cyrilzakka/clinical-trials huggingface dataset:
AIM to Improve Asthma: Airflow Improvements During Meal-Prep

The investigators propose a pilot trial of kitchen ventilation in the homes of children using a youth engaged research strategy.

In this trial of children ages 6-12, children and their households will receive an intensive home kitchen ventilation intervention after one week of baseline data collection. The intervention includes education regarding improving ventilation in their homes during cooking and replacement of their range hood if it has inadequate flow or an intolerable noise level. During baseline data collection periods the households will be encouraged to continue their regular cooking patterns. The investigators will measure home particulate matter \<2.5 microns (PM2.5) and nitrogen dioxide (NO2) levels for one week at baseline, and a final week after all remaining families receive the cooking ventilation intervention, to assess for changes within each household. The investigators will also examine changes in airways inflammation (as measured by the exhaled fraction of nitric oxide, FeNO), lung function (as measured by spirometry), and reported symptoms after the baseline and intervention period. Members of the research team have successfully conducted youth participatory action research in the low-income, high asthma prevalence community of Richmond, California (CA) as well as extensive youth participatory action research on other environmental health concerns in the low income city of Salinas, CA; using a similar model, the investigators aim to teach research methods to a new group of Richmond youth.

Eligibility Criteria:
Inclusion Criteria:

* Household has a gas stove
* Household has a range hood that vents to the outdoors
* Household in Richmond or San Pablo

Exclusion Criteria:

* Child has other significant medical illnesses (e.g. prematurity, diabetes)
* living with a smoker who smokes indoors
* family knows they will not have stable housing for the period of the study
* Parent is not fluent in English.
Effect of Biological Therapy on Biomarkers in Patients With Untreated Hepatitis C, Metastatic Melanoma, or Crohn Disease

RATIONALE: Studying samples of blood from patients with cancer, hepatitis C, or Crohn disease in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer and other diseases.

PURPOSE: This laboratory study is looking at the effect of biological therapy on biomarkers in patients with untreated hepatitis C, metastatic melanoma, or Crohn disease.

OBJECTIVES:

* To determine how a variety of immune-modulating therapies (i.e., interferon alfa \[IFN-α\] in patients with untreated acute or chronic hepatitis C, anti-tumor necrosis factor in patients with active inflammatory bowel disease (i.e., Crohn disease), and anticytotoxic T-lymphocyte antigen immunoglobulin in patients with metastatic melanoma) affect the tissue expression of indoleamine 2, 3 dioxygenase (IDO), a major immune-regulatory mechanism.
* To determine whether administration of pegylated INF-α in patients with untreated acute and chronic hepatitis C causes systemic changes in the IDO pathway, as indicated by lowered serum tryptophan (TRP) and elevated serum kynurenine (KYN).
* To determine whether administration of ticilimumab (i.e., anti-CTLA4 human monoclonal antibody CP-675,206) in patients with metastatic melanoma inhibits activation of the IDO pathway as indicated by normal serum TRP and normal serum KYN.
* To determine whether administration of infliximab in patients with Crohn disease inhibits activation of the IDO pathway, as indicated by normal serum TRP and normal serum KYN.

OUTLINE: Serum samples are collected from patients with hepatitis C and metastatic melanoma at baseline and at 3 to 4 weeks after treatment is initiated. Previously collected samples from patients with Crohn disease are also assessed at these time points. Samples are analyzed for tryptophan and kynurenine levels via high-performance liquid chromatography.

PROJECTED ACCRUAL: A total of 15 patients with untreated acute or chronic Hepatitis C, 15 patients with metastatic melanoma, and 20 patients with Crohn disease will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following:

  * Acute or chronic hepatitis C

    * Receiving pegylated interferon alfa and ribavirin
  * Metastatic melanoma

    * Receiving ticilimumab
  * Crohn disease

    * Received prior infliximab

Exclusion Criteria:

* Not specified

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Case Management Algorithm for Women Victims of Violence

A considerable body of research has demonstrated that women who are victims of interpersonal violence are at substantially elevated risk for the development of post-traumatic stress disorder (PTSD). In France, victims can request a medico-legal examination in a clinical forensic medicine unit. Although these units are also a place for initial psychological examination, women often don't attend future scheduled appointments. Decision-making algorithm using phone contact are effective in suicide prevention. Our aim is to assess the effectiveness of case management algorithm using early phone contact compared to a control group treated as usual on clinical outcome after consultation requested in a clinical forensic medicine unit by female victims of violence.

Method: Prospective, multicenter, open-label, randomized controlled clinical trial, for women victims of violence. Victims randomized in VIGITRAUMA group will be contacted by phone at 3 weeks after the consultation in a clinical forensic medicine unit, and a second phone call can be done. If the subject is not contacted after the second phone call, he will receive a postcard.

Control group will benefit from usual follow-up.

All the subjects included will be then evaluated at 3 months, 6 months and 1 year during a phone call.


Eligibility Criteria:
Inclusion Criteria:

* Women
* 18 years and older
* Consultation requested in a clinical forensic medicine unit after being victim of violence
* The person was exposed to: death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence (PTSD criterion A - DSM -5)
* With social insurance
* Consent to participate to the study

Exclusion Criteria:

* Do no consent to participate to the study
* Intrafamilial or intimate partner violence
* Do not speak french
Specific Lp(a) Apheresis for Regression of Coronary and Carotid Atherosclerosis

To evaluate whether specific lipoprotein(a) apheresis on the top of optimal medical therapy could affect atherosclerotic disease burden in coronary and carotid arteries of coronary heart disease patients with elevated Lp(a) levels.

Following the hypothesis that if Lp(a) excess has a pathogenic role in atherogenesis, then specific elimination of circulating Lp(a) should affect plaque growth and stability, we evaluated the efficacy of Lp(a) apheresis on changes in coronary plaque volume and composition and carotid intima-media thickness in patients with CHD on the background of optimal medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Stable coronary heart disease (CHD) requiring a clinically indicated coronary angiography.
* Lp(a) ≥50 mg/dL
* LDL-C \<2.6 mmol/L (100 mg/dL)
* Signed written informed consent form to participate in the study

Exclusion Criteria:

* history of acute coronary syndrome or surgical intervention within prior 3 months to inclusion
* chronic infectious and inflammatory diseases
* familial hypercholesterolemia
* TG ≥4.5 mmol/L (400 mg/dL)
* Active liver disease (ALT or AST \>3 upper limit of normal (ULN), or total bilirubin \>1.5 ULN);
* CK ≥3 ULN;
* Thyroid dysfunction;
* Renal dysfunction (creatinine clearance (Cockcroft-Gault Equation) ≤30 ml/min);
* Uncontrolled diabetes (HbA1c ≥7.0%);
* Coagulopathies;
* Lipid-lowering drugs, except statins for the last month
* Known statin or immunoadsorption intolerance
Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women

Whole blood sample procurement study from pregnant women with signs and symptoms of Preeclampsia.

This multicenter non-interventional observational sample acquisition study is designed to acquire whole-blood samples from pregnant women who present with signs and symptoms of Pre-E and are in the care at an OB-GYN and/or Maternal Fetal Medicine (MFM) site, defined as outpatient centers, clinic sites, and medical offices.

Study population includes subjects who are pregnant, of any race or ethnicity, 18 to 45 years of age, 28 0/7 to 36 6/7 weeks' gestational age with a singleton fetus and have provided written informed consent to provide whole blood specimens at one or more study visits.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 to 45 years of age
* Subject is willing to provide informed consent
* Subject enrolling at a study OB-GYN or MFM site is in the opinion of the physician able to provide 20 mL of whole blood and will comply with all study procedures
* Subject has a singleton fetus of 28 0/7 to 36 6/7 weeks' gestational age using 2014 ACOG Dating Criteria (pregnancies starting as twins but complicated with either vanishing twin syndrome or fetal demise of one twin before 14 weeks, are eligible for inclusion)
* Patient presenting with clinical suspicion of Pre-E based on one or more of the following clinical signs and symptoms of Pre-E:

