cyrilzakka/clinical-trials huggingface dataset:
Diffusion Weighted Magnetic Resonance Imaging and the Optic Nerve Neuropathy.

The aim of the project is to create a new, non-invasive and safe protocol for the early diagnosis of various types of optic neuropathies with the use of diffusion magnetic resonance imaging

In this study, it is planned to find twenty volunteers for each of the neuropathies and twenty healthy volunteers. Each volunteer will undergo clinical tests such as visual acuity, color vision, intraocular pressure measurement, assessment of the anterior chamber and fundus using a slit lamp and Volk lens, macular optical coherence tomography examination and examination of the optic nerve disc (OCT), neurological field vision and visual evoked potential (VEP) testing. Each of the volunteers will undergo magnetic resonance imaging. During active scanning, patients will be asked for not blinking or moving their heads by staring at the red dot on the outside of the camera reflected in the coil mirror. The obtained diffusion tensor data will be used for further analysis.

Eligibility Criteria:
Inclusion Criteria:

Optic neuropathy.

Exclusion Criteria:

common contraindications to MRI (presence of pacemaker, non-MRI-safety or claustrophobia)
Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury

The purposes of this study are to make Omegaven® available to cancer patients with liver disease and to determine if Omegaven® can improve or prevent further liver disease. The study will also look at the effects Omegaven® has on immune function.

This compassionate use study will include patients with advanced cancer requiring PN for long-term nutrition support who have developed PN-induced hepatic injury or who have existing hepatic dysfunction. Therapy with Omegaven will be provided at an initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. For patients \> 120% ideal body weight, adjusted body weight will be used. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Omegaven will be co-administered via a y-site infusion, with containers being changed every 12 hours. The patient may receive other lipids to meet Essential Fatty Acid (EFA) and/or additional calorie needs. Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. If an adverse reaction is observed, IV steroids \& benadryl will be administered \& Omegaven will be discontinued. Patients will continue to receive infusions at CTCA for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home with Coram. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month (see Table 2).

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female; ages 18 to 80 years old
2. Receiving treatment at Cancer Treatment Centers of America
3. Receiving PN (either in the infusion center or at home)
4. Have existing hepatic dysfunction defined as Elevation of \> 3x the normal level of one or more of the following:Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), or Alanine Aminotransferase ALT) and/or Bilirubin \> 2 mg/dl in the absence of biliary obstruction
5. Able to provide informed written consent

Exclusion Criteria:

1. Hypertriglyceridemia (triglycerides \[TG\] \> 400)
2. Allergy to fish or egg protein
3. Currently on therapeutic doses of Coumadin, heparin, or low molecular eight heparin
4. Hemodynamically unstable
5. Bilirubin \> 5 mg/dL
6. Documented liver metastases
7. Unstable diabetes with known diabetic ketoacidosis within 7 days of screening
8. Recent cardiac infarction (within 6 months) and taking plavix
9. Severe hemorrhagic disorders
10. Current anticoagulation therapy for deep venous thromboembolism or pulmonary embolism
11. Active sepsis
12. Undefined coma status
13. In patients with abnormal kidney function, renal insufficiency with calculated creatinine clearance \< 30 mL/min
14. Pregnancy or lactation
Pilot Study Comparing 10hz vs Theta Burst Stimulation

This pilot study aims at exploring the efficacy of iTBS compared to 10Hz protocol and explore potential biomarkers of treatment response


Eligibility Criteria:
Inclusion Criteria:

* outpatients
* voluntary and competent to consent
* Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Major Depressive Disorder (MDD), single, recurrent between ages 18-65
* failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of ≥ 3 in the current episode or have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2)
* have a score of ≥ 18 on the Hamilton Depression Rating Score 17-item (HDRS-17)
* have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening able to adhere to the treatment schedule
* Pass the TMS adult safety screening (TASS) questionnaire
* have normal thyroid functioning based on pre-study blood work

Exclusion Criteria:

* have a history of substance dependence or abuse within the last 3 months
* have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
* have active suicidal intent
* are pregnant
* have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
* have a MINI diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than MDD
Adjuvant Study of Pyrotinib in Combination With Trastuzumab in HER2 Positive Invasive Breast Cancer

This is an open label, phase III study evaluating the efficacy and safety of Pyrotinib in Combination With Trastuzumab and paclitaxel in patients HER2 Positive and lymph node negative invasive Breast Cancer


Eligibility Criteria:
Inclusion Criteria:

* Females 18-70 years old;
* Pathological confirmed of stage I-II breast cancer: histologically confirmed that the longest diameter of invasive cancer is no less than 1cm and no more than 5cm and the lymph node is negative (N0);
* The pathological type of immunohistochemistry must meet the following conditions: HER-2 (3+) or HER-2 (0-2 +) with FISH detection is amplified;
* For patients with invasive lesions on both sides, if both lesions are HER-2 positive and meet the tumor size requirements, then can be enrolled;
* Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 \* 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN#and with endogenous creatinine clearance rate of \>50 ml/min (Cockcroft-Gault formula);
* LVEF\>50%;
* The patient voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

Exclusion Criteria:

* Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy;
* Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ;
* Has metastic (Stage 4) breast cancer;
* Pregnant or breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
* Patients participating in other clinical trials at the same time;
* Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \< 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\>150/90mmHg, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
* Has severe or uncontrolled infection;
* Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders;
* The researchers considered patients to be unsuitable for the study.
Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days

Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins in the liver. The protein-acetaminophen product is called an "adduct." After a large acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of adducts are formed. However, we have found that lower levels may be formed even when people take recommended doses. The purpose of this study is to measure the amount of adducts formed when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.


Eligibility Criteria:
Inclusion Criteria:

1. age 21 years or older
2. provide written informed consent
3. consume, on average, less than 1 alcoholic beverage daily for the previous 3 months and would be considered non-drinkers

Exclusion Criteria:

1. History of ingesting more than 4 grams of acetaminophen per day for any of the 4 days preceding study enrollment
2. Currently taking isoniazid
3. Consumption of any alcoholic beverage during the run-in period
4. A detectable serum acetaminophen at baseline
5. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 50 IU/L at the start of the run-in period or at baseline
6. Platelet count less than 125,000/cc at baseline
7. Positive pregnancy test at baseline (female participants only)
8. Currently adheres to a fasting type diet as determined by self report
9. Currently has anorexia nervosa as determined by self report
10. Subject appears clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason
11. Known hypersensitivity to acetaminophen
A Study to Assess Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in Participants With Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer

This two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy of pertuzumab given in combination with trastuzumab (Herceptin) and vinorelbine in first line participants with metastatic or locally advanced HER2-positive breast cancer. Participants will receive pertuzumab and trastuzumab administered sequentially as separate intravenous (IV) infusions (followed by vinorelbine) and conventional sequential administration of pertuzumab and trastuzumab in separate infusion bags, followed by vinorelbine.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection
* HER2-positive as assessed by local laboratory on primary or metastatic tumor
* At least one measurable lesion and/or non-measurable disease evaluable according to RECIST v1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Left ventricular ejection fraction (LVEF) of at least 55%
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Previous systemic non-hormonal anti-cancer therapy in the metastatic or locally advanced breast cancer setting
* Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
* Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
* Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrent disease of less than 6 months
* History of persistent Grade 2 or higher (National Cancer Institute Common Terminology Criteria \[NCI-CTC\], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
* Radiographic evidence of central nervous system metastases that are not well controlled with local therapy (irradiation or surgery)
* Current peripheral neuropathy of NCI-CTC, version 4.0 Grade 3 or greater
* History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, or cancers with a similar curative outcome as those mentioned above
* Serious uncontrolled concomitant disease that would contraindicate the use of any of the investigational drugs used in this study or would put the participants at high risk for treatment-related complications
* Inadequate hematologic, liver, or renal function
* Uncontrolled hypertension or clinically significant cardiovascular disease
* Hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection
* Current chronic daily treatment with corticosteroids (\>/= 10 mg/day methylprednisolone or equivalent), excluding inhaled steroids
A Study of Healthy Subjects to Assess the Effect of LY450139 on Amyloid Beta Peptide Production Rate and or Dose Response.

To test that LY450139, a gamma-secretase inhibitor, will reduce the rate of newly synthesize Amyloid Beta by determining the amount of newly synthesized 13C6 leucine-labeled Amyloid Beta in lumbar cerebrospinal fluid from LY450139 treated subjects compared with placebo treated subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers: Men within the ages of 21 and 50

Exclusion Criteria:

* Have serious or unstable medical conditions
* Have a history of serious infections affecting the brain or head trauma resulting in protracted loss of consciousness within the last 5 years or multiple episodes of head trauma
* Have a history of primary or recurrent malignant disease
* Have a recent laboratory result indicating a clinically significant laboratory abnormality as determined by the investigator
* Have a history of chronic alcohol or drug abuse within the past 5 years
* Have a known history of Human immunodeficiency virus (HIV), afebrile seizures, or clinically significant multiple drug allergies
* Are judged clinically by the investigator to be at serious risk for suicide
* Have electrocardiogram abnormalities obtained at visit 1 that in the opinion of the investigator are clinically significant
* Use of prescription or over the counter medications that cannot safely be discontinued within 14 days prior to visit 2
* Have criteria that would preclude a LP such as allergy to all local anesthetics; have a local infection at the site of the LP or have any medical condition requiring treatment with warfarin or heparin.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Are investigator site personnel directly affiliated with this study and or immediate families.
* Are Lilly employees
Alpha Lipoic Acid on Clinical and Electrophysiological Recovery in Carpal Tunnel Syndrome Undergoing Surgical Release

The main purpose of this study is to determine the effectiveness of use Alpha lipoic acid before and after surgical release of carpal tunnel syndrome. Controlled Clinical trial.

The main purpose of this study is to determine the effectiveness of using an oral supplementation of alpha lipoid acid to improve clinical and electrophysiological recovery after carpal tunnel release surgery. This research is designed as a double blinded clinical trial, with a calculated sample size of 40 patients, divided in two groups of 20 (A placebo, B alpha lipoid acid). All patients will undergo open carpal tunnel release surgery, the procedure will be performed by an expert surgeon. A total of four visits will be performed as follows: T0. baseline 4 weeks before surgery, T1 immediately before surgery, T2: 4 weeks after surgery, T3: 8 weeks after surgery, T4: 12 weeks after surgery. The assessment to be perform on each visit includes: physical examination, Boston Questionary for Carpal Tunnel Syndrome. Nerve conduction study and ecographic evaluation will be performed on visits T0, T1 and T4. Statistical Analysis: Categorical variables will be assessed as counts and percent frequency and compared using the chi-squared test. All statistical analyses will be performed using the SPSS 21.0 package (SPSS Inc., Chicago, IL, USA). A two-tailed P value \< 0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* clinical and electrophysiological diagnosis of carpal tunnel syndrome

Exclusion Criteria:

* rheumatic diseases
* distal radio or carpal fractures.
* pregnant women
* alpha lipoid acid allergy
* local injections (ej. steroid carpal injections)
* peripheral nervous system diseases (which may cause nerve conduction study abnormalities).
A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.

This is a randomized double-blinded randomized comparison between injection of platelet rich plasma (PRP) and placebo for thumb basale osteoarthritis.

The aim of this study is to evaluate if high-concentration PRP injection decreases pain and disability in patients with thumb base osteoarthritis in the short-term and compare the effect to placebo.90 patients will be inlcuded (45+45). The primary outcome is pain on load (numerical rating scale) after 6 months. Patient-rated outcome measures, pinch grip and key pinch, range of motion of the CMC.1 joint will be assessed before treatment and at 3, 6 and months after the injection. Participants and assessors will be blinded.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis in the thumb base
* Radiological Eaton Littler class 1-3.
* Clinical signs of thumb base osteoarthritis )pain at palpation of the CMC-1 joint and pain during provocation/grinding test).

Exclusion Criteria:

* Rheumatoid arthritis
* Ongoing infection in the hand or wrist
* History of gout or pseudogout in the hand
* Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
* Chronic pain syndrome / centralized pain.
* Intra-articular injection in the affected joint within 6 months.
* Eaton Littler class 4 (symptomatic STT joint osteoarthritis).
Pre and Per-operative Electrophysiological Cartography of Speech Area With Cortical Electrode Matrices

New method for speech area cartography in patient individual cortical anatomy in view of improving functional area limit preservation during surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients needing cortectomy
* Male or female aged over 18 years
* Registered in the French social security scheme
* Signed informed consent

Exclusion Criteria:

•All categories of protected persons
Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents

The purpose of this study is to test if a mobile device delivered intervention program can improve breast-feeding self-efficacy in primiparous mothers.

The proposed study will test if a mobile device based intervention program, called "Happy, Healthy, Loved (HHL)", will impact breast feeding rates and breastfeeding self-efficacy when compared to care as usual. Primiparous women and their partners will be randomly assigned to the HHL program or usual care.

Eligibility Criteria:
Inclusion Criteria:

1. primiparous mothers,
2. living with a partner or spouse,
3. have an intention to breastfeed their infant for at least 6-weeks postpartum;
4. whose infant is not in the Neonatal Intensive Care Unit,
5. have a mobile phone with text message capability,
6. have no current self-reported depressive episode, and;
7. English as a primary language

Exclusion Criteria:

1. mothers who have other biological children,
2. have infants in the Neonatal Intensive Care Unit,
3. do not have a mobile phone with text message capabilities,
4. report current episodes of depression, or are receiving antidepressant treatment or psychotherapy for depression,
5. have initial study survey that indicates suicide risks (participants who are identified as suicidal ideation at 6 weeks or 6 months will receive further assessment and referral but not be excluded from the program because it may be more harmful and penalizing to remove them from the program if they find it helpful. We will remind the participant that continuing is voluntary and there is no penalty if they wish to discontinue participation)
6. do not speak, read and write English
Thrombin Generation Values and Percutaneous Coronary Intervention Results.

Cardiovascular diseases are the most common cause of death in the western world. Myocardial infarction pathogenesis usually involves the development of an atherosclerotic plaque and thrombus.

Past research has shown a correlation between thrombin generation values and ischemic heart disease, however, to our knowledge no investigation has been done into the correlation of thrombin generation and cardiac catheterization results in ischemic heart disease patients.

In the current research the investigator will investigate the correlation of thrombin generation values using calibrated automated thrombogram and cardiac catheterization results in active ischemic heart disease patients.

The aim of our study is to investigate the correlation of thrombin generation values using calibrated automated thrombogram and cardiac catheterization results in active ischemic heart disease patients.

In total 340 patients are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. the investigators will measure the thrombin generation over time in plasma assessed by the calibrated automated thrombogram (CAT). In addition information about the course and results of cardiac catheterization will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome: ST segment elevation myocardial infraction, unstable angina, non ST elevation myocardial infraction or patients presented with chest pain suspect for acute coronary syndrome .
* planned percutaneous coronary intervention.
* ability to give Informed consent.

Exclusion Criteria:

* Acute coronary syndrome in the last 6 month prior to current event.
* thrombophilia
* pregnancy
* liver failure or cirrhosis
* anticoagulant current use
* active cancer