cyrilzakka/clinical-trials huggingface dataset:
Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy

In this randomized placebo-controlled clinical trial, patients will be randomized to be administered viscous lidocaine or placebo preoperatively to elective upper GI endoscopy


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to and found fit for upper GI endoscopy in an out patient setting
* Between 18 and 75 years old
* Speaks and understands Danish

Exclusion Criteria:

* Patients admitted for upper GI endoscopy in an in-patient setting
* Patients with dementia and/or other cognitive dysfunction disorders
* Patients primarily complaining of dysphagia
* Patients allergic to lidocaine
* Patients with suspected retention
* Patients who will undergo upper GI endoscopy with nurse-assisted propofol sedation
* Patients who will undergo upper GI endoscopy with assistance of anesthesia-personnel
Short- and Long Term Growth in Children With Asthma

The purpose of this study is to assess if treatment with budesonide 200 microgram per day affects short- or long term growth in children with asthma

When children with asthma are treated with inhaled corticosteroids there is a risk of systemic adverse events such as growth suppression. It has been reported that treatment with budesonide 200 microgram per day does not affect short term growth in children with asthma. The aim of the present study is to assess if an unaffected short term growth means that also long term growth will be unaffected.

Short and long term growth in asthmatic children treated with budesonide will be compared with the growth in asthmatic children treated with montelukast.

Eligibility Criteria:
Inclusion Criteria:

* age 6-11,
* prepubertal,
* asthma,
* normal weight and height,
* informed consent

Exclusion Criteria:

* treatment with systemic/inhaled/intranasal corticosteroids within the last week,
* major surgery within 4 weeks,
* usage of drugs that significantly inhibit CYP3A4
Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Glabellar Lines

This study is intended to evaluate the efficacy and safety of MBA-P01 compared to BOTOX in treatment of glabellar lines.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 19 and 65
* Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
* Patients who can comply with the study procedures and visit schedule
* Patients who voluntarily sign the informed consent

Exclusion Criteria:

* Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
* Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
* Patients who have received other procedures which may affect glabellar lines within 6 months
* Patients who were injected with botulinum toxin within the past 6 months
* Patients with allergy or hypersensitivity to the investigational drugs or their components
* Patients who have bleeding tendency or taking anti-coagulant
* Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
* Patients with skin disorders or infection at the injection site
* Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
* Patients who are unable to communicate or follow the instructions
* Patients who are not eligible for this study based on the judgment of an investigator
Gelatin in ICU and Sepsis

This prospective, double-blind randomized controlled trial evaluates the differences in terms of efficacy and safety of gelatin based resuscitation as compared to crystalloid based resuscitation in two parallel groups of patients with severe sepsis / septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 18 years of age
* Women of child bearing potential must test negative on standard pregnancy test (urine or serum)
* Patients with body weight ≤ 140 kg
* Patients diagnosed severe sepsis / septic shock at admission on Intensive Care Unit who can be enrolled within 90 min after admission OR patients diagnosed severe sepsis / septic shock during Intensive Care Unit stay who can be enrolled within 90 min after diagnosis
* Patients where antibiotic therapy has already been started (prior to randomization)
* Patient who are fluid responsive. Fluid responsiveness is defined as increase of \> 10% in mean arterial pressure (MAP) after passive leg raising (PLR)
* Signed informed consent by patient, legal representative or authorized person or deferred consent

Exclusion Criteria:

* Administration of HES, dextrane solutions or \> 500 ml of Gelatin solutions within the 24 h prior to randomization
* Death expected within the next 48 h (moribund patients as defined by ASA ≥ class V)
* Patients for whom the need of pressure infusions are expected
* Patients with confirmed acute SARS-CoV-2 (COVID-19) infection (as available from routine medical records/ patient chart)
* Requirement for renal support (either continuous or discontinuous techniques, including intermittent haemodialysis, haemofiltration and haemodiafiltration)
* Patients receiving therapeutic heparin medication due to chronic coagulation disease / anticoagulation medication (i.e. partial thromboplastin time \> 60 sec)
* Acutely burned patients
* Contraindications according to summary of product characteristics of investigational test and reference product
* Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
Penicillin Prophylaxis in Sickle Cell Disease (PROPS)

To determine whether the regular daily administration of oral penicillin would reduce the incidence of documented infection due to Streptococcus pneumoniae in children with sickle cell anemia.

BACKGROUND:

For over 20 years children with sickle cell anemia have been known to have an increased susceptibility to severe bacterial infection, particularly due to Streptococcus pneumoniae. Meningitis, pneumonia and septicemia due to this organism have been recognized as the major causes of death for these children, with children under three years of age being at highest risk. The annual incidence of pneumococcal septicemia among young children with sickle cell anemia appears to have remained remarkably constant over the last two decades at approximately 10 percent. This illness can often be fulminant, progressing from the onset of fever to death in less than 12 hours, with a case fatality rate ranging as high as 35 percent.

Penicillin prophylaxis has been advocated as a preventive measure against severe pneumococcal infections in children with sickle cell anemia. One study had shown that the risk of pneumococcal infection in these children could be reduced by the use of parenteral penicillin.

DESIGN NARRATIVE:

Phase I was a multi-center, randomized, double-blind, placebo-controlled trial. One hundred and five patients were assigned to the penicillin group and 110 to placebo. The primary endpoint was a documented severe infection due to S. pneumoniae. The secondary endpoint was a severe infection due to an organism other than S. pneumoniae.

Because data were not available to define the age at which prophylactic penicillin could be safely discontinued, the NHLBI launched Phase II of the Prophylactic Penicillin Study beginning in 1987. Recruitment ended in August, 1993. The clinical phase of Phase II ended in August, 1994.

Phase II was a multi-center randomized trial to evaluate the hazards of discontinuing daily oral penicillin at the age of five years. Within three months of their fifth birthdays, all children were randomized to continue oral penicillin prophylaxis or to stop prophylaxis. Each child was followed for a minimum of two years. The primary endpoint was a comparison of documented pneumococcal infection in children continuing penicillin after five years of age versus children whose prophylaxis was stopped at five years of age. Ancillary studies conducted in subsets of patients included: the prevalence of colonization of the nasopharynx with antibiotic resistant microorangisms; and the relationship of antibody response to pneumococcal vaccination to the incidence of pneumococcal sepsis in this patient population.

Eligibility Criteria:
In the Phase I trial, Black children with sickle cell anemia aged 3 months to 3 years. In the Phase II trial, children with sickle cell anemia aged five years 3 months of age and younger who had received prophylactic penicillin for at least two yea
A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy

The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.


Eligibility Criteria:
Inclusion criteria:

1. confirmed diagnosis of T2DM
2. Glycated hemoglobin (HbA1c) \>=7.0 and \<=10/0% at Visit 1
3. Metformin therapy (at least 1500 mg/day, BID)
4. age\>=18 at Visit 1
5. body mass index \<=45 kg/m2

Exclusion criteria:

1. estimated creatinine clearance rate (eCCr) \<60 ml/min (Cockcroft-Gault formula) screening and/or run-in
2. a confirmed glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during placebo run-in
Pancreatic Enzyme Supplementation for Celiac Disease

The purpose of this protocol is to conduct a pilot study to investigate whether pancreatic enzyme supplementation will improve symptoms in individuals with celiac disease who suffer persistent symptoms despite a gluten free diet. This protocol specifically aims to:

1. Evaluate the efficacy of pancreatic enzyme supplementation for reduction of gastrointestinal symptoms in patients with celiac disease on a gluten free diet.
2. Assess the ability of fecal elastase levels to predict response to pancreatic enzyme supplementation in patients with celiac disease on a gluten free diet.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven celiac disease.
* Age 18-80.
* Ongoing symptoms defined as a CeD-GSRS score of greater than 3 during the run in period.
* Subject must be following a gluten free diet.
* tTG \< 40 units at screening.

Exclusion Criteria:

* Taking prescription or over the counter enzyme supplements for 1 month prior to enrollment.
* Pregnant, breastfeeding or planning pregnancy. Woman using acceptable methods of contraception will be included. Acceptable methods of contraception include oral hormonal contraceptives, implanted hormonal contraceptives, diaphragm with spermicide, condoms, intra-uterine device, abstinence, and male partner vasectomy.
* Patients with a pork allergy or who are unwilling to consume pork products.
* English proficiency unsuitable for completion of surveys.
* Known severe pancreatic disease.
* Known history of prior cancer (except squamous or basal cell skin cancer).
* Patients with lactose intolerance who are unable to tolerate a minimum of 1oz (2 tablespoons) of whole milk per day.
* Clinically significant abnormality in safety lab values (i.e. CBC and BMP) at screening that may impact subject safety or the scientific integrity of the study.
* Other known active GI condition including but not limited to inflammatory bowel disease, small intestine bacterial overgrowth, and obvious FODMAP intolerance.
* History of all major gastrointestinal surgery other than appendectomy or cholecystectomy.
* Comorbid condition that in the opinion of the investigator would interfere with the subject's participation in the study or would confound the results of the study.
Single-photon Emission Computed Tomography (SPECT) to Predict Peritoneal Chemotherapy

SPECT was performed in 51 patients after cytoreductive surgery in combination with intraperitoneal chemotherapy. The detected volume was compared to the number of subsequent sequential postoperative intraperitoneal chemotherapy courses that could be performed without further surgical intervention. SPECT data was found to predict feasibility of sequential postoperative intraperitoneal chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Cytoreductive surgery and intraperitoneal chemotherapy
* Single-Photon Emission Computed Tomography (SPECT) before the second course of treatment
Constraint Induced Movement Therapy Summer Camp

Constraint induced movement therapy (CIMT) is an intervention for unilateral cerebral palsy (CP). It is currently part of standard of care for children with unilateral CP, but is typically done one-on-one and with the child wearing a cast 24 hours a day during the duration of treatment. The purpose of this study is to assess the effects of an intensive group-based CIMT summer camp in which participants wear a removable cast on upper extremity function, occupational performance, and patient-specific goals. The investigators hypothesize that upper extremity skills and occupational performance will increase, and that patients will reach their individualized goals.


Eligibility Criteria:
Inclusion Criteria:

* Scores of level I, II or III on the Manual Ability Classification System
* Independent grasp
* Ability to ambulate independently or with an assistive device
* Sufficient cooperation and cognitive understanding to participate in a group.

Exclusion Criteria:

* Lack of hand function
* Fixed contractures
* Active seizures
* High tone
* Medical instability
* Non-English speaking parents.
Dose Escalation Upper Limb Rehabilitation in Stroke

A phase 1, single-ascending dose clinical trial will be conducted. This study will be designed to test increasing doses of multimodal exercise in successive cohorts of six participants (cumulative 3 + 3 design)\[22\] (Figure 1).

Maximum dose is reached when two or more participants experience DLT. DLT, dose-limiting tolerance.

The 'dose' will be defined as the ability to reach a fixed maximal level of exercise (type, duration (including session length) in the first two weeks post-stroke without experiencing dose-limiting tolerance (DLT). DLT thresholds will be based on failure to completeshould be less than 80% of prescribed 3-day rehabilitation dose due to pain, rate of perceived exertion, fatigue, or effort required.

Rehabilitation and measurement sessions will be held at either at the Stroke or Geriatric Units at Campus Sint-Jan, Genk or at the rehabilitation unit at Sint-Barbara, Lanaken and Cliniques Saint-Luc with medical services on site. All participants will be monitored for fatigue and pain pre, during and at post-intervention daily. The researchers (PI of project \[Dr Peter Hallet, ZOL\] Postdoctoral Researcher \[Dr Lisa Tedesco Triccas, UHasselt\] and PhD/Masters Students \[UHasselt) will conduct the clinical tests and will conduct the rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

1. a first-ever unilateral, diagnosed stroke by a neurologist as defined by the World Health Organisation,
2. been admitted to the acute hospital for rehabilitation,
3. UL hemiparesis or hemiplegia with a ≥ trace of muscle contraction (≥grade 1 at wrist extensors measured by the MRC Scale and severely motor affected by score of 2 or 3 on item number 5 on the NIH Stroke Scale (NIHSS),
4. the age of \> 18 years and (e) the ability to provide informed consent.

Exclusion Criteria:

1. other neurological impairments that could interfere with the protocol such as multiple sclerosis and Parkinson's
2. serious communication, cognitive and language deficits which might hamper the assessment (score of \>1 on the command item of the NIHSS).
TAMO Therapy Versus Postural Control Exercise in Children With Congenital Muscular Torticollis

A randomized control trial was conducted through convenient sampling. 18 subjects were randomly allocated into two groups, group A received postural control exercises in addition to conventional therapy, while Group B received TAMO therapy along with conventional therapy. analysis.

Torticollis is common in children and can be congenital or acquired. Acquired cases can result from neck muscles or bone injuries. Though distressing for parents, it usually improves over time. Treatment includes postural control exercise and TAMO therapy, along with conventional treatment. To compare the effects of TAMO therapy versus postural control exercises on children with congenital muscular torticollis on cervical range of motion. A randomized control trial was conducted through convenient sampling. Eighteen subjects were randomly allocated into two groups; Group A received postural control exercises in addition to conventional therapy, while group B received TAMO therapy along with conventional therapy. The duration of the treatment was eight weeks. Goniometer, still photography, muscle function. Eighteen participants (n=18) were included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 3 months
* Both genders
* Abnormal neck posture
* Torticollis of both sides

Exclusion Criteria:

* SCM mass present
* Deficit in cervical PROM greater than 15 degree
* Craniosynostosis (it is a birth defect in which the bones in a baby skull join together too early)
* Infectious
* Metabolic
* Scoliosis of spine
* Developmental plagiocephaly
* SCM tumor
* Visual disorder
Adherence of Apixaban and Warfarin in Patients With Arterial Fibrillation in Real-world Setting in Sweden

This will be a retrospective cohort study using national register linkage data (including prescription, inpatient, mortality, and socioeconomic data). The study period will be from May 29, 2013 to June 30, 2015. Patients will be followed from the start of treatment (index date) until their death, exiting the database, or until the end of the study period (June 30, 2015).


