cyrilzakka/clinical-trials huggingface dataset:
Shared Decision Making to Improve Goals of Care in the ED

This project will develop and refine a shared decision making (SDM) intervention (decision aid tool) to improve and normalize high quality end of life discussions in the Emergency Department (ED) setting.

Develop a shared decision making (SDM) intervention informed by insights elicited from patients and clinicians to improve goals of care discussions.

The process of decision aid design involves: (1) review and synthesis of the evidence; (2) an analysis of usual practice through observation of clinical encounters; (3) development of an initial decision aid prototype; (4) field testing in the context of clinical care to gain insights on both intended and unintended effects of its use in practice to facilitate patient centered goals of care discussions; and (5) successive iterations of the decision aid until thematic saturation is reached and it is ready for testing in a clinical trial.

Eligibility Criteria:
Inclusion:

1. Patients presenting to Mayo Clinic Rochester, Saint Marys' Emergency Department,
2. Patients at high risk for critical illness as determined by an Elderly Risk Assessment (ERA) score ≥ 16 or as determined by provider discretion,
3. ≥ 60 years of age,
4. Ability to provide informed consent,
5. Medically stable at the time of enrollment,
6. Able to participate without causing a delay in care.

Exclusion:

1. GCS scores \< 15,
2. Signs of altered mental status,
3. Known to be pregnant,
4. Incarcerated or in Police Custody,
5. Communication barriers such as visual or hearing impairment that may preclude use of the decision aid.
A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty

The main aim is to see how leuprolide works to treat central precocious puberty in children. Participants will receive an injection of leuprorelin acetate depot 11.25 mg every 12 weeks during 6 months and will visit their study clinic 6 times to complete some assessments.

The drug being tested in this study is called leuprorelin acetate depot 3M. Leuprorelin acetate depot 3M will be tested to treat children who have central precocious puberty. This study will look at the efficacy and safety of leuprorelin acetate depot 3M in the treatment of CPP.

The study will enroll approximately 80 participants with CPP. Participants with a bodyweight of ≥ 20 kg will receive the recommended dose of leuprorelin acetate depot 3M in a 24 weeks Treatment Period followed by a 12 weeks Post-treatment follow-up period. Participants will be assigned to the following drug administration:

• Leuprorelin Acetate Depot 3M 11.25 mg

Participants will receive leuprorelin acetate depot 3M 11.25 mg as subcutaneous (SC) injection on Weeks 0, 12, and 24. The gonadotropin-releasing hormone agonist (GnRHa) stimulation, basal luteinizing hormone (LH), and follicle-stimulating hormone (FSH) levels will be tested pre-dose of every SC injection of the study drug or at premature termination.

This multi-center trial will be conducted in China. The overall time to participate in this study is 38 weeks. Participants will make a follow-up visit to the site at approximately 12 weeks after the last dose of study treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Early appearance of secondary sexual characteristics: Girls ≤8 years, Boys ≤9years
2. Body weight ≥20 kg
3. According to the National Consensus Statement in China (2015), CPP is diagnosed when secondary sexual characteristics appeared before the age of 8 years in girls and 9 years in boys, a peak LH level \>5.0 IU/L with LH/FSH \>0.6 in stimulating test; evidence of gonadal development by ultrasonography (multiple ovarian follicles ≥4 mm in any ovary or uterine enlargement in females or testicular volume ≥4 mL in males); advanced bone age (BA) ≥1 year; linear growth acceleration with higher growth velocity (GV) than normal children. BA is determined by Greulich and Pyle standards or TW3 standards at screening.

Exclusion Criteria:

1. The participant has received GnRHa treatment in a previous clinical study or as a therapeutic agent.
2. The participant has a history or clinical manifestations of significant adrenal or thyroid diseases or intracranial tumor OR has a history of malignant disease.
3. The participant has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound.
4. The participant has a diagnosis of peripheral precocious puberty.
Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures

To compare efficiency, in terms of tissue morcellation and removal time, of two commercially available FDA-approved morcellators: the VersaCut and the Piranha in subjects undergoing HoLEP procedure for benign prostatic hyperplasia (BPH).

Holmium laser enucleation of the prostate (HoLEP) with mechanical morcellation is a surgical technique used for treatment of bladder outlet obstruction (BOO) secondary to benign prostatic hyperplasia (BPH). HoLEP represents a state of the art alternative to transurethral resection of the prostate (TURP). HoLEP has been shown to be safe and effective for treating prostates of all sizes and has low perioperative morbidity.

A holmium laser fiber is passed through a continuous-flow resectoscope and is used to resect the obstructing prostate tissue (enucleation). After enucleation is performed, the resected tissue is advanced into the bladder. The morcellator is then used to cut the tissue into small pieces which are then removed from the bladder via suction through the morcellator blades (morcellation). We currently use the first commercially available morcellator (VersaCut, Lumenis Incorporated, Santa Clara, CA). The Storz continuous-flow resectoscope (Karl Storz,Tuttlingen, Germany) is currently used to perform the enucleation portion of the procedure.

Recently, a new morcellator has been developed (Piranha, Richard Wolf, Knittlingen, Germany). The Wolf morcellator has been reported to remove tissue at a faster rate than the Lumenis device

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo HoLEP for bladder outlet obstruction due to the prostate.
* Able to give informed consent.
* Age 18 years or older

Exclusion Criteria:

* • Inability to give informed consent.

  * Age less than 18 years
Electronic MonitorIng of Events for dIffuse Large b Cell LYmphoma

Diffuse large B cell lymphoma is the most common malignant lymphoid hemopathy. More than half of the patients will be cured with an RCHOP-type immunochemotherapy protocol (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone). Monitoring of adverse effects, risk of relapse and quality of life are essential in overall management. Patients are the best candidates to report them. Managing these events should improve quality of life and reduce costs. The aim of this study is to assess the feasibility of monitoring these events by a web application (Oncolaxy©) and to compare it with a control population in the context of a randomized pilot study including 80 patients per arm with diffuse large cell B lymphoma in first-line treatment with R-CHOP.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with untreated large B cell lymphoma requiring a first line treatment by RCHOP or R-mini-CHOP
2. Patient aged 18 years or older at the time of signing Informed Consent Form
3. Additional Intrathecal or/and intravenous treatment with Methotrexate allowed, if indicated
4. Eastern Cooperative Oncology Group (ECOG) Performance Status \< 3
5. Patient with internet access (or has someone at home who can help send patients' symptoms or complete the form)
6. Patient enrolled in social security
7. Patient has given his written consent ahead of any specific protocol procedure

Exclusion Criteria:

1. Patient with symptomatic brain metastases,
2. Patient deprived of their liberty, under guardianship or trusteeship
3. Patient is being treated for another cancer and has not been cured
4. Patient with dementia, mental disorders or psychological pathology which could compromise patient informed consent and/or the observance of the study protocol
5. Patient cannot submit to the protocol for psychological, social, familial or geographical reasons
6. Patient is pregnant or breastfeeding
Immune Response to HPV Vaccine Among HIV-1-infected Subjects in Brazil

Besides the specific response to vaccine antigens, the investigators will analyze the anti-HPV immune response in HIV-1-infected men in different strata of immune deficiency. The hypothesis will be tested by stratification by T CD4 + lymphocytes in an attempt to assess the range of the count with the highest possibility of vaccine response. Thus, knowledge of vaccine response in HIV-infected patients, indicate which patients would have greater potential for vaccine response in vivo.

The study will be divided into three groups. Patients with HIV-1 infection will be subdivided into groups according to T CD4 + lymphocytes at the time of vaccination: Over 500 CD4 T cells count and bellow 500 CD4 T cells count. A healthy control group will be also studied.

Eligibility Criteria:
Inclusion Criteria: HIV

* Men with age between 35 and 45 years of age.

Exclusion Criteria:

* Current or previous infection with human papillomavirus (HPV)
SGLT2 Inhibition in Diabetes and Heart Failure

To determine the effects of SGLT2 inhibition with empagliflozin on cardio-respiratory fitness in patients with systolic heart failure.

The investigators hypothesize that Sodium-GLucose coTransporters (SGLT)-2 inhibition will improve cardio-respiratory fitness (CRF) in patients with systolic heart failure.

Participants treated with SGLT2 inhibitor Empagliflozin as standard of care will undergo assessments described below.

The investigators will measure CRF with a validated cardiopulmonary exercise test at baseline and after 4 weeks of treatment received as standard of care, to determine whether SGLT2 inhibition improves cardio-respiratory fitness assessed by changes in peak oxygen consumption (VO2)(mL/kg/min) and minute ventilation (VE)/carbon dioxide production (VCO2) slope, powerful independent clinical predictors of mortality in HF.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed clinical diagnosis of stable HF (NYHA class II-III) on maximally tolerated HF medical regimen including angiotensin-inhibitors, beta-adrenergic blockers, and loop diuretics
* Reduced left ventricular systolic function (LVEF\<50%) documented in the prior 12 months
* Poorly controlled T2DM (HbA1c levels between 6.5% and 10.0%)
* 18 years old and older.

Exclusion Criteria:

* Type I diabetes;
* Type II diabetes with episodes of severe hypoglycemia \<50 mg/dl by history, frequent changes in anti-diabetic regimen class in the past 3 months or with a prior episode of diabetic ketoacidosis (any time);
* Open label treatment with SGLT2 inhibitors (within the past month);
* Treatment with thiazolidinedione (within the past month), which may induce volume and sodium retention;
* Chronic Kidney Disease (GFR\<45 ml/kg\*min);
* Uncontrolled thyroid dysfunction (TSH\<0.4\>4.5 mcIU/ml);
* Pregnancy or of child-bearing potential;
* Active or recent (within 2 weeks) genital/urinal infection;
* Concomitant conditions or treatment which would affect completion or interpretation of the study including physical inability to walk or run on a treadmill such as decompensated HF (edema, NYHA class IV), significant ischemic heart disease, angina, arterial hypotension (BP systolic \<90 mmHg), orthostatic arterial hypotension, arterial hypertension (resting BP systolic \>160 mmHg), atrial fibrillation with rapid ventricular response, severe valvular disease, severe chronic obstructive or restrictive pulmonary disease, moderate- severe anemia (Hgb\<10 g/dl);
* Abnormal BP or heart rate response, angina or ECG changes (ischemia or arrhy- thmias) occurring during baseline cardio-pulmonary exercise testing;
* Chronic use of oral corticosteroids;
* Inability to give informed consent.
Effect of Mirabegron on Promoting Brown Adipose Tissue Activation

In previous preclinical studies, our group found that Mirabegron, a clinical drug, could activate brown adipose tissue and inhibit tumor growth in tumour-bearing mice.Investigators look forward to further evaluating the effect of Mirabegron-mediated brown adipose tissue activation, so as to provide new drug applications for clinical cancer prevention and treatment


Eligibility Criteria:
Inclusion Criteria:

* Health Volunteers

  1. Sign the informed consent before the study, and fully understand the content, process and possible adverse events.
  2. Both men and women, aged 18-75 years (including the boundary value) .
  3. Body mass index (BMI) is 19.0-26.0 kg/m2 (including the boundary value).
* Tumor patients

  1. Sign the informed consent before the study, and fully understand the content, process and possible adverse events.
  2. Tumor bearing and not in the period of chemotherapy and targeted drug intervention).
  3. Both men and women, aged 18-75 years (including the boundary value) .
  4. Body mass index (BMI) is 19.0-26.0 kg/m2 (including the boundary value).
  5. Proper bone marrow and organ function, as defined below:HB≥80h/L; ANC≥1.5\*109/L; PLT≥50\*109/L; ALT≤3 upper limit of normal ( ULN ); AST≤3 ULN ; TBIL≤1.5 ULN.
  6. The expected survival is 3 months or more.

Exclusion Criteria:

* Health Volunteers and Tumor patients

  1. A history of tuberculosis infection.
  2. Patients with contraindications to Mirabegron: allergic to Mirabegron or any of its excipients; Patients with poorly controlled severe hypertension(SBP≧180mmHg or/and DBP≧110mmHg).
  3. Women who are pregnant or breastfeeding.
  4. The subject may not be able to complete the study for other reasons or may not be able to participate in the study for other reasons judged by the investigator.
A Study to Investigate Efficacy and Safety of Weekly PEG-somatropin (GenSci004) in Treatment Naive Children With Growth Hormone Deficiency

The purpose of this study is to evaluate the efficacy and safety of weekly GenSci004 compared with daily Genotropin in treatment-naive children with growth failure due to GHD.

The purpose of this Phase 3 study is to evaluate the efficacy, safety, and tolerability of weekly GenSci004 compared to daily Genotropin over 52 weeks in prepubertal treatment-naïve children with growth failure due to GHD.

