cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Zinc Sulfate With Probiotics for the Treatment of Acute Diarrhea in Children

Diarrheal disease is one of the major causes of morbidity and mortality in children under five. Disease is treated symptomatically with oral rehydration (ORS) as a basic measure. In children with severe zinc deficiency, diarrhea is common and responds quickly to zinc supplementation. Zinc supplementation may also helpful in diarrheal children without zinc deficiency. Effectiveness of zinc was proven in developing countries but was not in Europe. Objective of our study is to assess whether zinc supplementation given with probiotics and ORS is effective in acute diarrhea in children in Poland.

A double-blind, placebo controlled trial

- We are going to enroll 256 patients (aged \> 1 months to 36 months) with acute watery diarrhea defined as 3 d or more watery stools per day lasting not less than 1 day and not longer than 5 days.

Exclusion criteria:

severe dehydration (\> 10%) Coexisting severe infection (E.g. Sepsis, pneumonia, meningitis) Immune deficiency Chronic digestive tract disease (e.g. celiac diseases, food allergy) Therapy with Antibiotics

Patients will be randomly assigned to 2 groups to receive: (a) zinc sulfate 10-20 mg/day for 10 days plus probiotics for 5 days (b) placebo for 10 days plus probiotics for 5 days. Patients will be observed in ambulatory or in the hospital (if necessary) and followed up for 15 days.

Randomization 1:1

Eligibility Criteria:
Inclusion Criteria:

* Age 1-36 months
* Acute diarrhea defined as 3 or more watery stools per day
* Informed consent (parents)

Exclusion Criteria:

* Severe dehydration (\> 10%)
* Coexisting severe infection (e.g. sepsis, pneumonia, meningitis)
* Immune deficiency
* Chronic digestive tract disease (e.g. celiac diseases, food allergy)
* Antibiotic therapy
Monitoring Arrhythmia Patients in in Hospital Monitoring

This is a prospective, single center, non-randomized study to evaluate the arrhythmia monitoring performance of the AVIVO™ System in a hospital setting.

The AVIVO™ System will continuously monitor the patient's cardiac activity which will be compared to the performance of standard telemetry system.

Eligibility Criteria:
Inclusion Criteria:

* Is female or male, 18 years of age or older
* Undergoing in-hospital electrocardiographic monitoring for primarily cardiac reasons

Exclusion Criteria:

* Is participating in another clinical study that may confound the results of this study
Influence of CYP2C19 Genotype on the Pharmacokinetics (PK) of Voriconazole

The purpose of this study is to:

* Evaluate the influence of CYP2C19 genotype on PK profiles of voriconazole.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects aged 20 - 50 years.
2. A body mass index (BMI) in the range 17-28 kg/m2.
3. Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.

Exclusion Criteria:

1. Presence or history of severe adverse reaction to any drug or a history of severe allergic disease.
2. Clinically relevant abnormal medical history that could interfere with the objectives of the study.
3. Presence or history of eye disease or eye field defect.
4. A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.
5. A subject whose liver function test (AST, ALT, GGT, ALP, LDH) result is over 1.25 times of upper limit of normal range.
6. A subject whose SBP is over 140 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
7. Presence or history of drug abuse.
8. Participation in other clinical trial within 2 months.
9. Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication within 1 week before first dose.
10. Blood donation during 2 months or apheresis during 1 month before the study.
11. Presence or history of alcohol abuse.
12. Smoking of more than 10 cigarettes/day.
13. Use of grapefruit juice, xanthine containing beverage, alcohol or smoking during restriction period.
14. Subject judged not eligible for study participation by investigator.
The Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery

The prevention of intraoperative allogenetic blood transfusion has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone tumor surgery. Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial, and intraoperative fluid administration strategy is an important confounding factor. The HEAL trial will assess whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion when applying goal-directed fluid therapy in patients undergoing bone tumor surgery.

Bone tumor surgery is associated with a significant risk of perioperative blood loss and transfusion, with blood loss usually in the range of approximately 500-1000 ml and an average transfusion of up to 2 units of allogeneic red blood cell. The increase in allogeneic blood transfusion volume is an independent risk factor for postoperative complications in patients undergoing bone tumor surgery, as well as affecting the long-term survival rate of cancer patients.

Acute normovolemic hemodilution (ANH) is a patient blood management measure. The clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial, and intraoperative fluid administration strategy is an important confounding factor. As goal-directed fluid therapy (GDFT) is increasingly used in clinical practice, it is of great importance to explore the efficacy of ANH in patients undergoing fluid management using GDFT.

