cyrilzakka/clinical-trials huggingface dataset:
A Study of JNJ-53718678 in Participants With Hepatic Impairment

The main purpose of the study is to evaluate the pharmacokinetc (PK) of a single oral dose of JNJ-53718678 in participants with varying degrees of impaired hepatic function (mild, moderate, and severe) when compared with participants with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin \[beta-HCG\]) test at screening and on Day -1 of the treatment period
* Contraceptive use by female participants or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
* If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 30 days after receiving the study drug
* A male participant must agree not to donate sperm for the purpose of reproduction from Day -1 of the study and for a minimum of 90 days after receiving the study drug
* For participants with mild, moderate or severe hepatic impairment: the participants must have a total Child-Pugh score of 5 to 6, inclusive (mild); or 7 to 9, inclusive (moderate); or 10-15, inclusive (severe). The Investigator will determine degree of hepatic impairment

Exclusion Criteria:

* Known allergies, hypersensitivity, or intolerance to JNJ-53718678 or its excipients
* Donated blood or blood products or had substantial loss of blood (more than 500 milliliter \[mL\]) within 90 days before the administration of study drug or intention to donate blood or blood products during the study
* Received an experimental drug (including investigational vaccines) or used an experimental medical device within 30 days or within a period less than 5 times the drug's half-life, whichever is longer, before the dose of the study drug is scheduled
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
* Preplanned surgery or procedures that would interfere with the conduct of the study
HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response

This research is examining how genetic and brain factors play a role in adolescents' health risk behavior as well as studying behaviors that young people engage in that may place them at risk for contracting a sexually transmitted disease like HIV/AIDS, and what kind of educational program works best to reduce these risky behaviors.

A baseline assessment is conducted, including a computer questionnaire assessing personality characteristics, attitudes toward and experiences with sex, alcohol, drugs, and cigarettes, among other things. The participant also meets with a therapist to conduct a brief motivational interview at this time. A "Time-Line Follow-Back" is conducted; this notes incidences of sexual intercourse, alcohol use, marijuana use, and cigarette use in a 30-day period. An fMRI is conducted, and a saliva sample is gathered. During the second session of the study, participants are randomly assigned to either a sex and alcohol risk reduction intervention, or a sex risk reduction intervention. After the intervention, participants are contacted at 3 month intervals (3 months later, 6 months later, 9 months later, and 12 months later) to meet. At these "follow-up" meetings, another Time-Line Follow-Back is conducted, along with another computer questionnaire (again assessing attitudes toward and experiences with sex, alcohol, drugs, and cigarettes).

Eligibility Criteria:
Inclusion Criteria:

* Adolescents age 14-18
* Involved in Juvenile Justice System OR enrolled in a private school

Exclusion Criteria:

* Currently taking anti-psychotics
* Involved in similar intervention-based study (2 similar studies being conducted simultaneously by this lab)
Heart and Hands Study II: A Retrospective Data Collection & Analysis Project

A recent pilot study conducted at HealthEast found use of manual pressure with the SoftSeal hemostatic pad for 15 minutes was successful in 9 out of 10 people fully anticoagluated using 4 French radial sheath. There was no evidence of radial artery occlusion in this small sample and bleeding was limited to grade 1. This evidence supports a larger retrospective study to confirm these results and define an alternative to the TR band use post radial artery access for cardiac catheterization.

Primary Objective Determine the incidence of arterial bleeding after real-world use of SoftSeal hemostatic device at a transradial access site with a 4 French system with with manual pressure by compression of the ulnar artery.

Secondary Objective Determine the incidence of thrombosis at the access site in all subjects as presence of thrombus in the radial artery by reverse barbeau test; the incidence of changes in circulation, movement and sensation (CMS) in the hand and wrist on the impacted hand; and the incidence of hematoma and ecchymosis, assessed just prior to discharge.

This is a non-randomized, retrospective study to observe the usefulness of SoftSeal. Only patients with radial procedures will be used in this study.

Study Procedure For patients with a 4 French catheter, SoftSeal will be applied per physician instruction. Current protocol for use includes compression of ulnar artery on the same visit.

Any bleeding observed at the site after manual pressure hold with SoftSeal will constitute a failure to achieve hemostasis patient will be managed per standard of care (SOC).

Data Plan Following completion of clinical care we will extract data related to primary and secondary objectives. Data extraction will include documentation of CMS, reverse Barbeau and incidence of hematoma and ecchymosis. Any additional statistical analysis or manuscript writing will be done as part of a separate agreement to be met with the approval of both HaelaTheast Medical Research Institute and Chitogen.

Sample Size Calculation Since this is a real-world data analysis project with no control group, there is not a sample size calculation. We believe approximately 50 patients will be enough to provide an understanding of use instructions for the SoftSeal product.

Eligibility Criteria:
Inclusion Criteria:

* Transradial access site with a 4 French system -\>18 years old

Exclusion Criteria:

* Current oral anti-coagulation therapy
* Prior participation in this study
* Positive standard-of-care pregnancy test
* Investigator discretionary exclusions
* Patient on dialysis
* GFR \<30
Relationship Between Central Sensitization and Kinesiophobia in Knee Osteoarthritis

Objective: The knee joint is one of most common locations in OA. In recent years, it has been accepted that there are different pain phenotypes and patient subgroups in knee OA and that central sensitization (CS) mechanisms are at the forefront in some patients. It is also known that fear of movement, known as kinesiophobia, develops in patients with chronic pain. The aim of this study is to investigate CS and kinesiophobia in patients with knee OA, their relationships with each other, and their effects on pain intensity, functional status, pain catastrophizing and depression.

Materials and Methods: Forty-two patients with knee OA and 42 healthy subjects participated in our study. Demographic data, body mass index, habits, comorbidities, medications of participants and disease duration and radiographic grade of knee OA patients were recorded. VAS was used to assess the severity of pain and WOMAC was used to assess pain and functional status in patients with OA. Algometer (pressure pain threshold measurement) and Central Sensitization Inventory were used to evaluate central sensitization in all participants. Pressure pain threshold (PPT) was measured at 3 different points: knee joint, cruris and forearm. The presence of kinesiophobia was assessed with the Tampa Scale af Kinesiophobia (TSK). Pain Catastrophizing Scale (PCS) and Beck Depression Inventory (BDI) were used to assess chronic pain related symptoms.

Forty-two patients with knee OA and 42 healthy subjects participated in our study. Demographic data, body mass index, habits, comorbidities, medications of participants and disease duration and radiographic grade of knee OA patients were recorded. VAS was used to assess the severity of pain and WOMAC was used to assess pain and functional status in patients with OA. Algometer (pressure pain threshold measurement) and Central Sensitization Inventory were used to evaluate central sensitization in all participants. Pressure pain threshold (PPT) was measured at 3 different points: knee joint, cruris and forearm. The presence of kinesiophobia was assessed with the Tampa Scale af Kinesiophobia (TSK). Pain Catastrophizing Scale (PCS) and Beck Depression Inventory (BDI) were used to assess chronic pain related symptoms.

Eligibility Criteria:
Inclusion Criteria for knee osteoarthritis group:

* Being a healthy volunteer between the ages of 45-75
* Being diagnosed with knee osteoarthritis according to ACR diagnostic criteria
* Knee pain for at least 6 months
* Kellgren-Lawrence 1, 2 or 3 radiologic grade of knee OA
* Body mass index below 35

Exclusion Criteria for knee osteoarthritis group:

* Presence of chronic widespread painful diseases other than osteoarthritis (fibromyalgia syndrome etc.), rheumatologic disease, peripheral neuropathy
* Presence of uncontrolled systemic disease
* Cooperation limitation or cognitive impairment
* Active arthritis in the knee joint to be evaluated
* Presence of prosthesis in the knees
* Pain in the forearm
* Body mass index of 35 and above
Dendritic Cell Vaccination With Standard Postoperative Chemotherapy for the Treatment of Adult Ovarian Cancer

Effective treatments are desperately needed for ovarian cancer patients. This phase I clinical trial assesses the safety of a novel personalized dendritic-cell vaccine administered to ovarian cancer patients. Secondary outcomes will be evaluated such as patient pharmacodynamics， progression-free survival and overall survival.

This is a single arm, non-randomized phase I study to evaluate the safety and feasibility of delivering a novel dendritic cell vaccine in 6 to 12 (n=6-12) adult patients diagnosed with ovarian cancer after undergoing surgical resection. The vaccine contains both tumor-associated antigen and patient specific neoantigens. Standard-of-care chemotherapy therapy will be followed as per routine,during which patients enrolled into this study will receive a personalized vaccine in addition to standard of care. Effective adjuvant therapies are urgently needed for these patients given that high rate of recurrence still occurs after standard of care with poor prognosis among ovarian cancer patients. The study is constructed in a 3+3 algorithm for two steps of dose escalation with rigorous and mandatory safety monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years old female patients；
2. Histopathologically diagnosed recurrent stage III/IV epithelial ovarian cancer;
3. Normal liver, heart as well as kidney functions and blood chemistry;
4. Predicted survival for more than 6 months；
5. Provision of signed and dated informed consent form.

Exclusion Criteria:

1. Allergic to human albumin, an excipient of the manufactured dendric cell vaccine；
2. Predicted survival for less than 6 months；
3. Diagnosed with brain metastasis and other diseases unsuitable for cell therapy including but not limited to Myelodysplastic Syndromes、Acute Myeloid Leukemia and Systemic Lupus Erythematosus;
4. Diagnosed with viral diseases including but not limited to HIV, TP, HCV and HBV ；
5. Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline;
6. Other conditions deemed unsuitable for this study by the leading investigators.
Web Intervention for Parents of Youth With Genetic Syndromes (WINGS)

The purpose of this study is to evaluate the effectiveness of an adapted, telehealth functional behavioral therapy (FBTsIDD) specifically focused on promoting appropriate communication and behavioral strategies in individuals with syndromic intellectual and developmental disorders.

Participants will be asked to complete virtual study assessments at intake and then on a monthly basis for the duration of 3-6 months. In addition, participants will attend weekly or biweekly virtual intervention visits with a study therapist.


Eligibility Criteria:
Inclusion Criteria:

* Age(s) 2-12 years old at time of enrollment
* Existing genetic syndrome based on clinical or genetic diagnosis and confirmed by medical records
* Documented diagnosis of global developmental delay (GDD) or intellectual disability (ID)
* estimated ID in all ranges
* Disruptive behavior challenges determined to be clinically appropriate for remote, parent-implemented coaching based on clinician determination of acuity of problem behaviors
* Caregiver who is able to consent in English.
* Parent/caregiver available for weekly intervention sessions
* Stable psychosocial and psychiatric treatments 3 months prior to baseline visit.

Exclusion Criteria:

* High levels of aggression that mitigate remote or outpatient treatment as defined by clinician judgement and/or ABC Irritability scores above 20 (i.e., higher level of care needed than provided by study procedures)
* Medical or psychiatric instability that may limit study participation
* Meaningful change in medication or psychosocial interventions 3 months prior to baseline visit
* Limitations in technology access that may hinder participation in remote trial (e.g., declining support provided by study participation)
Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed Condition

This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine besylate and atorvastatin calcium) tablets 10mg/80mg of Pfizer Ireland Pharmaceuticals Dublin, Ireland in healthy, adult,human subjects under Fed conditions.

Open label, randomized, two-treatment, two-period, two-sequence, oral bioequivalence study of Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg under Fed conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged between 18 and 45 years (both inclusive).
2. Subjects' weight within normal range according to normal values for Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight.
3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
4. Subjects having normal 12-lead electrocardiogram (ECG).
5. Subjects having normal chest X-Ray (P/A view) whose X-Ray was taken not more than 6 months prior to the dosing of Period 01.
6. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
7. Subjects having negative alcohol breath test.
8. Subjects willing to adhere to the protocol requirements and to provide written informed consent.

Exclusion Criteria:

1. Hypersensitivity to Amlodipine and Atorvastatin or related class of drugs.
2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
3. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
4. History or presence of significant alcoholism or drug abuse.
5. History or presence of significant smoking (more than 10 cigarettes or beedi's/day).
6. History or presence of asthma, urticaria or other significant allergic reactions.
7. History or presence of significant gastric and/or duodenal ulceration.
8. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
9. History or presence of cancer.
10. Difficulty with donating blood.
11. Difficulty in swallowing solids like tablets or capsules.
12. Use of any prescribed or OTC medication during last two weeks prior to dosing in period 01.
13. Major illness during 3 months before screening.
14. Participation in a drug research study within past 3 months.
15. Donation of blood in the past 3 months before screening.
16. Consumption of grapefruit juice, xanthine-containing products, tobacco containing products or alcohol for within 48 hours prior to dosing.
17. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
18. History or presence of significant easy bruising or bleeding.
19. History or presence of significant recent trauma.
A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure

The purpose of this clinical study is to estimate the safety and radiation dosimetry of a single dose of LMI1195 in healthy subjects and heart failure patients undergoing positron emission tomography (PET)


Eligibility Criteria:
Cohort 1 Inclusion:

* Healthy, age 18-40

Cohort 1 Exclusion:

* Significant or chronic medical illness
* Pregnant females
* Smoking within one month of enrollment
* Use of any prescription drugs within 4 weeks prior to dosing

Cohort 2 Inclusion:

* 30-70 year old subjects with a diagnosis of NYHA Class II-III heart failure
* Ejection fraction less than or equal to 35%
* Rest SPECT imaging within 90 days prior to enrollment

Cohort 2 Exclusion:

* Significant or chronic medical illness
* Pregnant females
* Known history of arrhythmogenic disorder or rhythm disorder
ESP Block in Radical Prostatectomy

Our study aimed to examine the effects of ultrasound guided erector spinae plane block in radical prostatectomy surgery on pain and surgical stress response, to reduce adrenocortical and sympathetic discharge due to anesthesia and surgery, and to reduce peroperative opioid analgesic consumption.

In this study 46 patients between the ages of 30-74, American Society of Anesthesiologists (ASA) score I-II and undergoing radical prostatectomy surgery at T.R. Ministry Of Health İstanbul Göztepe Prof. Dr. Süleyman Yalçın City Hospital were included. The patients were randomly divided into two groups as ESPB applied Group B (n=23) and not Group K (n=23). Patient-controlled analgesia (PCA) was initiated in all patients for postoperative analgesia. Patients' demographic data (age, gender, ASA score), intraoperative hemodynamic data, intraoperative and postoperative additional narcotic consumption, postoperative Numeric Rating Scale (NRS) scores (postoperative 0, 5 and 20 minutes and Then, 1, 3, 6, 12, 18 and 24 h), postoperative nausea-vomiting scores and possible complications related to block and / or surgery were recorded.Intraoperative MAP, HR, SpO2, BIS values of patients in both groups were recorded every 5 minutes. Blood glucose, insulin, cortisol, prolactin and C-reactive protein (CRP) were studied three times; preop morning at 6:00, intraoperative when surgical incision closing and postoperative 24h. in order to evaluate the surgical stress response in the patients.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II

Exclusion Criteria:

* diabetes
* coagulopathy
* local anesthetic
* drug allergy
* long hospitalization history,
* hormone disorder
* advanced organ failure
* history of steroid use
* vertebral anomalies
* mental retardation
Regional Distribution Mapping of Lymph Node Metastasis in Epithelial Ovarian Cancer

The goal of this observational study is to investigate the metastatic pathways of lymph node involvement in ovarian cancer patients. The main question it aims to answer is: • What are the sequential patterns of lymph node metastasis in ovarian cancer, and are there specific clinical factors associated with different metastatic pathways? Participants diagnosed with ovarian cancer who have undergone lymphadenectomy as part of their standard treatment will have their postoperative pathological lymph node involvement analyzed. The study will retrospectively collect and analyze patient data, including lymph node metastasis patterns, to identify potential progression routes.


Eligibility Criteria:
Inclusion Criteria:i) initial diagnosis and tumor cytoreductive surgery performed at the First Affiliated Hospital of Sun Yat-sen University; ii) confirmed postoperative pathology of epithelial ovarian cancer; iii) available lymph node status; and iv) accessible clinical features, including preoperative ultrasound and blood biochemistry tests

Exclusion Criteria: i) initial diagnosis or surgical treatment conducted at other hospitals; ii) absence of imaging results (CT/PET-CT/MRI) or postoperative pathology results for lymph node status. iii) presence of other cancers; and iv) incomplete medical history

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Nutritional Status in Children With ALL in Guatemala

This study proposes to investigate the association of nutritional status of a children assessed by body mass index (BMI), triceps skinfold thickness (TSFT), and mid upper arm circumference (MUAC), with body composition, measured by dual-energy X-ray absorptiometry (DEXA), in 60 children undergoing treatment of ALL at Unidad Nacional de Oncologia Pediatrica (UNOP), in Guatemala City, Guatemala. The study also aims to establish normative values of body composition in children residing in an LMIC by examining 160 healthy siblings of children under treatment, and to measure habitual physical activity in children with acute lymphoblastic leukemia (ALL) at diagnosis and during therapy.

The majority of children with cancer live in low and middle income countries (LMICs) where malnutrition, both under and over nutrition, is highly prevalent. Children who are malnourished while undergoing treatment for acute lymphoblastic leukemia (ALL) are shown to have chances of reduced survival. Children, who are malnourished at diagnosis, if the nutritional status is improved over the course of 6 months during the ALL treatment, have chances of similar survival as the ones who were nourished throughout. Therefore, it is important to study nutritional status in children with ALL, to understand and implement better treatment outcomes. Height and weight alone are considered incomprehensive in classifying nutritional status, especially in poorly nourished children. A more advanced nutritional assessment that distinguishes between fat and muscle mass is required. Treatment for ALL results in an increase in weight over the course of therapy with preferential gain in fat mass (FM) compared to fat free mass (FFM). Hence, there is a pressing need to advance nutritional assessment and implementation in pediatric oncology that includes monitoring of FM and FFM.

Eligibility Criteria:
Inclusion Criteria:

* Children under treatment for Acute Lymphoblastic Leukemia (ALL)
* Age under 18 years
* Getting treatment at UNOP

Exclusion Criteria:

* If they can't participate in the study due to illness or long distance to travel to UNOP
Functional Study of Metabolites in Patients With Aortic Dissection

Research on metabolites in patients with aortic dissection, with a view to finding products with high or low metabolism in patients with aortic dissection, looking for metabolic factors related to the onset of aortic dissection, and further verifying the role of metabolic factors in disease through functional verification The role of formation, and ultimately explore the early screening of potential aortic dissection patients


Eligibility Criteria:
Inclusion Criteria:

* patients with Aortic dissection

Exclusion Criteria:

* Sepsis