cyrilzakka/clinical-trials huggingface dataset:
MARIMPACH : Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia

Outcome after treatment of achalasia is usually assessed by the Eckardt score (ES). The timed barium esophagogram (TBE) is used to objectively assess esophageal clearance after treatment. High-resolution manometry with impedancemetry (HRiM) provides information on esophageal clearance of liquids in addition to motility parameters. The aim of this study was to compare esophageal clearance determined by HRiM and TBE in patients with achalasia treated by POEM.

Consecutive patients treated with POEM had pre and post-POEM assessment with ES, TBE, and HRiM. Treatment failure was defined by an ES \> 3 at 3 months post-POEM. Incomplete esophageal clearance (IEC) was defined by the presence of an esophageal stasis \> 2 cm at 5 minutes in HRiM and/or TBE. The Eckardt score is evaluated at one year to estimate the prognostic value of measurements of esophageal clearance after treatment on long-term symptoms. The evaluation of the Eckardt score will be compared to the quality of life score. All of these examinations are carried out as part of routine care.

The supposed superiority of HRiM in the evaluation of esophageal clearance, systematically carried out in the assessment of Achalasia, could lead to no longer using TBE which is a irradiating examination for the patient.

Eligibility Criteria:
Inclusion Criteria:

* The patients included are all patients treated by POEM at Bordeaux University Hospital between October 2020 and September 2024.

Exclusion Criteria:

* Primary POEM failure, lost to follow-up, absence of completion of the ES, TBE or HRiM pre or post poem at 3 months.
Nasopharyngeal Streptococcus Pneumoniae Carriage

Primary Objective: Evaluation of the

- Carriage rate of Streptococcus pneumoniae in the nasopharynx of children

Secondary Objective:

* Carriage rate and distribution of Streptococcus pneumoniae serotypes
* Estimation of prevalence rate of antibiotic-resistant Streptococcus pneumoniae strains
* Distribution of Staphylococcus aureus strain
* The influence of risk factors in the Streptococcus pneumoniae carriage rate in children


Eligibility Criteria:
Inclusion Criteria:

1. Children aged between 2 months and 5 years attending pediatric clinics in hospitals, day care centers or kindergartens.
2. Informed consent obtained from parents or legal guardian.

Exclusion Criteria:

1. Children younger than 2 months of age.
2. Children with following serious diseases: immunological disease, neoplastic disease, renal, cardiac or hematological disease, bronchodysplasia, Down's syndrome.
Comparison Between Supervised Group Exercise and Home Exercise Program for Knee Osteoarthritis

Physical exercise is a widely recommended treatment modality for osteoarthritis, which can be performed through a supervised group exercise or a home exercise program. However, up to now only little research has been conducted on the home exercise program in Brazil. The objective of this study is to compare the efficacy between supervised group exercise and home exercise program in people with knee osteoarthritis. Methods: The study population consists of 46 men and woman with knee osteoarthritis aged between 40 and 65. The patients should be clinically diagnosed with knee osteoarthritis and classified in Kelgreen-Laurence grades I, II and III. Primary outcomes are the Westerm Ontário and McMaster Universities (WOMAC), Lower Extremity Functional Scale (LEFS), Pain Catastrophizing Scale (PCS), Tampa Scale for Kinesiophobia, 40-meter walk test, isometric strength of hip (abduction and adduction) and knee (flexion and extension) and postural control. The patients are randomized into 2 groups, with one group receiving 12 sessions of supervised group exercise and the other group following an exercise program at home. The program lasts 6 weeks with both groups receiving the same exercise protocol consisting of stretching, isometric and isotonic exercises for major muscle groups in both lower extremities. The Mann-Whitney U test is used to examine the Anthropometric variables. The ANOVA is used to compare outcomes before and after treatment. A value of p\< 0.05 is considered to be statistically signifcant.


Eligibility Criteria:
Inclusion Criteria:

* age between 45 and 65 years;
* Kellgren-Lawrence Grade I, II and III with knee osteoarthritis determined clinically and radiographically.

Exclusion Criteria:

* history of surgery in the lower limb;
* patients who performed physiotherapy in the last six months;
* disease or disability which contraindicate the performance of the exercise training (vestibular problems, cardiorespiratory, rheumatic and neurological diseases).
Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer

A sentinel node procedure is recommended for patients with early stages of breast cancer to exclude metastases to local lymph nodes. This procedure is done with a "tracer" which is injected near to the tumor and drains to these nearby lymph nodes. The first draining lymph node(s) are called "sentinel" node(s). These sentinel nodes are excised by the surgeon for microscopic investigation using a detection probe. This study aims to further document the distribution and dynamics of a recently approved new tracer called Tilmanocept and comparing it with the standard used tracer (nanocolloid) to determine whether there is a significant difference between both products (which are both approved for clinical use in this scenario in the European Union). This will be done by randomly assigning patients between injection of Tilmanocept or Nanocolloid and making scans on multiple (3) time points.


Eligibility Criteria:
Inclusion Criteria:

* Early stage breast cancer (T1, T2)
* Clinically node negative (no enlarged axillary lymph nodes)

Exclusion Criteria:

* Prior surgery in same breast
* Pregnancy or breastfeeding
Raltegravir and Ezetimibe PK Study

Evaluation of the pharmacokinetics and safety of raltegravir and ezetimibe when co-administered to male and female healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
* Male or non-pregnant, non-lactating females
* Between 18 to 65 years, inclusive
* Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month after the study

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
* Positive blood screen for hepatitis B and/or C antibodies
* Positive blood screen for HIV-1 and 2 antibodies
* Current or recent (within 3 months) gastrointestinal disease
* Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study
* Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug
* Consumption of grapefruit, or Seville oranges or any grapefruit or Seville orange containing product within one week of first dose of study drug and for the duration of the study
* Use of any other drugs, including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug, unless approved/prescribed by the Principal Investigator as known not to interact with study drugs.
* Females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least 30 days after the end of the treatment period
* Previous allergy to any of the constituents of the pharmaceuticals administered in this trial
Influence of Light Exposure on Cerebral MAO-A in Seasonal Affective Disorder and Healthy Controls Measured by PET

This study aims to assess differences in monoamine oxidase A (MAO-A) distribution in the brain between seasonal affective disorder patients and healthy controls using positron emission tomography. In addition the investigators aim to demonstrate the impact of light therapy on MAO-A distribution

In addition, a pilot study and a sub-study in healthy controls were performed

This study aims to assess differences in monoamine oxidase A (MAO-A) distribution in the brain between seasonal affective disorder patients and healthy controls using positron emission tomography. In addition, the investigators aim to demonstrate the impact of light therapy on MAO-A distribution by investigating patients and controls in the winter before bright light therapy, in the winter after bright-light therapy, and in the summer. Bright light therapy will be placebo controlled, randomized, and double blinded.

Eligibility Criteria:
Inclusion Criteria for Patients:

* DSM-IV diagnosis of SAD established by diagnostic interview according to the SCID.
* Global Seasonality Score of 10 or higher on the Seasonal Pattern Assessment Questionnaire (SPAQ)
* Somatic health based on history, physical examination, ECG, and laboratory screening
* Aged 18 to 55 years
* No therapeutic treatment of SAD in the last 6 months (drugs and light therapy)
* Willingness and competence to complete the informed consent process

Inclusion criteria for healthy controls:

* Aged 18 to 55 years
* Somatic and psychiatric health based on history, physical examination, ECG, laboratory screening, SCID
* Willingness and competence to complete the informed consent process

Exclusion criteria for patients and healthy controls:

* Concomitant major medical or neurological illness
* Concomitant psychiatric disorders
* Current smoking
* Ingestion of antidepressants or other psychotropic agents targeting the serotonergic system, within the last 6 months.
* Bright light therapy within the last 6 months.
* Current substance abuse including alcohol, drugs of abuse, or any medication in a manner which is indicative of substance-related disorders (e.g. substance dependency) according to the DSM-IV.
* Failure to comply with the study protocol or follow the instructions of the investigators.
* Positive urine pregnancy test.
* For participants who participated in an earlier neuroimaging study using ionizing radiation, the total radiation exposure dose of 20 mSv over the last 10 years must not be exceeded, as specified in the legislation on radiation protection (Allg. Strahlenschutzverordnung 2010; www.ris.bka.gv.at).
Gasdermin-D and Pannexin-1 in Pregnancy

One -third of fertile women around the world are overweight or obese. This means increasing risk for both the mother and the child. Fat tissue is a factor in gestational DM development and the increase in material inflammation and oxidative stress. According to new knowledge, it is an important need to examine molecules that are not handled in new and human research in these mechanisms in fat and placenta tissues in obesity. For this purpose, the examination of the expression of gasdermin-D and pannex-1 proteins, which are shown to be produced in the cells of both tissues, is worth investigating in human fat tissue and placenta. Gasdermins and pannexins are proteins intersecting by interacting in cellular functions.

Gasdermins cause piroptosis, a type of litic proinflammatory cell death. Pannexin-1 plays in various cellular functions, including inflammation. These are examined in a small number of in vitro studies in material fat tissue and placenta, and the design of this study in people whose applications are applied is original in humans.

The status of the expressions of the gasdermin-D and pannexin-1 proteins, which will be examined for the first time in obese pregnant women's fat and placental tissues, are the subject of this research with each other and their relationship with other maternal and neonatal data.


Eligibility Criteria:
Inclusion Criteria:

* Being in the 20-35 age range
* Term pregnancy (37-41 weeks)
* Healthy pregnancy follow-up
* Planned cesarean section
* Having no complication in cesarean delivery
* Being a placenta with front or rear walls

Exclusion Criteria:

* Intrauterine surgical procedure
* Presence of prenatal placental structural disorder
* Multiple pregnancies
Messenger Ribonucleic Acid (mRNA) Transfected Dendritic Cell Vaccination in High Risk Uveal Melanoma Patients

1. Rationale

   Immunotherapy applying ex vivo generated and tumor antigen-loaded dendritic cells (DC) has now successfully been introduced in the clinic. A limited, but consistent, number of objective immunological and clinical responses have been observed. Most of the successful results have been observed in patients with minimal residual disease, rather than patients with advanced metastatic disease. Moreover, the investigators' preliminary results show that presence of tumor epitope specific T cells in biopsies taken from delayed type hypersensitivity (DTH) reaction sites highly correlates with prolonged progression free survival (PFS).

   Within uveal melanoma patients, a group with high risk of metastatic disease can be identified on basis of tumor specific genetic changes in loss of chromosome 3.

   At present no standard adjuvant or systemic treatment is available. Applying DC-based immunotherapy in this group of high risk patients might reduce the risk of recurrence without interference in the current treatment guidelines.
2. Objectives

   In this joint clinical study of Radboud University Nijmegen Medical Centre (RUNMC) and Rotterdam Eye Hospital, the investigators aim to determine the in vivo immunological response induced in high risk uveal melanoma patients vaccinated with mRNA-transfected DC.
3. Study design

   This study is an open label non-randomized phase II intervention study.
4. Study population

   The investigators' study population consists of HLA-A2 positive patients with a high risk uveal melanoma with proven expression of melanoma associated antigens tyrosinase and/or gp100.
5. Main study endpoints

This is an exploratory study aiming to demonstrate proof of principle. The first study endpoints are in vivo immunological response induced in high risk uveal melanoma patients vaccinated with mRNA-transfected DC, administered i.v./i.d. and toxicity. Secondary study endpoints are progression free survival, overall survival, and toxicity.


Eligibility Criteria:
Inclusion Criteria:

* histological documented uveal melanoma
* HLA-A2.1 phenotype (intervention arm)
* non-HLA-A2.1 phenotype (control arm)
* melanoma expressing gp100 and/or tyrosinase
* high risk genetic profile (loss of chromosome 3) determined by FISH
* interval since local treatment of uveal melanoma \< 12 months
* no signs of liver metastasis determined by diagnostic CT-abdomen
* normal serum LDH
* no signs of cerebral metastases
* bilirubin \< 25 micromol/l
* WHO performance scale 0-1
* age 18-75 years
* written informed consent
* expected adequacy of followup
* no pregnant or lactating women

Exclusion Criteria:

* history of second malignancy, except adequately treated basal cell carcinoma
* serious active infections
* autoimmune disease or organ allografts
* concomitant use of immunosuppressive drugs
* known allergy to shell-fish
Comparison of Reduced Cuff-pressure of the Laryngeal Tube Under General Anesthesia

Optimization the cuff pressure of the laryngeal tube (LT) in relation of the mechanical ventilation, and the reduction of potential leakage mucosal trauma. Comparison of the tightness of LT between the filling volume specified by the manufacturer (connectors are color coded syringe and blocker), 60cmH₂O, 50cmH₂O, 40cmH₂Ound 30cmH₂O. The measurement of the leakage occurs in ml / kg body weight.

The ventilation of both cuffs of the laryngeal tube by using the color coding of syringe and connector is a simple, fast and easy way to stabilize the tube and secure seal against the surrounding tissue.

The user of this method has only knowledge of the volume (ml), with which the cuff is vented, but not over the cuff pressure (cmH₂O) itself.

Permanently high pressures can cause to a lesions to necrosis in the adjacent tissue, on the other hand, the material of the bulging cuff fits less well the anatomy of the patient, leading to leaks in the breathing circuit.

Studies of pediatric anesthesia show that on 40cmH₂O reduces the volume of the leak in the laryngeal mask airway by reducing the cuff pressure and the ventilation is improved in sequence.

In the proposed study, the volume of leakage at the fill volume specified by the manufacturer (color coding), 60cmH₂O, 50cmH₂O, 40cmH₂O and 30cmH₂O to be captured.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 Years
* No concurrent participation in another study
* capacity to consent
* Present written informed consent of the research participant
* Elective surgery under general anesthesia
* Height\> 150cm

Exclusion Criteria:

* Age \<18 years
* Existing pregnancy
* Lack of consent
* inability to consent
* emergency patients
* Emergency situations in the context of a Difficult Airway Management
* ASA classification\> 3
* situations where the possibility of accumulated gastric contents
* Indications for intubation with endotracheal tube
* Height \<150cm
* Participation in another study
Confirmation of Association Between Cystic Fluid Analysis With Pancreatic Cystic Lesions

Through a comprehensive analysis of the pancreatic cystic fluid analysis, the role of the cystic fluid analysis is confirmed in terms of accurate diagnosis of pancreatic cysts, appropriate prediction of treatment response, and to select proper treatment indication through analytic results.


Eligibility Criteria:
Inclusion Criteria:

1. patients who diagnosed with pancreatic cystic lesion
2. patients who are able to acquire cystic fluid through EUS-FNA or surgery
3. patients aged 18 years and older

Exclusion Criteria:

1. patients who did not want to participate in this study
2. patients aged under 18 years old
3. severely mentally ill patients
4. pregnant women
COVID-19 Preventive Behavior in African Americans

The Center Disease Control has published a set of guidelines to contain the spread of the virus, since it is known to spread from person-to-person. Given the vaccine and specific antiviral treatment for Coronavirus disease (COVID-19) remain under development and will take months or years to develop, intermittent and sustained preventive behaviors may be needed into 2022 unless effective treatments or vaccines are developed. Thus, effectively implementing preventive behaviors remains a critical step in bringing the pandemic under long-term control. Leveraging the ecological momentary assessment (EMA) method developed in the parent R01 for smartphones, which allows for real-time data collection on individual's behaviors, the investigators propose a prospective single arm and longitudinal study to examine the effectiveness of self-monitoring EMA (SM-EMA) in promoting adherence to COVID-19 preventative behaviors. SM-EMA users will download the smartphone app which includes: (1) instructional videos to provide knowledge of preventative behaviors; (2) self-monitoring of preventative behaviors during intervention and follow-up phases; (3) tailored-feedback messages to encourage preventative behaviors; and (4) mobile-enabled website to provide an interactive learning platform. If proven efficacious, this intervention could be efficiently disseminated to reach the larger public and foster preventive behaviors into self-management as effective strategies for long-term control of the COVID-19 pandemic.

Given the vaccine and specific antiviral treatment for COVID-19 will take months or years to develop and finalize, preventive behaviors remain the most effective strategy thus far and may be needed until 2022 to control the pandemic. African Americans, who have 3-fold higher infection rate and 6-fold higher death rate compared to the white counterparts, are an especially vulnerable population to COVID-19. Immediately initiating a project that promotes and maximizes adherence to preventative behaviors is vital to addressing the ongoing COVID-19 pandemic. The investigators propose a prospective single arm and longitudinal study to examine the effectiveness of SM-EMA in promoting adherence to COVID-19 preventative behaviors. The intervention will include two daily pop-up messages during Week 1 (one in the morning and one in the afternoon), one daily pop-message in Week 2, and two pop-up messages a week in Weeks 3 and 4. The duration for the intervention will be four weeks. The study outcomes will be collected at baseline (pre-intervention, T1), post-(completion of the intervention, T2, primary endpoint), and monthly follow-up for three months (T3-T5). The total study duration will be four months.

Eligibility Criteria:
Inclusion Criteria:

* African American aged 60 or older
* Able to read and write English
* Willing to commit to use the smartphone app with the pop-up messages and then four follow-up surveys (total four months).

Exclusion Criteria:

* No children or others aged 59 years or younger