cyrilzakka/clinical-trials huggingface dataset:
Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study

Campylobacter bacteria, a Gram-negative bacillus commensal in the digestive tract of many animals and mainly responsible for human infections with digestive origins, has been little studied in the field of osteoarticular infections (OAI). Campylobacter spp. are, however, well described, mainly for C. fetus, and pose a dual therapeutic problem: i) a capacity for persistence due to the capacity of most strains to form biofilm; and ii) potential resistance to many antibiotics. The management of IOA caused by Campylobacter spp. is not codified, and is based on small series of cases reported in the literature.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Osteoarticular infection (whatever its type), mono or polymicrobial with Campylobacter spp., diagnosed between 01/01/2013 and 12/31/2022:
* Septic arthritis: compatible clinical signs + joint fluid sample positive in culture and/or PCR positive for Campylobacter
* Spondylodiscitis: clinical signs and MRI compatible + blood cultures and/or disco-vertebral biopsy puncture positive in culture and/or PCR positive for Campylobacter
* Osteitis/osteomyelitis: compatible clinico-radiological picture + bone sample (biopsy or intraoperative sample) positive in culture and/or positive PCR for Campylobacter
* Infection on joint prosthesis or osteosynthesis equipment: documented Campylobacter infection and meeting the definition of probable or confirmed JIBS infections
* Patient who was informed and did not object to participating in the study

Exclusion Criteria:

-
The Effectiveness of an Exclusive Cold Snare Polypectomy Snare for the Removal of Diminutive Colorectal Polyps

The use of an exclusive cold polypectomy snare enables a clean cut of diminutive colorectal polyps, resulting in an increase in the complete resection rate and a decrease in the adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Patients with colorectal polyps up to 10 mm in diameter.

Exclusion Criteria:

* patients are less than 20 years old, pregnant, ASA class III and IV, allergic to propofol used or its components (soybeans or eggs), with poor bowel preparation, and with previous colorectal surgical resection.
Genetic Risk Factors for Severe Asthma

The purpose of this study is to determine whether a specific genetic factor influences the severity of asthma symptoms.

Asthma is one of the most common chronic diseases in the United States. It is well known that asthma susceptibility is inherited; however, it is unknown if asthma severity is heritable. Studies suggest that levels of interleukin-16 (IL-16) may influence asthma severity. This study will examine the role of differences in the control region of the IL-16 gene in a racially diverse group of asthmatics and nonasthmatics and will determine if the IL-16 gene control region is related to asthma severity.

Participants in this study will undergo lung function and blood tests; they will also complete a questionnaire about their respiratory health. Asthmatic participants will complete a severity-of-asthma questionnaire.

Eligibility Criteria:
Inclusion Criteria for Asthmatic Participants:

* Diagnosis of asthma

Inclusion Criteria for Non-asthmatic Participants:

* No diagnosis of asthma
Claudication Evaluation During Rowing ExerciseS

Check the feasibility of the collection of reliable measures of tcpO2 the lower limbs in arteriopathy when performing rowing on effort.

Obtaining curve values of tcpO2 interpretable when recording the effort by rowing on rowing.

Show the occurrence of ischemia in the lower limbs during recording effort by rowing on rowing

Eligibility Criteria:
Inclusion Criteria:

* referred for an oximetry exercise test
* Patient able to walk on a treadmill
* Patient covered by the French health insurance
* Patient able to understand the protocol
* Patient agrees to be involve in the protocol and sign the consent form

Exclusion Criteria:

* any heart issues during the last 3 months
* pregnancy
Restoration of the Gut Microbiome After Cesarean Section

This study aims to develop a therapy for restoring the gut microbiome in infants born via CS. The Study will conduct a randomized, placebo-controlled feasibility trial to assess the ability of microbiome restoration by FMT and FVT in infants born by cesarean section.

