cyrilzakka/clinical-trials huggingface dataset:
Reliability and Validity of the ISNCSCI in Patients With Non-traumatic Spinal Cord Lesions

Aim of the study is to assess the psychometric properties of the International Standards for Neurological Classification of Spinal Cord Injury in subjects with non traumatic lesions.

All patients with non-traumatic SCI consecutively admitted to three Italian SCI centers (IRCCS Fondazione Santa Lucia, Montecatone Rehabilitation Hospital and Istituti Clinici Scientifici Maugeri IRCCS of Pavia) between January 1st 2017 and June 30th 2020 have been prospectively enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* having a non-traumatic SCI
* acute / subacute phase
* any level and severity (ASIA Impairment Scale) of injury
* having a cognitive status that allows collaboration in the exam.

Exclusion Criteria:

* presence of dementia or cognitive decline;
* having a pathology of the peripheral nervous system that may affect the evaluation of ISNCSCI;
* having a multiple sclerosis
Characteristics of Rheumatoid Arthritis Patients With Atlantoaxial Synovitis Detected by Plain X-ray and MRI

This study detects the presence of atlantoaxial joint affection in symptomatic versus asymptomatic rheumatoid arthritis patients revealed by plain X-ray and magnetic resonance imaging of the cervical spine

Atlantoaxial joint affection in rheumatoid arthritis patients may have life-threatening complications if not detected early. It may not be detected unless it becomes symptomatic. However, asymptomatic atlantoaxial joint affection is not uncommon. Investigators will try to detect atlantoaxial joint affection at an early stage and its relation to symptomatology and other disease criteria. So investigators will use conventional plain X-ray examination combined with magnetic resonance imaging of the cervical spine to detect soft tissue as well as bony changes of this condition.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis patients complaining or not complaining of atlantoaxial affection symptomatology

Exclusion Criteria:

* Pregnant females
* Patients with pacemakers or metallic bony plates.
* Patients that have claustrophobia
Open-Label Creatine Study for Female Meth Users

Study Purposes and Objectives:

The objectives should be stated in such a way that the reader can determine the appropriateness of the study design. If appropriate, state the specific hypotheses being tested and/or study aims. Use lay language.

Methamphetamine use is of great concern in the state of Utah because it's the primary drug of threat in the state, and is the primary drug of choice among females between the ages of 18 and 24. The primary hypothesis of the study is that eight weeks of oral creatine supplementation will result in improvements in depression rating scores in female MA users. Secondary hypotheses include the following: 1) creatine supplementation will result in a decrease in the number of positive MA screens; 2) NAA and Cr concentrations will increase after eight weeks of oral creatine supplementation; and 3) PCr/β-NTP levels in the frontal lobe using 31P MRS will increase after eight weeks of creatine monohydrate oral supplementation.


Eligibility Criteria:
Inclusion Criteria:

1. Must be female
2. Must be between the ages of 13 and 55 years
3. Methamphetamine must be primary drug of choice
4. Must have used methamphetamine within the last 6 months
5. For participants \> 18 years of age, must have a Hamilton Depression Rating Scale (HDRS or HAM-D) score of \> 17
6. For participants \< 18 years of age, must have a Children Depression Rating Scale (CDRS) score of \> 40
7. Must be able to give informed consent

Exclusion Criteria:

1. Significant current or past medical conditions, such as cardiovascular, renal or endocrine disorders
2. DSM-IV diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder
3. Known pregnancy or positive urine HCG test
4. Current serious homicidal or suicidal risk
5. Young Mania Rating Scale (YMRS) score \> 7
6. Inability to comply with the protocol
7. Contraindication to an MR scan
8. Positive HIV test
9. Known sensitivity to creatine monohydrate

Inclusion criteria for healthy comparison group:

1. Must be female
2. Must be between the ages of 13 and 55 years
3. Must be able to give informed consent

Exclusion criteria for healthy comparison group:

1. Significant current medical illness
2. DSM-IV disorder identified by the SCID (to include bipolar I, bipolar II, bipolar NOS, major depressive disorder, dysthymia disorder, depressive disorder NOS, primary psychotic symptoms, substance use disorders, and anxiety disorders)
3. Known pregnancy or positive urine HCG test
4. Contraindication to an MR scan
5. Inability to comply with the protocol
6. Positive urine drug screen (unless it is positive for a low dose prescription opiate that is taken as prescribed)
Inhalation of Low Concentration of CO2 in Preterm Infants Not Responding to Caffeine for the Treatment of Apnea

In premature infants, apnea of prematurity is one of their major clinical problems. Caffeine is currently a worldwide therapy to reduce the number and severity of these apneas. This practice has shown to be safe on cognitive and neurodevelopmental outcomes at 18 to 21 months of age. However, caffeine is not 100% effective, and may have little effect on hypoxemia and bradycardia. Infants with intractable apneas unresponsive to caffeine treatment may require endotracheal intubation and mechanical ventilation. This procedure is invasive and has been associated with complications and increased risk for chronic lung disease and adverse neurodevelopmental outcome. Therefore, an alternative treatment modality would be preferable if it would prevent the infants from requiring endotracheal intubation. The investigators have been testing the overall hypothesis that small concentrations of inhaled CO2 (\~1%) are effective in treating apnea of prematurity. The investigators have completed three studies in preterm infants showing that inhalation of low concentration of CO2, in infants not on caffeine, regularize breathing and decrease apneas significantly. The effects of inhalation of CO2 in infants already on caffeine, are unknown. The hypothesis to be tested is that inhalation of low concentration CO2 (1%) will significantly reduce apnea in infants treated with caffeine. The investigators have three specific aims in this proposal. 1) the investigators want to know if the apnea rate (number of apneas of ≥5 seconds/hour) is decreased with CO2 inhalation in preterm infants already on caffeine for the treatment of apnea of prematurity; 2) the investigators want to know whether inhalation of CO2 can make breathing more regular with less apneic time and whether it decreases prolonged apneas (\>20 seconds) in infants already on caffeine for the treatment of apnea of prematurity; 3) the investigators want to assess the effect of inhalation of low concentration of CO2 on the regional oxygen saturation of the brain measured by near-infrared spectroscopy (NIRS) during apneas. This is to see whether CO2, by protecting cerebral blood flow, minimizes the decrease in cerebral oxygenation during apneas. This study entails a new and possibly more physiological method of treating apneas of prematurity that can be added to the present treatment of caffeine. These two treatments together, could minimize the number and severity of apneas and possibly decrease the need for mechanical ventilation in preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* gestational age at birth \< 33 weeks
* on caffeine treatment for apnea of prematurity at a maintenance dose of 5 mg/kg/day
* having apnea of prematurity (at least 5 self-resolved apneas or 2 apneas requiring intervention/12 hours)

Exclusion Criteria:

* on mechanical ventilation
* presence of congenital anomalies, sepsis or other known causes of apnea
* failure to obtain parental consent
This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Metastatic Breast Cancer

The purpose of this study is to assess the efficacy of ZD6474 in patients with metastatic breast cancer at 2 dose levels.


Eligibility Criteria:
Inclusion Criteria:

* Histological and/or cytological confirmation of metastatic breast cancer which is refractory to anthracycline, taxane, with or without capecitabine therapies;
* WHO performance status 0, 1 or 2 on the day of registration;
* Females, aged \>= 18 years;
* No Gastrointestinal pathology which could affect the bioavailability of ZD6474.

Exclusion Criteria:

* Any evidence of severe or uncontrolled systemic diseases including known cases of Hepatitis B or C or human immunodeficiency virus (HIV).
* Significant cardiac event (including symptomatic heart failure or unstable angina) within 3 months of entry or any cardiac disease that in the opinion of the investigator increases risk for ventricular arrhythmia;
* History of clinically significant cardiac arrhythmia (multifocal PVCs, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTC grade 3) or asymptomatic sustained ventricular tachycardia;
* Chronic atrial fibrillation;
* Previous history of QT / QTc prolongation with other medication;
* Congenital long QT syndrome;
* Systemic anti-cancer therapy or other investigational agent within the last 4 weeks (6 weeks for nitrosoureas, mitomycin C, or suramin);
* Currently receiving drugs with known significant 3A4 inhibitory (ie, ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem, verapamil) or stimulatory (ie, phenytoin, carbamazepine, barbiturates, rifampicin) effects;
* Currently receiving therapeutic doses of warfarin (Coumadin?)
The Long-term and Short-term Efficacy and Safety of Transplantation Autologous Bone Marrow Cells (BMCs) in Patients With the First STEMI (ST Segment Elevation Myocardial Infarction)

The purpose of this study is to test the hypothesis that the intracoronary transplantation of autologous mononuclear and CD 133 + bone marrow cells will improve left ventricular contractile function and will reduce the combined end points after the primary STEMI (mortality, recurrent myocardial infarction, angina, heart failure, stroke).

The study was randomized, opened, controlled. 85 patients with the first STEMI were enrolled. Patients were divided to three groups. On admission all patients were received thrombolytic therapy by 1,5 million U streptokinase. Transplantation of autologous mononuclear bone marrow cells (BMMCs) and аutologous CD133 + cells by balloon catheter placed into infarct-related artery (IRA) was performed at once after stent implantation in 28 patients patients (1st group) and in 10 patients (2nd group) on the 7-21 days of STEMI. Another 47 patients (3nd group) undergo only stent implantation into IRA the same day of STEMI.

Autologous BMMCs were obtained from bone marrow aspirate by gradient centrifugation. Echocardiography, Holter monitoring were performed. Plasma concentration of the pro-inflammatory and anti-inflammatory cytokines (IL1, 6,8,10), of the growth factors (stem cell factor - SCF, vascular endothelial growth factor - VEGF, hepatocyte growth factor - HGF, fibroblast growth factor - FGF, insulin-like growth factor - IGF), the number of circulating CD34 +38-, CD133 +, СD117 +, CD90 +34- stem cells were determined in these patients in the acute and sub-acute myocardial infarction period.

It is going 7 years after the beginning of planned to evaluate left ventricular function of these patients, incidence of cardiovascular end points (death, recurrent myocardial infarction, angina, heart failure, stroke) and their combinations, to evaluate the safety of transplantation of autologous BMCs (formation of intra-myocardial tumor or neoplastic processes of other sites) after 7 years from the beginning of study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and to 75 Years
* Informed consent
* First STEMI
* Term admission to an intensive care unit in the first 24 hours of onset
* Time reperfusion of the IRA is not earlier than 4 hours after the initial onset of acute transmural myocardial infarction

Exclusion Criteria:

* Atrial fibrillation, a permanent form Valvular heart disease
* Severe comorbidity
Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants

The purpose of this study is to determine whether repeated use of 0.25% miconazole nitrate ointment in newborns and infants with a yeast infection in the diaper area causes the yeast to become resistant to the drug.

The objective of this study is to investigate the potential for the development of resistance in Candida spp. after repeated treatment courses of 0.25% miconazole nitrate ointment in neonates and infants up to one year of age.

Eligibility Criteria:
Inclusion Criteria:

* Male or female neonate or infant up to 1 year of age with Fitzpatrick Skin Type I-VI
* Clinical evidence of diaper dermatitis and a positive KOH result for pseudohyphae and/or budding yeast at baseline visit
* Overall Diaper Dermatitis Severity Index score at baseline visit of 4-8 (must include an overall clinical grade of at least 2 for erythema)
* Wear commercially available diapers day and night for at least 7 days prior to enrollment and during the course of the 2 year study
* Caretaker must complete informed consent process

Exclusion Criteria:

* Known sensitivity to any component of the formulation
* No other skin conditions that may confound the evaluation of the drug efficacy or tolerability
* Known sensitivity to skin care toiletry products or diapers
* History of HIV positive
* Chronic illnesses that require systemic medication that may confound the evaluation of study drug efficacy or tolerability (antibiotic therapy is not included)
* Treatment with a prescription product for diaper dermatitis or other skin condition 7 days prior to enrollment
A Study of the Safety and Effectiveness of Levofloxacin Compared With Cefaclor in the Treatment of Adults With Chronic Bronchitis Experiencing Rapid Onset of Worsening of Symptoms Caused by Bacteria

The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with cefaclor, another antibiotic, in the treatment of adults with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacteria.

This is a randomized, open-label, parallel group, multicenter study to determine the effectiveness and safety of 488 mg of levofloxacin (once daily by mouth for 5 - 7 days) compared with 250 mg of cefaclor (every 8 hours for 7 - 10 days) in adults with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacterial infection. The study consists of 3 visits: one visit for screening and enrollment, and 2 visits for assessment of safety and effectiveness (one visit on Days 3 - 5 of the study and one visit \[post-therapy\] 5 - 7 days after the last dose of the study drug). The total duration of patient participation in the study is approximately 2 weeks. Levofloxacin and cefaclor are antibacterial agents used for the treatment of many types of infections, including infections with a rapid onset and brief duration caused by bacteria. The primary assessment of effectiveness in this study is the microbiologic response to treatment (the rate of elimination of disease-causing bacteria, by patient, and by type of bacteria), 5 - 7 days after the last dose of study drug. Safety evaluations (incidence of adverse events, physical examination, laboratory tests) are performed throughout the study. The study hypothesis is that treatment with levofloxacin is at least as effective and as well tolerated as treatment with cefaclor in adult patients with chronic bronchitis experiencing sudden worsening of symptoms caused by bacterial infection. Levofloxacin 488 mg by mouth once daily for 5 - 7 days, or cefaclor 250 mg by mouth every 8 hours for 7 - 10 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic bronchitis with a rapid onset of worsening of symptoms caused by bacteria
* history of chronic obstructive lung disease (chronic bronchitis and/or emphysema)
* recent increase in cough
* change in type of sputum (the mucus produced on coughing) and/or an increase in the production of sputum
* received previous antibiotic treatment if the previous treatment lasted for 24 hours or less, or if the previous treatment lasted longer than 24 hours but there was no improvement or stabilization of the disease.

Exclusion Criteria:

* Illness requiring antibiotic treatment by injection into a vein, beneath the skin, or into a muscle, or has a requirement of an antibiotic medication taken orally in addition to the study drug
* infection due to bacteria known (prior to the start of the study) to be resistant to the study drug
* previous allergic or serious adverse reaction to similar antibiotics
* diagnosis of pneumonia, determined by a chest x-ray at the start of the trial
* has cystic fibrosis, seizure disorders, kidney disease, or an unstable psychiatric condition.
Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage

The purpose of this study is to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without bevacizumab injection.

Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. We believe that preoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy

Exclusion Criteria:

* follow-up period of less than 3 months
* not first vitrectomy
* abnormal blood coagulation
* uncontrolled hypertension
Handgrip Strength Value in Predicting Mechanical Ventilation Weaning

The purpose of this study is to test the association between ICU acquired weakness as evaluated by dominant handheld dynamometry (handgrip) and the mechanical ventilation weaning outcome

Previous studies have evidenced that Intensive Care Unit acquired peripheral muscle weakness may lead to delayed mechanical ventilation weaning (i.e difficult or prolonged weaning according to guidelines). Nevertheless, no study has ever tested the association between handgrip strength and extubation outcome. The investigators have generated the hypothesis that ICU acquired weakness, as tested by handgrip strength might be associated with extubation outcome. The investigators have planned to include 240 patients. Handgrip strength will be monitored, along with a full muscular assessment through Medical Research Council score by the attending physiotherapist. Physicians in charge of the patients will be blinded to these values and the weaning protocol will continue according to guidelines.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* under mechanical ventilation for at least 48 hours
* meeting readiness to wean criteria according to international guidelines
* with social security
* informed consent given by the patient or a proxy

Exclusion Criteria:

* baseline pre existing rheumatologic or neurologic condition preventing the patient to use the tested device
* confusion (as assessed by Confusion Assessment Method for the Intensive Care Unit )
* Patients whose extubation is a terminal extubation, or with prior decision not to resort a reintubation in case of post-extubation respiratory distress.
* known pregnancy
* Inability to deliver clear patient information (language barrier without an interpreter, for example)
* Participation in another intervention research
Probiotics for Birch Pollen Allergy

Birch pollen allergy is one of the most common forms of respiratory allergy in the Nordic countries. Treatment consists of antihistamine use. Specific probiotic strains have been observed to modulate the immune system. Since the body has a common mucosal immune system; it was hypothesised that consumption of probiotics may affect also the respiratory mucosal immune response and hence affect respiratory allergy.

Earlier studies with probiotics had been unable to show improvements in adults with pollen allergy. It was therefore hypothesised that children, who's immune system is not yet fully developed, might be better targets.


Eligibility Criteria:
Inclusion Criteria:

Physician verified birch pollen allergy

Exclusion Criteria:

Diagnosed asthma Habitual use of probiotics and/or prebiotics
C Reactive Protein in Home Quarantined Coronavirus Disease 2019 (COVID -19) Patients.

During the peak of the second COVID -19 wave, the hospitals were over-crowded. Many COVID -19 positive patients had to stay at home and reach out to their family physicians for guidance. Medical follow-up for these patients was a daunting challenge. As in - patient hospital facilities were not readily accessible due to over crowding, early objective tests to identify home quarantined patients prone to deterioration and timely medical intervention to avoid hospitalization were required.

Based on early assessment of inflammatory markers like CRP and clinical signs like persistent high-grade fever, need-based early medical intervention was initiated in home quarantined COVID -19 patients prior to the onset of hypoxia, in order to avoid complications and hospitalization

25 home quarantined COVID -19 patients who contacted online for medical guidance underwent clinical and biochemical evaluation. Radiological evaluation was done only if indicated.

Based on early objective biochemical tests like elevated CRP and clinical signs like persistent high-grade fever on the third or fourth day after onset of symptoms, early medical treatment was initiated prior to onset of hypoxia.

All the 25 patients recovered without any complications and did not require hospitalization.

Eligibility Criteria:
Inclusion Criteria:

1. COVID -19 positive patients under home quarantine
2. Patients consulting online on the 3rd or 4th day after the onset of symptoms.
3. Patients with oxygen saturation 94% and above.

Exclusion Criteria:

1. Patients consulting online on or after 5th day of onset of symptoms.
2. Patients with oxygen saturation less than 94% during the initial presentation.
3. Systemic disease known to increase CRP levels.