cyrilzakka/clinical-trials huggingface dataset:
Development of a Positive Psychology Intervention to Reduce Suicide Risk

This pilot study will recruit patients admitted to the inpatient psychiatric unit at MGH for suicidal ideation or a suicide attempt. Inclusion criteria will be broad to increase enrollment rates and obtain information for patients with a wide range of diagnoses and illness severity. Enrolled subjects will complete randomly-selected positive psychology exercises daily (on weekdays) until discharge and will rate the exercises in multiple domains. Subjects' participation will be complete at the end of their admission or when all exercises have been completed, whichever comes first.

Overall, our goal is to assess the acceptability and utility of eight possible positive psychology interventions related to gratitude, optimism, kindness, mindfulness, recollection, and forgiveness in suicidal inpatients.

This is a single-arm study, completed with patients who have been admitted to the hospital for suicidal ideation or a suicide attempt. It is aimed at developing a positive psychology treatment aimed at suicidal patients. The study consists of serial completion of different positive psychology exercises, once daily, during admission, to get subjects' input on their feasibility and impact. This will allow us to work collaboratively to identify the specific exercises that best fit this population. Subjects' participation ends when they are discharged from the hospital. The investigators plan to enroll 30 subjects at MGH (and total) in this study.


Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18 and older) admitted to inpatient psychiatric unit at Massachusetts General Hospital
* Suicidal ideation at time of admission OR
* Admission occurring in context of suicide attempt
* Ability to read and write in English

Exclusion Criteria:

* Psychotic symptoms
* Cognitive disorder
Three-min Step Test and Exercise Desaturation Detection in Chronic Respiratory Insufficiency Patients

The study project will aim at the evaluation of the occurrence of exercise desaturation phenomenon during two different modalities of exercise (walking and stepping condition). This study will allow determining the sensibility of the 3-minute step test to detect exercise desaturation, in comparison with the gold standard (6-minute walking test). The 3-minute step test could therefore appear as a complementary tool for the evaluation of oxygen desaturation in chronic respiratory disease.

The 6-minute walking test is currently the gold standard for the evaluation of oxygen desaturation phenomenon during exercise and for the adjustment of O2 flow rate. But, due to spatial constraints, this test remains difficult to apply in ecological conditions and the 3-minute step test could be a complementary method to the walking test for the evaluation of chronic respiratory diseases. For this study, patients will perform, during 2 visits, a maximal graded test and two field tests (6-min walking test and 3-min step test) under identical conditions. During these tests, pulsed oxygen saturation and psycho-physiological adaptations to exercise will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged by 18 and more ;
* Patient with an chronic obstructive respiratory insufficiency, confirmed by clinical and functional criteria ;
* Patient with exercise-induced oxygen desaturation ;
* Patient clinical ly stable, with no exacerbation period within the last 2 months before inclusion ;
* Consent form signed by the patient.

Exclusion Criteria:

* Patient in exacerbation period at the inclusion time ;
* Pregnant and breastfeeding women ;
* Patient with orthopedic disorder that could limit the ability of stair climbing;
* Any other disease that could influence exercise capacity of the patient or that could impair exercise test realization ;
* Patient with law protection (guardianship or protection of vulnerable adults)
An Examination of the Efficacy of a Self-Determination Theory and Motivational Interviewing Exercise Intervention

The current study involves conducting an intervention based on self-determination theory (SDT) and motivational interviewing (MI) to promote physical activity in a racially-diverse sample. It is expected that this intervention will successfully increase physical activity in participants.

