cyrilzakka/clinical-trials huggingface dataset:
Pain Reduction Caused by the Combined Treatment of Physiotherapy, Oral Gabapentin and Oral Ibuprofen Arginine.

In the present investigation the pain reduction effects of a physiotherapy technique combined with gabapentin and ibuprofen arginine will be compared to those produced by an ibuprofen arginine (only) treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

The present randomized clinical trial will perform a comparison of (group 1) the pain reduction effects produced by the application of a non invasive and non pharmacological median nerve neural mobilization (physiotherapy treatment) combined with a pharmaceutical oral gabapentin treatment versus (group 2) median nerve neural mobilization (physiotherapy treatment) combined with a pharmaceutical oral ibuprofen arginine treatment, to those effects produced by (group 3) ibuprofen arginine (only) treatment. Additionally, effects over the functionality of the affected upper limb will be evaluated and compared. Subjects will be invited to participate and randomly allocated to 2 different groups.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings).
* Full understanding of written and spoken Spanish (language).
* Participants must freely consent to participate.
* The presence of positive Phalen an Tinel sings.
* The presence of carpal tunnel syndrome signs and symptoms

Exclusion Criteria:

* The lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, kinesiophobia, deformities of the (affected) upper limb, recent skin injuries or infections (in the affected upper limb), autoimmune inflammatory conditions or flu type symptoms, allergy to gabapentin, allergy to ibuprofen arginine, and also: participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive)
Trail to Investigate the Effectiveness of CoSeal in Reducing Adhesions Following the Kasai Hepatoportoenterostomy for Biliary Atresia

The investigators plan to invite all children in the UK with biliary atresia, treated at the three national centres (Birmingham, Kings College and Leeds), over a three year period to take part in a randomised control study. The investigators aim to determine the effectiveness of CoSeal® Surgical Sealant (an anti-adhesive agent) in reducing intra-abdominal adhesions (scar tissue) and the morbidity caused by these adhesions in children treated with a Kasai hepatoportoenterostomy. Adhesions are common, if not invariable, after any abdominal surgery. They cause intra-abdominal organs to become stuck to each other and the abdominal wall. This means they are no longer completely free to slide over each other. In particular patients have a lifetime risk that the bowel can become kinked or twisted leading to complications such as bowel obstruction. Adhesions also make repeat abdominal operations more difficult. The adhesions have to be divided in order to separate the organs from each other and the abdominal wall. This can lead to blood loss and increases the risk of damage to these organs. Anti-adhesive agents have been created to reduce the severity of these adhesions, but there is little in the medical literature to evaluate their effectiveness, particularly in children. Biliary atresia is an obliterative obstruction of the bile ducts that occurs in infants. Initially they are treated by an abdominal operation called a Kasai portoenterostomy to restore bile flow from the liver to the intestines. However approximately 40% of these children will go on to require a liver transplant operation in the first two years of life. If CoSeal® Surgical Sealant is effective this could reduce the patients lifetime risk of complications from abdominal adhesions and also facilitate repeat abdominal operations for these children, in particular for those who go on to require a liver transplant.


Eligibility Criteria:
Inclusion Criteria:

* All patients with Biliary Atresia undergoing Kasai Hepatoportoenterostomy.

Exclusion Criteria:

* Patients with BA and malrotation
Towards a High-fat Feeding Intervention Study: Identification of Markers for Inflammation and Organ Damage

Patients undergoing major surgery, trauma or burns are prone to develop an exacerbated inflammatory response, which is potentially lethal to the individual. Recently, the researchers' group showed in a rodent model of hemorrhagic shock that high-fat feeding administered before shock attenuates inflammation and reduces intestinal and hepatic damage. In the mechanism that underlies this protective effect, the release of cholecystokinin in gut wall and activation of efferent vagus bundles are crucial events. Before investigating the effect of high-fat nutrition in clinical setting, suitable markers of inflammation and organ damage need to be selected. In this study, blood will be collected in patients undergoing different types of operations. Consequently several markers for inflammation and organ damage will be determined. Hence, suitable parameters for a future high-fat intervention study will be selected.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* elective liver / colon / femur surgery

Exclusion Criteria:

* Acute inflammation
* Chronic Obstructive Respiratory Disease
* Recent history of abdominal pain or diarrhea
* BMI \< 18.5
* Alcohol or Drugs abuses
* Recent intake of antibiotics
Cardiac Rhythm Disturbances in Hard-to-treat Epilepsy Patients Using Loop ECG Recorders

Seizure-related cardiac arrhythmias are one of the possible causes of sudden unexpected death in epilepsy (SUDEP). Identification of these patients is challenging because cardiac rhythm disturbances could emerge only during seizures. Furthermore, patients could have transitioned sinus or AV node blocks which could cause syncopes with brady-related seizures which could be treated as epilepsy-related seizures. Implantable loop recorders have an ability to recording single-channel ECG for up to 36 months which give an ability to detect these heart disturbances.

The purpose of this study is to look the incidence and types of arrhythmias which occur in 150 patients with hard-to-treat partial seizures and secondarily generalized seizures


Eligibility Criteria:
Inclusion Criteria:

1. Hard-to-treat focal epilepsy
2. Aged 18 to 60 years
3. If female not pregnant

Exclusion Criteria:

1. Known clinical relevant structural cardiac disease
2. Implanted pacemaker, including cardiac resynchronisation device, or defibrillator
3. Use of beta blockers or other antiarrhythmic medication
4. Diagnosis of psychogenic non-epileptic seizures
Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury

Acute kidney injury (AKI) is a major organ failure in septic shock. Current medical tests (serum creatinine and urea) cannot identify AKI until approximately 48 hours after it occurs. Neutrophil gelatinase-associated lipocalin (NGAL) may be able to predict ischemic AKI more effectively and faster than serum creatinine and urea levels.

The purpose of this study is to take a blood sample from patients at admission and then at 24 and 48 hours after to test their plasma for NGAL and compare the NGAL levels to their creatinine and urea levels. The investigators hypothesize that NGAL is an earlier marker to classify the kidney failure as acute tubular necrosis or pre-renal azotemia than creatinine and urea.

Primary Outcome Measures:

To correlate elevated serum NGAL with the diagnosis of intrinsic acute kidney injury in septic shock

Secondary Outcome Measures :

To compare serum NGAL with serum creatinine, serum urea and urine output in septic AKI Death within the intensive care unit Death from all causes at 28 days after inclusion

Eligibility Criteria:
Inclusion Criteria:

* Patients showing signs of infection and hypotension requiring the use of epinephrine despite of an appropriate fluid challenge.
* 18 years of age or older

Exclusion Criteria:

* Age under 18 years
* Prisoners or other institutionalized or vulnerable individuals
* Participation in an interventional clinical study within the previous 30 days
Air Optix Plus HydraGlyde Multifocal Daily/Extended Wear Contact Lenses

The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix plus HydraGlyde Multifocal soft contact lenses in a real-world setting when worn as daily wear or extended (overnight) wear.

This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. The baseline visit will be defined as the first office visit where an eye care practitioner provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for the study or comparator contact lenses was released. Subjects/charts meeting the eligibility criteria will be enrolled in the study.

Eligibility Criteria:
Key Inclusion Criteria:

* Best Corrected Visual Acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
* Must have worn or be wearing Air Optix plus Hydraglyde Multifocal or Biofinity Multifocal for at least 1 year in a daily wear modality, or 3 years in an extended wear modality;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any recurrent history or active anterior segment infection, inflammation or abnormality contraindicating regular contact lens wear at baseline;
* Use of systemic or ocular medications contraindicating regular contact lens wear at baseline and/or during the period of the retrospective chart collection;
* Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear;
* Participation of the patient in a contact lens or contact lens care product trial during the period of the retrospective chart collection;
* Other protocol-defined exclusion criteria may apply.
The Effect of Visual Stimuli on Itch Perception Intensity in Healthy and Atopic Dermatitis Patients

The purpose of this research study is to assess whether seeing other people itch affects itch perception in patients with atopic dermatitis and healthy subjects.

