cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Recombinant Human Alpha-mannosidase for the Treatment of Patients With Alpha-mannosidosis

This is a single-center, open-label, dose escalation study of patients with alpha-mannosidosis. 10 patients will be enrolled in this study receiving intravenous infusions of Lamazym. In order to avoid development of delayed hypersensitivity all patients will continue weekly treatment at the designated dose until the Safety Committee approves transfer to the rhLAMAN-03 protocol.

It is the hypothesis that Lamazym is safe to use.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must have a confirmed diagnosis of alpha-mannosidosis as defined by alpha-mannosidase activity \< 10% of normal activity in blood leukocytes
2. The patient must have an age at the time of screening ≥ 5 year and ≤ 20 years
3. The patient must have physical ability to perform 6-minutes walk test (6MWT), 3 minute-stair climb test (3MSCT) and pulmonary lung function test (spirometry, body plethysmography).
4. The patient must have the ability to mentally cooperate in the cognitive and motor function tests
5. The patient must have the ability to hear and follow a request. Hearing aids can be worn.
6. Patient or patient's legally authorized guardian(s) must provide signed, informed consent prior to performing any study-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject)
7. The patient and his/her guardian(s) must have the ability to comply with the protocol

Exclusion Criteria:

1. The patient cannot walk without support.
2. Presence of known chromosomal abnormality and syndromes affecting psychomotor development, other than alpha-mannosidosis
3. History of bone marrow transplantation
4. Presence of known clinically significant cardiovascular, hepatic, pulmonary or renal disease or other medical conditions that, in the opinion of the Investigator, would preclude participation in the trial
5. Presence of an ECHO with abnormalities within half a year that, in the opinion of the Investigator, would preclude participation in the trial
6. Any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the trial
7. Pregnancy
8. Psychosis within the last 3 months
C-Spine Movement - Shikani Optical Scope vs Macintosh Laryngoscope for Patients With Cervical Spine Injury

Patients undergoing surgery will have laryngoscopy performed using two widely accepted techniques - Macintosh Laryngoscope and Shikani Optical Scope. The techniques will be timed and compared for cervical spine movement using fluoroscopy.

Approval for the study has been obtained from the Review Board for Health and Sciences Research Involving Human Subjects of the University of Western Ontario. Informed and written consent will be obtained from patients who are undergoing elective surgery requiring general anesthesia with endotracheal intubation. Preoperative clinical assessment of the patients will include routine airway evaluation of dentition, mouth opening, tongue size, Mallampati score, and neck mobility.

While awake, the patients will be placed on the operating room table with a rigid board under their head, neck, and torso in order to simulate the table on which patients involved in trauma are placed in the emergency room. In-line stabilization (ILS), as recommended by the ATLS guidelines, will be applied to maintain the patient's head in the neutral position and reduce neck movement during laryngoscopy.

After standard pre-oxygenation, anesthesia will be induced in routine fashion with 2-3 mg/kg propofol and 2-5 mcg/kg fentanyl; rocuronium 0.8 mg/kg will be administered to effect muscle paralysis. The patient will be then be ventilated with sevoflurane in 100% Oxygen via bag and mask for 3 minutes.

After the patient is anesthetized, a sealed envelope containing computer a generated random assignment will be opened. Laryngoscopy will then be performed two times, with the Macintosh laryngoscope and with the Shikani Optical Scope, in random order as determined by the envelope. Between laryngoscopies, the patient will be ventilated with sevoflurane in 100% Oxygen.

For direct Macintosh laryngoscopy, a size 3 laryngoscope blade will be recommended in all patients. With laryngoscopy, the glottis will be exposed to enable positioning of the endotracheal tube at the vocal cords. During the second laryngoscopy in the above sequence, the trachea will be intubated.

The study is then complete. The hard board will be removed and the surgery will proceed in the usual fashion.

The laryngoscopy and intubation will be recorded by a portable fluoroscopy unit for subsequent review by the radiologist to assess relative neck movement.

Laryngoscopy time will be defined as the time from when the laryngoscope blade or Shikani stylet passes the teeth of the patient until the time the endotracheal tube is positioned at the opening of the larynx. If the intubation sequence is longer than 120 seconds, it will be deemed a failure and recorded as such.

The Cormack (11) of the larynx will be recorded for all patients.

