cyrilzakka/clinical-trials huggingface dataset:
Tobacco Cessation for Veterans With Post Traumatic Stress Disorder (PTSD)

The goal of this study is to improve the effectiveness of tobacco cessation treatment for veterans with Post Traumatic Stress Disorder (PTSD) through ongoing, integrated care management approach using telehealth and motivational interviewing counseling. Both tobacco dependence and PTSD represent enormous challenges to the Veterans Affairs (VA) healthcare system.

Background: Veterans smoke at a higher rate (30%) than the U.S. adult population (21%), and veterans with PTSD have even higher rates of smoking (53-66%). Evidence has shown that any tobacco dependence treatment strategy must be integrated in the health care system because consistent and effective delivery of tobacco cessation requires coordinated interventions. Persistent tobacco users typically cycle through multiple periods of relapse and remission. Veterans with PTSD (279,256 in 2005) who are treated for smoking cessation may need more comprehensive aid to be successful. Failure to appreciate the chronic nature of tobacco dependence may impede comprehensive and consistent treatment. Care management using telehealth has been shown to improve access to care while reducing costs for veterans with chronic diseases and has the potential to coordinate smoking cessation with care for other chronic diseases. Nurses have successfully managed chronic diseases using telehealth by focusing on increasing self-management, positive behaviors and knowledge. Nurses are vital to increasing the level of support in the community through education and motivation and by responding to medical events in order to improve veterans' health.

Objectives: The study is designed to determine if adding motivational counseling and care management using the PTSD Health Buddy to usual care improves smoking quit rates of veterans with PTSD. Specific Aims are to compare: 1) self-reported quit attempts, progression through the stages of change, and quit rates, 2) patient perception of care coordination, and 3) changes in PTSD symptoms in veteran smokers with PTSD who receive a nurse-driven telephonic motivational counseling intervention triggered by responses to stage-based smoking cessation questions in addition to usual care to those who receive usual care only.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders IV criteria (DSM-IV) for diagnosis code 309.81 PTSD
* Willingness to participate
* Currently smoking 1 or more cigarettes per day

Exclusion Criteria:

* Use smokeless tobacco, pipes or cigars instead of cigarettes
* Have imminent risk of suicide or violence
* Have severe psychiatric symptoms or psychosocial instability likely to prevent participation in protocol (provider will assess appropriateness)
* Have clinically apparent gross cognitive impairment
* Unable to connect Health Buddy in home
Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion

In this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. This study will provide important data on the role of misoprostol in health services offering an array of treatments for incomplete abortion. Women could significantly benefit from a non-invasive treatment option for incomplete abortion. While safe surgical services are becoming more widespread, there is still a serious risk of complications from these procedures. Especially in developing countries, infection, hemorrhage and uterine damage are still too common. Medical treatment of incomplete abortion using misoprostol would be a tremendous step to reducing morbidity and mortality due to abortion complications.


Eligibility Criteria:
Inclusion Criteria:

* Uterine size no larger than 12 weeks LMP at time of presentation for care.
* Past or present history of vaginal bleeding during pregnancy.
* Open cervical os.
* If ultrasound used evidence of incomplete abortion with substantial debris in the uterus.
* All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
* General good health.
* Willing to provide contact information for purposes of follow-up.
* Also in Egypt: 21 years of age or over or parental permission (there is no minimum age requirement in Niger, Mauritania and Senegal).

Exclusion Criteria:

* Contraindications to study drug
* Signs of severe infection, defined as at least one of the following: 1) foul smelling discharge, 2) fever \> 38 degrees C , 3) uterine tenderness
* Hemodynamic disturbances (pulse \>110/min and systolic bp \<100)
* Have an IUD in place; (the IUD may be removed making the woman eligible)
* Suspected ectopic pregnancy
An Epidemiological Study of Subjects With Immune Thrombocytopenic Purpura to Evaluate the Relationship Between Platelet Counts, Endogenous Thrombopoietin Levels, Endogenous Anti-Thrombopoietin Antibodies, and Selected Autoimmune Markers

This study involves the collection of blood samples from patients with immune thrombocytopenic purpura (ITP) to evaluate the relationship between platelet counts, blood levels of a hormone called thrombopoietin that controls platelet production by the bone marrow, and blood levels of antibodies against thrombopoietin that could interfere with the action of this hormone. Blood samples will also be stored if separately agreed to by the patient for analysis of genes that might affect platelet production. At a single outpatient clinic visit, patients will have a medical history taken, and blood samples drawn for testing. Results from this study may help further understand the control of platelet production in patients with ITP, and suggest new therapeutic approaches.

This study involves the collection of blood samples from patients with immune thrombocytopenic purpura (ITP) to evaluate the relationship between platelet counts, blood levels of a hormone called thrombopoietin that controls platelet production by the bone marrow, and blood levels of antibodies against thrombopoietin that could interfere with the action of this hormone. Blood samples will also be stored if separately agreed to by the patient for analysis of genes that might affect platelet production. At a single outpatient clinic visit, patients will have a medical history taken, and blood samples drawn for testing. Results from this study may help further understand the control of platelet production in patients with ITP, and suggest new therapeutic approaches.

Eligibility Criteria:
Diagnosis of ITP, based on the history, physical examination, complete blood count, and examination of the peripheral smear, which should exclude other causes of thrombocytopenia. These criteria for ITP are based on the American Society of Hematology practice guideline for ITP.

Subjects 5 years of age or older.

Before the study specific procedure, the subject or legally acceptable representative must give written informed consent(s) for participation in the study.

No subjects with documented history of Human Immunodeficiency Virus (HIV) or Hepatitis.

No subjects with known underlying causes of thrombocytopenia such as lupus erythematosus, autoimmune thyroid disorders, drug-induced thrombocytopenia, bone marrow disorders, and liver disease.

No psychiatric or addictive disorders that compromise the subject's ability to give truly informed consent for participation in the study.
Thiamine and Acute Decompensated Heart Failure: Pilot Study

Heart failure remains an increasing cause of morbidity and mortality in the United States even in the face of recent advances in the treatment of cardiovascular disease. There is an urgent need to reevaluate the treatment of heart failure. Shifting substrate utilization used in energy metabolism from fatty acids to glucose is beneficial to the heart presumably by increasing the efficiency of ATP production. Several new drugs for the treatment of cardiac ischemia work by this mechanism. There is increasing evidence that patients with heart failure may also benefit by the same type of intervention. Patients with heart failure are known to have low serum thiamine levels because of poor dietary intake and increased urinary excretion. Inadequate thiamine will deleteriously shift substrate utilization from glucose to fatty acids.

We hypothesize that thiamine supplementation will be beneficial for patients with heart failure by increasing glucose and decreasing fatty acid utilization. This will be initially tested in a pilot double-blinded placebo controlled study of thiamine supplementation in diabetic and non-diabetic patients presenting to the emergency department with acute decompensated heart failure.


Eligibility Criteria:
Inclusion Criteria:

1. History of heart failure on a loop diuretic.
2. Worsening dyspnea over the past 24 hours.
3. Currently dyspneic sitting or supine, on or off oxygen.
4. Radiographic cephalization of vessels. This criteria is not needed if the patient has no other reason for being dyspneic after being evaluated in the emergency department.
5. Elevated NT pro-BNP (\>450).
6. Able to communicate in English or Spanish.
7. Able and willing to provide informed consent.
8. Age \> 18 years.
9. A primary admitting diagnosis of acute decompensated heart failure.

Exclusion Criteria:

1. Renal failure on dialysis.
2. Severe valvular disease.
3. EKG criteria for acute myocardial infarction (ST segment elevation \> 1mm on two contiguous leads).
4. Initial troponin elevated.
5. Ventricular arrhythmia (ventricular tachycardia or fibrillation).
6. Supraventricular arrhythmia (atrial fibrillation / flutter) with a ventricular rate \>120 beats per minute.
7. Taking a daily thiamine supplementation (any multivitamin or specific thiamine supplementation within the past 2 weeks. Fortified foods, such as cereals, are acceptable
8. Taking a daily fatty acid supplement.
9. Pregnancy as determined by standard serum or urine b-HCG assay.
Evaluation of Prognosis With Integrated MRI/PET in Patients With Pancreatic Cancer

The aim of this study was to evaluate MR/PET with both functional and molecular imaging on the prediction of prognosis in patients with suspected pancreatic cancer.

The results of MR/PET will be compared prospectively to dedicated MDCT or MR imaging, pathologic results, and clinical outcomes to assess the value of MR/PET in pancreatic cancers.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as pancreatic cancer
2. Between 20\~90 years old
3. ECOG 0-2
4. Normal renal function
5. Measurable tumor size (\>1cm)

Exclusion Criteria:

1. Contraindication for MRI exam
2. Claustrophobia
3. Renal insufficiency
4. Other malignancy
5. Pregnancy and lactating women
Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation (KRYSTAL -19)

This study will evaluate the safety, MTD and/or RP2D, PK, and clinical activity of the combination of adagrasib with nab-sirolimus in patients with advanced solid tumors/NSCLC with a KRAS G12C mutation.

This study will evaluate the safety and tolerability and clinical activity of adagrasib in combination with nab-sirolimus in patients with advanced solid tumors harboring a KRAS G12C mutation.

The Phase 1 portion will enroll advanced solid tumors to establish the maximum tolerated dose (MTD) and/or to identify recommended Phase 2 combinatorial doses. The Phase 2 portion will enroll patients with NSCLC to further evaluate the safety/tolerability and clinical activity.

Adagrasib is an orally available small molecule inhibitor of KRAS G12C. nab-Sirolimus is a nanoparticle albumin-bound (nab) form of sirolimus, and sirolimus is an inhibitor of mechanistic target of rapamycin kinase (mTOR, previously known as mammalian target of rapamycin).

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of solid tumor malignancy (Phase 1) or NSCLC (Phase 2) with KRAS G12C mutation
* Unresectable or metastatic disease
* No available treatment with curative intent
* Adequate organ function
* Measurable disease per RECIST 1.1.

Exclusion Criteria:

* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
* History of interstitial lung disease or radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease or pneumonitis
* Cardiac abnormalities
Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)

The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction).

Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.

The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction).

Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.

Eligibility Criteria:
Inclusion Criteria:

* Signed ICF (Informed Consent Form)
* Subject-reported history of Drye Eye Disease (DED) in both eyes
* Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

* Women who are pregnant, nursing or planning pregnancy
* Unwillingness to submit a blood pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
* Clinically significant slit-lamp findings or abnormal lid anatomy at screening
* Ocular/peri-ocular malignancy
* History of herpetic keratitis
* Active ocular allergies or ocular allergies that are expected to be active during the study
* Ongoing ocular or systemic infection
* Wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study
* Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned ocular and/or lid surgeries over the study period
* Presence of uncontrolled systemic diseases
* Presence of known allergy and/or sensitivity to the study drug or saline components
* Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears or topical anti-glaucoma medication within 2 months prior to screening
Assessment of Adverse Events in a Naive Pediatric Population Treated With an Antipsychotic

We propose a prospective multicenter study, whose originality lies in the inclusion of the naive child and adolescent population. Its purpose is to evaluate the incidence of adverse events related to the use of l antipsychotic drugs in children and adolescents with no history of taking such drugs.

The inclusion criteria will be: (1) male or female inpatients, (2) aged from 6 to 18 years, (3) requiring antipsychotic treatment, (4) receiving antipsychotic drug for less than 28 days without taking antipsychotic before or with a history of antipsychotic over a maximum period of three consecutive months and discontinued for at least 6 months.

Therapeutic monitoring during the 12 month study period will include clinical assessments and laboratory testing. These assessments will be performed before treatment (at inclusion), and at 1, 3, 6, 9, 12 months after the introduction of the antipsychotic drug.

a prospective multicenter study, whose originality lies in the inclusion of the naive child and adolescent population

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients
* Aged from 6 to 18 years
* In whom antipsychotic treatment is indicated
* Who have never been treated with antipsychotic medication (other than metoclopramide (Primperan®) for pediatric indications) or with a history of antipsychotic over a maximum period of three consecutive months and discontinued for at least 6 months. .

The non-inclusion criteria:

* Any

The exclusion criteria:

* Refusal or withdrawal of consent by the patient or his/her parents.
Study of the Families Moving Forward Website Behavioral Intervention for Teachers of Students With Fetal Alcohol Spectrum Disorder

The purpose of this study is to find out if the FMF Connect Teacher Companion website is acceptable and usable by teachers. The FMF Connect Teacher Companion website is a website for teachers adapted from the Families Moving Forward (FMF) Program. The FMF Program is an evidence-based intervention for caregivers of children with FASD. The study will determine if the a web page intervention is feasible and acceptable by looking at enrollment and retention of study subjects and acceptability of assessments.


Eligibility Criteria:
Inclusion Criteria:

* Be an educational professional currently actively employed in a school setting in the United States
* Be above the age of 18 years old
* Have direct, consistent contact with a student with a diagnosed fetal alcohol spectrum disorder (FASD) or confirmed prenatal alcohol exposure (PAE) between the ages of 5-12, (i.e. grades K to 5) in a special or general education classroom
* Have reliable access to the Internet
* Be able to consent for themselves

Exclusion Criteria:

* They are unable to read English
* They do not have direct, consistent contact with a student with a diagnosed FASD between ages 5-12 (e.g., substitute teacher, principal)
A Study To Investigate The Effect Of Inhaled Fluticasone Propionate On The Bronchial Responsiveness To Leukotriene D4 In Asthmatics Patients

Investigate if asthmatics treated with FLIXOTIDE (FP) 500 mcg BID during 14 days get reduced bronchial reactivity after inhalation of Leukotriene D4. Two 14 days treatment periods where patients received FP 500 MCG BID and placebo. Washout at least 21 days between treatments. Bronchial challenge with methacholine and Leukotriene D4 were performed before the start of each treatment period and on treatment days 13 and 14 respectively.


Eligibility Criteria:
Inclusion:

* Diagnosed history of asthma
* Non smoker last two years
* \< 5 pack years
* FEV1 \>70% of predicted
* Mild and stable asthma
* Only using short acting b2-agonist as rescue for the last 4 weeks
* Have a history of atopy.

Exclusion:

* Any significant respiratory disease, other than asthma
* Subjects with seasonal asthma may not be included if they are in their season
* Use of oral or inhaled glucocorticosteroid for the last 3 months and long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and antileukotrienes within two weeks
* Upper or lower RTI within 6 weeks
* Evidence of any disease that in the investigators mind would affect the results of the study
* Participating in another study within 4 weeks
* Females who are pregnant, intend to be or who are lactating
* Methacholine PD20 \> 454mcg
* Negative scin prick test
Study the Usefulness of Bio-impedance Spectroscopy in the Early Assessment of Breast Cancer Related Lymphoedema

The goal of the study is to investigate the use of bio-impedance spectroscopy in the assessment of breast cancer related lymphoedema in patients operated with lumpectomy or mastectomy, axillary lymph node dissection and radiotherapy compared to inverse water volumetry. As a control group, patients with colon rectal cancer are used to compare volumetric and spectometric changes during follow-up.

Current assessment of lymphoedema consists of measuring volume changes objectively by a tape measure or water displacement. Early recognition of pre-clinical changes of interstitial fluid congestion in a limb at risk concerning lymph transport capacity is crucial. Objective measurement of extracellular fluids with bio-impedance spectroscopy can detect these early signs of lymphoedema. Multi Frequency Bioelectrical Impedance Analysis is completely non-invasive, highly reproducible (Ward et al 1997), highly sensitive (Cornish et al 2001), highly specific (Cornish et al 2001) and can be repeated as frequently as desired. BIS demonstrated excellent inter- and intra-rater reliability. All measures are highly reliably in women with and without lymphoedema (Szerniec et al 2010). For women with lymphoedema BIS detected a difference in the ECF in limbs which were not reflected in a corresponding difference in limb volume. This finding suggests that BIS may be particularly useful in the early detection of lymphoedema, before there is any volume change (Szerniez et al 2010). The mean ratio of extra cellular water (ECW) to intracellular water (ICW) is 1,5:1 (Ward et al 2009). Cornish et al (2001) predicted the onset of the condition up to 10 months before the condition could be clinically diagnosed. This is considerable shorter than the mean delay time of 3,5 years reported by National Summit on Lymphoedema, Adelaide 2000. The only risk factor identified as contributing to an increased risk of developing secondary lymphoedema was an increasing BMI which is consistent with previous reports (Box et al 2002).

Early detection with BIS is supposed possible even before clinical signs of swelling are available.

In this study we want to study this hypothesis and as control-group patients treated for colorectal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Gender: female
* Patients operated with lumpectomy or mastectomy, Sentinel node, axillary lymphnode dissection and/or chemotherapy and/or radiotherapy.
* Controls: operated for colon-rectal carcinoma with colectomy and adjuvant chemotherapy
* Patients 18 years or older
* No pre-existing clinical or volumetric signs of lymphoedema (CBO guideline: \>10% difference with contra-lateral side

Exclusion Criteria:

* Allergy against one of the used materials
* Patients who have a pacemaker or other inbuilt stimulator
* Women who are pregnant
* Patients with renal failure or heart failure
* Lymphoedema