cyrilzakka/clinical-trials huggingface dataset:
A Single Ascending Dose of HRS-4029 in Healthy Subjects

The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-4029 following a single intravenous dose administration in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 55 years.
2. Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive).
3. Agreed to take effective contraceptive measures during and 3 months after the last dose of the study period.
4. Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).

Exclusion Criteria:

1. Diseases with abnormal clinical manifestations that occurred before screening or are currently occurring and need to be excluded.
2. Vital signs, physical examination, 12-lead electrocardiogram,or laboratory examination deemed clinically significant by the investigator .
3. Subjects with positive tests for infectious diseases.
4. Female who are pregnant or breastfeeding.
5. Unable to tolerate venipunctures or have a history of fainting needles and blood.
6. Historic abuse of alcoholic beverages
7. Smoke ≥5 cigarettes per day within 3 months prior to the study
8. History of drug abuse.
9. Other reasons that the investigator consider it inappropriate to participate in the trial.
Durvalumab Combined With S-1 as Adjuvant Therapy of Resectable BTC

The aim of this study is to assess the efficacy and safety of durvalumab combined with S-1 as adjuvant therapy of resectable Biliary Tract Cancer(BTC) with high risk of recurrence

Radical surgical resection is still the most important radical treatment for biliary tract tumors, and the postoperative recurrence rate of BTC patients remains high. It is particularly important to choose appropriate and effective adjuvant treatment.

This study is a single center, single arm, prospective, phase II clinical study. This study plans to include 40 BTC patients after radical resection. The patients are evaluated by a multidisciplinary team (MDT) as high risk of recurrence. Adjuvant therapy with durvalumab combined with S-1 should be started no more than 12 weeks after radical surgery. These patients will first receive 8 cycles of adjuvant therapy and the regimens consist of durvalumab and S-1, with a 21-day dosing cycle. After 8 cycles of adjuvant therapy, if the patients do not experience disease recurrence or intolerance，then the patients wil receive 6 cycles of adjuvant therapy in maintenance therapy stage. The regimen of andjuvant therapy is durvalumab with 28-day dosing cycle.

If the patients experience recurrence, the subsequent treatment plan will be determined by the researchers based on treatment guidelines.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years, both males and females are eligible.
2. Intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer(Histologically confirmed).
3. TNM stage before surgery: GBC/DCC T2-T4, N+, M0; ICC T1b-T4, N+, M0; PCC, any T, any N, M0 (according to UICC/AJCC TNM staging (8th edition)) .
4. Patients must undergo radical resection, including liver resection or pancreatectomy, before enrollment.
5. Time between surgery and enrollment \< 12 weeks.
6. R0 resection.
7. ECOG PS 0-1.
8. No distant metastasis confirmed by MRI.
9. Adequate organ and marrow function, as defined below. Haemoglobin ≥ 9 g/dL Absolute neutrophil count ≥ 1.5 × 109/L Platelet count ≥ 100 × 109/L Serum bilirubin ≤ 1.0 × ULN ALT and AST ≤ 2.5 × ULN Calculated creatinine clearance \> 50 mL/minute as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine clearance.

Exclusion Criteria:

1. Patient diagnosed with Ampulla of Vater(AoV).
2. Time between surgery and enrollment \>12 weeks.
3. Receive anti-tumor treatment before surgery, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, local therapy, etc.
4. The tumor was not completely removed, or the postoperative pathology indicated that it was not a biliary tract tumor.
5. Receive other anti-tumor treatments, such as chemotherapy, radiotherapy, or other research drugs, during postoperative adjuvant therapy.
6. Severe infection within 4 weeks before enrollment.
7. Participated in another interventional clinical study.
8. Other factors deemed by the investigator to make the participant unsuitable for participation in this study.
Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device

Single blinding study comparing FDA cleared device for prevention of medically diagnosed migraine pain to placebo.

