cyrilzakka/clinical-trials huggingface dataset:
A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study

This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months. Adult subjects will receive open-label DE-117 Ophthalmic Solution for an additional 9 months.

Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:

* DE-117 Ophthalmic Solution once daily and Vehicle once daily, or
* Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3 and will provide additional safety data through Month 12 for subjects receiving DE-117.


Eligibility Criteria:
Inclusion Criteria:

• glaucoma or ocular hypertension

Exclusion Criteria:

* Females who are pregnant, nursing, or planning a pregnancy
* Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements
Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects

RPX2003 (biapenem) is being studied in combination with a beta-lactamase inhibitor to treat bacterial infections, including those due to multi-drug resistant bacteria.

The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. In particular, the recent dissemination of a serine carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.

Rempex is developing a fixed combination antibiotic of a carbapenem (RPX2003 or biapenem) plus a new beta-lactamase inhibitor (RPX7009) which has activity against serine beta-lactamases, including KPC. This Phase 1 study will assess the safety, tolerability and pharmacokinetics of biapenem, administered alone, in healthy adult subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males and/or females, 18 to 55 years of age
* Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
* Medically healthy with clinically insignificant screening results
* Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Day 1.
* Sexually abstinent or use acceptable methods of birth control

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
* Hypersensitivity or idiosyncratic reaction to compounds related to the study drug (e.g. beta-lactam antibiotics such as penicillins, carbapenems, etc).
* History of seizures (e.g., epilepsy).
* Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.
* Blood donation or significant blood loss (i.e., \> 500 mL) within 56 days prior to Day 1.
* Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).
Symbicort Onset of Action 1

The purpose of this study is to compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with asthma


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma and baseline lung function test results as determined by protocol
* Required and received asthma maintenance therapy within previous 4 weeks at doses determined by protocol

Exclusion Criteria:

* Severe asthma or asthma markedly affected by seasonal factors
* Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
PENG Block Plus Lateral Femoral Cutaneous Nerve Block for Posterolateral-approached Total Hip Arthroplasty

This study aims to analyze the effect of Pericapsular Nerve Group (PENG) Block combined with lateral femoral cutaneous nerve block vs. PENG block combined with wound infiltration for analgesia after elective hip replacement performed with a posters-lateral approach.

Half of participants will receive a PENG Block combined with femoral lateral cutaneous nerve block, while the other half will receive PENG Block combined with wound infiltration


Eligibility Criteria:
Inclusion Criteria:

* Elective hip replacement surgery performed with a poster-lateral approach
* ASA physical status score \< 4

Exclusion Criteria:

* Contraindications to regional anesthesia
* ASA physical status score ≥ 4
* Patient's refusal or inability to sign the informed consent
* Allergies to any drug provided by the study protocol
A Randomised Study Evaluating Diagnostics of Pleural Effusion Among Patients Suspect of Cancer.

Pleural fluid can be caused by cancer. Patients with repeated presentation of pleural fluid where initial diagnostic tests have been inconclusive are the focus of this trial. In this clinical trial patients are randomized into two groups and the efficacy of local anesthetic thoracoscopy (LAT) is compared to an ultrasound guided biopsy of the outer lining of the lung. The aim is not only the diagnostic yield in diagnosing cancer, but also the procedures ability to diagnose specific cancer mutations and immune system markings.

Methods and objectives:

Patients with reoccuring one-sided pleural fluid, with a marked clinical risk of cancer based on findings in medical work-up, radiological scans, biochemistry and medical history and who are undiagnosed upon initial pleural fluid analysis are the target patients of the trial. Patients are randomized into two groups to have undertaken either pleural biopsy at the optimal site for a repeat thoracentesis or LAT. Thus diagnostic yield for both fluid analysis and biopsy analysis will be compared to tissue samples taken with LAT.

