cyrilzakka/clinical-trials huggingface dataset:
Open-Label Test of the HM242 Medical Devices to Evaluate Safety and Local Tolerability

It is the first clinical study aimed at assessing the safety and tolerability of HM242-Solution and HM242-Gel after their application under occlusion on intact skin. The HM242-Solution is intended for chronic wounds (e.g. pressure, venous leg and diabetic foot ulcers). The HM242-Solution should be used for physical rinsing and cleansing and subsequent decolonization of the wound prior to treatment with hydrogels and dressings. The HM242-Gel is a hydrogel for wound bed preparation to support the healing of the skin due to cleansing, moistening and subsequent decolonization and the coating of the wound.

The study will be conducted in outpatient manner, adult patients who are healthy and has an intact skin.

This is an prospective, open label, monocentric study. No comparative control group is planned as no other preventing infection solution is commercially available at this time.

The objective of this study is to assess the local tolerability and safety of HM242-Solution and HM242-Gel after their application under occlusion on intact skin.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy male or female subjects aged ≥ 18 years and ≤ 65 years.
* Healthy skin on the upper arms
* Skin type visually assessed from pale white to light brown
* Females with childbearing potential must have a negative urine pregnancy test at baseline and must agree to use a highly effective method of contraception for the duration of the clinical investigation.
* Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial prior to any trial-related activity and that all information has been understood

Exclusion Criteria:

* Breastfeeding or pregnant women
* Extremely tanned skin that may interfere with the tolerability assessment based on Investigator judgment
* Subjects with known or suspected allergies or skin hypersensitivity (e.g. acute dermatitis)
* Subjects with known or suspected allergies or hypersensitivity to any of the components of the Investigational Medical Devices
* Any illness or circumstance that could affect the trial purpose in the opinion of the investigator (e.g. intensive UV exposure)
* Dermatologic diseases or skin conditions (e.g. tattoos, multiple birth marks in the test area) that might interfere with the evaluation of test site reaction
* Within 3 weeks prior to Day 1 and during the entire trial: Any systemic or topical medication or therapy likely to interfere with the trial purposes: e.g. immune-modulating or immunosuppressive therapy (e.g. corticosteroids, cytotoxics, cyclosporine or radiotherapy).
* Within 7 days prior to Day 1 and during the entire trial: any topical dermatological agents applied on the upper arms (drugs or medical device), except usual skin care preparations and skin cleansing preparations like anionic tensides, cleansing soaps ointments, oils, enzymes, etc. (not allowed on test areas during the trial)
* During the entire trial: exposure to sunlight that could lead to sunburns or photo sensibilization reactions
Brief Admission Skane: Replacing General Admission for Individuals With Self-harm and Acute Risk of Suicide

The purpose of the study is to test a standardized version of brief admission (BA) through randomized controlled trial (RCT). The main objective is to evaluate if BA can serve as a crisis management model for individuals with recurrent self-harm, including suicide attempts and at least three symptoms of Borderline Personality disorder. Participants will be allocated to BA + Treatment as Usual (TAU) or TAU.

When individuals with recurrent self-harm and suicidal behaviour seek acute admission to hospital due to a crisis and associated increased suicidal ideation, recommendations for clinical care are still conflicting. The risk for iatrogenic effects of inpatient care are considerable, and long hospital admissions without a clear treatment structure may predict decompensation in functioning. This has resulted in a clinical practice of avoiding admission for individuals diagnosed with Borderline Personality Disorder (BPD).

Brief admission (BA) as an intervention has a longstanding history in the delivery of mental health services in the Netherlands. The core elements of brief admission were determined through consultation with Dutch researchers, interviews with individuals with experience, Dutch clinicians familiar with Brief Admission, and local guidelines from hospitals familiar with implementing this crisis management intervention. Core elements of the intervention were standardized into a protocol, and an educational manual was developed to train clinicians involved in the trial. An objectively rated fidelity measure was developed in order to ensure adherence.

Eligibility Criteria:
Inclusion Criteria:

* Current episodes of self-harm and/or recurrent suicidality.
* Fulfilling at least three criteria for borderline personality disorder.
* Admitted to psychiatric hospital for acute care for at least 7 days or presenting to the psychiatric emergency department at least 3 times during the last six months.

Exclusion Criteria:

* No regular contact with outpatient psychiatric services.
* Homelessness. Housing crises are outside the scope of this RCT.
* Medical disorder from other organs that significantly contributes to inclusion criteria (e.g. if self-harm only occurs during episodes of hypoglycemia in a diabetic patient).
Prevalence of Age Related Macular Degeneration (ARMD) in Parkinson's Patients and Assesment of the Role of L-DOPA

Age related macular degeneration (ARMD) is a major and irreversible cause of blindness among the elderly. The sub-retinal space, located between the retinal pigmentary epithelium (RPE) and the external segments of the retinal photoreceptors, plays a crucial role in this pathology. A recent epidemiologic study in the US, has shown that Parkinson patients treated with L-DOPA, developed only later an ARMD when compared to the untreated patients.

The L-Dopa is an endogenous ligand of the GPR43 receptor (G protein-coupled receptors), located on the RPE's cell's apical pole.

This receptor, via several intracellular mechanisms, regulates the cell's exosomal and endosomal pathways: it would appear that the L-DOPA, by stimulating this receptor, decreases significantly the RPE's exosome release.

The contents of the exosomes is still uncertain, however in addition to their signalization role, it seems they transport pro-inflammatory components, possibly helping the cellular recruitment due to the mononuclear phagocytic systems, particularly toxic for the photoreceptors.

The aim of this study is to estimate the prevalence of ARMD in a sample of Parkinson's Patients followed at Fondation Ophtalmologique Adolphe de Rothschild and to compared it to the prevalence of ARMD of the general population.

Furthermore the study aims to explore a possible causal link between L-DOPA treatment and ARMD.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged of 50 years old and more
* Parkinson's disease

Exclusion Criteria:

* Patient under a measure of legal protection
Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders

This is an open-label whole-body PET/CT study for investigating the value of 68Ga NEB PET imaging in the diagnosis and evaluation of lymphatic disorders including lymphedema, lymphangioma, lymphangioleiomyomatosis, plastic bronchitis, lymphadenopathy caused by rheumatoid arthritis, etc.

No fasting, hydration or other specific preparation was requested on the day of imaging.

Patients for lymphatic drainage disorders imaging underwent whole-body PET/CT acquisitions 20-40 min after subcutaneously injected into first and second interdigital spaces of both feet or hands of 74-111 MBq (2-3 mCi) 68Ga-NEB with each bed position lasted for 2 min.

A MIM workstation was used for post-processing. The visual method was used to evaluate the lymphatic system, including the morphology and the distribution of the lymphatic system. Semiquantitative methods were applied for image analysis.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to provide a written informed consent; Males and females, ≥18 years old； Diagnostic CT or MRI suggesting a diagnosis of lymphatic system lesion(s). In suspicion of lymphedema, lymphangioma, lymphangioleiomyomatosis, plastic bronchitis, lymphadenopathy caused by rheumatoid arthritis, etc.

Exclusion Criteria:

* Females planning to bear a child recently or with childbearing potential; Known severe allergy or hypersensitivity to IV radiographic contrast； Inability to lie still for the entire imaging time because of cough, pain, etc. Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.

Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.
Postoperative Analgesic Requirements for the ProSeal Laryngeal Mask Airway Versus the Tracheal Tube in Females Undergoing Gynecological Laparoscopic Surgery

The ProSeal laryngeal mask airway is a relatively new airway device with a modified cuff to increase the seal and a drain tube to provide a channel for regurgitated fluid, prevention of gastric insufflation and insertion of a gastric tube. In the following randomized prospective double-blind trial, we test the hypothesis that the postoperative analgesic requirements is higher for the ProSeal laryngeal mask airway than the tracheal tube.


Eligibility Criteria:
Inclusion Criteria:

* Female
* ASA I-II
* Age 18-75
* Elective laparoscopic surgery

Exclusion Criteria:

* Known or predicted difficult airway
* Oropharyngeal pathology
* Mouth opening \< 3.0 cm
* A body mass index \> 35 kg m-2
* Increased risk of aspiration
* Inability to communicate or understand the visual analogue scale
* Analgesics within 24 hours of surgery
Phase I Study of QLS1103 in Subjects With Advanced Solid Tumors

This study is a phase I, dose escalation and dose expansion study of QLS1103, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS1103 in subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
* 2. Aged ≥18 years old;
* 3. Histologically or cytologically confirmed advanced or recurrent or metastatic solid tumor;
* 4. Failure of adequate standard treatment, or no effective standard treatment;
* 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
* 6. Life expectancy ≥12 weeks;

Exclusion Criteria:

* 1. Subjects received systemic anticancer therapy within 4 weeks prior to the first dose;
* 2. Subjects received experimental medication or therapy within 4 weeks prior to the first dose;
* 3. Subjects received major surgery within 4 weeks prior to the first dose;
* 4. Persistent toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade \>1 severity that is related to prior therapy;
* 5. Cardiovascular and cerebrovascular diseases with clinical significance;
* 6. Active gastrointestinal disease or other conditions that significantly interfere with drug absorption.
Achieving Tuberculosis (TB) Control In Zambia

To achieve TB control, innovative case finding interventions are needed that will reach the broader affected population including those that do not access the health facilities. Systematic community case finding with highly sensitive screening and diagnostic tools are needed. At the facility level, the index of suspicion for TB by health care workers needs to be raised to ensure that all those that need TB screening are appropriately screened.

The purpose of this study is to initiate sustained, active health facility and community-based case finding interventions to achieve improved TB case detection in high burden settings (Zambia) and contribute to TB control.

The interventions are expected to increase the impact of Xpert on TB case finding, thus increase TB case detection through scaling up of a combination of community level and facility level TB case finding interventions. The study will generate evidence on the added value of using Chest X-ray (CXR) screening at community level, whilst also comparing the performance of CXR with computer assisted diagnosis (CAD) and C-reactive protein (CRP) and symptoms as screening tools in terms sensitivity, specificity and cost effectiveness. Symptom screen alone has been shown to be suboptimal for screening as it misses a significant percentage of TB due to atypical presentation of TB in HIV-infected populations.

Eligibility Criteria:
Inclusion Criteria:

-

Program Implementation:

Inclusion criteria:

* Any adult or child with TB symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats)
* Ability to produce sputum
* Verbal consent of parent or guardian if \< 18 years old

Operations Research:

Inclusion criteria

* Adults (18 years and older)
* TB symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats)
* Ability to provide a sputum sample
* Willing to provide written informed consent
* Willing to undergo full clinical evaluation
* Willing to undergo a CXR
The Effect of High Intensity Interval Training on Cardiovascular Fitness in People With Progressive Multiple Sclerosis.

This is a pilot trial to explore the cardiovascular of eight weeks of twice weekly high intensity interval training in people with progressive multiple sclerosis. A control group of people with progressive multiple sclerosis will undergo continuous moderate intensity exercise, twice weekly for 8 weeks.

This is a pilot trial to explore the cardiovascular of eight weeks of twice weekly high intensity interval training in people with progressive multiple sclerosis. A control group of people with progressive multiple sclerosis will undergo continuous moderate intensity exercise, twice weekly for 8 weeks.

The training program will entail 6x1.5 minute intervals working at 80-95% heart rate max on a cycle ergometer. Each interval will be interspersed with 1.5 minutes of working rest at a light resistance of the participant's choosing.

The continuous moderate intensity exercise program will entail 20 minutes on a cycle ergometer working at 60-70% heart rate max.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a progressive form of MS
* Aged 18 years or older
* Known to members of staff of the MS service NHS Ayrshire \& Arran
* Ability to attend Douglas Grant Rehabilitation centre twice a week for eight weeks
* EDSS 4-6.0
* Able to cycle on ergometer

Exclusion Criteria:

* A relapse of symptoms requiring treatment within the past three months.
* A respiratory condition that would be exacerbated by high intensity exercise including but not limited to: chronic obstructive pulmonary disorder, uncontrolled or poorly controlled asthma.
* Uncontrolled high pressure at screening (\>190/100 mmHg)
* Cognitive impairment affecting ability to understand instructions as noted in patient's notes.
* Currently engaging in another research trial for their MS or that may affect their physiological or cardiovascular outcomes
* Weighing more than 110 kg (weight limit of ergometer)
* Any pathology or medical intervention that would preclude high intensity exercise, maximal exertion testing or could attenuate the cardiovascular effect of exercise including but not limited to: unstable angina; diabetes; peripheral vascular disease or intermittent claudication; having a pace maker or medicine pump; surgical clips; having another neurological condition other than MS; and pregnancy. To be established from patient's notes and at screening session.
* A serious cardiovascular event in the past year including but not limited to: transient ischaemic attack, cerebrovascular event and myocardial infarction.
* Taking any of the following medication: beta blockers; vasodilators; ACE inhibitors; diuretics or any other medication that could cause exercise induced hypotension; hypoglycaemic insulin; metformin or other oral insulin medicine.
Comparison of Cross Pin Configurations in Supracondylar Humerus Fracture Treatment: 2 Pins Versus 3 Pins

The objective of this prospective randomized controlled trial is to evaluate and compare the outcome of the 2wire vs 3 wire crossed pin configurations in the management of supracondylar humeral fractures in children.

Fortyfive children with supracondylar humeral fractures were randomly divided into two groups. One group was treated with 2 crossed pins and the other group with 3 crossed pins. The mean age was 6.04±2.49 (1-12).. The follow-up period was 5 years, with no patients lost to follow up.

Intervention: Twentytwo patients were managed by 2 crossed and 23 by 3 crossed pin method. All surgeries were performed by the same surgeon.

Main Outcome Measurements: Postoperative stability, ulnar nerve injury, range of motions, and pin tract infections were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria was children with closed extension Type III of supracondylar fracture of humerus.

Exclusion Criteria:

* Patients with Type I and Type II injuries, flexion type injuries, open fractures and patients above the age of 12 years were excluded from the study.
Parcopa Versus Carbidopa-levodopa in a Single Dose Cross-over Comparison Study

To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.

This is a study to compare orally dissolving levodopa (Parcopa) to the conventional immediate release oral levodopa. This is a single-dose, double-blind, placebo controlled crossover trial in participants with Parkinson disease.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between the age of 31 and 80 -Diagnosis of idiopathic Parkinson's disease for at least three years duration
* Patients requiring levodopa for their PD
* Good subjective response to levodopa
* Fluctuating symptoms defined by wearing off phenomenon, any dyskinesia, and/or dose failures
* A UPDRS -off- motor score of at least 25
* Subjects willing to give informed consent
* Subjects who are able and willing to comply with study procedures
* If female of child-bearing potential, will use one of the approved birth control measures:

  1. Hormonal contraceptives
  2. Spermicidal and barrier
  3. Intrauterine device
  4. Partner sterility

Exclusion Criteria:

* Subjects with evidence of significant dementia
* Subjects with significant oral lesions
* History of unstable cardiac disease including angina or congestive heart failure within 3 months prior to study entry
* History of clinically significant renal disease including renal insufficiency of sufficient degree to require adjunctive treatment or dietary restrictions
* History of clinically significant hepatic disease, including previously documented cirrhosis or hepatic insufficiency or jaundice within 3 months prior to study entry.
* Subjects with poor response to levodopa
* Women who are pregnant, breast-feeding, or planning to become pregnant during this study are excluded from participation due to unknown effects of the study drug on the fetus.
The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial

To explore the optimal urethral coverage in hypospadias repair by comparing the success rate of both covering techniques: Dartos fascia versus Tunica Vaginalis flap.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 6 months.
* Distal, mid-shaft penile hypospadias.

Exclusion Criteria:

* Glanular hypospadias.
* Penoscrotal, Scrotal \& Perineal hypospadias.
* Recurrent cases.
Pilot Study of App-delivered Sleep Coaching Among Cancer Survivors and Their Partners

The proposed study will test the feasibility and acceptability of enrolling and retaining cancer survivors and their bedroom partners in a study evaluating digitally delivered behavioral sleep interventions.

Poor sleep is a common issue among cancer survivors that can persist for years and has been linked to increased symptoms (e.g., depression, fatigue), worse quality of life, and worse clinical outcomes like cancer progression and mortality. Partners of cancer survivors also experience poor sleep, but current interventions typically focus on survivors, leaving partners underrepresented. The proposed study will test the feasibility and acceptability of enrolling and retaining cancer survivors and their bedroom partners in a study evaluating digitally delivered behavioral sleep interventions.

Eligibility Criteria:
Cancer Survivor eligibility criteria:

Inclusion Criteria:

1. Diagnosed with any cancer,
2. Completed curative treatment six months to five years before enrolling (excepting ongoing adjuvant endocrine therapy),
3. Score 8 to 14 on the Insomnia Severity Index (ISI)
4. Have a consistent bedroom partner (i.e., sleep in the same bedroom 4 or more nights per week).

Bedroom partner eligibility criteria:

1) No cancer within the past five years

Both survivors and bedroom partners:

Inclusion:

1. Age \> or =18 years,
2. Able to speak and read English,
3. Able to provide informed consent,

   Exclusion:
4. No changes in type or dose of prescription sleep medications in the past three months,
5. Not engaged in behavioral sleep treatment for six months prior to enrollment,
6. Not planning to travel across 3 time zones or more during the eight intervention weeks or for the two weeks leading up to study assessments,
7. Not pregnant at enrollment or planning to become pregnant during the study,
8. No diagnosed or suspected psychiatric or medical condition that could interfere with participation,
9. No commitments that would interfere with regular night time sleep patterns (e.g., shift work),
10. No known untreated non-insomnia sleep disorders (e.g., sleep apnea, restless legs syndrome, hypersomnia, circadian rhythm sleep-wake disorder).

Enrolled participants will be allowed to remain in the study even if the other member of their dyad withdraws.