cyrilzakka/clinical-trials huggingface dataset:
The Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease

We will estimate the responses of lansoprazole and ecabet sodium combination therapy and compare with lansoprazole and placebo therapy in patients who need additional therapy after standard proton pump inhibitor treatment for 4week or more in recurrent gastroesophageal reflux disease.


Eligibility Criteria:
Inclusion Criteria:

* age 19-75 years
* patients with typical gastroesophageal symptom or erosive reflux esophagitis on gastroduodenoscopy
* patients with recurrent gastroesophageal symptom after standard proton pump inhibitor treatment for 4 weeks or more

Exclusion Criteria:

* patients with gastric ulcer or duodenal ulcer
* patients with gastric cancer or esophageal cancer
* pregnant or postpartum women
Evaluating Investigational Medical Device for Breast Tumor Diagnosis Using Diffusion Optical Spectroscopy

This is a multicenter, pivotal clinical trial to evaluate the safety and efficacy of a diagnostic device used to assist in the differentiation of breast tumors in patients with breast lesions detected by ultrasound alone or by both ultrasound and mammography.


Eligibility Criteria:
Inclusion Criteria:

* Female aged 19 years or older
* ACR BI-RADS Category 3-5 (5th edition, 2023 update)

Exclusion Criteria:

* Pregnant, potentially pregnant, or currently breastfeeding
* Calcifications detected on mammography but do not have corresponding lesions identified on ultrasound
* Biopsy performed on the same breast within 7 days prior to the date of informed consent
* Significant trauma or scarring at the measurement site, or those suffering from mastitis.
* Breast implants, electronic medical devices such as pacemakers, or with a space left in the breast cavity due to implant removal
* History of phototoxic reactions or light sensitivity
Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

The purpose of this study is to measure the hair growth response to topical NEOSH101 when applied twice daily to the balding scalp for 16 weeks. One hundred eighty men with Norwood/Hamilton grades III-IV with thinning in the top and center of the scalp will participate. Three equally sized treatment groups (60 men each) will receive either topical NEOSH101 2.0%, minoxidil 5%, or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian men, in general good health, aged 18-49 years
* Norwood/Hamilton grades III-IV, with thinning hair in the vertex area

Exclusion Criteria:

* concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
* treatment with a systemic or locally acting medication which may interfere with the study objectives, such as minoxidil treatment in the 6 months prior to study start, finasteride treatment in the 12 months prior to study start, or treatment with other investigational hair growth products in the 6 months prior to study start
Study of Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With Unresectable Hepatocellular Carinoma

This is a prospective, open label, multi-center, interventional study to assess the safety and efficacy of Druvalumab plus Tremelimumab as first-line treatment in Chinese patients with unresectable hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed HCC based on histopathological findings from tumor tissue or radiologically findings
* No prior systemic therapy for HCC
* Barcelona Clinic Liver Cancer (BCLC) stage B (not eligible for locoregional therapy) or stage C
* Child-Pugh Score class A or B
* ECOG performance status (PS) of 0-2 at enrollment (Child-Pugh Score class A and ECOG PS of 0-1 will be enrolled in cohort 1 and Child-Pugh Score class B or ECOG PS of 2 will be enrolled in cohort 2)
* At least 1 measurable lesion per RECSIT 1.1 guidelines

Exclusion Criteria:

* Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
* Clinically meaningful ascites
* Main portal vein tumor thrombosis
* Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 6 months
* HBV and HVC co-infection, or HBV and Hep D co-infection
Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosus (SLE) is a highly specific autoimmune disease that involves multiple systems due to abnormal immune activation. It is a classical diffuse connective tissue disease with autoimmune inflammation as its prominent manifestation. B cells are the core of systemic lupus erythematosus (SLE) pathogenesis. B Lymphocyte Stimulator (BLyS, also called BAFF) and A Proliferation-Inducing Ligand (APRIL) are signals for B cell maturation. B Lymphocyte Stimulator (BLyS) participates in promoting the development and maturation of B cells, while A Proliferation-Inducing Ligand (APRIL) participates in promoting the activation of mature B cells and the secretion of antibodies by plasma cells. Telitacicept is composed of the extracellular specific soluble portion of Transmembrane Activator and Calcium-modulating Cyclophilin Ligand (CAML) Interactor (TACI) and the Fragment crystallizable (Fc) segment of human Immunoglobulin G1 (IgG1). It is the only globally approved dual-target biological agent for the treatment of systemic lupus erythematosus (SLE) , blocking B Lymphocyte Stimulator (BLyS) and A Proliferation-Inducing Ligand (APRIL), hindering the development and activation of B cells, and the production of antibodies, comprehensively inhibiting the maturation, proliferation, and differentiation of B cells at different stages. In this study, the investigators will explore the adherence and influencing factors of telitacicept in systemic lupus erythematosus (SLE) patients, its effectiveness, and safety, providing a stronger basis for clinical management of systemic lupus erythematosus (SLE) patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, not exceeding 70 years old (including 70 years old);
2. Patients diagnosed with systemic lupus erythematosus (SLE) according to 2019 American College of Rheumatology/European League Against Rheumatism (2019ACR/EULAR) international classification diagnostic criteria;
3. Accepting the treatment of telitacicept.

Exclusion Criteria:

Subjects who meet any of the following criteria should be excluded from this study:

1. Patients with other rheumatic immune system diseases;
2. Patients in the active stage of acute and chronic infections;
3. Patients using other biologics;
4. Patients with wasting diseases such as malignant tumors
The Effect of Eye Mask and Music on Sleep Quality and Delirium in Patients Monitored in Intensive Care Unit

After abdominal surgery, most patients experience problems such as respiratory complications, surgical wound infection, cardiac problems, renal failure, delirium, and insomnia, along with surgical trauma and underlying comorbidities. Postoperative delirium (POD) is an adverse postoperative complication that can occur in patients of all ages, from children to the elderly. Effective non-pharmacological treatment approaches for delirium include using an orientation board, calendar, clock, ensuring hydration, improving sleep quality, therapeutic activities, providing companionship of family members, and building private rooms. This study conducted as a randomized controlled and experimental study to determine the effect of eye patch and music on sleep quality and delirium in patients followed after abdominal surgery in the surgical intensive care unit.

It was planned to include a total of 34 patients who underwent abdominal surgery, 17 in the experimental group and 17 in the control group.Considering possible sample loss, the study was completed with 45 patients, 21 in the experimental group and 24 in the control group.

During the data collection phase, the Patient Information Form, Richard-Campbell Sleep Scale, Nursing Delirium Screening Scale and Richmond Agitation-Sedation Scale, were used.


Eligibility Criteria:
Inclusion Criteria:

* Those who have had abdominal surgery
* Those who volunteer to participate in the research
* Those who are over 18 years old
* Richmond Agitation-Sedation Scale -1, 0, +1
* Those who have been in intensive care for at least 3 days
* No communication problems (language, hearing impairment, etc.)
* No mental problems
* Patients who do not use sleeping pills or sedating drugs and who do not have alcohol or substance addiction will be included in the study.

Exclusion Criteria:

* Those who experience blood loss and fluid electrolyte imbalance after surgery
* There are contraindications to the use of eye masks (for example, head trauma),
* Patients with delirium before or after surgery will not be included in the study.
Nutritional Evaluation of Canola Protein in Comparison With Soy Protein

The objective of the study is to evaluate the nutritional and physiological properties of two canola proteins focusing on the bioavailability in humans.

The physiological effects of a single administration of two different industrially manufactured canola proteins (hydrolyzate, isolate) were investigated compared to soy protein.

Twenty-eight healthy men (ø 25 years) completed a double-blind, placebo-controlled, crossover study. The subjects were randomly divided into two groups (group A: canola protein isolate and soy protein isolate and group B: canola protein hydrolyzate and soy protein isolate). After a three-day run-in period, on the intervention day, the subjects consumed a protein drink containing 30.0 g protein powder added to a final volume of 500 mL tomato juice. Half of the subjects in each group consumed a protein drink containing 30.0 g canola protein, the other half received the soy protein. After taking of fasting blood samples in the morning of the intervention day, blood samples were drawn at regular intervals for a period of eight hours. At the end of the run-in period and on the intervention day, a 24-hour urine collection took place.

Within a second experiment (after 4 weeks), the protein source was crossed within the four subgroups for the second intervention.

Eligibility Criteria:
Inclusion Criteria:

* Nonsmoker
* Body mass index: 20-26 kg/m²

Exclusion Criteria:

* Intake of pharmaceuticals
* Allergy against canola protein or soy protein
* Kidney disease
Management of PADIS in Emergency Intensive Care Unit

Investigate the prevalence of PADIS in EICU, as well as the awareness and clinical implementation status of medical staff towards PADIS.

The investigators conducted a multicenter cross-sectional survey in mainland China, including a one-day point prevalence investigation and a questionnaire survey. The inclusion criteria encompassed all adult patients admitted to the participating emergency department intensive care units (EDICUs) during the on-site screening, while exclusion criteria comprised patients aged less than 18 years, EDICU stays duration less than 24 hours before the screening, and participation in other concurrent trials. Hospital and nursing records from the 24 hours preceding enrollment were examined to document the assessment rate of pain, agitation-sedation, and delirium. Physicians and nurses on duty 24 hours before the patients\&#39; enrollment was invited to complete the questionnaire survey regarding the ICU profiles, professional expertise, assessment and treatment of PAD, early mobilization, and sleep improvement practices.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the participating EDICU during the on-site investigation

Exclusion Criteria:

* Age less than 18 years;
* EDICU stay duration before the screening was less than 24 hours
* Enrollment in other concurrent trials.
Difference of Information Gain Between Video-base and Doctor Interview After Preanesthetic Visit

To investigate the differenec of patients' satisfaction and information gain betweem face-to-face interview and video introduction

We made up a video which showed the type, the method, the risk, and the benefit of all anesthesia with words, pictures, and image. A study nurse will ask the will of patients. The patients enrolled in the study will be randomly divided into traditional group(control group) and study group(study group). The study group will watch the video at first, then our anesthesiologist visit the patient. The control group will receive traditional anesthesiologist visit. After doctors' visit, the patients have to complete a test and a questionnaire. The patients who don't participate in the study will have traditional visit and no test.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients were included who were scheduled to undergo elective surgery

Exclusion Criteria:

* Postoperative stay in the intensive care unit was expected or unexpected.,Repeated general anesthesia had been performed in the previous 6 months,ASA classification was more than or equal to III,There were pronounced cognitive and or speech barriers
The Efficacy of Dexmedetomidine Versus Labetalol In Providing Controlled Hypotension In Dacryocystorhinostomy SurgeryA Comparative Randomized Prospective Study

The most important symptoms of nasolacrimal duct obstruction are excessive tearing and mucoid discharge.

The proposed treatment in this regard is dacryocystorhinostomy (DCR) surgery. Therefore, hemostasis is of great significance in performing DCR surgery. In this regard, the reduction of controlled hypotension and the control of hemodynamic responses of the body to stress effectively reduce the bleeding volume during surgery.

Hence, there is no enough studies about controlled hypotension in DCR we decided to perform such a comparison between the effect of dexmedetomidine and labetalol in providing controlled hypotension during DCR surgery.


Eligibility Criteria:
Inclusion Criteria:

* physical status I or II according to ASA classification, age between ( 18 - 60 years )

Exclusion Criteria:

* Patients with physical status other than 1 and 2 according to ASA classification as :Hypertension, Diabetes mellitus, Ischemic heart diseases, Severe anemia, COPD, History of stroke, Impaired liver or renal function, Increase intercranial tension.
* Allergy to any of the drug included in this study.
Tislelizumab Combined with Chemotherapy and Relayed Radiotherapy in First-line Treatment of ES-SCLC

To explore the efficacy and safety of Tislelizumab combined with chemotherapy and relayed radiotherapy in the first-line treatment of extensive small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years old, male or female, signed Informed Consent Form (ICF);
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
3. Histologically or cytologically confirmed ES-SCLC;
4. No prior systemic treatment for ES-SCLC;
5. At least one measurable (RECIST 1.1) chest lesion capable of 15Gy/5f irradiation;
6. Adequate hematologic and end organ function;

Exclusion Criteria:

1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis;
2. Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody;
3. Was administered a live vaccine ≤ 4 weeks before treatment;
4. Active autoimmune diseases or history of autoimmune diseases that may relapse;
5. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before treatment;
6. With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;
7. Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to treatment, including but not limited to tuberculosis infection;
8. Received therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to starting treatment;
Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean

Postdural puncture headache (PDPH) is a common complication after spinal anesthesia. The role of pregabalin and hydrocortisone in the treatment of PDPH is unclear. The aim of this work is to assess and compare the efficacy of both drugs in severe cases of PDPH after spinal anesthesia for elective cesarean section.

The study will be done on 30 patient with PDPH with VAS score ≥ 5 after spinal anesthesia for elective cesarean section. Patients will be divided into three groups: Control group (group C):will receive conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours. Pregabalin group (group P): will receive the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours. Hydrocortisone group (group H): will receive the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours. The three groups will be compared regarding the headache intensity using a visual analog scale.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent elective cesarean section under spinal anesthesia.
* Patients aged 18 to 40 years old.
* Patients classified as ASA I or II.

Exclusion Criteria:

* Patients with known sensitivity to any of the used drugs.
* Patients classified as ASA III or more.
* Preeclampsia.
* Patients with a history of chronic headache or migraine Patients receiving pregabalin for chronic pain.
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SOL-804 in Healthy Male Subjects

Study Design : A randomized, open-label, four-sequence, four-period, crossover, single dosing, phase 1 study

To evaluate the safety, tolerability and pharmacokinetic characteristics of SOL-804-F and Zytiga tablets following a single oral dose and Zytiga 1,000 mg in healthy male volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. healthy adult male volunteers between 19 to 50 years of age at screening visit.
2. Body mass index (BMI) between 19.0 to 30.0 kg/m2
3. The subjects voluntarily decide to participate in the study after receiving a full explanation and understanding and provide written consent
4. The subjects are suitable for this study as determined by the investigator (physical examination, clinical laboratory tests, etc.)

Exclusion Criteria:

1. Clinically significant abnormal physical examination, vital signs or ECG
2. The subjects who have a medical history of hepatobiliary, renal, neurological, immune, respiratory, endocrine, hematologic, oncologic, cardiovascular, urinary, psychiatric or sexual dysfunction.
3. The subjects who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
4. The subjects who have a history of drug abuse or positive with urine drug screening test
Comparison of Wash Wipes and Standard Care in the Prevention of Incontinence-associated Dermatitis in Elderly

Incontinence is a widespread problem in all health care setting. One of the main complications of incontinence is inflammation of the skin in the genital and anal region, also known as incontinence-associated dermatitis (IAD). IAD is a known risk factor of pressure ulcer development. Prevalence figures of IAD vary between 5.6% and 50%.

The primary aim of this study is to compare the effectiveness of a 3-in-1 genital wipe versus standard care (traditional water and soap) for the prevention of IAD. The second aim is to perform a health economic evaluation of the 3-in-1 genital wipe versus standard care, and third to compare the cost of a 2-in-1 total body wash wipe versus standard care for total body wash. Other outcomes are the comfort and tolerance of both the nurses and participants.

In this Randomized Controlled Trial, performed in 13 long-term care settings, the participants will undergo a 30 day study period. In the experimental intervention, the participants will be washed with body wash wipes and genital wipes. In the control group, the subjects will receive traditional care. IAD as well as Pressure Ulcer prevalence will be monitored. Subjective and objective time measurements will be performed.


Eligibility Criteria:
Inclusion Criteria:

* urinary incontinence, fecal incontinence or double incontinence
* depending on help for washing
* free of skin damage (without signs of pressure ulcers or IAD such as skin breakdown or redness)

Exclusion Criteria:

* not incontinent or minor incontinent (e.g. stress incontinence)
* urinary or fecal catheter
* use of incontinence wipes in the uro-genital area two weeks prior to the start of the study
* the use of a skin barrier product in the uro-genital area two weeks prior to screening
* presence of a bacterial/fungal infection in the uro-genital area
Comparison of Two Soft Bifocal Contact Lenses

The purpose of the study is to compare the visual performance of two soft bifocal contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* The subject must between 35 and 70 years of age.
* The subject must have presbyopic symptoms or be already wearing presbyopic contact lens correction.
* The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 or -9.00 to -10.00 in each eye.
* Refractive cylinder must be -0.75 D in each eye.
* The subject must have an ADD power of +0.75D to +2.50D in each eye.
* The subject must have best corrected visual acuity of 20/20-3 or better in each eye
* The subject's must have at least 20/30-distance vision OU with the study contact lenses.
* The subject must agree that they are comfortable with their vision prior to being dispensed the study lenses
* The subject must be an adapted soft contact lens wearer in both eyes.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.

Exclusion Criteria:

* Ocular or systemic allergies or disease that may interfere with contact lens wear.
* Systemic disease, autoimmune disease or use of medication, which may interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear
* Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation
* Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* History of diabetes
* History of binocular vision abnormality or strabismus