cyrilzakka/clinical-trials huggingface dataset:
Cold Agglutinin Disease Real World Evidence Registry

This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take part in the sutimlimab cohort study. Patients with CAD who have been enrolled in previous sutimlimab clinical trials (e.g., BIVV009-01/LTS16214 \[NCT02502903,CAD patients\], BIVV009-03/EFC16215 \[NCT03347396\], and BIVV009-04/EFC16216 \[NCT03347422\]) and who either completed or discontinued the corresponding clinical trial are eligible to participate in the registry.


Eligibility Criteria:
Inclusion Criteria:

1. Patient aged ≥18 years
2. Patient able to understand the purpose of the study and who (or whose legally authorized representative) provided signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations
3. Patient with a diagnosis of CAD or CAS as per Investigator judgment based on the diagnosis criteria listed in study protocol

Exclusion Criteria:

1. Patient with mixed warm and cold autoimmune hemolytic anemia, or warm autoimmune hemolytic anemia
2. Patient actively participating in a CAD or CAS interventional clinical trial. After a patient completes participation in said trial, he/she may be eligible for enrollment in this registry.
Unrestricted Diet for Screening Colonoscopy

Colonoscopy is the technique of choice for the evaluation of the mucosa of the colon. To be able to do the procedure in optimal conditions, it needs to be clean. Therefore, it is necessary to carry out a preparation as safe and tolerable as possible. This preparation generally consists in a low residue diet the days before the colonoscopy and in the intake of a laxative solution. In previous studies, it has been shown that the low residue diet does not play a relevant role as it was considered before. Recent studies demonstrated that reducing the days of low residue diet does not worsen the cleansing and improves the patient experience. The results of this study are required for determining the role of diet restrictive diet in colon cleansing.


Eligibility Criteria:
Inclusion Criteria:

* Individuals on the early colorectal cancer detection program who agreed to undergo colonoscopy after positive results on the fecal immunochemical test (FIT)

Exclusion Criteria:

* Individuals in which colonoscopy, cleansing solution or bisacodyl are contraindicated
* Subjects that are considered to have a linguistic barrier or to be unable to understand the instructions and / or give informed consent.
Long-term Observational Study to Evalution the Safety and Efficacy of FURESTEM-AD Inj.

Observational Study to Assess the Safety and Efficacy of FURESTEM-AD lnj. In moderate to Atopic Dermatitis

This is a observational study, single center, open label, study of safety and Efficacy of FURESTEM-AD Inj. in subjects with moderate to severe Atopic Dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.\[NCT02221258\]
* Subject who understands and voluntarily sign an informed consent form

Exclusion Criteria:

* In case follow-up is not possible from end of clinical trial Phase 1/2a to end of this study period
A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer

The main purpose of this study is to look at the potential effects of paricalcitol (a drug similar to vitamin D) on pancreatic tumors in patients who are planned for surgical removal of their tumor. The study will also look at the safety of paricalcitol prior to surgery.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated, apparently resectable, adenocarcinoma of the pancreas at registration.
* Age greater than or equal to 18 years
* Medically fit for surgery in the opinion of the treating surgeon
* Ability to provide written informed consent

Exclusion Criteria:

- Patients who are currently pregnant, planning to become pregnant, or breast-feeding.

Note: women of childbearing potential must agree to use a medically accepted form of birth control including (condoms, diaphragms, cervical cap, an intra-uterine device (IUD), surgical sterility \[tubal ligation or a partner that has undergone a vasectomy\], or oral contraceptives). OR must agree to completely abstain from intercourse for two weeks before beginning study treatment, during participation in this study, and for 2 weeks after the final study treatment

* Patients with hypercalcemia (blood levels greater than 11.5 mg/dL). Note: In patients with GFR 30-60 mL/min by Cockroft-Gault, blood calcium levels must be 9.5 mg/dL or lower before starting paricalcitol.
* Serum creatinine \> 2.5 x ULN OR GFR \<30 mL/min by Cockroft-Gault formula . Patients who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation.
Norwegian Microbiota Study in Anorexia Nervosa

