cyrilzakka/clinical-trials huggingface dataset:
Neoadjuvant Chemotherapy With or Without Huaier Granule in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery

RATIONALE:

Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely used in China for many years. The investigators have found that Huaier could exert synergistic effects with Epirubicin, Cyclophosphamide, and Paclitaxel on breast cancer cells. It is not yet known whether combination chemotherapy is more effective when given together with Huaier in the neoadjuvant setting .

PURPOSE:

To evaluate the effects of treatment with Huaier Granule in managing locally advanced breast cancers with synergistic action of the neoadjuvant chemotherapy.


Eligibility Criteria:
* Inclusion Criteria:

  * Age: ≥ 18, female;
  * Breast cancer (TNM II, III, IV) larger than 2cm in maximal diameter able to benefit from neoadjuvant chemotherapy;
  * Ductal or lobular histological type of the breast tumor;
  * The diagnosis and breast cancer has been confirmed by pathological examination;
  * The liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT) \< 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \< 1.5 ULN;
  * Other laboratory tests meet the following requirements within 3 days after surgery (excluding day 3): Hb ≥ 90g/l, platelet count ≥ 100×109/L, absolute neutrophil count \> 1.5×109/L;
  * The expected survival time ≥ 8 months;
  * The subjects volunteer to sign the informed consent.
* Exclusion Criteria:

  * Breast cancers of rare histological type (other than ductal and lobular);
  * Noninvasive cancer;
  * Presence of organ, bone, or skin metastases;
  * Pregnant or lactating women;
  * Those with active bleeding due to various reasons;
  * Those with HIV infection or AIDS-associated diseases;
  * Those with severe acute and chronic diseases;
  * Those with severe diabetes;
  * Those with serious infectious diseases;
  * Those who can not take drugs by oral route;
  * Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
  * Conditions that are considered not suitable for this study investigators
Vis-Rx Post-Market Evaluation

Post-market clinical evaluation of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) System and the Vis-Rx Micro-Imaging Catheter for use in Percutaneous Coronary Intervention (PCI) procedures.

Prospective, single-arm, unblinded, multi-center, post-market clinical evaluation assessing the imaging capabilities of the Gentuity HF-OCT System and the Vis-Rx Micro-Imaging Catheter for use in PCI procedures. Objectives are to evaluate the clinical and technical performance in the target patient population.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Willing and able to provide written informed consent to participate
* Transluminal interventional procedure for their coronary arteries

General Exclusion Criteria:

* Bacteremia or sepsis
* Major coagulation system abnormalities
* Severe hemodynamic instability or shock
* Acute renal failure
* Disqualified for Coronary Artery Bypass Graft (CABG) surgery
* Disqualified for PCI procedure
* Currently enrolled in another study to evaluate an investigational device or medication

Lesion-Specific Exclusion Criteria:

* Total occlusion
* Coronary artery spasm
* Large thrombus (visible under angiography)
* Any target vessel which has undergone a bypass procedure
Evaluation of Mobile X-ray Within the Triple Aim Method

Background:

In foreign countries, mobile x-ray already is being used where transfer to the radiology department at the hospital may be an obstacle. Using mobile x-ray, the x-ray examination is performed in the patients own home with transportable equipment that reminds of the transportable x-ray equipment that is being used in the intensive care units. At The Department of Radiology (DOR), Aarhus University Hospital there is an ongoing project mobile x-ray for patients living in nursing homes in Aarhus. The project will be evaluated inspired by the Triple Aim Approach in three sub studies.

Overall aim:

The overall aim is to conclude if mobile x-ray improves healthcare for fragile patients.

Hypotheses:

* Patients examined with mobile x-ray have fewer number of hospital admissions compared with patients examined with x-ray at DOR.
* Patients examined with mobile x-ray are more satisfied with their examination compared with patients examined with x-ray at DOR.

Sub study 1 - Population health

Aim:

The primary aim is to study if mobile x-ray improves the health of the defined population measured in hospital admission. Also to study challenges conducting a RCT.

The outcome measures:

The primary outcome is hospital admissions.

Sub study 2 - Experience of care

Aim:

The aim is to study the satisfaction with mobile x-ray compared the satisfaction to x-ray at DOR.

