cyrilzakka/clinical-trials huggingface dataset:
Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury

The purpose of this study is to evaluate if a specific type of additional walking therapy, called body weight supported treadmill training (BWSTT) affects walking ability following a traumatic spinal cord injury. Specifically, the study will look at whether starting BWSTT, which uses a body harness to support body weight while walking on a treadmill at different times within the first 6 months after the injury, makes a difference in how effective this therapy may be, While we know that the brain re-learns patterns following an injury, there has not been a lot of prior research evaluating how starting this type of walking therapy at specific times within the first 6 months after injury may impact any effectiveness of the additional therapy.

The study will randomize participants into four groups: those who start this therapy within 60 days, within 3 months, within 6 months or who do not receive this additional research therapy. Randomization means that which group you will be in as part of this study is determined by chance, like the flip of a coin. The additional walking therapy for this research study, if you are randomized for one of the three groups who receives the additional therapy, will be given on top of (meaning in addition to) any standard of care therapies that you may be receiving at that time point after your injury.


Eligibility Criteria:
Inclusion Criteria:

* History of Acute and Traumatic SCI with AIS classification of B, C, or D between the neurological levels of C5 and T12
* Between the ages of 16-74
* Weight bearing as tolerated in bilateral lower extremities
* Able to tolerate a harness
* Ability to provide informed consent. For minors, consent of parents or primary caregivers/guardians and assent of the minor
* Able to provide informed consent within 60 days of injury onset
* Able to participate in all study related activities, including 1-year follow up

Exclusion Criteria:

* Orthopedic injuries, fractures, surgeries, or other conditions affecting locomotor function or weight bearing
* A weight over 250lbs and if so a BMI greater than 30, or deemed clinically inappropriate due to body habitus
* Moderate to sever traumatic brain injury of other neurological conditions at a severity which impairs cognition
* Presence of uncontrolled orthostatic hypotension that limits active participation in intense physical rehabilitation program.
* Other medical complications such as severe heart failure or large/deep pelvic or lower abdominal wounds that may limit the ability to safely don and doff a harness for ambulation
* Pregnancy, as confirmed by blood draw
The Use of Nursing-students-led bCBTMI

The use of the internet is very popular in adolescence. Notwithstanding the benefits from the internet, many users are addicted to the internet and develop problematic behaviours which are regarded as "Internet addiction" (IA). Trained nursing students, who are the future nurses and well-equipped with basic health knowledge, as the interventionists to deliver a bCBTMI intervention to the eligible subjects. The result of this study is expected to provide evidence of the feasibility and effectiveness of training nursing students to conduct bCBTMI in Hong Kong Chinese adolescents with IA for a definitive RCT.

A two-arm, parallel-group, feasibility cluster randomized controlled trial will be conducted. 60 adolescents with IA will be recruited from secondary schools in Hong Kong. Participants in the intervention group will receive 4 weekly 30-45 minute sessions using the brief CBT and the brief MI models by nursing students. Control group participants will receive routine care for IA.

Eligibility Criteria:
Inclusion Criteria:

* Aged 13 to 17
* Studying Forms 2 to 4
* Classified as IA by the Chinese version of Young's 10-item Internet Addiction Test (IAT)
* Can communicate in Cantonese and read Chinese.

Exclusion Criteria:

* With physical or cognitive impairment and learning problems as identified from the medical records
Personalized Cellular Vaccine for Recurrent Glioblastoma (PERCELLVAC2)

The treatment option for recurrent glioblastoma is limited. Immune cell based therapy for glioblastoma has shown some efficacy. This study is designed to perform a personalized clinical trial by first analyzing the expression of tumor associated antigens in patients with recurrent glioblastoma and then immunizing the patients with personalized antigen pulsed DCs. Immune responses to the immunized antigens will be monitored. Safety and efficacy will be observed in this study.

This is an open label, single-arm, single-institution, Phase I study designed to investigate the safety and efficacy of personalized cellular vaccines for patients with recurrent glioblastoma (GBM). Recurrent GBM patients will undergo tumor resection. The tumors will be analyzed for the expression of a panel of glioma-associated antigens and immune-related genes. Patients will undergo leukapheresis to collect mononuclear cells for DC generation. Based on the expression profiles of tumor-associated antigens, in vitro transcribed mRNA will be generated to pulse autologous DCs. Patients will be conditioned with immune adjuvants before and during immunization. Patients will receive biweekly vaccines. The antitumor specific T cell responses will be measured. Safety and efficacy will be monitored. The objective is to assess the safety of the personalized cellular vaccines and T cell responses. The efficacy of the vaccines will be evaluated using iRANO criteria, progression-free survival and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent glioblastoma grade IV
* Patients at the age of 18-65.
* Patients undergo tumor resection.
* Patients with Karnofsky scores \> or =70
* Patients with normal range of hematologic and metabolic test results.
* Patients must have no corticosteroids treatment at least one week before vaccination.
* Patients capable of understanding the study and signed informed consent.

Exclusion Criteria:

* Breast feeding females.
* Pregnant women.
* Infectious diseases HIV, HBV, HCV
* Documented immunodeficiency
* Documented autoimmune disease
* Any serious or uncontrolled medical or psychiatric conditions, for example, severe pulmonary, cardiac or other systemic disease.
* Patient inability to participate as determined by PI discretion.
Comparison of Post-operative Symptoms After Two Surgeries for Patients With Pelvic Organ Prolapse

Collect and review the patients who underwent surgical treatment due to pelvic floor organ prolapse from 2020 to 2021, make statistics on their postoperative questionnaire data, and evaluate the clinical effects of different surgical methods


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 30 years;

  * Because pelvic organ prolapse in our hospital, we performed extraperitoneal high sacral ligament suspension or sacrospinal ligament fixation; ③ Those who have no surgical contraindication and can tolerate surgery and anesthesia.

Exclusion Criteria:

* Those who cannot tolerate surgery and anesthesia; ② Patients receiving other tip suspension techniques.
Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers

Regular aspirin use has been associated with a reduction in the development of a number of different malignancies including lung cancer. The mechanism of aspirin's cancer prevention is not known. This study will evaluate whether once daily aspirin use can reduce the production of a protein named prostaglandin E2 (PGE-2), which is known to promote cancer. Specifically, this study will evaluate if aspirin can inhibit the production of PGE-2 by blocking an enzyme named cycloxygenase-2 (COX-2). To accomplish these goals, participants will take either aspirin 325 mg daily, celecoxib 200 mg twice daily, or the combination of both during various days of this 16-day study. Urine be collected to evaluate for PGE-2 production at 4 timepoints in this 16-day study.


Eligibility Criteria:
Inclusion Criteria:

* Male gender
* Age ≥35
* Current smoker of at least 10 cigarettes per day with history of ≥10 pack-years (py)
* Former smoker, quit no more than 15 years ago with a history of at least 25 py
* Ability to comply with the design of the study
* Capacity to freeze urine sample at participant's residence if this participant desires to store the urine specimens in this manner
* Baseline urine PGE-M \> 13 ng/mg creatinine
* Serum thromboxane \> 150 μg/L

Exclusion Criteria:

* History of aspirin use 1-14 days prior to screening
* NSAID (ibuprofen, naprosyn, meloxicam, etc) use 1-7 days prior to screening
* Inhaled glucocorticoid use 1-7 days prior to screening
* Systemic glucocorticoid use 1-14 days prior to screening
* History of peptic ulcer disease
* Current or recent clinically significant bleeding
* Allergy, intolerance or contraindication to aspirin or NSAID use
* Thrombocytopenia (platelet count \< 100,000) in 30 days prior to screening visit
* Severe hepatic insufficiency
* GFR \< 30 mL/min/1.73 m2 in 30 days prior to screening visit
* History of aspirin or celecoxib allergy
* Elevated INR (\>1.5) in 30 days prior to screening visit
* Current diagnosis of malignancy or history of non-skin malignancy in last 5 years
* Current use of systemic anticoagulants (e.g., warfarin (Coumadin), enoxaparin (Lovenox), Fondaparinux (Arixtra), dabigatran (Pradaxa))
* Diagnosis of COPD
* Intake of \> 250 mg of fish oil supplementation daily
Effectiveness of the Farsi Diabetes Self-management Education (FDSME) Program for People With Type 2 Diabetes

To evaluate the effectiveness of the Farsi diabetes self-management education program on psychosocial, lifestyle, and clinical measures in people with newly diagnosed people with type 2 diabetes and those with already-diagnosed type two diabetes who had received little self-management education. The development of the program was guided by an innovative process of intervention planning: Intervention Mapping.

For designing the management program, we will use Intervention Mapping (IM) framework for systematically developing the theory and evidence based program.

Based on IM approach, this study will have seven phases:

Step 1: needs assessment (Development the problem analysis: health, quality of life, behavior, environment).

Step 2: We will develop proximal program objectives with a multidisciplinary expert panel of participants.

Step 3: After identification of the proximal program objectives, the next step will be to select theoretical methods and practical strategies based on evidence for alternative methods.

Step 4: The forth step of the program development will comprise of composing program materials and pre-testing these materials with a sample of patients at a diabetic outpatient clinic.

Step 5: By involving the future program facilitators (health care workers at outpatient clinics) a linkage system will be foreseen.

Step 6: planning for evaluation Step 7: Randomized Clinical Trial

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes (according to the WHO criteria)
* Older than 18 years

Exclusion Criteria:

* Pregnancy
* Unable to participate in a group program (for example, housebound or unable to communicate in Farsi)
* Having reduced cognitive ability
Effects of Hydrocortison Treatment on Angiotensin II and Angiotensin II Receptors in Patients With Septic Shock

This study aims to evaluate the role of angiotensin II, AT1, and AT2 on catecholomine responsive and catecholomine resistant septic shock, and the effect of hydrocortisone traetment on catecholomine resistant septic shock and angiotensin II, AT1, and AT2.Angiotensin II can be used as a biomarker of vasoplegia observed in refractory septic shock unresponsive to catecholamine. In these patients; therapeutic effect of hydrocortisone on hypotension was performed by decreasing AT 2 level, AT2 should be investigated as a therapeutic target in the treatment of vasoplegia-induced hypotension and SVRI measured by minimally invasive cardiac output method suggests that it can be used as a useful parameter in the diagnosis and follow-up of vasoplegia.

This study will be enrolled 40 patients diagnosed with septic shock according to Sepsis 3 criteria. The patients with septic shock who needed a noradrenaline infusion rate of up to 0.5µg/kg/min to maintain MAP\>65 mmHg will be classified as control group (n=20) and the ones who required a noradrenaline infusion rate above 0.5µg/kg will be classified as hydrocortisone group (n=20). Blood samples will be taken for analysis of plasma angiotensin II, AT1, AT2 levels at the time of diagnosis, one hour after and on the 3rd day of the bundle and the hydrocortisone treatment. Hemodynamic parameters simultaneously obtain by continuous minimal invasive cardiac output measurement method will record.

Eligibility Criteria:
Inclusion Criteria:

* septic shock patient

Exclusion Criteria:

* other causes of end-stage organ failure, immunodeficiency, presence of acute mesenteric ischemia, vasospastic disease, pregnancy, other shock causes (hypovolemic, cardiogenic, neurogenic), life expectancy less than 48 hours corticosteroid use in the last 4 weeks
A Phase 1 Dose Escalation Study of AMG 780 in Adult Subjects With Advanced Solid Tumors

This is a first in human, open-label, sequential dose escalation and expansion study of AMG 780 in up to 62 subjects with advanced solid tumors. The dose escalation part of the study is aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 780. The dose expansion will consist of up to 20 subjects and the dose level of AMG 780 will be dependent upon emerging safety and PK data from the dose escalation part of the study.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years old
* Must have a pathologically documented, and definitely diagnosed, advanced solid tumor that is refractory to standard treatment, or for which no curative therapy is available, or for subjects who refuse standard therapy
* Measurable disease by RECIST criteria
* Must be able to undergo MRI evaluation
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Competent to sign and date an Institutional Review Board approved informed consent form

