cyrilzakka/clinical-trials huggingface dataset:
A Study of 123I-CMICE-013 Radiopharmaceutical in Healthy Volunteers

The need exists for alternatives to 99mTc based perfusion radiotracers for cardiac patient management. An alternative radiotracer, I123-CMICE-013, has been developed at the Canadian Molecular Imaging Center of Excellence (C-MICE) at the University of Ottawa Heart Institute. Initial testing results in rats and pigs suggest that in addition to being a cyclotron-produced alternative to 99mTc tracers, I-123-CMICE-013 may be a superior tracer for measuring myocardial perfusion.This Phase 1 study will study the safety and tolerability, biodistribution, pharmacokinetics and radiation dosimetry, and distribution and localization of I123-CMICE-013in healthy adult volunteers.

Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) is an established, cost effective tool for the risk stratification and management of patients suspected or known to have coronary artery disease (CAD)Myocardial perfusion imaging is significantly affected by interruptions in the supply of 99mMo, the parent isotope of 99mTc used for the majority of MPI. An alternative radiotracer, I123-CMICE-013,developed at the Canadian Molecular Imaging Center of Excellence (C-MICE) at the University of Ottawa Heart Institute, has completed pre-clinical trial testing and is ready for Phase 1 human trials.

This Phase I study will be a single centre, open label study. Subjects will receive 2 doses of study drug. One rest dose and one stress dose will be administered on separate days, one week apart. Subjects will undergo a standard clinical exercise stress protocol for the stress dose. Gamma camera imaging following each administration will be done over 2 days.

Biodistribution, pharmacokinetics, dosimetry and safety variables will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 65 years
2. No significant medical history
3. Normal physical exam
4. BMI ≤ 30 kg/m2
5. No current use of prescription medication
6. No clinically significant abnormalities in baseline laboratory work
7. No clinically significant abnormalities in baseline 12 lead electrocardiogram
8. Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening

Exclusion Criteria:

1. Pregnancy
2. Known hypersensitivity to the investigational drug or any of its components
3. Claustrophobia or inability to lie still in a supine position
4. Unwillingness to provide informed consent
Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Treating Pediatric Patients With Atopic Dermatitis

Comparison of Protopic Ointment to Elidel Cream to assess the safety and efficacy in pediatric patients with Atopic Dermatitis

This is a two arm, randomized, investigator blinded study to compare Protopic Ointment to Elidel Cream in treating pediatric patients with moderate to severe Atopic Dermatitis

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Atopic Dermatitis which is rated moderate, severe or very severe using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body's surface area
* If female, and of childbearing potential, patient has a negative pregnancy test and agrees to practice effective birth control during the study

Exclusion Criteria:

* Patient has a skin disorder other than Atopic Dermatitis in the areas to be treated
* Patient has extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
* Patient has clinically infected Atopic Dermatitis at baseline
* Patient is likely to require systemic corticosteroids, or the patient is likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
* Patient has a known hypersensitivity to macrolides or any excipient of either study medication
* Patient has a chronic condition which is either not stable or not well controlled
* Patient is pregnant or breast feeding an infant
Effects of Ankle Support on Muscle Activation and Function

The purpose of this study is to examine the effects of ankle taping on improving muscle function and ankle motion in individuals who frequently twist (sprain) their ankle. It is thought that ankle taping may increase muscle function and ankle motion which would benefit individuals who frequently sprain their ankle.

Previous research has demonstrated improved dynamic balance following the application of fibular taping. The effects of fibular taping on ankle dorsiflexion ROM and muscle activation in individuals with CAI are unknown. The purpose of this study is to determine the acute effects of fibular taping on muscle activation of the fibularis longus (peroneus) and soleus muscles, ankle dorsiflexion range of motion (ROM) and dynamic balance. The investigators hypothesize that fibular taping will have similar effectiveness as mobilization interventions which have been shown to improve muscle activation, ankle dorsiflexion ROM,and dynamic balance. Outcomes will be measured immediately before and after intervention. A crossover design will be used and participants will complete two visits at least 48 hours apart, but not more than 1 week apart. After participants complete both arms of the study their participation will be complete (average time to completion for each subject is 1 week).

Eligibility Criteria:
Inclusion Criteria:

* Age 16-45 years
* History of one or more ankle sprains
* Scoring at least an 85% on the Foot and Ankle Ability Measure (FAAM) Sport or at least 3 on the Modified Ankle Instability Instrument (AII).
* At least 5° ankle dorsiflexion asymmetry compared to the contralateral limb OR ankle dorsiflexion ROM less than 21°

Exclusion Criteria:

* Lower extremity injury or surgery within the past 6 months (including lateral ankle sprain)
* Diagnosed ankle osteoarthritis
* History of ankle surgery that involves intra-articular fixation
* Potential for current pregnancy
Unilateral Stretch Crossover Effect RCT

The crossover-effect within resistance- and strength training is more or less confirmed with multiple studies showing similar results. The studies shows an increase in muscle strength within the contralateral extremity being exercised. Regarding muscle length or mobility (flexibility) the crossover-effect have not been studied.

For a person to gain an increase in muscle strength mobility training in the form of stretching and flexibility training of our skeletal muscle is a common exercise. However, the evidence are scare and there are only a few studies comparing the effect of prolonged static stretching (\> 90 sec) and dynamic flexibility training as to which of these methods has the best length-enhancing effect over time.

The purpose of this study is to compare the crossover-effect of eight weeks of oneleg dynamic flexibility training versus oneleg prolonged static stretching versus a nonstretching controlgroup on mobility in the hamstring muscles in adults with reduced mobility of the hamstring muscle. The aim is also to compare the sustained effect of flexibility training between the two groups, eight weeks after completion of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Passiv straigth leg raise \< 70 degrees
* Read and understand swedish

Exclusion Criteria:

* Injuries within the hamstrings muscle past 3 month
* Disabilities within the muscloskeletal system (i.e. lower back, thoracic spine, cervikal spine, hip, knee, ankle, fot) affecting the participants life
* Neurological, inflammatoric or heart-diseases
* Nociplasic pain disorders
* Medication with possibility affecting muscle strength of flexibility
* Positive neurodynamic test of the lower extremity
Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis

Inadequate recovery from Bell's palsy is not uncommon and as consequence, physical and social impairment are exist in these patients. The medical options for chronic condition of Bell's palsy are insufficient. Low-level laser therapy has shown a favorable prognosis in the regeneration of peripheral nerves. Moreover, laser acupuncture therapy (LAT) become widely used method to stimulate acupuncture points, but its efficacy as treatment method for Bell's palsy and during the chronic stage is unclear.

Background: Inadequate recovery from Bell's palsy is not uncommon and as consequence, physical and social impairment are exist in these patients. The medical options for chronic condition of Bell's palsy are insufficient. Low-level laser therapy has shown a favorable prognosis in the regeneration of peripheral nerves. Moreover, laser acupuncture therapy (LAT) become widely used method to stimulate acupuncture points, but its efficacy as treatment method for Bell's palsy and during the chronic stage is unclear.

Methods: This clinical trial settings are a randomized, placebo control, double blind pilot study including patients with the unsatisfactory recovery of Bell's palsy with the following two groups: LAT (N=16) and a sham LAT (N=16). The LAT will receive treatments for 6 weeks, compare to sham control group. The primary outcome measure will be change in the Facial Disability Index at week 6. Statistical analysis will also include changes in the House-Brackmann grading system, the Sunnybrook grading system and stiffness scale at 1, 3 and 6 weeks after randomization.

Expected outcome: The investigators hypothesis that LAT will have an effect on functional outcomes in patients with chronic facial paralysis. Moreover, changes in the S-B facial nerve grading system is also expected to have an improvement. Last, social subscale of FDI is expected to have an improvement.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed patients with Bell's palsy (ICD9- CM 351.0) with at least 3 months prior to screening.
2. Age- above 20 years old
3. Facial disability index (FDI) less than 80 on FDI physical subscale and less than 80 on the FDI social subscale.

Exclusion Criteria:

1. Patients with any of the following are excluded: uncontrolled hypertension, diabetes mellitus requiring insulin injection, other neurological diseases, patients with multiple cranial nerve palsies, pregnancy or breastfeeding woman, will be excluded.
2. Patients with other types of facial palsy or other known causes than Bell's palsy-Ramsay Hunt syndrome, cholesteatoma, Otitis media, traumatic facial palsy, iatrogenic facial palsy or parotid tumor will be excluded.
3. Patients with recurrent facial palsy or patients who have pre-existing facial deformity, contracture, synkinesis, and spasm for whatever reason will be excluded.
4. Patients with the following will be excluded:

Surgery: a surgical history for facial palsy, such as facial nerve decompression, reconstruction of the facial nerve or muscle within 3 months.
Achilles Tendon Elongation and Gait Pattern After Rupture.

The objective of this study is to determine if Achilles tendon elongation and gait pattern differ between patients treated using an individualized treatment algorithm and patients treated as usual (two control groups; patients treated operatively and non-operatively).

The individualized treatment algorithm is based on ultrasonographic status of tendon overlap and Copenhagen Achilles Length Measure (1). Patients are allocated for operative treatment if there the tendon overlap is less than 25 % or the tendon is elongated with 7% or more compared to the healthy, contralateral achilles tendon.


Eligibility Criteria:
Inclusion Criteria:

* Appointment in the Outpatients Department within 4 days of injury.
* Total Achilles tendon rupture.
* Initial treatment with split cast with the ankle in maximal plantar flexion must be started within 24 hours of injury.
* The patient must be expected to be able to attend rehabilitation and postexamination.
* The patient must be able to speak and understand Danish.
* The patient must be able to give informed consent.

Exclusion Criteria:

* Rupture of the Achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae.
* Previous rupture of the Achilles tendon in any of the two legs.
* Treated with fluoroquinolones or corticosteroids within the last 6 months.
* In medical treatment of diabetes.
* Suffers from rheumatic disease.
* Other conditions prior to the injury resulting in reduced function of any of the two legs.
* Contra-indication for surgery: severe arthrosclerosis with no palpable pulse in the foot, broken skin in the Achilles region of the injured leg.
* Inability to lie in prone position on the operating table.
* Terminal illness or severe medical illness: American Society of Anaesthesiologists physical status classification score higher than or equal to 3.
Validation of a Score of Predictive Factors for Complete Resection in Platinum-sensitive Recurrent Ovarian Cancer

The purpose of this study is to validate a score developed by the AGO-OVAR for complete resection of the tumor

The multicentre retrospective study AGO-DESKTOP OVAR 1 investigated in a multicentre-setting the question of prognostic factors for a successful (i.e. complete) debulking for recurrence. That way, a hypothesis for a score with 3 factors could be developed:

* PS ECOG = 0
* tumor-free after primary surgery (if unknown: FIGO I/II)
* Ascites \< 500 ml.

The goal of this study is to evaluate in a prospective multicentre setting, to what extent this retrospectively defined AGO-score has predictive validity. The criterion aimed at is therefore the rate of complete tumor resections if the three score characteristics are present in invasive epithelial platinum-sensitive ovarian-, fallopian tube- or primary peritoneal cancer. This study will be the second in a series of three: (1) hypothesis building for a potential predictive score for resectability, (2) prospective confirmation of the AGO-score, and (3) application of the AGO-score as inclusion criteria for eligible patients in whom a formal comparison of the role of secondary debulking of relapsed ovarian cancer could be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrence of invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage who have relapsed after a tumor-free interval of at least 6 months after completion of first-line therapy. The same interval applies to patients with second relapse who are enrolled after completed platinum-containing re-induction therapy.
* Women aged \> 18 years
* Patients who have given their signed and written informed consent to data transmission and -processing

Exclusion Criteria:

* Patients with non-epithelial tumors as well as borderline tumors
* Patients who undergo second-look surgery or completion surgery after end of chemotherapy or during the interval
* Only for the study collective: patients with second malignancies who have been treated by laparotomy, as well as other neoplasias, if the treatment could interfere with the treatment of relapsed ovarian cancer
* Patients with a third recurrence
* Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former platinum-containing therapy
Proving Hemodilution in a Human Model for Class I Hemorrhage

This study is a randomized control trial in volunteer blood donors to quantify the effect of blood loss and subsequent crystalloid infusion on hemoglobin and markers of resuscitation such as base deficit and lactate.

Blood donors were randomized to one of three arms after donation of 500cc of blood. The control group received no intravenous fluids, while donors in the two intervention arms wither received two liters normal saline or lactated ringers. Chemistries and blood gases were obtained before donation, after donation and after resuscitation. Donors hemoglobin levels were then compared over time and between study arms. Additionally, lactate and base deficit, which are markers of shock, will be collected at the time points as well to measure their response to resuscitation. Standard statistical tests were used to compare the laboratory values between groups.

Eligibility Criteria:
Inclusion Criteria:

* blood bank inclusion criteria for donation
* able to donate 500cc blood
* age \> or = 18

Exclusion Criteria:

* unable to obtain IV access
* multiple blood draws fail to run on laboratory assays
Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction

The current prospective, randomized, controlled MonAMI trial aims to systematically examine the effects of morphine on the platelet inhibitory effects of the orally administered platelet inhibitor ticagrelor in patients with acute myocardial infarction. In addition, the potential positive or negative effects of MCP in combination with morphine on platelet inhibition will be studied.


Eligibility Criteria:
Inclusion Criteria:

1. ST-elevation myocardial infarction \< 24 h after symptom onset or non-ST-elevation myocardial infarction with persistent chest pain \< 24 h after symptom onset
2. Intended revascularization by primary percutaneous coronary intervention
3. Informed consent
4. Age ≥18 years

Exclusion Criteria:

1. Age \<18 years
2. Active bleeding or bleeding diathesis
3. Oral anticoagulation
4. Current treatment with clopidogrel/prasugrel/ticagrelor/glycoprotein-IIb-IIIa-receptor-antagonists
5. Current treatment with morphine and/or MCP \<12 h
6. Contraindication for treatment with platelet inhibitors
7. Fibrinolysis \<48 h
8. Percutaneous coronary intervention or coronary artery bypass grafting \<3 months
9. Known glomerular filtration rate \<30 ml/min
10. Severe liver dysfunction
11. Hypersensitivity to ticagrelor or any excipients
12. History of intracranial hemorrhage
13. Known pregnancy, breast-feeding or intend to become pregnant during the study period
14. Participation in other trial
Study of Effectiveness of Different Lifestyle Interventions for Health and Wellbeing

The purpose of this study is to examine the effectiveness and applicability of different interventions designed for enhancing overall wellbeing. Lifestyle changes, as well as psychological and physiological health variables are assessed. The interventions are based on the principles of cognitive behavioural therapy, and delivered either face-to-face, via mobile phone application, or Internet.

The study focuses on targeting overweight, stress, and impaired overall wellbeing with new cost-effective intervention methods. The intervention methods are based on the principles of cognitive behavioural therapy (CBT) and further acceptance-commitment therapy (ACT). The interventions are delivered either face-to-face, via mobile application, or via Internet. The purpose of each intervention is to improve the subjects lifestyles and activate them towards beneficial changes in their everyday life. The psychological and physiological effects of interventions are measured with various invasive and non-invasive methods. The study gives new insight into effectiveness and acceptability of up-to-date psychological intervention methods, and new knowledge of different ways to deliver interventions for improving wellbeing of an individual.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) 27-34.9
* Psychological Stress (3/4 or 4/4 points in General Health Questionnaire)
* Possibility to use computer and internet connection

Exclusion Criteria:

* Diagnosed severe chronic illness

  * Symptomatic cardiovascular disease
  * Type 1 or 2 diabetes
  * Severe psychiatric conditions
  * Remarkable clinical operation within past 6 months
  * Heart attack or stroke within past 6 months
  * Kidney disease requiring Dialysis
* Regular use of cortisone pills
* Eating disorder: bulimia
* Disability pension for psychological reasons
* Pregnancy or breastfeeding within the pas 6 months
* Shift work (in three shifts) or night work
* Participation in other intervention studies during the present study
Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair

The investigators want to evaluate the effect of suturing the mesh versus using a self-adhesive mesh for Lichtenstein hernia repair. Effect parameters include chronic pain.

Pain is a frequent problem after open inguinal hernia repair. The most frequent operative technique for inguinal hernia repair in adults is the Lichtenstein mesh repair, where a polypropylene mesh is sutured to the tissue in the inguinal region. We therefore want to evaluate the effect of suture for mesh fixation on the occurrence of chronic pain 12 months after operation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males 18-80 years
* Primary inguinal unilateral hernia

Exclusion Criteria:

* Recurrent hernia
* Bilateral, scrotal or femoral hernia
* BMI above 35
Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis

The objective of this clinical trial is to compare the response rate obtained with two different vaccination schemes against HBV in cirrhotic patients. These patients must be candidates for liver transplantation, who have failed seroconversion (anti-HBs \< 10 IU/ml) after three intramuscular doses of 40 µg.


Eligibility Criteria:
Inclusion Criteria:

1. Cirrhotic patients, potential candidates for liver transplantation, with indication to HBV vaccination (HBsAg negative and anti-HBs negative).
2. Patients under treatment with HBVAXPRO® who do not show a response after the first cycle of vaccination of three intramuscular doses of 40 µg at 0, 1 and 2 months.
3. Patients over 18 years old.
4. Negative pregnancy test.
5. Patients who have given their consent to participate in the study.

Exclusion Criteria:

1. Absolute contraindication to HBV vaccine.
2. Medical history of allergy to any component of the vaccine.
3. Chronic renal failure on hemodialysis.
4. Presence of antibodies against Human Immunodeficiency Virus.
5. Patients with seroconversion (anti-HBs \> 10 IU /ml) after the first three doses of vaccine.
6. Lack of consent to participate in the study.