cyrilzakka/clinical-trials huggingface dataset:
Sacroiliitis in Systemic Sclerosis

One of the major problems of systemic sclerosis (SSc) patients is suggested to be articular involvement. Mostly involved joints in SSc were reported as wrist, carpometacarpal-interphalangeal, foot, knee, hip and shoulder however there have been little knowledge on sacroiliac joint. Here the investigators plan a study on the involvement of this joint in SSc.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as systemic sclerosis and rheumatoid arthritis and healthy volunteers

Exclusion Criteria:

* Not giving informed consent
Elucidating the Minimal Effective Dose of Prunes for Bone Health in Postmenopausal Women

The objective of this study is to examine if calcium and vitamin D supplements and/or prune can prevent bone loss in postmenopausal women.

Two hundred randomly assigned to one of two treatment groups: 1) 30 g prunes and 2) control (0 g prunes). Both groups received 500 mg calcium and 400 IU Vitamin D as a daily supplement. Blood samples are collected at baseline, 12 and 24 months to assess biomarkers of bone turnover. Physical activity recall and food records are obtained at baseline, 12 and 24 months to examine physical activity and dietary confounders as potential covariates. Dual-energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) will be completed at baseline, 12 and 24 months to examine bone mineral density and structure.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal
* BMD t-score is between 0.5 and 2 SD below the mean
* Not on hormone replacement therapy (HRT) and/or other pharmacological agents known to affect bone for at least three months prior to initiation of the study

Exclusion Criteria:

* Women whose BMD t-score at any site falls below 2.5 SD of the mean
* Subjects receiving endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism
* Subjects who smoke cigarettes or vape
* Regular consumption of dried plum or prune juice
Sodium Fluoride Imaging of Abdominal Aortic Aneurysms

The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron Emission Tomography-Computed Tomography - PET-CT) is able to help predict the rate of abdominal aortic aneurysm expansion.

Ruptured abdominal aortic aneurysms (AAAs) have a 90% mortality rate but there are currently no accurate methods of establishing the risk of rupture for an individual patient with an asymptomatic AAA. In vascular disease, microcalcification occurs in response to necrotic inflammation. Using computed tomography and positron emission tomography (PET-CT), early micro calcification can be identified using uptake of the radiotracer 18F-sodium fluoride. This can identify high risk-lesions in the aorta, coronary and carotid arteries, and appears to be indicative of necrotic and heavily inflamed tissue. The study investigators therefore propose to evaluate the ability of 18F-sodium fluoride to identify regions of necrotic inflammation in AAA and predict AAA expansion. The study investigators will explore its value as part of an ongoing clinical trial assessing the identification of macrophage activity using magnetic resonance imaging - the MA3RS Study (ISRCTN76413758). Patients already enrolled in the MA3RS Study will be recruited for the SoFIA3 study. Control patients with a normal calibre aorta will be recruited from the National AAA Screening Programme.

Eligibility Criteria:
Inclusion Criteria (AAA patients):

* Patients already enrolled in the MA3RS study (ISRCTN76413758)
* Patients with abdominal aortic aneurysm with AP diameter \>40 mm on ultrasound
* \>50 years of age

Inclusion Criteria (control patients):

* Patients with abdominal aorta with AP diameter \<30 mm on ultrasound
* \>50 years of age

Exclusion Criteria:

* Patients expected to undergo imminent AAA repair
* Patients who refuse or are unable to give informed consent
* Women of child-bearing potential without contraception
* Patients who are unable to undergo PET-CT scan
* Patients with collagen vascular disease
* Intercurrent illness, malignancy or comorbidity with life expectancy \<1 year
* Renal dysfunction (eGFR \<30ml/min/1.73m2)
* Contraindication to PET-CT or CTA
* Iodine allergy
Sun Protection Factor Assay (316/2016)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Effects of Parental Behavior on Child Anxiety Regulation

Does parenting style affect emotion regulation among children who initially demonstrate high levels of fear and anxiety? Although recent correlational research has demonstrated a linkage between parental behaviors, such as excessive intrusiveness, and children's manifestations of fear and anxiety, it is not clear if parenting behaviors directly influence children's ability to regulate these emotions. Alternatively, these parental behaviors may be elicited by children who express fears and anxieties more frequently than other children do. Experimental research designs would offer a more definitive test of these competing explanations of the extant correlational findings. Intervention studies, in particular, can test whether experimentally manipulating current family interaction patterns affects children's ability to regulate emotion. This study provides a preliminary experimental test of the relationship between parental behavior and children's regulation of fear and anxiety. Some 40 clinically anxious youth, aged 6-13, were randomly assigned to a family intervention program for childhood anxiety problems, which includes extensive parent communication training, or a child intervention program without parent-training. By comparing these two interventions, we tested if it was possible to improve parenting behaviors-such as intrusiveness-through intensive parent-training, above and beyond the effects of involving children in a child intervention program. We then tested the impact of this change in parental behaviors on children's ability to regulate fear and anxiety. We hypothesized that parent-training would reduce intrusiveness, which would in turn improve children's anxiety outcomes.


Eligibility Criteria:
Inclusion Criteria:

* The child met DSM-IV criteria for a diagnosis of a principal anxiety disorder based on a semi-structured interview
* The child was not taking any psychiatric medication at the initial assessment, or was taking a stable dose of psychiatric medication (i.e., at least one month at a stable dose prior to the baseline assessment), and
* If medication was being used, families stated an intention to maintain that dose throughout the study.

Exclusion Criteria:

* The child was currently in child-focused psychotherapy
* The family was currently in family therapy or a parenting class
* Either the child or the parents evidenced psychotic symptoms
* The child began taking psychiatric medication or increased his/her dose of medication during the intervention, or
* For any reason the child or parents appeared unable to participate in the intervention program.
The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction

One of the common complaints after ACLR with BPTB autograft anterior knee pain. It is thought that this may be due to harvesting the patellar tendon for graft use. Specifically, this may be due to the bone defect that is left after graft harvesting. There is currently no consensus on a gold standard for treating the bone defect with surgeons using multiple commercially available bone void fillers as well as autologous bone graft in standard practice.

The purpose of the proposed study is to evaluate the effect bone-void filler on anterior knee pain following ACL reconstruction BPTB autograft.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing ACLR with BPTB autograft
* Skeletally mature (as defined by closed growth plates on plain radiograph)
* At least 18 years of age
* Willing and able to provide consent

Exclusion Criteria:

* knee with intact ACL
* skeletally immature (as defined by open physis on plain radiograph)
* pregnant
* less than 18 years of age
* previous ACL repair or reconstruction
* unable to speak english or perform informed consent
* multiligamentous knee injury (two or more ligaments requiring surgical attention)
* varus or valgus malalignment greater than 3 degrees
A Prospective Clinical Cohort Study on Stratified Treatment of Rhabdomyosarcoma Based on Risk Factors.

The purpose is to explore the efficacy and safety of the SYSUCC-RMS regimen for pediatric RMS patients and to explore the impact of concurrent radiotherapy and chemotherapy on the survival rate of low-risk, medium risk, high-risk, and extremely high-risk patients in children.


Eligibility Criteria:
Inclusion Criteria:

1. 0 years \< age \< 18 years old, regardless of gender;
2. Tumor patients diagnosed by histopathology or bone marrow cytology;
3. Patients are treated for the first time;
4. ECoG score ≤ 2;
5. The expected survival time is more than 8 months;
6. Patient's parent or guardian signs informed consent.

Exclusion Criteria:

1. Combined with immunodeficiency disease
2. Second tumor
Evaluation of Protein Bars on Weight Management and Osteoarthicular Health

The goal of this intervention study is to evaluate the efficacy in subjects with overweight or obesity of protein bars consumption. The main questions it aims to answer are:

* Does the regular consumption of these protein bars help to loose weight?
* Does the regular consumption of these protein bars help to improve the osteoarticular health? Participants will be asked to follow the indications of consumption of the bars togather with healthy nutritional advice during 16 weeks.

Researchers will compare exparimental Versus placebo groups to see if weight is lost in similar or different ways.

The intervention is designed to evaluate the efficacy of the consumption of a protein bar vs placebo on weight control and osteoarticular health.

For this purpose, a total of 102 subjects will be randomised to either the experimental group or the placebo group, the only stratification performed will be acording to sex.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 37.5 kg/m2
* Normal physical examination and vital signs according to clinical examiners.
* Chronic pharmacological treatment is permitted if dosage is stable within at least three months prior the start of the intervention.

Exclusion Criteria:

* Any funcitonal or structural impairment in digestive system (hitus hernia, ulcers, inflammatory bowel disease, etc.)
* Excessive alcohol consumption (\> 14 units/week in women and \> 20 units per week in men)
* Bariatric surgery or similar
* Arthritis, hepatic diseases, cancer.
* Alergy to any component of the products
* Subjects presenting any cognitive or psichiatric impairment, that may impel them to follow the protocol.
* Subjects following any weight loss program
Effect of High-Definition Transcranial Direct Current Stimulation (HD-tDCS) on Attentional Control: an fMRI Study on Healthy Participants

In a randomized, triple-blind, sham-controlled clinical trial, we will assess the effect of a single session frontal cortex High-Definition transcranial Direct Current Stimulation (HD-tDCS) on brain activity and functional connectivity underlying the behavioral change in attentional control in healthy participants. Participants will be recruited after meeting the inclusion criteria and will be randomly assigned to active or sham stimulation groups. All participants will undergo resting-state functional Magnetic Resonance Imaging (rsfMRI) scan and perform an Attention Network Test (ANT) in a functional Magnetic Resonance Imaging (fMRI) scanner before and after receiving a single session of active or sham HD-tDCS.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed healthy adults
* Age range 20-39 years
* Normal or corrected-to-normal vision
* Willing and capable of following study protocol requirements given in the informed consent

Exclusion Criteria:

* Psychiatric conditions (e.g., depression and generalized anxiety disorder, etc.)
* Medical illness or neurological disorder (e.g., cardiovascular illness, anemia, respiratory illness, neurological illness, seizure, etc.)
* Current abuse of drugs or alcohol
* Any conditions that prevent undergoing an fMRI scan or tDCS stimulation according to the fMRI and tDCS safety checklists
Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.


Eligibility Criteria:
Key Inclusion Criteria:

* Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent)
* Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
* Screening genotype report provided by Gilead Sciences must show sensitivity to tenofovir (TFV) and emtricitabine (FTC)
* Adequate renal function as measured by estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula
* CD4+ cell count ≥ 200 cells/µL at screening

Key Exclusion Criteria:

* A new AIDS-defining condition diagnosed within the 30 days prior to screening as defined in the study protocol
* Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP)
* Chronic hepatitis B virus (HBV) infection
* Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but have a documented negative HCV RNA, are eligible)
* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
* Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Clinical Study of CD19 Targeted CAR-T for Patients With CD19+ Lymphoma and Leukemia

Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 T cells and the investigators will determine the safety and therapeutic effects of these cells.


Eligibility Criteria:
Inclusion Criteria:

CD19 positive leukemia and lymphoma，relapsed and/or refractory：

* survival\>12 weeks;
* FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
* LVEF≥50%;
* Creatinine\<2.5mg/dl;
* Bilirubin\<2.5mg/dl;
* ALT (alanine aminotransferase)/AST (aspartate aminotransferase)\<3 x normal;
* At least 7 days after last chemotherapy;
* provide with informed consent.

Exclusion Criteria:

* Active clinically significant CNS dysfunction
* Pregnant or breast-feeding women.
* Uncontrolled active infection including hepatitis B or C.
* HIV positive.
* Use of systemic steroids within 72 hours.
* Allogeneic lymphocyte treatments within recent 6 months.
* Any uncontrolled active medical disorder.
Optimal Catheter Placement During Sonohysterography: Comparison of Cervical to Uterine Placement

The primary objective of this investigation was to evaluate if the location of placement of the SIS balloon into either the uterine cavity or the cervical canal affected discomfort perceived during the examination.

The use of sonography combined with intrauterine saline instillation, termed sonohysterography

Eligibility Criteria:
Inclusion Criteria:

* Female patients undergoing SIS for diagnostic uterine cavity evaluation at our university's Reproductive Endocrine Infertility Program.

Exclusion Criteria:

* previous hysterectomy, current pregnancy, active PID, patulous or stenotic cervical os noted on previous history or physical exam.
Effects and Mechanisms of n-3 PUFAs and Irisin on Abnormal Glucose Metabolism After GDM.

The purpose of this study is to clarify the relationship between n-3 PUFA and irisin in regulating the glucose metabolism in GDM patients.

Gestational diabetes mellitus (GDM) is an important risk factor for type 2 diabetes in women. Studies have shown that n-3 polyunsaturated fatty acids (n-3 PUFA) are associated with improving insulin resistance and prevent type 2 diabetes in the general population; a newly discovered myokine, irisin, is associated with reduced insulin resistance and plays an important role in human glucose metabolism; and results from cell studies suggested that n-3 PUFA might increase the expression of irisin. Therefore, the investigators hypothesize that n-3 PUFA could improve glucose metabolism via the IRS-1/PI3K/AKT insulin signaling pathway by increasing expression of irisin and thus improving postpartum glucose metabolism in women with GDM. In order to test this hypothesis, the investigators plan to establish a prospective GDM cohort and collect related information at 24-28 weeks' gestation, 42 days postpartum, 1 year postpartum and 2 years postpartum, respectively. Then the following would be tested: the changes of n-3 PUFA and irisin during pregnancy and after delivery, and their association with postpartum abnormal glucose metabolism; and the correlation of n-3 PUFA and irisin. Furthermore, using a cell model of insulin resistance the investigators would examine the dose-response and time-response relationships between n-3 PUFA and irisin, and next explore the role of irisin in n-3 PUFA regulation of IRS-1/PI3K/AKT insulin signaling pathway. This study would help to clarify the relationship between n-3 PUFA and irisin in regulating the glucose metabolism, and might provide scientific evidence for the prevention of type 2 diabetes after GDM.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with gestational diabetes mellitus were screened by The Guidelines for diagnosis and treatment of gestational diabetes mellitus in China in 2014.

Exclusion Criteria:

* age \< 20 years or ≥ 45 years;
* women with diabetes, cardiovascular disease, thyroid disease, blood disease and polycystic ovary syndrome before pregnancy;
* multiple pregnancy and assisted reproductive technology pregnancy;
* women with severe postpartum endocrine disorders and diseases, such as pancreatitis, hyperthyroidism, nephritis;
* infection during pregnancy.
A Study Evaluating the Efficacy of Fluocinonide Cream 0.1% (Vanos) in Subjects With Atopic Dermatitis

The purpose of this research study is to better understand how fluocinonide cream 0.1% (Vanos®) works when people use it to treat atopic dermatitis for just a few days.

This is a single center study. This is an open label study of fluocinonide cream 0.1% (Vanos™) for subjects with mild to severe atopic dermatitis with an assessment of 2 to 4 on the Investigator Global Assessment scale (Appendix B). Up to 20 subjects age 12 and above will be enrolled after providing informed consent. All subjects will receive the study medication, fluocinonide cream 0.1% (Vanos™). Each subject will be instructed to use fluocinonide cream 0.1% (Vanos™) twice daily for three consecutive days (for a total of 6 doses). The study period will last for approximately 2 weeks. Subjects will be evaluated at baseline and Day 2 or 3 (as needed to achieve 6 doses), day 7 and day 14 (or end of study). Subjects will not apply any study drug after the 6 doses.

Eligibility Criteria:
Inclusion Criteria:

* Male or female with mild to severe atopic dermatitis, 12 years of age or older, that agree to participate and provide written consent (and assent if applicable)
* Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 - 4 in the Investigator Global Assessment (Appendix B))
* Percentage of overall body surface are of involvement (BSA) must be ≥2%
* Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control

Exclusion Criteria:

* Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids
* Application or use within 2 weeks of baseline of topical corticosteroid medications or topical anti-inflammatory medication, which may influence study outcome
* Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments
* Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study
* Amount of disease involvement that would require \>60 gm of cream in a 1 week period
* Subjects with known allergy or sensitivity to topical Vanos™ cream or components
* Pregnant women and women who are breastfeeding are to be excluded. Women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.
Safety and Efficacy of the DEVOIR Sirolimus-Coated Coronary Balloon in the Real-world Clinical Practice

The study is a prospective, non-randomized, multicenter, post-marketing surveillance study evaluating the CE-marked DEVOIR Sirolimus-Coated Coronary Balloon in 4 subgroups regarding device approved indications:

* In-stent restenosis lesions: either bare metal or drug eluting stent restenosis
* Bifurcation lesions (with drug-eluting stent in main branch and drug-coated balloon in side branch): treatment of lesion of all Medina types except (0,0,1) in native coronary arteries
* Small vessels: treatment of lesions ≤2.75 mm
* BMS implantation followed by DCB inflation


Eligibility Criteria:
Patient's inclusion and exclusion criteria are per device instructions for use's indications and contraindications.

Inclusion criteria:

1. Patient is at least 18 years old
2. Lesion lengths ranging from 8 to 38 mm and diameters ranging from 1.50 mm to 4.00 mm.

Exclusion criteria:

1. Patients with a hypersensitivity to Sirolimus drug or its structural activity related compounds.
2. Patients with a known hypersensitivity to excipients with phospholipid or related origins.
3. Patients whose diseased segment cannot be pre-dilated or prepared before drug coated balloon treatment.
4. Severely calcified lesions requiring treatment of other type for e.g. Rotational Atherectomy (Rotablator)
5. Patients judged to have lesion that prevents complete inflation of angioplasty balloon or proper placement of delivery catheter
6. Patients who cannot receive recommended antiplatelet or anticoagulation therapy.