cyrilzakka/clinical-trials huggingface dataset:
Treatment of Acne Scars With Fractional CO2 Laser Versus Radio-frequency Microneedling

The study is a prospective, randomized, controlled, intra-person split-face trial with blinded evaluations. The objective is to compare efficacy and adverse effects of ablative fractional CO2 laser resurfacing versus radio-frequency microneedling for treatment of atrophic acne scars in the facial area. Two comparable areas with acne scars on each side of the face are treated. One area will be treated with fractional CO2 laser and the other area with radio-frequency microneedling.

Outcome measures will be assessed by blinded investigators and included subjects at baseline before treatment and at follow-up visits 2-4 days and 1 and 3 months post-treatment. On-site assessment and OCT will be performed at the time of the visits. OCT scans will be offered to the subjects and are optional. Clinical photos are used for documentation.

15 participants will be recruited. The participants will be recruited to enter the trial in the clinic by investigators at the Department of Dermatology, Bispebjerg Hospital, and must meet the inclusion criteria (at least 18 years of age, acne scars in the facial area, comparable atrophic acne scars on each side of the face, fitzpatrick skintype I-III) to be eligible to enter the study. No personal remuneration will be awarded the investigators. None of the collaborators have any personal economic interest in the study. Participants will not receive remuneration.

All treatments are performed at the Department of Bispebjerg Hospital and patients are covered by the Hospital's patient insurance.

The declaration of Helsinki will be respected as well as the standards of good clinical research. Respect for privacy as well as physically and mentally integrity of the participants will be maintained. The study will be performed in accordance with Danish Health care authorities.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Acne scars in the facial area (predominantly rolling scars)
* Comparable atrophic acne scars on each side of the face
* Fitzpatrick skintype I-III

Exclusion Criteria:

* Pregnant or nursing women
* Treatment with isotretinoin within the last 6 months
* Current treatment with NSAID and prednisolone
* Known tendencies to produce hypertrophic scars or keloids
* Infection in the treatment area
* Considered unable to follow the study protocol, e.g. alcohol dependence syndrome
Hepatocellular Carcinoma Liver Organoids

The goal of this interventional study is to create hepatocellular carcinoma organoids from liver bioptic samples of individuals with hepatocellular carcinoma. The main questions it aims to answer are:

* the feasibility of hepatocellular carcinoma organoids integrated with host gut microbiota and peripheral blood mononuclear cells
* the molecular pattern of the organoid tumor microenvironment
* the in vitro therapeutic response of hepatocellular carcinoma organoids


Eligibility Criteria:
Inclusion Criteria:

* Ability to express informed consent
* Patients ≥ 18 years of age
* Radiological diagnosis of hepatocellular carcinoma (HCC)

Exclusion Criteria:

* Patients \<18 years of age
* Contraindications for liver biopsy: ascites, platelet count \<50.000, International Normalized Ratio (INR) \>1.7
* Active viral infection
* Refusal to give informed consent for the study
Comfort and Tolerance of Surface Neuro Muscular Electrical Stimulation in Parkinson's Disease.

The purpose of this study is to investigate issues relating to comfort and tolerance to surface neuro muscular electrical stimulation in a parkinson disease population.

The comfort and tolerance of Parkinson Disease (PD) patients to surface neuro muscular electrical stimulation (NMES) will be investigated.

Six muscle sites will be tested sensory, motor and pain thresholds recorded. Furthermore pain tolerance will be recorded as the level at which the stimulus is unbearable.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of idiopathic PD (UK, PD Brain Bank Criteria)
* A Hoehn and Yahr stage of 2 - 4
* Exhibiting Freezing of Gait or another gait abnormalityin the ON or OFF state.
* An ability to mobilise independently for the purpose of research when in the 'off' state
* An ability to walk unaided for 10 meters.

Exclusion Criteria:

* A serious cognitive impairment (MMSE\<24)
* Pregnant or currently involved in another clinical trial.
* Uncontrolled heart problems
* Pacemakers
* On opioid or neuropathic pain medication
SentiMag® Intraoperative Comparison in Breast Cancer

The purpose of this pivotal study is to provide prospective evidence that the SentiMag®/SiennaXP® is safe and non-inferior to the current standard of care for lymph node localization in patients with breast cancer as part of a sentinel lymph node biopsy (SLNB) procedure and to summarize measures of product safety and performance.