Exclusion Criteria:

* Presence of untreated or symptomatic primary central nervous system tumors or metastases
* Presence of leukemia or myelodysplastic syndrome
* Subjects with head and neck cancer
* Previous hematopoietic stem cell transplant (allogeneic)
* Unresolved hematological toxicities \> grade 1 with the exception of grade 2 lymphopenia and non-hematological toxicities \> grade 1, excluding alopecia and grade 2 neuropathy, from prior anti-cancer therapy
* Myocardial infarction within 1 year before study day 1, or unstable or uncontrolled disease/condition related to or affecting cardiac function
* History of stroke, arterial or venous thrombosis, or pulmonary embolism within 1 year before study
* Active peripheral vascular disease
* History of bleeding diathesis
* History of pulmonary hemorrhage or gross hemoptysis within 6 months before study
* Known history of adrenal hemorrhage
* Known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C
* Major surgery within 1 month before study
* Prior treatment with any agent targeting the angiopoietin-Tie2 signaling pathway
* Concurrent antitumor treatment, except Lupron for subjects with prostate cancer and selective estrogen receptor modulators (SERMS) for subjects with breast cancer, within 4 weeks (6 weeks for nitrosoureas or mitomycin) before study day 1
* Known sensitivity to mammalian-derived products, bacterially-produced proteins, or any of the products to be administered during dosing
* Investigational agent within 30 days before study
* Pregnant (eg, positive urine test) or breastfeeding
* Subjects of childbearing potential, or subject who has a partner of childbearing potential, and is not using highly effective contraceptive precautions
24-hour Control of Intraocular Pressure (IOP) in Ocular Hypertension

This study was designed to compare the 24-hour efficacy on intra ocular pressure (IOP) of drugs acting either on aqueous humor production ("inflow drugs") or on aqueous humor outflow ("outflow drugs") in human eyes affected by ocular hypertension and virgin to treatment. The enrolled patients will be exposed, in a cross-over design, to n = 2 aqueous suppressants and n= 3 uveoscleral outflow enhancers, and 24 hr IOP will be measured. It is hypothesised that outflow drugs may offer a better and more stable control of IOP through the 24 hours.

(a) study design: Prospective, open label, investigator-masked clinical trial, with cross-over design, both eyes treated, OD chosen for analysis; (b) study population: patients, showing ocular hypertension, who were never exposed to hypotensive treatment (see inclusion and exclusion criteria for details). (c) study drugs: Timolol and dorzolamide will be chosen as inflow drugs. The three prostaglandin analogues (PGA) Latanoprost, travoprost and bimatoprost will be chosen as outflow drugs. (d) study flow-chart: upon enrollment, patients will be initiated to the following schedule: 60 days timolol 0.5% bid, 60 days washout, 60 days timolol 0.5%-dorzolamide 2% fixed combination bid, 60 days washout, 60 days PGA1, 60 days washout, 60 days PGA2, 60 days washout, 60 days PGA3. Patients were assigned to the PGAs according to a sequence (L-T-B) randomly generated. Data will be collected at baseline and at the and of each study phase (i.e. active treatment and washout)(e) main efficacy outcome: change in the mean IOP (with respect to baseline) at the end of each study phase and change of IOP (with respect to baseline) at the different time points of the 24-hour phasing. IOP will be measured at 8 a.m., 11 a.m., 3 p.m., 6 p.m. and 9 p.m. by means of Goldmann applanation tonometry at the slit lamp. At midnight, 2 a.m. and 6 a.m. the Tonopen in supine position will be used. (f) statistics: the analysis of co-variance (ANCOVA) for paired samples with Bonferroni correction will be adopted. A minimum sample size of 51 patients is needed for a minimal expected difference in mean IOP between inflow and outflow drugs = 2.5 mmHg, with an estimated pooled variance = 4 , a power = 90% and an alpha probability = 5%.

Eligibility Criteria:
Inclusion Criteria:

* IOP \> 22 mmHg and \< 30 mmHg on at least three readings on separate days ,
* Open angle on gonioscopy,
* CCT \> 550 m,
* optic disk classified as "within normal limits" by Moorfields Regression analysis, HRTII,
* normal visual field (standard achromatic perimetry, Humphrey Field Analyzer, 24/2 SITA standard),
* Age \> 40 and \< 70 years,
* refraction between - 5 and + 2 dyopters,
* best corrected visual acuity better than 0.2 LogMAR,

Exclusion Criteria:

* PEX
* PDS
* ocular comorbidiities other than refractive problems and/or mild dry eye
* history of diabetes
* treatment with systemic beta blockers and steroids
* previous treatment with ocular hypotensive drugs
Beta-blocker vs. Ic Antiarrhythmic Drug for PVC

The standard medical therapy of idiopathic premature ventricular complex consists of beta blocker and Ic antiarrhythmic agent. However, the difference in the efficacy of two drugs has not been well investigated. This prospective randomized study aimed to compare the efficacy of beta-blocker and Ic antiarrhythmic agent in the treatment of symptomatic patients with idiopathic premature ventricular complex.

A premature ventricular complex is frequently observed in routine clinical practice and patients without structural heart disease occasionally have benign outcomes. The initial therapy of symptomatic premature ventricular complex is medical treatment with beta-blocker, calcium channel blocker or antiarrhythmic agents. However, no large prospective study has been performed to identify the difference in the efficacy between drugs. The current study was designed to compare the efficacy between beta-blocker and class Ic antiarrhythmic agent. Patient with symptomatic PVC more than 6000 episode per 24 hours is included. Exclusion criteria are evidence of structural heart disease, coronary heart disease, significant bradycardia or use of a concomitant antiarrhythmic agent. Patients are randomized into beta-blocker group (propranolol) and Ic antiarrhythmic agent group (propafenone). Response to the drug is evaluated after 2 months from randomization by 24 hours Holter and questionnaire. The primary endpoint is more than 80% PVC reduction or PVC burden less than 300 beats per 24 hours. The secondary endpoint is patient's symptom evaluated by questionnaire and the number of PVCs measured in 24 hours Holter.

Eligibility Criteria:
Inclusion Criteria:

* over 19 years old \>6000 PVCs/24hrs

Exclusion Criteria:

* Left ventricular ejection fraction \<50% or Significant valvular disease (≥moderate) History of coronary artery disease Use of a concomitant antiarrhythmic agent Significant bradycardia
Impact of Genetic Counseling for Female First Degree Relatives of Individuals With Mental Illness

Women with a close relative who has experienced mental illnesses like schizophrenia, bipolar disorder or schizoaffective disorder often have a poor understanding of the causes of the illness, and are often very worried about the chance that any children that they have will become affected with the same illness. Often, because of this fear, these healthy women choose not to have children.

Genetic counseling is a process where information about the causes of illnesses, and about chances for family members of individuals with these illnesses to become similarly affected is provided in a supportive environment by a specially trained healthcare professional. This study will investigate whether genetic counseling can reduce perceptions of risk and stigma, and increase perceived control and knowledge about the causes of the illness, amongst women who have a first degree relative with a major mental illness.

We will recruit 75 women who have a close relative with a major psychiatric disorder (as defined above). Each participant will be randomized into one of 3 groups of approximately equal size: one of which will receive genetic counseling within 1 month after enrollment (GC), another will receive the educational brochure within 1 month (EB), and the last will be assigned to waitlist (WT). After randomization (but prior to intervention for GC and EB groups, and within 1 month after enrollment for the WT group) we will gather baseline information regarding the 4 outcome measures (perceived risk and control, stigma, and knowledge). We will re-assess the 4 outcome measures immediately post-intervention for GC and EB groups. A further follow-up (for all groups) will be conducted two months after enrollment (which is 1 month post intervention for GC and EB groups).

Eligibility Criteria:
Inclusion Criteria:

* Fluent in English, and
* Have a first degree relative diagnosed with schizophrenia, bipolar, or schizoaffective disorder, and
* Reside in BC, and be able to attend 3 study visits over 1.5 months