cyrilzakka/clinical-trials huggingface dataset:
Genesis of Scleroderma: Role of Environmental Factors in 100 Patients With Scleroderma and 300 Controls

Scleroderma is an autoimmune disease of unknown origin. Recently, the role of environmental factors, and particularly toxic drug exposure, in the genesis of scleroderma has been suggested.

This prompted us to conduct this prospective, case-control, multicentric study, including 2 groups of subjects:

* 100 patients with scleroderma
* 300 sex- and age-matched healthy controls. The aim of our study is to determine whether exposure to toxics is higher in patients with scleroderma compared with healthy controls.

The data of patients with scleroderma and healthy controls will be compared regarding:

* a standardized questionnaire about "cursus laboris" at initial inclusion
* a search for toxics in blood, urine and hair: at initial exvaluation, 6 month and 2 year-follow-up

Eligibility Criteria:
Inclusion Criteria:

* patients with scleroderma with:

  * age range : 18 to 76 years
  * written consent

Exclusion Criteria:

* patients with other connective-tissue disorders
* pregnant women
* patients with psychiatric conditions
* unwritten consent
Impact of Burden in Caregivers of Patients Hospitalized for a Psychotic Episode: a Multicenter Study

Family support is a positive predictor for psychiatric patients. For example, since the 1980s, it has been shown that family psychoeducation improves patient adherence to care and statistically decreases patient relapse and hospitalization rates by half, resulting in lower care costs. Yet, the stress of hospitalizing a patient, seeing the feelings of shame or guilt of caregiver and the impact on their quality of life are rarely taken into account by caregivers during the first weeks hospitalization in a patient's psychiatry.

Barrelet emphasizes the importance of organizing the meeting in the first hours of hospitalization with the family in order to strengthen the alliance, to improve communication.


Eligibility Criteria:
Inclusion Criteria:

* Family members or relatives
* Over 18 years
* Having a relative

  * First hospitalized in psychiatry or hospitalized in psychiatry within 5 years
  * Over 18 years of age
  * Psychotic episode
  * Having been informed of their participation in this study
* In regular contact with the patient prior to hospitalization, at least 4 hours per week.
* French language
* Signed written informed consent.

Exclusion Criteria:

-Psychiatric pathology of another family member than the hospitalized.
Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis

The purpose of this study is to determine the effectiveness and safety of mitomycin C in the treatment of primary sclerosing cholangitis (PSC).


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 or older
* Previously established diagnosis of primary sclerosing cholangitis

Exclusion Criteria:

* American Society of Anesthesiologists class 4 or greater
* Serum creatinine \>= 1.7 mg/dL, eGFR \<= 30 mL/min, or dialysis dependence
* Serum hemoglobin \<= 7 g
* Left ventricular ejection fraction \<= 30%
* Dyspnea with minimal exertion (or supplemental oxygen dependence)
* History of bone marrow disease
* Prior recipient of organ transplantation
* Ongoing chemotherapy
* Obstruction of the upper GI tract
* Pregnant or lactating
* Inability to provide informed consent
Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)

This is a prospective, multicenter, observational, post-market clinical follow-up study in subjects treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization. Data collection will include safety and performance outcome relating to the use of Bearing nsPVA, through 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult women ≥ 18 years old at the time of enrollment.
* Subject has symptomatic uterine fibroid(s), suitable to embolization.
* Subject provides written informed consent.

Exclusion Criteria:

* Subject is pregnant.
* Subject has suspected pelvic inflammatory disease or any other pelvic infection.
* Subject has any malignancy of the pelvic region, (e.g., endometrial neoplasia).
The Lived Experiences of Persons with Early Stage Non-small Cell Lung Cancer and Their Significant Other(s) Following Surgery: a Rapid Ethnographic Approach

To understand the lived experiences, thoughts and habits about exercise and PA of persons with early stage non-small cell lung cancer and their significant other(s) following surgery.

It is important to gather information on the lived lives of persons and their significant other(s) following surgery for early stage non-small cell lung cancer (NSCLC). The adaptations these persons make, the challenges they face and their personal experiences need to be investigated so their thoughts and habits about exercise and physical activity (PA) can be better understood. In this way, rehabilitation programs focused on exercise and PA can be better individualized. The individualization of such programs is heavily influenced by the person's experiences, including beliefs and expectations regarding exercise and PA. Observations of and informal conversations with persons with early stage NSCLC and their significant other(s) following surgery will offer insight into the challenges faced by these individuals and the opportunities for exercise and PA, how this does and could fit, within their everyday lives so this can be enhanced. It is important to align exercise and PA to everyday activities, to make it meaningful to individuals (more likely to engage) and to obtain sustained effects in the long term. The investigators expect this study to show the highly personal views and behaviour of these persons, warranting an equally personal communication approach to discuss these issues with these persons in light of developing individualized rehabilitation programs.

Eligibility Criteria:
Inclusion Criteria:

* Persons who got surgery for early stage I-IIIA NSCLC, one to three months before inclusion;
* If persons received adjuvant chemotherapy/radiotherapy, the inclusion window is one to three months after the end of adjuvant chemotherapy/radiotherapy. If persons receive adjuvant immunotherapy after the end of adjuvant chemotherapy, persons can be included during the immunotherapy;
* Adults (18+ year);
* Ability to give informed consent.

Exclusion Criteria:

* Persons having progressive or recurrent lung cancer;
* Persons who had other malignancies in the last 2 years;
* Persons who do systematically perform or plan to perform structured exercise;
* Persons not living independently at home (e.g. care home, psychiatric institution);
* Psychiatric or cognitive disorders;
* Not understanding and speaking Dutch;
* Not living at home (e.g. nursing home, prison ...).
Short, Animated Storytelling (SAS) for Addiction Stigma Reduction

Stigma towards people with addiction is a well-documented problem that negatively impacts help-seeking, treatment and recovery. Social contact with people recovering from addiction can promote empathy and reduce stigma, but social contact is difficult to scale. Short, animated storytelling (SAS) is a novel health communication approach that scales easily because it can leapfrog barriers associated with language, culture, literacy and education levels. This study will investigate if a SAS video intervention can be used to reduce stigma, boost optimism and hope, and increasing empathy towards people with addiction. The study will also explore mechanisms of action of SAS interventions, by measuring the contribution of sound design to the effect of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Adults with basic English proficiency between the ages of 18-49

Exclusion Criteria:

* None
Rehabilitation of Stroke Patients for Maximal Neurological Restoration

Multimodal imaging of stroke patients. Patients included in the study will be investigated with multiparametric imaging tools including MRI and EEG imaging. Improvements in motor skills will be monitored clinically.

We aim to (i) quantify the size of the brain lesion and assess the surviving functional neural network connections; (ii) Analyze the type and degree of inflammation initiated by the stroke-induced brain lesion. We will stratify inflammation according to lesion volume, surviving functional neural network connections, age, NIHSS and Modified Rankin Scale (mRS) and analyze how inflammation markers change during rehabilitation; (iii) Train the surviving neural network to create new synaptic connections that can maximize restoration of motor functions; (iv) Apply and develop advanced mathematical and computational methods to model and predict how stroke rehabilitation can rewire the neural network connections to best facilitate restoration of lost motor function.

Eligibility Criteria:
Inclusion Criteria:

* subcortical strokes resulting in arm motor deficits.
* admitted to the stroke unit, St Olav´s Hospital during 2021-2023

Exclusion Criteria:

* Previous stroke
* neurodegenerative disease
* brain tumors
* previous neurotrauma or brain operation
* aphasia
* cognitive dysfunction and claustrophobia preventing MRI examinations.
A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation

The purpose of this study is to evaluate the efficacy of predilation with paclitaxel-eluting balloon and bare metal stent implantation VS conventional balloon and drug-eluting stent implantation in terms of restenosis


Eligibility Criteria:
Inclusion Criteria:

* age\> 18 years
* angina or stress test positive for ischemia
* de novo coronary stenosis\>50%

Exclusion Criteria:

* recent myocardial infarction (\<72h)
* severe chronic kidney disease
* allergy to Paclitaxel
* contraindication for combined antiplatelet treatment
* life expectancy \<1 year
* hypersensitivity or contraindication to one of the study drugs
* lack of consent
Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or Fendrix™

The current extension study will assess the persistence of anti-HBs antibodies at Months 12, 24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™. This protocol posting deals with the objectives \& outcome measures of the extension phase at Months 12, 24 and 36. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00291941).

Subjects who received complete full vaccination with Henogen HBV adjuvanted vaccine or Fendrix™ will participate in this persistence study for three long-term time points (12, 24 and 36 months after the first dose of primary vaccination). Blood sampling will be done at each time point to measure immune persistence.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from the subject/ from the parent/ guardian of the subject.
* Subjects who completed the full course of primary vaccination.

Exclusion Criteria:

* Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
* Any confirmed or suspected human immunodeficiency virus (HIV) infection.
A 5-year Observational Follow-up Study to Describe Treatment Patterns in Real World of HCV Patients in China.

A 5-year study to observe and describe long-term patient management and treatment patterns with associated outcomes of patients who previously enrolled in Protocol AI452009 (i.e., the CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279) and had their genotype characterized at diagnosis of HCV infection in a real world clinical practice in China.

A sample of 600 Han ethnic Chinese male or female who are ≥ 18 years old enrolled and completed in the study of AI452-009 (i.e., CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279). In the AI452-009 study, all patients had a recent confirmation of anti-HCV-antibody positive and HCV RNA positive but antiviral treatment naive from 28 university affiliated hospital in China. The primary objective of this study (AI452-018, CCgenos follow up phase, ClinicalTrials.gov Identifier: NCT01293279) is to observe and describe long-term patient management and treatment patterns with associated outcomes of patients who previously enrolled in Protocol AI452009 (i.e., the CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279) and had their genotype characterized at diagnosis of HCV infection in a real world clinical practice in China.

Eligibility Criteria:
Inclusion Criteria:

* None. Patients from AI452-009 study who accepted ICF to be follow up

Exclusion Criteria:

* \< 18 years old not Han ethnic Not be willing to be followed up to 5 years
Evaluation of Efficacy, Quality of Life and Cost Effectiveness of Short-course Radiotherapy Followed by Capecitabine Plus Oxaliplatin chemotheRapy and TME for High-risk Rectal Cancer (ESCORT Trial)

Multimodality treatment including surgery and radiotherapy is the current standard of care in locally advanced rectal cancer. Most clinical trials comparing short course radiotherapy (SCRT) with long course chemoradiotherapy(LCRT) did not find significant differences in oncological outcomes and short-term outcomes even though some debates. Recently, Stockholm III trial comparing SCRT plus delayed surgery with SCRT plus immediate surgery and LCRT demonstrated no differences with respect to short-term outcomes such as complications, mortality, and acute toxicity. However, overall quality of life (QoL) after curative treatment for rectal cancer is still major concern in both SCRT and LCRT. Furthermore, daily hospital visits for 5 weeks may be the cause of the increase of total medical cost due to indirect medical expense in patients with LCRT, especially in rural area. SCRT plus chemotherapy followed by delayed surgery may have the possibility of reducing total hospital costs as well as increasing QoL by proving non-inferiority in terms of perioperative outcomes. The present prospective single-arm phase 2 trial was designed to validate the efficacy, quality of life and cost effectiveness of preoperative short-course radiotherapy plus XELOX chemotherapy followed by delayed surgery for high-risk rectal cancer patient based on magnetic resonance imaging.


Eligibility Criteria:
Inclusion Criteria:

1. High-risk patients of rectal cancer on pretreatment MRI using the following risk stratification system Location of the lower part of the tumor is measured below less than 10 cm on the anal verge and lower part of the tumor is located below the lower limit of the peritoneal reflection.

   If there is more than one, classify as a high risk group Positive CRM threatening: 5mm ≦ Extramural depth Positive EMVI.

   cN2: Positive Lateral pelvic LN metastasis
2. Between 19 and 80 years of age;
3. Satisfactory performance status: ECOG≦2
4. American Society of Anesthesiologists (ASA) physical status classification system class I\~III
5. Adequate hematologic function: white blood cell(WBC) counts≥4,000/mm3, neutrophils counts ≥ 1,500/mm3, platelet counts ≥ 100,000/µL, hemoglobin ≥ 9g/L;
6. Adequate renal function: creatinine ≤ 1.5×upper normal limit

Exclusion Criteria:

1. The evidence of relapse of distant metastasis
2. Receiving treatment of other anti-cancer drug or methods
3. Patients have low compliance and are not able to complete the entire trial
4. Presence of uncontrolled life-threatening diseases
5. cT4 with infiltration of anterior organ on pretreatment MRI
6. cT4 with infiltration of internal or external anal sphincter on pretreatment MRI
Paraurethral Transplantation of Autologous Muscle Derived Stem Cells for Treatment of Stress Incontinency

This study was designed to provide confirmation of efficacy of muscle derived stem cells (MDCs) for the treatment of SUI in women.

The investigators will be assessed the 12-month potential efficacy of autologous muscle derived cells as therapy for stress urinary incontinence. A total of 20 women in whom stress urinary incontinence had not improved underwent intra-sphincter injection of low doses 50×106 of autologous muscle derived cells, which will be derived from biopsies of their deltoid muscle. Assessments will be made at 1, 3, 6 and 12 months after cell injection. Changes in stress urinary incontinence severity were evaluated by pad test, diary of incontinence episodes and quality of life surveys.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Stress Urinary Incontinence symptoms
* Urodynamic stress incontinence confirmed with multichannel urodynamic testing
* positive cough stress test
* urgency score \< stress score
* Patient's age between 40 - 65 years
* Desire to surgical correction of stress urinary incontinence or inadequate response to conservative treatment of SUI

Exclusion Criteria:

* Post-void residual volume \>100cc
* Detrusor overactivity on preoperative multichannel urodynamic testing
* History of previous synthetic, biologic or fascial sub-urethral sling or any other surgery on external genitalia, bladder neck, bladder or urethra
* Desires future childbearing
* Chronic inguinal or vulvar abscess or history of Hidradenitis Suppurative
* History of bleeding diathesis or current anti-coagulation therapy
* Inguinal lymphadenopathy or inguinal/vulvar mass
* Current genitourinary fistula or urethral diverticulum
* Current sever cystocele or rectocele
* Active urinary infection
* Non-treated urge incontinency or any significant voiding dysfunction
* Neuromuscular disorders
* Uncontrolled Diabetes
* Reversible cause of incontinence (i.e. drug effect)
* Contraindications for surgery
Cross-sectional Dietary Intake Survey on Ivorian School-Aged Children and Women of Reproductive Age

A cross-sectional dietary intake study was conducted with 423 Ivorian school aged children (SAC, 6-12 years) and 423 women of reproductive age (WRA, 15-49 years) from four cities, recruited by two-stage random sampling.

A cross-sectional dietary intake study was conducted with 423 Ivorian school aged children (SAC, 6-12 years) and 423 women of reproductive age (WRA, 15-49 years) from four cities, recruited by two-stage random sampling. Dietary intake data were collected by multiple pass 24-hour recall. For a sub-sample (10% subjects) two-day non-consecutive multiple pass 24-hour recall was collected.

Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* illness or disease
Electronic Patient-reported Outcomes (e-PROs) in Early Intervention

A major goal of early intervention (EI) is to employ a family-centered approach to helping children to optimally function at home and in the community. However, the effects of EI are poorly understood. The aims of this project are: 1) to test the feasibility, acceptability, and value of introducing novel electronic patient-reported outcome (e-PRO) measures in EI, to strengthen family-centered EI care; and 2) to obtain and pair these outcomes data with EI program data, to further determine the value of e-PRO data collection for examining links between EI service use and functional outcomes among families who are enrolled in a large, urban EI program.

Approximately 5,800 infants and toddlers with developmental disabilities (e.g., cerebral palsy, Down syndrome, complex chronic conditions) and delays access Early Intervention Colorado (EI-CO) annually. A primary goal of EI-CO is to employ a family-centered care approach to help children optimally function at home and in the community. Hence, early intervention is a common source of rehabilitation (i.e., physical, occupational, speech and language therapy) for EI-CO eligible families.

However, the effects of EI-CO are poorly understood. Numerous challenges exist with obtaining EI-CO outcomes data, including a paucity of validated and feasible functional outcome measures for use in EI outcomes reporting. These challenges have resulted in inadequate knowledge about EI service use and outcomes to guide service delivery. Despite these challenges, recent policy changes have resulted in EI-CO service providers being pressed to ensure high quality care with limited resources and evidence to guide their clinical decision-making about effective and efficient interventions. This proposal addresses the need to fill critical knowledge gaps about the adequacy of EI services with an eye toward improving care quality.

This study involves families who have/are receiving EI-CO services through Rocky Mountain Human Services (RMHS), the largest EI program in Denver Metro. The purpose of this study is to test the feasibility, acceptability, and value of collecting electronic patient-reported outcomes (e-PRO) data to engage families when their child is due for an annual evaluation of progress. To further demonstrate the value of e-PRO data collection, these data will be paired with program data to estimate the association between EI-CO service use and functional outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Caregiver is at least 18 years old;
* Caregiver can read, write, and speak English or Spanish;
* Caregiver had internet access;
* Caregiver has a child between 0-3 years old who had received early intervention at RMHS for at least 3 months.

Exclusion Criteria:

* Caregiver is less than 18 years old
* Caregiver reads, speaks, and writes in a language other than English or Spanish
* Caregiver does not have internet access
* Caregiver has a child who has received EI services for less than 3 months
* Caregiver has a child older than 3 years (36 months)
Dapagliflozin Therapy In Cardiac Surgery

This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery

Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2i) including dapagliflozin are widely used in the clinical treatment of type 2 diabetes mellitus(T2DM). In recent studies, SGLT2i were found to not only reduce blood glucose but also protect the heart and kidney, which can significantly reduce cardiovascular events, delay the progression of renal failure, greatly improve the quality of life of patients. Patients with T2DM have poorer cardiac surgery outcomes compared with non-diabetics. Based on the promising pharmacological profile of dapagliflozin, we hypothesize that perioperative dapagliflozin therapy would improve postoperative outcomes among patients undergoing cardiac surgery with T2DM. This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years at screening
2. Scheduled for cardiac surgery
3. Diagnosis of Type 2 Diabetes
4. Provision of signed informed consent prior to any study specific procedures

Exclusion Criteria:

1. Emergency surgery and non-primary surgery
2. Moderate and severe dehydration; systolic pressure≤90mmHg; unstable haemodynamics
3. History of diabetic ketoacidosis; type 1 diabetes mellitus
4. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment
5. Known allergy or hypersensitivity to dapagliflozin or other SGLT-2 inhibitors
6. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 or requiring dialysis; unstable or rapidly progressing renal disease at the time of randomisation
7. Serious hepatic disease
8. Women who are pregnant, nursing, or who plan to become pregnant while in the trial
9. Currently enrolled in another investigational drug study, or less than 30 days