cyrilzakka/clinical-trials huggingface dataset:
An Observational Study to Learn More About Treatment Patterns and Factors Determining the Choice of Treatment in Canadian Men With Metastatic Hormone Sensitive Prostate Cancer in Routine Medical Care

This is an observational study in which only data are collected from adult Canadian men with metastatic hormone sensitive prostate cancer (mHSPC) are studied. Participants will not receive any advice on treatment or any changes to the healthcare.

Metastatic hormone sensitive prostate cancer is a cancer of the prostate gland, a male reproductive gland found below the bladder. Metastatic means that cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with anti-hormonal therapy such as androgen deprivation therapy (ADT).

ADT lowers the level of testosterone and slows down the growth of cancer cells. However, in some cases, ADT alone is not sufficient and doctors recommend combining it with treatments like Androgen Receptor Pathway Inhibitors (ARPi) and/or docetaxel to stop the growth of cancer cells.

ARPi slow down the growth of the cancer cells by blocking a sex hormone called the androgens from attaching to the protein found in the cancer cells. ARPi includes medicines like apalutamide, darolutamide, and enzalutamide.

Docetaxel is a medicine used to treat different types of cancer and works by stopping the growth and spread of cancer cells. ADT, ARPi, and docetaxel are approved treatments for men with mHSPC in Canada.

The participants in this study are already receiving treatment for mHSPC as part of their routine medical care from their doctors.


Eligibility Criteria:
Inclusion Criteria:

* Men aged ≥ 18 years diagnosed with mHSPC verified by radiographic evidence of metastasis with Conventional Imaging (CI) or Prostate Specific Membrane Antigen-Positron Emission Tomography (PSMA-PET), and histologically confirmed carcinoma
* At least 6 months follow-up post-diagnosis period, unless the patient died earlier

Exclusion Criteria:

* ADT use for \>6 months or any use of ARPi (ADT use in the neoadjuvant or adjuvant setting where the patient has been off treatment for 12 months or more is allowed)
* This criterion is to ensure that we are capturing mHSPC patients and not Metastatic Castration-Resistant Prostate Cancer (mCRPC) patients who have progressed from earlier stages
* Evidence of inclusion in clinical trials during the study period
Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant

The purpose of this study is to compare Reduced Intensity Conditioning protocols containing either Thymoglobuline or Alemtuzumab in patients undergoing allogeneic transplant from voluntary unrelated donors.

The reduction of intensity of conditioning is currently indicated for patients who cannot undergo standard myelo-ablation due to their age, comorbidities or type of pathology. Furthermore, the rationale to use RIC regimens is based on the observation that the infusion of alloreactive donor lymphocytes may yield to a graft versus tumour effect. However, in this kind of regimens the morbidity and TRM due to GvHD are still a concern and in vivo T-depletion is a necessary treatment. Both monoclonal (Alemtuzumab) and polyclonal T-depletion protocols carry risks and benefits. Benefits being a better prophylaxis for GvHD, and risks being an higher incidence of post-transplantation infections and relapse. At the moment, it is not clear which type of regimen, monoclonal or polyclonal, is better for the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Group 1: 55-65 yo patients suffering from Acute Myeloblastic and Lymphoblastic Leukemia, Myelo-displasia, Chronic Myeloid Leukemia and Idiopathic Myelofibrosis (according to IBMDR operative manual)
* Group 2: patients \<= 65 yo suffering from lympho-proliferative diseases according the REAL classification:
* High-doses chemotherapy relapsed CLL (B and T)
* Follicular lymphoma relapsed after 2 standard chemotherapy regimens or after high-doses chemotherapy
* Mantellar lymphoma relapsed after 1 standard chemotherapy regimen or after high-doses chemotherapy
* Lympho-plasmacytoid and B marginal zone lymphoma in relapse after 2 standard chemotherapy regimens or after high-doses chemotherapy
* Advanced (stage ≥ III A) or relapsed T lymphomas
* Large B-cells lymphomas in 2nd or further complete remission after relapse from high dose chemotherapy and autotransplant or after 2 standard chemotherapy regimens
* Fungal mycosis in advanced stage (≥ III A) or in chemosensitive relapse after 2 lines of chemotherapy and Sezary syndrome in chemosensitive relapse after 1 line of chemotherapy
* Hodgkin disease relapse after autotransplant with chemosensitive disease or in relapse after 1 year from chemotherapy and not eligible for autotransplant since an insufficient mobilization of autologous hemopoietic stem cells.

Exclusion Criteria:

* Performance status \< 70% (Karnofsky)
* Left ventricular cardiac ejection fraction \< 40% or receiving treatment for heart failure
* DLCO pulmonary \< 40% or receiving continuous oxygen therapy
* Neuropathy (previous or at present)
* Pregnancy
* Patients with arterial hypertension not controlled with multi-pharmacological treatments
* HIV positive
* B-CLL with clear evidence of transformation into Richter syndrome
* Mycosis fungoides with clear evidence of transformation into blasts
* Hodgkin's disease refractory to chemotherapy
* Absence of informed consent
* Psychiatric disease or other condition compromising the signing of the informed consent form or compliance with the treatment
Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy

DDD pacing improves symptoms and relieves LV outflow tract (LVOT) obstruction in most patients with hypertrophic cardiomyopathy (HCM). Notably, when pacing is temporarily discontinued, the beneficial effects of pacing are evident in sinus rhythm. The long term results of this novel therapy are, however, uncertain. We propose (1) to record the hemodynamic changes following \>4 years of pacing; and (2) to determine whether DDD pacing continues to be necessary in patients who have had a substantial relief of their LVOT obstruction. Patients who have had \>50% reduction in LVOT pressure gradients will be randomized to two pacing modalities: DDD at 70 beats per minute and AAI pacing at 70 beats per minute (DDD switched off), and reevaluated after a six-month period.

DDD pacing improves symptoms and relieves LV outflow tract (LVOT) obstruction in most patients with hypertrophic cardiomyopathy (HCM). Notably, when pacing is temporarily discontinued, the beneficial effects of pacing are evident in sinus rhythm. The long term results of this novel therapy are, however, uncertain. We propose (1) to record the hemodynamic changes following \>4 years of pacing; and (2) to determine whether DDD pacing continues to be necessary in patients who have had a substantial relief of their LVOT obstruction. Patients who have had \>50% reduction in LVOT pressure gradients will be randomized to two pacing modalities: DDD at 70 beats per minute and AAI pacing at 70 beats per minute (DDD switched off), and reevaluated after a six-month period.

Eligibility Criteria:
Group 1:

HCM patients, aged grater than 20 years of either gender who received DDD pacemakers at the NIH at least 4 years ago, for relief of LVOT obstruction and drug-refractory symptoms.

Group 2:

HCM patients selected from Group 1 who at the follow-up cardiac catheterization are demonstrated to have either (1) no significant LVOT obstruction (less than 30mm HG at rest and less than 50mm HG with Isuprel); or (2) a substantial reduction of the LVOT obstruction (greater than 50% reduction in LVOT gradient).

Patient who have developed a heart block will be excluded from group 2.

Females must have a negative pregnancy test.
Improved Orthostatic Tolerance = Better Cognitive Function in Parkinson's Disease

Study on orthostatic Hypotension in Parkinson's disease

Orthostatic hypotension (OH) in Parkinson's disease (PD) may not only be related to dizziness or light headedness but to deficits in attention, visual, and verbal memory. Would a successful treatment of OH which includes physiotherapy significantly improve OH and these cognitive deficits? By means of a randomized cross-over trial, we want to measure and compare the effects of OH therapy on orthostatic tolerance, as well as on attention, visuo-spatial working memory, and verbal memory in patients with PD. If confirmed, therapy of orthostatic hypotension would provide a sound and simple approach to improve those cognitive deficits originating from orthostatic hypotension.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's patients
* Diagnostis of OH
* able to perform an ambulatory physiotherapy at Aachen University Hospital.

Exclusion Criteria:

* deep brain stimulation or Pacemaker
* severe psychiatric disease
* severe heart disease
* severe vascular encephalopathy
* dementia
* pregnant or lactating women
* extreme pain or immobility
Chemotherapy-induced Necrosis in Ewing Sarcoma

This is single institution cases series review of histological and clinical data

Investigators will retrieve from the database of the Rizzoli institute all the cases with a histological diagnosis of Ewing sarcoma from 01 Jan 1982 to 31 Dic 2012

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients surgically treated at Rizzoli Institute from 01 Jan 1982 to 31 Dic 2012
2. Patients with diagnosis of Ewing sarcoma of bone who have had neo-adjuvant chemotherapy
3. Diagnosis of Ewing sarcoma localized

Exclusion Criteria:

1. Metastatic disease at presentation
2. Soft tissue origin
3. Radiotherapy before surgery
The Efficiency of Colon Capsule Endoscopy in Colon Cancer Screening

Main objective is to improve colorectal cancer (CRC) screening programme in the Czech Republic and decrease the disease incidence and mortality. The secondary aim is to verify the effectiveness of incorporation of the new minimally invasive device in the prevention programme.

Multicentre, multidisciplinary (3 gastroenterology units; biostatistics department; cooperation with general practitioners), prospective study is focused on examination of individuals with average colorectal cancer (CRC) risk (asymptomatic, age 50-75 years).

In years 2017 - 2019, there will be 230 persons with positive semi-quantitative immunochemical fecal occult blood tests (FIT; QuikRead, Orion Diagnostica Oy, Finland) with cut-off level 75 ng/ml involved. Every person will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards.

Main objective is to show that the negative predictive value (NPV) of the CCE2 applied in patients with positive FIT results is sufficient to include this method in the National CRC screening as filter test with aim to reduce the necessity of subsequent optical colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* age 50 - 75 years
* asymptomatic (no enterorhagy, weight loss or anemia)
* signed informed consent with the study and with colonoscopy

Exclusion Criteria:

* CRC high-risk group patients

  * having first degree relatives diagnosed with colorectal cancer at age ˂ 60 years
  * FAP, HNPCC and other hereditary CRC syndromes probands
  * positive personal medical history of colorectal neoplasia (advanced adenomatous polyp, colorectal cancer)
* recent diagnostic, follow-up or preventive colonoscopy in ≤ 3 years (FOBT-positive colonoscopy, screening colonoscopy)
* colonoscopy contraindication
* severe acute inflammatory bowel disease
* severe comorbidities; likely non-compliance of the patient
* no informed consent signed (with the study and/or with colonoscopy)
Butyrate in Pediatric Inflammatory Bowel Disease

The first prospective randomised placebo-controlled study in the IBD pediatric population was conducted to evaluate the effectiveness of oral sodium butyrate as add-on therapy in IBD.

Butyric acid's effectiveness has not yet been assessed in the pediatric inflammatory bowel disease (IBD) population. This study aimed to evaluate the effectiveness of oral sodium butyrate as an add-on to standard therapy in children and adolescents with newly diagnosed IBD.

This was a prospective, randomized, placebo-controlled multicentre study. Patients aged 6-18 years with colonic Crohn's disease or ulcerative colitis, who received standard therapy depending on the disease's severity, were randomized to receive 150 mg sodium butyrate twice a day (group A) or placebo (group B). The primary outcome was the difference in disease activity and fecal calprotectin concentration between the two study groups measured at 12 weeks of the study.

Eligibility Criteria:
Inclusion Criteria:

* 6 to 18 years of age;
* newly diagnosed, based on the modified Porto criteria, IBD with colon involvement;
* informed consent of the child's parents or guardians to participate in the study.

Exclusion Criteria:

* age \<6 years;
* taking probiotics or dietary supplements in the last 2 weeks prior to study enrollment;
* lack of consent of parents or guardians to participate in the study.
A Longitudinal Study of Effect of Copaxone in RRMS Over 24 Months

To explore whether treatment with glatiramer acetate (GA) may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls.

This is a prospective, observational, single-blinded, longitudinal, 24-month MRI study of the evolution of iron deposits, as evidenced by SWI-filtered phase imaging, in RRMS patients treated with GA and in healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* MS patients diagnosed with clinically definite MS according to the McDonald criteria (Polman et al., 2005)
* Being on GA monotherapy (20mg/day sc) for at least 24 months prior to the 24-month MRI scan
* Having baseline clinical MRI scan that included SWI-filtered phase imaging in a 12-month window from the start day of the of the GA (MS patients)
* Having baseline clinical MRI scan that included SWI-filtered phase imaging (healthy controls)
* MS patients having a RR disease course (Lublin and Reingold, 1996)
* Age 18-65 (healthy controls will be matched to MS patients for age and sex)
* Signed informed consent at the 24-month follow-up
* Pass MRI health screening
* MS patients passing contrast screening
* MS patients having normal kidney function (creatinine clearance \>59)
* None of the exclusion criteria

Exclusion Criteria:

* Patients who had a relapse within 30 days prior to MRI baseline scan date
* Patients who received steroid treatment within 30 days prior to the MRI baseline scan date
* Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study
* MS patients who used other imunomodulatory or immunosuppressant treatment other than GA during the follow-up (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
* MS patients having abnormal kidney function (creatinine clearance \<59)
the Association Between Blood's and Urinary Heavy Metal Level in Pregnant Women and the Spontaneous Abortion

The aim of the study was to define the possible association between heavy iron level and the consequence of pregnancy especially spontaneous abortion and missed abortion. The study population will comprised the first-trimester pregnant women in the PUMCH (Peking Union Medicine College Hospital) during 2017 October to 2018 November. We categorised the patients into two groups, the study group where the patients suffered from spontaneous abortion or missed abortion, and the control group where the patients carry the normal live fetal for at least 8 weeks and ask for artificial abortion. All the cases included in the study were examined with respect to 6 kinds of heavy iron level in venous blood and urine, then correlation analysis was applied to define heavy iron level between two groups.


Eligibility Criteria:
Inclusion Criteria:

- early trimester pregnant women

Exclusion Criteria:

-
Evaluation of the Efficacy of Electroacupuncture in the Treatment of Functional Dyspepsia

Brief Summary Template for the Study:

The goal of this clinical trial is to evaluate whether electroacupuncture can treat functional dyspepsia (FD) in adult participants aged 18 to 65 years, including both males and females, who have been diagnosed with functional dyspepsia based on the Rome IV criteria. The main questions it aims to answer are:

* Does 5 Hz electroacupuncture improve symptoms in functional dyspepsia patients?
* Does 100 Hz electroacupuncture improve symptoms in functional dyspepsia patients?
* Are there differences in the efficacy between 5 Hz and 100 Hz electroacupuncture in treating functional dyspepsia and its subtypes (PDS and EPS)?

Researchers will compare the effects of 5 Hz electroacupuncture, 100 Hz electroacupuncture, and sham electroacupuncture to determine which approach provides more significant symptom relief and whether different frequencies have varying impacts on FD subtypes.

Participants will:

* Receive electroacupuncture treatment at specific acupoints (such as Liangmen, Tianshu, Zusanli, and Xiajuxu) for 30-minute sessions, 3 times a week for 4 weeks.
* Be randomly assigned to one of the following groups: 5 Hz electroacupuncture, 100 Hz electroacupuncture, or sham electroacupuncture (control).
* Have their functional dyspepsia symptoms, quality of life, and any adverse effects monitored and evaluated throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with functional dyspepsia based on Rome IV diagnostic criteria.
* Aged 18 to 65 years, inclusive, with no gender restrictions.
* Normal endoscopy results within the past year, showing no structural explanation for symptoms.
* No acupuncture treatment in the last month.
* Not participating in any other clinical trials in the past 2 months.
* Able to understand and provide informed consent.

Exclusion Criteria:

* Presence of serious or malignant diseases (e.g., cirrhosis, heart failure, gastrointestinal tumors) that could explain dyspepsia symptoms.
* Chronic atrophic gastritis detected in endoscopy results.
* Positive for Helicobacter pylori infection based on C-13 urea breath test or gastric biopsy.
* History of gastrointestinal surgery.
* Recent use (within 2 weeks) of medications affecting dyspepsia, including prokinetics, proton pump inhibitors, antacids, or antidepressants.
* Presence of severe mental or physical conditions, such as dementia or illiteracy, that could interfere with study participation.
* Severe coagulation disorders.
* Substance abuse or alcohol dependence.
* Pregnant or breastfeeding women.
Pain Related Sexual Dysfunction After Laparoscopic Inguinal Hernia Repair

Previous studies have reported that about 3 % of patients who have had open inguinal herniorrhaphy had a visceral, ejaculatory-related pain.

The investigators want to assess this problem among patients after laparoscopic inguinal hernia repair with(self-administered questionnaire study).


Eligibility Criteria:
Inclusion Criteria:

* Male patients
* \>18 yrs

Exclusion Criteria:

* Research protection
Use of PRP in Endometrial Reconstruction

Infertility, which affected 48.5 million couples worldwide in 2010 alone, has many causes; some causes result from issues related to the endometrium. Unfortunately, no cure exists for medical conditions resulting in the destruction of the endometrium, or for non-functional uterus. Thus, safe and effective therapies are needed to treat these diseases and to establish fertility in affected women. These novel techniques refer to the use and application of regenerative/paracrine factors to regenerate the endometrium in patients with Asherman's Syndrome (AS) and Endometrial Atrophy (EA).These new therapies based on the injection of the identified regenerative/paracrine factors and the platelet-rich plasma (PRP) from whole blood in an immunodeficient mouse model with AS/EA, evaluating their contribution and/or effect in the endometrial repair by functional proofs.

The objective is to know the effect of these regenerative factors obtained from Platelet-Rich Plasma in an immunodeficient murine model with AS/EA Blood from patients with Asherman's Syndrome (AS) and Endometrial Atrophy (EA) will be collected, maintained under anticoagulant solution and after several centrifugations PRP will be obtained. Demonstration of a functional endometrium will be proved determining pregnancy and implantation rates as well as the number of live pups/pregnant female in our mice model. Also, the uterus histology will be analysed in treated and untreated mice

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy.
* No pregnancy after hormonal treatment.

Exclusion Criteria:

* Psychiatric diseases.
Neurovascular Complications and White Matter Damage in Acquired Anemias

This is an observational trial, in patients with moderate to severe anemia and control subjects. The main purpose of this study is to understand whether normal brain blood flow, oxygen extraction reserve, white matter volumes, and brain functional connectivity are affected by acquired anemia. The investigators will perform baseline MRI monitoring for all subjects. All eligible subjects will be asked to provide informed consent before participating in the study.

This is an observational trial, in patients with moderate to severe anemia and control subjects. The main purpose of this study is to understand whether normal brain blood flow, oxygen extraction reserve, white matter volumes, and brain functional connectivity are affected by acquired anemia. The investigators will perform baseline MRI monitoring for all subjects. All eligible subjects will be asked to provide informed consent before participating in the study. Comprehensive cerebrovascular MRI, baseline bloodwork, and neurocognitive testing will be collected from all subjects.

Eligibility Criteria:
Inclusion criteria (observational component):

* Age between 16 and 60 years of age.
* Any ethnicity.
* Either sex.
* Anemic group: hemoglobin less than 10.5 g/dl on screening hemoglobin.
* Control group: hemoglobin \>13.2 g/dl for females, \>14.6 g/dl for males, comparable age, sex and ethnicity to currently enrolled anemic subjects.

Exclusion criteria (observational component):

* Diabetes requiring medication.
* Hypertension requiring medication.
* Sleep disordered breathing requiring intervention.
* Body mass index \>35 (morbid obesity)
* Contraindications to MRI, including pacemaker, severe claustrophobia, pregnancy.
* Known systemic inflammatory disease such as inflammatory bowel disease, systemic lupus erythematosus, or scleroderma.
* Known HIV.

Inclusion criteria (interventional component):

* Criteria for observational component, plus
* ron deficiency anemia based upon attending hematologist interpretation of transferrin saturation, ferritin, and other ancillary labs including hs-CRP, MMA.

Exclusion criteria (interventional component):

* Criteria for observational component, plus
* Prior reaction to intravenous iron.
* History of multiple drug allergies.
* History of severe asthma, eczema, or atopy.
* Systemic mastocytosis.
* Severe respiratory or cardiac disease.