cyrilzakka/clinical-trials huggingface dataset:
Disinfection Effect of Gaseous Ozone

The current study aimed to investigate the effect of gaseous ozone in disinfection the root canals of primary teeth. Thirty-six primary molars of 36 completely healthy patients (aged 5-10) were included in the study.The included teeth were randomly divided into three groups as follows:

- sodium hypochlorite applied group, ozone applied group, ozone and sodium hypochlorite applied group.The study hypothesized that the antimicrobial efficiency of gaseous ozone would be higher than the other groups compared.

The current clinical randomized study's primary purpose was to investigate the antimicrobial efficiency of gaseous ozone on primary teeth root canals.The included teeth were randomly divided into three groups, and in each group, the root canal therapies of 12 primary teeth were done. In the first group, 2.5% sodium hypochlorite was applied as an irrigation agent. In second group, 0.9% sterile saline solution was combined with 80 seconds.

OzonyTronX® application. 2.5% sodium hypochlorite was applied as an intracanal medicament in combination with 80 seconds OzonyTronX® in the last group. Microbial analyses assessed the colonization of Candida albicans and Enterococcus faecalis before and after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with no use of an antimicrobial agent in the last 3 months
* Teeth with positive responses to percussion and palpation, no sinus tract and intra-oral, extra-oral swelling,
* Teeth with no pathological and physiological mobility, and restorable with stainless steel crown.
* In radiographical examinations, the selected teeth needed to show the Res(i) and Res (1/4) scores according to the root resorption scoring system
* No radiolucency in the peri-radicular tissue and no internal-external root resorption were also among the including criteria. However, the teeth with lesions only in 1/3 percent of the bifurcation area were also included in the study

Exclusion Criteria:

* Patients who are not compatible with including criteria,
* Who cannot adopt the dental treatments,
* with whom rubber-dam İsolation was not possible were excluded from the study
Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

This study is designed to evaluate the single-dose effectiveness of two bronchodilator inhalers given at two dose levels in pediatric asthma patients.


Eligibility Criteria:
Inclusion Criteria:

* Persistent asthma for a minimum of six months duration that has been stable for at least four weeks
* Predicted FEV1 60-90%
* Demonstration of 12% airway reversibility

Exclusion Criteria:

* Continuous requirement for beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, anticholinergics and/or steroids other than those inhaled;
* Presence of clinically-significant non-asthmatic acute or chronic disease
Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)

The aim of the study is to examine the value of the new MRI techniques (spectroscopy and DWI), and FDG-PET in prognostication of male infertility.

The diagnostic workup of male infertility includes medical history, physical examination and semen analysis. In severe cases further workup includes testicular ultrasound, analysis of genes and hormones and in a few cases testicular biopsies are necessary.

Ultrasound is the first choice of imaging, but new MRI and PET techniques can provide additional information.

Research indicates that new MRI techniques can measure the activity of the testicular sperm cell production non-invasively and FDG-PET can measure the testicular metabolism with a radioactively marked glucose analog (FDG). These imaging modalities are combined in a PET/MRI and we wish to perform a PET/MRI in 10 men with normal sperm counts and 10 men with low sperm counts in order to evaluate whether a PET/MRI can distinguish testicles with and without sperm cell production. We hope that this new non-invasive technique can replace the need for invasive biopsies and will be able to target the harvesting of sperm cells in fertility treatment.

Eligibility Criteria:
Inclusion Criteria:

18-40 year old males referred to fertility treatment at Rigshospitalet, Denmark. 10 men with a normal sperm count and 10 men with no sperm cells in the ejaculate will be included. The patients shall be able to understand the patient information and be able to give informed consent.

Exclusion Criteria:

Severe claustrophobia Age: less than 18 or above 40 Severe obesity (\> 140 kg) Pacemaker or other electronic in-operated devices Non-MR compatible metallic devices Malignant testicular tumors suspected at clinical examination or ultrasound Infectious testicular diseases
A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of Digoxin in Healthy Volunteers.