We hypothesize that LAT is superior both to pleural biopsy and repeat thoracentesis in providing diagnostic clarification and providing sufficient basis for treatment without further procedures resulting in less time consumption, cost and discomfort for the patient.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older patients with single previous thoracentesis of a unilateral pleural exudate according to Lights criteria without malignant cells.
* Lights Criteria:

Pleural fluid protein/serum protein ratio greater than 0.5 pleural fluid LDH/serum LDH ratio greater than 0.6 Pleural fluid LDH greater than two-thirds the upper limits of the Laboratorys normal Serum LDH

* Contrast enhanced CT of the Chest and abdomen performed
* Clinical suspicion of cancer such as, but not limited to, weight loss, malaise, anemia
* Pet-CT results or former cancer diagnosis Informed consent

Exclusion Criteria:

* bilateral pleural effusions
* known cause of pleural effusion
* likely non-malignant course of a unilateral pleura effusion such as (but not restricted to) pneumonia, trauma, pleuritis, heart failure
* any contraindication to the study procedures
Neoadjuvant Fluzoparib Combined With Camrelizumab in Germline BRCA-mutated HER2-negative Breast Cancer

This study is an open-label, single-arm, multicenter clinical study. 94 patients with germline BRCA-mutated HER2-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of neoadjuvant fluzoparib combined with camrelizumab in the treatment of germline BRCA-mutated HER2-negative early breast cancer。


Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 and ≤ 70 years of age with treatment-naïve breast cancer
* Histopathologically confirmed early or locally advanced HER2-negative invasive breast cancer as defined by the ASCO/CAP guidelines while meeting the following conditions:

HER2 negative: IHC 0/1 + or IHC2 + but ISH negative; Tumor stage: II-III; Primary tumor size: ≥ 1 cm Nodal Status: N0-3

* ECOG score 0 \~ 1;
* Centrally confirmed BRCA1 or BRCA2 germline mutation;
* At least one measurable lesion according to RECIST 1.1
* Eligible level of organ function

Exclusion Criteria:

* Patients with metastatic breast cancer or bilateral breast cancer;
* Patients with inflammatory breast cancer;
* Participated in other drug trials or received any anti-tumor therapy within 4 weeks before enrollment, including endocrine therapy, bisphosphonate therapy, immunotherapy, biological therapy or tumor embolization;
* Previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or other therapies against PD-1/PD-L1 inhibitors;
* Previously received PARP inhibitors;
* Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis or combined hepatitis B and C co-infection; autoimmune hepatitis;
* Confirmed history of heart failure or systolic dysfunction (LVEF \< 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia; angina requiring antianginal medication
* Female patients who are pregnant or lactating
* History of definite neurological or psychiatric disorders, including epilepsy or dementia
* Presence of interstitial lung disease, pneumonitis, or uncontrolled systemic disease (eg, diabetes mellitus, pulmonary fibrosis, acute pneumonitis, etc.)
Automated Connective Tissue Torque Sensor

The purpose of this study is to develop a measure - the needle torque test - capable of detecting connective tissue abnormalities associated with musculoskeletal disorders.

Chronic musculoskeletal pain is a source of considerable disability, work absenteeism and health care costs. A major obstacle to the treatment of these conditions is the lack of methods to objectively assess connective tissues and measure the effect of treatments. Needle torque test technology under development in this project will potentially enable objective measurement of connective tissue abnormalities associated with musculoskeletal pain and dysfunction. This could help evaluate the efficacy of various treatments and enhance the objective monitoring of patient progress in clinical practice.

Eligibility Criteria:
Inclusion Criteria for chronic low back pain subjects:

* back pain that has disrupted activity for more than half the days in the past 12 months.

Inclusion Criteria for restricted hamstring subjects:

* 90/90 test of more than 20 degrees

Inclusion Criteria for systemic scleroderma subjects:

* physician diagnosis

Inclusion criteria for joint hyperlaxity subjects:

* Beighton test score of 7 or higher

Exclusion Criteria for all subjects:

* surgery or scars in thighs or low back
* neurological or major psychiatric disorder
* bleeding disorders
* acute systemic infection
* pregnancy
Effect of Full-thickness Gastroplication With the GERD-X System on Atypical Gastro-esophageal-reflux-symptoms

Patients with atypical symptoms of objectified gastroesophageal reflux disease will be treated by full-thickness gastroplication and the effect of this intervention will be measured by questionnaires and clinical diagnostics (for example pH/MII).


