cyrilzakka/clinical-trials huggingface dataset:
Trabecular Microbypass IStent in Patients with Glaucoma

The goal of this clinical trial is to assess the safety and efficacy of phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent) versus phacoemulsification alone in a Taiwanese population, as well as to investigate any differences in outcomes between patients with primary open angle glaucoma (POAG) and those with normal tension glaucoma (NTG). The main question it aims to answer is:

• How much do intraocular pressure (IOP) and the number of antiglaucoma medications change after iStent insertion, with subgroup analyses for POAG and NTG? Researchers will compare phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent) versus phacoemulsification alone to see if IOP and the number of antiglaucoma medications decrease.

Participants will receive their regular phacoemulsification and decided whether to receive iStent by themselves.


Eligibility Criteria:
Inclusion Criteria:

Patients evaluated by a clinician who require cataract surgery or cataract surgery combined with iStent implantation due to concomitant glaucoma and cataracts.

Exclusion Criteria:

* Eyes that have previously undergone vitrectomy or retinal surgery.
* Patients with ocular surface inflammation (e.g., corneal ulcers, orbital cellulitis, etc.).
* Patients with hypotony (intraocular pressure \<5 mmHg).
* Patients with a history of globe rupture.
Combined Cognitive and Vocational Interventions After Mild-to-moderate TBI: a Randomized Controlled Trial

A considerable number of patients with mild and moderate traumatic brain injury (TBI) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (RTW). Although several studies have described medical, psychological and work-related factors that predict RTW after TBI, well-controlled intervention studies regarding RTW in this group are scarce. Furthermore, there have traditionally been weak collaborations among rehabilitation services in the health sector, the Labor and Welfare Administration (NAV), and the work-places.

The current project proposal describes an innovative randomized controlled trial (RCT) which will explore the effect of combined manualized cognitive rehabilitation efforts and supported employment in real-life competitive work settings for patients who have not returned to work 8 weeks post-injury. The project combines the rehabilitation and vocational science perspectives; it involves multidisciplinary collaboration, and explores the efficacy of increased cross-sectorial collaboration between specialized health care services and the welfare system. If the intervention proves efficient, the project will further describe the cost-effectiveness and utility of the program, and thereby provide important information of use for policy makers. In addition, the study aims at generating knowledge on the RTW-process both for the persons with TBI, and their workplaces, and to disseminate this knowledge in order to create new multidisciplinary and collaborative practices. The project has potential to generate knowledge of relevance for other patients with neurological deficit.

Please, see protocol article: https://www.ncbi.nlm.nih.gov/pubmed/29041954

Eligibility Criteria:
Inclusion Criteria:

* reside in Oslo and Akershus counties in Norway
* mild-to-moderate TBI (Glasgow Coma scale score 10-15 at injury site). Confirmation of diagnosis of mild TBI will be done through documenting that acute symptoms adhere to the American Congress of Rehabilitation Medicine's (ACRM) definition of mild TBI.
* loss of consciousness \<24 hours
* posttraumatic amnesia (PTA) \<7 days
* employed in a minimum 50% position at the time of injury
* sick listed at the 50% or higher level due to post-concussive symptoms 2 months post-injury

Exclusion Criteria:

* history of severe psychiatric or neurological illness
* active substance abuse
* inability to speak and read Norwegian
Clinical and Radiographic Evaluation of Two Matrix Systems for Restoration of Class II Cavities in Primary Molars

this study aims to evaluate and compare the clinical and radiographical efficacy, operator ease, satisfaction and patient comfort in restoring class II cavities in primary molars using Fender Mate system with T-band system.

Restorations of posterior primary teeth can have a number of issues, including incorrect contact points and proximal overhangs. With the recognition of significance of restoring tooth's right contour and contact, and repair of all tooth surfaces, including proximal walls, different matrix systems were introduced,so this study aims to evaluate and compare the clinical and radiographical efficacy, operator ease, satisfaction and patient comfort in restoring class II cavities in primary molars using Fender Mate system with T-band system.

Eligibility Criteria:
Inclusion Criteria:

1. Apparently healthy children free from any systemic diseases.
2. Patients showing Frankel's positive and definitely positive behavior.
3. Parent willing to participate in the study and signed on informed consent.
4. Each child has at least two carious primary molars (class II) bilaterally, indicated for composite restoration with criteria as follow: -

   * No history of spontaneous pain or provoked pain.
   * Fully erupted teeth.
   * Fully erupted adjacent tooth.
   * Caries involving two surfaces - proximal and occlusal
   * Absence of clinical signs or symptoms suggesting a non-vital tooth such as sinus tract, soft tissue swelling, mobility or tenderness to percussion.
   * No pathological external or internal root resorption.

