cyrilzakka/clinical-trials huggingface dataset:
Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder

Behavioral interventions currently provide the most useful approach to addressing the behavioral and social needs of those with Mild Cognitive Impairment (MCI) due to Alzheimer's or other diseases. This randomized, multisite, 3-arm study will investigate the impact of computerized brain fitness vs yoga vs an active control group (wellness education) on changes in cognitive function, daily functioning and quality of life in persons with Mild Cognitive Impairment (MCI) and their partner. In addition, in vivo neuroimaging measures of plasticity during the pre- and post-intervention periods will be measured and compared between the three different treatment groups. These neuroimaging measures of plasticity will be investigated in their relationship to the cognitive outcomes within each group.


Eligibility Criteria:
For the patients diagnosed with MCI:

Inclusion Criteria:

1. Written informed consent for participation. Patient also needs to sign a legally authorized representative (LAR) addendum should MCI patient become incapacitated
2. A diagnosis of amnestic MCI (single domain or multi-domain)
3. A Clinical Dementia Rating scale score of 0 or 0.5
4. At least 50.
5. Either not taking or stable on nootropic(s) and/or pain medication for at least 3 months.
6. Fluent in English.
7. A score of at least 25 on the Telephone Interview for Cognitive Status for Memory.

Exclusion Criteria:

1. MRI contraindications (e.g., ferrous metal in the body, claustrophobia, pregnancy)
2. Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks or participation in the intervention.

For the care partners:

Inclusion Criteria:

1. Written informed consent for participation.
2. At least 21 years of age.
3. A score of at least 32 on the Telephone Interview for Cognitive Status for Memory.
4. Partner has at least twice-weekly contact with the participant.

Exclusion Criteria:

1. Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks or participation in the intervention.
Super Skills for Life Effectiveness in Clinical Settings

Super Skills for Life (SSL) is a transdiagnostic cognitive-behavioral protocol developed for children aged 6 to 12 with anxiety and comorbid problems (e.g., depression, low self-esteem, and lack of social skills).

SSL consists of eight sessions targeting common risk factors for internalizing disorders such as cognitive distortions, avoidance, emotional management, low self-esteem, social skills deficits and coping strategies.

The aim of the study is to investigate the short- and long-term effects of SSL on internalizing and externalizing symptoms in Spanish children attending the Child and Adolescent Mental Health Services.

To validate eligibility children and their parents will complete several psychometrically robust and developmentally appropriate measures. Participants meeting inclusion criteria will be randomly allocated to the conditions of the intervention group and the wait-list control group.

Parents and children from both groups will complete the same measures at baseline and post-treatment.

Parents and children from SSL will also complete these measures at 3 months follow-up, 6 months follow-up and 12 months follow-up.

The investigators will assess the benefits from pre-test to post-test in children participating in SSL compared to those in a wait-list control group on DSM-5 diagnostic remission, anxiety symptoms, anxiety impairment, depressive symptoms, self-esteem, behavioral problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.

The investigators will also assess these variables in the intervention group at 3 months, 6 months, and 12 months follow-up.

Ultimately, the goal of the study is to explore whether SSL can be a cost-effective psychological intervention for emotional disorders in the Spanish National Health System.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 8 - 12.
* Primary diagnosis of an anxiety disorder, a depressive disorder, and/or trauma- or stress-related disorder with anxiety and/or depressive symptoms.
* Speaking, reading, writing and understanding Spanish.
* Caregivers agree to attend all sessions and to receive feedback and suggestions.

Exclusion Criteria:

* Intellectual disability, behavioral symptoms, or autism spectrum symptoms whose severity precluded continued treatment.
* The child is at the same time in psychological treatment.
* The child is not on a stable dose of medication for at least 1 month prior to baseline assessment.
APPROACH 2.0: HIV, HCV and Syphilis Testing Through Pharmacies

Human Immunodeficiency Virus (HIV), hepatitis C (HCV), and syphilis are sexually transmitted and blood borne infections (STBBI) that affect millions of people worldwide and rates are rising in Canada. HCV and syphilis are curable, and HIV is treatable with virtually no risk of transmission to sexual partners when the infection is controlled, however, these outcomes require adequate testing. Unfortunately, an estimated 44% of Canadians living with HCV and 13% living with HIV are not diagnosed. These undiagnosed cases are the source of over half of new HIV infections. Furthermore, HIV-syphilis coinfection is common. Accessible testing forms a key pillar of an elimination strategy and acts as an access point for linking people to care. Community pharmacies are more accessible site for STBBI testing, compared to hospitals and doctors' offices. This is especially true for members of marginalized communities, some of whom are at higher risk of infection. The COVID-19 pandemic highlighted the need for low-barrier STBBI testing, as in-person healthcare services at doctors' offices and traditional screening clinics were scaled back. Pharmacies remained open throughout the pandemic.

The APPROACH 2.0 study will assess the impact of a pharmacy-based testing program for HIV, hepatitis C, and syphilis in participating pharmacies in three Canadian provinces: Newfoundland \& Labrador, Alberta, and Nova Scotia on finding new diagnoses and linkages with care. Participants will be offered point of care tests for HIV and/or HCV and/or a dry blood spot test which will test for HIV, HCV, and syphilis. These tests are easy to administer. Results from the point of care tests are available immediately during the pharmacy visit while participants will be contacted with dried blood spot test results when available (approximately 2 weeks). Participants with reactive tests are linked with confirmatory testing and care, and those with non-reactive results are offered preventative services including HIV PrEP (as indicated) and counselling.

This study builds on a pilot study completed in 2017 (www.APPROACHstudy.ca).


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 years and older, speaks English, has provincial health card number, and is able and willing to provide informed consent.

Exclusion Criteria:

* Unwilling or unable to provide informed consent. Participants who have been previously diagnosed with HIV infection will not be eligible for HIV testing (point of care test or dry blood spot test). Participants who have previously been diagnosed with HCV are not eligible for HCV point of care test, but may request a dry blood spot test.
Alternate-Day Buprenorphine Administration. Phase VI - 7

The purpose of this study is to determine if four times a subject's daily maintenance dose will hold for 96 hours without changes in agonist and antagonist effects.


Eligibility Criteria:
Please contact site for information.
Targeting ER-Golgi Homeostasis in an Advantageous Therapeutic Strategy in Lung Cancer

Lung cancer remains the most common cause of cancer-related death in the world. The major advances in treatment of lung cancer have brought only minor improvements in survival therefore novel systemic treatment methods are urgently needed.

Protein levels are regulated by the protein homeostasis network that generates and protects the protein fold (ER and Golgi included).

The heat shock protein 90 (Hsp90) is an essential molecular chaperon involved in the posttranslational folding and stability of proteins. Hsp90 inhibition leads to accumulation of unfolded proteins and ER stress. The therapeutic efficacy of such inhibition may be augmented by co-administering it with other drugs that disrupt ER-Golgi homeostasis like histone deacetylase (HDAC) or proteasome inhibitors. ER-Golgi homeostasis disruption affects a wide network of proteins and pathways as such affords a systemic target. Thus, the investigators aimed to examine the effect of combined treatment of Hsp90 antagonist with proteasome or HDAC inhibitors on human lung cancer cell lines and primary cells.


Eligibility Criteria:
Inclusion Criteria:

* PATIENTS WITH PROVED DIAGNOSIS OF LUNG CARCINOMA THAT ARE CANDIDATS FOR RADICAL SURGICAL TREATMENT

Exclusion Criteria:

* PATIENTS WITH SUSPICION FOR LUNG CARCINOMA WITHOUT PATHOLOGYCAL DIAFNOSIS BEFORE SURGERY
High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure

The study will be conducted on patients admitted to Department of Hepatology from Jan 2016 to Jan 2018 at Institute of Liver \& Biliary Sciences, New Delhi. Study group will comprise of patients with acute liver failure (ALF) who have no option for liver transplant (due to any reason) or have contraindications for liver transplant or have no prospective living donor and will be assessed for enrollment in the trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute liver failure defined as : Patients with jaundice which is complicated by encephalopathy and coagulopathy within 4 weeks of the onset of jaundice and without underlying chronic liver disease.