Eligibility Criteria:
Inclusion Criteria:

* For the AF cohort

  * Patients that have ≥1 AF diagnosis registered in the patient register
* Apixaban subcohort 1

  * Patients eligible for the AF cohort
  * Patients that had a first prescription for apixaban during the identification period without previous prescriptions for NOACs or warfarin during the preceding 12 months
* Warfarin subcohort 1

  * Patients eligible for the AF cohort
  * Patients that had a first prescription for warfarin during the identification period without previous prescriptions for NOACs or warfarin during the preceding 12 months
* Apixaban subcohort 2

  * Patients eligible for the AF cohort
  * Patients that had a first prescription for apixaban during

Exclusion Criteria:

* For the AF cohort:

  * Patients with valvular AF will be excluded (see definition Appendix 1)
* Warfarin subcohort 1:

  * Patients will be excluded from this sub-cohort if they had at least one prescription for warfarin or NOACs during the 12-month period preceding the first prescription for warfarin during the identification period, ie, the index date
Withdrawal Exposure With Withdrawal Regulation Training for Smoking Cessation

This is a pilot study of a withdrawal regulation training program compared to relaxation training for individuals that are interested in smoking cessation.

Participants will be recruited through newspaper and internet advertisements, advertisements on public transportation, community centers and community based organizations. All recruitment materials will contain a toll-free telephone number with 24-hour voice mail. The first contact with potential participant will be by telephone interview to assess for eligibility of participant. Participants who meet eligibility criteria will be invited to an orientation meeting where a breath carbon monoxide sample will be obtained. Women participant of childbearing potential will have a pregnancy test administered.

Participants will be randomized to one of two conditions: Early Withdrawal Exposure + Withdrawal Relaxation Training (E+WT) or Relaxation Training (RT) control. The E+WT condition will consist of the development, application, modification, and repeated practice of individualized withdrawal regulation for behavioral and cognitive strategies. the RT condition will control for the therapeutic contact received by those in the E+WT condition and will consist of the development, application, modification, and repeated practice of individualized relaxation techniques (e.g. breathing exercises, imagery).

Eligibility Criteria:
Inclusion Criteria:

* Men and women at least 19 years of age
* Reports smoking at least 10 cigarettes per day
* Must have expired breath carbon monoxide reading of at least eight parts per million
* Report the intention to quit smoking
* Reside in the Birmingham area with no plan to relocate outside of the area in the next six months
* Have access to a telephone for scheduling follow up assessments

Exclusion Criteria:

* Inability to speak English
* Presence of a condition that contraindicates use of transdermal nicotine patch (i.e. angina pectoris, arrhythmia, recent myocardial infarction, allergies to adhesives, serious skin disorders, and current pregnancy or breast feeding)
* Presence of conditions that might interfere with compliance with protocol or greatly complicate treatment (i.e. current alcohol or other substance dependence, dementia, psychosis, schizophrenia, bipolar disorder, suicidal or homicidal ideation, and any disease acutely life-threatening or so severe that the participant cannot comply with the protocol)
* Concurrent participation in a formal treatment program for smoking cessation
* Current use of any pharmacotherapy for smoking cessation
Non-invasive Assessment of Mechano-chemical Properties of Urine Proteins by Hybrid Brillouin-Raman Spectroscopy

The proteinuria is widely recognized as a marker of kidney disease severity, as well as the predictor of renal function decline, cardiovascular outcomes, and all-cause mortality. However, the severity of kidney disease progression and these outcomes differs among patients with various amount of proteinuria. The potential mechanism underlining this disparity may be relevant to the quality and quantity of filtered proteins, especially their mechano-chemical properties such as physical viscosity and stiffness, amino-acid sequence, and molecular weight (low, middle and high molecular weight proteins). The goal of the current project is to develop and validate combined Brillouin \& Surface-Enhanced Raman Scattering (SERS) Spectroscopy technique for simultaneous non-contact assessment of visco-elastic and chemical properties of urine proteins as biomarkers of kidney disease. Systematic studies of these properties of proteins in urine samples to be taken from diseased and healthy subjects will be cross-validated by Liquid Chromatography-Mass Spectrometry (LCMS). The project ultimately aims for the development of an optical spectroscopic sensor for rapid, non-contact monitoring of urine samples from patients in clinical settings.


Eligibility Criteria:
Inclusion Criteria:

* Both male and female patients with any ethnic group, aged between 18-65 years old
* Newly diagnosed patients with glomerulonephritis and different range of proteinuria

Exclusion Criteria:

* patients aged \<18 and \>65 years,
* eGFR\<60 ml/min,
* pregnant females,
* patients with diabetes mellitus, cancer, infectious diseases, and other life-treating comorbidities/conditions