Bone tumor surgery is an ideal setting to evaluate ANH in GDFT, as the procedure is associated with high blood loss and infusion. The 'Hemodilution on Intraoperative Allogeneic Transfusion' (HEAL) trial has been designed as a randomized, controlled trial to determine whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion when applying GDFT in patients undergoing bone tumor surgery.

Eligibility Criteria:
Inclusion Criteria:

1. age 18 to 75 years;
2. undergoing elective bone tumor resection surgery;
3. preoperative hemoglobin ≥11 g/dL;

Exclusion Criteria:

1. using a tourniquet;
2. palliative operation or minimally invasive surgery;
3. BMI\<18.5 or \>30Kg/m\^2;
4. international normalized ratio (INR) \>1.5 or platelet count \<100 × 10\^9/L;
5. cardiopulmonary insufficiency;
6. hepatic and renal dysfunction;
7. active infectious disease;
8. allergy to succinyl gelatin;
9. pregnancy;
10. declined participation in the study or declined blood transfusion
Study of Rimonabant/Metformin Combinations to Investigate Diabetes (Blood Sugar) Control in Patients With Type 2 Diabetes

The primary objective of the study is to demonstrate superiority of rimonabant/metformin combinations in Glycosylated Hemoglobin 1c (A1C) reduction over the corresponding single agent metformin and over rimonabant alone in patients with type 2 diabetes mellitus at 9 months.

The secondary objective is to investigate the effects of rimonabant/metformin combinations for reducing fasted plasma glucose, body weight and triglycerides, and raising High Density Lipoprotein Cholesterol (HDL-C) in comparison with metformin at 9 months.

Another objective is to evaluate the safety of rimonabant in combination with metformin over a period of up to 52 weeks.

The duration per patient is up to 65 weeks: 1 - 2 weeks screening, up to 52 weeks double blind treatment, and 75 days post last dose. This study will end for all patients when the last patient has been treated for at least 9 months.

Eligibility Criteria:
Inclusion Criteria:

* History of type 2 diabetes mellitus diagnosed prior to the screening visit 1 (ADA criteria)
* Patients must not have used any oral or injectable glucose lowering medication at least 12 weeks prior to the screening visit to establish a stable, comparable baseline A1C assessment in all patients
* A1C ≥7.0 % and ≤10.0 %
* Fasted plasma glucose at screening visit ≤260 mg/dL (14.44 mmol/L)

Exclusion Criteria:

* Treatment with any anti-diabetic oral agent, or injectable antidiabetic agent within 12 weeks prior to screening visit
* In the 3 months prior to the screening visit, use of any anti-obesity agent or drugs for weight loss, or administration of systemic corticosteroids for more than 7 days
* Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders
* Presence or history of cancer within the past five years
* Pregnant or breast-feeding women, or women of childbearing potential not protected by effective method of birth control

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower Limb

The socioeconomic costs of problematic and delayed wound healing following lower limb amputations are enormous to the society. Lower limb amputations is one of the longest known surgical treatments, but also one of the least investigated in the field of medical science. Negative Pressure Wound Therapy (NPWT) has emerged as a great instrument to aid healing. Studies have shown that it has a positive and measurable effect on wound healing following eg. total Knee and hip replacements. The aim of this study is to evaluate the effect of a closed NPWT on incidence of postoperative wound complications, in patients undergoing lower extremity amputation.

Historically lower limb amputations have been performed to treat infection or trauma, usually in the setting of war. Today however major amputations of the lower extremities (transfemoral- (TFA), knee disarticulations (KD) and transtibial amputations (TTA)) are, in developed countries, usually performed in elderly patients with untreatable vascular disease, diabetes or a combination of both. This fragile group of patients are characterized by a high degree of comorbidity, mortality and both surgical and postoperative complications; included herein problems with wound healing. The tissue is typically poorly vascularized and prone to wound break-down, infections, necrosis etc. 10-40% of patients undergoing TFA, KD or TTA have delayed wound healing and/or insufficient wound healing, resulting in problems with the aftercare, mobilization with a prosthesis and re-amputations. Recent retrospective studies show that Negative Pressure Wound Therapy (NPWT) may have beneficial effects on incisional healing following lower limb amputations. However to our knowledge it has never been reproduced in a prospective randomized controlled setting.The aim of this study is to investigate the effect of NPWT with a PICO®️ device (Smith \& Nephew) on the healing of the surgical wound following TFA, KD and TTA.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing transfemoral, knee disarticulations and transtibial amputations by non-traumatic indication
* Uni or bilateral amputations or re-amputations

Exclusion Criteria:

* Patients undergoing traumatic amputations
* Unwilling or unable to provide informed consent
* Inability to comply with planned study procedures
* Amputations due to malignancy
Proof-of-concept Study on Dyspnea Analysis Via GapCO2

Patients presenting to the emergency department with acute dyspnea undergo arterial blood gas measurement and monitoring of transcutaneous capnography using the TCM5 monitor. The aim of this study is to determine whether GapCO2, the difference between transcutaneous and arterial pCO2 (PaCO2 - PtcCO2), is correlated with the congestive or non-congestive origin of dyspnea.

