cyrilzakka/clinical-trials huggingface dataset:
Effects of Education on Stigma and Quality of Life in Individuals With Type 1 Diabetes

This clinical trial aimed to examine the effects of anti-stigma psychoeducation based on the Roy Adaptation Model on stigma and quality of life in individuals with Type 1 Diabetes.The main questions it aims to answer are:

1. Does anti-stigma psychoeducation reduce stigma of individuals diagnosed with Type 1 Diabetes?
2. Does anti-stigma psychoeducation improve the quality of life of individuals diagnosed with Type 1 Diabetes?

Researchers will compare the group that did not receive stigma prevention psychoeducation with those that did.

Participants will receive 7 sessions of the psychoeducation once a week. An evaluation session will be administered 3 months after the psychoeducation.

Researchers will assess all participants' stigma and quality of life before, after and 3 months after the psychoeducation.

Individuals who were diagnosed with Type 1 Diabetes at least 6 months ago, are between the ages of 18-75, and can speak and understand the language spoken will be included in the study. Individuals with hearing and visual impairments and those diagnosed with mental retardation will not be included in the study. Participants will be assigned to the intervention and control groups by the statistician through randomization. Each group will consist of 18 people.

Stigma prevention psychoeducation will be applied to the intervention group. This psychoeducation will be conducted as a group education. No intervention will be applied to the control group.

The researcher will evaluate the stigma and quality of life of the intervention and control groups before, after and 3 months after the education. pre-test and post-test and 3-month follow-up Group psychoeducation will be applied to the participants in the intervention group once a week. After the education, they will be evaluated according to the nursing outcome criteria

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Type 1 diabetes at least 6 months ago,
* Being between the ages of 18 and 75,
* Speaking and understanding Turkish,

Exclusion Criteria:

* Having hearing and vision impairment
* Being diagnosed with mental retardation
Sirius in Gynaecological Laparoscopic Surgery

Precision Robotics' Sirius Robotic Flexible Endoscopic System is a new fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction.

A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.

The study is a single-arm prospective study to evaluate the Performance and Safety of the SIRIUS Endoscope System.

Minimally invasive surgery (MIS) is well established in gynecological surgery. Compared to laparotomy, MIS is associated with reduced morbidity and quicker recovery. With advancement in laparoscopic technology and techniques, MIS in gynecology has progressed from multi-port to single incision laparoscopic surgery (SILS) and vaginal natural orifice transluminal endoscopic surgery (vNOTEs), thus further reducing morbidity and enhancing recovery.

One of the challenges of MIS is the restriction of the range of surgical movement. To overcome these technical challenges, articulated instruments are increasingly being used. The SIRIUS Endoscope System is a new, fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction. The articulated tip has three degrees of freedom, enabling C and S-shaped bending, and providing a wider field of view compared to conventional laparoscopes. This wider field of view is of advantage for SILS and vNOTEs. Presently available commercial systems do not have the same field of view or degrees of freedom.

A first in-human, proof of concept, and early development study of the SIRIUS Endoscope System was done at GHK in 2021 (HKU-GHK IRB 2021-01, ClinicalTrials.gov NCT05048407). The successful completion of 11 of 13 (85%) planned procedures in this sequentially reported, prospective case series, shows that the SIRIUS Endoscope System can be used with indications of safety, and efficacy for intermediate and major MIS laparoscopic procedures in gynecology. The findings have been submitted for consideration for publication.

Based on the outcome of this study, further improvements to the SIRIUS Endoscope System have been made to enhance safety, reliability, and usability. This proposed prospective study is a confirmatory study to evaluate the performance and safety of the SIRIUS Endoscope System in preparation for regulatory approval.

