cyrilzakka/clinical-trials huggingface dataset:
Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen

The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease.

The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.

Participants were

* randomized at baseline (treatment was initiated with 3 days of randomization)
* administered treatment in cycles of 14-days till a study withdrawal criterion was met
* followed up 30 days after discontinuation of treatment, and every 8 weeks until death or end of study.

The criteria for discontinuation of study treatment for a participant are:

* participant (or legal representative) chose to withdraw from treatment
* the investigator thought that continuation of the study would be detrimental to the participants well-being due to

  * disease progression
  * unacceptable AEs
  * intercurrent illnesses
  * non-compliance to the study protocol
* participant was lost to follow-up
* participant was unblinded for the investigational treatment

Eligibility Criteria:
Participants who met the following main selection criteria were included in the study.

Inclusion Criteria:

* Histologically or cytologically proven adenocarcinoma of the colon or rectum
* Metastatic disease that is not amenable to potentially curative treatment
* One and only one prior line of treatment for metastatic disease. This prior line should be an oxaliplatin based chemotherapy (participants who relapse within 6 months of completion of oxaliplatin based adjuvant chemotherapy are eligible)
* Prior treatment with bevacizumab is permitted.

Exclusion Criteria:

* Prior therapy with irinotecan
* Eastern Cooperative Oncology Group performance status \>2

The above information is not intended to contain all considerations relevant to participation in a clinical trial.
Client Centred 'Tune-ups': do They Enhance Community Reintegration After Stroke?

Once discharged from hospital many stroke survivors deteriorate medically, physically and in their mobility function and many report their level of function and quality of life to be poor 12 months after inpatient rehabilitation. There is an identified need for follow-up examinations of community dwelling stroke survivors to monitor changes in function and it has been suggested that maintenance therapy could curtail declines in function. The purpose of this trial is to determine whether brief periods of intense client-centered rehabilitation therapy (tune-ups) provided at 6 month intervals can alter the natural progression of impairment (physical capacity), function and community reintegration following stroke.

The extent to which impairment (physical capacity) and function influence community reintegration is unclear. One of the challenges is that physical parameters change over time as does the person's awareness and perception of what activities are important to be able to engage in at the community level. Interventions have led to gains in physical capacity, function and community reintegration, but the benefits have been shown to dissipate within three to six months. It has been suggested that maintenance therapy (tune-ups) for stroke survivors post-discharge could prevent or curtail decline in function of aging stroke survivors and enhance quality of life and well being; constructs that relate strongly to community reintegration. This study will determine whether tune-ups can alter the time course and magnitude of changes in physical capacity and function and their influence on community reintegration. Stroke survivors discharged from rehabilitation will be followed for a 15 month period with laboratory or home assessments conducted at 3 month intervals. Assessors will be blind to whether the subject is receiving a tune up. Evaluations conducted after the tune-up at 9 months and 12 months post-discharge will allow us to determine if the tune-up effectively reduced physical impairment, improved function and resulted in better community reintegration compared to control.

Eligibility Criteria:
Inclusion Criteria:

* first major unilateral hemispheric stroke,
* english speaking,
* adequate verbal communication,
* discharged home or residential care

Exclusion Criteria:

* serious comorbidities (eg. cancer, mobility limiting arthritis, leg amputation)
Regulation of Metabolism and Ion Handling

This study investigates the relation between ion-handling (K+) and fatigue development during exercise. Before and after a 6-week period of high intensity interval training, performance and ion-handling is assessed in young adults. In addition, mitochondrial function is examined.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men
* 45-55 ml/kg/min
* BMI 19-26 kg/m2
* Normal ECG (assessed by MD)

Exclusion Criteria:

* Allergic to n-acetylcystine (NAC) or digoxin
* Severe side effects from NAC or digoxin
* Chronic diseases (assessed by MD to be a potential hazard or to interfere with outcome measures)
Exparel vs Block for ACL Reconstruction

Liposomal bupivacaine or Exparel (Pacira Biosciences) is a long-lasting nonopioid analgesic that was initially utilized as an infiltrative agent but has more recently become U.S. Food and Drug Administration (FDA) approved for use in interscalene brachial plexus nerve blockade as well as infiltrative blockade. Delivery in this form is reported to provide up to 72 hours of extended-release bupivacaine. Exparel's use as a regional anesthetic has also become increasingly common and has shown promise when utilized in Anterior Cruciate Ligament (ACL) reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Paticipants with ACL rupture amenable to reconstruction with BTB autograft identified in clinic by one of 4 different surgeons
* Primary ACL Reconstruction with Autograft +/- Partial meniscectomy +/- Lateral extra-articular tenodesis
* Age 18 and older
* English speaking
* Ability to complete surveys by phone or in person
* Ability to provide informed consent

Exclusion Criteria:

* Revision cases
* Multi-ligamentous knee injuries
* Cartilage or meniscal procedures that prevent adherence to immediate weight bearing and range of motion rehab protocol
* ACL reconstruction utilizing non-bone-patellar tendon-bone autografts
* Allergies to study medications
* Non-English speakers
* Known alcohol or narcotic abuse history
* Existing contract with a pain specialist due to underlying preoperative pain syndrome
* Preoperative opioid use within the 3 months prior to surgery
Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder

The purpose of the protocol is to evaluate the efficacy and safety of olanzapine compared with placebo in patients with Borderline Personality Disorder (BPD).


Eligibility Criteria:
Inclusion Criteria:

* Patients must be of outpatient status at Visit 1 and through Visit 2
* Patients must be 18 through 65 years of age at Visit 1
* Patients must meet all of the DSM-IV-TR General Diagnostic Criteria for a Personality Disorder AND Patients must meet DSM-IV-TR diagnostic criteria for BPD as determined by the DIPD-IV, confirmed by a psychiatrist with training in the evaluation and assessment of BPD.
* The symptom severity as assessed by the total score of the ZAN-BPD, confirmed by a psychiatrist with training in the evaluation and assessment of BPD, must be greater than or equal to 9 at Visit 2.
* Female patients of childbearing potential must test negative for pregnancy and must be using medically accepted means of contraception throughout the study. Use of any oral or injectable contraception must be initiated prior to Visit 2.

Exclusion Criteria:

* Investigators, study site personnel directly affiliated with the study, or immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* Persons employed by Lilly (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
* Have previously participated (have been randomized) or withdrawn from this study or any other Lilly sponsored study investigating olanzapine.
* Have had previous treatment with olanzapine unless, in the opinion of the investigator, the patient's previous treatment was inadequate in dose or duration to provide an accurate assessment of the therapy, or the effect of olanzapine was confounded by concomitant medication.
* Female patients who are either pregnant or nursing.
Hector-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma

A preliminary study has shown that the hormone-similar, growth-retarding drug octreotide can prolong survival time in patients with primary liver cancer. Due to methodological deficiencies of the preliminary study the results will be re-checked by the comparison of octreotide with an pseudo-drug (so-called placebo) primarily regarding to the survival time and secondarily concerning costs, side effects, patient cooperation and quality of life as well as specific conditions in the tumor tissue in both groups with 108 patients with primary liver cancer.

A pilot study showed that octreotide can prolong survival time of patients with HCC. Due to methodological deficiencies the results of this pilot study will be re-evaluated by comparison of octreotide versus placebo primarily regarding to the global survival time and secondarily concerning the costs, side effects, patient compliance and quality of life as well as the Somatostatin receptors in the tumor tissue and its prognostic relevance in both groups with 108 patients with hepatocellular carcinoma.

An interim analysis was done after occurrence of the half of the events (deaths). No significant effect could be shown.

Eligibility Criteria:
Inclusion Criteria:

* Inoperable patients
* histologically confirmed HCC or patients who refuse surgery and who otherwise (e.g. due to the advanced tumor stage) are not applicable for palliative local therapy (e.g. PEI, TACE, RFTA).
* Age: 18 years or older

Exclusion Criteria:

General:

* Patient with symptomatic Cholecyst-/Choledocholithiasis
* Patient with severe psychiatric disease.
* Participation in another clinical trial within the last 4 weeks.
* Simultaneous participation in another clinical examination.
* Legally incapacitated patient, who is not able, to understand nature, meaning and consequence of the study.
* Continuous drug or alcohol abuse.
* Patient with known HIV infection and antiretroviral therapy.
* Patient with not controllable infection disease.
* Pregnancy.

Study- and indication-specific exclusion criteria:

* Secondary malignant tumor without complete remission.
* Secondary malignant tumor with complete remission but current adjuvant therapy.
* Preliminary or current therapy with tamoxifen
* Pretreatment of the HCC.
* First-time diagnosis \> 6 months before inclusion into the study.
* Severe hepatic encephalopathy, refractory to any treatment.
* Patients with operable HCC.
* Contraindication to i.m. injections.
* Hypersensitivity to octreotide.
The Effects of Probiotic Supplementation on the Results of Gastric Bypass Surgery

In this study, patients undergoing the bariatric surgery will be assigned to take either probiotic capsules or placebos from 1 month before surgery to 3 months after the surgery. Their anthropometric and biochemical measurements will be assessed every 3-6 months, and will be compared in two groups.


Eligibility Criteria:
Inclusion Criteria:

* BMI\> 40 or \>35 plus other morbidities
* Undergoing the gastric bypass surgery
* Willing to participate in the study

Exclusion Criteria:

* History of any chronic GI or kidney disorders, malignancies, or immune deficiencies
* Taking any immunomodulatory or immunosuppressor medications
* Taking Antibiotics from 4 weeks before and during the intervention
* Being on special diet such as vegetarian diet
* Doing as a professional Athlete
* Pregnancy and Lactation
Metabolic Consequences of CPT-1 Deficiency

The purpose of this study is to learn more about how long children with CPT-1 deficiency can wait between meals without developing low blood sugar or symptoms of low blood sugar. The other purpose is to learn more about how much fat is stored in the liver of a child with CPT-1 deficiency.

With the advent of enhanced screening (via tandem mass spectroscopy, MS/MS), the Northwest Regional Newborn Screening Program (NWRNSP) has identified a high incidence of carnitine palmitoyl transferase type 1A (CPT1A) deficiency in Alaska Native infants. Since October of 2003 approximately 80 Alaska Native infants have been identified with this condition; previously only 30 published cases were known worldwide. All of the infants are homozygous for a c.1436C-T sequence variant in the CPT1A gene, which results in the substitution of a leucine for proline at amino acid position 479 (P479L), and an approximately 80% reduction of CPT1A activity (non-classic CPT1A deficiency) (7). The clinical implications of this very restricted level of enzyme activity are not known. However, patients with more severe reductions of CPT1A activity (as the result of other mutations) are known to be at high risk for hypoketotic hypoglycemia, liver dysfunction, and sudden unexplained death (1). Hepatomegaly with micro- and macro-vesicular steatosis is also common (16). Currently the treatment of Alaska Native infants and children with CPT1A deficiency is based on data from patients with more severe forms of CPT1A deficiency and other fatty acid oxidation (FAO) disorders. Our ultimate goal is to establish evidence-based guidelines for treatment of the form of CPT1A deficiency prevalent in the Alaska Native population. This pilot study addresses two specific questions and will provide the first glimpse of the physiologic effects of homozygosity for the c.1436C-T sequence variant in the CPT1A gene. These data will aid in the development of strategies for clinical management that can be evaluated in future prospective studies, and provide preliminary data required for applications for NIH funding for more in-depth characterization of the clinical consequences of this condition.

Eligibility Criteria:
Inclusion Criteria:

* CPT-1 deficiency
* homozygous for the c.1436C-T sequence variant
* greater than 6 kg
* otherwise healthy
* siblings must be free of CPT-1 deficiency but heterozygous for c.1436C-T sequence variant and otherwise healthy

Exclusion Criteria:

* liver dysfunction
* diabetes
* renal disease
* metal plate in body
18F-Fluoroazomycin Arabinoside (18F-FAZA) in Lung Cancer

The purpose of this study is to look for low levels of oxygen (hypoxia) in lung cancer using a positron emission tomography (PET) scan. Hypoxia can influence how lung cancer grows and responds to treatments like radiotherapy and chemotherapy. The use of PET scans to measure hypoxia may be better and simpler than the approaches used previously. This study will assess whether or not PET scans can provide useful information about hypoxia in lung cancer.

In this study, a radiotracer called Fluoroazomycin Arabinoside (FAZA) will be used to measure hypoxia in the patient's tumour. FAZA has already been used in many cancers including lung cancer. Patients who consent to participate in this trial will receive 1 FAZA PET Scan prior to their first radiotherapy treatment


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Patients with stage II or III lung cancer (both NSCLC and SCLC) qualifying for radiotherapy to the primary tumor, with or without treatment of mediastinal or hilar lymph nodes
3. Intention to treat using radiotherapy according to the current treatment policies of the PMH Lung Group
4. Concurrent systemic therapy allowed
5. A negative serum pregnancy test within the two week interval immediately prior to PET-CT imaging, in women of child-bearing age
6. Ability to provide written informed consent to participate in the study

Exclusion Criteria:

1. Previous radiotherapy to intended treatment volumes.
2. Previous systemic therapy
3. Active malignancy other than lung cancer
4. Unable to remain supine for more than 60 minutes
5. Pregnancy
6. Age less than 18 years old
7. Failure to provide written informed consent
A Non-interventional Study of REVLIMID® (Lenalidomide) Treatment of IPSS Low- or Intermediate-1-risk Myelodysplastic Syndromes Associated With a Deletion 5q or Refractory/Relapsed Mantle Cell Lymphoma in Korea

The Drug Use Examination (DUE) is planned and designed for the safety evaluation of new indications after the approval of a new drug in Korea.

This DUE is a non-interventional, observational and post-marketing surveillance, which will be conducted by collecting the safety information of REVLIMID® for new indications in routine clinical practice in Korea.

Six-Hundred (600) adult patients, who start with REVLIMID® treatment based on the approved local package insert (PI) of REVLIMID® during routine clinical practice in Korea and have indications noted below.

1. Patients with transfusion-dependent anemia due to IPSS low- or intermediate-1-risk Myelodysplastic Syndromes associated with a deletion 5q cytogenetic abnormality (del \[5q\] MDS)
2. Patients with mantle cell lymphoma who have received at least one prior therapy (rrMCL)
3. Previously treated follicular lymphoma (FL), in combination with rituximab (an anti-CD20 antibody)


Eligibility Criteria:
Inclusion Criteria:

* Treatment of patients with transfusion-dependent anemia due to IPSS low- or intermediate-1-risk Myelodysplastic Syndromes associated with a deletion 5q cytogenetic abnormality according to International scoring system for evaluating prognosis in myelodysplastic syndromes according to IPSS or
* Treatment of patients with mantle cell lymphoma who have received at least one prior therapy
* Previously treated follicular lymphoma (FL)
* Patients who are registered in Celgene Risk Management Program" in Korea

Exclusion Criteria:

Pregnancy or females of childbearing potential

* Hypersensitivity to the active substance or to any of the excipients (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS)
* Patients with genetic disorder (e.g., galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption)
ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED)

The purpose of this study is to determine whether Zoster Vaccine Live and Pneumococcal Vaccine, polyvalent are as well tolerated and immunogenic when the vaccines are given together (in different body sites), as when they are given alone, in adults 60 years of age and older.


Eligibility Criteria:
Inclusion Criteria:

* 60 years of age or older
* Stable underlying conditions
* Postmenopausal if female
* Afebrile

Exclusion Criteria:

* Previously vaccinated with either vaccine
* Immune deficiency
* History of allergy to components in either vaccine
* Concomitant antiviral therapy
A Study of Famitinib in Patients With Advanced Metastatic Renal Cell Cancer

* Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the toxicity is manageable.
* The purpose of this study is to compare the efficacy and safety profile between Famitinib and Sunitinib in patients with metastatic renal cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery
* First-line therapy or second-line treatment (second-line treatment e.g chemotherapy or cytokine therapy as first-line treatment failure or resistant patients)
* With measurable disease (using RECIST1.0 standard conventional CT scan ≥ 20 mm, spiral CT scan ≥ 10mm, target lesion did not receive radiation therapy, cryotherapy)
* Male or female, age ≥18 and ≤75
* ECOG 0-1
* Life expectancy ≥ 3 months
* Subjects received surgery, chemotherapy, radiation therapy, cytokines treatment caused the damage has been restored, the time interval ≥ 4 weeks, and the wound has completely healed
* Normal major organ function
* Signed and dated informed consent

Exclusion Criteria:

* Previously received targeted therapy of the metastatic renal cell carcinoma (such as sunitinib, Sorafenib)
* Past or suffering from other cancer, but other than cure basal cell carcinoma and cervical carcinoma in situ
* Participated in other clinical trials within four weeks
* A variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction)
* Known brain metastases, spinal cord compression, cancer, meningitis, or screening CT or MRI examination revealed brain or leptomeningeal disease
* Patients with hypertension (systolic blood pressure\> 140 mmHg, diastolic blood pressure\> 90 mmHg). Patients with more than Class I, myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥ 440ms) and class I heart failure.
* Urine protein ≥ + + and confirmed the 24-hour urinary protein\>1.0 g
* Coagulopathy with bleeding tendency (such as active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy
* Previous hyperactivity / venous thromboembolic events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism
* The preexisting abnormal thyroid function, even in the case of medication still can not be maintained within the normal range
* With a history of abuse of psychotropic drugs or mental disorders
* Patients with Hepatitis B or Hepatitis C
* History of immunodeficiency, including HIV testing positive or suffering from acquired, congenital immunodeficiency disease, or a history of organ transplantation