cyrilzakka/clinical-trials huggingface dataset:
Digital Dialectical Behavioral Therapy (d-DBT) Skills for Acute Suicidality in Psychiatric Inpatients

Suicidality (ideation about taking one's life, suicide plans, and attempts) is a major public health concern in Ontario and worldwide. Psychiatric inpatients with suicidality represent a group that is high-risk for subsequent suicide. Current standard-care for suicidal psychiatric inpatients focuses on containment of risk and indirect treatment of suicidality by treating any underlying mental disorder. Though there is evidence that addressing suicidality directly is more effective than an indirect approach, there are limited evidence based treatments that target suicidality. Furthermore, there are few high-quality studies that have included inpatients. Psychotherapeutic interventions are under-utilized for inpatients and COVID-19 has further widened this gap given attempts by hospitals to reduce face-to-face contact with patients. Digital psychotherapy interventions have the ability to bridge this gap given their lower cost, ease of dissemination, acceptability by patients, and effectiveness. To our knowledge, there are no studies that have assessed the feasibility, acceptability and effectiveness of digital interventions for suicidal inpatients. Our study is a feasibility trial of a previously studied digital Dialectical Behavioural Therapy (d-DBT) skills intervention in suicidal psychiatric inpatients.

The study is a two arm randomized parallel group-controlled trial, 6-10 day, flexible timeline, randomized feasibility trial of a d-DBT skills intervention added to standard care for patients admitted to psychiatric inpatient units with suicidality. There will be 20 patients who will receive the intervention in addition to standard care and 20 patients who will receive standard care alone. There will also be a 4 week follow-up after discharge from hospital.

Participants will be admitted for psychiatric care at the Complex and Critical Care Units, Centre for Addiction and Mental Health (CAMH), Toronto.


Eligibility Criteria:
Inclusion Criteria:

1. patients with any DSM-5 diagnosis aged 18 years and above;
2. admitted to CAMH with suicidality and a baseline BSI score of \> 6;
3. capable and willing to give informed consent;
4. anticipated length of admission is greater than 5 days;
5. deemed suitable by the primary team to take part in a psychotherapeutic intervention as part of standard care

Capacity to consent will be evaluated by the research staff performing the informed consent process. It will be assessed as the participant's ability to understand and appreciate the risks and benefits of taking part in the proposed study.

Exclusion Criteria:

1. presence of psychiatric symptoms that interfere with the ability to complete the d-DBT
2. Concurrent treatment with ECT or MST
Effectiveness Basket Wires for the Maintenance of Stone and Pneumatic Probe in the Treatment of Ureteral Stones

Patients included in the study included the necessary tests U / A, K, Na, Cr, BUN, CBC, And U / C was checked and anesthesia counseling was done. Patients were prepared for action. The demographic and clinical data of the patients, including age, sex, size, and location of the stones were recorded.

Then patients as random allocation were divided into two groups: A (control group, no basket of bases and group B (use of pneumatic synchronous buccal waist). The dividing person and the patients themselves were not aware of which group they were in. They were double-blind was.

In each group, ureteroscopy was performed using a standard F9.5 ureteroscope. After reaching the rock in group A (control), the probe of the pneumatic crusher was passed through the working channel of the ureteroscope and began crushing the rock.

During the crushing process, the minimum flow of water, flattening and the single-shot impact was used to minimize the stone's retropulsion.

In group B (using a basket of wires3F) the helical type was passed through the four wires of the working channel of the ureteroscope and routed to the proximal part of the rock, and the stone was routed to the bowl, then the stone was ducted The gasket was kept, and the probe of the pneumatic crusher also passed through the working channel and proceeded to break it down. Conditions were observed during the stomach as the control group. Ureteroscopic crushing was performed by a urologist in both groups under similar technical conditions. Findings during and after the completion of crushing include the success, stone retropulsion or parts larger than 3 mm, which requires secondary measures (SWL - ureter stenting, resection ureteroscopy), the duration of stone breakdown and traumatic ureteric complications in both groups it is registered.


