cyrilzakka/clinical-trials huggingface dataset:
Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

The purpose of this study is to assess the safety, tolerability and preliminary efficacy of HRS-5041 in men with progressive metastatic castration resistant prostate cancer. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of HRS-5041 in phase II study.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent.
2. Age 18-80 years old, gender unlimited.
3. The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 \~ 1.
4. Predicted survival ≥12 weeks.
5. Histological or cytological confirmed adenocarcinoma of the prostate.
6. Patients progressed on taxane chemotherapy and at least one prior secondary hormonal therapy.

Exclusion Criteria:

1. Prior treatment with an androgen receptor (AR) degrader.
2. Plan to receive any other antitumor therapy during this trial.
3. Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study.
4. Patients with known brain metastases.
5. Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness.
Comparison of Pain Relief After Arthroscopic Knee Surgery: Adductor Canal Block and Genicular Nerve Block

This prospective randomized study aims to compare the analgesic efficacy of Adductor Canal Block (ACB) and Genicular Nerve Block (GNB) groups to relieve postoperative pain in participants between ages of 18-72 undergoing arthroscopic knee surgery under spinal anesthesia. The main question it aims to answer is:

To demonstrate whether Adductor Canal Block or Genicular Nerve Block is more effective in postoperative analgesia in patients undergoing arthroscopic knee surgery based on pain scores, opioid consumption and patient satisfaction.

Arthroscopic knee surgeries cause severe pain especially with movement in the post-operative period. After surgery, the movements of the participants are severely restricted because of pain, which increases the possibility of complications and postpones post-operative knee exercises. In this study, the participants' pain status, VAS score, opioid consumption and patient satisfaction will be measured with a simple scoring system for 24 hours at predetermined time points and then compared. Both types of blocks have pain-relieving effects. This study will only investigate which one is more effective in reducing pain, and there will be no deficiency in relieving the pain of the participants.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary willingness to participate in the study.
* Patients undergoing arthroscopic knee surgery (meniscus, ACL, arthroscopic intervention etc).
* ASA I-II-III classification.
* Aged between 18-72 years.
* No contraindications for regional anesthesia, and deemed suitable for regional anesthesia by the anesthesiologist.
* Undergoing surgery under spinal anesthesia.
* Fully oriented and able to cooperate.

Exclusion Criteria:

* Undergoing surgery under general anesthesia.
* Chronic analgesic use.
* Presence of an active infection at the procedure site.
* Outside the appropriate age range.
* Inability to comply with postoperative pain/NRS follow-ups.
* ASA IV-V classification.
* Non-voluntary patients.
* Pregnancy.
A Study of Fluoxetine in Major Depressive Disorder (MDD) Long-Term Dosing

This study will evaluate the safety and effectiveness of fluoxetine flexible dosing in the treatment of MDD in adult Japanese participants.

Participants who complete the short-term treatment phase of Study B1Y-JE-HCLV (NCT#: NCT01808612) will be allowed to enroll in this study, and receive fluoxetine treatment for an additional 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have completed Study B1Y-JE-HCLV (NCT#:NCT01808612)
* Agree to abstain from sexual activity or to use a reliable method of birth control

Exclusion Criteria:

* Significant suicidal risk
* Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or post-traumatic stress disorder
* Have a history of substance abuse or dependence within the past 6 months, excluding caffeine and nicotine
* Need to use thioridazine or pimozide during the study
* Have a positive urine drug screen for drugs with abuse potential
* Female participants who are either pregnant, nursing, or have recently given birth, or male participants who are planning for their partners to be or become pregnant
* Have frequent or severe allergic reactions to multiple medications
* Have a serious or unstable medical illness or condition, or psychological condition
* Participants deemed ineligible by the investigator or sub-investigator for other reasons
Hearing Loss and Communication Needs in a Group Care Setting for Older Adults

The purpose of this study is to develop and test a multicomponent hearing care intervention for the PACE staff members in order to learn more about communication and engagement.

The long-term objective of this proposal is to increase the accessibility and affordability of hearing loss treatment for older adults with hearing loss, with a particular interest in adults that have mild cognitive impairment (MCI) or dementia. Age-related hearing loss (ARHL) in persons with MCI or dementia may exacerbate dementia-related symptoms such as depression, apathy, agitation/aggression. Moreover, engagement and activity participation are recognized as critical aspects of dementia care management, but those individuals who also experience ARHL are at a disadvantage. A pilot testing of behavioral communication intervention will be completed at multiple Program for All-inclusive Care for the Elderly (PACE) sites in New England. A multicomponent hearing care intervention will be tested that includes staff training and non-custom personal amplification use with older adults in a group care setting. This feasibility study will lead to the refinement of the intervention protocols to be used in a future grant application that will test the real-world efficacy of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* PACE staff who work in the Day Health Center and are available to attend the training on-site at PACE are eligible for inclusion. All staff are invited to join the training (via Zoom, if necessary), but to complete the research activities, they have to complete the training in-person due to the hands-on component of learning to use the hearing device.

Exclusion Criteria:

* Staff members who cannot attend the (virtual) in-person training.
Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

This is a study of the effect of a customized probiotic on children and adults with autism, including effects on autism symptoms and gastrointestinal symptoms.

SunGenomics provides its customers with a customized probiotic based on an analysis of the microbiota in their stool samples. Customers who have autism spectrum disorders are invited to participate in this study by completing several questionnaires about their medical history, diet, autism symptoms, and gastrointestinal symptoms before taking the probiotic, and to repeat those questionnaires approximately 3 months later. This is effectively an open-label study.

Eligibility Criteria:
Inclusion Criteria:

1. New client of Sun Genomics (has applied for testing and treatment, but not yet begun treatment)
2. Diagnosis of ASD (initially based on self-report of ASD diagnosis by appropriate medical professional, and then verified by an evaluation of the Social Responsiveness Scale (SRS-2) by ASU staff.
3. Children and adults ages 2.5-75 years

Exclusion Criteria:

1. Antibiotic use in the last two months (not counting topical antibiotics)
2. Any changes in medications, nutritional supplements, therapies, in the last two months, or any plans to change them during the first 3 months of probiotic treatment.
Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section

The aim of this study is to compare Surgical Transversus abdominis plane block and Ultrasound guided transversus abdominis plane block (TAPB) as a postoperative analgesic regimen in female patients undergoing elective cesarean delivery.

Caesarean delivery rates have been increasing worldwide nowadays. At rate of \[52%\], Egypt stands out among countries with the world's highest cesarean delivery percentages . Within the Arab region, rate of cesarean section far higher in Egypt than other Arab countries.

A much simpler and theoretically superior means of establishing a TAP block. When using a transcutaneous (conventional) approach there is always the risk of peritoneal puncture with its attendant complications. Moreover, there are technical difficulties, especially in obese women and the procedure requires specialist equipment, a skilled operator and training in ultrasonography. Our approach obviates these risks and difficulties because the procedure is carried out under direct vision, and it is much easier to perform by the surgeon during caesarean section.

Eligibility Criteria:
Inclusion Criteria:

* Full term pregnant women
* Older than 21 years of age
* Had elective cesarean section with Pfannenstiel incision.

Exclusion Criteria:

* Patients with cesarean section using different surgical incision
* History of addiction \[including opioids and benzodiazepines\]
* Allergy to the anesthetic analgesia
* Psychological disorders
* Coagulopathies
* Infection at the block injection site.
Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea

The purpose of this study is to evaluate the sensitivity and specificity of the Belun Ring Pulse Oximetry system for screening of obstructive sleep apnea (OSA) in adults during standard polysomnography sleep study conditions. The primary outcome metric is the Apnea-Hypopnea Index (AHI).

The goal, in its entirety, is to evaluate the performance of the Belun Ring Pulse Oximeter during a standard polysomnography sleep study and its ability to compare to the determined Apnea-Hypopnea Index (AHI) of the subjects. It is expected that the Belun Ring Pulse Oximeter will adequately record SpO2, pulse rate, body position and heart rate variability throughout the duration of the study.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have the ability to understand and provide written informed consent.
* Subject is 18 to 90 years of age.
* Subject must be willing and able to comply with study procedures and duration.
* Male or female of any race.

Exclusion Criteria:

* Subject requires oxygen therapy or noninvasive ventilation.
* Subject has a current diagnosis of chronic obstructive pulmonary disorder (COPD), neuromuscular disease, periodic limb movement, or narcolepsy.
* Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
* Subject is on medication known to interfere with heart rate, such as beta blockers, digoxin, or calcium receptor agonists.
* Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported).
* Unwillingness or inability to remove colored nail polish from test digits.
* Other known health condition, which should be considered.
Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion

This protocol for SUN-131 1.5% TDS is developed for the treatment of chalazion. SUN-131 1.5% TDS is designed for local delivery of a corticosteroid, to the upper or lower eyelid. The purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as compared with placebo TDS in the treatment of a chalazion.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged ≥ 6 years of either sex and of any race
2. Subjects with a diagnosis of a single chalazion
3. Subjects with chalazion erythema score of ≥ 1
4. Normal eyelid function without active signs of eye and eyelid infection in either eye.
5. Must be willing and able to correctly apply and wear a transdermal patch to the eyelid
6. Avoid wearing contact lenses in the study eye

Exclusion Criteria:

1. Chalazion that has atypical features (a recurring chalazion at the same spot, abnormal surrounding lid tissue, associated loss of tissues).
2. History of chalazion incision and curettage in study eyelid.
3. Multiple chalazia in any one eyelid.
4. Active ocular or eyelid infection Presence of hordeolum in any one eyelid.
5. An abnormal skin condition on the study eyelid region (e.g., eczema, psoriasis, atopic dermatitis, etc.) where the study drug will be applied.
6. Diagnosed with glaucoma in either eye.
7. History of steroid-induced elevation of IOP.
8. Female subjects who are pregnant or lactating.
Maximizing Treatment Outcome in Post-Traumatic Stress Disorder (PTSD)

The purpose of this study is to examine the efficacy of exercise + therapy to therapy alone to determine if they can improve the effects of prolonged exposure therapy (PE) in reducing symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In addition the two strategies (i.e., exercise + therapy and therapy alone condition) will be compared in terms of levels of brain-derived neurotrophic factor (BDNF). BDNF is a protein that helps to support the survival of existing neurons and stimulate the growth of new neurons and synapses. BDNF is important to learning and memory in general and therefore may be associated with the learning and memory as it relates to PE and corresponding symptoms PTSD improvement.


Eligibility Criteria:
Inclusion Criteria:

* You have PTSD.
* You are between the ages of 18 and 65.
* You have written physician approval/medical clearance to participate in an exercise protocol.
* You are currently taking no psychotropic medications or are able and willing to discontinue these medications prior to the first PE session.

Exclusion Criteria:

* You are currently participating in a structured exercise program.
* You have severe depression.
* You have any history of bipolar disorder, psychotic disorder, or obsessive compulsive disorder.
* You have a diagnosis of eating disorder, or substance abuse or dependence (excluding nicotine) within the past six months.
* You have any history of a suicide attempt, or are at a significant risk or self-harm or harm to others.
* You have ever been diagnosed with organic brain syndrome, mental retardation, or other cognitive dysfunction.
Levosimendan Administration in Neonates With Transposition of the Great Arteries

Calcium sensitizer drugs such as Levosimendan may exert anti-ischemic effect in addition to positive inotropic and anti-stunning effects mediated by the opening of ATP-sensitive potassium (KATP) channels. The aim of the study is to test the myocardial protection effect of peri-operative iv infusion of Levosimendan in a cohort of neonates affected by transposition of the great arteries undergoing surgical correction by arterial switch.

Function of the myocardium of neonates with congenital heart disease may be affected by several factors in post operative phase: congenital insufficiency, cardiopulmonary bypass low perfusion, ischemima during the cross-clamp phase, low cardiac output syndrome, systemic inflammation. Furthermore, neonates have immature molecular mechanisms leading to calcium utilization inside myocytes. Calcium sensitizer drugs such as Levosimendan may exert anti-ischemic effect in addition to positive inotropic and anti-stunning effects mediated by the opening of ATP-sensitive potassium (KATP) channels. The aim of the study is to test the inodilator and myocardial protection effect of peri-operative iv infusion of 0.1 mcg/kg/min Levosimendan (without previuos bolus) in a cohort of neonates affected by transposition of the great arteries undergoing surgical correction by arterial switch.

Eligibility Criteria:
Inclusion Criteria:

* neonates affected by transposition of the great arteries scheduled to elective surgery

Exclusion Criteria:

* neonates affected by transposition of the great arteries who are not scheduled to elective surgery (urgent procedures, patients older than 30 days)
Six Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly

The purpose of the study is to evaluate the effect of a naturally occurring hormone, called Growth Hormone Releasing Hormone (GHRH), on the muscle, bone and fat tissues of the body. GHRH stimulates the production of growth hormone (GH), which regulates the build up of many tissues in the body, including muscles and bones. Many elderly people have low levels of GH. The overall goal of this research is to determine the effectiveness of GHRH to raise levels of GH and improve these body tissues. The purpose of the tests is to measure how the body handles sugar, fat, and proteins. GH can affect your body's use of sugar, fat and proteins.

Growth hormone (GH) is a major anabolic hormone that exerts important stimulatory effects on protein synthesis. Many of the peripheral tissue effects of GH are mediated by insulin-like growth factor I (IGF-I), produced systemically by the liver or locally in tissues in response to GH stimulation. IGF-I in turn regulates GH secretion by negative feedback mechanisms at the pituitary gland. Several investigators have shown that aging is associated with a decrease in spontaneous GH secretion and IGF-I levels. GH levels decline by 14% for each decade after puberty, and, in healthy 59-98 year old men, IGF-I levels below the 2.5 percentile of younger men are present in 85%. Reduction of GH release in aging is thought to be associated with an increase in somatostatin tone, decrease in hypothalamic GHRH output, and diminished response to GHRH. The fact that aging is accompanied by a decrease in protein synthesis leading to a loss of lean body mass (LBM) and a gain in body fat suggests that a decrease in GH secretion may contribute to these changes. It has been hypothesized that restoration of GH level in the elderly to the levels observed in younger individuals may lead to improvements in body composition.

Eligibility Criteria:
Inclusion Criteria:

* Documentation of low GH levels as assessed by a fasting IGF-1 level \<135ng/ml.
* Volunteers whose BMI is above normal range and below extreme obesity (BMI 25-40 kg/m2).

Exclusion Criteria:

* Diabetes.
* Known coronary artery disease.
* Liver, peptic or inflammatory bowel disease. Renal or hematologic disease.
* Hematocrit \<30% or \>50%.
* Clinically significant prostate hypertrophy.
* Elevated Prostate specific antigen (PSA) (4ng/ml).
* Prostate \& breast cancer.
* History of malignancy \<5 years other than basal cell of the skin.
* Chronic pulmonary disease or other systemic disorders.
* Use of certain drugs (such as thiazide diuretics, beta-blockers, steroids (except for replacement doses), coumadin, and or androgen supplements).
* Peanut allergy.
* Gross physical impairment.
* Sleep apnea.
* Uncontrolled hypertension(blood pressure \>160/95 and or requiring more than two antihypertensive medications).
* A clinically worrisome mammogram in women.
* Exercise training (\>2x/wk for 20 min at a level that produces sweating) in the last 6 months.
IUD Self-Removal Study

This is a pilot study designed to test the effectiveness of several techniques for intrauterine device (IUD) self-removal and to understand patient preferences regarding IUD self-removal and indicators of success as well as understanding the impacts of IUD self-removal on other clinical care.

The Investigators propose to test a novel method for self-removal of IUDs in an effort to increase the proportion of patients who are able to successfully and safely remove their IUD when desired. Participants will attempt self-removal in office, where a provider will be able to remove the IUD if unsuccessful. Participants will be instructed on current and novel techniques and the investigators will examine indicators of success as well as patient and provider preferences.

Eligibility Criteria:
Inclusion Criteria:

* Presenting at clinic for IUD removal or exchange
* Willing and able to give consent with literacy in English or Spanish

Exclusion Criteria:

* Participants who are referred for a complicated IUD removal such as a stingless IUD, prior failed IUD removal attempt, or an IUD failure.
Prolonged Exposure Therapy Versus Active Psychotherapy in Treating Post-Traumatic Stress Disorder in Adolescents

This study will compare the effectiveness of prolonged exposure therapy versus active psychotherapy in treating post-traumatic stress disorder (PTSD) in adolescents.

PTSD is an anxiety disorder that can develop after exposure to an event in harm to the life or physical integrity of oneself or others has occurred or was threatened. People with PTSD have persistent frightening thoughts and memories of their ordeal and often feel emotionally numb, especially with people to whom they were once close. Effective treatments for post-traumatic stress disorder are available, and research is yielding new, improved therapies that can help reduce symptoms of PTSD. Prolonged exposure (PE) therapy is a brief cognitive behavioral therapy that has been effective in treating symptoms of PTSD in adults. However, no treatments have been proven effective for the treatment of PTSD in adolescents. This study will compare the effectiveness of PE therapy versus non-trauma directed active psychotherapy in reducing the symptoms of PTSD in adolescents. In addition, this study aims to refine the existing PE treatment protocol for adolescents with PTSD.

Participants in this single-blind study will be randomly assigned to receive either PE therapy or AP. All participants will receive 12 to 18 therapy sessions, which will be conducted weekly. Assessments of PTSD symptoms, depression, and overall functioning will be conducted at baseline, immediately post-treatment, and 3 months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of PTSD
* In grades 6-12
* No change in medication regimen for more than 6 weeks

Exclusion Criteria:

* Diagnosis of ADHD, conduct disorder, thought disorder, or bipolar disorder