cyrilzakka/clinical-trials huggingface dataset:
A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)

This was an open-label, randomized, comparative, phase III study to evaluate the safety and efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular (i.m.) administered once a day in luteal phase support in 200 Chinese female subjects undergoing IVF/ET.

This was an open-label, randomized, comparative, multicentric, phase III study to evaluate the safety and efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular administered once a day in luteal phase support in Chinese female subjects undergoing IVF/ET. The study planned to enroll 200 female subjects who underwent pituitary down-regulation as per each center's normal practice prior to and during stimulation of multiple follicular development. The progesterone administration was started on the day of ET. Randomisation was performed on the day of ET. If pregnancy was confirmed on day 14 of the progesterone administration, the progesterone was continued for another 45 days. The subjects were followed up and the treatment outcome (negative pregnancy test or pregnancy) was recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patient has given written informed consent
* BMI \< 25 kg/m2
* Age \< 36 years
* \<3 prior ART cycles (IVF, ICSI and related procedures)
* Infertility
* Regular spontaneous ovulatory menstrual cycles

Exclusion Criteria:

* Habitual abortion
* Hydrosalpinges
* History of past poor response to COH
* Patients with serious arterial, lung, hepatic and renal diseases
* Hepatic and renal impairment
Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy Subjects

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single doses of HKI-357 administered to healthy subjects.


Eligibility Criteria:
Eligibility Criteria:

* Healthy adult men or women of nonchildbearing potential, aged 18-50.
Hydrogel Injection to Assist Endoscopic Submucosal Dissection

The aim of the investigators' study is to evaluate the mucosa-elevating capacity and clinical safety of Sodium Alginate (SA) mixed with Calcium Lactate in assisting Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection.

The study will evaluate the mucosa-elevating capacity and clinical safety of Gut Guarding Gel (the Sodium Alginate (SA) mixed with Calcium Lactate) in assisting Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection to treat early gastroenterological tumor and polyps.

All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection.

The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel".

Determine the rates of the delayed bleeding/perforation, postpolypectomy electrocoagulation syndrome, and the late tissue injury.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following inclusion criteria in order to be entered into the study:

A. Both genders of patients age 20 or older.

B. Superficial tumors or polyps found either in esophagus, stomach, or large intestine via endoscopic diagnosis.

C. Tumor or polyps ≧ 20 millimeters.

D. Superficial tumor or polyps found either in esophagus, stomach, or large intestine have never received any kind of endoscopic treatment.

E. No evidence of depth of submucosal invasion or metastasis via endoscopy.

Exclusion Criteria:

If patients meet any of the following criteria they may not be entered into the study:

A. Patients suffering from other advanced malignant tumors.

B. White Blood Cell\< 2000 μL or Severe thrombocytopenia（Platelet count \< 50,000 μL)，or blood coagulation abnormalities uncorrectable .

C. Patients taking anti- thrombocytopenia or anti-coagulation medicine, and medication cannot be stopped under physicians' consideration.

D. Main organs (heart, lung, liver, kidney) dysfunction who are not eligible for clinical trials under physicians' consideration.

E. Evidence of depth of submucosal invasion or metastasis via endoscopy.

F. Unable to follow-up by endoscopy.

G. Unwilling to sign informed consent.

H. Allergic to pharmaceutical excipients related to this medical device (Calcium Lactate or Sodium Alginate).
Frequency of Fibromyalgia in Behcet Disease

In various studies, the incidence of fibromyalgia in Behçet's patients is widely distributed. It was aimed to investigate the frequency and severity of fibromyalgia in Behcet disease in province Bursa.

There are few studies in the literature investigating the frequency of fibromyalgia in Behçet's disease. In various studies, the incidence of fibromyalgia in Behçet's disease was 5.7% -37.1%, which is widely distributed. There are no studies in literature comparing disease severity and pain thresholds at trigger points in fibromyalgia with and without Behcet's disease. In this study, it was aimed to investigate the frequency of fibromyalgia in Behcet's disease according to the criteria defined by the American Colloge of Rheuatology in 2010 and updated in 2013. It was also aimed to compare the severity of disease in fibromyalgia with and without Behcet's disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Behcet disease according to international study group criteria
* Patients diagnosed with fibromyalgia according to classification criteria that were defined by the American Collage of Rheumatology in 2010 and updated in 2013
* Patients older than 18
* Patients younger than 75

Exclusion Criteria:

* Participants which were previously diagnosed with diabetes mellitus
* Participants which were previously diagnosed with chronic renal failure
* Pregnant women
Clonidine With Morphine in Patient Controlled Analgesia Pump in Vaso-Occlusive Crisis in Sickle Cell Disease Patient

Vaso-occlusive crisis are highly painful in Sickle-cell patients. Morphine is the treatment of choice for this pain. Various adjuncts have been studied for the treatment of vaso-occlusive crisis.

The investigators aimed to study the effect of clonidine associated with morphine in PCIA (patient controlled intravenous analgesia pumps) regimen. The investigators will compare it to the morphine alone in PCIA for the treatment of vaso-occlusive pain.

The investigators will measure the morphine consumption of all patient, the impact on the apparition of the morphine secondary effect and on inflammation biomarkers and the biopsychosocial respond.

Each patient will be hospitalized and follow by haematologist from the hospital, pain doctors and nurses.

It will be a double blind randomised, prospective study. The randomisation will be done by the pharmacy.


Eligibility Criteria:
Inclusion Criteria:

* Vaso-Occlusive Crisis In Sickle Cell disease Patients

Exclusion Criteria:

* Minor
* Patient's refusal
* Pregnancy
* Contr-indication Clonidine therapy
An Observational Study to Assess RSV-associated Illness in Adults With COPD and/or CHF

The primary objective of this observational study is to determine the incidence of medically attended (inpatient or outpatient) acute respiratory illnesses or events leading to worsening cardiorespiratory status (ie, acute exacerbations of chronic obstructive pulmonary disease \[AECOPD\] or worsening CHF) associated with RSV infections in high-risk adults (ie, those with severe COPD and/or advanced CHF) across multiple consecutive RSV seasons.

It is expected that this observational study will provide further understanding of the clinical impact and true incidence rates of RSV-associated hospitalizations and medically attended acute respiratory illnesses or events leading to worsening cardiorespiratory status in adults with COPD and/or CHF who are at increased risk for serious sequelae associated with RSV infections. As part of the evaluation, this study will collect symptom and physiologic data, and blood, nasal swab, and sputum in order to investigate the relationship of RSV infections with clinical endpoints.

Eligibility Criteria:
Key Inclusion Criteria:

* Age 50 years or greater
* Hospitalization due to worsening COPD and/or CHF
* Severe COPD subjects (Global Initiative for Obstructive Lung Disease Stage III/IV); FEV1 \<50%
* Chronic CHF subjects (New York Heart Association Class III/IV or American College of Cardiology-American Heart Association Stage C/D); Ejection fraction \< 40%
* Expects to have direct contact with children at least once a month

Key Exclusion Criteria:

- Participation in another clinical study involving the use of investigational product
mHealth Behavioural Intervention to Increase Breast Cancer Screening Rates Among Members of the Public

Late-stage presentation of breast cancer cases are on the rise in Malaysia. Encouraging breast screening practices can assist in early breast cancer detection. Literature has proven that behavior interventions in the form of behavior change health communication using social messaging applications is a viable strategy and potentially effective at motivating breast cancer screening among the public. Such studies are scarce in the South East Asian region, particularly in Malaysia, which is the prime motivation for the current study,

Based on this promising prospect, a randomized controlled trial will be designed to study the effects of applying persuasive health communication materials to initiate behavior change among a group of Malaysian women. Materials are delivered in the form of a health communication program over a social messaging application to promote breast cancer screening practices, which is either a clinical breast examination, or a mammogram. The investigators hypothesize that Malaysian women who are exposed to such materials that are designed based on behavior science and behavior change principles will be nudged and hence more likely to attend breast cancer screening compared to a control group.

This study involves a randomized controlled trial to asses the effectiveness of a health communication program using specifically designed materials using behavior science and behavior change principles. Materials were designed based on findings derived from a scoping review and interviewing Malaysian women through a series of qualitative interviews to determine the barriers and facilitators of attending breast cancer screening. The interview also investigated women's preferences for certain characteristics in a health message and health communication program that would motivate them to attend screening.

Participants in the main experimental group will be compared with a control group, and another group which undergoes a standard health communication program.

Eligibility Criteria:
Inclusion Criteria:

1. Malaysian women aged 40 years and above
2. Possess a smartphone with the predetermined social messaging application (derived from Phase 1 of study) installed.
3. Have not been diagnosed with cancer before.

Exclusion Criteria:

1. Underwent Clinical Breast Examination in the past 12 months.
2. Mammogram screening in the past 2 years.
3. Subjects who are deemed to have cognitive impairment and unable to provide consent to the study.
Genetic Study of Lupus Patients and Their Families

The purpose of this study is to perform genetic testing in and to collect information from families affected by lupus in order to identify the genetic factors associated with systemic lupus erythematosus (SLE).

Little is known about the genetic factors that predispose people to developing SLE. Genes in patients with SLE may provide clues about SLE's pathogenesis. This study will compare genes from SLE patients, their unaffected family members, and control participants. Travel to the study site is not required.

In this study, blood samples will be collected from people diagnosed with SLE, their unaffected family members, and condition-matched controls. Participants will be asked questions about their health and will provide a small blood sample. Participants will also be asked to provide written permission for release of medical information, so that their disease status can be verified through medical record review or through consultation with their doctors. Study personnel may contact participants in the future for follow-up questions and additional blood draws, if the participant agrees.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SLE OR a family member of participant diagnosed with SLE

Exclusion Criteria:

* Pregnancy or breastfeeding
Study to Learn More About Safety of Aflibercept Injection in Japanese Patients With Neovascular Glaucoma (NVG)

This is a prospective, observational, multi-center and post-authorization safety study that includes patients with a diagnosis of Neovascular Glaucoma. The investigator will have made the decision to use Eylea for treatment.

The objective of this study is to assess safety and effectiveness of Eylea using in real clinical practice. Patients will be followed for a time period of 6 months from start of Eylea treatment or until it is no longer possible (e.g. lost to follow-up). In total, 480 patients will be recruited. For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visit and final visit, either by routine clinical visits (as per investigators routine practice).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NVG
* Patients who have received IVT-AFL treatment according to Japanese labeling.

Exclusion Criteria:

* Patients who are contraindicated based on approved label
* Diagnosis of other indication
Artificial Intelligence to Evaluate Postoperative Pain Based on Facial Expression

Patients' subjective complaints about pain intensity are difficult to objectively evaluate, and may lead to inadequate pain management, especially in patients with communication difficulties.

Analgesia nociception index (ANI 0-100) and patient-reported numeric rating scale (NRS 0-10) were trained on a convolutional neural network (CNN) model by linking the patients' facial expression with the score. By applying the predicted pain score by the AI model to evaluate pain, it is intended to measure the intensity of pain in an automatic, fast, and objective way for appropriate pain management.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19-75 years who were scheduled for elective laparoscopic abdominal surgery under general anesthesia
* American Society of Anesthesiology (ASA) class I-II

Exclusion Criteria:

* Patients who have difficulty in communicating and reporting pain
* Underlying diseases: liver, kidney, brain
* Patients with BMI greater than 30 and less than 18.5
* Alcohol or drug dependent patients
* Patients with severe or acute respiratory failure
* Opioid, NSAID allergy
* Patients who are scheduled to be admitted to the intensive care unit after surgery
* Patients who undergo cooperative surgery
Major Complication Rate in Cancer Patients with Neutropenic Fever Potentially Eligible for a Hospital At Home Program

This study investigates the major complication rate in cancer patients potentially eligible for a hospital at home program for management of neutropenic fever. "Hospital at Home" is a home care program that provides acute, inpatient care in a patient's home in place of a traditional hospital stay. Learning more about the characteristics of potentially eligible patients, including reasons for inpatient admission, rates of major complications, and situations or treatments that would be difficult to deliver in an at home setting may help to inform future program development.

PRIMARY OBJECTIVE:

I. Estimate the major complication rate among patients potentially eligible for a hospital at home program for management of neutropenic fever.

SECONDARY OBJECTIVES:

I. Describe the demographic and clinical characteristics of patients potentially eligible for admission to a hospital at home program for management of neutropenic fever.

II. Describe situations or treatments experienced by potentially eligible patients admitted for neutropenic fever that would be difficult to accomplish in a hypothetical hospital at home program (e.g., blood transfusions, echocardiograms, computed tomography \[CT\] scans).

OUTLINE:

Patients' medical charts are reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to MD Anderson Cancer Center through the Emergency Center with a diagnosis of neutropenic fever between 1/1/2019 and 12/31/2019
* Be at low risk for major complications as defined by a Multinational Association for Supportive Care in Cancer (MASCC) score \< 21

Exclusion Criteria:

* Reside in a nursing home
* Homelessness
* Hospice enrollment
* A secondary reason for admission to the hospital or high risk clinical feature not captured in the MASCC score that places them at high risk for major complications in a hospital at home program
Multi Center Observation of Sentinel Skin Graft for Detecting Acute Rejection After Renal Transplantation

The purpose of this study was to explore the accuracy of sentinel skin grafts from the same donor source in diagnosing renal allograft rejection, and to provide new ideas and options for the later clinical diagnosis of renal allograft rejection. Further, try to provide timing guidance for early immunization intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with end-stage renal disease undergoing renal transplantation;
2. 18-60 years old;
3. Postoperative follow-up points are complete (visit the hospital every week in the first month after surgery, every two weeks in 2-3 months, every four to six months, and every three months in 7-12 months. Follow up at any time when skin rejection is observed. The follow-up time may be adjusted when the condition changes);
4. The participants had good compliance, volunteered to participate in the test and signed the informed consent form.

Exclusion Criteria:

1. Untreated or disseminated malignant tumor;
2. Active period of infectious diseases;
3. Serious cardiovascular disease occurred recently;
4. Combined with other important organ failure;
5. History of mental illness or cognitive impairment;
Safety of Caprylic Triglycerides in ALS: A Pilot Study

The purpose of this study is to determine if AC-1204 is safe and tolerated in subjects with ALS. The reason why the investigator wants to use AC-1204 in patients with ALS is to determine if, by taking AC-1204, the body will make substances called ketone bodies. Further, if AC-1204 is well tolerated, the investigators want to change the amount the participant takes, to determine if the amount of ketone bodies in the blood increase in accordance with increases in the amount of AC-1204 the participant takes. The investigators want to do this study because when the investigators gave AC-1204 to mice with ALS, findings suggest the disease course is altered for the better and that the cause of this change is due to the presence of ketones in the blood. If AC-1204 can be proven to be safe and able to cause ketones to increase in the blood, the investigators will likely do subsequent studies to determine if the presence of ketone bodies will slow or stop the progression of the disease. However, this study is not designed to determine if AC-1204 will stop or slow the progression of ALS. It is designed to only determine if patients with ALS can tolerate AC-1204, if ketone bodies are produced and if the amount of ketone bodies produced increases with increasing dose.


Eligibility Criteria:
Inclusion Criteria:

* Familial or sporadic ALS diagnosed as probable, laboratory-supported probable or definite according to the World Federation of Neurology El Escorial criteria,
* Age 18 or older,
* Capable of providing informed consent and complying with trial procedures,
* Appel ALS score less than 100,
* Able to stand on a scale with assistance,
* Willing to chart food intake during the 12 week study,
* Patients either not taking Riluzole (Rilutek) or on a stable dose for 30 days or more,
* Not taking Coenzyme Q10 or on a stable dose and brand for 30 days,
* Absence of exclusion criteria.

Exclusion Criteria:

* Forced vital capacity \<40% of predicted,
* Dependence on mechanical ventilation for more than 12 hours per day,
* Exposure to any experimental agent within 30 days of entry or at any time during the trial,
* Women who are breastfeeding, who are pregnant or are planning to become pregnant,
* Women of childbearing potential not practicing a medically accepted form of contraception,
* Enrollment in another research study within 30 days of or during this trial,
* Mini-Mental State Exam (MMSE) score \<20,
* Patients with symptomatic cardiac disease or hypercholesterolemia,
* Patients with myocardial infarction within 6 months of this trial,
* Renal dysfunction defined as BUN and creatinine \>2xULN,
* Known mitochondrial disease,
* BMI\<18.5,
* Prior use of a 4:1 ketogenic diet or Atkins diet within 1 month of this trial,
* Impaired liver function, defined as AST or ALT of 3xULN,
* Patients who have a pacemaker or other internal electronic medical device,
* Known allergy or hypersensitivity to milk or soy products.
QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.

Glycemic control is often the main indicator of successful diabetes care, but a singular focus on glycemic control may lead to patients' overall health and wellbeing being overlooked or undervalued. The investigators have previously developed an intervention comprised of (a) a set of conversation cards designed to enable patients to identify aspects of life with diabetes important to them and to share them with their clinician to obtain their input; and (b) materials that help clinicians respond to patient concerns. The investigators will now conduct a randomized clinical trial to test the feasibility of the research procedures and efficacy of the intervention with respect to patient reported outcome measures.

The goal of this study is to assess the feasibility and efficacy of usual care with the QBSafe intervention compared to usual care alone within a cluster randomized clinical trial among patients with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

Clinicians

* any physicians, residents, nurse practitioners, and physician assistants who participate in the care of patients with type 2 diabetes (DM2) management (DM2) and prescribe medications for them

Participants

* diagnosed with DM2
* able to sign informed consent
* fluent in either English or Spanish
* HbA1c \>8%

Exclusion Criteria:

* Participants for whom an HbA1c target \>8% is clinically reasonable (e.g., those with limited life expectancy) and/or aligned with goals/preferences