cyrilzakka/clinical-trials huggingface dataset:
Preventing Opioid Misuse Through Safe Opioid Use Agreements Between Patients and Surgical Providers

The effect of pain agreements to reduce opioid misuse is an accepted practice in many settings, but it has never been applied to the acute care setting. Pain agreements are considered the standard of care for chronic pain management reliant on opioid prescribing, and they are a mandated component of care in many states. Therefore, the adjunct of safe opioid use agreements into acute pain management offers a logical extension of current practices from chronic pain management.

This study will test the use of agreements to improve safe opioid use to prevent misuse and opioid-related harm.


Eligibility Criteria:
Inclusion Criteria:

Adult patients (at least 18 years of age), of any gender, who speak English or Spanish, undergoing general surgery procedures with a high likelihood of receiving an opioid prescription (bariatric, inguinal hernia, or ventral hernia), who have their preoperative appointment at UT Physicians Health Center at Memorial Hermann Sugar Land Medical Plaza, Lyndon Baines Johnson, and Bellaire

Exclusion Criteria:

Patients with a known allergy or contra-indication to opioids, pregnancy, signification cognitive impairment, history of opioid misuse/abuse, chronic opioid use, readmission before the follow up appointment
Effect of the Intensity of Continuous Renal Replacement Therapy

In patients with sepsis and AKI, increasing the intensity of renal replacement therapy from 50 mL/kg/h (HVHF) to 85 mL/kg/h (EHVHF)will increase the survival at 28 days and 90 days.


Eligibility Criteria:
Inclusion Criteria:

met at least one of the following criteria: oliguria (urine output less than 100 mL in a 6 h period and unresponsive to fluid resuscitation), serum potassium concentration more than 6.5 mmol/L, severe acidemia (pH \< 7.2), serum creatinine more than 250 µmol/L, or presence of severe organ edema (e.g. pulmonary edema).

Exclusion Criteria:

* were presence of a malignant tumor, chronic renal insufficiency (serum creatinine \>133 µmol/L), or receiving any kind of renal replacement therapy before randomization.
Transcutaneous Electrical Acupoint Stimulation for Non-small Cell Lung Cancer Patients

To investigate the effect of percutaneous electrical stimulation on chemotherapy-induced bone marrow suppression in patients with lung cancer.

Lung cancer is the malignant neoplasm with the highest incidence and mortality in China as well as worldwide. Non-small cell lung cancer (NSCLC) accounts for 80%-85% of all lung cancer cases. Chemotherapy is the preferred treatment method for NSCLC, but many patients cannot tolerate the adverse reactions of chemotherapy. Among the most common and most severe adverse reactions is bone marrow suppression. The more serious the bone marrow suppression, the higher the direct medical cost of chemotherapy. Literatures showed Acupuncture was used to treat patients with chemotherapy-induced bone marrow suppression. In this study, the effect of percutaneous electrical stimulation of acupoints including Dazhui (DU14), Geshu (BL17), Zusanli (ST36), Sanyinjiao (SP6), and Hegu (LI4) will be investigated, compared with the medication group treated by oral administration of prophylactic agents, and the control group received routine nursing care on chemotherapy-induced bone marrow suppression in patients with lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Non-small cell lung cancer(NSCLC)
* age between 20 and 75 years
* chemotherapy naive after diagnosis
* GP regimen as treatment
* an expected survival of more than 12 weeks based on a score equal to or greater than 60 points on Karnofsky performance status (KPS) scale
* the ability to understand and speak Mandarin

Exclusion Criteria:

* diagnosis of a hematological system tumor
* mental illness
* bone marrow suppression prior to chemotherapy
* pregnancy
Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment

Study of novel surgical technic-suprachoroidal buckling for therapy of rhegmatogenous retinal detachment.It was excpted to reattached the retina and improve visual function of rhegmatogenous retinal detachment patients.

The operation was performed under a surgical microscope with a 25G Chandelier light source and a wide-field observation system to observe the fundus.Location, marking and freezing of the retinal tear on the scleral side .

Subretinal fluid is released from the outside of the sclera as needed. The spherical conjunctiva was opened and the radial full-thickness scleral incision (3mm)was made about 8-13mm away from the retinal tear. A "pocket" is formed by injecting some viscoelastic agent into the posterior edge of the sclera and separating the choroid from the sclera using the Healon packaged cannula (No.27 Rycroft cannula). The Healon 5 syringe was connected with a 450-um special tube (a 23 caliber curved tube with olive tip). The cannula is inserted into the supragromal space under microscopic and was scaned by iOCT . Monitor the location of retinal tear during intubation in real time, and adjust the position of the needle: posterior margin of the tear. Once confirmed in accord with the needle position, sodium hyaluronate injection, injection needles to in front of shift to injection, until the tear was completely surrounded in viscoelastic agent to create the choroid crest, usually need 0.2 mL to 0.5 mL. Exit the duct and close the incision with scleral presutures.

Eligibility Criteria:
Inclusion Criteria:

* (1) Clinical diagnosis of rhegmatogenous retinal detachment; (2)myopia \< 600 degrees； (3) retinal tear were peripheral part, non-proliferative round hole or horseshoe tear, single or multiple tears within one oclock area; (4) PVR grading: Grade A, B, C1, C2; (5) Subretinal fluid was confined around the tear. (6)phakic.

Exclusion Criteria:

* (1)Cataract, corneal degeneration, genetic diseases; (2)History of internal eye surgery; (3)The other eye was blind; (4)Postoperative follow-up could not be scheduled; (5)Systemic diseases (asthma, heart failure, myocardial infarction, liver failure, kidney failure and other serious diseases); (6)History of aspirin and other anticoagulant drugs; (7)Severe adverse reactions and systemic diseases occurred during follow-up.
Rationale for New Topical Anthroponotic Cutaneous Leishmaniasis (ACL) Treatment in Kabul

The aim of the randomized double blind trial with 134 patients presenting old world cutaneous leishmaniasis is:

* to evaluate the clinical efficacy of electro-thermo-cauterisation (ETC) followed by moist wound treatment versus ETC followed by moist wound treatment plus 0.05 % pharmaceutical chlorite that has been used in three European countries (Germany, Austria and Switzerland) in wound care management for more than 20 years;
* to judge whether early wound care management would present a viable improvement to the actual anti-parasitic treatments mostly neglecting the chronic wound problem and to evaluate its long-term effect on immunity through relapse control 6 months after wound healing.


Eligibility Criteria:
Inclusion Criteria:

* at least one suspected lesion positive in Giemsa smear

Exclusion Criteria:

* patients previously treated for leishmania
Evaluation of Pharmacokinetic and Safety of NVP-2102 and NVP-2102-R in Healthy Subjects

The purpose of this study is to compare the pharmacokinetics and safety of NVP-2102 and NVP-2102-R.

Evaluate the pharmacokinetics and safety of NVP-2102 compared to NVP-2102-R

Eligibility Criteria:
Inclusion Criteria:

* Healthy subject, 19 years of age or older
* Subjects who signed informed consent
* Body mass index(BMI) of 18 to 30.0 kg/㎡

Exclusion Criteria:

* Subject who has clinically significant medical history
* Inadequate subject for the clinical trial by the investigator's decision
* Subjects participated in another clinical trial within 6 months prior to the first administration of investigational product
Comparison Between Treatment With Yellow Micropulse Laser and Green Conventional Laser in Diabetic Macular Edema

Macular edema is the most important cause of visual impairment in diabetic patients. Intravitreal injections of antiVEGF (vascular endothelial growth factor) agents and laser treatment are two effective therapies for stabilising visual acuity. However, antiVEGF therapy is very expensive and potentially needs to to be repeated for all patients life. Laser treatment, according to modified ETDRS (early treatment diabetic retinopathy study), produces retinal burns with possible negative consequences such as alterations in the visual fields.

With micropulse treatment modality laser energy is delivered in short pulses ("micropulses") rather than as a continuous wave. In this way the amount of energy delivered to the retina and retinal pigment epithelium (RPE) is significantly reduced. This finer control of the photothermal effects should avoid any retinal and RPE damage. At the same time, according to several published reports, the efficacy of treatment appears to be equivalent to conventional laser therapy.

Previous studies investigated the effects of 810nm micropulse laser therapy. Recently, this treatment modality has been made available also with 577nm wavelength, which corresponds to the maximum absorption level for blood. Aim of this study is to assess the safety and efficacy of 577nm micropulse laser treatment compared to conventional modified ETDRS laser therapy.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent prior to study entry
* male or female patients \>= 18 years of age
* patients with diagnosis of diabetes type 1 or 2 and clinically significant macular edema
* visual impairment due to clinically significant diabetic macular edema
* best-corrected visual acuity included between 21 and 74 ETDRS letters
* central retinal thickness greater than 320 micron (Spectralis SD-OCT, Heidelberg Engineering, Germany)
* leakage and/or micro aneurysm in fluorescein angiography images within the area of retinal thickening
* HbA1C ≤10% with well-controlled blood pressure and renal function

Exclusion Criteria:

-
Studying Biomarkers in Samples From Patients With Rhabdomyosarcoma

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from patients with rhabdomyosarcoma.

OBJECTIVES:

* Determine whether circulating muscle-specific microRNAs, especially serum miR-206, are potential biomarkers for rhabdomyosarcoma (RMS).

OUTLINE: Archived serum samples are analyzed for miR-206 expression.

PROJECTED ACCRUAL: A total of 15 samples from patients with alveolar rhabdomyosarcoma (RMS), 15 from patients with embryonal RMS, and 10 from patients without RMS will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Serum specimens of rhabdomyosarcoma (RMS), embryonal RMS, and non-RMS available from the Soft Tissue Sarcoma committee of Children's Oncology Group

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Multiple Dose Trial of Anti-glycation Agent GLY-230 in Healthy and Diabetic Subjects

A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple dose levels of GLY-230 in healthy and diabetic subjects


Eligibility Criteria:
Inclusion Criteria:

* Nondiabetic and diabetic men age 18-55, engative drug screen, normal EKG, clinical chemistries. hematology parameters, HbA1c 7.5% if diabetic, give written informed consent

Exclusion Criteria:

* Sctive concomitant serious medical or surgical disease
Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery

The obvious hypothesis is that the application of peri-operative targeted biological agents may counteract the tumor growth effect of these circulating factors and improve patient outcome


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and over

  _ histological proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharinx or larynx
* Patients selected for a primary surgical treatment
* no distant metastases
* no active second malignancy during the last 5 years except non melanoma skin cancer or carcinoma in situ of the cervix
* no prior or concurrent evidence of uncontrolled severe pathology precluding administration of surgery
* life expectancy of more than 3 months
* not pregnant or nursing; fertile patients both male and female, must use effective contraception
* absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
* signed informed consent
* performance status ECOG 0-1

Exclusion Criteria:

* Nasopharynx cancer
* past or current malignancy other than HNSCC
* performance ECOG status more than 2
* concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
* use of any investigational agents within 4 weeks prior to entry
* Previous exposure to EGFR targeting therapy
* known grade hypersensitivity to cetuximab
* legal incapacity or limited legal capacity or medical or psychological condition which in the opiniion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
Intervention Study on Break Activities and Workers´ Psychological and Physiological Health & Performance

The objective of this research project is to understand and to improve workers´ recovery from work stress. Although recovery during lunch breaks is the most common within-workday break, it has received only minor research attention. Therefore, we will study whether lunch breaks including a relaxation session or exposure to nature have more favorable outcomes than usually spent lunch breaks concerning: a) recovery processes, b) health, c) well-being, d) job performance and e) creativity. We approach recovery by combining the theoretical frameworks of work and environmental psychology.

We conduct an intervention study in a sample of 200 knowledge-workers who engage in different lunch break activities for 15-minutes per day, two weeks in a row. We randomly assign participants to three experimental conditions: 1) exposure to nature, 2) relaxation and 3) control group (lunch break spent as usual). Online questionnaires before and after the intervention assess long term changes regarding recovery processes and the major outcome variables. Before, during and after the intervention, SMS and paper-pencil questionnaires measure the same constructs four times a day with fewer items. We also measure blood pressure and collect saliva samples to map cortisol excretion across the intervention period. A timed experimental task (i.e., the Alternative Uses Task) is used to examine differences in creativity between the three groups after the intervention period.

By combining the knowledge of work and environmental psychology about recovery and restorative experiences, by merging three recovery perspectives (settings, processes, and outcomes) and by using data triangulation, we produce valid results that broaden our view on mechanisms underlying recovery and enhance our understanding about their links to psychological, behavioural and physiological outcomes, resulting in a more comprehensive picture of work stress recovery in general.

Eligibility Criteria:
Inclusion Criteria:

* Being able to speak and understand Finnish language
* Paid work for at least 24 hours per week

Exclusion Criteria:

* Shift work, highly irregular working hours
* Serious illness or allergies that prevent participants from walking in nature
Effect of Computer-Based Game and HIIT Towards Symptoms, Executive Function and Neuroplasticity in Teens with IGD

The goal of this clinical trial is to learn how effective a combined therapy of computer-based game and also high-intensity interval training (HIIT) physical exercise to improve the clinical symptoms, executive function and neuroplasticity in teenagers with Internet Gaming Disorder (IGD). Executive function refers to the brain's ability to manage tasks such as planning, problem-solving, and decision-making. BDNF is a protein crucial for brain health and development. Neuroplasticity is the brain's ability to change and adapt throughout life. High-intensity interval training involves short bursts of intense exercise followed by periods of rest or recovery. The main questions it aims to answer are:

* How effective are computer-based game and HIIT exercises in reducing addiction symptoms of IGD?
* Will computer-based game and HIIT exercise help teens who are addicted to video games to improve their executive function (become more able to plan ahead and meet goals, display self-control and also follow multiple-step directions)?
* Do computer-based game and HIIT exercise help brains of teens with IGD to be more able to change and adapt?

Researchers will compare the improvement before and after the therapies.

Participants will:

* Undergo both therapies (computer-based game and HIIT) every week for 7 weeks. Computer-based game will be done 3 times/week and HIIT 2 times/week
* fill out forms, interviewed and also have their blood sample taken for a total of three times (before the start of the therapy, during the 4th week of therapy and after the final therapy session on the 7th week)

This is a study protocol of a clinical study to examine the effectiveness of computer-based game and high-intensity interval training towards improvement of clinical symptoms, executive function and neuroplasticity in adolescents with Internet Gaming Disorder (IGD).

According to calculations, our study will aim for a minimum of 44 participants using purposive sampling. Participants will drop-out of the study if they missed \>10% participation (\>3 sessions out of 35 total sessions). Analysis of the effectiveness of both interventions (computer-based game and HIIT exercise) on improvement of clinical symptoms of Internet Gaming Disorder will be done using McNemar test. Meanwhile, analysis of the effectiveness of both interventions towards executive function and neuroplasticity will be done using paired-T tests. Significance levels will be set at 0.05 for analysis. All data will be analyzed using IBM SPSS v. 26.0.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have filled and agreed to the study by signing the informed assent.
* Parents of the participants have filled and agreed to the interventions by signing the informed consent.
* Participants able to follow instruction and procedure of the study

Exclusion Criteria:

* Physical disabilities
* Hearing disabilities
* Color blindness
* Respiratory or cardiovascular comorbidities that hinders exercise abilities
* Other psychiatric comorbidities
A Study to Test How Well BI 3000202 is Tolerated by People With Type 1 Interferonopathies

This study is open to adults with selected type 1 interferonopathies. People can join the study if they have Aicardi-Goutières syndrome (AGS), Coatomer subunit alpha (COPA) syndrome, Familial chilblain lupus (FCL), or another type 1 interferonopathy with a specific gene mutation.

The purpose of this study is to find out how BI 3000202 is tolerated in people with selected type 1 interferonopathies. Participants take a lower dose of BI 3000202 as tablets for 4 weeks. Afterwards, they take a higher dose of BI 3000202 as tablets for 8 weeks. The participants may continue their regular treatment for their condition during the study.

Participants are in the study for about 6 months. During this time, they visit the study site 9 times. The doctors check the health of the participants and note any health problems that could have been caused by BI 3000202.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to \<75 years.
* Genetic diagnosis with mutations in the following affected genes: three prime repair exonuclease 1 (TREX1), ribonuclease H2 subunit A, B or C (RNASEH2B, RNASEH2C, RNASEH2A), SAM And HD domain containing deoxynucleoside triphosphate triphosphohydrolase 1 (SAMHD1), U7 Small Nuclear RNA Associated sm-like protein (LSM11), RNA component of the U7 snRNP (RNU7-1) for AGS; Coatomer subunit alpha (COPA) for COPA syndrome; TREX1, SAM And HD domain containing deoxynucleoside triphosphate triphosphohydrolase 1 (SAMHD1) for Familial chilblain lupus (FCL); DNA nuclease 2 (DNASE2), Adenosine triphosphate synthase family AAA domain containing 3A (ATAD3A) for other type 1 interferonopathies. Genotype documented in medical history is sufficient for eligibility determination and does not require confirmation. Variant identification as "pathogenic" or "likely pathogenic" is preferred according to a joint consensus recommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology. In the absence of such identification, clinical assessment of pathogenicity is required to be documented in the medical records.
* Patients may be either:

  * On standard of care, provided it is on stable doses
  * Not on standard of care
* If women of childbearing potential (WOCBP): must be ready and able to use highly effective methods of birth control.

Exclusion Criteria:

* Major chronic inflammatory or connective tissue disease other than selected type 1 interferonopathies, as assessed by the investigator.
* Increased risk of infectious complications based on investigator's judgement.
* Evidence of potential moderate to severe loss of kidney function.
* Evidence of hepatic impairment.
* If diagnosed with Aicardi-Goutières syndrome (AGS) or other interferonopathy with neurological involvement, AGS Severity Scale \>3.
* Further exclusion criteria apply.
The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)

Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to patients of community acquired pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* 16 years of age or older patients with CAP.
* Patients who were diagnosed as moderate in severity.

Exclusion Criteria:

* Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
* Hepatic dysfunction (AST, ALT, total bilirubin \> 3 times institutional normal).
* Severe renal dysfunction (creatinine clearance \< 30 ml/min).
* Patients who have a history of severe heart diseases (4th -degree of NYHA). Patients who have a congenital or sporadic long QT syndrome, or who are received the drugs with reported QT prolongation.
* Severe underlying disease.