cyrilzakka/clinical-trials huggingface dataset:
Diastolic Exercise Stress Testing in Heart Failure

Patients with an intermediate risk (HFA-PEFF score 2-4 points) for heart failure with preserved ejection fraction (HFpEF) will be further investigated with invasive right heart catheterization. All patients with a resting pulmonary artery wedge pressure (PAWP) \<15mmHg will undergo the following stress test modalities in a randomized order: (1) bicycle ergometry, (2) dynamic handgrip exercise, (3) 500ml fluid challenge over 5 minutes, (4) leg raise testing. Exercise induced HFpEF will be diagnosed if PAWP rises to \>25mmHg.

Patients reporting to the investigators' clinic for in- and outpatient consultation and a HFA-PEFF score of 2-4 points will be recruited if their dyspnea is not sufficiently explained by other causes than HFpEF. Patients will undergo a baseline clinical exam, transthoracic echocardiography with measurement of diastolic parameters, and ECG. NYHA class will be reported, standard lab works (NTproBNP, GFR, CRP, Hb, PLT, blood gas analysis) will be taken. The number of patients with a PAWP increase in right heart catheterization (brachial access under sonographic guidance) from a resting value of \<15mmHg to \>25mmHg during stress testing will be assessed across the four interventions. During bicycle ergometry (semi-supine position) spiroergometric data and gas exchange variables (cardiopulmonary exercise testing) will be co-assessed. Between the testing modalities a 10-minute break will allow hemodynamic variables to normalize.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Unclear etiology of dyspnea with non-invasive testing
* HFA-PEFF score 2-4 points and thus an intermediate risk for HFpEF
* Willingness to participate and obtained written consent

Exclusion Criteria:

* Consent for study participation not obtained
* Age \< 18 years
* Medical contraindications to perform right heart catheterization
Impact on Cognitive Function and Quality of Life of Adjuvant Chemotherapy in Patients Aged Over 65 Years: Application to Breast Cancer or Colon

The aim of the study is to investigate the impact of adjuvant chemotherapy on cognitive function in patients aged over 65 and suffering from breast cancer or colon.


Eligibility Criteria:
Inclusion Criteria for patients with chemotherapy :

* Patient(e) aged over 65 years
* Non metastatic breast cancer
* Adjuvant chemotherapy Breast cancer: FEC, including Docetaxel Protocols
* No major cognitive impairment
* Lack of personality disorders and psychiatric disorders evolutionary
* Having signed the informed consent of study participation

Inclusion Criteria for patients without chemotherapy (control group):

* Patient(e) aged over 65 years
* Breast cancer
* Patients receiving no adjuvant chemotherapy
* No major cognitive impairment
* Lack of personality disorders and psychiatric disorders evolutionary
* Having signed the informed consent of study participation
* Matching on age, sex, cultural level and tumor location

Exclusion Criteria for patients with chemotherapy :

* Metastatic
* Cancer primitive other than breast
* Patients under 65 years
* Patients with adjuvant chemotherapy is associated with targeted therapy
* Patients who have received other cancer treatments (chemotherapy or radiotherapy brain)
* disorders of higher functions existing in the administration of chemotherapy
* Pathology psychiatric evolutionary
* Refusal of participation
* Patients unable to meet the cognitive tests
* Drug use
* Heavy drinking
What is the Knowledge and Use of Emergency Contraception

The main objective is to assess the knowledge of women seeking abortion about emergency contraception.

The secondary objectives are to evaluate the use of emergency contraception among women seeking abortion and to identify barriers to the efficacy and use of emergency contraception in these women.


Eligibility Criteria:
Inclusion Criteria:

* women aged over eighteen years old
* the patient agreed that her questionnaire data should be collected and analyzed for this research.
* women who are able to read and write French
* woman seeking an abortion at the Orthogeny Center in University Hospitals of Strasbourg

Exclusion Criteria:

* refusal to participate in the study
Clinical Guidelines for APL Treatment

Therapeutic guidelines for treatment of patients with de novo APL to be used by every institution that wants to follow them. All patients who are reported may be retrospectively analyzed


Eligibility Criteria:
Inclusion Criteria:

* Genetic diagnosis of acute promyelocytic leukemia

Exclusion Criteria:

* No exclusion criteria
Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously

The purpose of the study is to determine the feasibility of infusing a full 4-week dose of Immune Globulin Intravenous (Human), 10% in a single subcutaneous site and the amount of recombinant human hyaluronidase needed to infuse that dose with no more than mild local adverse drug reactions.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from either the subject or the subject's legally acceptable representative
* Diagnosis of a PID disorder as defined by World Health Organization criteria1 for which the subject had been receiving a regimen of weekly or biweekly (every-other-week) subcutaneous IgG infusions or IGIV infusions every 21 to 28 days over a period of at least 8 weeks pre-study at an equivalent of a 4-week dose of 300 to 800 mg/kg bodyweight
* Adults/adolescents aged 16 years and older)
* For female subjects of child-bearing age: negative urine pregnancy test result at study entry and agreement to employ adequate birth control measures for the duration of the study

Exclusion Criteria:

* Subjects positive at enrollment for one or more of the following: HBsAg, PCR for HCV, PCR for HIV Type 1
* Subjects with levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal for the testing laboratory
* Subjects with neutropenia (defined as an absolute neutrophil count \[ANC\] \<= 500/mm3).
* Subjects with serum creatinine levels greater than 1.5 times the upper limit of normal for age and gender
* Subjects with current history of malignancy
* Subjects with a history of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident)
* Subjects with abnormal protein loss (protein losing enteropathy, nephritic syndrome, severe lung disease)
* Subjects with anemia that in the opinion of the investigator precluded phlebotomy for laboratory studies
* Subjects who had been exposed to any blood or blood product other than an intravenous immunoglobulin (IGIV), SC immunoglobulin (SCIG), immune serum globulin (ISG) preparations, or albumin within the 6 months prior to study entry.
* Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, SCIG and/or ISG infusions
* Subjects with IgA deficiency and known anti IgA antibodies
* Subjects who had received antibiotic therapy for the treatment of infection within 7 days prior to enrollment
* Subjects who had participated in another clinical study involving an investigational product or device within 28 days prior to study entry
* Subjects with inability or unwillingness to meet all the requirements of this study
* If female, pregnancy or lactation at time of study entry
Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore

To evaluate efficacy and safety of sericin and chitosan cream for preventing and limiting the progressive of pressure sore in 20 patients


Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years old
* 2-digit Stirling Pressure Sore Severity Scale less than or equal to 2.4
* No chitosan, sericin, and dimethicone allergy
* Without skin diseases
* Without Autoimmune diseases
* Willingness to participate

Exclusion Criteria:

* Have uncontrolled diseases
* Have complication or adverse effects during the time of participation
* Cannot follow protocol
* Pregnancy or lactation
* Participate in other study
Influence of CBD on Episodic Memory in Healthy Subjects

Placebo controlled, randomized, double blind, cross-over design.

Single vape of 0.25ml 5% CBD e-liquid (12.5mg CBD) and single vape of 0.25ml e-liquid, tastes like lemon and madeleine. 15min vape time each.

A total of 34 participants, equal number of male and female. There will be replacement of Drop-Outs until data from 34 participants are completed.

The primary endpoint will be performance in a verbal memory task. The secondary endpoint will be performance in a working memory test.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Normotensive (BP between 90/60mmHg and 140/90mmHg)
* BMI between 18 and 30 kg/m2
* Male or female
* Aged between 18 and 30 years
* Native or fluent German-speaking
* Able and willing to give written informed consent as documented by signature and comply with the requirements of the study protocol
* Willing to donate urine sample to control for pre-Visit CBD/THC consume

Exclusion Criteria:

* Acute or chronic psychiatric disorder including drug or alcohol abuse
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the study
* Smoking (\> 5 cigarettes per day)
* Participation in one of our previous studies using the same verbal test in the past 2 years
* Participation in a study with CBD / THC within the 30 days preceding and during the present study
* Known hypersensitivity or allergy to propylene glycol
* Intake of CBD / THC within the 7 days preceding and during the present study in any application form
* Long-term systemic medication or topical steroids to treat an underlying disease within last 3 months
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Clinical Outcome in Patients With INPH

The aim of this study is to determine the clinical spectrum and natural progression of idiopathic normal pressure hydrocephalus （iNPH ) and related disorders in a prospective single center study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the etiology and molecular mechanisms of these diseases.

Due to the heterogeneity of the etiology of idiopathic normal pressure hydrocephalus , almost all published studies on the clinical outcome and prognostic factors of iNPH are relatively limited, and most of them are retrospective. It is not clear which is the most reliable predictor of clinical outcome. Therefore, the researchers conducted this prospective cohort study to identify the occurrence, development and outcome of iNPH and determine the main prognostic factors through clinical scales, biomarkers and imaging.

At study visits a standardized clinical examination will be performed including application of clinical rating scales. At all study visits, patients will be asked to donate biosamples; biomaterial collection is optional and participants can elect to participate in sampling of blood, urine, CSF, and/or a muscle biopsy.

Optionally, additional examinations may be performed including imaging，such as DTIALPS, neurophysiological examination, analysis of patient or observer reported outcomes and analysis to characterize molecular biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* patients who was diagnosed as idiopathic normal pressure hydrocephalus

Exclusion Criteria:

* patient received surgical treatment or interventional treatment before patient is pregnant patient unable to complete follow-up patient with other types of hydrocephalus other nervous system diseases
Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy

High concentrations of parathyroid hormone (PTH) are common in patients with hepatocellular carcinoma (HCC). This study is aimed to investigate effects of vitamin D status and its multiple mega-dosage supplementation on PTH and clinical outcomes in HCC patients before and after hepatectomy. It's a single-center, prospective, parallel, double-blind, placebo-controlled study for 120 eligible subjects. The subjects will receive consecutively 3-day intervention treatments from 7th day before surgery. 30-day postoperative mortality, postoperative complications, and laboratory data will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* 1. ≥ 20-year HCC subjects receiving laparoscopic hepatectomy
* 2.Sign the informed consent

Exclusion Criteria:

* 1. Using estrogen drugs, bisphosphonates, or drugs for bone disease.
* 2. Consume calcium tablets within 2 weeks before operation
* 3. Sarcoidosis, multiple myeloma
* 4. Pregnant women or plan to become pregnant within 3 months after surgery
* 5. Autoimmune hepatitis (AIH)
* 6. Early liver recurrence
* 7. Used to participate in other clinical trials
A Parent Administered Sensorimotor Intervention and Developmental Outcome of Preterm Infants

Advances in medical technologies over the last three decades have increased survival rates in infants born preterm . Preterm infants are at high risk of developing developmental delays. Implementation of effective strategies aimed at improving the developmental outcome of preterm born children is critical.

The proposed study is designed to evaluate the addition of a parent administered sensorimotor program on the developmental outcome of infants who are born preterm.

Children who are born prematurely are at a higher risk of developing developmental delays than children born at term. Early experiences in the neonatal intensive care unit (NICU) can influence developmental outcomes. Sensorimotor interventions as well as parental engagement have been designed with the aim of improving the development of children born preterm. Substantial evidence supports the benefits of each intervention on improving developmental outcomes. However, there remains a significant gap in the literature on the efficacy of a parent administered sensorimotor intervention (PASI) program in the NICU on infant's development. The proposed study is designed to evaluate the potential benefits of such a program on infant's development. A randomized block clinical trial will be performed.

A total of 84 preterm infants (\< 34 weeks gestation) will be recruited and randomized. Infants in the experimental group will receive the sensorimotor program,consisting of tactile (whole body) and oral input for 15 minutes, one time per day, for 10 days. Infants in the control group will receive standard care. The following outcomes will be monitored time to attainment of complete oral feeds (primary outcome), rate of weight gain, length of hospitalization, and developmental outcomes at 36 weeks corrected gestational age and at 4, 8, 12, 18 and 24 months corrected age. Results from this study will provide us with further knowledge on the impact of sensorimotor intervention on infants' developmental outcome as well as the effect of active parental involvement on infants' development. Provision of a PASI program is a safe and low cost effective intervention that may increase the development and quality of life of preterm born children and their family.

Eligibility Criteria:
Inclusion Criteria:

* Infants born \< 34 weeks gestation
* Infants whose parent (s) intend on visiting regularly (\> 5 days)

Exclusion Criteria:

* Infants born with a metabolic disorder or congenital abnormality
* Infants whose parents are unable to participate due to cognitive, physical or social issues.
Evaluation of Physical and Cognitive Performance After Simulated Road March Combines Physical and Cognitive Load Using a Virtual Reality Environment

The aim of the research is to evaluate the influence of physical and cognitive load as pre-mission activity on the soldier's physical and cognitive performance, in compare to physical load alone.

In order to do so, 12 healthy subjects will perform stimulated road march using a virtual reality environment combined with cognitive load and without, and their physical and cognitive performance will be evaluated by tests before and after.

12 young, healthy civilian volunteers will participate in this study. After reading and signing an informed consent form, all subjects will undergo medical examination which includes ECG, anthropometric measurements and Vo2max test.

Afterwards, the subjects will perform randomly 3 experimental days, each consist of physical and cognitive performance evaluation before and after simulated road march using a virtual reality environment; once without additional load, once combining cognitive load during the road march, and once without physical load (without march, waiting between evaluations) as control.

The experiment will take place in a dome room, and the systems being used are:

1. CAREN high (Computer Assisted Rehabilitation Environment) which screens virtual scene in the dome.
2. MOTEK (Motek Medical©, the Netherlands) which is a two track treadmill (for each leg) placed on a rotatable platform.

cognitive tasks for example: navigation, identification and remembering cars/aircraft.

Physical and cognitive performance will be evaluated at each experimental day, before and after performing the protocol. at the end of the march, cognitive performance will be evaluated by validated tests on laptop (SYNWIN activity research services) and executive function evaluation based on Trail Making Test (TMT), afterwards, Physical performance will be evaluated by HRV and time to exhaustion test (30 min after the end of cognitive tests).

Eligibility Criteria:
Inclusion Criteria:

* aged 18-30
* healthy civilians volunteers
* with no background illnesses
* with history of combat unit service in the IDF.
* fit to perform 10 Km moderate march while carrying load.

Exclusion Criteria:

* The existence or suspicion of existing cardiac or respiratory disease.
* Hypertension.
* Diabetes.
* Any muscles or skeleton condition.
* Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.
* Infectious disease 3 days prior to the experiment.
Conventional Versus 3D Printing Duplication Techniques of Complete Denture

Twenty completely edentulous patients with old, removable dentures with ill-fitting maxillary dentures, proper vertical dimension, and proper occlusion will be recruited for this trial. They will be rehabilitated with duplicated complete dentures manufactured by conventional and two different 3D-printed CAD-CAM Complete Removable Dentures techniques.

Outcomes will be evaluated, including denture retention, which will be evaluated using a digital force gauge, and occlusal force distribution by using a t-scan.

The study will be conducted at the outpatient clinic of the Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University. This within-subject controlled clinical trial will involve twenty completely edentulous patients with old, ill-fitting maxillary complete dentures, who will be selected and recruited following approval by the Research Ethics Committee of the Faculty of Dentistry, Ain Shams University (FDASU-REC). These patients will be rehabilitated with duplicated complete dentures produced through conventional methods and two distinct 3D-printed CAD/CAM techniques.

Group I: The duplication of a refitted complete removable denture will be performed using the conventional heat-cured technique.

Group II: The refitted complete denture will be duplicated using a 3D-printed CAD/CAM technique, where the denture base will be printed separately with pink resin, and the teeth will be printed as a single unit in tooth-colored resin, followed by assembly of the two components.

Group III: The refitted complete denture will be duplicated using a 3D-printed CAD/CAM technique, with the entire denture printed as a single unit in tooth-colored resin, and the denture flange veneered with pink resin.

Outcomes will be evaluated by measuring denture retention with a digital force gauge and occlusal force distribution using the T-Scan system. The collected data will be recorded, tabulated, and subjected to statistical analysis using appropriate tests for group comparisons.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with old complete dentures without lost vertical dimension.
2. Patients with correct centric occluding relation.
3. The dentures should be esthetically and functionally satisfactory and exhibit reasonable retention and stability

Exclusion Criteria:

1. The presence of ridge or soft tissue pathology.
2. Diminished saliva production.
3. A history of medications affecting saliva quantity or quality.
4. Patients with temporomandibular joint problems.
5. The presence of sever ridge undercut.
6. Debilitated patients
A Randomized Controlled Study of Conservative Treatment of Granulomatous Lobular Mastitis Combined With Psychiatric Disorders

Granulomatous lobular mastitis (GLM) is a relatively rare chronic inflammatory disease of the breast in clinical practice. A small number of patients develop hyperprolactinemia during psychiatric drug treatment, and most of these patients are nulliparous. At present, there is no unified treatment mode at home and abroad, and surgery is generally the main treatment. GLM is a sterile inflammation, and glucocorticoids and methotrexate can effectively relieve clinical symptoms and even reach the standard of cure. In order to reduce the recurrence rate and protect the breast appearance as much as possible, we propose a conservative therapy. The purpose of this study was to compare this conservative therapy of granulomatous lobular mastitis with existing surgical treatment, and to compare the overall benefits of the two for patients with GLM. We aim to protect the breast appearance on the premise of low recurrence, improve the quality of life of GLM patients with psychiatric disorders .


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older with granulomatous lobular mastitis
* Patients with Psychiatric Disorders;
* Patients volunteered to participate in the study after informed consent.

Exclusion Criteria:

* Patients were diagnosed with mastitis with other definite etiology confirmed by pathology
* Patients in acute exacerbation of mental illness