The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754) affect the pharmacokinetics (ie, how the body affects the drug) of multiple doses of digoxin. The safety and tolerability of canagliflozin will also be assessed in healthy volunteers.

This study will be an open label (all volunteers and study staff know the identity of the assigned treatment), randomized (the treatment is assigned by chance), multiple dose, cross-over study (all volunteers will switch from one treatment to another) to determine how canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) affects the pharmacokinetics of digoxin (a drug used to treat various heart conditions). Volunteers will be randomly assigned to 1 of 2 treatment sequence groups: Group AB or Group BA. Volunteers assigned to Group AB will be given Treatment A: digoxin once a day for 7 days. Volunteers assigned to Group BA will be given Treatment B: digoxin and canagliflozin once a day for 7 days. A washout period (when no medication is given) of at least 14 days will follow the first 7-day treatment period. Following the washout period, volunteers will be assigned to the treatment that they did not receive during the first treatment period. This second treatment period will last for 7 days. Each volunteer will participate in the study for approximately 60 days.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
* Exclusion Criteria:
* History of, or current active illness, considered to be clinically significant by the Investigator, or any other illness that the Investigator considers should exclude the patient from the study, or that could interfere with the interpretation of the study results
Gemcitabine in Ovarian Cancer

The primary endpoint of this study is to assess the objective tumor response rate in patients with advanced epithelial ovarian cancer receiving combination of Gemcitabine at a dose 1250 mg/m2 (Day 1 and 8) with Cisplatin 75 mg/m2 (Day 1) as first-line treatment


Eligibility Criteria:
Inclusion Criteria:

* ECOG = 0-2
* Operated patients
* disease stage III-IV

Exclusion Criteria:

* No prior chemotherapy or radiation therapy
Hematological Clozapine Monitoring With a Point-of-care Device (CHEMPAQ)

Clozapine remain the drug of choice for treatment resistant schizophrenia and up to 60% of patients not responding to other antipsychotics will respond to clozapine. However, the use of clozapine is restricted due to the risk of agranulocytosis and consequently the need for mandatory hematological monitoring. CHEMPAQ XBC is a point-of-care device that can be used in patients home and analyze WBC and granulocytes by a single capillary blood drop. This study aims to investigate whether this new procedure increases the acceptability of clozapine


Eligibility Criteria:
Inclusion Criteria:

* Treated with clozapine
* Compliant with blood monitoring
* Willing to give informed consent

Exclusion Criteria:

* Prior case of agranulocytosis
Cyclophosphamide Added to Standard Immunosuppressive Therapy With Herombopag as Front-line Therapy in Patients With Severe Aplastic Anemia

This is a prospective, single-center, single-arm, phase 2 study. This study aims to evaluate the efficacy and safety of Anti-lymphocyte globulin plus herombopag in combination with moderate-dose cyclophosphamide for severe aplastic anemia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age ≥ 12 years
* Subject has a diagnosis of naïve severe or very severe aplastic anemia
* ECOG performance status ≤2
* Unwilling or unable to receive allogeneic hematopoietic stem cell transplantation.
* Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

* Previously received immunosuppressive therapy \> 4 weeks
* Previously treated with TPO-RA \> 4 weeks
* Have an allergy or intolerance to either herombopag or cyclophosphamide.
* Have an allergy to ALG
* Uncontrolled systemic fungal, bacterial, or viral infection
* Poorly controlled hypertension (≥140/90mmHg) or diabetes (a fasting plasma glucose concentration ≥7.0mmol/L or a random venous plasma glucose concentration ≥11.1mmol/L)
* Abnormal liver or kidney function: ALT or AST \>3 ULN, or serum creatinine (sCr)≥ 2.5 ULN.
* History of radiotherapy and chemotherapy for malignant solid tumors
* Combined with other serious disorders
* Pregnant or breast-feeding patients
* Patients considered to be ineligible for the study by the investigator for reasons other than the above.
89Zr-trastuzumab PET for Imaging the Effect of HSP90 Inhibition

HSP90 inhibition is a potentially new targeted drug modality in the treatment of HER2 positive, trastuzumab refractory breast cancer. Little is known about the pharmacodynamics of HSP90 inhibitors in vivo, but non-invasive PET/CT imaging in a xenograft mouse model could visualize and quantify HER2 reduction after AUY922 treatment by 89Zr-trastuzumab PET imaging. Two doses of 50 mg/kg AUY922 resulted in a decrease in HER2 expression of approximately 50%, quantified 6 days after the last administration of AUY922.

Visualizing HER2 expression in breast cancer patients before and early following HSP90 inhibition by means of 89Zr-trastuzumab PET, is likely to provide insight in the early in vivo effect of HSP90 inhibition and could potentially support patient tailored therapy.

This study is designed as a side study to the multicenter, international phase I-II trial with the HSP90 inhibitor AUY922 (protocol CAUY922A2101), as part of the biomarker assessment. In protocol CAUY922A2101, section 4, the design of this phase I-II trial is described (p36, 37). Briefly, a dose-escalation study is performed according to phase I design. This part is followed by a dose-expansion study according to a phase II design. In the latter part, breast cancer patients are enrolled that are either refractory to hormone- or trastuzumab treatment (both treatment arms, n=40 patients). Patients with HER2 positive, trastuzumab refractory breast cancer, will receive a 89Zr-trastuzumab PET scan as part of the present side study protocol, which will be performed in collaboration with the Royal Marsden Hospital (United Kingdom).

To this end, a 89Zr-trastuzumab PET scan will be performed before (baseline) and during treatment with the HSP90 inhibitor AUY922, as described below.

A minimum of six patients are needed to evaluate whether the 89Zr-trastuzumab PET scan can be used for the detection of a decrease of HER2 expression, induced by HSP90 inhibition.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HER2 positive, trastuzumab (and lapatinib) refractory breast cancer
* Participation in the phase I-II trial with HSP90 inhibitor AUY922 (in- and exclusion criteria for this study with AUY922 are described in protocol CAUY922A2101.

Exclusion Criteria:

* No participation in the phase I-II trial with HSP90 inhibitor AUY922 (CAUY922A2101. Clinical trials no. NCT00526045A)
Blinatumomab in Refractory Myasthenia Gravis (BLINA-MG)

The goal of this clinical trial is to evaluating the efficacy and safety of Blinatumomab in the treatment of refractory myasthenia gravis and exploring the immunological mechanisms of Blinatumomab therapy in refractory myasthenia gravis. The main questions it aims to answer are:

Will Blinatumomab improve the symptoms of participants? What medical problems do participants have when using Blinatumomab?

Participants will:

Continuous intravenous infusion of Blinatumomab for 5 days, pause for one week, and continue continuous intravenous infusion for 5 days Visit the clinic once every 1 month for checkups and tests Keep a diary of their symptoms


Eligibility Criteria:
Inclusion Criteria:

* 18 years old ≤ Age ≤ 75 years old
* patients with a Myasthenia Gravis Activities of Daily Living (MG-ADL) scale score of 6 or higher, and an ocular muscle score constituting less than 50% of the total score
* after receiving an adequate course of at least two conventional immunotherapeutic drugs (including both steroidal and non-steroidal immunosuppressants), the Post-Intervention Status (PIS) remains unchanged or worsens; or after receiving an adequate course of at least two conventional immunotherapeutic drugs, the PIS improves, but the MG-ADL score is still ≥6 points and persists for at least half a year; or after receiving an adequate course of at least two conventional immunotherapeutic drugs, the PIS is in remission or improvement, yet during the regular tapering of immunotherapeutic drugs, there are still at least two annual exacerbations of disease symptoms (MG-ADL score ≥6 points); or after the occurrence of a crisis, despite multiple immunotherapies such as intravenous immunoglobulin, plasmapheresis, and high-dose intravenous methylprednisolone, and active infection control, the patient still cannot be weaned off the ventilator due to MG-induced respiratory muscle weakness for more than 14 days
* positive for anti-AChR, and/or anti-MuSK, and/or anti-LRP4 antibodies.
* patient or their legal representative signs an informed consent form in writing

Exclusion Criteria:

* pregnant or lactating women
* individuals with an allergy to Blinatumomab
* individuals who have undergone thymectomy within the 12 months prior to baseline or who are planning to have a thymectomy during the 12-week study period
* individuals who have received biologic agents targeting CD19 or CD20 within 6 months prior to baseline are eligible for enrollment (subjects with CD19 or CD20 positive B cell counts above the lower limit of normal are allowed to participate)
* within the 3 months prior to baseline, use of Ecuzumab and Tocilizumab
* received intravenous immunoglobulin or plasma exchange therapy within 4 weeks prior to baseline
* currently participating in other clinical studies
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers

The purpose of this study is to investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histological or cytological confirmation of metastatic and/or unresectable metastatic colorectal, prostate, pancreatic, breast, ovarian, or urothelial carcinoma with measureable disease for solid tumors per RECIST v1.1 and for prostate carcinoma per PCWG3
* Presence of at least 2 lesions: at least one with measurable disease as defined by RECIST v1.1 for solid tumors and by PCWG3 for prostate carcinoma for response assessment; at least 1 lesion must be accessible for biopsy in addition to the target lesion
* Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting, if such a therapy exists, and have been considered for all other potentially efficacious therapies prior to enrollment
* ECOG performance status less than or equal to 2

Exclusion Criteria:

* Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease
* Participants with carcinomatous meningitis
* Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study treatment
* Participants with active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply
Clinical, Electrophysiological and E-field Modelling Evidence of High Density Transcranial Direct Current Stimulation in Motor Stroke

The present study aims to investigate the therapeutic potential of a high definition transcranial direct current stimulation protocol, stimulating frontal and cerebellar areas boosting the cognitive and motor recovery of stroke population.

Stroke cause direct network dysfunctions correlating with the underlying behavioral deficits In that context, characterize and boost neuronal reshaping towards a favorable state for recovery has become a distinguished therapeutic approach. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation able to locally modulate neuronal activity and modify neural arquitecture.

In such scenario, the investigators develop in this protocol a new tDCS multitarget fronto-cerebellar tDCS approach, exploring the benefits of boosting motor dysfunctions by means of a dual site-approach, up-regulating dlPFC and CB activity. The investigators here design a pilot experimental clinical trial exploring the accumulative clinical potential for motor skill \& learning recovery and EEG effects of a high-density bifocal transcranial direct current stimulation protocol (HD-tDCS).

The investigators hypothesize that the tDCS protocol will promote direct functional motor reorganization helping relearning motor process, will boost the activity of prefrontal settled systems correcting attentional deficits and increasing strength connectivity with premotor systems, and will normalize large-scale abnormalities increasing interhemispheric functional connectivity (i.e., functional integration), decreasing interhemispheric asymmetry (i.e., functional segregation) and restoring transcallosal balance, impacting positively either in motor and cognitive recovery. All in all, this study will be the first exploring the simultaneous modulation of two different targets in stroke population corresponding to different networks looking for a summative/synergistic effects helping motor and cognitive functions recovery.

Eligibility Criteria:
Inclusion Criteria:

* Received a diagnosis of supratentorial ischemic or hemorrhagic stroke confirmed by neuroimage (MRI, PET, CT, fMRI or DTI) in the middle cerebral artery territory or encompassing fronto-temporo-parietal hemorrhages
* Enrolled in a live rehabilitation program in the rehabilitation and physical medicine department
* Between 4 and 12 months after stroke episode
* Have signed the informed form

Exclusion Criteria:

* Medical instability with the presence of infections, assisted ventilation, epilepsy or recurrent seizures, untreated psychiatric disorders or an active treatment with sedative drugs
* tDCS contraindications as defined by the international safety guidelines
* Large aphasic, psychiatric and cognitive deficits limiting patient's comprehension
Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate?

This study evaluates the effect of Vitamin D3 supplementation in healing rate of tibia fractures in adult patients with low vitamin D. Half of participants will receive Vitamin D3 supplementation while the other will receive placebo.


Eligibility Criteria:
Inclusion Criteria:

* Tibial fracture
* ASA physical status classification system I-II.
* 25 hydroxyvitamin D below 30ng/ml)
* Fracture treatment with reamed intramedullary nail

Exclusion Criteria:

* Open Fractures Gustillo III B and III C
* Closed Soft tissue injury with Tscherne classification of III
* Acute Compartment Syndrome
* Pathology fractures (That occur in abnormal bone, for example in the presence of tumor, cyst or Paget disease)
* Other Fractures in lower limbs or spine that does not allow full weight bearing of the operated tibia after 4 weeks
* More than 7 days of evolution from fracture occurrence
* Diabetes mellitus with HbA1c more or equal than 7%
* Peripheral vascular disease
* Rickets
* Pre-existing disorders of the metabolism of Vitamin D and/or homeostasis of calcium and phosphorous (ie. Hepatic insufficiency, congenital defects of the vitamin D metabolism, disorders of the parathyroid glands, hypo or hyper calcemia)
* Renal failure with glomerular filtration rate below 60ml/min according to MDRD-4.
* Patients using nephrotoxic medications in high doses, requiring periodical monitoring of glomerular filtration rate
* Patients undergoing with nephrotic syndrome or that suffered it in the past
* Patients that suffered nephrolithiasis or urolithiasis
* Pregnant women
* Patients with allergy to vitamin D or other contraindications for vitamin D3 prescription
* Patients that are taking multivitamin supplements containing vitamin D and will not suspend taking them during the study.
* Patients that are not able to swallow a cup of water
Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy

The purpose of this study is to test the safety of different amounts (doses) of external radiation therapy (high-energy x-rays that shrink or destroy cancer) combined with chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* MSKCC-reviewed pathologically proven diagnosis of primary bladder urothelial carcinoma without evidence of regional (nodal) or distant spread (cT1-T4a, Nx or N0).
* Karnofsky Performance Scale (KPS) ≥ 70%
* Age ≥18 years old
* Adequately functioning bladder, defined as continent and without the need for an indwelling catheter
* Absolute neutrophil count (ANC) ≥ 1500/mL; platelets ≥ 100,000/mm3 serum bilirubin \< 1.5 x the upper limit of normal (ULN); aspartate aminotransferase (AST) and/alanine aminotransferase (ALT) ≤ 1.5 × ULN
* Adequate renal function: calculated creatinine clearance \> 30 mL/min/1.73 m2 using the following formula modified Cockcroft and Gault Formula for estimated Creatinine Clearance
* Patients must be considered able to tolerate systemic chemotherapy and pelvic radiation therapy.
* Patients must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Evidence of distant disease or histologically-proven nodal metastases. Patients with radiologic evidence of lymphadenopathy must have biopsy proof of N0 status.
* Previous pelvic radiation therapy
* Prior systemic chemotherapy non-cisplatin based neoadjuvant for urothelial carcinoma (prior intravesical chemotherapy or immunotherapy is permissible)
* Prior cisplatin based neoadjuvant systemic chemotherapy for more than \>4 cycles
* Active inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis)
* Women who are pregnant or lactating
Biomarkers for Ventilator-associated Pneumonia

The purpose of this study is to evaluate different peptide biomarkers, variations in the microbiome and patterns in the bacterial transcriptome as prognostic or diagnostic biomarkers of VAP.


Eligibility Criteria:
Inclusion Criteria:

* Admission to an intensive care unit
* Intubation within last 24 hours
* Anticipated mechanical ventilation of at least 48 hours

Exclusion Criteria:

* FiO2 above 70% or PEEP above 15
* Severe coagulopathy (spontaneous PK(INR) \>1.8 or thrombocytes \<50). Prophylaxis treatment dose of LMWH or factor Xa inhibitors/NOAC is not an exclusion criteria. If higher doses of these substances are administered, the responsible clinician should be consulted before sample collection.
* Ongoing infection of the lungs at admission to the ICU.
* Severely elevated or instable intracranial pressure.