cyrilzakka/clinical-trials huggingface dataset:
A Study to Review the Treatment and Outcomes of Teenagers and Adults With Non-histaminergic Angioedema With Normal C1 Inhibitor in Canada

The main aim of this study is to describe the characteristics of participants, check for number of hereditary angioedema (HAE) cases, their treatment and outcomes. Another aim is to check how the healthcare facilities were utilized for treatment.

Participants' data will be taken from their medical records (charts), which were already collected as a part of their routine care between January 1, 2012, and January 1, 2022.

This is a non-interventional, retrospective, observational study of participants with Hereditary Angioedema with normal C1 esterase inhibitor (HAE) and Non-histaminergic Angioedema (NHAE) with normal C1-inhibitor function (nC1-INH) receiving various treatments between January 1, 2012, and January 1, 2022. The study will assess case numbers, treatments, outcomes, and healthcare resource utilization in the real-world setting.

This study will enroll approximately 90 to 150 participants. Participants will be enrolled in the following two cohorts:

* Participants with HAE nC1-INH
* Participants with NHAE nC1-INH

This study will have a retrospective data collection from January 1, 2012 to January 1, 2022 by using data from the participant medical charts that were already collected as part of routine care.

This multi-center trial will be conducted in Canada. The overall time for data collection in this study will be approximately 10 years.

Eligibility Criteria:
Inclusion Criteria:

1. Participants ≥12 years of age with HAE nC1-INH or NHAE nC1-INH diagnosed by an HAE treating specialist based on some or all of the following:

1. Recurrent angioedema as documented by a healthcare professional within specialist charts
2. Normal C4
3. Normal C1 level and function
4. Condition worsened with estrogen if estrogen is/was being received
5. Lack of response to corticosteroid and high-dose regular and/or prophylactic antihistamine(s) treatment(s)
6. Family history of non-histaminergic angioedema for patients with HAE nC1-INH

Exclusion Criteria:

1. Other types of angioedema (type-1 HAE, type-2 HAE, acquired angioedema, etc.)
2. Not meeting the above diagnostic criteria for inclusion
3. Response to treatments used for histamine-related angioedema
Effects of Oral Doxofylline and Procaterol on Chronic Obstructive Pulmonary Disease

The goal of this clinical trial is to determine if doxofylline and procaterol are effective in treating patients with stable chronic obstructive pulmonary disease (COPD). It will also assess the safety of both drugs.

The main questions it aims to answer are:

* Does doxofylline demonstrate a comparable bronchodilator effect to procaterol in COPD participants?
* What medical problems do participants experience when taking doxofylline and procaterol?"

This study is a randomized crossover study. COPD patients aged 40 years or older with stable disease were included. Each patient received 4 weeks of treatment with either doxofylline or procaterol followed by a 2-week washout period, and then 4 weeks of treatment with the other drug. Respiratory symptoms were assessed by modified Medical Research Council (mMRC) dyspnea scale and COPD Assessment Test (CAT). Pulmonary functions were assessed by spirometry with bronchodilator testing, and adverse events were recorded. Spirometry data including forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and forced expiratory flow at 25-75% of FVC (FEF25-75) were also collected.

Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis confirmed by spirometry (post-bronchodilator FEV1/FVC \< 70%)
* Aged 40 years or older
* Smoking 10 pack-years or more
* Postbronchodilator FEV1 \< 80%

Exclusion Criteria:

* History of COPD exacerbation within 3 months
* Oral or intravenous corticosteroid treatment within 6 weeks
* Oral bronchodilators e.g. doxofylline, theophylline, procaterol, or salbutamol within 1 week before randomization
* Asthma
* Tracheostomy, invasive or noninvasive mechanical ventilation
* Inability to perform spirometry or 6-minute walk test
* Pregnant or breastfeeding women
Study of the Absorption, Metabolism, and Excretion Following a Single Dose of [14C]-Poziotinib in Healthy Male Subjects

This will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male subjects to evaluate the Absorption, Metabolism, and Excretion of Poziotinib following a single oral dose of \[14C\]-poziotinib to healthy male subjects.

Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the Clinical Research Unit (CRU) on Day -1. On the morning of Day 1, all subjects will receive a single oral dose of 8 mg (as the hydrochloride salt) containing approximately 100 μCi of \[14C\]-poziotinib in the fasted state.

Subjects will be confined to the CRU until at least Day 8.

Subjects will be discharged from the CRU on Day 8 if the following criteria are met:

* ≥90% mass balance recovery in combined urine and feces, and
* ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods in which fecal and urine samples are obtained.