The mental and physical benefits of physical activity are well-established. However, there is a racial disparity in exercise, such that minorities are much less likely to engage in physical activity than are white individuals. Research suggests that a lack of motivation may be an important barrier to physical activity for racial minorities. Therefore, interventions which increase participants' motivation may be especially useful in promoting physical activity within these groups. A previous meta-analysis has found that physical activity interventions based on self-determination theory (SDT) and motivational interviewing (MI) are especially effective in increasing white individuals' physical activity (Miller \& Gramzow, under review). However, it remains unclear the extent to which these results apply to minority populations. The current study involves conducting an intervention based on SDT and MI to promote physical activity in a racially-diverse sample. It is expected that this intervention will successfully increase physical activity in participants. Specifically, it is expected that there will be a greater relative increase in physical activity in minority individuals than white individuals within the intervention group because it is expected that their level of activity will be lower at baseline.

Eligibility Criteria:
Inclusion Criteria:

* participants were were willing to attend an exercise class once a week for 12 weeks, were willing to complete questionnaires at baseline and 12 weeks, allowed the intervention staff to monitor their attendance at the YMCA for 6 months post intervention, and allowed the exercise instructor to create an audio recording of all of the intervention sessions.

Exclusion Criteria:

* not have any illnesses that would prevent them from exercising once a week, not be pregnant or planning to get pregnant within the next 3 months
Congestive Heart Failure Trends in the Elderly 1970-94

To investigate trends in the incidence and survival rates of congestive heart failure (CHF) in two successive cohorts of elderly people (1970-74, 1990-94) in a health maintenance organization (HMO).

BACKGROUND:

The study constituted part of a growing body of research designed to understand not only the secular trends in mortality, morbidity, survival, and disability levels for selected major chronic diseases among older persons in the United States, but also the implications of the findings for health care utilization.

DESIGN NARRATIVE:

The design was that of a retrospective study of successive cohorts of a well-defined and well-documented elderly population for the purpose of identifying and explaining trends in congestive heart failure (CHF) incidence, survival, comorbidities and health services utilization during the 25-year period 1970-1994. The study sample consisted of two successive period cohorts of elderly people, identified for each of two five-year periods, 1970-1974 and 1990-94. The study tested the following hypotheses: 1) incidence of CHF had decreased among the younger old (65-74 years of age); 2) incidence of CHF had increased among the older old (75 years of age or above); 3) one-year survival time had increased following onset of incident CHF; and 4) prevalence of hypertension had decreased and prevalence of myocardial infarction and other manifestations of coronary artery disease increased among incident cases of CHF.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Effectiveness of Cryotherapy Study for Prostate Cancer

This is a single-centre prospective, non-randomized trial to investigate the efficacy of cryotherapy in patients with localized prostate cancer.The aim of study is to investigate the safety profile of cryotherapy in the treatment of prostate cancer and to evaluate the oncological control of prostate cancer by means of cryotherapy focal treatment.

Conventional treatment options for localized prostate cancer include prostatectomy, radiotherapy and active surveillance. However, prostatectomy and radiotherapy carry certain degree of morbidity, including the risks of urinary incontinence, erectile dysfunction and injury to the structures in the proximity. Active surveillance carries the risk of disease progression and psychological distress to the patients. Focal therapy employs the concept of only destroying the significant lesion, resulting in disease cure and improved functional outcome. Among the different options of focal therapy, cryotherapy is one of the most commonly employed energy sources. It exerts its effect through freezing of tissue and vascular injury, leading to destruction of cancer tissue. Our study aims at assess the safety and effectiveness of such treatment in prostate cancer management

Eligibility Criteria:
Inclusion Criteria:

* Men aged between 40 - 85 years
* Visible index lesion(s) on MRI
* Found to have localized prostate cancer after MRI-USG fusion targeted biopsy:

  1. Clinical tumour stage \<= T2, or
  2. Gleason score \<= 7, or
  3. PSA \<= 20 ng/ml

Exclusion Criteria:

* Patients unfit for contrast MRI exam
* Patients with active urinary tract infection
* Patients with bladder pathology including bladder stone and bladder cancer
* Patients with urethral stricture
* Patients with neurogenic bladder and/or sphincter abnormalities
* Patients who fail to give informed consent
Penile Fracture: A Comparison of Erectile Function After Immediate Repair Versus Delayed Repair

To prospectively compare erectile function at 12 months, utilizing the abbreviated International Index of Erectile Function-5 (IIEF-5) score, for men treated with an immediate repair versus a delayed repair.

