cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of Recombinant Adenovirus Type 5 AIDS Vaccine

This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to evaluate the safety and the immunogenicity of Adenoviral vector 5 HIV-1 vaccines in subjects receiving stable highly active antiretroviral therapy(HAART) .

Patients continue antiretroviral medications throughout the course of this study. Three groups of patients receive dose-escalation (2×10\^9VP, 2×10\^10VP or 2×10\^11VP) injections of Adenovirus vector vaccine (Ad5-gag). Two weeks post immunization of lower dose, if the vaccine is safe and well tolerant, the next dose of immunization will begin. patients are monitored for safety 72 hours after each immunization. In addition, each patient records adverse events in a diary. Patients have regular physical exams, pregnancy tests, and blood drawn for virologic and immunologic assessments. The induction of HIV-specific responses will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Are willing to participate this study and available for follow-up for the duration of the study.
* Men and women aged 18-50 years.
* Are HIV-positive.
* Have been taking stable anti-HIV drugs for at least 6 months.
* CD4 count ≥ 350 cells/mm3
* Plasma viral load \< 50 copies/ml.
* Willing to use acceptable forms of contraception at least 21 days prior to first vaccination until 56 days after the last vaccination.

Exclusion Criteria:

* Pregnancy or breast-feeding.
* History of previous vaccination with an HIV-1 vaccine.
* Use of immunoinhibitory agents, such as corticosteroids or cytotoxic drugs by oral administration, injection route or inhalation route within 6 months of study entry (But corticosteroids used for allergic rhinitis and skin topical application of corticosteroids were not included); Use of immunomodulatory agents including but not limited to interleukin-2(IL-2） and granulocyte-macrophage colony-stimulating factor (GM-CSF) within 30 days of study entry.
* Use of blood products within 3 months of study entry.
* Use of other experimental drugs within 3 months of study entry.
* Any immunization within 3 months of study entry.
* Comply with any of the following items： Active pulmonary tuberculosis； History of serious adverse reaction to other vaccines； Serious asthma； Have untreated thyroid disease; Syphilis
* Laboratory values（Comply with any of the following items）:

Hemoglobin \< 100 g/L (male subjects)，\<90 g/L (female subjects)； Absolute neutrophil count ≤ 1000 cells/mm3； Serum creatinine ≥15 mg/L，endogenous creatinine clearance rate \<50 ml/min； alanine aminotransferase（ALT）, aspartate aminotransferase(AST) ≥3× upper limit of normal range； Total bilirubin ≥2× upper limit of normal range

* Clinically significant electrocardiogram changes.
* Hypertension ( If it is well controlled by medication and is less than 150/100mmHg , should not be excluded) and other cardiac disease；
* Any medical, psychiatric, social condition, occupational reason judged by the investigator that would limit the evaluation of a subject.
Molecular Analysis in Peritoneal Washing Citology for Locally Advanced Gastric Cancer

Gastric carcinoma is a disease with a high mortality. Peritoneal washing cytology has a recognized prognostic utility. However sensibility of this study is not appropriate. Studies with PCR (polymerase chain retrotranscription) can increase sensibility and accurate staging information.

Objective: To analyze the sensibility and specificity of the expression of CK20, CEA and Ber-EP4 with PCR technique in peritoneal washings of advanced gastric carcinoma without clinical evidence of peritoneal carcinomatosis.

Methodology: Retrotranscription analysis (RT-PCR) and quantitative PCR (qPCR) of CK20, CEA and Ber-EP4 in peritoneal washing. Test the feasibility of qPCR with this new marker (Ber-EP4). Comparison of the results with data obtained with conventional cytology. Study of peritoneal recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Patients with resectable advanced gastric cancer
* Informed consent

Exclusion Criteria:

* Macroscopic peritoneal carcinomatosis
* Non operable patients
Prospective Multicentric Study Comparing the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization Therapy Recipients

Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality.

Adjusting atrio-ventricular (AV) delay, vector optimization and choice of different modes of stimulation can influence the acute hemodynamical consequences of CRT but also its medium-term and long-term clinical and echocardiographic effects.

The aim of the present prospective study is to investigate whether the different stimulation modes lead to different acute hemodynamic response, by evaluating the highest systolic pressure using the Finapress ® method.

This study is a non-randomized, prospective, interventional, multicentric study.

Patients implanted with an Abbott ® CRT pacemaker or defibrillator since less than 3 months are eligible for the study.

Recruited patients will be submitted to a non-invasive evaluation of different pacing modes. This will be performed using the Finapress NOVA device, which records blood pressure with a digital cuff. The peak of blood pressure will correspond to the optimal device settings

Three modes of stimulation of ABBOTT CRT devices will be compared:

* Classical bi-ventricular pacing mode at nominal value and with AV delay optimization
* SyncAV mode at nominal value or with left ventricular preexcitation optimization
* Multipoint Pacing (MPP) mode, alone or in combination with SyncAV mode This is an acute evaluation study without scheduled follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18
* Implantation of a CRT (CRT-P or CRT-D) less than 3 months before inclusion
* MPP and SyncAV-enabled ABBOTT Quadripolar CRT pacing system
* Patient who had signed an informed consent and is willing to comply with study requirements
* De novo implantation
* Patient covered by national healthcare insurance

Exclusion Criteria:

* Permanent/persistant atrial fibrillation/ supra-ventricular tachycardia
* Pacing indication for 2nd or 3rd degree AV block
* Upgrading from non-CRT system
* Pregnant or breastfeeding women
* Adult under legal protection
Clinical and Radiographic Evaluation of Revascularization of Immature Anterior Permanent Teeth Using Concentrated Growth Factor (CGF) Versus Blood Clot (BC)

The aim of this study is to compare clinical and radiographic evaluation treatment of necrotic immature permanent teeth using:

1. Concentrated Growth Factor
2. Blood Clot

Rationale for conducting the research:

Concentrated growth factor (CGF) is relatively a new generation of platelet concentrate product, it contains more cytokines and growth factors compared with PRP and PRF also promotes the proliferation, migration, and differentiation of stem cells.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged between 8_14 years.
2. Anterior tooth diagnosed with necrotic pulp (due to trauma, caries, or anomaly) responded negatively to sensibility tests.
3. Teeth not indicated for post and core.
4. A cooperative and compliant patient/parent.
5. Patients not allergic to medicaments necessary to complete the procedure.
6. Patients with no history of chronic systemic diseases.

Exclusion Criteria:

1. Medically compromised patient.
2. Teeth with vertical fractures.
3. Non-restorable teeth.
4. Teeth when bleeding could not be induced.
5. Unable to attend follow-up visits.
Analysis of Implantation Failure and Establishment of Therapy for Implantation Failure

Impaired endometrial growth (thin endometrial thickness) is a critical factor for implantation failure. In this study, effects of vitamin E on endometrial growth are studied.


Eligibility Criteria:
Inclusion Criteria:

* Endometrial thickness \< 8 mm

Exclusion Criteria:

* Women with fibroids
* Women receiving hormone therapy
Collagenase in the Treatment of Cellulite

The purpose of this study is to determine if collagenase injection will reduce or eliminate the appearance of cellulite of the thigh.

This is an open label study of collagenase injection therapy for reduction and/or elimination of cellulite of the posterolateral thighs.

Eligibility Criteria:
Inclusion Criteria:

* 10 x 10 cm area of cellulite of the posterolateral thigh(s)

Exclusion Criteria:

* any chronic, serious or uncontrolled medical condition
* inability to conform to study visits (12-15 per year)
Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?

Differences in terms of diagnostic capability and side effects related to the needle caliber used for prostate biopsy sampling in patients with suspected prostate cancer

To assess whether a larger caliber (16G) prostate biopsy needle increases the diagnostic capability of prostate neoplasia compared to a smaller caliber (18G) needle, while keeping perioperative complications constant.

Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion of prostate cancer (presence of elevated prostatic specific antigen and/or suspicious digital rectal examination);
* Presence of at least one suspicious prostate lesion on MRI (Prostate Imaging-Reporting and Data System ≥ 3) according to the Prostate Imaging-Reporting and Data System v2.1 performed before Magnetic Resonance Imaging/transrectal ultrasound fusion biopsy.

Exclusion Criteria:

* Patients under active surveillance or with a previous diagnosis of prostate neoplasia prior to biopsy.
* Previous radiotherapy to the prostate for neoplasia.
Self-management Support in Cancer Pain

Pain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life. Integration of patient self-management and professional care by means of care technology provides new opportunities in the outpatient setting. In this project a technology based and nurse delivered multicomponent self-management support intervention has been developed. Important components include monitoring, feedback, education, and nurse support. Following feasibility evaluation, the primary aim of this randomized controlled trial is to assess the effect of the intervention regarding pain intensity and quality of life as compared to care as usual. Secondary outcomes of the effect evaluation are self-efficacy, knowledge, anxiety and depression, and pain medication use. Besides, a cost-evaluation and summative process evaluation will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer
* Patients who are under (palliative) anti-tumour treatment in a day clinic or outpatient clinic, or patients who have no treatment options available anymore
* Cancer (treatment related) pain \> 2 weeks
* Pain is defined as a patient reported pain score of 4 or more on a numerical rating scale (scale 0-10)
* Living at home

Exclusion Criteria:

* Expected life expectancy \< 3 months
* Chronic non-cancer pain
* Known cognitive impairments
* Participation in other studies that interfere with this study
* Not being able to read and understand the Dutch language
* Reduced vision
* Non-reachable by phone
Smoking Cessation, Anxiety, Pain Relationship

Smoking, anxiety and pain are clearly related conditions. We aimed to reveal the relationship between smoking cessation before surgery and preoperative anxiety, postoperative anxiety and pain in chronic smokers.

METHODS ASA I-II group patients without chronic disease and history of drug use were included in the study. Those who did not want to participate in the study, patients with ASA III and above were excluded from the study. The patients were randomized into 2 groups: smokers (Group S, n = 60) and non-smokers (Group NS, n = 60). Group S was asked to quit smoking 2 weeks before the operation. Preoperative period and postoperative 0, 2, 4. And 6. hour Spielberger State-Trait Anxiety Inventory (STAI) values, postop 0., 2., 4., 6. hour Visual Analogue Scale (VAS) values were recorded.

it has been revealed in the current study that smoking, pain and anxiety are interrelated with each other. In the preoperative period, high anxiety scores are related to surgery and anesthesia stress. High anxiety scores in the smoker group both in the preoperative period and in the postoperative period are associated with smoking cessation. While the pain scores were similar in the postoperative period, high anxiety scores strengthened the idea of smoking withdrawal and this study gained value. We believe that future studies with a large number of patients, with different parameters and multiple centers will strengthen the results.

Eligibility Criteria:
Inclusion Criteria:

* ASA I,II patients
* planned Rhinoplasti cases
* accepted participating study

Exclusion Criteria:

* Patients with chronic systemic disorders,
* ASA III and above situation
* emergency and bleeding cases,
* patients with any cardiac and neurological disorders,
* refused to participate in the study
Effect of an Observer Tool on Learning Outcomes During High Fidelity Simulation

The increasing use of high-fidelity simulation is limited by the imbalance between the growing number of students and the human resources available in such a way that all residents cannot play a role during scenarios. The learning outcomes of observers need to be studied in more depth. Previous studies have provided controversial results but overall no significant differences in learning outcomes can be demonstrated between observers and participants engaged as players in scenarios.

Moreover, preliminary data suggest that learning outcomes of observers might be improved by using an observer tool during the scenario. However, no high-quality study has yet shown if this assumption is verified.

In the present study, 3rd-4th year residents in anesthesia will be randomized before high fidelity scenarios to act as observers only or active participants in some scenarios and observers in others.

The main outcome parameter will be the learning outcomes by comparing data obtained before and after the sessions by using questionnaires specifically dedicated to the knowledge of technical skills in the management of crisis scenarios.

The increasing use of high-fidelity simulation in France during the anesthesia curriculum is limited by the imbalance between the growing number of students and the human resources available in such a way that all residents cannot play a role during scenarios. This leads to a new situation in which not all residents can be an active participant in scenarios with some remaining observers all along the simulation sessions. Based on Kolb experiential theory, this situation should lead to a decreased knowledge acquisition. Previous studies have however provided controversial results but overall no significant differences in learning outcomes can be demonstrated between observers and participants engaged as players in scenarios.

Moreover, preliminary data suggest that learning outcomes of observers might be improved by using an observer tool during the scenario. However, no high-quality study has yet shown if this assumption is verified.

In the present study, after informed consent will be obtained, 3rd-4th year residents in anesthesia will be randomized before high fidelity scenarios to act as observers only or active participants in some scenarios and observers in others.

The main outcome parameter will be the learning outcomes by comparing data obtained before and after the sessions by using questionnaires specifically dedicated to the knowledge of technical skills in the management of crisis scenarios. In addition, self-efficacy of the simulation sessions will be explored through the responses to additional questionnaires evaluating the change in non-technical skills after the sessions.

Eligibility Criteria:
Inclusion Criteria:

residents in anesthesia

Exclusion Criteria:

none
Mental Health in Austrian Teenagers (MHAT)

The purpose of the Mental Health in Austrian Teenagers (MHAT) - Study is to collect the first epidemiological data on mental health and psychiatric disorders in a representative sample of Austrian adolescents between 10 and 18 years.

Knowing about the prevalence of psychiatric disorders and related risk and protective factors is essential for the development of prevention programs and therapeutic approaches. Up to now, no epidemiological data on prevalence rates of psychiatric disorders and related risk and protective factors based on a representative sample is available for Austrian adolescents.

The aim of the study is to present rates of behavioral, emotional and social problems as well as prevalence rates of mental disorders. Furthermore the investigators want to examine risk factors, protective factors and quality of life in a large sample of adolescents aged 10 to 18 years. A two step design is chosen for this purpose to obtain diagnoses based on the Diagnostic and Statistical Manual of the American Psychiatric Association, Version 5 (DSM-5):

1. Phase 1 (screening) is a screening for emotional, behavioral and social problems as well as social and demographic correlates, risk and protective factors and quality of life.
2. Phase 2 (interviews) includes structured diagnostic interviews to assess psychiatric diagnoses according to DSM-5 criteria with adolescents above a predefined cut-off score in the screening, and a random sample of adolescents scoring below the cut-off.

Eligibility Criteria:
Inclusion Criteria:

* adolescents aged 10-18

Exclusion Criteria:

* no written informed consent possible due to intelligence or no willingness by parents to include minor
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MTRX1011A in Patients With Rheumatoid Arthritis

This is a Phase I multicenter study that will be conducted in the United States and consists of a double-blind, placebo-controlled, SAD stage, followed by a double-blind, placebo controlled MAD stage. The study will be conducted in approximately 65 adult patients between 18 and 80 years old who have RA.


Eligibility Criteria:
Inclusion Criteria:

1. SAD Stage

   * RA diagnosed according to the ACR
   * For patients taking anti-rheumatic therapies, receipt of a stable regimen prior to randomization
   * Previous treatment with biologic agents, including anti-TNF agents, permitted but discontinued for an appropriate washout period
2. MAD Stage (same as above with the addition of the following)

   * Failure of at least one biologic agent, defined as lack of or loss of response or intolerance
   * Active disease defined by swollen and tender count

Exclusion Criteria:

* Significant systemic involvement of RA, including vasculitis, pulmonary fibrosis, or Felty's syndrome
* Malignancy, or prior malignancy, other than non-melanoma skin cancer or cervical carcinoma in situ that has been resected
* History of treatment with any T cell-directed therapy
Effects of Online Pilates and Face-To-Face Pilates on Healthy Individuals

Many studies on pilates have shown that these exercises positively affect the endurance of core muscles, mental health, and quality of life in healthy individuals when applied face-to-face.

In a few recent studies, the effects of online pilates training have been examined and shown to be effective on core endurance, depression, and quality of life. In the results of these studies, it has been emphasized that it is necessary to compare whether online pilates training is as practical as face-to-face pilates training. For this reason, the investigators thought that randomized controlled studies investigating the effects of online and face-to-face pilates methods in healthy individuals are needed. The investigators planned a randomized controlled study investigating the impact of online pilates and face-to-face pilates methods. The study aims to examine and compare the effects of online pilates and face-to-face pilates methods on core muscle endurance, depression, and quality of life in healthy individuals.

An experienced physiotherapist blind will evaluate participants by randomization at the start of the study and eight weeks later. The group participants belong to will not be disclosed to the participants until the end of the first assessment. Individuals who complete the initial evaluation will be randomly assigned to the online pilates group (OPG) or face-to-face pilates group (FPG) using a computer program. Both online and face-to-face applications will be carried out under the supervision of a physiotherapist with 11 years of experience.

Participants included in the study will be evaluated with data collection forms filled twice, before and after the training programs. The participants' demographic information (age, body weight, height, body mass index) will be recorded.

Statistical analysis will be performed using SPSS software, version 21 (SPSS Inc. Chicago, IL, USA). The normal distribution of the variables will be determined using histograms, probability plots, and the Shapiro-Wilk test. Due to the abnormal distribution, the median and interquartile range (IQR) will be used for descriptive statistics. A Mann-Whitney U test will be used to compare baseline and vary values between groups. The Wilcoxon test will compare baseline values within the group to values after six weeks. The significance level will be set-top \< 0.05 for all analyses. Effect sizes will be evaluated according to Cohen's d standards within pre-post differences. Effect size results will be interpreted as small (≥ 0.2), moderate (≥ 0.5), or large (≥ 0.8) according to the guidelines.

Eligibility Criteria:
Inclusion Criteria:

* 25-40 years of age.
* Voluntarily participate in research to accept

Exclusion Criteria:

* Any cardiovascular, orthopedic, visual, hearing, and perception problems that may affect the results of the research.
* Participating in other exercises or physiotherapy programs during the past 6 months.
Vitamin B12 for Aromatase Inhibitors Musculoskeletal Symptoms

Significant Aromatase Inhibitor-associated toxicity, affects as many as 50% of patients with breast cancer leading to early discontinuation of this life-saving cancer treatment. No effective pharmacologic therapy has yet been identified for management of these symptoms, as many patients do not experience relief of symptoms with analgesic therapy. Vitamin B12, whether as injection or oral forms, has been used as a naturopathic product to provide relief for joint pain caused by arthritis. This effect has not been studied in the setting of Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS).

Primary Objectives:

a. To assess whether daily oral Vitamin B12 decreases average joint pain in women with aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), as measured at baseline, 6 weeks and at 12 weeks by the modified Brief Pain Inventory Short Form (BPI-SF).

Secondary Objectives:

1. To investigate whether daily vitamin B12 improves functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES);
2. To explore the impact of treatment on serum inflammatory cytokine levels (C Reactive Protein) with 12 weeks of treatment between baseline and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent and Pain level \> 4 in the BPI scale,
* Stage I-III

Exclusion Criteria:

* \<18 yrs
* Stage IV
* BPI Score \<4
* Zubrod score \>2