cyrilzakka/clinical-trials huggingface dataset:
KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer

This is an open-label, phase 1 dose-escalation study of KN026 in subjects with HER2 positive advanced breast and Gastric Cancer. The standard "3 + 3" design was used for dose escalation. There are 3 proposed dose levels which are 10, 15, and 20 mg/kg, but dosing interval may be adjusted during the study (such as QW, OR Q2W, OR Q3W) based on emerging data from this trial and/or from phase 1 trial of KN026 in other country. Dose escalation will continue until the maximum tolerated dose (MTD) is reached or if MTD is not found, dose escalation will continue until the MAD of 20 mg / kg is reached.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject \>= 18 years
* Histologically/cytologically confirmed, locally advanced unresectable or metastatic breast cancer or gastric cancer.
* ECOG score 0 or 1
* Life expectancy \>3 months
* According to the definition of RECIST1.1, the patient has at least one measurable lesion
* Adequate organ function prior to start treatment with KN026
* Able to understand, voluntarily participate and willing to sign the ICF
* Subjects (women of child-bearing potential and males with fertile female partner) must be willing to use viable contraception method.

Exclusion Criteria:

* Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
* Accepted radiotherapy within 4 weeks before enrollment
* An anthracyclines antibiotic treatment was received exceeding 300 mg/m² within 90 days before first KN026 dosing, or other equivalent dose antharcyclines
* Subjects are eligible with clinically controlled and stable neurologic function \>= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
* Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study
* History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
* Severe chronic and active infection, need to system antibiosis/antiviral treatment
* Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage
Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases

Juvenile idiopathic arthritis (JIA) is a chronic disease characterized by persistent joint inflammation. The immune system disruption that leads to overproduction of pro-inflammatory cytokines (TNF-α, IL-1, IL-6) is a cascade of events on different levels-some molecular, some cellular, and some systemic. Our objective is to identify the mechanisms through which physical activity is liable to mediate inflammatory balance in autoimmune disease settings, and specifically in JIA patients.

Feasibility study

Eligibility Criteria:
Inclusion Criteria:

* Children between 8 and 12 years
* Tanner stage \< T2
* polyarthritis, oligoarthritis and ERA sub-type of JIA
* Stable disease during 3 months before starting study

Exclusion Criteria:

* Infection
* Fever
* Anti-IL6 treatment
* More than 6h per week of physical activity
* Systemic corticosteroid treatment during the 3 months before starting study
* Systemic JIA
* JIA not mastered by treatments
* Other autoimmunity or auto-inflammatory diseases
* Participation in another clinical research protocol
Prevention of Hypothermia During Caesarean Section: Continuous Core Temperature Monitoring With Zero-heat-flux

Nowadays, caesarean sections account for about 7% of all surgical procedures worldwide. Over 30% of the patients undergoing a caesarean section experience a fall of the body core temperature under 36°C during the procedure. Following a retrospective cohort design, this study aims to examine the magnitude of hypothermia in the parturient and newborn population as well as the impact and efficiency of forced-air warming on preventing it. The researchers plan to conduct a retrospective analysis of the caesarean section treatment protocol at our institution over a period of 5 months including approximately 300 patients who underwent both elective and emergency caesarean sections.

This research seeks to address the necessity of standardizing the use of forced-air warming and monitoring the maternal temperature during caesarean sections. We will also examine the impact of the maternal hypothermia on the newborn temperatures at the time of partus and also 2 hours after birth. The key research question of this study is whether the use of forced-air warming will significantly lower the hypothermia rates and account for a faster temperature recovery in our parturient patients.

A major contribution of our research is that it provides modern high-resolution, continuous and user-error free thermometry. This is achieved through zero-heat-flux technology and automatically recorded by data-loggers. Also, the heterogeneity of our study population, which has not been attended in previous studies, corresponds to the clinical reality of the most obstetric clinics.

This research could provide new information about the necessity of standardizing the use of forced-air warming and monitoring the maternal temperature during caesarean sections, in the concept of bonding the babies to the mother's chest immediately after birth, and derive practical implications on the efficiency of intraoperative warming for the standard clinical routine of the majority of the obstetric clinics.

Eligibility Criteria:
Inclusion Criteria:

Included will be all Caesarean section deliveries under spinal anaesthesia at our facility in the period from 01.04.2019 to 31.08.2019

Exclusion Criteria:

* different anaesthesia procedure (e.g. intubation anaesthesia, peridural anaesthesia etc.),
* American Society of Anesthesiologists (ASA) Classification III or higher,
* BMI( Body mass index) \>45 kg·m-2,
* patients with incomplete documentation,
* estimated perioperative blood loss \> 500ml,
* other perioperative complications (ex. insufficient analgesia and change of anaesthesia procedure).
Role of Intrapartum Ultrasound in Instrumental Delivery

Investigators will perform a multicentric randomized controlled trial comparing the effect of transabdominal and transperineal ultrasound in pregnant women in the second stage of labor, in whom it was decided an operative delivery. Our objective is to evaluate the impact of intrapartal ultrasound measurements, as an auxiliary to clinical evaluation, in the efficacy of an instrumental delivery.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women at term, in labor (≥ 37 weeks of gestation dated by a first trimester ultrasound
* live singleton pregnancy
* fetus in a cephalic presentation
* in the second stage of labor, after the decision to perform an instrumental delivery

Exclusion Criteria:

* fetal malformations
* emergency situation
Improving End of Life Care in Head and Neck Cancer

The purpose of this study is to improve the quality of care provided for head and neck cancer patients. By better understanding the end of life experiences of dying patients and their families, the investigators hope to better anticipate and improve upon the experiences of future patients and their families.


Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer patients who received their treatment at MSKCC who have died of noncutaneous squamous cell carcinomas of the upper aerodigestive tract and for whom family / next of kin contact information is available.
* Time of patient death must have been at least 6 months ago and no more than 4 years ago
* Patient age at time of death must be over 21 years of age.
* Those interviewed must be English-fluent.

Exclusion Criteria:

* Non-English speaking interviewees
* Next-of-kin who reported being unfamiliar with care received during the last month of life
* Next-of-kin who did not identify themselves as one of the patient's primary social supports during the last month of life
* Next-of-kin who were not physically present with the deceased at least once during the last week of his/her life
* Next-of-kin under age 21
The Effect on Glycemic Responses and Subjective Ratings of Satiety of a Snack With or Without Ingredients to Slow Carbohydrate Digestion

The objective of this trial is to compare a snack with ingredients (whole grains and dietary fiber) to slow carbohydrate digestion to a similar control snack without such ingredients and evaluate the effect of the snack on glycemic response and subjective satiety. The test product will be compared with a control product as well as white bread in a randomized, controlled, crossover trial including 20 healthy males or females between the ages of 18 and 70 and having a body mass index (BMI) between 25 and 30 kg/m2. Following an overnight fast, participants will be given each of the study products in a random order at least a week apart. Glucose and insulin will be measured before product consumption and over a period of four hours. Visual analog scales to measure subjective satiety will also be administered over a period of four hours.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males or females between the ages of 18 and 70 inclusive
2. No chronic medications other than oral contraceptives
3. Body Mass Index (BMI) between 25 and 30 kg/m2 inclusive.
4. Body weight stable in a 5 kg range in the 3 months prior to study entry

Exclusion Criteria:

1. Pregnant or nursing a baby
2. Women with child-bearing potential who are unwilling to use an effective means of contraception during the study which could include abstinence.
3. Adults unable to consent and prisoners
Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp

In this study, the activity, safety, and pharmacokinetics (PK) of KX2-391 Ointment was evaluated in adult participants with a clinical diagnosis of stable, clinically typical actinic keratosis (AK) on the face or scalp.

This study was an open-label, multicenter, activity, safety, tolerability, and PK study of KX2-391 Ointment administered topically to the face or scalp of participants with AK.

The study consists of Screening, Treatment, and Follow-up Periods. Eligible participants were received 3 or 5 consecutive days of topical treatment, applied at the study site. Blood samples for PK analysis were collected. Activity (lesion counts) and safety evaluations were performed.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥18 years old
2. Clinical diagnosis of stable, clinically typical actinic keratosis
3. A define treatment area on the face or scalp
4. Females must be postmenopausal, surgically sterile or otherwise incapable of pregnancy for at least 1 year; or must be using highly effective contraception for at least 90 days prior to treatment with KX2-391 Ointment
5. Males who have not had a vasectomy must agree to use barrier contraception
6. Participants who in the judgment of the Investigator, are in good general health
7. Willing to avoid excessive sun exposure
8. Able to comprehend and are willing to sign an informed consent form (ICF)

Exclusion Criteria:

1. Clinically atypical and/or rapidly changing AK lesions on the treatment area
2. Malignancy within 5 years prior to Screening except basal or squamous cell carcinoma not on the treatment area that were treated with curative intent and are without recurrence
3. Used any of retinoids at the most 90 days before Visit 1 glucocorticosteroids and methotrexate or other anti-metabolites within, at the most 28 days, before Visit 1
4. Used any topical therapies, treatments, or surgical or destructive modalities on the treatment area within, at the most 90 days, before Visit 1
5. Currently, or has experienced cutaneous malignancy, sunburn or body art on the treatment area within, at the most 180 days, before Visit 1
6. A history of sensitivity and/or allergy to any of the ingredients in the study medication
7. A skin disease or condition that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the participant to an unacceptable risk by study participation
8. Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the participant to unacceptable risk by study participation
9. Females who are pregnant or nursing
10. Participated in an investigational drug trial during which an investigational study medication was administered within 14 days or 5 half-lives of the investigational product, whichever is longer, before dosing.
Real-life Study of Patients After 3-months of Leuprorelin 5mg Implant in Prostate Cancer

To improve the management of patients suffering from prostate cancer, Laboratoires BOUCHARA-RECORDATI wish to set up an observational study to document, in daily practice, and over a large population, the profile and clinical and biological follow-up of patients undergoing leuprorelin 5 mg implant as well as the conditions for implant placement. The evolution of these prostate cancer patients will be monitored on the basis of data available in daily practice, including testosterone values, PSA values, and factors that may influence disease progression, in order to objectify whether the observed results are consistent with those described in the clinical studies.

To improve the management of patients suffering from prostate cancer, Laboratoires BOUCHARA-RECORDATI wish to set up an observational study to document, in daily practice, and over a large population, the profile and clinical and biological follow-up of patients undergoing leuprorelin 5 mg implant as well as the conditions for implant placement. The evolution of these prostate cancer patients will be monitored on the basis of data available in daily practice, including testosterone values, PSA values, and factors that may influence disease progression, in order to objectify whether the observed results are consistent with those described in the clinical studies.

The psychological dimension of the management of patients with prostate cancer will also be addressed by evaluating the strategies used by patients to cope with their prostate cancer \[(Prostate Cancer Patients' Coping Strategies Questionnaire (PCPCSQ)\].

Eligibility Criteria:
Inclusion Criteria:

* Patients with prostate cancer for whom the physician has decided to prescribe hormone therapy by subcutaneous leuprorelin implant 5 mg (Leptoprol®).

Exclusion Criteria:

* Patient who have already participated in another study or those who do not wish to participate in this study.
Text Message Program to Improve Eating Behaviors Among African Americans in New Orleans

The purpose of this pilot study is to test the feasibility and effectiveness of a mobile phone-based text messaging intervention to change the attitudes and eating behaviors of African American women residing in New Orleans, LA.

Design: The proposed study is a pre/post-test design where up to 60 female adult black/African Americans in Orleans and Jefferson Parish, Louisiana will be recruited to participated (Intervention, n=30; control n=30). If a woman is interested in participating, she will be asked to complete an evaluation/screen to determine if they are eligible for the study and asked to consent to participate. If a woman consents to participate they will be randomized to one of 2 groups:

1. Intervention group: Text messages to promote healthy eating: In this group, participants will receive personalized text messages to encourage healthy eating, specifically to increase consumption of fruits, vegetables and water; and a reduction in sugar sweetened beverages. They will receive some messages that will ask for a reply. They will receive an average of 1-2 messages per day for 4 weeks.
2. Control group: Control group participants will receive non-nutrition-related physical activity and general health/wellbeing text message. They will receive the text messages an average of 1-2 messages per day for 4 weeks

All participants will be asked to do the following tests that are not used to determine eligibility: Complete questionnaires about their background, nutrition habits, physical activity habits, health history, beliefs and opinions about health and habits. Data will be analyzed by comparing assessment outcomes within and across study arms (i.e., intervention, control).

Eligibility Criteria:
Inclusion Criteria:

1. Age range: 25 years of age or older
2. Gender: Women
3. Ethnic background: African American or Black
4. Location: Orleans and Jefferson Parish, Louisiana
5. Own a mobile phone
6. Open to being assigned to either the intervention or control group.
7. Willing and able to use their phone to read, receive and send text messages and phone calls.
8. No overt cardiovascular disease or acute symptomatology. (self-reported).

Exclusion Criteria:

1. Age range: under 25 years of age
2. Ethnic background: not African American or Black
3. Location: Live outside of Orleans and Jefferson Parish, Louisiana
4. Does not own a mobile phone
5. Not open to being assigned to either the intervention or control group.
6. Unwilling and unable to use their phone to read, receive and send text messages and phone calls.
7. Overt cardiovascular disease or acute symptomatology. (self-reported).
The Short Form-36: Pre- Versus Post-Surgical Administration in Cardiac Surgery Patients

The purpose of this study is to determine whether the SF-36 can be administered reliably to cardiac surgery patients (two to three days) post-surgery, with the patient answering the questions of this survey from a pre-surgical perspective.

The purpose of this study, is to determine whether the SF-36 can be administered reliably to cardiac surgery patients (two to three days) post-surgery, with the patient answering the questions of this survey from a pre-surgical perspective.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery patients who are between the ages of 18 and 100
* Are English speaking
* Able to give consent
* Undergoing cardiac surgery including (but not limited to):

  * Aortic valve replacement (AVR)
  * Mitral valve replacement (MVR)
  * Tricuspid valve replacement (TVR)
  * Coronary artery bypass graft (CABG).

Exclusion Criteria:

* Non-cardiac surgery patients
Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel

A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 21 days between the two study periods. Treatment groups were balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis

Exclusion Criteria:

* History of illnesses or any organic abnormalities that could affect the results of the study.
* History of abuse tobacco or alcohol or regular use of recreational or therapeutic drugs.
* Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.
Deep Learning for Fluorescein Angiography and Optical Coherence Tomography Macular Thickness Map Image Translation

Diabetic macular edema (DME) is one of the leading causes of visual impairment in patients with diabetes. Fluorescein angiography (FA) plays an important role in diabetic retinopathy (DR) staging and evaluation of retinal vasculature. However, FA is an invasive technique and does not permit the precise visualization of the retinal vasculature. Optical coherence tomography (OCT) is a non-invasive technique that has become popular in diagnosing and monitoring DR and its laser, medical, and surgical treatment. It provides a quantitative assessment of retinal thickness and location of edema in the macula. Automated OCT retinal thickness maps are routinely used in monitoring DME and its response to treatment. However, standard OCT provides only structural information and therefore does not delineate blood flow within the retinal vasculature. By combining the physiological information in FA with the structural information in the OCT, zones of leakage can be correlated to structural changes in the retina for better evaluation and monitoring of the response of DME to different treatment modalities. The occasional unavailability of either imaging modality may impair decision-making during the follow-up of patients with DME.

The problem of medical data generation particularly images has been of great interest, and as such, it has been deeply studied in recent years especially with the advent of deep convolutional neural networks(DCNN), which are progressively becoming the standard approach in most machine learning tasks such as pattern recognition and image classification. Generative adversarial networks (GANs) are neural network models in which a generation and a discrimination networks are trained simultaneously. Integrated network performance effectively generates new plausible image samples.

The aim of this work is to assess the efficacy of a GAN implementing pix2pix image translation for original FA to synthetic OCT color-coded macular thickness map image translation and the reverse (from original OCT color-coded macular thickness map to synthetic FA image translation).


Eligibility Criteria:
Inclusion Criteria:

* Patients from the retina clinic in Assiut University Hospital who had simultaneously undergone same-day FA and OCT with a diagnosis of confirmed or suspected DME.

Exclusion Criteria:

* Significant media opacity that obscured the view of the fundus
* OCT images with high signal-to-noise ratio expressed by the device as"TopQ image quality," below 60
* Vitreoretinal interface disease distorting the OCT thickness map.
* Patients with concurrent ocular conditions interfering with blood flow
* Patients with uveitic diseases
* High myopia of more than -8.0 diopters.
DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia

The purpose of this trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective , randomized, single center study

Results will be defined as:

Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization), Primary patency, Clinical success, Serious adverse events, and the patients will be followed-up for 1 years.

Primary endpoints:

Primary Patency at 12 months, TLR (clinical driven),

Secondary endpoints:

Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse events,


Eligibility Criteria:
Inclusion Criteria:

* Critical limb ischemia. Rutherford class 4-6
* Crural disease, long lesions, more than 2 cm.
* Life expectancy \> 1year
* \> 18 years

Exclusion Criteria:

* Pregnancy
* Patients disapproval
* Allergy to drug or contrast