cyrilzakka/clinical-trials huggingface dataset:
A Positioning Navigation Template for Assisting the Placement of Modular Hemipelvic Endoprostheses for Patients Undergoing Pelvic Bone Tumor Resection.

Background:

Acetabular reconstruction in situ after extensive pelvic resection is technically challenging because the significant loss of bone stock and bony landmarks. The aim of the present study was to investigate the feasibility of an individualized navigation template for acetabular reconstruction following pelvic malignancy resection.

Methods:

This retrospective cohort study included patients who underwent type II or II+III pelvic tumor resection and reconstruction using a modular hemipelvic prosthesis. In the template-guided group (n = 10), a navigation template was designed and applied to assist acetabular reconstruction. In the traditional operation group (n = 14), the patients underwent the same surgery but without the navigation template. To compare the displacement of the hip rotation center before and after surgery between the two groups, an innovative method based on pelvic CT was developed and a validation group of cases was used to assess the effectiveness of this measurement approach. In the validation group (n = 12), patients undergoing periacetabular puncture or curettage without hip joint reconstruction were included. The displacements for the validation group were calculated and compared with 0 cm, the theoretical value. Subsequently, the displacements between the template-guided group and the traditional operation group were compared.


Eligibility Criteria:
Inclusion Criteria:

1. All the patients diagnosed with a pelvic tumor；
2. Underwent limb salvage surgery following type II or II+III pelvic resection；
3. Acetabulum reconstruction using a modular, titanium hemipelvic prosthesis.

Exclusion Criteria:

1. A lack of postoperative CT images;
2. Having undergone revision surgery or noninitial/primary resection;
3. unable to calculate the hip displacement by the specific measurement method we proposed.
The Impact of M1/M2 Tumor Associated Macrophage (TAM) Polarization on Cancer Progression and Prognosis Prediction

The purpose of this study is to evaluate the correlation between M1/M2 phenotype of tumor associated macrophage (TAM) in lung cancer patients and clinical outcome.

Inflammatory response in the tumor micro-environment may facilitate the metastatic process (1). Macrophages are pivotal members of the inflammatory cells and the innate immune system within the tumor stroma. Tumor-associated macrophages can release growth factors, cytokines and inflammatory mediators that may facilitate cancer cell invasion, migration, angiogenesis, tumor progression or metastasis (1-5). A lot of studies showed TAM encounter factors that most frequently polarize them toward M2 type macrophage (1,4-5). It is interesting that in vitro studies macrophages have the potential to kill tumor by appropriate stimulation but these macrophage belonged to M1 and were not present in most tumor tissue (6). Some drugs target to suppress TAM have the promising results in animal models (7-9). Switching the TAM phenotype from M2 to M1 may promote anti-tumor activity (10). In this study we will correlate TAM M1/M2 ratio and patients' prognosis, the gene expression pattern of TAM.

References

1. Coussens LM, Werb Z. Inflammation and cancer. Nature 2002;420(6917):860-867.
2. Crowther M, Brown NJ, Bishop ET, Lewis CE. Microenvironmental influence on macrophage regulation of angiogenesis in wounds and malignant tumors. J Leukoc Biol 2001;70(4):478-490.
3. Lin EY, Nguyen AV, Russell RG, Pollard JW. Colony-stimulating Factor 1 Promotes Progression of Mammary Tumors to Malignancy. J. Exp. Med. 2001;193(6):727-740.
4. Mantovani A. Cancer Inflammation by remote control. Nature 2005;435(7043):752-753.
5. Pollard JW. Tumor-educated macrophages promote tumour progression and metastasis. Nature Reviews Cancer 2004;4(1):71-78.
6. Sica A, Schippa T, Mantovani A, Allavena P. Tumor-associated macrophage are distinct M2 polarized population promoting tumor progression: potential targets of anti-tumor therapy. Eur J of Cancer 2006;42:717-27
7. Sessa C, De Braud F, Perotti A, et al. Trabectedin for women with ovarian carcinoma after treatment with platinum and taxanes fails. J Clin Oncol 2005;23:1867-74.
8. Wahl L, Kleinman HK. Tumor-associated macrophages as targets for cancer therapy. J Natl Cancer Inst 1998;90:1583-4.
9. Giraudo E, Inoue M, Hanahan D. An amino-bisphosphonate targets MMP-9-expressing macrophages and angiogenesis to impair cervical carcinogenesis. J Clin Invest 2004;114:623-33.
10. Guiducci C, Vicari AP, Sangaletti S, Trinchieri G, Colombo MP. Redirecting in vivo elicited tumor infiltrating macrophages and dendritic cells towards tumor rejection. Cancer Res 2005;65:3437-46.

