cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer

This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4/6 inhibitor combined with endocrine therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).
2. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.
3. Life expectancy ≥ 3 months.
4. Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries/other local therapies.
5. At least one measurable lesion.
6. Laboratory test results meet the relevant requirements for organ function.
7. Subjects who agree to take effective contraceptive measures.

Exclusion Criteria:

1. Inflammatory breast cancer.
2. Patients unsuitable for endocrine therapy at the investigator's discretion.
3. History of other malignancies prior to the start of study treatment.
4. Patients with known metastases to central nervous system.
5. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.
6. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery.
7. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment.
8. Pregnant or lactating women.
9. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; ≥ NYHA (New York Heart Association) Class II; mean QTc interval ≥ 470 ms before the start of study treatment; left ventricular ejection fraction ≤ 50% before the start of study treatment.
10. History of ischemic stroke or severe thromboembolic disease before the start of study treatment.
11. Hepatitis B surface antigen positive and HBV (Hepatitis B Virus) DNA \> 2,000 IU/mL or \> 104 copies/mL; HCV (Hepatitis C Virus) antibody positive and HCV RNA positive; or known HIV infection.
12. History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product.
13. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment.
14. Presence of uncontrolled infections before the start of study treatment.
15. Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders.
16. Presence of other diseases that the risks of receiving the study treatment outweigh its benefits, as determined by the investigator, or any other reason for which patients are ineligible for the study as assessed by the investigator.
Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application

Insomnia is an important public health problem and the most common sleep disorder in the general population. Up to 20% of adults in the United States suffer from insomnia disorder, and it has been associated with increased morbidity, mortality, and healthcare costs. Cognitive behavioral therapy for insomnia (CBT-I) is the initial recommended treatment approach for insomnia. Combined therapy with CBT-I and medication has shown no advantage over CBT-I alone. CBT-I is not always accessible to patients, however, due to cost and availability of trained healthcare professionals. Web-based CBT-I is an inexpensive and effective self-management tool for treatment of insomnia.

This pilot study would test the efficacy of a new digital CBT-I application called Stellar Sleep, a cost effective and user-friendly version of wCBT-I, in patients with insomnia. This is the first digital CBT-I app that allows automatic entry of sleep diary data from wearable devices that track sleep (such as the Mi Band 5 or a FitBit, for instance). Testing the efficacy of this application will provide the preliminary data necessary for larger trials to further validate the application and determine its role for future patients. Use of this application can help bridge the gap in providing care to insomnia patients with transportation and cost barriers and to accommodate the long wait times for traditional in-person CBT-I. It will also be the first web-based CBT-I application that can directly upload data from a wearable device.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Daily access to a computer or smartphone with reliable internet connection

Exclusion Criteria:

* Currently pregnant or planning to become pregnant in the next year
* Visual impairment that prevents use of a computer
* Serious health conditions that will prevent taking part in the study over the next 3 - 6 months, such as severe medical or psychiatric disease, such as treatments for cancer or congestive heart failure, OR a condition that may require hospitalization or surgery
* Self-reported history of drowsy driving or fallen asleep while driving
* Night shift worker
* Prior exposure to Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment
* Insomnia severity index score \< 14
Case Series of Weekly Applications of dHACM in Treatment of Pressure Ulcers

A prospective case series investigating the efficacy and safety of dehydrated human amnion/chorion membrane (dHACM) in the treatment of patients with Stage II or III pressure ulcers


Eligibility Criteria:
Inclusion Criteria:

1. Index ulcer characteristics:

   1. Ulcer present for ≥ 30 days (Day 0)
   2. Index ulcer is located spine, lower back or buttocks
   3. Index ulcer area after debridement is ≥ 2 cm² and ≤ 25 cm² at the randomization visit
   4. Ulcer must be Stage II or III as determined by the National Pressure Ulcer Advisory Panel (NPUAP) pressure ulcer staging system
2. Subject criteria must include:

   1. Age 16 or older
   2. The subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study (minors will provide assent with consent provided by parent)

Exclusion Criteria:

1. Index ulcer characteristics that will make subject ineligible for enrollment:

   1. Stage I or IV ulcers as determined by NPUAP pressure ulcer staging system
   2. Signs and symptoms of local infection
   3. Previous surgical procedure performed at site
   4. Known or suspected local skin malignancy at index ulcer site
   5. Prior radiation therapy treatment at the index ulcer site
2. Subject criteria that will make subject ineligible for enrollment:

   1. Presence of other diseases which, in the Opinion of the Investigator, may result in allograft failure or has experienced graft failure in the past (examples include: immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV)
   2. Currently taking medications which in the opinion of the investigator may affect graft incorporation
   3. Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
   4. Any condition(s) that in the opinion of the investigator may seriously compromises the subject's ability to participate in this study. Examples include: known history of poor adherence with medical treatment, current drug or alcohol abuse or a medical/psychiatric condition
   5. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
   6. Subjects currently enrolled in this study (i.e. concurrent enrollment in the study is prohibited)
   7. Subject has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
   8. Any pathology that would limit the blood supply and compromise healing
   9. Subject is a prisoner
Topical Bromfenac for Intraoperative Miosis and Pain Reduction

To evaluate the effect of bromfenac ophthalmic solution 0.09% for reduction of intraoperative miosis and pain in patient who have undergone femtosecond laser-assisted cataract surgery.

This prospective cross-sectional randomized clinical study included 60 patients with senile cataract in the absence of significant ocular comorbidity. The patients received 0.09% bromfenac ophthalmic solution or control placebo twice a day for 3 days before surgery. Pupil diameter was measured at the initiation and finalization of femtosecond laser-assisted cataract surgery and pain quantification was assessed by analogous pain scale at one day follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male and female
* Subjects 18 years or older
* Patients scheduled for unilateral femtosecond laser-assisted cataract surgery cataract surgery with posterior chamber (PC) IOL implantation.

Exclusion Criteria:

* Presence of corneal abnormalities
* History of intraocular surgery
* History of ocular or systematic diseases (glaucoma, diabetes, uveitis
* Regular, systemic use of steroid or NSAIDs during the previous 3 months
Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device

This is a prospective, single-center image case collection study to acquire de-identified contrast-enhanced breast images on the Investigational Device to support continuing technology development. Eligible subjects include women at least 35 years old with a suspicious finding or breast abnormality on a screening or diagnostic mammogram who are indicated for a diagnostic exam or a biopsy procedure.

Contrast-Enhanced Mammography (CEM) is intended to be an extension for diagnostic mammography with the Investigational Device. It is a technique in which digital 2D mammography is supplemented with the use of intravenous iodinated contrast administration to facilitate cancer detection. The imaging acquired under a contrast agent has preferential uptake in regions of increased vascularity providing complement information for diagnosis. The CEM software application that will be tested is similar to the marketed software I-View™ 2.0 and is intended for use as an adjunct following mammography and/or ultrasound exams as a diagnostic work-up to localize and further characterize a known or suspected lesion.

Thus, to assess the clinical efficacy of the CEM imaging acquired in the Investigational Device, Sponsor is conducting a prospective case collection study to support the verification and validation of image quality assessments.

Eligibility Criteria:
Inclusion Criteria:

* Subject is female of any race and ethnicity.
* Subject is at least 35 years old
* Subject has a suspicious finding or breast abnormality on a screening or diagnostic mammogram and is indicated for a diagnostic exam or a biopsy procedure.
* Subject is able to read, understand, and sign the study-specific informed consent form (ICF) after the nature of the study has been fully explained to them

Exclusion Criteria:

* Subject is unable or unwilling to undergo informed consent or subject who requires a Legally Authorized Representative (LAR) for Informed Consent.
* Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view in the breast of interest.
* Subject has had an interventional procedure in the same breast as the suspicious finding within the last six (6) months
* Subject is pregnant or presumed to be pregnant.
* Subject is breastfeeding.
* Subject is actively being treated for cancer of any type with chemotherapy
* Subject is suspected to be at risk of complications from the iodinated contrast agent. These include contra-indications of standard iodinated contrast agents, such as the subject having renal insufficiency) and the subject being on dialysis.
* Subject has had a prior reaction to iodinated contrast; thus, a known allergy to iodinated contrast.
* Subject has had a prior reaction to gadolinium contrast agents; thus, a known allergy to gadolinium contrast.
* Subject who, based on the physician's judgment, may be at increased risk for complications associated with renal function, anticoagulant therapy, or bleeding disorders.
Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3

This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment naive.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of chronic hepatitis C.
* Liver biopsy performed within 2 years of Day 0 or during screening.
* Infected with hepatitis C virus genotype 2/3.
* Interferon alfa treatment naïve (ie, have never been treated with an interferon product).
* Subjects are eligible to enter the study if they (or their partners) are not pregnant or nursing, are sterile, or of non childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study and for 7 months after the last dose of ribavirin.
* Have compensated liver disease.

Key Exclusion Criteria:

* Decompensated liver disease including those subjects with a past history or presence of ascites, bleeding varices or hepatic encephalopathy.
* History of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt.
* Positive for human immunodeficiency virus (HIV-1) or hepatitis B surface antigen (HBsAG).
* Clinical diagnosis of other causes of chronic liver disease including but not limited to hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, hemochromatosis, Wilson's Disease, or alpha 1-antitrypsin deficiency.
* A history of immunologically mediated disease (eg, rheumatoid arthritis, inflammatory bowel disease, moderate/severe psoriasis, sarcoidosis, systemic lupus erythematosus).
* Active seizure disorder within the last 2 years.
* Organ transplant other than cornea and hair transplant.
* Clinically significant hemoglobinopathy (eg, thalassemia, sickle cell anemia).
* Cancer within the last 5 years(with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix).
* Drug or alcohol addiction within the last 6 months. Subjects in a supervised methadone treatment program may be enrolled in the study.
* Received any experimental agent within 28 days prior to Day 0.
Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer

Microwave Ablative (MWA) therapy, as a minimally invasive thermal therapy, has been attempted to treat breast cancer of small lesions . However, the optimal indications for MWA in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study was conducted to evaluate the efficacy and safety of MWA in the treatment of early-stage unifocal invasive breast cancer, and to explore the immune activating effect.


Eligibility Criteria:
Inclusion Criteria:

1. female patients aged 18-70 years;
2. patients with newly diagnosed invasive breast cancer confirmed by core needle biopsy;
3. the tumor smaller than 2cm in greatest diameter confirmed by US (ultrasonography), breast X-ray and breast MRI (contrast-enhanced magnetic resonance image ) were performed at the same time, and the difference of the largest diameter between breast US and MRI was less than 0.5 cm;
4. the single tumor without other suspicious lesions (BI-RADS (the Breast Imaging Recording and Data System) score ≥4) evaluated by breast US, X-ray and MRI;
5. the tumor without adhesion to chest wall, nipple or skin;
6. patients without distant metastasis;
7. Karnofsky performance status greater than 70%.

Exclusion Criteria:

1. multicentric or multifocal breast tumor;
2. the tumor located on nipple and areola area;
3. signs of extensive intraductal carcinoma on imaging examination (diffuse malignant calcification on breast X-ray or segmental distribution, non-mass enhancement, ductal or linear enhancement \> 2.5 cm on MRI);
4. extensive intraductal component in invasive cancer (more than 50% of the tumor volume) confirmed by pathology;
5. invasive lobular carcinoma, metaplastic carcinoma or carcinoma with sclerosing adenosis;
6. patients who were pregnant or breastfeeding;
7. patients with evidence of coagulopathy, chronic liver diseases or renal failure;
8. patients with previous treatment including chemotherapy, targeted drug therapy, or local radiation therapy, etc;
9. patients with substance abuse, or mental or psychological disorders that may interfere with study compliance;
10. any condition that is unstable or likely to compromise the patient's safety and compliance;
11. patients enrolled in other clinical trials;
12. diseases or symptoms that other investigators consider unsuitable for participation.
Natural History Study in Subjects With Usher Syndrome

Natural History Study in Subjects With Usher Syndrome ((USH1B) is a multi-centre, longitudinal, observational study designed to evaluate disease progression in subjects with USH1B by several vision-related assessments.

Natural History Study in Subjects With Usher Syndrome (USH1B) is being conducted to understand the progression of disease in USH1B patients as measured by visual acuity and visual field testing and a number of other vision-related assessments. Disease progression will be evaluated as change over time in these measures and associations between the endpoints will be examined.

The primary objective of this study is to evaluate the natural progression of disease over time in USHIB patients using visual field testing and best corrected visual acuity.

The secondary objectives of this study are to evaluate the progression of disease over time in USHIB patients through additional assessments:

* Microperimetry (only in selected centres)
* Fundus autofluorescence (FAF)
* Optical Coherence Tomography (OCT)
* Full-field Electroretinogram (ERG),
* Multifocal Electroretinogram,
* Vision-related function and quality of life, as measured by the 25-Item National Eye Institute Visual Function Questionnaire (NEI VFQ-25)

Eligibility Criteria:
Inclusion Criteria:

1. Must be willing to adhere to protocol for long-term follow-up as evidenced by written informed consent or parental permission and subject assent.
2. Subjects diagnosed with USH1.
3. Molecular diagnosis of USH1B due to MYO7A mutations (homozygotes or compound heterozygotes).
4. Age eight years old or older at the time of baseline.
5. Visual acuity ≥ 20/640 in at least one eye

Exclusion Criteria:

1. Unable or unwilling to meet requirements of the study.
2. Unable to communicate with suitable verbal/auditory and/or tactile sign language (in the opinion of the investigator)
3. Participation in a clinical study with an investigational drug in the past six months.
4. Pre-existing eye conditions that would interfere with the interpretation of study endpoints (for example, glaucoma, corneal or significant lenticular opacities, cystoid macular oedema, macular hole).
5. Complicating systemic diseases in which the disease itself, or the treatment for the disease, can alter ocular function. Examples are malignancies whose treatment could affect central nervous system function (for example, radiation treatment of the orbit; leukemia with CNS/optic nerve involvement). Also excluded would be subjects with immuno- compromising diseases, as there could be susceptibility to opportunistic infection \[such as cytomegalovirus (CMV) retinitis\].
6. Subjects with diabetes or sickle cell disease would be excluded if they had any manifestation of advanced retinopathy (e.g. macular edema or proliferative changes).
7. Prior ocular surgery within three months.
8. Any other condition that would not allow the potential subject to complete follow-up examinations during the course of the study and, in the opinion of the investigator, makes the potential subject unsuitable for the study.
Pain in Long COVID-19: the Role of Sleep

Pain is among the most frequently reported symptoms in Long COVID, along with sleep disturbances, fatigue, and cognitive impairments. Sleep plays a critical role in maintaining a pain-free state. The goal of this study is to characterize the type and severity of pain in Long COVID, to characterize sleep and sleep disturbances in Long COVID, and to understand the role of sleep in the development and persistence of pain symptoms in Long COVID.


Eligibility Criteria:
Inclusion Criteria:

* Females and males \>18 years
* Confirmed history of SARS-CoV-2 infection

Exclusion Criteria

* History of chronic pain prior to SARS-CoV-2 infection
* Raynaud syndrome
* Pregnant/nursing
Cascade Testing in Families With Newly Diagnosed Hereditary Breast and Ovarian Cancer Syndrome

Identification of BRCA mutations in ovarian cancer patients may help guide cancer therapies, prognosis, post-operative screening, and other preventative treatments beyond the initial diagnosis. Likewise, genetic testing of ovarian cancer patients for these germline mutations provides invaluable information for families regarding cancer risk, genetic testing, and subsequently indication for risk-reducing surgery. Cascade testing provides a unique opportunity to identify carriers of a deleterious BRCA mutation which can allow for surgical and chemoprevention of prevention of ovarian cancer. There is currently no literature on the rates of referral for the family members.

The objective of this study is to perform a pilot study, offering referral to a genetic counseling and genetic testing for family members of a probands known to have a mutation in BRCA1 or BRCA2. In addition to BRCA1 and BRCA2, the NCCN suggests consideration of risk-reducing surgery for mutations in BRIP1, MSH2, MLH1, MSH6, PMS2, EPCAM, RAD51C, RAD51D, investigators will include these subjects as well in the study.

Eligibility Criteria:
Inclusion Criteria:

* All subjects must have a diagnosis of epithelial ovarian cancer, Fallopian tube caner or primary peritoneal cancer with a known pathogenic genetic mutation.
* All subjects must agree to participate.
* All subjects must have first or second degree relatives who have not been diagnosed with the same genetic mutation.
* A previous diagnosis of cancer in the subject's first or second degree relative is allowed.

Exclusion Criteria:

* Subjects whose first and/or second degree relatives have already been tested with the subject's known mutations, and no other viable family members are available for testing.
Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)

The study is designed to evaluate the safety and efficacy of paroxetine on the long-term use in Japanese Social Anxiety Disorder (SAD) subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are diagnosed as having SAD
* Subjects who are expected to use paroxetine tablets for the first time

Exclusion Criteria:

* Subjects taking pimozide
* Subjects taking monoamine oxidase (MAO) inhibitor or within two weeks after discontinuation of MAO inhibitor
* Subjects with hypersensitivity to paroxetine
Effect of Laser Acupuncture on Menstrual Back Pain

effect of laser acupuncture on menstrual back pain

The aim of this study is to determine the effect of laser acupuncture on the points BL23, BL26, BL40 and SP6 in relieving menstrual back pain.

Eligibility Criteria:
Inclusion Criteria:

* All females will have low back pain during menstruation
* Age of the patients will range from 20-30 years.
* Their BMI will be range from 20-30 kg/ m 2

Exclusion Criteria:

* - Psychiatric disorders
* Pelvic floor dysfunction
* Lumber disc prolapse or any Previous surgery on spine.
* Tumor in lumbar spine