cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting

This purpose of this study is to evaluate the efficacy and safety of single and repeated doses of palonosetron hydrochloride in preventing nausea and vomiting caused by moderate and highly emetogenic chemotherapy in patients.

Group I (Highly Emetogenic Chemotherapy): Patients that accepted chemotherapy including Cisplatin≥50mg/m2, Carmustine\>250mg/m2, Cyclophosphamide\>1500mg/m2, Dacarbazine\>60mg/m2, Doxorubicin\>60mg/m2, Epirubicin\>90mg/m2, IFO≥10g/m2 or AC program.

Group II (Moderately Emetogenic Chemotherapy): Patients that accepted chemotherapy including any dose of Carboplatin, Daunorubicin, Oaliplatin, Irinotecan, or Doxorubicin\<60mg/m2(not include liposomal doxorubicin), Epirubicin≤90mg/m2, Carmustine≤250mg/m2, Methotrexate≥250mg/m2, Cyclophosphamide≤1500mg/m2, Arabinoside\>200mg/m2, IFO\<10g/m2, Cisplatin≥50mg/m2.

Total subjects: 1000, single dose of palonosetron group of 500 patients, repeated doses of palonosetron group of 500 patients. According to the study subjects receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy, subjects are stratified randomize.

Eligibility Criteria:
Inclusion Criteria:

1. Patients candidates to a chemotherapy treatment, with histologically or cytologically confirmed malignant disease;
2. The concrete chemotherapy plan does not limited, group I (Highly Emetogenic Chemotherapy), group II (Moderately Emetogenic Chemotherapy);
3. Male or female aged 18-75 years, ECOG≤2, estimates survival time≥3 months;
4. WBC≥3.0×109/L, ANC≥1.5×109/L, PLT≥80×109/L, total bilirubin≤1.5×ULN(Normal value upper limit), AST and ALT≤2.5×ULN(With transferability liver cancer≤5×ULN), Cr and BUN≤1.5×ULN, electrolyte and electrocardiogram are normal, conforms to the chemotherapy adaptation;
5. Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks);
6. Patients that voluntarily sign the consent form.

Exclusion Criteria:

1. Pregnancy, or patients during breast feeding;
2. Patients have accepted any radiotherapy during the experimental period;
3. Gastric outlet or intestinal obstruction;
4. Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder;
5. Patients have epilepsy, or have been used psychotropic drug and calm drug;
6. Received any drugs with potential anti-emetic efficacy, or experienced any vomiting, nausea or retching in the 24 hours prior to chemotherapy;
7. Patients with transferability brain tumor, have vomiting caused by skull high pressure, or can not speak sickness situation and adverse reactions by self;
8. Patients have known hypersensitivity to 5-HT3 antagonists;
9. Patients have chemotherapy contraindications;
10. Patients are participating, or have participated in other Clinical studies of new drugs within 2 weeks.
Ocular Findings in Women With Primary Antiphospholipid Syndrome

Antiphospholipid antibody syndrome (APS) is an autoimmune disease characterized by systemic thrombosis and bad obstetric history. APS secondary to another medical disorder is the most common. Visual and ocular changes e.g. vaso-occlusive disease of retinal and choroidal vessels are found in patients with secondary APS. Patients with primary APS have also been reported to have ocular changes e.g. retinal vascular occlusion

The aim of our study to detect prevalence of ocular changes in women diagnosed with primary APS and correlation of these changes with adverse obstetric outcome. If a correlation is present, ocular findings in women with APS could be used in the future as a predictor for poor obstetric outcome.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 35 years
* Females with primary antiphospholipid syndrome

Exclusion Criteria:

* Age: below 18 years and above 35 years
* Auto-immune diseases e.g. SLE and other connective tissue disease
* Medical diseases causing retinal vascular changes e.g. hypertension, diabetes mellitus, sickle cell anemia.
* Previous vitreo-retinal surgery
Approaches For ThE pRioritization of Patients in priMAry Care Post-COVID To Reduce Health Inequities (AFTERMATH)

