cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Artesunate-mefloquine as a Novel Alternative Treatment for Schistosomiasis in African Children

The SchistoSAM study is an open label, two-arm, individually-randomized controlled trial with a non-inferiority design, conducted in northern Senegal.

The study aims at determining if the efficacy of one and of repeated courses of artesunate-mefloquine (AM) is respectively similar to or higher than that of a standard praziquantel (PZQ) treatment. Secondly, the study will assess if novel DNA- and antigen-based diagnostics are more accurate than microscopy in assessing antischistosomal treatment response.

The SchistoSAM study is an open label, two-arm, individually-randomized controlled trial with a non-inferiority design, conducted in northern Senegal.

The study aims at determining if the efficacy of one and of repeated courses of artesunate-mefloquine (AM) is respectively similar to or higher than that of a standard praziquantel (PZQ) treatment. Secondly, the study will assess if novel DNA- and antigen-based diagnostics are more accurate than microscopy in assessing antischistosomal treatment response.

For this purpose, 726 school children, aged 6-14 years old and infected with Schistosoma (as demonstrated by presence of eggs in stool and/or urine) will be randomized in one of the following arms:

1. AM, available in fixed dose tablets of 25/50 mg and 100/200 mg will be administered once daily for three days in a dose closest to 4 mg/kg artesunate and 8 mg/kg mefloquine. This treatment course will be repeated 2 times at 6-week intervals.
2. PZQ, available in tablets of 600 mg, will be administered as a single dose of 40 mg/kg.

Trial participants will be regularly followed-up:

1. At each dose administration
2. At day 7 after each dose for follow-up of safety
3. At week 4, 10 and 16 for parasitological assessment and follow-up of safety
4. At week 6 and 12 for clinical assessment before the second and third drug administration (only in the AM arm)
5. At week 24 and 48 for assessment of Schistosoma spp. and malaria infection and associated morbidity (compared to baseline)

Eligibility Criteria:
Inclusion Criteria:

1. Children ≥6 and ≤14 years of age
2. Enrolled in one of the selected primary schools in the region
3. Infected with schistosomiasis (i.e. Schistosoma spp. eggs in urine and/or stool)
4. Informed consent from parents/guardians signed

Exclusion Criteria:

1. History of, or ongoing, epilepsy or psychiatric illness (I.e. recent history of depression, generalized anxiety disorder; history of psychosis, schizophrenia or other major psychiatric disorders) or known hypersensitivity to one of the three study drugs
2. Chronic medication for any reason
3. Any severe underlying illness, including severe malnutrition or severe chronic schistosomiasis, based on clinical judgement
4. Any febrile illness
5. Exposure to PZQ or ACT within the three previous months.
Clinical Characteristics and Risk Factors of Children Suffering From Inflammatory Bowel Diseases At Assiut University Children Hospital

Clinical Characteristics and Risk factors of Children Suffering from Inflammatory Bowel Diseases At Assiut University Children Hospital

All patients admitted with inflammatory bowel disease will be subjected to:

1. History: including name, age ,sex ,family history, consanguinity, history of rectal bleeding, mucus or blood in the stool, diarrhea, abdominal pain ,vomiting ,nausea and loss of appetite.
2. Examination: including general examination, chest, cardiac, abdominal and neurological examination
3. Investigation:including labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.

Eligibility Criteria:
Inclusion Criteria:

- Children aged less than 18 years with a confirmed diagnosis of IBD.

Exclusion Criteria:

* Children with colitis other than IBD or children with systemic diseases affecting GIT.
Prohepcidin, Inflammation and Iron Homeostasis in Hemodialysis Patients With Chronic Hepatitis C

The aim of this study is to address questions regarding the link among hepcidin, hematological iron markers, inflammation and hepatitis C in HD patients. In attempt to address this issue, we planned to measure serum levels of hepcidin prohormone (pro-hepcidin), inflammatory and iron parameters.

Hepatitis C virus (HCV) infection is the most common cause of chronic liver disease in the world and also common among chronic hemodialysis (HD) patients. Patients with chronic HCV often have increased liver iron, a condition associated with reduced sustained response to antiviral therapy, more rapid progression to cirrhosis, and development of hepatocellular carcinoma; however, little is known about the mechanism of iron accumulation in the liver. Recently identified hepcidin, a 25-amino acid peptide hormone exclusively synthesized in the liver, is thought to be a key regulator for iron homeostasis and is induced by infection and inflammation. Hepcidin expression is modulated by iron stores, so that it decreases in iron deficiency to facilitate iron absorption while it increases in iron repletion to prevent pathological overload. Interleukin (IL)-6 has been proposed as a major inducer of hepcidin, via direct transcriptional activation of hepatic hepcidin expression by binding to its receptor complex containing gp130 to activate janus kinase (JAK) and activator of transcription 3 (STAT 3).

Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis patients

Exclusion Criteria:

* Patients positive for hepatitis B virus surface antigen (HBsAg)
* Patients previously diagnosed nonrenal cause of anemia other than iron deficiency
* Patients with an evidence of active or occult bleeding
* Patients received blood transfusion within the past 4 months
* Patients with a history of malignancy, end-stage liver disease, or chronic hypoxia
* Patients with a history of recent hospitalization or infection requiring antibiotics within the past 4 weeks.
Multi-center Validation of a Hypothermia Prediction Mobile Application (APP)

There have been no fully validated tools for rapid screen of surgical patients at risk of intraoperative hypothermia. The aim of this study is to validate the performance of a previously established prediction model in estimating risk of intraoperative hypothermia using a prospective cohort before further implementation of the model. We hypothesize that the prediction model has helpful discrimination and adequate calibration \[1\] for clinical use.

This is a multicenter, prospective, observational cohort study to validate the property of a previously established mobile application (APP) \[2\] for estimating risk of intraoperative hypothermia. Patients scheduled for elective surgery under general anesthesia will be enrolled consecutively at 30 hospitals, which are randomly selected across China, between June, 2021 and December 2022. The total planned sample size is 3000 cases. Eligible participants will be identified, informed to sign the consent, and flagged at preoperative interview the day prior to the operation. Anesthetics and perioperative temperature management will be chosen at the discretion of the anesthesiologists without intervention. Intraoperative hypothermia risk score of each participant will be calculated by a mobile application of the predictor model \[2\] before surgery. A wireless axillary thermometer \[3\] will be used to continuously measure and record perioperative core temperature as the reference standard. All participants will be followed up until 30 days after the operation.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older
* undergoing elective operation with general anesthesia or combined with other anesthesia
* operation is expected to last more than 40 minutes

Exclusion Criteria:

* central hyperthermia (e.g., cerebrovascular disease, traumatic brain injury, cerebral operation, epilepsy or acute hydrocephalus)
* impaired thermoregulation (e.g., neuroleptic malignant syndrome, malignant hyperthermia, or known hyperthyroidism/hypothyroidism with current thyroid dysfunction
* infectious fever
* core temperature ≥38.5 ℃ attributable to other causes within 3 days before surgery
* operation with induced hypothermia (e.g. cardiopulmonary bypass)
* unsuited for infrared tympanic thermometry or axillary temperature monitoring
* unwilling to give signed consent
Probiotics for Girls With Recurring Urinary Tract Infections

Probiotics are dietary supplements containing potentially beneficial bacterial strains such as Lactobacillus. The safety of oral administration of probiotics has been demonstrated in hundreds of studies using adults over the last 30 years. Very few studies have been conducted with children. UTI in girls occur when virulent bacteria migrate from the rectum and colonize the vagina and peri-urethral mucosa, thus gaining access to the bladder.

This study will randomize girls to ARM A (probiotics + placebo) and ARM B (antibiotics + placebo) to determine if UTIs are decreased when the probiotics are given.


Eligibility Criteria:
Inclusion Criteria:

* Girls age 1 through age 17 years of age
* Must have had at least 3 symptomatic UTI, uncomplicated or complicated, in the year preceding study inclusion or already using any form of prophylaxis to prevent recurrences of UTI
* Must have had at least 3 symptomatic urinary tract infections in the year before the start of the prophylaxis.

Exclusion Criteria:

* Breastfeeding
* Pregnancy
* Prior adverse reaction to sulfa drugs or sulfamethoxazole/trimethoprim
* Known immunosuppression i.e., transplant recipients or children with congenital immunodeficiencies
* Poorly controlled diabetes
* Untreated HIV infection
* Use of high dose corticosteroids for autoimmune diseases or post-organ transplantation. Inhaled corticosteroids or oral steroids for asthma are allowed.
* Malnutrition
* Patients with a history of sulfamethoxazole/trimethoprim-resistant UTI will be excluded from the study
* Patients with renal insufficiency, liver insufficiency, or cardiopulmonary disease requiring medication will be excluded from the study
* Patients with known anemia will be excluded from the study
* Patients taking medications that may interact with sulfamethoxazole/trimethoprim will be excluded from the study
* Patients taking other probiotics will be excluded from the study
* Patients already taking prophylactic antibiotics will be excluded from the study
Working Memory and Physical Exercise Training in Patients With Mild Cognitive Impairment

The prevalence of dementia will double in the next three decades in the U.S.; effective treatment or prevention for dementia is urgently needed. The current exploratory project aims to evaluate and understand how the brain and cognition may improve after a 12-week intervention that combines brain training and aerobic exercise training to improve brain function, both in those with mild cognitive impairment (some with possible prodromal Alzheimer's disease) and with healthy aging. Findings from this pilot project will guide and refine the development of a future larger clinical trial that aligns with the goals of the National Alzheimer's Plan of Action (NAPA), especially regarding "Prevent and Effectively Treat Alzheimer's Disease (AD) by 2025.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women of all races and ethnicities who are 50-80 years of age will be eligible.
* Only sedentary adults will be eligible (engaging in structured activity for exercise \<3x/week) for Progressive aerobic exercise or Combined training
* Ability to use, and accessibility to, an iPad or computer is required for the Adaptive cognitive training and Combined training.
* Fluent in English.
* The diagnosis of MCI will first be confirmed at the screening evaluation using the clinical dementia rating (CDR) scale and the Montreal Cognitive Assessment (MoCA). We will also evaluate their ADL using instrumental activities of daily living (IADL) to ensure they have preserved independence in functional abilities despite the cognitive deficits. The primary caregivers will be interviewed (either in person or by phone) for the participants' IADL to corroborate the independent functional status.

Exclusion Criteria:

* Does not have access to a computer or internet to perform the Cogmed® training AND is unwilling to come to the lab for the training.
* Unable to undergo an MRI investigation based on claustrophobia or metal foreign bodies.
* Symptomatic heart disease, Coronary artery disease, congestive heart failure, uncontrolled hypertension, uncontrolled diabetes (HbA1c\>10%), significant cardiovascular disorders (on EKG and graded exercise test) that would prevent the participant from the exercise training; neurologic, musculoskeletal, or other condition that limits the subject's ability to complete study physical assessments.
* Estimated verbal Intelligence Quotient (IQ) below 70 (based on the Wechsler Test of Adult Reading) which would invalidate the informed consent process for the study.
* Self-reported moderate to severe substance use disorder(s) (e.g., self-reported intake \>3 oz liquor, or three 4 oz glasses of wine, or three 12 oz cans of beer per day or illicit drug use).
* Severe chronic or acute medical or other (non-MCI) neuropsychiatric conditions that might confound the cognitive or brain imaging measures (e.g., liver function tests \>2.5 normal range or evidence for renal failure).
* Body mass index \>40 kg/m2.
Prone-position CT for Diagnosing Inguinal Hernia

Background: The aim of this study was to investigate the efficacy of prone-position computed tomography (CT) for detecting and classifying inguinal hernia relative to supine-position CT before laparoscopic inguinal hernia repair.

Materials and Methods: Sixty-eight patients who underwent laparoscopic transabdominal preperitoneal repair of inguinal hernia were enrolled in this prospective study. Patients diagnosed with inguinal hernia by physical examination underwent abdominal CT in the supine and prone positions for preoperative assessment. The anatomy of the right and left inguinal regions was confirmed during the surgery and compared with the preoperative CT findings.


