cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of Protein Profiling of the Human Epidermal Cells After Ultraviolet Irradiation

The main focus of this pilot study is to construct a fairly complete protein profile of the epidermis. This will allow us to study how the epidermis responds to external stressors such as ultra-violet. We hypothesize that by using the cutting edge technology, proteomics, we will be able to construct a fairly complete profile of different epidermal cells (keratinocytes, epidermal nerve fibers (ENFs), melanocytes, Langerhans cell,...etc) of normal and ultraviolet (UV) irradiated skin.

We will investigate the changes of the epidermal cell proteome after UV irradiation to the forearms of healthy young male volunteers. Knowledge of specific molecular markers may provide knowledge of basic biological systems and possibly targeted therapy of inflammation.

By using combined proteomic methodologies we will be able to quantify protein changes at cytoplasmic and membrane protein levels of epidermal cells in normal vs. irradiated skins.

This study may allow us to obtain fairly comprehensive profile of membrane integrated and cytoplasmic proteins of epidermal cell populations which will facilitate our understand of biological responses to UV irradiation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Males age 18-30
* Caucasian
* No neurological disease

Exclusion Criteria:

* Use of any medication that affects skin
Assessment of Patient Satisfaction After Arthroplasty: A Comparative Study by Implant Type

The main objective of this study is to evaluate the benefit of personalized prostheses compared to conventional prostheses on patient satisfaction 24 months after total knee arthroplasty.

Prospective randomized monocentric prospective comparative study carried out as a single blind study on two parallel groups (standard implant or customized implant).

Secondary Objectives: Compare between groups :

* the functional outcome of the arthroplasty
* pain progression
* the evolution of the quality of life
* the conditions of the surgery (duration of surgery, length of hospitalization, blood loss)
* the frequency of adverse events related to arthroplasty

Eligibility Criteria:
Inclusion Criteria:

* Adult man or woman who has signed consent to participate in the study
* Patient with uni- or bilateral primary gonarthrosis
* For which an indication for total knee arthroplasty has been established

Exclusion Criteria:

* History of knee arthroplasty or osteotomy
* History of knee fracture
* Inflammatory rheumatic disease or any other progressive concomitant disease that may affect the patient's functional prognosis.
* Joint or extra-articular deformities of the lower limb of traumatic origin
* Neurological diseases, stroke sequelae
* Mental disability or any other reason that may hinder the understanding or strict application of the protocol
* Patient not affiliated to the French social security scheme
* Patient under legal protection, guardianship or trusteeship
* Patient already included in another therapeutic study protocol or having participated in another trial within the previous three months
* Arthroplasty actually performed
* Absence of per operative complications in bone (femoral or tibial bone), ligament (rupture or disinsertion of the patellar or quadricipital tendon) or nerve (lesion of the external popliteal sciatica).
Web-delivered Provider Intervention for Tobacco Control

This is a randomized control trial to determine the efficacy of a multi-modal intervention in improving smoking cessation processes of care and patient outcomes in community-based primary care practices. Our Overall Goal is to advance science related to the use and impact of the Internet in health services delivery, specifically smoking cessation, by targeting primary care clinical microsystems. A clinical microsystem is defined as the smallest functional healthcare unit. A clinical microsystem is not simply equivalent to a clinical team of doctors and nurses, but also the panel of patients cared for by the providers and the processes of care that are used.


Eligibility Criteria:
Inclusion Criteria:

* Community based primary care practices who have:

  * Internet access in office
  * Sees 4 - 5 smokers per week

Exclusion Criteria:

* Practices with more than five providers
Multi-Center Adolescent Clavicle Fracture Trial: Operative Vs. Non-Operative Treatment

Investigators from eight tertiary care, level 1 pediatric trauma centers have developed a protocol for the establishment of a formal, prospective multi-center adolescent clavicle registry, with designs for standardized radiographic assessment and the prospective collection of validated outcome measures and complications data, for all patients, ages 10-18, treated for clavicle shaft fractures, operatively and non-operatively. Eventually, the investigators would like to do comparative analysis for the operative and non-operative treatment arms, with additional sub-stratified analyses performed within these treatment arms by age and activity level. Among the primary goals of research projects stemming from the first arm of this registry, FACTS A, is to explore the hypothesis that non-operative treatment is associated with lower costs, greater safety, and equivalent or superior outcomes, compared with operative treatment, despite a national trend towards increasing surgical treatment. The second arm of the registry, FACTS B, will continue to investigate the same hypotheses, excluding cost outcomes, in patients only with completely displaced midshaft clavicle fractures.


Eligibility Criteria:
Inclusion Criteria:

* Aged 10-18
* Diagnosis of a primary diaphyseal clavicle fracture
* Fracture must be completely displaced
* Patient - BCH subjects must pursue follow-up at BCH main campus or Waltham must be 59 days or less from the primary fracture
* All study patients (across all sites) must agree to be contacted by a long-term follow-up coordinator based out of Boston Children's Hospital for long-term follow-up questions (out to the 2-year time point). This can/will be done via phone, mail, text message, and/or email.

Exclusion Criteria:

* Pathological fracture
* Previous ipsilateral fracture
* Unable to fill out outcome collection forms
* Refusal to participate
* Underlying neurologic or neurocognitive disorder that affects UE function
* Underlying metabolic bone disorder (e.g. osteogenesis imperfecta) that significantly alters normal bone healing
* Unable to project injury X-ray films if treated initially at an institution that is not a member of this register
Endoscopic Drainage of Collections After Pancreatic Surgery

The pancreatic surgery causing some pancreatic collections. And in a number of case, this surgery can require a surgical resumption, a percutaneous drainage or an endoscopic drainage.

The endoscopic care of the treatment of pancreatic collections post-surgery is not yet standardized.

After failure of the medical treatment, the drainage of collections by echo-endoscopy was described.

There are not much series on this specific subject. Only 2 series contain more than 20 patients with 31 patients for the most important.

The timing and the technical choice of the endoscopic treatment as well as the long-term follow-up are not clear.

The purpose of this study is to estimate the success and the complications of the endoscopic drainage by echo-endoscopy according to the techniques of drainage and the timing of the endoscopic treatment.

The not estimated long-term follow-up will be also considered.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patient having a pancreatic surgery complicated with a post-operative collection drained endoscopically

Exclusion Criteria:

* Contraindication surgery
Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

The investigators will be looking at the efficacy of the use of once daily use of low dose naltrexone (4.5mg) in subjects with symptomatic inflammatory bowel disease.

The investigators will compare the use of daily low dose naltrexone (LDN) (4.5 mg) compared with placebo in subjects that have symptomatic inflammatory bowel disease (IBD). Our subjects will be those with diagnosed with IBD and are symptomatic, defined by an inflammatory bowel disease questionnaire (IBDQ) score \< 170. The subjects will be randomly assigned either placebo or LDN. They will take the IBDQ prior to starting the trial, 6 weeks, 12 weeks and 6 months after starting the medication. Participants have to remain on their current IBD regimen throughout the trial and cannot make any changes within 4 weeks of starting the trial. The investigators will have a safety phone call at 6 weeks and a follow up letter at 12 weeks after starting the trial. The participants will be given a card to keep with them with a phone number and email address if any adverse effects arise.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic Crohn's disease or ulcerative colitis (defined as a response to the Inflammatory Bowel Disease Questionnaire less than 170)
* Confirmed Crohn's disease or ulcerative colitis through radiographic, endoscopic and/or histologic criteria
* On a stable dose of medication for IBD (i.e. no change in medication within 4 weeks of study enrollment)
* Age 18 or older

Exclusion Criteria:

* Patients on opioids or immodium within 7 days of starting the investigational therapy
* Women who are breastfeeding, pregnant, or plan on becoming pregnant within the next year
* Patients on Lomotil or opioid analgesics
* Patients already on low dose naltrexone
* Women of child bearing age not willing to use contraception or abstinence
* A history of the following diseases or procedures:

  * Acute hepatitis
  * Liver failure
  * Ileoanal anastomosis
  * Short bowel syndrome
  * Abnormal liver enzymes
Fertility and Pregnancy After Avelumab Treatment

Immune checkpoint inhibitors (ICIs), such as anti-PD-1/PD-L1 agents, initially evaluated in advanced non-curative pathologies, are now being evaluated in adjuvant or even neoadjuvant curative treatment conditions. This paradigm shift is leading to the treatment of young women, particularly in the context of gestational trophoblastic tumours. Given the potential autoimmune side-effects affecting endocrine functions, as well as their impact on maternal-foetal tolerance mechanisms, accurate assessment of post-ICT fertility is necessary. In the coming years, treatment with anti-PD-L1 (avelumab) could become a cornerstone of the therapeutic strategy for patients with gestational trophoblastic tumours.

However, these patients are often young and of childbearing age, so safety of use in terms of fertility and successful pregnancies is an essential factor in the widespread use of immunotherapy as a treatment option. Some studies have reported the possibility of conceiving after avelumab treatment, but no cohort has been reported. This study aims to explore fertility and the course of potential pregnancy in 50 patients treated with anti-PD-L1 (avelumab) over the last 5 years in several French centres.


Eligibility Criteria:
* Inclusion Criteria :

  * Patient aged over 18 years
  * Have received AVELUMAB treatment for GTT in the TROPHIMMUN or TROPHAMET trials, or have received AVELUMAB outside the trial for gestational trophoblastic tumour.
  * Did not object to participating in the study
* Exclusion Criteria :

  * Patient who has died
  * Patient who has had a hysterectomy
Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer

The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic squamous and nonsquamous non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed NSCLC (either nonsquamous or squamous) that is Stage IV (AJCC v8).
* No prior systemic treatment for the advanced/metastatic NSCLC
* Able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh tumor biopsy
* Measurable disease per RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least 3 months.
* Willingness to avoid pregnancy or fathering children.
* Adequate organ function as indicated by protocol-specified laboratory values. - Has been fully vaccinated against SARS-CoV-2 or is willing and able to be fully vaccinated against SARS-CoV-2 during the study by starting the vaccination process during screening.

Exclusion Criteria:

* Clinically significant cardiac disease within 6 months of start of study treatment.
* Any major surgery within 3 weeks of the first dose of study treatment.
* Thoracic radiation therapy of \> 30 Gy within 6 months of the first dose of study treatment.
* History of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may receive cisplatin, paclitaxel, or nab-paclitaxel.
* Untreated central nervous system metastases and/or carcinomatous meningitis.
* Evidence or history of interstitial lung disease or noninfectious pneumonitis that required systemic steroids.
* Active infection requiring systemic therapy or active tuberculosis. Note: If required by country or local regulations to be tested for COVID-19 during screening, a participant should be excluded if they have a positive test result for SARS CoV-2 infection until both the retesting result is negative and clinical recovery is obtained.
* Superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
* Has contraindications to chemotherapy agents used in the study.
* Has an active autoimmune disease that has required systemic treatment in past 2 years.
* Is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the first dose of study treatment.
* Has received a live vaccine within 30 days before the first dose of study treatment (and until 90 days after last dose of study drug).

Note: While based on approved SARS-CoV-2 vaccines available worldwide, many vaccines are not live (mRNA and adenovirus vaccines do not contain live virus), if a live vaccine against SARS-CoV-2 is the only available option, prior consultation with the medical monitor should be obtained.

• Has known active HBV or HCV (testing must be performed to determine eligibility)
Effectiveness of Manual and Instrumental Myofascial Release in Chronic Low Back Pain and the Posture of Practitioners CrossFit®

Background: Chronic low back pain (LBP) can lead to major functional disabilities and force people to take time off work, sports or leisure activities. Regular physical exercise is an important ally in reducing the risk factors for most diseases, and CrossFit® is one of the modalities that has been gaining momentum when choosing an exercise. However, the intensity recommended in training can collaborate with the development of musculoskeletal problems such as pain and postural changes, interfering with the development of the practice, with low back pain being one of the most common disorders in these practitioners, especially caused by mechanical stress. Considering that CrossFit® practitioners have already incorporated physical exercise into their routine, passive techniques such as myofascial release (ML) have been discussed as a form of treatment for LBP. For this reason, this study was designed to verify the efficacy of ML in the LBP of CrossFit® practitioners, comprising two techniques, one manual and one instrumental, and to see if the outcome of the LBP alters the posture of the spine.

This is a randomised controlled clinical that will be conducted in a CrossFit® box in the city of Goiânia-GO, Brazil. At least 51 people will take part who have been doing CrossFit® for at least 3 months, who have LBP, are aged between 18-59 and are not undergoing any other treatment for low back pain. There will be two experimental groups, one that will receive manual MR and the other, cupping therapy, as well as a control group that will not receive any technique. The sessions will take place twice a week for 8 weeks. The primary outcome will be low back pain intensity, assessed at baseline, weekly and after 8 weeks, and the secondary outcomes, which will be postural deviations, spinal mobility and history of musculoskeletal pain, assessed at baseline and at the end of 8 weeks. There will be no blinding between therapist and participants.

Discussion: This study will investigate whether MR is effective in relation to LBP, given that some results have already shown positive responses in acute conditions, while also verifying the repercussions on the postural aspect. The results could provide additional knowledge about the best technique to use and, having applicability to our outcomes, will favour and simplify treatment, helping professionals to make clinical decisions.


Eligibility Criteria:
Inclusion Criteria:

* men and women aged between 18 and 59 years;
* presence of low back pain for at least 12 weeks;
* have started regular CrossFit® activity at least 3 months ago.

Exclusion Criteria:

* perform other physical activity than CrossFit®;
* continuous use of painkillers;
* previous pathologies or spinal surgery;
* amputations;
* haematological disorders;
* fibromyalgia;
* hypersensitivity or skin lesions.
Oral Nutritional Supplementation in Hospital Patients

The study objective is to evaluate the benefits of Oral Nutritional Supplementation (ONS) plus Dietary Counseling (DC) in newly admitted hospital subjects with moderate or severe malnutrition.

Approximately 212 subjects (men and women) from multiple Institutions in India will participate in this study. Eligible subjects will be randomized into 2 treatment groups.

* Dietary Counseling only (n=106)
* Dietary Counseling + ONS (n=106)

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Recently admitted into hospital ≤36 hrs.
* Identified as having "moderate malnutrition" or "severe malnutrition".
* Anticipated length of hospital stay of at least 3 days.
* Life expectancy of ≥ 12 weeks
* Able to consume foods and beverages orally.
* Willing to abstain from nutritional supplements throughout the study period unless provided be study.

Exclusion Criteria:

* Alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, dysphagia, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances.
* Diabetes, burn injury covering greater than or equal to 15% of the body, advanced renal or hepatic disease, active malignancy.
* Ascites, pleural effusion, severe edema or dehydration.
* Severe edema.
* Medications/ supplements/substances that could profoundly modulate metabolism or weight
* Active tuberculosis, acute Hepatitis B or C, or HIV.
Clinical Trial Studying the Efficacy and Safety of IP2018 in Depressed, Erectile Dysfunction (ED) Patients

This is a Phase IIa, randomised, double-blind, placebo-controlled, 3-period, crossover study to assess two single oral dose levels of IP2018. It is planned to enrol 24 patients. Patients will take part in three treatment periods, in which they will be randomised to receive either a single dose of IP2018 or a single dose of placebo in each treatment period.


Eligibility Criteria:
Inclusion Criteria:

- Male patients with a diagnosis of mild to moderate depression and ED as determined from the Hamilton depression scale score of 7 to 23 and International Index of Erectile Function (IIEF-5) score of 12 to 18, respectively, with a body mass index of 18 to 32 kg/m2 (inclusive), of any ethnic origin.

Exclusion Criteria:

- Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal (GI), haematological, endocrinological, metabolic, neurological, psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of Investigator, may place the patient at unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion of drugs, or with the completion of treatment according to this protocol.
Neurophysiological Changes After Perturbation-based Training in Older Adults

This is an assessor-blinded neurophysiological study. Participants will be randomly assigned to perturbation-based training (PBT) or active control. Neurophysiological changes in the brain following PBT compared to control will be investigated.

A total of 88 participants will be randomly assigned to two groups receiving perturbation-based training (PBT) or active control. Written informed consent will be obtained from participants before baseline assessment. The study will be reported and conducted in line with the CONSORT statement. Participants will be recruited via convenient sampling in the local community. Both groups will receive two sessions of treadmill walking at their comfortable speed. Perturbations will be induced during the treadmill walking only for the PBT group. As informed from previous literature, two sessions of PBT could have improved postural stability for up to 1.5 years. Between-group differences in behavioral and MRI findings will be examined before and after training to identify training-induced changes in postural stability and structures and functional connectivities in the brain. Retention of the changes in the postural stability will be assessed four months after the training period. Incidents of falls will be followed up for 12 months after training.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 60 years old
* Community-dwelling
* Right-handed
* Able to communicate effectively in Cantonese or Mandarin
* Able to walk independently on level ground for ≥ 30 minutes
* Abbreviated Mental Test (Hong Kong version) score ≥ 6

Exclusion Criteria:

* Metal implants (e.g. pacemaker, artificial cochlea)
* Uncorrected vision or hearing impairment
* Osteoporosis
* Hip or knee replacement within the last year
* Musculoskeletal, cardiovascular, mental, or neurological disorders (such as Parkinson's disease) which can affect MRI examination, balance control, or exercise participation.