Eligibility Criteria:
Inclusion Criteria:

* Elective non-cardiac surgery patients requiring intubation for the surgery.
* Age 18-75
* ASA 1-3
* Body Mass Index (BMI) \< 40

Exclusion Criteria:

* patients with previous neck surgery or unstable C-spine
* patients with Reflux disease (GERD)
* patients who are or may be pregnant
A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)

This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for end-stage renal disease (ESRD). Participants will receive 6.5 and 6 weeks of the marketed oral oseltamivir suspension dosed according to the HD or CAPD schedule, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Adults greater than or equal to (\>/=) 18 years of age
* ESRD defined as no residual renal function or a creatinine clearance (CrCl) less than (\<) 10 milliliters per minute (mL/min)
* Well established HD or CAPD therapy over a period of 3 months with stable CrCl \< 10 mL/min
* Body mass index (BMI) 18 to 34 kilograms per meter-squared (kg/m\^2)
* Use of contraception among women of childbearing potential

Exclusion Criteria:

* Clinical significant comorbid disease or terminal illness
* Known human immunodeficiency virus (HIV) or hepatitis B or C
* History of drug or alcohol abuse within the prior year
* Donation or loss of \>/= 400 milliliters (mL) of blood in the 3 months prior to Screening
* Participation in a clinical study with an investigational drug in the 3 months prior to study drug
* Pregnant or lactating women
Continuous Sciatic Nerve Block vs Epidural Analgesia in Lower Limb Amputation for Postoperative Pain

Controlled clinical trial of two parallel groups, with random assignment 1:1, non-inferiority, blinded for the patient, for who administers the intervention and for who analyzes the data. 112 participants

Controlled clinical trial of two parallel groups, with random assignment 1:1, non-inferiority, blinded for the patient, for who administers the intervention and for who analyzes the data. 112 participants Outcomes: Primary: Numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain) was used for pain assessments daily for 15 days and subsequently monthly until completing 3 months. Co-primary: Assessment of symptomatology related to phantom limb pain daily for 15 days POP and subsequently monthly until completing 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years
2. Being scheduled for above or below knee amputation or for bone remodeling of lower limb amputees
3. Acceptance of continuous regional analgesic technique as part of their multimodal analgesia

Exclusion Criteria:

1. Traumatic cause of amputation
2. Allergy to local anesthetics
3. Contraindication for epidural technique or continuous blocks
4. Stage 5 kidney disease
5. Concomitant use of aspirin and clopidogrel
6. Pregnancy status
Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter

This prospective randomised controlled trial will be conducted to investigate that increasing the vitrectomy cutting rate from 10,000 cut/min to 20,000 cut/min will result more efficiency and shorter core vitrectomy time, and it is equally safe as compared to the current 10,000 cut/min. We plan to target the patients undergoing for vitrectomy for common vitreoretinal pathology. Our plan is to conduct a randomised study with 2 arms, one with the higher cutting rate (20,000 cut/min) versus a second arm using the existing system 10,000 cuts/min.

In addition, we will measure the core vitrectomy duration by Constellation Vision System stopwatch. We will count the duration when the vitrectomy probe enter into the eye to the moment the performing the air/fluid exchange by shaving the peripheral vitreous to complete the vitrectomy. For our second outcome measure to prove the no-inferiority of intraoperative and postoperative complications patients will have 3 months follow up visits.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age who are undergoing vitrectomy for the following conditions:

  * Macular hole
  * Epimacular membrane
  * Vitreous hemorrhage
  * Primary retinal detachment

Exclusion Criteria:

* Patient who is

  * unable to give proper consent
  * previous vitrectomy or scleral buckle surgery
  * cases requiring silicone oil tamponed
  * undergoing repeated retinal detachment surgery
  * undergoing surgery for tractional diabetic retinopathy
The Impact of Chronic E-Cigarette Usage on Microvascular Health

The study is focused on investigating the mechanisms involved in microvascular health in subjects that use e-cigarettes frequently. To explore microvascular health, different techniques and compounds. For one of the tests, iontophoresis, the drug's use will be stored and handled as described by the approved IND and non-IDS plan.

Electronic cigarettes or e-cigarettes have become increasingly popular, due to their promotion as a healthy alternative to traditional tobacco cigarettes. However, there are large discrepancies of knowledge in understanding how these e-cigarettes affect the subjects health and the way their body uses oxygen. The overall goal of this study is to evaluate e-cigarettes usage on subjects health.

Eligibility Criteria:
e-Cig users arm

Inclusion Criteria:

* Between 18 and 29 years of age
* Used e-cigarettes with nicotine (≥3 times/week for ≥6 months)

Exclusion Criteria:

* 17 years old and younger or 30 years old or older.
* Former combustible tobacco user/ former smoker
* Use of cigarettes for 15 days or more in the past 60 days
* Use of other tobacco products (cigars, hookah, smokeless), marijuana and/or illicit or prescription drugs weekly or more frequently in the past 60 days
* Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, cerebral diseases or sleep disorders
* Disorder or use of medication that affects cardiopulmonary health
* Evidence of pregnancy or current nursing

Non e-Cig using arm

Inclusion

- Between 18 and 29 years of age

Exclusion

* 17 years old and younger or 30 years old and older
* Use of cigarettes or other tobacco products more than 50 times in their lifetime.
* Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, cerebral diseases or sleep disorders
* Disorder or use of medication that affects cardiopulmonary health
* Evidence of pregnancy or current nursing
Sugar Sweetened Beverages (SSB)- Effects on Metabolism

The objective of this study is to investigate the impact of sugar sweetened beverages on the fat metabolism of healthy young men. It is well known that consumption of beverages sweetened with fructose is associated with different health risks such as type 2 diabetes. The present study has been designed to dissect differences in the metabolic pathways of fructose and glucose, but also metabolic adaptations during fructose, glucose and sucrose diets. During a period of seven weeks subjects will consume either fructose, glucose or sucrose sweetened beverages or continue their usual drinking habits. During these seven weeks there will be different metabolic investigations using stable isotope tracers. First, the rate of lipolysis and beta-oxidation will be determined. Second, the rates of fatty acid synthesis will be measured. During all examinations there will also be substrate- and energy-utilization measurements by indirect calorimetry, blood analysis and morphometric measurements. Based on the literature main hypotheses are: Fructose enhances de novo lipogenesis postprandially and also in the fasting state significantly more than glucose by enhanced expression of lipogenic enzymes. Fructose decreases beta oxidation via downregulation of oxidative enzymes.


Eligibility Criteria:
Inclusion criteria:

* Healthy male volunteers aged 18-30
* BMI between 19-24 kg/m2
* Non-smoker

Exclusion criteria:

* Acute or chronic infections, malignant disease, renal, hepatic (more than two-fold increased transaminases), pulmonary, neurological (epilepsy) or psychiatric diseases, manifested atherosclerosis, or any other disease precluding participation in the study.
* Diabetes
* Known alcohol, substance or drug abuse, concomitant medication
* More than three hours of physical exercise per week
* Consumption of more than 2 times 3 dl SSB daily
* Subjects likely to fail to comply with the study protocol
* Subjects who do not give informed consent
Alzheimer and Sleep

The aim of the study is the analysis of two inhibitors of Ach-E: galantamine and donépézil in over 65 years' old patients suffering from Alzheimer disease (MMSE between 20 and 26) without Alzheimer's medication.

Feasibility study, open, randomized, controlled, cross-over study in 65 years old patients.

Eligibility Criteria:
Inclusion Criteria:

* 65 and over years old
* Patients suffering from Alzheimer disease
* Patient living with someone at home
* Written consent given

Exclusion Criteria:

* Galantamine or Donepezil hypersensibility
* Patient living alone and in a medicalized structure
* Concomitant medication
* Chronical diseases
Study to Evaluate the Effect of Megestrol Acetate in Severe Chronic Obstructive Pulmonary Disease With Loss of Weight

The purpose of this trial is to study the effect of megestrol acetate in the gain of body weight in patients with severe Chronic obstructive pulmonary disease in order to improve the survival of the patients.

It has been demonstrated that the body weight measured as a Body mass index (BMI)is an independent risk factor of mortality in the severe COPD.It seems to be one influence of inflammatory factors in the development of denutrition in these patients.

The use of especial diets has no so good results in the aim to improve the weight, being necessary to complement with muscular rehabilitation or anabolic products. The megestrol acetate has demonstrated good results in a short period of time, nevertheless the studies are scarce.

The beneficial effects of the megestrol acetate seems to be mediated by cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnose of COPD (criteria ATS/ERS 2004)
* Clinical stability more than 3 months
* Smokers or ex-smokers of more than \> 10 boxes/year than do not modify their smoking habit during the study.
* FEV1 (post-bronchodilator) \< 50%. FEV1/FVC ≤ 70
* Negative answer to bronchodilator(≤ 20% del FEV1 o ≤ 200 ml.after 400 mcg.de salbutamol inhaled)
* BMI \< 21 Kg/m2 ó BMI 21-25 Kg/m with loss weight of 5% of the habitual body weight in the last 3 months, without other reason that could explain it independently of the COPD.

Exclusion Criteria:

* Use of nasogastric catheter
* Concomitant treatment with steroid, anabolics or other progestagens.
* Loss of body weight related with other causes: hyperthyroidism, enteral malnutrition ( Crohn disease...), neoplasias,etc
* Treatment with Megestrol Acetate in the last 6 months
Choroidal Thickness Change in Response to Physiological and Refractive Changes

There is a great need for precise and repeatable measurements of the choroidal thickness. Including the diurnal physiological changes, accommodation and refractive error impact on those measurements.


