cyrilzakka/clinical-trials huggingface dataset:
Registry for Patients Receiving Intravenous Nutrition at Home

The purpose of study is to build a Canadian HTPN Registry to collect pertinent demographic and clinical data on the HTPN population in Canada and to determine the factors affecting survival, complications and TPN-dependency. These results will help establish standards of practice and develop future multi-center studies. This will greatly benefit the HTPN patient population.

The HTPN Registry is website based. Only users inside of Canada will be able to access the website. All data is held in Ontario, Canada and is governed by Ontario and Canadian privacy and security laws. The entry point into the registry will be through a website www.htpnregistry.ca, using a specific HTPN program password for data entry. A code and date of birth will be used to identify each patient. Patient data will be kept confidential and be entered by a member of the TPN team from each participating program. Participating programs will have access to their own database and will be able to compare their patient population to the one of the entire registry. Data entered into the registry will include: 1) Patient demography 2) Nutritional assessment 3) Medications 4) Indications for HTPN 5) Gastrointestinal anatomy following surgeries 6) HTPN regimen 7) Current blood work 8) Vascular access 9) Hospitalizations 10) Survival, 11) Liver complications 12) Metabolic bone disease 13) quality of life. In addition, information regarding each HTPN program will be captured: organization of the TPN team, number of patients under the program, diagnosis and reasons for HTPN, source of funding, geographical coverage, home care utilization, providers. Data will be entered every two years by the one or more HTPN staff monitoring the patients. The data can be entered directly into the website or case report forms can be used to collect the data from the patient charts and facilitate data input into the website.

All patients will be followed prospectively until discontinuation of TPN or death. Descriptive statistics will be performed.

For the entire HTPN population, probability of survival, chronic cholestasis, complicated home parenteral nutrition related liver disease, line infection and metabolic bone disease will be calculated using the Kaplan-Meier method. As of February 2014, 433 patients (85 from UHN) have been entered into the Canadian HTPN registry. The recruitment and data collection is expected to continue for at least 5 more years (until 2019). Participating HTPN programs are: Toronto (Toronto General Hospital, St. Michael's Hospital), Hamilton (Hamilton Health Sciences),Winnipeg (St. Boniface General Hospital), Edmonton (Capital Health/University Of Alberta), Calgary (Foothills Medical Centre), British Columbia (BC Home Parenteral Nutrition Program) and Montreal (McGill University).

Eligibility Criteria:
Inclusion Criteria:

* Patients with long-term administration of home total parenteral nutrition Age \>18 years

Exclusion Criteria:

* None
Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Prostate cancer (PCa) is the most common non-dermatologic malignancy in U.S. men. Transrectal ultrasound (TRUS)-guided prostate biopsy is a commonly used diagnostic procedure for men with an elevated serum prostate-specific antigen (PSA) level and/or abnormal digital rectal examination (DRE). It is estimated that more than 1 million TRUS-guided prostate biopsies are performed annually in the U.S. alone. However, a freehand TRUS-guided systematic biopsy (SB) procedure has significant limitations. First, freehand biopsy cores are often spatially clustered, rather than uniformly distributed, and do not accurately follow the recommended, sextant template. Second, a freehand TRUS-guided biopsy does not allow precise mapping of the biopsy cores within the prostate. Targeted biopsy (TB) using special devices emerged to help the physicians guide the biopsy using multiparametric MRI (mpMRI). TB cores yield a higher cancer detection rate of clinically significance PCa than SB cores, but TB cores also miss a large number of clinically significant PCa that are detected by SB. Accordingly, TB is commonly performed concurrently with SB (TB+SB procedure).

This study attempts to improve TRUS-guided prostate biopsy by utilizing assistance from a novel robotic TRUS manipulator (TRUS-Robot) developed by our team. The hypothesis of the study is that clinically significant prostate cancer detection rate from the SB cores (at SB or TB+SB) can be improved above that of current devices. The objective of the study is to gain early evidence on the effectiveness of prostate biopsy assisted by the TRUS-Robot vs. a current TB device in a randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for an initial diagnostic biopsy
* Elevated serum PSA (prostate specific antigen\> 4 ng/ml) and/or abnormal digital rectal exam

Exclusion Criteria:

* Clinical diagnosis of prostate cancer
* Prior prostate biopsy
* Anal stenosis that prevents TRUS probe insertion
* Inadequate bowel prep
* Unwilling or unable to sign the informed consent
SSNB in Hemiplegic Shoulder Pain

The purpose of this study is to compare suprascapular nerve block with therapeutic ultrasound in stroke patients who have shoulder pain in weak side.

