cyrilzakka/clinical-trials huggingface dataset:
Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells

Mesenchymal stem cells have the capability to differentiate into hepatocytes and will be useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cells compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will receive autologous adipose tissue derived stromal cells which include such mesenchymal stem cells.

The population of the liver cirrhosis patients is enormous in Japan and the only radical treatment for them is liver transplantation. However, the number of giving donors is extremely limited. Mesenchymal stem cells have been capable to differentiate into mesodermal-lineage cells as well as endodermal-lineage cells such as hepatocytes. They reside in the mesenchymal tissues such as bone marrows as well as adipose tissues. The latter tissues are relatively enriched with mesenchymal stem cells compared to bone marrow cells. In this study, the cirrhotic patients will receive autologous adipose tissue derived stromal cells which contains substantial number of mesenchymal stem cells.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis patients
* Platelets count in peripheral blood: over 7.0x10\^4/microliter
* Serum creatinine: less than 1.5 mg/dl
* Capable of understanding the features of this clinical trial

Exclusion Criteria:

* Associated with risky gastroesophageal varices for bleeding
* Severe portal hypertension
* Complicated with severe heart failure
* Renal disease
* Respiratory disease
* Hematological disease
* Coagulation disturbance and judged to be excluded by doctors
* Associated with malignancy
* Past history of the following:

  * malignancy
  * ischemic heart disease
  * cerebrovascular disease (cerebral infarction, cerebral hemorrhage)
  * decompensated status of liver cirrhosis
* Pregnant, or possibility of pregnancy
* Infected with HIV
* Under mediation with adrenal corticoid steroid, anti-histamine drug
* Anticipated with difficulty of follow-up observation
* Anticipated with inconsistency of following the protocol
* Addiction of alcohol drinking and unable to stop drinking
* Other candidates who are judged to be not applicable to this study by doctors
Sleep Apnea, Coronary Atherosclerosis and Heart Failure in Diabetes Patients With Nephropathy

Background:

Diabetes, and especially diabetic kidney disease is associated with the development of cardiovascular disease such as calcification in the coronary arteries and heart failure. Sleep apnea is frequent among patients with diabetes and diabetic kidney disease and sleep apnea itself is a solitary risk factor in the development of cardiovascular disease. Nonetheless, sleep apnea is underdiagnosed in diabetes patients because of a discrepancy between sleep apnea severity and actual oxygen deficiency symptoms which makes the diagnosis difficult. For that reason, many diabetics have undiagnosed sleep apnea together with cardiovascular disease. Early discovery of sleep apnea among high risk diabetic patients may therefore be considered crucial before cardiovascular complications develop. For this reason, sleep apnea screening of high-risk diabetics can possibly improve early diagnostics of cardiovascular disease.

Aim:

This study will seek to establish the association between obstructive sleep apnea (OSA) and coronary calcification and heart failure in patients with diabetic kidney disease. The basic hypothesis of the study is that patients with diabetic kidney disease and concurrent OSA have a higher prevalence and severity of coronary calcification and heart failure compared to patients without OSA.

Methods:

Diabetic adult patients with scheduled check-ups at Steno Diabetes Center Aarhus, or Department of Renal Medicine on Aarhus University Hospital will be included in the study.

Firstly, all included patients are screened for sleep apnea with the devices SomnoTouch® and ApneaLink®. Based on the sleep apnea determination; 40 patients with moderate-severe sleep apnea are compared with 40 patients without sleep apnea. In both groups, the patients are examined for calcification in the coronary vessels using a CT-scan while the function of the heart is examined by ultrasound (echocardiography). The stiffness of aorta is measured and performed using radial artery tonometry (SphygmoCor®).

Furthermore, range of blood- and urine samples will be performed

The perspectives are that patients with diabetes should be regularly evaluated for sleep apnea and that patients with moderate/severe sleep apnea should undergo further examination for cardiovascular disease even though the patients don't display any symptoms of either cardiovascular disease or sleep apnea.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years.
* Diabetes Mellitus Type 2 with an eGFR between 10-60 ml/min/1,73 m\^2 (Equalling CKD-group 3, 4 and 5 non-dialysis).

