cyrilzakka/clinical-trials huggingface dataset:
QUANTACT : Impact of Pangenomic QUANTitative Alterations in Cancer Therapy

"Precision medicine and targeted therapies have played a crucial role over the past ten years in the personalized care of cancer patients. In this retrospective and observational study, we focused on patients for which no standard or curative treatment was available and for which the management was discussed in a Molecular Tumor Board (MTB).

The role of the MTB is to decide the most appropriate therapeutic options for patients according to the potential identification of molecular targets.

Among the analyses carried out, we focused on a quantitative genome-wide analysis: the CGH/SNP-array (Comparative Genomic Hybridization / Single Nucleotide Polymorphism on array). The objective was to evaluate the impact of CGH/SNP-array analyses in the identification of targeted molecular alterations.

"


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic ;
* no standard or curative treatment available;
* non-opposition of the patient collected.

Exclusion Criteria:

* multiple cancer patient;
* ECOG Scale of Performance Status (PS) ≥2
Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.

The study was terminated on 15-Dec-2008 due to an inability to recruit the protocol specified patient population. The study has not been terminated due to any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Have had a previous traumatic brain injury (more than 1 year and less than 20 years) prior to the screening visit.
* Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5.
* Have proven GHD deficiency

Exclusion Criteria:

* Active systemic malignancy or active intracranial tumor. A successfully treated tumor or malignancy is not an exclusion criterion if the patient has not had active disease for 5 years and is not currently receiving maintenance chemotherapy, (except for basal cell skin cancers.
* Receiving treatment with prednisolone in doses above 10 mg/day or treatment with other oral glucocorticosteroids above replacement doses is not permitted throughout the study. Topical and inhaled corticosteroids are permitted.
* History of dementia unrelated to TBI
* History of benign intracranial hypertension
Bevacizumab and Retinal Vascular Occlusions

To evaluate the effects of Intravitreal Bevacizumab in macular edema in retinal vascular occlusion.


Eligibility Criteria:
Inclusion Criteria:

* Vascular occlusion and edema macular diagnosticated by fluorescein angiography and coherent optic tomography

Exclusion Criteria:

* Previous surgery
* Uveitis
* Glaucoma
Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to develop a complement system targeted monoclonal antibody (mAb) to be used in treatment of subjects with chronic autoimmune diseases.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
* Body weight (BW) below or equal to 110.0 kg
* Body Mass Index (BMI) 20.0 - 27.0 kg/m\^2, both inclusive
* Good state of health: evidenced by medical history, physical examination and results of laboratory examinations

Exclusion Criteria:

* History of known or suspected cardiovascular diseases including: supine systolic blood pressure (BP) above or equal to 140 mmHg or below 90 mm Hg, diastolic BP above oe equal to 90 mm Hg or below 40 mm Hg, heart rate (HR) in supine position above 100 beats/minute or below 45 beats/minute
* Hepatic insufficiency: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above Upper Limit of Normal (ULN) (retesting is permitted within one week if first test is elevated but below 1.5 fold ULN)
* Renal insufficiency: Serum creatinine above ULN
* Positive for humane immunodeficiency virus (HIV) (by test)
* Positive for hepatitis B (HBV) or hepatitis C (HCV) (by test)
Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim

The purpose of this study is to see if advanced endoscopic imaging may be helpful to accurately distinguish pathological tissue from normal tissue and guide therapy of endoscopically identified pathology.

In this registry, the Fujifilm 4-LED system, which is considered non significant risk, will be used for routine endoscopic procedures at Mayo Clinic Florida and Rochester. Where indicated and based on clinical standards of care, a biopsy or tissue removal will be performed. Immediately prior to tissue removal, a standard set of electronic images will be captured including white light, BLI, BLI-bright, LCI. Each image will be stored in high resolution lossless format and later correlated with the final clinical and histological diagnosis.

Eligibility Criteria:
Inclusion Criteria:

1. All patients age 18-100 undergoing planned upper or lower endoscopy at Mayo Clinic Rochester
2. Informed Consent

Exclusion Criteria:

1. Patient unwilling to provide informed consent
HeRO Graft Compared to Permanent Catheters for End Stage Renal Disease (ESRD) Patients Receiving Hemodialysis

The main objective of this research study was to compare the following outcomes between patients with a Hemodialysis Reliable Outflow (HeRO) Graft and patients with a cuffed catheter for dialysis access over one year: quality of life and incidence of bacteremia, vascular interventions, hospitalizations, and death.

All eligible participants who provided informed consent were included in the study. Participants who refused HeRO Graft implantation, or did not have the HeRO Graft implanted for any other reason, were followed in the control group. Several patients did not receive the HeRO graft due to anatomical challenges and failure to complete both steps of the two-stage implant procedure. All consented participants who had an implanted HeRO Graft were followed in the study group. All participants were followed until the study end, withdrawal, loss to follow-up, or death. The analysis included only HeRO Graft patients and control patients who were not lost to follow-up; patients who were lost to follow-up, before data collection, were excluded from analysis.

After obtaining Institutional Review Board (IRB) approval, baseline demographic and clinical data was collected. Following surgery, implant procedure data was collected on study participants who received HeRO Grafts. HeRO Grafts were placed using a 2-step process with initial placement of the ePTFE portion, followed by completion of the graft by placement of the venous outflow component. Following enrollment, outcomes of interest were collected at follow-up visits scheduled weekly for 4 weeks, bi-weekly for 3 months, and monthly to 1 year, for a total of 18 follow-up visits. Study coordinators documented post-operative complications, incidence of thrombosis, hospitalizations, infection incidents, and deaths at each follow-up.

Quality of life data were also collected from all participants using the RAND Corporation's Short Form (36) (SF-36) Health Survey. This survey was completed at enrollment and again at 3 months, 6 months, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* ESRD patients requiring hemodialysis
* Age ≥ 18 years old
* Able to give informed consent
* Able to participate in quality of life survey
* All patients who are not candidate for arteriovenous fistula (AVF) or arteriovenous graft (AVG)
* Life expectancy 2 years or greater
* Willing and able to participate with follow-up examinations

Exclusion Criteria:

* Pregnant or breastfeeding females
* Disorder that compromises the ability to give informed consent and/or comply with the study procedures
* Any medical condition that in the opinion of the investigator may pose a safety risk to a subject in the study or which may interfere with the study participation
Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus

Pruritus is a major disorder among the skin derangements in advanced renal failure. Recent information suggests that interactions between dermal mast cells and distal ends of nonmyelinated C fibers may be important in the precipitation and regulation of the sensory stimuli.Patients having uremic pruritus have been noted to have increased levels of plasma histamine and tryptase as well as increased numbers of dermal mast cells.Cromolyn sodium is a mast cell stabilizing agent that inhibits degranulation of mast cells and the release of histamine, tryptase, and leukotrienes. It is hypothesized that oral cromolyn sodium may attenuate uremic pruritus by decreasing serum tryptase level.


Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis patients \> 18 yo suffering from pruritus for at least 6 weeks, and who have not responded to other drugs
* Willing and able to give informed concent

Exclusion Criteria:

* Known dermatologic, liver, metabolic disease, or any other disease or condition other than ESRD that causes pruritus
* Lactase deficiency
Phase I Study to Investigate the Alcohol Interaction of DA8159

This study is designed to to investigate the effects of alcohol on the pharmacokinetics of Udenafil tablet in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Adult males aged 19 to 55 years at screening.
* Subjects with body weight ≥ 55 kg and within ±20% of the ideal body weight : Ideal body weight = (height \[cm\] - 100)x0.9.
* Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria:

* Subjects with the test results of QTc \> 430 ms or non-sinus cardiac rhythm by ECG analysis.
* Subjects with hypotension or hypertension.
* Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
* Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
Efficacy of Injected Local Anesthetic vs Topical Anesthetic in Cosmetic Injectable Fillers.

The purpose of the study is to compare two modalities of local anesthetic administration prior to the placement of cosmetic facial injectable fillers. Both short and long term pain perceptions for the facial filler procedure will be compared in patients receiving 4% Topicaine gel on half their face, and 20% benzocaine gel prior to 2% lidocaine 1:100k epinephrine nerve block injections on the other half of their face. The objective is to quantify the subjective pain experienced by these two modalities of local anesthetic during the procedure of Juvederm XC filler injections.

The purpose of this study is to determine if local anesthesia injections will provide more profound analgesia than topical anesthesia during facial cosmetic filler injections. The study is a single group study design. The attending surgeon or residents will perform the procedure. Each procedure will start with a randomized coin flip to determine which side of the face will be anesthetized with local anesthesia or topical anesthesia. The head side of the coin will coincide with local anesthesia on the patient's right side. The tail of the coin will designate the patient's left side for local anesthetic injections.

To evaluate whether the additional anesthesia of a nerve block brings more pain relief than the initial pain of receiving a nerve block, the pain value will be collected from each nerve block administered. Procedural injection pain data will be collected from the nerve blocked facial half and from the topical anesthetic facial half to provide a comparison of anesthesia during the procedure. The primary outcome will be the collection of "overall" pain data from each side of the face 5-10 minutes after the procedure. Facial anesthesia preference data will also be collected at one week post treatment to determine overall pain perceptions from each method of facial anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Patients with deepened labiomental folds or decreased lip volume and architecture who are scheduled to receive Juvederm XC injections in DGMC Oral \& Maxillofacial Surgery clinic.

Exclusion Criteria:

* Pregnant or nursing
* History of any type of neuralgia or paresthesia, or paresis
* Allergy or contraindication to lidocaine or hyaluronic acid
* Use of hyaluronic acid in last 6 months
* Previous reaction to Juvederm or other hyaluronic acid based fillers
* Have an active inflammatory or infectious process at the injection site.
* Use of monoamine oxidase (MAO) inhibitors or tricyclic antidepressants
* Severe coronary artery disease
* Diagnosis of any cardiac dysrhythmia with an ECG finding other than normal sinus rhythm
Effects and Mechanisms of Smartphone-Based Stress Management Training on Well-Being in College Students

Studying can be a difficult time, and some students can find it challenging to deal with stress. This research project at Virginia Commonwealth University aims to understand how two different online stress management training programs affect students' daily experiences and activities. This research project will help us understand how those training programs help students to improve their emotional well-being.

Participants will be randomly assigned (like the flip of a coin) to one of the two online stress management training programs. For two weeks, participants will receive daily online lessons that will teach you how to deal with stress.

To investigate how this program affects mood, researchers will monitor participant's daily activities and experiences combining brief daily surveys with activity tracking via smartphones. The activities and experiences will be tracked for a week before the training, two weeks of the training, and one week after. Shortly after the training, researchers will also reach out to participants for a phone interview where they will ask about the training experience in more detail. Afterwards, researchers will check in with participants at the end of the semester for one more week of experience and activity tracking.

Eligibility Criteria:
Inclusion Criteria:

* 18-25 years old;
* Enrollment as a full-time student;
* Studying in-person;
* Reduced emotional well-being;
* Absence of major depressive, generalized anxiety, and panic disorder diagnoses;
* Little or no experience of the intervention;
* Ownership of a smartphone with an OS no older than iPhone 5 or Android 5 and an active data plan.

Exclusion Criteria:

• Diagnosis of major depression, generalized anxiety, and panic disorder
MR-HIFU for Bone Metastases

The aim of this study is to evaluate effectiveness of the Philips Sonalleve MR-HIFU device for the palliation of pain in patients with bone metastases.

Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) uses ultrasound to palliate pain caused by bone metastases. The main palliative mechanism of the method is due to local bone denervation, caused by the heat denaturation of the periosteum layer in the treated area. The importance of this therapy is that it offers a non-invasive, focal therapy, avoiding side-effects to surrounding normal tissue that occur with radiation therapy or the need for needle insertion as with radio-frequency(RF)ablation.

The study hypothesis is that MR-HIFU will be effective in treating the pain associated with bone metastases


Eligibility Criteria:
Inclusion Criteria:

* radiologic evidence of bone metastases from any solid tumour
* diagnosis of dominant painful bone metastasis
* target lesion less than 8cm

Exclusion Criteria:

* primary bone tumours rather than metastases
* Inability to tolerate stationary position during treatment
* pregnancy
* MRI incompatible metal implants
A Prospective Study of Application of Platelet Mapping in Chronic Liver Disease Complicated With ALI and/or AD in China

Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease (ACLF) has been well established. Thrombelastography measures the dynamics of thrombin production and provides a global assessment of coagulation incorporating the cumulative effect of the interactions at various levels between plasma components and cellular component of coagulation. Through the previous studies(NCT03281278 and NCT04119973), we found that ACLF patients with high ADP inhibition rate had high 28-day mortality.This study aims to validate that high ADP inhibition rate only occurs in patients with liver failure and is related to the severity of the disease.


Eligibility Criteria:
Inclusion Criteria:

1. chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients.
2. ALI(acute liver injury): including \[ALT \> 3 ULN(upper limited of normal),AST \> 3 ULN or TB \> 2 ULN within 1 week before enrollment\] or AD(acute decompensation) : including \[(having ascites, hepatic encephalopathy and/or bacterial infection within 1 month before enrollment)\].

Exclusion Criteria:

1. those who had hepatocellular carcinoma or other types of malignancies;
2. obstructive biliary diseases or other disease lead to bilirubin evaluation;
3. those who had acute hemorrhage one week before admission
4. those who received platelet, cryo transfusion or plasmapheresis one week before admission
5. pregnancy and breastfeeding
6. those who received liver transplantation or kidney transplantation;
7. combine with other disease lead to organ failure including heart failure (NYHA IV),respiratory failure（PaO2\<60mmHg),renal insufficiency(CKD 5) and conscious disturbance (GCS\<8)
8. readmission;
9. death within 24 hours.
Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections

The main objective of this non-interventional (retrospective) study is to describe the general treatment patterns, effectiveness, and safety of ceftazidime-avibactam in real-world settings in India. Eligible patients would be adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice from 01 June 2019 to 01 April 2020. Data of 500 patients will be collected through the abstraction of hospital medical records (electronic) if available or through the individual patient medical record in case electronic records are not available.


Eligibility Criteria:
Inclusion Criteria:

1. more than or equal to 18 years of age
2. Admitted to hospital with documented gram negative infection
3. Has received treatment for atleast 48 hours (complete) with Ceftazidime-Avibactam as a part of his routine clinical management

Exclusion Criteria:

1. The patient is enrolled in any clinical trial of an investigational product
2. Age \<18 years
3. Received Ceftazidime avibactam for less than 48 hours.
4. Patient with documented Acinetobacter infection.
5. Patient was a part of named access program or any other interventional study
Pharmacodynamics and Pharmacokinetics of Empagliflozin and Torasemide in Patients With Type 2 Diabetes

The primary objective of the study is to investigate the effect of BI 10773, hydrochlorothiazide and torasemide on changes in serum and urine electrolytes. Furthermore the pharmacodynamic and pharmacokinetic interactions between BI 10773 and diuretics should be assessed.


Eligibility Criteria:
Inclusion criteria:

1. male and female patients of type 2 diabetes
Examining the Usage of Dopamine Blockers in OCD Patients

We examine the usage of Dopamine blockers in OCD patients. We want to examine their frequency of usage, compare the course of the disease between those who receive and those who do not receive Dopamine blockers, and efficacy of the treatment.

The study will be done in two stages: 1. Collecting information the usage of Dopamine blockers from 150 OCD patients' files. 2. interviewing 60-70 patients to see the difference those who receive and those who do not receive Dopamine blockers in their current severity of disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* DSM-IV diagnosis of OCD
* Ability to understand patient information sheet, and consent to participate

Exclusion Criteria:

* Current or past Psychotic or Bipolar disorder
Bassini Inguinal Hernia Repair: Obsolete Or Still A Viable Surgical Option?

Retrospective review of hernia surgery patients at HHMcGuire VAMC focusing on repair type and postoperative complications.


Eligibility Criteria:
Inclusion Criteria: Inguinal hernia repair without mesh -

Exclusion Criteria: Mesh repair

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Chemotherapy With Pemetrexed in Combination With Platinum for Advanced Non-Small Cell Lung Cancer (NSCLC)

This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be included in about 15 centers in Germany and randomized to one of the above treatment regimens in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a standard length of 21 days. Primary objective will be the Progression Free Survival Time of patients as assessed in both treatment arms.


Eligibility Criteria:
Inclusion Criteria:

* Cytologically and/or histologically confirmed NSCLC Stage IIIb or IV
* No previous systemic chemotherapy for this cancer
* At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria In Solid Tumors (RECIST) criteria
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 and adequate organ function
* Prior radiation therapy allowed but limited to \<25% of the patient's bone marrow

Exclusion Criteria:

* Serious concomitant systemic disorder or active infection
* Mild to moderate renal insufficiency, but unable to interrupt salicylates or other nonsteroidal anti-inflammatory drugs
* Symptomatic central nervous system (CNS) metastases requiring concurrent corticosteroid therapy
* Presence of clinically significant third-space fluid collections
Validating Non-invasive Measurements of Central Blood Pressure in Type 2 Diabetic Patients

The investigators want to validate two non-invasive devices for the determination of central blood pressure, i.e. blood pressure in the aorta (artery leaving the heart).


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus, Type 2
* Age above 18 years

Exclusion Criteria:

* Atrial fibrillation or other cardiac arrhythmia
* known stenosis of aorta or arteria subclavia/brachialis