cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema

A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years of age or older
* Must currently be on ACE inhibitor therapy and have received a dose within 36 hours
* Presenting with ACEIA of the head/neck region within 12 hours after onset
* All females must have a negative urine pregnancy test prior to administration of the study drug. Those who have had a total hysterectomy, bilateral oophorectomy or are two years post-menopausal do not require a pregnancy test.

Exclusion Criteria:

* Hypersensitivity to ecallantide
* Pregnancy or breast feeding
* Patients who have had angioedema and were not concurrently on an ACE inhibitor
* Patients exhibiting urticaria
* Patients who are intubated or who have a tracheostomy related to the current episode of angioedema
* Opinion of the investigator that the patient would not be a good candidate
* Participation in another investigational study within 30 days prior to enrollment
Efficacy and Safety of Fosaprepitant in Preventing Chemotherapy-induced Vomiting in Children Treated With Medium and High Emetic Chemotherapeutic Drugs

This study was a prospective, randomized, double-blind, parallel controlled clinical trial. The children who met the inclusion criteria and were treated with medium and high emetic chemotherapy drugs were randomly included in the experimental group (forsapitan group) and the control group (placebo group) in the ratio of 1 ∶ 1. The children in the experimental group were infused with fosapitan, dexamethasone and granisetron before chemotherapy, and then continued to be infused with granisetron and dexamethasone until 48 hours after the end of chemotherapy. The antiemetic regimen of children in the control group was placebo instead of fosapitan, and the others were the same as those in the experimental group. In this study, CNNC antiemetic scale and pediatric scale proposed by Dupuis were used to evaluate the vomiting data. The primary end point was the proportion of children who achieved complete remission (CR) in the delayed period (within 24-120 hours after the start of chemotherapy); The secondary end points were the CR rate in the acute phase (within 24 hours after the first chemotherapy administration) and the overall phase. The antiemetic efficacy and adverse reactions of the two groups were observed and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* children aged 2-12 years at the time of study entry with documented cancer scheduled to receive MEC or HEC (more than 30% emetogenic potential) with Karnofsky score of 60 or more (for patients aged greater than 10 years) or Lansky play performance score of 60 or more (for patients aged 10 years or less) predicted life expectancy of at least 3 months; and written informed consent provided by parent or guardian

Exclusion Criteria:

* vomiting 24 hours before treatment day 1 known history of QT prolongation or allergic reaction to any of the study drugs symptomatic primary or metastatic CNS malignancy causing nausea or vomiting patients who received radiation therapy to the abdomen or pelvis in the week before treatment; active infection or any uncontrolled concurrent illness except for malignancy abnormal laboratory values at screening (peripheral absolute neutrophil count \<1000 cells per μL, platelet count \<100 000 cells per μL; alanine amino transferase or aspartate aminotransferase \>5 times of the upper limit of normal for age, bilirubin or serum creatinine \>1.5 times of the upper limit of normal for age) initiation of systemic corticosteroids within 72 hours before study drug administration or as part of the chemotherapy regimen; benzodiazepines or opioids initiated within 48 hours before treatment, except for single doses of triazolam, temazepam, or midazolam use of antiemetics within 48 hours of treatment use of CYP3A4 substrates or inhibitors within 7 days or CYP3A4 inducers within 30 days of treatment
Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001

The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Successful completion of study protocol 3104001
* Response or stable disease in study 3104001 at week 12

Exclusion Criteria:

* New serious concurrent medical condition
* Not able to swallow the study drug
Supervised Exercise Therapy vs Home Exercises for Patients With Subacromial Impingement

The purpose of this study is to determine whether there are any difference between supervised exercise therapy and homebased exercise when looking at pain and function for patients with shoulder pain.

Shoulder pain is common in the population. Various treatment modalities are used. According to the literature, it is equally good results for home exercises and for guided exercise therapy. The purpose of this study is to look at this again and determine whether there are any difference between supervised exercise therapy and homebased exercise when looking at pain and function for patients with subacromial impingement.

Eligibility Criteria:
Inclusion Criteria:

* Pain in one shoulder
* Had the condition for more than 12 weeks
* Pain at abduction (must be present in some part between 60 and 120 degrees)
* Pain/ weakness in isometric external rotation
* Positive Hawkins test

Exclusion Criteria:

* Instability
* Labral pathology
* Acromioclavicular joint (AC-joint) pathology
* Complete rupture in the rotatorcuff
* Glenohumeral osteoarthritis
* Previously operated on current shoulder
* The pain comes from neck pathology
* Rheumatoid arthritis or other serious physical or mental illness
* Lack of Norwegian language
* Unable to start
A Study To Investigate The Effect Of Erythromycin On The Pharmacokinetics Of PH-797804

The purpose of this study is to investigate the effect of co-administration with erythromycin on the time course of PH-797804 concentration in the blood following dosing by oral immediate release tablet formulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 21 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week for males.
Electro-Acupuncture for Obese Patients with Insulin Resistance

This clinical trial aims to evaluate the efficacy and safety of electro-acupuncture for obese patients with insulin resistance. 60 participants will be randomized and allocated to either the electro-acupuncture arm or the sham acupuncture arm.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 21 and 65 years old
* BMI ≥ 25 kg/m2
* HOMA-IR ≥ 2.14, (HOMA-IR = fasting insulin (ųU/mL)\* fasting glucose (mmol/L)/22.5)
* Not receiving any other weight control measures or any medical and/or drug history in the last 3 months

Exclusion Criteria:

* Diabetes mellitus
* Treating with drugs that may affect insulin sensitivity
* Changes 10% of usual body weight in the previous 6 months weight
* Endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder, etc.
* Heart diseases, including arrhythmia, heart failure, and myocardial infarction, participants with pacemakers
* Allergy and immunology diseases
* Bleeding tendency
* Pregnant or lactating women
* Impaired hepatic or renal function
* Stroke or unable to exercise
A Study to Evaluate the Effects of Tedizolid Phosphate on the Pharmacokinetics and Safety of Midazolam and Rosuvastatin (MK-1986-004)

The purpose of this study is to assess the effect of steady-state tedizolid phosphate on the single-dose pharmacokinetics of midazolam and rosuvastatin in healthy, adult participants.


Eligibility Criteria:
Inclusion Criteria:

* healthy, adult males or females (women of non-childbearing potential)
* continuous non-smokers who have not used nicotine-containing products for the previous 3 months

Exclusion Criteria:

* mentally or legally incapacitated or has significant emotional problems
* history or presence of clinically significant medical or psychiatric condition or disease
* history or presence of alcoholism or drug abuse within the past 2 years
* female participants who are pregnant, lactating, or of childbearing potential
* donated blood or had significant blood loss within 56 days prior to first dose of study drug
* plasma donation within 7 days prior to first dose of study drug
COPD Care Pathway Among Patients With Cancer

This study gathers information for the development of a COPD care pathway for patients with cancer that reduces the treatment burden of patients, implements critical components of COPD care, and overcomes common barriers to COPD care in the community oncology clinic.

Primary Objective: To design a feasible COPD care pathway for patients with cancer that reduces the treatment burden of patients, implements critical components of COPD care, and overcomes common barriers to COPD care in the community oncology clinic.

Secondary Objectives:

* To identify, characterize, and explain the treatment burdens of COPD and cancer as comorbidities, as reported by patients and providers.
* To identify, characterize, and explain barriers to COPD care in the oncology clinic, as reported by patients and providers.
* To identify, characterize, and explain important and feasible components of COPD care for patients with cancer.

Eligibility Criteria:
Inclusion Criteria:

* The participant has personal experience with medical management of COPD, defined as meeting at least one of the following criteria:

  1. patient with clinical documentation of COPD (either as a confirmed or suspected diagnosis) and has received at least one dose of an immune checkpoint inhibitor for cancer or
  2. provider who currently works at least part-time in a medical oncology clinic or
  3. provider who works at least part-time to care for patients with known or suspected COPD.

     A suspected diagnosis of COPD can be based on finding(s) by history, exam, or radiography (e.g., CT changes such as emphysema, bronchial wall thickening, or mucus plugging). A provider is defined as a physician, advanced practice provider, nurse, or respiratory therapist. Study team members are permitted to participate in the study if they meet eligibility criteria.
* Ability to understand and agree to participate on the study as described by the study information sheet.
* Capability of speaking or reading English.

Exclusion Criteria: Severe psychiatric symptoms; unusual social situation; or critical instability that would limit adherence to the study requirements, as determined by the study team.
Cedar Honey in Oral Lichen Planus

The study aimed to evaluate the effect of cedar honey in treatment of erosive and atrophic oral lichen planus ( a common oral problem).


