cyrilzakka/clinical-trials huggingface dataset:
Relapse and Failure Rates Between CAD/CAM and Conventional Fixed Retainers

The aim of this study was to compare the differences in relapse and failure rates in patients treated with fixed retainers (FRs) using Computer-Aided Design/Computer-Aided Manufacturing technology, lab-based technique, and chairside method.


Eligibility Criteria:
Inclusion Criteria:

* completion of comprehensive orthodontic treatment
* class I molar and canine relationships
* indication for a fixed retainer on the mandibular anterior teeth.
* no extractions done as part of their treatment.
* Treatment with preadjusted edgewise appliance.

Exclusion Criteria:

* refusal to participate
* refusal to have fixed retainers
* poor oral hygiene
* non-compliance
The MILESTONE Study

Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so it is assumed that denervation might reduce sympathetic overactivity and improve glucose metabolism and insulin sensitivity. The purpose of this study is to evaluate the effects of multi-electrode catheter-based endovascular denervation on glucose metabolism and insulin sensitivity in patients with T2DM.

Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so it is assumed that denervation might improve glucose metabolism and insulin sensitivity. Some clinical studies have shown that glucose metabolism is improved in patients with resistant hypertension both 1 and 3 months after denervation, and fasting glucose, insulin and C-peptide decreased significantly as did insulin resistance assessed by HOMA-IR. But in some clinical studies, denervation did not lead to a significant improvement of insulin sensitivity ≤12 months after treatment, and no effect in systemic sympathetic activity was observed after denervation. Therefore, the efficacy of denervation on glucose metabolism is still in controversy. The investigators wish to investigate the effect of multi-electrode catheter-based endovascular denervation on glucose metabolism and insulin sensitivity in patients with T2DM.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years and ≤ 70 years old
* Able and willing to provide informed consent
* Patients with established type II diabetes mellitus (HbA1C\>7.5%, diet or oral hypoglycaemic agents)
* Clinical stable as demonstrated by no change in background anti-diabetic medication in the last 30 days.
* Anticipated that patients are able to maintain a stable dose of medication for the duration of the study

Exclusion Criteria:

* Arterial anatomy ineligible for endovascular denervation
* History of prior renal artery intervention including balloon angioplasty, stenting or previous renal denervation
* Type 1 diabetes mellitus
* Pregnant, nursing or planning to be pregnant
* Orthostatic hypotension
* eGFR \<30 ml/min (MDRD formula)
* Patients that have allergy to contrast agent
* Myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion
* Cerebrovascular accidents and alimentary tract hemorrhage within 3 months before inclusion
* Any medical condition which, in the investigators opinion, may adversely affect the participants safety in the trial
Non-invasive MRD Assessment in Multiple Myeloma

The purpose of this study is to investigate the sensitivity and accuracy of non-invasive MRD assessment using liquid biopsy (blood draw) and functional imaging (whole body MRI) in participants with new diagnosed and previously treated multiple myeloma. The long-term goal of this study is to investigate whether non-invasive methods for MRD assessment can replace bone marrow aspiration and biopsy in a substantial percentage of participants with multiple myeloma.

There is an unmet clinical need for an easier, non-invasive, and reliable method to perform MRD assessments that can be used in clinical trials and routine practice. The two non-invasive modalities that are most promising for MRD assessment are liquid biopsy to detect circulating tumor cells (CTCs) and functional imaging to detect focal myeloma lesions. However, there are no prospective data on the sensitivity and specificity of non-invasive MRD assessment with respect to the gold standard of bone marrow sampling.

Eligibility Criteria:
Inclusion Criteria:

* Adults age ≥18 years
* Patients with newly diagnosed multiple myeloma
* Patients with previously treated multiple myeloma with a maximum of two prior lines of therapy
* Expected life expectancy of greater than one year and intention to start a new line of treatment

Exclusion Criteria:

* Patients without cognitive capacity to give informed consent for participation
* Patients with contraindications to MRI, which include the following:
* Claustrophobia, which, at investigator's discretion, would prohibit patient from undergoing whole body diffusion-weighted magnetic resonance imaging (WB-DWI)
* Pacemaker
* Metallic implants, which would prohibit patient from undergoing MRI All subjects will be screened for any contraindication to MRI as per their guidelines at the time of patient enrollment.
* Patients must not receive granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) injection within 1 week prior to WB-DWI.
* Patients must not have been initiated on treatment prior to baseline disease assessment by bone marrow aspiration/biopsy and/or WB-DWI Up to 160 mg of dexamethasone (or equivalent) and/or 1 dose of bortezomib (+/- Cyclophosphamide-Dexamethasone) is allowed prior to disease assessment by bone marrow aspiration and WB-DWI.
Second-line Chemotherapy in Castration Resistant Prostate Cancer

This study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of metastatic castration resistant prostate cancer (mCRPC) patients previously treated with docetaxel containing regimen. The primary endpoint is safety. Secondary endpoints include time to treatment failure, response rate, overall survival and quality of life.

The objective of this study is to explore new, biweekly schedule of cabazitaxel in metastatic castration resistant prostate cancer patients. A previous study has shown that the biweekly administration of docetaxel in 1st line setting of mCRPC is better tolerated than docetaxel administered every three weeks. Also, the efficacy of biweekly docetaxel was better than three-weekly docetaxel and biweekly dosing presented a significant overall survival benefit (ASCO 2011, Kellokumpu-Lehtinen et al. As the occurrence of neutropenia in the TROPIC trial was rather high, the hypothesis is to reduce the incidence of severe adverse events by administrating cabazitaxel more frequently, yet maintaining the same dose intensity as in every three weeks´ dosing schedule.

This study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of 60 patients with metastatic castration resistant prostate cancer (mCRPC) patients previously treated with docetaxel containing regimen.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic castration resistant prostate cancer
* Disease progression during or after docetaxel-containing regimen for mCRPC
* Surgical or medical castration
* WHO performance status \< 2
* Age \> 18 years
* Adequate bone marrow, liver and renal functions:

Hematology:

* neutrophils \> 1.5 x 109/ l
* hemoglobin \> 100 g/l
* platelets \> 100 x 109/l

Hepatic and renal functions:

* total bilirubin \<1 x ULN
* ALAT and ASAT \< 2.5 x ULN, alkaline phosphate \<6 x ULN.In the presence of extensive bone disease, alkaline phosphate \> 6 x ULN is accepted
* creatinine \< 1.5 x ULN (ie NCI CTC-AE grade \< 1)

Exclusion Criteria:

* Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment
* Prior therapy with radioisotopes
* Other malignant disease (except superficial non-melanoma skin cancer) within the past 5 years
* Serious liver disease
* History of severe hypersensitivity reaction (grade \> 3) to polysorbate 80 containing drugs
* Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who already are on these treatments)
* Other serious illness or medical condition:
* Serious cardiac disease; ischemic or thromboembolic cardiac disease, pulmonary emboli, cardiac infarction within 12 months
* Active infection
* Active peptic ulcer, uncontrolled diabetes mellitus or other contraindications for the use of corticosteroids
* Auto-immune disease (lupus, scleroderma, rheumatoid polyarthritis)
* Active grade \> 2 polyneuropathy
HIV Diversity and Pathogenesis in Donor-Recipient Clusters

To assess, in donor-recipient clusters, current models of HIV-1 genetic evolution and pathogenesis, based on the sequence diversity displayed by this lentivirus.

DESIGN NARRATIVE:

Based on anti-HIV-1 screening of a repository of 200,000 blood donor sera collected in late 1984, the Transfusion Safety Study identified and enrolled into ongoing followup 133 seropositive donors and 111 HIV-1-infected transfusion recipients. Included among these were 38 'transmission clusters' composed of a donor and from one to six linked, infected recipient(s), and, in four cases, infected recipients' sexual partners. Frozen cells and sera collected at six-month intervals over a six-year period from members of these clusters were available for study. Specimens were accessed such that sub-repositories of cellular DNA, PCR-amplified HIV-1 sequences, and viral isolates were generated for future investigations of these unique clusters. The studies included analysis of sequence diversity in envelope (env) V3, V4, and V5 hypervariable regions both within each infected individual over time, and between different members of each cluster and different clusters. Sequence diversity profiles from PBMC and serum were analyzed separately to discern differences in these different blood components at each sampling and over time. The pattern of turnover of specific sequence variants over time (evolution of viral genotypes) was correlated with clinical and immunological progression.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Transcranial Magnetic Stimulation of the Prefrontal Cortex: Effects on Risky Decision Making and Temporal Discounting.

The main objective of this study is to examine the effects of magnetic stimulation on the prefrontal cortex. We plan to use low frequency, repeated transcranial magnetic stimulation (1 Hz rTMS) to temporarily inhibit activity in the prefrontal cortex and measure the resulting effect on two decision-making tasks. The prefrontal cortex is thought to mediate or control cognitive functions like decision-making, planning, memory, and inhibit impulsive behavior.Previous research has indicated that rTMS over the right dorsal lateral prefrontal cortex will lead to preferences for riskier alternatives. Our hypothesis is that rTMS over the right DLPFC will lead to greater preference for the riskier alternative and greater temporal discounting.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants willing to give informed consent to participate
* complete the Transcranial magnetic stimulation Adult Safety Screen
* have a MRI scan
* wear ear plugs during rTMS
* receive rTMS over the designated course of days
* complete cognitive assessments and decision making tasks.
* return for post-testing on all tasks after completing all rTMS sessions

Exclusion Criteria:

* Diagnosed neurological and/or psychiatric disorders requiring hospitalization or medication
* pregnancy or the possibility of pregnancy at the time of consent
* a history of tinnitus
* metal implants in head or neck or a pacemaker
* poorly-controlled migraines
* a history of head injury, stroke, previous brain neurosurgery, or loss of consciousness due to head injury lasting greater than 10 minutes
* a personal or family history of epilepsy or seizures
Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers in GDM

The investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP) for gestational diabetes mellitus (GDM).

The investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP) for gestational diabetes mellitus (GDM).In this prospective observational study including 109 pregnant women, the fetal pancreas size and maternal serum biomarkers GA and IRAP were measured at the gestational age of 20-22 weeks and later at the gestational age of 24-28 weeks, in 19 participants of them, GDM was confirmed with the 75-g oral glucose tolerance test (OGTT) and the fetal pancreas size was measured in all the participants again.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age between 18 and 42 years
* Gestational age between 20 and 28 weeks

Exclusion Criteria:

* Multiple pregnancies
* Pregestational diabetes
* Fetal congenital malformations
* Placental and amniotic fluid abnormalities
* Preeclampsia
* Severe systemic disease
* Long-term systemic drug usage
A Study of the Efficacy of Erbium:YAG 2940nm in Combination With 1064nm Laser on Facial Rejuvenation

1. Facial aging is a progressive, multifactor-induced and multidimensional process which is naturally irreversible. The prominent clinical features of skin aging include loss of volume, pigmentation irregularity, low light reflectance, static and dynamic wrinkles, etc.
2. The development of superpulsed CO2 and Erbium: YAG 2940 nm resurfacing lasers was considered as the "gold standard" for the treatment of facial aging \[8,9\]. However, many drawbacks including intraoperative pain, post procedural erythema, edema, high risk of changes of pigmentation and long downtime have drawn concerns to patients and practitioners. Therefore, the facial rejuvenation therapies based on combined modalities to target various factors simutaneously have raised more and more interests.
3. The Fotona 4D laser platform incorporates the long pulsed 1064 nm and 2940 nm lasers, which provides versatile modalities to target various skin aging problems simultaneously. The 1064 nm laser can penetrate deep into the skin to explode pigment particles, destroy blood vessels and heat the dermal collagen by targeting melanin and haemoglobin. The 2940 nm Er:YAG laser in Fotona 4D system integrates a non-ablative Smooth® mode and cold peel SupErficial™ mode. the half-face treated by a 2940 nm laser alone showed a significant improvement on indexes of skin wrinkles, texture, pores and elasticity as compared to the baseline.


Eligibility Criteria:
Inclusion Criteria:

* Patients ranged in age from 35 to 60 years old.
* Patients had Dover scale between 2-4
* Fitzpatrick wrinkles scale between 1-3
* medium to very severe nasolabial fold depression with morphological scores of 2 - 3 points.

Exclusion Criteria:

* pregnancy,
* liver or kidney functional abnormality,
* skin ulceration
* skin cancer
* coagulation disorders
* patients on drugs of photosensitizing or anticoagulation agents
* systemic diseases such as cardiovascular disease, epilepsy, diabetes.
Phase I/II Study of SRP-4053 in DMD Patients

This is a first-in-human, multiple-dose 2-part study to assess the safety, tolerability, efficacy, and pharmacokinetics of SRP-4053 in Duchenne muscular dystrophy (DMD) patients with deletions amenable to exon 53 skipping.

Part 1: Randomized, placebo-controlled dose-titration to assess safety, tolerability and pharmacokinetics of 4 dose levels of SRP-4053 in genotypically-confirmed DMD patients with deletions amenable to exon 53 skipping.

Part 2: Open-label evaluation of SRP-4053 in patients from Part 1, along with newly enrolled DMD patients with deletions amenable to exon 53 skipping and an untreated group of DMD patients with deletions not amenable to exon 53 skipping.

Safety, including adverse event monitoring and routine laboratory assessments, will be followed on an ongoing basis for all patients.

Clinical efficacy, including functional tests such as the six-minute walk test (6MWT), will be assessed at regularly scheduled study visits. Patients in the treated groups will undergo one baseline and one follow-up muscle biopsy. Patients in the untreated group will not undergo biopsies and will follow an abbreviated schedule of study assessments.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with DMD, genotypically confirmed.
* Intact right and left biceps muscles or an alternative upper arm muscle group.
* Stable pulmonary and cardiac function.
* Minimum performance on 6MWT, North Star Ambulatory Assessment, and rise (Gowers) test as specified in the study protocol.
* On a stable dose of corticosteroids for at least 6 months.

Exclusion Criteria:

* Previous treatment with the experimental agents BMN-195 (SMT C1100) or PRO053.
* Current or previous treatment with any other experimental treatments within 12 weeks prior to study entry.
* Major surgery within the last 3 months.
* Presence of other clinically significant illness.
* Major change in physical therapy regime within the last 3 months.

Other inclusion and exclusion criteria may apply.
Autologous Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery

This study aims to evaluate the effect of bone marrow concentration on bone healing and spinal fusion by comparing clinical and imaging outcomes between patients receiving transforaminal lumbar intebody fusion with local bone graft and with intraoperative bone marrow concentration and those receiving transforaminal lumbar intebody fusion with local bone graft only.

Spinal arthrodesis has become the mainstay of treatment for severe spinal deformity, spinal instability, spondylolisthesis, and symptomatic degenerative disease. Its primary goal is to develop an osseous bridge between adjacent motion segments to prevent motion, relieve pain, and facilitate neurological recovery. One of the arthrodesis method is transforaminal lumbar intebody fusion. After removal of the problematic disc, iliac crest bone graft was harvested and impacted into the space with cage to facilitate fusion. However, patients are exposed to additional risk of harvesting site, such as pain, infection, wound healing problem or hematomas. Local bone graft harvested from decompression is one of the alternative solutions to avoid these complications. However, the effect of local boen graft is inferior to iliac crest bone graft because iliac crest bone graft contains three important ingredients for successful fusion: osteoconductive scaffold, osteoinductive factors, and the ability to osteogenesis. Mesenchymal stem cells (MSCs) are pluripotent cells that can differentiate into multiple mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a source of multiple growth factors to establish an environment conducive to soft and hard tissue regeneration. As bone marrow concentration has high concentration of mesenchymal stem cells, some studies have shown that autologous bone marrow concentration can improve bone healing. In this study, we will add bone marrow concentration into local bone graft during transforaminal lumbar intebody fusion and evaluate the effect of bone marrow concentration on bone healing and spinal fusion.

Eligibility Criteria:
Inclusion Criteria:

* With indication of transforaminal lumbar decomprassion and interbody fusion, ex. spondylolisthesis, symptomatic degenerative disease, spinal instability.
* Involved levels between T12 and S1
* Involved levels less than three levels
* Age between 20 and 70 years

Exclusion Criteria:

* With prior history of spinal surgery
* With current or prior history of tumor, trauma or infection at spine
* With current diagnosis of coagulopathy
* With current or prior history of cancer
* With current or prior history of hematological disease
* Pregnancy
* Patients who will not cooperate with one-year followup
68Ga-FAPI PET/MR for Atherosclerosis

A thin-cap fibroatheroma with a large necrotic core and macrophage infiltration marks the vulnerable plaque. Fibroblast activating protein (FAP) is an active serine protease, which can degrade type I collagen, potentially thinning the fibrous cap. Thus we speculate that atherosclerotic plaque could be imaged with 68Ga-FAPI PET/MR.

A thin-cap fibroatheroma with a large necrotic core and macrophage infiltration marks the vulnerable plaque. Fibroblast activating protein (FAP) is an active serine protease, which can degrade type I collagen, potentially thinning the fibrous cap. Previous ex vivo analysis of human aortic atheromata revealed that FAP was expressed in atherosclerotic plaques, and higher FAP expression was detected in thin fibrous caps than thick caps. Constitutive Fap deletion in atherosclerosis-prone mice models could reduce plaque formation and improve plaque stability with increased fibrous cap thickness. Thus we speculate that atherosclerotic plaque could be imaged with 68Ga-FAPI PET/MR.

Eligibility Criteria:
Inclusion Criteria:

* intracranial or carotid atherosclerosis patients
* signed informed consent

Exclusion Criteria:

* pregnancy, breastfeeding
* contradictions of MRI
* unstable vital signs
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study

This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial.

It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).


Eligibility Criteria:
Inclusion Criteria:

* Participating in the MOMs trial (Unique protocol ID: 2019-0429-1)

Exclusion Criteria:

-
AAI in Elderly Patient With Chronic Pain

BACKGROUND: Nowadays, there is a progressive aging of population. Chronic osteoarticular pain is associated to a bigger consumption of medication and a deterioration of life quality in elderly people that could be improved by boosting education for health from Primary Health Care. JUSTIFICATION: The need to develop non pharmacological treatments in order to get better results in people's global care. PURPOSE: To evaluate the effectivity of group intervention, based on Animal Assisted Therapy, on elderly people suffering from chronic osteoarticular pain and poli-medication; regarding decrease of chronic pain, use of analgesics and improvement of life quality. MATERIAL AND METHOD: Randomized clinical trial, two arms, controlled and open-label. Twelve group sessions of kinesiotherapy with the intervention of a therapy dog in the experimental group (EG), carried out in the Primary Health Centre.


Eligibility Criteria:
Inclusion Criteria:

* ≥65 years
* diagnosis of chronic benign joint pain
* polypharmacy (\>5 drugs or active ingredients, of which 2 or more had been prescribed for pain)

Exclusion Criteria:

* severe cognitive deterioration (GDS\> 5)
* allergy to or fear of animals