cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Clinical Activity of a Sequential Dose of REGN846 on Refractory Pruritus in Patients With Atopic Dermatitis

The purpose of this study is to assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria include, but are not limited to the following:

1. Men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
2. Patients must have applied a stable dose of an additive-free, basic, bland emollient twice daily for at least 7 days before the baseline visit
3. Chronic Atopic Dermatitis (AD)
4. Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
5. Refractory pruritus for ≥ 6 weeks before screening. Pruritus should be associated only with AD and not with any other condition(s).
6. Itching associated with AD

Exclusion Criteria:

Exclusion criteria include, but are not limited to the following:

1. A history of listeriosis.
2. Presence of any 1 of the following tuberculosis (TB) criteria:

   1. A history of active TB
   2. A positive QuantiFERON TB test at the screening visit
   3. Chest radiograph (posterior-anterior and lateral views) at screening or within 3 months before the screening visit (radiology report must be available) with results consistent with prior TB infection (including but not limited to apical scarring, apical fibrosis, or multiple calcified granuloma). This does not include non-caseating granulomata.
3. Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit.
4. Any clinically significant physical abnormalities observed during the screening visit.
5. Diabetic, hypertensive, or any known atherosclerotic vascular disease.
6. Hospitalization for any reason within 60 days of the screening visit.
7. History of or positive human immunodeficiency virus (HIV) screen result at the screening visit.
8. History of positive blood test for hepatitis B/hepatitis C or positive hepatitis screen result at the screening visit.
9. Known sensitivity to doxycycline or tetracycline.
10. Known sensitivity to any of the components or excipients of the investigational product formulation or history of hypersensitivity to any biologic agent.
11. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit.
12. Any medical or psychiatric condition that in the opinion of the investigator or Regeneron, would place the patient at risk, interfere with participation in the study or interfere with the interpretation of study results.
Increasing HPV Immunization Rates: The Rural Adolescent Vaccine Enterprise

The goal of this study is to engage rural primary care clinics and community organizations to test interventions designed to increase HPV vaccinations in both male and female patients aged 9-26 years.

The overarching goal of this study is to engage rural primary care clinics and community organizations to test interventions designed to increase HPV vaccinations in both male and female patients aged 9-26 years. Using a step-wedge randomized controlled trial, we will design and test the effectiveness of multi-component primary care practice-based interventions on the completion of the HPV vaccine series and will explore implementation timing in high and low functioning practices to determine how specific characteristics affect the delivery of the full series. Additionally, we will design and test the impact of a community organization-based intervention intended to educate the public about HPV and cancer risk and risk reduction via vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Oregon family medicine and pediatric clinics located in rural communities that see adequate numbers of patients in the age range we are studying (age 11-17 years).

Exclusion Criteria:

* We will not include neonates, decisionally impaired adults, and prisoners in this study.
Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Exercises

To test whether biofeedback (BF) added to pelvic floor muscle training (PFMT) promotes additional benefits over PFMT alone in the stress urinary incontinence (SUI) treatment.

Introduction: The aim of this study was to test the hypothesis that outpatient BF added to home PFMT results in increased frequency of home exercises sets per month performed by the patients and objective cure rate after 3 months of supervised training. Secondarily, to investigate other subjective and objective clinical parameters in the groups that received or not BF together with PFMT after 3 months of supervised training, and in a longer term of 9-month follow-up.

Method: 72 incontinent women were randomized to the: BF Group (outpatient BF + home PFMT) or PFMT Group (outpatient PFMT + home PFMT).

Assessments: baseline after 3 months of supervised treatment and at 9-month follow-up (after 6 additional months of home PFMT without supervision).

Primary outcomes: adherence - monthly exercises sets performed (exercise diary) and objective cure of SUI (pad test) after 3 months.

Secondary outcomes: urinary symptoms, muscle function, quality of life, adhesion and subject cure at the two time-points.

Eligibility Criteria:
Inclusion Criteria:

* SUI and mixed urinary incontinence with predominant symptoms of SUI with ≥ 2 g of leakage measured by pad test

Exclusion Criteria:

* younger than 18 years old
* chronic degenerative diseases
* pelvic organ prolapse greater than stage I by POP-Q
* neurologic or psychiatric diseases
* previously undergone pelvic floor re-education programs and/or previous pelvic floor surgeries
Quiting Marijuana Use: Self-report Study of Quitting Straegies and Withdrawal Symptoms

Background:

- Marijuana is the most widely used illicit drug in the world, yet relatively little is known about users who try to quit without formal treatment ( spontaneous quitting). Studies have suggested that there are some common strategies that many individuals use in spontaneous quitting, such as changing one s lifestyle or identity, reminding oneself of negative consequences, support from family and friends, and religion. However, more research is needed to determine potential treatment strategies for marijuana use.

Objectives:

* To identify strategies used to help with marijuana quitting among non-treatment seeking adult marijuana users.
* To identify withdrawal symptoms experienced during marijuana quitting and their relationship to the quitting strategies used and the outcome of the quit attempt.
* To evaluate whether subgroups of marijuana users differ in their experience of marijuana quitting.

Eligibility:

- Individuals at least 18 years of age who have made at least one attempt to quit marijuana use.

Design:

* The study will consist of one visit of approximately 1 to 2 hours.
* Participants will fill out three questionnaires. The questionnaires have different types of questions, and will ask about background and lifestyle, marijuana use and craving patterns and behaviors, and difficulties in previous attempts to quit using marijuana.

Marijuana is the most widely used illicit drug in the world, yet relatively little is known about users who try to quit without formal treatment (so-called spontaneous quitting). This study will use two self-report questionnaires to collect information on the socio-demographic characteristics, marijuana use history, most difficult marijuana quit experience, and marijuana craving from a convenience sample of 1230 adult, non-treatment-seeking marijuana users. The questionnaires take 45-60 minutes to administer. Data will be analyzed for patterns and correlations among the characteristics of the quit attempt, including any withdrawal symptoms, quitting strategies used, and its success. The marijuana craving data will be analyzed to evaluate the validity of this measure of marijuana craving. There are no direct benefits to subjects from study participation. The scientific benefit is an improved understanding of spontaneous quitting of marijuana use, which may lead to improved interventions for marijuana users in the future. There are no physical risks to subjects. There are risks of anxiety or embarrassment while taking the questionnaire and of loss of confidentiality of sensitive information collected about subjects.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. age 18 or older
  2. have made at least one attempt to quit marijuana use
  3. able to give valid informed consent
  4. ability to understand English
Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome

Other effects of fluvastatin are investigated in German patients with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Male and female patients, aged between 18 and 75 years
* Metabolic syndrome according to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII)

Exclusion Criteria:

* History of heart failure
* HIV positive
* Stroke

Other protocol defined inclusion and exclusion criteria may apply.
SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)

The study will involve administering the study drug as a single dose of study drug or placebo. This study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent CDI.

ECOSPOR is a Phase 2, multicenter, randomized, double blind, placebo controlled clinical study with 2 treatment arms (SER-109 or placebo). Patients who have diarrhea and a positive C. difficile test result on a stool sample, and who have responded to standard of care antibiotic treatment will receive study drug on Day 1.

Those patients who experience a recurrence of CDI up to 8 weeks after SER 109 or placebo treatment will be offered an opportunity to enroll in an open label SER 109 extension study (Study SERES 005).

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, indicating that the patient understands the purpose of and procedures required for the study. Patients who are unable to provide informed consent will not be included in the study.
2. Male or female patients ≥ 18 years.
3. ≥ 3 episodes of CDI within the previous 9 months, inclusive of the current episode with documentation of ≥ 2 episodes.

Exclusion Criteria:

1. Female patients who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
2. Known or suspected toxic megacolon and/or known small bowel ileus.
3. Active irritable bowel syndrome with diarrhea within the previous 12 months.
4. Major gastrointestinal surgery (eg, significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy) or any history of total colectomy or bariatric surgery.
5. History of inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 24 months.
6. Admitted to or expected to be admitted to an acute care facility or intensive care unit for medical reasons (not just boarding). Patients discharged from an acute care facility before Day 1 or residing in nursing homes or rehabilitation facilities may be enrolled.
7. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor).
Formative Phase of Reducing Hazardous Alcohol Use & HIV Viral Load

This study is the Formative Phase of a larger study; once this phase is completed, enrollment into the randomized controlled trial (RCT Phase) will begin. The primary objective of the Formative Phase is to gain a better understanding of the context in which drinking alcohol among ART client in Vietnam occurs, in order to culturally tailor the intervention to be tested in the RCT Phase. Formative Phase activities will consist of up to 40 in-depth interviews with hazardous drinkers who are either: a) ART clients in one of the ART clinics in Thai Nguyen, or b) who are people who inject drugs (PWID) that are not recruited from the ART clinics (whom we will refer to as general population PWID).


Eligibility Criteria:
Inclusion Criteria:

* being 18-49 years of age;
* having an AUDIT score ≥ 8 (hazardous alcohol use);
* being a current ART client at one of the Thai Nguyen ART clinics or a general population PWID;
* being capable of providing voluntary informed consent.

Exclusion Criteria:

* being unable to participate in study activities due to psychological disturbance, cognitive impairment or threatening behavior;
* currently participating in other HIV, drug use or alcohol studies.
Pilot Study of Non-exposure Simple Suturing EFTR With Sentinel Lymph Node Navigation for EGC (Senorita3-pilot)

Laparoscopic sentinel lymph node dissection and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. Current stomach preserving surgery after sentinel lymph node dissection produce transmural communication and expose the tumor to the peritoneum during operation. An endoscopic full-thickness resection method with a simple suturing technique that does not expose the gastric mucosa to the peritoneum (non-exposure simple suturing, NESS) was recently developed.

This is the pilot study to prove the feasibility of NESS-EFTR with sentinel node navigation in early gastric cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* single lesion of adenocarcinoma in preoperative endoscopic biopsy
* clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography
* tumor size: less than 3cm in differentiated type, less than 2cm in undifferentiated type
* location: 2cm far from the pylorus or cardia
* aged 20 to 80
* ECOG 0 or 1
* patient who signed the agreement
* patient who is suspected to underwent laparoscopy assisted gastrectomy

Exclusion Criteria:

* indication of endoscopic submucosal resection
* inoperable due to poor cardiac, pulmonary function
* pregnant
* having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen
* diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer
Decreasing Catheter-Associated Urinary Tract Infections in the Pediatric Intensive Care Unit

The purpose of this study is to identify risk factors associated with indwelling urinary catheters, as well as to assess the nurses' knowledge and adherence to hospital policies. The study will also include a very extensive literature search in an attempt to create a national standard or guideline.


Eligibility Criteria:
Inclusion Criteria:

1. Medical records of 67 patients 0 to 17 years of age diagnosed with a catheter associated urinary tract infection (defined by CDC) acquired during a PICU hospitalization.
2. Medical records of 67 patients 0 to 17 years of age who had an indwelling urinary catheter during a PICU hospitalization without a catheter associated urinary tract infection.
3. Nurses employed at Children's Mercy Hospital in the PICU.
4. Patient's who acquired a CA-UTI during 2009 and was adjudicated by infection control.

Exclusion Criteria:

Patients

1. Patients with community acquired urinary tract infections
2. Patients 18 years and older cared for in the PICU.
3. Patients with catheter associated urinary tract infections hospitalized outside the PICU at Children's Mercy Hospital.
4. Patients with UTI not related to catheterization

Nurses

1. Nurses floated to the PICU who are not permanent staff members (ICN nurse, float pool staff, travelers)
2. Nurses on the research team
Chicago Community Health Study

The study examined smokers from the initial COMPASS survey who live in one of three local Census tracks with large concentrations of minority populations and smoking rates, including Washington Park (98.8% African American, 60.5% smoker), Gage Park (76.7% Hispanic, 26.7% smoker), and Bridgeport (34.5% Asian, 27.0% Hispanic, 29.3% smoker), randomizing them to receipt of treatment as usual care advice (via a pamphlet form the National Cancer Institute) versus theoretically-driven and empirically-supported smoking cessation advice session delivered in-person at the UCM.


Eligibility Criteria:
Inclusion Criteria:

* Currently reside in either the Washington Park, Gage Park, or Bridgeport communities based on current physical address at the time of initial contact for study participation
* Identify as a current smoker (verified by self-report and exhaled carbon monoxide)
* Willing and able to sign an informed consent
* Stable residence and contact information throughout the follow-up period

Exclusion Criteria:

* Not a current smoker
* Does not live within the pre-determined neighborhood locations
* Unable to sign informed consent
Body Weight, Sleep, and Heart Health

A multidisciplinary investigation examining the circadian mechanisms regulating cardiovascular (CV) risk in obesity. Specifically, in a valid circadian protocol, the investigators aim to study resting cardiovascular risk markers and the reactivity of circadian rhythms in these risk markers to standardized stressors in obesity. Furthermore, using an ingenious approach, the investigators propose to explore impairment in pre/post synaptic function in the cardiac left ventricle.

Overall, these studies will help us answer whether CV rhythms predispose obese individuals to increased CV disease risk - particularly around the vulnerable morning period. The results will serve as a foundation for clinical trials of appropriately timed dosing of medications targeting aspects of the CV system in obesity that increase effectiveness while decreasing side-effects.

Eligibility Criteria:
Inclusion Criteria:

* Ages 25-65
* Lean and overweight (BMI 18.5-40kg/m2)
* Habitually sedentary

Exclusion Criteria:

* History of smoking/tobacco use
* Insomnia
* Moderate to severe obstructive sleep apnea.
* Prior shift work within 6 months prior to the study.
* Prescription medications
* Drugs of abuse
* Acute, chronic, or debilitating medical condition (including diabetes, hypertension, and metabolic syndrome)
Anti-thymocyte Globulin-induced Immune Senescence

The aim of the study is to investigate the impact of Anti-Thymocyte Globulin (ATG) on immune senescence. Markers of immune senescence expression is assessed in a prospective cohort of renal transplant recipients the day of transplantation and one year after renal transplantation.

The anti-thymocyte globulin (ATG) are used in the prevention and treatment of acute rejection in organ transplantation. They are at the origin of a brutal CD4 lymphocyte depletion followed by a gradual recovery of the lymphocyte pool. Nevertheless, CD4 lymphopenia can persist in some patients.

SIGAL study aims to characterize the immune responses of lymphopenic patients (after administration of ATG) in order to identify possible similarities with immunosenescence.The immunosenescence is a complex and profound remodeling of the immune system during life. It is mainly due to thymic involution and repeated antigenic stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Patient able to understand the reason of the study
* Signature of informed consent
* Patient who are waiting renal transplant

Exclusion Criteria:

* Inability to understand the reasons for the study; psychiatric disorders
* Any history in the last 2 years of immunosuppressive therapy (except steroids)
* History of cancer (except skin cancer) or treated hematological malignancy
A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow

It is known that several common eye diseases are associated with ocular perfusion abnormalities. Moxaverine is used in the therapy of perfusion abnormalities in the brain, the heart and the extremities because of its direct vasodilatory effects. The present study seeked to investigate whether moxaverine alters ocular blood flow in healthy volunteers after intravenous administration.


Eligibility Criteria:
Inclusion Criteria:

* 6 healthy volunteers of either sex
* Age 18-35 yrs.
* Body mass index between 15th and 85th percentile, nonsmokers

Exclusion Criteria:

* Regular use of medication
* Abuse of alcoholic beverages or drugs
* Participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
* Ametropy less 3 dpt
* Acute gastric bleeding, massive cerebral hemorrhage related to stroke
* Women: pregnancy or lactation.
Chemotherapy and Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by autologous bone marrow transplantation in treating patients with chronic myelogenous leukemia.

OBJECTIVES: I. Evaluate the ability of c-myb antisense oligodeoxynucleotide to purge bone marrow cells of clonogenic chronic myelogenous leukemia tumor cells and repopulate the bone marrow with normal stem cells in patients treated with high-dose busulfan and cyclophosphamide followed by autologous bone marrow transplantation using marrow treated with c-myb antisense oligodeoxynucleotide. II. Determine the response rate, degree of hematopoietic reconstitution, overall survival, and relapse-free survival of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients.

OUTLINE: Patients undergo bone marrow harvest. The bone marrow is treated with c-myb antisense oligodeoxynucleotide and cryopreserved. A portion of the marrow is cryopreserved untreated in case of engraftment failure. Patients receive oral busulfan every 6 hours on days -7 to -4 for a total of 16 doses. Patients receive cyclophosphamide IV over 1 hour on days -3 and -2. Bone marrow is reinfused on day 0. Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 0 and continuing until blood counts recover. Patients are followed every 2-3 months for 2 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 18-24 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically and cytologically proven chronic myelogenous leukemia Accelerated phase OR Chronic phase No hypocellular marrow (less than 25% cellularity) No patients under age 55 with a HLA-matched sibling donor

PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: 0-1 Hematopoietic: Granulocyte count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 3 times normal Renal: Creatinine less than 2.0 mg/dL Creatinine clearance greater than 60 mL/min Cardiovascular: Left ventricular ejection fraction normal No significant cardiac disease requiring digoxin, diuretics, antiarrhythmics, or antianginal medications Pulmonary: PFTs normal DLCO normal Other: No persistent infection requiring antibiotics No concurrent organ damage or medical problem that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior interferon therapy Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified