cyrilzakka/clinical-trials huggingface dataset:
Effects of the Use of Adjuvant Drugs After Extracorporeal Shockwave Lithotripsy (ESWL) in Renal Calculus

The investigators objective is to study if some drugs can improve the success rate of extracorporeal shockwave lithotripsy for renal stones.

Extracorporeal shockwave lithotripsy is one of the modalities of treatment of renal stones. It´s a machine that breaks the renal stones extracorporeally. Some drugs, like alpha blockers and calcium channel blockers, can improve the success rates of this procedure. Our objective is to study the real effects of two drugs, tamsulosin and nifedipine, compared to placebo, in the elimination of fragments after the extracorporeal shockwave lithotripsy treatment.

Eligibility Criteria:
Inclusion Criteria:

* radiopaque renal stone, 5 to 20 mm, located at renal pelvis or superior or middle calix

Exclusion Criteria:

* inferior calix, any contraindication for extracorporeal shockwave lithotripsy, pregnancy, coagulopathy, previous renal surgery, age under 18, abdominal aorta aneurism and urinary infection.
Re-link HCV in Substance-Use Telemedicine Program

This is an observational, retrospective \& prospective cohort study. The retrospective element of the study is a chart review to identify people with diagnosed but untreated HCV and re-link them to care. The observational prospective cohort element of the study will examine the HCV linkage to care, treatment initiation, treatment completion \& cure rates of these HCV clients achieved through this chart review and re-linking approach.

The study, led by trueNorth medical center in Ontario, focuses on re-linking people diagnosed with untreated Hepatitis C (HCV) to care through a community-based substance-use telemedicine program. HCV is a significant health concern in Canada, especially among people who inject drugs (PWID), who face barriers to accessing treatment. Integrating HCV treatment with substance use care may improve treatment uptake.

This observational study includes both retrospective and prospective cohorts. The retrospective aspect involves chart reviews to identify untreated HCV patients for re-linking, while the prospective cohort examines treatment outcomes such as linkage to care and cure rates. Participants include individuals over 18 with a positive HCV RNA result who have not completed a course of Direct-Acting Antiviral (DAA) treatment. Excluded are those unable to consent or with restricted access to their health records.

Study procedures involve identifying untreated HCV patients, attempting re-linkage via telecommunication, and offering treatment through the program. Outcome measures include the number of patients re-linked to care and their treatment outcomes. Data analysis will utilize IBM SPSS for logistic regression and descriptive statistics, aiming to evaluate the efficacy of this telemedicine approach in improving HCV care among PWID.

Ethical considerations include informed consent and data privacy, with oversight by the ADVARRA Canadian Institutional Review Board. The study seeks to address HCV care gaps in PWID populations by leveraging telemedicine for improved access and treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

For the retrospective chart review element of the study, inclusion criteria includes anyone who had a telemedicine visit at the community based substance use telemedicine program between January 1st 2023 and December 31st 2024.

For the prospective cohort element of the study, the inclusion criteria are listed below:

Aged ≥18. Ability and willingness of the participant to provide informed consent. Having a positive HCV RNA laboratory result and lacking a sufficient previous course of DAA treatment.

Exclusion Criteria:

For the retrospective chart review element of the study, exclusion criteria is: a consent directive to restrict access to their OLIS record.

For the prospective cohort study, exclusion criteria is an inability or unwillingness of the participant to provide informed consent.

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Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat Breast Cancer

This is a phase II, multicenter, single-arm, open-label safety and efficacy study of bavituximab in combination with carboplatin plus paclitaxel in patients with locally advanced or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Living in India for the duration of the study
* Adult females over age 18 years of age with a life expectancy of at least 3 months
* Confirmed breast cancer with evidence of locally advanced or metastatic disease
* Disease that is measurable by radiology imaging
* Ambulatory and capable of all selfcare but unable to carry out any work activities.
* Adequate laboratory results (hematologic, renal, hepatic)
* Negative pregnancy test

Exclusion Criteria:

* History of or susceptibility to bleeding or coagulopathy (e.g., von Willebrand Disease or Hemophilia)
* Any history of thromboembolic events (clots within blood vessels)
* Ongoing treatment with high doses of anticoagulants
* Use of hormone therapy
* Advanced peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities)
* Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
* Radiotherapy within 2 weeks entering the study
* Chemotherapy, immunotherapy or radiotherapy within 4 weeks of starting the study
* Allergies to Polysorbate 80 or drugs containing polyoxyethylated castor oil (e.g. cyclosporine)
* Diagnosed and active CNS disease or metastatic lesions
* Major surgery within 4 weeks of starting the study
* Pregnant or nursing
* Uncontrolled disease (e.g., diabetes, hypertension, thyroid disease)
* History of heart disease
* History of any condition requiring treatment with anti-inflammatory, anti-platelet drugs or steroids
* Diagnosed with HIV or hepatitis
Project VOICE: Vascular Outcomes Improvement Through Collection of PatiEnt Reported Data

The purpose of this study is to evaluate the feasibility of a digital health platform coupled with walking activity tracking for patients with Peripheral Artery Disease (PAD) and symptoms limited to claudication.

This is a two center, non-blinded, 2 period randomized crossover trial. 50 patient subjects are planned. Patient participants will be identified and recruited from clinical environments (including clinics and diagnostic testing departments) at participating sites. Diagnosis and testing will occur through usual clinical care, and participants will not incur financial costs related to participation. A crossover design will be utilized, where all participants will use the VOICE platform with activity tracking for 35 days and usual care for 30 days. Randomization will determine the order in which participation in the VOICE phase versus the usual care phase occur. Randomization will occur using a closed envelope system. For patients in the VOICE platform group, data collection will occur over a total of 35 days, including an initial 5-day "run in" period during which participants will orient themselves to the system. Each provider participant will receive a single end-user survey evaluating VOICE from their perspective.

Screening of patients electronic medical records will be done to determine subject eligibility. Subjects who meet all inclusion criteria will be approached to participate.

Total duration of subject participation will be 9 weeks during the control and intervention phases, with a final follow-up survey at 6 months post-enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of symptomatic PAD with claudication
* Ankle- brachial index (ABI) ≤ 0.9 or non-compressible leg arteries
* Walking exercise therapy recommended as treatment for PAD by the healthcare provider
* Willingness to be randomized to VOICE platform or control group
* Ability to access the internet
* Willing to sign an informed consent

Exclusion Criteria:

* Walking exercise therapy not recommended due to contraindication or any other reason
* Wheelchair dependence or inability to walk unassisted
* Presence of foot ulcers, wounds, or gangrene
* History of major extremity amputation
* Lack of objective physiologic data validating PAD diagnosis
* Claudication symptoms due to diagnoses other than PAD (i.e., popliteal entrapment syndrome)
* Inability to speak or read English
* Severe mental illness
* Inability to give informed consent
A Proteomic Analysis for Understanding the Link Between Migraine and Cardiovascular Disease

This is a multicenter, prospective observational study. Will be collecting data from 90 consecutive patients (aged 25- 60 years ) with and without migraine admitted at our Hospital. Primary aim of the study will be to assess the correlation between migraine and proteomic profiling of plasma and their possible correlation with known cardio and cerebrovascular disease and Cardiovascular (CV) risk factors.

Ninety consecutive patients hospitalized for noncoronary artery disease will follow their clinical course. They will be classified into symptomatic for migraine with aura (N=45) and migraine free (N=45) and will be enrolled in the study. Patients will be screened for migraine characteristics and a comprehensive clinical analysis, including sex-related cardiovascular risk factors, will be collected. To achieve the study objective, blood will be drawn to do targeted proteomic evaluation of proteins relevant to Cardiovascular disease (CVD), inflammation, immune response, and neurological disorders, in order to compare the profile of migraine patients with that obtained in patients without migraine.

Eligibility Criteria:
Inclusion Criteria:

* Age \>25 years and \> 60 years
* Signed patient informed consent form (ICF)
* Non-coronary disease

Exclusion Criteria:

* Age \< 25 years and \> 60 years
* Acute myocardial infarction (MI)
* Chronic kidney disease: glomerular filtration rate (GFR) \< 30 ml/min
* Severe mitral or aortic valvular disease
* Acute heart failure
* Reduced left ventricular (LV) function (Ejection Fraction \< 35%)
* Atrial Fibrillation
"Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients

This study aims at considering clinical heterogeneity of patients based on a "geriatric assessment" without taking into account the real age of the subject. This will allow physicians to adapt therapy according to three different groups of patients: frail, fit and intermediate and to evaluate the efficacy and feasibility of a therapy adapted to the different categories of patients.

Treatment:

1. Frail patients:

   * Pretreatment with PDN
   * Induction with Vinblastine and PDN
   * Maintenance with MTX, 6-MP, VBL and PDN
2. Fit patients:

   * Pretreatment with PDN
   * Induction with VCR, DNR and PDN
   * Consolidation with MTX, ARA-C and G-CSF
   * Autologous transplantation
   * Maintenance with MTX, 6-MP, VCR, and PDN
3. Intermediate patients:

   * Pretreatment with PDN
   * Induction with VCR, DNR and PDN
   * Consolidation with MTX, ARA-C and G-CSF
   * A second cycle of consolidation therapy
   * Maintenance with MTX, 6-MP, VCR, and PDN

Eligibility Criteria:
Inclusion Criteria:

* Age \> 60 years old
* Cytomorphologic and immunophenotypic diagnosis of ALL (all FAB groups except L3 and all immunophenotypes except SmIg+ B-ALL)
* Signed informed consent

Exclusion Criteria:

* Age \<= 60 years old
* Ph+ ALL
* Refuse to sign informed consent
BI 811283 in Combination With Cytarabine in Previously Untreated AML Ineligible for Intensive Treatment

Investigation of maximum tolerated dose, safety, efficacy and pharmcokinetics of BI 811283 in combination with cytarabine (LD-Ara-C) in previously untreated acute myeloid leukaemia (AML) patients


Eligibility Criteria:
Inclusion criteria:

* Male or female adult with previously untreated acute myeloid leukaemia (AML)
* Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)
* Patient is considered ineligible for intensive treatment
* Patient is eligible for low-dose cytarabine (LD-Ara-C) treatment
* Life expectancy \> 3 months
* Eastern co-operative oncology group (ECOG, R01-0787) performance score \<=2 at screening
* Signed written informed consent consistent with international conference on harmonisation good clinical practice (ICH-GCP) and local legislation

Exclusion criteria:

* Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification).
* Relapsed or treatment refractory AML.
* Hypersensitivity to one of the trial drugs or the excipients.
* Other malignancy requiring treatment.
* Known central nervous system involvement.
* Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (ULN).
* INR \> 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin).
* Bilirubin greater than 1.5 mg/dl.
* Serum creatinine greater than 2.0 mg/dl.
* LVEF (Left ventricular ejection fraction) \< 50% in echocardiography or clinical congestive heart failure New York Heart Association (NYHA) grade III or IV.
* Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia.
* Psychiatric illness or social situation that would limit compliance with trial requirements.
* Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug (i.e. other chemo- or immunotherapy, see also section 4.2.2).
* Contraindications for cytarabine treatment according to the summary of product characteristics (SPC).
* Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.).
* Pregnant or nursing female patients.
* Patient unable to comply with the protocol.
Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women (PART II)

Combined spinal-epidural (CSE) for labor analgesia has been used for many years and is practiced commonly at our institution, especially when the patient requests immediate pain relief. CSE is not only beneficial for its faster onset of analgesia, but also it is favorable in relation to the need for rescue analgesia, urinary retention, and rate of instrumental delivery compared to the traditional epidural. Despite its beneficial effects, there is a risk of about 15-30% of developing abnormal fetal heart rate following CSE. This is self-resolving with minimal or no intervention. Although the cause of fetal bradycardia is not fully elucidated, variations in uterine artery blood flow after epidural analgesia are thought to be due to the interaction of numerous events related to blockade of sympathetic innervations, fluid administration, maternal hypotension, uterine vascular effects of sympathetic block, fluctuations in circulating catecholamines, and possibly the effect of opioids. Similar mechanism is thought to be a cause of fetal bradycardia after the CSE with its faster onset and superior block.

Maternal or fetal circulation during labor can be assessed using continuous-wave Doppler ultrasound to monitor maternal uterine artery (UtA) and fetal umbilical artery (UmA) velocity waveforms to detect changes in blood flow. The velocimetry indices mentioned above have been often used to assess the changes in the blood flow before and after the induction of epidural analgesia during labor in several studies. Although there are some studies regarding the effect of labor epidural analgesia using velocimetry indices, but there is currently no published study evaluating velocimetry indices of uterine and umbilical arteries before and after the induction of CSE. Thus, the aim of this study is to investigate the impact of CSE to maternal and fetal blood flow to evaluate the relationships.

The investigators hypothesize that both uterine artery and umbilical artery blood flow are reduced after the induction of CSE, which may be responsible for the occurrence of fetal bradycardia.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Term pregnant patients requesting labor analgesia
* Singleton pregnancy
* Term pregnant patients in active labor
* ASA\<4
* No evidence of fetal congenital anomalies, fetal compromise or fetal decelerations prior to CSE
* Patients with and without diagnosed hypertensive disorders of pregnancy

Exclusion Criteria:

* Refusal to consent for the study
* Known spinal deformities
* Previous back instrumentation
* Patients with BMI\>50 kg/㎡ due to anticipated technical challenges in Doppler studies
Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis

Chronic rhinosinusitis (CRS) with nasal polyps is a particularly challenging form of chronic rhinosinusitis in several ways. Patients have significantly more severe symptom burden and worse quality of life than patients with chronic rhinosinusitis without nasal polyps. Many patients return to the health care providers with persistent symptoms after repeated medical and surgical treatment. Patients have usually tried several different types of treatments, ranging from less invasive procedures to extensive surgical treatment. The surgical treatment is often repeated several times. The most common surgical treatment is functional endoscopic sinus surgery, another established procedure is Vidian neurectomy.

The main object of this pilot study is to investigate the safety of onabotulinumtoxin A towards the sphenopalatine ganglion (SPG) in CRS patients with nasal polyps. Efficacy data will also be collected to provide indication on whether future placebo-controlled studies should be performed.

Onabotulinumtoxin A inhibits the secretion of acetylcholine, blocking the parasympathetic reflex cascade in the SPG. As a result, the investigators expect less mucosal swelling, secretion and nasal polyps. The duration of such a blockade is believed to last for 3-9 months and will not lead to damage of the nerve.

This study opens up for improved treatment with less complications.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* chronic rhinosinusitis with nose polyps (CRSwNP) according to European position paper on rhinosinusitis and nasal polyps (EPOS) criteria
* no satisfactory effect of medicinal or surgical treatment

Exclusion Criteria:

* systemic or local disease or condition that may result in a higher risk for complications
* psychiatric disorder that is indicates against the treatment
* pregnancy, breastfeeding, fertile female not using contraception
* abuse of drugs, narcotics or alcohol
* hypersensitivity against marcain, lidocain, xylocain, or adrenalin, and similar drugs
* anatomical conditions that hinder injection
* known sensitivity for botulinum toxin type A or for adjuvant substances
* treatment with drugs that interact with botulinum toxin type A:
* suspicion of polyps caused by an allergy
* suspicion of Samters triade
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.

No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be allowed to enter an open-label extension study

Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 49 years of age
* Diagnosis of either 1 or more uterine fibroids
* History of regular menstrual cycles of 21 to 35 days in length.

Exclusion Criteria:

* Any abnormal lab result the study-doctor considers significant
* History of severe reaction to or current use of hormone therapy
* History of osteoporosis or other bone disease
* History of uterine artery embolization, cryomyolysis, or electrical myolysis
* Subject currently breast feeding
* Hemoglobin \< 8 g/dL at baseline
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )

This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV placebo.


Eligibility Criteria:
Inclusion Criteria:

* 18-55 age
* Diagnosis of RMS (McDonald criteria 2010)
* Active disease
* Expanded disability status scale (EDSS) 0-5.5 (inclusive) at screening

Exclusion Criteria:

* Treatment with prior Anti-cluster of differentiate 20 (CD20) or other B cell directed treatment
* Treatment with the following therapies at any time prior to randomization: alemtuzumab, natalizumab, teriflunomide, leflunomide and stem cell transplantation
* Diagnosed with Primary Progressive MS (PPMS)
* Pregnant or nursing
A Study to Reveal the Patient Characteristics and Treatment Patterns of Stage III Non-small-cell Lung Cancer Patients

This large multinational, non-interventional study (NIS), will retrospectively collect data derived from established medical records over a period of up to approximately 6 years (2013 to 2018), building a platform to capture and consolidate information on treatment patterns, Overall Survival (OS) and treatment effectiveness outcomes in the real-world setting.

This is multi-centre, multicountry, longitudinal cohort of patients with primary stage III NSCLC (Non-small Cell Lung Cancer), identified through the review of established patient medical records. Patients diagnosed with primary stage III NSCLC between 01 January 2013 and 31 December 2017 will be targeted for study inclusion, allowing at least 9 months of follow-up for living patients recruited at last day of the enrolment window. It is estimated that a total of approx. 2000 patients from 15-20 countries (approax.)

Patients' demographic and clinical characteristics and treatment patterns will be described. Clinical outcomes such as Progression-Free Survival (PFS), Time to Progression (TTP), Objective Response Rate (ORR) and Disease Control Rate (DCR) will be described by Line of Therapy (LOT). Overall survival will be described, where available. Healthcare resource utilisation will be described, as available from medical records.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver was granted), according to local regulations
2. Adult male or female (≥18 years old or according to age of majority as defined by local regulations)
3. First ever diagnosis of lung cancer (absence of previous diagnosis of lung cancer, including small cell lung cancer \[SCLC\] and NSCLC) in the patient's medical records
4. Primary diagnosis of stage III NSCLC, confirmed by pathology, between 01 January 2013 and 31 December 2017
5. Available medical records

Exclusion Criteria:

1. Patients with a concomitant cancer at the time of diagnosis of stage III NSCLC, except for non-metastatic non-melanoma skin cancers or in situ or benign neoplasms. A cancer will be considered concomitant if it occurs within 5 years of NSCLC diagnosis
2. Patients initially diagnosed with stage I-II NSCLC who have progressed to stage III