cyrilzakka/clinical-trials huggingface dataset:
Self-Administered Intralesional Injections for Acne

The goal of this clinical trial is to test the safety of intralesional injections of triamcinolone self-administered into acne lesions via an injection assistance device. The main question\[s\] it aims to answer are:

* is use of the injection assistance device safe?
* is delivery of triamcinolone to acne lesions via the injection assistance device efficacious?

Participants will self-inject low dose triamcinolone into acne lesions and track lesion response via photos and survey for 14 days following injection.

This is an open-label, prospective, single-arm study. Approximately 150 subjects will be enrolled at approximately 3 study sites.

All subjects will receive standard-of-care intralesional injection with triamcinolone using an Injection Assistance Device (i.e., for self-administered intralesional injections) at Visit 1 (Day 1). Subjects will then submit photos via secure photographic app for asynchronous follow up on Day 2 (24-hours post-injection), Day 3 (48-hours post-injection), Day 4 (72-hours post-injection), Day 7, and Day 14.

Efficacy assessments (target lesion assessments) will be conducted remotely by the Investigator at time of each photo submission. Subjects will conduct lesion pain assessments and satisfaction assessments at the time of each remote check-in. Participants will be invited to also have additional photography captured by the study team at the study site or at a location as per participants' convenience.

Eligibility Criteria:
Inclusion Criteria:

1. Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative UPT at Baseline.
2. Diagnosed with facial acne vulgaris.
3. At least one (1) identifiable inflammatory lesion that, in the opinion of the investigator, is clinically indicated for standard-of-care intralesional injection(s) of triamcinolone.
4. Owner of smartphone with capacity for front-facing photography and app download from Apple App Store or Google Play.
5. Able to follow study instructions and likely to comply with virtual follow-up requirements.
6. In good general health as determined by medical history at the time of screening (Investigator discretion).
7. Sign the IRB-approved ICF (including HIPAA authorization) prior to any study-related procedures being performed.

Exclusion Criteria:

1. Female subjects who are pregnant or breast-feeding.
2. Known hypersensitivity or previous allergic reaction to any constituent of triamcinolone injection.
3. Active cutaneous viral infection in any treatment area at Baseline.
4. Have concomitant skin disease or infection (other than acne) or presence of skin comorbidities in the areas of skin where study device will be used.
5. History of poor cooperation or unreliability (Investigator discretion).
6. Subjects who are investigational site staff members or family members of such employees.
7. Exposure to any other investigational device within 30 days prior to Visit 1.
Silicone Tube for the Surgical Treatment of Glaucoma

The biocompatible silicone tube miniature drainage device is a small, non-valved implant to shunt aqueous humor underneath the conjunctiva to control the intraocular pressure. Efficacy and safety were evaluated with a minimum follow-up of 12 months.

Patients were examined postoperatively at 1 day, 1 week, 1, 3, 6, 12, 18, 24 months or more frequent when required. IOP, BCVA and slit lamp biomicroscopy were observed at every visit. History of all medication details and postoperative complications were recorded. One-way analysis of variance (ANOVA) with repeated measures was used to analyze the other differences over time in IOP and BCVA. Nonparametric K-related samples test was used to analyze the difference of medications number at different time points. Success rates were evaluated using Kaplan-Meyer survival analysis curves.

Eligibility Criteria:
Inclusion Criteria:Eligible patients were at least 18 years of age and presented with medically uncontrolled POAG requiring incisional surgery for IOP (intraocular pressure) reduction.

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Exclusion Criteria:Exclusion criteria included narrow angles, normal tension glaucoma, previous eye surgery (except cataract surgery), neovascular glaucoma, uveitis, any ocular abnormality that would preclude accurate IOP assessment, and inability to comply with the follow-up program or unwillingness to participate in this study.

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Comparison Between Abduction External Rotation Brace and Arm Sling After Arthroscopic Rotator Cuff

Comparison between Abduction External Rotation Brace and Arm Sling after Arthroscopic Rotator Cuff : A Randomized Controlled Trial Comparison of primary outcome : range of motion (at pre-operative , post-operative) , pain score , shoulder functional score

Comparison between Abduction External Rotation Brace and Arm Sling after Arthroscopic Rotator Cuff : A Randomized Controlled Trial Comparison of primary outcome : range of motion (at pre-operative , post-operative) , pain score , shoulder functional score There are gaps of knowledge which sling/brace are the best for post operative arthroscopic rotator cuff repair Because patient who underwent arthroscopic rotator cuff repair have to wear these sling/brace for at least 1 month after operation , the better one could reduce post-operative shoulder stiffness , decrease pain and improve functional shoulder score