Eligibility Criteria:
Inclusion Criteria:

* Individual interest in engaging in research
* Patients with ureter stones
* Symptoms of severe and resistant to supportive and therapeutic treatment
* Ureteral stones cause ureteral obstruction
* Ureteral stones, which is not likely to be disposed of by duration and size, have been selected for ureteroscopic lithotripsy.

Exclusion Criteria:

* Patients with urinary tract infection
* Not having a proper cardiovascular condition and not approved by a cardiologist or anesthetist
* Patients who are dissatisfied with ureteroscopic crushing and patients who do not have access to rocks during ureteroscopic surgery
* Individual interest in leaving the study
Treatment Pattern of NOACs (Non-vitamin K Oral Anticoagulants) in Outpatient Users in Colombian Databases

This population-based descriptive study will characterize first-time users of three NOACs (rivaroxaban, dabigatran and apixaban) in prevention of stroke in non-valvular atrial fibrillation (SPAF) patients and will assess the patterns of drug utilization in routine general practice in Colombia


Eligibility Criteria:
Inclusion Criteria:

* First prescription of NOACs (rivaroxaban, dabigatran and apixaban) in the outpatient setting.
* Non valvular Atrial Fibrillation (NVAF) Patients
* aged ≥18 years
* at least one year of enrollment in the Audifarma database
* one year since first encounter with healthcare provider will be included in the study

Exclusion Criteria:

* Patients with any record of index drug prescription prior to the enrolment period.
* Patients who qualify as members of more than one cohort study on the same day
Breast MRI in Evaluation of Pathologic Response in Patients With Breast Cancer With Neoadjuvent Chemotherapy

evaluation of pathological response in breast mass by use of breast MRI in patients receiving neoadjuvent chemotherapy via comparison with pathological results

evaluation of pathological response in locally advanced breast masses by use of breast MRI in patients receiving neoadjuvent chemotherapy via comparison with pathological results

Eligibility Criteria:
Inclusion Criteria:

* all women referred to the radiology department for breast MRI examination either for screening, evaluation of suspicious lesions onsono-mammography \\

  * Patients with locally advanced breast cancer
  * Patients with early stage breast cancer and chemo-responsive tumour markers (i.e. triple negative, Her2+), who will benefit from downsizing for breast conserving surgery (BCS)
  * Absolute or Relative contraindications to surgery (advanced age/multiple medical comorbidities) in the setting of estrogen receptor positive tumours (for consideration of neoadjuvant endocrine therapy)3
  * Patients must be elder than 18 years old.
* patients with accepted renal function

Exclusion Criteria:

* Patients with metastatic breast cancer.
* Patient with breast mass more than 5 cm .
* Patients with fungating breast mass .
* Patients with stage IV \[tumor spread to chest wall and to skin \].
* pregnant women especially in 1th trimester.
* Patient with presence of any paramagnetic substance as pacemakers.
* severely ill patients .
* patients with claustrophobia.
* arrhythmic patients
Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)

The primary objective of this study is to determine the Maximum Tolerated Dose (MTD) for belinostat when combined with CHOP regimen and establish the recommended belinostat dose for the Phase 3 study.

This is a Phase 1 dose finding study using the traditional escalation rule of 3+3 design to evaluate the Maximum Tolerated Dose (MTD) of belinostat when administered in combination with CHOP.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or above
* Life Expectancy \> 3 months
* Histologically confirmed diagnosis of PTCL
* Patients with transformed CTCL eligible for CHOP regimen
* Measurable disease based on Cheson 2007 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2

Exclusion Criteria:

* Known active Hepatitis B/ Hepatitis C/ HIV infection
* Known, uncontrolled CNS metastases or primary CNS lymphoma
* Deep vein thrombosis diagnosed within 3 months
* Ongoing treatment for pre-existing cardiovascular disease
* Neuropathy Grade 3 or more
* Previous extensive radiotherapy except limited field RT for locally advanced nasal NK PTCL or for pain palliation
* Prior therapy with severely myelotoxic regimens, including autologous and allogenic stem cell transplantation
* Prior therapy with HDAC inhibitors (except for CTCL)
* Inadequate hematological, hepatic, or renal function
Safety and Efficacy Study of NovoRapid™ in Patients With Coexisting Diabetes and Kidney Disease

This study is conducted in Asia. The aim of this observational study is to investigate the clinical safety profile and effectiveness while using SC NovoRapid™ (insulin aspart) in patients with coexisting diabetes and kidney disease under normal clinical practice conditions in India.