Exclusion Criteria:

1. Patients showing Frankel's negative and definitely negative behavior.
2. Children having primary molars with:

   * Caries involving less than or more than two surfaces
   * Extensively damaged teeth
   * Missing adjacent tooth.
   * Mobility.
   * Spaced dentition.
Benefit of a Single Preoperative Dose of Antibiotics for the Prevention of Surgical Site Infections

In a rural hospital in Tanzania the rate of surgical site infections (SSI) was 21.6%. Inappropriate choice of antibiotics and of administration time were determined as sole risk factors in this setting. After implementation of a standardized procedure with a single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively the rate of SSI dropped by 80% in spite of procedural risk factors like poor hygiene etc.

Surgical Site Infections (SSIs) have an important socioeconomic impact prolonging the period of hospitalization and rehabilitation. Patients with SSIs are five times more likely to be readmitted and are even twice as likely to die compared to patients with similar interventions without SSI. In non-industrialized countries, the incidence of SSIs is higher and the consequences of SSI are even more severe: Many hospitals lack appropriate facilities for early diagnosis and treatment. In addition, microbiological identification of pathogens and susceptibility testing are rarely available, a prerequisite for targeted treatment of SSIs. Overcrowding and understaffing are additional risk factors for SSIs, common in these countries.

A study conducted at the local surgeons' suggestion in an 82-bed department of general surgery, obstetrics and gynecology, urology and orthopedics at the St. Francis Designated District Hospital (SFDDH) in Ifakara (Southern Tanzania) showed an SSI-rate of 21.6%.

The analyses of this study identified two major risk factors for SSI in clean and clean-contaminated surgical procedures: Inadequate timing of administration of routine antimicrobial prophylaxis (AMP) and inappropriate selection of antibiotics not covering the most commonly observed pathogens.

Therefore, an intervention study was discussed with the local surgeon in charge to improve selection and timing of routine AMP and thereby reduce the rate of SSIs.

The study design and objective were presented to all the staff during a general meeting and special duties and responsibilities discussed with the individual colleagues. Furthermore we distributed pocket flow sheets to the involved staff and hung up some laminated flow sheets in theatre.

Eligibility Criteria:
Inclusion Criteria:

* surgical patient
* clean or clean-contaminated surgery

Exclusion Criteria:

* infection
* preoperative antibiotic treatment
* postoperative antibiotic treatment
* open fractures
Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With BTcP

Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. This is a phase IIa dose-response and safety study of inhaled fentanyl aerosol (25µg/dose) in Chinese patients with breakthrough cancer pain.

Consenting patients who met inclusion and exclusion criteria were allowed to enter the study. The medication for background pain during screening were maintained until the end of the study. Each patient would be treated and observed for 6 episodes of targeted BTcP. Patients were randomly assigned to 1 of the 6 prespecified dose sequences which were established by a computer-generated schedule of active drug and placebo in a 4:2 ratio. All patients and personnel involved with the study (including investigators and investigation site personnel) were blinded to the medication codes.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 18 years or above
2. Subjects must be diagnosed with cancer.
3. Subjects must experience persistent pain associated with cancer, and the pain score assessed by NRS should be \<4 within 1week before screening.
4. In the past 7 days, the subject must experience an average of 1 to 4 episodes of breakthrough cancer pain per day,The breakthrough cancer pain score should be ≥4 assessed by NRS
5. ECOG status of 0 to 2.
6. Subjects must consent to take adequate contraception during the study and 1 months after the study. Women of childbearing potential must show negative in the pregnancy test before dosing.
7. The subject must be able to understand the requirements of the study and provide a written informed consent.

Exclusion Criteria:

1. History or suspected allergies to fentanyl.
2. HGB \< 80 g/L, NEUT ≤1.0 × l09/L, PLT ≤50 × l09/L；ALT and AST higher than 3 times of ULN;total bilirubin and Cr higher than 1.5 times of ULN;PaO2 \<95%;FEV1/FVC\<70% and FEV1 accounted for less than 80% of the predicted value.
3. Any uncontrolled disease (e.g., severe mental, neurological, infectious, cardiovascular, respiratory and other systemic diseases).
4. Tumor infiltration to central nervous system.
5. Subjects are not able to slef evaluate pain intensity using NRS
6. Receive surgery in past 3 weeks
7. Treatment with any form of radiotherapy winth 1week prior to study entry that could alter pain or response to pain medication.
8. Taking monoamine oxidase inhibitors(MAOIs), CYP3A4 inhibitors or inducers within 14 days of the screening
9. Participated in other clinical trials in past 1months.
10. Pregnancy and breast-feeding women, women of childbearing age ready to conceive, and pregnancy test positive.
11. Other conditions that may affect the informed consent, compliance with the protocol, study results and safety of the subject.
Orbital Fractures Measurement: Intraoperative Versus Computed Tomography (CT) Scan

Purpose to compare the orbital fracture size measured by orbital CT scan and compare it to the actual orbital fracture size intraoperatively in patients who needed surgical intervention to correct the fracture.

Hypothesis: there is difference between the CT measure fracture size and the actual intraoperative size.


Eligibility Criteria:
Inclusion Criteria:

* With orbital fracture (trauma) proved by CT scan and need operative repair.
* Agree to participate.

Exclusion Criteria:

* Patients that refuse to be included in the study.
* Under the age of 18 years.
* CT not performed or not available.
* Not qualified to sign the consent form.
Feasibility and Acceptability of Primary Palliative Care Intervention in Patients Undergoing Hematopoietic Stem Cell Transplantation

Primary PC - or training HCT clinicians to deliver PC domains as part of routine practice - is an alternative model of supportive care. We have developed Sentinel, a primary PC intervention for HCT clinicians and patients. This study will assess Sentinel's feasibility and acceptability.

Patients hospitalized for hematopoietic cell transplantation (HCT) experience physical and psychological symptoms that lead to a deterioration in quality of life (QOL). Integrating specialty palliative care (PC) reduces physical and psychological symptom burden and improves QOL during HCT hospitalization. However, specialty PC remains unavailable and underused at many HCT centers. Primary PC - or training HCT clinicians to deliver PC domains as part of routine practice - is an alternative model of supportive care. We have developed Sentinel, a primary PC intervention for HCT clinicians and patients. We will train HCT clinicians to deliver PC to patients before and during HCT hospitalization. This study will assess Sentinel's feasibility and acceptability.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Undergoing autologous or allogeneic HCT at MGH

Exclusion Criteria:

* Prior receipt of inpatient specialty palliative care on two prior admissions in the past 6 months.
* Significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the primary oncologist believes prohibits informed consent or ability to participate in study procedures
* Inability to comprehend English as this is a preliminary/pilot study
Post Epidural Steroid Injection Follow-up

To determine the expected pain response timeline for patients receiving epidural steroid injections, our team plans to assess patient pain severity and degree of pain relief every 3 days for 23 days.

Patients who are already planning to receive an epidural steroid injection from their physiatrist will be approached by study members on the day of their injection. If enrolled, the patients will be contacted every 3 days for 23 days to determine the severity of pain and degree of pain relief from the injection.

Eligibility Criteria:
Inclusion Criteria:

* Any patient schedule for an epidural steroid injection (ESI) at Stallworth Rehabilitation Hospital through the department of Physical Medicine \& Rehabilitation.
* The epidural steroid injection will be performed as part of standard clinical care, this study only aims to describe the clinical response to the procedure.

Exclusion Criteria:

* ESI has been performed within the last 6 months
* Steroid injection elsewhere in body within last 8 weeks
* Oral or intramuscular steroids within last 8 weeks
* Unwilling or unable to provide informed consent
* Unable to comply with required follow up
* Please note that it is assumed that a patient scheduled for an epidural steroid injection clinically is assumed to not have any contraindications to the injection itself such as active systemic infection or pregnancy.
Evaluation of Organisational Changes to Promote Smoking Cessation

The Department of Family Practice at Michigan State University partnered with BCBSM with a grant from the Robert Wood Johnson Foundation to recruit primary care practices for a 3 year study designed to assess smoking cessation referral rates by primary care physicians in Michigan.

There are two main research questions to our study: 1) Whether provider referral rates to smoking cessation services and quitline counseling are enhanced by comparative feedback profiles to individual providers and provider groups (Study 1) and 2) Whether health plan members who receive pharmacotherapy for smoking cessation have higher participation rates in smoking cessation services if they receive proactive, invitational phone calls (Study 2).

Eligibility Criteria:
Inclusion Criteria:

* Primary care practice and thier Adult smokers

Exclusion Criteria:

* Non somkers
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients

This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in healthy subjects and in patients who have dyslipidemia. The effect of food on TAP311 concentration in blood and effect of TAP311 administration on simvastatin concentration will also be assessed in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects age 18 to 65 years of age included, and in good health as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening.
* OR untreated dyslipidemic patients.
* Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2.
* Able to communicate well with the investigator, to understand and comply with the requirements of the study.

Exclusion Criteria:

* Use of other investigational drugs at the time of enrollment.
* Active treatment for type 1 diabetes or type 2 diabetes mellitus.
* A past medical history of ECG abnormalities, documented cardiac arrhythmias or cardiovascular diseases.
* History of malignancy of any organ system, treated or untreated, within the past 5 years.
* Pregnant or nursing (lactating) women.
* Smokers.
* Use of any prescription drugs, herbal supplements and/or over-the-counter (OTC) medication, dietary supplements.
* History of drug or alcohol abuse within the 12 months prior to dosing.
* Any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study

Other protocol-defined inclusion/exclusion criteria may apply.
Using Group Commitment for Smoking Cessation

This study proposes a novel behavioral intervention to help smokers in Thailand to achieve their goals of quitting. Smoking treatment programs are rare throughout most of Asia and unlikely to meet the impending demand for quitting that tobacco control regulations is stimulating. New approaches are needed.

The present study is a randomized controlled trial to test the effectiveness of a novel, scalable approach to smoking cessation that is targeted toward rural Southeast Asian communities. Thailand is used as a test case to explore if pairs of smokers quit successfully after making financially-backed commitments and receiving cash incentives to quit. The control group receives education and counseling about quitting. In addition to education and counseling about quitting, the intervention includes two key components:

1. Each participant is encouraged to deposit his "cigarette money" on a weekly basis, to be returned only if the smoker quits successfully within three months. Such commitment contracts, based on theory from behavioral economics, are designed to help a person to maintain self-control and motivation in the face of temptation.
2. Each participant is paired with another study participant. If both quit, each receives a cash bonus. The joint incentives are designed to lead partners to support each other throughout the quit attempt.

Thus, group commitment contracts marshal a robust blend of elements: financial commitment, social support, peer pressure, and monetary rewards. A larger, follow-up evaluation will clarify the relative importance of each of these elements.


Eligibility Criteria:
Inclusion Criteria:

* Current smoker of at least 10 cigarettes per week and at least 100 cigarettes over the course of a lifetime
* Residents of the study area in Nakhon Nayok province, which includes the six subdistricts of Klong Yai, Chumpon, Bueng San, Pak Phli, Khao Phoem, or Ongkharak

Exclusion Criteria:

* Pregnant
* Plans to leave the study area within the next 12 months
Pulmonary Vasculature and Right Heart Dysfunction in Chronic Obstructive Pulmonay Disease

The pulmonary vasculopathy and right heart dysfunction in COPD are drawing increasing attention these days. Recent researches show that pulmonary vasculopathy and right heart dysfunction relate to greater severity in COPD. Applying appropriate modalities for early detection of pulmonary vasculopathy and right heart dysfunction is of great importance. What's more, the interaction mechanism between pulmonary vasculature, right heart and COPD still needs to be further studied. The aim of our study is to develop an assessment system of pulmonary vasculopathy and right heart dysfunction in COPD patients and elucidate their impact on COPD course and outcome.


Eligibility Criteria:
Inclusion Criteria:

* stable COPD patients

Exclusion Criteria:

* patents with other respiratory diseases and pulmonary hypertension other than group 3 PH;
* psychopath, addict or patients not able to coordinate;
* patients in pregnancy or breastfeeding;
* patients with limited life expectancy;
* patients with contraindiction for MRI or PET;
* patients having cerebrovascular events in 3 months;
* unstable COPD patients
Aerobic Exercise Effects on Cognitive Function in Aging Individuals

Positive effects are exerted by participating in moderate exercise training with physical activity which positively affects body health, including cognitive abilities, among older adults. Thus, the investigators are trying to study the potential effects of the supervised aerobic training regimen for 12 weeks on cognitive function among older adults based on molecular changes in cellular apoptosis.

Physical activity exerts many positive effects on body health, including cognitive abilities, among older adults. Nevertheless, a paucity of knowledge exists regarding the potential anti-apoptotic benefits of moderate exercise and its potential influence on cognitive function. The objective of the present study was to explore the possible connection between the anti-apoptotic mechanisms associated with exercise and cognitive performance in a cohort of 60 older adults who participated in a 12-week supervised aerobic training regimen.

A total of 120 healthy home residents and older subjects with an age range of 65 to 95 years were enrolled to participate in this study. Only, 60 subjects who met the inclusion criteria were included in this study.

The participants were categorized into two groups, specifically the control group (consisting of 30 individuals) and the exercise group (also comprising 30 individuals), based on their participation in an exercise program. Assessments of cognitive function, leisure-time physical activity (LTPA), and apoptotic-related markers such as Bcl-2, p53, and Cytochrome c were conducted both before and after a 12-week aerobic exercise intervention.

Eligibility Criteria:
Inclusion Criteria:

* home resident older
* healthy individuals
* the participants were aged between 65 and 95

Exclusion Criteria:

* Participants with Any physical impairments or conditions such as endocrine, immune, or psychiatric disorders
* participants with eating disorders
* participants' use of any glucocorticoid medications, which might impact the assessment of apoptotic and cognitive functions.