cyrilzakka/clinical-trials huggingface dataset:
Study of Safety and Efficacy of INC280 and Cetuximab, in Adult c-MET Positive mCRC and HNSCC Patients After Progression on Cetuximab or Panitumumab Therapy

This was an open-label, phase Ib, multicenter clinical trial to determine the MTD/RDE of the orally administered c-MET inhibitor INC280 in combination with cetuximab. This combination was to be explored in c-MET positive mCRC and HNSCC patients whose disease progressed on cetuximab or panitumumab treatment. The dose escalation part was to be guided by a Bayesian Logistic Regression Model with overdose control. At MTD/RDE, additional mCRC and HNSCC patients who progressed on cetuximab or panitumumab treatment were to be enrolled in two expansion groups to further assess the anti-tumor activity and the safety and tolerability of the combination of INC280 and cetuximab. Patients were to receive INC280 on a continuous bid dosing regimen and cetuximab every week. A treatment cycle was defined as 28 days with no scheduled break between cycles.

The trial was terminated because of difficulties in identifying patients who met the eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 18 years
* Metastatic colorectal cancer or head and neck squamous cell carcinoma
* c-MET positive (defined by c-MET IHC intensity score +2 in ≥ 50% of tumor cells and MET gene copy number ≥ 5 by FISH or IHC intensity score +3 in ≥ 50% of tumor cells) and K/NRAS WT status for mCRC patients only
* At least one previous line of treatment for the metastatic disease and the last treatment must have included cetuximab or panitumumab. Documentation of clinical benefit and subsequent progression on cetuximab or panitumumab as the most recent line of treatment is required for patients in the expansion part
* Measurable disease as per RECIST v1.1
* ECOG performance status ≤ 2

Exclusion Criteria:

* Prior treatment with c-MET/HGF inhibitors
* History of severe reactions to cetuximab and/or panitumumab (except for G3 rash and G3 hypomagnesaemia)
* History of acute or chronic pancreatitis
* Active bleeding within 4 weeks prior to screening visit
* Symptomatic brain metastases
* Feeding tube dependence
* Not adequate hematologic, renal and hepatic function
Observational Study to Evaluate the Safety of Levemir® in Diabetes

This observational study is conducted in North America. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or 2 diabetes
* Including newly diagnosed not on insulin or insulin analogue treatment
* Selection at the discretion of the physician
* Adult patients with type 1 and 2 diabetes mellitus, and type 1 patients 6 years and older

Exclusion Criteria:

* Current treatment with Levemir®
* Previously enrolled in the study
* Hypersensitivity to Levemir®
Mechanical Ventilation in Interstitial Lung Disease

To identify risk factors for mortality in patients with interstitial lung disease receiving mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

1. They were clearly diagnosed as interstitial lung disease in hospital;
2. They had progressive worsening of dyspnea and their oxygenation indexes were less than 300 in ICU;
3. They received at least 48 hours of mechanical ventilation after being admitted into ICU.

Exclusion Criteria:

* We excluded patients who were admitted into ICU because of postoperative monitoring.
High Dose Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether high dose chemotherapy plus bone marrow transplantation is more effective than high dose chemotherapy alone for intermediate- or high-grade non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy with or without bone marrow transplantation in treating patients who have intermediate- or high-grade non-Hodgkin's lymphoma.

OBJECTIVES: I. Assess the value of early intensification with autologous bone marrow transplantation or stem cell support in patients with poor prognosis intermediate or high grade non-Hodgkin's lymphoma.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by age (under 50 vs 50 and over), bone marrow involvement (yes vs no), and country. All patients receive cyclophosphamide, doxorubicin, and vincristine on day 1 and prednisone on days 1-5. Courses repeat every 21 days. Patients receive a minimum of 6 courses of treatment in the absence of disease progression and unacceptable toxicity. Arm I: Patients receive carmustine IV over 2 hours on day 1 in week 9 or 10. Etoposide and cytarabine IV are administered over 30 minutes on days 2-5. Melphalan IV is administered over 5 minutes on day 6. Patients receive cryopreserved bone marrow or peripheral blood stem cells on day 7. Arm II: Patients continue conventional therapy. Patients are followed at 8-9 weeks and 6 months.

PROJECTED ACCRUAL: This study will accrue 500 patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed intermediate or high grade adult non-Hodgkin's lymphoma: Follicular large cell lymphoma Diffuse mixed cell lymphoma Diffuse large cell lymphoma Diffuse immunoblastic lymphoma Poor prognostic features defined as the presence of 2 or 3 of the following: Stage III/IV Lactase dehydrogenase greater than normal ECOG performance status 2-4 A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: 16 to 65 Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics Renal: Not specified Other: No other medical condition prohibiting intensive therapy

PRIOR CONCURRENT THERAPY: At least 5 years since prior systemic therapy for cancer
Central Hypothyroidism and Cardiovascular Risk

Retrospective trial of 300 patients with pituitary insufficiency treated in Department of Medica Endocrinology, Rigshospitalet, Copenhagen University concerning levothyroxine (T4) replacement and cardiovascular risk factors. The hypothesis is that subtle central hypothyroidism is associated with adverse cardiac risk factors, such as body composition and serum lipids, and that improved T4 replacement will eliminate this increased risk, independently of other pituitary hormone replacements.

Retrospective trial of 300 patients with pituitary insufficiency treated in Department of Medical Endocrinology, Rigshospitalet, Copenhagen University concerning levothyroxine (T4) replacement and cardiovascular risk profile. The patient files are recruited among hypopituitary patients treated with growth hormone from the period 1993 to 2008. The trial is a retrospective assessment of data already collected for routine purposes and thus an audit of daily clinical practice. All information on the patients is obtained from the paper and electronic files existing in the department and no new measurements are foreseen.

Eligibility Criteria:
Inclusion Criteria:

* All patients with pituitary hypopituitarism

Exclusion Criteria:

* Unavailability of data
Celiac Plexus Radiosurgery for Pain Management

This prospective study evaluates celiac plexus radiosurgery for pain control in patients with upper abdominal malignancies.

This study aims as primary objective to evaluate short and long term pain relief following the administration of radiosurgery to the celiac plexus in patients with upper abdominal cancer. As secondary objectives it will describe acute and late side effects and quality of life measures of patients undergoing the treatment.

The study has a prospective, single arm design. It will be composed from an initial run-in safety assessment that will include 6 patients and then continue as a phase II trial. All eligible patients will receive the same protocol of celiac plexus radiosurgery and will be evaluated before, during and following this treatment.

The treatment duration is one and a half weeks (5 fractions delivered every other weekday).

Eligibility Criteria:
Inclusion Criteria:

* Patients with upper abdominal cancer (pancreatic/gastric/colon/hepato-biliary cancer) with typical retroperitoneal pain syndrome (somatic pain that radiates from the upper abdomen to the back) thought to be secondary to celiac plexus involvement, directly or indirectly, and have high level of pain despite opioids usage (NRS \>4). Patients with other cancer types metastatic to the celiac lymph nodes will also be eligible
* Recent abdominal imaging (CT, PET or MRI) should be at most 2 months old.
* Prior chemotherapy or biological treatment is allowed, but any active oncological treatment should be stopped at least 1 week prior to radiation and renewed at least 1 week following radiation. Following gemcitabine 2 weeks are required between final dose and commencement of radiation
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Exclusion Criteria:

* Patients under 18 years of age
* Patients who are well balanced in terms of pain control
* Patients with life expectancy \<8 weeks
* Patients with ECOG (Eastern cooperative oncology group) performance status 4
* Any concurrent chemotherapy or biologic treatment is prohibited during 1 week before until 1 week following radiotherapy
* Special populations: pregnant women, prisoners, patients with major psychiatric illnesses
* Previous radiotherapy to upper abdomen
* Conditions associated with increased side effects to radiotherapy (IBD (inflammatory bowel disease) for example)
Comparison Between OFDI and IVUS in PCI Guidance for Biolimus A9 Eluting Stent Implantation

The aim of this study is to assess clinical safety and efficacy of percutaneous coronary intervention (PCI) using a newer generation drug-eluting stent (DES) in the context of optical frequency domain imaging (OFDI) guidance or intravascular ultrasound (IVUS) guidance.

Intracoronary imaging techniques provide clinically useful information in the setting of PCI, such as lesion severity, tissue characterization, vessel sizing, and stent optimization. Current evidences suggest potential advantage of intracoronary imaging guidance in reducing the risk of major adverse cardiac events after stent implantation over conventional PCI under angiographic guidance alone. IVUS has been clinically used in two decades and it is known as one of the most dominant intracoronary imaging technique. OFDI is a new light-based intracoronary imaging technology which provides higher image resolution and higher-speed pullback compared to those of IVUS. Given the different properties between ultrasound-based IVUS and light-based OFDI, treatment and clinical impact of these two imaging techniques would be different.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable coronary artery disease who have symptoms or myocardial ischemia proven by non-invasive or invasive stress test.

Exclusion Criteria:

* Renal insufficiency with estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m2
* Left ventricular ejection fraction (LVEF) \<30% or history of congestive heart failure
* Acute coronary syndrome within 7 days after onset
* Considered as inappropriate for drug-eluting stent (DES) use or dual antiplatelet therapy for one year after the index procedure
* Life expectancy within one year
* Lesion length estimated by quantitative coronary angiography (QCA) \>28mm
* Chronic total occlusion
* Left main stem lesion
* Bifurcation requiring side branch balloon dilatation
* Severely calcified lesion
* Other conditions by which physicians in charge judged inappropriate to enroll the patients because of safety concern.
Effects of D-Chiro-Inositol Combined with Metformin on Insulin Resistance in People with Overweight or Obesity and T2DM

This study evaluates the efficacy of D-Chiro-Inositol (DCI) as an add-on therapy to metformin in improving insulin resistance, measured by the HOMA index, in people with overweight or obesity and type 2 diabetes mellitus (T2DM). Secondary outcomes include glycemic variability, indirect calorimetry, respiratory quotient, and other metabolic parameters.

The DIACHIRO trial is a randomized, double-blind, crossover clinical trial assessing the impact of DCI combined with metformin versus metformin plus placebo on insulin resistance in people with overweight or obesity and T2DM. The primary outcome is the change in the HOMA index. Secondary outcomes include glycemic variability parameters (e.g., time in range), oxidative stress markers, indirect calorimetry, respiratory quotient, and HbA1c levels. Participants are monitored using Flash Glucose Monitoring (FGM) systems.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of type 2 diabetes mellitus.
2. Age between 18-75 years.
3. BMI ≥25 kg/m².
4. HbA1c \< 9%.
5. Stable dose of metformin for at least three months prior to enrollment.

Exclusion Criteria:

1. Use of antidiabetic drugs other than metformin within three months prior to enrollment.
2. History of ketoacidosis or severe hypoglycemia within six months prior to enrollment.
3. Significant renal or hepatic impairment (eGFR \<60 mL/min/1.73 m²; ALT/AST \>2× ULN).
4. Pregnancy or lactation.
The Relationship Between Umbilical Cord ph and Feto-maternal Doppler Studies in Scheduled Nonlaboring Term Singleton Caesarean Deliveries

Perinatal asphyxia is a crucial reason for neonatal and childhood morbidity and death. Fetal and neonatal acidemia can be utilised as predictors for establishing such risk. Several researches have reported a marked relation between low values of fetal pH with short- and long-term adverse neonatal outcomes. Umbilical cord blood gas studies (UCGS) are considered critical data that gives an objective and certified evaluation of the oxygenation and metabolic status of the fetus. Before birth, the physician can evaluate fetal wellness through cardiotocography and prenatal ultrasound. Other studies had examined the role of fetal Doppler indices before birth and proposed that fetuses with lower impedance in the middle cerebral artery (MCA) or low cerebroplacental ratio (CPR) are at increased risk of adverse pregnancy outcome. However, no research has ever evaluated the possibility of a correlation between ultrasonographic fetal evaluation and fetal umbilical cord pH as a predictor of pre-delivery fetal pH.

The goal of our study was to discovered a potential association between the venous umbilical ph cord blood at delivery and the ultrasonographic feto-maternal doppler indices in patients with a scheduled nonlaboring term singleton caesarean deliveries (SCD), this research is a novel finding.

the investigators included in our study only singleton term (37 0/7 - 41 6/7 weeks of gestation) pregnancies delivered by a scheduled nonlaboring term singleton caesarean deliveries.

This was an observational study carried out at a single university tertiary care center

For every patient, an ultrasound examination was performed within one day of delivery and the fetal doppler indices were recorded. The umbilical venous pH were obtained immediately after delivery and before placental detachment with heparinized syringes

The primary endpoints were CPR, umbilical (UA) and fetal MCA arteries indices. The second endpoints analysed when measurable were ductus venosus (DV) and uterine artery (Ut) pulsatility indices, all indices were examined using colour Doppler ultrasound according to a standard procedure and CPR was evaluated as the ratio between the MCA and UA pulsatility indices.

The venous umbilical cord pH at birth was correlated with ultrasound doppler parameters, calculating the correlation coefficient r2 and P-value. Statistical significance was fixed at P\<0.05. the investigators performed a linear regression analysis to find the association between the different ultrasound indices and the venous pH.

Eligibility Criteria:
Inclusion Criteria:

* singleton term (37 0/7 - 41 6/7 weeks of gestation) pregnancies delivered by a scheduled nonlaboring term singleton caesarean deliveries

Exclusion Criteria:

* Pregnancies complicated by fetal malformations, stillbirth, preterm deliveries.
A Study of [11C]JNJ-42491293, a Possible PET Ligand for the mGlu2 Receptor, in Healthy Adult Volunteers

The purpose of this study is to evaluate \[11C\] JNJ-42491293 as a PET ligand in healthy adult volunteers.

