cyrilzakka/clinical-trials huggingface dataset:
Shiga Microalbuminuria Reduction Trial-2

The purpose of this study is to compare the effects of a direct renin inhibitor (DRI), aliskiren, on the urinary albumin excretion in hypertensive patients with type 2 diabetes under strict blood pressure control with angiotensin receptor blocker (ARB).


Eligibility Criteria:
Inclusion Criteria:

* Segment: outpatients
* Hypertension: taking an anti-hypertensive treatment or indicating mean sitting SBP/DBP more than130/80 mmHg
* Type 2 diabetes: diagnosed by ADA criteria or under an anti-diabetic drug treatment
* Microalbuminuria: 10 \< and \< 300 mg/gCr
* Informed consent: patients who understand well about this study based on own voluntary will and can give a written consent

Exclusion Criteria:

* Sever hypertension (over 180/110 mmHg), malignant hypertension and secondary hypertension
* Type 1 diabetes
* Patients whose investigator regards as difficult to comply with study protocol in reference to the package insert of aliskiren
* Patients who have history of operation in gastrointestinal tract surgery, and anamnestic or concurrent gastrointestinal disorders, which may interfere with drug absorption
* Serum potassium \> 5.6 mEq/L (hyperkalemia)
* Urinary microalbumin \< 10 or \> 300 mg/gCr
* Patients who participated in another clinical study within three months
Observation of Bevacizumab Plus Front-line Chemotherapy in Patients With Ovarian Cancer

Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events) of bevacizumab (Avastin) when added to chemotherapy as front-line treatment of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma

In the last decade, clinical studies with bevacizumab (Avastin) in various tumors have shown encouraging results in terms of efficacy/safety. However there is no data generated in Greek population with regards to safety and efficacy of bevacizumab in front line Ovarian Cancer. Two prior global phase III randomized trials showed that the addition of concurrent bevacizumab to standard chemotherapy and maintenance bevacizumab significantly increased the PFS in patients with advanced ovarian cancer It would be relevant to document the real life clinical data of bevacizumab in combination with chemotherapy (paclitaxel/carboplatin) in Front Line Ovarian Cancer as prescribed by the medical oncologists in Greece.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age ≥18 years
* Histologically confirmed advanced stage III (suboptimally debulked \>1cm of residual disease) or stage IV ovarian cancer fallopian tube carcinoma or primary peritoneal cancer following surgical debulking with the aim of maximal surgical cytoreduction
* One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria
* ECOG performance status ≤2
* Adequate haematological, renal and hepatic function
* Urine protein \<2+ (dipstick)
* Life expectancy of \>12 weeks

Exclusion Criteria:

* Previous front line treatment for ovarina cancer
* Previous radiotherapy to target lesions
* Patients with brain metastases and/or cancerous meningitis
* Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma
* Patients participating in interventional clinical trial
Evaluation of Post-extraction Socket Preservation With Camelline Versus Bovine Deproteinized Xenograft

Alveolar ridge preservation following tooth extraction has the ability to maintain the ridge dimensions and allow the implant placement in an ideal position fulfilling both functional and aesthetic results. Postextraction socket healing commonly results in resorption of the alveolar ridge.

To prevent this clinical situation, different authors have described several surgical procedures, ranging from regenerative techniques for socket preservation to immediate implant placement. Regenerative techniques have been widely tested in controlled and uncontrolled studies with various materials and clinical approaches: bone grafting alone, including autografts, allografts, xenografts, and alloplasts; membrane alone, whether absorbable or not; and membrane in conjunction with grafting.

Various classic studies in the 1960s showed that the resorption process of the postextraction alveolus in both jaws was significantly more pronounced on the buccal aspect. This comes as no surprise, as the buccal surface of the anterior alveolar ridge is commonly thin and fragile. The maxilla tends to exhibit greater reductions in width than in height. The loss of tissue contour takes place mostly during the first 1 to 3 months following tooth extraction. Because the healing patterns of human sockets are unpredictable architecture), then such common procedures as extractions may lead to intraoral situations in which the remaining healed ridge does not allow for an esthetic and functional solution without the aid of significant bone grafting.

Eligibility Criteria:
Inclusion Criteria:

* Teeth with: root fractures, endodontic treatment failures, advanced caries lesions or any other cause that make tooth non-restorable and indicated for extraction.
* Healthy non-smoker patients

Exclusion Criteria:

* Medically compromised patients.
* Pregnant females.
* History of malignancy or radiotherapy/chemotherapy for malignancy in the past 5 years.
* History of active bone metabolic disease.
BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.

The study is designed to compare the effects of BI 409306 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease


Eligibility Criteria:
Inclusion criteria:

* Patients with early signs of dementia of Alzheimer Type
* Male and female patients with an age of at least 55 years
* Previous use of Alzheimer's Disease (AD) medications (AChEIs, memantine) is allowed up 3 month prior to screening. Patients who are currently taking AChEIs are eligible as long as they have been using a stable dose for at least 3 months prior to screening and no change is foreseen for the duration of the study. This dose must be consistent with the product label in the concerned country. Patients currently taking memantine are excluded.
* Patients must have at least 6 years of formal education and fluency in the test language as verbally confirmed by the patient and documented by the study investigator.
* Patients must have a reliable study partner (per investigator judgement, for instance a family member, partner etc., guardian or, if applicable, a legal representative)

Exclusion criteria:

* Cognitive impairment or dementia with any etiology other than Alzheimer's Disease (AD)
* Substantial concomitant cerebrovascular disease (defined by a history of a stroke / intracranial haemorrhagia) temporally related to the onset of worsening of cognitive impairment per investigator judgement
* Medical history or diagnosis of any of symptomatic and unstable/uncontrolled conditions per investigator judgement
* Any other psychiatric disorders such as schizophrenia, or mental retardation
* Previous participation in investigational drug studies of mild cognitive impairment/Dementia of Alzheimer Type (DAT) within three months prior to screening. Having received active treatment in any other study targeting disease modification of AD like Aß immunization and tau therapies. Previous participation in studies with non-prescription medications, vitamins or other nutritional formulations is allowed.
* Clinically significant uncompensated hearing loss in the judgment of the investigator. Use of hearing aids is allowed.
Ritgens Maneuver for the Prevention of Anal Sphincter Tears at Delivery: A Randomized Controlled Trial

The aim of the investigation was to assess whether routine use of the modified Ritgen´s maneuver decreases the risk of anal sphincter injury at delivery, compared with simple manual protection of the perineum.Ritgen´s maneuver means that the fetal chin is reached for between the anus and the coccyx and pulled anteriorly, while using the fingers of the other hand on the fetal occiput to control speed of delivery and keep flexion of the fetal neck.

This application is made retroactively - the study was performed during December 1st, 1999 to July 31st, 2001, at Lund University Hospital and Helsingborg Hospital. Primigravid women in the area were informed about the study at the maternity care centers, receiving written information in gestational week 36. Eligible for the study were women with singleton pregnancy and a fetus in cephalic presentation, admitted for labor, rupture of the membranes or induction after 37 completed gestational weeks. Primigravid women received written information about the study at the maternal health care centers, and eligible women were asked for consent at admission in labor.

Randomization was done at the beginning of the second stage of labor (at full cervical dilatation), in each unit by a telephone call from the delivering midwife to the other department, where randomization lists with numbers for allocation were kept. In women allocated to Ritgen´s maneuver, the protocol stated that the delivery of the fetal head should be managed by this maneuver, i.e. lifting the fetal chin anteriorly, using the fingers of one hand placed between the anus and the coccyx, and thereby extending the fetal neck, whereas the other hand should be placed on the fetal occiput to control the pace of the expulsion of the fetal head. The technique for Ritgen´s maneuver was standardized, and midwives that were unfamiliar with the procedure were instructed by senior colleagues before the trial. In the other study group, the protocol entailed our standard care. The standard practice at delivery was using one hand to apply pressure against the perineum, and the other hand on the fetal occiput to control the expulsion of the fetal head, and only to use Ritgen´s maneuver in case of labor arrest or abnormal fetal heart rate pattern when the fetal head was at the pelvic floor.

Eligibility Criteria:
Inclusion Criteria:

* Women with singleton pregnancy and a fetus in cephalic presentation
* admitted for labor
* rupture of the membranes or induction after 37 completed gestational weeks
* and reaching full cervical dilatation.

Exclusion Criteria:

* Operative delivery
Multimodal Analgesia With NSAID vs. Narcotics Alone After Shoulder Instability Surgery

This will be a single-center, prospective observational study. The study will compare post- operative pain scores and narcotic consumption between two groups of patients - one cohort will receive ibuprofen (Motrin) and Percocet (to be used as needed) while the other cohort will receive only Percocet. Both pain management options are considered to be standard of care.


Eligibility Criteria:
Inclusion Criteria:

* ASA class I-II
* Patients scheduled for arthroscopic shoulder instability surgery

Exclusion Criteria:

* Contraindication to ibuprofen or oxycodone/acetaminophen (e.g. hypersensitivity, history of GI or bleeding disorder)
* Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
* Younger than 18 years of age or older than 65
* Any patient considered a vulnerable subject
* Patients on pain medication prior to surgery
Lenvatinib Plus PD-1 Antibody vs TACE for Intermediate-stage HCC Beyond Up-to-seven Criteria

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody compared with transarterial chemoembolization (TACE) for patients with intermediate-stage hepatocellular carcinoma (HCC) beyond up-to-seven criteria

Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of TACE for patients with hepatocellular carcinoma staged BCLC A/B especially for those with tumor beyond up-to-seven criteria. Recently, Lenvatinib was proved non-inferior to sorafenib in overall survival in advanced hepatocellular carcinoma, and Programmed Cell Death Protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated the efficacy and safety of lenvatinib plus PD-1 antibody in intermediate-stage HCC. Thus, the investigators carried out this prospective randomized control to demonstrate the superiority of lenvatinib combined with PD-1 antibody over TACE.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* Barcelona clinic liver cancer-stage B
* Beyond up-to-seven criteria (hepatocellular carcinomas with seven as the sum of the size of the largest tumor \[in cm\] and the number of tumors)
* Eastern Cooperative Oncology Group performance status of 0 to 1
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not applicable for transarterial chemoembolization, surgical resection, and local ablative therapy.
* The following laboratory parameters:

Platelet count ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

• Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease
Cerebral Blood Flow: Helmet vs Oronasal Mask During Continuous Positive Airway Pressure Ventilation

In this trial the investigators will evaluate blood flow in common carotid artery of healthy subjects treated with Continuous Positive Airway Pressure (CPAP) Ventilation, comparing two different devices: oronasal mask versus Helmet. The hypothesis is that Helmet CPAP reduces carotid flow compared to oronasal mask.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years,
* Ability to give informed consent

Exclusion Criteria:

* known cardiac pathologies
* known pulmonary pathologies
* known vascular pathologies
* history of concussion
* history of headache
Study of Effectiveness of Mexyn-A

Atomised Methoxymethane-in-Aqua (MEXYN-A) a new topical self-chilled, non-steroidal, non-flammable, pressurised spray which embodies in one simultaneous application, most of the currently recognised and effective chemical, mechanical and thermal anti-pruritic therapies and hydrotherapy.

The primary clinical endpoint was to establish MEXYN-A efficacy and safety in abolishing or reducing pruritus related to cutaneous diseases, insect bites and poison ivy, within few seconds of the application. The secondary endpoint was to measure the itch free period as a result of the new intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from severe itching due to : Atopic Dermatitis, contact dermatitis, psoriasis, urticaria, xerosis, prickly heat, genital pruritus, chicken pox, aquagenic pruritus, lichen planus, poison ivey, insect bites.
* Past experience with the use of at least one conventional medication for pruritus or conventional medication for the same disorder patients suffered.

Exclusion Criteria:

* Patients who have taken any anti-pruritic drug during the month prior to participation.
* Patients who have taken drugs for any reason for 2 days prior to participating in the study.
Effect of Spinal Stabilization Exercises on Epicardial Fat Tissue and Exercise Capacity in Hypertensives

It has been suggested that Epicardial Adipose Tissue (EAT) may be an adjunctive marker to classical risk factors for the presence and severity of coronary artery disease. EAT thickness is also associated with MetS and hypertension, high levels of low-density lipoprotein cholesterol and insulin resistance.Studies have shown that moderate-intensity and high-intensity aerobic exercise and resistance exercise training reduce EAT. However, aerobic and resistance exercises may be found challenging and demanding by individuals and in most cases, high or moderate intensity exercise may be considered difficult. In a study conducted in physically inactive individuals, it was concluded that there was a significant increase in heart rate and BP following spinal stabilisation exercises performed 4 days a week for a total of 8 sessions for 2 weeks, but the increase in these cardiac parameters would tend to decrease following regular exercise. In the current literature, there is no study evaluating the effect of spinal stabilisation exercise on EAT thickness, exercise capacity and cardiovascular parameters in individuals with HT.

Barriers to access to healthcare services such as distance, time and cost can be overcome with technology. COVID-19 has accelerated the transition of many physiotherapy services to telerehabilitation. Evidence has shown that telerehabilitation is an effective delivery model for providing face-to-face physiotherapy services with equal or even superior outcomes, especially in musculoskeletal treatment.

The aim of this study was to determine the effect of spinal stabilisation exercise with telerehabilitation on EAT and exercise capacity in individuals with HT.


Eligibility Criteria:
Inclusion Criteria:

1. Being followed up with Hypertension for at least 6 months
2. Volunteering to participate in the study
3. Speaking Turkish
4. Being literate
5. Not having participated in any structured exercise programme for at least 6 months

Exclusion Criteria:

1. Severe valvular disease
2. Having heart failure
3. Having cardiomyopathy
4. Myocardial infarction at least 6 months ago
5. Stable or unstable angina pectoris
6. Left ventricular ejection fraction below 40
7. Presence of peripheral artery disease
8. History of deep vein thrombosis, pulmonary embolism or stroke in the past
9. Chronic kidney disease
10. Having thyroid diseases
11. Active infectious or inflammatory disease
12. Body Mass Index \>40 kg/m2
13. Having a serious psychiatric illness such as panic disorder or major depression
DELP for Acute Hemorrhagic Stroke

Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) has been found to improve neurological function and life ability of AIS patients and approved for the treatment of AIS by China Food and Drug Administration (CFDA). Our recent study imply that the neuroprotective effect of DELP involved multiple neuroprotective mechanism such as anti-inflammation, free radical scavenging, and decreasing MMP-9. Based on the multiple mechanisms, we argue that DELP may exert neuroprotective effect on acute cerebral hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-80;
* Spontaneous cerebral hemorrhage;
* Deep supratentorial intracerebral hemorrhage (basal ganglia and thalamus) with hematoma volume 5-40ml;
* NIHSS: 4-22;
* Time from onset to DELP is less than 48 hours;
* Premorbid mRS 0 or 1;
* Signed informed consent;

Exclusion Criteria:

* Secondary cerebral hemorrhage (secondary to trauma, tumor, vascular malformation, hemorrhage transformation of ischemic stroke, etc.);
* Comatose patients on admission (GCS score 3-8 on the Glasgow Coma Scale);
* Patients with intracerebral hemorrhage ruptured into the ventricle;
* Planed surgery;
* Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
* Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
* Previous allergy to heparin or calcium;
* hypoproteinemia;
* Unsuitable for this clinical studies assessed by researcher.
p16Ink4a in Bronchopulmonary Dysplasia in Children

The bronchopulmonary dysplasia (BPD) is a respiratory disease of the premature child which lead to a reduction of gas exchange surface and to a prolonged respiratory failure. This disease has morphologic and functional consequences at adulthood and is today considered to be an early determinant of respiratory diseases at adulthood.

The physiopathology of BPD is not well known. Several mechanisms could be involved especially a reparation failure favored by an increase of cellular senescence which is a permanent stop of cellular proliferation. The transcription factor 16 Ink4a, considered as a marker of aging, is one of the essential markers of senescence. Its increase during prematurity was shown at the blood cells of the cordon, but its involvement in BPD and its evolution in child are not yet studied.


Eligibility Criteria:
Inclusion Criteria:

Premature(\< 28 GA) neonates

* Alive neonate born at less than 28 gestational age
* Signed inform consent

Term neonates:

* Alive neonate born at least at 37 GA or more
* Signed inform consent

Child from 7 to 15 years old with BPD:

* Child from 7 to 15 years old
* Child with a BPD diagnosed
* Signed inform consent

Child from 7 to 15 years old without BPD:

* Child from 7 to 15 years old
* Child receiving a blood test
* Signed inform consent

Exclusion Criteria:

Premature (\< 28 GA) and term neonates:

-Congenital malformation

Child from 7 to 15 years old with BPD:

* Cystic fibrosis
* Evolutive cancer
* Chronic inflammatory disease
* Known anemia
* Refusal of participation of child or parental authority

Child from 7 to 15 years old without BPD:

* Other respiratory disease: severe asthma, cystic fibrosis, deficit AAT, bronchial dilatation
* Evolutive cancer
* Chronic inflammatory disease
* Known anemia
* Refusal of participation of child or parental authority