Exclusion Criteria:

* Age \<12 or \> 75 years
* Hepato-Cellular Carcinoma
* Active untreated Sepsis/DIC
* Any evidence of active bleed secondary to coagulopathy
* Hemodynamic instability requiring high dose of Vasopressors
* Coma of non-hepatic origin.
* Pregnancy
* Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score \>3, or oxygen/steroid-dependent chronic obstructive pulmonary disease).
* Patients being taken up for liver transplant
* Refusal to participate in the study.
Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets

Study in healthy males to assess bioavailability of 4 different fostamatinib tablets


Eligibility Criteria:
Inclusion Criteria:

* Weight of at least 50 kg and body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive
* Volunteers must be willing to use barrier contraception ie, condoms, from the Day 1 of Treatment Period 1 until 2 weeks after the final dosing of the investigational product (IP)

Exclusion Criteria:

* History of any clinically significant disease or disorder
* History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (except for cholecystectomy)
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of drug
* Volunteers who smoke more than 5 cigarettes or the equivalent in tobacco per day
* Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results as judged by the Investigator
Best Regimen for Phenylephrine Administration During Cesarean Section

During Cesarean delivery, phenylephrine is used to maintain the patient's blood pressure. Low blood pressure is the most common side effect of the spinal medication used to anesthetize the patient prior to the start of surgery. This low blood pressure can also trigger unpleasant side effects such as nausea, vomiting and low Apgar scores for the baby.

Currently there are 2 methods of phenylephrine administration during Cesarean section. One method is by intermittent bolus and the other is by continuous infusion. It is ideal to have a regimen for phenylephrine administration that maintains blood pressure without compromising cardiac output.

In this study, cardiac output and blood pressure will be measured by transthoracic bioimpedance, which is a new technique of noninvasive continuous cardiac output monitoring.

The hypothesis of this study is that the continuous infusion of phenylephrine will be equally effective in maintaining blood pressure as compared to the intermittent injection, and will induce less hemodynamic changes.


Eligibility Criteria:
Inclusion Criteria:

* Ability to communicate in English
* Elective Cesarean Delivery under spinal anesthesia
* Normal singleton pregnancy beyond 36 weeks gestation
* ASA physical status I/II
* Weight 50-100 kg, height 150-180 cm
* Age over 18 years

Exclusion Criteria:

* Patient refusal
* Inability to communicate in English
* Allergy or hypersensitivity to phenylephrine
* Preexisting or pregnancy-induced hypertension
* Cardiovascular or cerebrovascular disease
* Fetal abnormalities
* History of diabetes, excluding gestational diabetes
* Contra-indications for spinal anesthesia
Early Shockwave Therapy for Post-RP ED

This pilot study aims to explore the feasibility, safety and effectiveness of two different extracorporeal shock wave therapy (ESWT) protocols for patients receiving nerve-sparing radical prostatectomy (RP).

This is an open-label, randomized, 2-parallel-arm trial (n=94). All patients will receive (A) sham (n=47) or (B) active ESWT (n=47) twice/week for 6 weeks (12 sessions total). Concurrently, all patients will receive daily tadalafil 5mg for 24 weeks. Patients will then undergo a 4 week washout period without erectogenic aids, and return for a 28-week evaluation. Subsequently, patients requiring further erectogenic aids after 28 weeks will be offered intracavernosal injections (ICI) of prostaglandin E1 (PGE1).

Random assignment will be performed by computer program (eg. randomizer.org), in a design that obtains equal sample size per group.

All patients will be followed for a period of 24 months post-RP. Follow-up protocol includes evaluation of the IIEF, EHS, GAQ, ICI usage and tolerability, stretched flaccid penile length, urinary incontinence, and oncologic status.

Eligibility Criteria:
Inclusion Criteria:

* Men scheduled for robotic bilateral nerve-sparing radical prostatectomy
* Diagnosed with low/intermediate-risk prostate cancer:

  * PSA \< 20 ng/ml
  * Gleason score \< 8
  * PCa stage =\< T2b
* Baseline IIEF-ED 22-30 without erectogenic aids
* No urinary incontinence (no usage of urinary pads)
* Sexually active, in a stable heterosexual relationship
* Able to understand and complete patient questionnaires
* Consent to participate

Exclusion Criteria:

* Anatomical abnormalities in the genitalia or pelvic region
* Post-RP complications that could impact safety or effectiveness of ESWT (eg. hematoma, fistula, unresolved anastomotic leak)
* Incomplete tumor removal (positive surgical margin)
* Tumor upstaging beyond T2b
* Nerve sparing score \< 4
* Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
* Untreated hypogonadism (serum total testosterone \< 300 mg/dL)
* Anti-coagulant medication, or any blood coagulation disorders (INR \> 3)
* Any other condition that would prevent the patient from completing the study, as judged by the principle investigator
Effect of Topical Tetracycline and Dexamethasone on Periodontal and Pulpal Regeneration of Replanted Avulsed Teeth

To evaluate the effect of topical tetracycline and dexamethasone on periodontal and pulpal regeneration of avulsed permanent teeth after an observation period between 9-16 years.

Two different medications were applied prior to replantation. A) Topical tetracycline, B) topical dexamethasone. Teeth were splinted using a non-rigid titanium trauma splint for 7-14 days. Endodontic treatment was performed within 1-7 days, except for teeth with an open apex and a short extraoral dry time. All patients received systemic tetracycline for 10 days after accident and were subsequently re-examined.

Follow-up examinations included periodontal examination, percussion, Periotest measurements, pulp sensitivity using CO2 snow, periapical radiograph and intraoral photographs. Additionally a OHIP-14 questionnaire was carried out to determine the oral health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Avulsion of a permanent tooth
* Written informed consent

Exclusion Criteria:

* Extended dry period of more than 60 minutes
Changes in Physical Inactivity in Patients with Knee Osteoarthritis

This is an objective cohort study using objective recording of physical activity (accelerometry) during and after the GLAiD intervention to investigate if a sedentary behavior change by participating in an 6-week physiotherapy-led exercise and education program (GLAiD) occurs. The GLAiD intervention is an education and exercise based intervention aiming at decreasing pain and improving function in patients with knee osteoarthritis.

The primary outcome is change in objective recorded physical activity between baseline and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* ≥40 years
* Diagnosed with knee OA
* Willing and able to complete study visits and procedures
* Owner of a smartphone or tablet
* Eligible for participation in the GLAID treatment
* Speaks, reads and writes Danish language

Exclusion Criteria:

* Any condition, which in the opinion of the Investigator, would put the subject at increased safety risk by participation, or otherwise make the subject unsuitable for this study.
Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)

This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48 with a safety follow-up at Week 60 to assess the long term efficacy and safety of AIN457 treatment in combination with MTX in RA.


Eligibility Criteria:
Inclusion Criteria:

* Presence of RA classified by ACR 1987 revised criteria. Patients with active RA should have been on MTX for at least 3 months and must currently be treated with a stable dose of MTX (\> or =7.5 mg/week - \< or = 25 mg/week) for at least 4 weeks
* At Baseline: Disease activity criteria defined by \> or = 6 out of 28 tender joints and \> or = 6 out of 28 swollen joints WITH either Screening value of hsCRP \> or = 10 mg/L OR ESR \> or = 28 mm/1st hr

Exclusion Criteria:

* RA patients functional status class IV classified according to the ACR 1991 revised criteria
* Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine)
* Any therapy by intra-articular injections (e.g. corticosteroid) required for treatment of acute RA flare within 4 weeks before randomization

Other protocol-defined inclusion/exclusion criteria may apply
Coenzyme q 10 and Fertility Outcome in Women With Clomiphene Resistant PCOS

The study evaluates the effect of coenzyme q 10 on ovulation and subsequent pregnancy in women with polycystic ovarian syndrome. Half of the participants will receive coq10 and ovulation induction with clomiphene and other half would receive a placebo with clomiphene.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of polycystic ovarian syndrome PCOS based on the revised 2003 consensus on diagnostic criteria and long-term health risks related to PCOS (2003).
* All women were previously treated with 100 mg of CC daily for 5 days per cycle, for two to three cycles with persistent anovulation or ovulate with very thin endometrium \<5 mm at the time of hCG administration

Exclusion Criteria:

* Non-consenting.
* known autoimmune disorders
* prior treatment of endometriosis or surgery to reproductive tract
* prior history of pelvic inflammatory disease
* those with tubal factors and uterine factors as assessed on history and confirmed by normal hysterosalpingogram.
* Thyroid disorder as assessed by history examination and TSH level
* Patients with raised FSH
Introduction of Mycotic Prophylaxis At Cystectomy Trial.

This study aims to introduce a perioperative antifungal prophylaxis for patients undergoing cystectomy: surgically removal of the urinary bladder with construction of a urinary diversion. We wish to investigate the effect of antifungal prophylaxis on complications after the operation.

Cystectomy with construction of a urinary diversion, is a major cancer surgery and one of the most complex surgeries in the urological specialty. After cystectomy, the most commonly performed urinary diversion is an ileal conduit, where a section of the terminal ileum is shunted out and connected to the upper urinary tract and a stoma is created. During this procedure, the abdominal cavity is exposed to bacteria and fungus from the ileum. Besides the perioperative contamination, micro-leakage in relation to the anastomosis is suspected to contribute to a local infectious response that may result in postoperative complications as ileal paralysis. Paralytic ileus is a serious complication that affects many patients after cystectomy, resulting in a prolonged length of stay, low quality of life postoperatively, and increased risk of complications such as aspiration, pneumonia, wound rupture, deep venous thrombosis, undernourishment and infections.

Current guidelines support the use of perioperative antibiotics targeting gram-negative and gram-positive bacteria, typically administered as broad-spectrum medicine such as piperacillin/tazobactam or cephalosporins. Regarding fungal infections, emerging data show that 48% of the patients undergoing RC have candida albicans in samples from the terminal ileum. Also, it is well known that fungal infections are highly prevalent in patients undergoing gastrointestinal surgery where it is associated with a high risk of mortality.

Small retrospective studies suggest that the addition of antifungal medicine to perioperative antibiotics can reduce the risk of bowel- and infectious complications after abdominal surgery.

The compelling theoretical and clinical rationale for addition of antifungal prophylaxis to standard-of-care antibiotic prophylaxis for patients undergoing radical cystectomy provides the basis for initiation of a randomized clinical trial representing the highest level of evidence.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older
* Willingness to participate in the study and the ability to understand and sign an informed consent
* Indication for performing cystectomy
* The urinary diversion is limited to the ileal conduit

Exclusion Criteria:

* Patients with contraindications to Fluconazole. This includes allergies and treatment with non-pausable medication that in combination is contraindicated
* Patients in active treatment for mycotic infections
A Phase 1 TR-701 FA Study of Blood Pressure Response Post Tyramine Challenge

Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered with tyramine

This is a Phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to determine the effect of 200 mg oral TR-701 FA on SBP response when administered with tyramine in healthy adult male and female volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18 to 45 years of age, inclusive
* Body mass index between 19 kg/m2 and 31 kg/m2, inclusive
* Healthy subjects with no clinically significant abnormalities identified by a detailed medical history,

Exclusion Criteria:

* Systolic blood pressure \>130 mmHg or \<90 mmHg measured after 10 minutes in the supine position at Screening or at admission to the study center
* Heart rate \>90 bpm or \<45 bpm measured after 10 minutes in the supine position
* Electrocardiogram (ECG) finding of QTc interval \>500 msec, or other clinically significant ECG abnormality at the Screening Visit