cyrilzakka/clinical-trials huggingface dataset:
Hypoxic-Ischemic Encephalopathy Therapy Optimization in Neonates for Better Neuroprotection With Inhalative CO2

This is a Phase I, open-label, single center trial to evaluate the feasibility and safety of low concentration CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled, mechanically ventilated newborns at risk of hypocapnia with The hypothesis is that hypocapnia, which is driven by hyperventilation in the presence of metabolic acidosis, is deleterious to the injured brain and can be safely avoided with low concentration CO2 inhalation.

Specific aims:

1. To test the feasibility of low concentration inhalative CO2 gas mixture (5% CO2 + 95% air) administration to achieve a desired range of pCO2 of 40-60 mmHg in asphyxiated, cooled, mechanically ventilated newborns at risk of hypocapnia with moderate to severe hypoxic-ischemic encephalopathy.
2. To test the safety of CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled, mechanically ventilated newborns at risk of hypocapnia with moderate to severe hypoxic-ischemic encephalopathy.

Term infants (≥ 36 weeks of gestation) will have to be at risk of hypocapnia to be eligible, as defined by a temperature corrected pCO2 ≤ 40 mmHg in blood gas analysis, at any time within six hours of life.

The gas mixture will be administered through patient circuits in conventional ventilators. Administered CO2 level will be closely monitored at the inhalation circuit (constant 5% = 36 mmHg). Blood gas samples will be taken hourly to ensure targeted and tolerable pCO2 levels.

Eligibility Criteria:
Inclusion Criteria:

* At any time within six hours of life the temperature corrected pCO2 is less than or equal to 40 mmHg after the parameters of mechanical ventilation is set according to standard protocol (SIMV+VG 5ml/kg, fr 20/min, PEEP 5 H20cm, Ti 0,35-0,45 sec).
* Moderate hypoxic- ischaemic encephalopathy, fulfilling TOBY criteria (A, B, C).
* ≥ 36. gest. week
* \< 6th hours of life
* Hypothermia treatment
* Parental consent form
* Spontaneous breathing
* Endotracheal intubation
* AUC, VUC in place

Exclusion Criteria:

* Major birth defect
* Meconium aspiration syndrome
* Need for combined catecholamine therapy
* FiO2 \> 40%
* Htc \< 35%
* Acid-base status: pH \< 6.8, lactate \> 15mM
* Excessive bicarbonate administration during initial stabilization (\> 1mmol/kg)
Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder

The purpose of the study is to learn about the safety and effectiveness of oral (taken by mouth) topiramate in treating Sleep-Related Eating Disorder (SRED).

This is a single center, 13-week, outpatient, randomized, double-blind, placebo-controlled, parallel group, pilot study of topiramate in subjects with Sleep-Related Eating Disorder (SRED). The primary objective of this study is to investigate the efficacy and safety of topiramate compared to placebo in the treatment of Sleep-Related Eating Disorder. SRED is a disorder that consists of out of control eating during the night with little or no awareness of the events. In this study we are comparing topiramate to placebo. A placebo is a pill that looks exactly like the study drug, but it does not have any active drug in it. Topamax (topiramate) is approved by the U.S. Food and Drug Administration (FDA) as a therapy for epilepsy, but topiramate has not been approved by the FDA for SRED.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-65
* Diagnosis of SRED
* Must be able to swallow capsules and follow instructions

Exclusion Criteria:

* Women who are pregnant or lactating
* Other sleep disorders
* Kidney or Liver disease
* Night shift workers
* Previous history of Topiramate or Topamax use for any condition
Balloon Dilation of the Eustachian Tube

In this study, patients with dysfunction of the eustachian tube will be included. They will be randomized to one of two treatment groups.

1. balloon dilation of the eustachian tube or
2. nasal saline Patients will undergo follow-up for one year and will be able to crossover to the treatment arm after three months

Patients will eustachian tube dysfunction will be asked to participate in the study.

They will be randomized to one of two groups

group 1 - surgical dilation of the eustachian tube in general anaesthesia

group 2 - daily nasal saline spray, twice a day

Regular Follow up with Tympanogram and Questionnaire

After three months patient in the control group (nasal saline) can switch in the intervention group.

Eustachian tube dilation will be carried out with a Health Canada and FDA approved device, usually used for endovascular balloon dilation. It has the same size and pressure properties as the eustachian tube dilation device and has shown a good safety profile in a previous preclinical and clinical pilot study.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old (of both sexes)
* Diagnosed with persistent obstructive eustachian tube dysfunction (OETD) for at least 3 months prior to enrolment uni- and/or bilateral

Diagnosis (both required):

i. Persistent OETD symptoms assessed by Eustachian Tube Dysfunction Questionnaire (ETDQ-7) with overall score of ≥3 (moderate to severe symptoms) for 3 months or more prior to enrollment.

ii. Refractory to medical therapy (minimum of 4 weeks of daily intranasal steroid spray or one completed course of an oral steroid within 3 months before study enrollment).

Exclusion Criteria:

* Patulous eustachian tube
* Prior eustachian tube intervention
* Presence of myringotomy ventilation tube or a tympanic membrane perforation
* Active chronic or acute otitis media
* Chronic otitis media with cholesteatoma
* Fluctuating sensorineural hearing loss or Meniere's disease
* Chronic rhinosinusitis, allergies, or reflux disease not controlled with medication
* History of head or neck surgery within 3 months
* Prior radiation to the head and neck
* Active temporomandibular joint disorders
* Cleft palate or Craniofacial syndrome
* Cystic fibrosis or Ciliary dysmotility syndrome or Systemic immunodeficiencies
* Active acute upper respiratory infection
* Nasal endoscopy with evidence of anatomic conditions that would prevent transnasal access to the Eustachian tube
* CT temporal bone scan with evidence of carotid artery dehiscence, superior semicircular canal dehiscence, or extrinsic eustachian tube compression
* Patient unable to follow protocol for any reason
Neurofeedback in Individuals With Substance Use Disorders

The aim of this study is to train individuals with opioid use disorder to control their brain activity in a way that has been associated with their symptoms. Participants in the experimental group will be given direct feedback regarding their brain activity while they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to learn to control their brain activity during these feedback sessions. A separate group of participants will be given a control form of feedback that we do not believe can have clinical benefits. Our primary hypothesis is that the neurofeedback training will reduce opioid use and clinical features of opioid use disorder more than the control feedback.


Eligibility Criteria:
Inclusion Criteria:

1. non-methadone opioid positive urine screen (as assessed during standard treatment) or indicated via Utox or self-reported past-month opioid use at screening
2. Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for opioid use disorder, as assessed via structured clinical interview (SCID)
3. ≥3 months of methadone treatment

Exclusion Criteria:

1. Having any current neurologic or psychiatric disorders including current moderate to severe other DSM-5 substance use disorders with the exceptions of opioids, cocaine, tobacco and cannabis, as assessed using the SCID.
2. Failure to pass a magnetic resonance imaging (MRI) screening
3. Having significant underlying medical conditions requiring medications.
4. Women who are pregnant or nursing
5. Baseline scanning with excessive motion based on frame to frame displacement
Immunosuppressive Drugs and Gut Microbiome: Pharmacokinetic- and Microbiome Diversity Effects

Kidney transplant recipients of living- and deceased donor grafts and treated with both mycophenolate mofetil (MMF) and tacrolimus (Tac) will be included. A 12-hour pharmacokinetic (PK) investigation of both mycophenolate (MPA) and Tac will be performed in pharmacokinetic steady state conditions between 3 to 8 weeks and one year after transplantation. Feces samples will be collected before (if possible), 1 week after transplantation and at the day of the 12-hour PK investigations. Data on dietary intake and physical activity will be obtained in association with the feces sampling in all patients. Patients will be invited to a follow-up visit one year after transplantation where the 12-hour PK investigation, feces sampling, dietary and activity data collection is repeated. Standard follow-up data after renal transplantations, such as acute rejection episodes, infections, renal function, post transplant diabetes mellitus (PTDM), protocol biopsies, adherence to immunosuppressive drugs, graft loss and death will be collected for all patients up to 5 years after transplantation according to standard schedule at the transplant center.

A subgroup of kidney transplant recipients scheduled for living donor transplantation will be included before transplantation for pre-transplant investigations in addition to the investigations after transplantation. These patients will be randomized to either receive one week of treatment with MMF or Tac before transplantation. Feces samples and a 12-hour PK investigation will be performed after one week of treatment (before transplantation).

The analyses of feces samples will be performed by utilizing shotgun, next generation sequencing in order to determine the bacterial, fungal sand viral microbiome. Drug concentrations will be analyzed with high performance Liquid chromatography With double mass spectrometry detector (HPLC-MS/MS) technology and both free and total plasma MPA concentrations, total mycophenolate glucoronide (MPAG) concentrations and total whole blood Tac and methylated Tac-metabolite concentrations will be determined.

Eligibility Criteria:
Inclusion Criteria:

* De novo standard risk kidney transplant recipients.
* Patients scheduled to receive tacrolimus and mycophenolate mofetil as part of their immunosuppressive therapy following transplantation (clinical decision not influenced by this study).
* First kidney transplant only.
* Adult patients.

Exclusion Criteria:

- Pregnant or lactating female patients.
Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery

A prospective, randomized, placebo controlled, double-blinded study at a single institution.

Pain medicine literature and the principal investigator's anecdotal experience in posterior cervical and lumbar instrumented spine surgery suggest that pre-incisional IV ibuprofen significantly reduces postoperative pain without increasing surgical complications or fusion rate, which leads to earlier ambulation, less dependence on narcotic medications, shorter hospital stays, and earlier return to work. The purpose of this study is to assess if these anecdotal findings hold true in a randomized clinical trial of patients with cervical or lumbar spondylosis, who are undergoing decompression and instrumented fusion of the spine.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age
* Able to give consent
* Diagnosed with spondylosis, stenosis, and/or instability of the cervical spine
* Diagnosed with spondylosis, stenosis, and/or instability of the lumbar spine
* Require a posterior decompression with internal fixation
* Likely to complete the trial

Exclusion Criteria:

* Patients with previous surgery at the treated spine segment
* Women who are pregnant or plan to become pregnant during the study period Renal/liver disease
* Anemia; coagulopathy
* Thrombocytopenia (\<30,000)
* Coronary artery disease
* Previous coronary artery bypass graft (CABG)
* Patients taking Coumadin, Plavix, Lithium, or ACE-inhibitors plus Lasix; non-steroidal anti-inflammatory drug (NSAID) hypersensitivity
* Gastric ulcers
* Recent stroke
* Traumatic brain injury, or intracranial surgery
Cetuximab Monotherapy Maintenance Treatment in mCRC

Investigating the efficacy of Cetuximab Monotherapy versus Continuation after induction treatment with chemotherapy + Cetuximab in inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with mFOLFOX6/FOLFIRI and Cetuximab treatment. Reinduction treatment will be done in case of progression.

Investigating the efficacy of Cetuximab Monotherapy versus Continuation after induction treatment with chemotherapy + Cetuximab in inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with mFOLFOX6/FOLFIRI and Cetuximab treatment. Reinduction treatment will be done in case of progression. This treatment is continued until progression or severe toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histological proof of colorectal cancer (in case of a single metastasis, histological or cytological proof of this lesion should be obtained);
* Distant metastases (patients with only local recurrence are not eligible);
* Unidimensionally measurable disease (\> 1 cm on spiral CT scan or \> 2 cm on chest X-ray; liver ultrasound is not allowed). Serum CEA may not be used as a parameter for disease evaluation;
* In case of previous radiotherapy, at least one measurable lesion should be located outside the irradiated field;
* Ongoing or planned first line treatment with 6 cycles of mFOLFOX6/FOLFIRI plus Cetuximab.

At randomisation:

* WHO performance status 0-1 (Karnofsky PS \> 70%);
* Laboratory values obtained ≤ 2 weeks prior to randomisation:

  * adequate bone marrow function (Hb \> 6.0 mmol/L, absolute neutrophil count \> 1.5 x 109/L, platelets \> 100 x 109/L),
  * renal function (serum creatinine ≤ 1.5x ULN and creatinine clearance, Cockroft formula, \> 30 ml/min),
  * liver function (serum bilirubin ≤ 2 x ULN, serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases);
* Negative pregnancy test in women with childbearing potential;
* Expected adequacy of follow-up;
* Institutional Review Board approval;
* Written informed consent Exclusion criteria;
* History or clinical signs/symptoms of CNS metastases;
* History of a second malignancy ≤ 5 years with the exception of adequately treated carcinoma of cervix or basal/squamous cell carcinoma of skin.

Exclusion Criteria:

* Prior adjuvant treatment for stage II/III colorectal cancer ending within 6 months before the start of induction treatment;
* Any prior adjuvant treatment after resection of distant metastases;
* Previous systemic treatment for advanced disease.
the Ameliorating Effects of Antioxidant Gel on Female Arousal Disorder and Sexual Dysfunction

The aim of this study is to evaluate the quality of sexual life of females with sexual interest or arousal disorder before and after accurate application of a formulated emulgel made from natural ingredients, including kaempferol as an API


Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 28 and 45
* had regular periods and previous menstrual bleeding lasted between three and seven days

Exclusion Criteria:

* sensitivity to drug of therapy,
* cancer,
* autoimmune illness,
* smoking or drinking,
* liver disease,
* irregular menstruation
Effects of Aerobic Exercise Versus Weight Training in Breast Cancer Survivors During Chemotherapy

The purpose of this study is to compare the effects of two different types of exercise, aerobic exercise training (AET) and resistance exercise training (RET), on quality of life (QoL) in early stage breast cancer survivors receiving chemotherapy. It is hypothesized that both AET and RET would have beneficial effects on QoL.

The study was a prospective, three-armed, randomized controlled trial. Participants were stratified by site (Edmonton, Ottawa, and Vancouver) and planned chemotherapy protocol (taxane-based versus nontaxane-based) and randomly assigned to AET, RET, or usual care (UC) in a 1:1:1 ratio using a random-numbers table. Participants assigned to the AET group were asked to perform aerobic exercise three times per week on a recumbent or upright cycle ergometer, treadmill, or elliptical. Exercise duration began at 15 minutes for weeks 0 through 2, and then systematically increased by 5 minutes every three weeks thereafter to 45 minutes for weeks 18 and beyond. Exercise intensity began at 60% of VO2max for weeks 0 through 2 and then systematically increased by 10% every 6 weeks thereafter to 80% of VO2max for weeks 12 and beyond. Warm-up and cool-down periods consisted of 5 minutes of aerobic activity at the power output of the ventilatory equivalent for oxygen (approximately 50% of peak oxygen consumption). Participants assigned to the RET group were asked to perform resistance exercise three times per week, which consisted of two sets of 10 repetitions of 9 different exercises performed at 60-70% of 1-repetition maximum. The specific exercises were: leg extension, leg curl, calf raises, chest press, latissimus pulldown, overhead press, triceps extension, biceps curls, and modified curl-ups. Resistance was increased by approximately 10% or the next weight level when the participant was able to complete 12 repetitions per set without difficulty.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer early stage I -IIIA
* Completed axillary surgery
* Scheduled to receive adjuvant chemotherapy for 9 - 24 weeks
* Approval of the treating oncologist
* Able to understand and provide written informed consent in English or French (Ottawa)
* 18+ years of age
* No uncontrolled hypertension, cardiac illness, psychiatric condition
* No contraindication to exercise as determined by a fitness test

Exclusion Criteria:

* Pregnant.
* Unwilling to accept randomization.
* Any medical condition that would be a contraindication to exercise. The clinicians will make this decision.
* Unwilling to travel to/participate in the exercise program as defined by the protocol.
* Previous chemotherapy (previous cancer is NOT an exclusion criteria).
* Cancer recurrence.
* Planned/known absence of greater than 2 weeks during the intended study period.
* Previous therapy for known breast cancer.
* Those who have had TRAM (i.e., Transabdominal Rectus Abdominus Muscle Reconstructive Surgery) done.
* Moderate lymphedema (\>20% or \>200mL difference between the affected arm and the unaffected arm).
Near-death Experience in ICU Survivors

This observational study aims to describe the incidence of near-death experience (NDE) in patients who survived a critical illness. In order to help determine the potential risk factors of NDE, dissociative status and spirituality are also investigated. Finally, in patients who experienced NDE, a magnetic resonance imaging is performed to search for any structural modifications.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients who survived critical illness

Exclusion Criteria:

* Glasgow Coma Scale \< 15/15
* Confusion (CAM ICU scale)
* Refusal
Clinical Testing of the Cortrium C3 Device

Clinical data validation of the C3 device as a Vital Sign Monitoring System for patients under cancer treatment.

Cortrium has developed the C3 device. The C3 device contains sensors that monitors Electrocardiogram (ECG), Respiratory rate (breathes per minute), and Body surface temperature. Also, the C3 device contains an accelerometer for registration of the body posture.

The following thesis will be tested:

Thesis 1) Pulse: The C3 device produces clinically validated pulse data. Thesis 2) Respiratory rate: The C3 device produces clinically validated respiratory rate data (breaths per minute). Thesis 3) Infection: With no justified statistical significant correlation between skin and body temperature, the study is exploring how to prevent aggravated or lethal outcomes of cancer treatment, e.g. chemotherapy, by using vital signs measurements combined with accelerometer data to detect infection levels. Thesis 4) The qualitative study: The study will report the advantages and disadvantages regarding new technological solutions, and the change in workflow and healthcare provision as it is experienced by the healthcare personnel and the patients. The data validation studies (thesis 1-3) will be tested in comparison with golden standard measurements methods and/or data validated medical equipment.

Eligibility Criteria:
Inclusion Criteria:

* Legally competent persons - i.e., patients considered able to understand the information given about the clinical trial
* Person is 18 years or older
* Person has given a written informed consent

Exclusion Criteria:

* Not legally competent patients
* Pregnant and lactating women
* Fertile women, who do not use contraceptives
* Patients under 18 years
* Patients with known heart-related disease
To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis

This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis.

This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis. The study has 2 parts: first part (randomized double-blind) and second part (open).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥18 years old.
2. Subjects with moderate to severe plaque psoriasis with or without psoriatic arthritis.
3. At screening and baseline, PASI score ≥ 12, BSA ≥ 10%, sPGA ≥ 3.
4. Suitable for systematic therapy assessed by investigators.
5. Subjects who are women of childbearing potential must be practicing an adequate, medically acceptable method of birth control during the study and for at least 6 months after the last investigational drug administration.

Exclusion Criteria:

1. Types of psoriasis other than chronic plaque-type psoriasis.
2. Drug-induced psoriasis.
3. Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
4. Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
5. History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.
6. Progressive or uncontrolled symptoms or signs of circulatory, respiratory, digestive, neuropsychiatric or psychological,hematological, endocrine and other systems before randomization.
7. History of malignant tumour within 5 years before screening.
8. Previous or current autoimmune diseases.
9. Allergic to any component of the investigational drug, or have had severe allergic reactions to monoclonal antibodies.