This was a prospective randomized study conducted at 2 tertiary level institutions in Jamaica, the University Hospital of the West Indies (UHWI) and the Kingston Public Hospital (KPH). All cases of penile fracture were recruited from the emergency room (ER) of both hospitals between the period January 2015 to January 2017 and all patients were over 18 years of age.

Information on demographics, length of time since the injury, mechanism of injury and risk factors for erectile dysfunction (Diabetes mellitus, Hypertension, Dyslipidemia, Smoking) was collected. Erectile function was objectively assessed utilizing the abbreviated International Index for Erectile Function-5 (IIEF-5), and scores at initial presentation were taken to represent the premorbid erectile function.

A block randomization sequence was created and cases were allocated 1:1 to either immediate repair (group 1) or delayed repair (group 2). Allocation sequence numbers were kept concealed in sequentially numbered folders and access was only granted to the principal investigator.

For Group 1 (Immediate repair)

Patients were admitted to hospital and underwent emergency repair via a subcoronal circumferential degloving approach.

For Group 2 (Delayed repair)

Patients were not admitted. Instead, they were discharged from hospital and given an elective surgery date 7 - 10 days after the injury. Oral Diclofenac Sodium 50mg was prescribed to be taken as needed and instructions to abstain from any sexual activity.

All patients were then re-examined at 6 weeks for quality assurance. They were then instructed that resumption of sexual activity would be safe.

Routine clinic visits were scheduled at 3 months, 6 months, and 12 months. IIEF-5 scores were obtained from all patients at 12months.

Eligibility Criteria:
Inclusion Criteria:

* Men with penile fracture presenting to the emergency room

Exclusion Criteria:

* Suspicion of concomitant urethral injury (blood at the meatus, gross/microscopic haematuria, urinary retention)
Ultrasound-CT Fusion Image-guided Minimally Invasive Interventional Treatment of Lumbosacral Nerve Roots

The study is aimed at patients with low back and leg pain. The patients in the experimental group were guided by ultrasound-CT fusion imaging to insert the lumbar nerve root puncture needle.

Patients in the control group underwent the insertion of the lumbar nerve root puncture needle under the guidance of ultrasound alone.

A total of 80 patients with low back and leg pain were randomly divided into two groups, 30 people in each group. The patients in the experimental group were guided by ultrasound-CT fusion imaging to insert the lumbar nerve root puncture needle.Patients in the control group underwent the insertion of the lumbar nerve root puncture needle under the guidance of ultrasound alone.Follow-up of VAS pain score after lumbar nerve root block treatment. This study aims to establish a standardized operation method and process for lumbosacral nerve ultrasound-CT fusion guided interventional pain treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who need lumbar nerve root block treatment

Exclusion Criteria:

1. Tumor patients
2. Patients who have had lumbar spine surgery before
Risk Stratification in Acute Care: The Meaning of suPAR Measurement in Triage

Will clinical outcome for patients be improved if triage in Acute wards and Emergency rooms is supplemented with a prognostic biomarker?

In a health care system where the general population is growing, more patients are living with chronic conditions and the hospitals are reducing beds and length of stay, it is crucial to perform safe and fast risk stratification of patients presenting in the Emergency departments. Risk stratification is currently performed with a combination of measurement of the vital signs and assessment of the primary complaint. The aim of the current study is to assess whether the supplement of biomarkers can improve the risk stratification in regard to mortality, readmissions and improve overall patient flow in the Emergency departments. Soluble urokinase plasminogen activating receptor (suPAR) is the soluble form of urokinase-type plasminogen activator receptor (uPAR). uPAR is present on various immunological active cells, as well as endothelia and smooth muscle cells. It is believed that suPAR mirrors the inflammatory response in patients. Previous studies have shown a strong association with mortality and severity of disease in a broad variety of conditions (infection, hepatic-, renal-, cardiac- and lung disease) as well as a possible marker of disease development in the general population. These abilities indicate that suPAR although unspecific would be ideal to identify patients at high- and at low-risk. The aim is to target interventions and limited clinical focus where it is most beneficial. In unselected patients suPAR is one of the strongest prognostic biomarker available to date.

It is not known whether information on prognosis in the Emergency department can be used to prevent death, serious complications or reduce admissions and readmissions.

The purpose of the current study is to examine if introduction of the biomarker suPAR and education of doctors in the meaning of suPAR levels and association to disease, can reduce mortality, admissions and readmission in patients referred to the emergency rooms.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting acutely to the Acute ward/Emergency department and have blood samples done which include both Hemoglobin, C reactive protein and Creatinine within 6 hours of registration within the study period. The study is carried out in 2 Hospitals in the Capital of Denmark.

Exclusion Criteria:

* Patients presenting in Pediatric, Gynecological or Obstetric units. Patients not being examined with blood samples.
Ventricular Arrhythmia After Myocarditis in Sportsman

The study aims to assess the prevalence of ventricular rhythmic disorder after an acute myocarditis in sportsmen.

50 patients with acute myocarditis, confirmed by MRI, will be assessed by ECG Holter and Treadmill stress test during a 1-year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* acute myocarditis, diagnosed on the association of (a) recent viral infection (upper airway, gastro-intestinal) , (b) troponin increase, and (c) chest pain AND myocarditis confirmed by cardiac magnetic resonance 2 out of 3 Lake Louise criteria, either T2 hypersignal, early enhancement or late gadolinium enhancement.
* regular physical activity, recreational or competitive: \>=4 hours weekly
* written informed consent

Exclusion Criteria:

* coronary artery disease
* acute inflammatory cardiomyopathy (sarcoidosis, fulminant myocarditis, Tako Tsubo, eosinophilic myocarditis, Lyme disease)
* history of myocarditis
* contra-indication to cardiac MRI
* patient unable to perform a treadmill stress test
Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients

The primary objective of this study is to confirm the efficacy (superiority) of Symbicort® Turbuhaler® 160/4.5 µg twice daily for 8 weeks in comparison to Pulmicort® Turbuhaler® 200 µg twice daily + Theolong® tablet 200 mg twice daily.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma with a documented history of at least 6 months duration prior to Visit 1
* Prescribed daily use of an IGCS for \>=12 weeks prior to Visit 1. The dose of IGCS must be 400 to 800 µg/day of Pulmicort® Turbuhaler® or corresponding dose of IGCS. The prescribed dose of IGCS should be constant for at least 4 weeks prior to Visit 1
* Prescribed daily use of sustained release theophylline for at least 8 weeks prior to Visit 1, or confirmed steady-state blood theophylline concentrations within the effective range (5-15 µg/mL) during 8 weeks prior to Visit 1. The prescribed dose of theophylline should be constant (400 mg/day) for at least 4 weeks prior to Visit 1

Exclusion Criteria:

* Any significant disease or disorder that may jeopardize the safety of the patient
* Respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to Visit 1
* Treatment with oral, parenteral or rectal GCS within 4 weeks prior to Visit 1

Additional inclusion and exclusion criteria will be evaluated by the Investigator
SENSIMED Triggerfish

The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.

60 subjects will be enrolled in total. Enrolled patients will be randomized into one of 8 device groups of 6 subjects each or into the control group containing 12 subjects. Patients in the device arm will receive one session of 3-to 24-hour continuous IOP monitoring with SENSIMED Triggerfish®. SENSIMED Triggerfish® monitoring will begin at 18h ± 2 hours for all patients. SENSIMED Triggerfish® will be installed randomly on right or left eyes. During SENSIMED Triggerfish® monitoring on one eye, GAT and/or Perkins IOP measurements will be taken in the fellow eye every 3 hours. Outside this time they will receive GAT and/or IOP measurements every 3 hours in both eyes until the end of the 24-hours period. Patients in the control group will receive GAT and/or ICare PRO IOP measurements every 3 hours for 24 hours in both eyes.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent for the investigation
* Confirmed diagnosis of primary open angle glaucoma or normal tension glaucoma of similar degree in both eyes
* Age 18-85
* Stable anti-glaucomatous therapy 4 weeks before and throughout the investigation

Exclusion Criteria:

* Patients not able to understand the character and individual consequences of the investigation
* Patients with contraindications for silicone contact lens wear
* Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring
* Diagnosis of pseudoexfoliation syndrome / pseudoexfoliative glaucoma and of pigment dispersion syndrome / pigmentary glaucoma
* Severe dry eye
* Patients who have had ocular surgery within the last 3 months
* Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation
* Allergy to corneal anaesthesia
* Simultaneous participation in other clinical research
Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge

This clinical study aims to train the algorithm and assess the performance of the Ainos Flora Women's Vaginal Health Tester in identifying vaginal infections.

Ainos Flora Women's Vaginal Health Tester is an in vitro diagnostic device implementing electronic nose technology to detect vaginal infections by examining metabolized gases of vaginal bacteria. The electronic nose system mainly comprises the Micro-Electro-Mechanical Systems (MEMS) gas sensor array and the Artificial Neural Network algorithm. The primary purpose of this study is to train the algorithm and assess the performance of the Ainos Flora in identifying vaginal infections. In addition, the primary outcome measures of this study, including sensitivity and specificity, will be used as a reference for the feasibility and sample size assessment of the next phase of pivotal clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Female, Age ≥20 to ≤50.
* Have had sexual experience.
* Fully understand the subject's informed consent process and be willing to undergo all study-related assessments and procedures.

Exclusion Criteria:

Women who meet any of the following criteria by participant report will be excluded from the study:

* During menstruation.
* Have performed vaginal washing within three days.
* Have been treated for vaginal infections within one week.
Cervarix Long-term Safety Surveillance

This study aims to assess whether the use of Cervarix® is associated with a modified risk of central demyelination, type 1 diabetes (DT1), Cutaneous Lupus, inflammatory arthritis, idiopathic thrombocytopenic purpura (ITP), Lupus erythematosus, myositis and dermatomyositis, Guillain-Barre syndrome and/or Autoimmune thyroiditis and Graves disease by using the PGRx information system.

PGRx is an information system that intends to bridge the resource gap to assess the effect of a drug on the risk of adverse events that are infrequent and/or with a long delay of onset. It uses some characteristics of the ad hoc case-control or case-referent design, transposed on a prospective, on-going, population-based recruitment plan. This particular design is called here systematic case-referent design in contrast to the ad hoc case-control or case-referent methodology. The PGRx information system is based on the routine and targeted recruitment of cases of a series of pathologies, compared to population-based referents for the study of exposure to a wide variety of drugs. Drug exposure ascertainment is obtained from two different sources in the PGRx.

system: A) A structured patient interview (telephone-administered questionnaire) B) The medical data form with the computerized medical prescriptions (interview guide)

Eligibility Criteria:
Inclusion Criteria:

* Male and female
* Age 14 to 79 years-old (included)
* Patient residing in France
* Patient accepting to participate in the study
* Patient can read and respond to a telephone interview

Exclusion Criteria:

* Prior reported history of the disease
* Patient or Patient's parent cannot read the interview guide or answer a telephone interview questionnaire in French
* Refusal to participate
Safety Study of FP-1039 To Treat Cancer

The primary purpose of this study is to evaluate the safety and tolerability of FP-1039, a new biologic treatment for cancer.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with metastatic or locally advanced unresectable solid tumors for which standard curative or supportive measures do not exist or are no longer effective
* Male or female 18 years of age or older

Exclusion Criteria:

* Presence or history of melanoma
* Primary brain tumor
* Presence or history of glaucoma