Upon arrival at the emergency department, patients are placed in the vital emergency reception area for monitoring. An emergency physician will review the selection criteria and offer the patient participation. The information sheet will be provided to the patient along with a copy of the non-opposition form in case of patient agreement.

Before the introduction of any treatment, a TC 92 sensor is placed on the earlobe (or on the forehead if the earlobe is inaccessible), connected to a Radiometer TCM5 monitor, measuring SpO2 (Massimo technology), perfusion index, and transcutaneous capnography (PtcCO2).

After a 5-minute equilibration period, measurements were taken throughout the duration of patient management. Standard diagnostic and therapeutic management will be provided according to the attending physician's prescription. The attending physician won't consider PtcCO2 (nor GapCO2) measurements in patient management.

At the time of data analysis, an adjudication committee comprising 2 emergency physicians from the inclusion service but not involved in patient care will review the complete medical records of patients to determine whether dyspnea was of congestive or non-congestive origin.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient presenting with acute dyspnea defined by a sensation of respiratory discomfort with at least one of the following criteria: RR ≥ 22 and/or SpO2 \< 95%
* Arterial blood gas sampling performed as part of care
* Inclusion less than 1 hour after arrival time to the emergency department
* Non-opposition to participation in the study

Exclusion Criteria:

* Temperature greater than or equal to 37.5°C
* Patient who has already received a diuretic or vasodilator treatment in the emergency department or by a prehospital medical team
* Systolic blood pressure less than or equal to 100 mmHg and/or signs of peripheral hypoperfusion
* Inability to express refusal to participate in the study
Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure

Paravertebral Block (PVB) combined with general anesthesia (GA) is a conventional pain treatment for breast surgery but sometimes failures can occurs. The efficacy of this block has to be evaluated. Also, for the intra-operative analgesic evaluation of this block, it is necessary to measure intra-operative analgesia index. A monitor of nociception for patients under GA, the PhysiodolorisTM device, offers an index for measuring nociceptive inputs during surgery in anesthetized patients : the ANI index (based on the single R-R interval analysis). The purpose of this observational and prospective study is to assess the variations of this ANI index during breast surgery with or without axillary node dissection with a PVB. This will allow us to quantify the analgesic effect of a PVB during GA for unilateral radical breast surgery with or without axillary node dissection.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists score (ASA) I or II
* Woman
* Patients aged over 18 years
* BMI between 17 and 30 kg/m2
* Radical mastectomy with or without axillary node dissection.

Exclusion Criteria:

* Preoperative consumption of opioid
* Local Anesthesia allergy
* Local skin inflammation at the puncture area
* Inability to respond to pain assessment using a Numerical Rating Score (NRS)
* Any contra-indication or patient's refusal for regional anesthesia B blocker medication
* Pace maker
* Inability to perform the PVB (at the appreciation of the anesthesiologist)
* Change of surgical procedure other modified radical mastectomy with or without axillary node dissection.
* Patient with a severe side effect or who cannot be controlled by additional therapy will be removed from the trial
Culturally Tailored HPV Psychoeducational Multimedia Intervention

Community members ages 18 - 45 years old from the El Paso, Texas, U.S.-Mexico Border Region will be recruited to compare psychoeducational multimedia interventions focused on the human papillomavirus (HPV). Our hypothesis is that adults who view culturally tailored multimedia stories encouraging HPV vaccination will report higher vaccine uptake rates.