Exclusion Criteria:

* Known sleep apnea in continuous positive airway pressure(CPAP) treatment.
* Known mild sleep apnea (AHI 5-14) after the sleep apnea measurement.
* Participants with central apnea (\> 50 % of central apnea episodes in the AHI ≥ 15 group.) or Cheyne Stokes after the sleep apnea measurement.
* \< 4 hours of recording (ApneaLink)
* Known coronary arterial disease with previous revascularization (PCI or CABG)
Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection

The aim of this study is to compare clinically significant prostate cancer detection rate by the 4 biopsy methods: TRUS-guided, cognitive, fusion and transperineal template mapping biopsy.

It is recommended to combine MRI-guided biopsy with systematic (TRUS-guided or transperineal template mapping biopsy) biopsy for high yield of prostate cancer diagnosis. Nevertheless, it remains unclear which biopsy combination is more precise for prostate cancer detection.

Taking into consideration the variety of prostate biopsy methods (TRUS-guided, cognitive, fusion and transperineal template mapping biopsy), the issue of indications for each of them remains unresolved. Current EAU guidelines recommend combining MRI-guided biopsy with systematic (TRUS-guided or transperineal template mapping biopsy) one for high yield of prostate cancer diagnosis. Nevertheless, it also remains unclear which biopsy combination is more precise for prostate cancer detection.

This is a prospective single-arm study.

All patients underwent prostate TRUS examination and mpMRI. Suspicious lesion found on MRI were classified with the Pi-RADS v2.1. First step: the "unblinded" urologist №1 performed a fusion and transperineal template mapping biopsy. Second step: the "blinded" urologist №2 performed TRUS-guided and cognitive biopsy.

Objectives of the study: to determine clinically significant prostate cancer detection rate, overall cancer detection rate, clinically insignificant prostate cancer detection rate, sampling efficiency (positive biopsy cores' number, maximum cancer core length (MCCL)). Results were calculated for each biopsy method separately and for combinations of TRUS-guided and cognitive biopsy (combination №1) and fusion and transperineal template mapping biopsy (combination №2).

Eligibility Criteria:
Inclusion Criteria:

* PSA \>2 ng/mL, and/or positive digital rectal examination (DRE), and/or suspicious lesion on TRUS
* Pi-RADSv2.1 ≥3 score

Exclusion Criteria:

* previously diagnosed PCa;
* acute prostatitis within the last 3 months;
* 5-α reductase inhibitors therapy within the last 6 months;
* extracapsular extension;
* prostate volume ≥80 cc;
* contraindications for mpMRI.
Assessment of the Effects of a 24-hour Cold and Heat Exposure on the Factors Influencing Food Intake

Military personnel and athletes have a very high energy expenditure which is increased during certain key periods (intense training, competition and mission). Compensating for this expenditure through food can be complicated by physiological ingestive limits and logistical and organizational constraints (number of meals, availability of food), which leads these populations to regularly experience energy deficit situations (intake below requirements), which could alter physical and cognitive performance and major physiological functions.

Among the many constraints to which military personnel and athletes are exposed to (stress, sleep deprivation, travel, etc.) that can increase the risk of energy deficits, the impact of thermal environmental constraints is not well known. The seasonal impact and travel to countries with very different thermal environments can lead these populations to experience cold and hot conditions for long periods.

Understanding how heat and cold exposure modifies appetite and energy intake therefore appears to be of great importance.

The hypothesis of this study is that a 24 h heat exposure would produce a rapid and long-lasting anorexigenic action impacting energy intake, while a cold exposure would produce the opposite effect (orexigenic action).


Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged 18 to 40 years old
* Active (≥ 3 hours of physical activity per week)
* Healthy (no metabolic pathology)
* Affiliated to the social security system
* Having given written consent to participate.

Exclusion Criteria:

* Unusual eating pattern (\< 3 meals per day) or irregular eating pattern
* Pattern of dietary restriction (determined by the Three-Factor Eating Questionnaire-21)
* Unusual sleep pattern (Epworth score \> 10, insomnia severity score \> 14, Pittsburgh Sleep Quality Index \> 5), sleep duration \< 6 h per night or difficulty falling asleep)
* Metabolic pathology
* On medication
* Previously exposed to unusual levels of heat or cold (vacation, missions) in the 4 months prior to inclusion
* Refusal to participate.
Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan

The purpose of this study is to evaluate the efficacy of Losartan use post-operatively for reducing or preventing the development of arthrofibrosis and the associated adverse impacts on clinical outcomes.

This is a double-blind, randomized, placebo-controlled clinical trial proposed to evaluate the efficacy and safety of Losartan for reducing or preventing arthrofibrosis and improving patient-reported outcomes after total knee arthroplasty (TKA). Fibrosis will be evaluated over time after TKA using measures of knee range of motion and capsular thickening.

120 patients scheduled to undergo total knee arthroplasty will be recruited from the clinical practice of the Principal Clinical Investigator or his designee at The Steadman Clinic (TSC) and randomized into one of two arms (1:1).

Eligibility Criteria:
Inclusion Criteria:

1. Planned primary total knee arthroplasty of a single knee;
2. Male or female ≥ 18 years of age;
3. Capacity to personally give informed consent (consent via legally authorized representative will not be accepted) and who are willing to comply with all study-related procedures and assessments.

Exclusion Criteria:

1. Breastfeeding, pregnant, or planning to become pregnant during participation in the study;
2. Diagnosed with inflammatory or other arthritis caused by autoimmune disease affecting the study knee;
3. Previous knee arthroplasty on the study knee;
4. Previous infection affecting the study knee;
5. Planned total knee arthroplasty of contralateral knee to occur at any point during the study participation period;
6. Are hypotensive as confirmed by Principal Clinical Investigator or appropriate designee;
7. Planned lower extremity surgery (other than TKA in the study leg) for the duration of study participation;
8. Any condition other than knee osteoarthritis that significantly impairs ability to walk or perform other activities of daily living;
9. Currently taking: Losartan or other medication in the same drug class; Warfarin or related anticoagulants;
10. Opioid analgesics taken in the past 8 weeks and are not willing to discontinue these medications through the duration of the study (except as prescribed as standard of care in the immediate post-operative period);
11. Allergic to any active or inactive ingredient of Losartan;
12. Taking medication with known adverse Losartan interaction;
13. Subjects that have any medical condition, including malignancies, laboratory findings, and/or findings in the medical history or in the pre-study assessments that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation, or prevent the patient from fully participating in all aspects of the study.
CRT In Narrow QRS Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping

Cardiac Resynchronisation Therapy (CRT) is a specialist pacemaker procedure that aims to improve the efficiency of the heartbeat. This treatment is used routinely in patients with heart failure and a delay in electrical conduction across the heart seen on the surface ECG (heart tracing). Also CRT has been seen to improve some heart failure patients with a normal electrical conduction (seen on the ECG as a narrow QRS complex). The investigators aim to see if cardiac MRI can be used to select patients with normal electrical conduction for CRT, therefore expanding the number of people who would stand to benefit from this treatment.


Eligibility Criteria:
Inclusion Criteria:

* • Participant is willing and able to give informed consent for participation in the study.

  * Male or Female, aged 18 years or above.
  * NYHA grade III-IV heart failure
  * LVEF\<35%
  * QRS duration \<120ms
  * On optimum medical therapy for heart failure
  * Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
  * Able (in the Investigators opinion) and willing to comply with all study requirements.
  * Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria:

* • Female participants who is pregnant, lactating or planning pregnancy during the course of the study.

  * Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
  * Participant who is terminally ill or is inappropriate for placebo medication
  * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  * Contraindication to an MRI scan
  * Rate uncontrolled atrial fibrillation precluding a cMR
  * Significant peripheral vascular disease precluding an EP study
  * A contraindication to anticoagulation
  * A prosthetic aortic or tricuspid valve
  * Significant Aortic valve disease
  * Known LV thrombus
  * Insufficient capacity to consent to the study
Substitution of the Normal Levels of Iron and Hemoglobin in Pregnant Women With Iron Supplement

The purpose of the study is to investigate the effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the hemoglobin, hematocrit and iron in serum and assess the course of treatment.

The purpose of the study is to investigate the effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the hemoglobin, hematocrit and iron in serum and assess the course of treatment

Eligibility Criteria:
Inclusion Criteria:

1. Age more or equal of 18 years
2. Registration consent
3. Have complete 12h week of pregnancy
4. Hemoglobin levels \<10,5 ptl
5. Hematocrit \< 32 %

Exclusion Criteria:

1. Age \<18 years
2. Absent registration consent
3. Step of pregnancy less than 12 weeks
4. Coadministration formulations iron oral or parenterally
5. Background of liver kirrosis
6. Background of aimosidirosis
7. Background acquired or chronic aimatochromatosis
8. Aplastic , Hemolytic anemia and chronic diseases
9. Chronic pancreatitis
10. Subjective renal or/and liver disease
11. Hypothyroidism or yperthyreoeidismos
TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine

An evaluation of tablet disintegration and absorption and gastric transit of sumatriptan and naproxen sodium from a TREXIMA tablet and eletriptan from a RELPAX 40mg tablet.


Eligibility Criteria:
Inclusion Criteria:

* Consented males and nonpregnant females using adequate contraception, between 18 and 55 years of age, with at least 1-6 migraines per month for past 6 months. Subjects will be excluded for confirmed or suspected ischemic heart disease, uncontrolled hypertension at screening; a history of epilepsy or structural brain lesions which lowered the convulsive threshold; confirmed or suspected cardiovascular, cerebrovascular, peripheral vascular, congenital heart disease, or ischemic bowel disease; impaired hepatic or renal function; basilar or hemiplegic migraine. Other exclusion criteria included use of a monoamine oxidase inhibitor within 2 weeks before screening; ergot prophylactics in past 3 months; anticoagulants; smoking more than 10 cigarettes/day, evidence of alcohol or substance abuse; GI bleeding disorders, inflammatory bowel disease; or any concurrent medical or psychiatric condition that in the investigator's opinion could affect interpretation of efficacy or safety information or which otherwise contraindicated participation in the study.
Time Dependent Professional Toothbrushing Study

Aim:

The study was designed to test the time dependent efficacy in plaque removal of four toothbrushes: one electric toothbrush, the Philips Sonicare Elite with long (A) and short (B) brushing head and two manual brushes, the Gaba Sensitve (C), and the ADA reference brush (D) and.

Materials and Methods:

The study was a single-blind, randomized clinical timer study consisting of four identical experiments testing each brush in one quadrant. The distribution of the quadrants and brushes was randomized so that always all brushes were used within one participant. The teeth were brushed by a dental hygienist for 10, 20, 30, 45, 60 und 90 seconds per quadrant. No toothpaste was used throughout this study. The plaque assessment (Tureskey modified QHI) was done after each time interval blinded on six sites per tooth by a separate investigator. Ninety subjects participated in the study and received a professional prophylaxis prior to the experiment. They were requested to refrain from brushing their teeth for 48 hours prior to the experiment.


Eligibility Criteria:
Inclusion Criteria:

* at least 24 evaluable teeth in the mouth

Exclusion Criteria:

* systemic disease
* regular drugs or actual antibiotics
* orthodontic banding or retention wires
* oral lesions or sites with a probing pocket depth X5 mm
XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome.

The primary objective of this trial is to assess the long-term safety and efficacy of XP13512 (Gabapentin Enacarbil) taken once daily for the treatment of patients suffering from Restless Legs Syndrome (RLS).

Study XP055 is a multicenter, open-label, 52-week extension study of XP13512 (Gabapentin Enacarbil \[GEn\]) given once daily to eligible subjects with Restless Legs Syndrome (RLS) who had previously completed 1 of the following studies and met eligibility criteria: XP052 (110963 \[NCT00298623\]), XP053 (111460 \[NCT00365352\]), XP081 (111462 \[NCT01332305\]), and XP083 (111463 \[NCT01332318\]).

Eligibility Criteria:
Inclusion Criteria:

* Patients who have successfully completed one of the following studies: XP052 (110963 \[NCT00298623\]), XP053 (111460 \[NCT00365352\]), XP081 (111462 \[NCT01332305\]), and XP083 (111463 \[NCT01332318\]).

Exclusion Criteria:

* Subjects who, in the opinion of the Investigator, would be non-compliant with the study visit schedule, procedures, or medication administration.
Perio. Maint. With Diode LBR

The primary aim of this pilot study is to determine whether the test methods described feasibly achieve the goal defined for a future clinical study. The purpose is a quantitative assessment of the bactericidal effect of two adjunctive treatments compared to that of conventional periodontal maintenance debridement. Patients who meet eligibility criteria and are enrolled in the study will receive the standard of care, whole mouth periodontal maintenance treatment using ultrasonic scalers to debride deposits within the gingival sulcus. Subsequently, each of three of the quadrants will be randomly assigned to a test group (keeping the fourth quadrant as the control), thus, a "split-mouth" study design. Microbial samples will be collected using sterile paper points inserted into each tooth site involved in the study at baseline (S1) before test treatment and one week after test treatment (S2). Samples will be analyzed with real time qPCR to identify and quantify specific periodontal pathogens. Data analysis will compare the post-treatment results to baseline, the control treatment arm to the test treatment arm, and the test treatments among each other.


Eligibility Criteria:
Inclusion Criteria:

* • Adults, over 30 years old

  * At least one site in each quadrant having CAL 4-6mm and/or PPD 5-7mm (at least 4 sites per patient) with all adjacent sites having PPD\<5mm
  * Patients who received SRP treatment in the past 12 months, who are returning for routine periodontal maintenance debridement, whose pockets are stable at PPD 5-7mm (not showing improvement or decline)

Exclusion Criteria:

* • Patients who have had periodontal surgery within 12 months

  * A site adjacent to the potential study site having either an implant placed or a PPD\>7mm
  * Patients taking systemic antibiotics or immunosuppressants during or within 3 months of the study
  * Chronic smokers or smokeless tobacco users
Evaluation of Richmond Agitation Sedation Scale According to Alveolar Concentration of Sevoflurane During a Sedation With Sevoflurane in ICU Patients

Describe the Richmond Agitation Sedation Scale (RASS) values corresponding to the values of Minimum alveolar concentration of sevoflurane during sedation of patients in ICU

Prospective clinical study in ICU with sedated ventilated patients with sevoflurane using the Mirus® system. Pharmacological study of the concentration-effect relationship by administration at increasing and decreasing concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Requiring sedation by sevoflurane in ICU
* Adult patients
* Patients covered by french health care system
* Patients who have given their consent or his family

Exclusion Criteria:

* Pregnant or lactating women
* Sevoflurane anaphylaxia
* Known or suspected risk of malignant hyperthermia
* Refusal Protocol
* Brain-damaged patients
* Hemodynamic conditions not compatible with the use of sevoflurane
* ARDS patients
* Minor patients
Expanded Access to Risankizumab

This is an expanded access program (EAP) for eligible participants with Crohn's Disease (CD). This program is designed to provide access to risankizumab, prior to approval by the local regulatory agency, to patients with the highest unmet need and an urgent need for treatment, where risankizumab may prolong survival, prevent occurrence of clinical events associated with significant morbidity and/or mortality, or stabilize a progressive debilitating disease. Availability will depend on a review of the eligibility of the patient and local approval status of risankizumab for CD. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria: