cyrilzakka/clinical-trials huggingface dataset:
An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study

This single-arm, open-label, multicenter extension study will provide continued bevacizumab therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech sponsored study and who derived benefit from the bevacizumab therapy. Participants will receive the same dose and regimen of bevacizumab as used in the previous parent trial and continue this treatment until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.


Eligibility Criteria:
Inclusion Criteria:

* Participant is treated with bevacizumab at the end of the Roche/Genentech sponsored parent trial and continues to have benefit as judged by the investigator
* Eligible for continuation of bevacizumab treatment at the end of a parent trial, according to parent trial protocol
* Able to comply with this extension study protocol (MO25757)

Exclusion Criteria:

* Evidence of disease progression assessed according to parent trial protocol during the screening phase for this extension study
* Evidence of any adverse event potentially attributable to bevacizumab, for which the local label recommends permanent discontinuation
* A treatment interruption with bevacizumab of more than 42 days since the last administration of bevacizumab in the parent trial
* Evidence of any other disease that would put the participant at high risk for treatment-related complications
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

Purpose of this study is to test the hypothesis that treatment with inclisiran sodium 300 mg s.c. administered on Day 1, Month 3 (Day 90), and every 6 months thereafter taken in addition to well-tolerated high-intensity statin therapy in participants with established ASCVD will significantly reduce the risk of 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI) and non-fatal ischemic stroke. This will be compared to placebo in adjunct to well-tolerated high-intensity statin therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Fasting LDL-C ≥ 70 mg/dL at randomization visit
2. Stable (greater than or equal to 4 weeks) and well-tolerated lipid-lowering regimen (including e.g. with or without Ezetimibe) that must include a high-intensity statin therapy with either atorvastatin greater than or equal to 40 mg QD or rosuvastatin greater than or equal to 20 mg QD
3. Established CV disease defined as ANY of the following three conditions

   1. Spontaneous Myocardial infarction ≥ 4 weeks from screening visit
   2. History of ischemic stroke occurred ≥ 4 weeks prior to the Screening visit
   3. Symptomatic peripheral arterial disease (PAD) evidenced by either intermittent claudication with ankle brachial index (ABI) \< 0.85, prior peripheral arterial revascularization procedure, or, amputation due to atherosclerotic disease.

Exclusion Criteria:

1. Acute coronary syndrome, stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease \< 4 weeks before screening visit
2. Treatment with PCSK9 inhibitors (e.g. evolocumab, alirocumab) within 90 days or planned use post first study visit
3. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or re-vascularization within the 6 months after the first study visit
4. Heart failure NYHA class III or IV
5. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver
6. Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years
7. Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 5 years
8. History of malignancy that required surgery radiation therapy and/or systemic therapy during the 3 years prior to the first study visit
9. Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.
Mifepristone Treatment of Alcohol Use Disorder

This is an 8-week, randomized, double-blind, placebo-controlled, 2 arm, parallel groups, study of 1-week of treatment with mifepristone (0, 1200 mg/d) given in conjunction with 8 weeks of manual-guided counseling, and a follow-up visit at Week 12.


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers, 18-65 years of age
* Meets Diagnostic and Statistical Manual (DSM)-V criteria for current alcohol use disorder of moderate or greater severity, defined by DSM-V as ≥ 4 symptoms
* Abstinent a minimum of 3 days (but not more than 30 days) prior to randomization
* In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, ECG, urine test and lab tests
* Females with childbearing potential must have a negative serum pregnancy test on the screening visit and a negative urine pregnancy test at randomization and agree to use non-hormonal effective birth control for the study duration and one month thereafter

Exclusion Criteria:

* A medical condition or chronic use of a medication that contraindicates the administration of mifepristone
* Significant medical disorders or clinically significant findings on ECG (e.g., prolongation of the corrected QT interval,urine or blood tests that increase potential risk or interfere with study participation as determined by the Study Physician. Note: serum potassium below the normal range must be replaced to normal prior to randomization; individuals with serum potassium outside the range of normal will not be randomized
* Liver function tests more than 3 times the upper limit of normal or elevated bilirubin
* Female subjects with childbearing potential who are pregnant, nursing, or refuse to use effective non hormonal birth control for the 1-week of medication administration and one month thereafter
* Meets Diagnostic and Statistical Manual -V criteria for a major Axis I disorder including mood or anxiety disorders or substance use disorders other than alcohol or nicotine use disorders
Segmentectomy for Ground Glass-dominant Invasive Lung Cancer (ECTOP-1012)

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1012. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for ground glass-dominant invasive lung cancer with size of 2-3cm. The main questions it aims to answer are:

* The 5-year disease-free survival of patients having ground glass-dominant invasive lung cancer with size of 2-3cm;
* The post-operative lung function tests after receiving segmentectomy. Participants will receive segmentectomy as the surgical procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients who sign the informed consent form and are willing to complete the study according to the plan;
* Aged from 18 to 80 years old;
* ECOG equals 0 or 1;
* Not receiving lung cancer surgery before;
* Confirmed to be invasive lung adenocarcinoma intraoperatively or postoperatively;
* Ground glass-dominant lung nodules
* Consolidation-to-tumor ratio (CTR) ranges from 0 to 0.5, and tumor size ranges from 2 to 3cm;
* cN0 without distant metastasis;
* Tumors could be completely resected assed by surgeons;
* Not receiving chemotherapy or radiotherapy before.

Exclusion Criteria:

* CTR is not 0-0.5, or size is not 2-3cm;
* Tumors could not be completely resected assed by surgeons;
* Not lung adenocarcinoma diagnosed cytologically or pathologically;
* Receiving lung cancer surgery before;
* Receiving radiotherapy or chemotherapy.
Effect of Therapeutic Techniques on Leg Stretching in Healthy Subjects

There are physiotherapy techniques, known as lumbar mobilization, proprioceptive neuromuscular facilitation, massage therapy, windsheets and foam roller that present good results in stretching the legs. This study aims to evaluate which of these techniques has a better result in leg stretching. It is believed that massage therapy and lumbar mobilization will provide better results.

A randomized clinical trial blind crossover. The aim of this study is comparing the immediate effect of five interventions on the flexibility of hamstrings in healthy individuals. Participants will be assessed pre and post intervention through the extended leg elevation test and photogrammetry. The techniques of unilateral lumbar mobilization, proprioceptive neuromuscular facilitation, massage, ventosa therapy and foam roller will be applied on different days with a 48-hour interval between interventions. The techniques will be compared using the repeated measures ANOVA after verification of normality by the Shapiro-Wilk test, adopting the significance level of 5% and 95% confidence interval.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 35 years of age.
* No pain in the posterior thigh.

Exclusion Criteria:

* Volunteers who present deep venous thrombosis.
* Cutaneous allergy.
* Cutaneous lesion.
* Posterior thigh edema.
* Lower limb prosthesis.
* Shoulder or wrist injuries.
* Phobia of the techniques.
* Scarring in the posterior region of the thigh
* Have performed myofacial release or stretches during the days of intervention.
* Pilates and yoga practitioners
* No attend every day intervention.
* Injury of hamstrings in the last year.
* Previous injuries to the spine or lower limbs in the last 6 months.
* Symptoms of low back pain or hip joint.
* Diabetes mellitus, since people with diabetes have limited responses in the elevated leg elevation test.
Dysport® Pediatric Lower Limb Spasticity Study

The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 2 to 17 years with cerebral palsy
* Equinus foot position
* Ambulatory
* Intensity of muscle tone equal to or greater than 2 in affected lower limb, as measured on the Modified Ashworth Scale

Exclusion Criteria:

* Fixed contracture
* Previous phenol, alcohol injection or surgical intervention
* Other neurological / neuromuscular disorder
* Severe athetoid or dystonic movements
The Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer

This study aims at evaluating and comparing the anti-tumor effects of metformin and statins (hydroxyl-methyl-glutaryl-CoA reductase inhibitors) in patients with non-metastatic breast cancer (stage I, II, \& III).

Worldwide, BC is the most frequently diagnosed life-threatening cancer in women. In EGYPT, breast cancer is the foremost oncologic problem, contributing to 20% of all cancers and 43% of female cancers. Metformin and atorvastatin have anti-tumor effects. To date, there are limited data to investigate and compare the anti-tumor effect between metformin and statins in patients with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with radiologically and histologically (biopsy) confirmed diagnosis of breast cancer and with stage I, II, and stage III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).
* Patients with no contraindication for chemotherapy, metformin, or statins
* Females aged ≥ 18 years old
* Performance status \< 2 according to the Eastern Cooperative Oncology Group (ECOG) score

Exclusion Criteria:

* Patients with metastatic breast cancer (stage IV)
* Pregnant or lactating women.
* Patients with hepatic or renal impairment.
* Patients with myopathy.
* Patients with any condition predispose to acidosis (COPD, heart failure, ....)
* Patients who had dementia, mental retarded, and any psychiatric condition that would prohibit the understanding or signing of informed consent.
A Single-Center Pilot Study to Assess Macular Function

This study seeks to evaluate a novel endpoint for future dry AMD clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Subjects in good health aged 20-29 or 60-90 years (normal cohorts)
* Subjects with early non-exudative age-related macular degeneration (AMD cohort)

Exclusion Criteria:

* Enrollment in a investigational drug or device study and have used an investigational drug or device within 7 days of enrollment into this study
Self-management Program in Chronic Pelvic Pain

Chronic pelvic pain is a serious health condition with an estimated prevalence of 15% women worldwide.Treatment is a challenge given the different pain generators described. It is important to develop self-management interventions to reduce the frustration associated with its management.

Chronic pelvic pain is defined as non-cyclic pain lasting for 6 or more months, that localizes to the anatomic pelvis, anterior abdominal wall at or below the umbilicus, the lumbosacral back, or the buttocks and is of sufficient severity to cause functional disability or lead to medical care. It can occur continuously or intermittently, with intensity severe enough to limit activities of daily living. It is frequent in women. The primary aim of this study isto evaluate the efficacy of a self-management intervention, as compared with an educational booklet in improving health-related quality of life and coping strategies, occupational performance, activity level and psycho-emotional symptoms in women with chronic pelvic pain.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic pelvic pain with at least 6 months of evolution

Exclusion Criteria:

* Active urogenital infection
* Pregnancy
* Cancer
* Dementia
* A surgical intervention involving lumbo-pelvic region over the past year
Vital-signs-integrated Patient-assisted Intravenous Opioid Analgesia

This is a closed-loop system which is embodied in a novel and intelligent algorithm that takes into account patients' vital signs. The system allows better and responsive titration of personalized pain relief together with non-invasive physiological monitoring that measures oxygenation, breathing and heart rate continuously.

A glaring safety gap in the administration of commonplace Patient Controlled Analgesia (PCA) opioids unfortunately exists. A significant proportion of patients may suffer from respiratory depression with the use of PCA opioids and it is imperative to discover solutions to improve the safety of PCA opioids, therein improving medication safety, enhancing quality of postoperative care and providing economic cost savings. Currently, no continuous monitoring system that integrates an intelligent decision making response exists.

The investigators primary aim is to develop and commercialise a Vital-signs-integrated (using oxygen saturation, respiratory rate, heart rate) Patient-assisted Intravenous opioid Analgesia (VPIA) that can be integrated into the hospital-wide monitoring systems is capable of making intelligent decision making responses to bridge the PCA safety gap within 12 months.

This VPIA delivery system will be a closed-loop system for safety and efficacy. It will be integrated with continuous vital signs monitoring, and provide appropriate response to breach of safety parameters. It will be part of a larger surveillance system that provides tiered medical and nursing alerts to safety parameters.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-70 years old, female
* Healthy participants who are American Society of Anesthesiologists physical status 1 and 2 (with well controlled medical problems)
* Undergoing elective surgery with the intent of using postoperative PCA with morphine for postoperative analgesia

Exclusion Criteria:

* Allergy to morphine
* With significant respiratory disease and obstructive sleep apnea
* Unwilling to place oxygen saturation monitoring devices during study period
* Unable to comprehend the use of patient controlled analgesia
* Pregnant
Monitoring of Arrhythmias in Patients Treated With Antipsychotics

Antipsychotics may be associated to life-threatening arrhythmias and sudden cardiac death. This is the fist study to estimated the arrhythmic burden using long-term monitoring by implantable loop recorder in patients treated with antipsychotics.

Aims and objectives To estimate frequency of potential malign arrhythmias and cardiovascular outcome in a population with patients treated with antipsychotic drugs compared to healthy controls.

Background Life expectancy is about 20 years shorter for patients with mental illness compared to the general population. Increasing evidence suggest that antipsychotic drugs can cause cardiac arrhythmias and hence sudden death. However, the evidence as well as the incidence of rhythm disturbances in patients treated with antipsychotic drugs is insufficient reported. Prolonged monitoring with external portable monitors is difficult for practical and technical reasons. In addition, long-term consistent and structured timing of clinical visits is often a challenge in this vulnerable patient group. In recent years, patients who have been suspected of rarely occurring arrhythmias, have been offered long-term monitoring using an 'implantable loop recorder' (ILR). However, no study has evaluated the arrhythmic burden in patients treated with antipsychotic drugs using ILR.

Methods and materials The study is a national joint project between departments of psychiatry and cardiology across Denmark. After written informed consent and a baseline evaluation including echocardiography, ecg and biochemistry, an ILR will be implanted. During follow-up, arrhythmias will be monitored at regular clinical visits. Cardiovascular endpoints will be monitored using Danish national registries.

Expected outcome and perspectives The present study is the first to reveal arrhythmias among patients treated with antipsychotics using consistent long-term monitoring. The results will give valuable insights into possible mechanism of the observed early death and risk of sudden death in patients treated with antipsychotics.

Eligibility Criteria:
Inclusion Criteria:

* Patients with SMI defined according to ICD-10 as:

  * F20.0-F20.9 schizophrenia
  * F22.0-F22.9 paranoid psychosis
  * F25.0-F25.9 schizo-affective psychosis
  * F28 other non-organic psychosis
  * F29 non-organic psychosis unspecified
  * F31.0-F31.9 bipolar affective disorder.
* Patients treated with or initiating antipsychotics with ≥ 0.5 daily defined dosage
* \>18 years old and \<50 years.

Exclusion Criteria:

* Patients not capable to understand the aim of the study as judged by investigator.
* Current in treatment with methadone.
* Left ventricular hypertrophy (echocardiographic septal thickness ≥1.3 cm for women and ≥1.4 cm for men, or LVM/BSA ≥109 g/m2 for women or ≥132 g/m2 for men).
* Heart failure (echocardiographic LVEF \<35%).
* Ischemic heart disease (patient reported coronary bypass grafting or percutaneous coronary intervention.
* Congenital cardiovascular disease (patient reported).
A Study to Test the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK1006 (MK-1006-002)(COMPLETED)

This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of MK1006


Eligibility Criteria:
Inclusion Criteria:

* Participant is between 18 and 55 years of age. Participants up to 65 years of age may be enrolled in Panels B and C
* Female participants must be postmenopausal or otherwise unable to have children
* Participant has a body mass index (BMI) less than or equal to 42 kg/m\^2 at the screening visit
* Participant has type 2 diabetes and is being treated with either diet and exercise or a single oral anti-hyperglycemic medication. For Panels B and C, participant may be treated with combination oral anti-hyperglycemic medications
* Participant is willing to follow the American Heart Association (AHA) diet and exercise program throughout the study
* Participant is a nonsmoker or has not used nicotine-containing products for 6 months prior to study start

Exclusion Criteria:

* Participant has a history of stroke, seizures, or other neurological disorders
* Participant has a recent history of eye infection or other inflammatory eye conditions
* Participant has glaucoma or is blind
* Participant has had eye surgery within 6 months of study start (Lasik is permitted)
* Participant has type 1 diabetes
* Participant cannot stop taking any of their current prescription or non-prescription medications during the study
* Participant consumes more than 3 alcoholic beverages per day
* Participant consumes more than 6 caffeinated beverages per day
* Participant has had major surgery or has donated blood within 4 weeks of study start
* Participant has multiple and/or severe allergies to drugs or food
Drug-interaction Trial in Healthy Subjects With Oral Administration of Empagliflozin (BI 10773), Rifampicin and Probenecid

The objectives of the trial are to investigate the effect of concurrent administration of rifampicin and probenecid on the pharmacokinetics of empagliflozin.


Eligibility Criteria:
Inclusion criteria:

1. healthy male and female subjects

Exclusion criteria:

1. any relevant deviation from healthy conditions
Development and Validation of a Blood Test for Early Diagnosis of Colorectal Cancer

This is a prospective, multicenter, case-control study. The aim is to develop an optimized algorithm by combining the levels of molecular markers in plasma together with risk factors for developing colorectal cancer and clinical data of patients diagnosed with CRC or AA and healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 who are able to understand the participant information and sign the informed consent.
* Patients who are going to undergo colonoscopy or surgical resection for tumor (CRC).

Exclusion Criteria:

* Patients who had developed any type of cancer in the 5 years prior to their participation in this study.
* Patients who have received previous chemotherapy or radiotherapy.
* Patients diagnosed with non-advanced adenomas, serrated polyps, Familial Adenomatous Polyposis or Lynch Syndrome.
* Patients with inadequate bowel preparation for colonoscopy.
* Patients who have undergone colonoscopy/polipectomy in the previous 5 years.
* Patients with hemolyzed plasma.
Cohort Study of German Hematological / Oncological Wards to Assess the Effect of Contact Precautions on Nosocomial Colonization With Vancomycin Resistant Enterococci

The study aims to evaluate the impact of contact precautions on the rate of VRE- the rate of colonization and infection aand hospital-acquired VRE transmissions.

Hematological and oncological wards in hospitals with a non-outbreak setting for VRE and adhering to at least the following standard of care are eligible for study participation:

Fecal screening for the presence of VRE of all patients within 72 hours of each admission by use of a rectal swab or stool sample Follow-up fecal screening once a week and within 72 hours of discharge Implementation of clinical standards aimed at VRE decolonization is not allowed on wards participating in this study, including in the context of clinical studies.

Sites will be grouped according to their approach regarding contact isolation (see group description).

As a control for external factors a hand hygiene program, including training and adherence assessments, will be implemented.

This observational study prospectively compares wards with different approaches to isolation. All screening and isolation measures are already in place on participating wards (i.e. constituted a site selection criterion) and are exclusively implemented as part of the standard of care. Sites are free to adjust their standard of care as they see fit. No intervention will be performed.


Eligibility Criteria:
* Inclusion criteria:

  * Inpatient hospitalization during the study period on one of the participating wards.
* Exclusion criteria:

  * None