cyrilzakka/clinical-trials huggingface dataset:
Benefits of Amantadine in Patients With Coma State

The study was a single center observational-prospective study and approved by local ethics committee. Patients in coma state due to traumatic brain injury, cardiac arrest or ischemic stroke who are older than 18 years of age were included in the study. Patients who received amantadine 200mg/day for fourteen days according to ICU protocols decided by primary physician formed the amantadine group, and the rest of the subjects were included in the control group. All patients were evaluated for Glasgow Coma Score, JFK Coma Recovery Scale and Disability Rating Scale once a week for three months.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years, ≤ 65 years
* GCS score ≤ 8
* Coma state due to ischemic stroke, brain hemorhage, anoxic brain damage

Exclusion Criteria:

* \<18 years, \> 65 years
* Patients admitted to the critical care without diagnosis of coma state
* Patients admitted to critical care with coma state that are not duo to ischemic stroke, brain hemorhage, anoxic brain damage
* Metastatic malignant neoplazm
* Congenital or acquired brain function problem (cerebral palsy, autism etc)
* Patients with amantadine allergy
* Progressive degenerative diseases (Alzheimer, Parkinson diseases etc)
A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in patients with severe haemophilia A without inhibitors.


Eligibility Criteria:
Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine the suitability for the trial - Male patients aged 18 years or older at the time of signing informed consent, diagnosed with severe haemophilia A (FVIII activity below 1%), based on medical records or results at screening Exclusion Criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Known inherited or acquired bleeding disorder other than haemophilia A - Presence of inhibitors (neutralising antibodies) to Factor VIII (equal to or above 0.6 Bethesda Units) at screening measured by the Nijmegen method
A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures

To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to \<16 years with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2 Anti-Epileptic Drugs (AEDs).


Eligibility Criteria:
Inclusion Criteria:

* An epileptic patient with generalized tonic-clonic seizures that are classifiable according to the International League Against Epilepsy classification of epileptic seizures (Epilepsia, 1981)
* A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to the Combined Baseline Period and during the Combined Baseline Period

Exclusion Criteria:

* Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
* Diagnosis of Lennox-Gastaut Syndrome
* Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imaging features
* A history of convulsive or nonconvulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1
Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension

This research study is looking at the use of the drug ambrisentan and if it can improve right ventricle function in people with systemic sclerosis-associated pre-pulmonary arterial hypertension. It is also looking at using right ventricle function changes as a marker of disease severity.

This research study is looking at the use of the drug ambrisentan and if it can improve right ventricle function in people with systemic sclerosis-associated pre-pulmonary arterial hypertension. It is also looking at using right ventricle function changes as a marker of disease severity.

Pre-pulmonary arterial hypertension is a borderline elevation in blood pressure in the lungs. Pre-pulmonary arterial hypertension is not currently treated with the drug therapies that are used for pulmonary arterial hypertension. It represents a group of patients that are at risk for developing pulmonary arterial hypertension.

The administration of ambrisentan is the experimental part of this study. Ambrisentan has not been approved by the FDA for use of improving right ventricle function in people with pre-pulmonary arterial hypertension. You will still receive your normal clinical care.

The purpose of this study is to learn more about ambrisentan and its role in treating systemic sclerosis-associated pre-pulmonary arterial hypertension. Ambrisentan is already approved for use in people with systemic sclerosis-associated pulmonary arterial hypertension, but this study wants to research its role in people with pre-pulmonary arterial hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years, \< 80 years
* Systemic sclerosis with any of the following features:

  1. Duration of Raynaud's phenomena \>8 years
  2. Anticentromere antibody positivity
  3. isolated nucleolar-pattern ANA positivity
  4. Extensive telangiectasias
  5. DLCO \< 60% in the absence of extensive ILD
  6. FVC%/DLCO% \>1.6
  7. Unexplained dyspnea
* Right heart catheterization-proven pre PAH (mean PAP 20-25 mmHg and pulmonary capillary wedge pressure \<15 mmHg)
* Systolic blood pressure \>100 mmHg
* Reliable contraception for women of childbearing age
* Informed consent