Eligibility Criteria:
Inclusion Criteria:

* inguinal hernia

Exclusion Criteria:

* emergency surgery for incarcerated hernia
* femoral hernia
* recurrent inguinal hernia after laparoscopic inguinal hernia repair
Case-control Pilot Study of the Immune Modulating Effect of FEIBA on Patients With Haemophilia A and Inhibitors

This study aims to evaluate the immunomodulatory effect of FEIBA® in patients with severe haemophilia A and inhibitors.

This is an observational, multicentric, case-control and one-single-visit study of patients with severe haemophilia A and inhibitors against FVIII in therapy with FEIBA®.

Two subject groups will be included: Group 1 (cases) will be composed of patients with severe haemophilia A and inhibitors in prophylaxis with FEIBA®; Group 2 (controls) will be composed of patients with severe haemophilia A and inhibitors on-demand treatment with FEIBA®.

Eligibility Criteria:
Inclusion Criteria:

1. The subject has signed and dated the Informed Consent form for participation in this study.
2. Age ≥ 18 years old.
3. Patient with severe haemophilia A (FVIII \<1%) and high-responding inhibitor (titre \>5 UB) at some point in their life, currently on therapy with FEIBA® to control bleeding.
4. Group 1: Patients in prophylaxis with FEIBA®: The patient has been on prophylaxis regimen with FEIBA® for at least 6 months prior to the study visit. Group 2: Patients on-demand regimen with FEIBA®: The patient has been under on-demand treatment with FEIBA® for at 6 months prior to the study visit.

Exclusion Criteria:

1. The presence of any inflammatory condition at the time of the study visit or the previous 30 days that, according to the medical criterion, would affect the study objectives.
2. The patient is under immune tolerance treatment or has been at any time during the 30 days prior to the study visit.
3. The administration of any anti-inflammatory or immunosuppressive drug 15 days before the study visit.
4. Levels of CD4 \<200/l regardless of the HIV status.
5. Altered hepatic or renal function defined by the presence of abnormal levels of alanine aminotransferase (ALAT) or serum creatinine, respectively.
6. Administration of any haemostatic treatment to control bleeding within the 5 days prior to the study visit.
Assessment of Physical Activity Awareness Training in Healthy Young Adults

According to the World Health Organization, physical activity is defined as any bodily movement produced by skeletal muscles that requires energy expenditure. Positive effects of leading a physically active life and exercise have been shown in many areas ranging from diabetes to cardiovascular diseases, cancer to mortality, pain to autoimmunity .

Despite the many proven benefits of regular aerobic exercise, physical inactivity remains an important public health problem. In young adults, the perception that exercise is not fun and lack of time for exercise have led to a decrease in physical activity participation . However, studies in the literature have reported that after first creating awareness in individuals about the effects of physical activity on health, creating the necessary time for exercises provides sufficient motivation for individuals to start and continue a more active life.

Eligibility Criteria:
Inclusion criteria:

* 18-25 years of age.
* Being cooperative.
* Voluntarily participating in the study
* Obtaining informed consent from them (Annex-1)

Exclusion criteria:

* Serious musculoskeletal disorders (disc herniation, etc. orthopedic or neurological diagnosis)
* Having a serious systemic disease
* Having a serious injury in the last 3 months.
* Having any neurological problem.
Human Milk and Infant Intestinal Microbiome Study

This study will explore the effects of skin-to-skin contact (SSC) between mothers and their babies on the infant intestinal microbiome, the maternal skin microbiome and the breast milk microbiome. This will be accomplished by administering an intervention education session to one group and a placebo education session to the second group in order to influence the magnitude of total SSC defined by the frequency and duration of contact time between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women scheduled to deliver at the University of Virginia Health System
* Women 18 years or older and their newborn infant
* Stated intent to exclusively breastfeed for the duration of post-partum hospital admission
* To have physical custody of their child when they are discharged from the hospital

Exclusion Criteria:

* Maternal antibiotic use in the 3 months prior to delivery
* Consumption of alcohol in the 3 months prior to delivery
* Recreational drug use in the 3 months prior to delivery
* Serious gastrointestinal conditions requiring medical intervention or medication during pregnancy (e.g. Crohn's disease, ulcerative colitis, celiac disease, gastrointestinal infections)
* Serious health conditions that require medication during pregnancy
Ziprasidone Pharmacokinetics Using a Reduced Food Effect Formulation Compared to Pharmacokinetics From Commercial Capsules

Commercial ziprasidone capsules show a large increase in bioavailability with food. The formulation tested in this study aims to reduce or eliminate that increase.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Signed informed consent document

Exclusion Criteria:

* Any significant physical or psychological disease
* Concomitant administration of other pharmaceuticals
Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI

This study aims to assess the effect and safety of erenumab compared to placebo for the treatment of acute posttraumatic headache (PTH) in military service members and civilians with mild traumatic brain injury (mTBI).

Headache is recognized as one of the most common and disabling symptoms following head trauma. This study is designed to assess a calcitonin gene-related peptide (cGRP) monoclonal antibody (erenumab) for the preventive treatment of PTH based on the rationale that headache posttrauma is similar to migraine and is mediated by the activation of the trigeminal vascular system and subsequent release of cGRP. This study is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of erenumab 140 mg for the treatment of PTH in military service members and civilians with mTBI at military treatment facilities across the United States.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 and ≤50 years of age
* mTBI from any cause including impact, rotational acceleration, blast, or a combination, has occurred within the prior 7 days
* PTH has occurred within the prior 7 days
* Able to provide informed consent
* Likely to stay in the same geographical area for the duration of study
* Has a personal health care provider for standard of care PTH and TBI, including education, diagnostic procedures including neuroimaging and treatment, as deemed clinically indicated by the health care provider

Exclusion Criteria:

* Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury:

  1. abnormal structural imaging
  2. loss of consciousness for \>30 minutes
  3. alteration of consciousness/mental state for \>24 hours 3. post-traumatic amnesia for \>1 day
* Participants with ongoing chronic migraine or other chronic daily headache disorders at the time of injury
A Pilot Study of the Feasibility and Accuracy of the TrueVie CGM System - A Non-Significant Risk Study

The purpose of the investigation is to obtain sufficient preliminary information about the performance of the TrueVie Continuous Glucose Monitoring (CGM) device to identify any need for any design modifications.

After being informed about the study and potential risks, all participants giving written informed consent will be screened for participation. Qualifying participants will insert CGM sensors and come to 3 clinic visits at the beginning, middle and end of the 15 days intended sensor life. At the clinic visits participants are served two meals and perform a brief period of exercise of moderate intensity while blood samples are drawn according to a planned schedule timed to coincide with the TrueVie measurements.

Eligibility Criteria:
Inclusion Criteria:

1 Type 1 diabetes mellitus 2. Must be and have been in stable treatment regimen for at least 3 months with a multiple daily insulin dosing regimens or Continuous Subcutaneous Insulin Infusion (CSII), irrespective of delivery device(s).

3. Must have normal exercise tolerance.

Exclusion Criteria:

1. Skin adhesive tolerance issues in the area of sensor placement
2. HbA1c \> 9%.
3. Insulin meal dosing based on fixed dose regimens.
4. Absence of established corrective factor for high glucose.
5. Hematocrit below 10% under the lower limit of the normal range.
6. Body mass index \< 20 kg/m2.
7. Inadequate intravenous access on arms.
8. Absence of moderate exercise tolerance per history
9. Pregnancy, planned pregnancy within the study period, or unwillingness to use reliable contraception during the study period.
10. Planned MRI, CT scan or diathermic procedure for the duration of the study.
11. Any medical history of malignant melanoma or breast cancer.
12. Medical history of any other cancers within the last five years except adequately treated basal cell or squamous carcinoma of the skin, or cervical carcinoma in-situ.
13. History of alcohol or drug abuse within the last year.
14. Any condition that in the opinion of the investigator may interfere successful completion of study procedures.
15. Participation in other clinical trials involving receipt of investigational drug that cannot be disclosed within the last 30 days.
16. Inability or unwillingness to conform to the required protocol procedures including giving informed consent.