  * New onset increased blood pressure in otherwise normotensive patient
  * Worsening hypertension in a patient with pre-existing hypertension
  * New onset proteinuria or worsening of pre-existing proteinuria
  * Any other clinical finding typically associated with suspicion of Pre-E and requiring workup to rule-out Pre-E

Exclusion Criteria:

* Pregnancy is non-viable, as evidenced by absence of fetal cardiac activity
* Major fetal anomaly or chromosomal aneuploidy
* Current dialysis for kidney failure, including continuous ambulatory peritoneal dialysis
Tracking Wound Infection With Smartphone Technology

This study aims to evaluate if a smartphone-delivered tool can help assess for wound infections, and if this improves access to care and results in earlier treatment. Participants will be randomised to one of two groups. The intervention group will receive the smartphone-delivered wound assessment tool (SWAT), to access if they have concerns about their wound. The trial period is 30 days.

Surgical site infection (SSI) is defined by the Centre for Disease Control and Prevention (CDC) as an infection in the skin and soft tissues of a surgical wound, within 30 days of the operation. It is a common problem, and complicates 2-10% of general surgery operations. The majority of cases are diagnosed outside of hospital and can be treated with oral antibiotics.

Interest in the use of technology in medicine is increasing, with the potential that more advanced technology will help facilitate communication between clinicians and patients, aid in the assessment of patients, and improve clinical decision making. Over two-thirds of people now own smartphones, and regularly use them to access the internet. The investigators wish to use a smartphone delivered questionnaire to help assess SSI and see if this improves access to care and time to treatment.

The investigators will be recruiting emergency surgery patients with smartphones at the Royal Infirmary and Western General Hospitals in Edinburgh.

Participants will be divided into two groups. One group will receive the wound assessment tool, if they are concerned about their wound, they can use the tool to answer a series of questions. If their answers suggest SSI, a clinician will contact them to advise further assessment and treatment. The participants will also be asked to respond to the tool three times during the trial (to collect responses from those without symptoms), and upload photos of their wounds to a secure database.

The second group of participants will receive normal post-operative care.

After 30 days, participants will have a follow-up consultation, to determine if they have had a wound infection (this can be via telephone or face-to-face, according to participant preference). They will also answer questions about their experience of the study, and use of services.

Eligibility Criteria:
Inclusion Criteria:

* Emergency Abdominal Surgery Patients
* Smartphone Owners
* Able to give valid consent

Exclusion Criteria:

* Significant visual impairment
Effects of Gender-Affirming Hormone Therapy Among Transgender Women

In this study, investigators plan to evaluate the cardiometabolic effects of initiating gender-affirming hormone therapy among transgender women with and without HIV. As part of this study, participants will undergo cardiovascular and metabolic phenotyping within 3 months of starting and after 12 months of gender-affirming hormone therapy. Cardiovascular phenotyping will include cardiac MRI/MRS imaging to evaluate cardiac function and structure. Metabolic phenotyping will include oral glucose tolerance testing, abdominal MR imaging to evaluate visceral adiposity, and whole body, lumbar, and hip DEXA imaging to evaluate fat and lean body mass as well as bone mineral density, respectively. Traditional markers of CVD risk as well as immune, hormonal, and coagulation parameters will also be assessed longitudinally.


Eligibility Criteria:
Inclusion Criteria:

* transgender women or non-binary individual
* age ≥16
* For women with HIV only: on ART therapy for ≥3 months
* initiation of testosterone suppression with spironolactone or leuprolide and estrogen therapy with oral 17-β estradiol, transdermal 17β estradiol, sublingual estradiol, intramuscular estradiol, or subcutaneous estradiol by medical provider

Exclusion Criteria:

* For women with HIV only: CD4 count\<50
* history of CAD, ACS, ASCVD risk score ≥ 7.5%, LDL-C ≥ 190, or angina (e.g. current indication for statin use)
* history of heart failure
* history of diabetes
* eGFR \< 30 ml/min/1.73m2
* standard contraindication to MRI, including history of severe allergy to gadolinium or Dotarem
* prior orchiectomy
* gender-affirming hormone therapy for greater than 5 months directly prior to enrollment
* current or past anti-platelet therapy or anti-coagulant therapy within the last 6 months •current or past statin therapy within the last 6 months
* concurrent enrollment in conflicting research study
Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy

Randomised control trial of 150 paediatric patients aged between 3-8years. One group will receive a preoperative carbohydrate oral drink and the other group will receive current standard care (no drink) prior to undergoing tonsillectomy and/or adenoidectomy.

Outcomes to be reported will be: 1) patient and parent satisfaction; 2) post operative pain score at: recover, 1 hour post op, prior to discharge home and then day 1 postoperatively; 3) PONV rates in recovery, prior to discharge home and again on Day 1 postoperatively; 4) sleep quality night after surgery.

Children undergoing tonsillectomy and/or adenoidectomy will be consented via parents prior to the day of surgery and then randomised to 1 of 2 groups who will either receive the intervention or current standard care. Patients will be recruited from the ENT outpatient clinics in conjunction with the ENT surgeons.

Data collection will be undertaken with the aid of experience research assistants.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing Tonsillectomy and/or adenoidectomy
* consented to undertake preop carbohydrate drink and follow up procedures

Exclusion Criteria:

* Increased risk of aspiration or unable to swallow liquids
* outside age range
* non-consent to undertake treatment or follow up
Study of the QOL Evaluation of Trelagliptin in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to assess the reduction in treatment burden during 12 weeks of trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy only.

The purpose of this study is to assess the reduction in treatment burden during 12 weeks of trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy only. Eligible participants will be randomized to either the study drug (trelagliptin) group or the comparative drug (daily DPP-4 inhibitor) group. Treatment burden will be assessed using Diabetes Therapy Related -QOL (DTR-QOL) questionnaire and Diabetes Treatment Satisfaction Questionnaire (DTSQ).

Eligibility Criteria:
Inclusion Criteria:

1. Participants diagnosed as type 2 diabetes.
2. Participants with a stable diet and exercise therapy only for at least 12 weeks prior to the start of the screening period.
3. Participants who require a DPP-4 inhibitor treatment.
4. Participants with Hemoglobin A1c (HbA1c) \>=6.5 % and \<10.0 % at the start of the screening period.
5. Participants who completed DTR-QOL questionnaire at the start of the screening period.
6. Participants who have received less than 2 types of medication for treatment of comorbidities (such as hypertension or dyslipidemia) at the start of the screening period (any number of daily doses).
7. Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical study and complying with the study protocol requirements.
8. Participants who can provide the written informed consent prior to the initiation of any study procedures.
9. Participants aged \>=20 years at the time of informed consent.
10. Outpatient.

Exclusion Criteria:

1. Participants who are receiving any oral anti-diabetic medication for the treatment of type 2 diabetes at the start of the screening period.
2. Participants diagnosed with type 1 diabetes.
3. Participants with severe renal impairment or renal failure (e.g., estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m\^2 or on dialysis).
4. Participants with serious heart disease or cerebrovascular disorder, or serious pancreatic, blood, or other disease.
5. Participants with a history of gastrointestinal resection.
6. Participant with a proliferative diabetic retinopathy.
7. Participant with malignancy.
8. Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors.
9. Pregnant, lactating or planning pregnancy during the study period.
10. Participants who may need to add or discontinue concomitant medication or change the dose during the study period.
11. Participants who will require treatment with a prohibited concomitant medication during the study period.
12. Participants participating in other clinical studies.
13. Participants assessed ineligible in the study by the principal investigator or the investigator.
Postoperative Pain After Volar Plating for Distal Radius Fractures

The investigators undertook to evaluate early postoperative pain levels after the volar plating of distal radius fractures performed under regional anesthesia, and to determine whether periarticular multimodal drug injections into the joint, ligament, periosteum, subcutaneous tissue, and skin, and into interosseous and superficial radial nerves (as an additional sensory nerve block) provide additional pain management benefits.

To evaluate whether periarticular injections (PI) had additional pain management benefits, patients were randomly allocated to two groups, that is, the PI and No-PI groups, using a randomization table. Members in the PI group received intra-operative periarticular injections and additional sensory nerve blocks just before skin closure. For the periarticular injections and additional sensory block, local analgesic solution was injected into the wrist joint, joint capsule, periosteum, subcutaneous tissue, skin, and around the anterior and posterior interosseous nerves and the superficial radial nerve.

A volume of 2ml was injected into the joint capsule and periosteum, and of 3ml into the wrist joint, subcutaneous tissue, skin and into each nerve. The anterior interosseous nerve was blocked in the course of the pronator quadratus and posterior interosseous nerve in the 4th dorsal extensor compartment.

The mixture of anesthetics consisted of 2 ampules of ropivacaine HCl (Naropin®, 0.75%, 7.5mg/ml, 20ml/ⓐ), 1 ampule of morphine sulfate (5mg/ⓐ), 1 ampule of epinephrine HCL (1mg/ml, 1ml/ⓐ) and normal saline 20cc.

Eligibility Criteria:
Inclusion Criteria:

* distal radius fracture with or without a styloid fracture not requiring surgery

Exclusion Criteria:

* multiple trauma
* a combined distal radio-ulnar joint instability or a large ulnar styloid fragment requiring fixation
* regularly narcotics user
* those with a psychiatric illness, a major systemic illness or a known allergy or contraindication to opiates or local anesthetics.
N-acetyl Cysteine for Ovulation Induction in Clomiphene Citrate Resistant Polycystic Ovary Syndrome

Polycystic ovary syndrome is a major endocrinological disorder affecting 5-8% of reproductive aged women. Anovulation is a major feature of the syndrome, managed primarily by clomiphene citrate. Failure to respond to clomiphene citrate is termed clomiphene resistance and second line treatment is either laparoscopic ovarian drilling or gonadotrophin ovulation induction. Although laparoscopic drilling is effective in restoring ovulation and achieving pregnancy, some women still remain anovulatory and infertile after the procedure. N-acetyl cysteine has emerged as a novel therapeutic adjuvant to laparoscopic drilling to improve ovulation and pregnancy rate.

Resistance to ovulation induction therapy with clomiphene citrate (CC) is a significant problem affecting as many as 25% of patients. Laparoscopic ovarian drilling is an accepted second line treatment option, achieving ovulation in 75-90% and pregnancy in 50-69% of the CC resistant patients.

Adjuvants to laparoscopic drilling have been explored by researchers some studies have shown evidence of improved outcome with the use of N-Acetyl cystiene (NAC), a long used mucolytic drug which has been used for various other indications including detoxification and cancer chemoprotection. Several studies have addressed the possibility of using NAC as adjuvant therapy to Clomiphene citrate for induction of ovulation in resistant patients with some showing encouraging results. The use of NAC as adjuvant to laparoscopic ovarian drilling was addressed in a single pilot study showing good results with improved ovulation and pregnancy rates compared to the non users.

Eligibility Criteria:
Inclusion Criteria:

* PCOS patients according to Rotterdam criteria who failed to respond to 6 month ovulation induction therapy with clomiphene citrate,
* normal semen analysis of partner
* normal tubo-peritoneal anatomy as assessed by laparoscopy

Exclusion Criteria:

* patients who have other causes of infertility
* patients receiving gonadotrophin ovulation induction
Occupational Therapy Trauma Informed Workshops and Consultations for Teachers at Head Start

This study will utilize a pre/post mix method design

Quantitative data will be gathered through surveys (including satisfaction questionnaires) administered pre/post workshops.

Qualitative data will be obtained through interviews post- workshop and consultations.


Eligibility Criteria:
Inclusion Criteria:

* Home Visitors or Teaching Staff at Head Start within San Bernardino County
* Between 18-65 years of age
* All genders
* English Speaking

Exclusion Criteria:

* NA