When a child is born vaginally, the passage through the birth canal provides the first and very important bacterial colonization. As the child ages, various environmental exposures, such as dietary changes and the presence of older siblings in the home, facilitate a natural maturation of the child's gut microbiome, providing a vast and continuous stimulation of the child's developing immune system. However, factors such as mode of delivery and intrapartum antibiotics can perturb this natural developmental process and cause long-term microbial derangements. The prevalence of cesarean section (CS) birth has increased globally in recent decades, and with it, antibiotic treatment to prevent perinatal infection. Similar patterns have occurred for the prevalence of chronic childhood disease, particularly asthma, with an estimated 300 million asthmatic cases worldwide.

The hypothesis is that early intervention with mother-to-infant FMT can restore a CS-perturbed microbiome to a normal microbial trajectory. Another hypothesis is that seeding the virome fraction (FVT) will cause the neonate's microbiome to resemble the mother's since the transferred phages are enriched and preserved in the intestinal mucus layer, thereby providing the recipient with selective antimicrobial protection while allowing species resembling the mother's own to establish during subsequent bacterial transmission.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \< week 38+0 days
* Proficient in spoken/written Danish
* Single pregnancy (no twins or triplets)
* Pre-pregnancy BMI between 18.5 and 35 kg/m2
* No chronic intestinal, endocrine, cardiac, or kidney disorders
* No known gestational complications (gestational diabetes, preeclampsia, gestational hypothyroidism)
* No regular use of prescription medication or any drugs that, in the research team's opinion, may interfere with the study's results.
* Willingness to abstain from giving the child products with probiotics (fermented dairy like yogurt or A38 are allowed).

Exclusion Criteria:

Maternal:

* Use of antibiotics within one month of stool donation
* Acute gastroenteritis within one month of stool donation
* Use of antibiotics within one month of birth
* Time since last travel abroad relative to data of fecal donation according to the requirements for blood donations ("Regler for tappepauser" - blooddonor.dk)
* Positive test results for pathogens during donor material screening.
* Antibiotic treatment at birth (vaginal births only)
* Spontaneous onset of labor or emergency cesarean section before scheduled cesarean section.

Infant:

* Instances of major birth defects or intrauterine growth retardation (IUGR)
* Infants requiring pediatric support at the time of transplant administration
Trial of High Dose Vitamin D in Patient's With Crohn's Disease

Crohn's disease is more common in areas of the world with less sunlight exposure. Sunlight is a major source of vitamin D. There is some research to suggest that patient's with higher vitamin D levels are less likely to undergo surgeries and have better control of their disease. We intend to study the effects of high dose vitamin D supplementation in patients with vitamin D deficiency and Crohn's disease. We hypothesize that patients given high doses will have less hospitalizations, surgeries, steroid use.

Subjects are randomized to low or high dose vitamin D, and outcomes including steroid prescriptions, CD-related hospitalizations, CD-related surgeries, and the modified Harvey-Bradshaw Index are measured.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CD
* Age \>= 18 and \<75
* Vitamin D deficiency or insufficiency (serum 25-hydroxyvitamin D \< 30ng/ml)

Exclusion Criteria:

* Corticosteroid use in the last 4 weeks
* CD-related surgery in the last 6 months
* CD-related hospitalization in the last 4 weeks
* Pregnancy, intended pregnancy during the study period or nursing
* Serum calcium \>10.2 mg/dL
* History of primary sclerosing cholangitis
* History of undergoing an ileal pouch-anal anastomosis
* Current active perianal disease
* History of nephrolithiasis in the past 2 years
* Anticipated change in therapy in the next 30 days (steroids, biologic initiation)
* modified Harvey-Bradshaw Index of 10 or more
* History of decreased renal function (glomerular filtration rate \<30ml/min based on MDRD) or polycystic kidney disease
* History of sarcoidosis
* History of hyperparathyroidism
* Any other chronic condition that may preclude high doses of Vitamin D such as lymphoma
* Concurrent use of hydrochlorothiazide, phenytoin, phenobarbital, carbamazepine or primidone
* Osteoporosis
Dexamethasone in Total Knee and Total Hip Arthroplasty

This study will evaluate if the addition of dexamethasone to a local infiltration analgesia mixture will improve functional outcomes following total hip and knee arthroplasty.

The addition of dexamethasone to an local infiltration analgesia (LIA) mixture for postoperative analgesia following total knee arthroplasty (TKA) has a limited evidence base. Although there is increasing support in the literature for its use in peripheral nerve blockade, there have only been a handful of studies assessing its applicability in periarticular LIA. Moreover, the evidence from peripheral nerve blocks suggests that one of the key benefits of dexamethasone is a prolongation of nerve blockade. Additionally, dexamethasone has been shown to prolong the local analgesic effect of bupivacaine microcapsules.

With respect to total hip arthroplasty (THA), there have only been two small studies that included corticosteroids in the LIA mixture; there was analgesic benefit and better early rehabilitation outcomes when compared to placebo. However, there is limited high-quality evidence for either THA or TKA demonstrating an improvement in functional outcomes when dexamethasone is used in an LIA mixture. This study will evaluate if the addition of dexamethasone to a local infiltration analgesia mixture will improve functional outcomes following total hip and knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective, primary, unilateral total hip or knee arthroplasty under spinal anesthesia
* ASA-PS I-III
* 18-85 years of age, inclusive
* 50-100 kg, inclusive
* BMI 18 - 40

Exclusion Criteria:

* Revision hip/knee arthroplasty
* Bilateral hip/knee arthroplasty
* Inability or refusal to provide informed consent
* Any contraindication to spinal anesthesia (e.g., bleeding diathesis, infection, neuropathy)
* Allergy to local anesthesia, ketorolac or dexamethasone
* Allergy to opioids
* Chronic pain state, neuropathic pain
* Opioid dependence
* Diabetic patients will NOT be excluded except those with significant peripheral neuropathy
Drug Interaction Study Between Erdosteine and Bepotastine Besilate in Healthy Adult Volunteers

The purpose of this study is to evaluate the drug-drug interaction between Erdosteine and Bepotastine besilate in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 20 - 45 years
* A body mass index in the range 18.5 - 25 kg/m2
* Willingness to participate during the entire study period
* Written informed consent after being fully informed about the study procedures

Exclusion Criteria:

* Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
* History of clinically significant drug hypersensitivity
* Use of medication within 7 days before the first dose
* Heavy drinker/smoker
* Whole blood donation during 60 days before the study
* Judged not eligible for study participation by investigator
Near Infrared Technology for the Detection of Proximal Caries

This study aims to determine the effectiveness of an intraoral scanner with near-infrared imaging (NIRI) for the diagnosis of proximal caries.

A total of 639 proximal surfaces (mesial-distal) of 22 volunteers without restoration of premolars and molars were examined. Results were scored for 4 different examination methods; intraoral examination by visual-tactile method (VTM), bitewing radiography (BWR), panoramic radiography (PR) and near-infrared imaging (NIRI). Scoring was made according to the type of lesion (0:no caries, 1:early enamel lesion(EEL), 2:lesion involving the dentin-enamel-junction (DEJ). Data were analyzed with IBM-SPSS-V23. McNemar-Test was used for comparison between the methods. The Kappa Test was used to examine the agreement between two methods in categorical data, and the Fleiss-Kappa Test was used to assess the agreement between more than two methods. The analysis results are presented as frequency(percentage).The significance level was considered p\<0.05.

Eligibility Criteria:
Inclusion Criteria

1. Presence of premolar and molar tooth
2. Having an appointment for restorative treatment

Exclusion Criteria

1. Restored proximal surfaces
2. Full mouth crowns and removable dental prothesis
Acute Rosuvastatin for Preventing Myocardial Damage in Patients With ACS

Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI


Eligibility Criteria:
Inclusion Criteria:

* 18-75 year old
* diagnosed as acute coronary syndrome
* Plan to PCI

Exclusion Criteria:

