cyrilzakka/clinical-trials huggingface dataset:
Prinomastat and Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Non-small Cell Lung Cancer

RATIONALE: Prinomastat may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. Drugs used in chemotherapy stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase III trial to determine the effectiveness of prinomastat plus cisplatin and gemcitabine in treating patients who have metastatic or recurrent non-small cell lung cancer.

OBJECTIVES: I. Compare the overall survival, progression free survival, symptomatic progression free survival, and one year survival of patients with metastatic or recurrent non-small cell lung cancer treated with prinomastat (AG3340) or placebo in combination with gemcitabine and cisplatin. II. Compare the disease response and duration of response in these patients on these regimens. III. Compare the quality of life of these patients on these regimens. IV. Evaluate the safety of these regimens in these patients.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients receive oral prinomastat or placebo twice daily beginning on day 1, followed by gemcitabine IV on days 1 and 8 and cisplatin IV on day 1. Courses repeat every 3 weeks.

PROJECTED ACCRUAL: Approximately 420 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Stage IV or recurrent or T4 lesion non-small cell lung cancer Measurable or evaluable disease No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for non-small cell lung cancer Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone

The purpose of the study is to determine if short-term outcomes of rectal resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to rectal resections with only mechanical bowel preparation.

The design involves random allocation of eligible patients to full bowel preparation or only mechanical bowel preparation in 1:1 ratio. After that rectal resection is performed in both groups.

Short-term outcomes are assessed in 30 day period after surgery. This is a superiority trial evaluating statistical superiority. Rate of surgical site infection is anticipated to decrease from 12% (data from local registry) to 6%. For power of 80% enrolment of 622 patients is required.

The intent-to-treat principle is used for the data analysis.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed adenocarcinoma of the rectum or rectosigmoid junction
* clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
* indications for surgical rectal resection
* ECOG status 0-2
* At least 18 years of age
* Written informed consent

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
* Pregnancy or breast feeding
* Medical contraindications for surgical treatment
* Any use of antibiotics 30 days prior to inclusion
* Functioning stoma
* Contraindications for use of MBP or OA drugs or their components
* Indications for obstructive resection or abdominoperineal excision
* Acute bowel obstruction, bleeding or perforation
* Other malignancies not in remission
Transcatheter Leak Closure With Detachable Coils Following Incomplete Left Atrial Appendage Closure Procedures

Although the clinical impact of left atrial appendage (LAA) leaks still requires confirmation, the open pouch with residual flow resulting from incomplete LAA closure may promote blood stagnation and thrombus formation, and increase the risk of thromboembolic events. The main purpose of this trial is to evaluate the safety and efficacy of percutaneous leak closure with detachable vascular coils.

Therapies locally targeting the LAA via occlusion, exclusion, or excision have emerged as an alternative and effective approach for stroke prophylaxis in AF patients, especially those with OAC contra-indications. Despite mounting evidence of their safety and efficacy in comparison with standard oral therapy, device-related thrombus and incomplete LAA closure resulting in residual, significant leak may occur, potentially hindering an effective stroke prevention. To date, detachable coils have found a wide range of applications for transcatheter occlusion/embolization procedures (e.g., cerebral aneurysms, pulmonary, renal and cerebral arteriovenous malformations, patent ductus arteriosus, endoleaks). The main purpose of this trial is to evaluate the feasibility and efficacy of transcatheter leak closure with detachable coils in patients with evidence of incomplete percutaneous/epicardial LAA exclusion.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years.
* Presence of a significant LAA leak (moderate/severe following percutaneous occlusions or mild/severe after epicardial exclusions with the LARIAT suture delivery device).
* Less moderate embolic risk (CHA2DS2-VASc ≥2)
* High associated hemorrhagic risk (HASBLED ≥ 3), or absolute contraindication to OAC, or need for prolonged dual antiplatelet therapy, or history of thromboembolic events despite LAA occlusion/exclusion after other potential causes.
* written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion Criteria:

* Life expectancy \< 2 years.
* pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
* presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Differential Influences of Integral and Incidental Emotion on Cancer-related Judgments and Decision Making

Background:

Researchers are testing new methods for research projects. They want to see how people respond to different types of communication, including videos. They also want to learn how people respond to life events and how they pay attention to computer tasks. They want to learn about how various risks and threats affect the way people make decisions.

Objectives:

To learn how different stimuli and events affect the way people make decisions.

Eligibility:

Adults ages 18 and older with a U.S. computer address

Design:

Participants will be recruited online.

Participants will take one of three studies online. Each study will take about a half hour.

Participants in Study 1 will watch a short video from a popular movie then answer questions. They will also complete 2 questionnaires. One will be about how likely they think it is that they will experience different risks and threats. The other will be about goals for behavior change.

Participants in Study 2 will write in detail about a life event. Then they will answer questions. They will also complete the same 2 questionnaires as Study 1.

Participants in Study 3 will pay close attention to words and images on a computer. They will answer questions about attitudes toward different behaviors, products, and experiences.

...

Despite evidence that both integral (i.e., related to the decision) and incidental (i.e., unrelated to the decision) emotions influence cancer-related decision making, no research has systematically examined whether these two types of emotion generate similar patterns of influence, as predicted by decision-making models. This is important because incidental emotions are often used experimentally to draw causal conclusions about how emotions influence cancer-related decisions with the notion that results will generalize to produce knowledge about integral emotions as well. Across three studies, we plan to directly compare integral and incidental emotional influences on judgments and decisions related to cancer control. We plan to examine whether effects are contingent on the type of emotional influence (the discrete emotions anger and fear, or general positive affect) or type of emotion induction (video, autobiographical induction, or evaluative conditioning). Across experiments, we predict that emotion will influence both judgment and decision-making outcomes when the induced emotion is integral as well as when it is incidental. However, we predict that the magnitude of the effect of emotion on these types of responses will be significantly greater when emotions are integral to a judgment or decision, compared to when emotions are incidental.

Eligibility Criteria:
* INCLUSION CRITERIA:

Adults ages 18 and older with a U.S. computer address
Patient-reported Outcomes in Neuroendocrine Neoplasms: a Prospective Quality of Life and Quality of Care Study Within NETwerk

Neuroendocrine tumors (NET) are rare tumors that require specific diagnosis and treatment. Therefore, this poses a challenge for clinical practice. Diagnosis and treatment can be optimized when physician specialists and other healthcare providers, across various hospitals, join forces to provide patients the best care. Based on this idea, a hospital network called NETwerk was set up. The following hospitals are part of this network: University Hospital Antwerp, VITAZ, AZ Monica, AZ Voorkempen, AZ Klina, Gasthuiszusters Antwerpen, Ziekenhuis Netwerk Antwerpen and AZ Rivierenland. In this NETwerk, patients with a neuroendocrine tumor or patients suspected with a neuroendocrine tumor are discussed with the specialists and treated.The aim of this study is to map the quality of life of NET patients within NETwerk in order to optimize the quality of care. Throughout the diagnosis, the treatment process and the follow-up, the patient will be asked to fill out three questionnaires (QLQ-C30, QLQ-GI.NET21 and a satisfaction survey). These questionnaires will be filled out every six months at home. Patients will be asked to complete these questionnaires over a period of five years.


Eligibility Criteria:
Inclusion Criteria:

* NEN patient
* 18 years or older
* Patient should appear in Oncobase

Exclusion Criteria:

* Patients who do not have an email address
Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi

This study is designed to provide an evaluation of currently available disposable flexible ureteroscopes in real-world conditions. Due to high re-processing costs associated with re-usable flexible ureteroscopes, there has been a demand for Urologic device manufacturers to provide single-use flexible ureteroscopes.

Patients randomized to the experimental group will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.

Data will be collected and stored electronically in REDCap. Quality assurance steps will include testing of the database, including any potential data calculated by command functions within REDCap

Scope performance survey will be administered with REDcap.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females 18-89 undergoing ureteroscopy for laser treatment of renal calculi
* Willing to sign the Informed Consent Form
* Able to read, understand, and complete patient questionnaires, pain texts, and medication diary.

Exclusion Criteria:

* Patients having a concomitant procedure along with ureteroscopy (example: contralateral PCNL)
* Pregnancy
A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis

This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Women newly diagnosed with postmenopausal osteoporosis
* Naive to prior bisphosphonate therapy

Exclusion Criteria:

* Inability to stand or sit upright for at least 60 minutes
* Inability to swallow a tablet whole
* Hypersensitivity to any component of ibandronate
* Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months
* Other osteoporosis drug within last 3 months
* Malignant disease diagnosed within previous 10 years, except resected basal cell cancer
A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients

Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)

The purpose of this study was to provide efficacy and safety data on 0.5 mg ranibizumab intravitreal injections compared to laser photocoagulation in Chinese patients with visual impairment due to DME. Treatment was driven by achieving vision stabilization.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female Chinese patients ≥ 18 years of age with diabetes mellitus and with HbA1c ≤10.0%
* Stable medication for diabetes within 3 months prior to Visit 1
* Visual impairment due to DME with BCVA score between 78 and 39 letters as measured by ETDRS-like charts at 4 meters

Key Exclusion Criteria:

* Stroke or myocardial infarction less than 3 months prior to screening visit
* Uncontrolled hypertension
* Active ocular infection or intraocular inflammation in any eye
* Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
* Active proliferative diabetic retinopathy in study eye
* Use of other investigational drugs within 30 days and systemic anti-VEGF drugs within 6 months prior to baseline visit
* Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye
* History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening
Determination of Grass Pollen Allergen Concentration Inducing Rhinoconjunctivitis Symptoms in Subjects Allergic to Grass Pollen in ALYATEC Allergen Exposure Chamber

The aim of this study is to determine the optimal concentration of grass pollen allergens inducing rhinoconjunctivitis in subjects allergic to grass pollen in ALYATEC allergen exposure chamber.

Four concentrations of grass pollen allergen (Phl p 5) are tested during 3-hour exposures: 0, 30, 60 and 90 ng/m3.


Eligibility Criteria:
Main Inclusion Criteria:

* Subjects with symptoms of allergic rhinoconjunctivitis to grass pollen without associated asthma, requiring anti-allergic treatment for at least 2 consecutive pollen seasons;
* Subjects with positive skin prick tests to grass pollen extracts (Phleum pratense): papule diameter ≥ 5 mm compared to the negative control (NaCl reaction \< 2 mm));
* Subjects with Phl p 5 specific recombinant Immunoglobulin E ≥ 0.70 kIU/L;
* Forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted value at screening and before allergenic exposures;
* Women of childbearing age must have a negative pregnancy test at screening and before exposure visits;

Main Exclusion Criteria:

* Specific immunotherapy (SIT) to grass pollen allergens for more than one month in the 3 years preceding the screening visit;
* Ongoing specific immunotherapy to another allergen
* History of anaphylaxis following exposure to grass pollen or grass SITs;
* Asthma
* Ear, Nose \& Throat or ocular surgical intervention in the 6 months preceding inclusion;
Registry for Acute Decompensated Heart Failure Patients

The purpose of the ADHERE study is to develop a multi-center, observational, open-label registry of the management strategies of patients treated in the hospital for acute Heart Failure in the United States.

The objective is to compile a clinical database on the strategy for the medical management of patients hospitalized with acute Heart Failure (HF). Through the use of the information collected from acute care hospitals across the United States the following information may be coming out of this study: 1) Assist hospitals in evaluating and improving quality of care for patients with acute HF by tracking quality indicators and providing benchmark data reports; 2) Describe the demographic and clinical characteristics of patients who are hospitalized with acute HF; 3) Characterize the initial emergency department evaluation and subsequent inpatient management of patients hospitalized with acute HF; 4) Identify patient characteristics and medical care practices associated with improved health outcomes in those hospitalized with acute HF; 5) Characterize trends and changes over time in the management of acute HF; 6) Offer surveillance of adherence to practice guidelines as these emerge for the inpatient management of acute HF. Observational Study - No investigational drug administered

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years at the time of admission to the hospital
* Received or is eligible to receive a principal hospital discharge diagnosis of HF
* Decompensated HF is present as determined clinically by the patient care team

Exclusion Criteria:

* HF is present as a co-morbid condition, but is not a principal focus of diagnosis or treatment during this hospitalization episode
NW Roselle in Grade 1 Essential Hypertension: Phase III Clinical Trial

In this Phase III clinical trial, researchers evaluate the efficacy and safety of NW Roselle®, a powdered medicinal product developed by Natural Wellness. NW Roselle combines extracts from Hibiscus Sabdariffa (HS) flowers and Olea europaea (OE) leaves. The trial aims to gather evidence on the efficacy and safety of NW Roselle as a potential treatment option for Grade 1 essential hypertension.

Hypertension is a major risk factor for heart, brain, and kidney diseases, and is a leading cause of death and illness globally. Natural Wellness has developed NW Roselle®, a powdered medicinal product that combines extracts from Hibiscus Sabdariffa (HS) flowers and Olea europaea (OE) leaves.

In this Phase III clinical trial, researchers are evaluating the efficacy and safety of NW Roselle, in the treatment of Grade 1 essential hypertension. Eligible participants who meet the criteria will be enrolled and randomized in a 1:1 ratio. They will be assigned to receive either NW Roselle or an active control, Captopril 25 mg twice daily.

Before the treatment begins, participants will provide informed consent and undergo assessments to collect information about their medical history, hypertension status, lifestyle factors, and demographics. Throughout the trial, the participant's vital signs, physical exams, and laboratory tests will be conducted to monitor their health and response to the treatment. Adherence to the assigned treatment will be monitored, and any potential adverse events or side effects will be tracked.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with grade 1 essential hypertension (Systolic Blood Pressure: 140-159 mmHg, and/or Diastolic Blood Pressure 90-99 mmHg) (Williams et al., 2018).
2. Not currently taking any medication for hypertension.
3. Able and willing to provide written informed consent.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Patients with BMI \> 45 Kg/m2 or BMI \< 18 Kg/m2.
3. Patients with a known history of secondary hypertension (e.g., hyperaldosteronism, pheochromocytoma, renal artery stenosis, Cushing syndrome).
4. Renal impairment (Estimated Creatinine Clearance (Cr.Cl.) \< 30 ml/min as measured by the Cockcroft-Gault formula).
5. Known Severe hepatic impairment, biliary cirrhosis, or cholestasis.
6. Patients with a history of arrhythmias, ischemic heart diseases, obstruction of the outflow tract of the left ventricle (e.g., hypertrophic obstructive cardiomyopathy, and high-grade aortic stenosis), congestive heart failure, valvular disease, myocardial infarction (MI), angina, myocardial revascularization, or cerebrovascular accident (CVA) within 6 months prior to study entry.
7. Participation in other clinical studies within 30 days before screening.
8. Known or suspected allergy or any contraindications to the trial products.
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial

The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB

Rationale: to compare two different types of gastric bypass operations on surgical outcome.

Objective: to compare two established procedures in order to find the optimal procedure in terms of weight loss and metabolic control that is associated with the fewest side-effects and complications, and decreased invasiveness.

Study design: A multicentre, open label, non-inferiority randomized controlled trial Study population: Patients are eligible for inclusion if their body-mass index (BMI) was 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, osteoarthritis of the hip or knee) and a positive evaluation by our bariatric multidisciplinary team (BMDT) and are aged 18-65.

Intervention: Group 1: One Anastomosis Gastric Bypass with 150cm biliopancreatic limb. Group 2: Roux-en-Y gastric bypass with biliopancreatic limb of 150cm and 75cm alimentary limb.

Main study parameters/endpoints:

Primary endpoint:

% Excess BMI loss at two years

Secondary endpoints:

Metabolic status Nutritional status Comorbidity remission QOL Complications or serious adverse events (SAE's)

Eligibility Criteria:
Inclusion Criteria:

* body-mass index (BMI) of 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, osteoarthritis of the hip or knee)
* a positive evaluation by our BMDT

Exclusion Criteria:

* Presence of H. Pylori, resistant to eradication therapy
* chronic diarrhoea
* history of previous bariatric or extensive abdominal surgery