cyrilzakka/clinical-trials huggingface dataset:
Sacral Erector Spinae Plane Block Versus Caudal Block in Penile Surgeries in Pediatrics

The study will be conducted to compare the efficacy of ultrasound guided Sacral Erector Spinae Plane Block to caudal block on pain management in penile surgeries in pediatrics.

The erector spinae plane block (ESPB) is a relatively new interfacial plane block that is used for postoperative analgesia in penile surgeries in pediatrics.

The sacral ESPB is a technique known to block the posterior branches of the sacral nerves. Also it blocks the lumbosacral plexus especially the sacral spinal nerves (S2_S4) when applied to high levels.

Caudal epidural block in children is one of the most widely administrated technique of regional anesthesia; it is an efficient way to offer perioperative analgesia for painful sub umbilical interventions. It enables early ambulation, hemodynamic stability and spontaneous breathing in patient groups at maximum risk of difficult airway.

Caudal block is a known worldwide technique but with some risks such as subdural, intra vascular injection, infection, injury to the nerve root or local anesthesia. Therefore, we try a new technique as sacral ESPB.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 3 to 6 years.
* Male children.
* American Society of Anesthesiologists (ASA) I - II.
* Male who admitted for penile surgeries.

Exclusion Criteria:

* Parents who refused regional anesthesia.
* Patients presented with symptoms or signs of increased intracranial tension.
* Patients presented with advanced kidney, cardiac or liver diseases.
* Coagulation and bleeding disorders.
* Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
* Pre-existing neurologic disease (e.g. lower extremity peripheral neuropathy).
* Patients with known allergy to study drugs.
* Patints with developmental or mental delay.
Safety and Repeatability of Bronchial Challenge With Grass-pollen

The study is meant to establish a one-step challenge with grass-pollen in patients sensitized for grass-pollen. Therefore the investigators compare a multi-step challenge with grass-pollen with an one-step challenge in order to survey the repeatability and safety.

Background:

Specific provocation with inhaled allergens is an established tool in clinical practice and research, supporting the understanding of pathophysiology of allergic asthma, and analysing the efficacy of new therapies. This study examines the repeatability of a bolus-dose inhalative allergen challenge with grass pollen.

Method:

Forty grass pollen allergics should undergo an incremental-dose grass pollen challenge to calculate their PD20-dose. This calculated dose will be applicated twice to analyse the repeatability of the bolus dose challenge. Before and twenty-four hours after the provocation, exhaled nitric oxid (FeNO) will be determined as a marker of bronchial inflammation.

Eligibility Criteria:
Inclusion Criteria:

* age \>12 \<45 years
* known sensitization for grass-pollen
* informed consent

Exclusion Criteria:

* age \<12 \>45 years
* clinical asthma requiring regular inhalation
* vital capacity \<80%
* FEV1 \< 75%
* chronic disease conditions or infections
* pregnancy
* inhalative or systemic steroid use
* substance abuse
* incapability of understanding the study's purpose and performance
Evolutionary and Sociocultural Aspects of Human Milk Composition

It is well-known that breastfeeding protects infants from illness, especially in the poorest regions of the world. The full nature of this protective effect, however, is less well understood. A major barrier to understanding is the fact that almost nothing is known about the factors that influence the considerable variation in milk composition around the globe, or about the effects of this variation on infant health. This INSPIRE project represents the first comprehensive investigation of the global differences in human milk composition along with the various microbial, evolutionary, environmental, and sociocultural factors that might influence both milk composition and infant health. An international, interdisciplinary collaboration of physiologists, nutritional scientists, anthropologists, microbiologists, and mathematicians will collect biological data from breastfeeding women and their infants, in concert with extensive anthropologic and ecological data, in both developed (US, Spain, Sweden) and developing countries (Central African Republic, Gambia, Ghana, Peru, and Kenya). To test the possibility of a correlation between milk oligosaccharide composition, milk microbiota, and the gastrointestinal microbiome of infants, milk samples and infant fecal samples will be analyzed using state-of-the-art biochemical and genomic techniques. This study will allow important cross-cultural comparisons of milk composition and infant feeding practices; it also will utilize sophisticated computational methods to integrate the extensive, diverse body of combined biological and anthropological data to elucidate the relationships among sociocultural factors, evolutionary history, environmental exposures, microbial constituents and milk composition. The researchers predict that what is considered "normal" milk composition in one population may not support optimal health in another. This information is crucial to the humanitarian quest to understand how infant nutrition and overall health can be improved around the world. In addition, this project will provide extensive research training opportunities for undergraduate, graduate and postdoctoral scientists.


Eligibility Criteria:
Inclusion Criteria

* Breastfeeding or pumping at least 5 times daily (to assure adequate milk production)
* Self-reported healthy women and infants
* ≥ 18 yr of age (maternal)
* 1-3 mo postpartum

Exclusion Criteria

* Current indication of breast infection (e.g., breast pain, discomfort, lumps, mastitis with fever, red streaks, or hard red portions of the breast)
* Breast pain that the woman does not consider "normal" for lactation/breastfeeding
* Any antibiotics to mother or infant in the previous month (30 days)
* Infant has had signs/symptoms of acute illness in the previous 7 days including the following: fever, diarrhea (≥ 3 excessively "loose" stools in a day), vomiting not associated with feeding, severe cough, rapid breathing
Eye Tracking in Laryngology

The purpose of this study is to assess whether eye-tracking technology can be used to differentiate the visual gaze patterns of experienced and novice laryngoscopists while reviewing prerecorded laryngeal videos with both normal and abnormal findings and to characterize any differences arising between level of training groups.

Novice and experienced participants will be recruited to take part in this study. Novices include medical students without practical experience in otorhinolaryngology and resident physicians at different stages in training. Trainees, residents and experts from fields of gastroenterology and pulmonology will also be included. The experienced group will be defined as consultants and speech pathologists.

This study will look at multiple areas within otolaryngology including laryngology, rhinology, facial plastic surgery, head and neck oncology, and otology. Participants will view prerecorded videos and/or still pictures absent of patient identifiers.

There will be two tasks each taking approximately 10 minutes. Task order will be alternated between subjects with one task asking participants to view 7 still images from video laryngoscopy examinations. After each image participants will rate how likely the image is to represent glottic cancer and what portion of the image they deemed most important to their decision. For the second task, participants will be asked to view a 5 second video of a flexible laryngoscope exam, after which, they will be asked to identify the presence and side of vocal fold paralysis as well as note the location they deemed most important to their decision.

Eligibility Criteria:
Inclusion Criteria:

* Adults, age 18 and over.
* Already professionals in a laryngology related field, residents in a related field or students considering a related field.
* Related fields include otolaryngology, laryngology, and speech language pathology.

Exclusion Criteria:

- Anyone not meeting the inclusion criteria or anyone not wishing to participate.
Diabetes Mellitus Type 2 Basal Insulin Dosing Requirements Study

The main purpose of this study is to determine the number of daily basal insulin rate changes that are needed to achieve short-term near normal glucose control in insulin pump patients with type 2 diabetes

Subjects will be taught CHO counting after which they will be introduced to an insulin pump. They will wear the insulin pump for three weeks to adjust to the pump and its functions. Then the subject will wear a Continuous Glucose Monitoring System to determine rate changes needed to achieve short-term near normal glucose control. The primary endpoint is what are the mean number of changes in the basal infusion rate and what are the mean differences and mean duration of these changes. The secondary endpoint is what mathematical formulas describe the relationship between the dosing factors and do they significantly differ from those previously established by King and Armstrong.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes \> 3month duration
* Age 18
* Hb A1C \<12%
* On any hypoglycemic therapy including insulin for 5 patients and 5 patients naive to insulin and failing oral treatment
* Normal creatine
* Negative for GAD antibodies
* SMBG \>4/d and willing/able to comply with study requirements
* Demonstrated adherence to visits and instructions.

Exclusion Criteria

* Severe hypoglycemic during the last month
* Severe cardiac, pulmonary or cerebral disease
* Demonstrated non compliance with clinical recommendations
* Pregnancy, nursing or women who could potentially become pregnant
* Presence of physical, psychological or cognitive impairments that would interfere with adherence to an intensive insulin therapy program or compliance with dietary, diary keeping or maintenance of CGM sensor or pump
Traditional Thai Massage and Scapulocostal Syndrome

The purpose of this study is to evaluate the efficacy of traditional Thai massage on pain intensity, pressure pain threshold, muscle tension, anxiety, cervical range of motion, patient satisfaction and side effects in the treatment of scapulocostal syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Age between 18 - 50 years old
3. The participants have experienced spontaneous scapular pain (VAS ≥ 3) for longer than 12 weeks (chronic) and that at least one trigger point will be present in the scapular region (serratus posterior superior, rhomboid groups, levator scapulae and trapezius muscles). Trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition.
4. The participants will be able to follow instructions.
5. Good communication and cooperation.

Exclusion Criteria:

1. A history of the following diseases or disorders:

   * Rotator cuff disease
   * Cervical radiculopathy
   * Degenerative shoulder joint disease
   * Shoulder stiffness
2. Contraindications of traditional Thai massage

   * Contagious skin disease
   * Injury or inflammation of muscle
   * Bone fracture and/or joint dislocation
   * Open wound
   * Uncontrolled hypertension
   * Drug and/or alcohol intoxication
Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol) injection may treat cysts by killing the lining cells of the cyst, and is an accepted treatment for cysts of other organs. In this study, participants with pancreatic cysts underwent endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This was a pilot study to assess safety and efficacy.

The hypotheses of this study were 1) complications of EUS guided ethanol injection requiring hospitalization will occur in \<10% of subjects, and 2) EUS guided ethanol injection, with retreatment as necessary, will ablate at least 50% of pancreatic cysts.

EUS is performed via the mouth under sedation. After a needle is placed into the pancreas cyst under EUS guidance, an ethanol solution is placed into the cyst via the needle. The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.

After this treatment, usual clinical follow-up is obtained including assessments of the cyst by CT or MRI scans. If a cyst of significant size persists, additional EUS-guided ethanol injections of the cyst were offered.

Eligibility Criteria:
Inclusion Criteria:

1. Presence of a pancreatic cystic lesion, \> 1 cm in maximum diameter
2. Treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy
3. Age \> or = 18 years
4. Able to give informed consent
5. Surgical treatment has been considered, and a surgical consultation offered to the patient, but:

   1. Subject's cyst does not meet consensus criteria for surgical resection, or
   2. Subject is deemed a poor operative candidate, or
   3. Ethanol ablation would allow a subtotal rather than total pancreatectomy, or
   4. Subject has decided not to undergo surgical treatment.

Exclusion Criteria:

1. Known or suspected pregnancy, or nursing
2. History of pancreatitis within past 3 months
3. Main pancreatic duct is dilated to \> 4mm in neck, body, or tail
4. Cyst is known to communicate with the pancreatic duct
5. Cyst has a primarily microcystic architecture on EUS
6. Cyst is immediately adjacent to the main pancreatic duct on EUS
7. Cyst has a connection to the main pancreatic duct seen during EUS
8. During initial cyst aspiration, more fluid is recovered than expected (suggesting communication to the main pancreatic duct)
9. Pancreatic cytology has demonstrated cancer
Invasive vs. Conservative Management in Cancer Patients With Non-ST Elevation MI (CAN-NSTEMI)"

This retrospective study investigates the impact of invasive versus conservative management strategies in cancer patients presenting with non-ST elevation myocardial infarction (non-ST MI). Patients aged 18 and older, who were treated for non-ST MI in a hospital setting and had a confirmed cancer diagnosis, are included. The primary outcome is hospital mortality, assessed using GRACE scores to evaluate mortality risk. Patients are grouped based on their received interventions-either invasive (including coronary angiography and revascularization) or pharmacological treatment. Risk factors contributing to mortality, such as cancer type, metastasis presence, comorbidities, and laboratory findings, will also be analyzed to better understand the interplay of oncologic and cardiovascular conditions in this population.


Eligibility Criteria:
Inclusion Criteria:

* Age: Patients aged 18 years and older.
* Diagnosis: Patients with a confirmed cancer diagnosis.
* Acute Condition: Patients diagnosed with non-ST elevation myocardial infarction (non-ST MI).
* Treatment: Patients who received either invasive treatment (including coronary angiography and revascularization) or conservative (pharmacological) treatment for non-ST MI.
* Consent: Patients who have provided informed consent or are part of a retrospective study where consent is waived.

Exclusion Criteria:

* Age: Patients younger than 18 years.
* Non-cancer diagnoses: Patients without a cancer diagnosis.
* ST-Elevation Myocardial Infarction: Patients with ST elevation myocardial infarction (STEMI) instead of non-ST elevation myocardial infarction (NSTEMI).
* Pre-existing severe comorbidities: Patients with severe or terminal comorbidities (e.g., end-stage liver disease, end-stage renal disease, or severe cognitive impairment) that would confound the outcomes.
* Incomplete medical records: Patients with missing data on relevant clinical variables (e.g., GRACE score, treatment received, or mortality data).
* Pregnancy: Pregnant patients, as their conditions may complicate the interpretation of results.
* Inability to provide informed consent: Patients unable to provide informed consent (if applicable).
Augmented BLAdder NecK rEconstruction Trial for Improved Urinary Function After Radical Prostatectomy

The investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo prostatectomy with a standard BNR. An aBNR here consists of the autologous medial umbilical ligament sling as well as a bladder neck intussusception stitch. The standard BNR group will receive the intussusception stitch only.

A bladder neck reconstruction is a standard step in performing a radical prostatectomy. Over the years, various maneuvers to improve continence have been tried and studied including intussusception stitches and slings. Slings of various origins have been used by surgeons at the time of radical prostatectomy without consistent evidence demonstrating a benefit (vas deferens, biologic). However, use of the medial umbilical ligament to create a sling has not previously been studied in a randomized trial.

The medial umbilical ligaments are normally cut during intraperitoneal robotic-assisted laparoscopic radical prostatectomy to allow the surgeon access to the Retzius space between the bladder and pubic bone. To create a medial umbilical ligament autologous sling, the ligaments are dissected out and wrapped around the vesicourethral anastomosis.

The investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo prostatectomy with a standard BNR. An aBNR here consists of the autologous medial umbilical ligament sling as well as a bladder neck intussusception stitch. The standard BNR group will receive the intussusception stitch only.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 40 to 70 years of age with localized prostate cancer (clinical stage T2c or less, Gleason grade 5+5=10 or less without any evidence of distant metastases)
* Scheduled to undergo curative robot-assisted radical prostatectomy

Exclusion Criteria:

* Planned pre-operative or post-operative (within 1 month) androgen therapy
* Planned pre-operative or post-operative (within 1 month) radiation therapy
* History of spinal trauma or surgery to the brain or spinal cord
* Pre-operative history of stress urinary incontinence
Phase III Cat-PAD Follow-on Study

The purpose of this study is to evaluate the continued effectiveness and safety of Cat-PAD in cat allergic subjects for up to five years after the start of administration of treatment. The study is an optional follow-up study to a phase III double-blind, placebo controlled, Cat-PAD study; no further investigational product is administered.


Eligibility Criteria:
Inclusion Criteria:

* previously completed clinical study CP007 \[NCT01620762\]

Exclusion Criteria:

* started allergen therapy since completing CP007
* Institutionalised due to a legal or regulatory order
Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome

The purpose of this study is to determine whether vitamin D3 supplementation is effective in the treatment of clinical signs, biomarkers of inflammation and oxidative stress due to Irritable Bowel Syndrome (IBS).

This randomized double blind clinical trial will be performed on 90 patients (45 in intervention and 45 in control group) diagnosed with IBS. The intervention group will receive 50000 IU vitamin D3 and the control group will receive placebo contains edible paraffin once every 2 weeks for six months. Variables including biomarkers of inflammation and oxidative stress, serum levels of calcium and vitamin D, anthropometric indicators and blood pressure will be measured at baseline and end of the study. The investigators will use Rome III questionnaire for evaluating the clinical signs of the disease. The questionnaires will be filled out at baseline and every 2 weeks by the patients for six months.

Eligibility Criteria:
Inclusion Criteria:

* The patients who are diagnosed with Irritable Bowel Syndrome (IBS) according to ROME III criteria; Signed consent by the patient.

Exclusion Criteria:

* Patients who have celiac disease (diagnosed by a duodenal biopsy or celiac serological tests)
* Any other diseases of the gastrointestinal tract such as Inflammatory Bowel Disease (IBD)
* Any kind of abdominal surgery
* Chronic disease such as diabetes
* Cardiovascular, hepatic
* Kidney and severe infection
* Pregnancy
* Breastfeeding
* Smoking
* Alcohol consumption
* Use of dietary supplements
* Use of vitamin D and calcium supplement during the last year before the study
* Use any medication for signs improvement during the study period.
The Effect of ColcHicine on the Incidence of Knee or Hip Replacements

The goal of this clinical trial is to evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip osteoarthritis on the incidence of first occurrence of knee or hip replacement. The main question it aims to answer is:

Does colchicine lower the number of knee or hip replacements in participants with osteoarthritis?

Researchers will compare colchicine to a placebo (a look-alike substance that contains no drug) to see if colchicine works to treat osteoarthritis.

Participants will:

* take colchicine every day for 3 tot 4.5 years
* visit the clinic every year for check-up and tests such as blood samples and x-rays
* fill in questionnaires every 3 months


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of knee or hip OA
* 45 ≤ age ≤ 80 (upper age limit is similar to that in the LoDoCo2 trial and takes in consideration the lower number of joint replacements in people older than 80 years)
* documented radiographic changes typical for advanced knee/hip OA (Kellgren \& Lawrence score ≥ 2), or at least 2-year history of complaints due to OA in the hip and/or knee

Exclusion Criteria:

* On a waiting list for primary joint replacement surgery of the hip or knee, irrespective of cause
* Any absolute contraindication for knee or hip replacement in the future
* More than one previous hip or knee replacements
* Other known medical disease that may affect joints
* Known generalized pain syndromes such as fibromyalgia
* Renal impairment as evidenced by serum creatinine \>150µmol/l or estimated glomerular filtration rate (eGFR) \<50mL/min/1.73m2
* Liver function impairment as evidenced by serum alanine transferase (ALAT) \> 3 ULN (upper limit of normal)
* Blood dyscrasia
* High frailty (clinical frailty scale ≥ 7) or predicted life expectancy \< 5 years
* Peripheral neuritis, myositis or marked myo-sensitivity to statins
* Current use of colchicine for another indication
* Intolerance to colchicine
* use of macrolide antibiotics (i.e. clarithromycin, erythromycin, azithromycin), antimycotics (i.e. ketoconazole, itraconazole and voriconazole), protease inhibitors \& anti-retroviral drugs (i.e. ritonavir, lopinavir, tipranavir, atazanavir, darunavir, indinavir, saquinavir, and cobicistat), anti-arrhythmic drugs (i.e. verapamil, diltiazem), or immunosuppressant (i.e. cyclosporine)
* Current enrollment in another trial
* Incapacitated patients
* Pregnant or breastfeeding female
* Fertile female participants not taking sufficient anti-conception
* Male participants unwilling to use effective contraception during the study to prevent pregnancy