cyrilzakka/clinical-trials huggingface dataset:
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).

The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* body weight \>85kg (187lbs);
* CHC (genotype 1);
* liver biopsy (in \<24 calendar months of first dose), with results consistent with CHC infection;
* use of 2 forms of contraception during study and 6 months after the study in both men and women.

Exclusion Criteria:

* women who are pregnant or breastfeeding;
* male partners of women who are pregnant;
* conditions associated with decompensated liver disease;
* other forms of liver disease, including liver cancer;
* human immunodeficiency virus infection;
* previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.
Electronic Symptom Follow-up of Cancer Patients

Use of ePROs in oncological care have resulted in improvement of QoL, decreased ER visits, and improvement of overall survival. Furthermore, ePRO follow-up resulted in better QoL, improved ECOG status and more active cancer treatments at disease relapse, and improved survival among cancer survivals. The current study investigates electronic patient reported outcome tool in the follow-up of cancer patients receiving chemotherapies or targeted therapies.

The aims of the current study are: 1) The number of alerts triggered by Kaiku Cancer medical treatment side-effects questionnaire and their correlation to treatment side-effects, other relevant medical events, tumor progression, and survival 2) Changes in Kaiku QLQ-C30 QoL questionnaire and their correlation to cancer treatment response, side-effects, other relevant medical event or survival 3) Patient compliance to Kaiku ePRO surveillance during treatment period according to response rates of Patient experience survey, Kaiku Cancer medical treatment side-effects questionnaire and Kaiku QLQ-C30 QoL questionnaire

In addition, in the CRC (colorectal cancer) cohort:

1. Integration of laboratory values to patient reported symptoms when prescribing a new chemotherapy cycle
2. Number of phone calls related to prescribing a new chemotherapy cycle
3. Unscheduled doctor appointments in oncology unit
4. ER visits
5. Days in hospitalization
6. Unscheduled investigations in health care
7. Development of peripheral neurotoxicity
8. The number of chemotherapy dose reductions
9. The number of chemotherapy delays
10. Health care user experience survey


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent prior to any study procedure
2. Advanced breast, lung, colorectal, or pancreatic cancer
3. New cancer medical treatment, chemotherapy or targeted therapy initiated within -/+ 2 weeks from signed consent
4. Age ≥18y
5. ECOG 0-2
6. CRC cohort: Patients with adjuvant treatment, or first or second line of treatment for metastatic disease
7. Patient compliant with study procedures

Exclusion Criteria:

1. Initiation of new cancer medical treatment \> 2 wks from signed consent
2. Any medical condition that the Investigator considers significant to compromise the safety of the patient or that impairs the interpretation of study assessments
3. No internet access/email
Pulmozyme to Improve COVID-19 ARDS Outcomes

This is a randomized double-blind placebo-controlled Phase II trial of recombinant human deoxyribonuclease I (rhDNase I) - Pulmozyme - in mechanically ventilated patients with COVID-19 pneumonia.

Patients admitted to the ICU with severe COVID-19 pneumonia who require mechanical ventilation will be invited to participate in this study. Potential subjects will be identified from medical record review or from direct contact with physicians. Investigators will check medical history and confirm eligibility. Informed consent will be obtained from either the patient or designated healthcare proxy.

60 subjects will be enrolled. After obtaining informed consent, patients will be randomized 2:1 to Pulmozyme 2.5 mg BID for up to 28 days or until they are no longer receiving mechanical ventilation, whichever is sooner plus standard of care vs. placebo normal saline 2.5 ml plus standard of care.


Eligibility Criteria:
Inclusion Criteria:

* ICU admission for pneumonia complicated by respiratory failure.
* RT-PCR (or equivalent) confirmed COVID-19 infection.
* Intubated and on mechanical ventilation within 120 hours of initiation of mechanical ventilation.
* Age ≥ 3 years of age.

Exclusion Criteria:

* Allergy or known intolerance to Pulmozyme or Chinese Hamster Ovary cell products
* History of moderate to severe asthma, cystic fibrosis, or severe COPD (baseline FEV1 ≤ 40% predicted)
* Active malignancy other than basal cell melanoma or in situ breast cancer
* Unstable angina
* Chronic liver disease as judged by the investigator that would pose significant risk to participation
* Chronic renal disease as judged by the investigator that would pose significant risk to participation
* Inability to obtain informed consent from patient or legally authorized representative (LAR)
* Pregnant or breastfeeding Use of extracorporeal membrane oxygenation (ECMO)
* Prisoner status
* Concurrent treatment with other inhaled investigational agent for COVID-19\*\*
* Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
* Moribund patient not expected to survive 24 hours
* Active hemoptysis
Refusal to Participate in a Randomized Trial Involving Pregnancy and Childbirth: Factors Associated with Refusal and Reasons for Refusal and Acceptance

The main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving pregnancy and childbirth in France. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate.

1. Determine the acceptance/refusal rate among all women identified, eligible and offered RCT.
2. Comparison of demographic characteristics between the two groups

   * Group 1: women accepting to participate in RCT
   * Group 2: women refusing to participate in RCT
3. Assessment of motivations for acceptance (based on questionnaire given to women who agree to participate)
4. Evaluation of reasons for refusal to participate - obstacles (based on the questionnaire given to women who refuse to participate).

Eligibility Criteria:
Inclusion Criteria:

The study will be offered to all women who have been offered to participate in a randomized trial relating to their pregnancy and/or childbirth in participating services.

Exclusion Criteria:

None
MSC for Occlusive Disease of the Kidney

To determine the safety and toxicity of intra-arterial infused autologous adipose derived mesenchymal stromal (stem) cells in patients with vascular occlusive disease of the kidney.

Individuals with unilateral arterial occlusive disease will be treated to injured kidney with autologous cells.

Eligibility Criteria:
4.1 Inclusion Criteria

1. Are between ages 40 and 80 years old.
2. Advanced vascular occlusive disease (atherosclerosis) affecting one or both kidneys: defined as a) loss of parenchymal volume and renal blood flow (measured by MDCT as previously described (17) and/or duplex ultrasound velocity above 300 cm/sec to the affected kidney to be infused with MSC's.
3. Have serum creatinine below 2.5 mg/dL
4. Have no-contraindications to angiography: severe contrast allergy
5. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
6. Ability to comply with protocol
7. Competent and able to provide written informed consent

4.2 Exclusion Criteria

1. Advanced CKD: Stage 5 (two kidney eGFR \< 15 ml/min/1.73 m2) contralateral renal artery occlusion/stenosis above 75% or ESRD requiring dialysis
2. Clinically significant abnormalities on laboratory examination, including Bilirubin (\> 2 x normal), platelets (\<100 thousand), potassium (\>5.5 mEq/L), and sodium (\<130 mEq/L), ALT or AST more than 2 x normal, Prothrombin time (INR\>1.4), Hemoglobin \<10.0 g/dL.
3. Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure) that would, in the opinion of the investigators, compromise the safety of the patient.
4. Specific exclusions:

   1. Clinical history of deep vein thrombosis within three months of MSC administration
   2. Uncontrolled hypertension (Systolic BP \>180 mmHg despite therapy)
   3. Active infection
   4. Reduced ejection fraction (below 30%)
   5. Evidence of hepatitis B,C, or HIV
   6. Diabetes treated with insulin and/or glucose lowering agents
   7. Anemia (Hgb\<10 g/dL)
   8. Regular use of potentially renotoxic drugs, e.g. non-steroidal anti-inflammatory agents (NSAID's): (\>2 x weekly)
5. History of cancer including melanoma (with the exception of localized skin cancers)
6. Investigational drug exposure within thirty (30) days of baseline
7. Beck's depression score above 16
8. Pregnant or breast feeding.
9. History of clinically significant auto-immunity or any previous example of fat-directed autoimmunity
Right Ventricular Function in Patients With Obstructive Sleep Apnea

The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in right ventricular function evaluated by three dimensional echocardiography.

Several studies have reported the association between sleep disorders to an increased risk to the development of cardiac disease. However, there is no substantial that about the influence of Obstructive Sleep Apnea on the right ventricular function. Objective: to analyse the right ventricular function in patients with Obstructive Sleep Apnea by means of Real-Time Three dimensional Echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* Individuals \> 18 years old and \< 70.

Exclusion Criteria:

* Body mass index greater than 35
* Past of clinically significant cardiac conditions
Glue Sealing for Patients With Low-Output ECFs

Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output ECFs. The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG) and a commercially available fibrin sealant Bioseal® in the management of patients with low-output volume ECFs.

* This is a prospective, randomized, single-centered study clinical, safety and economic outcome of ECFs patients.
* Subjects are randomized to one of 2 groups:

  * Group 1: Autologous PRFG-treatment (PRFG + SOC)
  * Group 2: Commercial FG-treatment (Bioseal® + SOC)
* Study will include three phases:

  * Phase 1: Screening, consent and enrollment
  * Phase 2: Patients will receive either PRFG, or Bioseal only for 14 days
  * Phase 3: Follow up: for patients with closed fistula within 14 days, we will follow up them for 6 months. For patients whose fistulas were still open will be treated with other therapeutic option and follow up for 6 months after closure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a single tubular ECF
* Low output volume (\<200 ml/24h)
* Tract length \>2cm
* Tract diameter \< 1cm

Exclusion Criteria:

* Cancer-infiltrated fistula
* Abscess
* Foreign bodies
* Distal bowel obstruction
* Inflammatory bowel disease
Head-to-head Comparison of Diagnosis Value of Pulmonary Fibrosis on 68Ga-FAPI-04 and 18F-FDG PET-CT

68Ga-fibroblast activating protein inhibitors(FAPI) has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as inflammatory bowel disease. And it might be more sensitive than FDG in detecting a certain type of inflammations according to our preliminary research. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of Pulmonary fibrosis than 18F-FDG PET/CT.

Pulmonary fibrosis is a prototype of chronic, progressive, and fibrotic lung disease.Healthy tissue is replaced by altered extracellular matrix and alveolar architecture is destroyed, which leads to decreased lung compliance, disrupted gas exchange, and ultimately respiratory failure and death.Pulmonary fibrosis is diagnosed by identification of a pattern of usual interstitial pneumonia on the basis of radiological or histological criteria in patients without evidence of an alternative cause. Activated fibroblasts are crucial for fibrotic processes in Pulmonary fibrosis. 68Ga-FAPI has been developed as a tumortargeting agent as fibroblast activation protein is overexpressed in cancerassociated fibroblasts and inflammation. Recently，a study shows that FAPI-PET/CT imaging is a promising new imaging modality for Pulmonary fibrosis.This head-to-head comparisons aims to evaluate the severity of pulmonary fibrosis and the therapy response of 68Ga-FAPI-04 compared with 18F-FDG in the same group of pulmonary fibrosis patients.

Eligibility Criteria:
Inclusion Criteria:

* suspected or confirmed pulmonary fibrosis patients;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* known allergy against FAPI
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Prevalence and Determinants of Anemia During the Third Trimester of Pregnancy

This cross-sectional study was conducted on 383 pregnant women who attended the antenatal care clinic during their third trimester at Beni-Suef University Hospital.

A proper history was taken from each participant. All women were subjected to routine antenatal care, including physical examinations, ultrasound examinations, and routine laboratory tests.

According to WHO criteria, anemia was diagnosed with a hemoglobin level of less than 11.0 g/dl. Anemia was further divided into three degrees; mild with hemoglobin level 10-10.9 g/dl, moderate with hemoglobin level 7-9.9 g/dl, and severe with hemoglobin level \< 7.0 g/dl.

This cross-sectional study was conducted on 383 pregnant women who attended the antenatal care clinic during their third trimester at Beni-Suef University Hospital.

A proper history was taken from each participant regarding age, educational level, residency (urban or rural), occupation, family income, frequency of antenatal visits, obstetric history, medical history, and surgical history. Nutritional history is taken to detect the frequency intake of meat/month, chicken/week, fish/week, fruits/week, vegetables/week, and tea/day. History of iron supplements intake was taken. All women were subjected to routine antenatal care, including a physical examination (e.g., measuring blood pressure), ultrasound, and umbilical artery Doppler examination. A blood sample was taken from each enrolled woman for standard laboratory tests such as complete blood picture, blood group, RH type, and blood sugar test if there is a risk. A urine sample was taken for urine analysis. Blood from each participant was drawn from the cubital vein into appropriate blood collection tubes using vacuum tube needles (Becton Dickinson Medical Devices Co. Ltd., Franklin Lakes, USA). K2EDTA tubes were used for CBC. Samples were transported and tested within 4 hours after collection. Measured CBC parameters included RBC, HGB, HCT, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), MCH concentration (MCHC), platelet count (PLT), WBC, and WBC differentials, including percentages and absolute counts of neutrophils (NEUT% and NEUT), lymphocytes (LYM% and LYM), monocytes (MONO% and MONO), basophils (BASO% and BASO), and eosinophils (EO% and EO).

According to WHO criteria, anemia was diagnosed with a hemoglobin level of less than 11.0 g/dl. Anemia was further divided into three degrees; mild with hemoglobin level 10-10.9 g/dl, moderate with hemoglobin level 7-9.9 g/dl, and severe with hemoglobin level \< 7.0 g/dl.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women during their third trimester

Exclusion Criteria:

* Women with chronic medical illness
Knee Replacement Outcome Predicted by Physiotherapists

The aim is to assess if physiotherapists attending inpatients at elective orthopaedic wards can predict the future course (post hospitalisation) of recovery of patients undergoing KA. The prediction is made at hospital discharge using a 1-10 numerical rating scale (1=poor prognosis; 10=best prognosis).

To identify candidate prognostic factors, the therapist are asked to qualify their prognosis narratively, by listing at least 3-5 factors that they consider important for their projected prognosis score. There will be no maximum number of factors the physiotherapist can list.


Eligibility Criteria:
Inclusion Criteria:

1. Received primary knee replacement surgery for knee OA
2. Age ≥ 18 years
3. Reads and speaks Danish
4. Has an email address
5. Signed informed consent

Exclusion Criteria:

1. Cognitive impairments that preclude reliable answers to online questionnaires (e.g. dementia)
2. Revision surgery
Trisomy 21 in Adulthood

Trisomy 21 or Down syndrome, is the most common genetic cause of cognitive disability. Currently, in Alsace, the birth prevalence is about 1 in 1600 live births, which means 10 liveborns with Down syndrome each year.If screening and prenatal diagnosis of children with trisomy 21, as well as medical care, social and educational integration in childhood was the subject of much research and has led to remarkable progress in terms of health and medical care, it is not the same for the knowledge about adolescents and adults.Despite a more and more higher life expectancy, the evolution of trisomy 21 in adulthood is often marked by a deterioration in health status, with a regression of acquired psychomotor skills, often attributed only to the precocious occurrence of Alzheimer's dementia. Nevertheless, it seems that the diagnosis of Alzheimer's dementia is often overdiagnosed, and it is well established that only a fraction of Down syndrome patients will develop this type of dementia. Too often a decline in general health, behavioral changes and decreased cognitive abilities are only attributed to the Down syndrome with an early dementia without looking for an underlying, potentially curable, disease.This study aims to better evaluate the health and social status of 100 adults with trisomy 21 in Alsace. The medical evaluation will include a comprehensive assessment of health status and quality of life conducted by the geneticist, a cardiac, sensory, hormonal, biological and radiological evaluation. A speech-language and psychomotor evaluation will also be conducted. A psychiatric consultation and a psychometric assessment will aim to assess cognitive function and to search for associated mood disorders.The expected results are to better know the natural history of trisomy 21 in adulthood, with the determination of the frequency of morbid events specific to adulthood, and also to improve the medical and paramedical care with the establishment of a monitoring program to prevent the occurrence of these morbid events.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman older than 18 years
* Down syndrome (clinical diagnosis, eventually confirmed by blood karyotype)

Exclusion Criteria:

* children
* pregnancy
Development of an MHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for MOUD

This study is to develop and test a medical health application based on cognitive behavioral therapy for insomnia and augmented with other evidence-based sleep interventions that address common sleep-related problems in opioid use disorder. An initial program will be built utilizing input from persons beginning medications for opioid use disorders.

This pilot randomized controlled trial will assess the feasibility and acceptability of an evidence-based behavioral sleep intervention delivered via a mHealth app to individuals initiating treatment with medications for opioid use disorder. Additional outcomes include changes in sleep disturbance over the course of the 6-week intervention. Participants (N=40, 20 per group) will be randomized to download the mHealth app to their smartphones and complete the intervention within 6 weeks. The control group will receive a simplified version of the app with sleep hygiene instructions. Both groups will complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity. At the end of the 6th week, they will complete an online series of questionnaires, including validated feasibility/acceptability measures and measures of insomnia severity.

Eligibility Criteria:
Inclusion Criteria:

* No experience of withdrawal symptoms in past 2 weeks
* Being stabilized on buprenorphine

  1. Initiated buprenorphine in past 3 months
  2. Modified buprenorphine dose in past 3 months (e.g., reducing dose with goal of transitioning to vivitrol)
* Currently experiencing clinically significant sleep disturbance (PSQI \> 5)
* Able to read and understand English
* Owns an Android or iOS smartphone
* At least 18 years of age

Exclusion Criteria:

* Current psychotic symptoms
* Current active suicidal ideation
* Severe visual impairment
* Current use of benzodiazepines
* Current severe SUD other than OUD (i.e., \> 5 criteria met for any other SUD type per DSM-5)
* Peripartum women
Verification of Computerized Sleep-wake Analysis in Sleep Disorders

Objective: Computerized sleep staging has been verified in a normal population. This study attempts to investigate and verify the interpretation of this computerized sleep staging program in patients with sleep disorders, and improve the accuracy of actigraphy algorithm for sleep duration and postures.

1. Compare the accuracy of computerized sleep-wake analysis with current sleep quality indicators: through actigraphy and heart rate sensors, compare the computerized sleep-wake analysis program with polysomnography, and verify its clinical reliability and validity in sleep disorder patients.
2. Establish the sleep posture detection system: through three-axis accelerometer, develop algorithms for position recording and monitoring during sleep, and upgrade its accuracy according to photography.

Methods: Patients ranged from age 20-50 with primary insomnia, periodic limb movement in sleep, simple snores, and obstructive sleep apnea will be enrolled in our study. Routine polysomnography will be applied in sleep center at Chang Gung Memorial Hospital, Taoyuan, as well as sleep-related questionnaires. At the same time, actigraphy and heart rate sensor patch will be used for sleep posture detection and further computerized sleep-wake analysis. Results will be verified the consistency by comparison with sleep-wake analysis from polysomnographic data and sleep-related questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* age 20-50
* diagnosed as primary insomnia, periodic limb movement in sleep, simple snores, and obstructive sleep apnea

Exclusion Criteria:

* arrhythmia
* sleep efficiency\<50%
* combined other sleep disorders
Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

This prospective randomized trial is to prove the equivalence of primary sigmoid resection with end colostomy(Hartmann)(GROUP A) and primary sigmoid resection and immediate anastomosis with diverting stoma (GROUP B)with regard to morbidity and mortality in patients with peritonitis caused by perforated left-sided colon diverticulitis.


Eligibility Criteria:
Inclusion Criteria:

* Intraoperative demonstrated peritonitis caused by perforated left-sided colon diverticulitis

Exclusion Criteria: