cyrilzakka/clinical-trials huggingface dataset:
Impact of the Different Information Channels in Reducing Anxiety in Participants of Cervical Cancer Screening

When participating in population-based screening for cervical cancer, women experience great anxiety during the weeks of waiting since they learn that they have an altered screening result until the colposcopy is performed. In this study we want to verify how anxiety decreases when the information is improved and an audiovisual support is added when giving it.

This study is designed as a double-blind clinical trial. Candidate patients for this study are women referred to a colposcopy consultation after an altered result of the screening test. Those women who have previously been in the colposcopy consultation or have had this test performed in a private center are excluded.

The initial recruitment is done by telephone. If they accept, they are given an appointment at the hospital one day where, after being informed again and signing the informed consent, they are randomized and assigned a group. There are 2 groups, in one they receive an envelope with the information in writing that was created in Osakidetza and is available on the website of said organization, and the other group receives a sheet with the links to the videos created for this study in the same envelope. In this way, both groups assume that they are receiving information and we avoid bias. The principal investigator is the one who carries out this phase and distributes the envelopes, but is unaware of their contents. Previously, a collaborator fills in the envelopes according to the randomization code and indicates outside the envelope the order in which they should be delivered. Only she knows the randomization code and she will not reveal it until the end of the study.

To analyze the level of anxiety, the participants will fill out 2 scales before receiving the information, and they will return them on the day of the colposcopy before performing it. The scales used are the Spielberger´s State-trait anxiety inventory (STAI) and the Cohen´s PerceivedStress Scale 14 (PSS14). The STAI scale has 40 items, scored from 0 (never) to 3 (very much) points. The final result can range between 0 and 60, higher scores are related to a higher level of anxiety. The PSS14 scale consists of 14 items with a five-point scale response format (0 is never and 4 is very often). The scale scores from 0 to 56; higher scores indicate higher perceived stress.

It will also be analyzed whether the waiting time until the colposcopy and the level of academic studies influence the level of anxiety. And the perception of the colposcopy will be analyzed, with the VAS scale, according to their level of anxiety and the way they received the information.

Eligibility Criteria:
Inclusion Criteria:

* Patients who participate in the Osakidetza cervical cancer screening program and are referred to the colposcopy consultation of the Hospital Universitario Donostia due to an altered screening test.

Exclusion Criteria:

* Patients who have previously been in the colposcopy consultation or have gone to a private center to receive information about their altered result or to undergo colposcopy.
Glucocorticoid Injection in Patients With Lumbar Radicular Pain

The purpose of this study is to demonstrate the efficacy of intramuscular betamethasone injection on pain and other clinical parameters in patients with radicular pain due to lumbar disc herniation. The investigators also aimed to determine the effects on electrophysiological findings.

Low back pain is an important health problem that causes difficulties in daily living activities, loss of work performance and disability. Some patients with low back pain have radicular symptoms due to intervertebral disc herniation. Lumbar radiculopathy is characterized by radiating buttock and leg pain in a lumbar nerve root distribution.

The pathophysiology of radiculopathy is related to compression of the nerve, as well as the local release of inflammatory cytokines. Systemic corticosteroids have been used for treatment of lumbar radicular pain for a long time. The effects of corticosteroids are related to their anti-inflammatory effects, which may help reduce swelling and related compression on the affected nerve. Corticosteroids can be used systemically (i.e. oral, intravenous, or intramuscular routes) or administered directly into spinal structures through injections.

In the current study, the investigators aimed to demonstrate the efficacy of intramuscular betamethasone injection on pain, disability and health related quality of life in patients with lumbar radicular pain due to disc herniation. The investigators also aimed to determine the effects on electrophysiological findings.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 65 years old with acute (less than 6 weeks) lumbar radicular pain due to intervertebral disc herniation.
* Neurological findings such as sensory, motor and reflex abnormality matching the L4, L5 or S1 nerve distribution.
* Patients who confirmed to have root compression (radiculopathy) by electrophysiological investigations.

Exclusion Criteria:

* Contraindication for steroid usage (acute infection, uncontrolled diabetes and hypertension, severe cardiac failure), hypersensitivity to steroids
* Acute trauma
* Inflammatory low back pain
* Indications for neurosurgery (pronounced motor weakness or cauda equina syndrome)
* Lumbar spinal stenosis
* History of back surgery, history of steroid injection in the last 3 months
* Pregnancy, lactation
* Malignancy
Motor Imagery in Aphantasia

The present study aims to characterize and modulate motor imagery abilities in individuals with aphantasia. The investigators will characterize the neurophysiological and physiological underpinnings of mental imagery abilities in participants with aphantasia by investigating several indices of motor imagery abilities and comparing them to participants with typical mental imagery abilities. The investigators will investigate whether non-invasive brain stimulation applied to the primary motor cortex improves mental imagery abilities in participants with aphantasia.

The investigators will recruit 20 participants with aphantasia and 20 participants with typical mental imagery capacities (no-aphantasia groups). Participants in both groups will complete a 3-hour visit for inclusion and baseline measurements (Visit 1) which will include neurophysiological, autonomic nervous system, cognitive and behavioral measures.

Participants in the aphantasia group will complete 2 additional visits to receive active and sham tDCS sessions (Visit 2 and 3), according to a randomized, double-blind, sham-controlled, crossover design. Mental training will be done concurrently with tDCS using a sequential finger tapping-task (Truong et al., 2022). Participants will receive the instructions of trying to imagine themselves performing the motor task, by feeling their fingers moving as if they were actually moving it (kinesthetic modality of motor imagery).

Visits will be separated by at least 7 days.

Eligibility Criteria:
Inclusion Criteria:

* For the aphantasia group only: congenital aphantasia defined as a life-long inability to generate mental imagery (confirmed by a total score of 32 or less on the VVIQ, which is the gold standard questionnaire for aphantasia)
* For the no-aphantasia group only: typical mental imagery capacities (confirmed by a total score of more than 32 on the VVIQ)
* Covered by public health insurance
* Understanding the French language
* Signed written informed consent after being informed about the study

Exclusion Criteria:

* Presence or history of a somatic, neurologic, or mental illness
* Actual pain or musculoskeletal disorders at the upper limb
* Having a regular musical activity (more than once a week) because of high manual dexterity
* Contraindication for noninvasive brain stimulation including the presence of ferromagnetic or magnetic sensitive metal objects implanted in the head or in close proximity (e.g., brain stent, clip, cochlear implants, or stimulator)
* Pregnancy (controlled by urine pregnancy test in females without reported contraception)
* Active seizure disorder or history of seizures
* Participants under curatorship/guardianship
Long Term Results in Hypoplastic Aortic Arch Repair in Neonates Using a Glutaraldehyde Treated Autologous Pericardial Patch

Hypoplastic aortic arch is a congenital heart defect that is prejudicial for the growth of newborns. It is often associated to other heart defects. Different surgical techniques exist to address this defect, but the literature is very poor with regards to the use of an autologous pericardial patch. Most use extensive dissection techniques or synthetic patches. Here investigators report institution's original approach using the newborns own pericardium for what investigators believe to be an optimal correction of the hypoplasia., with preserved growth potential.

Retrospective analysis of an already well codified surgical intervention carried out in HUDERF under extra-corporeal circulation

Eligibility Criteria:
Inclusion Criteria:

* Newborns with a hypoplastic aortic arch undergoing a first intervention

Exclusion Criteria:

* none
Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer

The majority of patients with small cell lung cancer have incurable extensive stage disease. The usual initial treatment for this condition is chemotherapy which produces responses in about 50-80% of patients. Despite this, the cancer usually returns. Once common body region where it re-grows is in the chest, which can cause symptoms such as shortness of breath, cough, difficulty swallowing, pain and bleeding. These symptoms can worsen a patient's quality of life and in some situation be life-threatening. In this study , we propose to give patients who have extensive stage small cell lung cancer which responds to chemotherapy radiotherapy treatments to the chest. By giving this type of radiation before the cancer has a chance to re-grow, we hope to control the disease within the chest and prevent future symptoms that it may cause if the cancer were to re-grow in the chest. Patients treated on the protocol will be checked regularly for disease control, quality of life and radiation side effects, if any.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic confirmation of small cell lung cancer
* extensive stage disease
* adequate pulmonary function tests (FEV-1\>1.0, DLCO\>50%)
* patients of childbearing potential must practice adequate contraception
* age ≧ 18 years
* Karnofsky performance status ≧ 70
* documented objective response to initial chemotherapy
* signed study-specific informed consent form

Exclusion Criteria:

* complete or subtotal tumor resection
* non-small cell histology
* prior or concurrent malignancy except non-melanoma skin cancer unless disease-free for at least 5 years
* prior chest or neck RT
* inadequate pulmonary function tests (FEV-1\<1.0 OR DLCO\<50%)
* pregnant
Comparison Between Different Sampling Sites for Detection of Respiratory Viruses

The goal of this observational study is to validate the use of less invasive samples (saliva, orobuccal or nasal swabs) than nasopharyngeal swab for testing common and clinically relevant respiratory viruses in children and adults presenting to an emergency departements with symptoms compatible with respiratory tract infection. The main question it aims to answer is:

- Is the precision of reverse transcription polymerase chain reaction (RT-PCR) for Influenzavirus A or B, respiratory syncytial virus (RSV), and Rhinovirus, on saliva, orobuccal swabs and nasal swabs comparable to the gold standard nasopharyngeal swab in a pediatric and adult population presenting with symptoms compatible with respiratory tract infection.

Among participants the following samples will be collected (nasopharyngeal swab is standard of care and not part of the study samples):

* Saliva
* Orobuccal swab
* Nasal swab


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting at the emergency departments or hospitalized at Inselspital Bern university hospital with any symptom compatible with an acute respiratory tract infection in whom a nasopharyngeal swab to test for respiratory viruses is performed (standard of care)
* Written informed consent from the trial subject has been obtained; for patients aged 0-13 years, or not able to provide informed consent, consent obtained from the legal representative; for patients between 14-18 years, written informed consent obtained from the respective patient as well as the legal representative.

Exclusion Criteria:

* Patients unable to provide a saliva (e.g. patients with reduced level of consciousness). Children too young to be instructed to provide saliva are not excluded, but saliva won't be collected.
* Patients with swallowing disturbances
* Patient's lack of accountability and inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly AND legal representative not available.
Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma

B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of non-Hodgkin's lymphomas (NHL), lymphoblastic leukemias (ALL) and chronic lymphocytic leukemias (CLL). Current treatments for B cell malignancies include chemotherapy, radiation therapy, bone marrow transplantation, and peripheral blood stem cell transplantation. Despite these treatment modalities, most patients will remain incurable. Welgenaleucel (UWC19) is a CD19-directed genetically-modified autologous immunotherapy. This study is designed to evaluate safety and feasibility of administering Welgenaleucel (UWC19) transduced with anti-CD19 lentiviral vector to patients with advanced refractory hematologic malignancies, including DLBCL and ALL.


Eligibility Criteria:
Inclusion Criteria:

* CD19+ leukemia or lymphoma patients with no available curative treatment options who have limited prognosis with currently available therapies
* Absolute lymphocyte count, ALC )≧600/μl
* HIV, HTLV, Syphilis negative
* GPT ≦200 U/L
* Cr ≦221 umol/L
* Adequate venous access for apheresis, and no other contraindications for leukapheresis.
* Voluntary informed consent is given.

Exclusion Criteria:

* Body weight \< 20Kg
* Pregnant women.
* Uncontrolled active infection.
* Active hepatitis B or hepatitis C infection.
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
* Previously treatment with any gene or cell therapy products.
* Any uncontrolled active medical disorder that would preclude participation as outlined.
* Expected survival\< 12 weeks
* Received investigational drug or device within 30 days pre-trial;
* Patients with any other serious diseases considered by the investigator(s) not in the condition to enter the trial.
Sulphate-bicarbonate-calcium Water, Body Weight and Gut Microbiota

Overweight and obese patients will be recruited and randomly assigned to two groups of intervention. To the first group \[sulphate-bicarbonate-calcium water and low-calorie diet (SW-D)\] will be administered "Acqua Santa di Chianciano"®, associated to a personalized low calorie diet, while the second group \[tap water and low-calorie diet (TW-D)\] will follow the personalized low calorie diet but will be asked to drink the same quantity of tap water, over a 4 week period. Stool samples will be collected and analyzed for changes in gut microbiota composition. Patients' body weight will be recorded at the beginning and at the end of the study.

Overweight (BMI\>25) and obesity in adults is a global public health concern because weight excess increases the relative risk of disease and mortality 1-4. A range of diseases, notably cardiovascular disease, diabetes and a number of cancers, are related to excess weight 5. Traditional low-calorie diets are frequently ineffective 6. Although a number of pharmacological approaches for treatment of obesity have been investigated, only few are safe and most of them have adverse effects 7,8. Thus, further studies are necessary in order to find natural antiobesity remedies. Gut microbiota composition is thought to influence body weight 9.

As recently demonstrated in our previous study 10, "Acqua Santa di Chianciano"® helps to maintain the body weight and the values of serum lipids stable in subjects under a relatively high-calorie diet. Possible mechanisms may be a) changing the gut microbiota composition and/or b) increasing the concentration and/or the qualitative pattern of serum bile acids with a subsequent increase of the energy expenditure 11. This study wants to assess the effectiveness in losing weight of "Acqua Santa di Chianciano"® in addition to a low-calorie diet and its effects on gut microbiota composition.

Eligibility Criteria:
Inclusion Criteria:

* Women with BMI between 29 and 35 kg/m2
* Age between 18 and 65 years

Exclusion Criteria:

* Therapy with antibiotics, bile salts, cholestyramine, laxatives, pre- or probiotics during the last 3 months before enrollment
* Helycobacter Pylori positivity
* Previous cholecystectomy
* Gallbladder disease
* Cholestasis
* Consumption of more than 20 g of alcohol/day
* Inflammatory bowel diseases
* Previous gastrointestinal surgery modifying the anatomy
* Pregnancy or lactating state
* Prescribed hypocaloric diet in the three previous months
Acute Phase Reactant in Non-COVID-19 Bacterial Pneumonia

This study is a cross-sectional study, was conducted at Chest department of Kasr Al-ainy Hospital, Cairo university during the period between October 2020 and April 2021.

The aim of the work was to evaluate levels of acute phase reactants(APR) in Non-COVID-19 bacterial pneumonia, and to correlate between levels of APR and the disease severity.

51 patients were included in our study, diagnosed as Non-COVID pneumonia

Inclusion criteria:

1. PCR(polymerase chain reaction) negative for COVID.
2. All patients of both sexes with pneumonia .

Exclusion criteria:

1. Non pulmonary infections.
2. Post surgery patients.
3. Renal patients.
4. hepatic patients.
5. Cardiac patients.
6. Recent pulmonary embolism.

Methodology in details:

All patients were subjected to:

1. Full history with emphasis on:

   * Epidemiological features (age, gender).
   * Risk factors (smoking, DM).
   * Clinical presentation (cough, Fever and duration of illness).
2. Clinical examination (local chest examination).
3. Laboratory investigations: venous blood samples were taken to measure APR

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 negative bacterial pneumonia

Exclusion Criteria:

* COVID-19 positive
* other non-pulmonary infections
The Impact of Individual-based Discharges From Acute Admission Units to Home

The present non-blinded randomized controlled trial (RCT) investigates the effect of a comprehensive discharge model in adult medical patients discharged directly home from an Acute Admission Unit (AAU). In addition, eligible patients should have, at least, one hospital admission 12 months prior to index hospitalization and be discharged for further follow-up by general practitioner, home care nursing or in an out-patient clinic. The model consists of 3 main steps during the short term stay in the AAU. First, patients are screened for pre-hospital conditions that might have contributed to the index hospitalization i.e. functional ability, ongoing treatment including drug treatment, need for additional assistance to maintain daily living, relatives, and use of e.g. hearing aid, glasses, walker. Second, at point of discharge there will be a thorough assessment of the discharge plan focusing on the patients' comprehension of the discharge plan as well as accept of the suggested treatment and follow-up. Third, within 2 days after discharge the patient will receive a discharge letter by email or postal mail written in plain language and repeating the information provided in the discharge summary to the general practitioner. Subsequently, the patient will receive a telephone follow-up from the research nurse addressing the content in the discharge letter and possible unresolved issues related to the index hospitalization. Patients in the control group receives the usual discharge practice in the AAU which does not include a discharge letter to the patient and telephone follow-up after discharge.

The primary endpoint is number of readmissions within 72 hours and 30 days after discharge. Secondary endpoints are healthcare service utilization within 30 days after discharge this includes number of contacts to general practitioner, out-of-hours physicians, emergency departments and if possible visits by home care nurses. Additionally, Quality-of-Life measured 30 days after discharge by the questionnaire EQ5D and Patient Experience of the discharge process is measured 7 days after discharge by a Danish national patient experience survey - serves as secondary endpoints.


Eligibility Criteria:
Inclusion Criteria:

* medicine diagnosis
* discharged directly to home
* 1 admission during the last 12 months
* having a planned follow-up after discharge (general practitioner, home care nurse, out-patient clinic)
* read and understand Danish

Exclusion Criteria:

* demented, living outside the council of Aarhus, included in a rival study
Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease

This study will assess the safety and efficacy of AIN457 in patients with moderate to severe active Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female; 18-75 years old
* Diagnosis of Crohn's disease for at least 3 months prior to screening
* Confirmation of Crohn's disease by endoscopic or imaging examination
* Moderately active Crohn's disease at baseline, defined as:
* CDAI ≥220 and ≤450
* Active disease despite prior treatment with corticosteroids for at least 2 weeks, or immunosuppressants for at least 3 months. Treatment with azathioprine, 6-MP or MTX is allowed but must have been on a stable dose for at least 10 weeks, corticosteroids are allowed but must have been on a stable doses of prednisolone not exceeding 40 mg for two weeks prior to baseline. Immunosuppressants other than those listed above, such as cyclosporine, tacrolimus and mycophenolate, are not allowed and must be stopped (wash-out periods defined in the protocol);

Exclusion Criteria:

* Body Mass Index \>34
* Positive PPD tuberculin skin test or QuantiFeron test
* Any subject with evidence of active pulmonary disease or evidence of latent tuberculosis or fungal infection at screening or within past 3 months
* Symptoms associated with active bowel structuring disease and pre-stenotic dilation on radiographs
* Fistulizing disease if complicated by sepsis and/or untreated abscess
* Multiple bowel surgeries and clinically important short bowel syndrome defined as an inability to maintain caloric intake
* Use of certain medications as specified in the protocol
* Clinical improvement due to other Crohn's therapy

Other protocol-defined inclusion/exclusion criteria may apply
Nutritional Therapy Enriched With Omega-3 in Patients With Lung Resection

The aim of this study is to analyze the effect of enriched formula with omega-3 in the 30-day incidence infection and inflammatory response following lung resection surgery in lung cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Lung cancer diagnosis
* Elective surgery for lung resection schedule at least four days before surgery
* Signed informed consent.

Exclusion Criteria:

* Acute or chronic organ failure as hepatic or renal insufficiency
* Patients with fish-allergy
* History of any surgery within 3 months
* Immunocompromised patients