cyrilzakka/clinical-trials huggingface dataset:
NMF-CsA-Dupi Trial

The goal of this study is to investigate whether stratification of children with atopic dermatitis on the NMF biomarkers results in an improvement of effectiveness and efficiency in the use of systemic treatment (ciclosporin and dupilumab) in moderate-to-severe atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents, aged 2-18 years, with moderate-to-severe atopic dermatitis (diagnosed according to the UK working party criteria)
* Patient and parents/guardians able to participate in the study and willing to give written informed consent
* EASI (Eczema Area Severity Index) ≥ 6 at screening and baseline (corresponding with moderate-to-severe disease)
* IGA (Investigator Global Assessment) ≥ 3 at screening and baseline (corresponding with moderate-to-severe disease)

Exclusion Criteria:

* Children under the age of 2 years and patients older than 18 years
* Contraindication for ciclosporin
* Contraindication for dupilumab
* Patient (or one of the parents/guardians) not willing to be randomized
* Children with a history of any known primary immunodeficiency disorder
* Children with a history of cancer
* EASI \< 6 at screening or baseline
* IGA \< 3 at screening or baseline
Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients

Because of their anti-Xa and ease of administration activity, the Low molecular weight heparin represent an attractive alternative to the unfractionated heparin. Several clinical trials have demonstrated that Low molecular weight heparin was more effective than Unfractionated heparin without increasing bleeding complications. Enoxaparin has been the most studied. Its use is recommended.

Demonstrate that Enoxa® is comparable to that of Lovenox® in the anti-Xa activity action.

Single-center randomized controlled trial, single-blind, including patient with an acute coronary syndrome confirmed, to measure the anti-Xa activity between H0 and H4.the study was done on two groups ; ENOXA® group : In this case the patient is given an injection of enoxaparin ( ENOXA® ; UNIMED Laboratories) intravenously. Curative dose (100 IU/10 kg).

Control group ( LOVENOX ® ):

In this case the patient receives LOVENOX intravenous injection curative dose of 100 kg IU/10 .

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 year old
* With an acute coronary syndrome confirmed

Exclusion Criteria:

* Age less than 18 years
* Persistent ST segment elevation
* Contre indication of enoxaparin and heparin in general.
* Patient participating in another study,
* Pregnant or nursing women
* patients taking an anticoagulant in the last three months,
* Patients with coagulopathy
Photodynamic Treatment of Actinic Keratoses With Different Light Doses

Aim of the study: To evaluate clinical effectiveness of two different light doses when treating actinic keratoses with photodynamic therapy with 20% 5-aminolevulinic acid.

To determine and compare clinical and histological effectiveness of different (70 J/cm2 ir 100 J/cm2) light doses when treating actinic keratoses with photodynamic therapy.

To determine pain intensity during photodynamic therapy with visual analogue scale and factors influencing pain during the procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject older than 50 years.
2. Subject has to read Patient Information Sheet and read and sign the Informed Consent form prior to any study related procedure.
3. AK with the largest diameter ≤3 cm (measuring the longest axis).
4. 2 or more AK with symmetrical distribution on the face or scalp.
5. Clinically and histologically confirmed AK of grade I or II.
6. Subject must be willing and capable of cooperating to the extent and degree required by the protocol.
7. Patient is not the subject of the administrative or legal judicial proceeding.
8. Subject has social health security required by laws of health care institutions.

Exclusion Criteria:

1. Patients with more than 5 AK in the planned treatment area.
2. A recurrent AK: AK that has been previously treated in the study area.
3. Very hyperkeratotic, grade 3 (on a 0-3 scale) AK lesions among the target lesions.
4. AK located on the nose.
5. Other skin lesions (diseases) in the tumor study area.
6. Subject with known hereditary basal cell carcinoma syndromes (Gorlin-Goltz, Basex-Dupre-Christol et al.).
7. Subject with a history of cutaneous photosensitization or porphyria or Xeroderma pigmentosum, hypersensitivity to porphyrins, or photodermatosis.
8. Subject who had received photosensitizing drugs 30 days before study start.
9. Subjects who had received immunomodulatory or immunosuppressive therapies, including systemic and topical steroids, imiquimod or solaraze, interferon and acitretin 6 months prior to study treatment initiation.
10. Subject who had participated in another investigational drug or device research study within 30 days of enrolment.
11. Subject had received in the study area laser resurfacing, chemical peels, topical application fluorouracil or other drugs for the treatment of AKs within 2 months before study entry.
12. Subject with known hypersensitivity to 5-aminolevulinc acid, a similar compound or excipients of the cream.
13. Subject with known status after organ transplantation.
Screening and Therapeutic Monitoring of Multiple Myeloma by MALDI-TOF MS Analysis

To provide a comprehensive MALDI-TOF mass spectrometry method for detecting, characterizing, and quantifying M-protein, and to track M-protein in a very sensitive and specific manner during patient treatment, providing a more precise test for diagnosing disease and monitoring patient response to treatment.

M-protein is a serum biomarker directly related to clonal plasma cell load in Multiple myeloma (MM) patients and can be used as a diagnostic marker to make out disease and a quantitative marker to track disease progression and response to treatment. Identification, typing and quantification of M-proteins are useful for initial diagnosis of disease, risk stratification and monitoring of response to treatment. Although the determination of M-protein can be used as an auxiliary diagnosis of multiple myeloma, the early diagnosis and risk assessment of MM still lack convenient and effective tools for large-scale screening. In recent years, the use of matter-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) for proteomic analysis of complex biological mixtures has attracted extensive attention, and has become one of the most promising methods for the detection of m proteins. In this study, we screened the population by MALDI mass spectrometry in order to detect low level circulating M-protein by a faster and more sensitive method.

Eligibility Criteria:
Inclusion Criteria:(1) Inclusion criteria for cases: Serum samples from related people diagnosed with multiple myeloma were included in MALDI-TOF-MS analysis by serum protein electrophoresis (SPEP), serum immunofixation electrophoresis (IFE), Ig isotype detection and other methods. (2) Inclusion criteria of the controls were as follows: individuals in good health without obvious disease and with normal physical examination report; Avoid people who have not suffered from major chronic diseases in recent years, such as hypertension, diabetes, chronic kidney disease, etc; controls were appropriately selected that matched cases for age and sex.

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Exclusion Criteria: samples with incomplete sample information and untraceable source; Samples whose sample volume is insufficient for testing; Samples that do not meet the requirements for sample collection and storage

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Calcium + Vitamin D Supplementation for Low Bone Mass in Adolescent Idiopathic Scoliosis (AIS)

The purpose of this study is to determine whether Calcium and Vit D supplementation is effective for improving low bone mass in Girls with Adolescent Idiopathic Scoliosis (AIS).

Adolescent Idiopathic Scoliosis (AIS) is a prevalent condition mainly affecting females with disease onset at early puberty. It can lead to serious health problems and is associated with low bone mass which can persist with growth. Osteopenia is found to be an important prognostic factor for curve progression in AIS. Nutritional studies indicated AIS subjects had low dietary calcium intake. Evidences suggested that Vit D insufficiency could be present in AIS. Calcium and vitamin D supplementation can therefore be a viable treatment option for low bone mass in AIS subjects. The primary objective of this prospective randomized double-blinded placebo-controlled trial is to find out whether calcium and vitamin D supplementation can improve bone mineral density (BMD) in osteopenic AIS subjects. The secondary objective of this study is to evaluate whether the supplementation is effective in controlling curve progression in AIS.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 11-14 (Tanner stage \< IV)
* Low BMD (z-score \< 0 from age-matched population mean)
* Cobb's Angle greater or equal to 15°
* Presentation at the Scoliosis Clinic without prior treatment for low bone mass.

Exclusion Criteria:

* Scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia, or
* Patient with known endocrine and connective tissue abnormalities, or
* Patient with eating disorders or GI malabsorption disorders or
* Prior treatment for low bone mass before being recruited into the study.
* Patient currently taking medication that affects bone metabolism eg corticosterone or estrogen.
A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter Syndrome

This is a six-part prospective, multicenter, multiregional observational study of patients with mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, to assess biomarkers potentially related to disease severity and/or treatment response and prospectively assess the progression of disease in participants with MPS II who are aged ≤30 years at the time of enrollment.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria (Part 1):

* Participants aged 2 through 10 years
* nMPS II subgroup: participants with a development quotient (DQ) \<85 and/or a decline of at least 7.5 points in DQ, assessed at least 6 months apart, or with the same genetic mutation as a blood relative with confirmed nMPS II

Key Inclusion Criteria (Part 2):

* Participants aged 2 through 30 years
* nMPS II subgroup: patients with an age-adjusted DQ \<85 and/or a decline of 10 points or more in DQ in the previous 6 months or more, or with the same genetic mutation as a blood relative with confirmed nMPS II
* Scheduled to undergo general anesthesia or CSF sampling for non-study-related medical reasons and parent(s)/legally authorized representative consent to donate CSF for research purposes during that procedure, or an adult patient is able to provide consent and agrees to participation in the study for CSF collection/donation

Key Inclusion Criteria (Part 3):

* nMPS II participants aged \<8 years

Key Inclusion Criteria (Part 4):

* nnMPS II participants aged 6 to 17 years

Key Inclusion Criteria (Part 5):

* Participants aged ≤ 3 years
* Have undetermined MPS II phenotype

  * Do not have a large deletion(s) or rearrangement(s) in the IDS gene or other definitive mutation indicative of nMPS II
  * Do not have a DQ \< 85 at the screening/baseline neurocognitive assessment and/or a documented decline of at least 7.5 points in DQ in the previous 6 to 18 months
  * Do not have the same IDS gene variant as a blood relative with confirmed nMPS II or nnMPS II

Key Inclusion Criteria (Part 6):

* nMPS II participants aged 1 to 17 years
* Have received an MPS II gene therapy or allogeneic HSCT \> 12 months prior to screening
* Have a post-HSCT or post-gene therapy DQ \< 85 at the screening/baseline neurocognitive assessment and/or a documented decline of at least 7.5 points in DQ in the previous 6 to 18 months

Key Exclusion Criteria (All Parts):

* Have unstable medical condition that would make participation in the study unsafe or would interfere with necessary medical care
* Have received any central nervous system (CNS)-targeted MPS II investigational therapy within the previous 6 months
A Long-term Study on the Side Effects of TRADIANCE in Japanese Patients With Type 2 Diabetes

Study objectives is to investigate the safety of long-term daily use of TRADIANCE® Combination Tablets AP and BP in Japanese patients with Type 2 Diabetes mellitus (T2DM) used in routine care.


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients with Type 2 Diabetes mellitus (T2DM) who are prescribed with TRADIANCE® Combination Tablets AP or BP
* Patients who have never been treated with TRADIANCE® Combination Tablets AP or BP before enrolment

Exclusion Criteria:

None
A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in COVID-19 Patients

To evaluate the preliminary efficacy and safety of HH-120 nasal spray in the treatment of asymptomatic or mild COVID-19.

During this study, participants will receive HH-120 nasal spray treatment for 6 consecutive days, the efficacy and safety of HH-120 will be assessed throughout the study period based on viral clearance, clinical recovery, illness severity and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old.
* Participants with mild COVID-19 with symptom onset≤5 days or asymptomatic COVID-19.
* Participants being able and willing to provide informed consent prior to any study-specific procedure.

Exclusion Criteria:

* Participants with moderate or severe COVID-19.
* Participants within the pregnancy or breastfeeding period or plan to be pregnant during the study period.
* Participants requiring oxygen treatment (such as non-invasive ventilation, invasive mechanical ventilation, ECMO, etc.).
* Participants with nasal disease that is inconvenient or intolerant of nasal spray administration, or cannot use the nasal spray treatment.
* Participants with comorbid Malignancy or with a history of malignancy.
* Participants with active or uncontrolled systemic autoimmune disease.
* Insufficient function of key organs.
* Other reasons considered by the investigator to be unsuitable for the trial.
Is There an Interaction Between Recurrent Miscarriage and Dental Health

Oral infections can trigger the production of pro-inflammatory mediators that may be risk factors for miscarriage. The investigators investigated whether oral health care patterns that may promote or alleviate oral inflammation were associated with the history of miscarriage in Turkish women.

Power analysis was performed with the G-Power software package to determine sample size.

To cover possible data loss, 10% of a group were added to each group. Medical and dental examination will be performed both of control and experimental groups. In dental examination decayed, missing, or filled teeth (DMFT) index will be used according to World Health Organization (WHO 1997) criteria. All teeth were visually using the International Caries Detection and Assessment System (ICDAS-II).

To analyze the correlation between oral health status and miscarriage linear regression test and for comparison of both the groups (case and control), two sample t test and chi square test were used.

Eligibility Criteria:
Inclusion Criteria:

* history of at least two unexplained recurrent miscarriage below 20th week of pregnancy
* systemically healthy females with at least two normal births
* no poor obstetric history such as preeclampsia and premature birth

Exclusion Criteria:

* history of thyroid disease, hyperprolactinemia, antiphospholipid syndrome, systemic lupus erythematosus, autoimmune diseases, thrombophilia, diabetes mellitus, uterine/cervical abnormalities, polycystic ovary syndrome, active liver disease, cardiovascular disease, premature ovarian failure, acute or chronic upper respiratory tract diseases, IVF pregnancy, multiple pregnancy, preeclampsia, arterial or venous embolism, infection,
* habit of smoking, alcohol, drug or caffeine,
* abnormal embryo karyotype,
* infection with hepatitis B or C, and HIV,
* chromosomal abnormalities,
* dental fluorosis,
* fluoride supplements,
* orthodontic appliances,
* body mass index ≥ 30 kg / m2
* age of the partner is found to be over 40
Fluorescence-navigated Thoracoscopy for Pulmonary Segmentectomy

Recently developed fluorescence-navigated thoracoscopy with indocyanine green (ICG) is being used for various kinds of pulmonary surgery, and several studies have reported the application of this novel technique in demarcation of the intersegmental border for segmentectomy. This study is performed prospectively to find out, for the first time, the optimal dosage of ICG in human body to ensure safe and sustained imaging during segmentectomy.


Eligibility Criteria:
Inclusion Criteria:

* Suitable for segmentectomy and signed informed consent

Exclusion Criteria:

* Liver dysfunction.
* Allergic to indocyanine green.
* Can't tolerate thoracoscopic surgery.
Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair

This clinical trial examines whether intravenous preoperative administration of tranexamic acid (TXA) before arthroscopic rotator cuff repair (ARCR) can improve arthroscopic visualization during the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-100
* Male and Female
* Patient able to read and understand consent form
* Non-traumatic, simple small or medium sized rotator cuff tear as defined by pre-operative MRI
* Booked to operating room for elective rotator cuff repair
* Beach chair positioning

Exclusion Criteria:

* Patient refusal to participate
* Massive rotator cuff tear
* Acute traumatic rotator cuff tear
* Known coagulopathy
* Patients with a history or risk of thromboembolism
* Known hypersensitivity to tranexamic acid
* Patient unable to be off anti-coagulant medication for long enough to counter effects
* Patient has a clinic systolic blood pressure \> 150mmHg
* Lateral positioning
* Requirement or insistence by patient or anesthesiologist on regional block
* Patients who have smoked nicotine products within the last year
* The presence of other inflammatory conditions (calcific tendonitis, rheumatoid arthritis, etc.)
* The presence of active thromboembolic disease, such as deep vein thrombosis, pulmonary embolism, and cerebral thrombosis
* Patient has a seizure disorder
* Patients on medications identified as having drug-drug interactions (hormonal contraceptive, hydrochlorothiazide, desmopressin, sulbactam-ampicilllin, carbazochrome, ranitidine, or nitroglycerine
* Patient is pregnant
* Patients with history of subarachnoid hemorrhage
* Patients with renal insufficiency
* Patients with acquired disturbances of color vision
CAERvest® - A Novel Endothermic Hypothermic Device for Core Body Cooling. Safety and Efficacy Testing.

Cooling the whole body to 32-34 degrees Centigrade from the normal of around 37 degrees Centigrade for 24 hours has been shown to be an effective way of reducing damage to brain function after return of spontaneous circulation when someone has been resuscitated from cardiac arrest. Cardiac arrest is a form of heart attack where the heart stops pumping.

The device is a prototype cooling vest. The investigators anticipate that this will be useful in ambulances, helicopters and emergency departments where there is a need for a portable, safe, easy-to-use, inexpensive, external, effective, readily-controlled and single-patient use device able to reduce body temperature by at least 1 degree Centigrade an hour to initiate cooling. What the investigators are doing in these trials is to demonstrate that the investigators can cool people and to get the best design possible for patient use. That means some of the initial prototypes will not resemble what we expect the eventual device to look like. The investigators will be undertaking the initial trials on 30 normal volunteers.


Eligibility Criteria:
Inclusion Criteria:

Human volunteers aged over 18. The upper age limit, as is standard for risk mitigation in such studies, is 35. The volunteer must have capacity to understand the trial and give informed consent to participate. If the volunteer's first language is not English we will make use of Sussex Interpreting Services, a professional interpreting service.

Exclusion Criteria:

Pregnancy. Any disclosed medical condition. Any medical condition detected on examination. Core temperature outside stated parameters.

We will ask the volunteer to confirm that they are otherwise healthy, taking no regular medication (except the oral contraceptive pill), are not using recreational drugs and have no significant past medical history, in particular cardiovascular disease of any sort, thyroid disease, diabetes mellitus or other metabolic disease.
Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies

Background:

The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from participants' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.

Objective:

This study will allow participants to be followed for up to 15 years following treatment on an NCI Surgery Branch Gene Therapy Trial as required by the FDA.

Eligibility:

Participants must have been enrolled on an NCI Surgery Branch Gene Therapy Protocol

Design

Participants will be followed with a physical examination and blood tests for up to 15 years as required by the FDA

Background:

* Patients receiving care at the NIH Clinical Center are required to be enrolled on a clinical protocol.
* Following participation in a treatment protocol, it may be in the best interest of the patient to continue to be followed at the Clinical Center.
* The National Cancer Institute Surgery Branch (NCI-SB) conducts clinical trials utilizing gene transfer. The current U.S. Food and Drug Administration (FDA) requirements for long-term follow-up are up to fifteen years for some products. As this time-period is frequently longer than studies are expected to be open, a long-term follow-up protocol is necessary to ensure the follow-up of these participants.

Objective:

-Primary objective:

--Provide a mechanism for long-term follow-up of participants who have participated in research studies in the NCI-SB.

Eligibility:

* Age greater than or equal to 18 years.
* Participant has been enrolled on an NCI-SB treatment protocol.

Design:

* Participant will undergo physical exams, laboratory evaluation, imaging, or phone follow-up as clinically indicated.
* Procedures that entail more than minimal risk to the patient should not be performed for research purposes on this protocol.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Age greater than or equal to 18 years.
* Participants who have received treatment on an NCI-SB protocol, including gene therapy protocols. (Note: Participants may be enrolled on this protocol and, at the same time, participate in an active treatment study).
* For Cohort A:Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. For Cohort B: Participant is able to provide informed consent.

EXCLUSION CRITERIA:

-For Cohort B: Individuals of child-bearing potential (IOCBP) who are pregnant or plan to become pregnant because of the potentially dangerous effects of the investigational treatments administered on NCI-SB treatment protocols.