Anorexia nervosa (AN) is a serious mental disorder occurring mainly in women. AN is characterized by severely restricted food-intake and subsequent low weight. The disease burden for the individual is high with medical complications and psychiatric comorbidities. Despite decades of research, there are large gaps in the understanding of the biological aspects of AN and lack of effective interventions. Current clinical treatment is associated with gastrointestinal problems, high rates of relapse and poor outcome causing long-term sickness absence and disability. During the COVID19 pandemic the prevalence and severity of AN has spiked. Therefore, there is great need of novel strategies for AN treatment, that can be easily implemented in the clinic without adding complexity to the standard care of treatment. During the resent years it has been proposed that mental disorders might be treated via manipulating the composition and function of the microbes that live in the gut (the microbiota) by adding or restricting fermentable nutrients (prebiotics) in the diet. However, in order to use prebiotics to treat the microbiota in AN patients, more knowledge is needed on how the AN microbiota is affected by the current standard care treatment. Whether prebiotics can be useful for normalizing AN microbiota remains to be established. The overall aim of the "Norwegian study of Microbiota in Anorexia Nervosa" (NORMA) is to join forces of researchers, clinical health care services and voluntary sector in a transdiciplinary approach to improve the understanding of the role of the gut microbiota in AN patients. The current project will include a clinical trial in AN patients and experimental studies to screen novel prebiotics for their ability to modify and normalize AN derived microbiota. The long-term goal of the project is to pave the way for a targeted and clinically feasible individualized treatment for better tolerable weight-restoration and improved health in AN patients.


Eligibility Criteria:
Inclusion Criteria AN group

1. Sex: Female
2. Age: 16-50 years
3. BMI: \<18.5 kg/m2
4. fulfilling ICD-10 criteria for AN
5. currently referred to specialized inpatient nutritional treatment for AN
6. able to understand the Norwegian questionnaires.

Exclusion Criteria AND group:

1. history of inflammatory bowel disease, celiac disease, or GI tract surgery;
2. treatment with oral antibiotics the past two months
3. high intake of probiotic supplements over the past two months.

Inclusion criteria control group

1. Sex: Female
2. Age: 16-50 years
3. BMI: \>= 18.5 \& \< 27
4. able to understand the Norwegian questionnaires.

Exclusion Criteria AND group:

1. history of inflammatory bowel disease, celiac disease, or GI tract surgery;
2. treatment with oral antibiotics the past two months
3. high intake of probiotic supplements over the past two months.
Bupivacaine or Radiofrequency for Shoulder Pain

Comparative study between pulsed radiofrequency in suprascapular nerve or bupivacaine block for chronic shoulder pain

Prospective, randomized, comparative study of 40 participants with chronic shoulder pain allocated into two groups. Patients in group 1 underwent pulsed RF (180sec, with a fixed temperature at 42C, twice) on the suprascapular nerve, and the other group, 2, underwent nerve block with bupivacaine (5ml). After the procedure, patients were evaluated for 3 months regarding pain intensity, shoulder range of motion and dose of rescue opioids.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Chronic shoulder pain (more than 3 months)
* Clinical and imaging diagnosis: rotator cuff injury, adhesive capsulitis, supraspinatus, tendinopathy, bicipital tendinitis, impingement syndrome, subscapularis tendinopathy, , subacromial and subdeltoid arthrosis, acromioclavicular arthrosis, subdeltoid subacromial bursitis
* Pain intensity ≥4 on movement, on a numerical scale from zero to 10 (where zero means no pain and 10 the most intense pain imaginable).

Exclusion Criteria:

* Arrhythmia
* Cognitive change (inability to answer questions)
* Psychiatric illness
* Infection at the site of the procedure
* Coagulopathy,
* Use of anticoagulants
* Hypersensitivity to medications
* Pregnant
* Use of pacemaker
OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate

The purpose of this clinical investigation was to collect clinical evidence of the safety and efficacy of the OsseoScrew System. The OsseoScrew System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The study was designed to compare the safety and efficacy of OsseoScrew compared to any other commercially available fenestrated pedicle screw system augmented with PMMA for posterior spinal fixation after surgical correction of spinal deformity or pathology.

This was a randomized, open-label, controlled, multi-center study in which patients were randomized in a 1:1 ratio to receive either the OsseoScrew or any commercially available fenestrated screw augmented with polymethylmethacrylate (PMMA) (Control group) for posterior spinal fixation after surgical correction of spinal deformity or pathology. The study was planned to include up to 150 skeletally mature patients with spinal instability and osteopenia at up to 10 sites. Patients were to return postoperatively at 6 weeks (± 2 weeks) and at 6, 12, and 24 months (± 2 months) for assessments.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Spinal instability or deformity requiring fusion with instrumentation
3. Osteopenia defined as (T-Score of less than -1.0)
4. No response to nonoperative treatment modalities preceding enrollment.
5. Subject is willing and able to provide informed consent and agrees to release medical information for purposes of this study and to return for scheduled follow-up evaluations

Exclusion Criteria:

1. Active systemic or local infection
2. A life expectancy less than the study duration
3. Autoimmune disorders
4. Currently an alcohol, solvent, or drug abuser
5. Psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements
6. History of allergies to any of the device components including but not limited to commercially pure titanium, titanium alloy, polymethylmethacrylate or Zirconium Oxide (ZrO2)
Effect of CPAP on Respiratory Load in COPD

Both intrinsic positive end expiratory pressure (PEEPi) and dynamic hyperinflation are considered as inspiratory loads which increase work of breathing in patients with COPD. The application of extrinsic positive end expiratory pressure (PEEPe) supplied by CPAP has been claimed to reduce inspiratory load based on change in esophageal pressure which could be significantly affected by change in lung volume and airflow. The investigator hypothesized that CPAP could increase respiratory load because it increases lung volume.

Objective: To assess the effect of CPAP on respiratory load and lung volume in stable COPD. Methods: Patients with COPD were recruited to breath under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O). Diaphragm EMG, esophageal pressure (Pes) and transdiaphragmatic pressure (Pdi) were recorded using balloon esophageal electrode catheter (Yinghui, Guangzhou, China). End inspiratory lung volume (EILV) was measured directly from a pneumotachograph combined with a three way valve under the different CPAP levels. Sensation of breathing difficulty was also assessed. In an additional study, the effect of airflow on pressure was investigated by a physical mode.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to participate after informed consent
2. Males and females, any race and aged 40-80 years
3. GOLD II-IV COPD (post-bronchodilator FEV1 \< 80 % of the predicted normal, and a post-bronchodilator FEV1/FVC \< 0.70)

Exclusion Criteria:

1. Patients recovering from acute exacerbation less than 4 weeks.
2. Patients with concomitant pulmonary disease (e.g. lung fibrosis, interstitial lung disorder).
Shift Work and Risk of Cardio-vascular Disease

The purpose of this research is to test the hypothesis that those with non-traditional work schedules (e.g. shift workers) have a higher cardio-metabolic risk than those with traditional work schedules (e.g. day workers), and that both accumulated sleep debt and the degree of circadian disruption predict the elevated cardio-metabolic risk. The findings of this research are expected to increase our understanding of physiologic tolerance to non-traditional work schedules and provide the basis for the development of methods for the early detection of adverse health effects and determine coping strategies for the millions of workers with non-traditional work schedules.


Eligibility Criteria:
Inclusion Criteria:

Age 18 and older Full-time workers- working between 7:00 a.m. and 7:00 p.m. employed full time at a medical center.

Non-traditional full-time workers- working between 7:00 a.m. and 7:00 p.m and between 7:00 p.m. and 7:00 a.m., employed full time at a medical center.

Exclusion criteria include:

Acute illness or recent change in medication. Persons employed for less than 3 months at their current job

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Mindfulness as a Method of Improving the Well-being, Quality of Life and Health of Primary School Pupils

This study evaluates the short and long-term effect of 5-10 minutes daily mindfulness and compassion training in school among children aged between 6-16 years old. The mindfulness intervention will last for 10 weeks and the results will be compared to children who do not perform mindfulness in school. Due to practical reasons, the study is not randomized; classes are instead placed in the mindfulness or control group. Anxiety, mental, physical and social health, quality of life, and school performance will be evaluated via questionnaires and school registries, before and after the intervention and thereafter once a year until the end of ninth grade (age 16 years). Long term health (diagnoses, medical consumption, and drug prescriptions) and family income (proxy for socioeconomic status) will be followed in regional and national registries until 25 years of age.

The hypothesis of the study is that mindfulness can prevent mental disorders and anxiety, and increase well-being in children and adolescents. The primary aim is to subsequently evaluate if regular, daily, mindfulness and compassion training (5-10 minutes) prevents anxiety and mental disorders in children and adolescents. Secondary aims are to evaluate 1) the effect of mindfulness on daily life, quality of life, and health in school pupils; 2) the effect of mindfulness on school performance; 3) the effect of mindfulness and compassion on the class room environment; 4) the effect of potential individual, family, and school-level risk factors on mental health in children and adolescents; 5) the effect of mindfulness on these potential risk factors.

Sessions are led by school teachers who have been educated in mindfulness. Their own levels of stress and mindfulness will be evaluated by a questionnaire and compared to teachers in control classes both before and after the intervention. The teachers will also be interviewed to evaluate the effect of mindfulness on the class room environment.

In a sub-study, the effect of mindfulness on brain structure and function will be examined by magnetic resonance imaging in school pupils aged 15-16 year old. This will be preceded by a pilot study, in which feasibility of the method is tested in the target group.

To achieve sufficient statistical power, taking into account a cluster effect to adjust for grouping of the pupils, 1750 children and adolescents will be recruited. Written informed consent is a prerequisite for participation.


Eligibility Criteria:
Inclusion Criteria:

* School pupils in grade 0-9

Exclusion Criteria:

* No exclusion criteria
Structural Mitral Valve Project

This is a prospective Quality Improvement (QI) study using the Model for Improvement framework.

The objective of this study is to implement a structured, comprehensive, innovative, and sustainable approach to the management of patients with advanced mitral valve (MV) disease and heart failure (HF) in Southeastern Ontario and to improve healthcare delivery, patient care, and patient outcomes in the context of structural surgical and percutaneous MV interventions. This will be achieved through the strategic implementation, promotion, and evaluation of:

i.The first local Southeastern Ontario Structural Mitral Valve Clinic using an Interdisciplinary heart team (IHT) at the Kingston Health Sciences Centre (KHSC) and its integration with the KHSC's existing Heart Failure Clinic; ii.The first provincial Structural Mitral Valve Clinic electronic referral service on the Ontario electronic services platform; and iii.The promotion of the above through targeted KT (Knowledge Transfer) outreach activities.

Patients for this study will be recruited through medical referral within the south eastern Ontario, Canada region.


Eligibility Criteria:
Inclusion Criteria:

All adults (≥18 years of age) patients with primary and secondary moderate to severe MR with HF (preserved or reduced ejection fraction with New York Heart Association (NYHA) Class \>II), who have had at least one previous hospitalization for HR, require specialist advisement, and have provided signed informed consent.

Exclusion Criteria:

* Those who are not eligible for either an MV surgical intervention or a TMVI procedure.
* Females of childbearing age who are not willing or unable to use a reliable method of birth control.
* Inpatient referrals.
PROMMO Trial: Oral Misoprostol vs IV Oxytocin

This is a prospective, randomized trial looking at the ideal method of labor induction for women with prelabor rupture of membranes and an unfavorable cervical Bishop score. The study will compare oral misoprostol and intravenous oxytocin.

The purpose of this study is to look at optimal induction management of prelabor rupture of membranes (PROM) at or beyond 34 weeks gestational age.

Objective 1: To determine if there is a decrease in time from initiation of induction of labor to vaginal delivery in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin.

Hypothesis: Cervical ripening with misoprostol will be beneficial in women with an unfavorable cervix.

Sub objective 1: To determine if the use of oral misoprostol for cervical ripening decreases the rate of postpartum hemorrhage in women with PROM.

Hypothesis: Misoprostol use will result in significantly lower rate of postpartum hemorrhage.

Sub objective 2: To evaluate the rates of infectious morbidity in peripartum women and neonates exposed to misoprostol versus oxytocin in PROM.

Hypothesis: The use of oral misoprostol will result in lower rates of infectious morbidity in mother and neonate.

Sub objective 3: To analyze patient satisfaction surveys. Hypothesis: Patients in the oral misoprostol group will be more satisfied with their labor experience.

Exploratory Outcome To determine if there is a difference in cost between induction of labor in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin.

Hypothesis: The use of oral misoprostol will be cost effective in women presenting with PROM and an unfavorable cervix.

Eligibility Criteria:
Inclusion Criteria:

* Early Term to late term pregnancy (\>37 weeks and 0 days and \<42 weeks and 0 days)
* Late Preterm Pregnancy (34 weeks and 0 days and \<37 weeks)
* Confirmed rupture of membranes by either sterile speculum exam or AmniSure
* Simplified Bishop Score ≤ 6
* Maternal Age \> 18 years old
* Singleton gestation
* Appropriate gestational age dating by certain LMP or ultrasound performed prior to 20 weeks gestational age

Exclusion Criteria:

* Concern for intra-amniotic infection
* Previous Cesarean delivery
* Lack of appropriate dating criteria for the pregnancy
* Inability to give informed consent in the patient's native language
* Known bleeding disorder such as von Willebrand's disease or hemophilia
* Anticoagulation administration within 24 hours of delivery
How Long Must the MRI Follow-up Last to Safely Identify Middle Ear Residual Cholesteatoma

Previous studies demonstrated the high diagnostic value of non-echoplanar diffusion weighted magnetic resonance imaging (non-EP DWI) for residual cholesteatoma. However, limited data are available regarding a suitable length of imaging follow-up. The present study aimed to determine the optimal duration of non-EP DWI follow-up for residual cholesteatoma

A retrospective, monocentric study was performed between 2013 and 2019 and included all patients regularly followed-up after canal wall-up tympanoplasty with at least two non-EP DWI performed on the same 1.5T MRI scanner. MR images were reviewed independently by two radiologists. Sensitivity and specificity values were calculated as a function of time after the surgery. Receiver operating characteristics (ROC) curves were analyzed to determine the optimal follow-up duration.

Eligibility Criteria:
Inclusion criteria:

- patients regularly followed-up for middle ear cholesteatoma, who underwent two or more non-EP DWI performed on the same 1.5 Tesla MRI scanner

Exclusion criteria:

- congenital cholesteatomas, tympanoplasty with canal wall-down technique, or suspicion of residual cholesteatoma on the first MRI follow-up
An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma

The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* 12 years and older unless not permitted by local regulations; in that case 18 years old and older
* Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1
* Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition)
* Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma)
* Measurable disease per RECIST v1.1

Exclusion Criteria:

* Active brain metastases or leptomeningeal metastases
* Uveal or ocular melanoma
* Participants with active, known, or suspected autoimmune disease
* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured

Other protocol defined inclusion/exclusion criteria could apply