Eligibility Criteria:
Inclusion Criteria:

* Patient with full thickness rotator cuff tear
* Plan for arthroscopic rotator cuff repair

Exclusion Criteria:

* Revision cuff surgery
* Unable to answer question
* Previous shoulder surgery
* Full thickness subscapularis tear
Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms

The purpose of this study is to assess the safety and performance of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* Patient from 18 to 85 years old
* A symptomatic unruptured saccular intracranial aneurysm with a neck ≥4mm (or a dome to neck ratio \<2) and a parent vessel diameter between 2.5 to 5.0 mm (inclusive) in both the anterior and posterior circulation of the brain, that is amenable to stent-assisted coiling. "Symptomatic" is defined as any neurological symptoms attributed to the target aneurysm.
* Life expectancy \>6 months
* Signed Informed Consent

Exclusion Criteria:

* Aneurysm with branches from the aneurysm base
* Rapidly growing aneurysm
* Daughter aneurysm
* Aneurysm with partial or complex calcifications
* Females who are nursing, pregnant or intend to become pregnant during the study. Females of child-bearing potential must have a urinary pregnancy test within 7 days of enrollment and use an approved highly efficient contraceptive method during the study
* Multiple untreated cerebral aneurysms at study entry
* Recent history of stroke, TIA, subarachnoid hemorrhage, intracranial hemorrhage, or major surgery within one month of enrollment
* Previous brain surgery or irradiation of the target treatment territory that would, in the opinion of the investigator, interfere with the treatment of the target aneurysm
* Admission platelet \<150,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy
* Underlying unstable Coronary Artery Disease, cardiac insufficiency or Myocardial Infarction
* Contraindication to angiography such as elevated creatinine or known allergy to angiographic contrast
* Contraindication to CT and/or MRI scans
* Known allergy to the metal component of the Penumbra Liberty Stent System
* Evidence of active infection (WBC \>10x109/L)
* Any medical conditions that will not allow the necessary follow-up for this study (e.g., pre-existing neurological or psychiatric diseases)
* Current substance-abuse/illicit drug use
* Angiographic evidence of an arterial stenosis proximal to the target lesion that could prevent device deployment
* Contraindications to study medications (heparin, aspirin, clopidogrel, and radiographic contrasts)
* Patients unable to sign Informed Consent due to the emergency conditions of the intervention
Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients

Intervention therapy study of moringa oliefera extract on the degree of activity of rheumatoid arthritis patients. The research subjects were patients with rheumatoid arthritis-intervention with moringa oliefera for 30 days.

Rheumatoid arthritis is a progressive autoimmune disease. Delay in therapy and delay in remission will result in disability. This study is a randomized clinical trial using a new drug for rheumatoid arthritis, moringa oliefera. The choice of moringa oliefera was due to the ability of moringa oliefera in anti-inflammatory and immunosuppressant terms. This drug has also been proven in experimental studies on rheumatoid arthritis animals. This study with 30 research samples divided into two groups, containing 15 samples each for the treatment group and 15 for the control group. The treatment group was given Moringa oleifera extract of 40.50 mg/KGBW/day, while the control group was given a placebo for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA criteria according to the ACR / EULAR 2010
* Visual analog score of more than three.

Exclusion Criteria:

* Pregnancy
* Using Methylprednisolone\> 8 mg per day
* Using NSAIDs
* Chronic Kidney Disease
* Diabetes Mellitus
* Heart Failure
* Lever disease
Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain

The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients with osteoarthritis knee pain.

Exclusion Criteria:

* Serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
* Previous exposure to duloxetine.
Effect of Simulation on Emotional Expression and Perceived Family Burden of Caregivers

The aim of this study is to determine the effect of Auditory Hallucination Based Voice Hearing Simulation on the emotional expression and perceived family burden of caregivers of individuals diagnosed with schizophrenia.

Objective: The aim of this study is to determine the effect of Auditory Hallucination Based Voice Hearing Simulation on the emotional expression and perceived family burden of caregivers of individuals diagnosed with schizophrenia.

Method: This study was designed in a pre-test - post-test, randomized controlled design. The study was conducted with 20 caregivers in the intervention group and 20 caregivers of individuals diagnosed with schizophrenia in the control group. Data were collected between March 2023 and October 2023 using the Emotional Expression Scale and Perceived Family Burden Scale. Auditory Hallucination Based Voice Hearing Simulation was applied to the intervention group. This sound recording is three-dimensional. While the audio recording is played to the caregivers; Users were asked to complete two tasks, each lasting 10 minutes. The tasks were carried out under the guidance prepared by the researchers. In the control group, the routine practices of the clinic continued.

Eligibility Criteria:
Inclusion Criteria:

* Having been living with an individual diagnosed with schizophrenia for at least one year.
* Being primarily responsible for the care of the individual diagnosed with schizophrenia,
* Being between the ages of 18-65,
* Being literate,
* Speaking Turkish,
* Volunteering to participate in the study.

Exclusion Criteria:

* Having a physical disability to perform the assigned tasks,
* Having any health problem related to hearing ability,
* Having any mental illness,
* Having received 2 or more points from the General Health Questionnaire-12.
Bleeding and Blood Transfusion in MVR

To identify the best approach for mitral valve replacement to decrease risk of bleeding and restrict blood transfusion and its complication.

Mitral valve disease is the most common form of the valvular heart disorders including mitral regurgitation and mitral stenosis. Surgical treatment includes repair and replacement with different approaches as conventional median sternotomy or minimally invasive approaches.

Since minimally invasive mitral valve surgery (MMVS) was first described in the mid-to-late 1990s by pioneer surgeons Alain Carpentier and Randolph Chitwood, the techniques have evolved to include mini-thoracotomy, port-access thoracoscopic, partial sternotomy, and robotic. Right lateral mini-thoracotomy has become the standard approach for mitral valve surgery in many centers. These approaches may result in less surgical trauma, blood transfusions, and pain, thereby leading to a shorter hospital stay and faster return to daily activities. A reduction in postoperative hemorrhage and transfusion requirements have been suggested as a potential advantage of minimally invasive valve surgery. This benefit is important given the significant morbidity and mortality associated with transfusions and re-exploration for bleeding. Observational studies suggested that patients undergoing MMVS required fewer units of pRBCs transfused per patient and patients were at lower risk of transfusion. RCTs did not reach statistical significance. So, more studies were required to reach a definite conclusion.

Through this study our aim is to evaluate postoperative bleeding and needs for blood transfusion in conventional median sternotomy mitral valve replacement in comparison to minimally invasive approach.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing mitral valve replacement through minimally invasive or median sternotomy at Assiut Cardiothoracic surgery department.

Exclusion Criteria:

* Patients refused to be enrolled in research. Emergency, redo procedures, active infectious endocarditis, and combined surgery (valve surgery and coronary artery bypass graft).
Catheter Ablation in Congenital Heart Disease: French National Prospective Registry

Arrhythmias represent one of the main late complications in patients with congenital heart disease. Atrial arrhythmias are associated with a significant morbidity and are the first cause of urgent hospitalization, and sudden death from ventricular arrhythmias is a leading cause of death in this population.

The exponential increase of the number of patients with congenital heart disease and the improvement of ablative technologies are associated with a significant increase of the number of catheter ablation procedures.

Most of available studies are retrospective or include a limited number of patients.

The aim of this study is to assess the efficacy of catheter ablation in patients with congenital heart disease through a national prospective registry. Secondary objectives are i) to identify factors associated with catheter ablation efficacy in different cardiac defects, ii) to describe complications associated with catheter ablation in this specific population, and iii) to assess the impact of catheter ablation on quality of life of patients with congenital heart disease.


Eligibility Criteria:
Inclusion Criteria:

* All patients with congenital heart disease referred for catheter ablation

Exclusion Criteria:

* Absence of patient's consent
* Patient under guardianship or curatorship
* Pregnant woman
Clinical Evaluation of the RAVI-Guide

Hypothesis: The RAVI-Guide provides superior patient acceptability to the conventional lid speculum during intravitreal injections

Aims: To compare patient acceptance and procedural complication rates of the RAVI-Guide with those of the conventional lid speculum and caliper approach


Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 years or older who undergo intravitreal injection for clinical indications.

Exclusion Criteria:

* Patients under the age of 18 years
* Patients unable to give informed consent
* Disorders that preclude the ability to judge pain or discomfort associated with intravitreal injection
* Disorders that preclude the ability to assess for complications of intravitreal injection
* Inability to assess the landmarks by which localization of intravitreal injection sites is determined, such as obscured corneal limbus
* Inability to communicate directly to the physician and immediately after the procedure the level of pain or discomfort
Ibuprofen and Neural Mobilization Treatment in Carpal Tunnel Syndrome.

In the present investigation, the pain reduction effect of median nerve neural mobilization and oral ibuprofen treatments will be compared to those produced by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

The present randomized clinical trial will perform a comparison of the pain reduction effects produced by median nerve neural mobilization and oral ibuprofen treatments to the total lack of treatment in subjects diagnosed with carpal tunnel syndrome. Effects over the functionality of the affected upper limb will be evaluated and compared. Subjects will be invited to participate and randomly allocated to 3 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 and Tinel signs.
* The presence of carpal tunnel syndrome signs and symptoms.

Exclusion Criteria:

* The lack to meet inclusion criterions,
* The presence of cognitive impairment,
* Tumors
* Cancer
* Upper limb surgery or trauma
* Pregnancy
* Deformities of the (affected) upper limb,
* Recent skin injuries or infections (in the affected upper limb)
* Autoimmune inflammatory conditions or flu type symptoms
* Allergy (or contraindication) to non steroidal anti inflammatory drugs (NSAID)
* Participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).
Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis and Crohn's Disease

The purpose of the study is to evaluate the PK, safety and tolerability of PF-06687234 and \[124I\]IB-PF-06687234 (simultaneously given) in subjects with moderate to severe Ulcerative Colitis or Crohn's Disease. The study used PET-CT scan imaging to assess the distribution of PF-06687234 and \[124I\]IB-PF-06687234 over 24 and 72 hours in colon (inflamed and non-inflamed), plasma, colon, liver, spleen, kidney and small intestine.


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female subjects of non-child bearing potential, 18 years to 75 years of age inclusive at the time of informed consent
* Only women of non-child bearing potential
* Diagnosis of active UC (histologic) or CD prior to study entry for a minimum of 4 months
* Subjects with moderate to severe, active UC as defined by Mayo endoscopic index of at least 2; or subjects with moderate to severe, active CD as defined by SES-CD score of at least 7.

Exclusion Criteria:

* Clinically significant/unstable clinical conditions (eg. cancer hematological, endocrine etc)
* Active enteric infections
* Other forms of colitis such as infectious colitis etc
A Collection of Case Studies in Infants With UCD to Evaluate Infant Growth and the Safety of a New Medical Food for UCD

Original study: Study aims to enroll 3-5 children with confirmed Urinary Cycle Disorder (UCD). Subjects meeting the inclusion and exclusion criteria are included during the baseline visit. All subjects will receive the investigational product for a period of 16 weeks. At baseline, 2, 4, 8, 12 and 16 weeks the study parameters are assessed.

The study amendment aims to collect case studies retrospectively of children who have used UCD Anamix Infant for at least 16 weeks, in countries where UCD Anamix Infant is already available on the market. It is aimed to collect the same study parameters of the original study at preferably the same timepoints.


Eligibility Criteria:
Inclusion criteria:

Prospective study:

* Male and female infants diagnosed with UCD, aged from birth to 30 days of age
* Parent / primary caregiver is able to give informed consent
* Infants who will receive and will be able to take study medical food as part (40-70%) of their protein requirements in the day

Retrospective study:

* Male and female term infants diagnosed with UCD, that started UCD Anamix Infant when aged from birth to 30 days of age.
* Parent / primary caregiver is able to give informed consent
* Infants who received UCD Anamix Infant as part of their protein requirements (40-70%) in the day for at least 16 weeks.

Exclusion Criteria:

* Infants \< 5lb 8oz (\< 2.5 kg) at birth
* Infants \<34 weeks of gestation and using a special premature formula at study start
* Infants with severe concurrent illness or major congenital malformations, except conditions consequent to urea cycle disorder
* Infants with suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus)
* Infants with evidence of significant cardiac, respiratory, haematological, gastrointestinal, or other systemic diseases
* Infants currently taking cytotoxic drugs
* Investigator's uncertainty about the willingness or ability of the parent to comply with the protocol requirements
* Participation in any other study involving investigational products concomitantly or prior to entry into the study
* An infant of any personnel connected with the study
* Infants whose parent / primary caregiver is younger than the legal age of consent
Colon Investigation - Factors Determining Choice of Procedure

Registration of patients referred for colon investigation by barium enema, CT colonography and colonoscopy in two hospitals and one radiology centre in Telemark, Norway, for a period of minimum six months. Indications, delay and results of procedure will be recorded.Hypothesis: Choice of procedure for colon investigation is not based solely on clinical indication, but factors like delay, patient preference, lack of knowledge about the the procedures by the referring physician may have a decisive influence. The study will also analyse the correlation between patients symptoms, clinical findings and laboratory results and major pathology findings by colon investigation. Further, delay from patient´s first symptoms to finally diagnosis by colon investigation will also be registered and analysed.

see extensive protocol in Norwegian

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to colon investigation
* Patients must be 18 years or older

Exclusion Criteria:

* Patients not able to give a written consent