Methods:

Observations, interview and questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* patients referred to a mobile X-ray examination in Aarhus Municipality

Exclusion Criteria:

* all other patients referred to an x-ray examination
Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (P08648)

The purpose of this study is to determine the safety and efficacy of epinastine nasal spray compared to placebo for the treatment of subjects with seasonal allergic rhinitis


Eligibility Criteria:
Inclusion Criteria:

* A documented history of seasonal allergic rhinitis to mountain cedar or other spring pollen

Exclusion Criteria:

* Significant medical condition
* Significant nasal abnormality
* Significant cardiac condition
* Recent infection
* Use of other allergy medication during the study
* Use of asthma medication other than as-needed albuterol
Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women

We will compare between using isosorbide mononitrate together with misoprostol versus the misoprostol alone in induction of labor in postdate women


Eligibility Criteria:
Inclusion Criteria:

* age (20-35 yrs)
* single fetus
* gestational age \> 40weeks
* not in labor
* bishop score \< 7
* no medical disorder

Exclusion Criteria:

* Gestational age ≤40 weeks
* patient with a ripe cervix
* rupture of membranes
* suspected chorioamnionitis
* placenta previa
* history of major uterine surgery
* hypertonic uterine pattern
* contraindicated to receive PG
* fetal malpresentation
* multiple pregnancy
* intrauterine growth retardation
* women with any general medical disorder
Older Emergency Department Users and Hospitalization After an Index Visit: Results of ER2 Database

This study evaluates the recommendations of a screening tool called: ER2 (Emergency Room Evaluation and Recommendations Form).This stool is used in Emergency Department by nurses, and it supposes to measure patient risk score.

Crowding and delay became chronic conditions in emergency departments (EDs) in high income countries. Emergency medicine has the mandate to provide care to any patient requesting treatment 24 hours a day. As there is a lack of primary care physicians who are able to provide the necessary care to patients, they are forced to seek care in ED. Among these ED users, more and more patients are aged over 65 and account for up to a quarter of all ED users. Older ED users comparted to their younger counterparts are more at risk for long length of stay in ED and hospital, and hospital admission during an index ED visit. The occurrence of these short-terms adverse events may be reduced if older ED users risk is assessed upon their ED arrival. Few studies have examined risk for short-terms adverse events. They suggested that clinical tools based on a brief geriatric assessment with timely appropriate interventions could reduce the occurrence of short-terms ED adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Being 75 years and over
* Brought at Emergency on medical stretcher

Exclusion Criteria:

* Being less than 75 years old
* Never come at Emergency
Incidence, Associated Factors, and Burden of Post COVID-19 Condition in Brazil

This is a national retrospective cohort study with internet-based recruitment which intends to enroll 1,694 adult patients with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil. Participants with confirmed symptomatic COVID-19 after january 2022 will be evaluated in order to assess incidence, potential risk factors and impact of post COVID-19 condition according to the WHO definition on health-related quality of life and other relevant patient-centered outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Brazilian resident;
* Symptomatica COVID-19 confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or antigen test for SARS-COV-2 after January 2022, with diagnosis at least 90 days before recruitment.

Exclusion Criteria:

* No availability to participate in remote research appointments;
* Communication difficulty (aphasia, important hearing loss, non-portuguese speaker, severe dementia)
* Refuse to provide informed consent
A Study of JNJ-64281802 in Participants With Confirmed Dengue Fever

The purpose of this study is to investigate the antiviral activity of JNJ-64281802 versus placebo in terms of reduction of dengue virus (DENV) ribonucleic acid (RNA) in primary DENV infection.


Eligibility Criteria:
Inclusion Criteria:

* Participant with a referral note/documentation from a health care facility or practitioner indicating non-structural 1 protein (NS1) positive for dengue virus (DENV), positive NS1 rapid test at pre-screening during an ambulatory visit, or participant who tests NS1 positive at the site
* Participant reported a fever with an onset within the last 48 hours
* A woman of childbearing potential must have a negative serum pregnancy test at screening
* A woman must be: a. not of childbearing potential, b. of childbearing potential and practicing a highly effective, preferably user-independent method of contraception (failure rate of less than \[\<\] 1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until at least 90 days after last dose- the end of relevant systemic exposure
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention

Exclusion Criteria:

* Participant with any clinical signs and symptoms for severe dengue according to the world health organization (WHO) criteria (such as severe plasma leakage leading to dengue shock syndrome \[DSS\], fluid accumulation with respiratory distress, severe bleeding, sever organ involvement)
* Use of any cytochrome 3A4 (CYP3A4) inducers (example, phenytoin, rifampin), UDP glucuronosyltransferase family 1 member A9 (UGT1A9) inducers (example, rifampin), or substrates for CYP3A4 with a narrow therapeutic range (example, alfentanil, cyclosporin), or sensitive breast cancer resistance protein (BCRP) substrates (example, pravastatin and folic acid) from 14 days before first dose of study drug until 28 days after last dose of study drug. Systemic use of strong CYP3A4 inhibitors (example, clarithromycin, itraconazole) or UGT1A9 inhibitors (example, probenecid, mefenamic acid) from 7 days before first dose of study drug until 28 days after last dose of study drug
* History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
* Had major surgery, (example, requiring general anesthesia) within 4 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunomodulation therapy such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients

A prospective, controlled, single blinded study was planned. 20 patients with Acromegaly (Acromegaly Group) and 20 healthy subjects (Control Group) were planned to include in the study. Connecticut Chemosensory Clinical Research Center (CCCRC) test was applied to evaluate olfactory functions. Olfactory bulb(OB) volumes were measured with a 1.5 T General Electric Signa Excite MRI scanner.

Acromegaly patients were assessed at the Endocrinology Department for their clinical symptoms, and the nasal examination and olfactory evaluation were done at the Department of Otorhinolaryngology. OB volume was evaluated by a single blinded radiologist. Control group patients that had similar demographical characteristics with the Acromegaly Group were recruited in the study.

The CCCRC test is composed of n-butanol odor threshold test and odor identification test. Olfactory tests were scored out of 7 (0: worst, 7: best olfaction) and mean score was calculated as the total CCCRC test score. OB measurements were done individually on the right and left olfactory bulbs and the mean OB volume was calculated in cubic millimeters.

Eligibility Criteria:
Inclusion Criteria:

* Acromegaly diagnosis
* Healthy subjects that had no nasal problems

Exclusion Criteria:

* Previous nasal surgery
* Acute respiratory tract infection
* Nasal polyposis
* Nasal pathologies that causes nasal obstruction
Clinical Decision Unit (CDU) - Evaluation of a Novel Approach to Address Emergency Department Overcrowding

This randomized controlled trial will introduce a Clinical Decision Unit (CDU) into the University of Alberta Hospital Emergency Department(ED)and assess the influence on ED length of stay, patients who leave without being seen, and other ED Overcrowding outcomes.

The study will take place over a 6-week period that will be spilt into three-two-week blocks. Using computerized blocks of 2 weeks, days of the week will be randomly allocated so that each day of the week receives one intervention (CDU) and one control day for the study period. The CDU involves transforming an ED bed location to a 6-chair internal waiting room with 2 adjacent beds assigned to act as assessment and treatment locations. Patients will transition between the chair and stretcher to optimize the use of ED space.

Eligibility Criteria:
Inclusion Criteria:

* Only adult patients (\>17 years of age) presenting to the University of Alberta Hospital Emergency Department (UAH ED), during the study interval will be included in the evaluation.

Exclusion Criteria:

* Direct admits/Pediatric patients.
Evaluation of CPP-ACP Prophylactic Effect on Enamel Surface During Orthodontic Treatment

This study is aiming in preventing the formation of WSL associated with orthodontic treatment which occurs to more than 50% of orthodontically treated patients through applying CPP-ACP on the enamel surface once every 2 weeks for 3 months.

CPP-ACP will be applied on premolars to be extracted in orthodontic patients whose treatment plan indicates extraction of at least 2 premolaes of the maxillary arch. Application will continue on one premolar either the right or left one once every 2 weeks for the first 3 months of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* severe crowding
* Increased overjet
* Protruded maxillary base
* Sound maxillary premolars
* medically free
* molar classification class II
* Canine classification class II

Exclusion Criteria:

* spacing of teeth
* Decreased overjet
* Molar classification III Medically compromised patients
* pregnant females
* carious premolars
* hypoplasia
Retaane® in Age-Related Macular Degeneration

The treatment of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration currently presents a great challenge. With visual loss threatening, there are only very few therapeutic options.

While these patients are neither suitable for laser therapy nor for photodynamic therapy with Verteporfin, antiangiogenic drugs applied intravitreally are now available.

Some patients however reject this therapeutic option because of potential complications such as endophthalmitis and the frequency of necessary injections. 20 patients who rejected intravitreal therapy were treated with Anecortave acetate (Retaane®) which was applied as a juxtascleral depot injection.


Eligibility Criteria:
Inclusion Criteria:

* rejection of intravitreal injections
* presence of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration

Exclusion Criteria:

* conditions precluding judgement of the fundus
Meaning-Centered Intervention for Muslim Patients Who Are Being Treated for Advanced Cancer

This study will compare the effectiveness of the Masterful supportive care intervention with that of the non-faith-based active control supportive care intervention, which uses the American Cancer Society's patient education materials, for Muslim patients who have advanced cancers.

All 3 sessions may occur within one week or over multiple weeks (nonconsecutively), depending on the participants preference. The participant will have up to 12 weeks from recruitment to complete all sessions and follow up surveys.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* identify, either as self-report or on the MSKCC EMR, as Muslim
* are in treatment including surveillance, for a confirmed diagnosis of stage III or IV cancer (solid or liquid) as per clinician or pathology report
* have an estimated life expectancy of at least 6 months, as determined by their primary oncologist
* are cognitively intact (oncologist's clinical impression or judgement of study staff)
* able to speak and read English or Arabic (self-reported preference or on the MSKCC EMR system).
* To assess English proficiency, participants will be asked two questions: (1) the Census limited English proficient item "How well do you speak English?" with response options "Not at all, Not well, Well, or Very well" and (2) "What is your preferred language for healthcare?"
* Participants who are eligible for the study and are fluent in English will be identified by the response "Very well" to the 1st question and a response indicating English as the preferred language for healthcare.

Exclusion Criteria:

* Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation
* patients diagnosed with primary brain tumors as per clinician report, as they may have difficulty completing the intervention and answering the questionnaires
* undergoing hematopoietic stem cell transplantation (HSCT) as per clinican report or the EMR
* currently in psychotherapeutic treatment. Symptoms of anxiety and depression are common among patients with stage III or IV cancer. Antidepressants, anxiolytics, and other psychotropic medications do not diminish the effects of psychotherapy; thus we will not exclude patients who are being treated with these medications, as long as they are not in psychotherapy.
Environment and Reproductive Health; Human Exposure to Bisphenol A, Phthalates and Fertility and Pregnancy Outcomes

The purpose of the study is to investigate the relationship between environmental agents and reproductive health. Environmental agents of interest include exposure to chemicals such as polychlorinated biphenyls (PCBs), flame retardants, dioxins, bisphenol A, phthalates, pesticides, and metals like lead and cadmium. We are also interested in the relationship between reproductive health and lifestyle risk factors, such as exposure to environmental tobacco smoke. Enrollees are asked to participate in this study because they and their partner are patients of the MGH Fertility Center, trying to get pregnant, either naturally or by undergoing Intrauterine Insemination (IUI) and/or In Vitro Fertilization (IVF).

Specific Aim #1: To determine the association of a mixture of paternal urinary concentrations of phthalate metabolites, BPA and parabens with the primary outcomes of implantation failure and live birth, and the secondary outcomes of chemical pregnancy (with no subsequent clinical pregnancy) and spontaneous abortion.

Hypothesis 1: Higher paternal urinary concentrations of a mixture of anti-androgenic phthalate metabolites of DEHP, DBP, DiBP, BBzP, and DiNP is associated with increased risk of implantation failure and reduced live birth rate, and increased risk of chemical pregnancy and spontaneous abortion.

Hypothesis 2: Higher paternal urinary concentrations of a mixture of estrogenic chemicals (BPA and parabens) is associated with increased risk of implantation failure and reduced live birth rate, and increased risk of chemical pregnancy and spontaneous abortion.

Specific Aim #2: To determine the association of a mixture of maternal urinary concentrations of phthalate metabolites, BPA and parabens with implantation failure and live birth rate, and the secondary outcomes of chemical pregnancy and spontaneous abortion.

Hypothesis 2: Higher maternal urinary concentrations of a mixture of anti-androgenic phthalate metabolites of DEHP, DBP, DiBP, BBzP, and DiNP is associated with increased risk of implantation failure and reduced live birth rate, and increased risk of chemical pregnancy and spontaneous abortion.

Hypothesis 3: Higher maternal urinary concentrations of a mixture of estrogenic BPA and parabens is associated with increased risk of implantation failure and reduced live birth rate, and increased risk of chemical pregnancy and spontaneous abortion.

Specific Aim #3: To determine the joint effect of maternal and paternal urinary concentrations of phthalate metabolites, BPA and parabens with primary outcomes of interest including implantation failure and live birth rate, and the secondary outcomes of chemical pregnancy and spontaneous abortion.

Eligibility Criteria:
Inclusion Criteria:

1. Couples undergoing treatment for infertility at MGH Clinic
2. Men 18-55 years old
3. Women 18 - 45 years old

Exclusion Criteria:

1. Any individual or couple who is not undergoing infertility treatment at MGH Clinic and or who is outside of age range.