cyrilzakka/clinical-trials huggingface dataset:
Determination of the Optimum Delivery Route for Botulinum Toxin A in Patients With Epiphora

Epiphora or excessive tearing is a significant disability for many affected patients diminishing their quality of life. There is a growing consensus that injection of Botulinum Toxin A (BTX-A) into the lacrimal gland provides relief in patients with hyperlacrimation secondary to aberrant regeneration of the 7th nerve, and limited evidence that it might help to reduce normal tear production in patients with epiphora from anatomic or functional outflow obstructions. BTX-A has been injected both transconjunctivally into the palpebral lobe of the lacrimal gland and transcutaneously into the orbital lobe. Both delivery routes have been successful in symptom relief with minimal complications. However, the effectiveness of transconjunctival versus transcutaneous injections has not been systematically compared. Also, whether the incidence of side effects is related to the dosage, concentration, or location of injection is unknown and has also not been systematically studied. The investigators plan to conduct a randomized clinical trial in patients with functional tearing comparing the transcutaneous delivery route of BTX-A to the transconjunctival delivery route (the most common route described in the literature). The investigators will also compare the side effect profile of each delivery route.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* ability to give informed consent
* symptoms of epiphora in the setting of either a patent lacrimal outflow system or an obstructed outflow system for which the patient does not desire surgical therapy or is a poor surgical candidate

Exclusion Criteria:

* pregnancy
* ocular motility abnormalities
* prior ptosis, and/or strabismus surgery
* more than 2 mm of pre-existing ptosis
* inability to give informed consent
* history of a bleeding disorder
Attitudes and Unmet Needs Among Type 2 Diabetes Patients

The main purpose of this study is to explore experiences and understand the unmet needs of people with Type 2 Diabetes (T2D) among those who are being managed with basal insulin and those who are insulin naïve in order to understand perspectives for a once weekly insulin option; including any potential barriers to being managed with insulin therapy overall. Study participants will be recruited to complete a 15-minute self-administered online survey.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age above or equal between 18 to 65 years at the time of signing informed consent.
3. Diagnosed with T2D and currently treating T2D with at least one medication
4. Insulin user that is not using insulin pump
5. Lives in a target country

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
3. Does not meet inclusion criteria requirements
Edwards PASCAL Transcatheter Valve Repair System Registry

This registry will collect prospective and retrospective clinical data on patients treated with the Edwards PASCAL Transcatheter Valve Repair System outside of the Post-Market Clinical Follow-up (PMCF) study.

Patients treated per standard of care at their medical facilities and a written informed consent will be collected to allow the data to be collected. This registry intends to enroll patients under commercial usage and will serve as a mechanism to collect clinical data to further characterize the safety, performance and effectiveness of the PASCAL Transcatheter Valve Repair System.

Eligibility Criteria:
Inclusion Criteria:

* Patient signs informed consent to participate in the registry
* Patient is intended to or has received the PASCAL device

Exclusion Criteria:

* Patient does not consent to participate
* Patient is part of an ongoing Edwards Pre or Post Market Clinical study for the PASCAL Transcatheter Valve Repair System.
Immediate Effect Of Kinesiological Taping

In this study, it is aimed to examine the immediate effect of kinesiological taping on functionality in hemiplegic patients. 40 hemiplegic patients with a mean age of 63±15 years were included to the study. The patients were divided into two groups using the computerized randomization method. Kinesiology tape was applied to the 1st group (study group), and a patch tape was applied to the 2nd group (control group). The demographic and physical characteristics of the people who agreed to participate in the study were recorded. In both groups; before taping, right after taping, 45 min. after and 4 days after taping Timed Get Up and Go Test (TUG) were administered. Both groups were asked not to remove the tapes at the end of the 4th day.


Eligibility Criteria:
Inclusion Criteria:

* agree to participate in the study after detailed information about the study,
* to have sufficient cognitive functions, to be diagnosed with hemiplegia by a specialist physician,
* to be 18 years of age or older

Exclusion Criteria:

* Diagnosis of other neurological diseases (Parkinson's, Multiple Sclerosis, etc.),
* cancer other than hemiplegia, heart failure, surgery in the area to be applied,
* vascular problems in the lower extremity,
* chronic kidney failure,
* infection.
Short Term Effect of Glucocorticoids on Brown Adipose Tissue Thermogenesis in Humans

Interventional, Placebo controlled cross-over study to investigate the short-term effects of glucocorticoids (prednisone) on human brown adipose tissue.

Active brown adipose tissue (BAT) has recently been unambiguously discovered in human adults. Active BAT increases energy expenditure and improves glucose tolerance. Pharmacological use of glucocorticoids (GCs) is widespread in clinical practice due to their high anti-inflammatory efficacy. While short-term administration even of high doses usually is well tolerated, long-term use of medium to high amounts of GCs leads to unfavorable metabolic changes, characterized by an increase in intra-abdominal fat mass, a decrease in muscle mass and insulin resistance.

In line with these well-known side-effects of GCs, several in vitro studies and animal models demonstrate an inhibiting effect of GCs on BAT thermogenesis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* BMI between 19-27 kg/m2

Exclusion Criteria:

* Cold induced thermogenesis of less than 5% basal metabolic rate (determined during screening visit)
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
* History of depressive disorder, anxiety disorder
* History of tuberculosis or latent infection
* Increased intraocular pressure
* History of peptic / gastrointestinal ulcer disease
* Concomitant medication: Non-steroidal anti-inflammatory drugs (NSAID), other glucocorticoids, diuretics, antihypertensives, fibrates or statins, metformin
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus),
* Hypersensitivity to cold (e.g. Raynaud Syndrome)
* Allergy to local anesthetic
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* Hypothyroidism without sufficient substitution
* Claustrophobia
* MRI incompatible implants
* Enrolment into another study using ionizing radiation within the previous 12 months.
The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass

The purpose of this study is the randomized blind research of the assessment of the different levels of glycemia during Coronary Artery Bypass Graft (CABG) with cardiopulmonary by-pass (CPB) between clonidine and placebo. As clonidine decrease the inflammatory response during cardiac surgery, the investigators would like to know if the glycemia levels in clondine group will be lower than placebo group.


Eligibility Criteria:
Inclusion Criteria:

* elective CABG EF \> 40% Sinus ritmy

Exclusion Criteria:

* precordialgia emergency surgery combinated surgery not agreement
Postoperative Pain Control by Use of Many Drugs in Small Doses Intrathecally

Cesarean section is one of the painful operations that require adequate postoperative analgesia. Patients are divided into two groups: Multimodal (DMM) group ( 30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam.

Morphine (M) group (30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 200 µg morphine


Eligibility Criteria:
Inclusion criteria:

* ASA I-II
* Age 20-40 years.
* Pregnant women with living fetus.
* Body mass index 20- 35 kg/m2.

Exclusion criteria:

* Patient refusal.
* Age \< 20 or \> 40 years
* Body mass index \< 20 or \> 35.
* Contraindication to spinal anesthesia (severe mitral or aortic stenosis, coagulopathy, Systemic or local infection, increased intracranial pressure and hypovolemia).
* Placental abnormalities: placental abruption, placenta previa or accrete.
* Allergy to drugs used in the study.
Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD

The purpose of this trial is to test the effectiveness of atomoxetine in treating symptoms of ODD in children with ADHD and ODD.


Eligibility Criteria:
Inclusion Criteria:

* Patients are male or female outpatients who are at least 6 years of age and not more than 12 years of age at study entry.
* Patients must meet DSM-IV diagnostic criteria for ADHD and ODD.
* If other comorbid conditions are present, either the ADHD or the ODD diagnosis must be the patient's primary diagnosis.
* Patients must have laboratory results, including serum chemistries, hematology, and urinalysis showing no significant abnormalities.
* Patients must have an ECG performed at study entry that is absent of any abnormality that, in the opinion of the physician, should exclude the patient.

Exclusion Criteria:

* Patients who weigh less than 20 kg or greater than 60 kg at study entry.
* Patients who have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder.
* Patients who have a current diagnosis of Major Depressive Disorder (\[MDD\]; with or without psychotic features), PTSD, or CDRS-R total raw score \>40 at study entry.
* Patients with a history of any seizure disorder.
* Patients determined by the investigator to be at serious suicidal risk.
Intrathecal Dexmedetomidine Versus Transversus Abdominus Plane Block (TAP) for Postoperative Analgesia After Cesarean Section.

Spinal anesthesia is the most commonly used technique for lower abdominal surgeries as it is very economical and easy to administer. However, postoperative pain control is a major problem because spinal anesthesia using only local anesthetics is associated with relatively short duration of action, and thus early analgesic intervention is needed in the postoperative period The transversus abdominus plane (TAP) block is a regional analgesic technique which blocks T6-L1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries


Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status classes I and II
2. Scheduled for elective cesarean section
3. Aged between 20-45 years .

