cyrilzakka/clinical-trials huggingface dataset:
Extended Treatment With Vancomycin for Clostridium Difficile Colitis

BACKGROUND: Clostridium difficile-associated colitis is an infection of the large bowel, usually associated with previous use of antibiotics. The disease course may be complicated by fulminant disease requiring removal of the colon or by multiple recurrences requiring re-hospitalization. The incidence and severity of Clostridium difficile infection is rising, and it poses an increasing burden on the health system. For example, in one of our previous studies we found that 804 in-patients and 568 out-patients had a positive test for Clostridium difficile toxin at Beaumont Laboratories in 2003. The standard treatment is a 2 week course of Vancomycin or Metronidazole. The clinical response to Metronidazole appears to be declining, and many practicing clinicians prefer Vancomycin as a first-line treatment. The recurrence rate after the treatment is similar for Vancomycin and Metronidazole and is usually in the range of 15-25%, although recent reports noted a recurrence rate up to 50% during outbreaks with a virulent strain. Recently, it has been suggested that a 2 week duration of treatment might not be adequate in clearing the infection.

Our HYPOTHESIS is that a prolongation of Vancomycin treatment from 2 weeks to 4 weeks will lead to a decrease rate of recurrent Clostridium Difficile colitis.

METHODOLOGY: Patients with a first episode of Clostridium difficile colitis will be offered a prolonged course of Vancomycin. It will be disclosed that this is not the standard of care, but that a prolonged course might decrease the relapse rate. After the initial treatment with Vancomycin 125 mg four times daily, the patients will be randomly assigned to receive either 2 weeks of Vancomycin 125 mg four times daily or 2 weeks of placebo. The placebo solution will be prepared by our pharmacy to match the color and taste of the Vancomycin solution. The initial 2 weeks of therapy for both groups will be dispensed at patients' pharmacy. Patients will be called back at the end of 2 weeks and the blinded-phase drugs will be dispensed by our pharmacy staff.

We will ask permission for a follow-up phone call at the end of treatment (1 month) and at a 3-month interval. The patients will be followed longitudinally for a 3-month period. At the end of the follow-up interval, a review of any new medical records of the patient will be made and the patient will be contacted by phone for further details.

Eligibility Criteria:
Inclusion Criteria:

* First episode of Clostridium difficile colitis, defined by a positive toxin assay plus at least one of the following: diarrhea, toxic megacolon or leukocytosis.

Exclusion Criteria:

* previous diagnosis of Clostridium difficile colitis
* concomitant use of oral Metronidazole, Rifampin, Rifaximin, Nitazoxanide, Sacharromyce boulardii or Lactobacillus spp.
* age less than 18 years-old
* pregnancy.
Percutaneous Transluminal Angioplasty Registry

Percutaneous transluminal angioplasty (PTA) is a minimally invasive procedure for dilating blood vessels in the treatment of peripheral artery disease.

The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PTA. This registry is an open-end observational study to assess the characteristics and outcomes in patients with undergoing PTA.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing PTA

Exclusion Criteria:

* \< 18 years
A Single and Multiple Ascending Dose Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of KP-1199

This is a Phase I, randomized, placebo and active-controlled, double blind, single and multiple ascending dose study in healthy adults to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of KP-1199


Eligibility Criteria:
Inclusion Criteria:

* Healthy Adult 18-45 years of age at time of screening, inclusive.
* Have a body mass index (BMI) between 18.0 and ≤32 kg/m2, inclusive, and a weight of ≥50 kg at screening.
* Be determined to be healthy on the basis of a pre-study physical examination, medical history review, vital sign measurements, and the results of laboratory tests.
* For both male and females: using acceptable method of birth control
* If Female: not-pregnant or not breast feeding and not planning on becoming pregnant
* All prescribed medication must have been stopped at least 14 days prior to admission to the clinical research site. An exception is made for hormonal contraceptives, which may be used throughout the study.
* All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research site.
* Must be adequately informed and understand the nature and risks of the study and must provide written informed consent prior to enrollment at screening.

Exclusion Criteria:

* Subjects who participate in one part of the study are not eligible to participate in subsequent parts of the study.
* Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
* Males with female partners who are planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
* History or evidence of significant clinical or psychiatric disorder, condition, or disease that, in the opinion of the Investigator would pose an unacceptable risk to the subject safety or interfere with the study evaluations, procedures, or completion of the study.
* Documented congenital QT syndrome, and/or corrected QT interval (Fridericia correction; QTcF) at screening or first admission \> 450 ms.
* Positive screening test for hepatitis B surface antigen, anti-hepatitis C virus antibodies or anti-human immunodeficiency virus 1 and 2 antibodies.
* History of drug allergy diagnosed by a physician.
* Use of tobacco within 30 days prior to the first study drug administration.
* History of alcohol consumption exceeding 2 standard drinks per day on average.
* Routine or chronic use of more than 0.5 grams of acetaminophen daily.
* History of donation of more than 450 mL of blood within 60 days prior to dosing in the clinical research site or planned donation before 30 days has elapsed since intake of study drug.
* Plasma or platelet donation within 7 days of dosing
* Use of any investigational drug or device within 30 days of the first dose of study.
Shifts in the Oral Biofilm of Patients With Known Oral Health Risk Factors

This study is observational only and is intended to evaluate changes in the makeup and function of bacteria naturally present in the mouth during treatment with braces to straighten teeth.