Eligibility Criteria:
Inclusion Criteria:

* lung cancer with malignant pleural effusions

Exclusion Criteria:

* None
Comprehensive Lifestyle Modification for Patients With Hypertension and Metabolic Syndrome: a Multicenter Randomized Controlled Trial

Different forms of diet, e.g. Mediterranean diet, DASH diet, or fasting, have demonstrated efficacy in reducing elevated blood pressure. Moreover, Mediterranean diet, and fasting seem to be effective in improving insulin sensitivity in type 2 diabetes. Further, studies on meditation or mindfulness-based interventions have shown positive effects in patients with hypertension and/or type 2 diabetes. Comprehensive Lifestyle Modification, this is a combination of diet, exercise, and stress management, have improved coronary atherosclerosis. However, no studies have yet investigated the effects of Comprehensive Lifestyle Modification in patients with metabolic syndrome and/or in combination with fasting therapy.

This study is supported by a grant from the Corona-Foundation, Germany.


Eligibility Criteria:
Inclusion Criteria:

* Hypertension or antihypertensive medication or subclinical atherosclerosis
* Metabolic syndrome
* Basic mobility

Exclusion Criteria:

* Diabetes type 1
* Insulin bolus therapy
* Coronary artery disease
* Myocardial infarct, pulmonary embolism, or stroke within the past 3 months
* Heart failure
* Peripheral vascular disease
* Chronic kidney disease
* Eating disorder
* Dementia
* Other severe internal disease
Natural History of Inflammatory Muscle Diseases

Objective:

To collect information and biospecimens (such as blood, muscle, and skin samples) that will be used to research causes and treatments of inflammatory muscle diseases.

Eligibility:

People aged 12 years and older with suspected or confirmed inflammatory muscle disease. Healthy volunteers aged 18 years and older are also needed.

Design:

Participants will have at least 1 clinic visit. Each visit will last 4 to 8 hours. Some may return for additional visits.

All participants will undergo these procedures (unless they are unable to):

* Physical exam, including blood and urine tests.
* Magnetic resonance imaging (MRI) scan of the thigh. Participants will lie still on a table with padding around 1 thigh. The table will slide into a tube. The scan will last for approximately 40 minutes.

Some procedures are optional:

* Muscle biopsy. An area of skin will be numbed. A quarter-inch cut will be made. Several pieces of muscle tissue, about the size of grains of rice, will be removed.
* Skin biopsy. An area of skin will be numbed. A piece of skin about a quarter inch in diameter will be removed.
* Genetic testing. Some of the samples collected may be used for genetic testing.

Study Description:

This is an observational study to characterize the different types of inflammatory myopathies, understand their etiology, pathogenesis, prognosis, and response to different treatments.

Objectives:

Primary objective: Define the different types of inflammatory muscle diseases, their etiology, pathogenesis, prognostic factors, and response to different treatments.

Secondary objectives: Study different diagnostic modalities that may help to diagnose and monitor the evolution of the disease in patients with myositis.

Endpoints:

Primary endpoint: Severity of muscle, skin, pulmonary, and joint involvement. Study of the immune dysregulation, transcriptomic changes, and genetic modifications in patients with inflammatory muscle diseases.

Secondary endpoints: Utility of standard of care laboratory, radiologic, electrophysiologic, and clinical studies to diagnose and monitor the evolution of the disease in patients with myositis.

Eligibility Criteria:
* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Ability of subject, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent and/or assent document.

2a. Patients are adults and minors of age 12 or older, with possible inflammatory myopathy (suspected or confirmed)

OR

2b. Healthy volunteers will be adults aged 18 or older.

EXCLUSION CRITERIA:

1. Unwilling to participate in research studies or to provide research samples or data.
Ketamine for Major Depressive Disorder

The purpose of this study is to measure the amount of ketamine in blood over time in subjects diagnosed with Major Depressive Disorder (MDD) and explore the anti-depressive effects of ketamine delivered by transdermal patch.

SHX-C301 is a Phase 1, first in human, single-blind, multi-center clinical study to evaluate the pharmacokinetics (PK), safety and antidepressant effects of SHX-001 transdermal patch low dose delivered based on prediction and high dose delivered based on the estimation from the low dose PK in subjects with MDD and sub-optimally controlled by standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Present a current depressive episode of at least 8 weeks
* Have a body mass index (BMI) of 18-35 kg/m2 (inclusive) at screening
* Agree to use adequate methods of contraception during the study (and for X days after discharge)

Exclusion Criteria:

* A history of alcohol consumption exceeding 14 drinks/week within the 5 years before study entry.
* Use of prescription or non-prescription drugs, vitamins, or dietary supplements within 14 days prior to the first dose of study medication except ongoing stable dose of antidepressant.
* Treatment with any investigational drug, use of any known CYP3A4 enzyme-inducing/inhibiting agents (e.g., barbiturates, phenothiazines, cimetidine, St. John's Wort) or herbal supplements within 7 days prior to the first dose of study medication
* A history of drug abuse or dependence within 180 days of screening
* A febrile illness within 5 days prior to the first dose of study medication.
* A known hypersensitivity to ketamine
* A history of use ketamine for Major Depressive Disorder and did not respond to ketamine
* Recent use of ketamine in any formulation for any indication (within 4 weeks prior to screening)
An Exploratory Study of ctDNA-MRD in Predicting the Efficacy of Esophageal Squamous Cell Carcinoma

The purpose of this study is to observe and evaluate the correlation between ctDNA-MRD and the therapeutic effect and prognosis of stage II-IVA operable esophageal squamous cell carcinoma.

ESCC patients with II-IVA resection will undergo MRD examination at the following time: the first examination is before the operation, the second examination is 7-10 days after the operation, and then 1 month after the operation, 2 weeks after the end of adjuvant treatment (if available), the follow-up period (every 3 months if there is no postoperative treatment) and the progress (the progress of the disease confirmed by the researcher), the patients will receive close MRD monitoring to evaluate the correlation between ctDNA-MRD and therapeutic efficacy and prognosis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with stage II-IVA Esophageal squamous cell carcinoma confirmed by clinical pathological staging;
2. ≥18 years;
3. Eastern Cooperative Oncology Group performance status score (ECOG PS) is 0 \~ 1 points;
4. Expected survival time ≥ 6 months;
5. Patients agree and have the ability to follow the planned study visits, laboratory tests and other research steps.

Exclusion Criteria:

1. Patients with other malignant tumors;
2. Patient had undergone surgery before admission;
3. Pregnant or lactating women;
4. Patients with other serious diseases;
5. Patients who could not understand the experiment content and could not cooperate with them and refused to sign the informed consent form;
6. Patients with contraindications to radiotherapy and chemotherapy;
7. Other researchers think it is not suitable.
Collection of Blood and Bone Marrow From Patients With Aplastic Anemia for Analysis of Adhesion Molecules, Chemokines and Their Receptors

This study is designed to collect bone marrow and/or peripheral blood cells and plasma, for the analysis of adhesion molecules, chemokines and their receptors from newly-diagnosed aplastic anemia patients, and patients treated with antithymocyte globulin plus cyclosporine


Eligibility Criteria:
Inclusion Criteria:

* patients who fulfilled entry criteria of acquired aplastic anemia age range 16-70 years

Exclusion Criteria:

* Patients complicated with diabetes, tumor, pregnancy, active infection, or connective tissue diseases, such as systemic lupus erythematosus.
Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

The study aims to investigate the modulation of regional brain activation in schizophrenic patients by psychopharmacological treatment with either haloperidol, amisulpride or olanzapine. The study will be performed with functional magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI).

The current study aims to investigate the following issues:

* Changes in cognitive activation patterns under therapy with the typical neuroleptic haloperidol as compared to the atypical antipsychotics amisulpride and olanzapine
* Relationship of these changes in activity to psychopathological, neuropsychological and pharmacotherapeutic variables (e.g. drug plasma level) as well as to certain biological markers (HVA, prolactin)
* Relationship between diffusion anisotropy as an indicator for structural connectivity and cognitive activation patterns under antipsychotic treatment

Eligibility Criteria:
Inclusion Criteria:

* In- and outpatients of either sex
* Able to comply with the protocol
* Having given their written informed consent of their own free will
* Total BPRS (PANSS-derived, 1-7 points) minimum 36 points at baseline
* Schizophrenic or schizophreniform disorder according to DSM-IV criteria (295.10, .30, .40, .90)
* Definite right-handedness (according to the modified Edinburgh Handedness Inventory)
* Age 18 - 50 years

Exclusion Criteria:

* Co-morbid psychiatric axis I disorder (DSM-IV) other than schizophrenia
* Axis II disorder according to DSM-IV
* Present or past history of substance and drug dependence (including alcohol dependence)
* Participation in a clinical trial within the previous three months
* Lack of insight
* Suicidal ideations or aggression against others
* Consumption of caffeine-containing beverages within 6 hours before assessments
* Clinically significant findings in ECG or EEG
* Known intolerance against neuroleptics
Health Care Access for Asylum Seekers in Brittany : Description, Associated Factors and Levers of Improvement

The main objective of this research is to study the logics and the associated factors with asylum seekers use of dedicated health structures.

This objective aims to address major concerns related to the entry and continued participation in the health care system of asylum seekers, including the medical and social dimensions.

It aims to produce, then analyze and disseminate data on the factors associated with seeking asylum seekers to optimize the care of migrants in the French health system


Eligibility Criteria:
Inclusion Criteria:

- Adult asylum seekers who have applied for asylum in the prefecture of Brittany from May 22, 2018 to May 21, 2019 (or one year after obtaining authorization from the CCTIRS and the CNIL).

Exclusion Criteria:

* Migrants not asylum seekers (with tourist visa, migrants of the European Union (foreign nationality and not membership in the Schengen area), migrants arriving in a family reunification, migrant in irregular situation).
* Minor : unaccompanied foreign minor or with their family
* Incapacity of a person to consent
Habitual Abortion Study: Oral Dydrogesterone Treatment During Pregnancy in Women With Recurrent Miscarriage

The purpose of this clinical study is to demonstrate the shift from inflammatory cytokines to non-inflammatory cytokines in women suffering from habitual abortion treated with dydrogesterone (Duphaston).


Eligibility Criteria:
Inclusion Criteria

* Women with a history of idiopathic recurrent miscarriage, based on a documented history of at least three spontaneous consecutive miscarriages before 20 weeks gestation with the same partner Exclusion Criteria
* Any verifiable cause of the recurrent miscarriages apart from luteal phase defect (e.g. systemic lupus erythematosus \[SLE\], infections with chlamydia or mycoplasma)
* Any gynecological neoplasias or anatomical abnormalities that oppose pregnancy
* Concurrent infertility treatment/superovulation protocol
Endostar in Combination With Chemoradiotherapy in Patient With Advanced Non-small Cell Lung Cancer

To investigate the safety and efficacy recombinant human endostatin(endostar) durative transfusion combined with cocurrent chemoradiotherapy in advanced non-small cell lung cancer(NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* 1. Male or female patients, age: 18-70 years of age
* 2. Pathology was diagnosed as non-small cell lung cancer. According to the Tumor Node Metastasis（TNM）stage of the 8th edition of the International Association for the Study of Lung Cancer in 2017, And the pathological stage was identified as stage IIIa-b.
* 3. No previous chest radiotherapy and radiotherapy, immunotherapy or biological therapy.
* 4. Eastern Cooperative Oncology Group (ECOG) test scored 0-1.
* 5. Serum hemoglobin ≥ 100g/L, platelet ≥ 100 × 109/L, absolute number of neutrophils ≥ 1.5 × 109/L.
* 6. Serum creatinine ≤ 1.25 times the upper limit of normal(UNL) or creatinine clearance ≥ 60 mL/min.
* 7. Serum bilirubin ≤ 1.5 times UNL, Aspartate aminotransferase (AST) and adenosine triphosphate (ALT) ≤ 2.5 times UNL, alkaline phosphatase ≤ 5 times UNL.
* 8. Forced vital capacity rate of one second（FEV1）\>0.8 litre.
* 9. Coagulation function is normal
* 10. lesions are measurable according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST1.1)standard
* 11. Sign the inform consent form with good compliance

Exclusion Criteria:

* 1. Carcinoid or small cell lung cancer
* 2. Patients with any distant metastasis
* 3. patients with previous or current malignancy, except for skin non-melanoma or carcinoma in situ in the cervix
* 4. Any other disease or condition is a contraindication to chemoradiation (eg, active infection, 6 months after myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy).
* 5. Pregnancy or breastfeeding women
* 6. Women who may be pregnant but are unwilling to take appropriate contraception
* 7. Hereditary bleeding or coagulopathy
Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Essential Tremor

The objective of this study is to evaluate the safety and feasibility of Auto Focusing (AF) echo imaging using the ExAblate Neuro system

This clinical investigation is a feasibility study designed to evaluate the safety and feasibility of the ExAblate Neuro system to perform AF echo imaging in patients diagnosed with idiopathic Essential Tremor. during the standard care procedure for ET, patients will be injected with Definity microbubbles which will enable the ExAblate Neuro system to perform the AF imaging.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female age 22 years or older
2. Able and willing to give consent and able to attend all study visits
3. A confirmed diagnosis of Essential Tremor resistant to medication therapy
4. Able to fit into MRI unit
5. Able to tolerate the procedure with or without some form of sedation
6. Able to communicate sensations during the ExAblate MRgFUS procedure
7. Able to activate Stop Sonication button during the ExAblate MRgFUS procedure

Exclusion Criteria:

1. Presence of unknown or MRI unsafe devices anywhere in the body.
2. Patients with known intolerance or allergies to the MRI contrast agents
3. Women who are pregnant
4. Patients with advanced kidney disease or on dialysis
5. Significant cardiac disease or unstable hemodynamic status
6. Patients exhibiting any behavior(s) consistent with ethanol or substance abuse
7. History of a bleeding disorder
8. Patients receiving anticoagulant or drugs known to increase risk of hemorrhage
9. Patients with cerebrovascular disease
10. Patients with brain tumors
11. Individuals who are not able or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours)
12. Patients who are currently participating in another clinical investigation
13. Patients unable to communicate with the investigator and staff
14. Patients who have cardiac shunts
15. Patients with relative contraindications to Definity ultrasound contrast agent including subjects with a family or personal history of arrhythmia's
16. Patients with chronic pulmonary disorders
17. Patients with a history of drug allergies, uncontrolled asthma or hay fever
18. Patients who have had deep brain stimulation or a prior neuroablative procedure
19. Women who are pregnant or nursing
20. Patients who have been administered botulinum toxins into the arm, neck, or face for 5 months prior to enrollment in the study.
Prevention of the Progression of Coronary Calcification With Use of Spironolactone in Peritoneal Dialysis Patients

Vascular calcification is a frequent complication in dialysis patients and is strongly associated with mortality. Its pathogenesis is complex and involves a series of markers that act on the vascular microenvironment. There is evidence that aldosterone is one of the biomarkers and may have a role in osteoinductive pathways.The aim of this study was to evaluate the effect of spironolactone, an inhibitor of mineralocorticoid receptor, in the progression of coronary calcification in patients undergoing peritoneal dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Coronary calcium score \> 30 Agatston unit
* Peritoneal dialysis for at least 6 months

Exclusion Criteria:

* Use of spironolactone in the last 3 months
* Mean serum potassium \> 6 mEq/L in the last 3 months
* Cardiac revascularization surgeries
* Arrhythmias
* Pregnancy