cyrilzakka/clinical-trials huggingface dataset:
Microneedling With Topical Preparations in the Treatment of Atrophic Post-acne Scars

To examine the anti-scarring effect of topical glycolic acid 35% combined with microneedling against that of topical insulin combined with microneedling for post acne scars

Acne vulgaris (AV) is a common chronic inflammatory disease of skin that develops from sebaceous glands associated with hair follicles. Typically AV begins at puberty and may continue through adulthood affecting the comedogenic areas of face, back and chest .

One of the undesirable outcomes of acne is acne scars that are divided into two main types based on a loss (atrophic) or gain (hypertrophic) of collagen. Atrophic type is the most common type, further subdivided into three subtypes: icepick, boxcar and rolling scar .

Post acne scars occur in nearly 75% of patients with acne affecting both male and female equally . Acne scars impair quality of life and may be a risk factor for depression, suicide, low academic performance and unemployment .

There are different therapeutic modalities for atrophic acne scars including microneedling, chemical peeling, laser, filler, surgical procedures (punch excision, punch grafts) and fat transfer.

Microneedling is considered safe for all skin types. It is performed by dermapen or dermaroller to induce new collagen formation that remains for a few months after the procedure.

Microneedling enhances the effect of topical preparations when used combined with them due to increasing their absorption by creating small channels through the epidermis to the dermis .

It was reported that combination of glycolic acid (GA) with microneedling gave excellent results in treatment of post acne scars compared to microneedling alone.

Glycolic acid is an alpha hydroxy acid that decreases corneocytes cohesion leading to increasing keratinocytes turnover rate and faster desquamation .

It was found that glycolic acid increases dermal hyaluronic acid and collagen gene expression through increasing the secretion of IL6 .

the administration of topical human insulin was investigated for the treatment of atrophic post-acne scars and concluded that topical insulin following microneedling was associated with significant improvement.

Topical insulin induces collagen formation and neovascularization through synthesis of transforming growth factor (TGF b1) and vascular endothelial growth factor (VEGF).

Eligibility Criteria:
Inclusion Criteria:

* All types of facial atrophic acne scars
* Patients aged \>18 years
* Both sexes

Exclusion Criteria:

* Pregnancy and lactation
* Active acne or any active facial lesion
* History of keloid scar
* History of systemic diseases as DM or hypotension
* Bleeding and coagulation disorders
* Infection and immunosuppression
Pilot Trial: Comparing Buzzy to Intradermal Lidocaine for Peripheral IV Cannulation in Adults

IV placement is necessary for surgical procedures. Unfortunately, some patients say that placing an IV is painful. The investigators are conducting this study to evaluate two techniques that could make the placement of the IV more comfortable.

Currently, some medical providers administer the IV without any pain-relieving techniques. Some medical providers inject a numbing medication underneath the skin prior to the IV placement. This requires an additional needle stick. Some medical providers place a device called Buzzy® on a patient's arm prior to the IV placement. The Buzzy® device is the combination of an ice pack and a vibrator in the shape of a bumble bee. Literature shows that the Buzzy® device makes IV placement more comfortable for children, but there is minimal data in regard to whether it is helpful for adult patients.

The investigators are conducting this study to compare the effectiveness of the Buzzy® device with that of the injection of numbing medication underneath the skin for IV placement in adults. This device has been FDA approved for use.

Eligibility Criteria:
Inclusion Criteria:

1. Adults ages 18 to 99
2. Non-pregnant women and men
3. Adults that are able to consent
4. Patients requiring intravenous catheter insertion for their operation/procedure

Exclusion Criteria:

-
Long Term Physical Functional Limitations in Daily Living in SARS-CoV2 Infected Patients Hospitalized in the Acute Phase Then Requiring Rehabilitation

Infection with coronavirus SARS-CoV2 (COVID-19 disease) is unique with its speed of propagation, structural medical reorganizations and length of stay in intensive care needed, diversity of the affected population (in particular between young persons or fragile subjects), and impact on physical and mental health generated by confinement of populations.

Fatigue is a major component of COVID-19. Global muscular weakness is related to immobility, inflammation, corticosteroids treatment, hypoxemia due to pulmonary and/or cardiac infectious attacks and undernutrition suggests major physical functional repercussions. Thus, patients affected by COVID-19 with acute hospital management require sometimes complex rehabilitation management.

Retrospective studies on physical functional capacities in patients infected with SARS CoV1 showed long term physical activity limitations.

The aim of this study is to study factors associated with physical functional limitations in daily living in patients SARS-CoV2 infected and hospitalized in the acute phase then requiring rehabilitation.

Eligibility Criteria:
Inclusion criteria :

* patient infected with SARS-CoV2
* in-patient hospitalization in the acute phase because SARS-CoV2 infection
* patient requiring rehabilitation after SARS-CoV2 infection acute phase
* patient adult, aged more than 18 years old
* patient accepting to participate in the study

Exclusion criteria :

* patient with cognitive disorder (Folstein Mini-Mental State Examination less than 22 on 30 points)
38 Week Extension Study to CAIN457C2303

A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet's patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma

This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.

Pharmacogenomic study, prospective, multicenter. Individualized treatment based on EGFR mutations and level of BRCA1 expression in patients with advanced lung adenocarcinoma

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 years or more.
* Histologically confirmed diagnosis of non-small-cell lung carcinoma.(and indifferentiated and BAC histology).

  * Only patients with advanced disease, defined as stage IV or IIIB with/without pleural effusion, will be included.
  * Tumor sample available.
  * A measurable lesion, as defined by RECIST criteria.
  * Karnofsky score 60% or more (ECOG \< 2).
  * Patients should not have received previous treatment with chemotherapy or other agents for disseminated disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neoadjuvant treatment.
* Patients with cerebral disease are permitted, without any time limitations after holocranial irradiation or complementary antiedema treatment.
* Patients with hepatical, renal and hematology normality values.
* Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological samples of tumor and blood.
* Patients of childbearing age of either sex must use effective contraceptive methods (barrier methods or other birth control methods) before entering the study and while participating in the study.
* Patients must be available for clinical follow-up..

Exclusion Criteria:

* Patients who have received an investigational medicinal product in the 21 days before inclusion in the study or antiEGFR receptor agent.
* Severe comorbidity.
Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites.

This is an observational study evaluating the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic.

A total of 475 participants will be recruited, including 4 different cohorts: 1) cancer free patients, 2) patients with Oral Potentially Malignant Disease (OPMD), 3) patients with Oral Squamous Cell Carcinoma (OSCC), and 4) patients with OroPharyngeal Cancer (OPC). OSCC and OPC participants will be recruited from secondary care facilities, OPMD and cancer free participants will be recruited from primary care facilities.

Participants will complete health questionnaires and collect saliva samples using at home/ in clinic kits provided by Viome. The duration of study participation will be 1 clinic visit for cancer free participants, and up to 1 year for those with OSCC/OPC/OPMD.

Eligibility Criteria:
Inclusion Criteria

* Signed Informed Consent obtained
* 18 years and older
* At a high risk of developing oral or throat cancer based on clinician's discretion

Exclusion Criteria

* Pregnancy
* Use of fertility enhancing medications
Cycling and Treadmill With Dual Task for Parkinson's Disease Improvement

Motor impairment in lower extremities is common in individuals with Parkinson disease (PD). Development sensitive test for early motor deviations is important. Conventional walking test cannot induce the PD related motor impairments, such as freezing of gait. Therefore, finding a safe substitute test to induce PD related motor impairments is important.

Studies showed that working memory related dual task walking was a sensitive test for PD. However, the optimal cognitive test needs to be clarified. Studies also showed that the neuromuscular control mechanism of leg movements during cycling were similar to those during walking. Therefore, dual task cycling test is potential to be a safe and sensitive testing model.

Studies showed that exercise could improve cognitive function and induce brain plasticity. Dual task exercise training was shown to be more effective than single task exercise training for older people to prevent fall. Whether the added cognitive task could improve to detriment brain plasticity in PD should be investigated. Transcranial magnetic stimulation can evaluate the motor cortex plasticity on-invasively and can evaluate the exercise induced brain plasticity.

The purpose of this three-year project is to develop PD-sensitive. The purposes of the first year are to translate the dual task walking test to dual task cycling test, and to establish the reliability of the dual task cycling test.

The purposes of the second year are to compare the motor cortex plasticity induced by single task cycling versus dual task cycling and to compare the difference response between PD and healthy control people.

The purpose of the third year is to evaluate the effect of 8 week long term cycling training or treadmill training of individuals with PD on motor cortex plasticity, dual task performance, and ambulation ability.


Eligibility Criteria:
Health subjects:

Exclusion Criteria:

* Musculoskeletal injuries on legs.
* Osteoporosis.

PD subjects:

Inclusion Criteria:

- Clinical diagnosis of Parkinson disease.

Exclusion Criteria:

* Musculoskeletal injuries on legs
* Osteoporosis.
* Any peripheral or central nervous system injury or disease patients.
Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate for Very Early Preterm Tocolysifs

Objective: This trial is designed to compare between the effectiveness of nifedipine plus magnesium sulfate (MgSO4) and MgSO4 alone for tocolysis in women with threatened preterm labor.

Patient Population: The population will include pregnant women at gestational age between 28 and 31 weeks who are 18 years old or older and have signs of threatened preterm labor.

Study Design: This is a single-center, prospective, randomized controlled clinical trial. A total of 264 women pregnant between 28 and 31 weeks having threatened preterm labor will be enrolled and randomized into two parallel treatment arms. Patients in the group A will receive nifedipine plus MgSO4, while patients in group B will MgSO4 only.

Treatment: All patients will be randomized on the day of enrollment. Patients with threatened preterm labor will receive the respective tocolysis in each group. All patients will receive corticosteroids for lung maturity according to the local protocol.

Primary outcome: Number of women not delivered within 48 hours of starting tocolytic therapy.

Secondary outcomes: perinatal mortality, a composite of adverse neonatal outcomes, birth weight, days on ventilation support, length of admission in neonatal intensive care, prolongation of pregnancy more than 7 days, delivery after 37 weeks of gestation, number of days till delivery, maternal mortality, maternal infection, and harm to mother from intervention.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with threatened preterm labor defined as 3 or more uterine contractions in 30 minutes confirmed by cardiotocography.
* Gestational age from 28 week + 0 days to (inclusive) 31 weeks + 6 days.
* Women with singleton or multiple pregnancy.
* Women with preterm prelabor rupture of membranes (PROM) will be included if they have uterine contractions.

Exclusion Criteria:

* Contraindications for the use of either drugs, such as cardiac disease, hypotension, myasthenia gravis, or renal impairment.
* Contraindications for tocolysis, such as intrauterine demise, intrauterine infection, fetal distress, placental separation, or severe pre-eclampsia.
* Cervical dilatation \> 5 cm.
* Cervical length \> 30 mm by trans-vaginal ultrasound.
* Cervical cerclage.
Evaluation of 20% Betulinic Acid Ointment for Treatment of Dysplastic Nevi (Moderate to Severe Dysplasia)

The purpose of this study is to evaluate the safety and effectiveness of an experimental 20% betulinic acid ointment (BA ointment) as a treatment for dysplastic nevi with the potential to transform into melanoma.

Approximately 200 patients may be enrolled and screened in order to find twenty-eight (28) patients who qualify to be involved in this research at UIC.

Dysplastic melanocytic nevus (DMN) is a histopathologic term implying a disordered proliferation of melanocytes associated with discontinuous and variable cellular atypia. DMN is graded into mild, moderate, and severe based on standard histological criteria. DMN is considered to be a likely precursor for melanoma, and individuals with DMN often have multiple instances of it scattered over their trunk and extremities. For this study, only DMN where the dysplasia is either moderate or severe will be included.

Eligibility Criteria:
Inclusion Criteria:

* All races are eligible for entry into the Study.
* All patients must have been histologically documented (by a punch biopsy) for dysplastic nevi with moderate to severe dysplasia (DMN). A similar biopsy proven DMN that will serve as the control needs to be available.
* Patients must be healthy and active in normal pursuits of life and be able to provide informed written consent.
* Localized dermatological conditions like psoriasis or actinic keratosis will not be an exclusion criteria.
* Patients must be ambulatory with an ECOG status \< 2; they will not be hospitalized as part of the Study.
* All patients in this study will have, in addition to a normal clinical examination, a thorough skin examination. Whenever possible, periodic photographs of their lesions will be taken. Additional tests for all patients within 30 days of the initiation of topical application include urinalysis, a liver function test (LFT), and blood tests for complete blood count (CBC), BUN, and creatinine.

Exclusion Criteria:

* Women who are pregnant and/or nursing will be excluded. A pregnancy test will be performed on each pre-menopausal woman within two days of entry into the Study, and a negative pregnancy test must be recorded on the case report form prior to initiating use of the topical application.
* Patients who are being treated for other chronic debilitating diseases (cardiac, pulmonary, or any other organ specific diseases).
* Immuno-suppressed patients, either due to chemotherapy and radiation therapy or known immunodeficiency diseases (e.g., AIDS).
* Patients with other active malignancies within the past five years, excluding noninvasive skin or cervical carcinoma.
* Patients with any other serious medical or psychiatric illness that would prevent informed consent.
* Patients with extensive chronic skin diseases such as extensive psoriasis, atopic dermatitis, or xeroderma pigmentosa will be excluded from the Study.
Improving Mental Health in Diabetes: A Guided Self-Help Study

This study employs a Randomised Controlled Trial design to investigate whether a CBT-based guided self-help intervention can improve anxiety, depression, psychological well-being, quality of life, Diabetic self-care and adherence; as compared to controls. The study aims to recruit 42 individuals with Diabetes and mild to moderate anxiety or depression. Anxiety and depression are common in patients with Type 2 Diabetes, and has been shown to affect Diabetes control. Literature suggests that CBT can benefit individuals with Diabetes and comorbid mental ill-health, however little research has been done to date on the effect of guided self-help in this population. It is expected that this intervention will improve patient's mental health, as well as extend the limited knowledge-base on guided self-help in chronic illness.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with a diagnosis of Type 2 Diabetes with mild-moderate anxiety and/or depression (scoring 8 to 15 on the HADS scale) will be recruited, provided they do not meet any one of the exclusion criteria listed below. Patients will be able to provide written informed consent.

Exclusion Criteria:

* Individuals with a history of clinically diagnosed psychotic symptoms, schizophrenia or bipolar disorder.
* Participants with a known Learning Disability or severe visual impairment.
* Participants who cannot read or write
* Participants under 18 years of age or over age 75
* Long-term hospital inpatients
* Individuals with a diagnosis of Diabetes secondary to a major physical condition (consultation will be sought from medical professionals where appropriate on an individual basis)
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).


Eligibility Criteria:
Key Inclusion Criteria:

* Individuals with chronic HCV genotype 1 infection
* Documented as treatment experienced with a direct acting antiviral-containing regimen without achieving sustained viral response
* Absence of cirrhosis or presence of compensated cirrhosis
* Screening laboratory values within defined thresholds
* Must use specific contraceptive methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

* Co-infection with HIV or hepatitis B virus (HBV)
* Current or prior history of clinical hepatic decompensation
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
* Pregnant or a nursing female

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Clinical Performance of the Osia 3 Sound Processor Compared with the Osia 2 Sound Processor in Adult Osia Implant Users

This study aims to investigate the clinical performance of the Osia 3 Sound Processor in comparison to the Osia 2 Sound Processor in adults with mixed or conductive hearing loss or single-sided deafness implanted with an Osia implant. Participants will attend four study visits, where they will complete various hearing assessments using the Osia sound processors.


Eligibility Criteria:
Inclusion Criteria:

* Implanted with a Cochlear Osia Implant (OSI100 or OSI200)
* Conductive or mixed hearing loss in the implanted ear. Bone conduction threshold 4-frequency pure tone average (PTA4; mean of bone conduction thresholds at 0.5, 1, 2 and 4 kHz) ≤ 55 dB HL.

OR Single-Sided Deafness in the implanted ear. Air Conduction threshold 4-frequency pure tone average (PTA4; mean of air conduction thresholds at 0.5, 1, 2 and 3 kHz) ≤ 20 dB HL in the good ear.

* Aged 18 years or older, at time of consent.
* Minimum experience of 1 month with the Osia 2 Sound Processor.
* Fluent speaker in the language used to assess speech perception performance.
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Sensitivity to loud sounds.
* Ongoing infection at or around the sound processor area.
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
* Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).