cyrilzakka/clinical-trials huggingface dataset:
Aspirin Resistance and Sleep Apnea in Type-2 Diabetic Patients

Type-2 Diabetes and Sleep Apnea Syndrome (SAS) are both related to an increase in platelet activation. Type 2 diabetes is often associated with sleep apnea syndrome with a prevalence up to 60%.

The main objective of our study is to analyze the influence of sleep apnea on the response to antiplatelet therapy in stable aspirin-treated type-2 diabetes patients.

Consecutive stable aspirin-treated type-2 diabetes patients referred for suspicion of sleep apnea will be recruited after providing informed consent. Response to aspirin will be assessed with the Verify Now Aspirin(TM)rapid analyser in the morning after nocturnal polysomnography, and compared with a group of type-2 diabetes free of sleep apnea. Other endocrine, metabolic, hematologic and cardiovascular confounders will also be assessed at baseline to determine their influence on the response to aspirin.

Then, Patients with severe SAS (Apnea-Hypopnea Index\> 30 events/h) and response with Aspirin (ARU \> 454) will be randomized to 3 months of active or sham continuous positive airway pressure treatment in a pilot study. After the 3-months of intervention, response to aspirin will be compared between the sham and effective CPAP groups.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged \> 18 years old
* With Type 2 diabetes
* Stable Atherothrombosis for more than 3 months
* Using aspirin for more than 10 days or without aspirin (in this last case, they will do only the observational study.)
* Without any modification in their treatments for 10 days
* Ambulatory patient
* Without any cardiovascular event or inflammatory disease for 3 months before inclusion

Exclusion Criteria:

* Pregnant women
* Other active clinically significant illness, including unstable cardiovascular, or neoplasia which could interfere with the study conduct or counterindicate the study treatments or place the patient at risk during the trial or compromise the study participation
* Patients participating in an other study
* Patient without any medical care insurance
* Any treatment that could interfere with aspirin
* Previous treatment by CPAP
Impact of Acute Cerebral Diseases on the Autonomous Nervous System: Progression and Correlation to Therapy and Outcome

The pupilometer determines the alteration of the pupil diameter after a defined light stimulus. In this study data is collected from pupilometer measurements of patients with an acute cerebral disease. The measurements take place during daily neurological routine examinations. The values are compared to outcomes resulting from pupilometer measurements done on patients having not an acute cerebral disease (e.g. cerebral aneurysm without symptoms). The study aims to establish the not invasive method of pupillometry for detecting neurological degradations early.

The pupilometer determines the alteration of the pupil diameter after a defined light stimulus providing information of the autonomic nerve system. The result collecting from pupillometry is objective and more precise than the subjective-visual evaluation of the pupil and its reactivity.

In this observational study data is collected from pupilometer measurements of patients with an acute cerebral disease. The measurements take place during neurological routine examinations. The first measurement is done during the initial diagnosing examination, followed by daily measurements and ending with measurements after 3 and 6 month upon hospital discharge. The values are compared to standard values resulting from pupilometer measurements done on patients having non-acute cerebral disease (e.g. cerebral aneurysm without symptoms). The study aims to establish the not invasive method of pupillometry for detecting neurological degradations early.

Eligibility Criteria:
Inclusion Criteria:

* male or female patient, age ≥ 18 years
* signed consent
* treatment group:
* patient with acute, cerebral disease verified by CT, MRI or spinal tap
* control group
* patient with non-acute cerebral disease like a new diagnosed aneurysm without symptoms

Exclusion Criteria:

* female or male patient aged \< 18 years
* absent of signed consent
* persons who have a dependent or working relationship with the sponsor or investigator
* persons who are sheltered in an institution by juridical or governmental order
* concurrent participation in an other clinical study
A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With Schizophrenia

This is a study designed to evaluate the efficacy and safety of lurasidone in acutely psychotic patients with chronic schizophrenia and to confirm the non-inferiority of lurasidone relative to quetiapine XR.


Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent and aged between 19 and 75 years of age.
2. Meets DSM-5 criteria for a primary diagnosis of schizophrenia.
3. CGI-S ≥ 4 at screening and baseline.
4. Subject is not pregnant (must have a negative serum pregnancy test at screening) or nursing (must not be lactating) and is not planning pregnancy within the projected duration of the study.
5. Subject is able and agrees to remain off prior antipsychotic medication for the duration of the study.
6. Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening.

Exclusion Criteria:

1. The subject has evidence of any chronic organic disease of the CNS (other than schizophrenia)
2. Subject has participated in a prior trial of lurasidone.
3. Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
4. In the opinion of the investigator, subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
5. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
A Study of GDC-0134 to Determine Initial Safety, Tolerability, and Pharmacokinetic Parameters in Participants With Amyotrophic Lateral Sclerosis

This first-in-human, double-blind, placebo-controlled Phase I study will be conducted in participants with amyotrophic lateral sclerosis (ALS) to explore safety, tolerability, and pharmacokinetic (PK) properties of GDC-0134. It will include three components: a Single-Ascending-Dose (SAD) stage, a Multiple-Ascending-Dose (MAD) stage, and an Open-Label Safety Expansion (OSE) stage.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants with a diagnosis of possible, laboratory-supported probable, probable, or definite ALS according to modified El Escorial criteria
* Upright forced vital capacity of at least 50 percent (%)
* Ability to fast from food for 8 hours prior to dosing and 2 hours after dosing

Exclusion Criteria:

* Currently taking riluzole unless on a stable dose for the 3 months prior to Day -1 and without current liver enzyme or liver function abnormalities
* Currently taking edaravone unless after completion of at least the second 14-day drug-treatment period, as long as Day 1 occurs during a drug-free period at least 24 hours after the last edaravone dose and at least 5 days prior to the first dose of the next cycle
* Positive for hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency virus (HIV) antibody
* Clinically significant thrombocytopenia
* Currently taking nutritional/herbal supplements, except for over-the-counter vitamins that are within Recommended Dietary Allowance (RDA), unless discontinued at least 7 days prior to Day -1, except upon approval of both the investigator and Sponsor
* For participants participating in a designated drug-drug interaction (DDI) cohort in the MAD stage of the study, who require midazolam/caffeine administration: known allergy, religious prohibition, or other condition limiting midazolam or caffeine administration
To Assess Adherence to the Treatment and Quality of Life in Patients With Hypertension

The main goal of this study is to achieve a deeper knowledge of the adherence to antihypertensive drug treatment and to evaluate the quality of life in this population. This work has the following goals: primary objective is to assess the antihypertensive treatment adherence in patients with essential hypertension on treatment for more than 6 months.

The secondary objectives include the assessment of quality of life, identification of associated factors that affect adherence, knowledge of drugs used and comparison of levels of adherence according to the different drug regimes

Two questionnaires shall be prepared The first questionnaire shall be anonymously completed by the patient willing to participate. It is divided into two parts:

1. Treatment Adherence Scale (MMAS): this survey is made up of 4 questions having YES/No answers and it grants 1 point per every "NO" answer, and zero points to every "YES" answer.
2. The second part is the health-related quality of life Questionnaire (MINICHAL). The questions refer to the "last 7 days" with 4 possible answer options: 0 (no, absolutely not), 1 (yes, sometimes), 2 (yes, frequently) and 3 (yes, a lot). It is made up of 16 items, 10 correspond to the "State of Mind" dimension and 6 to the "Body-related Symptoms," also described as "Physical symptoms".

The second questionnaire shall be completed by the intervening physician as regards patients that attend medical visits, and who have answered the anonymous questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of essential hypertension under the criteria established by the Joint National Committee VII (9) and those patients under pharmacological treatment with the same therapeutic regime during at le

Exclusion Criteria:

* Patients with secondary HBP
* Pregnant women or nursing mothers
* Patients with acute illnesses or having a definite psychiatric diagnosis, as well as those patients who are unable to completed
Sirolimus Treatment for Refractory PRCA

Pure red cell aplasia (PRCA) is a kind of anemia characterized by severe reticulocytopenia and obvious bone marrow erythroblastic cells decreased. Cyclosporine and /or steroids are the first line therapy but some patients were refractory or intolerance to the treatment. The effects of the second line therapy are also not satisfactory and sometimes not available. The investigators aim to explore the efficacy and side-effect of sirolimus for refractory PRCA.

Pure red cell aplasia (PRCA) is a rare normocytic normochromic anemia with reticulocytopenia, characterized by a reduction of erythroid precursors from the bone marrow, could be divided into congenital and acquired PRCA according to pathogenesis. Congenital PRCA, also known as Diamond-Blackfan syndrome, has been associated with pathogenic variant in GATA1 and TSR2 and gene encode ribosomal proteins. Acquired PRCA can be a primary disease which is usually mediated by immunology, or secondary to other diseases, such as lymphoproliferative diseases, autoimmune diseases, thymoma, infection, or drugs. The first line therapy of acquired PRCA is Cyclosporine A and steroids, the second line therapy are anti-CD20, ATG, immunosuppressive drugs like cyclophosphamide, bone marrow transplantation. Unfortunately, some patients did not response or tolerate the above treatments.

Sirolimus (rapamycin) is an agent produced by the bacterium Streptomyces hygroscopicus, inhibits the mammalian target of rapamycin (mTOR). mTOR is a serine/threonine kinase that regulates cell growth, proliferation, metabolism and survival in eukaryotic cells, and is identified as two interacting complex, mTORC1 and mTORC2. Sirolimus primarily inhibits mTORC1, has been approved for prevent organ transplant rejection, especially in renal transplantation, sirolimus also promises to treat autoimmune, degenerative and hyperproliferative disorders. Recently, sirolimus has been reported to be effective and well tolerated for many immune-mediated cytopenias, such as autoimmune lymphoproliferative syndrome, immune thrombocytopenia, EVANS syndrome, etc. However, due to the rare occurrence of PRCA and good response rate to cyclosporine, there are very few studies of sirolimus on refractory PRCA so far.

In this study, It is anticipate to evaluate the effect of sirolimus on 30 patients with refractory PRCA, the side-effects was documented and plasma concentration of sirolimus will be monitor.

Eligibility Criteria:
Inclusion Criteria:

1. Refractory pure red cell aplasia.
2. Excluding other diseases which might cause hematological abnormalities.
3. No response or intolerant to first and second line therapies.
4. 18-80 years old.
5. All subjects must: agree not to donate blood or be counseled about pregnancy precautions and risks of fetal exposure.
6. Written informed consent.

Exclusion Criteria:

1. NOT refractory pure red cell anemia.
2. Response and well tolerate to first or second line therapy.
3. Patients who are under 18-year-old or over 80-year-old.
4. Pregnant or lactating.
5. Patients unwilling to or unable to comply with the protocol.
Treatment of Moderate Vein Graft Lesions With Paclitaxel Drug Eluting Stents: The VELETI Trial

HYPOTHESIS

1. Sealing moderate SVG lesions with the TAXUS stent prevents SVG atherosclerosis progression as evaluated by IVUS.
2. Sealing moderate SVG lesions with the TAXUS stent does not accelerate SVG atherosclerosis in the angiographically non-diseased segments of the SVG as evaluated by IVUS.

OBJECTIVES

1. To determine the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on limiting SVG disease progression as evaluated by IVUS.
2. To evaluate by IVUS the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on atherosclerosis progression in angiographically non-diseased SVGs segments.

This will be a prospective randomized study assessing the efficacy of stenting moderate SVG lesions with the taxus stent in the prevention of atherosclerosis progression of SVGs as evaluated by IVUS. Patients with previous coronary bypass surgery with SVG implantation undergoing coronary angiography by clinical indication will be screened. If the patient has a moderate lesion at any level of the SVGs it will be includable in the study. After inclusion, the patients will be randomized to either stenting the moderate SVG lesion with the taxus stent or standard medical treatment. The use of a filter wire during dilation will be strongly recommended. Following this procedure, all patients will have clinical controls at 1 month and at 6 months and an angiographic and IVUS control study at 1 year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Written and signed informed consent.
* Patients ≥18 years old.
* Clinical indication for cardiac catheterization and SVG angiography.
* Presence of at least one SVG lesion of 30% to 70% diameter stenosis by visual estimation which is (are) not the culprit lesion (s) responsible for the clinical syndrome of the patient.

Exclusion Criteria:

* Ejection fraction \<20%.
* Renal insufficiency with creatinine \> 250 mg/dl.
* Presence of more than 3 moderate SVG stenosis or significant diffuse SVG disease.
* Unsuccessful angioplasty (residual stenosis \>30% and/or TIMI flow \<3) of any other lesion treated during the same procedure.
* Coronary angioplasty of the target SVG in the past.
* Cardiogenic shock .
* Remaining lesion (s) with a treatment planned within the following year.
* Pregnancy.
* Contraindication to aspirin and/or clopidogrel treatment.
* Allergy to paclitaxel.
* Any disease with a limiting life-expectancy (to less than 2 years).
* Definite presence or high suspicion of thrombus or ulceration in the target lesion.
* Target lesion located in the same SVG than the culprit lesion (if present) and the distance between the target lesion and the most proximal or distal part of the stent implanted at the culprit lesion is \< 4 cm.
* Vein graft diameter \< 2.5 mm.
The Effect of High Frequency Oscillation on Biological Markers of Lung Injury

Although mechanical ventilation is life saving, it is associated with a number of severe complications collectively referred to as ventilator induced lung injury (VILI). VILI contributes to the high morbidity and mortality associated with the acute respiratory distress syndrome (ARDS). Within the context of a randomized study evaluating the feasibility of conducting a study comparing high frequency oscillation to conventional lung protective ventilation in early severe ARDS, we are evaluating the effect of both ventilator strategies on biological markers of VILI.

Specific objectives:

To measure known biomarkers conventionally associated with VILI and biotrauma To measure potential novel biomarkers of VILI and biotrauma To identify the best time point for biomarker measurement To collect and store samples for differential expression and genomic analysis

Eligibility Criteria:
Inclusion Criteria:

Informed consent previously obtained for enrollment in the OSCILLATE study:

1. Acute onset of respiratory failure
2. Endotracheal intubation or tracheostomy
3. Hypoxemia (P:F \<200 mmHg)
4. Bilateral alveolar consolidation

Exclusion Criteria:

1. Refusal of consent to participate in this biomarkers substudy
Serratus Plane Block for Postoperative Pain Control

This is a randomized, double-blinded, placebo-controlled trial of serratus plane blocks in subjects undergoing outpatient unilateral or bilateral breast surgery. Ninety subjects will be enrolled into the study at presurgical testing. Subjects will be stratified based on surgery type and randomized to receive a serratus plane block with either bupivicaine HCL or placebo. All patients will receive standard intraoperative anesthesia and standard postoperative pain control. The primary endpoint is the amount of opioid administered postoperatively. Secondary endpoints include postoperative pain intensity at timed intervals, amount of opioid administered intraoperatively and postoperatively, incidence of nausea and vomiting, time to discharge and patient satisfaction


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III.
* Undergoing outpatient breast surgery requiring general anesthesia, including but not limited to mastectomy, lumpectomy, reconstruction with tissue expanders or implants and reconstruction revision.

Exclusion Criteria:

* Unable to provide informed consent.
* Patients who are pregnant or nursing.
* ASA IV-V.
* Alcohol or narcotic dependence in the last 2 years.
* Concurrent condition requiring regular use of analgesia that may confound post-surgical assessments as determined by principle investigator.
* Hepatic disease.
* Allergies to amide anesthetics as determined from medical history or patient self-report.
* Evidence of infection at injection site.
* Contraindication to pain medications such as acetominophen, morphine, oxycodone, keterolac, dilaudid, Toradol.
* Body weight \<50kg.
* BMI\>40kg/m2.
* History of hypotension.
* Abnormal renal (creatinine \> 1.5 mg/dL) function.
* Heart block.
* Any physical, mental or medical condition, that in the opinion of the investigator, makes study participation inadvisable.
Molecular Characterization of CTCs and ctDNA in Blood and Plasma Samples From Patients With Metastatic and/or Hormone-Resistant Prostate Cancer

This research trial studies molecular characterization of circulating tumor cells (CTCs) and circulating tumor (ct) deoxyribonucleic acid (DNA) in blood and plasma samples from patients with prostate cancer that has spread to other places in the body and/or has not responded to previous treatment with hormones. Studying samples of blood and plasma collected from patients with prostate cancer before, during, and/or after treatment in the laboratory may help doctors learn more about changes that occur in DNA and identify the development of drug resistance.

PRIMARY OBJECTIVES:

I. Perform molecular analysis of plasma samples from 25 patients with metastatic prostate cancer collected before and during treatment of the disease with abiraterone acetate (Zytiga) or enzalutamide (Xtandi).

II. Perform molecular characterization of circulating tumor cells (CTCs) and plasma collected from 75 patients with progressing advanced metastatic prostate cancer.

OUTLINE: Patients are assigned to 1 of 2 groups based on the timing of specimen collection.

GROUP I: Previously collected plasma samples are analyzed for ctDNA via polymerase chain reaction (PCR) and next generation sequencing (NSG).

GROUP II: Patients undergo collection of blood samples before and following systemic therapy for analysis of CTC enumeration, ribonucleic acid (RNA) expression, and ctDNA via PCR and NSG.

Eligibility Criteria:
Inclusion Criteria:

* GROUP I: Samples for Group I will be selected from existing sample sets obtained from concluded studies (USC IRB #'s 10-00006 and 11-00450)
* GROUP I: Excess plasma collected and stored in these trials from patients treated with abiraterone or enzalutamide will be used for the molecular analysis of the current protocol
* GROUP II: The second group of samples (Group 2) will involve prospective collection of peripheral blood from patients with advanced, treatment-resistant metastatic prostate cancer
* GROUP II: Histologic documentation of prostate cancer
* GROUP II: Metastatic cancer diagnosed by imaging and other clinical criteria
* GROUP II: Treatment-resistance determined by at least one of the following factors: increase in prostate-specific antigen (PSA) value over a baseline measurement; increase in size or number of metastatic deposits determined on imaging; and/or progression in cancer related symptoms
Safety and Efficacy of STR001-IT and STR001-ER in Patients With SSHL

a multicenter, double-blind, placebo-controlled study in patients with Sudden Sensorineural Hearing Loss (SSHL). Patients will be treated with STR001 thermogel (STR001-IT) / STR001 tablets (STR001-ER) and corresponding Placebo on top of standard of care.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged ≥ 18
2. Patients with a SSHL within 96 hours of its perception
3. Sudden Sensorineural Hearing Loss including

   1. idiopathic unilateral Sudden Sensorineural Hearing Loss or
   2. acute uni- or bilateral acoustic trauma-induced Sudden Sensorineural Hearing Loss

Exclusion Criteria:

1. Patients with a history of Meniere's Disease
2. Patients with a hearing threshold above 100 dB across at least 6 frequencies
3. Patients with endolymphatic, hydrops or history of fluctuating hearing loss
4. Patients with suspected perilymph fistula, membrane rupture, retrocochlear lesions or a barotrauma
5. Patients with an air-bone gap of ≥ 20 dB in 3 contiguous frequencies at baseline
6. Previous SSHL incident at the same ear
7. Patients with acute or chronic otitis media or otitis externa.
8. Patients with congenital hearing loss
9. Patients with known hypersensitivity to pioglitazone, other thiazolidindiones or any formulation component
10. Use of thiazolidinedione (e.g. pioglitazone, rosiglitazone) in the last 6 months prior to baseline
11. Any use of CYP450 2C8 inducers (e.g. rifampicine)
12. Fibrates (e.g. gemfibrozil, fenofibrate) in the last 6 months prior to baseline
13. Patients where oral administration of pioglitazone is contraindicated (i.e. cardiac failure or history of cardiac failure (NYHA stages I to IV), hepatic impairment, diabetic ketoacidosis, current bladder cancer or a history of bladder cancer, uninvestigated macroscopic haematuria
14. Women who are breastfeeding, pregnant or plan to get pregnant during the trial duration
15. Women of childbearing potential unwilling or unable to practice effective method of contraception
16. Participation in other clinical trials in the last month prior to baseline