cyrilzakka/clinical-trials huggingface dataset:
Third Ward Wellness Study for Families

The Third Ward Wellness Study aims to pilot test a wellness program for families with toddler age children. Participants will be recruited from the Third Ward neighborhood in Houston, TX and then randomly assigned to one of two wellness programs. The goal of both programs is to enable and inspire parents to help their toddler age children develop healthy habits that will stay with them through life. Participating families will complete an assessment batter before and after the program. Both programs will meet once per week for 10 weeks.

Dietary and activity habits begin to develop in early childhood. Parents have the most influence on children's health behaviors at this age. Many parents, particularly those from lower income and underserved areas may benefit from programs to inspire and enable them to raise their toddler age children with good health habits. The experimental group was developed to help parents instill healthy habits in their children through a healthy home environment. This study will pilot test the experimental group among parent-toddler dyads residing in Greater Third Ward neighborhoods, where \> 80% of the residents are AA or Hispanic and 35%-54% have annual household incomes \<$25,000. The aims are to ascertain 1) recruitment and retention barriers and facilitators, 2) treatment success barriers and facilitators, and 3) the estimated effect sizes of outcomes to inform a fully powered RCT. The exploratory hypotheses are that compared to those in the control group, parents in the experimental group will have greater increases in positive parenting skills (Comprehensive General Parenting Questionnaire), and toddlers will have greater increases in indicators of a healthy home environments, diets and activity habits (MVPA, sedentary activity, and sleep).

Eligibility Criteria:
Inclusion Criteria:

Parents need to be...

* The legal custodian of a toddler,
* At least 18 years,
* Able to make food decisions in the home,
* Have access to a phone at home,
* Be fluent in English Toddlers need to be...
* Between 12 and 36 months of age
* Be able to walk.

Exclusion Criteria:

* Adults unable to consent for themselves and their child,
* Parents or toddlers who have mental or physical health conditions that would prevent them from fully engaging in activities of the program (e.g., reliance on feeding tube).
Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

The objective of this study is to determine the effect of various mood stabilizers (MS) on the insulin resistance syndrome (IRS; also called the metabolic syndrome) alone and in patients treated with antipsychotic drugs (APDs). Patients will be switched from their current antipsychotic medication to aripiprazole (Abilify) or ziprasidone (Geodon) (unless clinically contraindicated) for comparison with metabolic levels during treatment with the former medication.

The metabolic syndrome is an empirical concept based on extensive evidence that a constellation of 5 metabolic abnormalities, e.g. increased cholesterol, hypertension, low HDL, taken together, predict marked increases in the risk of CVD, stroke and some types of cancer.


Eligibility Criteria:
Inclusion criteria

To be eligible, patients must :

* Be male or female, age 18-65
* Be diagnosed with schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features according to DSM-IV criteria
* Be currently receiving antipsychotic drugs (clozapine, haloperidol, olanzapine, quetiapine, or risperidone) (APDs) alone, mood stabilizer(s) (MS) alone, or a combination of the two
* Have a history of compliance with the above medication
* Have presumptive IRS as indicated by a TG/HDL ratio \> 3.5 on current antipsychotic medication
* Be Medicaid eligible or maintain insurance covering requested lab procedures
* Be able to provide written informed consent Exclusion criteria

A patient will be considered ineligible if he/she:

* Has a diagnosis other than schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features according to DSM-IV criteria.
* Has a history of noncompliance with prescribed psychiatric medications
* Has a TG/HDL ratio \< 3.5 on current medication
* Is uninsured or is unable to self-pay potential costs of required lab procedures not covered by insurance.
* Is unable to provide written informed consent.
* (Females only) Is pregnant, lactating or plans to become pregnant during study participation

Exclusion Criteria:

-
A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384

The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects. In addition, will evaluate A4250 in combination with cholestyramine.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males or non-pregnant, non-lactating healthy females
2. BMI of 18 to 32 kg/m2 or, if outside the range, considered not clinically significant by the investigator
3. Willing and able to communicate and participate in the whole study
4. Provided written informed consent
5. Agreed to use an adequate method of contraception

Exclusion Criteria:

1. Had participated in a clinical research study within the previous 3 months
2. Were study site employees, or immediate family members of a study site or sponsor employee
3. Had previously been enrolled in this study
4. History of any drug or alcohol abuse in the past 2 years
5. Regular alcohol consumption, in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
6. Current smokers and those who had smoked within the last 12 months. A breath carbon monoxide (CO) reading of greater than 10 ppm at screening
7. Females of childbearing potential who were pregnant or lactating (female subjects must have had a negative urine pregnancy test at admission)
8. Did not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
9. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
10. Positive drugs of abuse test result
11. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
12. History of cardiovascular, renal, hepatic, chronic respiratory or GI disease as judged by the investigator
13. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients eg lactose or contraindications to cholestyramine/Questran
14. Presence or history of clinically significant allergy requiring treatment as per the judgement of the investigator Hayfever was allowed unless it was active
15. Donation or loss of greater than 400 mL of blood within the previous 3 months
16. Were taking, or had taken, any prescribed or over-the-counter drug (other than up to 4 g per day paracetamol, hormone replacement therapy \[HRT\] and hormonal contraception) or herbal remedies in the 14 days before IMP administration unless they were not considered to have interfered with the objectives of the study, as agreed by the PI and sponsor's medical monitor on a case by case basis
17. Failed to satisfy the investigator of fitness to participate for any other reason
Clinical and Microbiological Evaluation of Periodontal Treatment of Diabetic Patients: A Longitudinal Study

The purpose of this study is to determine whether periodontal treatment improves the periodontal clinical parameters in the periodontal patients with diabetes regarding non-diabetics: two years follow-up.

All the subjects in the study will receive non surgical periodontal treatment in one session (full-mouth scaling and root planing). Clinical parameters will be assessed in all teeth (except third molars) by one experienced and trained examiner before treatment and every 3 months for 2 years. Visible plaque index (VPI) will be represented a mean percentage of sites with visible plaque calculated for all teeth analyzed (four sites per tooth). Others parameters will be assessed at six sites per tooth using a manual periodontal probe (15mm). Bleeding on probing (BOP) will be represented the mean percentage of sites with bleeding (up to 15 seconds after probing) calculated for all teeth analyzed. Probing depth (PD - distance between the gingival margin and the bottom of the sulcus/pocket), gingival recession (GR - distance between the cementoenamel junction and gingival margin) and clinical attachment level (CAL - distance between the cementoenamel junction and the bottom of the sulcus/pocket) will be represented a mean distance calculated per site for all teeth analyzed. For blood parameters, an outside laboratory will perform all blood analysis. It will be requested for each subject with diabetes (DG) at baseline, each 3 months post-treatment. Fasting plasma glucose (FPG) will be expressed in milligrams per deciliter and HbA1c will be expressed as a percentage. Statistical analysis will be performed using an available software program and the patient will be considered as the unit of analysis.The data will be processed and analyzed by descriptive and inferential statistics, probably nonparametric.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronical periodontitis according to Lopez et al. 2002 (one or more teeth with at least one site with PD \>= 4mm or CAL \>= 3mm);
* And have at least 8 natural teeth (excluding third molars), and older than 18 years and of both genders.

Exclusion Criteria:

* Any systemic diseases or complications (except Type 2 Diabetes Mellitus) such as cardiovascular disease, Alzheimer's, lung or brain diseases and metabolic syndrome;
* Use of antibiotics or periodontal treatment within the past 6 months;
* Long-term administration of anti-inflammatory or/and immunosuppressive agents;
* Current smoker or former smoker for the past 5 years;
* Pregnant or breastfeeding;
* And presence of orthodontic appliances.
Anterior Wedge in Patients With Osteoarthritis Hip

Ostearthritis is a great source of pain. In symptomatic hip the pain can lead the major disability and poor quality of life. Understand the musculoskeletal factores can lead to a better clinical management. The muscle strenghening of posterolateral complexo of hip is a important consideration. General Objective: Perform a Kinetic analysis 2D using na anterior wedge. Specific objective: Analyze the influence of posterolateral hip complex. Controlled clinical trial, composed by 30 individuals with and without osteoarthritis of hip e will be used a tools; Analogic Visual Scale, manual dynamometry to analyze force and kinetic analyze of gait through of Myovídeo analysis software.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary individuals
* Both genders
* Age equal to or greather than 50 years
* Diagnosis of osteoarthritis level II and III

Exclusion Criteria:

* fractures
* Neuromuscular diseases
* Other diseases of hip
Probiotics, Immunity, Stress, and QofL

The purpose of this graduate student research study is to evaluate the efficacy of a multi-strain probiotic and investigate if sex differences influence the role of probiotics on stress and immunity biomarkers.

Visit #1

* Participants will read and sign informed consent forms, HIPPA form, and SAHP Covid-19 screening form.
* Participants will perform a baseline oral saliva swab to test for the stress biomarker cortisol and immune markers, including Interleukin-1β (IL-1β) and Tumor Necrosis Factor (TNF).