In order to determine if nocturnal jaw clenching can be an influence on chronic migraine pain, the FDA cleared "NTI" (Nociceptive Trigeminal Inhibition) device with the Indications for Use of "for prophylactic treatment of medically diagnosed migraine pain" was compared to a similar device that had no influence on jaw clenching.The HIT-6 (Headache Impact Test) score was selected as the outcome measure, as the goal was to focus on improving disability in sufferer's lives, as in chronic migraine, changes in headache days may not be as helpful as improving disability.

Eligibility Criteria:
Inclusion Criteria: Diagnosed with chronic migraine at a neurology clinic -

Exclusion Criteria: none

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Comparison of Maternal Hemodynamics During Spinal Anesthesia with Different Cesarean Delivery Positioning

Cesarean delivery is a common surgical procedure, and maintaining maternal hemodynamic stability during the procedure is crucial for both maternal and fetal outcomes . Hemodynamic instability, such as hypotension following spinal anesthesia, is a frequent complication and can lead to adverse maternal and neonatal outcomes. Traditionally, after spinal anesthesia, women are positioned supine, sometimes with a slight left lateral tilt to mitigate the risk of aortocaval compression . However, recent studies and clinical observations suggest that delayed supine positioning-keeping the patient in a sitting or semi-sitting position for a period following spinal anesthesiamay improve hemodynamic stability. These alternative positions may help to mitigate the abrupt drop in blood pressure commonly seen after spinal anesthesia by allowing for a more gradual redistribution of blood volume . Understanding the optimal positioning strategy could lead to improved clinical protocols that enhance maternal and fetal safety. By comparing immediate supine positioning with delayed supine positioning (in sitting and semi-sitting positions), this study aims to provide evidence on which positioning strategy offers the best hemodynamic outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women scheduled for elective cesarean delivery.
* Age between 18 and 40 years.
* ASA (American Society of Anesthesiologists) physical status II.

Exclusion Criteria:

* Emergency cesarean delivery.
* Pre-existing cardiovascular disease.
* Severe preeclampsia or eclampsia.
* Multiple pregnancies.
* Known fetal anomalies.
A Study of EDP-323 in Healthy Subjects

This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-323 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease.
* Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening and infection with SARS-CoV-2 at the Day -1 visit
* Pregnant or nursing females.
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
* A positive urine drug screen at screening or Day -1.
* Current tobacco smokers or use of tobacco within 3 months prior to screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
* History of regular alcohol consumption.
* Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose.
The Effect of Entecavir Consolidation on Post-TDF Treatment Durability

Clinical relapse occurred much earlier and tended to be more severe after cessation of TDF than ETV. The follow-up interval and intensity would be different between ETV and TDF after discontinuation of therapy. Whether switch therapy from TDF to ETV can modify the pattern of relapse is interesting but unclear. Our hypothesis is that entecavir consolidation on post-TDF treatment patients reduce and delay the clinical relapse effectively. Hence in this proof of concept study we would like to evaluate the effect of 6 months and 12 months of entecavir consolidation on post-TDF treatment durability.

Long term nucleoside/nucleotide analogues (NAs) treatment is required in the treatment of chronic hepatitis B (CHB). According to current treatment guidelines from APASL 2015, NAs treatment can be stopped if, after HBsAg loss following either anti-HBs seroconversion or at least 12 months of a post-HBsAg clearance consolidation period or after treatment for at least 2 years with undetectable HBV DNA documented on three separate occasions, 6 months apart. In Taiwan, the National Health Insurance system only reimburse 3 years NAs for CHB patients. Previous study from Jeng et al. suggested that the 1-year rate of clinical relapse (HBV DNA\>2,000 IU/mL plus ALT\>2X ULN) after cessation of entecavir(ETV) therapy by APASL stopping rule (treatment \>2 years, HBV DNA undetectable \>1 year) in HBeAg-negative chronic hepatitis B(CHB) patients was 45%, of which 25.6% occurred within 6 months. Recently, another study from Jeng et al showed that 34 HBeAg(-) patients who stopped TDF therapy by APASL stopping rule were followed-up every 1-3 months for \>6 months. Of these 34 patients, mean age was 51.8 years, 82.4% were males and 14(41.2%) were cirrhotic. The 1-year cumulative clinical relapse rate was 46%, of which 93.3% occurred within 6 months, and 13.3% developed decompensation. Clinical relapse occurred much earlier and tended to be more severe after cessation of TDF than ETV. The follow-up interval and intensity would be different between ETV and TDF after discontinuation of therapy. Whether switch therapy from TDF to ETV can modify the pattern of relapse is interesting but unclear. Our hypothesis is that entecavir consolidation on post-TDF treatment patients reduce and delay the clinical relapse effectively. Hence in this proof of concept study we would like to evaluate the effect of 6 months and 12 months of entecavir consolidation on post-TDF treatment durability.

Eligibility Criteria:
Inclusion Criteria:

* \>20 yrs old.
* No history of Lamivudine or telbivudine resistance.
* HBsAg positive for more than 6 months.
* HBeAg (-).
* HBeAg-negative CHB under TDF treatment for mora than 2 years and fulfilled APASL 2012 guideline's stopping rule: HBeAg (-): undetectable HBV DNA on 3 separate occasions at least 6 months apart.

Exclusion Criteria:

* Lamivudine/telbivudine resistance.
* HBeAg (+).
* HIV, HCV co-infection.
* Under immunosuppressant treatment (including steroid and biologics).
Evaluation of Adherence to Clinical Treatment of Glaucoma

Evaluation of adherence to clinical treatment of glaucoma in patients of a Reference Ophthalmological Hospital in Goiânia using Morisky Adhesion scale as a validated questionary.


Eligibility Criteria:
Inclusion Criteria: have glaucoma diagnosed -

Exclusion Criteria: not having glaucoma diagnosed

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Impact of Health Literacy on Outcomes and Effectiveness of Shared Decision Making Programs in Patients With Chronic Diseases

Study objective was to explore the impact of health literacy on effectiveness of an educational intervention describing life-style and behavior modification for patients "Living with Coronary Artery Disease." Our hypothesis was that a VHS/DVD version of this educational program would be "superior" to printed material alone in its impact on patients' knowledge about coronary artery disease and important life-style changes. Furthermore, we believed this effect would be most notable among patients with low health literacy. We also were interested in the impact of the interventions on secondary outcomes including - health behaviors, health outcomes and patients' subjective experiences.

187 patients with coronary artery disease (CAD) were randomized to one of two educational interventions prior to scheduled ambulatory visit: VHS/DVD plus printed booklet; or booklet alone. Main measures included health literacy, CAD knowledge assessment; clinical outcomes and health behaviors including - blood pressure, weight, smoking status, exercise and dietary habits.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18,
* Diagnosis of ischemic heart disease.

Exclusion Criteria:

* Nursing home resident,
* Did not speak English, or
* Had a significant visual impairment that precluded their ability to read or watch television.
Effects of White Wine vs. Tea Intake During and an Alcoholic Digestive Following a High Fat, High Calorie Cheese Fondue Meal on Gastric Emptying and Abdominal Symptoms in Healthy Volunteers

Tradition holds that the intake of different drinks with a meal has an important influence on the digestion of food and postprandial symptoms such as fullness, bloating and satiety; however this assumption have never been subjected to controlled study

A classic example is the Swiss cheese fondue. The intake of white wine, tea and cherry schnapps (Kirsch) are often attributed either positive or negative effects on the gastrointestinal tract.

In this study the effect of white wine vs. tea intake during and an alcoholic digestive following a high fat, high calorie Swiss fondue meal on gastric emptying and visceral perception will be investigated using a randomized, controlled study design.

The fondue will be labeled with non-radioactive 13C octanoate for assessment of gastric emptying by breath-test.


