cyrilzakka/clinical-trials huggingface dataset:
A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis

This is a three year open-label study in subjects with axillary hyperhidrosis.


Eligibility Criteria:
Inclusion Criteria:

* Marked axillary hyperhidrosis

Exclusion Criteria:

* Previous use of botulinum toxin for hyperhidrosis
High Resolution Ultrasound of Scapulae Alatae - a Prospective Case Control Study

Scapula alata, caused by disturbance in the scapulothoracic stabilizer muscles due to nerve injury, is a relatively rare but also underreported disease. It can lead to years of invalidity of the affected upper extremity, considerable pain and social and emotional consequences for the patients. Unrecognized and misdiagnosed scapula alata and, consequently, wrong or delayed treatment is a general problem in this patient group. Today the diagnosis is based on the clinical examination and the electrophysiological examination. One of the problems is that the electrophysiological examination in a fair part of the patients is not showing any pathology even though the history of the patient and the clinical evaluation are indicating scapula alata.

This study is a single-blinded, prospective, controlled multicentre study. The aim of the study is to investigate whether ultrasound can be used as a supplement to the electrophysiological examination when diagnosing scapula alata. Ultrasound will be used to visualize possible thickening of the cross-sectional area of nerves and the degree and pattern of muscle involvement in patients with scapula alata. By comparing measurements from scapula alata patients with the measurements from healthy controls, we are able to see if ultrasound can distinguish these two groups from each other. Furthermore, we will examine whether the ultrasound measurements correlate with the electrophysiological findings in patients and, when available, compare the ultrasound measurements of muscle thickness with MRI (magnetic resonance Imaging) findings. The use of ultrasound in scapula alata patients may help determine the presence and severity of a nerve lesion and the subsequent degree of muscle involvement and may therefore serve as a supplement to the clinical diagnosis.


Eligibility Criteria:
Patients:

Inclusion Criteria:

* Clinical suspicion of scapula alata

Exclusion Criteria:

* Winged scapula due to other cause than nerve damage. eg. myopathy

Healthy subjects

Exclusion Criteria:

* History of Shoulder trauma or shoulder disease
* History of cervical radiculopathy
* History of upper extremity peripheral neuropathy/plexopathy
* Peripheral vascular disease
Longitudinal Analysis of Drug Burden Index

Anticholinergic and sedative drugs are frequently prescribed to older people, despite their negative impact on older people's physical and cognitive function. To estimate the cumulative exposure to anticholinergic and sedative drugs, Hilmer et al. published the Drug Burden Index (DBI) in 2007. The present study aims to complement previous study findings showing higher DBI values to be associated with physical and cognitive impairment. Most previously conducted studies of the DBI were either cross-sectional or were longitudinal but with short follow-ups. Furthermore, it remains unknown whether higher DBI values carry extra risks for patients with dementia. Finally, relatively little is known about the stability of DBI values over time. The current project therefore aims to examine (1) longitudinal relationships between long-term cumulative exposure to anticholinergic and sedative drugs as measured with the DBI and cognitive and physical function, (2) to examine interaction effects between DBI exposure and dementia, and (3) to examine trajectories of DBI exposure, i.e. DBI exposure remaining stable, declining, increasing or fluctuating over time. These project aims will be studied with longitudinal data from eligible participants \> 60 years from the LASA study with participants being followed-up during two decades, and the longitudinal data from the InterRAI consortium. Various clinical outcomes regarding cognitive and physical function will be studied. Data will be analysed with generalised linear mixed models and Latent Class Growth Analysis.


Eligibility Criteria:
LASA:

Inclusion criteria:

* 55 years and older

Exclusion criteria:

* problem drinkers in the past and the present
* very severe vision and hearing problems

InterRAI:

Inclusion criteria:

* 55 years or older

Exclusion criteria:

* consumption of 5 or more units of alcohol on one occasion
* unknown sex or age
Non-Heme Iron Load Quantification in the Brain - MRI of Patients With Stroke

This study will determine if MRI imaging can be used to estimate the amount of iron in areas of the brain affected by a stroke. This may help future patients if the scan can be used to predict the amount of brain damage and therefore the effects on the patient.

New research treatments are being used to reduce the amount of iron build-up in the brain. The effects of that treatment may also be estimated using new MRI techniques.

Hemorrhagic stroke has devastating consequences. The mechanisms resulting in early and delayed brain injury following a hemorrhagic stroke is poorly understood. One of the mechanisms demonstrated in

animal studies points towards deposition of iron in the brain tissue following hemorrhage. Preliminary data in animal studies also support a favorable effect of iron chelate agents. Iron chelate agents are compounds that bind iron to them and may show the extent of neural tissue damage.

Initial results of human trials based on this hypothesis demonstrated the safety of increasing amounts of desferroxamine given to human patients. The evaluation of iron chelate agents for hemorrhagic stroke is entering into phase II/III trials.

There is no modality at this date that can quantify the iron in tissue non invasively. Some preliminary studies have demonstrated the role of MRI in identifying parenchymal iron deposition in traumatic brain injury.

We propose to validate an MRI based method to not only identify but also quantify the non heme iron levels deposited in brain tissue following hemorrhagic stroke. Once validated this method will be a robust mechanism to reliably quantify tissue iron in the brain which then can be closely followed through iron chelate therapy in a trial setting.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females between the age of 18 and 85 who have suffered a stroke confirmed by a CT of the head.

Exclusion Criteria:

1. You cannot take part in this study unless you have evidence of having a stroke (hemorrhage in your brain).
2. You cannot take part in this study if you are not able to safely have an MRI exam.
3. Women cannot take part in this study if they are pregnant.
4. Women may not participate in this study if they are attempting to become pregnant or think they might be pregnant. We will provide a one-time pregnancy test for anyone who is uncertain about being pregnant.
5. You cannot take part in this study if you have evidence of a large amount of calcifications found on CT exams that have been performed as part of the clinical evaluation for your current condition.
Efficacy and Tolerability of Zolmitriptan Nasal Spray

The purpose of this study is to evaluate the effectiveness and tolerability (the ability not to experience ill effects from the study drug) of a zolmitriptan nasal spray, 5.0 mg, compared with placebo (inactive drug) for 2 migraine headaches for up to 12 weeks in adult subjects with migraine headaches


Eligibility Criteria:
Inclusion Criteria:

* Subject has an established diagnosis of migraine headache, with or without aura
* Subject has a medical history indicating the presence of migraine attacks for at least 1 year before the start of the trial or a minimum of 2 and maximum of 6 migraine attacks per month on average for 3 months preceding the study
* Subject has non migraine headaches on fewer than 6 days each month for 3 months preceding the study

Exclusion Criteria:

* Subject has history of basilar, ophthalmoplegic or hemiplegic migraine or serious neurologic condition associated with headache
* Subject has used a MAOI within 2 weeks of randomisation or has been given SSRI therapy or migraine prophylactic agent within 3 months of randomisation. Subject requires treatment with propranolol or cimetidine or has had an intolerable or serious adverse event while using another triptan
* Subject has a history or symptoms suggestive of ischemic heart disease, coronary artery vasospasm or other significant underlying cardiovascular disease or clinically significant abnormalities seen on an ECG or uncontrolled hypertension
A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer

This single arm study will determine the efficacy and safety of an epothilone D and Herceptin combination regimen in patients with HER-2 positive locally advanced or metastatic breast cancer. Epothilone D will be administered intravenously on days 1, 8 and 15 every 4 weeks at a dose not exceeding 100mg/m2. Herceptin will be administered intravenously on a weekly schedule; a 4mg/kg loading dose will be followed by a weekly maintenance dose of 2mg/kg. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* women \>=18 years;
* locally advanced or metastatic breast cancer;
* HER-2 overexpression (FISH + or IHC 3+);
* \>=1 measurable lesion;
* up to one prior anthracycline-based chemotherapy regimen in a metastatic setting.

Exclusion Criteria:

* pre-existing neuropathy \>=grade 2;
* known CNS metastases;
* congestive heart failure, or myocardial infarction within the last 6 months;
* previous malignancies in last 5 years, except for cured basal cell cancer of the skin, or cancer in situ of the cervix.
Pharmacokinetic Properties of Lorcaserin in Subjects With Hepatic Impairment

The purpose of this study is to evaluate and establish whether lorcaserin dose adjustment is required in patients with mild or moderate hepatic impairment.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged between 18 and 75 years (inclusive)
2. Able to give signed informed consent
3. Hepatic function will fall into one of the following categories:

   * One-third of patients will have normal hepatic function (defined as having all of the following parameters within the normal range of the clinical laboratory used for this trial: AST, ALT, alkaline phosphatase, total bilirubin)
   * One-third of patients will have mild impairment (Child-Pugh score 5-6)
   * One-third of patients will have moderate impairment (Child-Pugh score 7-9)
4. All subjects will have a BMI of 27-45 kg/m2, inclusive.
5. Eligible male and female patients must agree not to participate in a conception process
6. Considered to be in stable health in the opinion of the Investigator.

Exclusion Criteria:

1. Prior participation in any study of lorcaserin.
2. Clinically significant new illness in the 1 month before screening
3. Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
4. History of any of the following cardiovascular conditions:

   * Myocardial infarction (diagnosed by cardiac enzyme\[s\] and/or diagnostic ECG), CVA, TIA or RIND within 6 months of screening
   * Cardiac arrhythmia requiring initiation of new medical or surgical treatment within 6 months of screening (stable medical therapy for \> 6 months, pacemakers and/or defibrillators implanted \> 6 months prior to screening are acceptable)
   * Unstable angina
5. Surgically implanted portacaval shunts are excluded with the following exception: transjugular intrahepatic portosystemic shunts (TIPS) will be allowed if placed no less than 3 months prior to dosing
6. Malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins)
7. Initiation of a new prescription medication within 1 month prior to screening.
8. Recent history (within 3 months prior to the screening visit) of alcohol or drug/solvent abuse or a positive screen for drugs of abuse at screening.
9. Use of SSRI's, SNRI's, and other medications must meet the required washout periods.
10. Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to dosing
The Ideal Length of the Nasotracheal Tube Considering Nasotracheal Tube Size

The nasotracheal intubation is preferred for oral surgery; it provides an easier view of the surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are often not fitted in anatomy of Korean people because of small nostril. When the size of the tube is chosen by nostril size, the length of nasotracheal tube is not appropriate to the glottis. The aim of this study is to evaluate the appropriateness of the tube depth and to suggest the ideal length of the nasotracheal tube during the intubation of the selected tracheal tube in consideration of the size of the nasal cavity in Koreans. 146 patients (73 males and 73 females) who are scheduled for nasal intubation for general anesthesia will be enrolled. The primary outcome is the ideal length of tube that allows the distance from the vocal cords to the proximal portion of the tube cuff to be greater than 2 cm and the tip of the intubated tube to be located 5 ± 2 cm above the tracheal carina. The size of nostril, length from the nare to the carina and vocal cord are measured.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are scheduled for nasotracheal intubation for general anesthesia

Exclusion Criteria:

1. age\<20 years
2. ASA class III or more
3. pregnancy
4. emergency surgery
5. nasal airway disease
6. expected difficult intubation (difficult intubation history, Modified Mallampati score 4, mouth opening \<2cm, facial anomaly)
7. cervical movement disorder (cervical disease, cervical pain)
Lenalidomide Dose Escalation Combined With Rituximab/Fludarabine in Untreated CLL

The aim of this study is to determine the maximal tolerated dose level of lenalidomide combined with fludarabine/rituximab in the therapy of patients with previously untreated CD20-positive chronic lymphocytic leukemia. Following a dose escalation phase lenalidomide will be given at the pre-determined maximum tolerated dose in combination with rituximab to further determine the efficacy and tolerability of this regimen.

This is a non-randomized, multicenter, open-label, single-arm Phase I/II study in patients with previously untreated CD20-positive CLL. Phase I of the study will evaluate the maximal tolerated lenalidomide dose level in combination with fludarabine/rituximab chemoimmunotherapy in 10 patients. Phase II will determine efficacy using the combination in the previously defined maximal tolerated dose. Both phases will be followed by a maintenance phase evaluating the tolerability and possibility to further improve response quality.

Eligibility Criteria:
Inclusion Criteria:

* B-CLL (CD23+, CD5+, CD19+, CD20+)
* Treatment indication according to NCI criteria
* Age \>= 18 yrs
* No previous treatment of CLL by chemo-, radio- or immunotherapy
* Life expectancy \> 6 months
* Written informed consent
* Women of non-childbearing potential or women of childbearing potential and men using effective contraception

Exclusion Criteria:

* Active bacterial, viral or fungal infection
* Positivity for HIV, Hepatitis B or C
* Reduce organ functions and bone marrow dysfunction not due to CLL
* Creatinine clearance below 30 ml/min
* Patients with medical conditions requiring long-term use of systemic corticosteroids during study treatment
* Patients with a history of severe cardiac disease
* Other known co-morbidity with the potential to dominate survival
* Transformation to aggressive B-cell malignancy
* Known hypersensitivity to humanised monoclonal antibodies or any of the study drugs
* Pregnant or breast-feeding women
* Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
Identification of Jaundice in Newborns Using Smartphones

Neonatal jaundice is a common and most often harmless condition. However, when unrecognized it can be fatal or cause serious brain injury. Three quarters of these deaths are estimated to occur in the poorest regions of the world. The treatment of jaundice, phototherapy, is in most cases easy, low-cost and harmless. The crucial point in reducing the burden of disease is therefore to identify then children at risk. This results in the need for low-cost, reliable and easy-to-use diagnostic tools that can identify newborns with jaundice.

Based on previous research on the bio-optics of jaundiced newborn skin, a prototype of a smartphone application was developed and tested in a pilot study and the application refined.

This smartphone application will now be evaluated in a clinical trial set in two hospitals in Norway. The smartphone application gives immediate estimates of bilirubin values in newborns, and these estimates will be compared to the bilirubin levels measured in standard blood samples, as well as the results from ordinary transcutaneous measurement devices.

The smartphone jaundice app system works by taking pictures of newborns with a custom-made color calibration card placed on their chest. This makes it possible to measure the skin color precisely regardless of the specific light source that is used to illuminate the newborn. The measured skin color is then compared with items in a database of simulated newborn skin colors. These simulated newborn skin colors have been created using numerical simulations of how light moves through skin, with varying skin parameters including, but not limited to, skin thickness, blood concentration, melanin, and of course bilirubin, the pigment that causes jaundice. By comparing the measured skin color with the simulated skin colors that are most similar to it, the investigators can then estimate the bilirubin concentration in the newborn's skin by e.g. averaging the bilirubin concentrations used to create these simulated skin colors.

In a group of 200 newborns with varying degree of jaundice, correlation between smartphone bilirubin estimates will be compared with total serum bilirubin and standard transcutaneous bilirubinometry.

Eligibility Criteria:
Inclusion Criteria:

* Born in St.Olavs hospital, Trondheim or in Haugesund Hospital, Norway
* Born with gestational age \>36+6
* Birth weight ≥ 2500g and \<4500g
* Age 1 - \<15 days
* Are having a blood sample performed, as newborn screening or for jaundice assessment

Exclusion criteria:

Infants needing intensive treatment. This includes:

* Infants in the need for respiratory support
* Infants with conditions that could compromise skin circulation, as sepsis, heart failure or other
* Infants that have received phototherapy
Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities

Text2Breathe (T2B) is a randomized controlled trial aimed at improving communication between parents and their children's' primary care providers about asthma. The overarching goal of this study is to reduce disparities among a population with high rates of pediatric asthma morbidity. The investigators are testing the efficacy of a short message service (SMS)-enhanced health communication (HC) intervention ("Text2Breathe") designed to equip urban, low-income parents with tools for communicating effectively with their children's primary care provider (PCP).

Potentially eligible participants are approached and screened in person during an admission of their child to the emergency department for asthma care. Those participants randomized to the intervention will receive additional education on effective communication with their child's primary care provider (PCP). These participants will also receive educational text messages for three months after their initial visit. Text messages will include education on effectively communicating with their child's provider and general asthma information. Both the control group and intervention group will receive text message reminders to schedule regular follow up visits with their PCP and get an annual flu shot. Both groups will be contacted for follow up phone interviews at 3, 6, 12, 18 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Unlimited text messaging

Is the parent of child who is:

* Receiving asthma related care in the emergency department
* 2-12 years old inclusive
* Medicaid insured (no Private insurance)
* Physician diagnosed asthma for at least 12 months

Exclusion Criteria:

Is the parent of child who:

* Has seen a pulmonary or allergy sub-specialist more than once in the last 6 months
* Has seen a sub-specialist (not pulmonary or allergy) more than once in the last 12 months
* Has been hospitalized for more than 30 days
* Is currently enrolled in another asthma program or study
Dilute Betadine Soak and Scrub for Foot and Ankle Surgery

Infection and wound complications are the most common complications following orthopaedic foot and ankle procedures, and the infection rate following these procedures is higher than in procedures involving other areas of the body.The purpose of this randomized controlled trial is to determine whether a standard chlorhexidine prep can be augmented with a soak \& scrub of the foot in dilute betadine to reduce the rate of positive cultures from the hallux nail fold prior to surgery.

Infection and wound complications are the most common complications following orthopaedic foot and ankle procedures, and the infection rate following these procedures is higher than in procedures involving other areas of the body. This is at least in part because the anatomy of the human foot presents inherent challenges for preoperative sterilization techniques due to the many folds and crevices associated with the toes. In particular, the nail folds of the toes are known to harbor large amounts of bacteria.

A systematic review and meta-analysis of previous studies that have investigated the efficacy of various foot and ankle preparation agents (including alcohol, chlorhexidine, chloroxylenol, and iodine/iodophors) showed that no single agent or combination of agents eliminates positive culture growth to undetectable levels for all patients. Articles have suggested superiority of a chlorhexidine prep solution over other types of preps; hence, chlorhexidine prep is now considered the gold standard at many institutions. But even a chlorhexidine prepped foot has been shown to contain culturable bacteria in the nail folds in 30% of cases.

The purpose of this randomized controlled trial is to determine whether a standard chlorhexidine prep can be augmented with a soak \& scrub in dilute betadine to reduce the rate of positive cultures from the hallux nail fold.

It is hypothesized that in comparison to feet receiving the standard chlorhexadine prep, feet receiving the standard prep plus the betadine soak \& scrub will be less likely to have culture positive swabs of the hallux nail fold.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Patient requires a foot or ankle operative procedure
3. Patient provides informed consent

Exclusion Criteria:

1. Patient refuses
2. Patient is incarcerated, incapacitated, or otherwise unable to provide appropriate informed consent