cyrilzakka/clinical-trials huggingface dataset:
The Effect of Real-time Continuous Glucose Monitoring on Severe Complications to Pregnancy in Women With Diabetes

The purpose of the study is to investigate the effects of Real-time Continuous Glucose Monitoring on severe complications to pregnancy in women with diabetes.

Pregnancy outcome in women with type 1 or type 2 diabetes is still significantly poorer than in the background population. The prevalence of large fat babies (LGA) is 50% in both types of diabetes, and perinatal death and preterm delivery is 4-7 times higher than in non-diabetic women. These complications are all closely related to non-optimal glycemic control in pregnancy, and improved metabolic control is crucial in our strive for improved pregnancy outcome in these patients.

In 2007, a new generation of "real-time" Continuous Glucose Monitoring (CGM) became available in Denmark. These sensors estimate tissue glucose values automatically and frequently with immediate display of the glucose level. In addition it is possible to set alarms for high and low glucose levels, and the patient can react immediately with changes in diet or insulin dose.

In this trial, 154 patients were randomized to either continuous glucose monitoring at five times in pregnancy in addition to standard care ot to unchanged standard care. The main aim is to evaluate if the use of CGM in pregnancy can reduce the prevalence of LGA from 50 to 30%, but other outcome measurements such as preterm delivery, neonatal disease, hypoglycemia, low grade inflammation and vascular dysfunction, quality of life and self- care are also recorded.

Eligibility Criteria:
Inclusion Criteria:

* Pregestational diabetes, type 1 or type 2
* Single intrauterine pregnancy
* At least 18 years old
* Informed consent

Exclusion Criteria:

* Past gestational week 14 at inclusion
* Mental disorders
* Language barriere
* Gemelli
* Diabetic nephropathy
Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Hormone Therapy

Patients treated for breast cancer with hormone therapy (HT) suffer from hot flashes. This side effect impacts treatment adherence. Indeed, approximately 50% of women take less than 80% of the prescribed dose, and up to 50% abandon their treatment before the fifth year of prescription, significantly increasing the risk of recurrence. Moreover, these hot flashes strongly impact the quality of life. According to the CANTO study, these hot flashes can persist up to two years after diagnosis, affecting social relationships, return to work, and physical and mental health.

Some side effects resulting from HT (sleep disturbances, fatigue, hot flashes) could be alleviated by a non-pharmacological approach involving the patient.

Our hypothesis is that a non-pharmacological solution, such as the use of self-hypnosis, could reduce hot flashes and the side effects related to HT or the perception thereof in patients treated for breast cancer. Consequently, this could improve the quality of life and lead to better treatment adherence.

The principal objective is to evaluate the effect of daily guided self-hypnosis sessions in reducing hot flashes in patients with non-metastatic breast cancer receiving anti-aromatase hormone therapy.

The secondary objectives are to evaluate :

* Patient adherence to guided self-hypnosis via a digital solution
* Quality of life
* Sleep quality
* Satisfaction with care
* Usability of the digital tool

The originality of this clinical trial is the proposal of self-hypnosis sessions over three weeks with three different themes using a digital solution.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient,
* WHO ≤ 2,
* Patient who is premenopausal, perimenopausal, or postmenopausal at diagnosis,
* Patient being treated for non-metastatic breast cancer,
* Ongoing adjuvant endocrine therapy, with or without concomitant anti-CDK 4/6 targeted therapy,
* Patient reporting at least 50 hot flashes per week or at least 7 hot flashes per day
* Patient has a computer device capable of accessing the self-hypnosis program link,
* Information provided and informed consent signed,
* Patient affiliated with the social security system.

Exclusion Criteria:

* Male,
* Patient with hearing impairments,
* Patient with psychotic and/or cognitive disorders As assessed by the clinician,
* Patient who does not understand the French language,
* Patient not diagnosed with non-metastatic breast cancer,
* Patient not undergoing anti-aromatase treatment,
* Patient reporting fewer than 50 hot flashes per week or fewer than 7 hot flashes per day,
* Prior participation in a hypnosis or self-hypnosis program before inclusion,
* Patient participating in a therapeutic program related to hot flashes,
* Patient already included in another therapeutic trial on the same topic,
* Patient already included in another therapeutic trial with an experimental drug,
* Pregnant or breastfeeding woman,
* Patient deprived of liberty (including guardianship and curatorship).
Nationwide Research on the Rewilding of Kindergarten Yards

Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities that is associated with altered commensal microbiota and a rising burden of immunological disorders among urban children.

The investigators will estimate how rewilding of kindergarten yards affects commensal microbiome, prevalence of allergies, asthma, atopic dermatitis and infections, cortisol levels, cognitive skills and plasma cytokine levels of children.

Our specific aims are:

To assess if rewilding diversifies health-associated skin, saliva and gut microbiota and reduces infectious diseases and atopic or allergic symptoms.

Assess whether the rewilding has positive effects on cognitive skills. Assess whether the rewilding changes cortisol and plasma cytokine levels. The investigators will recruit altogether 320 (160 per treatment) study subjects aged between 1-5 to questionnaire study (Task 2), from which 120 study subjects will be analyzed more detailed using microbiological and blood samples (Task 1).


Eligibility Criteria:
Inclusion Criteria:

* Attendance in kindergarten

Exclusion Criteria:

* Use of antibiotics in the year before sampling
A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes

The purpose of this study is to compare LY900014 to insulin lispro, both in combination with insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed (clinically) with T2D, based on the World Health Organization (WHO) classification for at least 1 year prior to screening.
* Have been treated for at least 90 days prior to screening with:

  * Basal insulin (insulin glargine U-100 \[Basaglar/Abasaglar or LANTUS\] or U-300, insulin detemir, insulin degludec U-100 or U-200, or neutral protamine Hagedorn \[NPH\] insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro U-100 or U-200, insulin aspart, insulin glulisine, or regular insulin) Or
  * Premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily
* Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) in accordance with local regulations:

  * Metformin
  * Dipeptidyl peptidase-4 (DPP-4) inhibitor
  * Sodium glucose cotransporter 2 (SGLT2) inhibitor
  * Sulfonylurea
  * Meglitinide
  * Alpha-glucoside inhibitor
* Have an HbA1c value between ≥7.0 and ≤10.0%, according to the central laboratory at the time of screening.
* Have a body mass index (BMI) of ≤45.0 kilograms per meter squared at screening.

Exclusion Criteria:

* Have been diagnosed, at any time, with type 1 diabetes (T1D) or Latent Autoimmune Diabetes in Adults.
* Have hypoglycemia unawareness as judged by the investigator.
* Have had any episode of severe hypoglycemia within the 6 months prior to screening.
* Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
* Have used thiazolidinediones, Glucagon-Like Peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.
A Study to Evaluate MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma

This is a multicenter, randomized, double-blind, placebo-controlled study designed to demonstrate the safety and efficacy of MILR1444A compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult patients with mild allergic asthma. The study will randomize approximately 24 patients at five study centers. In the event of patient discontinuation from the study, additional patients may be enrolled at the discretion of the Sponsor.


Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for the diagnosis of allergic asthma
* Diagnosis of asthma ≥ 6 months
* Currently treated with only intermittent short-acting inhaled β-adrenergic agonists
* Body weight between 40-120 kg
* Normal chest X-ray within 2 years of screening

Exclusion Criteria:

* Require daily controller medication for asthma
* History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to MILR1444A (e.g., monoclonal antibodies, polyclonal gamma globulin)
* Documented medical history of anaphylaxis
* Immunotherapy currently or within the past 3 months prior to screening
* Lung disease other than mild allergic asthma
* Previous treatment with other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer
* Pregnant or lactating
* Significant concurrent medical illness other than asthma
* Clinically significant abnormality on ECG at the screening visit
* Smoked in the previous 6 months or have a history of smoking more than 10 pack-years
* History of helminthic infection
The Effect of HMG-CoA Reductase Inhibition on Postprandial GLP-1 Secretion

The primary objective of the present study is to evaluate the effect of HMG-CoA reductase inhibition during 14 days on the postprandial plasma GLP-1 response in healthy individuals. Secondary objectives include the evaluation of HMG-CoA reductase inhibition on postprandial glucose tolerance, gallbladder emptying, gastric emptying, plasma responses of lipids, bile acids and pancreatic and enteric hormones known to influence glucose metabolism and appetite, and faecal content of bile acids and gut microbiota composition.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \>18.5 kg/m2 and \<35 kg/m2
* Caucasian ethnicity
* Normal haemoglobin
* Glycated haemoglobin (HbA1c) \<43 mmol/mol
* Fasting plasma glucose \<6 mmol/l
* Informed and written consent

Exclusion Criteria:

* Diabetes
* First-degree relatives with diabetes (both type 1 diabetes and type 2 diabetes)
* Liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>2 times normal values) or history of hepatobiliary disorder
* Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
* Reduced kidney function or nephropathy (estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m2 (based on serum creatinine) and/or albuminuria
* Taking any kind of medicine on a regular basis
* Intake of antibiotics two months prior to study
* Active or recent malignant disease
* Any treatment or condition requiring acute or sub-acute medical or surgical intervention
* Any condition considered incompatible with participation by the investigators
* If the subjects receive any antibiotic treatment while included in the study they will be excluded
Improving HbA1c Levels by Methylcobalamin Vitamin in Diabetic Volunteers

The current study was conducted to evaluate the prognostic implications of vitamin B12 admission on BMI and HbA1c levels in type 2 diabetic patients treated with Dapagliflozin as a routine medication.

Eighty diabetic patients were enrolled in this study; 37 females and 43 males with inclusion criteria of vitamin B12 levels less than 233 ng/ml. The participants were divided into two groups, the Dapagliflozin group (active comparator group) received only the diabetic-controlling drug Dapagliflozin 10 mg/daily orally for twelve months, whereas, vitamin B12 and Dapagliflozin group (Experimental group) received Vit. B12 supplements as methylcobalamin 500 µg orally once daily with Dapagliflozin 10 mg/daily orally for twelve months. Glycemic control was measured by monitoring levels of HbA1c and Vitamin B12 in the participant's blood four times at time intervals of three months during the study period. Additionally, the weight measurements were recorded during the study period at time intervals of three months and BMI was calculated. The data obtained was treated by statistical analysis using SPSS software (version 20) for the significant correlation of the independent variables of the study groups after vitamin B12 supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patient treated with Dapagliflozin

Exclusion Criteria:

* The levels of Vitamin B12 more than 200 ng/ml
"Multifactorial Risk Stratification in Acute and Chronic Cardiovascular Disease"

The aim of this study is to develop risk prediction models for the early detection of high-risk patients with structural, rhythmological or inflammatory cardiovascular diseases.


Eligibility Criteria:
Inclusion Criteria:

* Decision-eligible male and female patients ≥18 years of age
* Acute or chronic condition due to structural, rhythmologic, or inflammatory cardiovascular disease
* Informed consent for participation in the clinical trial

Exclusion Criteria:

* missing infromed consent
* pregnant or breast-feeding women
Patient Performance and Acceptance of Virtual Reality Visual Field Devices

The purpose of this research is to study the effectiveness and patient experience when measuring visual fields using virtual reality goggles.


Eligibility Criteria:
Inclusion Criteria:

* Any patient \>13 years old at Bascom Palmer Eye Institute
* Patients who either have glaucoma, are glaucoma suspects, or have a strong family history of glaucoma

Exclusion Criteria:

* Adults unable to consent, pregnant women, prisoners
* Patients under the age of 13
HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol

To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the relative safety and efficacy of 2 doses of HPMPC as maintenance regimens.

In Stage 1, up to 30 patients are randomized to either observation with deferral of treatment until the retinitis progresses (observation group), or to intravenous HPMPC at the higher dose for two consecutive weekly induction doses, followed by the lower dose every other week for maintenance. In Stage 2, up to 70 patients are randomized to observation or to HPMPC at the higher dose for two consecutive weekly induction doses followed by either dose every other week for maintenance, for a total of three treatment groups. Concomitant saline hydration and probenecid are administered to patients receiving HPMPC.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Oral trimethoprim/sulfamethoxazole.
* Aerosolized pentamidine.
* Dapsone.
* Fluconazole.
* Ketoconazole.
* Itraconazole.
* Rifabutin.
* Filgrastim (G-CSF).
* Antiretroviral agents.

Patients must have:

* AIDS by CDC criteria.
* CMV retinitis as determined by a SOCA-certified ophthalmologist, with lesion size, location, and severity as specified in the Disease Status field.

Prior Medication:

Allowed:

* Prophylaxis with anti-CMV agents.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Ongoing therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity.
* Therapy with nephrotoxic drugs, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine.

Patients with the following prior conditions are excluded:

* History of renal disease or renal dialysis.
* History of clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
* History of clinically significant probenecid allergy.

Prior Medication:

Excluded:

* Prior therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity.
* Therapy with nephrotoxic drugs within the past 7 days, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine.

Drug or alcohol abuse sufficient to hinder compliance with study.
Coroflex ISAR 2000 Extended Registry (ISAR2000 Extended)

Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" patients with de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries.

The aim of the study is to assess the safety and efficacy of elective deployment of the Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries of 2.0 mm up to 4.0 mm in diameter and up to 30 mm in length for procedural success and preservation of vessel patency.

Eligibility Criteria:
Inclusion Criteria:

* patients suitable for percutaneous coronary intervention with proof of ischemia
* at least 18 years of age

Exclusion Criteria:

* Intolerance to sirolimus and/or probucol
* Allergy to components of the coating
* Pregnancy and lactation
* Complete occlusion of the treatment vessel
* Severely calcified stenosis
* Cardiogenic shock
* Risk of an intraluminal thrombus
* Haemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
* Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
* Severe allergy to contrast media
* Lesions which are untreatable with PTCA or other interventional techniques
* Patients with an ejection fraction of \< 30 %
* Vascular reference diameter \< 2.00 mm
* Treatment of the left stem (first section of the left coronary artery)
* Indication for a bypass surgery
* Contraindication for whichever accompanying medication is necessary
Surgical Treatment of Hepatic Hydatidosis in Elderly Patients

Cystic echinococcosis is a clinically complex chronic parasitic disease and a major socioeconomic problem in endemic areas. The safety of liver resection in elderly patients is often debated among medical professionals. The investigators analyzed the postoperative morbidity and mortality rates of elderly patients who underwent surgery at our unit.

Retrospective observational study from prospective database focused on liver hydatidosis carried out at our Hepato-Pancreato-Biliary Surgery Unit. The study period spanned from January 2006 to October 2020. The study was approved by the Research Ethics Committee of our hospital. An informed consent from the patient was not required since the study was retrospective and observational, and entailed no risk. Seventy years of age was the cutoff age to consider patients as elderly.

Inclusion criteria of patients: liver hydatid cyst (LHC) diagnosed by preoperative computed tomography (CT) or magnetic resonance imaging (MRI) and pathological diagnosis after surgery, and LHC treated by total or partial pericystectomy.

Exclusion criteria of patients: emergency surgery and simple drainage of cyst.

Eligibility Criteria:
Inclusion Criteria:

* liver hydatid cyst (LHC)
* pathological diagnosis after surgery
* LHC treated by total or partial pericystectomy

Exclusion Criteria:

* emergency surgery and simple drainage of cyst
Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia

The purpose of this study is to test multiple doses of sarizotan to establish a dose with maximal safety and efficacy for treating treatment associated dyskinesia in Parkinson's disease participants.


Eligibility Criteria:
Inclusion Criteria:

* The participant is an out-patient
* The participant presents with a diagnosis of idiopathic Parkinson's disease
* Prior therapy with all registered Parkinsonian medication is allowed

Exclusion Criteria:

* (For female participants) The participant is pregnant or lactating
* The participant is participating in another clinical study or has done so within the past 30 days
* The participant has received neurosurgical intervention related to Parkinson's disease
* The participant has relevant renal impairment
* The participant has relevant hepatic impairment
* The participant is suffering from any dementia or psychiatric illness
* The participant has a history of allergic asthma
Anterior Gen Plus Study

A clinical study evaluating patients treated with the Demineralized Bone Matrix (DBM) as compared to a Cellular Bone Matrix (CBM) in anterior lumbar interbody fusion.

A prospective, single-center, clinical study evaluating patients undergoing primary, contiguous 2-level ALIF without supplemental fixation treated with Demineralized Bone Matrix (DBM) as compared to a Cellular Bone Matrix (CBM).

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Requires anterior lumbar interbody (ALIF) fusion
* Are physically and mentally able and willing to return for the scheduled follow up visits, follow post-operative instructions
* Willing and able to sign study specific Informed Consent Form

Exclusion Criteria:

* Signs of acute infection
* Active malignancy and/or current chemotherapy
* Prior fusion at operative or adjacent level
* Institutionalized or a prisoner
* Documented history of alcohol or drug abuse
* Undergoing a worker's compensation case
* Pregnancy
* Participation in another research study involving another implant or drug that may affect the outcomes of this clinical study
* Any other condition that the Investigator determines is unacceptable for enrollment into this clinical study
Clinical Effect Of Cross Titration Of Antipsychotics With Ziprasidone In Schizophrenia Or Schizoaffective Disorder

The primary objective is to compare effectiveness of ziprasidone treatment to current treatments (haloperidol, olanzapine or risperidone) measured by change in Brief Psychiatric Rating Scale (BPRS) scores versus baseline


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of schizophrenia or schizoaffective disorder, using DSM-IV criteria.
* Currently receiving either haloperidol, olanzapine or risperidone within -/+ 25% of the recommended daily dose (as delineated by the medication's package insert

Exclusion Criteria:

* Resistance to conventional antipsychotic drugs
* With antipsychotic agents other than olanzapine, risperidone or haloperidol at start of treatment regimen within 12 hours prior to first dose of study drug