cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial on Pharmacokinetic and Tolerability of AP701

This study aims to investigate the uptake of AP701, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.

Pharmacokinetic parameters and tolerability of AP701 is studied over 30 hours after single dose administration in healthy volunteers in a prospective and open-label manner at a single study center.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent form
2. Male in the age of 35 - 60 year at study start
3. Body mass index of 18 to 30 kg/m2
4. Non-smoker, no use of any Tabaco products
5. Good general health status (Karnofsky Score = 100)
6. Current ECG without abnormal findings (i.a. QTcF \< 450 ms)
7. Physical examination, medical history without exclusionary findings
8. Pulse rate between 50 and 90 bpm
9. Blood pressure between systolic 90 - 140 mmHg, diastolic 50 - 90 mmHg
10. Lab values for liver function (ALT, AST, AP, Bilirubin total) within normal ranges
11. Lab values for renal function (S-Creatinine, eGFR) within normal range
12. Negative test result on HIV I, HIV II, hepatitis B cell surface antigen, hepatitis C antibody
13. Negative test result of urine screening for Cannabis, alcohol, and substance abuse

Exclusion Criteria:

1. Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
2. Use of Cannabis products within the last 8 weeks
3. Use of opioids
4. Former or present dependency (e.g. to alcohol, medicinal products, drugs)
5. Participation in another clinical trial within the last four weeks prior to study inclusion
6. Present, former, or family history of mental illnesses such as severe de pression, psychosis, bipolar disorder, mania, obsessive compulsive disorder, and anxiety disorder
7. Acute severe somatic disease (e.g. gastrointestinal diseases, influenza)
8. Body temperature ≥ 38 °C
9. Present cardiovascular, respiratory, diabetic, or cancer disease
10. Hepatitis or other liver and renal disease
11. Other diseases or conditions that do not allow the participant to assess the nature and scope, and possible consequences of participating in this clinical trial
12. Indications that the participant is unlikely to comply with the study protocol (e.g. lack of cooperation)
13. Taking any pharmaceutical products (including any medication interacting with metabolism of THC, e.g. St. John's wort)
Novel Method for Diagnosing Lateral Patellar Compression Syndrome Using X-ray: a Retrospective Case-Control Study

This study evaluates whether the patellar axial radiograph of lateral patellar curvature angle （LPCA）with knee flexion at 30 ° can be used as a new diagnostic surrogate of lateral patellar compression syndrome（LPCS）. We believe that the new index LPCA has high sensitivity and specificity in initial diagnosis of LPCS using axial patellar radiograph with knee flexion at 30 ° , and has high application value.

Background: A well-established reference is lacking for diagnosing lateral patellar compression syndrome (LPCS), and this diagnosis currently depends on clinicians' subjective judgment and several examination results. X-rays are primarily used to diagnose LPCS, but they have low detection rates of patellar tilt using the congruence angle (CA) and patellar tilting angle (PTA).

Purpose: To investigate whether patellar axial radiography of the lateral patellar curvature angle (LPCA) of knee in 30° flexion can diagnose LPCS.

Methods: We enrolled 87 patients between 2016 and 2019 and divided them as per diagnosis into three groups of 29 each: LPCS, patellar dislocation (PD, control), and meniscus tear (MT, negative control) groups. A senior radiologist and the chief physician of sports medicine examined their patellar axial radiographs of the knee in 30° flexion using a computer imaging system, measuring LPCA, PTA, and CA. Univariate analysis of variance and Kruskal-Wallis H test were used to compare measurement data with normal distribution and non-normal distribution, respectively. Bonferroni correction was used to analyze different indicators for different groups. The area under the curve (AUC) was calculated to verify the value of LPCA in initial diagnosis of LPCS.

Eligibility Criteria:
Inclusion Criteria:

* Patients were diagnosed as LPCS ，MT and PD respectively

Exclusion Criteria:

* patients with ligament injury, malunion of patella fracture, free bodies in the joint, surgical contraindications, and with both knees affected.
House Calls and Peer Mentorship

Live donor kidney transplantation (LDKT) offers the most optimal survival and quality of life benefit for those with late-stage chronic kidney disease. However, minorities, especially blacks, are much less likely to receive LDKT than whites. Given the shortage of deceased donor organs, interventions expanding access to LDKT are needed, particularly for minority patients. House Calls (HC), an educational intervention developed by this study's PI has been shown to be an effective program for raising rates of live donation, especially for black patients. While the HC program has shown outstanding results, participant feedback suggested that follow-up may provide even more benefits. Previous research suggests that peer mentorship (PM) from former or current patients with ESRD may be effective in raising rates of living donation. As such, peer mentorship programs may act as an effective follow-up for HC participants. This study will examine the impact of the HC intervention combined with the peer mentorship program of the National Kidney Foundation on rates of live donor kidney transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Black race (including possible Cape Verdean, Haitian, Dominican)
* ≥18 yrs old
* English speaking
* Meets eligibility criteria for kidney transplant evaluation
* Ability to provide informed consent
* Resides within 1.5 hr drive of HC educator

Exclusion Criteria:

* Temporarily Unavailable (TU) on the waiting list and TU is likely to exceed 6 months based on judgement of kidney transplant team
* Awaiting combined kidney-liver transplantation
* Awaiting simultaneous pancreas-kidney transplantation
* Participation in another study to increase the likelihood of LDKT
* Prior participation in a transplant HC
* Prior or current participation in the NKF PM program
Effects of Isometric Muscle Fatigue on Trunk Muscle Stiffness

Interventional study of the effects of a trunk extensor muscles fatigue protocol on trunk extensors stiffness.

Single visit interventional study of the effects of a trunk extensor muscles fatigue protocol on multifidus and erector spinae muscle stiffness measured by Ultrasound based Shearwave elastography.

Eligibility Criteria:
Inclusion Criteria:

* Physically active at least 3 hours a week

Exclusion Criteria:

* Low back pain in the past 6 months
* History of chronic low back pain
* History of spinal or pelvic operation
* Hypermobility, more than 4 points on Beighton scale
* Cardiovascular or systemic diseases
* Pregnancy
The Effects of Case Management in a Medicaid Managed Care Plan

The purpose of this study is to evaluate whether or not case management by a social worker and nurse can decrease the number of emergency room visits, increase the number of primary care doctor visits, and increase quality of life of people in a Medicaid managed care plan.

This study will assign participants based on Zip Code to one of two conditions: control and experimental. In the control group, participants will receive telephonic assessments at baseline, three months, and six months. These assessments will be conducted by a member of the Medical Center's Department of Geriatrics under the supervision of the Principal Investigator. Participants in the experimental group will receive medical case management provided by a nurse and social worker in the homecare setting including an in-home assessment. Assessments will be conducted at baseline, three months, and six months during routine homecare visits. Dependent variables being measured include: access to primary care physicians, emergent hospitalizations/admissions, articulation of advance directives, and quality of life. Data will be collected through the participants' medical claims and records to analyze the number of emergent hospitalizations/admissions, documentation of advance directives, and number of visits to primary care physicians. To measure participants' quality of life, the Depression Self-Rating Scale and the Clinical Anxiety Scale will be utilized. Data will be compared between and within the groups via statistical analyses. The researcher will conduct pre-post comparisons of utilization and other database-derived outcomes for both groups, comparing the 12 months prior to and up to 20 months following enrollment.

Eligibility Criteria:
Inclusion Criteria:

* participation in a Medicaid managed care plan
* resident of identified zip codes in Brooklyn, NY
* frequent hospitalizations and low frequency of primary doctor visits

Exclusion Criteria:

* residents outside the catchment area
* patients not being managed in a Medicaid managed care plan
Personalizing Immune Checkpoint Inhibitor Therapy

This prospective, observational study will evaluate whether vitro testing of tumor tissue and white blood cells from patients with lung cancer who are being treated with immune checkpoint inhibitors and other standard of care approaches, predicts clinical response to these agents.

Overall Goal: The long-term goal of this study is to predict whether checkpoint inhibitors will be effective in individual patients with solid tumors.

Objectives: In this pilot study to be conducted in ten subjects with lung cancer who are to receive checkpoint inhibitors, we will use cellular and molecular techniques to characterize

* tumor immunogenicity
* anti-tumor T-cell response
* effect of checkpoint inhibitors on antigen presentation and T-cell response, and
* the tumor microenvironment

Planned enrollment:

• Ten subjects with lung cancer

Methods for Informed Consent:

Investigators will approach subjects for informed consent

Eligibility Criteria:
Inclusion Criteria:

* Subjects with lung cancer about to undergo diagnostic/excisional biopsy with the intent to receive therapy with immune checkpoint inhibitors
* Availability of fresh tumor tissue removed at excisional biopsy or diagnostic biopsy
* Informed consent

Exclusion Criteria:

• Lack of informed consent
Mindful After Cancer: A Mindfulness-based Therapy Intervention for Sexual Health After Cancer

The objectives of this study are to: 1) adapt a mindfulness-based therapy program designed to help women manage their sexual and body image concerns after cancer (Mindful After Cancer, MAC) to a videoconference format and 2) assess the feasibility, acceptability, and preliminary effects of the program among breast and gynecologic cancer survivors.

The specific aims are: 1) Assess the feasibility of the MAC program when delivered via videoconference and 2) Assess preliminary effects of the the program.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast or gynecologic cancer at least one year prior to enrollment
* English speaking
* Have access to a computer, smart phone, or tablet with internet access
* Ability to spend 15-30 minutes per day on program activities

Exclusion Criteria:

- Stage 0 (carcinoma in situ)
Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)

The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the reasons for attrition along the PrEP cascade in a cohort of pregnant and breastfeeding women. The specific aims are to: (1) Evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services; (2) Describe the PrEP cascade of initiation, retention, and adherence in a cohort of 220 HIV-uninfected pregnant and breastfeeding women, (3) Evaluate attrition and associated factors across the PrEP cascade.


Eligibility Criteria:
Inclusion Criteria:

1. Documented HIV-negative according to two fingerpick rapid tests (per routine antenatal care protocol in this setting), confirmed with a 4th generation antigen HIV test at study enrollment
2. No previous exposure triple-drug antiretroviral therapy
3. Age 18 years or older
4. Lives within 20 kilometers of a clinic
5. Without psychiatric or medical contraindications to PrEP use
6. Able to provide informed consent for research

Exclusion Criteria:

Failure to meet any of the inclusion criteria
Pilot Study of Free From Falls Program in Multiple Sclerosis

This pilot study will compare how often people with multiple sclerosis (MS) fall before participating in the Free From Falls (FFF) educational program, during the program, and for 8 weeks after the program. The protocol will also evaluate the accuracy, efficiency and convenience of an email survey to count how often people fall.

This pilot study will recruit people with MS who report falling at least twice in the previous 2 months to participate in the FFF program. All subjects will record their falls and injurious falls on a daily basis for at least 3 weeks before the program, during the program and for 8 weeks after the program. The program will consist of a weekly 2 hour session. One hour of the session will be educational and one hour of the program will involve exercise. The outcome of this study will be change in fall rate between the periods before, during and after the program.

Eligibility Criteria:
Inclusion Criteria:

* MS of any type
* Age 18 years or older
* Able to walk at least 100 meters with intermittent or unilateral constant assistance (cane, crutch or braces) with or without resting
* Self-reported history of 2 or more falls in the previous 2 months
* Clinically stable MS with no relapses within 30 days
* Willing to provide informed consent
* Fluent in written and spoken English.
* Daily access to email and willing to respond to a daily email questionnaire

Exclusion Criteria:

* Serious psychiatric or medical conditions that would preclude reliable participation in the study.
Study Comparing Adapalene Gel 0.3% to Differin® and Both to a Placebo Control in Treatment of Acne Vulgaris

The objectives of this study are to evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%).

The objectives of this study are to evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Subjects aged 18 years and older must have provided written consent. Subjects aged 12 to 17 years must have provided written assent accompanied by written consent from their legally acceptable representative. All subjects or their legally acceptable representatives must sign Health Insurance Portability and Accountability Act authorization.
* Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
* Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Exclusion Criteria:

* Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
* Have a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients.
* Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.
Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea

This study will evaluate the safety and tolerability of AGN-199201 for the treatment of erythema associated with rosacea.


Eligibility Criteria:
Inclusion Criteria:

* facial erythema associated with rosacea on both sides of the face

Exclusion Criteria:

* Laser light-source or other energy based therapy in the last 6 months
* Excessive hair around the treatment area
The Value of Sintilimab Consolidation Therapy After Definitive Concurrent Chemoradiotherapy for Locally Advanced Thoracic Esophageal Cancer

Esophageal cancer is a kind of disease with high incidence and mortality. Definitive concurrent chemoradiotherapy is an important treatment for locally advanced esophageal squamous cell carcinoma. To Investigate the value of immunotherapy consolidation in locally advanced esophageal squamous cell carcinoma after completing radical concurrent chemoradiotherapy.

In East countries, especially China, more than 75 percent of esophageal cancers are primary squamous cell cancers located in the middle and upper thoracic segments, whereas adenocarcinoma accounted for less than 20 percent.Unlike other malignancies, more than half of esophageal cancer were diagnosed as locally advanced at the time of diagnosis. Definitive concurrent chemoradiotherapy is an important treatment for locally advanced esophageal squamous cell carcinoma.

Immune checkpoint inhibitors are a new class of antitumor drugs. They are different from traditional cytotoxic chemotherapy drugs and can target the regulatory molecules that play an inhibitory role in the tumor immune system.

Recent clinical studies had shown that for locally advanced non-small cell lung cancer, maintenance therapy with the immune checkpoint inhibitor could significantly improve the overall survival for locally advanced non-small cell lung cancer after definitive concurrent chemoradiotherapy. Moreover, the immune checkpoint inhibitor PD-1 has also been shown to be a promising anticancer agent in esophageal cancers. Therefore, the present study intended to give a standard dose (50.4Gy/28F) to locally advanced esophageal squamous cell carcinoma for radical chemoradiotherapy, and than to give the Sintilimab as consolidation therapy for 1 year after completion of radiotherapy. At the time point of 6 weeks after radiotherapy, all participates need a full evaluation of the treatment response. In patients with residual disease, we would give them an additional radiotherapy boost to 61.2 Gy/34F under the guidance of PET-CT or ultrasound endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* ECOG 0-1; Life expectancy \>6 months;
* Stage II/III esophageal cancer;
* Pathology confirmed squamous cell carcinoma;
* Hemoglobin ≥10g/dl, WBC ≥3.0 x 109/L, platelet ≥100 x 109/L; CR≤ 1.0x normal upper limit, total bilirubin ≤ 1.5x normal upper limit, AST and ALT≤ 1.5x normal upper limit, AKP≤ 2.5x normal upper limit;
* Have a full understanding of this study, participate voluntarily, have follow-up conditions and sign the informed consent;

Exclusion Criteria:

* Stage IV esophageal cancer;
* Esophageal adenocarcinoma;
* Gastric esophageal junction adenocarcinoma;
* ECOG \> 2;
* Progression after first-course radiotherapy;
* Existing active infection, such as active tuberculosis, hepatitis, etc.;
A Phase I Open Label Study to Assess PK and Safety of Plant Cannabis Extract

This study is an open-label, single-dose, healthy volunteer phase 1 study after overnight fasting designed to study the safety and PK of medicated drops and tablet formulation for sublingual administration.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy, male or female, between 18 and 45 years of age (inclusive).
2. Body mass index (BMI) between 20-30 kg/m2 (both inclusive)
3. No recent cannabis usage within 30 days from screening
4. Normal rage hepatic functions
5. No electrolytes abnormalities
6. Vital signs at screening (after five minutes resting measured in the supine position) within the following ranges:

   1. Body temperature between 35.0 to 37.5 °C
   2. Systolic blood pressure, 90 to 150 mmHg\*
   3. Diastolic blood pressure, 60 to 90 mmHg\*
   4. Pulse rate, 50 to 90 beats per minute\*.
   5. \*Blood pressure and pulse rate will be taken again in a standing position. After two minutes standing, there shall be no more than a 20 mmHg drop in systolic or 10 mmHg drop in diastolic blood pressure, associated with clinical manifestation of postural hypotension).

Exclusion Criteria:

1. Blood donation within 90 days
2. History of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastroenterology, endocrine, immunology, dermatologic, neurologic or psychiatric disorders
3. Subjects with a history of alcohol, drug abuse, chronic cannabis use within 2 years of study
4. Pregnant women
5. Subjects who used any prescription or OTC medication in the past 14 days with the exception of paracetamol or ibuprofen.
6. Sexually active males whose partner is of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP. Sexually active females of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP
7. Pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
8. Subjects who had postural drop of \> 20 mmHg in systolic blood pressure at screening
9. Patients with heart failure,
10. Subjects with a history of psychotic state in the past or anxiety disorder,
11. Subjects at age of less than 30 years with a history of psychiatric disease in a first-degree family member
12. Subjects with a history of addiction or drug abuse
Impact of the Daily Use of Emollient on Corticosteroids Consumption in Patients With Atopic Dermatitis

This study aims at assessing the reduction of consumption of corticosteroids (same mid-potent corticosteroids for all patients) afforded by the use of a specific emollient in comparison to the usual one in subjects suffering from atopic dermatitis.

The study is conducted in compliance, as closely as possible, with the current version of the world medical association declaration of Helsinki, local regulations based on International Council on Harmonisation (ICH) guidelines for Good Clinical Practice.

The primary objective of this study is to compare the tested emollient and the usual emollient through the weight of used dermocorticosteroid. The weight of used dermocorticosteroid is compared at the end of the study by a Student t-test (or a non parametric Wilcoxon test depending on the data distribution).

The following hypotheses are used for the estimation of the sample size calculation:

* Power (1 - β) = 80%
* Two-sided significance level (α) = 5%
* Expected inter-group difference = 0.6g
* Standard deviation = 1.4g.

Statistical analyses is performed with SAS® version 9.4 or higher (SAS institute, North Carolina, USA).

Continuous variables are summarized as number of observations, mean, standard deviation, standard error, median, minimum and maximum (95% confidence interval will be provided if necessary). For categorical variables, subject counts and percentages will be provided.

Analyses use 2-sided tests at the 5% significance level, except the normality tested at the threshold of 1% (Shapiro-Wilk test).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of atopic dermatitis must meet Hanifin's criteria (at least 3 basic features and at least 3 minor features)
* mild atopic dermatitis present for at least 6 months before inclusion (SCORAD at inclusion between 20 and 30)
* able to apply the emollient (each morning and evening) during a three-month period

Exclusion Criteria:

* presenting with another dermatological condition that could interfere with clinical evaluation
* having received any systemic treatment, including PUVAtherapy for atopic dermatitis in the month prior to Day 0
* who intend to expose themselves to the sun during the trial