  * Swabs will be individually packaged. After opening the package, participants will place the swab under their tongue for 1-2 minutes.
  * After swabbing is complete, the swab will be placed into the collection tube and capped immediately.
  * Completed swabs will be placed and held in a sub negative 70° Fahrenheit freezer.
* Participants will complete a Quality-of-Life Questionnaire (10-15 minutes).
* As this study is double blinded, participants will be separated by gender (male and female) and will select a 90-day supply of placebo or probiotic sample at random. For each gender group there will be 50 samples to select from, comprised of a mix of 25 placebo and 25 probiotic bottles.
* Participants will be instructed to take 1 capsule per day for the following 90 days. If a participant misses a day, they should resume taking 1 capsule per day the next day. The capsule should not be crushed or chewed. The capsule may be taken with or without food per participant preference. The participant should consistently take the probiotic at a similar time each day (example: always take it in the morning or evening) Visit #2
* Participants will complete the same Quality-of-Life Questionnaire from visit #1
* Participants will perform a post-study oral saliva swab in the same manner as visit #1

Eligibility Criteria:
Inclusion Criteria:

* Males and Females
* 18-90 years of age
* Participants should be of good health

Exclusion Criteria:

* Women who are self-reported as pregnant and/or breastfeeding
* Those who suffer from any systemic illness, such as diabetes mellitus, HIV, cancer, or chronic kidney disease.
* Persons who are diagnosed with clinical depression or anxiety, or other mental health diagnoses such as schizophrenia or Alzheimer's.
* Persons who have taken any probiotic for 5 or more days in the 3 months prior to the trial
* Persons having received antibiotics or non-steroid anti-inflammatory therapy in the last 3-month period prior to the study
* Persons who work night shift
* Persons who consume probiotic rich foods daily, such as yogurt, kimchi, kombucha, kefir, sauerkraut, tempeh, miso, and buttermilk
* Anyone who is allergic to any ingredient in the probiotic or placebo
Group-based Life Skills and Health Empowerment for Married Women to Avoid Unintended Pregnancies in India

The goal of the cluster randomized trial is to evaluate the impact of a reproductive health and empowerment intervention (TARANG) compared to the standard of care health information (control group) on the prevalence of contraceptive use and time-to-pregnancy (primary outcomes) in Rajasthan, India.

Participants will participate in TARANG intervention and receive the following sessions:

1. Navigating newly formed relationships (e.g. spousal communication, healthy relationships with in-laws, establishing peer network, and negotiation skills)
2. Improving women's awareness of sexual reproductive health
3. Challenging inequitable gender norms with an aim to reduce unintended pregnancies.
4. Life skills education to enable them to have improved social mobility, decision-making, and agency.

Investigators will compare the TARANG intervention with the standard of care to see if it delays unintended pregnancies among women.


Eligibility Criteria:
Inclusion Criteria for newly married women:

* Age 18-25 years at the time of the wedding
* Married women have permanently moved in their husbands home in the most recent wedding season (recruitment month going backwards up to October of the previous year)
* Not wanting to get pregnant within 1 year at recruitment/enrollment
* Have not had a live birth previously and not currently pregnant
* Women not planning to migrate out of the area for the period of the intervention

  • Has a living husband who is willing to consent and participate in the study in person or remotely (over phone)
* Has a living, co-residing mother-in-law type person\* (see definition below) who is willing to consent and participate in the study in person (A mother-in-law type of person should be staying in the same household for the period of the intervention and has consented to participate in the study. Mother-in-law is defined as any senior woman (from a previous generation of the DIL) who are responsible for their daughter-in-law and cohabiting in the same household as their daughter-in-law (Note - household would mean a family unit which shares the same kitchen). This will usually be the biological mother of the husband, but it can be stepmother, grandmother, aunt, etc.)

Inclusion criteria for husband:

* 18 years or more at the time of the wedding
* Mother and wife are eligible for the study participation

Inclusion criteria for mother-in-law:

* Consent to participate in the study
* Assents for daughter-in-law to participate in the study
* Son and the daughter-in-law are eligible for study participation

Exclusion criteria for newly married women:

* Wanting to have a child in the next 12 months at the time of baseline
* Cognitive ability to participate in surveys
FiH Study to Assess Safety and PK of SAD and MAD of ANT3310 Alone and in Combination With Meropenem in Healthy Subjects

The purpose of this study is to evaluate the safety and tolerability of single and multiple intravenous ascending doses of ANT3310, a novel, specific, competitive inhibitor of serine β-lactamases, alone and in combination with meropenem in healthy subjects.


Eligibility Criteria:
Main Inclusion Criteria:

* Participant capable of giving signed informed consent
* Contraceptive use by women or men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Participants are overtly healthy as determined by a medical evaluation including medical history without clinically relevant pathologies, physical examination, vital signs, ECG assessment, and clinical laboratory result
* eGFR ≥ 90 mL/min and \< 160 mL/min for males or \< 150 mL/min for females
* Body weight within 50.0 and 100.0 kg and BMI within 18.0 and 30.0 kg/m2

Main Exclusion Criteria:

* History of any clinically-relevant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrine, haematologic, neuromuscular or allergic disease(s), metabolic disorder, cancer, cirrhosis, significant acute infection, local infection within 2 weeks of dose administration,
* ECG: any history of clinically-significant ECG abnormalities, an uninterpretable ECG, or any of ECG abnormalities, unless considered not significant by the Investigator
* Abnormalities in clinical chemical, haematological, or coagulation variables considered medically relevant by the Investigator,
* Positive urine drug screen, positive breathalyzer for alcohol
* Positive results in any of the following virology tests: HIV-1 and -2 antibodies, HBsAg, and anti-hepatitis C virus antibody
* Positive SARS-CoV-2 antigen test
* Women who are pregnant or nursing,
* Donation or loss of over 500 mL of blood within sixty days prior to the first study drug administration,

Part C with co-administration of meropenem:

1. History of epilepsy (or known seizure disorder), brain lesions or other significant neurological disorders,
2. Known history of clinically-significant hypersensitivity or urticaria, or severe allergic reaction to β-lactam antibiotics,
3. History of Gilbert syndrome,
4. History of any severe antibiotic-associated superinfections,
Effect of Cannabis on E-Cigarette Use Behavior

The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of electronic cigarettes. The study's goals are to test demand for e-cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. Researchers will compare multiple doses of THC and a placebo in participants who smoke e-cigarettes and either smoke or vape THC in the laboratory.

A full-factorial laboratory study will be conducted to determine the impact of acute THC administration on the dose-related motivational, subjective, and physiological effects of electronic cigarettes. This study will employ a double-blind, placebo-controlled, within-subjects crossover design to examine the dose-effects of THC on e-cigarette use. The study will use multiple active doses of THC and placebo (0, 5, and 30 mg; corresponding to 0, 1, and 6 standard THC unit doses). Participants will be randomized to either smoked or vaporized THC administration using a between-subjects approach to evaluate the effect of congruent versus incongruent routes of THC and tobacco administration on study outcomes.

Eligibility Criteria:
Inclusion criteria:

1. Healthy non-treatment seeking adults aged 21 or older
2. Report daily use of e-cigarettes
3. Biological confirmation of e-cigarette use: have an expired carbon monoxide (CO) level of less than 6 ppm and a positive urine cotinine test at screening
4. Report current use of cannabis (at least 1 occasion per week)
5. Have experience with the inhalation route of administration for cannabis
6. Biological confirmation of cannabis use: have a positive urinary THC drug test at screening.
7. For women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study.

Exclusion criteria:

1. Report current intention to reduce or quit cannabis or tobacco use within the next 30 days
2. Meet Diagnostic and Statistical Manual (DSM-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine
3. Test positive for illicit drugs other than cannabis and tobacco
4. Positive breath alcohol test at study admission
5. Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity
6. Have a lifetime history of suicidal behavior (i.e. past suicide attempt), or current suicidal behavior or ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
7. Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding
8. Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina)
9. Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.
The Effects of Anesthesia on Patients Undergoing Surgery for Repair of a Thoracoabdominal Aneurysm.

Alzheimer's disease represents a growing public health problem in developed countries. Although the pathogenesis is not clearly defined, accumulation of extracellular amyloid, neurofibrillary tangles and neuronal loss are the hallmarks of Alzheimer's disease. The effect of anesthetic agents on changes in these proteins in humans is not well characterized, but in-vitro evidence suggests that anesthetic agents can accelerate potential pathogenic mechanisms, such as increasing amyloid formation or rates of apoptosis in cultured cells and increasing amyloid levels in mice. Human data on the effect of anesthetic agents on amyloid and tau proteins is limited to a small series of 11 patients and showed a significant increase in tau levels after exposure to anesthetics. In this study the investigators propose to measure CSF and serum biomarkers in a population of patients with normal CSF dynamics, who are undergoing surgery for repair of a thoracoabdominal aneurysm. The investigators will also obtain preliminary data on whether changes in CSF levels of these proteins are associated with postoperative delirium or cognitive change.


Eligibility Criteria:
Inclusion Criteria:

* age 21-100 years of age
* Patients presenting for surgical repair of a thoracoabdominal aneurysm
* Insertion of a CSF spinal drain for clinically indicated reason

Exclusion Criteria:

* Patients with pre-existing delirium
* Inability to speak and understand English
* Severe hearing impairment, resulting in inability to converse
* Pregnancy. Pregnancy status will be assessed using a serum pregnancy test during preoperative evaluation as part of the standard of care.