Eligibility Criteria:
Inclusion Criteria:

1. clinically and histopathologically confirmed oral lichen planus without dysplasia in histopathologic evaluation
2. Severity of pain≥2 (VAS score)
3. Severity of lesions≥2 (tong prasom criteria)
4. absence of any treatment in the last month
5. absence of kidney or liver diseases( due to systemic administration of fluconazole to both groups)

Exclusion Criteria:

1. evidence of lichenoid reaction in clinical or histopathologic assessment
2. loss of follow up
3. pregnant patients
4. diabetic patients
5. any other mucosal disease
6. any severe systemic disease
7. patients who refuse doctor's advice
8. any unexpected adverse effect of honey
Efficacy and Safety of Aliskiren and Valsartan Versus Placebo in Patients Stabilized Following an Acute Coronary Syndrome

The purpose of this study is to test the hypothesis that the inhibition of the renin-angiotensin-aldosterone system (RAAS) with the angiotensin receptor blocker valsartan or the renin antagonist aliskiren will improve ventricular hemodynamics, as reflected by a greater reduction in levels of N-terminal proB-type natriuretic peptide (NT-proBNP) compared to placebo in subjects stabilized following acute coronary syndrome (ACS) who are determined to be at high risk due to an elevated concentration of natriuretic peptides.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients 18 years old or older
* Subjects who are hospitalized for ischemic chest discomfort at rest lasting at least 10 minutes and consistent with cardiac ischemia
* Final diagnosis of acute coronary syndrome
* Elevated concentrations of natriuretic peptide 3-10 days after admission for their qualifying acute coronary syndrome event

Exclusion Criteria:

* Known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin receptor blockers (ARBs), renin antagonists, or to drugs with similar chemical structures.
* Presence of clinically overt heart failure
* Known evidence of left ventricular systolic dysfunction
* Percutaneous coronary intervention (PCI) less than 24 hours before randomization.
* Patients on chronic ACEI or ARB therapy for whom therapy with an ACEI or ARB is clinically required with no reasonable alternative therapy available.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Safety and Effectiveness of Ureteral DJ Stent With Magnet (Blackstar, Urotech) Removal Under Ultrasound Control

Evaluation of safety and effectiveness of ureteral DJ stent with magnet (Blackstar, Urotech), severity of stent-association symptoms and pain level syndrome after stent extraction compared with stent extraction by flexible cystoscope

Inclusion Criteria:

* age from 18 to 70 years
* males
* Indications for rigid or flexible URS
* ASA score: 1-3

Exclusion Criteria:

* Active urinary tract infection
* taking alpha-1 adreno and M-cholinoblockers

All patients will be randomized into 2 groups:

* group A - male patients who will undergo ureteral stent placement by conventional polyurethane DJ stent, Fr 6.5. N=30
* group B - male patients who will undergo ureteral stent placement by polyurethane DJ stent with magnet (Blackstar, Urotech ), Fr 7. N=30 Patients are to be assigned a randomization number that will match their treatment. Block randomization using 10 blocks is to be performed by a central randomization organization (www.randomize.net) using a computerized algorithm.

Using the Visual Analog Scale of Pain (VASP) and Ureteric Stent Symptom Questionnaire (USSQ) we are going to assess the pain syndrome and the severity of stent-associated symptoms. The USSQ will be filled twice: 3 days after stent placement and on the day of stent removal, just before the procedure. All stents will be removed 30 days after placement. Also, immediately after stent removal, patients will complete the VASP questionnaire. In the control group, the stent will be removed using flexible cystoscopy. In the experimental group under ultrasound control using a magnetic retriever, with a bladder capacity of at least 150 ml.

Primary assessed outcomes:

1. Age
2. Body mass index
3. Operation side
4. The density of the stone
5. Type of the operation
6. Applying of the ureteral accessing sheath
7. Type of the ureteral stent
8. Troubles with stent placement
9. USSQ (Ureteral stent symptom questionnaire) 3 days after surgery
10. USSQ before stent extraction
11. VASP (Visual Analog Scale Pain) immediately after stent extraction
12. Duration of stent extractiom by magnetic retrieval device
13. Duration of stent extraction by cystoscopy
14. Stent removal success (yes/no)

Secondary assessed outcomes:

1. Assessment of Stone-free status after surgery by performing computed tomography of kidneys and urinary tract without intravenous contrasting 1 month after surgery
2. Stent encrustation

Eligibility Criteria:
Inclusion Criteria:

* age from 18 to 70 years
* males
* Indications for rigid or flexible URS
* ASA score: 1-3

Exclusion Criteria:

* Active urinary tract infection
* taking alpha-1 adreno and M-cholinoblockers
An Exploration of Apatinib Combined With S-1 in Patients With Advanced Non-small Cell Lung Cancer

This study is to explore the potential efficacy and safety of low-dose Apatinib combined with S-1 in patients with advanced lung cancer. Patients with advanced NSCLC will be treated with oral apatinib and S-1 after treatment failure of standard regimen.

Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2). The anti-angiogenesis effect of apatinib has been proved in preclinical tests. Phase II study has showed an improvement of progression free survival in pretreated patients. S-1, an oral fluoropyrimidine has considerable effectiveness with mild side effect in patients failed to standard treatments. The purpose of this study is to evaluate the potential efficacy and safety of low-dose Apatinib combined with S-1 in heavily pretreated patients with advanced lung cancer. And to explore the biomarkers of antiangiogenesis therapy and the possible mechanisms of treatment resistance on the basis of next generation sequencing.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed Non-small cell lung cancer
* Patients with extracranial measurable lesions
* Patients with NSCLC failed for standard treatments
* Eastern Cooperative Oncology Group performance status score: 0\~2 and life expectancy of more than 3 months
* Major organs functioning properly
* Compliance is good and agreed to cooperate with the survival of follow-up
* Informed consent

Exclusion Criteria:

* Contraindications for investigational agents
* Patients with clinical symptoms of brain metastases or meningeal metastasis
* Tumor invade big vessels or close to big vessels
* Uncontrolled hypertension
* Abnormal coagulation (INR\>1.5 or Prothrombin Time\>ULN+4, or Activated Partial Thromboplastin Time\>1.5 ULN), bleeding tendency or receiving coagulation therapy
* Hemoptysis, more than 2.5ml daily
* Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
* Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
* Received big surgery, had bone fracture or ulcer in 4 weeks.
* Urine protein≥++, or urine protein in 24 hours≥1.0g
The Impact of Home Delivery of Antiretroviral Therapy on Virological Suppression

Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) has the potential to reduce key barriers to ART care retention. The aim of this study is to determine whether CHW-led home delivery of ART for patients who are stable on ART combined with facility-based care for those not stable on ART is non-inferior to the standard of care (facility-based care for all ART patients) in achieving and maintaining virological suppression. The primary endpoint of this trial is the proportion of ART patients (regardless of whether they were clinically stable on ART at enrollment) who are in viral failure at the end of the study period. The non-inferiority design applies only to this primary endpoint. The margin of non-inferiority was set at a Risk Ratio (comparing intervention to control) of 1.45. This is a cluster-randomized controlled trial set in Dar es Salaam. The unit of randomization is a healthcare facility with its surrounding neighborhoods (the 'catchment area'). We matched all 48 healthcare facilities offering ART services and having affiliated public-sector CHWs in Dar es Salaam into pairs (stratified by district) based on having a similar number of patients currently on ART. In each pair, one cluster was randomized to the intervention and one to the control arm. The intervention consists of home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART care and CHW home visits at least every three months without ART home delivery). In addition, within each study arm, half of the healthcare facilities were randomized to enhanced CHW-led nutrition counseling and half to standard counseling.


Eligibility Criteria:
Inclusion Criteria:

* Having attended one of the participating healthcare facilities for ART care during the enrolment period
* Living in a neighborhood that is in the healthcare facility's catchment area

Exclusion Criteria:

* ART patients who are pregnant at the time of enrollment
* Inability to provide written informed consent
Does Body Mass Index Impact the Outcome of Dural Puncture Epidural in Parturients Undergoing Normal Vaginal Delivery

Recently, the dural puncture epidural (DPE) technique has emerged as a novel method of labor analgesia. The DPE technique is a modification of the combined spinal epidural (CSE) technique, where a dural perforation is created from a spinal needle but intrathecal medication administration is withheld. The DPE technique has been shown to improve caudal spread of analgesia compared with epidural technique without the side effects observed with the CSE technique.

Investigators designed this prospective interventional study to determine if morbid obesity would influence DPE technique regarding labor analgesia onset and block characteristics.

Eligibility Criteria:
Inclusion Criteria:

1. 18 - 45 years old,
2. Physical status American society of anesthesiology (ASA) II,
3. Singleton,
4. Vertex fetuses at 37-41 weeks' gestation,
5. Nulliparous and multiparous women,
6. Immediately before epidural placement, subjects marked a VNRS score during an active contraction and parturients with VNRS ≥ 50 were included
7. Cervical dilatation \< 5 cm

Exclusion Criteria:

1. Contraindications to regional anesthesia
2. Refuse to participate
3. No pain
4. Severe systemic disease (kidney, liver, pulmonary, endocrine, cardiac)
5. Conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery) and vaginal birth after cesarean delivery