cyrilzakka/clinical-trials huggingface dataset:
Baby 2 Baby Beneficial Bacteria

The investigators will recruit mother-infant dyads to attend weekly lactation support groups and randomize infants to receive either an HMO consuming or non-HMO consuming probiotic. The investigators will collect infant stool before and after support group attendance. The investigators will use qPCR and metagenomic sequencing to test if the study probiotics or other bacteria transmit between infants. The investigators anticipate HMO consuming bacteria will and non-HMO consuming bacteria will not transmit between infants.

The investigators will recruit mother-infant dyads to attend weekly lactation support groups for five weeks and randomize infants to receive either an HMO consuming (B. longum subsp. infantis) or non-HMO consuming (L. reuteri) probiotic. The investigators will collect a baseline infant stool sample and maternal milk sample before attendance at the first lactation support group meeting. At the first support group meeting, mothers will be provided with the open label probiotic their infant was randomized to receive, and will give the probiotic daily for the next 28 days. The investigators will collect a second infant stool sample and a second milk sample at the final lactation support group meeting. The investigators will use qPCR and metagenomic sequencing to test if the study probiotics or other bacteria transmit from the infants who received a specific species to the infants who did not receive that species. We will also test to see if the probiotic given to infants is detectable in milk samples. The investigators anticipate HMO consuming bacteria will and non-HMO consuming bacteria will not transmit between infants.

Eligibility Criteria:
NOTE: Age limits listed are for mothers. For infants, age limits are a minimum of 1 day and a maximum of 1 month

Inclusion Criteria:

* Healthy singleton pregnancy, term delivery (\>= 36 weeks corrected gestational age)
* Maternal intent to exclusively breastfeed for the first six months of infant life (intent to breastfeed for six months correlates with longer duration of breastfeeding, this increases the chance that mothers will still be breastfeeding at the end of the study)
* Maternal vaccination against COVID19 (2 doses Pfizer or Moderna and within 6 months of second dose or 2 doses Pfizer or Moderna and booster.) COVID vaccination is required for maternal participation as this is a study meant to enable transmission of beneficial bacteria species between infants, and infants are too young to be vaccinated.

Exclusion Criteria:

* Maternal drug abuse
* Infant congenital abnormalities
* Infant age greater than 1 month at first lactation support group meeting (younger infants will have less developed microbiomes, increasing the chance of successful transmission of bacteria)
* Intent to provide a non-study probiotics to the infant
* Known immunocompromised status of the infant.
Comparison of Platelet Rich Plasma and Alternative Therapies for the Treatment of Tennis Elbow (Lateral Epicondylitis)

"Tennis elbow" is the most common cause of lateral elbow pain, generally caused by either work or sports related repetitive strain. In this condition, a tendon along the outside of the elbow becomes inflamed leading to pain, especially with flexing and extending the elbow.

Many treatments have been attempted, including physiotherapy and steroids, with little success. One treatment which has been very effective is the injection of the patients own blood (taken from their other non-affected arm) into their abnormal tendon. The blood recruits the patients own healing factors and heals the damaged tendon. As platelets are thought to be largely responsible, injection of concentrated platelets, extracted from the patient's blood (platelet rich plasma) is a newer, but expensive, technique.

At this point, it is unclear whether whole blood, concentrated platelets, or simply passing a ultrasound-guided needle through the abnormal tendon as a means to stimulate tissue healing (tendon fenestration) is the better treatment.

The objective of this trial is to compare platelet rich plasma, whole blood, dry needle tendon fenestration, and sham injection (with physical therapy) to identify the best and most cost-effective therapy for this debilitating condition.


Eligibility Criteria:
Inclusion Criteria:

* Adult man or woman aged 18 years or greater.
* Clinical diagnosis of lateral epicondylitis based on site of pain, pain elicited with active extension of the wrist in pronation and elbow extension.
* Documented sonographic diagnosis of common extensor tendinosis based on tendon thickening, areas of hypoechogenicity, and loss of the normal echotexture.
* Chronic symptoms (equal or greater than 3 months).
* Pain of at least 5 out of 10 on a visual analog scale (VAS).
* Provision of informed consent.

Exclusion Criteria:

* Acute symptom onset (less than 2 months).
* History of acute elbow trauma (less than one week).
* History of rheumatoid arthritis.
* History of malignancy.
* Pregnancy
* Patients requiring anti-platelet medication for the treatment of heart attack, stroke or other medical condition.
* Previous surgery for lateral epicondylitis.
* Previous local injections, including steroids within the past 6 months.
* Signs of other causes for lateral elbow pain (posterior interosseous nerve entrapment, osteochondral lesion).
Does Botulinum Toxin Injections Improve Outdoor Activity in Children With Cerebral Palsy?- a Pilot Study

Background:

Motor impairment limits social and recreational activities in children with cerebral palsy (CP), compromising participation and impacting on quality of life. Improvement of motor function by medical treatment may advance in participation of outdoor activities and expand social and recreational activities. While Botulinum toxin (BTX) injections are effective and safe treatment for spasticity in children with CP, there is insufficient evidence for improvement of motor function and enhanced participation in this population.

Objective:

To examine outdoor activity as a functional outcome following lower limb BTX in children with CP.

Methods:

In this pilot study the investigators will use Global Positioning Systems (GPS) to measure walking speed, distances, number of walking events and destinations in ambulatory children with CP following BTX injection to the lower limbs; age and gender matched sibling will be studied as a control group. Outdoor activity will be measured at 1, 3 and 6 months following BTX treatment will be compared to baseline and to those of siblings. Outdoor activity will be correlated with leisure activity preferences and quality of life questionnaires.

Significance: Improvement in outdoor activity following BTX injections in this pilot study will assist construction of a larger study evaluating participation and quality of life in children with CP.


Eligibility Criteria:
Inclusion Criteria:

* ambulatory children with CP following BTX injection to the lower limbs

Exclusion Criteria:

* significant psychomotor retardation, psychiatric symptoms or behavioral problem that may impact on outdoor activity prefernces
Combined Intrathecal Morphine and Dexmedetomidine Analgesia

The current study investigated the effect of adding dexmedetomidine to intrathecal morphine for postoperative analgesia in cancer patients undergoing major abdominal surgery.

Opioids, administered intrathecal or epidural, are widely used for postoperative, and chronic nociceptive pain secondary to cancers. Intrathecal injection of morphine to provide postoperative analgesia during the initial 24 h after operation is a widely used technique.The Human studies on the antinociceptive effects of co-administrated intrathecal morphine and dexmedetomidine in postoperative pain are still lacking. In this study, the investigators aimed to compare the synergistic interaction and side-effects of combined intrathecal morphine and dexmedetomidine with either drug alone for postoperative analgesia in cancer patients undergoing major abdominal surgery. Patients were randomly allocated into three groups of 30 patients each to receive either; hyperbaric bupivacaine 0.5% (Group I/Bupivacaine Group), bupivacaine and 0.5 mg morphine (Group II/Morphine Group), bupivacaine and 0.5 mg morphine plus 5 µg of dexmedetomidine (Group III/Morphine-DEX Group). The assigned drugs were dissolved in 1ml physiological saline and administered intrathecal with bupivacaine before induction of general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

- major abdominal cancer surgery (e.g. hemi-colectomy or cystectomy)

Exclusion Criteria:

* known allergy to study drugs
* Significant cardiac, respiratory, renal or hepatic disease.
* 2nd or 3rd degree heart block.
* Coagulation disorders.
* Low back pain or other back problems.
* Drug or alcohol abuse.
* BMI\>30kg\\m2.
* Psychiatric illnesses that would interfere with perception and assessment of pain.
CT-Angiography Prior to DIEP Flap Breast Reconstruction

This study will Investigate whether or not preoperative computed tomography (CT) angiography will lower operative times and post operative complications for breast reconstruction performed with a deep inferior epigastric artery perforator flap (DIEP).


Eligibility Criteria:
Inclusion Criteria:

* Planning breast reconstruction with DIEP flap
* Age 18 to 75 years

Exclusion Criteria:

* Mild to moderate loss of kidney function (Estimated Glomerular Filtration Rate (eGFR) \< 60)
* Decisionally challenged
* Pregnant
* Hepatic failure
Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment

Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The propose of this trial is evaluate the effectiveness of clemastine fumarate 1, 0 mg/g + dexamethasone 0, 5 mg/g compared to dexchlorpheniramine maleate 10 mg/g in eczema treatment.

Study design:

• Double blinded, superiority, prospective parallel-group, intend to treat trial.

Study design:

* Experiment duration: 22 days
* 2 visits (days 1,7,15 and 22)
* Reducing Eczema Area and severity index evaluation
* Adverse events evaluation

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Patients with acute or sub-acute eczema.
3. Presence of symmetric lesions to compare on side to the other.

Exclusion Criteria:

1. Pregnancy or risk of pregnancy.
2. Lactation
3. Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study).
4. Sunlight over exposure in the last 15 days.
5. Any pathology or past medical condition that can interfere with this protocol.
The Patient's Journey - the Time to Final Diagnosis in Patients With SiNET

"The patient's journey" is an interview based study assessing the patients' experience from the first symptoms to a final diagnosis focusing on patients with small intestinal neuroendocrine tumors.

The project focus on patients with small intestinal neuroendocrine tumors (SiNET's) with an incidence of 1-2/100 000 yearly. The primary tumor(s) are often small and symptoms usually arise when the disease has become metastatic with hormonal symptoms and/or symptoms due to local growth. As the tumors grow slowly and the symptoms in many cases are rather diffuse and develops gradually over a long time period there is often a long delay from onset to a final diagnosis both depending on "patient's delay" and "doctor's delay" The aim of the current project is to map and analyze the patient's journey from the first appearance of symptoms to the time point of a final diagnosis and to try to identify factors contributing to a delayed process.

The method is interview based and the interviews will be analyzed through the Design Thinking Methodology

Eligibility Criteria:
Inclusion Criteria:

* Patients living in Western Sweden
* \> 18 years of age
* Performance status 0-3
* Expected remaining survival of \> 6 months
* Diagnosed with a small intestinal neuroendocrine tumor during 2016-2018

Exclusion Criteria:

* Not able to read and/or understand Swedish language
* Dementia/memory loss
* Performance status \>3
Impact of Nesiritide Infusion for Decompensated Heart Failure in the Emergency Department

The purpose of this study is to determine if an 8hr infusion of nesiritide in the emergency department in the Acutely decompensated heart failure patients will decrease 30 day recidivism.

In view of the high return admission rate to our county ED for heart failure, we hypothesized that our higher risk patient population might realize a decrease in the return admission rate as a benefit from early ED administration of nesiritide. We also acknowledged that the safety of nesiritide in our patient population had not been well established. Thus, we opted to test the hypothesis that an 8-hour ED infusion of nesiritide \[in addition to protocol specified standard therapy\] in ADHF patients from an urban patient population consisting of predominately African Americans and Hispanics will decrease 30-day readmission rates without provoking harm.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were adults greater than 18 years of age
* A history of established heart failure
* Dyspnea at rest or with minimal exertion and with a respiratory rate greater than 24 breaths per minute
* Evidence of volume overload based on physical exam findings or chest radiograph, and a brain natriuretic peptide (BNP) level greater than 100 pg/ml.

Exclusion Criteria:

* Systolic blood pressure of less than 90 mm Hg
* Frank or impending cardiogenic shock
* Cardiopulmonary arrest
* Evidence of low cardiac output (cold clammy extremities
* Mental status changes)
* New onset congestive heart failure
* Suspected acute coronary syndrome (elevated troponin, New electrocardiographic changes, or history consistent with cardiac ischemia)
* High clinical suspicion of pulmonary embolism
* End-stage renal disease (on dialysis or imminent)
* Active use of nitroglycerin or inotropic infusions in the ED
* Ventricular tachycardia
* Allergy to nesiritide or its components
* Patient not needing intravenously diuretic therapy in the ED
* Normal BNP level
* Inability to follow-up
* Pregnancy or suspected pregnancy; or
* Actively receiving other investigational drug.
Gap CO2 in Septic Patient to Predict Cardiomyopathy Septic

the investigators included 98 patients admitted for sepsis and septic shock (68.4% men, 31.6% women) with an average age of 60.42 years ± 15.13, ranging from 21 to 96 years. The average length of hospital stay was 7.53 days. The most noted medical histories were diabetes (38.8%), hypertension (28.6%), and renal insufficiency (17.1%). Regarding laboratory findings: the mean white blood cell count was 15,985.16 cells/mm³, the mean C-reactive protein (CRP) level was 227.69 mg/L, and the mean procalcitonin level was 50.43 µg/L. In terms of blood gas analysis: the mean lactate level was 3.67 mmol/L, and the mean PCO2 gap (DELTAPCO2) was 4.85. All our patients were continuously monitored by pulse wave analysis: the mean cardiac output was 5.69 L/min, and the mean cardiac index was 4.14 L/s/m² All our patients underwent an echocardiogram, which is a routine examination in our department and is performed at the patient's bedside. The average left ventricular ejection fraction (LVEF) was 51.73%, and the average subaortic peak velocity (ITV) was 14.66 cm.

Subsequently. the investigators examined the clinical and paraclinical profile of patients with septic cardiomyopathy. the investigators identified 19 patients with this condition, while 79 patients did not exhibit cardiac involvement. The percentage was significantly higher in the population with cardiac involvement, accounting for 28.3%. Among the patients with cardiac involvement, 76.5% had a PCO2 gap (DELTAPCO2) ≥ 6 mmHg, a significantly reduced cardiac output with an average of 3.3 L/min, and a predominantly low cardiac index, with 64.3% having an index \< 2.2 L/min/m². The mortality rate was significantly increased at 73.7%.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the intensive care unit
* sepsis or septic shock
* at least one echocardiogram and were monitored by pulse wave contour analysis
* stay of 72 hours in the intensive care unit

Exclusion Criteria:

* Patients without sepsis or septic shock.
* Patients with COVID-19.
* Patients who died within 48 hours of hospitalization.
* Cases with incomplete medical records or patients not monitored.
* Patient with pre-existing cardiac conditions.
* post-operative patients from cardiac and thoracic surgeries.
Assessment of Dyslipidemic Patients' Knowledge, Quality of Life, and Adherence

A randomized, parallel two-arm interventional study, the patients were divided into 1:1 ratio, in which both groups offered optimal pharmacological therapy also one group (interventional) offered predesign pharmaceutical care plan aimed to improved patients knowledge, adherence, satisfaction, and quality of life, while the other group (non-interventional) received conventional pharmaceutical care plan.


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with dyslipidemia and received at least one statin therapy (in the previous 6 months), and patients on the same class of pharmacological therapy (statins).

Exclusion Criteria:

1. Pregnant women
2. Nephrotic syndrome
3. Active steroid user
4. Hypersensitivity for any mediation during the trial
5. History of a major cardiovascular event in the previous 3 months
6. Patients with mental disease or disability
7. Had a stroke in the previous 6 months
Assessment of Automatic Relays by Intensive Basis Advantage Compared With Manual Relays, on the Hypotension Risks, During Noradrenalin Administration

Circulatory failures are the main cause of admissions in the intensive care unit. It is recommended to prescribe to these patients an intravenous injection of catecholamine to correct this dysfunction and to keep an hemodynamic stability. Electric pumps are used to administrate a continuous flow of drugs to patient. When a syringe of drugs ends, it is replaced by a full syringe, it is named "relay". This change may cause a flow interruption and hypotension.

In the intensive care unit at departmental hospital (CHD) Vendee, the manual relays used in common practice will cause hemodynamic instabilities : hypotensions in 20% cases. Since 4 years, new devices are also used to make the relays. It is "smart pumps" allowing to manage automated the drug delays. This new method allows to not interrupt the drug flow. It could reduce the occurence of hypotension. A 50% decrease of relative number of hypotension will show that the use of automatic method is the most sure medical strategy.

Our study want to compare manual and automatic method watching the variations of medium arterial pressure (MAP) during the fifteen minutes after the relay compared to baseline (MAP before the relay). Noradrenalin is the catecholamine most administrated so we choose to study only the relay for this drug.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years,
* Patient receiving only noradrenalin as catecholamine,
* Collection of patient's non-objection or his trustworthy person, if appropriate.

Exclusion Criteria:

* Pregnant or breast feeding patient,
* Patient receiving an other treatment on the catecholamine way,
* No affiliation at a social security,
* Refusal of patient's trustworthy person or parent, if the patient is unable to give his non-objection.
* Refusal of patient's participation when he is conscious,
* Subjects deprived of liberty, under guardianship, hospitalized in a health facility or social or hospitalized without their consent,
* Patients with secreting tumor, kind pheochromocytoma ou carcinoid tumor.
Routine Antibiotic vs. Directed Antibiotic Treatment in Snake Bite

Clinicians tend to overuse antibiotics in snake bite despite evidence from three previous clinical trials that failed to show a benefit. But, none of these trials was done in India. Further, the species of snake in two of these trials was quite different from that seen in the Indian setting limiting generalization of these findings. Hence, home-grown evidence is needed to persuade clinicians to use antibiotics rationally.

Snake bite is a common clinical problem in India and elsewhere, affecting agricultural workers and rural population, resulting in thousands of deaths every year. Apart from causing systemic manifestations such as coagulopathy, acute renal failure, and neuroparalysis, local effects of the venom manifest as swelling of the bitten limb. Despite administration of adequate antivenom, the limb swelling progresses in the first 48-72 hours accompanied by considerable pain. Often the limb swelling is accompanied by formation of blebs and gangrenous skin changes. At times, the limb swelling is severe enough to result in compartment syndrome, necessitating surgical interventions such as fasciotomy and debridement. Animal bites are typically associated with a risk of infection by the oral flora. Likewise, apart from releasing the venom, inoculation of oral flora as a result of snake bite could result in local infectious complications adding to the deleterious effects of the snake venom.

Observational studies suggest that the risk of infection following simple bites on the lower limbs is much less than what is often believed, and evidence from clinical trials also does not support routine use of antibiotics in snake bite. For this reason, clinical practice guidelines do not recommend routine prophylactic use of antibiotics in snake bite. But, in reality, many clinicians continue to use antibiotics routinely in all venomous snake bites hoping to prevent a local infection. While such a strategy may not reduce the risk of infection, it would result in overuse of antibiotics promoting antimicrobial resistance and escalating treatment costs.

The investigators hypothesize that clinically-directed use of antibiotics would be non-inferior to routine use in preventing local infectious complications of snake bite, while being superior in reducing the antibiotic consumption. Non-inferiority would be inferred if the one-sided 95% CI of the difference does not exceed 10% in favour of the routine use arm.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* History of snake bite with features of local envenomation with/without systemic features
* Less than 24 hours since bite, AND
* No prior antibiotic treatment

Exclusion Criteria:

* Upper limb bites
* Multiple (\> 1) bites
* Wound manipulation
* Extensive local necrosis or blebs
* Seriously-ill patients with hypotension/capillary leak/life threatening bleeding.
* Suspected cobra bite, OR
* Pregnant/breast-feeding women