cyrilzakka/clinical-trials huggingface dataset:
Adjuvant Dual Anti-HER2 Therapy in Patients With Small, Node-negative, HER2-positive Breast Cancer

This phase II trial aims to study the efficacy and safety of adjuvant Pyrotinib plus trastuzumab in patients with tumors \<8mm, node-negative, HER2-positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18-70 years old
2. Have finished radical operation
3. Histologically confirmed invasive ductal carcinoma (IDCA)
4. According to AJCC ,pT\<8mm, pN0, no evidence for metastasis
5. Operation specimens are available for ER, progesterone receptor (PR) and HER2 detection, patients should be HER2 positive tumor (IHC staining of 3+ \[uniform, intense membrane staining of \>30% of invasive tumor cells\], or a FISH result of .6 HER2 gene copies per nucleus or a FISH ratio \[HER2 gene signals to chromosome 17 signals\] of \>2.2), nuclear grade 3.
6. Should have tumor tissue available and sufficient for multi-spots sampling.
7. It has been \<84 days since the date of definitive surgery, and there is adequate wound healing as determined by the Treating Physician.
8. Has Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1, expected survival time \> 12 months
9. Cardiac function had to be within normal limits (left ventricular ejection fraction \[LVEF\] ≥50%), as established by multiple gated acquisition scan or echocardiography.
10. Adequate bone marrow function, adequate liver and renal function, and adequate coagulation function.
11. Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable and effective method of contraception to avoid pregnancy during the study.
12. Written informed consent according to the local ethics committee requirements.

Exclusion Criteria:

1. pT≥8mm or node positive
2. Metastatic breast cancer
3. Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days
4. With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
5. Patients with medical conditions that indicate intolerant to adjuvant target therapy and related treatment, including severe infection, coagulation disorder, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
6. Has symptomatic peripheral neuropathy \> grade 2 according to NCI
7. Known severe allergy to any drugs in this study
8. Has cardiac dysfunction or lung dysfunction defined as follows:

   * grade ≥3 CHF according to NCI CTCAE v 5.0 or NYHA≥II
   * angina which requires drug control, cardiac infraction, and any other vascular disease with apparent clinical symptoms
   * uncontrolled high-risk arrhythmia
   * uncontrolled hypertension
9. Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
10. Patient is pregnant or breast feeding
Safety and Efficacy Study of TAK-700 in Patients With Nonmetastatic Castration-resistant Prostate Cancer and a Rising Prostate-specific Antigen

This is a multicenter phase 2 open-label single-arm study that will evaluate the safety and efficacy of TAK-700 in patients with castration-resistant prostate cancer (CRPC) without radiographic evidence of metastases who have a rising prostate-specific antigen (PSA).


Eligibility Criteria:
Inclusion Criteria:

Each patient must meet all of the following inclusion criteria:

* Male patients 18 years or older
* Eastern Cooperative Oncology Group performance status 0-2
* Male patients who Practice effective barrier contraception during study and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse.
* Voluntary written consent
* Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma without radiographic evidence of metastasis but with a rising PSA during or following the patient's most recent antineoplastic therapy despite castrate concentrations of testosterone
* Baseline PSA must be greater than or equal to 2 ng/mL and PSA doubling time must be less than or equal to 8 months OR baseline PSA must be greater than or equal to 8 ng/mL if PSA doubling time is greater than 8 months
* Has undergone orchiectomy or will continue receiving GnRH analogue therapy
* Meet screening laboratory values as specified in protocol

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

* Known hypersensitivity to TAK-700 or related compounds
* Received any of the following within 30 days prior to the first dose of TAK-700: any investigational compound; prior herbal product known to decrease PSA; radiation therapy for prostate cancer; OR chronic therapy with corticosteroids
* Received prior therapy with aminoglutethimide or ketoconazole
* Received antiandrogen therapy within 4 weeks for flutamide and 6 weeks for all others prior to first dose of study drug
* Received prior chemotherapy for prostate cancer
* Current bladder neck outlet obstruction caused by prostate cancer, current spinal cord compression, or current bilateral hydronephrosis
* Symptoms that investigator deems related to prostate cancer
* Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
* History of adrenal insufficiency
* Uncontrolled cardiovascular condition
* Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
* Unwilling or unable to comply with protocol
* Major surgery or serious infection within 14 days of first dose of TAK-700
* Life-threatening illness unrelated to cancer
* Uncontrolled nausea, vomiting or diarrhea
* Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of TAK-700
Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers

The goal of this integrated project targeting the Childhood Obesity Prevention Challenge Area is to reduce the prevalence of obesity among children attending Head Start in Michigan. The proposed intervention program is based on Social Cognitive theory and the premise that enhancing children's capacity for emotional and behavioral self-regulation is a key component of effective obesity prevention. A randomized controlled trial design is proposed to evaluate, among 600 Head Start children and their parents, the effectiveness of 2 approaches to obesity prevention: (1) the Parents of Preschoolers Prevention Series (POPS), a curriculum delivered to preschoolers and their parents focused on obesity-related health behaviors; and (2) POPS in combination with the Incredible Years Series (IYS), an evidence-based program designed to improve preschoolers' emotional and behavioral self-regulation. The research objective is to test the hypotheses that: (1) POPS, compared to Usual Head Start exposure, will lead to greater improvements in obesity-related health behaviors and adiposity indices; and (2) POPS + IYS will lead to the greatest improvements in obesity-related health behaviors and adiposity indices, and this effect will be mediated by improved self-regulation. The extension objective is to evaluate the feasibility, fidelity, and educational effectiveness of the POPS and POPS + IYS interventions, as delivered by paraprofessionals and educators within Extension and Head Start. The education objective is to provide Extension and Head Start staff non-formal training and educational curricula which can be widely disseminated. The long-term goal of this project is disseminate a novel and effective approach to obesity prevention in preschoolers.


Eligibility Criteria:
Inclusion Criteria:

* child is enrolled in Head Start

Exclusion Criteria:

* Significant developmental disabilities that would preclude participation
* Child is a foster child
* Parent is non-English speaking
Effects of a Specific Substance in Smokers

Although rates of cigarette use are declining, the proportion of nondaily smokers is rising, particularly among young adults. Among young adults, nondaily smoking is associated with negative health consequences and, for some, may lead to the establishment of life-long smoking patterns. The goal of this project is to understand the behavioral, psychological and neurobiological factors that contribute to cigarette use in nondaily smokers to aid the development of tailored evidence-based interventions.

The purpose of this study is to investigate the neurobiological mechanisms associated with cigarette use in young nondaily smokers (ages 21-25). Nondaily smokers experience fewer symptoms of cigarette withdrawal than daily smokers; however, they still experience difficulty quitting. Since smoking cessation before the age of 30 substantially attenuates the long-term health consequences associated with smoking, understanding the factors that motivate cigarette use in young nondaily smokers and developing tailored interventions will be critical for curbing cigarette use and improving public health. The proposed project will use functional magnetic resonance imaging (fMRI) to examine how other substances (e.g. stimulates, sedatives, or analgesics) impact brain function and will assess the extent to which substance-induced changes in brain function correlate with impulsive choice, cigarette craving, and craving regulation in young adults. Furthermore, the investigators will assess how substance-induced changes in brain function, impulsivity, craving, and capacity for craving regulation predict cigarette use over the course of 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 21-40 years old
* Right-handed
* Fluent in English
* Report smoking cigarettes or e-cigarettes 1-27 days in the past month
* Report binge drinking based on NIAAA criteria (5 or more drinks per occasion for males, 4 or more drinks per occasion for females) at least 1 time in the past 90 days without adverse incident

Exclusion Criteria:

* Seeking treatment for substance use (e.g. nicotine or alcohol use)
* Moderate or Severe Nicotine Dependence
* Current alcohol use disorder
* Illicit substance use other than marijuana use in the past year
* Marijuana use more than 10 times in the past year
* Major neurological or medical illness - Significant head trauma - Current use of medication affecting the central nervous system
* MRI contraindications (e.g. irremovable metal on the body or pregnancy)
Pharmacokinetic Analysis of Nicotinamide Riboside

Nicotinamide riboside is a newly discovered vitamin B3. The pharmacokinetics in humans is so far not analyzed.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18-25, healthy, male,

Exclusion Criteria:

* liver or kidney diseases, other diseases
The Effectiveness and Efficacy of the Combination of the Integrated Psychological Therapy and Metacognitive Training.

The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia.

Is it effective and efficacious?

Individuals with schizophrenia and treatment resistant schizophrenia will participate on a group cognitive behavioral therapy and rehabilitation, in which Integrated Psychological Therapy and Metacognitive Training are going to be implemented. The therapy will last 60 biweekly sessions. This is a non randomized trial.

Speed of processing, working memory, verbal memory, visual memory, reasoning and problem solving, social cognition, symptoms, functional outcome and recovery will be evaluated before, after therapy and in a 6 months follow up.

MCCB, Social Perception Scale, the Greek Test for verbal memory, PANSS, WHO DAS 2. 0 (Greek), PSYRAT and the Recovery Assessment Scale will be used ih this study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia
* No relapse and hospitalization
* Ambulant psychiatric treatment

Exclusion Criteria:

* Other psychotic disorders
* Relapse and hospitalization
* Substance abuse
Hormone Evaluation in Artificial Reproductive Technology

The aim is to be able to predict the hormonal response according to gonadotropin receptor genotype and hormone type used for treatment of women undergoing in vitro fertilization or egg donation.

Outcome will be measured as pregnancy success, live born babies and unwanted side effects.

Women undergoing in vitro fertilization receive high doses of the gonadotropins follicle stimulating hormone (FSH) and human chorionic gonadotropin (hCG), which is acting as luteinizing hormone (LH) for stimulation of the ovaries in order to obtain a high number of eggs. There are however marked individual differences in the hormonal response, ranging from lack of increased egg maturation to hyper stimulation. The hypothesis is that genetic variants in the gonadotropin receptors (LH and FSH receptors), are influencing the outcome. This assumption is supported by a recent study on more than 600 women undergoing in vitro fertilization, demonstrating that whereas only 10% of women with asparagine in both genes (FSHR N680S and LHR N312S) became pregnant, 40% of those with serine did (Lindgren I et al. Hum Repr 2016; 3:672-83).

Most (90%) of the women were treated with rFSH (recombinant). However, of the 10% asparagine carriers who actually became pregnant, most if not all, were treated with menotropin - a urine derivated compound (Menopur, Ferring), which contains both LH and FSH. This finding was not stressed in the manuscript as it could have been due to chance because of the small number of women treated with menotropin.

The objective is therefore to perform a prospective randomized study regarding efficacy of treatment in the first and second in vitro fertilization trial with rFSH and menotropin, respectively, genotype taken into account.

In total 890 women, 445 in Poznan, Poland and 445 in Malmö, Sweden, with unexplained infertility or a male or tubal factor indication for treatment will be invited to participate in the study. At first appointment, information is provided and informed consent retrieved. Two blood samples are drawn and stored at -20°C; one for subsequent genotyping and one for anti mullerian hormone measurement. The succeeding treatment is according to normal procedures at respective clinic.

Eligibility Criteria:
Inclusion Criteria:

* Normal ovulatory cycles 26-32 days
* First and second IVF treatment
* Indication for IVF is male factor, tubal factor or unexplained infertility
* Medical indication for IVF; \>12 months unprotected intercourse

Exclusion Criteria:

* Anti Müllerian Hormone \<5pmol or cycle day 2-3 FSH \>12
* Endometriosis
* polycystic ovarian syndrome
* pre ovarian failure
* smoking
* male age more than 56.
Visual Processing Speed and Objective Analysis of Ocular Movements in Multiple Sclerosis

This project aims to analyze ocular motility problems, visual processing speed and microperimetry, and their relationship with consolidated retinal structural biomarkers (optical coherence tomography, OCT) in patients with Multiple Sclerosis w/w reading complaints comparing with healthy subjects.

Anamnesis, ophthalmological medical history including difficulties in reading with appropriate glasses.

The following protocol will be applied:

* Comprehensive eye examination
* Stereopsis
* Primary gaze position
* Cover test: far and near
* Vergence and version eye movements
* Presence of nystagmus
* Far and near best corrected visual acuity, with updated refraction

  -.Pupillary light reflex
* Biomicroscopy of the anterior pole
* Intraocular pressure
* Recording of eye movements during two standardized tests: International Reading Speed Texts test (IReST®) and Developmental Eye Movement Test (DEM™) with Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software.
* Visual processing speed
* Microperimetry
* Optical coherence tomography
* Eye fundus
* Patients with a history of clinical optic neuritis will additionally undergo contrast sensitivity tests, the Farnsworth® test (Farnsworth test 28 Hue x 100) and normal monocular perimetry using the standard Swedish Interactive Thresholding Algorithm (SITA-central 24-2) perimeter test. Humphrey® (Humphrey visual field analyser) and other tests at the discretion of the investigator.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple Sclerosis
* Best distant corrected visual acuity equal or greater than 0.7 (decimal scale). Glasses or soft contact lenses users.
* Best close corrected visual acuity equal to or greater than 20/30 (Snellen scale).Glasses or soft contact lenses users.

Exclusion Criteria:

* Patients with a history of acute optic neuritis (ON) and/or who experienced an episode of ON \<6 months prior to the study, to avoid potential interference of papilledema with accurate peripapillary RNFL thickness measurements.
* Patients with other retinal and optic nerve diseases, advanced cataracts according to the international Lens Opacities Classification System III (LOCS III) (opacities greater than C2N2)
* Patients with other ophthalmological diseases that could affect central visual acuity
* Subjects with high refractive error (+ - 6 diopters).
* Subjects with other demyelinating disorders (neuromyelitis optica or acute disseminated encephalomyelitis).
Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined With Gemcitabine in Patients With Ovarian Cancer

This is an open-label, randomized phase II trial comparing treatment with a monoclonal antibody (mAb) drug immunoconjugate, SGN-15, administered weekly in combination with weekly Gemzar® (Gemcitabine) to treatment with Gemzar® alone. The primary objectives of this study are to determine the toxicity and safety profile of the combination of SGN-15 and Gemzar®, to estimate the clinical response rate and to estimate the duration of response of this combination therapy administered to patients with advanced ovarian cancer, compared to treatment with Gemzar® alone.


Eligibility Criteria:
Brief Overview of Inclusion Criteria:

* Patients must have pathologically confirmed ovarian cancer, which is advanced or recurrent carcinoma, who have failed at least two, but no more than three prior therapies for metastatic disease
* Patients must have \> 20% Lewis-y antigen expression documented by immunohistochemistry
* LVEF \> 50% by echo or MUGA
* Must be platinum resistant as defined by:

  * Progression while on initial platinum therapy or
  * Progression while on retreatment with initial platinum regimen or
  * Relapse \< 6 months after initial therapy

Brief Overview of Exclusion Criteria:

* Patients who have had prior therapy with Gemzar®
* Cumulative anthracycline exposure \> 300 mg/m2
* More than three prior chemotherapy regimens for ovarian cancer (Retreatment with Taxane/Platinum after initial combination is considered only one regimen)
The Exploratory Clinical Trials on the Primary Safety and Effectiveness of High Myopic Posterior Scleral Fixation System

The purpose of this study is to assess the primary safety and efficacy of High Myopic Posterior Scleral Fixation System in the treatment of macular schisis caused by high myopia.

Posterior Scleral Reinforcement（PSR） is the only surgical method that can delay the the development of high myopia. However, The surgical method is restricted by the material source limitation and macular ischemia in the eye after reinforcement. The investigators have designed a new posterior scleral fixation system，Its basic material is medical silicone，The product is designed to solve the problem of material source limitation and macular ischemia in the eye after reinforcement.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18\~65, male or female;
2. Refractive ranges from -6.00d to -25.00d;
3. The axial length of the operative eye was 26-32mm;
4. Macular cleavage 200-1000μm;
5. Corrected visual acuity of the operative eye \< 0.3;
6. Able to understand the purpose of the test, voluntarily participate and sign the informed consent form.

Exclusion Criteria:

1. Known allergy to silica gel and patients with scar constitution;
2. Ocular inflammation;
3. Fundus hemorrhage;
4. Macular hole;
5. Macular cleavage of the contralateral eye greater than 200μm;
6. Corrected visual acuity of contralateral eye \< 0.4;
7. Opacity of the refractive medium;
8. Eye tumor;
9. History of hyperthyroidism;
10. Other ophthalmic concomitant diseases that cannot be controlled, such as diabetic retinopathy, hypertensive fundus lesions, optic nerve atrophy, etc.;
11. Severe impairment of liver and kidney function and/or severe systemic diseases (such as cardiovascular, respiratory, digestive, nervous, endocrine, genitourinary, etc., depending on the tolerance of surgery);
12. Women who are pregnant (determined by a blood pregnancy test at the first visit), who are preparing for pregnancy during the test, and who are breastfeeding;
13. a history of drug abuse or alcohol abuse;
14. participate in other drug or medical device clinical trials within 30 days prior to the screening of this clinical trial;
15. Any condition of the subject that the study physician considers to be an impediment to the clinical trial (e.g. subject's susceptibility to mental stress, uncontrollable mood, depression, etc.);
16. Poor compliance of the subject, unable to complete the test process as required.
Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms

Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular occlusion using detachable coils, with or without expendable stent assistance. A new endovascular technique has recently been developed, using flow diverter stents without associated coils. Clinical results already published are encouraging but have to be confirmed. Furthermore, these medical devices are expensive in comparison to the coiling strategy. The purpose of this study is to compare the clinical efficacy, safety, and cost-effectiveness of endovascular coiling and endovascular flow diversion for unrupted saccular intracranial aneurysms.

Main Outcome Measure: Percentage of patients with an aneurysm with complete occlusion, defined as the absence of visible blood flow to the consideration of angiography performed 12 months post-endovascular intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patient's age ≥ 18 years old
* Unruptured saccular intracranial aneurysm diagnosed by angiography or CT angiography or MR angiography, located in the intra-dural area, with a neck diameter between 4 and 10 mm, with a sac diameter between 7 mm and 20 mm, with a ratio "dome/nek" greater than 1, and with a diameter of the parent artery between 2 and 5 mm.
* No prior treatment of the aneurysm
* Agreement for participating in the study and informed consent signed by the patient
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Patient's age \< 18 years old
* Adult patient protected by law
* Contraindications to the endovascular procedure
* Contraindications to antiplatelet or anticoagulant treatment
* Prior treatment of the aneurysm
* Presence of an arteriovenous malformation
* Extradural location of the aneurysm
* Fusiform aneurysm
* Active bacterial infection (clinical signs)
* Intracranial hemorrhage from aneurysm in the previous month
* Pregnant or breastfeeding woman