria:

* severe focal coronary stenosis
* visually calcified stenosis
* aorto-ostial lesion location and unprotected left main stenosis
* pre-menopausal female patients
* diabetes mellitus
* unstable angina pectoris and/or acute Q-wave myocardial infarctaion within the past 72 hours
* current vasoactive medication
* previous percutaneous transluminal revascularization at the site of the target lesion
* lesion which has extremely angulated segments \>90%
* vessel with escessive tortuosity of the proximal segment
* severe hypotension
* severely reduced left ventricular function
* severe carotid stenosis
* patients with pace maker
* patients with elevated liver enzymes
* patients simultaneously participating in another device or drug study
* inability of unwillingness to comply with the study protocol
Improving Management of Emergency Department Patients With Undifferentiated Syncope: Prospective Validation of the Canadian Syncope Risk Score

Among Kaiser Permanente Northern California (KPNC) health plan members, age ≥16 years, with recent syncope and presyncope undergoing emergency department (ED) management with a point-of-care clinical decision support (CDS) tool, how well does the Canadian Syncope Risk Score predict 30-day serious outcomes that were not evident during index ED evaluation?


Eligibility Criteria:
Inclusion Criteria:

* Age ≥16y
* Member of Kaiser Permanente Northern California (KPNC) health plan
* Presentation to the ED with an ED diagnosis of recent syncope or presyncope (\<24h) without a serious etiology identified during the initial ED diagnostic assessment, that is, patients with unexplained syncope.
* Subjects who meet criteria will be identified electronically within the CDS tool in the electronic health record.

Exclusion Criteria:

* Age \<16 years old
* Non-members of KPNC
* Patients with obvious witnessed seizure, prolonged loss of consciousness (\>5 minutes), post-traumatic loss of consciousness, and new mental status changes
* Patients requiring hospitalization for traumatic injuries (e.g., syncope leading to motorized vehicle collision), because their outcomes may be related to trauma rather than syncope
* Patients with impaired communication capacity, e.g., intoxication, language barriers, and dementia.
DNA Array Analysis of Patients With Cervical Cancer

The goal of this clinical research study is to find out if the expression of certain genes is linked with the response of cervical cancer to radiation. Researchers will study a large number of genes located in tumor material to learn this information.

Patients in this study are already scheduled to begin radiation therapy. Researchers will get tumor cells by taking two biopsies of the cervix. The first biopsy of the cervical tumor will be done before any treatment is given. The second biopsy will be performed about 48 hours after the radiation treatment has begun. They will then study the cells in the lab with a new technique for studying gene expression called DNA array, as well as human papillomavirus (HPV) analysis, quantification of apoptosis levels, hematoxylin and eosin staining, and storage of tissue for future research.

The patterns of gene expression in the biopsies will be compared with the success of radiation treatments.

Some of the material will also be stored and used in the future for other research projects.

This is an investigational study. A total of 18 patients will take part in this study. All will be enrolled at UTMDACC.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed cervical cancer: clinical Stage IB -IIIB
2. Invasive pure squamous cell carcinoma
3. Planned treatment with concurrent cisplatinum/5-fluorouracil chemotherapy and pelvic radiation

Exclusion Criteria:

1. Previous cervical cancer treatment including but not limited to transvaginal cone irradiation
A Single Dose Study to Assess the Safety, Effects, and Blood and Urine Drug Levels of AZD3293 in Healthy Subjects

This is a single dose study in healthy male and female (of non-child bearing potential) volunteers, to assess the safety, effects on the body, and blood and urine drug levels of AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 Including an Open-Label Food Effect Group in Healthy Male and Non-Fertile Female Volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female (of non-childbearing potential) subjects
* Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

* History or presence of psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders
* History of neurological disease, including seizures, recent memory impairment, or clinically significant head injury
* History of use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs
* Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products
Effect of Covid-19 Epidemic on Primary PCI in Patients With STEMI

The epidemic of covid-19 has spread all over the world and has a great impact on people's health and life. It is necessary to study the treatment of STEMI patients in the real world under the influence of the epidemic,which provide effective suggestions and strategies for emergency and severe treatment.

The epidemic of covid-19 has spread all over the world and has a great impact on people's health and life. The patients' prognosis is poor because the epidemic situation runs on medical resources, delays the diagnosis and treatment of other diseases such as cardiovascular diseases, and the patients' willingness to see a doctor is reduced. In particular, the delay in the treatment of STEMI, which needs PCI treatment, will cause more damage to the patients. It is necessary to study the treatment of STEMI patients in the real world under the influence of the epidemic. In this study, STEMI patients who experienced emergency PCI treatment after the covid-19 outbreak in 2020 were included, and compared with the data of the same period in 2019,we will analyze the pre hospital treatment time, vascular opening time,and the major cardiovascular adverse events, which provide effective suggestions and strategies for emergency and severe treatment.

Eligibility Criteria:
Inclusion Criteria:

* Continuous inclusion of patients with definite diagnosis of acute ST segment elevation myocardial infarction and emergency PCI intervention.

Exclusion Criteria:

* Febrile patients, patients with severe infection,
* ST segment elevation myocardial infarction during hospitalization,
* Patients who could not cooperate with each other.