cyrilzakka/clinical-trials huggingface dataset:
mHealth to Increase Measles Immunization - a Randomized Controlled Trial in Guinea-Bissau

The question that this project seeks to answer, is whether mobile phones can be used to increase the measles vaccination coverage and timeliness in Guinea-Bissau. The intervention will be evaluated in terms of direct health outcomes and cost/benefit analysis, generating evidence that could help policy makers making informed decisions about implementing mHealth interventions at a national level.

The intervention takes the form of a randomized controlled trial in which text messages (SMS) as well as voice calls are scheduled and delivered to mo thers to remind and encourage them to have their children timely vaccinated against measles. In addition, the messages will include relevant information about opening hours and availability of the measles vaccine at the mothers' local health facilities thus improving coordination. The trial will include three different randomization groups with approx. 350 participants in each group. The first group will receive SMS messages, the second group will receive a voice call in addition to the SMS messages, and the third group is a control group that does not receive any intervention.

Study participants will be enrolled following birth at one of three health centers in different rural regions of Guinea-Bissau. Before the measles vaccine is scheduled to be given, at 9 months of age, mothers will receive the intervention message depending on their assigned randomization group. When the measles vaccine is administered, the child will be registered as having received the measles vaccination.

A follow-up phone interview will be conducted at 12 months of age for all children participating regardless of randomization group and whether or not they received the measles vaccine. All participating children, who at that time still have not received the measles vaccine, will be offered the vaccine at the expense of the project.


Eligibility Criteria:
Inclusion Criteria:

* the mother has access to a cell phone (either her own phone or the phone of a household member)
* the mother lives in the uptake area of the health center.

Exclusion Criteria:

* the mother does not have access to a mobile phone.
Endoscopic Mucosal Resection With Circumferential Incision for Colorectal Neoplasms

This is a prospective randomized trial to improve the results of treatment of patients with colorectal neoplasms.

Generally, endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are the methods of choice for the removal of benign and early malignant neoplasms of the colon. However, there are certain difficulties in terms of the EMR technique - this is an increase in the frequency of fragmentation with a lesion size of more than 20 mm, which in turn increases the risk of recurrence; with regard to ESD technique, this is a long procedure time; high incidence of complications; significant time required for teaching the technique; technical difficulties. In this regard, it is worth paying attention to the method of "endoscopic mucosal resection with circumferential mucosal incision" (C-EMR). This method deserves interest due to the fact that it allows more often to perform en-block resections in comparison with the classical method of endoscopic mucosal resection (EMR - endoscopic mucosal resection); technically easier to do; takes a short procedure time.

Eligibility Criteria:
Inclusion Criteria:

* patients with benign colon neoplasms without signs of deep invasion (I, II, IIIL and IV type according to Kudo, I and II type according to Sano)
* the size of the neoplasm is from 20 mm to 30 mm
* patient for treatment

Exclusion Criteria:

* unsatisfactory tumor lifting
* refusal of the patient from research at any stage of treatment
Effects of Royal Jelly Supplementation in Chronic Kidney Disease

The objective of this study is to evaluate the effects of royal jelly on inflammation and cellular senescence in patients with chronic kidney disease (CKD) on hemodialysis (HD).

Royal jelly is a substance produced in the hypopharyngeal glands of bees that operate young, and rich in bioactive compounds such as polyphenols, free fatty acids and exclusive peptides capable of mitigating inflammation and premature aging (genomic instability, mitochondrial dysfunction, shortening of telomeres) existing in patients with chronic kidney disease (CKD) on hemodialysis. However, to date there are no studies evaluating the effects of royal jelly on such complications in patients with RDC. Objectives: To evaluate the effects of royal jelly on inflammation and cellular senescence in patients with CKD. Methods: Clinical, longitudinal, randomized study, with washout and crossover period. Patients with CKD on HD received 140 mL bottles containing propolis and turmeric, and were instructed to take 10 mL/day (dosing cup), containing a dose equivalent to 110 mg/day of standardized green propolis extract (EPP-AF) plus 130 mg of curcuminoids/day or placebo for 8 weeks. After this supplementation, patients will enter the washout period (8 weeks) and after this period, the intervention group will receive placebo and vice versa. The collection of biological material (blood and feces) will be done before and after each study period. The mRNA expression of the transcription factors Nrf2 and NF-κB, as well as their target genes, antioxidant enzymes, inflammatory cytokines and the expression of genes and proteins that modulate the protein will be evaluated using rtPCR, western blotting and assay methods. multiplex. Uremic toxins from the intestinal microbiota such as indoxyl sulfate (IS), p-cresyl sulfate (p-CS) and Indole-3-acetic acid (IAA) will be confirmed by HPLC and plasma lipopolysaccharide (LPS) levels will be analyzed by ELISA. The determination of antioxidant capacity will be determined by the FRAP, ORAC AND DPPH methods. The analysis of the composition of the intestinal microbiota will be evaluated by high-throughput sequencing of the V4-V5 region of the 16S ribosomal RNA gene. Nutritional status and dietary intake will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* patients with CKD undergoing hemodialysis for more than 6 months
* patients with arteriovenous fistula (AVF) as vascular access.

Exclusion Criteria:

* pregnant,
* lactating,
* smoker
* patients using antibiotics and antioxidant supplements in the last three months
* patients with autoimmune and infectious diseases,
* patients with cancer, liver disease, and AIDS
EFFECT OF MYOFASCIAL RELEASE THERAPY IN PATIENTS WITH CERVICAL MYOFASCIAL PAIN SYNDROME

Objectives: To investigate the effects of myofascial release therapy (MRT) on pain, number of trigger points (TP), pressure pain threshold (PPT), cervical range of motion (ROM), neck disability, and quality of life in the neck pain due to cervical myofascial pain syndrome (MPS).

In this prospective study, patients in Group I (n=30) underwent a standard physical therapy program. Patients in Group II (n=30) additionally underwent MRT 3 days a week. Before and on the 15th day after treatment, patients' pain was measured by visual analog scale (VAS), TP numbers by palpation, PPTs by pressure algometer, cervical ROM by goniometer, disability by Neck Disability Index (NDI) and quality of life by Nottingham Health Profile (NHP) was evaluated.


Eligibility Criteria:
Inclusion Criteria:

* volunteer patients between the ages of 18-65 who complained of neck pain lasting more than 1 month and met the Travell and Simons criteria for the diagnosis of Myofascial pain syndrome

Exclusion Criteria:

* presence of known infectious, inflammatory, tumoral, and advanced degenerative diseases that may cause neck pain, presence of pain reflected from internal organs, history of spine or shoulder fracture or surgery, presence of nerve root involvement findings due to cervical discopathy, having a history of neck manipulation or invasive procedures in the last 3 months.
Cardiovascular Risk Reduction Program Aimed at African American Women (The HHER Lifestyle Program)

Cardiovascular disease (CVD) is a serious health problem among African American women. This study will evaluate a health care center-based program that aims to encourage African American women to eat a low fat diet and increase their physical activity levels to reduce the risk of developing CVD.

CVD is the leading cause of death for women in the United States. It affects African American women at a higher rate than it does white women. People at risk for CVD are encouraged to maintain a healthy weight, eat a healthy diet that is low in fat and cholesterol, and increase their physical activity. Heath care centers are excellent places to provide counseling to people on ways to reduce their risk of CVD. In this study, researchers will evaluate the effectiveness of a community health care center-based counseling program aimed at reducing CVD risk factors among African American women from financially disadvantaged backgrounds.

This study will enroll African American women. Participants will be randomly assigned to one of two groups-either a basic program or a comprehensive program. During a routine, scheduled visit with their health care providers, all participants will learn about the importance of increasing physical activity and eating a low fat diet. All participants will also receive educational materials and a community resource guide. In addition to this, participants in the comprehensive program will receive a pedometer and will be asked to keep a daily log of their physical activity and eating habits. Once a month, these same participants will receive telephone calls from a health counselor and a newsletter by mail that encourages them to maintain a healthy lifestyle. All participants will receive home visits from study staff at baseline and Months 6 and 12. During these visits, participants will undergo blood pressure, weight, height, and waist measurements and a blood collection. Participants will complete questionnaires to assess their medical history, diet, and physical activity habits. For 1 week after each visit, participants will wear a physical activity monitor and keep an activity diary.

Eligibility Criteria:
Inclusion Criteria:

* African American women
* Able and willing to complete survey instruments and assessment procedures

Exclusion Criteria:

* Physical disability or orthopedic problem that limits physical activity
* Elevated blood pressure (i.e., greater than 160/95 mm Hg)
* Insulin-dependent diabetes
* Pregnant or planning to become pregnant during the study period
COVID-19: Immunological Mechanisms in Multisystem Inflammatory Syndrome in Children

This study seeks to explore immunological mechanisms in patients with Multisystem Inflammatory Syndrome in Children (MIS-C) to improve the understanding of this pathogenesis of this disease.

In a cohort of MIS-C patients diagnosed during the Wild type, Alpha, Delta and Omicron waves, research samples will be analyzed for whole-blood RNA expression, proteomics, inflammatory cytokines, cellular immune populations, autoantibodies, as well as host genetic markers.

BACKGROUND Multisystem inflammatory syndrome in children (MIS-C) is a rare severe complication to SARS-CoV-2 infection in children. Thousands of children worldwide have been hospitalized with this new disease. Yet, the immunological mechanisms are sparsely described.

AIM The project seeks to explore immunological mechanisms in patients with MIS-C.

METHOD From a prospective nationwide cohort of patients with MIS-C from Denmark (May 2020-March 2022), research samples will be investigated for whole-blood RNA expression, proteomics, inflammatory cytokines, metabolomics, cellular immune populations, autoantibodies, as well as host genetic markers allowing for detailed mapping this disease. Samples from MIS-C patients will be compared to patients with bacterial and viral disease, and other inflammatory diseases.

TIME FRAME Sample identification: February 1 2022 to April 1, 2022. Sample analysis: April 1, 2022 to December 31, 2022

PERSPECTIVES New molecular-based tools may lead to improved understanding of the pathogenesis of MIS-C. This could form basis for development of novel diagnostic markers, identification of severe phenotype and therapeutic interventions.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with MIS-C, according to the CDC criteria aged 0-17 years

Exclusion Criteria:

* Patients from whom patient/parent/legal guardian signed consent is not received
Evaluation of Endoscopic Surgical Field Clarity Using Hot Saline Versus Lactated Ringer's Irrigation

This study is designed to determine whether Normal Saline or Lactated Ringer's irrigation is superior in maintaining superior endoscopic surgical field clarity in surgery for pituitary adenoma.

The aims of this study are to determine whether the endoscopic surgical view is objectively clearer using Normal Saline versus Lactated Ringer's Irrigation during endoscopic skull base surgery for pituitary adenoma. Other objectives include determining whether lactated Ringer's irrigation decreases total estimated blood loss and whether use of lactated Ringer's irrigation shortens surgical time.

Hot saline irrigation at 40 degrees Celcius has been shown to improve endoscopic surgical field clarity and its use is common practice in both endoscopic inflammatory sinus surgeries and skull base procedures. Saline irrigation dilutes blood in the surgical field keeping the endoscopic view clean and more bloodless and the elevated temperature promotes hemostasis.

Preliminary evidence suggests that the use of calcium-containing irrigant may further improve endoscopic surgical views. This mechanism is thought to be mediated through the activation of platelets and providing a calcium source to calcium-dependent factors in the coagulation cascade thereby promoting hemostasis. Using lactated Ringer's, a calcium-containing fluid, may result in improved surgeon visualization, decreased blood loss, and decreased complications during endoscopic approaches to the skull base.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with a primary pituitary adenoma, macro or micro adenoma.

Exclusion Criteria:

* Age \<18
* Pregnancy
* Revision surgery
* Non-surgical candidate due to medical, surgical, or anesthesia contraindications
Personalized Therapy Study - HFRS (TriageHF) Post Approval Study

Medtronic is sponsoring the HFRS PAS to evaluate the HFRS feature (TriageHF) when used in routine clinical practice following commercial release. The HFRS PAS is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

The HFRS PAS is a global, prospective, observational, multi-site study. Patients implanted with a Medtronic Cobalt™ XT CRT (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead (ASQ)) or ICD device who are enrolled in the Medtronic CareLink (CL) Network and the PSR will be followed per the standard of care practices of their care provider.

Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive or be treated with an eligible ICD or CRT device or Patients may be enrolled pre-implant and up to 30 days post-implant following confirmation of patient eligibility.
* Patient is enrolled in the Medtronic CareLink® Network for remote monitoring.

Exclusion Criteria:

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results.
Immunogenicity and Safety of a DTPa-HBV-IPV/Hib Vaccine Given at 2, 3 and 4 Months of Age

The purpose of this study is to show that the immunogenicity of newly formulated DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed formulation of the vaccine. The vaccine will be administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age and its safety and reactogenicity will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* A healthy male or female between, and including, 8 and 12 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parents/guardians of the subject.
* Born after a normal gestation period of 36 to 42 weeks.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth until first primary vaccination dose.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Administration/planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose, with the exception of the human rotavirus (HRV) vaccine.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B and/or Haemophilus influenza type b (Hib) vaccination or disease.
* Hepatitis B virus (HBV) vaccination at birth.
* History of seizures or progressive neurological disease.
Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease

The purpose of this study is to determine whether Non-invasive endoscopic procedures (pillcam colon capsule endoscopy, PCCE) and non-ionizing radiological modalities (MR enterocolonography, MREC and ultrasound, US) - offer a sufficiently high diagnostic validity in patients with suspected CD compared to the traditional invasive approach using ileocolonoscopy with biopsies as first line diagnostic modality

This is a prospective, blinded, multicenter study of the diagnostic validity, inter-observer agreement, image quality and subjective experience of discomfort with PCCE, MREC and US in patients with suspected CD. Ileocolonoscopy serves as the diagnostic gold standard. Patients are recruited from 3 centers in the Region of Southern Denmark managing adult patients with inflammatory bowel diseases. Each patient goes through a standardized work-up including medical history, physical examination, C-reactive protein, fecal calprotectin, ileocolonoscopy, PCCE, MREC and US. All examinations are reviewed and described in a standardized fashion. The radiologists and physicians describing PCCE, MREC, and US are blinded to the findings at ileocolonoscopy and the other imaging modalities.

Eligibility Criteria:
Inclusion Criteria:

General criterion

All of the following:

* Clinical suspicion of CD
* Age \> 15 years
* Negative serologic markers for celiac disease, negative stool culture (or polymerase chain reaction) for pathogenic bacteria and a negative microscopy for intestinal parasites
* Fecal calprotectin \> 50 mg/kg
* Signed informed consent

Clinical criterion Diarrhea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) associated with one or more of the following findings: (1) C-reactive protein (CRP) \>5 mg/L, (2) thrombocytosis (\> 400 x 109/L), anemia (hemoglobin \< 7.0 mmol/L for women and \< 8.0 mmol /L for men or a decrease \> 0.5 mmol/L compared to the usual level), (3) prolonged fever (\> 37.5 C for more than 2 weeks), (5) weight loss (≥ 3 kg or ≥ 5% compared to the normal body weight), (6) perianal abscess/fistula, or (7) a family history of inflammatory bowel disease.

Exclusion Criteria:

* Acute bowel obstruction
* Intake of NSAIDs or acetylsalicylic acid ≤ 4 weeks before inclusion except prophylactic treatment with low dose Aspirin (≤ 150 mg per day)
* Pregnancy or lactation
* Alcohol or drug abuse
* Known gastrointestinal disorder other than inflammatory bowel disease
* Renal failure defined by a plasma-creatinine above the normal reference range
* Claustrophobia, cardiac pacemaker or implanted magnetic foreign bodies that precludes MREC
* Interpreter required or inability to understand the oral and written information
* Colonoscopy contraindicated, performed within 3 months or unwillingness to go through colonoscopy
REassessement After Hospitalization for Sars-COV-2 disordER

Currently, the sequelae and short-term medical and psychological impact of the sars-cov-2 infection ("CoVID-19") remain poorly described. The clinical and functional sequelae that may persist after acute sars-cov-2 ("CoVID-19") infection are essential to explore, in order to ensure the best possible follow-up of patients after discharge from hospital.

Since sars-cov-2 ("CoVID-19") is a newly defined infection, its sequelae and short-term medical and psychological impact remain poorly described.The clinical and functional sequelae that may persist after acute sars-cov-2 ("CoVID-19") infection are essential to explore, in order to ensure the best possible follow-up of patients after discharge from hospital.

Indeed, some patients may develop chronic respiratory failure, pulmonary fibrosis, or other comorbidities including cardiovascular or metabolic diseases. The psychological impact is also essential to assess. The sequelae and comorbidities of patients could also vary depending on the severity of the initial acute involvement.

Investigators propose to explore the sequelae of patients who have been hospitalized for acute sars-cov-2 infection, between 3 to 6 months after discharge from hospital, by characterizing the incidence of chronic respiratory failure and fibrosis, as well as of various comorbidities such as cardiovascular, metabolic, and psychological diseases.

Eligibility Criteria:
Inclusion Criteria:

* patient who was hospitalized within 3 to 6 months for a sars-CoV infection

Exclusion Criteria:

* Absence of signed informed consent
* pregnancy or breastfeeding
* patient under guardianship or curatorship
Functional Exhaustion of T Cells in COVID19 Patients

The primary end-point of our prospective, observational study is to count T cells in patients with laboratory-confirmed COVID-19 and healthy controls. In addition, the expression of T cell exhaustion marker was measured in COVID-19 cases.

COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has posed great threat to human health. T cells play a critical role in antiviral immunity but their numbers and functional state in COVID-19 patients remain largely unclear. The immune response against viral infections depends on the activation of cytotoxic T cells that can clear infection by killing virus-infected cells, so boosting the numbers and function of T cells in COVID-19 patients is critical for successful recovery. However, the factors which might cause the reduction in count, and the activation status of T cells in COVID-19 patients, remain uninvestigated. Thus demonstration of T cell exhaustion during COVID-19 infection suggest that more urgent, early intervention may be required in patients with low T lymphocyte counts.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Covid-19 test positive; hospitalized subjects; both sexes; given informed consent.

Exclusion Criteria:

* no exclusion criteriae