Shoulder pain is a common complication after a cerebrovascular accident.Hemiplegic shoulder pain has been shown to affect stroke outcome in a negative way.It interferes with recovery after stroke:it can cause distress and reduced activities and can markedly hinder rehabilitation.Suprascapular nerve block has been shown to be effective as an analgesic for different indications such as shoulder capsulitis.The purpose of this study was to evaluate the effectiveness of this technique conjunction with a rehabilitation program to reduce shoulder pain in hemiplegic patients.

Eligibility Criteria:
Inclusion Criteria:

* Stroke patients who develope shoulder pain at weak limb.
* Good conscious and able to access pain score.
* No history of drug reaction with xylocaine
* No history of fracture,tumor or blood tendency.
* Willing to enrolled to study and signs inform consent.

Exclusion Criteria:

* Patients who do not meet the inclusion criteria.
Antiretroviral-Sparing Concept With HIV-specific T Cell Precursors With High Proliferative Capacity (PHPC)

PHPC-02 is a phase II, randomized, placebo-controlled trial designed to investigate whether therapeutic immunization during highly active antiretroviral therapy (HAART) induces elevations of HIV-specific T cell precursors with high proliferative capacity (PHPC) in HIV-1-infected individuals, and whether the quantity of PHPC correlates with the viral load set point following analytical treatment interruption (ATI). Subjects will be randomized to receive either DermaVir Patch (8 subjects per cohort) or DermaVir Patch Placebo (8 subjects per cohort) every four weeks for three applications while receiving maximally suppressive HAART. HAART will be discontinued at Week 9 for an ATI period of 20 weeks.

16 subjects on maximally suppressive HAART were randomized to receive three doses of either DermaVir or Placebo immunotherapy.

Subjects receive three DermaVir/Placebo treatments over eight weeks (Weeks 0, 4 and 8) while receiving HAART. HAART is discontinued for a 20 week ATI.

Resumption of HAART during ATI is subjects experience:

* A confirmed CD4+ cell decrease by \> 50%
* A confirmed CD4+ cell decrease to less than 350 counts/mL
* A confirmed VL increase \> 300,000 copies
* Emergence of CDC AIDS related event(s)
* Signs or symptoms of clinically significant immunosuppression
* The subject or the subject's clinician wishes to restart HAART
* The subject becomes pregnant

Eligibility Criteria:
Main inclusion Criteria:

* HIV-1 infection
* On a non-hydroxyurea based HAART for at least one year
* Pre-HAART CD4 nadir \> 250 cells/mm3
* Pre-HAART viral load \> 5,000 copies/mL
* Undetectable viral load for the six month period preceding the study
* CD4 T-cell count \>500 cells/mm3 for the six month period preceding the study

Main exclusion Criteria:

* No skin disease
* No hypersensitivity to adhesive tape or Tegaderm
* No history of keloid
* No history of vitiligo, melasma, skin cancer
* No tattoos or changes in pigment at the skin treatment sites
* No autoimmune diseases
* No hepatitis B, C coinfections
Usage and Health Effects of Embodied Conversational Agents Among Older Adults

Rationale: Embodied Conversational Agents (ECAs), could be a highly effective medium to address health behaviour change among older adults. As compliance to health advice is important for positive health outcomes, successful design of persuasive ECAs can have huge health benefits. However, insights in the mechanisms underlying usage and health behaviour change via ECAs are lacking.

Objective: The objective is to unravel the mechanisms behind the use of an ECA intervention, and understand the mechanism behind the observed behaviour change

Study design: A randomized staggered-entry waitlist-controlled trial will be carried out.

Study population: The study population consist of Dutch-speaking older adults, who live independently, are without partner, are retired, 65+ and possess basic computer skills.

Intervention: The application PACO has been created for (and with) older adults with the goal to motivate them to improve their eating behaviour and decrease their feelings of loneliness.

Main study parameters/endpoints: The main study parameters are use, loneliness, and eating behaviour.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects are not exposed to any risks, nor have they any costs. They do have to fill in questionnaires and use the application. The duration and data collection moments are needed to gain a fine-grained understanding of the use, relationship development and health change process. For subjects, the main benefit is to gain insight in their health behaviour via the PACO-application. Although this might be experienced as confronting by some. The technology was developed based on sound theories, with input from the target group, so the investigators expect positive experiences and an improvement in participants loneliness and eating behaviour. However, this can only be proven after the study.


Eligibility Criteria:
Inclusion Criteria:

* Living independently at home
* Living without a partner
* No paid profession and at least 65 years of age
* Dutch speaking
* Able to use a tablet or computer
* Internet connection at home

Exclusion Criteria:

* Not willing to provide inform consent
Standalone OMNI Surgical System for Open-angle Glaucoma

The emergence of minimally invasive glaucoma surgeries (MIGS) has seen a variety of potential innovative surgical alternatives to help better control intraocular pressure (IOP). The OMNI™ Surgical System (Sight Sciences, Menlo Park, CA, USA) is a promising MIGS procedure. It combines two procedures known as trabeculotomy and viscodilation of Schlemm's canal in one hand held device without the need for additional incisions or extra instrumentation. The device recently received FDA approval in the United States for certain indications in ophthalmic surgery. To date, no study has examined the effect of standalone viscodilation and trabeculotomy on glaucoma drop burden and IOP.

The emergence of minimally invasive glaucoma surgeries (MIGS) has seen a variety of potential innovative surgical alternatives to help better control intraocular pressure (IOP).1 The OMNI™ Surgical System (Sight Sciences, Menlo Park, CA, USA) is a promising procedure which targets the conventional outflow pathway.2 This device treats the trabecular meshwork, Schlemm's canal and the distal collector channels, all conventional pathway points of aqueous outflow resistance. Its designed microcatheter allows for cannulation of Schlemm's canal, dilation using the controlled delivery of viscoelastic as well as a trabeculotomy by stripping the trabecular meshwork will retracting the catheter.3 Goniotomy-assisted transluminal trabeculotomy (GATT) has shown promising results in using an ab interno approach to cleave the trabecular meshwork.4 Alternatively, viscodilation alone has also shown an IOP lowering effect. 5 The OMNI Surgical System combines both procedures in one hand held device without the need for additional incisions or extra instrumentation. The device recently received FDA approval in the United States for delivery of small amounts of viscoelastic fluid during ophthalmic surgery and to cut trabecular meshwork tissue during trabeculotomy procedures.6 To date, no study has examined the effect of standalone viscodilation and trabeculotomy on glaucoma drop burden and IOP.

Eligibility Criteria:
Inclusion Criteria

* Patients aged 30-95 with primary or pigmentary / pseudoexfolliative / juvenile / normal pressure open angle glaucoma or combined mechanism glaucoma.
* An IOP of 10-40 mmHg on maximum tolerated medical therapy who are either progressing, above IOP target, or poorly adherent or tolerant to medical therapy.
* Phakic or pseudophakic eyes and previous laser trabeculoplasty will be included.

Exclusion Criteria:

* Other forms of glaucoma,
* prior incisional glaucoma surgery,
* prior corneal graft (PKP, DALK, DSAEK, DMEK),
* Shafer angle grading \<2 in 2 or more quadrants.
A Study To Asses Mass Balance And Absolute Bioavailability Of 14C PF-06826647 In Healthy Male Participants

The purpose of the study is to determine the metabolism and excretion following a single oral administration of 14C-PF-06826647-LR (14C labelled PF-06826647 with lower radioactivity per mass unit) in fed conditions. This information will enable assessment of clearance mechanisms of PF-06826647 as well as identify metabolites. In addition, this study will determine absolute bioavailability of PF-06826647 and understand intravenous (IV) pharmacokinetic (PK).


Eligibility Criteria:
Inclusion Criteria:

* Healthy Male participants must be 18 to 55 years of age, inclusive.
* Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, including BP and pulse rate measurement, laboratory tests, and 12 lead ECG.
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
* BMI of 17.5 to 30 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* History of irregular bowel movements including irritable bowel syndrome or frequent episodes of diarrhea or constipation defined by less than 1 bowel movement on average per 2 days or lactose intolerance.
* Participants who currently use or have formerly used (within 6 months of dosing) tobacco or nicotine containing products.
* Total 14C radioactivity measured in plasma exceeding 11 mBq/mL.
Pharmacokinetics，Safety and Efficacy of ZSP1273 in Children 2-17 Years Old With Influenza A

This trial is conducted in China. The aim of the trial is to investigate safety,pharmacokinetics and pharmacodynamics of ZSP1273 granules


Eligibility Criteria:
Inclusion Criteria:

1. Subjects and their guardians who are able to understand the study and comply with all study procedures, and willing to provide written informed consent/assent prior to the predose examinations appropriately.
2. Male or female subjects aged ≥ 2 to ≤17 years at the time of signing the informed consent form.
3. Subjects with a diagnosis of influenza virus infection confirmed by all of the following:

   * Positive rapid antigen test (RAT) for influenza with nasal or throat swabs;
   * The time interval between the onset of symptoms and enrollment is 72 hours or less;
   * Fever ≥ 38ºC (axillary temperature); and at least one following respiratory symptoms associated with influenza virus infection is present

Exclusion Criteria:

1. Subjects with severe influenza virus infection；
2. Subjects with any medical history in gastrointestinal that interferes with the absorption of drugs；
3. Immunodeficiency,including malignant tumor,organ or marrow transplant,human immunodeficiency virus \[HIV\] infection,or patients receiving immunosuppressant therapy 3 months prior to enrollment；
4. Have received any other investigational products within 3 months prior to dosing；
5. Positive urine pregnancy test；
6. Subjects with concurrent infections requiring antimicrobial therapy；
7. Subjects who are considered inappropriate for the study by the investigator.
Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

Results of recent systematic reviews suggest favorable results of embolization for the treatment of Pelvic Congestion Syndrome (PCS) compared with pre-procedure symptoms for several outcomes, including pain reduction, overall patient satisfaction, and technical feasibility. Reported complication rates appears relatively low.

Pelvic vein embolization is a relatively new technology and the results may provide background for an evidence based decision to offer embolization of pelvic varicosities for women with PCS in Norway.


Eligibility Criteria:
Inclusion Criteria:

* Pelvic pain (lasting for more than 6 months)
* Symptoms of PCS - deterioration of pain when standing and improvement in supine position (with or without dyspareunia or dysmenorrhea).
* Confirmed pelvic varicosities by magnetic resonance examination.
* Signed, written and informed consent

Exclusion Criteria:

* Inability to communicate in Norwegian
* Known endometriosis
* Uterine myoma, uterine anomalies, or cancer
* Postmenopausal
* not having been pregnant
Multicenter Validation of a Predictor Model of ACHD Patients and Cardiac Surgery

This multicentre study is to validate prediction modeling for the ACHD population undergoing cardiac surgery. The validation of this prediction model will support and generalize its use as a risk stratification tool in the ACHD population.

The prediction model resulted from a preceding study, which uniquely based on comorbidities, was developed using 783 adults (\>16 years) who underwent surgery for congenital heart disease at Toronto General Hospital (TGH) during 2004-2015. It identifies five pre-operative variables, namely presence of cognitive impairment, hepatic function, \>3 chest incisions, anatomy diagnosis, and Body Mass Index \<20 and \>28, as significant predictors of composite adverse outcomes such as in-hospital mortality, prolonged ventilation (exceeding 7 days) and acute kidney injury.

This newly prediction model developed in a single-center has only been internally validated. It requires further external validation to demonstrate its utility in ACHD populations who require cardiac surgery in other cardiac institutions both nationally and internationally.

Eligibility Criteria:
Inclusion Criteria:

* all ACHD patients \>16 years of age undergoing cardiac surgery requiring an open sternotomy or thoracotomy and cardiopulmonary bypass (CPB) or CPB standby at TGH and the collaborating institutions from April 2019.

Exclusion Criteria:

* CHD patients \<16 years of age
* ACHD patients undergoing chest wall debridement and chest re-explorations for bleeding
* Non-cardiac surgery procedures and cardiology laboratory interventions
Peri-implant Tissues on Aesthetic Slim Abutment Galimplant (PSG)

This is a randomized, single-blind, split-mouth clinical trial to evaluate the performance of peri-implant tissues (bone and soft tissues) in conventionally loaded Galimplant implants, using a classic multi-position, anti-rotational abutment, comparing it to the new multi-abutment aesthetic slim anti-rotational placed both at the time of the implant surgery. To this end, 80 Galimplant implants with a diameter of 4 mm and 10 mm in length will be placed in areas of mature scarred post-extraction bone. Patients be divided into 2 study groups, group C: straight pillar; Group T: Slim pillar. The bone and clinical radiological stability of the peri-implant tissues will be evaluated at 6 weeks post-surgery and at 6-12-24 months post-prosthetic loading.


Eligibility Criteria:
Inclusion Criteria:

* Patients without systemic pathology that are grounds for absolute contraindication
* Older adults who agree to be part of the study and sign the informed consent
* Consumption of tobacco less than 5 cigarettes / day
* Do not be completely toothless
* Absences of at least two pieces in posterior area with or without free ends to distal, maxillary or mandibular that do not require regenerative techniques. In case of odd absences (3,5,7), a Slim pillar will be placed, being the group to always be the majority.
* Area of mature bone healed at least 6 months post-extraction.
* Patients with a sufficient amount of bone to place implants 4 mm in diameter and 10 mm long

Exclusion Criteria:

* Immunosuppressed
* Aesthetic edentulous areas of 13-23 and 33-43
* Smokers of more than 5 cigarettes
* Index of bleeding greater than 30%
* Patients with less than 2 mm of keratinized gingiva
* Implants with primary stability with ISQ \<55
* Implants with ISQ index \<55 at 8 weeks
* When a margin of safety can not be assumed to the inferior dental nerve of at least 1 mm