cyrilzakka/clinical-trials huggingface dataset:
Intervention for Resistant Pregnant Smokers

This 31-month supplement to Sustaining Women's Smoking Cessation Postpartum (Project PANDA) designed, implemented, and evaluated an intensified intervention for pregnant women who were unable to stop smoking with minimal assistance.

DESIGN NARRATIVE:

The substudy was a population-based experiment with White, Black, and Hispanic pregnant women whose continued smoking made them ineligible for randomization into the parent study. It was unique in focusing on heavier, more addicted pregnant smokers. PANDA research sites and protocols offered a special opportunity for a low cost test of a disseminable intervention which this project team was uniquely qualified to design and implement. The new intervention, One- to-One, used telephone counselors to assess the counselee's stage in the change process and give stage-appropriate messages, using established techniques of motivational interviewing. Between the two counselor calls spaced 10 days apart, counselees received personalized written feedback and suggestions. The primary aim, increasing quitting during pregnancy, was assessed by unobtrusive urine samples taken during prenatal visits in the ninth month and identified only by study group.

A series of postpartum interviews with subsample cotinine validation was used to examine the second important aim, reduction of infant smoke exposure. A combination of messages, peer modeling, and support helped women sustain cessation after delivery and eliminate smoking around the baby. Project PANDA videotapes and newsletters already contained these messages and required only minimal supplementation to be used with the One-to-One experimental group, regardless of their success in quitting in pregnancy. As in Project PANDA, the assessments were separated from the experiment by enrolling subjects in a university-sponsored study of new mothers' health practices and baby care and by presenting the program as usual care by the health care site.

Eligibility Criteria:
No eligibility criteria
Scheduled Telephone Intervention for Individuals With Spinal Cord Injury and Their Families

The purpose of this study is to evaluate whether scheduled telephone intervention with individuals with spinal cord injury (SCI) and their caregivers in the first year following discharge from acute inpatient rehabilitation will reduce rehospitalizations and emergency room visits as well as improve adjustment to SCI.

This project is a two-group randomized control trial. The control group will receive usual care given to all patients being discharged from acute inpatient rehabilitation following SCI. At 6 months and one year post injury an examiner blinded to group status will contact Control Group participants to collect outcome data.

The Telephone Intervention group (Treatment Group) will also receive their usual care following discharge and a welcome letter, which will include the same information as the Control Group, but also remind them of the up-coming telephone call schedule. Treatment Group participants and their significant others will be contacted by telephone within 24 to 48 hours after discharge and 10 additional times at weeks 1, 2, 4, 6, and months 2, 3, 4, 6, 8, and 10. The frequent early telephone contacts are meant to address early concerns that frequently arise after discharge are expected to last between 30 and 45 minutes. Later phone calls may be brief if no concerns are raised and are expected to address resource needs as well as ongoing questions that arise through the first year after injury. Content of each phone call will be dependent on issues raised by each individual participant and their significant other and/or follow-up on concerns raised in prior phone contacts rather than a specific structured interview. Treatment Group participants will also be contacted at 6 months and one year post injury by the examiner blinded to group status to collect outcome data.

Eligibility Criteria:
Inclusion Criteria:

* new traumatic SCI
* inpatient acute rehabilitation at the SCI system hospital
* residence in the catchment area at the time of injury

Exclusion Criteria:

* lack of a telephone
* non-English speaking
* severe psychiatric condition such as psychosis
Evaluation of Inhalation Technique in Patients With COPD, Asthma or ACOS Using a Dry Powder Device (DPI)

This study analyzes the prevalence of patients using inhalation devices via incorrect technique and access the adherence of patients to correct inhalation technique when taught along with their subjective improvement of symptoms.

This is a one group pretest- posttest design conducted in all patients presenting in Chest clinic of Dhulikhel Hospital-Kathmandu University Hospital, Nepal from March 2017 to May 2017. Patients diagnosed of having COPD, Asthma or Asthma-COPD Overlap Syndrome (ACOS) and were under inhalation bronchodilators in the form of Dry Powder Device via Rotahaler were included. Enrolled patients are assessed for inhalation technique compliance at their routine medical (pre-training) visits by physician. The use of inhaler device is evaluated in a practical manner by asking the patients to demonstrate their inhalation technique. After the assessment, instructions and training are given until they can use the device correctly. One month later (post-training), all patients are re-evaluated in regards to inhalation technique and subjective improvement of symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years,
* Diagnosed of having of asthma or COPD or ACOS
* Using dry powder inhaler therapy with Rotahaler

Exclusion Criteria:

* Use of inhaler devices other than Rotahaler
* Newly started on dry powdered inhalational therapy or patients who had recently received face-to-face training program on inhalation technique within the past one month
* Patients in acute exacerbation
* Patients failing to give consent
Quality of Life Assessment in Patients Who Are Under Surveillance for IPMN

Over 500 patients were participating in the IPMN follow up between september 2014 and august 2016 at the Helsinki University Hospital. In this study we are going to determine the effects of the IPMN surveillance on the quality of life and anxiety levels of the patients.

Intraductal papillary mucinous neoplasm (IPMN) is a cystic neoplasm of the pancreas. The incidence of the tumors has increased during the last years. Some of the IPMN-tumors develop over time increasing dysplasia and at the end IPMN associated carcinoma. All IPMN-patients are kept under surveillance because of the cancer risk. This follow up can last decades and includes MRI and blood samples every 6 to 12 months. This is very expensive and the effects on the patients quality of life have not been studied before to our knowledge.

This study determines the effects of the surveillance on the patients quality of life and anxiety levels. The study will be conducted by 15D- quality of life -questionnaire and state-trait anxiety inventory (STAI) -questionaire. Both will be send to the patients before a IPMN follow up MRI and 3 months later. It is anticipated that the anxiety and the effect on the quality of life would be the highest right before the MRI and would normalize a few months after the MRI.

Eligibility Criteria:
Inclusion Criteria:

* all patients under IPMN surveillance

Exclusion Criteria:

* no exclusion criteria, all patients under IPMN surveillance are included
Antenatal Allopurinol During Fetal Hypoxia

A former study (submitted) in 32 severely asphyxiated infants participating in a randomized double blind study, in which early postnatal allopurinol or a placebo (within 4 hours after birth) was administered to reduce free radical formation and consequently reperfusion/reoxygenation injury to the newborn brain, showed an unaltered high mortality and no clinically relevant improvement in morbidity in infants treated with allopurinol. It was hypothesized that postnatal allopurinol treatment started too late to reduce reperfusion-induced free radical surge and that initiating allopurinol treatment of the fetus with (imminent) hypoxia already via the mother during labor will be more effective to reduce free radical-induced post-asphyxial brain damage.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age of 36 weeks or more
* Non-reassuring CTG, significant events on the STAN-monitor AND/OR FBS \< 7.20

Exclusion Criteria:

* Chromosomal abnormalities
SHORTness of Breath In the Emergency Department (SHORTIE)

SHORTIE is a two-phase study to determine the impact of the Triage Profiler S.O.B. (Shortness Of Breath) Panel on patient management, outcome, and cost.

Patients presenting to the ED with a primary complaint of shortness of breath will a have blood sample collected at enrollment and tested using the Triage® Profiler S.O.B. Panel (measuring creatine kinase MB \[CK-MB\], myoglobin, troponin I, B-type natriuretic peptide \[BNP\], D-dimer). The test is used as an aid in the diagnosis of myocardial infarction (MI), an aid in the diagnosis and assessment of severity of heart failure (HF), and an aid in the assessment and evaluation of disseminated intravascular coagulation including pulmonary embolism (PE). Phase I is an observational study and results of the Triage Profiler S.O.B. panel will be blinded to all attending physicians and health care workers. In Phase II, patients will be assigned to either the experimental arm or the control arm of the study. In the experimental arm, the Triage Profiler S.O.B. Panel results will be available to the treating physician and can be incorporated into the decision making process. In the control arm, treating physicians and staff will be blinded to the Triage Profiler S.O.B. Panel results. Time to appropriate treatment, length of ED stay, patient outcome and hospital costs will be assessed in all patients and used to determine the impact of Triage Profiler S.O.B Panel on these parameters. Furthermore, the diagnostic accuracy of the Triage Profiler S.O.B Panel will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older.
* Visit to the ED is due to a primary complaint of shortness of breath alone or shortness of breath with associated chest pain, cough or edema.

Exclusion Criteria:

* Blood sample cannot be collected before treatment is initiated, specifically CPR or treatment with i.v. diuretics, injectable anticoagulants, thrombolytics
* Patient is unwilling or unable to give consent to participate in the study
* Patient has renal disease requiring dialysis
* Patients with a clear exacerbation of isolated asthma
* Patients with trauma that interferes with normal breathing function
National Database of the Virtual Institute of Cerebrovascular Diseases

The primary aim of the study is to develop a national registry of cerebrovascular diseases in order to define the subtypes of these diseases associated with a worse prognosis. Secondly, the study aims to find clinical, radiological, and biological markers capable tof predicting the outcome of cerebrovascular diseases and the onset of complications related to therapeutic procedures, and to calculate predictive prognostic scores composed of multiple variables.

Each participating center will collect clinical, radiological, and biological data from the medical records of the study participants. Patients included in the study will not undergo any additional medical procedures to those of normal clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cerebrovascular pathology defined according to the NINDS special report of 1990 as "all disorders in which there is an area of the brain transiently or permanently affected by ischemia or bleeding and/or in which one or more blood vessels of the brain are mainly altered by a pathological process", falling within the following codes of the International Classification of Diseases, 9th revision (ICD-9): ICD-9 430-438;
* Informed consent provided by the patient or his legal representative in the case of mental incapacity or by the parents/guardians in the case of minors.

Exclusion Criteria:

* The patient, his legal representative in the case of mental incapacity or his parents/guardians in the case of minors clearly state their will to leave the study;
* Onset of cerebrovascular disease before January 1, 2016.
Neuroregenerative Potential of Intravenous G-CSF and Autologous Peripheral Blood Stem Cells

The current study describes a randomized, double-blind, cross-over study of intravenous G-CSF followed by infusion with autologous mobilized peripheral blood mononuclear cells (mPBMCs) in children with cerebral palsy (CP) to determine the safety and feasibility of the procedure, as well as the potential efficacy for improving neurological impairment.

We hypothesized that mobilized peripheral blood mononuclear cells (mPBMCs) would be a better source of cell therapy for children with CP, if these cells had a similar neuroregenerative potential to bone marrow/cord blood mononuclear cells (MNCs). Multipotent precursor cells exist in peripheral blood, and a fraction of elutriated blood cells from normal individuals contains MNCs that have the potential to be MSCs. There are several advantages to using mPBMCs for cell therapy in children with CP: the G-CSF that is used to mPBMCs has neuroregenerative potential; the collection and fractionation of stem cells can be repeated; and, the therapy is suitable for most children with CP.

Eligibility Criteria:
Inclusion Criteria:

* Non severe type of cerebral palsy
* Evidences of abnormal MRI findings such as periventricular leukomalacia
* Collected mobilized peripheral blood mononuclear cell counts \> 1×10\^8/kg or CD34+ cell counts \> 1×10\^6/kg
* Consent form

Exclusion Criteria:

* Previous trials of autologous cord blood infusion or erythropoietin/G-CSF
* Chromosomal abnormalities
A Study of rhBMP-2/CPM in Closed Fractures of the Humerus

The primary objective of this study is to assess whether fracture union is accelerated in subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy (standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard of care alone.


Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature subjects age 18 years or older.
* Subjects with either a closed proximal humeral fracture or a diaphyseal humeral fracture.
* Treatment plan that includes only conservative (nonoperative) therapy within 48 hours following injury.

Exclusion Criteria:

* Shoulder dislocation at the time of injury.
* Planned procedure(s) at that would stimulate fracture union at the time of application of the initial immobilization device.
* Fractures located in the distal third of humerus.
Generating Fast and Slow for Entree Level Medical Knowledge

The generative artificial intelligence tool, ChatGPT, has garnered widespread interest since its launch. This innovative multimedia platform has the potential to enhance medical communication and health education, thereby improving medical accessibility and reducing the burden on healthcare professionals. Some studies have indicated that ChatGPT achieves higher levels of satisfaction in counseling compared to human healthcare professionals. Additionally, research has shown that ChatGPT's performance in answering objective structured clinical examination questions is comparable to that of typical medical students. However, in both scenarios, it still requires editing by professionals before being used. Moreover, a recent meta-analysis evaluating ChatGPT's ability in various types of medical exams revealed inconsistent results. Before its application and actual integration into clinical practice, the investigators need to comprehend the advantages, disadvantages, and relevant limitations of ChatGPT in the field of medical communication. This study aims to simulate virtual consultations between ChatGPT, acting as a health professional, and study participants, serving as patients. It will evaluate the participants' satisfaction with the virtual consultation questions, categorized by different levels of cognition through Bloom's Taxonomy. This study plans to recruit medical professionals, healthcare-related professionals, medical students from National Taiwan University Hospital, and the general public. Two researchers will select 20 questions from the USMLE step 3 practice tests and the second stage of the Taiwan Medical Licensing Examination. These questions will be categorized into different levels of cognition based on knowledge, comprehension, application, analysis, synthesis, or evaluation. ChatGPT 3.5 and 4.0 will answer these 20 questions without specifying the question's level of cognition. Each participant will review the answers to these 20 questions and assign a satisfaction score based on the appropriateness of each answer.


Eligibility Criteria:
Inclusion Criteria:

1. National Taiwan University Hospital

   * Medical professionals
   * Healthcare-related professionals
   * Medical students
2. Taiwan Emergency Medical Technician Association.

   * Volunteers

Exclusion Criteria:

* N/A.
Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors

The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk native prostate cancer.

The study is being done to evaluate the safety and effectiveness of Magnetic Resonance Imaging (MRI)-guided focal laser therapy with the Visualase Thermal Therapy System to treat low-risk prostate cancer tumors. Unlike surgery or radiotherapy which affects a large portion of the prostate or the entire organ, localized or focal therapy is intended to treat a small portion of tissue in which the cancer has been found by biopsy.

Eligibility Criteria:
Inclusion Criteria

* Male, 45 years of age or older.
* Diagnosis of prostate adenocarcinoma.
* Clinical stage T1c or T2a.
* Gleason score of 7 (3+4 or 4+3) or Intermediate risk Gleason 6
* PSA less than or equal to 20 ng/mL
* Three or fewer biopsy locations with prostate cancer which correlate with MRI findings.
* No lesion \> or = 2cm
* One, two, or three tumor suspicious regions identified on multiparametric MRI
* No definite radiographic indication of extra-capsular extension.
* Estimated survival of 5 years or greater, as determined by treating physician.
* Tolerance for anesthesia/sedation.
* Ability to give informed consent.

Exclusion Criteria

* Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
* History of other primary non-skin malignancy within previous three years.
Determination of Forces Used in Palpatory Diagnosis

In this study, we are experimentally investigating the assessment of forces used by skilled clinicians and beginning practitioners in palpatory techniques. The study will assess pressure used during palpatory diagnosis of the paraspinal region.

The study will assess pressure used during palpatory diagnosis of the paraspinal region. The research hypothesis is that both experience and gender will affect the amount of pressure exerted with diagnostic springing. The data will be valuable in characterizing practice parameters of novice and skilled osteopathic clinicians in palpation and will provide data on skill maturation from novice to experienced clinician. It will also allow far more precise teaching of these skills to students, who can use the transducers to determine how much pressure they are using compared to skilled clinicians. For measuring the palpatory forces, a thin film pressure transducer will be used in the hand of the clinician. Data will be collected on a portable computer via an analog to digital interface.

Eligibility Criteria:
Inclusion Criteria:

* osteopathic student first year or senior or experienced osteopathic clinician

Exclusion Criteria:

* none
A Study of MK0859 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia (MK-0859-011)(COMPLETED)

This is a study to assess the safety, efficacy, and tolerability of MK0859 in patients with primary hypercholesterolemia (large amounts of cholesterol in the blood) or mixed hyperlipidemia (high levels of LDL cholesterol, triglycerides, and low levels of HDL cholesterol in blood) This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* Patient is between 18 and 75 years of age
* Patient can be on a stable diet for the study
* Patient has a stable weight for more then 6 weeks before the study and has not participated in a weight loss program

Exclusion Criteria:

* Patient has chronic heart failure or a history of heart disease
* Patient has blood, digestive, or central nervous system disorders
* Patient is pregnant or nursing
* Patient is HIV positive
Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Asian Participants With Chronic HCV Genotype 1 (MK-3034-107)

The purpose of this study is to estimate the difference in the efficacy between a 16-week treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated participants with chronic hepatitis C (CHC) genotype 1 in Asia who achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA).


Eligibility Criteria:
Inclusion Criteria:

* weigh ≥ 40 kg and ≤ 125 kg
* have CHC genotype 1 infection
* has had a liver biopsy or non-invasive liver fibrosis test that shows no evidence of cirrhosis and hepatocellular carcinoma
* must agree that the participant and the participant's partner will each use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations (for a female participant who is of childbearing potential or male participant with female sexual partner who is of childbearing potential)

Exclusion Criteria:

* participates in any other interventional clinical trial within 30 days of the screening visit in this trial or intends to participate in another interventional clinical trial during participation in this trial
* is co-infected with human immunodeficiency virus (HIV) or hepatitis B virus
* has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
* has evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
* has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
* has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
* has been previously treated with an interferon or ribavirin regimen or HCV direct acting anti-viral regimen, or treated for hepatitis C with any investigational medication
* taking/plans to take significant inducers of inhibitors of Cytochrome P450 3A4 (CYP3A4) substrates 2 weeks prior to start of study medications, or herbal supplements, including but not limited to St. John's Wort 2 weeks prior to start of study medications (Day 1)
* has pre-existing psychiatric condition(s)
* has a clinical diagnosis of substance abuse
* has any known medical condition that could interfere with the participation in and completion of the trial including immunologically-mediated disease, chronic pulmonary disease, or current or history of any clinically significant cardiac abnormalities/dysfunction
* is pregnant or nursing (for female participant) or female partner intends to become pregnant (for male participant)