If these criteria are not met by Day 8, subjects will remain in the CRU until all discharge criteria are met up to a maximum of Day 15 in order to continue 24-hour blood, urine, and feces collections, unless otherwise agreed upon by the Sponsor and Investigator.

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index between 18.0 and 32.0 kg/m2, inclusive
* In good health at Screening and/or at Check-in
* Subjects must be surgically sterile for at least 90 days, or when sexually active with female partners of childbearing and non-childbearing potential will be required to use a male condom with spermicide from CRU Check-in until 90 days after discharge. Subjects are required to refrain from donation of sperm from CRU Check-in until 90 days after discharge
* Able to comprehend and willing to sign an ICF and to abide by the study restrictions
* History of at least 1 bowel movement per day

Key Exclusion Criteria:

* Stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
* Swallowing difficulties or ongoing diarrhea of any etiology
* Participation in a clinical study involving an investigational drug in the past 30 days prior to dosing
* Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to Check-in
* Use or intend to use any prescription medications/products within 14 days prior to Check-in
* Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Check-in
* Exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in
Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation

The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.


Eligibility Criteria:
Inclusion Criteria:

* Patient meets protocol specified criteria for constipation
* Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests and colonoscopy as applicable

Exclusion Criteria:

* Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study
* Patient reports loose stools
* Patient has IBS with pain/discomfort as predominant symptom
* Patient needs medications prohibited as specified in the protocol
Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers

The objective of this study is to determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus.

This is a prospective, randomized, multi-center, unmasked, controlled study. All patients will receive care for the diabetic foot ulcer during the study.

Participation in the study is for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

Participants included in the study must:

* Have Type 1 or Type 2 diabetes mellitus
* Have a diabetic foot ulcer on the bottom of the foot or heal which has been present for three (3) weeks but less than two (2) years and is sufficient size to qualify for the study
* Be able to visit the study doctor regularly for 24 weeks

Exclusion Criteria:

Participants may not be included if:

* The diabetic foot ulcer is infected
* They have poor circulation in their study foot
* Cannot or will not wear a special boot to take pressure off the study ulcer
* They have certain other diseases or laboratory values which are not within a specified range
Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs

This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.

BACKGROUND:

Mtb infects one-third of the world's population and ranks seventh in terms of global morbidity and mortality. Patients with bilateral pulmonary tuberculosis (TB), cavitary disease, and persistently positive sputum smears pose a special risk for treatment failure and/or relapse.

DESIGN NARRATIVE:

Cavitary pulmonary TB will be studied and interferon-gamma will be used as the intervention. The outcome of this study will be the changes in mycobacteriology, chest radiography, and bronchoalveolar lavage (BAL) cells.

The primary outcome will be sputum conversion, which will be measured at Weeks 4 and 8.

The key secondary outcomes of this study will include a chest computerized tomography (CT) scan and BAL to measure the flow of cytometry and cytokine levels. Both outcomes will be measured at baseline and at Month 4.

Eligibility Criteria:
Inclusion Criteria:

* Positive acid-fast bacillus (AFB) smear within 14 days prior to randomization
* Cluster of Differentiation 4 greater than 200 if HIV positive
* Ability to sign consent
* Bilateral, cavitary pulmonary TB

Exclusion Criteria:

* Multidrug-resistant (MDR) TB
* Extrapulmonary TB
* HIV positive with opportunistic infection within 30 days of study entry
* Cancer
* Asthma
* Pregnant or lactating women
* Chronic heart disease
* Chronic liver disease
* Chronic renal disease
* Seizure disorder
* Bleeding or clotting disorder
* Diabetes mellitus
Botulinum Toxin Type A in Diabetic Peripheral Neuropathy

Background: Diabetes mellitus is commonly complicated by diabetic peripheral neuropathy. Due to common side effects and poor tolerance to medication, poor adherence to medication is common in diabetic peripheral neuropathy. Botulinum toxin A intradermal injection has proved efficacy in cases of diabetic peripheral neuropathy however there is a need to compare its effect with other lines of treatment. The aim of the study was to compare botulinum toxin type a verses conventional oral treatment as a second line treatment of painful diabetic peripheral neuropathy. This study was conducted as a comparative study on 30 patients with type 2 diabetes mellitus proved by nerve conduction study on carbamazepine. Patients were divided randomly into 3 groups. First group was add on duloxetine, second was add on gabapentin and the third group was injected intradermal with botulinum toxin A.

This study is a comparative study on 30 patients with type 2 diabetes mellitus proved by nerve conduction study on carbamazepine. Patients were divided randomly into 3 groups.

First group was add on duloxetine, second was add on gabapentin and the third group was injected intradermal with Botulinum toxin A. Base line Assessment before treatment and follow up assessment as performed The treatment options were explained to the patients and the choice of Botulinum toxin A Intradermal injection was the patient own decision based on inability to be tolerate or adhere to oral treatment.

Eligibility Criteria:
Inclusion Criteria:

* diabetic patients type 2 were included on single line of treatment with carbamazepine

Exclusion Criteria:

* any sever medical condition that might interfere with the results.
Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes

The study will be focused on determining the integrated in-vivo mechanisms responsible for Ramipril's effects on delaying type 2 diabetes and restoring normal (blood sugar levels) glycemia in patients with impaired glucose tolerance.

Hypothesis - Ramipril effects will delay the onset of type 2 diabetes and restore normal glycemia in patients with impaired glucose tolerance.

Several studies have demonstrated that therapeutic agents used to reduce glucose levels and/or weight can delay the onset of type 2 diabetes. Intriguingly, angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) also result in reduction in the onset of type 2 DM. The most striking effect was found with Ramipril in the HOPE study. The onset of new type 2 DM was reduced by 34% (p\<0.001) as compared to placebo. Furthermore, the results of the DREAM trial demonstrate that Ramipril at a dose of 15 mg can significantly reverse impaired glucose tolerance. However, the mechanisms underlying Ramipril effects to delay type 2 diabetes are not known.

The proposal will be focused on determining the integrated in-vivo mechanisms responsible for Ramipril's effects on delaying type 2 DM and restoring normal glycemia in patients with impaired glucose tolerance.

The specific aims of the project are:

* to determine the effect of Ramipril on insulin resistance at the level of the liver and peripheral tissues,
* to determine the effect of Ramipril on endothelial function,
* to determine the effects of Ramipril on insulin secretion, and
* to determine the effects of Ramipril on substrate flux, lipolysis and inflammatory cytokines.

Eligibility Criteria:
Inclusion:

* 48 (24 male / 24 female) with impaired glucose tolerance.
* Impaired blood glucose values as outlined by the American Diabetes Association guideline. Fasting plasma glucose between 100 and 126 mg/dl or 2 hour post prandial glucose between 140 and 200 mg/dl
* BMI \> 25 kgM2
* Age: 20-65 years
* Treated or Untreated hypertension defined as measurement of seated BP at screening visit of systolic BP 120 to 150 and/ or diastolic BP 80 to 100.

Exclusion:

* Patients receiving agents that can increase or lower blood glucose, i.e., metformin, thiazolidinediones, sulfonylureas, glitinides, acarbose, GLP-1 receptor agonists
* Untreated or treated while seated Systolic Blood pressure \>150and/or Diastolic Blood pressure \>100
* Taking hypertensive medications of HCTZ or ACE/ARB
* Allergy to HCTZ, heparin, nitroglycerin or lidocaine
* History of allergy or unacceptable side effects from ACE inhibitors
* Pregnancy or intent to become pregnant during the study
* Smoking
* Subject unable to give voluntary informed consent

Physical Exam Exclusion Criteria

* Clinically significant Cardiac Abnormalities (e.g. Heart Failure, Arrhythmia) from history or ECG in subjects \> 40 years old
* Pneumonia
* Hepatic Failure/Jaundice
* Renal Failure
* Acute Cerebrovascular/ Neurological deficit
* Fever greater than 38.0 C

Screening Laboratory Tests Exclusion Criteria according to protocol
Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment

To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) in the pain relieving treatment during 48h postoperative period, by comparing with morphine i.v. PCA.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of either sex aged 18 to 65 years old, with a standard body weight \[standard body weight = height (cm) - 100\] ±15%.
2. ASA I and II.
3. Scheduled on elective open upper abdominal surgery under general anesthesia (liver, gall bladder, spleen, stomach, kidney, colon surgery), of which predicted operation duration is between 2-4h.
4. Hospitalized patients on non-emergency condition who have been given appropriate preoperative treatments.
5. Patients who are willing to participate in the study and have signed the written informed consent.
6. Negative pregnancy test result should be obtained for women of child-bearing age.

Exclusion Criteria:

1. Long-term analgesics or psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants) taken for the chronic pain, or patients abusing alcohol.
2. Body weight is less than or over ±15% of the standard body weight.
3. Severe impairment of liver and renal function at preoperative stage (ALT, AST, BUN, Cr).
4. Medical history of recovering from abnormal surgery anesthesia.
5. Medical history of hypertension (Systolic blood pressure ≥180Hg, Diastolic blood pressure 110Hg).
6. Esophagus reflux disease.
7. Sedatives, anti-emetics, and anti-pruritic drugs were taken 24 hours before operation.
8. Have known hypersensitivity to opioids.
9. Monoamine oxidase inhibitors and antidepressant drugs were taken within 15 days.
10. Patients with shock.
11. Patients with COPD.
12. Patients can not understand the VAS or unable to use PCA.
13. Pregnant or parturient women.
Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients

Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients

This is a cross-sectional, population-based study. No randomization procedure will be executed in this study. Approximately 1000 subjects over a 36-month period. The aim of this screening study is to identify the Fabry disease as the cause in patients with young stroke.

To measure the level of α-Gal A activity, male subjects will initially provide a DBS sample and female subjects will start with a test by whole blood sample.

The prevalence of Fabry disease among patients with young stroke will be estimated by a confirmative diagnosis in gene testing.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 or over
* Patients aged under 56 years old, not included 56
* Patients with acute stroke
* Patients and/or their legal representatives are willing to provide written informed consent

Exclusion Criteria:

* Patients with a confirmed diagnosis of Fabry disease
Effects of Spinal Cord Injury on Female Sexual Response

The long term aims of this project are to 1) Understand the effect of varying degrees and levels of SCI and dysfunction(SCI/D)on females sexual response: 2) Identify the specific neuronal pathways involved in female sexual responses; and 3) Develop and evaluate new assessment and treatment methods for neurogenic sexual dysfunction in women.


Eligibility Criteria:
Inclusion Criteria:

* MS or SCI
* Normal menstrual periods
* Normal hand function
* Have ability to feel sensation from lower abdomen to upper thigh region.

Exclusion Criteria:

* Pregnant
* Menopausal
Vagus Nerve Stimulation for Post-COVID Syndrome

The aim of this study is to increase parasympathetic activity and decrease the severity of symptoms by providing vagal stimulation with the t-VNS method in order to suppress the increased sympathetic activity in patients with prolonged Covid symptoms.The main question\[s\] it aims to answer are:

Question 1:Is left ear transcutaneous vagus nerve stimulation effective in suppressing the symptoms of patients in Post Covid syndrome?

Question 2:Is bilateral auricular transcutaneous vagus nerve stimulation effective in suppressing the symptoms of patients in Post Covid syndrome?

A 5-minute heart rate variability measurement will be performed to measure the effectiveness of vagus nerve stimulation in participants.HRV is a non-invasive method used to evaluate ANS activity and is a measure of heart rate change over a period of time


Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older
* Experiencing at least one of the post-covid symptoms for 12 weeks or longer

Exclusion Criteria:

* Considering that the female reproductive hormones level in the body and menstrual cycle may affect the ANS in female patients, female participants in perimenopausal, post-menopausal and pregnancy conditions were excluded from the study.
* Participants who used medication for the treatment of ANS dysfunction in the last six months were also excluded from the study.
Nicotine Lozenge to Reduce Smokeless Tobacco Use

Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has as many health risks associated with its use as cigarettes. While there are many treatment programs that focus on stopping tobacco use, there are no interventions that specifically focus on reducing tobacco use. This study will evaluate the effectiveness of nicotine lozenge at reducing tobacco use in ST users.

Individuals who use ST are at risk for developing heart disease, stroke, high blood pressure, and cancer. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Many individuals who use ST recognize the health risks associated with ST, but either do not want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. The need exists for a program specifically aimed towards reducing, rather than quitting, tobacco use. The purpose of this study is to evaluate the effectiveness of nicotine gum at reducing ST use, as well as assessing the motivation to either quit or sustain lower levels of ST use.

This 8-week study will enroll frequent users of ST. Participants will be randomly assigned to receive either nicotine lozenge plus behavioral counseling or behavioral counseling alone. All participants will be asked to alternate use of their usual ST brand with nicotine lozenge or placebo in order to reduce nicotine intake by 50% during the first 4 weeks and by 75% the following 4 weeks. Participants will be required to maintain a daily tobacco use diary. Study visits will occur once a week. Tobacco levels will be monitored with urine tests, and questionnaires will be completed to assess tobacco use. Follow-up evaluations will occur 12 and 26 weeks following the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* No interest in stopping ST use within 90 days of study entry
* Using ST at least 6 times a day in the 6 months prior to study entry
* Willing to use contraception throughout the study

Exclusion Criteria:

* Current use of tobacco or nicotine products, other than ST
* Current unstable medical condition
* Use of any medication that may affect tobacco use or be affected by a reduction in tobacco use
* Meets DSM-IV diagnostic criteria for any psychiatric disorder or substance abuse disorder within 6 months of study entry
* Use of any psychotropic medication within 6 months of study entry
* Pregnant or breastfeeding