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 years and 80 years
* symptomatic, objectified reflux disease (atypical symptoms - Montreal-classification)

Exclusion Criteria:

* Rejection of study-participation,
* Pregnancy
* negative pH-metry / impedance monitoring (non-objectified reflux)
* hiatal hernia bigger than 2 cm or gastroesophageal junction \> Hill IV classification
* different potential reasons for atypical symptoms like heterotopic gastric mukosa in the cervikal esophagus
* Achalasia, esophageal spasm
* Presence of contraindications for the interventions
A Study to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects

Carbetocin is an oxytocin receptor agonist that selectively binds to receptors in the smooth muscle of the uterus, stimulates rhythmic contractions of the uterus, increases the frequency of existing contractions, and raises the tone of the uterine musculature. Carbetocin is approved in \>100 countries for the prevention of postpartum hemorrhage due to uterine atony in women following cesarean or vaginal delivery. Per regulatory requirements, the current trial will evaluate the effects of high clinical exposure of carbetocin on the QT interval corrected for heart rate (QTc) as measured by ECG in healthy men and women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male or female subjects, 18-45 years of age, inclusive, at the screening visit.
* Body mass index (BMI) ≥ 18.5 and ≤29.9 kg/m2 at the screening visit.
* Continuous non-smoker who has not used nicotine- or tobacco-containing products for at least 3 months prior to first dosing.

Exclusion Criteria:

* Sustained supine systolic blood pressure ≥130 mmHg or \<90 mmHg, supine diastolic blood pressure ≥80 mmHg or \<50 mmHg at screening or first check-in.
* History or presence of clinically significant ECG findings in the opinion of the Principal Investigator (PI) or designee at the screening visit or first check-in, including each of the following:

  * HR \<45 bpm or \>100 bpm.
  * QTcF is ≥450 msec (males) or ≥460 msec (females).
  * QRS ≥110 msec; if ≥110 msec, result will be confirmed by a manual over read.
  * PR ≥200 msec.
* History or presence of:

  * Risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT syndrome, Brugada syndrome, or sudden cardiac death).
  * Sick sinus syndrome, second- or third-degree atrioventricular block, myocardial infarction, angina, pulmonary congestion, symptomatic or significant cardiac arrhythmia, or clinically significant conduction abnormalities.
  * Clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, or hypomagnesemia, in the opinion of the PI or designee.
Children's Activities and Social Participation

The goal of this observational study is to learn the perception of caregivers about the limitations of activities, and the restriction in the social participation of children who are in Neurofunctional physiotherapy. The main questions it aims to answer are:

* What is the ability to perform tasks, and
* how is the social participation of children with atypical motor development?

Participants will answer two of three questionnaires:

* The Participation and Environment Measure - Children and Youth or the Young Children's Participation and Environment Measure, depending on the age of their child

.The Pediatric Evaluation of Disability Inventory - PEDI.

The limitation in the execution of activities and tasks, as well as the restriction in the social participation of children considered atypical are considered biopsychosocial aspects of health according to the model of the International Classification of Disability and Health Functionality (ICF). The perception of the difficulties and limitations in the execution of the tasks, the barriers and facilitators of the environments and the participation and its restrictions, can be important to follow minimal or expressive improvements, indicate important changes in the environment and favor positive changes in the lives of children.

Eligibility Criteria:
Inclusion Criteria:

* Legal guardians of children aged up to 11 years and 11 months with motor disability
* Most be in Physio-therapeutic care at the School Clinic on the Realengo campus of the Federal Institute of Education, Science and Technology of Rio de Janeiro.

Exclusion Criteria:

* Guardians of children with a health condition associated with the Nervous System without motor limitations
* Other health conditions.
Ultrasound Guided Erector Spinae Plane Block Combined With General Anaesthesia Versus Conventional General Anaesthesia in Lumbar Spine Surgery

Ultrasound guided erector spinae plain block combined with general anaesthesia versus conventional general anaesthesia in lumbar spine surgery, it's hypothesized that combined regional anaesthesia with general anaesthesia in lumbar spine surgery may reduce the anaesthetic requirements, aid in controlled hypotension and improve the perioperative pain management.

Primary outcomes:

• Anaesthetic requirements: based on entropy monitoring(state and response entropy monitoring and the difference as a measure for adequacy of analgesia) and haemodynamic parameters ( heart rate and mean arterial blood pressure) at the following time intervals: before induction, after induction, after giving either ESP block or multimodal analgesia and starting surgical stimulus, at 30 min intervals, at end of anaesthesia, at eye opening.

Secondary outcomes:

* Stress response measurement based on serum cortisol and blood glucose levels
* Controlled hypotensive anaesthesia: various drugs required and doses given
* Intraoperative and postoperative analgesia.
* Postanaesthesia care unit data concerning recovery.

Eligibility Criteria:
Inclusion Criteria:

patients undergoing lumbar spine surgery

Exclusion Criteria:

* Coagulation disorders.
* BMI \> 30 or \< 18.5.
* Patients with surgical site infection.
* Patients with unstable spine integrity like fractures or scoliosis.
* Hypertensive ,cardiac and diabetic patients.
Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan

This study is a regulatory post-marketing surveillance of Zevalin (ibritumomab tiuxetan) in Japan. In-111 Zevalin is, at first, injected to patient for gamma scan imaging to assess biodistribution of the Zevalin. When the imaging shows no altered distribution, Y-90 Zevalin is injected to the patient for the actual treatment. The objective of this study is to assess appropriateness and necessity of revision of the standardized criteria for image interpretation of In-111 Zevalin by comparing assessment by the investigator and the members of the committee for image interpretation of In-111 Zevalin. A total 40 patients will be recruited.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received In-111 Zevalin to verify that expected biodistribution is present.

Exclusion Criteria:

* Patients who are contraindicated based on the product label.
DCP3 Based Multi-component Intervention for Hypertension Management and Control

This study aims to enable delivery of a multi-component intervention comprising of strategies based on Disease Control Priorities 3rd edition for management of hypertension among hypertensive patients. The secondary objective is to test the feasibility, acceptability and adaptability of a multi-component intervention delivered at a tertiary level health-care facility in the cultural context of Pakistan. A formative research study was conducted before so as to develop and test the intervention in a tertiary care hospital setting. The investigators employed qualitative research methods to explore the feasibility, applicability, and acceptance of DCP3 based intervention comprising of strategies for hypertension management. Focus group discussions and in-depth interviews with selected study participants were conducted at Armed Forces Institute of Cardiology (AFIC/NIHD), Rawalpindi for which a prior written and verbal consent was obtained from all research participants. The study adhered to the ethical principles of involving human subjects in the research. All information provided by the participants was recorded and was kept strictly confidential.


Eligibility Criteria:
Inclusion Criteria:

* • Pakistani nationals both male and female of age 18 years and above will be invited to participate in the study

  * Similarly; known hypertensive patients having a systolic blood pressure of ≥140 mmHg on current treatment will be included \&
  * Patients with co-morbidities will also be included such as those suffering from cardiac ailments (angina or transient ischemic attack (TIA) and diabetes

Exclusion Criteria:

* • Patients with compromised neurological or cognitive state who are unable to provide their consent will be excluded

  * Patients suffering from non-cardiovascular diseases and life-threatening illnesses such as angiographically proven coronary disease, peripheral or cerebral vascular disease, pulmonary hypertension, having history of myocardial infarction, stroke/PCI/stent or high-risk conditions will be excluded from participation
  * Patients with chronic conditions and co-morbidities requiring surgical intervention or treatment such as cardiomyopathies or congenital abnormalities \&
  * Patients receiving dialysis will also be excluded from the study
A Trial Assessing The Association Between Type Of Local Anesthesia Treatment And Postoperative Pain In Patients In Having Undergone Arrhythmia Surgery

The goal of the proposed study is to investigate the relationship between two standard treatments, lidocaine or a mixture of lidocaine and bupivacaine, and 1) postoperative pain, and; 2) narcotic use following pacemaker or defibrillator insertion in subjects who undergo arrhythmia surgery at Baylor Heart and Vascular Institute while adjusting for pertinent clinical and/or demographic factors. No control group is necessary.

Patients receiving a pacemaker or defibrillator are currently given Bupivacaine, Lidocaine, or a mixture of the two for local anesthetic treatment (in addition to general anesthesia). The choice of local anesthetic to be used during surgery is based primarily on the differences in time for the anesthetic to take effect and duration thereafter. Lidocaine typically works in less than 1 minute and lasts approximately 45 minutes. Bupivacaine works within 2 to 3 minutes and lasts 4 to 6 hours. Lidocaine is often preferable due to its shorter time of effectiveness. However, its relatively short duration may translate into a higher use of narcotics for pain management during postoperative care - particularly within the first hour following emergence from general anesthesia. Therefore it is conceivable that these patients would have higher levels of pain, higher cost of care related to cost of narcotics, and higher cost of caregiver time required to administer them.

Eligibility Criteria:
Inclusion Criteria:

* Arrythmia patients receiving pacemaker or cardiac defibrillator devices at Baylor Heart and Vascular Institute.

Exclusion Criteria:

* Receiving complicated procedures
* Replacement of parts, not inclusive of leads