* STEMI patient
* emergency PCI(\<2h) for NSTE-ACS
* History of liver disease and myopathy (ALT/AST\>3 x upper limit of normal,CK\>5 x upper limit of normal)
* TG\>500mg/dl,CCr\<30ml/min
* inflammatory disease
* allergic to rosuvastatin
* nephrotic syndrome,hypothyroidism,systemic lupus erythematosus,myeloma,et.al.
Pain and Bleeding in Subjects With Acute Anal Fissure: Comparative Evaluation of Three Treatments

Starting from the observation that acute anal fissure (AAF) in 6-8 weeks can heal spontaneously and that some of the commonly used commercial products in clinical practice would seem to be useful, the rationale of the comparative study is to try to identify, in compliance with the protocol of Helsinki (2013), the most effective short-term treatment for the disappearance of pain in defecation and cessation of bleeding, shortening the duration of the healing process and favoring the patient's rapid return to his / her activity, respect for patient safety.

Starting from the observation that anal fissure in 6-8 weeks can heal spontaneously and that some of the commonly used commercial products in clinical practice would seem to be useful, the rationale of the comparative study is to try to identify, in compliance with the protocol of Helsinki (2013), the most effective short-term treatment for the disappearance of pain in defecation and cessation of bleeding, shortening the duration of the healing process and favoring the patient's rapid return to his / her activity, respect for patient safety.

The comparative study will be conducted by comparing the following products:

* Centella® Complex 1 cps 60 mg per os after meals twice a day for 15 days;
* Proctocella® Complex cream to be applied in anal area and anal canal after hygiene treatment for 4 weeks;
* Flavonil® 1 cps 300 mg per os after meals twice a day for 15 days;
* Flavonil® Cream Cream to be applied in anal region and anal canal after hygiene treatment for 4 weeks;
* Rectalgan Mousse cleansing cleanser for anal and perineal region for 4 weeks.

Our approach attempts to blend, based on the evidence of the most recent scientific literature, the experience of decades of colonproctologic clinical practice that has a predominantly surgical approach, with the clinical evidence of the Science of Nutrition which has a conservative vision in the treatment of ailments and constipation, a predisposing factor in the pathogenesis of anal fissure, in order to obtain healing without surgery. The control group will receive the traditional basic treatment consisting in the application of lubricated anal dilators of increasing gauge according to predetermined pattern, hygiene and diet. The two groups with which they will be compared for the results will receive, in addition to the foregoing (for controls), or Flavonoids (ProtFlav) or Asian Centella Extract (ProtCent), in the form of local mouth and cream tablets to be applied at the perianal level and possibly in the anal canal with gloved finger, containing the same active principles also administered by mouth.

Eligibility Criteria:
Inclusion Criteria:

* Subjects With Acute Anal Fissure
* Collaborative patients able to understand and want;

Exclusion Criteria:

* Pregnancy
Furosemide Treatment Before Blood Transfusion in Patients With Systolic Dysfunction

The study Objective is to assess the clinical and echocardiographic changes of patients with systolic dysfunction receiving blood transfusion, with or without prior treatment with furosemide

More than 4 million patients receive a blood transfusion each year in the United States, many of them suffer from congestive heart failure. The reported prevalence of anemia in CHF is unknown, ranges widely from 4% to 70%, due to a lack of an established, consistent definition of anemia in CHF.

Treating CHF patients with furosemide prior to blood transfusion became a common practice, even though no randomize clinical trial had examine this issue. Nand et al. measured the pulmonary capillary wedge pressures in 20 adults with chronic severe anemia (Hg \<6 mg/dl) and no systemic disease before and after transfusion of 700ml of whole blood. Ten of these patients were treated with furosemide (40 mg intra-venous) immediately prior the transfusion. The PCWP had increased significantly among patient who did not receive the furosemide and decreased by 3.75% among patients in the furosemide group, although this change was not was statistically significant. In another study, the same group of Nand et al. measured the PCWP among 40 chronic anemia patients receiving blood transfusion. None of the patients suffered from cardiopulmonary disease. The patients were randomly divided into 4 groups: the difference between the first 3 groups was the speed of the transfusion (2 ml/min, 5 ml/min and 10 ml/min). The fourth group patients were treated with 40 mg of furosemide before the transfusion was given in a rate of 5 ml/min. The PCWP increased significantly in the first 3 groups, with the rise being proportionately greater with faster transfusions (15.8, 20.9 and 32.2% in groups A, B and C, respectively). In the furosemide group, however, the PCWP decreased significantly by 21.7%.

Eligibility Criteria:
Inclusion Criteria:

* Subject is over 18 years old.
* Documented ejection function equal to or over 40% in prior tests
* The treating physician decided to treat the patient with packed cell

Exclusion Criteria:

* Known hypersensitivity to furosemide.
* Calculated creatinine clearance over 20% (by MDRD)
* Past adverse reaction to blood product.
Management of Patients With Type 2 Diabetes and Hypertension Using Mobile Health Care System

The purpose of this study is to determine whether cellular phone based health care system is effective in the treatment of diabetes and hypertension.

Diabetes care is facilitated by a patient's being engaged in a self-management program with the advice and counsel of physicians, but many diabetic patients can not receive the continous monitoing and advice from his physician in their every day life. It is very difficult to keep up life style modification in their real life.

Few studies have examined the effects of cellular phone based intervention that provide an interactive component daily. Our goal is to test the hypothesis that diabetes and hypertension management using cellular phone based health care system would result in significant improvement of blood glucose and blood pressure level.

Eligibility Criteria:
Inclusion Criteria:

* type II diabetes using only oral hypoglycemic agents
* 7% \< HbA1c \< 10%
* systolic blood pressure \> 130 or diastolic blood pressure \> 80
* BMI \> 23
* 20 \< age \< 75

Exclusion Criteria:

* type I diabetes or type II diabtes using insulin treatment
* liver, renal or heart disease
* recent change (within 1 month) in the type or dosage of anti-diabetic agent, anti-hypertensive medication
Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients

There is little information of Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 patients analyzed in the clinical trials. The rate of patients recruited into Treatment Chemotherapy as 1st Line in Advanced NSCLC clinical trials is less than 20 percent.

This low rate makes the investigators think about the possibility of a bias selection, due to the existence of this exclusion criteria that do not permit to include patients with deteriorated performance status.

In these types of patients, the toxicity is an important issue to decide the therapeutic strategy. Gemcitabine and Docetaxel combination is very interesting because they have a different toxicity profile. This combination has demonstrated activity in several types of tumours, as breast cancer, sarcoma and lung cancer.

The strategy performed in this study is biweekly combination of Gemcitabine and Docetaxel; activity and dose intensity will be the same, but toxicity will be significantly low.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced NSCLC.
* Stage III with pleural effusion and stage IV.
* Patients with ECOG PS 2.
* Patients must have at least one measurable lesion, no previously irradiated.
* Life expectancy of at least 12 weeks.
* Adequate organ function according to the following criteria:

  * Bone marrow: ANC =\> 2.0x10(9)cells/L; Platelet count =\> 100x10(9)cells/L; Hemoglobin =\> 10 g/dL.
  * Liver function: Bilirubin \<= 1.5 X ULN; Alkaline phosphatase \<= 5 x ULN; AST and ALT \<= 1.5 x ULN.
  * Renal function:serum creatinine \<= 2mg/dL.

Exclusion Criteria:

* Prior systemic chemotherapy for advanced disease.
* Prior radiotherapy for NSCLC.
* Patients with symptomatic brain metastases.
* No measurable bone metastases or malignant pleural effusion as only measurable lesion.
* History of prior malignancies, except curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
* History of hypersensitivity reaction study drugs.
* Pregnant or lactating women (women of childbearing potential must use adequate contraception).
* Concurrent treatment with other experimental drugs.
* Current peripheral neuropathy NCI grade 2.
* Participation in clinical trials within 30 days of study entry.
* Major surgery, open biopsy or traumatic lesion 28 days before to study start.