cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults and adolescents (≥12 years and ≥40 kg)
* Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit
* Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit
* Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
* ≥10% body surface area (BSA) of atopic dermatitis involvement at the baseline visit
* History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable

Exclusion Criteria:

* Prior treatment with dupilumab or tralokinumab
* Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit
* Treatment with any of the following agents within 4 weeks prior to the baseline visit:

  * Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
  * Phototherapy and photochemotherapy (PUVA) for AD
* Treatment with the following prior to the baseline visit:

  * An investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer
  * Cell-depleting biologics, including to rituximab, within 6 months of baseline
  * Other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever is longer
* Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study
* Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma
* Evidence of active acute or chronic hepatitis
* History of human immunodeficiency virus (HIV) infection or positive HIV serology
* History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting

The purpose of this study is to assess the efficacy and safety of SP-01 in chemotherapy-induced nausea and vomiting (CINV) associated with the administration of moderately or highly emetogenic (ME or HE) multi-day chemotherapy，which will provide scientific and reliable clinical data in the drug registration in China.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 18years
* Histologically and/or cytologically confirmed cancer
* The physical status score ECOG ≤ 2
* Life expectancy of ≥3 months
* Will receive multi-day ME/HE chemotherapy (≥2 days) with the emetogenic potential of level 3-5
* In accordance with the indication of chemotherapy and basic requirements;

  * Peripheral Haematology: Hb ≥ 9.0 g/dL, absolute neutrophil count ≥ 1.5×10e9/L, platelet count ≥ 80×10e9/L
  * Blood biochemistry: Total bilirubin \< 1.25×ULN, ALT and AST ≤ 2.5×ULN; if liver metastasis, ALT and AST \< 5×ULN, Creatinine ≤ 1×ULN, basic normal serum electrolyte (Na, Ka, Cl, Ca)
  * Other important organs function normally
* Subjects voluntarily participate and signed the informed consent form
Follow-up on the HIGH: Low Study - the Longterm Effects of Growth Hormone

A follow-up study on the randomized, controlled, double-blind HIGH: low study. We will examine the participants from the HIGH: low study min. 6 months after finishing the HIGH: low study. We will look at the parameters: quality of life, sugar-metabolism, fat-metabolism, fat-redistribution and cytokines. The study will use the participants control visit, and the only additional examination will be the danish MOS-HIV questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* Participated in and completed the HIGH: low study
* informed consent signed

Exclusion Criteria:

* Patient stopped at Hvidovre Hospital, or didn't finish the HIGH: low study
Circulating Tumor DNA in Surgical Lung Cancer Patients

Conduct a prospective study to detect the change of ctDNA of surgical lung cancer patients.

Studies have shown the feasibility of detecting mutation status by blood circulating tumor DNA (ctDNA) in lung cancer patients.

The investigators plan to test the blood ctDNA in surveillance of surgical lung cancer patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.

Eligibility Criteria:
Inclusion Criteria:

Aged 18 to 80 years Undergo radical surgery Histologically confirmed diagnosis of lung cancer Considered primary lung cancer by clinical criteria Patients must have given written informed consent

Exclusion Criteria:

Unable to comply with the study procedure Malignant tumor history Patients who received any treatment prior to resection Unqualified blood samples
Postoperative Pain and Polyamines-poor Diet (DOLAMINE)

Animal studies have shown that the level of pain sensitivity is highly dependent on the amount of polyamines in food. This fundamental observation of a nutritional approach to pain led the authors to develop diets completely depleted in polyamines whose anti-nociceptive properties have been confirmed in animals.

Postoperative pain after foot surgery are currently fairly well controlled but at the cost of a high consumption of grade II analgesics which is associated with a high rate of side effects (nausea, vomiting ...). The investigators' hypothesis is that a diet low in polyamines may have an additive effect on pain control and reduce the consumption of level 2 analgesics.

The objective of this study is to show the efficacy of a polyamines-poor diet on postoperative pain in ambulatory surgery of the foot.


Eligibility Criteria:
Inclusion Criteria:

* foot ambulatory orthopedic surgery
* surgery scheduled at least 10 days after the inclusion consultation

Exclusion Criteria:

* other diet susceptible to interfere with the poor or high-polyamines diets (e.g. diabetic patients)
* contraindication to tramadol or to NSAIDs
* pregnant or breastfeeding woman
* patient under legal protection
* patient's opposition to participate in the study
* poor understanding of French
* absence of affiliation to social security
* participation to another study
Oral Isotretinoin for Photoaging: Results of a Randomized Controlled Phase II Trial

A clinical and histological randomized controlled phase II trial to evaluate the efficacy and safety of oral isotretinoin for treating photoaging was performed with 32 menopausal or sterilized women aged 40-55y. The subjects were included in two randomly selected groups: A- 21 women received 20mg oral isotretinoin 3x week, moisturizer, sunscreen SPF 60 during three months; B- 11 women received only same moisturizer/sunscreen.

Clinical assessment ranging from -2=very bad to +2=very good for all patients. Also, profilometry, corneometer and skin elasticity tests in periocular regions and left forearm; skin biopsy on left forearm before/after treatment in B and in 10 randomly selected patients from A. Microscopic evaluation of corneal layer and epidermal thickness, dermal elastosis, new collagen and p53 epidermal expression performed by quantitative digital image analysis. Blind evaluations (group/time) conducted by two independent observers.

Clinical evaluation results showed no alterations (0) or slight improvement (+1) for all patients; profilometry, corneometer and skin elasticity measurements presented a significant difference in pre and post treatment values (p=0,001 to 0,028) with no differences between A/B. Regarding histological findings and p53 expression no previous differences between groups before the treatment were observed (p\>0,1).Quantitative microscopic digital analysis demonstrated no differences between groups at the end of the study for the majority of variables. However, slight but significant difference between A/B subjects was found for p53 with major expression reduction for those treated with oral isotretinoin \[0,66±0,31 vs 0,94±0,34 respectively (p=0,04)\]. The main side effects were cheilitis in 15 patients (75%) and xerophthalmia in 5 (25%). No significant alterations occurred in biochemical tests.

Eligibility Criteria:
Inclusion Criteria:

* menopausal or sterilized women

Exclusion Criteria:

* woman at risk of pregnancy, with alterations on liver function or lipid profile
Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women

The purpose of the study is to evaluate the efficacy and safety of two doses of ERB-041 (75 mg and 150 mg) relative to placebo on the relief of endometriosis-related symptoms (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive aged women.


Eligibility Criteria:
Inclusion Criteria:

* Surgical diagnosis of endometriosis within the last 10 years
* Sexually active, nonpregnant, nonlactating women (18-45 years) with regular menstrual cycles who are willing to use non-hormonal contraception

Exclusion Criteria:

* Conditions requiring the use of chronic pain therapy
* Prophylactic use of analgesics to avoid endometriosis-related pain
Lung Ultrasound Guided Prevention of Postoperative Pulmonary Complications in Moderate to High Risk Patients

Postoperative pulmonary complications (PPCs) occur in many patients, especially those with high risks, and are associated with increased hospital length of stay, morbidity and costs of care. According to European Perioperative Clinical Outcome definitions, major pulmonary complications include atelectasis, respiratory infection, pleural effusion, and pneumothorax. Because identifying patients at high risk for PPCs may allow earlier treatment, predictive scores ( the Assess Respiratory Risk in Surgical Patients in Catalonia score \[ARISCAT\]) have been developed.Lung ultrasound (LUS) is more accurate than chest X-ray in diagnosing pulmonary complications, and lung ultrasound performed in the postanesthesia care unit may identify patients at higher risk for pulmonary complications. So we aimed to study if lung ultrasound can guide the prevention of PPCs in moderate to high risk patients.

patients recruited are randomized into the two groups: LUS group and Control group. Patients in LUS group received ultrasound examination and guided the treatment according to the ultrasound results, while the control group did not receive ultrasound examination, just the same as the routine clinical practice. This study aims to explore whether ultrasound-guided clinical treatment can reduce the incidence of postoperative pulmonary complications in moderate to highrisk patients. Before operation, informed consent was signed according to the inclusion criteria, and the incidence of pulmonary complications within 5 days after operation (or before discharge) was recorded after operation.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 Estimated ARISCAT score ≥26分

Exclusion Criteria:

* transferred to ward or ICU directly day surgery (patients won't stay in hospital longer than 24 hours after surgery actual ARISCAT score \< 26分 the technical incompatibility of the acoustic window patients refused pregnant
Phase I Clinical Study of AV-1959R: Abeta-targeting Anti-Alzheimer's Vaccine

This Phase 1 clinical trial evaluates the safety, tolerability, and immune response of the adjuvanted AV-1959R vaccine in healthy adults aged 40-60. Participants will receive three intramuscular injections of either adjuvanted AV-1959R (100 µg or 300 µg) or adjuvanted placebo at Weeks 0, 4, and 14, followed by an 8-week follow-up. Researchers will monitor for side effects and measure anti-Aβ antibody levels to assess immune response. This study will help determine if AV-1959R is safe and effective in generating a targeted immune response.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female adults, 40-60 years old.
* BMI 18.0-32.0 kg/m².
* No significant medical conditions or abnormal MRI, ECG, or lab tests.
* Signed informed consent and ability to follow study procedures.
* Females must be postmenopausal or surgically sterile.
* Males must use contraception or be vasectomized.

Exclusion Criteria:

* History of Alzheimer's, stroke, or neurodegenerative disease.
* MRI abnormalities, such as infarcts or microbleeds.
* Serious illness, surgery, or hospitalization in the last 4 weeks.
* Significant heart, lung, liver, kidney, or immune disorders.
* Recent drug/alcohol abuse or severe allergies.
* Abnormal lab tests (e.g., high liver enzymes, kidney dysfunction, HIV, Hepatitis B/C positive).
* Use of investigational drugs or amyloid/tau therapies in the last year.
* Chronic use of immunosuppressants, anticoagulants, or blood products.
* Pregnant, breastfeeding, or women of childbearing potential.
* Recent blood donation (\>400 mL) in the last 30 days.
Project A4sc - An Atlas of Airways at a Single Cell Level

The increasing incidence of chronic respiratory diseases is a public health problem affecting hundreds of thousands of people around the world, including children. Directly exposed to atmospheric aerocontaminants (pollution, allergens), the respiratory tracts represent a complex ecosystem that involves different cells that develop complex interactions with the surrounding connective tissue but also with their rich immune environment and with the microbiota. Although a pathophysiological continuum is postulated between the nasal and bronchial airways in certain diseases, such as allergic diseases, we have identified broad gradients in gene expression between nasal and bronchial samples. This is why cellular variability throughout the respiratory tree needs to be studied in detail.

The sequencing of RNAs specifically present in a particular cell, and its comparison with neighboring cells, allows us to document precise cellular contributions and intercellular relationships. Our project will establish protocols to stabilize airway swabs by brushing and/or biopsy, under conditions that will then allow the analysis of gene expression profiles at the single cell level (single cell RNA sequencing).

The development of the "single cell" stabilisation and analysis protocol will first be carried out on primary respiratory epithelium cultures and then extended to respiratory specimens taken from healthy volunteers. Through sampling at several levels of the respiratory tree, variations in expression along the tracheobronchial axis will be fully documented. Finally, the interaction between the epithelial compartment and the immunological compartment will be studied by analyzing gene expression on a single cell in different physiopathological contexts.


Eligibility Criteria:
Inclusion Criteria:

* age \<40 years
* non-smoker
* absence of known acute or chronic disease
* absence of symptoms suggestive of progressive disease
* normal clinical examination

Exclusion Criteria:

* recent rhino-bronchial infection (\<6 weeks)
* mental disability
* pregnant women (a urine test will be performed for all women of childbearing age)
A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects with DME

This is a multicenter, randomized, parallel study to evaluate the efficacy and safety of two doses of ENN0403 in subjects with diabetic macular edema (DME). Approximately 60 subjects will be randomized to receive ENN0403 capsule orally once a day at the low dose or high dose with a 1:1 ratio. The study period consisted of up to 2 weeks of screening, 12 weeks of treatment and 2 weeks of follow-up, and the entire trial period was up to 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent;
2. Aware of the entire study process and requirements, understands the importance of medication compliance and completing all assessments on time throughout the study, and agrees to strictly follow the protocol and study procedures, including restrictions on drug combination during the study;
3. Diagnosis of type 1 or type 2 diabetes mellitus and HbA1c≤10.0% with regular use hypoglycemic drugs and stable glycemic control 1 month before screening (at the discretion of the investigator);
4. The decrease of BCVA is mainly caused byDiabetic Macular Edema in the study eye;
5. BCVA letter score of ≤ 73 (Snellen 20/40) and ≥ 24 (Snellen 20/320) at screening visit and at baseline. If both eyes meet the inclusion criteria, the study eye will be determined by the investigator from a medical perspective. ( If both eyes meet the inclusion criteria，the eye with poor baseline vision will be selected as the study eye; If the BCVA number is the same, choose the eye with the thicker CRT as the study eye) ；
6. Optical Coherence Tomography (OCT) foveal CRT at screening measuring ≥300 μm.

Exclusion Criteria:

1. Study eye with any eye disease or medical history other than DME that causes or may cause irreversible vision loss;
2. Study eye had glaucoma filtration surgery in the past or may have the surgery during the study;
3. Study eye had previously undergone vitreoretinal surgery;
4. Study eye received intraocular hormone drugs within 6 months prior to baseline or periocular or systemic hormone drugs within 3 months prior to baseline;
5. Any eye received intraocular injection of VEGF within 3 months prior to baseline;
6. History of idiopathic or autoimmune uveitis in any eye;
7. Uncontrolled glaucoma in any eye (defined as IOP ≥25 mmHg after treatment with anti-glaucoma drugs)
8. History of allergy to the investigational drug or any ingredient, or to any ingredient used during the treatment;
9. Use of any other investigational drug or device within 3 months or 5 half-lives prior to baseline (whichever is longer);
10. Other factors considered inappropriate for inclusion in this study at the discretion of the investigator.
A Study to Assess the Pharmacokinetic (PK) Comparability of 2 Fixed Subcutaneous (SC) Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous (IV) Dose in Healthy Volunteers

The primary objective of the study is to evaluate the pharmacokinetic (PK) comparability of 2 fixed subcutaneous (SC) doses of aducanumab with a single, weight-based intravenous (IV) dose of aducanumab in healthy volunteers. The secondary objectives of the study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional PK parameters of 2 fixed SC doses of aducanumab and a single, weight-based IV dose of aducanumab.


Eligibility Criteria:
Key Inclusion Criteria:

* Have a body mass index between 18 and 30 kilograms per meter square (kg/m\^2), inclusive
* Japanese participant has both biological parents and all 4 grandparents of Japanese descent
* Have a negative polymerase chain reaction test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -1

Key Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator
* History of severe allergic, anaphylactic or systemic hypersensitivity reactions, or of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by aducanumab, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study
* History of, or positive test result at Screening for, human immunodeficiency virus
* History of hepatitis C infection or positive test result at Screening for hepatitis C virus antibody
* Symptoms consistent with SARS-CoV-2 infection, per the judgment of the Investigator, within 14 days prior to Day -1, including but not limited to fever (temperature \> 37.5 degrees Celsius \[°C\]), sore throat, new and persistent cough, shortness of breath, diarrhea, muscle aches, or loss of taste or smell
* Current enrollment in any other drug, biological, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Day -1, or 5 half-lives, whichever is longer
* Any immunization or vaccination given within 10 days prior to administration of study treatment and for 10 days after administration of study treatment
* Mini mental state examination score of \< 27 at Screening

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Iliopsoas Nerve Block and Femoral Nerve Block in Hip Fracture Surgeries

This study aims to compare iliopsoas nerve Block (IPB) to femoral nerve block (FNB) regarding pain control, patient satisfaction, and early ambulation in patients undergoing hip fracture surgeries

Hip fractures are among the most frequent fractures seen in the emergency department and orthopedic trauma teams. The terms hip fracture and neck of femur fracture are used synonymously. Both terms describe a proximal femur fracture between the femoral head and 5 cm distal to the lesser trochanter.

Iliopsoas nerve Block (IPB) is a promising motor-sparing analgesic technique that selectively targets the sensory branches of the hip joint originating from the femoral nerve and accessory obturator nerve, sparing the motor supply of quadriceps muscles.

A femoral nerve block (FNB) is a simple nerve block that can be performed easily without or under ultrasound guidance. Under ultrasound guidance, the femoral artery and femoral nerve were identified clearly, and a needle was inserted using an in-plane approach from the lateral to the medial direction. Once the needle tip's position was confirmed, 10 ml of 0.5% bupivacaine was injected adjacent to the femoral nerve.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I and II.
* Patients who are scheduled for elective surgical correction of hip fracture either through open fracture internal fixation (ORIF), partial hip arthroplasty or total hip arthroplasty.

Exclusion Criteria:

* Refusal to participate.
* Coagulopathy.
* Patients with a history of drug allergies to study drugs.
* Inability to cooperate.