Eligibility Criteria:
Inclusion Criteria:

* ASA I or II (ASA I is a healthy patient, ASA II is patient with minor systemic disease)
* Patient must be receiving orthodontic treatment at the University of North Carolina School of Dentistry and not yet be in active treatment

Exclusion Criteria:

* Patients who have used antibacterial therapy in the past 3 months
* Patients who report current smoking
* ASA III or above (Patients with severe systemic diseases)
Persistent Pain to Impair Daily Activities Following Thoracic Surgery

Can pain impairment of daily activities be shown to be procedure specific, and thus used as an alternative to pain scoring.


Eligibility Criteria:
Inclusion Criteria:

* Age \< 18 years old
* Elective lung cancer surgery (VATS)

Exclusion Criteria:

* Non-Danish residence
The Effect Of Pumpkin Seed Extract Capsules On Nutritional Status and Haemoglobin Level in Pregnant Women.

The goal of this to measure the effect of supplementation of Yellow Pumpkin Seed Extract Capsules in pregnant women on hemoglobin levels and nutritional status of pregnant women.

The main question\[s\] it aims to answer are:

* is there a difference in changes in nutritional status (increase in body weight and MUAC) in pregnant women who receive supplementation of Pumpkin Seed Extract Capsules and iron tablets
* is there a difference in changes in hemoglobin levels in pregnant women who receive supplementation of Pumpkin Seed Extract Capsules and iron tablets.

The research sample was divided into two groups, namely the intervention group and the control group. In the intervention group, pregnant women received pumpkin seed extract capsules for 12 weeks, while the control group received iron tablets for 12 weeks as well. Measurements of nutritional status (including measurements of body weight and Mid Upper Arm Circumference/MUAC) were carried out before and after the intervention and were monitored every month until 12 weeks when the intervention was carried out. As for measuring blood hemoglobin levels, it was taken before the intervention and after the intervention for 12 weeks

This study was designed with an experimental method using a randomized double blind with a control group. The research sample was divided into two groups, namely the intervention group and the control group. In the intervention group, pregnant women received pumpkin seed extract capsules for 12 weeks, while the control group received iron tablets for 12 weeks as well. Measurements of nutritional status (including measurements of body weight and Mid Upper Arm Circumference/MUAC) were carried out before and after the intervention and were monitored every month until 12 weeks when the intervention was carried out. As for measuring blood hemoglobin levels, it was taken before the intervention and after the intervention for 12 weeks. The research will be conducted in the village of the stunting locus, Bone Regency, South Sulawesi, Indonesia. Data analysis was carried out with SPSS, where to see the difference between the intervention group and the contro group, a paired t test was used if the data was normally distributed and an alternative test if the data was not normally distributed.

Eligibility Criteria:
Inclusion Criteria:

1. in the one or second trimester of pregnancy;
2. having no complications;
3. willing to participate in this study;
4. domiciled in the stunting locus village Bone regency .

Exclusion Criteria:

* Pregnant women with complications
Effects of Parent-Adolescent Joint Interventions for Adolescents With Adverse Childhood Experiences

The study aims to examine the effectiveness of joint parent-adolescent intervention in improving the mental health outcomes of participants, specifically by reducing symptoms of depression, anxiety, and PTSD, as measured by the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder-7 scale (GAD-7), and the Child PTSD Symptom Scale for DSM-5 (CPSS-5). Adolescents will be recruited from middle schools and randomly assigned to one of three groups: (a) psychoeducation, (b) psychoeducation + emotional skills enhancement, or (c) psychoeducation + emotional skills enhancement + positive childhood experience promotion. The school-based intervention will consist of 4-8 sessions, with assessments conducted at baseline, post-treatment, and a 3-month follow-up. Investigators will conduct multilevel models (MLMs) and structural equation models (SEMs) to investigate the impact of Adverse Childhood Experiences (ACEs), Positive Childhood Experiences (PCEs), alexithymia, and emotion regulation abilities on mental health outcomes in adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Middle school students studying in school and their parents
* Capable of hearing, speaking, reading, and writing

Exclusion Criteria:

* High suicidal risks
* Severe mental disorders
Effect of BTL-899 Device for Non-invasive Lipolysis on Human Upper Arms

This study will evaluate the clinical safety and the performance of the BTL-899 device during the treatment of upper arms.

The aim of the study is to confirm the efficacy and the safety of the treatment. The efficacy (reduction of excess adipose tissue) will be assessed via correct identification of pre-treatment and 3-months follow-up images by at least two out of three independent blinded evaluators. The fat reduction will be also measured by means of ultrasound. Comfort and satisfaction will be assessed via standard questionnaires.

Safety measures will include documentation of adverse events (AE) during and after the procedures.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 20 to 35 kg/m2.
* Visible excess of adipose tissue at the treatment site
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation.
* No procedure for fat reduction in the area in the last six months.
* Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting a significant change of weight in either direction during the study participation.

Exclusion Criteria:

* Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
* Cardiovascular diseases
* Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
* Disturbance of temperature or pain perception
* Pulmonary insufficiency
* Metal implants
* Drug pumps
* Malignant tumor
* Hemorrhagic conditions
* Septic conditions and empyema
* Acute inflammations
* Systemic or local infection such as osteomyelitis and tuberculosis
* Contagious skin disease
* Elevated body temperature
* Pregnancy
* Breastfeeding
* Injured or otherwise impaired muscles in the arms
* Scars, open lesions, and wounds at the treatment area
* Basedow's disease
* Previous liposuction in the treatment area in the last six months
* Any other disease or condition at the investigator's discretion, e.g. dislocated shoulder or carpal tunnel syndrome than can pose danger to the patient or compromise the study
Comparison of Lung Deposition With the Aeroneb Solo Adapter and a Standard Jet Nebulizer by SPECT-CT

Aeroneb Solo Adapter is a vibrating-mesh nebulizer Aeroneb Solo combined to a spacer specifically designed for spontaneously breathing patients. This device has not been investigated in vivo yet.

It's known that using a spacer during nebulization improves aerosol delivery. We hypothetized that lung deposition could be highly increased with the Aeroneb Solo Adapter in comparison to a standard jet nebulizer.


Eligibility Criteria:
Inclusion Criteria:

* Healthy respiratory function

Exclusion Criteria:

* Pulmonary disease
Elastography in Patients With Hemiplegia

In our study, we aimed to examine the muscles and tendons of the shoulder region on the plegic side of patients with hemiplegia by elastography and to investigate whether there is a relationship between the course of the disease and the course of the lesions that will occur in the shoulder.

Patients over the age of 18 who apply to our clinic and have hemiplegia complaints will be evaluated. Patients' age, gender, occupation, habits, disease duration, upper extremity with complaints, dominant upper extremity, additional disease, weight and height values will be recorded. In the physical medicine and rehabilitation department examination of the patients, the patients will be evaluated with the brunnstrom staging used in hemiplegic patients. The elastography of the shoulder on the side with hemiplegia and the elastography of the shoulder on the side without complaints will be examined. Thus, the patient's side with the complaint will be checked by comparing the healthy side.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteer patients
2. Patients over 18 years old
3. Patients with hemiplegia
4. Patients without any rheumatic disease
5. Patients without any neurological deficit and muscle disease
6. Not having received ftr treatment to the shoulder area in the last 3 months
7. No injection to the shoulder area in the last 3 months
8. Not having any surgical procedure on the shoulder area
9. Not to be pregnant

Exclusion Criteria:

1. Patients with any rheumatic disease
2. Patients with any neurological deficit and muscle disease
3. To have received ftr treatment to the shoulder area in the last 3 months
4. Being under 18 years old
5. Having an infectious disease
6. Having any benign or malignant disease
7. Any surgical procedure to the shoulder area
8. Pregnancy
A Single Patient Will be Treated With Individual Patient TCR-Transduced PBL

A single patient will be treated with Individual Patient TCR-Transduced PBL

Background:

-Please refer to National Cancer Institute Surgery Branch (NCI-SB) protocol 18-C-0049, Amendment F.

Objective:

-Under Individual Patient Expanded Access, to treat a patient with metastatic breast cancer with autologous peripheral blood lymphocytes (PBL) that have been transduced with genes encoding T-cell receptors that recognize mutated neoantigens in the autologous cancer.

Eligibility:

* Must have measurable, metastatic disease as assessed per RECIST v1.1 criteria.
* Must sign the informed consent document.
* Willing to sign Durable Power of Attorney Form.
* Must have all regulatory approvals prior to start of treatment.

