cyrilzakka/clinical-trials huggingface dataset:
Let's K-Talk - HPV Study for Ethnic Koreans

The goal of this clinical trial is to test the feasibility, acceptability, and preliminary efficacy of a storytelling video-based intervention using AI chatbot technology (K-Talk) to promote HPV vaccination behavior among Korean Americans aged 18 to 45.

The main questions this study aims to answer are:

* Is the K-Talk intervention feasible for use among Korean Americans aged 18 to 45?
* Is the K-Talk intervention acceptable to the target population?
* What is the preliminary efficacy of the K-Talk intervention in promoting HPV vaccination uptake?

Participants will be Korean Americans aged 18 to 45 who are at risk for HPV infection. Participants will be asked to complete a baseline survey and then will be "randomized" into one of four groups: Group 1 (chatbot + storytelling intervention), Group 2 (chatbot only), Group 3 (storytelling only), and Group 4 will be only exposed to written didactic HPV education materials. All groups will receive written didactic HPV education materials. Researchers will compare how Group 1, a combination of AI Chatbot and storytelling intervention is more effective than other intervention groups in promoting HPV vaccination uptake among underserved, hard-to-reach Korean Americans.

The objective of this study is to conduct a pilot Multiphase Optimization Strategy trial (MOST) to evaluate the acceptability, feasibility, and preliminary efficacy of K-Talk as an intervention to improve HPV vaccination initiation and completion among Korean American men and women. K-Talk is a user-centered intervention that combines AI chatbot technology with storytelling to enhance health communication, foster connection, and provide accurate advice related to HPV vaccination. The study design follows an optimization phase of the MOST, utilizing a 2 x 2 factorial design with two factors (storytelling and chatbot) and two levels (Yes/On and No/Off). The study aims to recruit a total of 160 participants, with 40 participants assigned to each experimental condition. The sample will consist of 80 males and 80 females who are eligible for participation in factorial experimentation using the MOST design. Interested individuals will undergo an online eligibility screening survey. If eligible for the study, participants will receive an online survey link containing informed consent, a baseline survey, written HPV information, and random assignment to an intervention group.

Eligibility Criteria:
Inclusion Criteria:

1. Identify as a Korean ethnic person
2. Reside in the U.S.
3. between the ages of 18 and 45
4. be able to speak or read English
5. not have been vaccinated against HPV
6. use a mobile device.

Exclusion Criteria:

1. Participants who do not identify as a Korean ethnic person
2. Participants who do not reside in the U.S.
3. Participants who are not between the ages of 18 and 45.
4. Participants who cannot speak or read English.
5. Participants who have been vaccinated against HPV.
6. Participants who do not use a mobile device.
A Study of Two Anti-HIV Drug Combinations in HIV-Infected Patients

The purpose of this study is to compare the safety and effectiveness of giving HIV-infected patients delavirdine (DLV) plus zidovudine (ZDV) plus 2 doses of indinavir (IDV) or ZDV plus IDV plus lamivudine (3TC). This study also examines how the body processes DLV when it is given in combination with other drugs.

In this multicenter, open-label study, 45 HIV-1-positive patients receive either combination drug therapy with delavirdine (DLV), zidovudine (ZDV), and indinavir (IDV) or combination drug therapy with ZDV, lamivudine (3TC), and IDV. NOTE: Patients are treated for 24 weeks and may opt to continue on study for 24 additional weeks, if HIV-1 RNA is less than 5,000 copies/ml or at the investigator's discretion.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV-1 positive.
* CD4 count above 50.
* HIV-1 RNA greater than 20,000.

Prior Medication:

Allowed:

Less than 1 month prior treatment with zidovudine.

Exclusion Criteria

Prior Medication:

Excluded:

* Prior 3TC, protease inhibitors, or non-nucleoside reverse transcriptase inhibitors.
* Prior ZDV of greater than 1 month total duration.

Prior Treatment:

Excluded:

* Lamivudine.
* Protease inhibitors.
* Non-nucleoside reverse transcriptase inhibitors.
The Establishment of the Integration of Surgery and Postoperative Intensive Recovery of Patients With CSM

This study aims to establish the specialist consensus of the integration of posterior approach surgical treatment and postoperative intensive recovery management for CSM or OPLL patients, and verify its safety, practicability and reliability.

In order to establish the specialist consensus of the integration of posterior approach surgical treatment and postoperative intensive recovery management, and verify its safety, practicability and reliability, this study enrolled 130 patients with CSM or OPLL undergoing C3-7 open-door laminoplasty. Patients are divided in two groups randomly. The study group has 80 patients, treated with postoperative intensive recovery management, and the control group has 50 patients. The data is collected preoperatively, at 3-month follow-up and 1-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* (1) Age: 18\~70 years. (2) Diagnosed as CSM or OPLL. (3) Going to receive C3-C7 open-door laminoplasty. (4) Agree to join this study and sign the informed consent.

Exclusion Criteria:

* (1) Anterior and posterior combined surgery. (2) Posterior laminoplasty combined fusion. (3) Severe osteoporosis. (4) Morbid obesity. (5) patients with mental disorder. (6) patients with previous history of cervical spine surgery. (7) Abnormal laboratory report of liver function, kidney function and hematologic system.(8) Poor compliance. (9) Patients with other surgical contraindications. (10) Patients with intemperance or taking drugs. (11) Patients who joined other study within the last 3 months.
Duloxetine Stress Urinary Incontinence Efficacy and Safety Study

Study F1J-MC-SBBU will examine the effect of duloxetine treatment in women with SUI. The inclusion and exclusion criteria of this Phase 3 study will ensure that all subjects have a clinical diagnosis of SUI.


Eligibility Criteria:
Inclusion Criteria:

* Present with SUI based on the disease diagnostic criteria, average at least one incontinent episode per day on the screening diary, and have had symptoms of SUI for a minimum of 3 months prior to study entry.
* Are women of non-childbearing potential by reason of hysterectomy, other surgery, or natural menopause, or are women of childbearing potential who test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a medically accepted means of contraception (for example, intrauterine device \[IUD\], oral or injectable contraceptives, implant, barrier device, sterilization, abstinence, or sex with a vasectomized male partner) for the duration of the study. Women using oral contraceptives or hormone replacement therapy must have a stable dose and regimen for greater than or equal to 3 months prior to entry into the study.
* Are free of UTI symptoms and have a negative urine dipstick for nitrates and leukocyte esterase.
* Have discrete episodes of incontinence (that is, are dry between episodes and not continuously leaking urine, synchronous with increased intra-abdominal pressure from coughing, sneezing, exercising, etc.).
* Have seven (7) or more incontinence episodes per week, urinary diurnal frequency of eight (8) or less per day and nocturia of two (2) or less per day with denial of urge incontinence as a predominant symptom per micturition history collected at Visit 1. An incontinence episode is defined as an easily noticeable leakage of urine that would wet a pad, containment garment, or article of clothing. Diurnal refers to the voiding episodes that occur during the normal awake hours. Nocturia refers to the voiding episodes that occur during the normal sleeping hours and that wake the subject.

Exclusion Criteria:

* Suffer from severe constipation (for example, have impacted rectum at time of physical examination despite recent evacuation).
* Has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.
* Are on a medication regimen (including diuretics) for which dose and/or frequency has not been stable for at least 12 weeks prior to randomization, or is anticipated to change during the course of the study.
* Have had any major inpatient surgery within 3 months prior to study entry.
* Have current diagnosis of any of the following conditions, disorders, or diseases of the genito-urinary tract:

  1. Ureteric, bladder, urethral, or rectal fistula
  2. Uncorrected congenital abnormality leading to urinary incontinence
  3. Detrusor instability or noncompliant bladder
  4. Adult enuresis
  5. Voiding difficulty (i.e., subject complains of difficulty emptying their bladder).
Combined Ribavirin With Sofosbuvir/Velpatasvir/Voxilaprevir in Retreatment of Chronic Hepatitis C Non-responders

This study aims to assess the role of ribavirin as an adjuvant to sofosbuvir/velpatasvir/voxilaprevir combination in retreatment of chronic hepatitis C with previous treatment failure.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years) patients with chronic hepatitis C and detectable HCV RNA by Polymerase Chain Reaction (PCR) after completion of previous direct-acting antiviral regimen, and eligible for antiviral treatment.

Exclusion Criteria:

* Patients with decompensated cirrhosis (Child-Pugh score B and C).
* Patients with platelet count less than 50000/ mm³.
* Patients with HCC or extrahepatic malignancy.
* Pregnancy or inability to use an effective contraceptive method.
Clomiphene Citrate for Treatment of Acromegaly

To assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatments (somatostatin analogues, dopamine agonists and/or growth hormone receptor antagonist)

Acromegaly, a disease caused by a growth hormone secreting pituitary adenoma, results in reduced life span. Despite the many modalities available to treat this disease,as surgery, medical treatment and radiotherapy, uncontrolled disease persists in a significant portion of patients

Oral estrogens, alone or in combination with somatostatin receptor analogues, have been shown to control acromegaly in women. Selective estrogen receptor modulators (SERMs) resulted in similar effects in both genders. Clomiphene citrate, a SERM that increases luteinizing hormone and follicle stimulating hormone secretion, improves hypogonadism and fertility outcomes.

The aim of this study is to assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatment.

In this prospective, open label, single center trial, sixteen male patients were studied. Clomiphene citrate (50 mg/day) was added to previous medical treatment for 3 months and hormonal assessment was performed prior to and during the intervention. Hormones included: growth hormone, insulin like growth factor, total testosterone, follicle stimulating hormone, luteinizing hormone and prostate-specific antigen.

Eligibility Criteria:
Inclusion Criteria:

* patients with active acromegaly on regular use of a stable dose of Octreotide-LAR and/or cabergoline for at least one year,
* Insulin like growth factor 1 above the reference range during the last year of follow-up and
* testosterone levels within or below the third inferior tertile of normality.

Exclusion Criteria:

* radiotherapy in the last 10 years, previous venous embolism (including family members),
* previous prostatic cancer or symptomatic benign hypertrophy,
* triglyceride levels above 400 mg/dL,
* renal failure defined by estimative of renal filtration below 30 ml/min,
* liver disease defined by hepatic enzymes 3 times above normal limit,
* active oncologic disease in the last 10 years and previous cardiac or cerebrovascular disease.
Cohort Follow-up of Epidemic and Neuroimaging for Patients During the 1st Wave of the COVID-19 in China

Our main objective is to analyze the development of physical impact, mental health and blood profile over follow-up time during the 1st wave of the COVID-19. Besides, we aim to establish a database of post-COVID-19 based on simultaneous cortico-spinal magnetic resonance imaging data to identify high-risk patients with long COVID and prevent the neurological symptoms evolution, optimize the tactics of management in China.

This is an observational, cross-sectional, and multicenter study. It will be performed at 9 public hospitals. Participants with confirmed cases of mild or moderate COVID-19 infection will complete the following programs at acute infection phase and after 3, 12 months for exploring biological mechanism and predictive biomarkers of post-COVID-19: 1) fill in the behavioral psychology scales, 2) submit blood samples at a local laboratory, 3) accept the simultaneous cortico-spinal magnetic resonance imaging scan. The uninfected healthy controls will complete the same programs as infected group mentioned above only at the time of inclusion. We will establish the simultaneous cortico-spinal magnetic resonance imaging database containing neuropsychological scales and blood parameters of post-COVID-19 in China.

Eligibility Criteria:
Inclusion Criteria:

Confirmed diagnosis of mild Covid-19 (WHO criteria)/Confirmed diagnosis of moderate Covid-19 (WHO criteria)/Healthy people who have not had COVID-19

Exclusion Criteria:

History of central nervous system diseases, such as mental disorder, degenerative diseases of central nervous system, tumors, trauma, etc. Participants with indication for MRI studies
Effect of Technology-assisted Physical Therapy for Patient With High Risk of Sarcopenia

This research aims to identify whether the effects of video-assisted physical therapy, including home resistance training, is superior to traditional physical therapy, education leaflet for example.

This is an interventional research, single-blind, randomized control trail. We recruit high risk of sarcopenia people (low muscle strength and low physical performance) Two groups of participants are divided into traditional group and video-assisted group, both group are taught the same resisted exercise by physical therapist.

Both group will record his/her baseline activity level with a given pedometer. After one week recording, we started initial evaluation (history taking, physical examination) and intervention.

Participants are taught thera-band resisted exercise, including large musculature of upper and lower extremities, each exercise are conducted 10-15 times for 3 sets.

Traditional group will receive an education leaflet and a notebook to record his/ her daily activity and frequency of exercise to record the compliance.

Video-assisted group will receive a QR code, which contain a website of exercise video on the cloud.

After 3 months intervention, participant will come back to our center for final examination.

Eligibility Criteria:
Inclusion Criteria:

* Age above 65 years old
* MMSE \> 24 points
* walking more than 6 meters independently

Exclusion Criteria:

* people who cannot participate for 3 -day exercise for each week
A Natural History Study to Evaluate Functional and Anatomical Progression in Retinitis Pigmentosa

This study will assess the progression of RP as seen on newer modalities including spectral-domain optical coherence (SD-OCT) and macular assessment integrity (MAIA) microperimetry to evaluate disease status. Understanding the natural history of the disease is not only essential to monitoring and comparing patient populations in clinical trials. It is also fundamental in the predevelopment phase in order to optimize the study duration needed to observe a statistically significant outcome. Furthermore, since the progression of RP is usually slow, relying on traditional tests can take an unfeasible length of time to observe any meaningful changes and assess therapeutic efficacy for new drugs. Therefore, the results of this study will be beneficial in establishing reliable endpoints and outcome measures for future clinical trials. Such outcome measures may be able to detect treatment response with more precision. More importantly, investigators may be able to detect changes early enough to prevent irreversible vision loss.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patients diagnosed with Retinitis Pigmentosa
* Ability to provide informed consent
* Ability to authorize use and disclosure of protected health information

Exclusion Criteria:

* Concomitant ocular pathology that limits central macular function, including but not limited to age-related macular degeneration, diabetic retinopathy, and retinal vein occlusion
* If EZ width ≤200µm
Efficacy of Red and Infrared Lasers in Treatment of Temporomandibular Disorders

The study hypothesis was that the red (600nm) and infrared (800nm) laser therapy have the same efficacy in relieving pain and improving the quality of life of TMD patients

The aim of the present study was to evaluate and compare the efficacy of red (600nm) and infrared (800nm) laser therapy in relieving pain and improving the quality of life of TMD patients.

Eligibility Criteria:
Inclusion Criteria:

* systemic health;
* Temporomandibular Disorder diagnosed by the Research Diagnostic Criteria for Temporomandibular Disorders questionnaire (RDC);
* pain score ≥ 5 on palpation according to a visual and numerical scale (VNS)

Exclusion Criteria:

* participants who made frequent use of analgesics, NSAIDs and antidepressants;
* patients with previously undergone TMD treatment, or suffered facial trauma
Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection

The primary aim of this study is to compare the rate of acute urinary retention (AUR) after immediate compared to early (24-hours) removal of urinary catheter (UC) in patients undergoing minimally invasive colorectal resection. The study hypothesis is that immediate UC removal is non-inferior to 24-hours UC removal in terms of AUR rate.

The secondary outcomes focus on goals that could be positively impacted by the immediate removal of the UC at the end of the surgery. In particular, the rate of urinary tract infections, perception of pain, time-to-return of bowel and physical functions, postoperative complications and postoperative length of stay will all be measured.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 years and 80 years old
2. Patients scheduled to undergo minimally invasive resection of the colon under general anesthesia
3. Willingness to participate
4. Compliance to study purpose
5. Written informed consent

Exclusion Criteria:

1. Need for an anastomosis below the anterior peritoneal reflection
2. Need for a major resection other than colorectal
3. Need for post-operative intensive care monitoring or intensive care unit (ICU) stay
4. Anesthesia time longer than 300 minutes
5. Presence of chronic indwelling UC
6. Presence of an entero-vesical fistula
7. Need for ureteral stent placement, bladder resection or repair
8. A previous and unsolved history of AUR or overt voiding dysfunction
Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab

This study is designed to evaluate the safety after switching to garadacimab from another prophylactic hereditary angioedema (HAE) treatment (marketed kallikrein \[KK\] inhibitor or plasma-derived C1-esterase inhibitor \[pdC1INH\]prophylactic) when administered once monthly for approximately 3 months in participants aged greater than or equal to (\>=) 12 years with HAE.


Eligibility Criteria:
Inclusion Criteria:

* Aged \>= 12 years at the time of providing written informed consent / assent.
* Have a history of response to on-demand HAE treatment for the treatment of acute HAE attacks.
* Documented laboratory diagnosis in medical records of C1-esterase inhibitor hereditary angioedema (HAE-C1INH) type 1 or type 2:

  * Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria),
  * C1-esterase inhibitor (C1INH) antigen concentration or functional activity less than (\<) 50% of normal as documented in the participant's medical record, or
  * C4-antigen concentration below the lower limit of the reference range as documented in the participant's medical record.

For HAE-nC1INH: Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria); an HAE-associated FXII gene mutation (eg, FXII point mutation Thr328Lys or Thr328Arg, or deletion of 72 base pairs \[c.971_1018 + 24del72\], or duplication of 18 base pairs \[c.892-909dup\]), as documented in the participant's medical record, OR an HAE-associated plasminogen gene mutation (PLG) gene mutation (eg, PLG point mutation Lys330Glu), as documented in the participant's medical record; C1INH antigen concentration or functional activity 70 to 120% of the normal level, as documented in the participant's medical record.

• Use of lanadelumab, berotralstat, or pdC1INH for the prophylactic treatment of HAE and be on a stable (consistent) dose / regimen of such medication for at least 3 months prior to Screening.

Exclusion Criteria:

* Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria.
* Use of androgens, antifibrinolytics, or investigational products (other than garadacimab) for routine prophylaxis against HAE attacks.
* Known or suspected hypersensitivity to monoclonal antibody therapy or hypersensitivity to the active substance (garadacimab) or to any of the excipients.
Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty

This study was performed to compare healing and hearing outcomes of two tympanoplasty techniques, performed for patients with total or subtotal tympanic membrane perforations. The first group underwent temporalis fascia tympanoplasty, augmented with platelet rich fibrin, while the second group underwent cartilage tympanoplasty. preoperative data, operative techniques, and postoperative outcomes were analyzed.

Two groups are included. In the platelet rich fibrin augmented tympanoplasty group, a piece of temporalis fascia is harvested and used as a graft material. A layer of platelet rich fibrin is added to improve healing process. In the cartilage tympanoplasty group, a piece of cartilage is harvested from the patient concha and used for grafting. Both groups will be compared in terms of healing and hearing. Healing is considered successful if an intact tympanic membrane is achieved withing 12 weeks follow up period. Hearing outcomes are analyzed by comparing the preoperative pure tone audiometry values with the postoperative values.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients older than 18 years.
* Chronic suppurative otitis media mucosal type with total or subtotal perforation.
* Inactive for 3 months.

Exclusion Criteria:

* Recurrent perforation after previous tympanoplasty.
* Active inflammation of middle ear.
* Chronic suppurative otitis media epithelial type.
* Ossicular disruption or fixation diagnosed intraoperatively.
* Immunocompromised patients including uncontrolled diabetics, chronic liver and kidney diseases.