Exclusion Criteria:

* \< 18 years or \> 80 years
* Left ventricular ejection fraction \< 55%
* Systolic or diastolic left ventricular congestive heart failure
* Liver disease (abnormal AST/ALT, chronic hepatitis, or cirrhosis)
* Extensive ILD or FVC\< 60%
* Pregnant
* Breast-feeding women
* Cyclosporine use
ECLAXIR:Search for an Association Between CX3CR1 V249I Polymorphism, Preeclampsia and Endothelial Injury

The study hypothesis is the involvement of the couple CX3CR1/CX3CL1 in occurrence of endothelial injury in preeclampsia. According to this hypothesis, Carriers of the I249 allele who express less CX3CR1 shoud be protected against this risk. The main objective of the study is the search of an association between CX3CR1 V249I polymorphism and preeclampsia. The secondary aims are the search of an association with the most severe forms of preeclampsia and endothelial injury.

It is a case-control multicenter study 185 caucasian pregnant women with preeclampsia and 185 paired controls without preeclampsia will be included.

The frequency of the V249I polymorphism in african black population will be determined by studying 200 subjects (100 cases and 100 controls).

The V249I polymorphism will be identified by PCR followed by enzyme digestion. Endothelial injury will be identified using three assays : von Willebrand factor, soluble VCAM-1 and thrombomodulin plasma levels.

CX3CR1 involvement in preeclampsia would have potential diagnostic and therapeutic consequences.

Eligibility Criteria:
Inclusion Criteria:

* cases: pregnant woman, evolutive pregnancy, preeclampsia, caucasian, consenting to the study

Exclusion Criteria:

* Cases:

multiple pregnancy, proteinuria \> 300 mg/24h before 21th gestation week.
Incidence of MRI Sacro-Iliac Joint Anomalies in Young Women

Prospective multicenter study assessing the incidence of inflammatory and structural lesions seen on MRI of the SI joints in a consecutive population of women aged 18-50 years old.

The study hypothesis is SpA may be misdiagnosed on MRI in post partum women due to increased stress on the joint following pregnancy and childbirth, as MRI of the SI joints may show lesions that could mimics axial spondyloarthritis. The primary objective of this study is to determine the incidence of SI lesions seen at MRI in women. The secondary objectives are to compare the incidence and pattern of MRI inflammatory and structural lesions of the SI joints and to determine the factors associated with inflammatory or structural changes of the SI joints in a population of women. the investigators will especially compare the population of women within a year after childbirth versus the population of women who never gave birth or who gave birth over 24 months ago or more.

500 women aged of 18 to 50 years old, including 100 women who gave birth within the year, referred to the Imaging department for pelvic MRI for the exploration of pelvic or gynecologic pathology will be recruited consecutively.

MRI will be performed on a 1.5 T MRI according to standardized exploration of the pelvis and will include axial T1-weighted sequences and T2STIR (or T2 fat sat or T2 Dixon) of maximum 6 mm thickness .

An additional Axial STIR sequence may be added as part of the research (duration 3 minutes), if the standard protocol does not include any STIR, T2 fat sat T2 or T2 Dixon sequence.

SI lesions will be assessed in a centralized randomized and independent review of all MR images by 2 musculoskeletal radiologists according to ASAS criteria.

Patients will complete a standardized questionnaire on the day of MRI to collect the following data : patient's and family history of chronic inflammatory disease, number and date of pregnancies, practice of sports, back pain, joint pain.

Eligibility Criteria:
Inclusion criteria:

* Women aged 18 to 50 years old
* MRI of the pelvis requested as part of an exploration of a gynecological or pelvic pathology
* Women who delivered within the year OR women who never gave birth or gave birth 24 months ago and over

Exclusion criteria:

* Patients with a personal or family history of inflammatory disease (SpA , ulcerative colitis , chron , PSO , RA, SAPHO)
* Patients with a history of trauma or surgery of the pelvis
* Pregnant women
* Women who gave birth over a year ago and less than 2 years ago
Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer

The aim of the present randomized double-blinded placebo-controlled clinical trial is to investigate if melatonin can protect against acute radiation dermatitis in patients with early breast cancer receiving radiation therapy, and whether this has an impact on the patients' quality of life.

The study will be a randomized, placebo-controlled, double-blinded clinical pivotal trial. Patients will be allocated in a ratio of 1:1 to the melatonin or placebo group. Patients will be stratified according to the type of surgery (lumpectomy or mastectomy). Randomization will be performed in blocks of randomized sizes. The study will be performed in the Department of Oncology, Rigshospitalet, Denmark.

Eligible patients with early breast cancer receive adjuvant radiation therapy over 15 to 30 daily fractions (5 fractions per week) of ionizing megavoltage photon radiation to a total of 40 - 60 Gy within 3-5 weeks according to the guidelines of the Danish Breast Cancer Cooperative Group. In this study, the patients will administer approximately 1 g of cream containing melatonin (25 mg/g) and dimethyl sulfoxide (DMSO) (150 mg/g) or a placebo cream topically twice daily on the irradiated skin area. The patients are scheduled to do this every day from the first to the last fraction of radiation therapy, including the days where they do not receive radiation therapy. The investigators have chosen placebo as the comparator due to it being safe and the most reasonable method of evaluating any effects of the intervention. On days where the patients receive radiation, the melatonin/DMSO or placebo cream will be applied no less than 2 hours prior to radiation. Throughout the study, the patients will meet with an investigator once weekly who will monitor compliance and assess outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with early breast cancer
* Over 49 years old
* Have had radical tumor resection surgery
* Follows treatment regimens and follow-up at Rigshospitalet
* Written informed consent after written and verbal information

Exclusion Criteria:

* Inability to understand Danish, written or spoken
* Mental illness (Defined as having a diagnosis and being in medical treatment, or if anticipated poor compliance)
* Previous therapy with ionizing radiation in the thoracic or neck area
* Use of bolus for radiation therapy (A bolus is a material which has dose absorption properties equivalent to tissue. It is placed on the irradiated area to alter dosing or target of the radiation therapy)
* Pregnancy
ZEBinix® Retention Rate in Epilepsy in Elderly Patients

The incidence of provoked and unprovoked seizures is known to increase with advancing age. Eslicarbazepine acetate (ESL) is one of the third generation of antiepileptic drugs (AEDs) that have been developed in the last ten years with a favorable safety profile. ESL is approved in Europe and the USA as adjunctive or monotherapy in adults with partial-onset seizures. Nevertheless, retrospective data in monotherapy condition in the elderly epileptic population are sparse. The aim of the ZEBRE study is to evaluate the efficacy and the safety of ESL in elderly epileptic patients (\> 65 years). The completion of this study will provide crucial information on the most appropriate ESL treatment for elderly patients suffering from partial seizures.

The ZEBRE (ZEBinix® Retention rate in epilepsy in Elderly patients) study is a prospective, multicenter, descriptive study. ESL will be prescribed according to the usual care. Posology and method of administration of ESL are defined by the summary of product characteristics.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 65 years
2. Ability of patient/legal representative to understand the study and to give his/her non-opposition (at the investigator's discretion)
3. Epilepsy with refractory partial-onset seizures with or without secondary generalization confirmed or with primary generalized tonic-clonic (PGTC) seizures
4. At least one seizure in the last three months
5. Treatment for partial-onset seizures with ESL as a first line monotherapy or with an adjunctive therapy

Exclusion Criteria:

1. History of ESL treatment
2. History of status epilepticus, seizures occurring in cluster, pseudo-seizures
3. History of severe hepatic impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2 times ULN, gamma-glutamyltranspeptidase (GGT) \> 5 times ULN)
4. History of severe renal impairment (clearance CLCR \<30ml/min)
5. History of hypersensitivity to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine)
6. History of severe hyponatremia (\< 120 mmol/L)
7. Second or third degree atrioventricular block
8. More than one other antiepileptic drug
The Relation Between BSS Solution Temperature and Endothelial Cells and Post Phaco Discomfort

patients underwent phacoemulsification , balanced saline solution used during the operation will be at room temperature in one group and cool 2.7 c in the other group. the patients will be followed for 3 months after phacoemulsification regarding corneal endothelial cells and anterior segment inflammatory signs

patients underwent phacoemulsification , balanced saline solution used during the operation will be at room temperature in one group and cool 2.7 c in the other group. the patients will be followed for 3 months after phacoemulsification regarding corneal endothelial cells and anterior segment inflammatory signs

Eligibility Criteria:
Inclusion Criteria:

* patients with cataract
* more than 40 years
* no glaucoma
* no retinal abnormalities
* no retinal abnormalities

Exclusion Criteria:

patients with corneal diseases patients less than 40 patients with previous eye surgery
Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine

The purpose of this study is to determine whether short-term Atorvastatin can increase the immunity response to hepatitis B vaccination in vaccine Nonresponders.

20 person of vaccinated individuals who have HBsAb\<10 after 3 dose hepatitis B vaccination who called Nonresponders will be randomly allocated in 2 groups. one group receive short-term Atorvastatin and other group receive placebo.both group will be vaccinated with hepatitis B vaccine and then immunity response will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Previous 3 dose hepatitis B vaccination
* Negative HBc Ab
* Negative HBs Ag
* HBs Ab less than 10 in ELIZA

Exclusion Criteria:

* positive serologic evidence of Hepatitis B infection
* Chronic use of Atorvastatin
* Immunosuppressive Disease
Study Measuring the Effects of Patient Data for Total Hip and Total Knee Arthroplasty Patients Using an APP Based Sensor for Home Exercise Performance Before and After Operation

Multicenter, Prospective, Randomized, Comparative Study Measuring the Effects on Clinical Outcomes, Patient Satisfaction, Costs and Benefits of Combined Pre-, Intra- and Postoperative Patient Data for THA and TKA Patients Using an APP Based Sensor for Home Exercise Performance Before and After Operation


Eligibility Criteria:
Inclusion Criteria:

* Primary, unilateral total knee and hip replacement patients
* Participant is min. 18 years of age
* Participant is able and willing to provide written informed consent
* Participant with ability to work with smart devices
* Participant having its own device (Apple iPhone or iPad with latest iOS version or Android tablet or smart phone min. Android version 6) and are able to handle the app and/or sensor

Exclusion Criteria:

* Pregnancy
* Participant has mental in capabilities - unable to give informed consent
* Participants who are unwilling or mentally and/or physically unable to adhere to study procedures
* Participant is having orthopaedic co-morbidities such as: previous HTO at indexed joint or prior UKA
* Flexion contracture \> 15°
* Varus/valgus deformity \> 10°
* Participant is having dementia or other cognitive impairment
Comparison of the Protective Effect of Desflurane and Propofol in Patients With Renal Transplantation

Ischemia/reperfusion (IR) injury is the major cause of early renal dysfunction and acute renal failure of the transplanted kidney after renal transplantation. In 1986, Murry et al. described the phenomenon "ischemic preconditioning". Also, it was reported that a few non-ischemic stimuli could provide cellular tolerance against major ischemia through a mechanism similar to ischemic preconditioning. In an animal study, 1 minimal alveolar concentration of volatile anesthetics - a clinically relevant concentration - was reported to have a protective effect against ischemia/reperfusion injury, the effect being variable between types of anesthetics. Also, there were somm reports that intravenous anesthetics such as propofol could reduce IR injury by decreasing oxidative stress and apoptosis.

By reducing the ischemia/reperfusion injury of the grafted kidney, the morbidity and mortality related to renal transplantation can be reduced as well. The objective of this study is to find out whether, according to the type of anesthetics (Desflurane vs. Propofol), there is a difference in the protective effect against ischemia/reperfusion injury of the grafted kidney in patients receiving renal transplantation.


Eligibility Criteria:
Inclusion Criteria:

* healthy kidney donors and their recipients of renal transplantation.

Exclusion Criteria:

* a donor that has any medical or surgical history,
* a recipient that is scheduled to have any other surgery with renal transplantation surgery.
The Effect of Two Different Endoscopic Entry Techniques on Postoperative Gastrointestinal Function

The purpose of this study is to determine effect of veres needle entry and direct trocar entry on postoperative gastrointestinal functions.

Women planned to have laparoscopic surgery will be randomized into two groups, in first group pneumoperitoneum will be provided by veres needle, in other group direct trocar entry will be used to provide pneumoperitoneum. After surgery gastrointesitinal functions, shoulder pain, blood loss will be compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic surgery for benign or malignant disease

Exclusion Criteria:

* Patients with gastrointestinal intervention
* Patients who had undergone previous operations
* Patients with gastrointestinal intervention dysfunction
Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications

Ventilator-associated pneumonia and ventilator-associated treakeabronchitis in respiratory tract infections associated with ventilator are common infections in intensive care unit and cause significant morbidity, mortality and health expenditures in nosocomial infections. Adequate and effective oral care by nurses in intensive care patients, possible complications, intensive care unit stay in the intensive care unit and is very important in terms of mortality.

The aim of this study will (1) evaluate the effect of 0.12% chlorhexidine gluconate on ventilator-associated pneumonia, ventilator-associated treakeabronchitis, (2) determine the effect of preventing microorganism colonization, and (3) assess the mortality rate for each patient and the cost-effectiveness in the health expenditures.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Admission in critical care with in 24 hours
* Having an endotracheal tube

Exclusion Criteria:

* History of chlorhexidine allergy
* Duration of mechanichal ventilation less than 48 h
* Confirmed diagnosis of pneumonitis before admission in the ICU
* Transfer from another ICU
* Receiving chemotherapy or radiotherapy
* Patients with immunodeficiency
* Patients with tracheostomies
* Required specific oral hygiene procedures
* Facio-maxillary or dental trauma/surgery
* Being pregnant
Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)

Given that 5-HT3 receptors are indirect inhibitors of cortico-mesolimbic DA release, the 5-HT3 receptor antagonist ondansetron augmentation might potentially have efficacy in the treatment of resistant Obsessive Comulsive Disorder (OCD) patients on combined SRIs and antipsychotics.

METHOD: Fourteen patients with a DSM-IV diagnosis of treatment resistant OCD, under stable treatment with SSRI's and neuroleptic augmentation will enter an 12-week single blind trial of ondansetron initiated at a dose of 0.25 mg twice daily for 6 weeks, that will be titrated to 0.5 mg twice daily for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. adults aged 18 to 55
2. a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of ≥ 20 after ≥ 12 weeks of treatment with an established effective dose of an Selective Serotonin Reuptake Inhibitors or clomipramine and after ≥ 10 weeks of augmentation treatment with antipsychotics (risperidone at least 2 mg/day quetiapine at least 150 mg/day; olanzapine at least 5mg/day; haloperidol titrated at least 10 mg/day; aripiprazole at least 10 mg/day)

Exclusion Criteria:

1. a history of alcohol or substance abuse
2. current severe depressive symptoms, bipolar disorder, panic disorder, schizophrenia, or other psychiatric conditions
3. heart disease, arrhythmia, liver problems, including cirrhosis, seizures, glaucoma or serious medical disease
4. hoarding as only Obsessive Compulsive symptom
5. women of childbearing potential not using a medically acceptable contraceptive method.