The objectives of this study are to quantitatively assess the effect of visual stimuli on perception of itch and to assess if visual stimuli affect individuals with atopic dermatitis differently than healthy people.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women who are between 18 and 65 years of age
* Diagnosis of moderate to severe atopic dermatitis including involvement of the forearm confirmed by published consensus diagnostic criteria35 (except for healthy control subjects). Severity of AD will be based on an investigator's global assessment score (IGA).
* Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of their skin or which would increase their health risk by study participation
* Women of child bearing potential will be required to have a negative pregnancy test in order to enroll in the study and will be required to maintain adequate birth control throughout the study.
* All subjects in Groups 1 and 3 will be required to cease use of oral antihistamines for a period of one week prior to and during the study visit.
* Subjects in Groups 1 and 3 must cease using topical agents on the forearm where experimentation is going to be performed at least 1 week prior. Topical agents can be used in all other parts of the body.
* Baseline COVAS ratings of more than 9/100 after histamine iontophoresis at the screening visit

Exclusion Criteria:

* Adults over age 65
* Children less than 18 years of age
* Unable to complete the required measures
* Currently enrolled in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy and subjects undergoing treatment with another investigational drug or approved therapy for investigational use within 28 days prior to study participation
* Consumption of more than 4 caffeinated beverages per day
* Current treatment with oral lipophilic beta blockers, opioids, glucocorticoids, theophylline, antihistamines or other medications known to interfere with itch perception or heart rate variability as determined by the investigators
* Uncontrolled asthma or COPD
* Uncontrolled thyroid disease
* Poorly controlled diabetes mellitus
* Poorly compensated congestive heart failure
* Use of illicit drugs
* History of chronic urticaria
* History of anaphylactic shock
* History of neuropathy causing disease such as diabetes and uremia
* Allergy to histamine
* Blindness
* Baseline COVAS ratings of less than 9/100 after histamine iontophoresis at the screening visit
* Subject participation in more than one group.
* Positive pregnancy test
Tacrolimus Ointment in Oral Lichen Planus

The purpose of this study is to compare the effectiveness of topical tacrolimus, triamcinolone and placebo in alleviating signs and symptoms of oral lichen planus (OLP).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OLP made by a specialist in oral pathology based on clinical and histopathological features
* Clinical score for OLP ≥ 20 at baseline
* Symptomatic OLP at baseline
* Washout period of 2 weeks
* Age over 18

Exclusion Criteria:

* Pregnant or lactating women
* Allergy to tacrolimus or other macrolides
* Allergy to other drugs or substances used in the study
* Abnormal liver function
* Netherton's syndrome
* Cyclosporin medication
* Other regular medication that could have significant interactions with tacrolimus
Diabetes Prevention for Black Men

Geographic analyses of diabetes burden have found that poor glycemic control, high rates of diabetes-related hospital utilization, and a high prevalence of microvascular diabetic complications all cluster in the same neighborhoods.This proposed study seeks to identify Black barbers with undiagnosed diabetes or prediabetes using point-of-care HbA1c testing, perform qualitative interviews to identify health behaviors that may explain poor sugar control, and develop a workplace-based food intervention to promote primary prevention and test its effect on sugar control in these individuals.


Eligibility Criteria:
Inclusion Criteria:

* Black or African American men who work as barbers at Black-owned barbershops
* Barbershop clients.
* Workplace in neighborhood geographically identified as having higher diabetes burden
* No prior history of clinical diagnosis of diabetes
* Identified on initial and second point-of-care testing to have an HbA1c of 5.7 or greater

Exclusion Criteria:

* Individuals with a history of blood loss or blood disorder that would lead to incorrect results on point-of care HbA1c testing
* Individuals with a history of food allergies that requires specific dietary restrictions
* Individuals who are not English speaking
* Individuals who have a significant cognitive impairment that will be a barrier to communication, valid consent and participation
Evaluation of the Anti-aging Efficacy of Four Skin Health Products

The purpose of this study is to assess the anti-wrinkle and anti-aging efficacy of four different cosmetic products compared to an untreated control (split-face study design)


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent to participate in the study
* Willingness to actively participate in the study and to come to the scheduled visits
* Female and male
* From 40 to 65 years of age
* BMI \< 30 kg/m2
* Healthy skin in the test areas
* Uniform skin color and no erythema or dark pigmentation in the test area
* Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2
* Ethnicity: at least one Black, Asian and Hispanic subject per study group

Exclusion Criteria:

* Female subjects: Pregnancy or lactation
* Drug addicts, alcoholics
* AIDS, HIV-positive or infectious hepatitis
* Conditions which exclude a participation or might influence the test reaction/evaluation
* Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
* Active skin disease at the test area
* Documented allergies to face/eye care products
* Diabetes mellitus
* Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension (if not adjusted with medication), cardiovascular diseases
* Epilepsy
* Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, freckles, etc. at the test area that could influence the investigation
* Sun-tanned skin (important for the subgroup of subjects planned for Raman measurements)
* Regular use of tanning beds
* Any topical medication at the test area within the last 7 days prior to the start of the study
* Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) and/or within the last 7 days prior to the start of the study
* Past cosmetic surgery procedure in the test area (e.g. laser, facelift)
* Cosmetic surgery procedure in the test area, e.g. IPL (Intensed Pulsed Light), botox, chemical peel, dermabrasion within the last 2 years prior to the start of the study and/or throughout the entire course of the study
* Medical treatment for wrinkle reduction (e.g. peeling with vitamin A or fruit acids) on the face within the last 2 weeks prior to the start of the study
Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects

This trial is conducted in Asia, Europe, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding episodes during surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects with the diagnosis of severe (FVIII less than or equal to 1%) haemophilia A from age 12 (except for Israel where the age limit will be 18 for the first 10 subjects recruited in the trial) to 56 years having a weight of 10 to 120 kg
* Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
* No history of FVIII inhibitors greater than or equal to 0.6 BU/mL. The inhibitor should be measured regularly for at least the last 8 years or since the first treatment of haemophilia A
* No detectable inhibitors to FVIII (greater than or equal to 0.6 BU/mL) (as assessed by a Central Laboratory at the time of screening)

Exclusion Criteria:

* Congenital or acquired coagulation disorders other than haemophilia A
* Creatinine levels 50% above normal level (as defined by central laboratory range)
* Known or suspected allergy to trial product (N8) or related products
Investigator Initiated Trial to Evaluate Efficacy and Safety of LAENNEC (Human Placenta Hydrolysate) Administered by Ultrasonography Guided Subacromial Bursa Injection in Patients With Shoulder Impingement Syndrome

To patients with shoulder collision syndrome, LAENNEC (Human Placenta Hydrolysate) is administered as an injection in the ultrasonic induction underglone, to evaluate the effectiveness and safety.


Eligibility Criteria:
Inclusion Criteria:

1. At the time of screening, 19 or 70 years
2. Those who are suspected of rotator cuff lesions or damage due to shoulder pain
3. Those who are judged to have a shoulder joint disease during screening
4. Neer test, Hawkins-Kennedy inspection, job test, Painful Arc inspection or resisted showder external rotation test
5. Those with a significant pain of 30 mm of Visual Analogue Scale (VAS)
6. Those who can sign a test subject or to comply with the matters required for clinical trials.

Exclusion Criteria:

1. A person who appears in the movement of two or more shoulder joints with more than 50% of the joint movement limit on the passive shoulder joint operation scope test.
2. Those who have confirmed the rupture of the entire layer by ultrasound
3. Those with serious damage to the shoulders and the past power
4. Those who have suspected fractures, dislocations, degenerative arthritis, and calcification in the shoulder radiation test in the shoulder radiation test.
5. Those who complain of shoulder pain due to stroke, spinal cord injury, and other surgery
6. Those with other shoulder diseases other than fifty dogs (rheumatoid arthritis, osteoarthritis, bone defect injuries, malignant tumors, etc.)
7. Those who are accompanied by diseases of cervical spine or other upper limbs that have a significant effect on the shoulder
8. Those who have performed steroid injections in the joint steel within 3 months of participation in clinical trials
9. Those who have administered anti -inflammatory drugs within two weeks of participation in clinical trials
10. Those with all other joint diseases that have musculoskeletal diseases that may affect effective evaluation, or that it is impossible to participate in this clinical trial.
11. Those who are diagnosed with mental illness and taking drugs
12. Pregnant women and lactation departments, fertility women who are not willing to contraceptive during the clinical trial period
13. Those who have received medication, oriental medicine, physical therapy, and injection treatment in relation to shoulder pain within the last two weeks 14 Those who are participating in other clinical trials during screening

15. Those who determine that other testors are inadequate
A Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Participants

This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects.


Eligibility Criteria:
Inclusion Criteria:

* Is male or female, using highly effective contraception
* Has a body mass index (BMI) 18.0 to 30.0 kg/m2, inclusive
* Is in good general health
* Having signed informed consent, is willing and able to comply with requirements of the study

Exclusion Criteria:

* Does not satisfy all screening criteria per protocol
* Is employed by or related to any personnel involved in the trial
* Has any history or condition that per protocol or in the opinion of the investigator could compromise the participant's safety or analysis of results