Eligibility Criteria:
Inclusion Criteria:

1. Prepubertal children with GHD in Tanner Stage 1
2. Baseline HT at least -2.0 SD below the mean HT for CA and sex (HT SDS ≤ 2.0).
3. Body mass index (BMI) within ±2.0 SD of the mean BMI for BA and sex.
4. Growth hormone stimulation tests: ≤10 ng/mL
5. Baseline IGF 1 level of at least 1.0 SD below the mean IGF 1 level standardized for age and sex (IGF 1 SDS ≤-1.0)
6. Normal 46 XX karyotype for girls.
7. Children with multiple hormonal deficiencies must be on stable replacement therapy for other hypothalamo-pituitary axes for at least 3 months
8. Written, signed informed consent of the parent(s) or legal guardian(s) of the participant and written assent of the participant

Exclusion Criteria:

1. BA≥CA
2. Prior exposure to rhGH, long-acting growth hormones, or IGF 1 therapy.
3. Major medical conditions or presence of contraindication to human growth hormone (hGH) treatment
4. Participation in any other trial of an investigational agent within 3 months prior to Screening.
5. Any reason per investigator's discretion
Musical Dual Task Training to Improve Attention Control for Dementia

The purpose of this project is to determine if the Musical Dual Task Training program improves attention control that influences measures of gait performances under dual tasking, balance, fear of falling, and behavioral disturbance in patients with mild to moderate dementia. This Musical Dual Task Training protocol is structured with musical content and patients are required to do musical tasks including singing and playing instruments contingent on visual or auditory cues while walking. This paradigm is designed to include music making because it involves great demands on attention and memory that might elicit experience-dependent plasticity in the brain. Musical Dual Task Training is proposed to strengthen brain networking for attention control that consequently may improve the gait performances in patients with dementia, as indicated by reducing dual task cost on gait.


Eligibility Criteria:
Inclusion Criteria:

* a mild to moderate dementia diagnosis with Clinical Dementia Rating (CDR) score: .5, 1, or 2
* ability to walk 10 meters independently without the use of a walker or cane, or the assistance by another person

Exclusion Criteria:

* other known neurologic disorders such as stroke or Parkinson's disease
* significant orthopedic, visual, and hearing impairment that hinders ambulation
Efficacy of the Nanodropper Device on Intraocular Pressure in Patients With Glaucoma

Glaucoma is the leading cause of irreversible blindness worldwide. Previous studies demonstrate that smaller eye drops used in the treatment of glaucoma are just as efficacious as their larger counterparts. The proposed study hopes to demonstrate the non-inferiority of using Nanodropper to lower intraoccular pressure (IOP) in glaucoma patients compared to standard of care eye drops.

The proposed study strives to demonstrate the non-inferiority of using Nanodropper to lower IOP in glaucoma patients compared to standard of care (SOC) eye drops in a randomized trial.

Primary Aim: Demonstrate non-inferiority of using Nanodropper to lower IOP compared to standard of care eye drops in glaucoma patients.

Stable glaucoma participants and ocular hypertension participants of ages 18+ will be randomized to either use Nanodropper for eye drop administration in both eyes OR administer drops regularly (standard of care) in both eyes. Participants will be followed-up at 1 month and 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or older
2. Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT)
3. Use of prostaglandin analogue (PGA) eye drop
4. Stable disease status (no visual field loss progression or increase in IOP-lowering medications in the last 6 months)

Exclusion Criteria:

1. Uncontrolled glaucoma
2. Have had eye surgery (including laser procedures) within the past six months
3. Have a diagnosis of acute angle-closure glaucoma and/or other retinal diseases
4. Use of non-PGA class of IOP-lowering medication
The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory

The investigators hypothesize that ten sessions of repetitive transcranial magnetic stimulation yield ability to upregulate the function of primary motor cortex and prefrontal cortex that play key roles in motor and frontal memory processing.

Excitatory (\>3Hz) rTMS could facilitate the brain cortex and neuroplasticity that benefits motor control and working memory when the coil is applied over primary motor cortex or dorsolateral prefrontal gyrus.

Eligibility Criteria:
Inclusion Criteria:

1. Ischemic or hemorrhagic cerebrovascular lesion,
2. Parkinson's disease

Exclusion Criteria:

* Seizure
* With metal implantation
* Dementia or severe cognitive impairment
Internet Delivered CBT for Olfactory Reference Syndrome

The primary aim of the study is to test the feasibility and efficacy of, a manual based, Internet-delivered, cognitive behaviour therapy (CBT) for patients with Olfactory Reference Syndrome (ORS) who live in Sweden. The secondary aim is to investigate smell sensitivity and body odor in these ORS-patients.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of ORS
* Outpatients
* Male or female
* Signed informed consent
* Have regular access to a computer with Internet access and skills to use the web

Exclusion Criteria:

* Not able to read or understand the basics of the ICBT self-help material
* Psychotropic medication changes within two months prior to treatment
* Completed CBT for ORS within last 12 months
* Ongoing substance dependence or misuse
* Lifetime bipolar disorder or psychosis
* Suicidal ideation
* Axis II diagnosis that could jeopardize treatment participation
* Serious physical illness that will be an obstacle in ICBT
* Other ongoing psychological treatments that could affect ORS symptoms
* Epilepsia
The Value of Combined Detection of Orexin-A, HLA Gene, PSG and MSLT in the Evaluation of Patients With Narcolepsy

By comparing the differences of orexin-A, HLA gene, PSG, MSLT and other parameters in the evaluation of narcolepsy patients, investigators could find out the relatively high value indicators in the diagnosis of narcolepsy, which is helpful to guide the clinical discovery, diagnosis and treatment of narcolepsy.

Narcolepsy is a lifelong sleep disorder disease, mainly occurs in the 15\~30 year old youth. The incidence rate in different country population is different, which is 0.04% in China. Because of its low incidence rate, and the lack of clinicians' knowledge, it is easy to cause missed diagnosis and misdiagnosis. The decrease of cerebrospinal fluid orexin-A level, positive HLA-DQB1 \* 0602 and MSLT all have directive significance for the diagnosis of narcolepsy, but patients with other diseases and healthy people can also show positive indicators. These false positives may lead to wrong judgments. By comparing the differences of orexin-A, HLA gene, PSG, MSLT and other parameters in the evaluation of narcolepsy patients, investigators could find out the relatively high value indicators in the diagnosis of narcolepsy, which is helpful to guide the clinical discovery, diagnosis and treatment of narcolepsy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 10-70 years old;
2. The symptoms lasted for at least 3 months;
3. With or without cataclysm;
4. MSLT showed that the sleep latency was less than or equal to 8 min, there were two or more times of sleep, the onset of REM sleep;
5. Somnolence can not be explained by other diseases, such as insufficient sleep, OSAHS, delayed sleep phase, drug or drug use, etc.

Exclusion Criteria:

1. Somnolence was caused by sleep disorders, central nervous system diseases, brain trauma and other non narcolepsy;
2. Recent lack of sleep or irregular sleep;
3. PSG and MSLT examination can not be diagnosed as narcolepsy;
4. Poor compliance, taking drugs or food and beverage containing central inhibitory components during the trial;
5. Severe neuropsychiatric disorders can not cooperate with the examination;
6. Patients with history of rheumatism, diabetes, ankylosing spondylitis and other HLA related diseases.
Safety, Tolerability and Efficacy of ACZ885 on Leg Artery Structure in Patients With Peripheral Artery Disease

This study was designed to assess the safety, tolerability and efficacy of ACZ885 on the leg artery structure and physical activity in patients with atherosclerotic peripheral artery disease and leg pain from walking.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have a signed informed consent form.
* Must be between the ages of 18 and 85
* Must experience leg pain associated with walking and have an ankle brachial index between 0.40 and 0.9
* Must be on stable aspirin and statin doses for at least 6 weeks
* Blood pressure within ranges specified in the protocol
* Able to communicate well with the Investigator and understand and comply with the study procedures

Key Exclusion Criteria:

* Recent use of any other experimental drugs
* Pregnant or nursing women
* Women of child bearing potential unless willing to use contraception as detailed in the protocol
* Cannot walk 15 meters (50 feet)
* People on restricted medications as listed in the protocol
* Any open or non-healing wounds with 3 months of study start or infection within 2 weeks or study start
* Significant heart disease
* Uncontrolled diabetes
* Significant kidney or liver disease
* Live vaccinations within 3 months of study start
* History of untreated tuberculosis or active tuberculosis (TB)
* Patients with metal in their body (excluded due to MRI scan) as detailed in the protocol.