cyrilzakka/clinical-trials huggingface dataset:
An Observational Study to Assess the Protocol for the COVID-19 Treatment in Burkina Faso

This is an observational study to evaluate the effectiveness of the combinations Hydroxychloroquine + Azithromycin (HCQ-AZ) and Chloroquine + Azithromycin (CQ-AZ) in the treatment of Coronavirus (Covid-19) infection in Burkina Faso.

All patients who received one of the two combinations will be included in the study and followed-up until the patient is discharged from the hospital. They will be seen daily during the period of their active clinical follow-up at the hospital. At each visit, the medical history since the last visit (including treatments taken), signs and symptoms in progress if any, will be collected. A nasopharyngeal swab will be collected on Day 0, 3, 7 and 14 and then on day 21 if he is still positive in order to assess the evolution of the viral load. However if until the end of the follow-up on D21 the test is still positive, the sampling will be continued until the patient become negative as recommended by the national standard of care for the Covid patients management in Burkina Faso.

In terms of safety, an ECG will be performed on day 0 prior to the treatment administration and this will be repeated on day 7 and day 14 and every week until it normalizes or the patient will be recommended to see a cardiologist to check the normalization of his ECG after discharge from hospital. Adverse events will be recorded including biological parameters (biochemistry and hematology) will be monitored, as well as changes in relevant laboratory parameters.

Eligibility Criteria:
Inclusion Criteria:

* Any patient over 18 years treated according to the standard of care
* Willing to participate in the study by giving an informed consent

Exclusion Criteria:

* Patients under 18 years of age
* Not willing to participate in the study
Medtronic Market-Released DF4 Lead Imaging

The Medtronic Market-Released DF4 Lead Imaging Study is a prospective, non-randomized study, multi-center clinical investigation.

The purpose of this clinical investigation is to collect high quality medical images of the Medtronic Market-Released DF4 lead in the shoulder and heart. Images collected during the study will allow for lead design and testing processes better tailored to the implanted environment.


Eligibility Criteria:
Inclusion Criteria:

* Patients greater than 18 years of age.
* Patients able and willing to attend imaging session.
* Patients able and willing to give informed consent.
* Patients with an implanted device/lead(s) for a minimum of 3 months.

Exclusion Criteria:

* Subjects who require a legally authorized representative to obtain consent.
* Subjects with exclusion criteria required by local law (e.g. age, breastfeeding
* Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control.
Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy

The goal of this clinical trial is to assess the number of harvested locoregional lymph nodes in rectal cancer patients undergoing laparoscopic total mesorectal excision and indocyanine green (ICG)-guided lymphoadenectomy after neoadjuvant chemoradiation. The main questions it aims to answer are:

* Does the use of ICG increase the total number of harvested lymph nodes?
* Does the use of ICG increase the number of harvested extra-mesorectal lymph nodes?

Participants will intraoperatively receive a trans-anal administration of ICG near to rectal cancer; during laparoscopic surgery, ICG-fluorescent nodes beyond the mesorectum will be separately excised and sent for pathology. A comparison will be performed with a recent cohort of patients affected by rectal cancer treated with standard surgery without the use of ICG.


Eligibility Criteria:
Inclusion Criteria:

* Low or middle rectal adenocarcinoma
* Indication for sphincter-saving surgery
* Neoadjuvant chemoradiation
* Indication for laparoscopic surgery
* Signed informed consent

Exclusion Criteria:

* Distant metastases at diagnosis, included peritoneal carcinomatosis
* Squamous cell cancer
* Allergy to indocyanine green
Adolescent Normative Sport Movement Analysis

The objective of this study is to collect baseline data from a normative population of adolescents who participate in organized "land-based" sports, that gender and age matches some of the population of patients expected to be treated at Mary Bridge Children's Therapy Services, MultiCare affiliated therapy centers, and Mary Bridge Specialty Clinics who will be seen in the Research and Movement Lab. This project will recruit 40 patients between the ages of 13-25 years old. Non-invasive measurements of movement patterns will be collected during common sport-related activities over a single data collection session.


Eligibility Criteria:
Inclusion Criteria:

* Age between 13-25 years.
* Participate in a "land-based" organized sport in the last 1 year with intent on continued participation in the next year.
* Perform sport-related activities such as running/sprinting, cutting maneuvers, and jumping.
* Tolerate adhesive markers placed on skin and clothing.
* Willing and interested in participating.

Exclusion Criteria:

* Neuromuscular disorders such as cerebral palsy, muscular dystrophy, myotonic dystrophy, spinal muscular atrophy, peripheral neuropathy, or other generalized muscle and/or nerve issues.
* Currently undergoing treatment or receiving medication that affects movement.
* Requires ankle/knee bracing to safely perform running, sprinting, jumping activities.
* History of orthopedic surgery to lower limbs.
* In last 6 months: receiving/seeking medical treatment for injury.
* Difficulty performing sport-related activities.
* Pain that has inhibited participation in sports/daily activities in the last 3 months.
Different Effects of Delayed Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women

Objective:The aim of this study was to investigate the relationship between delayed cord clamping and neonatal bilirubin levels in pregnant women with intrahepatic cholestasis of pregnancy.

Method:This observational prospective cohort study included a total of 200 pregnant women at 37-40 gestational weeks. Among them, 100 pregnant women with intrahepatic cholestasis of pregnancy were divided into 50 cases of immediate cord clamping group （ICC in pregnant women with ICP）and 50 cases of delayed cord clamping group（DCC in pregnant women with ICP）, and 100 normal pregnant women were also divided into 50 cases of immediate cord clamping group （ICC in normal pregnant women）and 50 cases of delayed cord clamping group（DCC in normal pregnant women）. The bilirubin levels of neonates in each group were compared.


Eligibility Criteria:
Inclusion Criteria:

1. The pregnant woman is born at a gestational age of 37-40 weeks;
2. The pregnant woman has a single child;
3. Regular obstetric examination durinv pregnancy with complete obstetric examination data was diagnosed as intrahepatic cholestasis of pregnancy(ICP).

Exclusion Criteria:

1. Pregnancy complicated with medical and surgical diseases, such as thyroiddysfunction and chronic hypertension;
2. Insufficiency of vital organ function or complicated tumor;
3. Pregnant women with other pregnancy complications besides ICP, such as preeclampsia, etc.
Cystic Fibrosis Adherence Study

This study aims to assess the role of some factors which can influence the chest physiotherapy adherence in adult with cystic fibrosis.

At first, we are going to try to consider the adherence of chest physiotherapy. Then, after dividing the patients into two groups - adherent or not adherent - we will attempt to identify the factors which can influence this adherence.

It consists in a short questionnaire that the patient will fill during usual visits.

The hypothesis is that the following factors can play a role in adherence of chest physiotherapy:

* Age
* Age of diagnostic
* Sex
* Fev1
* Number of antibiotic course
* Anxiety/depression
* Work time
* Socio-professional category
* Individual situation
* Physiotherapy with liberal physiotherapist and transport time
* Sport practice
* Family support
* Feeling of work time burden
* Feeling of physiotherapy efficiency
* Feeling of physiotherapy burden


Eligibility Criteria:
Inclusion Criteria:

* respiratory symptoms
* subnormal respiratory function (FEV1 \< 80%)
* without lung transplant

Exclusion Criteria:

* lung transplantation approach
T2 Weighted Imaging of the Liver With Fast Spin Echo MRI

The purpose of this study is to test two new MRI (magnetic resonance imaging) sequences to see how they compare to previously used imaging sequences as they may improve the quality of abdominal MRI.

* Approximately 50 patients undergoing routine liver MRI in our practice imaged with one of our 4 clinical scanners will undergo our standard liver MRI protocol with the addition of 2 breath-hold sequences (FSE Flex and eSSFSE) only increasing the scan time by approximately 3 minutes.
* Data will be retrieved from examinations that have been performed from the patient's electronic imaging file stored in our picture archiving and communication system (PACS).
* Images will be completely anonymized. No patient identifiers will be available on the images during the analysis.
* Analyses will include the visual assessment of image quality, presence and severity of imaging artifact and other non-invasive imaging outcomes performed by radiologists blinded to patient information and the type of sequence performed. Data will be presented in a Likert type scale (1=poor, 2=suboptimal, 3=average, 4=above average and 5=excellent) and imaging parameters will be compared using the Wilcoxon sign rank test.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing routine liver MRI imaged with one of our 4 clinical scanners (MR 750W, General Electric, Milwaukee WI)

Exclusion Criteria:

* Patients not undergoing routine liver MRI
Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of Apatinib Combined With CHOP Regimen(cyclophosphamide, vincristine, epirubicin, prednisone in the treatment of newly diagnosed peripheral T-cell lymphoma.

Patients with peripheral T-cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional CHOP regimen. Apatinib is a small-molecule multitargeted tyrosine kinase inhibitor. The investigators have been proceeding this trial to evaluate the efficacy and safety of the Apatinib Combined With CHOP Regimen(cyclophosphamide, vincristine, epirubicin, prednisone in the treatment of newly diagnosed peripheral T-cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Age range 14-70 years old; ECOG performance status 0-2.
* Estimated survival time \> 6 months.
* Histological confirmed Peripherial T-cell lymphoma.
* Have taken no treatment.
* None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal.
* At least one measurable lesion.
* None of other serious diseases, cardiopulmonary function is normal.
* Pregnancy test of women at reproductive age must be negative.
* Patients could be followed up.
* None of other relative treatments including the traditional Chinese medicine, immunotherapy, biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
* Volunteers who signed informed consent.

Exclusion Criteria:

* Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, 30 days after major surgery, hypertension uncontrollable drugs, grade III-IV cardiac insufficiency, severe liver and kidney dysfunction);
* Abnormal coagulation (INR \> 1.5 or prothrombin time (PT) \> ULN + 4 seconds or APTT \> 1.5 ULN), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy；
* Urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g;
* Disagreement on blood sample collection.
* Patients allergic of any of drug in this regimen or with metabolic disorder.
* Pregnant or lactating women.
* Serious medical illness likely to interfere with participation.
* Serious infection.
* Primitive or secondary tumors of central nervous system.
* Chemotherapy or radiotherapy contraindication.
* The evidence of CNS metastasis.
* History of peripheral nervous disorder or dysphrenia.
* Patients participating in other clinical trials.
* Patients taking other antitumor drugs.
* Patients estimated to be unsuitable by investigator.
Probiotic Supplement Versus Placebo for the Treatment of Patients With Non-alcoholic Fatty Liver Disease

Probiotic supplement versus placebo for the treatment of patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial

Probiotic supplement versus placebo for the treatment of patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial by access liver biochemistry, MRI-PDFF, fibroscan and metabolic profile

Eligibility Criteria:
Inclusion Criteria: Male and female adults ≥20,\<80 years of age who suspected or confirmed diagnosis of NASH/NAFLD suggested by the historical data, they must meet one of the following criteria:

Fatty liver by imaging then fibroScan with CAP ≥ 248 dB m Liver biopsy compatible with NASH/NAFLD

Exclusion Criteria:

1. Supplement with probiotic/prebiotic within 2 weeks
2. Previous antibiotic/antifungus within 1 month
3. History of significant alcohol consumption for a period of more than three consecutive months within 1 year before screening. Significant alcohol consumption is defined as equal to or greater than approximately two alcoholic drinks per day for males and approximately 1.5 alcoholic drinks per day for females
4. Regular use of drugs historically associated with NAFLD, which include, but are not limited, to the following: amiodarone, methotrexate, systemic glucocorticoids at greater than 5 mg/d
5. Chronic liver diseases from other cause such as viral hepatitis, autoimmune hepatitis
6. Hepatic decompensation or impairment defined as presence of any of the following:

   * History of esophageal varices, ascites or hepatic encephalopathy.
   * Serum albumin \<3.5 g dl-1, except as explained by nonhepatic causes.
   * INR \> 1.4
7. Use of GLP-1 agonist therapy (for example, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide and albiglutide), vitamin E and pioglitazone
8. Active autoimmune disease, including actively treated lupus, rheumatoid arthritis, inflammatory bowel disease
9. Active malignancy on treatment
10. New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction \<30%
11. Known immunocompromised status, HIV or who have recurrent or chronic systemic bacterial, fungal, viral or protozoal infections
12. Respiratory compromised
13. Severe renal impairment (eGFR \<30 ml/min/1.73 m2)
14. Pregnancy
Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol

The Efficacy and safety of Non-anesthesiologist administered propofol (NAAP) for gastrointestinal endoscopy have been widely documented although there is not information which has evaluated the outcomes of colonoscopy it self when the endoscopist has to fulfill the additional task of supervising the sedation.

Objective: To determine the equivalence of adenoma detection rate (ADR) in colorectal cancer (CRC) screening colonoscopies performed with NAAP and performed with monitored anesthesia care (MAC).

Method: Single blind non-randomized controlled equivalence trial. Patients: Adults between 50 - 69 years old from National CRC screening program (CRCSP). Intervention: The patients are blindly assigned to undergo either colonoscopy with NAAP or MAC according to the arrival of fecal occult blood test, patient's suitability for colonoscopy date and availability of places at endoscopy schedule (with NAAP or MAC).


Eligibility Criteria:
Inclusion Criteria:

Healthy patients -

Exclusion Criteria:

Patients with familial colorectal cancer history

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PLAYshop: A Parent-focused Physical Literacy Intervention for Early Childhood

The PLAYshop program is a novel, brief, theory-based, parent-focused physical literacy intervention designed to address this major public health issue of childhood physical inactivity and to support families.

Primary Research Question: Does the PLAYshop program increase preschool-aged children's physical literacy, including fundamental movement skills and motivation and enjoyment, compared to controls?

The overall goal for the proposed study is to examine the efficacy of the PLAYshop program, a novel, brief, theory-based, parent-focused physical literacy intervention, on child- and family-specific outcomes.

Research Questions:

Primary: Does the PLAYshop program increase preschool-aged children's physical literacy, including fundamental movement skills and motivation and enjoyment, compared to controls? Secondary: Does the PLAYshop program increase preschool-aged children's physical activity and co-participation in physical activity with parents, compared to controls? Tertiary: 1) Does the PLAYshop program increase parents' capability, motivation, and opportunity to support preschool-aged children's physical literacy development, compared to controls? 2) What is the level of, and factors that influence, implementation at the family and program delivery level?

Hypotheses:

Increases in preschool-aged children's fundamental movement skills, motivation and enjoyment, physical activity, and parent-child co-participation in physical activity will be greater in the intervention group, compared to the control group. Additionally, increase in parents' capability, motivation, and opportunity to support preschool-aged children's physical literacy development will be greater in the intervention group, compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3-5 years and their parents
* Living in non-rural areas of Alberta or British Columbia, Canada as defined by Statistics Canada

Exclusion Criteria:

* Children diagnosed with developmental delay or disorder/condition that may affect gross motor development or limit their ability to be physically active.
* Families with parents who do not comfortably speak or read English.
* Families that do not have access to a smartphone/tablet with camera and microphone.
* Families that have participated in prior PLAYshop pilot and feasibility trials.
Adapting the HITSystem to Support Prevention of Mother-to-child HIV Transmission

The purpose of this study is to modify the HITSystem to engage and retain HIV+ pregnant women before, during and after delivery and evaluate the HITSystem impact on prevention of mother-to-child transmission (PMTCT) related behaviors and outcomes. HITSystem 2.0 intervention will support a range of PMTCT outcomes including retention in care, ART adherence, and integration of maternal and pediatric HIV services in low-resource settings.

The study will be conducted in three phases:

Phases 1: The researchers will conduct formative research (focus groups and interviews) with HIV+ pregnant women and PMTCT providers to customize communication strategies for text messaging and inform patient flow and optimal implementation across the various PMTCT-related services at the intervention site.

Phase 2: The researchers will design and refine the HITSystem 2.0 technical components to support PMTCT outcomes guided by clinical content experts, technology analysts, and findings from Phase 1.

Phase 3: The researchers will implement HITSystem 2.0 at one hospital over an 18 month period, and compare targeted PMTCT outcomes to those at a matched control hospital.

The study will be conducted at two government hospitals in Kenya. HIV+ pregnant women will be enrolled in the HITSystem 2.0 at Kapsabet Hospital. HIV+ pregnant women receiving the current standard of PMTCT care at Nandi Hills Hospital will be the comparison group.

Eligibility Criteria:
Phase 3

Inclusion Criteria:

* HIV+ pregnant women
* Present for first PMTCT appointment at one of the study Hospitals
* Own or have reliable access to mobile phone

Exclusion Criteria:

* N/A
Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference

To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference

To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference

Eligibility Criteria:
Inclusion Criteria:

1. age \>18 years
2. male patient scheduled for cystoprostatectomy as treatment of muscle invasive bladder cancer (clinical T2-T3, any N) or high risk non-muscle invasive bladder cancer (pT1 or CIS)
3. no known diagnosis of prostate cancer
4. no contraindication to undergo multiparametric MRI
5. Signed written informed consent prior to any screening procedures being performed
6. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen

Exclusion Criteria:

1. allergy against MR contrast media
2. diagnosis or previous treatment of prostate cancer
3. severe renal insufficiency (GFR \<30ml/min)
4. Bladder cancer infiltrating the prostate (T4)
5. Pelvic metallic implants such as hip prosthesis
6. Patients scheduled for cystoprostatectomy with prostate capsule sparing
7. Patients unable to provide informed consent
8. Patients having a prostate biopsy \<6 month
Smoking Cessation Outcomes and Effective Factors

The study is a cross-sectional-descriptive study. Cases who met the inclusion criteria, agreed to participate in the study voluntarily, were active smokers, passive smokers and non-smokers will be included. The subjects will be given the maximal voluntary breath-hold test, the 6-minute walk test, and the 30-second sit-and-stand test, and will be asked to answer questions about smoking. The physical conditions of the groups will be compared.

The study is a cross-sectional-descriptive study. Cases who met the inclusion criteria, agreed to participate in the study voluntarily, were active smokers, passive smokers and non-smokers will be included. Active smoking, passive smoking status and non-smoker status of the cases will be determined within the framework of the definitions given below.

* Active smoker: Having smoked at least 1 cigarette per day for at least 2 years.
* Passive smoker: Being exposed to secondhand smoke for more than 15 minutes at home, school, office or anywhere in the past year, once a week.
* Non-smoker: Not being an active or passive smoker.

The subjects will be given the maximal voluntary breath-hold test, the 6-minute walk test, and the 30-second sit-and-stand test, and will be asked to answer questions about smoking.The physical conditions of the groups will be compared.

Eligibility Criteria:
Inclusion Criteria for Active Smokers

* Being between the ages of 18-75
* Smoking at least 1 cigarette a day for at least 2 years

Inclusion Criteria for the Passive Smoker Group

* Being between the ages of 18-75
* Being exposed to cigarette smoke for more than 15 minutes at home, school, office or anywhere in the last year, once a week.

Inclusion Criteria for the Non-Smoker Group

* Being between the ages of 18-75
* Not being an active or passive smoker

Exclusion Criteria:

* Having any disease that prevents him from doing exercise tests
* Not signing the voluntary informed consent form