Eligibility Criteria:
Inclusion Criteria:

* Any subject with coexisting kidney disease and type 1 or type 2 diabetes is eligible for the study, including: newly-diagnosed subjects, insulin naïve and subjects who have received insulin or an insulin analogue before
* Subjects with kidney disease (stage I-IV) including transplant patients will be eligible for the study, if initiated with NovoRapid™"

Exclusion Criteria:

* Subjects who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit
* Subjects with stage V of chronic kidney disease
* Subjects who previously enrolled in this study
* Known or suspected allergy to trial product(s) or related products
Effect of Pregabalin on Shoulder Pain in Patients With Central Sensitization After Arthroscopic Rotator Cuff Repair

This study aims to investigate the effects of Pregabalin intake on shoulder pain management in patients with central sensitization undergoing arthroscopic rotator cuff repair. Although Pregabalin is known to be effective in controlling pain after shoulder arthroscopy, research on its efficacy in pain management for patients with central sensitization is scarce. Utilizing a list that identifies central sensitization, this study will explore whether Pregabalin can reduce postoperative pain in these patients and potentially improve joint mobility, emotional, and physical functioning. A prospective randomized study is planned, with inclusion criteria set for patients aged between 19 and 70 who have undergone arthroscopic rotator cuff repair.

The study will compare clinical outcomes up to one year postoperatively between two groups of 38 patients each. The case group will receive standard postoperative medications (NSAIDs) plus Pregabalin oral intake from the day before surgery to six weeks postoperatively, while the control group will receive only the standard postoperative medications without Pregabalin.


Eligibility Criteria:
Inclusion Criteria:

* Age over 19 to under 70
* Underwent arthroscopic rotator cuff repair due to a tear of the rotator cuff.
* Clinical diagnosis of myofascial pain syndrome
* Central sensitization (Central Sensitization Inventory (CSI) score of 40 or above).

Exclusion Criteria:

* Previous history of Pregabalin prescription
* Hypersensitivity reactions or severe complications after taking Pregabalin.
* Diagnosed with and are being treated for psychiatric disorders
* Localized infection, sepsis, or previous neurological abnormalities
* Uncontrolled hypertension (evidenced by a resting blood pressure of more than 100 mmHg)
* Liver function abnormalities (aspartate aminotransferase or alanine aminotransferase \&gt;60 IU/litre).
* major cardiovascular diseases or renal impairments
Adverse Health Effects of Mainstream and Secondhand Hookah Smoke in NYC Hookah Bars

The primary purpose of this study is to examine the health effects of mainstream and secondhand hookah (i.e. water pipe) smoke on pulmonary and cardiovascular functions as well as serum levels of inflammatory biomarkers. Investigators would like to demonstrate that inhalation of both mainstream and secondhand smoke generated by hookah produces adverse pulmonary and cardiovascular effects and alterations in serum levels of inflammatory biomarkers.

A total of 20 participants are going to be enrolled in this study; 10 participants smoke hookah and 10 participants are exposed to second hand hookah smoke for 2 hours in NYC hookah bars. Subjects in the control group will also be paired as they were for the hookah bar visit but will visit a control location, where they will be asked to consume a similar amount of food and drink at a wine bar. Pulmonary function, cardiovascular changes, and blood and urine markers of inflammatory mediators before, immediately after and 24 hours after the participants' visits to hookah bars and wine bars will be examined. Air quality monitoring will also be performed at the hookah bar and at the control location. Physiological changes will be assessed by measuring pulmonary function, blood pressure, heart rate, and blood oxygenation status. To determine the extent of tobacco exposure and associated inflammatory changes from secondhand hookah smoke, investigators will measure blood inflammatory biomarkers, oxidative stress, gene expression, tobacco-related carcinogenic metabolites, and exhaled carbon dioxide levels.

Eligibility Criteria:
Inclusion Criteria:

* Competent adult English speaking subjects
* Have used hookah in the past

Exclusion Criteria:

* Age \<21
* Pregnancy
* Current cigarette smokers
* Has pulmonary disease, such as asthma or Chronic Obstructive Pulmonary Disease (COPD)
* Subjects are unable to give voluntary informed consent because they are non English speaking, are unable to read or write, or any other impediments that prohibits giving written informed consent
* Recent nasal surgery (within 6 months)
* History of bleeding or other blood related disorder.
Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic Fibrosis

The aim of this study is to investigate the efficacy of antibiotic therapy with any antibiotic (IV) and IV (Nebcin®) tobramycin for 5 days followed by Solution for nebuliser inhalation (Tobi®) for 9 days and antibiotic cures using 14 days of tobramycin IV. In the case of positive results, the reduction of the duration of IV treatment of tobramycin from 14 days to 5 days would limit the risk of toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Patient with cystic fibrosis confirmed by sweat or genetic test
* Patient with clinical signs of exacerbation (increased cough, sputum (abundance, purulence), fever, anorexia, weight loss and FEV1) or acute exacerbations (defined at the clinician's discretion )
* FEV1 ≥ 25%
* Pseudomonas aeruginosa chronic carriers (defined by at least two antipyocyanic precipitation arcs or at least 3 successive positive ECBCs over a period of 18 months)
* Patient who received at least 1 IV course of antibiotics in the 18 months prior to inclusion.

Exclusion Criteria:

* Severe exacerbation (requiring hospitalization due to severe amputation of FEV 1, oxygen deficiency, or severe impairment of general health).
* Patient with 3rd antibiotic therapy (triple therapy)
* Patient colonized in Burkholderia cepacia
* Patient colonized by an atypical mycobacterium
* Patient with pulmonary transplant or transplant

  * chronic tinnitus
  * patient using hearing aid
* Hypersensitivity to tobramycin and other antibiotics of the aminoglycoside family
* Cirrhosis of Grades B and C according to the Child-Pugh Classification
* Myasthenia gravis
* Simultaneous administration of another aminoglycoside
* Renal failure
* Recent history of severe hemoptysis (within 2 months before inclusion)
* Patient participating simultaneously in another clinical study conducted on a drug for the duration of its participation in this research
Computer Aided Gap Balancing Improves Sagittal Stability and Outcomes for Cruciate-Retaining Total Knee Arthroplasty

Computer Aided Surgery in total knee arthroplasty improves knee stability and functional outcomes more than conventional total knee arthroplasty.

The success of total knee arthroplasty depends on restoration of limb alignment, precise implant positioning and optimal gap balancing. The advent of computer aided surgery (CAS) has improved limb alignment and implant positioning. The objective of this study was to evaluate the functional outcome of computer aided soft tissue gap balancing in total knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* primary osteoarthritis of the knee

Exclusion Criteria:

* rheumatoid arthritis, previous knee surgery, infection and those who could not be treated with unconstrained cruciate retaining TKA and a short stem tibial implant
Proton Radiotherapy for Upper Gastrointestinal Malignancies

The primary objectives are to determine feasibility and the acute toxicity profile of proton therapy with concurrent continuous infusion 5-FU chemotherapy. Secondary objectives are to determine late toxicities and to generate preliminary data on clinical efficacy.

This protocol invites patients with cancer of the upper digestive tract who will receive simultaneous proton radiation therapy and chemotherapy. The purpose of this study is to use a newer form of radiation therapy called proton radiation and to determine if its use is safe and effective in people with this type of cancer. Doctors will assess the safety of this method of treatment, record the side effects participants experience while receiving the standard dose of proton radiation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologic diagnosis of adenocarcinoma of the upper gastrointestinal tract, including patients with any of the following diagnoses and settings who are candidates to receive radiation which concurrent continuous infusion 5-FU chemotherapy: Pancreatic adenocarcinoma (unresected and adjuvant), Duodenal adenocarcinoma (unresected or adjuvant), Cholangiocarcinoma (unresected or adjuvant), Gastric adenocarcinoma (unresected or adjuvant), Gastroesophageal junction adeno carcinoma (adjuvant)
* Patient must be \>18 years of age.
* Patient must have an ECOG Performance Status of 0-2, and a life expectancy of greater than or equal to 3 months.
* Patient must be able to provide informed consent.
* Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented.

Exclusion Criteria:

* Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
* Pregnant women, women planning to become pregnant and women that are nursing.
* Patients who experience surgical complications which prevent radiation from starting for 3 months or more.
Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods

Previous studies on iron absorption have focused on the effects on the addition of iron absorption enhancers like ascorbic acid and EDTA to a meal and more recently the enzymatic phytic acid removal through phytase. The investigators want here to investigate the effects of fat on iron absorption with and without the addition of exogenous phytase as a potential iron absorption enhancer in lipid nutrient supplements (LNS) products compared to micronutrient powder(MNP) products.

Furthermore the investigators will evaluate the effects of Lipids- on iron absorption to induce the ileal brake by ingestion of a fat emulsion prior to a meal. Increasing the caloric density of a meal by increasing its fat content might enhance iron absorption by delaying gastric emptying, gastric acid secretion and increasing Fe stomach residence time.


Eligibility Criteria:
Inclusion Criteria:

Reproductive age females 18-45 years

* Normal body mass index (17.5-25 kg/m2)
* No intake of mineral/vitamin supplements 2 weeks before and during the study
* No metabolic or gastrointestinal disorders
* No food allergies or other chronic disorders or eating disorders assessed by self-report
* Having received full oral and written information about the aims and procedures of the study
* Willing to comply with the study procedure
* Having provided oral and written informed consent

Exclusion Criteria:

* Regular intake of medication (except oral contraceptives)
* Blood donation or significant blood loss (accident, surgery) over the past 4 months
* Currently participating in another clinical trial or having participated in another clinical trial during the last 30 days prior to the beginning of this study
* Former participation in a study involving administration of iron stable isotopes
* Subject who cannot be expected to comply with study protocol
* Pregnancy or lactation
Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis

The primary objective of the study is to determine the proportion of patients with elevated triglycerides (TG), without familial chylomicronemia syndrome (FCS) due to loss of function (LoF) mutations in lipoprotein lipase (LPL), and a history of hypertriglyceridemia (HTG)-associated acute pancreatitis (AP) who experience a recurrent episode of AP after treatment with evinacumab versus placebo.

The secondary objectives of the study are:

* To determine the change in the standard lipid profile after therapy with evinacumab versus placebo
* To determine the changes in specialty lipoprotein parameters (ApoC3, ApoB48, ApoB100, and nuclear magnetic resonance \[NMR\] lipid profile) after therapy with evinacumab versus placebo
* To measure the number of AP episodes per patient
* To assess the safety and tolerability of evinacumab
* To assess the potential immunogenicity of evinacumab
* To assess the concentrations of total evinacumab and total angiopoietin-like 3 (ANGPTL3)


Eligibility Criteria:
Key Inclusion Criteria:

1. Adults without FCS due to LPL loss of function mutations
2. Documented history of 1 HTG-associated AP episode within 24 months of screening
3. Fasting serum TG value \>880 mg/dL (10 mmol/L) or \>500 mg/dL (5.6mmol/L) determined during the screening period as described in the protocol
4. Stable dose of lipid-lowering therapy (≥8 weeks) and willingness to maintain a stable regimen throughout the study
5. Body mass index ≥18.0 and ≤45.0 kg/m2
6. Compliance with a stable diet and exercise regimen at screening and willingness to continue the diet through the end of the study

Key Exclusion Criteria:

1. Hospitalization for AP within 4 weeks of screening
2. Known genetic FCS defined as homozygous or compound heterozygous LoF mutations in LPL as defined in the protocol
3. Symptomatic gallstone disease within 6 months prior to screening as defined in the protocol
4. Use of any medication or nutraceutical known to alter serum lipids which has not been part of a stable therapeutic regimen for at least 8 weeks, and there are no plans to change the regimen during the study
5. Presence of any clinically significant, uncontrolled endocrine disease known to influence serum lipids as defined in the protocol
6. Has received a COVID-19 vaccination within 1-week of planned start medication or for which the planned COVID-19 vaccination would not be completed 1-week prior to start of the study

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply