cyrilzakka/clinical-trials huggingface dataset:
Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

The use of bosentan, sildenafil and tadalafil in neonates with persistent pulmonary hypertension (PPHN) depends mostly on the empirical experience of pediatricians. Moreover, the recommended dose of those three drugs in treating PPHN remains controversial. Therefore, our aim is to study the pharmacokinetics and pharmacodynamics of bosentan, sildenafil and tadalafil in neonates of PPHN then dose a tailor-made therapeutic regimen.


Eligibility Criteria:
Inclusion Criteria:

* Age: postnatal age ≤ 28 days;
* Patients have been diagnosed with PPHN;
* Bosentan, sildenafil and/or tadalafil used as part of regular treatment.
* Parental written consent

Exclusion Criteria:

* Expected survival time less than the treatment cycle;
* Major congenital malformations;
* Undergoing surgery within the first week of life;
* Receiving other systemic trial drug therapy;
* Other factors that the researcher considers unsuitable for inclusion.
A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea

Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 7 days.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea

Exclusion Criteria:

* \> 72 hours of treatment with metronidazole, vancomycin, or other antibacterial therapy specifically targeting the current acute episode of CDAD
* Patient not considered sufficiently stable clinically to complete the study period
A Clinical Study of Nemtabrutinib in Japanese Participants With Hematological Malignancies (MK-1026-002)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of nemtabrutinib in Japanese participants with mature B-cell neoplasms.


Eligibility Criteria:
The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Histologically confirmed B-cell malignancy:

  * Chronic lymphocytic leukemia (CLL)
  * Small lymphocytic lymphoma (SLL)
  * Waldenström's macroglobulinemia (WM),
  * Lymphoplasmacytic lymphoma (LPL)
  * Other B-cell neoplasm
* Failed or intolerant to either at least 2 prior regimens given in combination or sequentially OR have received 1 prior Bruton's tyrosine kinase (BTK)-containing regimen when a BTK inhibitor is approved as first line therapy
* Have the ability to swallow and retain oral medication
* Is Japanese

Exclusion Criteria:

* Active Hepatitis B virus (HBV)/Hepatitis C virus (HCV) infection at study entry
* History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
* Known history of human immunodeficiency virus (HIV) infection
* Clinically significant gastrointestinal abnormalities that might alter absorption (eg, gastric bypass surgery, gastrectomy)
* Underlying history of severe bleeding disorders
* History or concurrent condition of pneumonitis/interstitial lung disease
Clinical Multicenter Randomized Controlled Study of Non-invasive Brain Oscillation Modulation in the Treatment of AD-MCI Patients

A multicenter randomized controlled clinical study was conducted in the Xuanwu hospital of Capital Medical University to preliminarily explore the efficacy and safety of transcranial electrical stimulation in the treatment of AD-MCI patients, to clarify the effective mechanism and form an effective clinical treatment plan.

This project plans to recruit 124 patients with AD-MCI. They were randomly divided into transcranial electrical active stimulation group and sham stimulation group. Patients receive treatment 3-7 days a week, and the daily treatment time is 20-60 minutes. The duration of treatment is 1-12 weeks. Before treatment, cognitive assessment, resting EEG, head MRI and PET examination were completed. Complete the overall cognitive assessment, resting EEG and MRI examination within one week after the treatment, and complete the overall cognitive assessment and PET examination at the follow-up 6 months after the treatment. Fill in the treatment side effect scale and adverse event form. Keep the original oral drug dosage unchanged during the treatment process.

Eligibility Criteria:
Inclusion Criteria:

Male or female AD-MCI patients between the ages of 50-85; The psychological evaluation was in accordance with MMSE score of 18-30 (including 18 and 30) and CDR score of 0.5.

Can cooperate to complete clinical research.

Exclusion Criteria:

There is a definite history of cerebrovascular stroke, and there are definite symptoms or signs of neurological deficit at the time of onset, and there are corresponding responsible lesions left by neuroimaging.

Those who have a history of alcoholism, or drug addiction, or neurological diseases such as brain trauma, epilepsy, encephalitis, normal intracranial pressure hydrocephalus, etc. that can cause cognitive impairment.

Suffering from systemic diseases that may lead to cognitive impairment (such as liver and kidney insufficiency, endocrine diseases, vitamin deficiency).

Have a history of using antipsychotics for more than five years before diagnosis.

There are contraindications for head MRI examination.
TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

Tree nut immunotherapy Route Assessment and DEvelopment (TRADE) is a randomized controlled trial that evaluates the efficacy and safety of sublingual immunotherapy and lower, more tolerable, doses of oral immunotherapy than currently in use.


Eligibility Criteria:
Inclusion Criteria:

* Allergic to tree nut with baseline threshold of 444 mg protein or less and provides consent, and where applicable, assent.

Exclusion Criteria:

1. History of anaphylaxis to tree nut severe enough to cause shock, syncope, or intubation
2. Eosinophilic or other inflammatory gastrointestinal disease within the past 2 years
3. Severe (GINA severity class 5) or uncontrolled asthma including exacerbation within past 6 months
4. Use of biologics, other food immunotherapy or experimental treatment in past 6 months.
5. Ongoing other allergic diseases severe enough to preclude discontinuing antihistamines for 7 days prior to assessment visits
6. Pregnancy or significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease; allergy to the oat-based placebo) which would put the participant at excessive risk for food allergic reactions as judged by local investigator
Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for the Management of Hypomagnesemia From Anti-Cancer Therapies

Hypomagnesemia (hMg) is a common side effect of important anti-cancer therapies such as epidermal growth factor receptor inhibitors (EGFRIs) and platinum-containing anti-cancer drugs. EGFRIs, including cetuximab (cmab) and panitumumab (pmab), have been estimated to cause hMg in over 18% and 27% of patients respectively1, while 90% of patients receiving cisplatin will develop hMg if left untreated. The development of severe hMg may result in increased symptoms such as fatigue, neuromuscular changes, mental status changes and cardiac arrhythmias which could result in treatment delays and may compromise treatment efficacy. Despite the common occurrence of this toxicity, little is known regarding the optimal magnesium management strategy. As physicians do not know what the "best" treatment for patients is, genuine uncertainty ("clinical equipoise") exists. Physicians will choose between different "standards" of magnesium replacement in their personal practice, using idiosyncratic decision making processes, without the physician or the patient knowing the optimal option. This is not good for patients, physicians and society as a whole. Determining the optimal treatment remains an important medical issue for patients, physicians and society. This study will use a novel method to allow comparisons of established standard of care prophylactic treatment using the "integrated consent model" as part of a pragmatic clinical trial7. By integrating medical and clinical practices, physicians will be able to inform their patients about the randomized control trial, akin to a typical conversation between the physician and patient, without written informed consent. This clinical interaction would then be documented, as ordinarily done in practice. Medical and clinical practice will be intertwined with the patients' welfare at the forefront of our best interests.


Eligibility Criteria:
Inclusion Criteria:

* • Palliative-intent treatment with Cisplatin, Carboplatin, Panitumumab or Cetuximab and expected to receive ≥ 2 months of further therapy.

  * Potassium level within normal limits
  * Developed grade ≥1 hMg (Mg \< lower limit of normal)
  * ECOG less than or equal to 2
  * ≥19 years of age
  * Able to swallow tablets/capsules
  * Able to provide verbal consent

Exclusion Criteria:

* baseline creatinine \>1.5x upper limit of normal ULN
* Current use of oral or IV magnesium supplementation (patients who receive 1 gram of magnesium with their standard Cisplatin/Carboplatin chemotherapy regimens are eligible).
Interactive Exoskeleton Robot for Walking - Ankle Joint

A novel interactive exoskeleton robotic system with embedded force and motion sensors will be developed to facilitate walking of stroke patients with hemiparesis. The robot will synchronise with the gait pattern of the stroke patient to provide assistance in ankle dorsiflexion during swing phase. It is hypothesised that the robot can facilitate stable and longer walking distance for stroke patients with drop foot problem. It can be applied on unilateral side, which is suitable for stroke patients with hemiparesis. The whole system design is lightweight, compact, comfortable, and user-friendly in hospital or at home settings.

In this clinical trial, participated stroke patients will be divided into two groups: Robotic group and Sham group. Stroke patients in both groups will participate in a 20-session gait training program, which includes overground walking and stair climbing exercises. Robotic group will walk with the powered Ankle Robot, which provide ankle dorsiflexion support during swing phase of walking; Sham group will walk with the Ankle Robot with very low assistance level, which provide only tactile feedback but no ankle support in order to evaluate the placebo effect. A series of clinical assessments will be carried out to assess the functional recovery in stroke patients before and after the gait training program.

Eligibility Criteria:
Inclusion Criteria:

1. Ischemic or hemorrphagic stroke with drop foot problem.
2. Sufficient cognition to follow simple instructions and to understand the content and purpose of the study. (Mini-Mental State Examination \> 21)
3. Capable of standing and walking independently for an extended period of time. (Functional Ambulation Category \> 3, Berg Balance Scale \> 40)

Exclusion Criteria:

1. Any medical or psychological dysfunctions that would affect their ability to comply with test study protocol, such as lower back pain, neuralgia, rotational vertigo, muscloskeletal disorders, injuries, and pregnancy.
2. Any severe contractures in hip, knee, or ankle joint that would preclude passive range of motion in the lower extremity.
3. Participation in any therapeutic treatment ("outside therapy") performed with the lower extremity during the planned study, including the baseline and the follow-up.
Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision

To compare the efficacy of rotational narrow strip conjunctival graft to full conjunctival graft in primary pterygium excision. Risk analysis of factors that may affects the recurrence rate.

Pterygium is a raised, wing-shaped growth of fibrovascular tissue that extends horizontally from the bulbar conjunctiva, crossing the limbus, and onto the cornea. It is a common ocular surface disease in Malaysia.

Pterygium can cause chronic ocular irritation, redness, tearing, visual impairment and poor cosmesis. Treatment of symptomatic pterygium remains surgical. Surgery should achieve low recurrence rate and acceptable cosmesis. Various surgical techniques had been described with variable success.

In this study, we compared the efficacy of Rotational Narrow Strip Conjunctival Graft with the conventional full conjunctival graft in pterygium excision. Patient will be follow up for a year after pterygium surgery. Outcome will be recurrence rate between the two groups at one year. Risk analysis of certain factors that affects the recurrence rate will be discussed.

Eligibility Criteria:
Inclusion Criteria:

1. Significant and symptomatic primary pterygium clinically requiring excision
2. Willingness to participate in research project and to attend research time

Exclusion Criteria:

1. Age \< 21 years
2. Glaucoma in the study eye
3. Other concurrent ocular surface pathology
4. Infection of the ocular surface
5. Poor general health
Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

The objective of this study is to determine if an intervention with a fracture manager to arrange bone densitometry after a hip fracture is more effective in diagnosing and treating osteoporosis when compared to "usual care". "Usual care" consists of no intervention to arrange bone mineral density (BMD) testing or therapy other than what normally occurs in the community. The investigators postulate that a fracture manager will be more effective in getting BMD done and in starting appropriate therapy.

All hip fracture patients in the Edmonton area will be screened for eligibility (mini-mental status \>20, not on active osteoporosis pharmacologic therapy). All patients will have informed consent obtained. Patients will be randomized to 2 groups:

* Group 1: Active intervention. The fracture manager will arrange for bone densitometry (DEXA) to be done 3-6 months after the fracture. If the patient meets standard criteria for osteoporosis, therapy with a bisphosphonate (alendronate or risedronate) will be instituted by the study physicians.
* Group 2: Usual care. Patients will receive basic information about calcium and vitamin D and osteoporosis and told to follow up with their family doctor. At 6 months, patients will be contacted to determine if they have had a BMD done or started on active (drug) osteoporosis therapy. If not, the fracture manager will arrange the BMD and if appropriate therapy will be started by the study physicians.

All patients will be followed for 1 year. The primary endpoints are the number of patients who get a BMD and the number who are started on active osteoporosis therapy.

Eligibility Criteria:
Inclusion Criteria:

* Ages 50 or over; males or females.
* Reside in the community or have access to bone densitometry
* Hip fracture
* Patient can consent or proxy consent available
* No contraindications to bisphosphonates

Exclusion Criteria:

* Patient refuses consent process
* Already receiving active drug therapy for osteoporosis other than calcium and vitamin D
* Dementia or delirium
* Pathological fracture
* Chronic corticosteroid therapy
Confocal Endomicroscopy for GI Neoplasia Study

The purpose of this study is to enhance probe stabilization using a 4mm clear cap attached to endoscope in comparison to standard "free-hand" image acquisition.

The aim of this study is to optimize and validate in-vivo imaging systems capable of highly accurate, real-time classification of colorectal neoplasia.

Eligibility Criteria:
Inclusion Criteria:

* Those patients undergoing colonoscopy for screening or surveillance of colon polyps will be included in this study.

Exclusion Criteria:

* Patients with known polyposis syndromes, inflammatory bowel disease, allergy to fluorescein, or refusal to provide informed consent.
Mitochondrial Dysfunction in Trauma-related Coagulopathy

Bleeding control often poses a great challenge for clinicians due to trauma-induced blood clotting disorder (TIC), a condition that is present in one-third of bleeding trauma patients. As platelets are considered as central mediators in TIC, the understanding of mitochondria-mediated processes in thrombocytes may disclose new therapeutic targets in the management of severely injured patients. The investigators hypothesize that mitochondrial dysfunction occurs in the platelets of trauma patients with TIC. The investigators intend to quantitatively characterize the derangements of mitochondrial functions in TIC; and assess the relation between mitochondrial respiration and clinical markers of platelet function

Hemorrhage control often poses a great challenge for clinicians due to trauma-induced coagulopathy (TIC), a condition that is present in one-third of bleeding trauma patients. As platelets are considered as central mediators in TIC, the understanding of mitochondria-mediated processes in thrombocytes may disclose new therapeutic targets in the management of severely injured patients. The investigators hypothesize that mitochondrial dysfunction occurs in the platelets of trauma patients with TIC. The investigators intend to quantitatively characterize the derangements of mitochondrial functions in TIC; and assess the relation between mitochondrial respiration and clinical markers of platelet function measured with aggregometry, viscoelastic tests and conventional laboratory analysis.

Eligibility Criteria:
Inclusion Criteria:

* Trauma patients
* Injury Severity Score (ISS) 16 or greater,
* age of 18 years or greater,
* hemorrhage confirmed with extended focused assessment with sonography in trauma (eFAST) or computer tomography (CT)

Exclusion Criteria:

-
This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2

Double blind, randomized, placebo controlled, Phase 3 study to investigate the efficacy and safety of low doses and high doses of A4250 compared to placebo in children with progressive familial intrahepatic cholestasis (PFIC) types 1 and 2.

Up to 50 sites in the following countries will take part in this study:

Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden, Turkey, United Kingdom, United States, and Saudi Arabia

Eligibility Criteria:
Key Inclusion Criteria:

* A male or female participant with a clinical diagnosis of PFIC Type 1 or 2 and with a body weight above 5 kg
* Participant must have clinical genetic confirmation of PFIC-1 or PFIC-2
* Participant must have elevated serum bile acid (s-BA) concentration
* Participant must have history of significant pruritus and a caregiver reported observed scratching in the eDiary
* Participant and/or legal guardian must sign informed consent (and assent) as appropriate.
* Participants will be expected to have a consistent caregiver(s) for the duration of the study
* Caregivers and age-appropriate participants (≥8 years of age) must be willing and able to use an eDiary device as required by the study

Key Exclusion Criteria:

* Participant with pathologic variations of the ABCB11 gene that predict complete absence of the bile salt export pump (BSEP) protein
* Participant with past medical history or ongoing presence of other types of liver disease including, but not limited to, the following:

  1. Biliary atresia of any kind
  2. Benign recurrent intrahepatic cholestasis, indicated by any history of normal s BAs
  3. Suspected or proven liver cancer or metastasis to the liver on imaging studies
  4. Histopathology on liver biopsy that is suggestive of alternate non-PFIC related etiology of cholestasis
* Participant with past medical history or ongoing chronic diarrhea
* Any participant with suspected or confirmed cancers except for basal cell carcinoma
* Participant with a past medical history of chronic kidney disease with an impaired renal function and a glomerular filtration rate \<70 mL/min/1.73 m\^2
* Participant with surgical history of disruption of the enterohepatic circulation (biliary diversion surgery) within 6 months prior to start of Screening Period
* Participant has had a liver transplant or a liver transplant is planned within 6 months of randomization
* Decompensated liver disease
* Participant suffers from uncontrolled, recalcitrant pruritic condition other than PFIC
* Participant who has been previously treated with an IBAT inhibitor whose pruritus has not responded to treatment
The Beta Cell Responsiveness to Glucose-dependent Insulinotropic Polypeptide (GIP) With and Without Sulfonylurea in Patients With Type 2 Diabetes

The investigators hypothesize that the impaired insulinotropic effect of the incretin hormone GIP may be due to inadequate sensitization and ATP induced closure of beta cell K-ATP channels. By closing the channels through the use of sulfonylurea (SU) we hope to restore the insulinotropic effect of GIP.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus diagnosed according to WHO criteria
* Diet and/or metformin treatment
* HbA1c \> 7,0% for metformin treated patients
* HbA1c \> 7,5% for diet treated patients
* Age: 18 years or older
* 25 \> BMI \> 40 kg/m2
* Signed informed consent
* Sufficient birth control in case of child bearing capacity

Exclusion Criteria:

* Proliferative retinopathy
* Diabetic nephropathy with s-creatinine \> 130 microM and/or macroalbuminuria
* Liver disease (ALAT \> 2 x normal value)
* CAD (NYHA group III or IV)
* Positive screening for islet-cell and/or GAD-65 autoantibodies
* Type 1 diabetes i first degree relatives
* Gastrointestinal surgery with intestinal resection
* Anemia
* Pregnancy and/or breastfeeding