cyrilzakka/clinical-trials huggingface dataset:
Levothyroxine Intervention in Pregnant Women with TSH （2.5 MIU/L-upper Limit of Reference Range） and Negative Thyroid Peroxidase Antibody

The goal of this clinical trial is to learn if levothyroxine (L-T4) works to treat pregnant women with TSH 2.5 mIU/L-the upper limit of reference range (ULRR) of pregnancy and TPOAb-negative. It will also learn about the safety of L-T4. The main quesitons the investigator want to answer are:

* Will L-T4 reduce miscarriage rates and have an impact on pregnancy complications in pregnant participants?
* What medical issues do participants have when taking L-T4 during pregnancy? -Investigators will compare L-T4 with placebo (a substance with a similar appearance without medication) to see if L-T4 could reduce miscarriage rates

Participants should:

* Take L-T4 or placebo during the whole pregnancy.
* Visit the hospital once every 6-8 weeks during pregnancy for checkups and tests
* Keep a diary of their pregncny complications and daily record of L-T4 or placebo intake.
* Visit the hospital for examination 42 days postpartum for checkups and follow up by phone at 6 and 12 months postpartum.


Eligibility Criteria:
Inclusion Criteria:

1. Women of childbearing age（18-45 years old）, natural pregnancy, singleton pregnancy.
2. Measure thyroid related indexes within 8 weeks of pregnancy: TSH 2.5mIU/L-ULRR, FT4 is normal and TPOAb negativity.
3. Willing to sign an informed consent form.

Exclusion Criteria:

1. History of recurrent miscarriage (≥3 times).
2. Assisted reproduction (artificial insemination, in vitro fertilization and embryo transfer);
3. Suffer from diseases that seriously affect pregnancy outcome, including hypertension, diabetes, heart disease, liver and kidney dysfunction, etc.
4. Failure of vital organs.
5. Except autoimmune thyroid disease，suffer from other autoimmune diseases.
6. Thyroid diseases (including hyperthyroidism, thyroid cancer, thyroid amyloidosis and other extensive intrathyroidal diseases, current subacute thyroiditis, iodine-deficiency endemic goiter, thyroidectomy or 131I treatment, previous thyroid Ultrasound prompts diffuse thyroid disease, etc.).
7. Use of thyroid-related drugs (lithium carbonate, thioureas, sulfonamides, sodium para-amino salicylate, potassium perchlorate, phenylbutazone, sulfate, tyrosine kinase inhibitor, etc.) during screening and affect thyroid Functional testing drugs. (Including glucocorticoids, metoclopramide, propranolol, amiodarone, sodium valproate, etc.)
8. Secondary hypothyroidism or central hypothyroidism. (Including pituitary tumors, surgery, radiotherapy, lymphocytic hypophysitis, etc.)
9. L-T4 allergy.
10. Unwilling to sign an informed consent.
11. Other clinicians judged that they are not suitable to participate in the study.
Novel Coating to Minimize Bacterial Adhesions and Tooth Wear in Denture Acrylic

This study evaluates the effect of coatings on bacterial adhesion on denture acrylic and the wear of denture teeth.

Denture stomatitis is a prevalent disease among removable denture wearers. The cause of this disease stems from a myriad of factors including host immunity and poor oral hygiene. Denture acrylic material is very conducive for the growth and adhesion of bacteria because of its porous nature. The application of plasma enhanced chemical vapor deposited (PECVD) coatings on the surface of acrylic dentures can produce a less porous surface which may minimize the adhesion of bacteria and therefore colonization. The goal is the application of these coatings will help minimize the occurrence of denture stomatitis.

Another issue of removable dentures is the low wear resistance of denture teeth. The application of these coatings on denture teeth should minimize wear of these teeth and prolong the life of removable dentures.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are missing some teeth and will need removable dentures

Exclusion Criteria:

* Medical contraindication for dental treatment
Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus Limbal Relaxing Incision (LRI) Patients

A prospective evaluation of postoperative corneal aberrations and visual parameters in patients assigned to either an AcrySof IQ Toric intraocular lens (IOL) group or a group implanted with a SN60WF IOL and having concomitant limbal relaxing incision.


Eligibility Criteria:
Inclusion Criteria:

1. operable cataracts
2. good ocular health
3. 0.5 D to 2.0 D of corneal astigmatism

Exclusion Criteria:

1. \> 2.0 D astigmatism
2. irregular astigmatism
3. prior or ongoing corneal disease or scarring
4. history of ocular disease
Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation

The principal objective of the CONFIDENT trial is to assess the efficacy of two units (400-500 mL in total) of convalescent plasma, as compared to Standard of Care (SoC), to reduce day-28 mortality in patients with SARS-CoV-2 pneumonia who require mechanical ventilation.

Design : multicenter randomized openlabel, phase II trial.

Number of patients to include : 500 (250 with plasma, 250 without plasma).

The principal objective is to assess the efficacy of the treatment to reduce day-28 mortality in patients with SARS-CoV-2 pneumonia who require mechanical ventilation.

Hypothesis: Passive immunization with plasma collected from patients having contracted COVID-19 and developed specific antibodies may alleviate symptoms and viral load of SARS-CoV-2 and reduce mortality.

The patients will receive currently accepted standard of care for both COVID-19 and usual organ dysfunctions observed in such cases. half the patients will be administered either Convalescent plasma, depending on the randomization process. All patients will be followed-up for one year after inclusion. The study will be considered either positive or negative, based on the principal objective. This means that the product convalescent plasme will be considered effective if mortality at day 28 is lower is patients treated with convalescent plasma than without it. The follow-up will allow to assess a series of secondary objectives, addressing the evolution of organ failures, viral infection, inflammatory response and long-term physical of psychological impact of COVID-19. Interim analyses will be performed every 100 patients included in order to stop the trial if an exceptionally good or bad result is observed, to prevent using or not using the product appropriately in further patients. These analyses will be supervised by an independent committee.

The choice to include only those patients under mechanical ventilation for severe respiratory failure makes this study different from other trials testing convalescent plasma, as most trial include less severe patients.

Eligibility Criteria:
Inclusion Criteria:

* age at least 18 years
* hospitalization in an intensive care unit participating to the study
* medical diagnosis with SARS-CoV-2 pneumonia as defined by both:

  * extended interstitial pneumonia on CT scan or a chest X-ray, consistent with viral pneumonia, within 10 days prior to inclusion
  * Positive result of SARS-CoV-2 PCR test, or any emerging and validated diagnostic laboratory test for COVID-19, within 15 days prior to inclusion
* under mechanical ventilation administered through an endotracheal tube, for less than 5 days
* prior Clinical Frailty Scale \< 6.
* written consent of the patient, or - if impossible - of a relative acting as the legal representative, or - if impossible - of a physician from a non-participating department of the same hospital acting as an impartial witness .

Exclusion Criteria:

* Pregnancy
* Prior episode of transfusion-related side effect
* Medical decision to limit therapy
* Current participation in another trial testing a COVID-19 therapy
Impact of Automated Calls on Pediatric Patient Attendance in Chile

Missed health care appointments present a serious challenge to patient care. Especially in government funded health systems like that of Chile, missed appointments can lead to delayed care, wasted resources, and escalating costs.

This private-public-research collaboration seeks to provide a rigorous, practical evaluation of a new patient reminder system, evaluate how health beliefs impact patient attendance, and capture the potential for scaling up this or other health technology systems. Using a mixed-methods approach this study will provide contextualized, triangulated analysis of pediatric patient attendance in Chile.

The Health Call study is divided into two phases. The first phase is a randomized controlled trial and side-by- side cost-benefit analysis. Enrolled guardians of pediatric patients will complete a questionnaire at the point of referral and then be randomized to intervention, the automated reminder system, or no reminder. The investigators will then monitor attendance status at their subsequent appointment and evaluate whether the appointment reminders affected attendance as well as the cost-benefit ratio of using the reminder system.

The second phase will involve interviewing guardians and healthcare professionals. These interviews have two foci. First, combined with patient, guardian, and/or household data from the randomized trial, these results will be used to develop a more comprehensive understanding of why pediatric patients attend appointments. The second focus is on improving the reminder system and developing new health technology interventions that can increase patient attendance.

Eligibility Criteria:
Inclusion Criteria:

* Guardian with a phone number (land-line or mobile) who is able to receive and answer voice calls
* Guardian who is willing to take part in the study and complete the consent form
* Guardian who is sufficiently proficient in Spanish so as to complete the questionnaire
* Guardian's patient who has a referral appointment at Hospital Luis Calvo Mackenna who is 18 years of age or younger

Exclusion Criteria:

* Guardian or child who do not meet the inclusion criteria
* Anyone that lives in the same household as an enrolled study participant.
Alternative Treatments in Acute Mountain Sickness

The purpose of this research is to support a hypothesis that osteopathic manual medicine (OMM) and / or a 10 cmH2O end-expiratory pressure (PEEP) could be used in the prevention of acute mountain sickness (AMS).

During altitude exposure, an exaggerated hypoxemia and the increase of intracranial pressure are both known to be major physipathological ways of AMS development.

The goal of the osteopathic protocol is to release tension on the circulatory structures directly related to cranial circulation and drainage. The main hypothesis is that it could lead to lower intracranial pressure and help reducing AMS signs. Furthermore the investigators would like to define a osteopathic score for individual AMS sensitivity, based on cranial bones mobility.

Several studies have shown that using PEEP at altitude (or hypoxia) increases SpO2. As for osteopathy protocol, the investigators would like to apply this experimental condition during real altitude exposure in a randomized controlled protocol.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Experienced alpinist
* No previous acclimatization

Exclusion Criteria:

* Heart failure, respiratory failure, kidney failure
* Pregnant woman
Long Term Follow up on Functional Gastrointestinal Disorder (FGID)

Long term prognosis and risk factors in functional gastrointestinal disorder (FGID) is largely unknown. The investigators plan to retrospectively analyse a cohort of children who were referred to the Pediatric Clinic due to abdominal pain with the aims to learn more about symptoms and effects of investigations performed. Furthermore, the investigators plan to contact the cases for a follow up using a validated questionnaire and analyse the long term prognosis and risk factors for prolonged severe symptoms.

Long term prognosis and risk factors in functional gastrointestinal disorder (FGID) is largely unknown. The investigators plan to retrospectively analyse a cohort of children who during the years 2010-2015 were referred to the Pediatric Clinic of Umeå University Hospital due to abdominal pain. The aims are to explore and descriptively describe the symptoms and effects of investigations performed. Furthermore, the investigators plan to contact the cases five years after the first contact for a follow up using a validated questionnaire of the ROME-III-criteria and analyse the long term prognosis and risk factors for prolonged severe symptoms.

Eligibility Criteria:
At time of first visit the children had:

1. At least 2 months of abdominal pain
2. Age 3-18 years
3. No organic gastrointestinal diseases
4. No neuromuscular disease
Creation of a Biotheque of Patients of Seine-Maritime With Meningococcal Infection

The main objective of this study is to constitute a biotheque of patients with meningococcal disease to enable results to be interpreted and genetic factors to be determined


Eligibility Criteria:
Inclusion Criteria:

* Subjects of Seine-Maritime with a meningococcal disease from the year of 2000
* parental authority assent if necessary

Exclusion Criteria:

* no parental authority assent
* child under supervision
Creation of a Patient Database for Silicon Patient Simulation, Glucose Sensor Variability and Pharmacokinetic Study of Debiotech Jewelpump

The aim this study is the acquisition and management of a data base for the development of the glycaemic regulation algorithms. This database will integrate the measures of blood glucose and the glycaemia level of the Dexcom sensor on a regular time, the injections of insulin delivered by Debiotech JewelPUMP and the level of insulin in the blood. This database will also contain the bolus of insulin injected at meals and the content of meals, the reduction insulin level during physical activity and the quantification of this physical activity. A study will also be conducted to compare the pharmacokinetics of a bolus of insulin identical with the JewelPUMP either the usual pump of the patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes type 1 Treaty by external insulin pump
* Duration of diabetes than 2 years or c indosable peptide
* Practicing insulin functional (IF) or food plan sets
* Patient having a HbA1c \< 10%
* Patient age over 18 years
* Patient having signed the form of collection of free consent and informed
* Patient affiliated with the social security

Exclusion Criteria:

* Patients with diabetes type 2
* Patient pregnant or likely to be
* All serious pathologies that can interfere with the study (in particular kidney or heart failure)
* Psychiatric pathologies incompatible with the study
Integration and Interactions Between Visual and Proprioceptive Feedbacks

Mental imagery is a rehabilitation technique for stroke patients, involving the mental representation of movement. Recent technical advancements have enabled the use of visual, proprioceptive, and mixed feedback to enhance motor stimulation. Currently, all post-stroke patients receive these techniques indiscriminately. This study aims to demonstrate differences in the integration of visual and proprioceptive feedback in stroke patients and understand the determinants based on the affected brain area.

Patients with motor disabilities will perform motor imagery tasks with various feedback types while their cortical activity is recorded using EEG. EEG data for each type of feedback will be correlated with the lesion area in order to better understand the ongoing mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* Hemiplegic subjects : Male or female, aged 18 to 80 years, first ischemic or hemorrhagic stroke, having signed the written consent and affiliated or entitled to a social security scheme

Exclusion Criteria:

* Severe cognitive impairment, severe Aphasia or severe neglect that impair ability to understand instructions or to execute tasks
Reduction of Inappropriate Implantable Cardioverter Defibrillator (ICD) Therapies in Primary Prevention Patients

The purpose of this study is to determine efficacy of a dedicated programming concept for avoidance of inappropriate implantable cardioverter defibrillator (ICD) therapies in patient with primary prevention ICD indication.

Inappropriate ICD therapies still remains a major issue with respect to patient's quality of life and proarrhythmic risk.

It's the aim of this study to determine efficacy of a dedicated programming concept for avoidance of inappropriate ICD therapy in patients who received the ICD for primary prevention of sudden cardiac death.

Eligibility Criteria:
Inclusion Criteria:

* Approved indication for new ICD implantation for primary prevention of sudden cardiac death
* Age \>=18 Years
* Written informed consent

Exclusion Criteria:

* ICD indication for secondary prevention reasons
* ICD indication for "electrical" disorders (i.e. long/short QT syndrome, Brugada syndrome etc...)
* ICD change or upgrade
* Pregnancy
* Nonage
* Patient is already participating to another study with active therapy arm
* Patient will most likely not be able to participate to the routine follow ups in the study center.
Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transvaginal Ventral Hernia Repair

This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for ventral hernia repair, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES ventral hernia repair. Data will be collected and reviewed through 12 months post-op.


Eligibility Criteria:
Inclusion:

1. Umbilical or incisional hernia greater than 2 cm in size
2. Female, age 18-75
3. Mentally competent to give informed consent
4. Scheduled to undergo a transvaginal NOTES ventral hernia repair

Exclusion:

1. Pregnant women
2. Patients with defects measuring greater than 10 cm in size
3. Patients with complex hernias requiring fascial mobilization for closure
4. Morbidly obese patients (BMI \>45)
Retrospective Study of Intestinal Microbiota in Association With Diabetes

The microbiota interacts with several human organs and influences the physiological process in the host. The predominant Phyla of species in the gut microbiota are Bacteroidetes (B) and Firmicutes (F), accounting for 60-80%, and Proteobacteria (P) and Actinobacteria (A) in minority. When some of the bacterial Phyla species are unbalanced, the pathological state of dysbiosis occurs. A laboratory index used for clinical analyzes is the F / B ratio \<0.8, which characterizes an intestinal dysbiotic state.

Many causes can affect the intestinal microbiota, thus altering it in a dysbiotic state, first of all the diet. In fact, dysbiosis can be characterized both by the severity with which it manifests itself and is also distinguished in putrefactive and fermentative dysbiosis.

Furthermore, the variation in the "normal" percentages of the Phyla is also related to some pathological alterations.

The aim of this study will be to monitor the population and heterogeneity of the microbiota in the Italian population. Knowing the complex implications of dysbiosis and the extensive data on it, this study will want to detail the state of the gut microbiota in the previously indicated population, focusing attention on peculiar profiles that could reflect a pathogenic spectrum or metabolic disturbances.

The study aims to investigate the diffusion and state of the microbiota in the Italian territory and if it occurs in association with certain pathologies and / or diet.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 16 and 80 years old,
* Patients with completed questionnare
* Dysbiosis symptoms

Exclusion Criteria:

* Under 16 years old,
* over 80 years old,
* patients misidentified
Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer

This study will evaluate the efficacy and safety of adjuvant therapy with liposomal irinotecan in combination with oxaliplatin, and S-1 compared with capecitabine combined with capecitabine in participants with pancreatic ductal adenocarcinoma after radical surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients able and willing to provide a written informed consent aged 18-75 years.
2. Histologically confirmed resected ductal pancreatic adenocarcinoma (including adenosquamous carcinoma).
3. Undergone radical resection and confirmed macroscopic complete resection (R0 and R1).
4. Full recovery after surgery; able to start adjuvant treatment within 12 weeks after surgery.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
6. The main organs function well.

Exclusion Criteria:

1. Patients with other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, pancreatoblastoma, and solid-pseudopapillary tumor.
2. Macroscopic incomplete tumor removal (R2 resection).
3. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
4. Presence or history of metastatic or locally recurrent pancreatic adenocarcinoma.
5. CA 19-9\> 180 U / ml within 21 days before randomization.
6. The toxicity of previous therapy has not recovered to Grade 1 or below.
7. Known peripheral neuropathy (CTCAE ≥ Grade 2).
8. Known deficiency of dihydropyrimidine dehydrogenase (DPD)
9. Subjects with a confirmed diagnosis of Gilbert's syndrome
Study to Demonstrate the Preliminary Safety and Effectiveness of IPBS in Performing MRI-Guided Targeting and Intervention of Breast Tissue in Female Patients Indicated for MRI-Guided Breast Biopsy

A preliminary demonstration of the Safety of IPBS in positioning a vacuum assisted biopsy (VAB) tool to enable an MRI-guided automated breast biopsy. This will consist of 10-15 biopsy procedures facilitated by the MRI-guided system. Patients will be followed after the procedure to assess clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Female patients over the age of 18 with suspected or confirmed breast cancer requiring a manual MRI-guided breast biopsy for diagnosis and staging.
* Individuals Capable of giving a free and informed consent.

Exclusion Criteria:

* Any patient for whom the manual MRI-guided breast biopsy procedure would not be possible (size of patient, etc.).
* Patients who refuse the procedure for any reason will be excluded from the study at the investigators discretion.
* Patients who are not suitable for the procedure will be excluded at the investigators discretion.
* Patients unwilling to complete associated study questionnaires or follow up visits.
* Women who are pregnant or who plan to become pregnant within the study duration.