cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Effects of EECP on Circulation, Blood Glucose Level and Blood Pressure in Type 2 Diabetes Mellitus

The purpose of this proposed Department of Defense study is to evaluate the effect of Enhanced External Counterpulsation (EECP) on circulation, blood glucose control and blood pressure of type 2 diabetic patients receiving EECP therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Age equal to or greater than 18
2. Diagnosis of Type 1 or Type 2 diabetes mellitus
3. Prescribed EECP therapy in the DGMC EECP clinic
4. Medically cleared for EECP therapy
5. TRICARE beneficiary

Exclusion Criteria:

1. DGMC EECP clinic patient withou a diagnosis of Type 1 or Type 2 diabetes mellitus
Whole-body Electromyostimulation Versus Conventional Low-volume Strength Training in Overweight Individuals

The main purpose of this study is to compare the effects of whole-body electromyostimulation versus a conventional low-volume strength-training program, each combined with an individualized, weight-reducing diet, on the cardiometabolic risk profile, muscle strength, body composition, inflammatory markers and subjective health outcomes in overweight individuals at increased cardiometabolic risk.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \>25
* presence of at least 2 cardiometabolic risk factors

Exclusion Criteria:

* Healthy persons or patients under age
* Overweight persons without any additional cardiometabolic risk factors
* Pregnancy, Lactation
* Psychological disorders, epilepsy, sever neurological disorders
* Participation in other exercise- or nutrition studies within the last 6 months
* acute cardiovascular disease
* malignant disease
* Rheuma
* Intake of anabolic drugs,
* Skin injuries in the area of electrode placements
* Electronic implants (defibrillator, pacemaker)
* Persons in mental hospitals by order of authorities or jurisdiction
OCT Image Quality Performance Evaluation

To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources.

To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources with equivalent specifications: the micro-electro-mechanical short cavity tunable laser and the micro-electro-mechanical tunable vertical cavity surface emitting laser.

Eligibility Criteria:
Inclusion Criteria

1. Participants must be at least 18 years of age
2. They must be able to complete all testing (all OCT scans)
3. They must volunteer to be in the study and sign the consent form

Exclusion Criteria

1. Subject with history of ocular disease or ocular pathology
2. Subjects unable to complete all OCT imaging modes
Bioindicators Associated With Sarcopenia Before and After Intensive Lifestyle Intervention

The goal of this clinical trial is to explore whether the bioindicators of body composition, nutrition-related indicators (lymphocytes, albumin), lipids, and thyroid hormones are associated with sarcopenia and the changes in these indicators after an intensive lifestyle intervention. The main questions it aims to answer are:

* whether the bioindicators such as lymphocytes, albumin, lipids, thyroid hormones, fat mass, fat-free mass, and basal metabolic mass are associated with the development of sarcopenia.
* the changes of these bioindicators that occur in older adults after going through an intensive intervention.

Participants will receive a 3-month intensive intervention consisting of an intensive nutritional intervention and an individually designed exercise intervention. Nutritional and exercise prescriptions are co-designed through a nutritionist and rehabilitation physician.

Researchers will compare bioindicators in the sarcopenia group before and after intensive lifestyle intervention to determine the association with sarcopenia.


Eligibility Criteria:
Inclusion Criteria:

* 1) Resident elderly aged 65-90 years old in the district.
* 2) Voluntary participation in the trial and signing the informed consent form.

Exclusion Criteria:

* 1) People with systemic severe diseases, organ failure, malignant tumors, neuromuscular degenerative diseases, or active weight loss.
* 2) People with cognitive impairment, incapacitation, or severe mental illnesses who cannot cooperate with the test.
* 3) People with cardiac pacemakers and artificial joint implantation or others who cannot undergo the BIA test.
* 4) People with severe cardiorespiratory dysfunction and physical disabilities who cannot complete the exercise training.
* 5) Incomplete data, refusal to participate in the survey, body composition analysis, and blood collection.
Perioperative Active Warming Techniques in Colorectal Surgeries

We propose a study in which we compare two intraoperative active warming devices for maintenance of normothermia in patients undergoing colorectal surgery. A novel underbody resistive warming mattress (VitaHeat) will be compared to the forced air warming blanket (3M Bair Hugger) that is currently used in our institution. Our hypothesis is that the underbody resistive warming mattress will be equally effective as forced air warming in maintaining normothermia in colorectal surgery.

Stratified randomization will be performed using a computerized randomization table where the strata will be type of surgery (open vs closed) and the treatment will be forced air blanket or underbody mattress warming device. This will allow equal groups of both warming devices in both types of surgery.

Group 1: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut.

Group 2: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation.

Both groups will have IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.

Participation in the study is voluntary. The patients may choose not to enroll in the research. Patients who choose not to enroll will use the standard forced air warmer.

Preoperative and postoperative temperatures will be measured orally. Intraoperative core and skin temperatures will be monitored continuously at 1 minute intervals using an esophageal probe and skin temperature probe using a skin temp probe placed on the great toe and covered to prevent any contact with the warming devices.

Intraoperative period: The participants temperature will be monitored and documented at prescribed times.

Postoperative period: The participants will have temperature monitored in the post anesthesia care area.

Participation in this study will last for 30 days following surgery at which point study member will call patient for a 2-4 minute phone call.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old undergoing laparoscopic or open colorectal surgical procedures under general anesthesia.

Exclusion Criteria:

* Any patient who is less than 18 years old.
* Emergent surgery
* Any patient with thyroid problems
* Any patient with preoperative fever
* Any patient who is pregnant
* Any adult patients unable to consent
* Prisoners
The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia

This comparison is made between the effects of sertindole and risperidone on vulnerability indicators in schizophrenia. More specifically: the effects of these two antipsychotic compounds on basic processing of incoming information is studied. The investigators expect that the newer antipsychotic sertindole to be more effective in restoring information processing in schizophrenia patients than risperidone.

The study is has a so-called double blind, randomized - yet balanced - cross-over design, in which 24 male patients with schizophrenia are included. After inclusion in the study, patients will be assessed in a test-battery, in which psychophysiological parameters of their basic information capabilities are quantified. Following this, the patients will be treated with either risperidone or sertindole for a period of 10 weeks, after which they will cross-over to the other treatment (the order of treatments is randomized (and balanced)). The battery of tests is repeated after the first and second treatment period. In addition, a second test-battery will be performed at these follow-up intervals, to assess neuropsychological parameters of information processing. To evaluate the extend of the treatment effects, the patients will be matched (age, gender, parental socioeconomic status) to 24 healthy controls.

Eligibility Criteria:
Inclusion Criteria:

Healthy controls:

* matched by age (+/- 2 years), gender and parental socioeconomic status to patients with schizophrenia.
* age between 18-55 years
* male
* physically and mentally healthy and no daily intake of medicine
* no current substance abuse

Patients:

* patients who fulfill both ICD-10 and DSM IV diagnostic criteria for schizophrenia.
* age between 18-55 years
* male
* patients who need a change in their medication
* diagnosed with schizophrenia within the last 10 years
* not formerly treated with risperidone (Risperdal) or sertindole (Serdolect) where treatment was stopped because of side effects or lack of effect
* physically healthy
* no current substance abuse

Exclusion Criteria:

Controls:

* a history of mental illness in the first degree relatives
* hearing disabilities
* head injury accompanied by unconsciousness for more than 5 min.
* physical illness with a need of daily intake of medicine
* positive screening for drugs of abuse at baseline.

Patients:

* head injury accompanied by unconsciousness for more than 5 min.
* serious medical conditions (more specific: brain diseases and diseases which cause a daily intake of medicine, heart, liver or kidney diseases, diabetes and prolongation of the QTc-interval (or a family history of such) and patients with phenylketonuri)
* abuse of alcohol or medication/ narcotics during the last 6 months or positive screening for drugs of abuse at baseline.
* former treatment with risperidone (Risperdal) or sertindole (Serdolect) where treatment was stopped because of side effects or lack of effect
* hearing disability
* allergy towards the content in the medicine used in the study
* bradycardia (pulse under 50 beats per minute) and QTc\>450 ms
Trial Comparing Part-time Versus Minimal-time Patching for Moderate Amblyopia

The goals of this study are:

* To determine whether the visual acuity improvement obtained with part-time (6 hours) patching is equivalent to the visual acuity improvement obtained with minimal patching (2 hours) for moderate amblyopia.
* To develop more precise estimates than currently available for the visual acuity improvement that occurs during treatment of amblyopia with patching.
* To identify factors that may be associated with successful treatment of amblyopia with patching.

Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Patching has been the mainstay of amblyopia therapy. It is generally held that the response to treatment is best when it is instituted at an early age, particularly by age two or three, and is poor when attempted after eight years of age.

For moderate amblyopia, patching is the most commonly prescribed treatment although other modalities such as atropine penalization are also prescribed. There is no specific patching regimen that is widely accepted for treatment of moderate amblyopia and limited or no data available to favor the use of one specific regimen; both minimal occlusion (e.g., 2 hours per day) and six or more hours per day of patching are prescribed in clinical practice.

The study is a randomized trial comparing daily patching regimes for children with moderate amblyopia. It will consist of about 160 children. Patients in the moderate (20/40-20/80) group will patch part-time (6 hours) or minimal time (2 hours) of each day for the 4-month study period. There are at least two follow up visits during the 4-month period. Visual acuity is the major study outcome. It is assessed at the 4-month exam.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be less than 7 years of age with the original cause of amblyopia as strabismus or anisometropia.
* Visual Acuity in the amblyopic eye must be between 20/40 and 20/80.
* Visual acuity in the sound eye of 20/40 or better.
* There must be at least 3 lines of acuity difference between the two eyes.

Exclusion Criteria:

* Patching treatment (other than spectacles) within six months prior to enrollment and other amblyopia treatment of any type used within one month prior to enrollment.
Evaluate Recovery of Testosterone for Patients Using Eligard

The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard.

This is a Multi-center, open-label study to evaluate testosterone recovery after six months of neo-adjuvant treatment with ELIGARD (TM) 22.5mg used with Radiation Therapy in patients with TNM T1, T2 or T3A adenocarcinoma of the prostate. The 60 patients will receive two subcutaneous administration of ELIGARD (TM) 22.5mg (Baseline and Month 3) and receive Radiation Therapy (Month 2-4).

Eligibility Criteria:
Inclusion Criteria:

* Must be outpatient, not hospitalized
* Male Patient between ages 50-80, inclusive
* Histologically/Cytologically graded adenocarcinoma of the prostate
* Must have T1, T2 or T3a adenocarcinoma of the prostate
* Must be a candidate for radiation therapy. Hormone refractory patients excluded
* WHO/ECOG score of 0,1 or 2

Exclusion Criteria:

* NO evidence of urinary tract that would put the patient at risk in the opinion of the Investigator.
* Used the following treatments for prostate Cancer

  \*immunotherapy \*chemotherapy \*External Beam Radiation \*brachytherapy \*hormonal therapy \*biological response modifiers
* Prior Prostate Surgery (excluding TUNA or TURP)
* Undergone Orchiectomy, adrenalectomy, hypophysectomy or be receiving any product which could alter the function of these organs
* Use of Investigational Drug, Biologic or device within five half-lives of its physiological action or three months prior to base line, whichever is longer
* Over the counter or alternative medical therapies which have estrogenic or anti-androgenic effect
* uncontrolled CHF within 6 months to baseline
* Myocardial Infarct, coronary vascular procedure or Clinically SignificantCardiovascualr Disease within 6 months of baseline Visit
* Venous thrombosis with in 6 Months of Screening
* Uncontrolled Hypertension defined as \>170/100 or Symptomatic Hypotension within 3 months of Baseline
* Insulin dependant Diabetic Patients Must not administer in an anatomic region where they will receive Eligard.
* Drug or Alcohol Abuse 6 months prior to Baseline
* Other Serious Illness at the discretion of the Investigator
* Patients receiving anti-coagulant or anti-platlet medication must be on a stable dose for 3 months prior to Baseline
* Hypersensitivity to GnRH, GnRH agonists
0.6 vs. 1.2 mg Atropine Together With Neostigmine 2.5 mg on Heart Rate in Patient Receiving Muscle Relaxant

Balanced general anesthesia with neuromuscular blocking agents has been widely used for surgery.. At the end of surgery, neostigmine has been given for the reversal of neuromuscular blocking agents with several adverse effects such as bradycardia and profuse secretion. Atropine has been used to prevent those side effects of neostigmine. The routine dosages of the two drugs are 2.5 mg of neostigmine and 1.2 mg of atropine.

Tribuddharat S ey al. (1) has demonstrated that after giving 0.9 mg atropine together with 2.5 mg of neostigmine the mean heart rate during 1-8 minutes after the administration was increase 2-26 beats/min (bpm). At 9 and 10 minutes after administration of the drugs, the mean heart rate were decrease 0.9 and 1.6 bpm In the control group which receiving 1.2 mg of atropine, the mean heart rate during 1-10 minutes after administration was increase 4-32 bpm. However this study did not report the incidence of bradycardia and blood pressure. The mean heart rate prior to atropine and neostigmine was 74.43 + 11.82 bpm.(1)

Salem MG et al. (2) has demonstrated that after receiving 1.2 mg of atropine and 5 mg of neostigmine the mean heart rate during 2-110 minutes was decrease 5-29 bpm with the lowest heart rate at 40 minutes after administration. This study also did not report the blood pressure.

The baseline heart rate (HR) before administration of the reversal was associated with the following heart rate. Heinonen J et al. (3) has demonstrated that 80% of the patients after receiving 0.015 mg/kg of atropine 3 minutes before 0.03 mg of neostigmine for the reversal of pancuronium experienced bradycardia (heart rate \< 50 bpm) compared with none in patients receiving alcuronium. However, before administration of atropine and neostigmine, the mean heart rate of patients was significantly lower in the pancuronium group.

Either tachycardia or bradycardia with hypotension causes adverse affect to patient especially in specific group like patient with coronary artery disease or undergoing craniotomy.

The primary objective of our study is to demonstrate the effect on heart rate (HR) and blood pressure of 0.6 mg atropine and 2.5 mg neostigmine for the reversal of muscle relaxant compare to 1.2 mg atropine.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1-3
* age = or \> 18 years
* patient receiving neuromuscular blocking agent

Exclusion Criteria:

* baseline heart rate before administration of the study drugs \< 65 bpm
* history of allergy to the study drugs
* patient receiving either of the following drugs include beta-blockers, calcium channel blocker, amiodarone or digoxin
* history of complete heart block or second degree AV block.
Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery

The purpose of this study was to determine the effectiveness of pre-emptive Quadratus lumborum block on intra, postoperative pain assessment and opioid requirements in laparoscopic bariatric procedures.


Eligibility Criteria:
Inclusion Criteria:

Patients included in this study are

* Both genders
* Age between 18-50 years
* Those undergoing laparoscopic bariatric surgery (as laparoscopic sleeve gastrectomy or gastric bypass).
* BMI ≥ 35 Kg/m2 with comorbidity or ≥ 40 Kg/m2 without comorbidity.

Exclusion Criteria:

Patients excluded from this study were

* those with obstructive sleep apnoea and/or Pickwickian syndrome.
* if the laparoscopy procedure was converted to laparotomy.
* patients suffering from known coagulation defects.
* known hypersensitivity to bupivacaine, or those with contraindication to the use of NSAIDS.
* Presence of sepsis at the site of injection.
Indirect Comparison Topotecan Cervical Carcinoma

Indirect comparisons were performed using data from GOG-0179 versus GOG-0169 to permit comparison of topotecan in combination with cisplatin versus cisplatin plus paclitaxel via the common comparator of cisplatin monotherapy. Both GOG-0179 and GOG-0169 were conducted in patients with stage IVB, recurrent or persistent carcinoma of the cervix, but there were some differences between the respective study populations. Patients with prior chemotherapy were eligible for GOG-0179 but ineligible for GOG-0169 (except when chemotherapy was used for radiation sensitisation). Fewer patients had received chemotherapy as a radiosensitiser in GOG-0169 (27%) than in GOG-0179 (\~60%) and these patients were unevenly distributed between treatment arms in GOG-0169. In addition, the proportion of patients receiving cisplatin as a radiosensitiser in GOG-0169 is unknown. For these reasons, there are limitations associated with the indirect meta-analysis.


Eligibility Criteria:
Inclusion Criteria:

* randomised clinical trials, or systematic reviews and meta-analyses
* treatment with topotecan or platinum-based single and combination regimens in female patients of any race with cancer of the cervix recurrent after radiotherapy or stage IVB disease

Exclusion Criteria:

* None
SNS to Increase HIV Testing Uptake and Linkage to Double Cascade Services Among Adolescent MSM and TGW in Thailand

UNAIDS aims to end AIDS by 2030 using "90-90-90" diagnosis-treatment-viral suppression targets. Thailand has achieved elimination of HIV mother-to-child transmission, but continues to see new infections among adolescent men who have sex with men (YMSM) and transgender women (YTGW). Reaching and engagement of key populations to HIV services remains a major challenge, with differentiated care needed to address this. Investigators propose a study on outreach for HIV at-risk adolescents using peer-led social network strategies (SNS), linkage to facility-based HIV self-testing, and same day HIV prevention or treatment. The study will focus on the 15-19 year age group who have the highest HIV incidence in Thailand (6.9-10 per 100 person years, PY), but will also include young adults aged 20- 24 years of age, due to their frequently intertwining sex networks and very similar HIV incidence of 4.9-7.2 per 100 PY.

Eight hundred adolescent and young adult (AYA) MSM and TGW aged between 15-24 years will be recruited into a double HIV cascade care system. AYA aged between 15-24 years will be trained as recruiters to approach and refer their peers, 'network members' (NMs) to our adolescent clinic. NMs will be offered a choice of either blood-based or oral fluid-based HIV self-testing. HIV positive cases will be offered same-day antiretroviral therapy (SDART) and high-risk adolescents will be offered same day preexposure prophylaxis (PrEP). The project will be conducted at adolescent differentiated care services previously established by CIPHER grants in Thailand, located at King Chulalongkorn Memorial Hospital (KCMH), Bangkok. It will inform both Thailand and other Asia-Pacific region countries with similar epidemic patterns through an implementation research lens on strategies to engage YMSM and YTGW into HIV services, which investigators believe will make high-impact contributions to our collective ultimate goal of ending AIDS.


Eligibility Criteria:
Recruiters

Inclusion Criteria:

* ages 15-24 years
* assigned male gender at birth
* self-defined gender identity of either MSM or TGW
* any one of the following: living with HIV, using HIV pre-exposure prophylaxis, receiving intermittent HIV testing for ongoing HIV risk
* good rapport with King Chulalongkorn Memorial Hospital (KCMH) Adolescent Health Clinic, knowledgable on HIV and comfortable discussing HIV with peers

Network Members

Inclusion Criteria:

* ages 15-24 years
* assigned male gender at birth
* self-defined gender identity of either MSM or TGW
* self-reported oral and/or anal sex with a man in the past 12 months and at risk of HIV infection (multiple sex partners in the preceding 6 months and/or inconsistent condom use)
* no history of HIV testing or last HIV test \> 3 months prior to study entry

Exclusion Criteria:

* Known to be living with HIV