The COVID-19 pandemic significantly impacted primary care across Canada. Inequities in prevention activities and chronic disease management likely increased but the extent is unknown. Pragmatic interventions are required to prioritize patients and improve the quality of primary care post-COVID. In AFTERMATH, the investigators will conduct a pragmatic cluster randomized controlled trial (cRCT) at the largest primary care Practice-Based Research Network (PBRN) in Ontario, focused on a highly marginalized population: adults living with mental illness and one or more additional chronic diseases. The investigators will test an intervention that builds on the investigators' past work and combines data and supports to primary care providers to improve quality of life, reduce gaps in prevention activities and improve chronic disease management. The investigators' project will result in new evidence on ways to improve access to care and reduce inequities, and inform future efforts to use data beyond COVID-19.


Eligibility Criteria:
Inclusion Criteria:

A. Family Physicians: Any family physician in the University of Toronto Practice-Based Research Network (UTOPIAN) with 10+ community-dwelling patients living with depression, schizophrenia or bipolar disorder plus one or more additional chronic disease (COPD, diabetes, hypertension, osteoarthritis, dementia, epilepsy and Parkinson's).

B. Patients: Patients from the included family physician practices living with depression, schizophrenia or bipolar disorder plus one or more additional chronic disease (COPD, diabetes, hypertension, osteoarthritis, dementia, epilepsy and Parkinson's).

Exclusion Criteria:

A. Family Physicians: None

B. Patients: Patients under 18
Envarsus XR in Lung Transplant

Patients undergoing a lung transplant will be enrolled. All patients will undergo lung transplantation with standard post-operative management, including triple immunosuppression. As soon as the patient is deemed appropriate to take medications via the oral route, they will be converted from IR tacrolimus to Envarsus XR. Patients will be followed per site's standard of care.

Lung transplantation will be performed per standard-of-care techniques. All post-transplant management, including initial triple immunosuppression, will be carried out per standard of care. Once the patient is able to take medications via the oral route, they will be converted to Envarsus XR, which will be maintained for the first year post-lung transplant.

Eligibility Criteria:
Inclusion Criteria:

Prospective arm:

* Age ≥ 18 years
* Received a lung transplant at NYU Langone Health
* Be able to convert to Envarsus XR within the first month post-transplant
* Able and willing to provide informed consent

Historical control:

* Age ≥ 18 years
* Received a lung transplant at NYU Langone Health
* Completed one year from transplant on IR tacrolimus

Exclusion Criteria:

Prospective arm:

* Contraindication to tacrolimus due to allergic or adverse reactions
* Pregnant or nursing women
* Multi-organ transplant recipient

Historical control:

* Contraindication to tacrolimus due to allergic or adverse reactions (not including chronic kidney disease)
Psychiatric Disorders and Electrophysiological Markers

Schizophrenia is considered as the most frequent and the most severe chronic psychotic disorder. Its evolutionary modes and its clinical symptomatology remain particularly heterogeneous. Moreover, the brain processes involved in schizophrenia are still far from being clearly understood. Current empirical studies provide a mean duration comprised between 1 and 3 years without any specific diagnosis or treatment. These diagnosis issues are partly based on difficulties in the early distinction between schizophrenia and bipolar affective disorders (BD).

These results emphasize the necessity of new early indices (or endophenotypes). Such markers are intended to be more specific than classical clinical manifestations. In other words, they have to be absent among patients with differential diagnosis, such as BD. Among other possible early indices, several electrophysiological disturbances have been explored.

Our study is designed to mainly describe the N400 component among patients with schizophrenia or BD. This component is classically interpreted as indexing the integration the meaning of a linguistic stimulus in its preceding context. Our main hypothesis aims to show a specific alteration of N400 component among patients with schizophrenia when compared to participants with BD.

The second aim of this study concerns the exploration of four other event related potentials (ERPs) among patients with schizophrenia or BD:

* the P50 component, involved in early sensory gating processes,
* the P300 component, thought to reflect attentional resource allocation and working memory updating of stimulus context,
* the P600 component, elicited during same paradigms than N400, and reflecting their syntactic congruity.
* the CNV (Contingent Negative Variation), reflecting processes of motor anticipation

Regarding to their potential 'endophenotypes' status, our aim consists in comparing the N400 and three other ERPs among patients with schizophrenia or bipolar affective disorder. Since the schizophrenic specificity of such ERPs alterations still remains rarely studied, we also propose to describe the possible relations between these ERPs results and clinical scores observed among patients.