This is a pivotal, prospective, open label, multicenter, paired comparison of the SentiMag® and SiennaXP® magnetic sentinel node localization system with the standard of care (radioisotope with blue dye) for lymph node localization in the detection of lymph nodes in patients with breast cancer undergoing a sentinel lymph node biopsy. The trial is designed to provide powered evidence that the lymph node detection rate of the SentiMag® and SiennaXP® system is non-inferior to the standard of care in patients with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of primary breast cancer or subjects with pure ductal carcinoma in situ (DCIS).
* Subjects scheduled for surgical intervention, with a sentinel lymph node biopsy procedure being a part of the surgical plan.
* Subjects aged 18 years or more at the time of consent.
* Subjects with an ECOG (Eastern Cooperative Oncology Group) performance status of Grade 0 - 2.
* Subject has a clinical negative node status (i.e. T0-3, N0, M0).

Exclusion Criteria:

* The subject is pregnant or lactating.
* The subject has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes.
* The subject has a known hypersensitivity to Isosulfan Blue Dye.
* The subject has participated in another investigational drug study within 30 days of scheduled surgery.
* Subject has had either a) previous axilla surgery, b) reduction mammoplasty, or c) lymphatic function that is impaired in the surgeon's judgment.
* Subject has had preoperative radiation therapy to the affected breast or axilla.
* Subject has received a Feraheme® (ferumoxytol) Injection within the past 6 months.
* Subject has intolerance or hypersensitivity to iron or dextran compounds or to SiennaXP.
* Subject has an iron overload disease.
* Subject has pacemaker or other implantable device in the chest wall.
Comparison of 5G Mobile Stroke Unit to Standard Management by Emergency Medical Services For Acute Ischemic Stroke Treatment

While Mobile Stroke Units (MSUs) are considered as a relatively new model for acute stroke treatment, 5G Mobile Stroke Units (5G MSUs) have already come into service for stroke treatment in some parts of China. Since limited evidence has been found to suggest their advantages over conventional Emergency Medical Services (EMS), well-conducted clinical studies are required to further assess their effectiveness and safety. This study aims to evaluate whether 5G MSUs outperform standard management (SM) by EMS in terms of functional outcomes of acute ischemic stroke (AIS) patients within 4.5 hours after symptom onset in urban and rural areas of China.

This Multicenter, Prospective, Open-label, Blinded Endpoint , Week-wise Randomized, Controlled trial will allocate patients to one of two study arms for the analyses：one group will receive pre-hospital diagnosis and treatment in a 5G MSU followed by transfer to a Comprehensive Stroke Center (CSC) Emergency Department (ED) for further management; the other group will undergo standard pre-hospital triage with subsequent transport by EMS to a CSC ED for evaluation and treatment. The main criteria to enroll a patient into the study include: a.History and physical/neurological examination consistent with acute stroke；b.Age≥18；c.Last seen normal within 4hr 30 min of symptom onset；d.Pre-stroke modified Rankin scale ≤3 (Being able to ambulate)；e.No Recombinant tissue Plasminogen Activator（rt-PA）/Tenecteplase（TNK）exclusions per guidelines, prior to CT scan or baseline labs; f. Informed consent obtained from patient (if competent) or legal representative. The primary outcome was the distribution of modified Rankin Scale (mRS) scores (a disability score ranging from 0, no neurological deficits, to 6, death) at 3 months.

We hypothesize that the 5G MSU pathway, compared to EMS, can enable earlier evaluation and treatment of AIS patients within 4.5 hours of onset, thereby improving functional outcomes three months after stroke while ensuring safety.The successful completion of this project will provide data on important outcomes and costs associated with the use of 5G MSU vs SM in China that will help determine the value of integrating 5G MSUs into the pre-hospital environment in this country.

Eligibility Criteria:
Inclusion Criteria:

1. History and physical/neurological examination consistent with acute stroke.
2. Age≥18.
3. Last seen normal within 4hr 30 min of symptom onset.
4. Pre-stroke modified Rankin scale ≤3（Being able to ambulate）.
5. No rt-PA/TNK exclusions per guidelines, prior to CT scan or baseline labs.
6. Informed consent obtained from patient (if competent) or legal representative.

Exclusion Criteria:

1. Malignant or other severe primary disease with life expectancy \<1 year.
2. Participation in other interventional randomized clinical trials within 3 months before enrollment.
Study of Vorinostat (MK-0683) With Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL), or Mantle Cell Lymphoma (MCL) Participants (MK-0683-103)

The purpose of this study is to evaluate the safety, tolerability, and efficacy of vorinostat (MK-0683) in participants with relapsed and/or refractory follicular lymphoma. The exploratory purpose of this study is to evaluate efficacy of MK-0683 in participants with relapsed/refractory non-FL indolent B-NHL or relapsed/refractory MCL. The primary hypothesis is that MK-0683 will show efficacy in relapsed/refractory FL patients as measured by the Overall Response Rate.


Eligibility Criteria:
Inclusion Criteria:

* Participant has an histopathologically confirmed follicular lymphoma (FL), or other indolent B-cell non-Hodgkin's lymphoma (B-NHL) or mantle cell lymphoma (MCL)

  * Only relapsed/refractory FL can be included outside Japan
* Participant has at least one measurable lesion by computerized tomography (CT) scan which is defined by Cheson's 1999 criteria
* Participant has received at least 1 but up to 4 prior chemotherapeutic regimens, the most recent therapy must have failed to induce a partial response, or there must be recurrence in case of the most recent therapy has shown complete response, or there must be relapse in case of the most recent therapy has shown partial response
* Life expectancy of \>4 months
* Participant must have adequate organ and marrow function
* Women of child bearing potential must be negative for pregnancy and agree to use effective contraceptive measures until 30 days after the last dose of MK-0683.
* Men must agree to use effective contraceptive measures until 6 months after the last dose of MK-0683

Exclusion Criteria:

* Participant has undergone allogenic transplant treatment or autologous stem cell transplant within 6 months
* Participant with other active malignancies or central neurological infiltration with lymphoma
* Participant with severe hepatic insufficiency
* Participant with history of allergic reactions attributed to any component of MK-0683
* Participant is known to be human immunodeficiency virus (HIV) antibody-, hepatitis B virus antigen- or hepatitis C virus antibody-positive
* Participant has undergone prior/concomitant treatment with MK-0683 or other histone deacetylase (HDAC) inhibitors
Persistence of Oral Tolerance to Peanut

ITN049AD (LEAP-On) Study is a continuation of the ITN032AD LEAP Study (NCT00329784).

Peanut Allergy, a recognized public health concern, is a common and potentially life-threatening food allergy for which there is no treatment. ITN032AD (LEAP) Study evaluated whether early exposure to peanut promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema. ITN049AD (LEAP-On) Study will evaluate persistent tolerance to peanut by assessing the effect of twelve months of cessation of peanut consumption in LEAP Study participants who consumed peanut and those who avoided peanut over the previous five years.

This is a two-sample comparison employing all available study participants in both arms of the LEAP (NCT00329784) study at visit 72. After obtaining informed consent, LEAP participants who are evaluable for peanut allergy at age 60 months (V60) will be enrolled into this study, the LEAP-On (NCT01366846) Study. All LEAP-On participants will avoid peanut for an additional 12 months regardless of their previous allocation to the LEAP Study consumption arm (Group A) or the LEAP Study avoidance arm (Group B).

At V72, after 12 months of this new intervention, all participants will have skin prick testing (SPT), specific IgE and a repeat oral challenge to peanut to determine the frequency of peanut allergy in both groups. The LEAP Study decision table will be used to determine the presence of peanut allergy. Briefly, peanut allergy will be based on the presence of a positive oral peanut challenge with objective signs of allergy. Tolerance will be established on the basis of a negative oral peanut challenge (tolerating 5 g of peanut protein in the absence of symptoms). For participants who do not have an oral challenge or an oral challenge at V72 with a determinate outcome, the following criteria will be used to determine their outcome at V72:

* If the participant is tolerant and has an IgE \> 0.1 and/or SPT \> 0 mm at V60, the participant will be considered non-evaluable and will not be included in the analysis.
* For all other participants, the V60 outcome will be applied to the V72 outcome (last observation carried forward).

Predictive values of peanut-specific IgE and/or SPT will not be used in the LEAP-On study because participants in the peanut consumption arm in the LEAP study are tolerating peanuts despite having high IgE and/or SPT.

Eligibility Criteria:
Inclusion Criteria:

* All LEAP Study participants who are evaluable for peanut allergy at year 5 by LEAP (ClinicalTrials.gov ID NCT00329784) Study criteria.
* Parent or guardian willing to provide informed consent.

Exclusion Criteria:

* Unable or unwilling to comply with study intervention and procedures.
* Participation in other food allergy intervention trials.
Comparison of Resilience Between ADHD and Controls.

To explore if resilience serves as a mediator between adverse life events and emotional and behavioral problems, and compare the difference of resilience and its mediating effects between children and adolescents with and without ADHD.


Eligibility Criteria:
Inclusion Criteria:

* ADHD; Control without ADHD

Exclusion Criteria:

* ASD, other major physical and psychiatric diseases
Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery

The purpose of this study is to determine whether intraoperative goal-directed fluid management (with goal = cardiac stroke volume maximization) based on respiratory-induced pulse pressure variation monitoring may improve outcome after intrabdominal surgery

Recent studies strongly suggest that intraoperative oesophageal doppler guided fluid management may improve outcome after intrabdominal surgery. In these studies, however, the number of patients was often small, and management in control groups as well as postoperative complications were usually not precisely defined. In addition, widespread use of oesophageal doppler cannot be advocated in routine surgery, and the strategy necessitates repeated volume loading. This may lead to unnecessary intravenous fluids which may be deleterious, and intraoperative fluid restriction has also been shown to improve clinical outcome. In this context, indices reflecting the hemodynamic changes during mechanical ventilation (the so-called "dynamic indices", and more specifically the respiratory-induced pulse pressure variation) have been shown to accurately predict fluid responsiveness in mechanically ventilated patients. Automated and continuous calculation of pulse pressure variation variation from standard peripheral (typically radial) arterial line has recently been validated. This study was thus designed to determine whether intraoperative goal-directed fluid management (with goal = cardiac stroke volume maximization) based on pulse pressure variation monitoring would improve outcome after intrabdominal surgery.

Eligibility Criteria:
Inclusion Criteria:

* major elective intrabdominal surgery

Exclusion Criteria:

* arrhythmia
* hepatectomy
* associated thoracic surgery
* laparoscopy
* pregnancy
* allergy to colloid solution or anesthesia protocol
* arterial catheter not possible
The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (\<350 ng/dL)after 6 weeks of continuous dosing.

Study will require 7 visits, which includes 2 overnight stays in a clinic. One visit is an eye exam. Blood samples are required at all visits including sampling every hour for a 24 hour time period during the 2 overnight stays. A six month extension study will be available for all subjects completing the 6-week study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males between the ages of 18 and 65 years of age exhibiting morning testosterone ≤350 ng/dL.
* All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
* Ability to complete the study in compliance with the protocol
* Ability to understand and provide written informed consent
* Agreement to use a condom, and with a fertile female partner, another form of contraception.
* Agreement to provide a semen sample in the clinic

Exclusion Criteria:

* Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3 months prior to study
* Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
* Use of Clomid in the past year or during the study
* Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study.
* A hematocrit ≥51 % or a hemoglobin ≥17 g/dL
* Clinically significant abnormal findings on screening examination
* Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication
* Known hypersensitivity to Clomid
* Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study
* Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary)
* History of breast cancer
* History of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA \>3.6
* History of known hyperprolactinemia with or without a tumor
* Chronic use of medications use such as glucocorticoids
* Chronic use of narcotics
* Subjects known to be positive for HIV
* Subjects with end stage renal disease
* Subjects with cystic fibrosis (mutation of the CFTR gene)
* Subjects unable to provide a semen sample in the clinic
* Subject has a BMI \>42 kg/m2
Multiple Sclerosis in the Elderly: Epidemiology, Clinical and MRI Characteristics

Little is known about old MS patients. In a previous work, systematic search in Bordeaux, Strasbourg and Dijon university hospital regional MS center databases European Database for Multiple Sclerosis (EDMUS) retrieved 2% of 75 years old or older Multiple Sclerosis (MS) patients in the 3 databases. Data analysis showed that MS may switch off in the very old patients with mild progression and very few relapses. The project is to continue this preliminary work and extend it with a systematic study of MS in the elderly.

The scientific aims: To add new insights into long lasting MS natural history in the growing population of elderly patients with MS.

75 to 77 years old MS patients whose disease began at 65 years old or earlier will be retrieved from the "Observatoire français de la sclérose en plaques" (OFSEP) which includes more than 50 000 MS patients in France. Accuracy of these patients' data from 65 to 75 years old will be thereafter checked and completed in 3 French MS centers: Lyon, Rennes and Bordeaux, participating to this database directly from the patients' clinical files. From these 3 MS centers around 150 MS patients from 75 to 77 years old are expected to be analysed on site.

The data wich will be retrieved for these patients are: irreversible disability status scale progression, relapses, Magnetic Resonance Imaging (MRI) data, CSF data, Lublin classification of type of MS, McDonald 2005 and 2010 criteria, date and age at beginning of progression, characteristics and modality of relapses and clinical impairment at the beginning of the disease, treatments used, treatment failures and side effects, co morbidity, Barthel index, EuroQol-5D (EQ-5D), cognitive impairment (SDMT test), social life data and socio economic data. To the investigator's knowledge this will be the first systematic description of very old MS patients with data on long term natural history of MS and characteristics in this population of elderly MS patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with McDonald 2001, 2005 or 2010 criteria of multiple sclerosis 75 to 77 years old MS patients at the time of inclusion
* Patients whose beginning of MS was before 65 years old or 65 years old
* Patients who signed OFSEP 's consent

Exclusion Criteria:

* Patients whose clinical data cannot be entered or for whom too much clinical data are missing
* Alive patients older than 77 years or younger than 75 years the day of the inclusion in the study
* Patients died before 65 years old