cyrilzakka/clinical-trials huggingface dataset:
Radioembolization of Primary and Secondary Liver Malignancies and The Effect On The Immune System

The goal of this study is to understand the immunologic effects radioembolization has on the immune system. This will be done by evaluating the changes on biopsy, peripheral blood monocytes, and cytokines.

This is a single institution non-interventional study designed to evaluate the immune reaction to radioembolization (RE) of primary and secondary malignancies of the liver.

RE has been established as a standard of care treatment for both primary and secondary cancers of the liver. The treatment consists of a mapping, or planning angiogram, followed by a delivery angiogram where the dose of yttrium 90 (y90) is delivered. Data has been published on the immune modification powers of external beam radiation (XRT). However, very little data is available on the ways in which RE modifies the immune system. The goal of this study is to determine changes in the peripheral blood monocytes, cytokines and the treated and untreated liver tumors through sample collection prior to and for 12 weeks after standard of care RE.

The prior to, the RE delivery procedure patients will have a blood draw to evaluate for levels of 11 immunologically relevant cytokines (IL-1α, IL-1β, IL-2, IL-6, IL-10, IL-12p70, IL-18, TNFα, IFN-ϒ, Fit ligand 3, and MCP-1). These blood draws will be repeated at 7 days (- 2 days, + 5 days), 4 weeks (± 2 weeks) and 12 weeks (± 2 weeks) after RE.

The patients will also have the infiltration of immune relative cells into treated tumors evaluated. This will be done by the patients undergoing biopsy of the largest tumor to be treated prior to treatment and at 2 weeks (±7 days) following RE. If patients have other areas of tumor, which are not included in the initial treatment site, these areas will also be biopsied.

Finally, the change in immunologically important peripheral lymphocytes will be collected. This will be done with a blood draw on the day of, but prior to RE serving as an internal control. Patients will then also have blood draws performed at 7 days (±2 days), 4 weeks (± 2 weeks) and 12 weeks (± 2 weeks) after RE.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy or image (in the setting of hepatocellular carcinoma (HCC)) diagnosed hepatic malignancy
* Total bilirubin \< 2 mg/dL
* ECOG status ≤ 2
* Life expectancy \>3 months as documented in the medical record by the enrolling physician
* Age \>22 years
* Lesion \>2.0 cm which is amenable to percutaneously biopsied

Exclusion Criteria:

* Unwilling or unable to attend all study related follow ups
* Technetium 99 macro aggregated albumin (MAA) lung shunt fraction \>20%
* Arterial anatomy which precludes the ability to safely perform RE
* INR \> 1.8 or platelet count \<50,000 which cannot be corrected
* Patients who are unable to hold anticoagulation and/or antiplatelet therapy in the periprocedural setting
Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma

This is a study to evaluate the safety, efficacy and pharmacokinetics of temsirolimus in Asian patients with advanced renal cell carcinoma. The trial is only being conducted in Japan, Korea, and China.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC. The American Joint Committee on Cancer (AJCC) staging and classification criteria will be used.
* ECOG performance status of 0-1.
* At least one measurable lesion per RECIST.
* Age greater than or equal to 20 years.
* Japanese, Chinese, or Korean ethnicity.

Exclusion Criteria:

* CNS metastases at screening or history or CNS metastases.
* Prior targeted, chemotherapeutic, cytokine-based, or other investigational agents for the treatment of RCC within 4 weeks before first dose of test article. Subjects must have documented objective progressive disease after any prior systemic RCC treatment and have recovered to grade 1 or lower toxicities from effects of prior systemic therapy for RCC.
* In past 5 years, other prior malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ).
The Role of Tuberculosis in Chronic Obstructive Lung Disease

Influence of tuberculosis (TB) on natural course of chronic obstructive lung disease (COPD) has not been well known. This study was designed to investigate the effects of history of TB on the long-term course of COPD.

Patients hospitalized with COPD exacerbation were consecutively included (n=598). Cases were classified into two categories: those with a history of TB and those without. Clinical, demographic, and radiological features were meticulously recorded and patients were followed up for mortality. 93 patients (15%) had past TB. On average, patients with a history of TB were four-year younger (p=0.002). Our study revealed that patients with TB history were diagnosed with COPD five-year earlier and died five-year earlier as compared to the patients without TB. In addition, in the TB history positive group, the rate of hospital admissions per year was higher compared to the group that lacked TB history (2.46±0.26 vs. 1.56±0.88; p=0.001). The patients with TB history had higher PaCO2 and lower FEV1 (p=0.008 and p=0.069 respectively). Median survival was 24 months for patients with past TB, and was 36 months for those without. Kaplan-Meier analysis revealed that although 3-year survival rate was lower in patients with TB history, it was not statistically significant (p=0.08). Cox regression analysis showed that while factors such as age, PaCO2, hematocrit, BMI and the Charlson index affected mortality rates in COPD patients (p\<0.05), prior history of TB did not seem to have a significant impact on the mortality.

Our results showed that past TB caused more hospitalizations, lower respiratory functions and higher arterial carbon dioxide levels. It was found that, though the mortality rates were similar, COPD patients with past TB was diagnosed and died five-year earlier. We conclude that history of TB has an important role in natural course of COPD.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with COPD exacerbations

Exclusion Criteria:

* Not diagnosed with COPD exacerbations
Prosthetic Management of All on Four Versus All on Six to Rehabilitate Completely Edentulous Maxillary Ridge Opposed by Natural Teeth

the aim of the study to compare the anterior maxillary bone index changes for patient rehabilitated with implant supported fixed prosthesis opposed by natural teeth


Eligibility Criteria:
Inclusion Criteria:

* 1. All patient wearing a maxillary implant supported overdenture or implant supported fixed restoration and mandibular natural teeth or fixed restoration within natural dentition.

  2. All patients were unsatisfied by the maxillary restoration and presented clear preference for a better prosthesis.

  3. They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.

  4. At least one year passed after the last restoration. 5. At least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class I according to Ahuja and Cagna).195 This was detected by a tentative jaw relation.

Exclusion Criteria:

* 1. Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.

  2. Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders which might affect implant lifespan.

  3. Long term immunosuppress and corticosteroid drug therapy. 4. Patient with abnormal habits as clenching and bruxism. 5. Smoking patient. 6. Uncooperative patients. 7. Neuromuscular diseases. 8. Patient with problems in TMJ.
Evaluation of Architectural Changes in Mandibular Bone Pattern After Functional Treatment by Fractal Dimension Analysis

In this study it was aimed to examine the changes in mandibular bone after functional treatment by using fractal dimension (FD) and cortical thickness (CT) analysis.

In this study it was aimed to examine the changes in mandibular bone after functional treatment by using fractal dimension (FD) and cortical thickness (CT) analysis. The study will perform on 42 mandibular retrognathia cases. The treatment group (T), comprised of 30 cases treated with functional appliance for one year in puberty. The control group (C) consists of 12 patients who had insufficient oral hygiene; didn't take any orthodontic treatment for one year. FD and CT analysis will evaluate for both sides. FD measurements will perform on processus condylar, antigonial notch, and ramus regions in the panoramic radiographs. Paired t-test will apply to analyze all between groups (before (T1) and after treatment (T2), before (C1) and after (C2) control). Also, independent t-test wişll use to determine whether there was any difference between the treatment group (∆T=T2-T1) and the control group (∆C=C2-C1).

Eligibility Criteria:
Inclusion Criteria:

1. Males and females were matched.
2. Treatment period of the treatment group was 1 year.
3. Observation period of the control group was also 1 year.
4. All groups had Class II malocclusion (ANB ≥ 5) with the retrognathic mandible in the period of puberty and had no systemic problem and impacted teeth.
5. Monoblock and twin-block appliances were applied to the treatment group.
6. Patients in the control group had insufficient oral hygiene and after oral-care was provided, they were taken into treatment.

Exclusion Criteriteria:

1. Radiographic images that do not have sufficient diagnostic quality
Gait Disturbances and Hips Bone Mineral Density

The objective of this study is to investigate the role of gait disturbance as a cause for difference in Bone Mineral Density (BMD) between both hips. Each subject will undergo the following tests: Functional Mobility Testing, Gait analysis, Motion Analysis, Assessments for Balance and Gait and Cognitive assessments.


Eligibility Criteria:
Inclusion Criteria:

1. differeneces in hips in Bone Mineral Density test in one group.
2. Age 40-80.

Exclusion Criteria:

1. bone disease,
2. arthritis,
3. congenital skeletal malformations,
4. pregnancy,
5. neurological disease
Microarchitecture, Bone Strength and Fracture Risk in Long-term Type 1 Diabetes

This single center case control study will assess differences in bone structure between women and men with longstanding type 1 diabetes (diabetes duration\>/= 25 years) and healthy controls.

Based on a cross-sectional approach the investigators aim to assess microstructural, biomechanical and densitometric bone characteristics in patients with longstanding type 1 diabetes and age- and sex-matches controls. The investigators examine whether the presence of microvascular disease and/or poor diabetic control is associated with an altered bone microarchitecture and whether any such effect is independent of bone mineral density. Furthermore, the investigators aim to look into the relationship between an altered bone microarchitecture and advanced glycation end product (AGE) formation as well as biochemical markers of bone formation and bone turnover. The study aims to identify type 1 diabetic patients with high fracture risk by assessing the discriminatory power of parameters of cortical and trabecular microstructure measured via high resolution peripheral quantitative computed tomography (HR-pQCT) of the distal radius and tibia and high resolution quantitative computed tomography (HR-QCT) of the proximal femur and tibia with and without adjustment for bone density.

Eligibility Criteria:
Inclusion Criteria:

* women and men with longstanding type 1 diabetes (age 40-80 years, BMI 18-37 kg/m2 and age- and sex matched non-diabetic controls
* presence of type 1 diabetes for at least 25 years (defined by history of Insulin treatment)

Exclusion Criteria:

* Patients unable to give written informed consent, e.g. with severe dementia or patients not understanding German (or other local language)
* Any medical or psychiatric condition which would preclude the participant from adhering to the protocol
* Idiopathic or premenopausal osteoporosis or coexisting metabolic bone disease (e.g. Paget´s disease, primary hyperparathyroidism)
* Previous treatment with osteoporosis medication (bisphosphonates, denosumab) or intake of medications that are known to affect bone metabolism (e.g. steroids, anticonvulsants) within 6 months prior to enrollment
* Patients with medical conditions known to affect bone health ( e.g. metastatic bone disease, celiac disease, inflammatory bone disease, hypogonadism, thyrotoxicosis, hypercortisolism, chronic kidney disease stage IV and V (KDIGO), liver dysfunction (serum aspartate amino transferase (ASAT) \>3 times the upper limit of normal)
* Inability to keep the extremities still for a few minutes of an HR-pQCT examination (e.g. Parkinson disease, spastic syndrome)
* Pregnant or breastfeeding women
To Assess the Predictive Value of D-dimer Level on the Occurrence of Cardiovascular Events

The primary aim of the study was to assess whether D-Dimer level at entry or an increase of D-Dimer level during the follow-up could predict the occurrence of subsequent cardiovascular events in patients with atrial fibrillation.

Patients will be followed-up every 4 months with clinical assessment and D-dimer blinded measurement.

Eligibility Criteria:
Inclusion Criteria:

* atrial fibrillation

Exclusion Criteria:

* follow-up not possible, poor prognosis within 3 months
Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum

1. Demonstrate superiority of treatment with the Ulthera DeepSEE System compared to untreated control for the improvement of skin laxity of the lower face and submental area.
2. Demonstrate the safety of treatment with the Ulthera DeepSEE System for the improvement of skin laxity of the lower face and submental area.

Subjects in the study received a single treatment with Ulthera DeepSEE system on the midface, lower face, submental (under the chin) and upper neck area using 3 DeepSEE (DS) transducers (DS 10-1.5, DS 7-3.0, DS 7-4.5) at either Day 1 or Day 90. Subjects treated at Day 1 were followed for 180 days after treatment and subjects treated at Day 90 were followed for 90 days after treatment.

Eligibility Criteria:
Inclusion Criteria:

- Mild to moderate lower face and/or submental laxity that is amenable to improvement with non-invasive intervention and is not severe enough for surgical intervention;

Exclusion Criteria:

* Scarring in area(s) to be treated;
* Any active implants (e.g., pacemakers or defibrillators) in the area(s) to be treated;
* Any metallic implants in area(s) to be treated;
* Any open wounds or lesions in the area(s) to be treated;
* Body mass index (BMI) less than 19 or greater than 30; or
* Gain or loss of ≥ 2 BMI units within the previous 90 days or has the intention to gain or lose ≥ 2 BMI units during the course of the trial.
Characterization and Risk Factors of Folliculitis After Hair Transplantation

We retrospectively reviewed 1317 patients who had undergone HT and completed 9-month follow-up between January 2018 and June 2021 at 4 medical centers. The incidence of postoperative folliculitis and the patient demographics were assessed. Logistic regression analysis was used to identify the risk factors, and the characteristics of different types of folliculitis were compared.

Postoperative folliculitis is a common complication after hair transplantation (HT) and requires effective preventive interventions. This study aimed to characterize postoperative folliculitis and determine the risk factors in patients underwent HT. The study was conducted at 4 clinical sites: Nanfang Hospital of Southern Medical University, the First Affiliated Hospital, Zhejiang University School of Medicine, the Affiliated Hospital of Guilin Medical University, and Peking University Third Hospital. Data of 1317 patients who had undergone HT and completed a 9-month follow-up from January 2018 to June 2021 were collected. The incidence of postoperative folliculitis and the patient demographics were assessed. Logistic regression analysis was used to identify the risk factors, and the characteristics of different types of folliculitis were compared.

Eligibility Criteria:
Inclusion Criteria:

- 1. Healthy adults between the ages of 18 \~ 60

2. patients suitable for autologous hair transplantation according to "the standard of hair transplantation"

Exclusion Criteria:

1. Coagulation disorders, pregnancy and lactation, immunosuppression
2. With severe mental and psychological illness, impairment of body image
3. All kinds of immune-related alopecia in the progressive active stage
4. Patients judged by the investigator to be unsuitable for this study
Discontinuation of TyrosIne Kinase Inhibitors (TKI) in Chronic Myeloid Leukemia (CML) and Impact on the Immune System

Tyrosine kinase inhibitors (TKI) have revolutionized the management and prognosis of chronic myeloid leukemia (CML). Daily treatment with TKI, which is necessary due to lack of cure, is frequently associated with moderate, chronic and sometimes severe adverse effects. The ability to permanently stop treatment with TKI has thus become a major goal in CML to prevent the occurrence of adverse events, improve quality of life and reduce the general cost of the treatment; we talk about Treatment Free Remission (TFR). It now remains to be demonstrated in a comparative prospective study that a strategy of de-escalation of the TKI treatment dose before treatment discontinuation optimizes TFR results. At the same time, it is possible to reduce adverse reactions and improve the quality of life of patients. In this context, the investigator propose to conduct a randomized clinical trial including CML patients, allowing to compare the results of TFR at 24 months between a sudden stop of treatment after a maintenance phase of dosage for 12 months and a de-escalation arm of dose (dosage reduced by 50%) for 12 months before stopping. A secondary immunological translational objective of this project will be to compare the quantitative and qualitative evolution of innate CD8 T cells between the 2 arms (abrupt cessation of ITK treatment versus progressive withdrawal) and look for a predictive innate CD8 T cells blood signature at the time of stopping treatment of a successful TFR in both arms.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 year-old.
* Diagnosis of chronic phase CML according to WHO 2016 criteria with a typical BCR::ABL1 rearrangement (e13a2 or e14a2)
* Duration of treatment by Imatinib ≥ 4 years / ITK2G ≥ 3 years /Imatinib and ITK2G ≥ 4 years and no change of TKI or decrease in dosage in the last 6 months prior to inclusion
* Deep Molecular Response (DMR) duration ≥ 1 year
* Absence of contraindication to the continuation of the same TKI for 12 months at the same dosage according to international recommendations nd the PCR of each TKI:

Imatinib (≥ 300 mg/j) Dasatinib (≥ 50 mg/j) Nilotinib (≥ 300 mg/j) Bosutinib (≥ 200 mg/j)

* Patient not participating in another interventional study for the duration of the interventional study
* Sexually active men should use effective contraception when taking Dasatinib
* Having an health insurance
* Having signed the consent form

Non-Inclusion Criteria:

* Patients with progressive severe pathology of poor prognosis immediately compromising participation in the entire study and/or with uncontrolled chronic pathology
* ECOG ≥ 3
* Prior resistance to TKI
* Patients who have already experienced an attempt of TKI cessation
* Patients with a malignant tumour that has been treated with chemotherapy within 2 months of inclusion or undergoing chemotherapy or that will be treated with post-inclusion chemotherapy
* Protected person
* Pregnant women or women of childbearing age without appropriate contraceptive measures
Preventing Propofol-associated Injection Pain

Injection of propofol is associated with discomfort in subsets of patients. Local anesthetics have been shown to attenuate this response in some patients. This randomized, double-blind, placebo-controlled trial tests the hypothesis that lidocaine mixed with propofol will be superior to lidocaine administered directly into the vein, under tourniquet control, prior to injection of propofol. Both groups are expected to be superior to placebo.


Eligibility Criteria:
Inclusion criteria:

* weight \>40kg, \<100kg
* ambulatory surgery

Exclusion criteria:

* allergy to propofol or lidocaine
* taking opioids, benzodiazepines, or nonsteroidal antiinflammatory drugs (NSAIDs)
LCAR-B38M Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma

This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of LCAR-B38M CAR-T cells in treating patients diagnosed with refractory/relapsed multiple myeloma (r/r MM).

Multiple myeloma (MM) is a usually incurable malignancy of plasma cells. Current therapies for multiple myeloma often cause remissions, but nearly all patients eventually relapse and die, an clear unmet clinical needs. As early as mid-2014, the investigators have started to develop a series of proprietary CAR-T products to target B cell maturation antigen (BCMA), a cell surface molecule which the investigator believes to be a desirable target antigen for multiple myeloma. All pre-clinical data and CMC data for LCAR-B38M CAR-T cell technology has been established by mid-2015 and a phase I proof-of-concept clinical trial has been planned since then.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a confirmed prior diagnosis of active multiple myeloma as defined by the updated IMWG criteria.
* Patients with refractory multiple myeloma. Clear BCMA expression must be detected on malignant plasma cells from either bone marrow or a plasmacytoma by flow cytometry or immunohistochemistry.
* Refractory disease：1) At least 3 prior regimens, which must at least have contained bortezomi. or 2) other circumstances identified by clinical doctors.
* Relapse criteria in NCCN clinical practice guidelines in Oncology: Multiple Myeloma (2016.V2)

Exclusion Criteria:

* Women of child-bearing potential or who are pregnant or breastfeeding.
* Have any active and uncontrolled infection: hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection.
* Systemic corticosteroid steroid therapy of greater than 5 mg/day of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to either the required leukapheresis or the initiation of the conditioning chemotherapy regimen.
* Patients with any uncontrolled intercurrent illness or serious uncontrolled medical disorder.
* Patients with CNS metastases or symptomatic CNS involvement (including cranial neuropathies or mass lesions and spinal cord compression).
* History of allogeneic stem cell transplantation. Have active acute or chronic graft-versus-host-disease (GVHD), or require immunosuppressant medications for GVHD, within 6 months of enrollment.
* Patients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritis.