cyrilzakka/clinical-trials huggingface dataset:
Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease

The aim of the study was to compare the results of conservative and surgical treatment, to create an algorithm for the management of the disease, and gain more information about the etiology, pathogenesis, and course of the disease. The investigators hypothesise that surgical treatment of UPS will be better than conservative management in terms of recurrence rate, healing time, patient comfort and satisfaction, and cost effectiveness.

Because of its rarity, umbilical pilonidal sinus (UPS) is still poorly understood in terms of diagnosis, etiology, and the best treatment options.

UPS is thought caused by hair penetrating the skin, leading to a foreign-body reaction and development of a sinus lined with granulation tissue. Most of the patients complain of pain, discharge or bleeding from the umbilicus when symptoms develop. It can be diagnosed with a careful examination, in which hairs can be seen deep in the umbilicus and usually protrude from a small sinus.

Regarding the optimal treatment of the disease, a complete consensus has not yet been achieved. Some publications are recommended conservative treatment, while surgical treatment is recommended in others.

A more meaningful comparison of the two modalities is that of a randomized controlled trial. We, therefore, present our data of prospective randomized controlled clinical trial comparing conservative versus surgical treatment of UPS.

This was a multicenter, prospective balanced randomization, double blind, active-controlled, parallel-group, superiority study conducted in Turkey, under the direction of a principal investigator (MK). Eligible patients with UPS were randomized for either conservative treatment (CT) or surgical treatment (ST), and then the results of both groups were compared.

Eligibility Criteria:
Inclusion Criteria:

* all patients willing to participate to the study with the diagnosis of umbilical pilonidal sinus

Exclusion Criteria:

* no informed consent
* serious coagulation abnormalities
* known allergy to local anesthetics
* pregnancy, or women who refused contraception at the time of treatment
* other concomitant umbilical pathologies such as umbilical hernia, granuloma, dermoid cyst
* the patients who diagnosed with urachal and omphalomesenteric anomalies through radiological investigation
* patients who underwent umbilical operation
Evaluation of the Pathobiology of CALR-mutated MPN Cells

The purpose of this study is to understand why there is a greater risk of thrombosis in patients who have the JAK2 mutation as compared to those with CALR mutations.

This biospecimen study is designed to evaluate the expression levels of TLR 2 and TLR 4 on mononuclear cells in CALR mutation positive MPN participants and compare to JAK2 V617F mutation positive MPN patients and healthy controls. Patients who have MPN with the CALR mutation positive will be approached for interest in participating in this study. A research blood collection will occur at any time during the participant's cancer trajectory after enrollment, during a standard of care blood draw. The participant's demographics, MPN subtype, CALR mutation status, history of thrombosis/other medical history, and current, concomitant medications will be collected once. Clinical data will be collected, including results from the CBC with differential, complete metabolic panel (if available), and PT/PTT/INR (if available) drawn closest to the research blood collection. This study will initially open as a single center study at AHWFBCCC.

Eligibility Criteria:
Inclusion Criteria:

* Written (or electronic) informed consent and HIPAA authorization for release of personal health information by participant or his/her legally authorized representative (LAR).
* Age ≥ 18 years at the time of enrollment
* Diagnosis of myeloproliferative neoplasm (MPN) according to 2022 World Health Organization classification of MDS/MPNs
* CALR-positive genetic mutation

Exclusion Criteria:

- Diagnosis of MPN with JAK2 V617F mutation
The Ecological Role of Yeasts in the Human Gut

Irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) (categorised into Crohn's disease (CD) and ulcerative colitis (UC)) are chronic gut disorders with debilitating symptoms that profoundly impact quality of life, healthcare systems and the economy through lost work days. IBS is common with a prevalence of up to 22%, whereas IBD has a prevalence of 0.3% for CD and 0.5% for UC in Europe. Despite a suggested immunological and genetic aspect of IBD, the causes of IBS and IBD are unknown, however, both have been linked to yeasts in the gut.

Due to their lower abundance (constituting only around 0.1% of the total microorganisms in the gut) yeasts have been less studied than bacteria. More recently, significantly altered diversity and composition of yeasts have been identified in IBS and IBD but further investigation is required to fully develop the role of yeasts in the gut.

This observational study will assess yeasts and their function in the gut, comparing diseased subjects with healthy controls. The overall aim is to determine if yeasts could be targeted as a potential therapeutic for IBS and IBD to provide relief to sufferers as well as reducing the burden on healthcare systems.


Eligibility Criteria:
Inclusion Criteria:

* Aged 20-60 years old.
* Either healthy or diagnosed with a gut disorder: Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD) which may include Crohn's disease or ulcerative colitis.
* In good general health.
* Provided written informed consent and willing to participate in this study.

Exclusion Criteria:

* Received antibiotics in the previous six months.
* Consume prebiotics or probiotics on a regular basis (at least 3 times per week) in the last 2 weeks or intend to throughout the course of the study. (Examples of these include: Multibionta multivitamins, Danone Actimel yoghurt drink; Danone Activia yoghurt; Yakult fermented milk drink; Kellogg's Rice Krispies multigrain and Muller Vitality yoghurts/drinks).
* Current use of immunosuppressive drugs.
* Use of other medication which affects gastrointestinal motility and/or gut discomfort.
* History of alcohol or drug misuse.
Upper Limb Task-Oriented Rehabilitation With Robotic Exoskeleton for Hemiparetic Stroke Patients

The aim of this study is to evaluate the effects of an assisted rehabilitation treatment through a robotic exoskeleton device on the functional recovery in a group of patients with hemiparesis from lesion of the first motor neuron (post-stroke), compared with a group of patients subjected to a conventional rehabilitation treatment. The patients enrolled in the study are chronic stroke injured with right hemiparesis of moderate to severe degree, by the system injury pyramid, never undergoing rehabilitation treatment with robots.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of a first-ever left hemisphere ischemic or hemorrhagic stroke at least 6 months prior to entry into the study;
* minimum ability for shoulder humeral elevation;
* upper-extremity motor function Fugl-Meyer (FM) score ≥ 15(out of 66);
* absence of neurological or muscular disorders that interfere with neuromuscular function;
* absence of severe cognitive deficits that would limit patients' ability to complete the study;
* minimum score of 2 in the Modified Ashworth Scale;
* not participating in any experimental rehabilitation or drug studies at the same time
* no previous experience with robotic treatments.
Effect of Cognitive Empathy Training on Dementia Caregivers

The goal of this project is to investigate the effect of cognitive empathy training on mental health, inflammation, and immune function in caregivers of people living with dementia (PLWD), and to examine the underlying psychological and neurobiological mechanisms.

The primary aim is to establish the effectiveness of cognitive empathy training in improving caregiver mental health and immune function, and in decreasing caregiver inflammation

The secondary aim is to investigate the psychological and neurobiological mechanism by which cognitive empathy training improves caregiver well-being

In the U.S., over 7 million people currently live with Alzheimer's disease and related disorders (ADRD), a number projected to exceed 16 million by 2060. Family caregivers, numbering more than 11 million, play a crucial role in managing the care of these individuals, often bearing significant emotional and financial burdens. In 2021, the cost of care for dementia reached $593 billion, with families contributing a substantial portion. Caregivers frequently experience negative mental and physical health impacts due to chronic stress, including increased rates of depression and inflammation. Research indicates that caregiving leads to decreased immune function, with elevated Epstein-Barr virus antibody titers serving as a marker for immune health. Interventions aimed at supporting caregivers, such as psychoeducational programs, have shown benefits, particularly in enhancing coping skills. Additionally, fostering cognitive empathy in caregivers may improve their mental health and the quality of care provided to individuals with dementia, potentially mitigating some of the adverse health effects associated with caregiving stress.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers must live with their care recipient
* Caregivers must have a Zarit Burden Scale score of 19 or higher
* Caregivers must have no plans to move their care recipient to an institutional setting within the next year
* Caregivers must be able to read and write English
* Care recipient not in hospice
* Access to a mobile phone that can take and email photographs

Exclusion Criteria:

* Subjects with a history of seizures or other neurological disorders, alcoholism, or any other substance abuse
* Subjects with a history of psychiatric illness (excluding depression and anxiety disorders) will also be excluded
* Subjects with a history of head trauma based on Survey
* Subjects with MRI contra-indications
ORal-motor Assessment and Rehabilitation Mobile App (ORAR App)

The goal of this study is to set up a database of oral-motor and speech functions of post-stroke patients in Hong Kong via an artificial intelligence-powered mobile-health application. The main study objectives are:

1. To establish an image database of oral-facial movements of neurologically healthy adults and adult stroke patients in Hong Kong.
2. To evaluate the oral-motor functions of neurologically healthy adults and stroke patients via instrumental and behavioral assessment.
3. To investigate the correlation between image-based analysis of oral-facial functions and instrumental evaluations and subjective judgment by the speech-language therapist.


Eligibility Criteria:
For Neurologically healthy adults,

Inclusion Criteria:

1. age between 20 and 85 years old;
2. no severe systemic diseases such as uncontrolled diabetes, cerebrovascular diseases, head and neck tumors, or neurological disorders;
3. not undergoing radiation therapy or chemotherapy;
4. normal or corrected-to-normal vision and hearing; and
5. fluent Cantonese speakers

Exclusion Criteria:

1) participants who are unable to sign the "Informed Consent Form" due to cognitive impairments

For stroke patients,

Inclusion Criteria:

1. age between 20 and 85 years old;
2. a history of stroke;
3. not undergoing radiation therapy or chemotherapy;
4. normal or corrected-to-normal vision and hearing;
5. premorbid fluent Cantonese speakers; and
6. able to follow simple commands.

Exclusion Criteria:

1. individuals currently on non-oral feeding; and
2. participants who are unable to sign the "Informed Consent Form" due to cognitive impairments
OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)

The purpose of this study was to evaluate the safety and efficacy of donidalorsen in participants with HAE and effect of donidalorsen on the quality and pattern of HAE attacks and their impact on quality of life (QoL).

This was a Phase 3, multi-center, double-blind, randomized, placebo-controlled study of donidalorsen in 91 participants. Participants were randomly assigned in a 2:1 ratio to Cohort A (donidalorsen or placebo every 4 weeks) or Cohort B (donidalorsen or placebo every 8 weeks), respectively. Within each Cohort, participants were randomized in a 3:1 ratio to receive donidalorsen or matching-placebo. The study included an up to 8-week Screening Period, a 24-week Treatment Period, and an up to 13-week Post-treatment Period.

Eligibility Criteria:
Key Inclusion Criteria

1. Participants, or their legally appointed and authorized representatives, must provide written and signed informed consent form (ICF)/assent
2. Participants must be aged ≥ 12 years at the time of informed consent and, as applicable, assent
3. Participants must have a documented diagnosis of hereditary angioedema type 1 (HAE-1)/hereditary angioedema type 2 (HAE-2)
4. Participants must:

   1. Experience a minimum of 2 HAE attacks (confirmed by the Investigator) during the Screening Period
   2. Be willing to complete the participant reported outcomes (PRO) assessments throughout the study
5. Participants must have access to, and the ability to use acute medication(s) to treat angioedema attacks

Key Exclusion Criteria

1. Concurrent diagnosis of any other type of recurrent angioedema, including acquired, idiopathic angioedema or HAE with normal C1-INH (also known as HAE Type III)
2. Any clinically-significant abnormalities in screening laboratory values that would render a participant unsuitable for inclusion in the study
3. Treatment with another investigational drug or biological agent within 1 month or 5 half-lives, whichever is longer, of Screening
4. Participated in a prior ISIS 721744 study
5. Exposure to any of the following medications:

   1. Angiotensin-converting enzyme (ACE) inhibitors or any estrogen containing medications with systemic absorption within 4 weeks prior to Screening
   2. Chronic prophylaxis with Takhzyro, Haegarda, Cinryze and Ruconest or Orladeyo within 5 half-lives prior to Screening
   3. Oligonucleotides (including small interfering ribonucleic acid \[siRNA\]) within 4 months of Screening if single dose received, or within 12 months of Screening if multiple doses received. This exclusion does not apply to vaccines
6. Recent history (3 years) of, or current drug or alcohol abuse
Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC

This pilot clinical trial will evaluate the initial safety and feasibility of microbiota transplant therapy (MTT) inpatients with primary sclerosing cholangitis (PSC). This trial will inform development of future trials in treatment of PSC.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-76
* Serum total bilirubin at screening ≤ 2x the upper limit of normal
* Absence of biliary obstruction and malignancy by ultrasound or equivalent imaging within 6 months of study entry
* Anticipated maintenance of current medication regimen through the treatment period (UDCA, azathioprine, corticosteroid, methotrexate, 5-ASA, biologic therapy and/or probiotic)
* 3-month washout period of obeticholic acid or other experimental therapies for PSC
* Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence.
* Informed consent

Exclusion Criteria:

* Antibiotic therapy (except vancomycin) within 3 months or anticipated antibiotic use in the course of the MTT treatment
* Presence of complications of advanced PSC, such as hepatic encephalopathy, ascites, history of esophageal varices, portal hypertension, hepato-renal syndrome, portopulmonary syndrome, and hepato-pulmonary syndrome
* Evidence for viral hepatitis (history of Hepatitis C is eligible with undetectable HCV RNA); HIV/AIDS
* Metabolic or inherited liver disease (e.g., Wilson's, hemochromatosis, alpha-1-antitrypsin deficiency)
* Another disease involving bile ducts (e.g., primary biliary cholangitis, IgG4-related cholangitis, secondary sclerosing cholangitis)
* Evidence of cirrhosis on the last magnetic resonance cholangiopancreatography (within 6 months)
* Pregnancy or attempting to become pregnant or breastfeeding.
* History of liver transplantation, anticipated need for liver transplantation within 12- months from randomization, or a Model of End Stage Liver Disease (MELD) score of ≥15
* Active malignancy
* Active alcohol overuse (\>4 drinks per day for men, and \>2 drinks per day for women)
* Moderate-to-severe renal impairment with a calculated creatinine clearance of \< 45 mL/min
* Neutropenia (an absolute neutrophil count \< 0.5 x 109 cells/L)
* History of allergic reaction to vancomycin
* History of allergic reaction to amoxicillin or other beta-lactam antibiotics
* Any other conditions or abnormalities that, in the opinion of the investigator, may compromise the safety of the subject or interfere with the subject participating in or completing the study
* Total colectomy
Evaluation of a New Technique to Fill the Defect Generated After Conservative Surgery in Breast Cancer

The placement of a small silicone prosthesis in the partial defects generated by conservative breast cancer surgery improves the aesthetic result, compared to the usual surgical technique, in a safe and reproducible way and compatible with adjuvant treatments. It could also potentially improve the quality of life of patients

Conservative surgery in breast cancer is performed more than 50% of cases, however, aesthetic results are suboptimal, because reconstructive techniques are performed in less than 5% of them. Objective: To demonstrate that the placement of a silicone prosthesis in partial defects generated by breast cancer conservative surgery improves the aesthetic result, compared to the usual surgical technique, safely, reproducibly and compatible with adjuvant treatments.

Methodology: Prospective randomized clinical trial, controlled with blind evaluator. Inclusion criteria: Women with breast cancer candidates for conservative surgery. Intervention: In the cases the study technique will be carried out consisting in the filling of the defect with a silicone prosthesis of size adjusted to it (2-4cm). Controls: usual surgical procedure. Main result variable: aesthetic results (visual analog scale) according to the patient, surgeon and blind external evaluator. Secondary variables: surgical complications, local complications derived from adjuvant treatments, rate of local recurrence, rate of reintervention due to affected margins, behavior in mammographic follow-up, professional satisfaction and impact on quality of life.

Eligibility Criteria:
Inclusion Criteria:

- Women, over 18 years old, with breast cancer who attend breast pathology consultations at the Sant Pau Hospital in which conservative surgery is indicated.

Exclusion Criteria:

* Multicentric tumors
* Tumors larger than 5cm
* Locally advanced tumors (T4): Deep plane involvement or skin involvement
* Patients in stages IV (distance dissemination)
* Patients who need mastectomy
* Patients with disabilities or who do not understand the terms of the study or do not agree to participate in the study
The Efficacy of Paracetamol in Reducing Pain During Ophthalmological Examination for Retinopathy of Prematurity: a Prospective Randomised Trial

Retinopathy of prematurity (ROP) is one of the major morbidity among preterm infants. Although, local anesthetics reduce pain to some extent, eye examination still remains as a painful procedure. The investigators aimed to evaluate the effect of oral paracetamol combined with local anesthetics for pain relief during ophthalmological examination.


Eligibility Criteria:
Inclusion Criteria:

* gestational age below 32 weeks or birth weight below 1500 grams

Exclusion Criteria:

* congenital anomalies, necrotising enterocolitis, surgical problems
Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis

The purpose of this study is to assess the ability of once-daily (QD) treatment with dexlansoprazole modified release (MR) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).

This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily dexlansoprazole MR (30 mg and 60 mg) with that of placebo, in maintaining healing of EE.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or T-EE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy. Complete healing was assessed for change in LA Esophagitis Classification grades A, B, C, or D to healed (defined as anything less than the criterion for Grade A). The subject was counted as healed if endoscopy findings did not meet the Grade A criterion.

Exclusion Criteria:

* Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study.
* Use of antacids (except for study supplied) throughout the study.
* Use of drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
* Chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.
* Need for continuous anticoagulant therapy.
* Evidence of uncontrolled systemic disease.
* Subjects who have participated in either maintenance study (T-EE04-086 \[NCT00255164\] or T-EE04-087 \[NCT00255151\]).
* Subjects who, in the opinion of the investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.