cyrilzakka/clinical-trials huggingface dataset:
Dose Reduction of Lopinavir in Children

To study the pharmacokinetics of low-dose and standard dose, lopinavir/ritonavir in ARV PI naive HIV-1 infected Thai children.

To study clinical and immunological efficacy after 48 weeks of lopinavir/ritonavir in PI naïve HIV-1 infected Thai children

In 2002, the Thai Ministry of Public Health (MOPH) launched the National Access to Antiretroviral Program for People living with HIV/AIDS (NAPHA) with the aim of providing treatment to all Thai patients who needed antiretroviral treatment. By the end of 2005, 80,000 HIV-infected Thais were treated in the NAPHA program, including about 6,000 children. The antiretroviral treatment regimen consists of three antiretroviral drugs (ARV). The first-line regimen used in NAPHA are mainly generic drugs produced by Thai government pharmaceutical organization (GPO), including a fixed-drug combination of stavudine, lamivudine, and nevirapine (GPOvir);and a fixed-drug combination of zidovudine, lamivudine, and nevirapine (GPOvir-Z). Majority of patients respond very well with first-line regimen(1,2), however about 15% of patients have drug resistance to first-line regimen and require second-line regimen(3). The protease inhibitors (PIs) is used as a second-line regimen, however there are limitations in terms of cost and metabolic complications(4).

Lopinavir/ritonavir is the most widely use protease inhibitors in children because of its high efficacy and a syrup formulation that easy to use in small children. There is evidence supported that the recommended dose according to US-FDA or EU guidelines resulting in much higher plasma blood level in Thai children. Data from 19 Thai children demonstrated Cmin of 5.9 mg/L compare to 3.4 mg/L in US children when use the same dose (the minimum acceptable Cmin is 1.0 mg/L) (5,6). There is a study HIVNAT019, which demonstrated acceptable LPV plasma concentration and treatment outcome in Thai HIV-infected adult when use reduced dose of LPV/r 266mg/66 mg compare to standard dose of 400mg/100mg (7).

Therefore, the study of pharmacokinetic of low dose of LPV/r in Thai HIV-infected children is very important to assess the safety and efficacy of this strategy. This will lead to appropriate ARV dose in children to reduce long-term adverse events, and also reduce the ARV cost.

Eligibility Criteria:
Inclusion Criteria:

* Age from 2- 18 years old
* Documented positive test for HIV-1 infection
* PI-naïve
* HIV RNA viral load \> 1,000 copies
* Written informed consent

Exclusion Criteria:

* Active opportunistic infection
* Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
* Use of concomitant medication that may interfere with the pharmacokinetics of lopinavir/ritonavir
* Pregnancy or lactating
* Inability to understand the nature and extent of the study and the procedures required.
BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

The objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus placebo in constipated adults.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects at least 18 years of age
2. Constipated, defined by the following adapted ROME II definition

   Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for at least 12 weeks (which need not be consecutive) in the preceding 12 months:
   * Straining during \> 25% of defecations
   * Lumpy or hard stools in \> 25% of defecations
   * Sensation of incomplete evacuation for \> 25% of defecations
3. If female, and of child-bearing potential, is using an acceptable form of birth control
4. Negative serum pregnancy test at screening, if applicable
5. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

1. Report loose (mushy) or water stools in the absence of laxative use for more than 25% of BMs during the 12 weeks before Visit 1
2. Meet the Rome II criteria for Irritable Bowel Syndrome.
3. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
4. Subjects who have had major surgery 30 days before Visit 1; appendectomy or cholecystectomy 60 days before Visit 1; abdominal, pelvic, or retroperitoneal surgery 6 months before Visit 1; bariatric surgery or surgery to remove a segment of the GI tract at any time before Visit 1
5. Subjects with hypothyroidism that is being treated and for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of Visit 1
6. Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from Visit 1 until after completion of the study
7. Subjects who are pregnant or lactating, or intend to become pregnant during the study
8. Subjects of childbearing potential who refuse a pregnancy test
9. Subjects who are allergic to any study medication component
10. Subjects taking narcotic analgesics or other medications known to cause constipation
11. Subjects with clinically significant cardiac abnormalities identified at the Visit 1 ECG
12. Subjects with clinically significant laboratory abnormalities, deemed as a potential safety issue by the Investigator
13. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
14. Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
15. Subjects with an active history of drug or alcohol abuse
16. Subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before Visit 1
17. Subjects who withdraw consent at any time prior to completion of Visit 1 procedures
Cardiology Prevention in Systemic Lupus Erythematosus (SLE)

We propose a feasibility study of aggressive CV risk factor management directed by preventive cardiology compared to usual care. We will determine: 1) the efficacy of a preventive cardiology program compared to usual care in slowing the progression of carotid IMT and plaque, and 2) the effect of a preventive cardiology program versus usual care at achieving CV risk factor target goals.

We hypothesize Lupus patients randomized to the preventive cardiology program will have less cardiovascular progression over two years than those lupus patients who are given standard care for cardiovascular risk, defined by carotid intima-media thickness and plaque.

We will recruit 30 eligible patients from the Lupus Center of Excellence outpatient clinic. Patients will either be randomized into a preventive cardiology program for aggressive treatment, or randomized to usual care (1:1 ratio) in a single-blinded, randomized trial of 24 months duration. In this feasibility trial we hope to identify and refine any limitations in anticipation of designing a larger, randomized intervention study.

For both arms of the study, at baseline, 6 month, 12 month, 18 month, and 24 month visits (5 visits in total) all patients will be seen by Dr. Elliott, Principal Investigator. Visits will include an interview, fasting laboratory tests completion of questionnaires regarding demographics, socioeconomic status, health status, and risk factors (traditional, inflammatory, and lupus-specific). Dr. Elliott will perform the physical examinations on all patients and complete the lupus-specific disease activity and damage questionnaires. At the Baseline visit, 12-month visit, and 24 24-month visits, all patients will have a carotid ultrasound.

Cohort 1: Preventive Cardiology Program arm: Above and beyond the standard care, which is listed below, the patients in this arm will be aggressively treated by the cardiologist. As deemed prudent, the following may be prescribed: antihypertensives, lipid reducing agents, anti-platelets, further cardiac testing, and behavioral modifications. No standard care treatment will be withheld.

Cohort 2: Standard Care arm: The PI will send a letter of all testing results to their designated PCP. No standard care treatment will be withheld.

Eligibility Criteria:
Inclusion Criteria:

1. Definitive diagnosis of SLE
2. \>18 years of age
3. Followed by rheumatologists (not the investigator, Dr. Elliott) at the Lupus Center of Excellence
4. Informed consent signed
5. Effective form of birth control

Exclusion Criteria:

1. Prior cardiovascular disease history (MI, coronary angioplasty, coronary artery bypass graft, abnormal coronary angiography, abnormal nuclear or treadmill stress test)
2. Prior evaluation by preventive cardiology
3. Active cardiac issues
4. Pregnancy, breastfeeding, or anticipating pregnancy in the next 2 years
Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic

This study will compare 2 currently marketed formulas in healthy full term babies: Nutramigen A+ (a hypoallergenic formula) and Nutramigen-Enflora (hypoallergenic formula with Lactobacillus GG (LGG)) during 3 months of formula feeding. The investigators' aims are to compare 3 outcomes in these babies: (1) normal baby crying time; (2) the composition of intestinal microbiota (bacteria in the stool); and (3) a lab test which measures the number of white blood cells in the large intestine (fecal calprotectin). The investigators predict that LGG supplementation (Nutramigen-Enflora) will facilitate its establishment as an important component of the neonatal intestinal microbial community and reduce fecal calprotectin.


Eligibility Criteria:
Inclusion Criteria:

* Sixty healthy full-term colicky infants (gestational age 32 wks to 41 wks)

Exclusion Criteria:

* chronic lung disease,
* diarrhea (stools that take the shape of a container \> 5x daily)
* fever
Study to Measure and Enhance the Health Related Quality Of Life in Cancer Patients

The ME-Q study aims to validate a patient reported outcome tool called FACT-ICM, which measures health related quality of life (HRQOL) in patients receiving immune checkpoint modulator (ICM) therapy. In addition, this trial seeks to answer if HRQOL can be improved by monitoring and managing patient symptoms whilst they are treated with ICMs.

Immunotherapy has revolutionized cancer care by extending survival, but with a unique set of toxicities known as immune-related adverse events (irAEs), less is known about impact of ICMs on HRQOL.

The ME-Q trial will produce two major innovations: 1) the first validated tool to measure HRQOL in patients on ICMs that can be used in clinical trials and routine clinical care; and 2) a system to monitor and manage patient symptoms on ICMs which can enhance health care delivery for these cancer patients.

ME-Q will randomize patients who are treated with standard of care ICMs to either a monitoring arm developed specifically for this trial or the usual care arm, which is currently how they are managed. All participants will respond to HRQOL questionnaires of which FACT-ICM is a core component. A study nurse will review and manage responses which indicate new or worsening symptoms for those in the monitoring arm. The nurse will contact the patient via telephone or video teleconferencing to conduct a clinical assessment and develop a management plan following irAEs management guidelines. We hypothesize that patients on the monitoring arm will have better HRQOL, longer overall survival, fewer presentations to the emergency department and less hospital admissions than the usual care arm.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Diagnosed with advanced, incurable solid tumors
* Eligible for immunotherapy (monotherapy or combination ICM)
* Life expectancy ≥ 6 months
* ECOG PS 0-3
* Fluent in English
* Able to provide informed consent
* Able to complete questionnaires using digital device or web based application

Exclusion Criteria:

* Participation in a therapeutic clinical trial testing anticancer therapies
* Receiving adjuvant immunotherapy
Effect of Food on the Pharmacokinetics of TEW-7197 in Healthy Subjects

Participants in this study will receive 200 milligram (mg) TEW-7197 taken at 7days apart. One dose will be given under fasting . The Other dose will be given with a high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug gets into the blood stream. Side effects will be documented. This study will last approximately 2weeks not including screening.

Through screening (D-30 \~ D-1) prior to the first dose of the investigational product, a total of 16 subjects (Group 1: 8 subjects, Group 2: 8 subjects) who were eligible for the inclusion criteria and exclusion criteria were enrolled. This clinical study has a randomized, open, single dose, 2-sequence, 2-period cross-over design and TEW-7197 50 mg x 4 tablets were administered as a single dose in the same individual for 2 periods after fasting or a high fat diet, and each period was repeated with an interval of at least 1 week of wash-out. Pharmacokinetics and safety were evaluated in all subjects according to the planned schedule

Eligibility Criteria:
Inclusion Criteria:

1. Healthy sterile males
2. BMI 18.0kg/m2 - 27.0 kg/m2
3. No congenital or chronic disease and no pathological symptoms or pathological findings
4. Investigator confirm that the subject is eligible through a medical examination (medical history taking ,vital signs, ECG, cardiac ultrasonography, blood science)

Exclusion Criteria:

1. Has pathological symptoms or pathological findings
2. Has a history of disease that may affect the absorption, distribution, metabolism and excretion of a drug
3. SBP\>140 or \<90 mmhg , DBP\>90 or \<60mmHg ,Pulse\>100
4. No abnormal Clinical Lab findings
Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Classical Hodgkin Lymphoma

The primary objective is to estimate the efficacy of experimental treatment with the anti-PD-1 antibody cemiplimab (REGN2810) in combination with simultaneous or subsequent radiotherapy (RT) in early-stage favorable classical Hodgkin lymphoma (cHL).

Secondary objectives are to assess the safety and feasibility of the 2 experimental strategies.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically proven classical HL
* First diagnosis, no previous treatment
* Stage I-II without risk factors as defined in the protocol

Key Exclusion Criteria:

* Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL)
* Prior malignancy within the previous 5 years (except for locally treatable cancers that have been apparently cured by complete resection)
* Prior chemotherapy or radiation therapy
* Concurrent disease precluding protocol treatment as defined in the protocol
* Pregnancy or breast-feeding
* Non-compliance as defined in the protocol

Note: Other protocol-defined Inclusion/Exclusion criteria apply
SPECT Imaging of DAT Genotype

A polymorphism in the dopamine transporter (DAT) may determine how much dopamine is available at the synapse and this may affect the underlying reasons for relapse in smokers. This research will use Single-photon emission computed tomography SPECT and the DAT-specific ligand, TRODAT (Dopamine Transporter Density by \[99mTc\]), to examine the availability of DAT in smokers grouped by genotype in the sated (just having smoked) and withdrawal (4 hours without smoking) conditions.

There will be 2 SPECT scans for each smoker who participates in this research. One SPECT scan when the smoker is sated with nicotine and one where the smoker is in withdrawal

Eligibility Criteria:
Inclusion Criteria:

1. Physically healthy male or female nicotine dependent patients ages 18-60 without other current drug dependence (excluding marijuana) or psychiatric diagnosis.
2. Smoke at least 10 cigarettes per day for at least 6 months prior to study start date.
3. Females must be non-pregnant, non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of child bearing potential, but practicing a medically acceptable method of birth control from at least 48 hours prior to SPECT imaging until 30 days following the scan. Examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine device (IUD), oral contraceptives, levonorgestrel implant, or complete abstinence.
4. Subjects provide voluntary informed consent.
5. Subjects must read on 8th grade (or above) level.
6. Not using other methods for smoking cessation

Exclusion Criteria:

1. Participation in clinical trial and receipt of investigational drug(s) during previous 60 days
2. History of head trauma or injury causing loss of consciousness, lasting more than three (3) minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI.
3. HIV positive on medication for symptoms. This will be determined on an individual basis by results from the physical examination and final approval by our study physician.
4. Symptomatic presence of other hematological disease.
5. Clinically significant cardiovascular, hepatic (liver), renal (kidney), neurological, or endocrinological (including Type II diabetes) abnormalities.
6. Asthmatic condition which requires the use of an inhaler more than twice per week
7. History of psychosis, seizures, or organic brain syndrome.
8. Use of medications or natural herbs that may cause sedation or may effect the brain systems that are being studied (medication use will be evaluated by our study physician on a case-by-case basis).
9. Claustrophobia, trypanophobia (needle phobia) or other medical condition preventing subject from lying in the SPECT scanner for approximately one (1) hour.
10. Individuals with an intelligence quotient of 80 or less.
11. Smoke non-filtered cigarettes
12. Treatment for alcohol or drug dependence within the last 3 months
13. A significant alcohol or drug use history (multiple treatments, 5 years of dependence, positive urines, etc.).
Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children

This study will examine the potential effectiveness of a virtually delivered parent-mediated intervention for insistence on sameness behaviors in autism and investigate 1) whether caregivers can learn to deliver the adapted Supportive Parenting for Anxious Childhood emotions (SPACE) intervention for IS via telehealth and 2) whether children will show greater improvement in IS behaviors.


Eligibility Criteria:
Inclusion Criteria:

* 6:0 to 10:11 years at the time of consent
* diagnosed with ASD (based on history, review of available medical records including diagnostic testing completed by psychologist)
* IQ \> or = 75 (based on history, review of available medical records)
* report three or more family accommodations for insistence on sameness based on screening measures
* English-speaking parent and youth able to consistently participate in study procedures

Exclusion Criteria:

* children with significant hearing, language or motor impairment
* unstable behavioral and pharmacological treatments (e.g., anxiety medication) to treat anxiety or IS behaviors prior to two months to the start of the study and no anticipated changes in treatments during the course of the trial
* caregivers who have participated in formal SPACE training
* concurrent psychosocial treatment for anxiety or Insistence on Sameness
* children who have a history of prominent school refusal, self-harm, or suicidal ideation
Efficacy Of A Cognitive Behavioral Therapy To Decrease Threat Appraisal In HIV Participants Initiating Antiretroviral

Studies in the field of health and HIV indicate that threat appraisal is associated with poor adherence to treatment, anxiety, poor quality of life, avoidance behavior, less antiretroviral adherence, negative affect, social, instrumental and emotional stress, depression, global distrés, poor subjective health and psychological distres. Most psychological interventions have been oriented to behavioral aspects, leaving aside cognitive aspects such as threat appraisal, so is necessary to investigate psychological treatments and its impact in threat appraisal an in an clinical and psychological outcomes.

Primary objective: To evaluate the efficacy of a cognitive behavioral therapy (CBT) to decrease threat appraisal in comparison with Usual Care (UC) in HIV patients initiating antiretroviral treatment at week 8.

Secondary objectives: To evaluate the effect of a cognitive behavioral therapy intervention compared with Usual Care in HIV patients initiating antiretroviral treatment in the following variables: challenge appraisal, affect (positive and negative), adherence, quality of life, anxiety and depression, HIV viral load and loss to follow-up at weeks 8, 20 and 52.

Exploratory objectives: To assess the threat appraisal cut-off value that predicts favorable outcomes in adherence, virologic suppression, retention in care and adverse events at week 52.

The study is an open label, single center, parallel group clinical trial, in which 50 participants will be randomly assigned using a blocked design to one of the 2 arms: Usual Care (single individual psycho-educative session) or Cognitive Behavioral Therapy (Usual care + 6 sessions of individual Cognitive Behavioral Therapy). The sample will be conformed with 50 adults with HIV, naïve to ARV treatment, starting care at INCMNSZ, who have scores of threat appraisal ≥40 in the CEAT scale, without severe mental disorders or cognitive impairment. We will use independent t test and chi square and intention to treat analysis for the primary outcome, also for secondary outcomes t student for continuous variables, chi square for categorical variables and per protocol analysis in participants adherent to the intervention.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* HIV diagnosis confirmed
* Naïve to antiretroviral treatment
* Threat appraisal greater than or equal to 40%
* Enrolled at INCMNSZ for medical care
* Be able to read and write
* Willing and able to provide written informed consent

Exclusion Criteria:

* Psychotic symptoms
* Severe depression
* Severe anxiety
* Suicide risk
* Substance dependence
* Cognitive dysfunction
* Psychological or psychiatric treatment within previous 3 months
* Require emergency medical attention
Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)

The purpose of this study is to determine whether epidural Depodur alleviates the pain of OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the ICU setting.

The purpose of this study is to determine whether epidural Depodur alleviates the pain of OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the ICU setting. It will be compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, 18-99 years old
* All patients who will have surgery for OP-CABG

Exclusion Criteria:

* Pregnant females
* Patients with allergy to morphine
* Patients nursing an infant
* Patients with migraine headaches
* Patients taking Coumadin within 7 days or demonstrating INR \> 13
* Patients taking Heparin unless documented normal partial thromboplastin time
* Patients taking Clopidogrel in previous 7 days
* Patients taking Ticlopidine in previous 14 days
* Patients taking Aspirin in previous 48 hours
* Patients receiving low molecular weight heparin therapy within 24 hours previous
* Patients with Narcolepsy and/or sleep apnea
* Patients on chronic opioid therapy
* Patients participating in another study