cyrilzakka/clinical-trials huggingface dataset:
Study Intended to Evaluate the Safety and Effectiveness of a Johnson & Johnson Vision Care Inc, (JJVCI) Contact Lens for Use on an Extended-wear Basis for up to 7 Days (6 Nights).

Study in the US intended to evaluate the safety and effectiveness of a Johnson \& Johnson Vision Care Inc, (JJVCI) contact lens for use on an extended-wear basis for up to 7 days (6 nights).


Eligibility Criteria:
Inclusion Criteria:

* The subject must be at least 18 years of age.
* The subject must read and sign the statement of informed consent and be provided with a copy of the form.
* Minimum of 7 days of successful lens wear
* Contact lens prescription requiring between -1.00 to -6.00 D spherical power
* Less than 1.00 D of astigmatism in either eye

Exclusion Criteria:

-
Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer

The aim of this randomized study is to investigate local tumor control,survival outcomes and complications on patients of liver metastasis in small cell lung cancer.

Small cell lung cancer (SCLC) is a kind of disease with high degree of malignancy and poor prognosis.Based on the effectiveness of systemic chemotherapy, the treatment of primary lesions and whole brain radiotherapy can bring survival benefits to patients with extensive stage small cell lung cancer.Patients with liver metastasis have a worse prognosis than those with other organ metastases.Local radiotherapy for patients with liver metastasis may have a better prognosis.However, clinical data of the safety and efficacy of whole liver radiotherapy for liver metastasis are still lacking.The purpose of this prospective study is to evaluate the safety, efficacy, and tolerability of liver metastatic radiotherapy in small cell lung cancer (SCLC).

Eligibility Criteria:
Inclusion Criteria

1. Informed consent (radiation, medication) before treatment;
2. Age 18 to 70 years old,regardless of gender;
3. Initial SCLC confirmed by histopathological or cytological examination;
4. Metastatic lesions in the distant area: included liver metastasis；
5. Physical status score ECOG: 0 to 2；
6. The expected survival time is more than 3 months;
7. Bone marrow function:hemoglobin(HGB)\>90g/L,platelet(PLT)\>100×109/L,neutrophil cell(WBC)\>1.5×109/L(\*normal value);
8. Liver function:alanine aminotransferase(ALT) and aspertate aminotransferase(AST)\<1.5 times of the upper limit of normal(ULN);Total bilirubin \<1.5ULN;
9. Renal function:Serum creatinine was lower than 1.5ULN,and the endogenous creatinine clearance rate(Ccr) is higher than 55mL/min;
10. Initial treatment (previously did not receive any thoracic radiotherapy or surgery).

Exclusion Criteria:

1. patients with history of mental illness;
2. patients combined with other malignancies;
3. Active period of disease caused by bacteria, fungi or viruses; and these severe infection requiring intravenous antibiotics,antifungal or antiviral therapy;
4. Patients with serious cardiovascular disease ,including uncontrolled hypertension, unstable angina,history of myocardial infarction within the past 12 months,and severe arrhythmias.
5. Patients with poorly controlled diabetes who are judged to be unfit for chemotherapy by doctors.
6. History of hepatitis and cirrhosisi ;
7. pregnant, lactating patients;
8. Patients with poor compliance；
9. Researchers believe that it is not appropriate to participate in this test.
Aerosolized Beta-Agonist Isomers in Asthma

Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two new medications that have been approved by the United States Food and Drug Administration (FDA): levalbuterol and formoterol. Both of these drugs are similar to standard asthma bronchodilator drugs but offer theoretical advantages in terms of fewer side effects. There are also newer devices to deliver these medications into the lungs: breath actuated nebulizers (BANs) and non-static chambers (Aerochamber-max) that can be used with metered dose inhalers (MDIs or "puffers"). The purpose of this study is to deliver these new medications using several different devices and measuring lung function, heart rate, and sensations of breathlessness.

Patients will be studied on five separate mornings. The duration of the study and frequency of the visits will be solely dependant on the subject availability. Each subject will receive all 5 treatments in the same order.

Eligibility Criteria:
Inclusion Criteria:

* stable mild to moderate persistent asthma as defined by the National Asthma Education and Prevention Program
* greater than 18 years of age
* requiring bronchodilator therapy either routinely or on a as needed (PRN)basis
* stable with respect to respiratory disease and at least four weeks removed from the most recent acute exacerbation of the disease
* patients may or may not be on inhaled corticosteroids

Exclusion Criteria:

* no unstable cardiovascular symptoms
* no unstable angina
* must be at least four weeks removed from an acute coronary syndrome
Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT

Our main hypothesis is that self-propelled Percutaneous Endoscopic Gastrojejunostomy tube (PEG-J) that has a balloon on it's tip is associated with lower J-tube retrograde migration rate, and lower rates of short- and long-term complications when compared to standard PEGJ feeding tubes.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult patients (18-80 years of age) with need for post-pyloric feeding (patients unable to eat due to stroke, intubated patients with respiratory failure, patients with acute pancreatitis, etc).
* Ability to give informed consent.

Exclusion Criteria:

* Unable to give informed consent
* Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
* Acute gastrointestinal bleeding
* Coagulopathy defined by prothrombin time \< 50% of control; PTT \> 50 sec, or INR \> 1.5), on chronic anticoagulation, or platelet count \<50,000
* Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
* Cirrhosis with portal hypertension, varices, and/or ascites
* Allergy to egg
Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide (Double Doses)

This study was conducted to compare the rate and extent of absorption of valsartan and hydrochlorothiazide. To maximize the possibility of finding drug-drug interactions, the dose of valsartan and hydrochlorothiazide was doubled (320 mg of VAL and 25 mg of HCT).


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old and not more than 45 healthy male volunteers
* Actual weight no more than ± 30% from ideal body weight based on sex, height, and body frame
* Who had passed all the screening parameters
* Free of any drug exposure known to interfere with the pharmacokinetics or assay of fexofenadine for at least 10 days prior to the study
* Who had to be able to communicate effectively with study personnel, be literate, and able to give consent.

Exclusion Criteria:

* A clinically significant abnormal physical exam, medical history, or laboratory studies
* If they showed a sitting SBP of \>140 or \<100 mmHg, DBP \> 90 or \<60mm Hg, or a pulse rate of \> 95 or \< 50 beats/min at screening
* A history of serious intolerance, allergy, or sensitivity to fexofenadine
* The use of any prescription drug within the previous month or use of any over-the-counter medication (with the exception of acetaminophen) within the past 14 days
* A history of blood dyscrasias
* A history of alcohol or drug abuse within the past year
* Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study
* Unable to tolerate vein puncture and multiple blood samplings
* Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion
* Cannot follow instructions, in the opinion of the investigator.
Fostering Inmates' Well-being and Mental Health

The objective of the project was to provide an assessment of the impact of Transcendental Meditation on prison inmates' well-being. To achieve this goal the investigators conducted a before-and-after study in Her Majesty's Prison Warren Hill (HMP) (England). Meditation is correlated with better self-regulation and is innovative because it fosters generalisable psychological processes that support cognitive, emotional and behavioural regulation, with self-regulation being an important factor behind a variety of outcomes.

Unfortunately, the trial couldn't be completed as the investigators didn't manage to recruit a sufficient number of participants.

The meditation intervention consists of teaching four one-hour lessons of the Transcendental meditation technique developed and offered by the David Lynch Foundation. The technique involves the use of a sound (mantra) to effortlessly allow the mind to settle down to a state of inner calm. Meditation enables those who have learned it and regularly practice it to be more self-aware and respond in a calmer and more considered manner to whatever happens in their present experience.

Eligibility Criteria:
Inclusion Criteria:

* any inmate with no history of drug or alcohol abuse
* recreational drug users who have refrained from using drugs for two weeks before learning the meditation technique
* alcohol or drug addicts who are recovering from alcohol or drug use and have refrained from drug use for at least three months before taking part to the programme

Exclusion Criteria:

* informed consent not signed.
* expected stay in HMP Warren Hill shorter than six months since the beginning of the project.
* drug users and alcoholics not in rehabilitation
* people with serious mental health problems
* people who do not speak English as a first language.
Determine the Haemostatic Efficacy of TT-173, Reducing the Bleeding Time in the Donor Site of Skin Grafting

The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the bleeding time in the donor site of skin grafting.

As the TT-113 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety and efficacy of TT-113 in the donor site of sking grafting

Eligibility Criteria:
Inclusion Criteria:

* Subjects who signed the informed consent.
* Subjects that have to undergo a skin graft.
* Subjects of both sexes older than 18 years.
* Subjects that present a burn or traumatic skin injury affecting less than 30% of corporal surface.
* Subjects with a platelet count not compatible with pathology.
* Subjects who present haemogram results not indicative of any of the situations mentioned in the exclusion criteria.
* Subjects who present biochemical results not indicative of any of the situations mentioned in the exclusion criteria.
* Subjects who present coagulation parameters not indicative of any of the situations mentioned in the exclusion criteria.
* Women of childbearing age who take contraceptive measures and are willing to maintain them until the end of follow up of this study.
* Women of childbearing age who present a negative test pregnancy at the moment of study inclusion

Exclusion Criteria:

* -Subjects with personal or family history of abnormal hemorrhagic episodes.
* Subjects affected of any kind of congenital or acquired coagulopathies.
* Subjects that present a burn or traumatic skin injury affecting more than 31% of corporal surface.
* Subjects affected of any blood, heart or liver disease, chronic renal failure, severe chronic obstructive pulmonary disease, active oncologic process in the past three months, diabetes type I or who has suffered a stroke.
* Subjects who experienced excessive bleeding after surgical procedures, childbirth or tooth extraction.
* Subjects affected by any acute infectious disease.
* Subjects affected of any systemic disease that may worsen the prognosis if any adverse effect occurs (decompensated type 2 diabetes mellitus, uncontrolled hypertension or severe systemic disease).
* Subjects who should take antiplatelet therapies one week before and 48 hours after the surgery (AAS, trifusal, dipiridamol, clopidogrel, abciximab).
* Subjects with known hypersensitivity or allergy to any component of the drug.
* Subjects who consume abuse drugs excluding cannabis and its derivatives.
* Subjects who are unable to follow or understand properly the instructions and requirements of the study.
* Subjects who are not free to give informed consent or who are mentally incapacitated to the discretion of investigators.
* Subjects who participate or have participated in the past three months in another clinical trial with drug treatment.
* Subjects that are the investigators, collaborators, nurses, center employees or any other person directly related to the development of the protocol.
* Subjects who are positive to HIV or HCV serology, or who present active HBV infection.
* Subjects who are pregnant or lactating.
Postoperative Gastrointestinal Dysfunction After Cardiac Surgery - Occurrence and Search for Biomarkers

The purpose of this study is to investigate the frequency and grade of gastrointestinal dysfunction in patients after thoracic cardiovascular surgery, and to search for biomarkers of gastrointestinal dysfunction. All adult patients undergoing elective cardiac surgery requiring cardiopulmonary bypass at Örebro University Hospital, Örebro, Sweden, are asked for participation in this study. All participating patients sign informed consent at the inclusion. The first three postoperative days the function of the gastrointestinal tract is scored according to a rating scale (grade 0-4), along with other clinical parameters. Plasma blood samples are collected from each patient preoperatively and the first three postoperative days. The plasma samples are stored in a biobank for later determination of plasma proteins. In the analysis, the patients are divided according to the gastrointestinal rating scale and the plasma protein expression, gastrointestinal complications and all-cause mortality are compared between the groups.


Eligibility Criteria:
Inclusion Criteria:

* Accepted for an elective thoracic cardiovascular surgical procedure requiring cardiopulmonary bypass
* \>18 years old

Exclusion Criteria:

* Present and severe symptoms from the gastrointestinal tract
* Previous major/extensive abdominal surgery
* Presence of astomy
A Trial of E-cigarettes in Current Cigarette Smokers

The purpose of this study is to examine cigarette smokers' use of electronic cigarettes (e-cigarettes), and how use of e-cigarettes affects short term smoking behavior.

Study initiation will commence after the first telephone contact (phone pre-screen), at the baseline visit. Additional lab visits will occur at days 8, 15, and 22 (visits 2-4). At the first study visit, 2/3rds of the participants will be randomly assigned to sample e-cigarettes and 1/3rd will not. Participants in the e-cigarette group will be provided with sufficient product to sample and use as they wish, but with minimal instruction on purpose and level of use (non-use is an outcome). Smokers in the control group will smoke their own brand of cigarettes, as they wish, for the duration of the sampling period. All participants will engage in ecological momentary assessments, which will be completed 3 times daily for 3 weeks. In-person follow-up assessments will be conducted at 1, 2, and 3 months after the final lab visit (Day 22).

Overall, each participant will be contacted 8 times: at the phone pre-screening, the 4 lab visits, and 3 follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* age 18+
* current smoker of at least 5 cigarettes per day for at least 1 year
* at least some concern for health effects of smoking
* having an easily accessible email address

Exclusion Criteria:

* past six month use of any e-cigarette
* lifetime ever purchase of any e-cigarette
* recent history of cardiovascular distress (heart attack in past year; arrhythmia; uncontrolled hypertension)
* recent history (past 3 months) of Chronic Obstructive Pulmonary Disease (COPD), cancer (any non-dermatologic), or uncontrolled diabetes mellitus
* pregnant or breastfeeding
* any major current psychiatric impairment, including current alcohol/drug abuse/dependence
* use of non-cigarette tobacco products (e.g., cigarillos) in the last 30 days
* current use of any smoking cessation medications
* current enrollment in a smoking cessation treatment study
An Efficacy and Safety Study for Epoetin Alfa (PROCRIT) in Cancer Patients Not Receiving Chemotherapy or Radiation

The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa (PROCRITÂ®) administered 80,000 Units every three weeks in cancer patients that are not receiving chemotherapy or radiation therapy.

The current approved dosage for epoetin alfa is 40,000 Units once per week with an escalation to 60,000 Units once per week if the response is inadequate after four weeks of treatment at 40,000 Units. This dosing scheme, while proven to be efficacious, is often inconvenient for both patients and medical personnel. This is an open-label, non-randomized, multi-center pilot study with the objective to investigate the efficacy of epoetin alfa (PROCRIT®) with regard to hematopoietic response when administered at 80,000 Units subcutaneously every three weeks in anemic patients with cancer not receiving chemotherapy or radiation therapy. Patients will receive two epoetin alfa injections (40,000 Units per injection) under the skin once every three weeks for a maximum of 13 weeks, totalling a maximum of four treatments. Doses may be reduced depending on the patients' hemoglobin level.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of non-myeloid malignancy
* Baseline hemoglobin value of \<= 11 g/dL unrelated to transfusion
* Patients must not be receiving or planning to receive chemotherapy or radiotherapy within the 13-week study period. However, patients receiving hormonal therapy or non-myelosuppressive therapies are allowable
* Female patients with reproductive potential must have a negative serum pregnancy test at screening
* Patients must have signed an informed consent

Exclusion Criteria:

* Uncontrolled hypertension
* History (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
* Transfusion within 28 days prior to first dose
* Planned chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry
* No prior treatment with Epoetin alfa or any other erythropoietic agent within the previous two months
Trial of Collaborative Depression Care Management for HIV Patients

This project will integrate a depression treatment and brief medication adherence counseling intervention into clinical care at three HIV clinics and will use a randomized controlled trial to assess whether, relative to usual care, the intervention leads to improved HIV medication adherence. The depression treatment intervention uses a model known as Measurement-Based Care which equips Depression Care Managers with systematic measurement tools, a decision algorithm, and psychiatric backup and trains them to provide decision support to HIV clinicians to implement, monitor, and adjust antidepressant therapy.

Our goal in this project is to conduct a randomized controlled trial of an evidence-based depression treatment intervention known as Measurement-Based Care (MBC), combined with brief Motivational Interviewing (MI) adherence counseling, in depressed people living with HIV/AIDS to assess its impact on ART adherence and clinical outcomes. MBC employs Depression Care Managers with expertise in depression management to screen for depression and help non-psychiatric physicians implement guideline-concordant, algorithm-driven antidepressant treatment. The Depression Care Manager use standardized metrics (depressive symptoms, side effects) and an algorithm to monitor treatment response and recommend changes. Weekly supervision from a psychiatrist ensures quality care. Biweekly contact between patients and the Depression Care Manager will include brief MI adherence counseling.

We will recruit 390 people living with HIV/AIDS on antiretroviral therapy (ART) with confirmed depression, and will conduct a randomized trial of the MBC intervention versus enhanced usual care. Our aims are: (1) to test whether MBC improves ART adherence and HIV clinical outcomes, (2) to assess the cost-effectiveness of MBC, and (3) to collect process measures concerning MBC implementation to inform replication at other sites. Since the Depression Care Manager role can be effectively filled by a behavioral health provider or nurse given appropriate training and supervision and the intervention has limited time requirements, this model is potentially replicable to a wide range of resource-constrained HIV treatment settings.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* HIV-positive
* Patient Health Questionnaire-9 (PHQ-9) total score \>= 10
* Confirmed current major depressive episode
* English-speaking

Exclusion Criteria:

* History of bipolar disorder
* History of psychotic disorder
* Failure of adequate trials of two different antidepressants at effective doses in the current depressive episode
* Current substance dependence requiring inpatient hospitalization
* Not mentally competent
* Acute suicidality or other psychiatric presentation requiring immediate hospitalization
Characteristics of Patient Population With Endometriosis

The purpose of this study is to collect and analyze data on the characteristics of women who are seeking treatment for endometriosis, suspected endometriosis, pain and/or infertility as part of their standard medical care. Data collected will contribute to the development of guidelines for the surgical management of endometriosis. In addition, specimens will be collected for future testing regarding diagnosing, and/or staging of endometriosis, or suspected endometriosis, pain and infertility.

Patients seen at Saint Louis University Center for Endometriosis (which has offices locations at St. Mary's, St. Luke's and the SLU-UMG clinic - all of which are in the SLU Epic system), and operated on for endometriosis, suspected endometriosis, pain and/or infertility at St. Mary's hospital (only).

A preoperative questionnaire will be provided to the subject. Questions from the survey include information on baseline demographics, severity and type of pain, and previous medical and surgical history. Operative data will also be collected and analyzed.

A post-operative questionnaire will be administered to the participants at 6 months, and then at regular yearly intervals after the surgery by a secure on-line process using the RedCap software. Improvement in quality of life and pain scores will be analyzed.

Specimens will also be collected and stored for future testing regarding diagnosing, and/or staging of endometriosis, suspected endometriosis, pain and infertility.

Eligibility Criteria:
Inclusion Criteria:

* Female patients
* 13-55 years of age
* Anyone seen at the Center for Endometriosis

Exclusion Criteria:

* Prior bilateral salpingo-oophorectomy
* post natural menopause
* Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study.