Eligibility Criteria:
Inclusion Criteria:

Eligible women, 18 or older, who are planned for laparoscopic gynaecological surgery and willing to provide informed consent prior to surgery

Exclusion Criteria:

1. Patient is pregnant, or planning on becoming pregnant
2. Obese patients (BMI \>35)
3. Patient with known contraindication(s) to Laparoscopic Gynecological Surgery
4. Patient with operations planned for longer than 4 hours
5. Subjects are considered ineligible for the study as judged by the investigator.
Study of ARO-DUX4 in Adult Patients With Facioscapulohumeral Muscular Dystrophy Type 1

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ARO-DUX4 in participants with facioscapulohumeral muscular dystrophy Type 1 (FSHD1). In Part 1 of the study, participants will receive one dose of ARO-DUX4 or placebo. In Part 2 of the study, participants will receive 4 doses of ARO-DUX4 or placebo. Participants who complete Part 1 will have the option to re-screen and re-randomize into Part 2. All participants will undergo pre- and post-dose MRI-guided muscle biopsies (a total of 2 biopsies). Participants who complete Part 1 and enroll in Part 2 will be required to undergo an additional screening biopsy. Participants completing Part 1 or Part 2 may have the option to continue to receive drug in an open-label extension study or may be eligible to participate in later-stage clinical studies.


Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed FSHD1 based on Screening evaluation or source verifiable medical record
* Clinical severity score between 3 and 8 (scale, 0 to 10)
* Must have eligible lower extremity muscle for biopsy as determined from MRI by a central reader
* A 12-lead electrocardiogram (ECG) at Screening with no abnormalities that may compromise participant's safety in the study
* Participants of childbearing potential and their partners must use highly effective contraception during the study and for at least 12 weeks following the end of study or last dose of study medication, whichever is later. Males must not donate sperm during the study from Day 1 until at least 12 weeks following the end of study or last dose of study medication, whichever is later.

Exclusion Criteria:

* Human Immunodeficiency Virus (HIV) infection as shown by presence of anti-HIV antibody (seropositive) at Screening
* Seropositive for hepatitis B (HBV) or hepatitis C (HCV) at Screening
* Uncontrolled hypertension
* Severe cardiovascular disease
* History of thrombolic events
* Platelet count less that the lower limit of normal at Screening
* History or presence of: a hypercoagulable state, nephrotic range proteinuria, antiphospholipid antibody syndrome, myeloproliferative disease, inability to ambulate, use of hormone-based contraceptives.
* Any contraindication to muscle biopsy or MRI

Note: additional inclusion/exclusion criteria may apply per protocol
Pharmacogenetics of Alcohol: Treatment Implications

This study will explore the hypothesis that effects of alcohol are in part mediated by increased production of neuroactive steroids, which interact with GABAA-receptors. We propose to study non-dependent drinkers using a 4-session within-subjects design in which alcohol / placebo is paired with dutasteride / placebo pretreatment. Dutasteride is a 5-alpha steroid reductase (5AR) inhibitor that limits the production of dihydrotestosterone and the 5a-reduced neuroactive steroids allopregnanolone, pregnanolone and 3a,5a-androstanediol.

Alcohol has multiple pharmacological effects, though which of these effects relate to the risk of alcohol dependence is not clear. Animal studies indicate that the neuroactive steroid allopregnanolone is an alcohol-modulated endogenous agonist at GABAA receptors and that genetic variation in steroid 5a-reductase type I gene which generates neuroactive steroids, may moderate alcohol effects. To better define the role of neuroactive steroids we will conduct a laboratory study of non-alcohol dependent drinkers using a 4-session design in which alcohol/placebo beverage is paired with dutasteride/placebo pretreatment. Dutasteride, an inhibitor of both type I and type II 5a-reductase enzymes, blocks the production of 5a-reduced neuroactive steroids. This study will extend our preliminary findings with finasteride by including a) a placebo control for alcohol, b) a more specific inhibitor of both 5a-reductase isoenzymes, c) a larger group of subjects (including both light and heavy drinkers).

Eligibility Criteria:
Inclusion Criteria:

* Main Study: Subjects will be healthy volunteers with or without parental history of alcoholism who are 21-45 years old and who have a BMI \>18.5 and \<32.5. Drinking history: All subjects must report at least one occasion in the prior month of drinking at least 3 drinks on a single day; additionally, LD subjects will be selected if they drink 1-3 drinks, 1-3 times per week (up to 5 drinks per week on average), with no more than one occasion in the past 2 months on which they drank \>4 drinks. HD subjects will be selected if they report drinking at least 10 drinks per week, with at least one episode per week of heavy drinking.

Exclusion Criteria:

* Main Study: Subjects cannot have a current or past DSM-IV diagnosis of alcohol or drug dependence, current or past 24-months diagnosis of alcohol or drug abuse or another major psychiatric disorder, neurological illness, have had a hypersensitivity reaction to dutasteride, evidence of liver dysfunction, currently be using benzodiazepines, other psychotropic medications or medications that are known to influence steroid hormone levels or metabolism or modify the effects of alcohol. Nicotine-dependent subjects will be excluded to avoid the confounding effects of nicotine withdrawal during day-long laboratory sessions. Women are not allowed to participate. Subjects anticipating moving from the area during the period of their planned study participation will be excluded from study entry.
Alpha-blocker Plus Diuretic Combination Therapy as Second-line Treatment for Nocturia in Men

The aim of the present study was to determine whether the combined administration of a diuretic agent, hydrochlorothiazide, at night would improve the frequency of nocturia unresponsive to alpha-blocker monotherapy in men with LUTS.

Because nocturia may result in sleep disturbances, daytime fatigue, a lower level of general well-being, and an increased risk of falling at night, it is among the most bothersome of the lower urinary tract symptoms (LUTS). Nocturia is related to a variety of conditions such as aging, overactive bladder (OAB), benign prostatic hyperplasia (BPH)/LUTS, medications, diabetes mellitus, diabetes insipidus, anorexia nervosa, and sleep disturbance. In a previous study, we suggested that treatment with terazosin can reduce episodes of nocturia, both subjectively and objectively, in some men with LUTS. Other study showed that in men with nocturnal polyuria, furosemide resulted in a significant reduction in night-time frequency and percentage of the voided volume.

Eligibility Criteria:
Inclusion Criteria:

* no response or \< 25% reduction in subjective nocturia by the IPSS question 7 after 4-weeks of treatment with terazosin
* no response or \< 25% reduction in objective nocturia by the FVC after 4-weeks of treatment with terazosin
* nocturia on average two times or more per night (according to the FVC) after 4-weeks of terazosin therapy

Exclusion Criteria:

* use of medications for the control of bladder symptoms
* use of sedatives or tranquillisers for treating sleep disturbances
* bladder tumours
* bladder stones
* urethral strictures
* neurogenic bladder dysfunction
* restricted mobility
* working primarily at night
* a documented history or clinical symptoms of prostatitis, prostate cancer, or prostatic intraepithelial neoplasia on biopsy
* serum PSA levels of \>20 ng/mL
* a history of prostate surgery or radiotherapy, acute urinary retention or an indwelling catheter
* evidence of acute urinary infection (pyuria and bacteriuria)on urine analysis
Aerosolized Randomized Iloprost Study II (AIR - II) Long-Term Safety, Tolerability, and Clinical Effects of Iloprost Inhalation in Patients With Primary or Secondary Pulmonary Hypertension

The purpose of this study is to determine whether the study drug is effective in the long-term treatment of primary or secondary pulmonary hypertension

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients
* Secondary pulmonary hypertension
* Mean pulmonary artery pressure equal or above 40 mmHg or primary pulmonary hypertension with a pressure equal or above 30 mmHg while resting during appropriate conventional treatment
* Written informed consent after having been duly informed about all diagnostic and therapeutic measures involved in the study

Exclusion Criteria:

* Clinical Instability at baseline
* Pulmonary venous obstruction
* Global respiratory insufficiency
* Obstructive ventilation disorders, Interstitial pulmonary disease
* Cerebrovascular events
* Myocardial infarction or major cardiac surgery within 3 months prior to baseline
* Bleeding disorders or bleeding risk
* Severe hepatic insufficiency or renal insufficiency
* Malignant diseases
* HIV positive
* Pregnancy, female patients of child-bearing potential without adequate contraception and nursing mothers
* Congenital or acquired valvular defects and myocardial function disorders not related to pulmonary hypertension
* Prior pulmonary embolism
* Collagenosis
* Pulmonary arterial or valvular stenosis
A Long Term Follow-up Study of Patients From the REP 301 Protocol

The REP 301 treatment protocol involved the treatment of patients with chronic hepatitis B / hepatitis D co-infection with two agents: REP 2139-Ca and pegylated interferon (peg-IFN). In this protocol, similar reduction/clearance of serum HBsAg and improved response to immunotherapy were observed in addition to clearance of serum HDV RNA. The REP 301 protocol was designed to include a 24 week follow-up period after treatment, however given the strong antiviral response against HBV and HDV infection in these patients, it is now important to extend the follow-up period in these patients to monitor over a longer period after treatment the safety and efficacy combined REP 2139-Ca / peg-IFN treatment in patients in the REP 301 protocol.

The REP 301-LTF is a long-term follow-up, non-blinded study of patients from the REP 301 protocol. In this study, all eligible patients from the REP 301 protocol will have their followup evaluation extended for an additional 3 years, consisting of 6 visits scheduled every 6 months following the last follow-up visit scheduled in the REP 301 protocol. During each visit a physical examination and documentation of any symptoms, experiences will be conducted as well as blood tests for safety and virology as described below. This study will examine the long term safety effects in patients who have completed of treatment exposure in the REP 301 trial (REP 2139-Ca therapy for 30 weeks and PEG-IFN taken for 48 weeks with a 15 week overlap in combination) and the duration of suppression of serum HBV and HDV viremia observed in the REP 301 protocol. This requires that subjects have completed antiviral treatment in the REP 301 protocol and are not immediately transitioned to further antiviral treatment unless necessary. The total duration of this study for each subject is 3 years.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent.

Exclusion Criteria:

1. Any patients not enrolled in the REP 301 protocol or not successfully completing all treatment and follow-up visits in the REP 301 protocol
2. A history of alcohol abuse within the last year
3. The use of illicit drugs within the past two years.
4. Inability to provide informed consent.
5. Inability or unwillingness to provide blood samples.
A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS

The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will assess the safety and immunogenicity of the combination therapy. The target population is women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive. Participants will receive 6 vaccines along with 2 doses of trastuzumab.

This study began at the Abramson Cancer Center of the University of Pennsylvania and will continue at H. Lee Moffitt Cancer Center and Research Institute.


Eligibility Criteria:
Inclusion Criteria:

* Women \>= 18 years.
* Ductal carcinoma in situ (DCIS) that express HER-2 3+ on 10% of the DCIS that have not had definitive surgery are diagnosed by core biopsy or NL surgical biopsy with positive margins.
* Patients that are ER+ will take anti-estrogen therapy for treatment of their DCIS during vaccinations.
* Women of childbearing age with a negative pregnancy test documented prior to enrollment.
* Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
* Women of childbearing potential must agree to use a medically acceptable form of birth control during their participation in the study.
* Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.

Exclusion Criteria

* Pregnant or lactating.
* Positive for HIV or hepatitis C at baseline by self-report.
* Potential participants with coagulopathies, including thrombocytopenia with platelet count \<75,000, INR\> 1.5 and partial thromboplastin time \> 50 sec
* Major cardiac illness MUGA or ECHO \<50% EF.
* Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).
Clinical Evaluation of Narrow Band Imaging Colonoscope

The purpose of the study is to determine if colonoscopic examination using a colonoscope with a narrow band imaging light is more effective at detecting polyps compared to a colonoscope with standard full spectrum white light.

This is a clinical study to evaluate whether the use of a new type of colonoscope may improve the detection of colon polyps. Though colonoscopy is currently the best test for colon cancer screening, it remains imperfect. Research has found that about 25% of polyps may actually be missed during colonoscopy using standard full spectrum white light imaging. Advances in colonoscopic technology hold the potential to decrease the miss rate of colorectal neoplasms. A new colonoscope uses narrow band imaging, whereby the colon is illuminated using only a subset of the white light spectrum, 415nanometers (blue) and 540 nanometers (green) rather than the standard full spectrum white light (red, green and blue). Initial studies by other groups suggest that these narrow band images highlight small blood vessels of colon polyps. As such, we hypothesized that the use of NBI would improve the identification of neoplasms through the color differentiation of precancerous or cancerous polyp (appearing brown) from normal colon mucosal lining (appearing green), and potentially lead to a reduction in polyp miss rate. We aimed to study the polyp miss rate, and compare narrow band imaging to white light examination.

Eligibility Criteria:
Inclusion Criteria:

* referred for elective outpatient colonoscopy

Exclusion Criteria:

* known inflammatory bowel disease
* personal or family history of polyposis syndrome
* referral for resection of a known lesion
Institut Paoli Calmettes Myelodysplastic Syndromes Database

Database of Institut Paoli-Calmettes patients diagnosed with Myelodysplastic Syndromes


Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of Myelodysplastic Syndromes

Exclusion Criteria:

* None
The Role of Placental Myeloid Cells During Gestation, Labor and Disease

Immature myeloid cells (IMCs) that are generated in the bone marrow, and differentiate into mature granulocytes, macrophages and dendritic cells (DCs) in the steady state. Recently, it was demonstrated that the IMC population expands in malignancy, both in animal models and in humans. These cells were described as immunosuppressants but have also been shown to promote tumor angiogenesis. Accordingly, IMCs were also found to take part in the burn injury wound healing process and other pathologies that involve angiogenesis. It was shown in the investigators' laboratory, that a very similar population of IMCs populates the mouse and human placenta, and that these cells actively promote angiogenesis.

Dendritic cells (DCs) that can differentiate from IMCs, are antigen presenting cells (APCs) that initiate and coordinate the innate and adaptive immune responses. DCs can take up a diverse array of antigens and present them to T cells as peptides bound to MHC products. These antigen-specific responses are critical for resistance to infection and tumors. Conversely, DCs have roles in autoimmunity, transplant rejection and immunological tolerance. In the reproductive system, DCs were shown to account for 5%-10% of all hematopoietic cells in the uterine decidua at the embryonic implantation site. They were shown to promote angiogenesis during early pregnancy, especially during implantation. Very little is known about their function in the placenta and in the latter part of pregnancy when significant angiogenesis takes part.

The investigators' preliminary mouse experiments and human data, demonstrate a shift in IMC/DC populations with the development of the placenta. The investigators hypothesize that this population shift may contribute to the labor and delivery process.

The investigators' aim is to understand the role of these myeloid cell populations during pregnancy, to characterize their phenotype and try to shed light on the cellular and molecular mechanisms of pregnancy complications, such as preeclampsia, pre-term labor, intrauterine growth restriction, etc.

: Identification of proangiogenic myeloid cell populations in human placentas. Placental myeloid cells from different stages of pregnancy will be analyzed, using flow cytometry.

Aim 2: Characterization of the physiology of myeloid cells identified. Cells will be isolated, cultured and tested for proangiogenic properties using Matrigel plug assays, endothelial tube formation assays, etc. Immune tolerance will be analyzed in vitro using T cell proliferation studies, cytokine production, etc.

Aim 3: The role of placental myeloid cell populations in pathologies of pregnancy.

Placentas from human pregnancy pathologies that involve placental dysfunction, such as preeclampsia, pre-term labor, intrauterine growth restriction, will be analyzed using the methods mentioned above

Eligibility Criteria:
Inclusion Criteria:

* pregnant women

Exclusion Criteria:

* none