cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Proactive Telephone Counseling for Pregnant Smokers Enrolled in a Managed Care Organization

The principal objective is to test whether offering pregnant smokers a proactive telephone counseling program throughout pregnancy and for 2 months postpartum increases the rate of smoking cessation at end of pregnancy and 3 months postpartum, compared to a "best practice" control condition.

A randomized controlled trial compared the efficacy of a proactive pregnancy-tailored telephone-delivered smoking cessation counseling program with a "best practice" brief counseling control condition among pregnant women referred by prenatal care providers and a managed care plan in Massachusetts. Intervention group patients received up to 105 min of cognitive-behavioral counseling delivered in a motivational interviewing style by trained counselors throughout pregnancy and for 2 months postpartum. Control group patients received 5 minutes of brief counseling at 1 telephone call. All participants were mailed written self-help smoking cessation material tailored to pregnancy. The primary outcome measure was cotinine-validated tobacco abstinence at the end of pregnancy. Secondary outcomes were cotinine-validated abstinence at 3 months postpartum and self-reported significant (\>50%) reduction in daily cigarette use.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* current cigarette smoker (smoked \>1 cigarette in the past 7 days)
* 18 years old or older
* Willing to consider altering their smoking behavior during their pregnancy

Exclusion Criteria:

* More than 26 weeks' gestation at study entry
* No telephone access
* Not planning to live in New England for 1 year
* Unable to read and speak English
Prospective Assessment of Cost-effectiveness and Side-effects of Depressive Patients Treated With ECT or TCA

Prospective observational cohort study to determine cost-effectiveness of ECT compared to medication in the treatment of major depressive disorder (MDD) in the Netherlands.

Rationale:

Currently, detailed information on the cost-effectiveness of ECT based on real-world data is lacking, as well as the comparative cost-effectiveness with respect to medication. Reliable information on outcomes of ECT in comparison with antidepressant treatment and its cognitive side-effects is needed for patients and clinicians to make a balanced and shared decision regarding choosing or refraining from ECT.

Objective:

Primary Objective: determine (cost)-effectiveness of ECT compared to medication by determining the impact of treatment for MDD with ECT or TCA on remission rates using a one-year time horizon (trial-based economic evaluation)

Secondary Objective: determine side-effects of ECT compared to medication by determining the impact of treatment with ECT or medication on side-effects and quality of life during a one-year follow-up

Study design: Observational, parallel inception cohort study of patients who will undergo standard clinical care according to current guidelines.

Study population: 110 patients (\>18 yrs.) with a depressive episode (unipolar MDD) who will start ECT (ECT group) and 110 patients (\>18 yrs.) with a depressive episode (unipolar MDD) who will undergo treatment with antidepressants will be recruited from specialized clinics (academic hospital, general hospital and GGz-institute) and followed-up for one year to gather reliable data on efficacy including relapse rates, cost-effectiveness, quality of life and cognitive functioning.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (\>18 years) with a major depressive disorder who will either start with ECT or medication
* failed response to at least 1 adequate dose-duration trial with antidepressants
* moderate or severe depression (HDRS-17 \>16)

Exclusion Criteria:

* lifetime diagnosis schizophrenia or schizoaffective disorder, current substance abuse disorder, organic brain syndrome
* the presence of a concurrent significant medical condition impeding the ability to participate
Stationary Bike Use During Ice Bath and Virtual Reality

The purpose of this study is to evaluate the effectiveness of different technologies, in particular Virtual Reality, inclusive of passive content, active content, cognitive load modulation, and positive encouragement coaching to increase the pain threshold as assessed by immersing a hand in ice water while utilizing a stationary bike.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age
* English speaking
* Hearing intact

Exclusion Criteria:

* Patients who do not consent
* Are currently taking beta blockers or other chronotropic heart medication(s)
* Have a history of severe motion sickness
* Currently have nausea
* Currently experiencing seizures
* Are clinically unstable
Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection

To provide ruxolitinib through an expanded access program for the treatment of cytokine storm due to COVID-19 in the United States to patients who are eligible but not able to be hospitalized or who are hospitalized with a clinical diagnosis and/or positive test for SARD-CoV-2 infection.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 12 years of age or older.
* Clinical diagnosis of COVID-19 and/or locally accepted positive test; if feasible, swab should be taken and saved for quantitative testing to determine viral load.
* Disease severity making the patient eligible for hospitalization (whether or not hospitalization is available), with evidence of cytokine storm as determined by the treating physician. Manifestations of cytokine storm can include the following:
* Severe shortness of breath (respiratory rate \> 24 breaths/minute).
* SpO2 of \< 90% on ambient air.
* Need for invasive or noninvasive mechanical ventilation.
* Acute respiratory distress syndrome.
* Multiple organ failure.
* Be willing to avoid pregnancy or fathering children
* Able to provide written informed consent, consent from the patient's legally authorized representative, and/or assent from the patient, parent, or guardian.

Exclusion Criteria:

* Patients, patient's legally authorized representative, or legal guardians unable to review and sign ICF.
* Females who are pregnant or breastfeeding, and males and females who cannot comply with requirements to avoid fathering a child or becoming pregnant.
* Patients with inadequate liver function (ALT above 4 × ULN or direct bilirubin 4 × ULN and the laboratory abnormalities are considered to be due to underlying liver dysfunction).
* Patients with platelet counts \< 50 × 109 /L
* Any underlying or current medical or psychiatric condition that, in the opinion of the treating physician, would place the patient at an unacceptable risk if he or she were to participate in the program.
* Previous allergic reactions to JAK inhibitors or excipients.
* Concomitant use of any other JAK inhibitor.
* Is eligible or able to access ruxolitinib through an Incyte-sponsored clinical study or is eligible for another therapeutic clinical trial for cytokine storm at the treating institution..
Technical Evaluation of Brahms PCT Direct

Validation of the technical performance of the BRAHMS PTC direct point-of-care assay under routine conditions with native patient samples. The clinical validation is planned as a method comparison to a reference method (BRAHMS PCT sensitive KRYPTOR, Elecsys BRAHMS PCT). The study hypothesis is to show a highest correlation between the new product and the reference methods.

Procalcitonin (PCT) is a highly sensitive and specific marker which can be detected in the blood stream in response to a bacterial infection. In contrast to conventional infection disease markers PCT permits the differential diagnosis between bacterial and viral infections. The marker is implemented on Intensive Care Units (ICU) and Emergency Departments (ED) worldwide since 1996. Until now various technologies all basing on the use of serum or plasma samples are available in the market.

BRAHMS GmbH (Clinical Diagnostics Division of Thermo Fisher Scientific) as manufacturer of the Procalcitonin assays has developed a new quantitative immunochromatographic whole blood point-of-care assay, the BRAHMS PCT direct. The test follows the principle of a sandwich assay with two anti-PCT antibodies, one immobilized on a nitrocellulose membrane and the tracer antibodies labeled with gold.

Validation of the technical performance of the product under routine conditions with native patient samples. The clinical validation is planned as a method comparison to a reference method (BRAHMS PCT sensitive KRYPTOR, Elecsys BRAHMS PCT). The internal pre-studies were performed with blood samples spiked with recombinant PCT and with native patient samples.

The primary objective of this study is to show a highest correlation between BRAHMS PCT direct with the PCT reference method for PCT- positive and negative samples.

The secondary object of this study is to show the advantage of BRAHMS PCT direct in time to result in comparison to the reference method.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* possible infection at initial presentation
* informed consent

Exclusion Criteria:

* none
Adjuvant Chemotherapy Combined With Targeted Therapy or Not in the T3-4N2 Colorectal Cancer Patients

The goal of this clinical trial\] is to compare in resectable stage T3-4N2 colorectal cancer. The main question it aims to answer is: whether the use of targeted therapy in combination with adjuvant chemotherapy is associated with improved disease-free survival (DFS) compared to adjuvant chemotherapy alone.


Eligibility Criteria:
Inclusion Criteria:

1. Both sexes, aged 18-75 years;
2. Pathologically confirmed pT3-4N2 stage colorectal adenocarcinoma after surgery;
3. ASA grade \< IV and/or ECOG performance status score ≤ 2 points;
4. Fully understand and voluntarily sign the informed consent form for this study.

Exclusion Criteria:

1. A history of other malignant tumors;
2. Patients with severe liver, kidney, cardio-pulmonary, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy;
3. Patients allergic to any component in the study;
4. Patients with severe uncontrollable recurrent infections or other severe uncontrollable concurrent diseases;
5. Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe abnormalities in laboratory tests;
6. Patients with emergent surgery due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;
7. Patients with a history of severe mental illness;
8. Pregnant or lactating women;
9. Patients with other clinical or laboratory conditions that the investigators consider inappropriate for participation in this trial.
Prevalence of Malnutrition in Oncologic Patients

Malnutrition is a common phenomenon in cancer patients. Deteriorated nutritional status is associated with poor clinical outcome. The purpose of this study is to determine the prevalence of hospital malnutrition and its impact on functionality, quality of life and mortality in cancer patients and to test the reference percentiles of phase angle values (Bosy Westphal et al JPEN 2006) as indicator of cancer cachexia and predictor of mortality.

Hypothesis:

The fifth reference percentile of the phase angle norm values is a prognostically relevant cut off value indicating cancer cachexia in terms of malnutrition, fatigue and impaired functional status, as well as predictive of 6-month mortality


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from cancer.
* Patients who have signed a written Informed Consent.

Exclusion Criteria:

* Patients with implanted pacemaker or defibrillator
* Patients with neuromuscular disease or hemiplegia.
Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)

This study will assess the efficacy of subsequent protease inhibitor (PI)-containing therapy in subjects who have acquired HIV-1 protease mutations whilst receiving a GW433908 (fosamprenavir)-containing regimen.


Eligibility Criteria:
Inclusion criteria:

* Prior participation in study APV30005 AND one of the following studies: APV30001, APV30002, AZL30006, APV30003.
* Must be failing virologically (\>1000 copies at two consecutive time-points) and have a screening genotype with evidence of at least one new APV-associated protease mutation: V32I (+/- I47V), I50V, I54L/M, I84V acquired since commencing treatment with GW433908.

Exclusion criteria:

* Have 2 or more of the primary resistance mutations D30N, G48V, V82A/F/T/S and L90M.
* Have a medical need for use of an non-nucleoside reductase transferase inhibitor (NNRTI).
* Have an acute CDC Class C event requiring therapeutic intervention.
* Are pregnant or lactating.
* Have any other condition which in the opinion of the investigator would preclude their participation.
An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age

The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term safety, tolerability and efficacy profile of aliskiren compared to the active comparator enalapril in children, 6 - 17 years old with hypertension (msSBP ≥ 95th percentile for age, gender and height, at baseline in study CSPP100A2365). Patients will be randomized to receive either aliskiren or enalapril. Weight-group based doses of aliskiren or enalapril will be administered once daily and children will receive study medication in a double-blind manner. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in pediatric patients 6-17 years of age (age at baseline in Study CSPP100A2365).


Eligibility Criteria:
Inclusion Criteria:

* msSBP (mean of 3 systolic blood pressure measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization), in study CSPP100A2365
* Must be ≥ 20 kg and ≤ 150 kg at Visit 2 (randomization), in study CSPP100A2365
* Must be able to swallow minitablets (2mm in diameter) administered in soft food
* Successful completion of Phase 1 (dose response phase) and at least 1 week of Phase 2 (placebo withdrawal phase) of the CSPP100A2365 protocol, with no serious drug-related adverse event(s).

Exclusion Criteria:

* Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
* Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or obstructive valvular disease
* msSBP ≥ 25% above the 95th percentile
* Second or third degree heart block without a pacemaker
* AST/SGOT or ALT/SGPT \>3 times the upper limit of the reference range
* Total bilirubin \> 2 times the upper limit of the reference range
* Creatinine clearance \< 30 mL/min/1.73m² (calculated using Modified Schwartz formula to estimate glomerular filtration rate \[GFR\]), based on the serum creatinine concentration obtained at the screening visit)
* WBC count \< 3000/mm³
* Platelet count \< 100,000/mm³
* Serum potassium \> 5.2 mEq/L
* Other protocol-defined inclusion/exclusion criteria may apply
Ulipristal Acetate Versus GnRH Analogue Treatment Before Hysteroscopic Resection of Uterine Leiomyoma

The uterine leiomyoma is the most common female benign disease. Submucosal fibroid are about 10%, they distort the endometrial cavity causing heavy and/or irregular bleeding (AUB) and infertility. Hysteroscopic removal of submucosal myomas improves this conditions. GnRH analogues are commonly used before hysteroscopic myomectomy to make surgery easier and safer, but they are expensive, have potential side effects and lack a robust evidence base to support this practice. Ulipristal acetate treatment was able and faster to control in 90% of cases uterine bleeding associated with fibroids than GnRH agonists. UPA significantly improved quality of life and pain reduction.

The uterine leiomyoma is the most common benign tumor of the female genital tract. The myomas are usually clinically apparent in 25% of patients. Submucosal fibroid are about 10% of all uterine myoma; they distort the endometrial cavity causing heavy and/or irregular bleeding (AUB) and infertility. According to the degree of myometrial penetration, the European Society for Gynaecological Endoscopy (ESGE) classified submucosal myomas in Type 0 (totally intracavitary fibroids), Type I (\<50% myometral penetration), or Type II (\>50% myometral penetration).

Hysteroscopic removal of submucosal myomas improves menorrhagia and AUB. GnRH analogues are commonly used before hysteroscopic myomectomy to make surgery easier and safer, but they are expensive, have potential side effects and lack a robust evidence base to support this practice. A recent meta-analysis of data demonstrated that symptomatic relief in patients undergoing surgery was similar either following pre-operative GnRH-a administration or without GnRH-a administration, mainly due to the persistence of abnormal bleeding due to the protrusion of the myoma into the uterine cavity.

In recent studies, Ulipristal acetate treatment was able to control uterine bleeding associated with fibroids in more than 90% of cases. Moreover, it controlled bleeding faster than GnRH agonists, with median times to amenorrhea of 5-7 days in patients receiving UPA compared to 21 days in patients receiving a GnRH agonist. It was demonstrated that UPA significantly improved also quality of life. Pain, as measured by the visual analogue scale, showed a degree of relief similar to that achieved for postoperative pain with narcotic and non-narcotic analgesics. This pain reduction is related to the high amenorrhea rate during treatment (severe bleeding being responsible for uterine contractions and prostaglandin secretion). No sub-analysis have been conducted on submucosal fibroids but, according to our experience, this subgroup of myomas may be the one who most benefits from the administration of UPA.

Eligibility Criteria:
Inclusion Criteria: submucosal leiomyoma, symptoms of menomethrorragia, menstrual disorder, infertility, pelvic pain.

Exclusion Criteria: intramural or subserosal leiomyomas, endometrial hyperplasia with atypia, history of uterine surgery
The Effects of Smell on Mood and Physical Responses

The purpose of this study is to examine the body's response to relaxing and stimulating fragrances commonly used in aromatherapy.

Despite aromatherapy's popularity, efficacy data are scant, and potential mechanisms are controversial. This randomized controlled trial examined the psychological, autonomic, endocrine, and immune consequences of one purported relaxant odor (lavender), one stimulant odor (lemon), and a no-odor control (water), before and after a stressor (cold pressor); 56 healthy men and women were exposed to each of the odors during three separate visits. To assess the effects of expectancies, participants randomized to the "blind" condition were given no information about the odors they would smell; "primed" individuals were told what odors they would smell during the session, and what changes to expect. Experimenters were blind.

In each case we measured several different aspects of the cellular immune response, as well as skin barrier repair following tape stripping. This design allowed us to examine the ability of the odors to modulate endocrine and immune function, and health-relevant cutaneous responses.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults with a normal sense of smell

Exclusion Criteria:

* Treatment with medication that has immunological or endocrinological consequences
* Chronic health problems that affect immune or endocrine systems
* Allergy to perfume or cosmetics
* Problems with sense of smell
* Respiratory problems
* Smoker
* Current active asthma
* Use of psychoactive drugs or mood-altering medication
* History of anxiety disorder, major depression, bipolar disorder, schizophrenia, or other psychotic disorders
* History of chest pain or ventricular fibrillation
Efficacy of Latanoprostene Bunod in Lowering Intraocular Pressure in Japanese Healthy Male Volunteers

The objective of this study is to evaluate the effect of latanoprostene bunod dosed once daily (QD) in reducing intraocular pressure (IOP) measured over a 24-hour period in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a corrected decimal visual acuity (VA) of 0.5 or better in both eyes.

Exclusion Criteria:

* Subjects with known hypersensitivity or contraindications to latanoprostene bunod, or any of the ingredients in the study drug.
* Subjects with known contraindications to NO treatment.
* Subjects who are unable to discontinue contact lens use at least 7 days prior to Visit 2 (Day 0/1/2) and during the 14 to 15-day study treatment period.
* Subjects who are unable to discontinue the use of all topical ophthalmic medications, including artificial tears, at least 7 days prior to Visit 2 (Day 0/1/2) and during the 14 to 15-day study treatment period.
* Subjects with any condition that prevents reliable applanation tonometry in either eye.
* Subjects with glaucoma in either eye.
* Subjects with any condition that prevents clear visualization of the fundus.
* Subjects who are monocular.
* Subjects with aphakia in either eye.
* Subjects with an active corneal disease in either eye.
* Subjects with severe dry eye in either eye.
* Subjects with a history/diagnosis of a clinically significant or progressive retinal disease in either eye.
* Subjects with any intraocular infection or inflammation within 3 months (90 days) prior to Visit 1 (Screening).
* Subjects with a history of ocular laser surgery within the 3 months (90 days) prior to Visit 1 (Screening).
* Subjects with a history of incisional ocular surgery or severe trauma.