Exclusion Criteria:

1. patient refusal.
2. patient with significant cardiovascular disease , hepatic dysfunction , renal failure , chronic pulmonary disease .
3. neuromuscular disorder.
4. infection.
5. bleeding disorder.
6. Obesity ( BMI \> 30 kg/m2 ) .
7. History of allergy or sensitivity to any of the study drugs in previous surgeries .
Intravenous Administration of Vitamin B Complex Improves Renal Recovery in Patients with AKI

Animal and human studies have shown that the administration of vitamin B3 (niacin) improves renal ischemia; helping to recover from acute kidney injury (AKI) more effectively; Therefore, its use in patients with AKI could improve short-term outcomes: accelerating the recovery of renal function, reducing the days of hospital stay and costs; as well as reducing the incidence of chronic kidney disease (CKD) or progression of CKD after an episode of AKI.

Our main objective is to determine the usefulness of the administration of vitamin B complex as a treatment for established acute kidney injury and its effect on short and long-term outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age who meet modified KDIGO criteria for Acute Kidney Injury, based on serum creatinine or urinary volume criteria.

Exclusion Criteria:

* Patient under 18 years of age
* Patients with stage G5 chronic kidney disease
* Patients with chronic kidney replacement therapy.
* Pregnant women
* Transplant patients
The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults

Some research suggests that administration of oxytocin with oxycodone may reduce its abuse liability and improve its ability to reduce pain. In a 6-session laboratory study, we will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, and decision-making.

The overall project goals are to determine oxytocin effects on oxycodone's subject-rated abuse liability, and experimental pain. Generally healthy individuals (determined via medical history review and a screening session) will, after informed consent, self-administer intranasal oxytocin (or placebo, containing the same ingredients but no oxytocin) shortly after oral oxycodone or placebo in a non-residential, double-blind, randomized, placebo-controlled, within-subjects laboratory study. Prescreening will assure drug application safety and, using a validated, comprehensive pain history interview, determine previous or existing chronic pain conditions, including current pain medication use.

Eligibility Criteria:
Inclusion Criteria:

* Individuals fluent in English will participate.
* Must report some experience with opioids (e.g., oxycodone, defined as use at least once in the subject's lifetime).
* Be within 20% of their ideal body weight.
* Are not currently experiencing chronic pain (pain on most days during the past 3 months)
* Have a systolic blood pressure of \<=140 and diastolic blood pressure of \<= 90, and a heart rate \<= 90 beats per minute.
* Participants must also have a normal electrocardiogram (EKG) reading and bloodwork indicating no major health contraindications.

Exclusion Criteria:

* Significant current physical disease or major (uncontrolled) psychiatric disorder.
* No self-reported current interest in drug abuse treatment.
* Women who are pregnant or nursing.
* Any severe comorbid illicit substance use disorders or current clinically significant withdrawal for any abused drug excluding nicotine and caffeine.
Tiotropium Respimat Administration With and Without Aerochamber Disease (COPD)

COPD patient on Tiotropium Respimart divided into two group, Group A given aerochamber and Group B without aerochamber enroll in the study for total 18 week .

1. COPD patient who is on Tiotropium Respimart and other inhalers continued.
2. Those fullfill inclusion criteria will be randomized into two group.
3. To do Baseline CAT score and SGRQ questionnaires with Lung function test.
4. Assess inhaler technique with and without aerochamber.
5. Teach proper inhaler technique by templates and demonstrate to patients.
6. Group A given aerochamber and Group B without aerochamber enroll in the study for total 18 week .
7. First phase for 8 week after that 2 week of washout periode (without aerochamber both arm).
8. Then Group A without aerochamber and Group B with aerochamber continue with all inhalers for 8 week.
9. Followed up at 8th , 11th and 18th week to assess inhaler techniques ,Lung function test and do CAT score, and SGRQ questionnaire.
10. Analysis data

Eligibility Criteria:
Inclusion Criteria:

1. COPD patients under Respiratory clinic UKM follow up

   * Patients who are with stable COPD (no exacerbation past 2 months)
   * Age same and more than 40-year-old
2. Patient able to perform inhaler medication
3. Patient able to perform technically acceptable pulmonary function test

Exclusion Criteria:

1. Drug hypersensitivity
2. Bronchial Asthma
3. Significant disease that may influence patient's ability to participate in the study.
4. Unable to provide signed informed consent
5. Mental condition rendering the subject unable to understand the nature, scope and the possible consequences of the study.
Effectiveness of ICCMS in Reducing the Incidence of Dental Caries in Children

The aim of the present study is to evaluate the effectiveness of using the ICCMS (International Caries Classification And Management System)in reducing caries lesions incidence compared to a control group that use different criteria as a not systematic and standardized prevention strategy. The study will be performed among children attending to the social project of Social Service of Commerce (SESC), Sao Paulo. The sample will be composed of 460 children aging between 7 to 12 years old registered in CURUMIM Program from eight dental centers of SESC. A randomized controlled study with parallel group will be conducted. The centers will be randomized between the 2 strategies, defining 2 groups with 4 centers each. The experimental group that will follow the criteria defined by the ICCMS will evaluate clinical and behavioral variables, it will define: evaluation of the caries risk of the patient, evaluation of the intraoral risk, diagnosis of the caries lesion and its respective activity, plan decision individualized treatment for the patient and indication of recall interval according to the risk of caries. In the control group, children need will be solved according to rthe routinely dental practices in the center, but the determination of the child's general and intraoral risk of developing new caries lesions will not be performed nor the scheduling of specific recall intervals according to the risk.


Eligibility Criteria:
Inclusion Criteria:

* Children who participate in the CURUMIM Program
* Children whose parents sign the term of informed consent confirming their participation.

Exclusion Criteria:

* Children with cognitive impairment, motor impairment and feeding tube.
Efficacy of Preoperative Intravenous Dexamethasone in Primary Total Knee Arthroplasty

To determine efficacy of preoperative IV dexamethasone for postoperative pain control after TKA.

Preoperative intravenous over 0.1 mg/kg of dexamethasone could be reduced pain after primary TKA.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
* 50-85 years old
* ASA class 1-3

Exclusion Criteria:

* Unable to perform spinal anaesthesia
* History of drug allergies: steroids
* Renal impairment (CrCl \<30 mL/min)
* Liver impairment
* Cognitive function disorders
* Poor controlled DM (HA1C \> 7.5)
* Morning DTX at operative day \> 180 mg%
* Received corticosteroids within 3 months before surgery
An Exploratory Clinical Trial to Evaluate the Efficacy and Safety of a Novel Antibacterial Bone Traction Needle

The goal of this clinical trial is to test in wound infection. The main question it aims to answer is: Whether this antibacterial bone traction needle is safe and has a good effect on wound infection. Participants will be implanted with an antibacterial bone traction needles and the infection grade of wound after surgery will be observed. If there is a comparison group: Researchers will compare the control group without antibacterial ability to see if the experimental group Can effectively inhibit wound infection.


Eligibility Criteria:
Inclusion Criteria:

1. Limb fractures, infections, defects and deformities caused by various congenital or acquired factors, such as multiple fractures of tibia and fibula, infectious bone defects of tibia, knee varus, horseshoe varus foot, etc.;
2. The subject understands the significance of this project, voluntarily acts as the subject and signs the informed consent.

Exclusion Criteria:

1. The subjects are pregnant or lactating women;
2. Pathological fractures (such as primary or metastatic tumors);
3. The patient is allergic to iodine and its compounds;
4. The patient is allergic to metal implants;
5. Patients with coagulopathy (such as hemophilia, vitamin K deficiency, severe liver disease, etc.);
6. The patient had participated in other clinical trials in the past 3 months;
7. The patient had contraindications to anesthesia and surgery;
8. The patient is currently receiving chemotherapy or radiotherapy, systemic corticosteroid use (continuous use for more than 3 months);
9. The patient had poor compliance and was judged by the researchers to be unable to complete the experiment according to the research plan, such as alcohol addiction, drug abuse, schizophrenia, dementia, and did not provide consent for voluntary participation in the clinical study.
Kinematic Parameters of Running in Individuals With Pronated Foot

The aim of the study is to examine the kinematic parameters of individuals with pronated foot compared with individuals with normal foot

Individual with and without pronated foot will be recruited. Pronation will be defined according to navicular drop test. Inclusion criteria : individual who run on a regular basis at least 3 times per week for one hour, can run 5 Km in less then 40 minutes, without past injuries during the last year of Achilles tendon or other lower extremities pain.

Individuals will be asked to run for 5 Km in self selected velocity. The Milestone pod device will be used to monitor kinematic parameters.

functional test will be conducted before and after the running as follows: heel raise test and one leg hop for distance test.

Eligibility Criteria:
Inclusion Criteria:

* running on a daily basis at least 3 times per week with minimum of 1 hour
* capable to run 5 km in less then 40 minutes
* willing to participate in the study

Exclusion Criteria:

* previous surgery in lower extremities
* Achilles tendon pain during the last year