cyrilzakka/clinical-trials huggingface dataset:
Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion

This study investigates whether alteplase can help to improve pleural fluid drainage and dyspnea (breathlessness) in patients with non-draining malignant pleural effusion. Alteplase helps dissolve blood clots and is used to treat heart attacks, strokes, and clots in the lungs. Alteplase may help to control symptoms of breathlessness.

PRIMARY OBJECTIVE:

I. To evaluate dyspnea using the Borg score at one week in patients with symptomatic septated malignant pleural effusion (MPE) and indwelling pleural catheter (IPC) with inability to drain fully that are treated with intrapleural alteplase.

SECONDARY OBJECTIVE:

I. To evaluate dyspnea using the visual analog scale (VAS) scale at one week in patients with septated MPE and IPC and inability to drain fully that are treated with intrapleural alteplase.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained.

ARM II: Patients receive placebo instilled into the IPC which is capped for 1-2 hours before the catheter is drained. Beginning 1 week later, patients may receive alteplase as in arm I.

Eligibility Criteria:
Inclusion Criteria:

* Referral to pulmonary services for inability to drain fully via IPC
* Presence of a symptomatic septated pleural effusion
* A pleural effusion of significant moderate to large volume based on:

  * Chest radiograph: effusion filling \>= 1/3 of the hemithorax, or
  * Computed tomography (CT)-scan: AP depth of the effusion \>= 1/3 of the AP dimension on the axial image superior to the hemidiaphragm, including atelectatic lung surrounded by effusion, or
  * Ultrasound: effusion spanning at least three intercostal spaces, with a \>= 3 cm in at least one intercostal space, while the patient sits upright
* Age \> 18
* Borg score \>= 3
* Absence of a blocked IPC as demonstrated by a flush with 20 cc of saline x1 without resistance
* Draining \< 150 cc and \> 50 cc via IPC at follow up post IPC placement based on patient's drainage record
* Presence of septated effusion based on ultrasound (US) and chest CT

Exclusion Criteria:

* Inability to provide informed consent
* Study subject has any disease or condition that interferes with safe completion of the study including:

  * Uncorrectable Coagulopathy based on criteria followed by cardiopulmonary center for procedures. This will include patients on anticoagulation that can't be stopped
  * Active bleeding
  * Known allergic reaction to thrombolytics
* Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
* No septations and/or no loculations on bedside pre-procedure ultrasound
* Patient is asymptomatic
* Blocked IPC as determined by saline flush
* Inability to undergo CT chest
Clinical Trial to Study Quality of Life in Prostate Cancer Patients by Randomizing Anti-androgen Versus Total Androgen Blockage Prior to Curative Intended Radiation Therapy

Phase III clinical trial to study quality of life in prostate cancer patients by randomizing anti-androgen versus total androgen blockage prior to curative intended radiation therapy.

Primary objective: To study the difference in quality of life in relation to anti-androgen versus total androgen blockage.

Exploratory parameters: ▪ Time to PSA relapse

* Time to symptom giving metastasis
* Overall survival

Patients with localized /locally advanced prostate cancer were subject to treatment with curative intention. They could be divided into three groups according to the risk of metastasis. Mainly intermediate risk group of patients were included in this study. Patients with low risk could be included if they were subject to neo-adjuvant hormonal therapy. Different risk groups were defined as below:

Low risk group: PSA ≤10 ng/ml Gleason score ≤ 6 Tumour stage ≤ T2b Intermediate risk group: Presence of 1-2 factors of high risk. High risk group: PSA \>10 ng/ml Gleason score ≥7 Tumour stage T2c - T3b

Eligibility Criteria:
1. Histopathologically verified prostatic adenocarcinoma.
2. All consecutive patients referred for radiation therapy with combination method i.e. both external beam RT and HDR brachytherapy or other fractionation with curative intention.
3. Patients with intermediate risk group of prostate cancer will mainly be included in this study where radiotherapy with intention to cure is indicated and possible to perform. The intermediate risk group is defined as having 1-2 high risk factors for metastasis. Patients with low risk can only be possible to include if there is an indication of neo-adjuvant hormonal therapy.
4. No signs of distant metastasis.
5. Informed consent.

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Exclusion Criteria:

1. Failure to fulfill inclusion criteria.
2. Severe hepatic or renal failure, according to clinical and laboratory examinations, serum creatinine \> 225 mmol/l.
3. Concomitant diseases that would influence the planned treatment (e.g. Inflammatory bowel disease, urinary incontinence, severe atherosclerosis, myocardial infarction within last 6 months.
4. Previous diagnosis of other malignant diseases excluding patients who are free from relapse after at least 5 years of diagnosis. Patients with basal cell carcinoma are includable.
5. Inability of the patient to cope with the study rules, due to abuses, mentalstatus or other reasons
6. Participation in other clinical studies at the same time if it considers may hamper the assessment of QoL.

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Immediate Fever During Anaesthesia Recovery After Surgical Procedure With Scoliosis

Fever is a common clinical symptom in patients with postoperative scoliosis. However, there are rare reports of immediately fevers occurring following operative procedures.

Postoperative fever is a common clinical symptom in patients following spinal surgery, with an incidence of 13.2%, and 64.5% of patients with neuromuscular scoliosis were observed to develop postoperative fevers. The most frequently observed cause of fever is surgical trauma, which is associated with inflammatory responses to surgery, and such fevers typically resolve within 2-3 days. This self-limited cause of postoperative fever is non-pathological,4 and the severity and duration of such fevers depend on the duration, scope, and type of surgery, and whether a mesh graft was inserted. The aetiology of immediate postoperative fever for patients following hip prosthesis implantation is unknown, and it is inexpedient to initiate antibiotic treatment or to increase the prophylactic antibiotic dosage. However, there are rare reports of chills and fevers occurring immediately following spinal surgery, to the best of our knowledge, there have been no reports on the mechanism of immediate postoperative fever following spinal surgery.

Based on this evidence and on observation, when patients experience postoperative fevers, nearly all surgeons seek to exclude infection as a cause. The case presented in this paper is that of a 15-year-old female with idiopathic scoliosis who underwent posterior idiopathic scoliosis incision and correction for pedicle fixation. The clinical symptoms of interest, including chills, a high fever, an increased heart rate and increased blood pressure, were observed immediately during the course of anaesthesia resuscitation. In this report, risk factors, treatment and prevention are assessed based on the case evidence.

Eligibility Criteria:
Inclusion Criteria:

* N/A

Exclusion Criteria:

* N/A
Investigate Effect of Secukinumab on the PK of Midazolam in Patients With Mod to Sev Plaque Psoriasis

To determine whether secukinumab can alter the activity of cytochrome P450 (CYP) 3A4 using midazolam as probe substrate in patients with moderate-to-severe plaque psoriasis.

This will be an open-label, confirmatory study investigating potential disease-drug-drug interaction of secukinumab and midazolam in male and female patients with moderate-to-severe plaque psoriasis. A total of approximately 25 patients are required to obtain at least 20 completers in the study Patients who meet the eligibility criteria at screening, will have a baseline assessment day (within 1 week prior to the start of secukinumab) during which a full midazolam PK profile after a single oral dose of 5 mg will be assessed by collecting blood over the 12 hour postdose period.

On Day 1 (Week 0), Day 8 (Week 1), Day 15 (Week 2), Day 22 (Week 3) and Day 29 (Week 4) patients will receive 300 mg s.c. secukinumab (2 injections of 150 mg s.c.). On Day 8 and on Day 36 (Week 5), patients will receive additional single doses of 5 mg oral midazolam (total of 3 single doses). The midazolam PK profile will be assessed over the 12 hour postdose period.

On those days when midazolam PK profiles are assessed, samples will be collected and analyzed for circulating IL-6, inflammatory panel (collected at screening, baseline and pre-dose Day 1 only), total IL-17A (after following initiation of secukinumab treatment), hsCRP and for 4-beta-hydroxycholesterol (exploratory endogenous phenotyping marker of CYP3A activity).

There will be an extended treatment period during which patients will receive secukinumab 300 mg s.c. at Weeks 8, 12, 16, 20 and 24.

Then there will be a follow-up period of 12 weeks following the last dose administered at Week 24. Visits will be at Weeks 28, 32 and 36.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe plaque psoriasis as defined at baseline by: PASI score of 12 or greater and IGA mod 2011 score of 3 or greater (based on a scale of 0 - 4) and Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
* Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy
* Men or women at least 18 years of age or older at time of screening.

Exclusion Criteria:

* Forms of psoriasis other than chronic plaque-type
* Pregnant or nursing (lactating) women,
* History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection.
* Subjects with known history of hypersensitivity to midazolam
ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma

This trial studies the effectivity of low-dose radiation therapy with 10x2Gy for the treatment of patients with stage I-II stomach or duodenal Lymphoma (Marginal Zone or Follicular)

* Prove the effectiveness of 20 Gy (and non-inferiority to actually recommended 30 Gy) with respect to response rate 6 months after radiotherapy.
* Correlation of blood serum biomarker levels with lymphoma response to radiation treatment
* Recording of survival rates, quality of life (QoL), radiogenic toxicities and inflammation relevant molecules in blood serum.

Primary Objective:

Response rate 6 months after end of treatment, 4 categories according to GELA-criteria: CR (complete remission) = CR or pMRD (probable minimal residual disease), PR (partial remission) = rRD (responding residual disease), NC (no change), PD (progressive disease)

Secondary Objectives:

QoL according to EORTC (QLQ C30 and STO22). EFS=Event-free survival (time to any failure or death from any cause, patients in CR or PR), LSS=lymphoma-specific survival (time to death related to lymphoma or associated with the treatment, all patients), PFS=Progression-free survival (time to progression of lymphoma or death from any cause, all patients), OS=overall survival (time to death from any cause, all patients). Level of cytokines IL-1β, IL-4, IL-8, TNFalpha and other inflammation relevant molecules Syndecan1, MMP-2 and S100 proteins. Acute toxicities during treatment according to NCI-CTC, chronic toxicities according to NCI-CTC/ LENT-SOMA.

Monitoring of Adverse Events (AEs) and Serious Adverse Events (SAEs)

-Assessment of safety: Monitoring of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Eligibility Criteria:
Inclusion Criteria:

* primary indolent gastric or duodenal lymphoma
* pathology: marginal zone lymphoma (MZL) or follicular lymphoma (FL)
* stage: clinical stage I or II (Ann Arbor classification)
* H. pylori negative or antibiotic resistant lymphoma
* IPI or FLIPI score low - high (0-4)
* any size of tumor or affected lymph nodes
* male or female with age ≥ 18 years
* performance status ECOG 0 - 3
* written informed consent by the patient

Exclusion Criteria:

* prior radiation treatment of the gastrointestinal lymphoma
* stage: clinical stage III or IV (Ann Arbor classification)-unability to understand the informed consent or unwillingness to participate in the study
* severe comorbidity or organ dysfunction contraindicating the use of RT (liver cirrhosis Child-Pugh C, chronic obstructive pulmonary disease GOLD 4, heart insufficiency NYHA IV, dialysis dependent renal insufficiency, uncontrolled epilepsy)
* known seropositivity for HIV
* acute hepatitis B or C infection
* chronic inflammatory bowel disease
* prior malignant disease (exclusion: basalioma, non-metastasized solid tumor in constant remission diagnosed \>3 years ago)
* pregnancy or breastfeeding
* active substance abuse or severely compromised compliance
Subthreshold Stimulation on Chronic Low Neck Pain Myofascial Trigger Points

This study will investigate the effect of subthreshold stimulation on pain and muscle activity in patients with chronic low neck pain and myofascial trigger points.

The study will include 2 groups. One group will receive subthreshold stimulation and other will not receive any treatment. The measurements will include pain and myscle activity.

Eligibility Criteria:
Inclusion Criteria:

* chronic neck pain
* One or more trigger point

Exclusion Criteria:

* any musculoskeletal or neuromuscular diseases
Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet Syndrome

This Phase 3 study will enroll participants diagnosed with Dravet Syndrome (DS) who are still experiencing at least one tonic-clonic, clonic, and/or focal seizures with motor components (FSMC) per week, despite ongoing treatment with up to three antiepileptic drugs (AEDs), and meet the other inclusion/exclusion criteria.

Following a 28-day baseline period, participants will begin an 84-day treatment period. Participants will be assigned to receive twice-daily doses of placebo or cannabidiol oral solution at the highest dose determined to be safe in a previous trial.

Following study completion, all participants will be invited to receive Cannabidiol Oral Solution in an open label extension study (under a separate protocol).


Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception, including clinical diagnosis of refractory DS and onset of seizures according to protocol-specified criteria
* Is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the Institutional Review Board before the conduct of any study procedure
* In the opinion of the Investigator, the subject and/or parent(s)/caregiver(s) are able to keep accurate seizure diaries and the participant is able to take study drug and comply with the protocol, including dosing, medications and diet

Exclusion Criteria:

* Medical history is outside protocol-specified parameters
* Clinically significant history of allergic reactions or significant sensitivities to cannabinoids or to any of the other ingredients in the study drug
* Inadequate supervision by parents or guardians
* History or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters
* Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results
Ivabradine Effects in Cardiogenic Shock Requiring Inotropic Support

Data regarding the safety and efficacy of ivabradine use in severely decompensated HFrEF requiring inotropic support is limited to case series.1 This study aimed to evaluate ivabradine safety and tolerability in admitted cardiogenic shock patients who started on dobutamine infusion for inotropic support.

Background and study rationale:

Ivabradine is a Heart Rate (HR) lowering agent which acts by inhibiting the If current in the sinoatrial node. It is currently indicated in patients with chronic heart failure with reduced ejection fraction (HFrEF). Dobutamine is an inotropic drug used in cardiogenic shock patients and it is associated with an increase in HR and incidence of cardiac arrhythmias.2 However, studies have suggested that increased heart rate may be deleterious in decompensated HFrEF due to an inverted Bowditch-Treppe response. Data regarding the safety and efficacy of ivabradine use in severely decompensated HFrEF requiring inotropic support is limited to case series.1, 2

Aim of the work:

* This study aims to evaluate ivabradine safety and tolerability in admitted cardiogenic shock patients who started on dobutamine infusion for inotropic support.
* Design: Randomized open-label interventional clinical trial.

Methods and patients:

* Study Type: Interventional (Clinical Trial)
* Estimated Enrollment: 200 participants
* Allocation: Randomized
* Perspective: Prospective Study
* Intervention Model: Two Group Assignment
* Masking: None (Open Label)
* Primary purpose: Treatment
* Official title: Ivabradine effects in cardiogenic shock requiring inotropic support (IVA-CS)
* Start Date: 01 August 2022
* Estimated Primary Completion Date: 01 January 2023

Eligibility Criteria:
Inclusion Criteria:

* Decompensated heart failure with reduced ejection fraction (HFrEF) admitted for cardiogenic shock requiring inotropic support.

Exclusion Criteria:

* Decompensated heart failure with reduced ejection fraction (HFrEF) not requiring inotropic support.
* Patients with no oral intake
* Patients who refused to sign the consent
Cartesia eXTend 3D Study

The purpose of the study is to document patient outcomes including effectiveness for Boston Scientific Corporation's Vercise Cartesia 16-contact Directional Lead(s) (X/HX) with Deep Brain Stimulation (DBS) systems for the treatment of Parkinson's Disease (PD).

Subjects will receive Deep Brain Stimulation with a 16-contact Directional Lead to treat their Parkinson's Disease.

Eligibility Criteria:
Key Inclusion Criteria:

* Candidate for DBS implant in the treatment of Parkinson's disease
* Must be on stable anti-parkinsonian medications for 28 days prior to Informed Consent
* Persistent disabling Parkinson's disease symptoms such as dyskinesias, motor fluctuations, or disabling "off" periods despite optimal medical therapy
* Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging system, etc.).

Key Exclusion Criteria:

* Any intracranial abnormality or medical condition that would contraindicate DBS surgery
* Have any significant psychiatric or cognitive condition likely to compromise the subject's ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster B personality disorders)
* Any current drug or alcohol abuse, as determined by the investigator
* Any history of recurrent or unprovoked seizures
Long Peripheral Intravenous Catheter Insertion Site and Catheter-related Complications in Antimicrobial Therapy

This study applies long PIVCs to patients undergoing antimicrobial therapy, and compares the effects of different placement sites, aiming to provide a reference basis for patients undergoing antimicrobial treatment to select the optimal placement site, thus reducing complications, prolonging catheter retention time, and alleviating the patient's pain.

This study investigates the use of long PIVCs in patients undergoing antimicrobial therapy, and compares the effects of different insertion sites. The aim is to provide evidence-based recommendations for the optimal placement site for long PIVCs in antimicrobial treatment, with the goals of reducing complications, prolonging catheter retention time, and alleviating patient discomfort.

Eligibility Criteria:
Inclusion Criteria:

* ① estimated time of intravenous infusion ≥1 week; ② age: ≥18 years; ③ antimicrobial therapy was only used for treatment during hospitalization, with a pH value of 5-9 and osmotic pressure \&lt; 900 mOsm/L; and ④ patients were conscious and able to communicate normally; ⑤ the catheter-to-vessel ratio is less than 45%.

Exclusion Criteria:

* ① a history of radiotherapy, thrombosis, and trauma at the catheterization site and ② plans to discharge with a catheter during the study duration.
Bupivacaine With Epidural Volume Extension

In this study the investigator will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures.

Due to risks to both the mother and fetus, neuraxial anesthesia - spinal, epidural, or combined spinal-epidural (CSE) - is preferred over general anesthesia for all obstetrical procedures. However, one downside to neuraxial anesthesia is the increased time patients have to stay in the post-anesthesia care unit (PACU) due to residual numbness from the neuraxial block. In this study, the investigators will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures. This will be accomplished by performing a CSE with: 1) injecting the local anesthesia in the spinal space; 2) injecting sterile saline into the epidural space to help increase the spread of the local anesthesia in the spinal space. The idea is that physicians will be able to use less local anesthetic due to getting a greater spread of medication. This lower amount of local anesthetic will lead to a decreased duration of the spinal block; therefore, it will significantly decrease PACU length of stay. This technique will be compared to our traditional dose of spinal anesthetic without EVE in the CSE. Both groups will have an epidural catheter in place to allow us to give any additional local anesthetic to keep the patient comfortable throughout the procedure if the spinal anesthesia begins to wear off. The aim of this study is to determine if low dose spinal bupivacaine in conjunction with EVE can decrease the PACU recovery time for short obstetric procedures while still providing an adequate surgical block.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing short obstetric procedure in the operating room requiring neuraxial anesthesia.

Exclusion Criteria:

* coagulopathy
* platelets \<80,000
* allergy to local anesthetic or fentanyl
* previous spinal surgery
* spinal or intracranial mass
* history of lower extremity weakness