Eligibility Criteria:
Inclusion Criteria:

* participants with refractive error
* willing and able to understand and sign an informed consent form

Exclusion Criteria:

* patient unable to participate in the study
* any disease that causes visual opacity of optic media that unable to perform OCT scanning
* current enrolment in another clinical trial/research project
Carbachol´s Headache Inducing Characteristics and Effects on the Cerebral Blood Flow

To investigate headache score and accompanying symptoms during and after infusion of carbachol.

To investigate headache score and accompanying symptoms during and after infusion of carbachol.

Changes in regional cerebral blood flow (rCBF) in the area supplied by middle cerebral artery (MCA), blood flow in MCA, diameter of the superficial temporal artery (STA) and radial artery (RA)

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Aged 18-40
* 50-100 kg
* Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen.

Exclusion Criteria:

* Tension type headache more than once/month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the halflife for the specific drug except contraceptives
* Pregnant or lactating women
* Exposure to radiation within the last year
* Headache within the last 24 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease
Distribution of Immune Cells and Their Subtypes in Peripheral Blood of Gout

The purpose of this study is to evaluate whether immune cells and their subtypes in peripheral blood affects the asymptomatic hyperuricemia, gout flare, intercritical gout and advanced gout.

A number of studies have reported that innate immunity cells (such as blood monocytes and neutrophils) play a crucial role in the initiation and amplification of gout flare resulted from MSU deposition in the joint or tissue, leading to release NLRP3 inflammasome-mediated production of bioactive IL-1β. Further investigation demonstrated the role of blood neutrophils might contribute to the resolution of gout flare by forming aggregated neutrophil extracellular traps. Recently, a few in vitro experiments have indicated that adaptive immunity may be involved in mechanisms of gout. However, a global understanding of blood immune responses underlying gout is still unclear. Thus, we want to investigate the relationship between immune cells and their subtypes in peripheral blood and the gout.

Eligibility Criteria:
Inclusion Criteria:

* gout flare:diagnosis with gout flare at this hospital according to the criteria approved by the ACR Board of Directors and the EULAR Executive Committee in 2015
* intercritical gout: remission of gout patients were classified into intercritical gout group without tophi, chronic gouty arthritis, or imaging erosion(All of these gout remission patients underwent dual-energy CT test within one month, and were detected to have MSU crystal deposition in local joints)
* advanced gout: gout remission patients were classified into advanced gout group characterized by tophi, chronic gouty arthritis, or imaging erosion(All of these gout remission patients underwent dual-energy CT test within one month, and were detected to have MSU crystal deposition in local joints)
* asymptomatic hyperuricemia: hyperuricemia in men was defined as SUA ≥ 420 mmol/L without any complications

Exclusion Criteria:

* primary osteoarticular diseases
* unwilling participation in the study
* corticosteroids or indomethacin use in the past 3 months;
* septic arthritis or another joint disease (such as rheumatoid arthritis);
* impaired renal function (creatinine clearance \<30 mL/min) and other conditions which may increase the level of blood uric acid
Speed of Injection and Pain During Routine Infant Vaccinations

Vaccine injections are a significant source of pain for infants. Altering the injection speed when administering vaccines may be an effective intervention and is feasible (cost neutral). At present, there are no data regarding impact of injection speed on vaccine injection pain in infants. The aim of this study is to address this knowledge gap and to compare the impact of slow and fast vaccine injection speeds on pain during routine infant vaccinations.

To date, there has been no evidence-based guidance regarding the rate at which vaccines should be injected to minimize pain. This has led to a disparity in practice. Some vaccinators favour a slow rate of injection (around 8-10 sec/mL) while others prefer a more rapid rate of injection (around 2-4 sec/mL).The slow injection method leads to a longer needle dwelling time with the increased possibility of the needle moving around and causing pain by damaging muscle tissue. Rapid injection, on the other hand, may lead to a sudden distension of muscle tissue, which itself could be painful. Allowing the muscle sufficient time to distend in order to accommodate the vaccine might minimize pain. This study will address the identified knowledge gap by comparing pain in infants undergoing routine vaccinations with a fast vs. slow injection speed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy 2 and 4 month old infants receiving their primary vaccine injections, PediacelTM (0.5mL) and PrevnarTM (0.5mL) (in conjunction with and preceded by oral RotarixTM vaccine) and healthy 6 month old infants receiving their routine vaccine injection, PediacelTM (0.5mL)

Exclusion Criteria:

* Infants with impaired neurological development; history of seizures; administration of sedatives or narcotics in the preceding 24 hours; parental inability to use study tools; parent vaccine refusal; prior participation in the trial; and refusal to be video recorded