A sample of vaccine-naive (unvaccinated or under-vaccinated) adult community members ages 18 - 45 years old from the El Paso, Texas, U.S.-Mexico Border Region, will be recruited to participate in a human papillomavirus (HPV) multi-media intervention. Hypothesis: Vaccine-eligible adults who view culturally tailored multimedia stories encouraging HPV vaccination will report significantly stronger vaccine intentions and, subsequently, significantly higher vaccine uptake rates when compared to vaccine-eligible adults exposed to a standard HPV vaccination fact sheet and generic HPV vaccine videos.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages 18 and 45 years old
* Adults who have not completed the HPV vaccine series (unvaccinated or under-vaccinated)
* Adults currently living or working in El Paso County, Texas

Exclusion Criteria:

* Adults who participated in Phases I or II of the larger research project \[cross-sectional phases\]
* Adults younger than 18 years of age
* Adults older than 45 years of age
* Adults that do not reside, plan to live or work in El Paso County, Texas, within the next 12 months after the start of the intervention
* Adults who are unable to participate in the full study intervention and follow-up time-points
* Adults who cannot complete study participation and activities in either the English or Spanish languages.
Adaptation and Evaluation of a Culturally and Gender Relevant Tobacco Cessation Among Women in Brazil: an Integrated MHealth Approach

We developed and established the efficacy of a theory-based, culturally- and gender-relevant Community Health Worker (CHW) intervention for low-income Brazilian women that augments the tobacco cessation program offered through the public health system. This study represents the continuation of our gender-relevant tobacco control efforts in Brazil by proposing the adaptation of this CHW-delivered tobacco cessation program to be integrated with mHealth support through mobile devices (App). We are proposing an integrated CHW-mHealth application that (a) is culturally- and gender-relevant, (b) is theory-based (Social Cognitive Theory), (c) considers the existing structure of the Brazilian health care system, and (d) will be adapted based on an efficacious intervention as well as salient features of other mHealth applications that have been shown to be successful in engaging users. During phase I we will make the adaptations and determine feasibility of a CHW-delivered intervention that is integrated with a mHealth tobacco cessation application (interactive App for participants and tracking system for CHWs) through formative assessments among all involved stakeholders, pretesting, and pilot testing of the intervention. In phase II we will assess the effectiveness of the integrated CHW-mHealth tobacco cessation intervention through a group randomized trial with towns as the unit of randomization (8 towns, N=344). The comparison group will be the same as the previous intervention (consisting of a home visit by a CHW during which the participant is scheduled to attend the tobacco cessation program at the neighborhood public health clinic) to allow for comparisons. We hypothesize that at 6-months, women smokers who receive the integrated CHW-mHealth intervention will have significantly higher 7-day point prevalence abstinence (defined as no cigarettes in the past 7 days) than women smokers in the control condition. Self-report will be verified through measurement of exhaled carbon monoxide levels among 30% of participants. If shown to be effective, this approach could be utilized as a model for a population-based intervention in low-resource settings, including rural and disadvantaged women in the U.S.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Current tobacco use
* Willingness to quit tobacco use
* resident in the town assigned to intervention or control

Exclusion Criteria:

* None
Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome

irritable bowel syndrome (IBS) is a well-known risk factor for diseases of the anal region (hemorrhoids, anal fissures, etc.) and large intestine (colon cancer, diverticular disease). Untreatable IBS disease not only impairs the patient's quality of life but also reduces the success of surgical treatment in these diseases.

Today, only one-third of IBS patients achieve successful results with the treatment methods and diets used routinely. Balancing the composition of the gut microbiota may yield satisfactory results in this patient group. With the results of our study, we aim to reveal the effect of microbiome analysis and personalized diet on symptoms and its place in treatment in patients with IBS disease.

Patients applying to Gastroenterology outpatient clinics in respective centers due to IBS will be randomized into two groups. The patients in the control group will follow the FODMAP diet protocol for IBS; In the study group, a personalized diet will be applied according to the gut microbiota. No nutritional supplements will be used in either group. Changes in defecation habits and quality of life scale of both groups will be evaluated at the end of 6 weeks and the results will be compared.


Eligibility Criteria:
Inclusion Criteria:

* To be between the ages of 18-65
* To be diagnosed with IBS (IBS-D, IBS-C, IBS-M) according to the Rome IV Criteria
* To give consent to participate in the study voluntarily
* Being a smartphone and/or internet user (for dietitian follow-up and clinical follow-up)
* Not meeting any of the exclusion criteria

Exclusion Criteria:

* Pregnant or planning to become pregnant
* Having another known diagnosis of gastrointestinal disease (inflammatory bowel disease, malabsorption of any macronutrient, intestinal resection, celiac disease, etc.)
* Colonoscopy history (in the last 1 year)
* History of abdominal surgery other than appendectomy or hysterectomy
* Psychiatric comorbidity
* Chronic diseases that will affect the microbiome (cancer, diabetes, cardiovascular disease, liver diseases, neurological diseases, etc.)
* Use of drugs that may affect digestive function in the 4 weeks prior to the study (antibiotics (including use in the last 4 weeks), probiotics, narcotic analgesics, lactulose (prebiotics))
* Patients taking dietary supplements
* Excluded from the study if following a restricted diet.