cyrilzakka/clinical-trials huggingface dataset:
Anorectal Microbicide Project(AMP): Rectal Health, Behaviors and Microbicide Acceptability

Observational, cross-sectional, single-visit study of 896 men and women in Los Angeles, CA and Baltimore, MD including a computer-assisted interview focusing on the behavioral repertoire surrounding RAI, symptoms, and health seeking behaviors and a multidimensional assessment of behaviors, anorectal examination, and testing for sexually transmitted infections (STIs).


Eligibility Criteria:
Inclusion Criteria:

Men and women are eligible who meet all of the following criteria:

1. At least 18 years of age
2. Willing to be tested for STIs including HIV
3. Willing to undergo an anal exam
4. Mentally competent to understand study procedures and give informed consent.
5. For the NO-RAI groups:

   No RAI in the past year for the non-RAI men and women
6. For the practicing RAI groups:

Males: report RAI in the past 30 days Females: report RAI in the past 12 months

Exclusion Criteria:

1. Less than 18 years of age
2. Unwilling to be tested for STIs (and HIV)
3. Unwilling to undergo an anal exam
4. Unwilling to complete study questionnaire
5. Not mentally competent to understand study procedures and give informed consent.
Block REducing Pain After Surgery Trial

This observational study evaluates difference in chronic pain after six months from surgery between patients who received PECS block and general anesthesia versus general anesthesia alone.

PECS block is used as a pain relief technique during breast surgery. However at the actual state of knowledge there is no strong evidence that its use could lower incidence of chronic pain compared to general anesthesia alone.

Moreover for its use an adequate skill with ultrasound machine is required. For this reason only some anesthesiologists in our reality use this technique it in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* programmed breast surgery
* informed consent

Exclusion Criteria:

* bilateral breast surgery
Tissue Distribution, Pharmacokinetics, Safety, and Tolerability After a Single Dose of TNP-2092 in Participants Undergoing Primary Total Hip or Knee Arthroplasty

This study will investigate TNP-2092 distribution into joint tissues in participants undergoing a total hip arthroplasty (THA) or a total knee arthroplasty (TKA). Tissue distribution is the primary objective, and plasma pharmacokinetics (PK), safety, and tolerability are secondary objectives.

This is a Phase 1, open-label study to evaluate the tissue distribution, plasma PK, safety, and tolerability after a single 300 mg intravenous (IV) dose of TNP-2092 administered before induction of anesthesia in adult participants undergoing THA or TKA. Sixteen patients who are scheduled to undergo primary THA or TKA will be enrolled.

The enrolled participants who meet the inclusion/exclusion criteria will receive the study intervention (a single 300 mg IV dose of TNP-2092) 2 hours before induction of anesthesia on Day 1. Tissue samples from bone and synovial fluid will be collected during surgery and analyzed for TNP-2092 and cefazolin concentrations. Plasma samples will be collected on Day 1 and Day 2 for PK analysis. Safety and tolerability information will be collected on Day 1 and Day 2 at the clinical center, on Day 7 by phone, and on Day 14 at a final follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

Participants are eligible to be included in the study only if all inclusion criteria are met:

1. Male or females, 18 years of age or older
2. Participants who require primary THA or TKA
3. Body mass index (BMI) \>=18 kg/m2 but \<=40 kg/m2
4. Capable of giving signed informed consent

Exclusion Criteria:

Participants are excluded from the study if any of the following exclusion criteria are met:

1. History or hypersensitivity or intolerability to any of the following drugs: any member of fluoroquinolones, rifamycin, cefazolin or TNP-2092
2. History of known methicillin-resistant Staphylococcus aureus (MRSA) infections
3. Presence of any surgical or medical condition that in the opinion of the principal investigator and the medical monitor that could impact the interpretation of the results of the study;
4. Evidence of significant hepatic, hematologic or immunologic disease;
5. History or evidence of severe renal disease
In Vivo Sun Protection Factor Determination

The study aims to determine the Sun Protection Factor (SPF) of 8 cosmetic products in vivo on the back of human participants, according to the International Standard Sun Protection Test method by using a sun simulator.


Eligibility Criteria:
Inclusion Criteria:

* Understanding of the study and willingness to participate as demonstrated by voluntary written informed consent
* Age between 18 to 70 years (inclusive)
* Uniform skin and no erythema or dark pigmentation in the test area
* Skin type I, II or III according to Fitzpatrick scale
* Individual typological angle (ITA°) \> 28 in the test area
* Willingness to discontinue the use of detergents, cosmetic products in the treatment areas and to avoid any exposure of the test area to artificial or natural ultraviolet (UV) light throughout the study

Exclusion Criteria:

* Breast feeding, pregnant women or who are intending to become pregnant over study duration
* Acquired immunodeficiency syndrome (AIDS) or infectious hepatitis, insulin dependent diabetes, cancer, active skin disease at the test area, asthma or hypertension if not medicated, medical history of dysplastic nevi or melanoma, allergies to cosmetic products
* Electronic implant that cannot be removed during irradiation
* Sun exposition, UV therapy, artificial tanning within the last 4 weeks, or irregularly tanned skin in the test area
* Application of leave-on cosmetics at the test area within the last 24 h prior to the study start
* Moles, tattoos, scars, irritated skin, hair, etc. at the test area that could influence the investigation
* Usage of medications with known photo-toxic and/or photo-sensitizing potential within the last 14 days prior to study start and/or throughout the entire study course
* Systemic therapy with immuno-suppresive drugs and/or antihistamines within last 7 days prior to study start and/or throughout the entire study course
* Systemic therapy with anti-phlogistic agents or analgetics within last 3 days prior to study start and/or throughout the entire study course
* Participation or in waiting period of 2 months after participation in similar cosmetic and/or pharmaceutical UV studies
* Known or suspected intolerance or hypersensitivity to cosmetic products
* Alcohol or other substance of abuse within the last 5 years
* Employee of the sponsor or the study site or members of their immediate family
Use of Pain Medication Following Periodontal Procedures

This study had the following aims: i. to determine the relationship between anticipated pain and actual pain experienced following periodontal surgery; and ii. determine the factors that predict the amount of pain and the amount of pain medication use following periodontal surgery.

It was hypothesized that experienced pain will be significantly less than anticipated pain. It was also hypothesized that the following factors will affect pain experienced: sex, type of surgery, nervousness, anticipated pain, sedation, age, smoking status, supplement use and pain pill usage. It was hypothesized that the following factors will affect pain pill usage: sex, type of surgery, nervousness, anticipated pain, sedation, age, smoking status, supplement use, and actual pain.

Patients may delay or avoid periodontal procedures because of fear of dental pain they will experience. By understanding factors that influence pain experienced, practitioners can provide potentially provide accommodations for their patients. This study investigated if anticipated pain is similar to actual pain experienced and if there are certain factors that influence the amount of pain experienced and/or pain pill usage.

Patients kept a 7 day diary in which they recorded anticipated pain (prior to periodontal surgery) and actual pain experienced for 7 days following the surgical procedure. Patients recorded their pain (anticipated and actual) using a visual analog scale (VAS). Patients also recorded daily pain medication and nutritional supplement use in the 7 day diary.

Other information recorded included factors that could influence pain experienced and pain pill use. For pain experienced, the influence of the following factors were assessed: sex, age, type of surgery, nervousness, sedation use, smoking status, anticipated pain, nutritional supplement use and pain pill use. For pain pill use, the influence of the following factors were assessed: sex, age, type of surgery, nervousness, sedation use, smoking status, anticipated pain, nutritional supplement use and pain experienced. These factors were analyzed using regression analyses.

Eligibility Criteria:
Inclusion Criteria:

* require dental implant surgery or soft tissue graft surgery

Exclusion Criteria:

* regularly took pain medication for pre-existing health conditions
* previous implant or soft tissue graft surgery
A Study of Second-line Treatment With Apatinib for Advanced Intrahepatic Cholangiocarcinoma

The propose of this study is to confirm safety and efficacy of Apatinib monotherapy in patients with advanced cholangiocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-65 years;
2. Eastern Cooperative Oncology Group performance score (ECOG): 0-2;
3. Estimated survival time \> 3 months;
4. Patients with recurrent or metastatic cholangiocarcinoma with histologic or cytological diagnosis;
5. Previous first-line GP programmes failed, or were not able to withstand first-line treatment;
6. At least one measurable lesion \[spiral CT scan ≥ 10 mm (CT scan thickness not greater than 5mm)\], Measurable lesions were not treated with radiotherapy or other topical treatments unless progress was achieved after treatment was completed (RECIST version 1.1);
7. Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 75×109/L, HB ≥ 8 g/dL,ALB ≥2.8g/dL，TBIL ≤ 3×ULN, ALT or AST≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Cr clearance ≥ 50 mL/min;Thyroid function is normal；
8. No serious history of drug allergy；
9. Subjects volunteered for the study. Sign informed consent, good compliance, with follow-up.

Exclusion Criteria:

1. Patients have received targeted therapy；
2. Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction)；
3. Coagulation dysfunction (INR\> 1.5, PT\> ULN +4s or APTT\> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment；
4. Urine routine showed that urine protein ≥++ or the urine protein in 24 hours\>1.0 g；
5. Pregnant or lactating women；
6. History of other malignancy within 5 years except for effectively treated skin basal cell carcinoma, cutaneous squamous cell carcinoma and / or effectively excised orthotopic cervical and / or breast cancer;
7. The researchers judged other conditions that might affect clinical research and the outcome of the study.
Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI \[GS-9350\])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
* Plasma HIV-1 RNA levels ≥ 5,000 copies/mL at screening
* No prior use of any approved or investigational antiretroviral drug for any length of time
* Screening genotype report must show sensitivity to FTC, TDF, and ATV
* Normal electrocardiogram (ECG)
* Adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula)
* Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 x the upper limit of the normal range (ULN)
* Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
* Adequate hematologic function
* Serum amylase ≤ 5 x ULN
* Males and Females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
* Age ≥ 18 years
* Life expectancy ≥ 1 year

Exclusion Criteria:

* A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
* Receiving drug treatment for hepatitis C, or anticipated to receive treatment for hepatitis C
* Subjects experiencing decompensated cirrhosis
* Females who are breastfeeding
* Positive serum pregnancy test (female of childbearing potential)
* Implanted defibrillator or pacemaker
* Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
* History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
* Medications contraindicated for use with EVG, COBI, FTC, TDF, ATV, or ritonavir or subjects with any known allergies to the excipients of Stribild tablets, Truvada tablets, ATV capsules or ritonavir tablets
* Participation in any other clinical trial without prior approval
* Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements
A Clinical Trial to Evaluate the Safety and Effectiveness of Resorbable Collagen Membrane - MatrixflexTM

This is a randomized, single blind, parallel-arm, multi-center, non-inferior clinical trial. 174 patients are recruited in total, and they are treated by Guided Tissue Regeneration (GTR). The patients are split in to two groups evenly: 87 in the experimental group and 87 in the control group.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 65 years, male or female;
2. patients were clinically diagnosed with chronic periodontitis according to the international classification of periodontal disease in 1999;
3. Only solitary lesion site requires surgical treatment and must meet the following criteria:

   1. The baseline PD≥7 mm ;
   2. After debridement during operation, the defect of the vertical bone at the adjacent surface ≥4mm, and at least one alveolar buccal wall can be detected;
   3. The wideness of the keratinized gingiva≥2 mm;
   4. Based on the X-Ray image, the dental crowns at the bottom of the bone socket should be at least 3mm;

Exclusion Criteria:

1. The test tooth has open surgical debridement history within the most recent one years;
2. Known allergy to collagen of animal origin;
3. Clinical or radiographic signs of untreated acute infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cemento-enamel projections not easily removed by odontoplasty, untreated carious lesions at the cemento-enamel junction (CEJ) or on the root surface, subgingival restorations and/or restorations with open margins at or below the CEJ;
Open Label Trial to Evaluate the Adhesion of TK-254RX in Healthy Volunteers.

This study is a multi center, multiple dose, open label trial to evaluate the adhesion of TK-254RX in healthy volunteers. The primary purpose of this study is to evaluate the adhesion of TK-254RX. Secondary purpose is to show TK-254RX is safe and to explore and compare adhesion assessment methods.


Eligibility Criteria:
Inclusion Criteria:

* age: 18 to 64 years
* good state of health
* non-smoker or ex-smoker for at least 3 months
* written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial

Exclusion Criteria:

The following must not apply:

* any injury of body which may induce the restriction of body movement
* excessively hairy skin at application site
* current skin disorder or shaving hair at application site
* history of excessive sweating/hyperhidrosis inclusive of application site
* participation in a clinical study within 30 days before inclusion in the study or concomitantly
* drug or alcohol abuse in the opinion of the investigator
* pregnant and lactating women
* women of child-bearing potential who do not agree to apply highly effective contraceptive methods
* known hypersensitivity to active ingredient, its racemate or one of the excipients of the TK-254RX
* existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
* existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
* known liver or kidney insufficiency
* existing gastrointestinal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
* history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
* systolic blood pressure \< 90 or \> 139 mmHg
* diastolic blood pressure \< 60 or \> 89 mmHg
* pulse rate \< 50 bpm or \> 90 bpm
* subjects who use any impermissible medication
Damage and Renal Clearance of Glycocalyx in Cardiac Surgery

The glycocalyx is a component of the vascular endothelium that currently plays a relevant role in the modified Starling theory.

The manipulation of the heart during cardiac surgery stimulates the release of the natriuretic atrial peptide, which causes endothelial wear in patients undergoing extracorporeal circulation. Dilation of the atrium produces natriuretic atrial peptide, which reduces plasma volume by increasing renal excretion and vascular permeability. The atrial peptide degrades the surface of the coronary endothelium, causing loss of the side cam protein nucleus. This study investigates the relationship between clamping time in cardiac surgery and the clearance of endothelial inflammation markers.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Patients who underwent cardiac surgery for a single valve change or replacement

Exclusion Criteria:

* Stage 3 renal failure patients
* Patients with a previous diagnosis of hematological malignancy
* Patients undergoing pulmonary valve change surgery.
* Patients undergoing Bentall and Bono surgery.
* Patients Undergoing Coronary Artery Bypass Surgery
Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam

Psychological distress is common among Vietnamese cancer patients but often underestimated and not detected by professionals due to lack of time and overload of clinical work. Currently no established, evidence-based intervention exists to help address the mental health needs of cancer patients in Viet Nam besides the 'Stronger Together' peer mentoring intervention model that the investigators piloted in 2021-2023. The goal of this 2-arm, parallel, single-blind randomized controlled trial (RCT) is to pilot and evaluate the Vietnamese Self Help Plus (vSH+) stress management intervention among breast and gynecologic cancer patients in Viet Nam.

Aim 1- the investigators pilot the adapted vSH+ intervention. After recruitment and screening, participants are randomized into either the intervention (vSH+) or enhanced usual care (EUC) study arms. Participants are invited to attend an in-person informational session (IS) specific to their study arm, where informed consent is obtained.

Aim 2- the investigators assess the potential effectiveness of the vSH+ intervention. Quantitative surveys of study outcomes measures are administered at three timepoints: T0 (baseline, in-person, during info-sessions); T1 (1-2 weeks post-intervention, via phone); and T2 (3 months post-intervention, via phone).

Aim 3- the investigators conduct a qualitative process evaluation, via in-depth interview (IDIs) and focus group discussions (FGDs), to assess the acceptability and feasibility implementing and scaling up the vSH+ intervention model. Satisfaction surveys will be administered during vSH+ sessions and in-depth interviews (IDIs) will be conducted following the conclusion of the intervention. IDIs wil also be conducted with Facilitators, in addition to evaluation surveys during vSH+ sessions and supportive supervision sessions. Between T1 and T2, the investigators will conduct IDIs with Healthcare Workers and focus group discussions with Caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Have a clinician-confirmed diagnosis within the past 12 months of first-time breast and/or gynecologic cancer (e.g., cervical, ovarian, uterine, vaginal, vulvar) in stages I-III
* Currently or will receive treatment with curative intent
* Score less than 8 on the National Comprehensive Cancer Network (NCCN) Distress Thermometer, indicating low to moderate levels of distress
* Score less than 15 on the Patient Health Questionnaire-9 items (PHQ-9, indicating low to moderate levels of depression

Exclusion Criteria:

* Selected '2 Several days' or '3 Almost everyday' on PHQ9 item #9, indicating indicating imminent risk of suicide
* Have severe chronic diseases (e.g., coronary heart disease, chronic obstructive pulmonary disease (COPD), chronic renal failure), at the discretion of the treating clinician or study investigator
* People with a risk for psychosis, mania, and alcohol abuse, based on screening questions commonly used in the field
* Cannot attend the intervention activities at the hospital during the proposed intervention period
An Integrated Program to Promote Anti-cannabis Messages

The number of youngsters abusing cannabis is surging, the public health consequences caused by cannabis can be unpredictable. Educating the public especially the young population about cannabis need to be highlighted. To successfully promote anti-cannabis messages to youngsters and prevent them from taking cannabis, the involvement of their parents and modern technology such as robots can be helpful. This project aims to educate the young population and their parents about cannabis, particularly its legal consequences and clarifying their misconceptions.

A pre-post study design will be used. A total of 50 nursing students and 150 parent-child-dyads will be recruited by sending mass emails or sending invitation letters. The nursing students are in their year 2 or above bachelor program in the Hong Kong Polytechnic University. The inclusion criteria for parent-child-dyads include: (1) children who are aged 13 - 20, (2) children who have a parent who are willing to join with the child, and (3) parent-child dyads who are able to speak in Cantonese and write in Chinese. The outcome measures will cover demographic data, the knowledge about cannabis-related harm, the permissive attitude towards smoking cannabis and drugs trafficking.

Eligibility Criteria:
Inclusion Criteria

* children who are aged 13 - 20
* children who have a parent who are willing to join with the child

Exclusion Criteria:

-parents and children who are not able to speak Cantonese and write in Chinese