Eligibility Criteria:
Inclusion Criteria:

* Subject showing no severe or progressive somatic pathology, including neurological pathology (head injury, epilepsy, tumor process or multiple sclerosis causing EEG changes incompatible with the observation of ERP characteristics of both psychiatric disorders explored)
* Subject showing a diagnosis of schizophrenia or a diagnosis of bipolar affective disorders, as defined in the DSM IV-TR, in time of inclusion.
* Subject showing no disorder related to the use of a substance according to DSM IV-TR during the last 12 months prior to enrollment.
* Subject not showing another psychiatric disorder according to DSM IV-TR (axis 1 disorders), including schizoaffective disorder or a delusional disorder (not schizophrenic).

Exclusion Criteria:

* Subject unable to give informed consent
Erector Spinae Plane Block Versus Paravertebral Block During Non-intubated Thoracoscopic Lung Resections.

A randomized prospective trial to test the non-inferiority of Erector Spinae Plane Block (ESPB) in comparison with paravertebral block during non-intubated thoracoscopic lung resection

A prospective randomized trial which aims to evaluate a new technique of peripheral nerve block for pain management, the Erector Spinae Plane Block (ESPB) in patients undergoing minimally invasive lung resection in spontaneous breathing, with intravenous sedation ("non-intubated thoracic surgery"). ESPB will be compared with a largely employed procedure for loco regional pain management: the Paravertebral block (PB). Both procedures are performed under ultrasonographic guidance to allow proper visualization of the target site. Surgery is carried out by means of a minimally invasive approach (Video Assisted thoracic Surgery) with two keyhole incisions on the affected side.

Eligibility Criteria:
Inclusion Criteria:

Wedge Resection of pulmonary nodules performed with a two-portal or three-portal VATS approach.

Peripheral (within 3 cm from the surface of the inflated lung) nodules, less than 2 cm in diameter.

Acceptance of awake VATS with written informed consent

Exclusion Criteria:

Age \< 18 years

Patients who are pregnant or lactating

Morbid obesity (BMI \> 35 )

Inability to understand and sign the Informed consent

Proven allergy to local anesthetic drugs as required by this protocol

Expected pleural adhesions (previous thoracic trauma, previous pleuro-pulmonary infection, redo surgery on the affected side)
Use of a Dietary Supplement to Support Digestive Health in Children With Chronic Diarrhea

Micronutrients missing in the diet may assist in supporting digestive health in children with chronic GI issues. This study will monitor changes in symptoms associated with digestive problems in children provided with a dietary supplement that will be taken in conjunction with the standard of care.

Children with GI symptoms have varying response to the standard of care treatments. A dietary supplement of polyphenols from green tea and pomegranate extracts provides micronutrients often missing from conventional American diets. The objective of this study is to monitor changes in GI symptoms when the supplement is provided alongside the standard of care for children with symptoms that have been present for more than two weeks.

Eligibility Criteria:
Inclusion Criteria:

* Out-patients with diagnosis of unresolved gastrointestinal distress
* Parent or guardian willing to administer the dietary supplement orally once daily for up to 21 days
* Parent or guardian willing to record changes in GI symptoms on a questionnaire
* Parent or guardian willing to bring the child for a clinic visit to close-out participation in the study

Exclusion Criteria:

* requires care in an ICU
* has documented intestinal stricture, stenosis, obstruction, or abscess
* has concomitant congenital diseases
* are immunodeficient
* has malformation of the GI tract
* is unable to swallow fluids
* parent or guardian is unable or unwilling to provide informed consent
The Effects of Atorvastatin Treatment in COPD Patients

Rationale: Retrospective studies suggest that statins improve outcomes in COPD patients possibly as a result of an anti-inflammatory effect.

Objectives: To determine whether statins have an anti-inflammatory effect on the lungs of patients with COPD.

A controlled, parallel group study to compare the effects of Atorvastatin in comparison to placebo as an add-on treatment to Formoterol therapy in patients with mild to moderate COPD in group of 20 patients. All subjects will have spirometry, lung volumes, DLCO, SGRQ, 6MWD, serum lipids and hs-CRP measured before and after treatment. Bronchoscopy and transbronchial lung biopsy (TBB) will be carried out at baseline and after 12 weeks of treatment, and TBB specimens will be processed for histology, immunohistochemistry and microarray analysis.


Eligibility Criteria:
Inclusion Criteria:

. Written informed consent must be obtained before any assessment is performed. 2. Male and female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.

3. Patients with moderate to very severe stable COPD (Stage II-IV) according to the GOLD guidelines.

4. Patients with a post-bronchodilator FEV1 \< 80% of the predicted normal, and a post-bronchodilator FEV1/FVC \< 0.70 at Visit 1.

5. Current or ex-smokers who have a smoking history of at least 10 pack years

Exclusion criteria

1. Pregnant or nursing (lactating) women
2. Women of child-bearing potential, unless they are using effective methods of contraception during dosing of study treatment. 5. 3. Patients with a clinically significant abnormality at Visit 1.

4. Patients with a clinically relevant laboratory abnormality at Visit 1 5. Patients with a history of malignancy of any organ system (including lung cancer).

6. Patients contraindicated for treatment with statins 7. Patients unable to perform acceptable spirometry and lung volumes procedures.

8. Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.

9. Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.

10. Patients requiring oxygen therapy (\>15 hr/day) on a daily basis for chronic hypoxemia 11. Patients with any history of asthma or onset of symptoms prior to age 40 years.

12. Patients with concomitant pulmonary disease, (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, tuberculosis).

13. Patients with primary bronchiectasis. 14. Patients with a diagnosis of α-1 anti-trypsin deficiency. 15. Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation.

16. Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study.

17. Patients receiving any medications in the class listed in Table 5.1 18. Use of other investigational drugs within 30 days prior to visit 1.
Rapid Activity of Platelet Inhibitor Drugs Study

The aim of the RAPID study is to assess the rapid onset of action of the 2 novel oral antiplatelet agents, Prasugrel and Ticagrelor, in 50 patients with STEMI undergoing PPCI with bivalirudin monotherapy.

Fifty consecutive patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed ) will be randomized to receive 60 mg Prasugrel loading dose (n= 25) or 180 Ticagrelor loading dose (n= 25) before PPCI. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the 2 hours after drug loading dose a new loading dose will be administered. All interventions will be performed by the femoral approach according to current standards. The use of thrombectomy before infarct-related artery stenting, of everolimus eluting stent and of closure devices will be strongly encouraged. Bivalirudin will be administered as a bolus 0.75 mg/kg followed by 1.75 mg/kg/h infusion during PCI. After PCI a reduced bivalirudin infusion of 0.25 mg/kg/h for 4 hours will be allowed. Dual antiplatelet therapy (100 mg aspirin associated with 5 or 10 mg Prasugrel or 180 mg Ticagrelor) will be recommended for 12 months.

Residual platelet reactivity will be assessed in all patients at baseline (time of loading dose), and after 2, 4, 8 and 12 hours by a point-of-care test VerifyNow bedside available in the Intensive cardiac care Unit. High residual platelet reactivity will be defined as a Platelet Reactivity Units (PRU) \> 240 by VerifyNow. At the same time point, Activated Clotting Time (ACT) will be also assessed. Follow-up will be performed by outpatient visits or telephone interviews at 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting within 12 hours from the onset of symptoms with STEMI
2. Informed, written consent

Exclusion Criteria:

1. Age \< 18 years
2. Active bleeding; bleeding diathesis; coagulopathy
3. History of gastrointestinal or genitourinary bleeding \<2 months
4. Major surgery in the last 6 weeks
5. History of intracranial bleeding or structural abnormalities
6. Suspected aortic dissection
7. Any previous TIA/stroke
8. Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux, GPI.
9. Known relevant hematological deviations: Hb \<10 g/dl, Platelet count \<100x10\^9/l
10. Use of coumadin derivatives within the last 7 days
11. Chronic therapy with prasugrel or ticagrelor
12. Known malignancies or other comorbid conditions with life expectancy \<1 year
13. Known severe liver disease, severe renal failure
14. Known allergy to the study medications
15. Pregnancy
Home-Based Health Management of COPD Patients

Minnesota HealthSolutions Corporation (MHS) proposes to develop and evaluate a program to motivate and monitor people with chronic obstructive pulmonary disease (COPD) to complete home exercise as part of pulmonary rehabilitation (PR). The proposed system has two components: home-based activity monitoring and health coaching. The investigators will conduct a randomized, wait-list controlled clinical study to evaluate the effects of the activity monitoring system and health coaching on quality of life and daily steps.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of GOLD stage II, III, or IV COPD
* current or previous smoker with at least 10 pack-years of cigarette smoking
* be hospitalized for an exacerbation of COPD

Exclusion Criteria:

* high likelihood of being lost to follow-up or contact
* inability to provide good data or follow commands
* inability to do mild exercise
Dentin Hypersensitivity - Varnish or Laser?

Dentin hypersensitivity is a common condition described as a short and sharp pain caused by thermal, evaporative, tactile, osmotic, or chemical stimuli to exposed dentin that cannot be related to another defect or dental pathology. The variety of treatment options and products on the market might seem overwhelming. This study aims to show that laser treatments are efficient in reducing pain scores compared to a desensitizing agent (Gluma). 80 patients with at least two hypersensitive teeth will be enrolled in this study. Patients will be divided randomly into four groups (control group (Gluma), laser group 1 (2.94 µm wavelength), laser group 2 (1064 nm wavelength), laser group 3 (970 nm wavelength)). Visual Analog Scale will be measured before treatment, right after treatment, one week after treatment, one month after treatment, three months after treatment. Mixed Anova's and descriptive analysis will be used for statistical evaluation.

A total of 80 patients meeting the inclusion criteria will be included in this randomized clinical study. Participants will be randomly divided into four groups. Pain scores will be measured before treatment, right after treatment, 1 month after treatment and 3 months after treatment using the Visual Analog Scala (VAS). Patients will not know which treatment will be performed before nor will the patients from the laser groups know the wavelengths. Pain scores at check-up meetings will be collected by another doctor other than the one who will perform all laser treatments.

Eligibility Criteria:
Inclusion Criteria:

* all genders
* 18-70 years
* good general health
* at least two hypersensitive teeth in either jaw
* initial VAS-score \>3

Exclusion Criteria:

* Active carious lesions, insufficient restorations, enamel cracks, reversible pulpitis
* Active periodontal disease, periodontal surgery (in the last 6 months)
* Bleaching procedure in the last 3 months
* Analgetic use in the last 72 hours
* Pregnant/lactating women
Staccato Loxapine Multidose PK

The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine.

The purpose of the present Phase 1 study in schizophrenic patients is to assess the safety and pharmacokinetics of multiple doses of Staccato Loxapine given within a 24 hour time period. The study will be conducted in schizophrenic patients who are on chronic, stable antipsychotic medication. Patients meeting entry criteria will be randomized to one of three dose sequences of Staccato Loxapine or to Staccato Placebo. Following administration of medications, safety, tolerability and pharmacokinetic assessments will be conducted at serial time points.

Eligibility Criteria:
Inclusion Criteria include:

1. Male and female subjects between the ages of 18 to 65 years, inclusive.
2. Subjects who are on stable, oral, chronic (\>2 mos) antipsychotic medication regimen and who are able to tolerate the rapid oral dose taper and substitution regimen.

Exclusion Criteria include:

1. Subjects who are currently treated with injectable depot neuroleptics within one dose interval must be excluded.
2. Subjects who have received loxapine or amoxapine within the last 30 days must be excluded.
3. Subjects with a history of allergy or intolerance to dibenzoxazepines (loxapine and amoxapine) must be excluded.
4. Subjects with a history of movement disorders including Parkinson's disease or a history of neuroleptic malignant syndrome must be excluded.
5. Subjects who have a history within the past year of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded.