cyrilzakka/clinical-trials huggingface dataset:
Investigating the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer

To analyze the metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer.

Participants will be asked to receive a glucose infusion (U-13C- glucose intravenous) during routine breast cancer surgery at which time, tumor biopsy samples and blood samples will be collected to be used in research experiments to help provide insight into the metabolic activity of the tumor. The length of time on study for each patient will be three - four weeks including two to three hours for glucose infusion and breast cancer biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Have hormone receptor (HR) positive \[estrogen receptor( ER)+/progesterone receptor (PR)+, ER+/PR- or ER-/PR+)/Her2 negative breast cancer previously diagnosed by biopsy.
* Have early stage, clinical or anatomic stage I, II or III breast cancer (cT1cN0, cT1cN1, cT2N0, cT2N1, cT3N0)
* Candidates for intended curative primary resection who have not had neoadjuvant therapy (endocrine/hormonal therapy, chemotherapy with or without immunotherapy).
* Willing to undergo mandatory intraoperative small excisional and core biopsies (4-6 passes) of tumor and normal tissue for research purposes at the time of proposed surgical resection.

Exclusion Criteria:

* Is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study.
* Has triple negative (ER-/PR-/Her2-) or HER2+ breast cancer.
* Concomitant active malignancy
* Is of child-bearing potential who has not had a recent negative pregnancy test done outside of this clinical trial (i.e., as part of standard preparation for diagnosis and treatment for her cancer)
Efficacy of an Early Rehabilitation on Decannulation Time of Patients With Severe Acquired Brain Injury

All the patients hospitalized in the neuro-rehabilitation after a severe acquired brain injury carrying a tracheal cannula will be retrospectively analyzed. Patients coming from emergency department started a rehabilitative treatment during their hospitalization in ICU. Patients transferred from an external ICU started the rehabilitation in neurorehabilitation department. Aim of the study is to evaluate if an early rehabilitation, started since the acute stage of the damage, is able to reduce the decannulation time in this group of patients.


Eligibility Criteria:
Inclusion Criteria:

* presence of a tracheostomy at admission in NRehab
* patient moved from an ICU
* GCS≤11 at admission in ICU
* tracheostomy performed for decreased mental status due to the ABI,

Exclusion Criteria:

* tracheostomy performed prior to admission to the ICU
* need for ventilation support.
Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries

In the Emergency Department, there is no standard of care for pain medication distribution for children with an acute musculoskeletal injury when there is no fracture present. Currently, ibuprofen is a favorable choice for the treatment, but studies have shown concern for delayed healing activity associated with NSAIDs like Ibuprofen. Homeopathic Arnica Montana is a well-established complimentary medicine and may provide a good alternative for managing acute pain from musculoskeletal injuries, especially in children, given the palatability and rarity of side effects. This study aims to compare usual care vs. usual care plus Arnica 1M\* (oral) or the placebo for management of pain in acute musculoskeletal extremity injuries without fracture by utilizing a double-blind clinical trial design. The primary outcome is to determine if subjects use less ibuprofen when given Arnica 1M.


Eligibility Criteria:
Inclusion Criteria:

* Patient presents to the Emergency Department with an acute, soft tissue ankle or forearm injury
* ED Provider orders an X-ray for evaluation of injury
* Patient's initial pain score is of a 4 or higher
* Patient has noticeable swelling at the site of the injury

Exclusion Criteria:

* Patient is diagnosed with a fracture
* Patient has an allergy to ibuprofen
* Patient is already on a NSAID, acetaminophen, anticoagulant or oral corticosteroid therapy for chronic pain treatment (a NSAID given in triage or use for the current injury is allowed)
* Use of other concurrent complementary medicine therapy, e.g. massage, acupuncture, physical therapy
* Patient has been treated for this injury in the past
* Patient has a bleeding/bruising disorder
* Patient is pregnant or is lactating
* Patient has a liver or kidney disease, malignancy, infection, immunodeficiency or metabolic syndrome
* Patient is allergic to the Asteraceae family of plants (arnica, ragweed, chrysanthemum, marigold, or daisy are the most common)
* Patient is nonverbal, and thus unable to give a pain score
* Patient does not have a working telephone (required for follow-up call)
* Family requires foreign language interpreter during their ED visit
Bioequivalency Study of CM082 Tablet in Healthy Volunteers

The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers.

The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers under fasted state or after meal. In addition, the safety of single dose administration of CM082 tablet in Chinese healthy volunteers will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Male body weight≥50.0kg or female body weight≥45.0kg; BMI between 19.0-26.0 kg/m2(inclusive)
* Generally in good health, with no history of chronic disease or sever disease
* No (clinical significant) abnormal findings in clinical laboratory tests and physical examinations
* No plan for pregnancy in coming 6 months, and must practice effective contraception; No plan for sperm or egg donation
* Written informed consent

Exclusion Criteria:

* History of food or drug allergies
* Clinical significant disease or disorders
* Received surgery in 3 months before screening, or have plan for surgery during the study
* Participated in other clinical trials within 3 months before screening
* Intolerant of venipuncture, history of fainting needle and blood
* Lactose intolerant
* Drug abusing in 3 months
* Donated ≥200 mL of blood within 3 months before screening
* Pregnant or under lactation period (female subjects)
* Received any prescription drug, over-the-counter drug, prescription drug and Chinese herbal drug in 2 weeks, with the exception of vitamins and acetaminophen
* Received any vaccine in 4 weeks
* Excessively smoking, alcohol or coffin-containing beverage drinking in 3 months
* Other circumstances that is deemed not appropriate for the study
The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis

The study is conducted to determine if image-based computer grading can of acne, melasma, rosacea and seborrheic dermatitis correlate well to expert based clinical severity grading.

The study is conducted to determine if image-based computer grading can of acne, melasma, rosacea and seborrheic dermatitis correlate well to dermatologist based clinical severity grading.

Eligibility Criteria:
Inclusion Criteria:

* Adults with acne, rosacea, melasma or seborrheic dermatitis

Exclusion Criteria:

* Prisoners
* Adults unable to consent
* Artificial facial markings on day of facial photography (such as piercings and tattoos) that may interfere with imaging in the opinion of the investigator
Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)

The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing mild to moderate soft tissue injuries when applied to the painful area.

This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with mild to moderate soft tissue injuries.

Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the diclofenac topical patch or a matching placebo patch to be applied once daily for 14 days. Patients will return to the clinic for assessments on Day 3, Day 7 and Day 14; a follow-up assessment will be conducted on Day 21. Patients will complete an electronic diary in which assessments including pain intensity and pain relief will be recorded twice daily. Functional disability and global impression of change will be recorded in the diary at study visits, ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18-75 years of age
* Sustained recent, painful unilateral mild to moderate soft tissue injury (between the mid-bicep to wrist or mid-thigh to ankle)
* Meet baseline pain criterion

Exclusion Criteria:

* Open wound or infection at site of injury
* Evidence of severe injury, including fracture or nerve injury
* Use of oral NSAIDs or opioids within 12-24 hours of injury
* Presence or history of peptic ulcers or GI bleeding
* A history of intolerance to NSAIDs, acetaminophen, adhesives
* Positive pregnancy test
* Positive drug screen
The Role of Micro Nutrient Supplement in Improvement of the Sperm DNA Fragmentation

Male from infertile couples are tested for semen analysis and sperm DNA fragmentation. Any case with high DNA fragmentation index (DFI) will be randomized indicated for multi-micro nutrient supplement (PROfortil™) in 3 months and then checked again post-treatment for (DFI). The IVF/ICSI cycles will be analyzed for pregnancy outcomes

Higher DFI is correlated with poor embryo development, lower implantation rate in intracytoplasmic sperm injection (ICSI) cycles and higher miscarriage rate.

The effectiveness of micro nutrients (PROfortil™) has been proven in improving sperm quality including sperm cell density, progressive motility and normal morphology.

This randomized controlled trial includes male from infertile couples treated at the Center for Reproductive Endocrinology and Infertility, Hue University hospital, Vietnam from November 2019 to November 2020.

The semen samples were collected from the husband after 3-5 days of abstinence and then evaluated for sperm motility, vitality, concentration and morphology by the guideline of World Health Organization (WHO) 2010.

Sperm DNA fragmentation (SDF) was measured using a sperm chromatin dispersion (SCD) test (Halosperm® kit, Halotech, Madrid, Spain). A total of 500 sperms were examined by only one highly trained technician to decrease variability. DFI was expressed as the percentage of sperms with small halo, without halo and degraded sperms over total of 500 sperms.

Any case with high DNA fragmentation index (DFI \>=30%) will be randomized indicated for (group 1) micro nutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months and (group 2) only Vitamin E (Enat 400 once per day) then checked again post-treatment for (DFI).

The IVF/ICSI cycles will then be analyzed for embryo quality, pregnancy outcomes including biochemical pregnancy rate, clinical pregnancy rate, on-going pregnancy, miscarriage.

Eligibility Criteria:
Inclusion Criteria:

- Male from infertile couples

Exclusion Criteria:

* Men with acute systemic diseases
* acute urinary tract infection
* hepatic function disorders
* malignant diseases
* retrograde ejaculation
* azoospermia
Doravirine Concentrations and Antiviral Activity in Cerebrospinal Fluid in HIV-1 Infected Individuals

Doravirine is a new HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) that has demonstrated a good efficacy and safety profile in clinical trials. It functions by inhibiting viral replication of both wild-type virus and most common NNRTI variants. It is dosed orally once daily and always given in combination with other HIV-1 active agents as part of highly active antiretroviral therapy. Initial pharmacokinetic studies demonstrated not extensive binding to plasma proteins, which may be crucial determinant for penetration to different reservoirs such as the central nervous system (CNS). This study will address two important issues: The pharmacokinetic profile of Doravirine in cerebrospinal fluid (CSF) as well as the maintenance of HIV suppression in CSF. The assessment of concentrations as well as the antiviral activity of new antiretroviral drugs in compartments such as CNS is relevant to avoid HIV-related neurocognitive disorders as well as for future cure strategies. In addition, the role of unbound ARV drug concentrations has been scarcely evaluated.

15 asymptomatic, virologically suppressed, HIV infected patients will be offered to switch their antiretroviral treatment to Doravirine+Emtricitabine/TAF. After 4 weeks of treatment all subjects will undergo lumbar puncture and bloods in order to assess CSF and plasma (total and unbound) Doravirine concentrations. HIV RNA also will be assessed. All subjects will complete a follow up visit 4 weeks after

Eligibility Criteria:
Inclusion Criteria:

1. Asymptomatic, HIV-1 infected individuals ≥ 18 years of age
2. Be on a stable ART continously or ≥3 consecutive months preceding the screening visit. Patients already receiving TAF/FTC+DoravirineC for at least three consecutive months will be eligible.
3. Plasma HIV-1 RNA at screening \<40 copies/mL for at least 3 months at the Screening visit.
4. Signed and dated written informed consent prior to inclusion.
5. Subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit throughout the duration of the study.

Exclusion Criteria:

1. Severe hepatic impairment (Child-Pugh Class C)
2. Ongoing malignancy
3. Active opportunistic infection
4. Primary resistance to any of the ARV included in the study or history of virologic failure with risk of resistance selection to any of the study drugs.
5. Any verified Grade 4 laboratory abnormality
6. ALT or AST ≥ 3xULN and/or bilirubin ≥ 1.5xULN
7. Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min
8. Females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding.
9. Current treatment with antiaggregant or anticoagulant therapy.
10. History of any neurologic disease/condition/treatment may alter the blood brain barrier permeability.
Classification of Adenocarcinoma of the Esophagogastric Junction

The Siewert classification of oesophageal cancer is the standard approach in anatomically subdividing cancer of the lower oesohagus.

Retrospective review of tumour biology, pathological staging and outcomes in the participants based on Siewert classification. The investigators to scrutinise this scoring system to evaluate if it is indeed appropriate.

Eligibility Criteria:
Inclusion Criteria:

* All patients

Exclusion Criteria:

-
An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum

The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of classic pyoderma gangrenosum
* An active pyoderma gangrenosum ulcer
* Contraceptive measures adequate to prevent pregnancy during the study

Exclusion Criteria:

* Clinical evidence of acutely infected pyoderma gangrenosum
* History of allergic or anaphylactic reactions to monoclonal antibodies
* History of recurrent or chronic systemic infections
* Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply
Reducing Sedentary Behaviour in University Students Using Text Messages

The primary purpose of the current study was to determine whether a text message intervention would increase break frequency and length of break from sitting, time spent standing, and time spent in light and moderate intensity physical activity in university students

Sedentary behaviour (SB) has been linked to many health problems (e.g., type 2 diabetes, heart disease). Interventions aimed at office workers, overweight and obese individuals have proven successful in reducing SB; however, no studies have examined university students.Text message-based interventions have succeeded to aid in smoking cessation and increase both physical activity and healthy eating, but have not been shown to reduce SB. Eighty-two university students were randomized into intervention (SB related text messages) or control (text messages unrelated to SB) groups. Participants received daily text messages and reported various SBs (i.e., breaks from sitting, standing, light and moderate intensity physical activity) at four time points (baseline, 2, 4 and 6 weeks).

Eligibility Criteria:
Inclusion Criteria:

* be able to read and write English
* own a cell phone with unlimited incoming text messages
* be a student at Western University

Exclusion Criteria:

* be under 18 or over 64
Cerebrospinal Fluid Rhinorrhea After Functional Endoscopic Sinus Surgery

Sinus surgery is a common procedure. A potential complication is injuring the membranes of the brain. This can lead to leakage of brain fluid through the nose. We would like to estimate the incident rates of that complication. At the end of the operation, a thin gauze is inserted into the nose on both sides in addition to the usual tampon. This gauze will be analyzed at the laboratory for beta-2-transferrin, which is a biomarker for brain liquid.

Sinus surgery is a common procedure in rhinology for the treatment of chronic inflammation, tumors and other pathologies. These procedures are performed in the immediate vicinity of the skull base. The risk of injuring the membranes covering the brain in a way that requires further treatment is less than 1% \[ 1\]. Such Injuries to the skull base could lead to the loss of cerebrospinal fluid (CSF). The destruction of the natural barrier raises the potential risk of ascending infections of the membranes and the brain itself from the nose. Leakage of cerebrospinal fluid in the usually bloody surgical field of view is not always distinguishable and is sometimes only noticed postoperatively. The spontaneous closure of a leaky membrane of the brain without further surgical treatment is known. This is why small traumata in the skull base often remain undetected.

At the end of the operation, a thin gauze is inserted into the nose on both sides in addition to the usual tampon. The tampon and the additional gauze are removed the day after the operation and will be sent with a tube of venous blood to the laboratory. The gauze and the venous blood will be checked for beta-2-transferrin, which is a biomarker for cerebrospinal fluid.

During further clinical standard controls will the patient be asked about symptoms of fluid leak through the nose.

If positive, regardless to this study, the patient must have an additional CT scan of the sinuses and another blood sample checking for beta-2-transferrin.

Eligibility Criteria:
Inclusion Criteria:

* All patients with planned sinus surgery in terms of Ethmoidektomie / Sphenoethmoidektomie or Frontosphenoethmoidektomie
* Male and female patients aged 18 to 99 years
* Written consent of the participating person after the enlightenment

Exclusion Criteria:

* Olanned or accidental opening of the skull base
* Tumor in the skull base
* Pre-existing known rhinoliquorrhoe
* Lack of understanding the study or investigation
Knowledge Attitudes Behaviours and Practices Regarding HIV of Men Who Have Sex With Men in the French Antilles and French Guiana

determine the Knowledge attitudes behaviours and practices regarding HIV of men who have sex with men in the French Antilles and French Guiana


Eligibility Criteria:
Inclusion Criteria:

* men who have sex with men aged over 18

Exclusion Criteria:

* refusal to participate
A Study of AK0529 in Adults Patients Hospitalized With RSV Infection

This is a randomized, double-blind, placebo-controlled, multicenter, phase II study to be conducted in adults hospitalized with RSV infection in China. The main objectives of this study are to investigate the safety, pharmacokinetics and efficacy of AK0529 in adult RSV patients.


Eligibility Criteria:
Main Inclusion criteria:

1. . Male or female patients of any ethnicity with an age of 18-85 years.
2. . Diagnosis of RSV infection by any virological means within 36 hours preceding initial dosing.
3. . At least one of the following high-risk diseases or states for RSV infection

   1. Asthma or chronic lung disease (such as COPD or cystic fibrosis),
   2. immunocompromised,
   3. Heart disease (such as congenital heart disease, congestive, heart failure, or coronary artery disease), except high blood, pressure without heart-related symptoms,
   4. Chronic kidney disease,
   5. Age ≥65 years old.
4. . With at least 1 new onset respiratory infection symptom or exacerbation of existing respiratory symptoms (respiratory symptoms include: sore throat, nasal congestion, runny nose, sneezing, coughing, wheezing, sputum production, shortness of breath), and any individual score is 2 or moderate.
5. . Onset of RSV infection symptoms should be ≤ 7 days.

Main Exclusion criteria:

1. . 3 days for drugs with potential antiviral effects on RSV such as ordinary interferon, 8 days for long-acting interferon, and 35 days for ribavirin for 5 half-lives before expected administration.
2. . Prohibited medicine are being used or planned to be used during the study treatment periods.
3. . Severe gastrointestinal diseases that affect the absorption of study drugs (such as vomiting, malabsorption syndrome, short bowel syndrome due to necrotizing enterocolitis, etc.).
4. . Received or planned to have bone marrow transplantation, stem cell transplantation or solid organ transplantation within 1 year.
5. . Patients with malignant tumors who had surgery within recent 6 months and/or requiring radiotherapy, chemotherapy and biological immunotherapy.
6. . Patients with autoimmune diseases who are in the induction treatment.
7. . HIV infection, CD4 count\< 350 cells/mm3 with opportunistic infection and need treatment.
8. . Other patients who are judged by the investigator to be unsuitable for participating in the study, such as acute/chronic heart, lung, liver, kidney, rheumatic immunity, psychiatric, blood and other diseases in the unstable period.
9. . History of drug abuse within 12 months prior to screening.
10. . Allergy to the investigational drug or its component.
11. . Female patients with positive pregnancy test or breastfeeding.