Design:

* Please refer to NCI-SB protocol 18-C-0049, Amendment F.
* The patient will be treated with a non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine, followed by the infusion of autologous transduced PBL and then high-dose aldesleukin. The patient will also receive pembrolizumab on Day -2 prior to cell administration and additional doses every 3 weeks following cell infusion until the time of disease progression.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
LGI1-antibody Patients Follow-up

Autoimmune encephalitis involve autoantibodies targeting central nervous system, and particularly the synapse or its structure like for LGI1 protein. Anti-LGI1 encephalitis is revealed by an inflammation of the limbic system, with mainly temporal lobe, faciobrachial dystonic or generalized seizures, and cognitive disorders.

This disease is rare and its clinical, EEG and radiological characterisation is not sufficiently established. The investigators will evaluate these three aspects for the anti-LGI1 cohort of patients of the National Reference Center of autoimmune encephalitis.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Diagnosis of anti-LGI1 encephalitis based on sera or CSF samples in the National Reference Center of autoimmune encephalitis from 2011/06 to 2019 july 1st.
* Clinical follow-up in France

Exclusion Criteria:

* Anti-LGI1 antibody associated with another encephalitis antibody
* Foreign follow-up
NaROA STUDY: National Register of Open Abdomen

National Register of Open Abdomen Open Abdomen Procedure (Observational and Prospective Study)

The open abdomen technique has widely been proven useful in the treatment of traumatic patients, but its indication in non-traumatic patients with catastrophic abdomen (peritonitis, ischaemia, pancreatitis) generates controversy. Its heterogeneous implementation is based on insufficient evidence and originated in health systems very different from ours. Its low prevalence imposes the need for a multicentre study.

AIMS : Establish a national, prospective, multi-centre national registry of non traumatic patients with open abdominal indication whether or not they undergo damage control surgery and open abdomen for:

1. Describe in real time the indications, surgical technique, materials, time, risk factors, definitive closure, reinterventions and complications according to the Clavien-Dindo classification and mortality.
2. Compare the results of the application or non-application of the open abdomen in non-traumatic patients between the different participating centers.
3. Set the limits of the open abdomen in non-traumatic patients indication.

Eligibility Criteria:
Inclusion Criteria:

* Indication to Open Abdomen in non-trauma patients
* Informed consent

Exclusion Criteria:

* Open Abdomen in trauma patients
* No indication to Open Abdomen
* Informed consent refusal
General vs Spinal in Total Joint Arthroplasty (TJA)

The purpose of this research is to compare post-operative outcomes from patients undergoing TJA. The study team wants to learn about outcomes like length of hospital stay, post-operative pain scores, post-operative nausea, deep and superficial surgical site infection, periprosthetic fracture (a broken bone that occurs around an orthopaedic implant), implant dislocation, readmission rates, and revision rates.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a primary total hip or knee arthroplasty
* Subjects must be capable of providing informed consent
* English or Spanish speaking

Exclusion Criteria:

Patients with contraindications for spinal anesthesia such as:

* Prior lumbar surgery with hardware insertion
* Elevated intracranial pressure
* Infection at the site of the procedure
* Thrombocytopenia or coagulopathy
* Severe mitral and aortic stenosis and left ventricular outflow obstruction
* Severe spine pathology (spinal stenosis, spondylolisthesis, spondylosis) with radiculopathy and/or neurogenic claudication
* Preexisting neurological disease

Patients with contraindications for general anesthesia such as:

* Congestive heart failure
* Severe aortic stenosis
* Patient is unable/unwilling to consent
* Current pregnancy or women planning on becoming pregnant in the next year, and women who think they might be pregnant, or women who become pregnant during the study period will be removed from the study.
* Prisoners
Screening Evaluation for Studies of Chronic Obstructive Pulmonary Disease (COPD)

This research is being done to study mechanisms of progression of COPD and to develop treatments for it. The investigators are doing the present study to identify people age 40 and older with mild to moderate COPD who will qualify for such studies to include in a database. The study will include establishing a screening evaluation or characterization of the following two studies:

* Emphysema Progression in COPD- Losartan's Effects on Airway Parameters - NA_00009980
* Sleep-Related Physiology and Inflammation in Chronic Obstructive Pulmonary Disease - NA_00001771

This is a program to recruit and screen participants for clinical trials or more detailed observational studies of COPD. There are no interventions or comparative results to be published from this study.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 years and older, either sex
* Mild to moderate COPD (FEV1/Forced vital capacity (FVC) ratio ≤ 0.70, FEV1 30-70% predicted, Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥35% predicted)
* On stable maintenance therapy for 2 months
* Current or former smoker (patient report of at least a 10 pack-year history)
* Ability to understand and willingness to sign consent documents

Exclusion Criteria:

* COPD exacerbation requiring treatment within past 6 weeks
* Untreated arterial hypertension (systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg)
* Decompensated heart failure
* Myocardial infarction within past 3 months or ever
* Evidence of interstitial, occupational or chronic infectious lung disease
* Renal dysfunction
* Supplemental oxygen \> 2 liters/m at rest
* Failure to keep screening appointments