This is an open-label (volunteers will know the identity of assigned treatment) study in healthy adult volunteers and will consist of 4 consecutive parts, A, B, C, and D. Advancement to parts B, C, and D will occur only if the objectives of the preceding parts are met. Healthy adult volunteers will be recruited for each part of the study. This will be the first study in which 42491293 will be given to healthy adult volunteers. Part A will investigate the measurement of radiation (referred to as radiation dosimetry) of 42491293. Part B will measure the regional brain kinetics (activity) and binding properties of 42491293. Part C will assess the dose dependent blocking of 42491293 by 40411813 in brain tissues following single oral doses of 40411813. Part D will assess the 'duration of occupancy' of the metabotropic glutamate receptor-2 (mGluR2) positive allosteric modulator (PAM) site in the brain by 40411813 compared to peripheral clearance. In this study, 42491293 will be radio-labeled and evaluated as a potential positron emission tomography (PET) ligand for use in imaging studies of the brain to detect binding of 40411813, a compound being developed for treating patients with psychiatric conditions such as schizophrenia and anxiety disorders. In Parts A,B,C, and D, \[11C\] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection. During Part C and D, JNJ-40411813 (up to 500mg) will be administered orally (by mouth) 1.5 to 3 hours prior to scheduled PET scans.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18 and 30 kg/m2, inclusive (BMI = weight/height2)
* Nonsmokers (at least 3 months before screening)
* Healthy on the basis of results from physical examination, vital signs, and 12-lead ECG, clinical laboratory tests performed at screening as determined by the Investigator (study physician)
* Willing to adhere to the prohibitions and restrictions specified in this protocol
* Healthy volunteers must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* History of or current medical illness that the Investigator considers to be clinically significant
* History of or current psychiatric or neurological illness including claustrophobia (an abnormal fear of being in narrow or enclosed spaces)
* Exposed to \> 1 mSv of ionizing radiation participating as a volunteer in research studies in the year before the start of this study
* Any clinically significant Magnetic Resonance Imaging (MRI) abnormalities at screening, as determined by a neuroradiologist, which are relevant for the study (not applicable for part A)
* Metal implants (pacemakers, joint replacements, etc.) or metal splinters or heavy tattoos, which are relevant for MRI (not applicable for Part A).
A Comparative Study of Two Endoscopic Operations for Lacrimal Duct Obstruction

To compare the clinical effects between the silicone nasolacrimal intubation under nasoendoscopy and dacryocystorhinostomy on patients with lacrimal duct obstruction.

Lacrimal duct obstruction is common among patients with epiphora,which is seriously affect the quality of life. The treatment principle is to restore or rebuild the lacrimal duct drainage channel. The classic operation type is dacryocystorhinostomy(DCR), which is complex for face-section particularly. However, with the development of endoscopy, the investigators prefer to the silicone nasolacrimal intubation under nasal endoscopy, which is more simple and efficient. With endoscopy, the investigators can see anatomical structures clearly and then can perform the operation much more perfectly.Compare to the classic one called DCR, its short and long term therapeutic effects are equal and even better.Therefore,the latter type does do good to both doctors and patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Nasolacrimal Duct Obstruction based on a clinical of epiphora and purulent secretion, another punctiform orifices with reflux in subsequent flushing in lacrimal passage irrigation;
* Must be able to withstand surgery
* At least 18 years old
* NO lacrimal tumor and acute inflammation
* Nasolacrimal duct obstruction in digital subtraction dacryocystography
* A sufficient level of education to understand study procedures and be able to communicate with site personnel and adhere to the follow-up;
* Accepted informed consent verbally and in writing

Exclusion Criteria:

* The Poor Health
* Be allergic to anesthetics
* Lacrimal duct abnormalities
* Lacrimal tumor and acute inflammation
* Children
* The same Surgery failure before

Exit Criteria

* Postoperative infection and persistent inflammation
* Operation failure.
Nutritional Status in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

A cross sectional observation study of body composition in COPD patients consecutively hospitalized with acute exacerbation.

Skeletal muscle dysfunction and changes in body composition are important extra-pulmonary manifestations of chronic obstructive pulmonary disease (COPD) that occur in all stages of disease and are associated with poor outcome. In patients with COPD, bioelectrical impedance analysis (BIA) has usually been used to estimate fat-free mass (FFM) and body composition through predictive equations. Very few studies had focused on raw BIA data. The aim of this study is first describe the measurement of phase angle in patients with with acute exacerbation and second to determine the validity of phase angle in this group by assessing its relationship with established markers of function, disease severity and prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of COPD based on history
* Hospitalization with acute COPD exacerbation

Exclusion Criteria:

* Patients with history of recent surgery (major) and trauma (major)
* Patients with concomitant disease that might alter nutritional status (heart disease, cirrhosis, uncontrolled diabetes, chronic renal failure, uncontrolled cor pulmonale).
* Contraindication to BIA including an implanted pacemaker, defibrillator or joint prosthesis