cyrilzakka/clinical-trials huggingface dataset:
Manganese-enhanced Magnetic Resonance Imaging (MEMRI) in Heart Failure With Preserved Ejection Fraction

Heart failure with preserved ejection fraction (HFpEF) is a condition in which the heart cannot fill with blood effectively. As a result, people with HFpEF suffer fatigue, breathlessness, and develop swollen limbs. The condition often requires multiple admissions to hospital and is associated with a marked loss of lifespan.

Despite being so common, very little is known about why people develop HFpEF and there are hardly any known treatments. Type 2 diabetes (T2D) is a major risk factor for HFpEF, and people with both HFpEF and diabetes are at a heightened risk of hospitalisation and premature death. It is unclear why the combination of diabetes and HFpEF is particularly harmful. This may be related to the hearts of people with type 2 diabetes being unable to take up the mineral calcium properly, as well as due to their hearts being less energy efficient. Both of these are vital to heart muscle pumping and filling, but until recently it has not been possible to assess these in humans.

New advances in heart MRI scans, with dedicated scanner techniques and dyes (manganese contrast), now allow extremely detailed pictures of heart structure, function, calcium uptake and energy efficiency, all during the same scan. The investigators will enlist 40 volunteers with HFpEF (20 with T2D and 20 without T2D), and up to 20 healthy volunteers, to undergo a heart MRI scan with manganese contrast to assess calcium uptake and energy efficiency. This will allow the comparison of people with HFpEF with and without T2D, to see how their hearts are different to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Capacity to provide informed consent
* Symptoms (e.g. breathlessness, orthopnoea, ankle swelling, fatigue), signs (e.g. elevated jugular venous pressure, peripheral oedema, third heart sound) or established diagnosis of HF with LV ejection fraction ≥ 50%, or
* Meets HFpEF diagnostic criteria in accordance with the HFA-PEFF diagnostic algorithm form the Heart Failure Association of the European Society of Cardiology, in which a score ≥5 points confirms diagnosis of HFpEF

Exclusion Criteria:

* Known diagnosis of Type 1 Diabetes
* Pregnancy or breast-feeding or females of child bearing age without a negative pregnancy test
* Receiving an investigational drug or device within 30 days prior to participating in the study
* Decompensated heart failure or pulmonary oedema
* History of prolonged corrected QT interval or torsades de pointes
* Second- or third-degree atrioventricular block
* Abnormal liver function tests (\> 3x upper limit of normal) or history of liver disease
* Baseline eGFR \< 30mL/min/1.73m2
* Any contraindications to MRI including implanted devices/pacemakers
* Severe native valve disease, restrictive cardiomyopathy, constrictive pericarditis or hypertrophic cardiomyopathy, myocarditis or takotsubo cardiomyopathy.
* Recent myocardial infarction within the previous 3 months
* Known diagnosis of pheochromocytoma
Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children

This is a randomized, controlled trial studying the effects of various antimicrobial treatments on the intestinal microbiome of small children. The participating children with acute otitis media are treated wither with amoxicillin, amoxicillin-clavulanate or without antibiotics. The children with allergy to amoxicillin receive a course of macrolide and they will be monitored as a separate group. The main outcomes of this trial are the changes in the intestinal microbiome after the treatment.

Antimicrobial treatment of acute otitis media has been proven efficacious in children. It has been suggested that antimicrobial treatment makes a lot of harm to intestinal microbiome and may thus have effects on the child's health and wellbeing. However, data on these changes and their magnitude is scanty. This is a randomized, controlled trial studying the effects of various antimicrobial treatments on the intestinal microbiome of small children. The participating children with acute otitis media are treated wither with amoxicillin, amoxicillin-clavulanate or without antibiotics. The children with allergy to amoxicillin receive a course of macrolide and they will be monitored as a separate group. The main outcomes of this trial are the changes in the intestinal microbiome after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* acute symptoms of respiratory infection AND
* signs of inflammation on the tympanic membrane in otoscopy AND
* middle ear effusion found in pneumatic otoscopy

Exclusion Criteria:

* Suspected or proven complication of acute otitis media (for example acute mastoiditis or perforated tympanic membrane)
* Severe acute otitis media: severe pain and fever \> 39 degrees C
* Bilateral acute otitis media in a child younger than 2 years
* Primary or secondary immunodeficiency or Downs syndrome
* Impaired general condition or suspected severe bacterial infection
* Allergy to both amoxicillin and macrolide
* Acute otorrhea through tympanostomy tube
* Antimicrobial treatment ongoing or during previous 7 days
Expanded Access Use of Myozyme (Alglucosidase Alfa) in Patients With Late-onset Pompe Disease

Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The objective of this protocol is to provide enzyme replacement therapy with alglucosidase alfa on an expanded access basis, to severely affected patients with late-onset Pompe disease for whom there is no alternative treatment and who do not meet the clinical characteristics described in the inclusion criteria for participation in other Genzyme Corporation-sponsored studies currently enrolling patients with late-onset Pompe disease.


Eligibility Criteria:
Inclusion Criteria:

* The patient or the patient's legal guardian(s) must provide written informed consent prior to any study-related procedures being performed.
* The patient has/had onset of symptoms compatible with Pompe disease after 12 months of age. Age at onset of symptoms must be documented in the patient's medical record(s).
* The patient has documented GAA deficiency consistent with a diagnosis of Pompe disease, or the patient has a confirmed diagnosis of Pompe disease by documented genotype. Tissues used for determination of GAA deficiency may include blood, muscle or skin fibroblasts.
* The patient must have the following conditions: a. The patient must be wheelchair bound (unable to ambulate with the use of assistive devices, such as walker, cane, or crutches) AND b. The patient requires the use of invasive ventilation (defined as the use of any form of ventilatory support applied through an endotracheal tube).
* Female patients of childbearing potential must have a documented negative pregnancy test prior to dosing each month. In addition, all female patients of childbearing potential must use a medically accepted method of contraception throughout the program. Male patients who are sexually active must use a barrier method of contraception.

Exclusion Criteria:

* Use of any investigational product within 30 days prior to program enrollment.
* Major congenital abnormality;
* Clinically significant organic disease (with the exception of symptoms relating to late-onset Pompe disease), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study or potentially decrease survival.
* The patient meets the clinical characteristics described in the inclusion criteria for participation in other Genzyme Corporation-sponsored treatment study currently enrolling patients with late-onset Pompe disease.
Vitamin D Deficiency Among Women With Unexplained Infertility

Does vitamin D is more deficient in women with unexplained infertility than in fertile pregnant women or not?

The study will be done on women with unexplained infertility as a case group and fertile pregnant women as control group to detect if there's a difference in serum level of vitamin D between two groups which will help in the future for curing unexplained infertility women.

Eligibility Criteria:
Inclusion Criteria:

* women with unexplained infertility.
* pregnant fertile women as control group.

Exclusion Criteria:

* • Endocrinopathies such as (diabetes mellitus, thyroid disorders, parathyroid disorders and hyperprolactinemia), cardiovascular related diseases, severe infection, malignancies and concomitant diseases contribute to Vit D deficiency.

  * Women with ovulatory factor like PCOS,anovulation and poor ovarian reserve are excluded.
  * Women with endometriosis are excluded.
  * Women with autoimmune diseases like antiphospholipid antibodies or lupus erythematosus are excluded.
  * Documented uterine anomalies, tubal factor, cervical factor and other local causes of infertility.
  * Male factor of infertility is excluded.
  * Bone and metabolic disease, liver diseases and kidney related diseases.
Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz

Efavirenz causes neuropsychiatric side effects and sleep disturbance, including vivid dreams, dizziness, and abnormal tiredness. These symptoms are frequent during the first weeks of treatment, with subsequent attenuation but may not completely resolve even years after efavirenz initiation.

The investigators plan a twelve week, randomized, placebo-controlled, double-blind study. In group 1, efavirenz will be replaced with efavirenz placebo plus etravirine, in group 2, efavirenz would be continued, and etravirine placebo given in addition. After six weeks, patients in group 1 would switch to the regimen of group 2, and vice versa.

The primary endpoint of the trial will be patient preference. Sleep quality, daytime sleepiness, and anxiety will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \> 18 years
* Signing the study consent form and agree to change ART regimen
* Stable HAART including EFV since at least 3 months
* HIV-RNA below 50 copies for at least 3 months

Exclusion Criteria:

* No major psychiatric disease (psychosis, severe depression) diagnosed before the initiation of EFV
* Mentally incompetent patients
* Pregnancy or lactation Women of childbearing potential must use one or two reliable contraceptive methods during the trial, from day 1 to the end of week 12. Acceptable methods include the birth control pill, IUD, condoms with spermicides. Non-acceptable methods include (non-exhaustive list): Withdrawal, calendar (Onigo method), or spermicides alone.
* Concomitant renal or hepatic disease:

  * Creatinine above 150 micromol/L
  * Transaminases above 5 times upper normal limit
  * Prothrombin (Quick) value below 50%
Effect of Treatment With Metformin in Type 2 Diabetes Patients on Alternative Genes Splicing

Main objective : Show that treatment with metformin in patients with type 2 diabetes has an effect on alternative splicing of the insulin receptor.

Secondary objective : demonstrate that the effect on the ratio A/isoform B isoform with discontinuation of treatment with metformin can be réversé by the resumption of metformin treatment.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetic patients usually treated with metformin (≥ 1400 mg/day), associated or not to other oral anti-diabetic treatment or. injection treatment
* Patients major.
* Patients with a social security number
* Patients having signed a consent to participate in the study

Exclusion Criteria:

* Intolerance metformin
* Patients with type 1.
* Patients on pioglitazone or rosiglitazone
* Renal failure by an anomaly of the creatinine clearance (\< 60 mL/min).
* Patients pregnant or likely to be.
Epigenetic Regulation of Exercise Induced Asthma

The purpose of this study is to investigate the micro ribonucleic acid (mRNA) profiles of patients with EIA without allergic sensitization and EIA with house dust mite sensitization compared to that of healthy controls.

Patients with known EIA are periodically reexamined by medical history, clinical examination, bodyplethysmography, spirometry, exhaled nitric oxide (eNO), skin prick test, methacholin challenge test and exercise-challenge in a cold-chamber at 2-4°C (ECC). Additionally the investigators gathers the questionnaires: Asthma Control Test (ACT) and Dyspnoe Index (DI).

Besides these standard procedures the investigators want to investigate the micro-RNA profiles in two EIA subgroups: EIA with house-dust allergy (n = 24) and EIA without house-dust allergy (n = 24).

Both groups are characterized by different eNO levels. The patients with EIA and house-dust allergy should have an eNO \> 30 ppb, the patients with EIA without house-dust allergy an eNO \< 20 ppb.

The micro-RNA profiles of the both EIA subgroups will be compared the micro RNA profiles of 20 healthy controls .

Therefore blood will be taken (for a complete blood count and micro RNA analysis) at three points of time: before ECC, directly after ECC and after 24 hours ± 4 hours after ECC.

Eligibility Criteria:
For EIA patients

Inclusion Criteria:

* written agreement
* age \>=12 and \<= 24
* known exercise induced asthma
* Group 1: skin prick test positiv house-dust allergy, eNO \> 30 ppb, MCT PD20 \< 0,1 mg
* Group 2: skin prick test negative house-dust allergy, eNO \< 20 ppb, MCT PD20 \< 1 mg
* lung function before ECC forced vital capacity (FVC) ≥ 75% and forced exspiratory pressure in one second (FEV1) ≥ 70%

Exclusion Criteria:

* age \< 12 und \> 24 years
* lung function FVC \< 75% und FEV1\< 70%
* inability to understand the range of the study
* chronic asthma with systemic cortisone therapy
* regular therapy with inhalative corticosteroids or leukotriene-antagonists \<14 days before visit 1
* intake of long acting beta-agonists (LABA) 48 h before examination
* intake of short acting beta-agonists (SABA) 8 h before examination
* acute severe infection (pneumonia) within the last 4 weeks
* other chronic diseases or infections (HIV, Tbc)
* pregnancy

For healthy controls

Inclusion Criteria:

* written agreement
* age \>=18 and \<= 24

Exclusion Criteria:

* age \< 18 and \> 24 years
* known asthma bronchiale or other chronic lung diseases
* lung function FVC \< 90% and FEV1 \< 80%
* allergic sensitization in skin prick test
* eNO \> 30 ppb
* inability to understand the range of the study
* acute severe infection (pneumonia) within the last 4 weeks
* other chronic diseases or infections (HIV, Tbc)
* pregnancy
The Effect of Hyperglycemia on LV Function and Exercise Capacity in Diabetics With and Without Heart Failure.

Diabetes and Heart Failure are diseases with high morbidity and increased risk of death. Former investigations has shown that diabetes worsens the prognosis of heart failure. However it is uncertain how short term diabetic dysregulation in type 2 diabetics affect cardiac function.

Our hypothesis is that short term dysregulation affects left ventricular function and exercise capacity in insulin treated type 2 diabetics with and without heart failure.

To elucidate this hypothesis diabetic patients with and without heart failure will be investigated after overnight state of either high or normal blood glucose levels on two separate occasions. Metabolic and hormonal parameters will be measured. Systolic and diastolic cardiac function will be assessed, exercise capacity and post exercise regional myocardial tissue velocity as well as 6 minutes walk test will be investigated on both occasions. The study will be a randomized cross-over design.


Eligibility Criteria:
Inclusion Criteria:

* Either normal ejection fraction (EF) or heart failure (EF =\<45%)
* Insulin treated type 2

Exclusion Criteria:

* Forme stroke with significant physically or mentally disabilitating disorders
* advanced renal disease (creatinine levels \>220 mM)
* advanced lever disease (alanine aminotransferase \> 3 times over reference level).
* pregnancy
* other significant disabilitating disorders
Treosulfan Based Conditioning Acute Myeloid Leukaemia (AML)

This is a multicenter, multinational, non-randomized, non-controlled open-label phase II trial to evaluate the safety and efficacy of treosulfan in a combination regimen with fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in patients with AML.

The aim is to demonstrate a clinical benefit compared with historical data on intravenous busulfan (BusulfexTM, BusilvexTM), the only drug so far registered in the indication conditioning before allogeneic stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute myeloid leukaemia (AML) according to WHO classification (\> 20% myeloblasts in peripheral blood or bone marrow at initial diagnosis) with \< 5% myeloblast in the bone marrow, indicated for allogeneic transplantation
* Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD) HLA-identity defined by the following markers: A, B, DRB1, DQB1.
* Target graft size (unmanipulated)
* bone marrow: 2 - 10 x 106 CD34+ cells/kg BW recipient or \> 2 x 108 nucleated cells/kg BW recipient or
* peripheral blood: 4 - 10 x 106 CD34+ cells/kg BW recipient
* Age \> 18 and \< 60 years
* Karnofsky Index \> 80 %
* Adequate contraception in female patients of child-bearing potential
* Written informed consent

Exclusion Criteria:

* Therapy related secondary AML
* AML with t(8;21)(q22;q22) in CR1
* Acute promyelocytic leukaemia with t(15;17)(q22;q12) in CR1
* Secondary malignancies
* Previous allogeneic transplantation
* Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or cardiac function)
* Known and manifested malignant involvement of the CNS
* Active infectious disease
* HIV- positivity or active hepatitis infection
* Impaired liver function (Bilirubin \> upper normal limit; Transaminases \> 3.0 x upper normal limit)
* Impaired renal function (Creatinine-clearance \< 60 ml/min; Serum Creatinine \> 1.5 x upper normal limit).
* Pleural effusion or ascites \> 1.0 L
* Pregnancy or lactation
* Known hypersensitivity to treosulfan and/or fludarabine
* Participation in another experimental drug trial within 4 weeks before day -6
* Non-co-operative behaviour or non-compliance
* Psychiatric diseases or conditions that might impair the ability to give informed consent
HISTOACRYL: A Study of Its Efficacy in Final Scar Formation

The use of tissue adhesives for the closure of surgical incisions is becoming increasingly common. Several publications exist purporting the equivalence of tissue adhesive to suture with regard to dehiscence, infection, and cosmesis. Two of the most frequently used adhesives are Histoacryl© and Dermabond©. Despite their popularity, only one study exists comparing the two. In this non-English study only small wounds in an exclusively pediatric population were studied (12). Operative time, cost, and objective measures of scar size were not examined. In the present study we aim to evaluate the relatively large surgical incisions resulting from breast reduction, mastopexy, panniculectomy, and abdominoplasty closed with either Histoacryl©, Dermabond©, or subcuticular suture. The primary aim is to investigate differences in time to wound closure. Secondary aims are to compare the three approaches with respect to cost, dehiscence, infection, scar size, and cosmesis.


Eligibility Criteria:
Inclusion Criteria:

* Age: Younger than 21
* Gender: Females only. Given the nature of the procedures, as well as our clinical experience, we cannot anticipate recruiting enough male patients to be able to evaluate them as a subgroup. Since there may be differences in distributions of measures, to keep the groups more homogeneous we plan to recruit only females from the outset. Having either:
* Reduction Mammoplasty or mastopexy patients:

  * Patients who present to the plastic surgery clinic and are scheduled for breast procedures will be recruited and consented by a clinical studies co-ordinator.
  * This will include patients undergoing a standard Wise pattern reduction mammoplasty (reduction and lift) or a standard Wise pattern mastopexy (lift only). See exclusion criteria below.
* Abdominoplasty or panniculectomy patients:

  * Patients who present to the plastic surgery clinic and are scheduled for abdominal procedures will be recruited and consented by a clinical studies coordinator. See exclusion criteria below.

Exclusion Criteria:

* Though women of childbearing age will be allowed to participate in this study, no pregnant patients will be enrolled.
* Patients with any factors that may have an adverse effect on wound healing:

  * previous hypertrophic scars or keloid
  * known vitamin C deficiency
  * known zinc deficiency
  * smoking
  * steroid use
  * known connective tissue disorder
  * hypoalbuminemia
  * any factor not listed that the attending consultant seeing the patient feels would adversely effect wound healing.
* Patients who have a known sensitivity to adhesives
Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer

This study will be a randomized, open-label, pretest post-test with two study groups.

The randomization procedure will be performed by a simple drawing of lots (A or B) which determined whether participants would receive Shock wave therapy ( group A) or vacuum-assisted closure therapy (group B). Patients in both groups will receive the same medical treatment and nursing care.

Eligibility Criteria:
Inclusion Criteria:

All patients had chronic diabetic foot ulcers that did not heal within six weeks of the incidence.

Exclusion Criteria:

Patients with acute cellulitis, osteomyelitis, or gangrene anywhere in the affected extremity.

Patients with renal, hepatic, neurological, or malignant diseases.

Patients with severe protein malnutrition (serum albumin \< 2.0 g/dl) or severe anemia (Hgb \< 7.0 g/dl).

Patients with an ankle-brachial index \< 0.7, absence of the dorsalis pedis or posterior tibial artery pulse.

Patients who had debridement; pregnancy.

Patients who refused to join the study, or to sign the written consent.