Eligibility Criteria:
Inclusion criteria: • able to communicate well with the investigators and provide written consent

• Body Mass Index: 19-30 kg/m2

Exclusion criteria: • physical co-morbidity requiring active treatment

* psychiatric (DSM IV) disorders limiting the ability to comply with study
* use of medications influencing upper GI motility
* evidence of current drug or alcohol abuse
* history of gastrointestinal disease or surgery except appendicectomy or hernia repair
Training Community Members to Deliver HIV Prevention Programs to Urban Youth

This study will examine methods for involving local community members in programs to teach urban youth about how to prevent transmission of HIV.

HIV is a sexually transmitted virus that damages or destroys a body's immune system. When the infection progresses to its later stages, AIDS can develop. Several programs have been developed for educating adolescents about how to prevent HIV transmission. Preventing infection is particularly important because there is not yet a way to cure HIV. This study will examine the processes needed to train community members to deliver HIV prevention programs to urban youth.

This study has three steps. In Step 1, an existing group of urban community members who have already delivered the Be Proud! Be Responsible! HIV prevention program will be invited to serve as mentors for new HIV educators in the community. Participants in this step will complete self-administered assessments of their willingness to collaborate with university-based researchers, their confidence in skills necessary for collaborative projects, and any foreseeable obstacles to participation. The goal of this step is to examine the response over time to ongoing HIV leadership.

In Step 2, parents from the targeted community will be recruited and trained in HIV prevention programs. They will be randomly assigned to one of three programs: Becoming a Responsible Teen, Be Proud! Be Responsible!, and Reducing the Risk. All three of these programs involve group meetings with adolescents to discuss puberty, sexuality, communication, self-esteem, HIV/AIDS, and setting and achieving goals and dreams. Participants in this phase will undergo the same assessments as those in Step 1.

In Step 3, the parents trained in Step 2 will be randomly assigned to a middle school or high school where they will deliver the program in which they were trained. Randomly selected adolescent participants from these schools will be assigned to whichever program is being offered at their school. All three prevention programs will include four to six sessions over 4 to 6 weeks. Adolescent participants will be required to complete interviews and questionnaires when they enter the study, after 3 months, and after 15 months. These interviews and questionnaires will measure HIV/AIDS knowledge, self-esteem, intention to protect health, and engagement in risk-taking behaviors. Parent participants in Step 3 will repeat the assessments from Steps 1 and 2 before and after delivering their prevention curriculums.

Eligibility Criteria:
Inclusion Criteria

* Adult community HIV educators who are parents of a middle or high school aged child
* Adult participants must be between 25 and 60 years of age
* Youth participants must be between 12 and 15 years of age
* Residents of target communities in Bronx, NY

Exclusion Criteria:

* Parent or guardian is excluded if youth participant cannot provide informed consent because of mental health or substance abuse diagnosis
* Significant cognitive impairment that might interfere with understanding of program content or informed consent process
Impacts of Static Magnetic Fields on Dysmenorrhea Pain

Study to determine the effectiveness of a certain type of magnet to reduce period pain

Young women with their period pain levels of 6 or greater on a pain scale of 0-10 will wear a concentric magnet or a sham that is positioned close to the maximum pain site. The pain score after wearing either the magnet or sham will be recorded.

Eligibility Criteria:
Inclusion Criteria: Female with period pain score consistently equal to or greater than 6 on a pain scale of 0-10 -

Exclusion Criteria:

1. Pain not experienced on almost all menstrual cycles
2. Having secondary dysmenorrhea including endometriosis, fibroids or pelvic inflammatory disease
3. Having a pacemaker or any implanted wires or devices -
Intraarticular Injections of Platelet-rich Plasma in Pain's Treatment of the Osteoarthritic Knee

Platelet-rich plasma (PRP), due to its high content of cytokines, bioactive proteins and platelet growth factors, may contribute to diminish the pain of arthritic knee. It was also recently recognized a regenerative cell potential improving the concentration of hyaluronic acid and stabilizing angiogenesis in arthritic knees

This study therefore seeks to assess the analgesic power of PRP in osteoarthritic knees intraarticularly infiltrated, and which patients would benefit most from treatment, eliminating false expectations in the rest.

This is the first clinical trial developed following the report of the Spanish Competent Authority on May 23, 2013, considering the PRP as a medicinal product for human use and establishing minimum guarantees required of the product and the process of manufacturing. It has been conducted from the perspective of both the trauma and the specialized treatment of chronic pain anesthesiologist, and manufacturing the PRP on the premises of a Regional Centre for Transfusions, all belonging to the Public Health System and therefore without commercial interests.

Eligibility Criteria:
Inclusion Criteria:

* Arthritis in the knee rated I, II, or III (Kellgren-Lawrence Grading Scale)
* VAS greater than 5
* Between 40and 80 years of age

Exclusion Criteria:

* Level IV arthritis of the knee
* Either surgery, corticoid infiltration, or viscosupplementation in the knee in the previous three months
* Frontal deformity greater than 10 degrees
* Ipsilateral pathology of the knee or ankle
* Range of motion or flexibility of the knee less than 90 degrees
* Deficit of knee extension greater than 15 degrees
* Anticoagulation treatment, antiplatelet treatment
* Hepatopathy
* Hematological neoplastic pathology
* Active infection
* Fibromyalgia
* Chronic fatigue syndrome
Modified Barium Swallow in Measuring Swallowing Function After Surgery in Patients With Oropharyngeal Cancer

This pilot clinical trial studies the modified barium swallow in measuring swallowing function after surgery in patients with oropharyngeal cancer who have undergone surgery. New diagnostic procedures, such as the modified barium swallow, may be effective in studying the side effects of cancer therapy in patients who received treatment for oropharyngeal cancer

PRIMARY OBJECTIVES:

I. To compare aspiration in oropharyngeal carcinoma patients that underwent transoral robotic surgery (TORS) vs. chemoradiotherapy (CRT) via an objective instrument, the modified barium swallow (MBS).

SECONDARY OBJECTIVES:

I. To compare patient-perceived swallowing function of oropharyngeal carcinoma patients that underwent TORS vs. CRT via a subjective instrument, the M.D. Anderson Dysphagia Inventory (MDADI) using the total MDADI score.

II. To compare patient-perceived swallowing function of oropharyngeal carcinoma patients that underwent TORS vs. CRT via a second subjective instrument, the Eating Assessment Tool (EAT-10) using the total EAT-10 score.

III. To estimate the correlation between the maximum Penetration Aspiration Scale (PAS) score and MDADI total score in TORS or CRT oropharyngeal carcinoma patients regardless of treatment modality.

IV. To estimate the correlation between the maximum PAS score and EAT-10 total score in TORS or CRT oropharyngeal carcinoma patients regardless of treatment modality.

V. To estimate the correlation between MDADI total score and EAT-10 total score in TORS or CRT oropharyngeal carcinoma patients regardless of treatment modality.

VI. To estimate cervical esophageal stricture diameters after TORS vs. CRT via an objective instrument, the MBS.

OUTLINE:

Patients undergo the modified barium swallow, comprising swallowing boluses of thin liquid barium, barium honey, barium pudding, and barium crackers while undergoing fluoroscopic imaging.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have undergone TORS or CRT for oropharyngeal carcinoma 6-24 months prior at Wake Forest University Baptist Hospital (WFUBH)
* In CRT treated participants, CRT had to be delivered as a primary modality with curative intent
* In TORS treated participants, TORS had to be done as a primary modality with curative intent
* Written informed consent
* No evidence of recurrent disease or second primary tumors on physical examination

Exclusion Criteria:

* Previous head and neck surgery, radiation, or chemotherapy preceding TORS
* Previous head and neck surgery preceding CRT
* If CRT patient, candidacy for TORS is not met
* Known neurologic dysfunction affecting swallowing
* Evidence of recurrent or second primary cancers on examination
* Patient pregnancy (due to radiation exposure risk to unborn fetus)
* Inability to grant informed consent