cyrilzakka/clinical-trials huggingface dataset:
Treating Pyelonephritis an Urosepsis With Pivmecillinam

Febrile urinary tract infections and urosepsis are common and potentially serious infections that require effective antimicrobial treatment. The duration of parenteral treatment depends on oral alternatives. These alternatives are few and due to antimicrobial resistance, quinolones are "standard of care". The increased use of quinolones is concerning because of its negative ecological aspects and it is confirmed an increasing incidence of resistant E.coli to quinolones in Norwegian isolates.

Pivmecillinam is an antibiotic with high susceptibility to E.coli but the evidence for treating febrile urinary tract infections is insufficient. This trial will investigate the efficacy and safety of pivmecillinam in treating pyelonephritis and urosepsis caused by E.coli.

The hypothesis is that urosepsis can safely be treated with pivmecillinam when it is given after 2-3 days with empirical i.v. antibiotics.

This trial will be conducted at Vestfold Hospital, Norway, and is a prospective observational study with intention to treat. Participants will be consecutively included among hospitalized patients suffering from urosepsis - see eligibility criteria. After 3 days with parenteral antibiotics, when clinical improvement and absence of fever/leukocytosis is confirmed, the participants will start on pivmecillinam 400mg four times daily and be discharged. Pivmecillinam is to be taken for one week. The participants will be contacted by phone on day 4, 10 and 33 (days after admission). On day 17 (test of cure, TOC) they will meet for physical examination. They will report symptom score (standardized schema) on day 0, and 17. Urine samples will be collected on day 10 and 17. Blood samples on day 17. All data will be stored anonymously. The trial will be monitored by extern resources.

Eligibility Criteria:
Inclusion Criteria:

* E.coli in blood culture
* AND identical isolate in urine sample (\>= 1.000 CFU) OR relevant clinical signs of UTI

Exclusion Criteria:

* Bacterial infection origin from another organ (e.g. pneumonia)
* Severe sepsis with multiorgan failure
* Perinephritic abscess
* Pyonephrosis requiring drainage
* Allergy to pivmecillinam
* E.coli isolate resistant to pivmecillinam
* Pregnancy/breastfeeding
* Severe neutropenia
* Prostatitis
* Severe kidney failure (eGFR\<15 ml/min)
* Using valproate
Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

Patients of cirrhosis aged 18 to 75 years who have no esophageal varices will be enrolled. After baseline evaluation, the participants will be randomized to receive either Placebo or Carvedilol 12.5 mg BD. After randomization they will be followed up for one year.


Eligibility Criteria:
Inclusion Criteria:

* Patients of cirrhosis aged 18 to 75 years who have no esophageal or gastric varices.

Exclusion Criteria:

* Any contra-indication to beta-blockers
* Any past EVL or sclerotherapy
* Any past history of surgery for portal hypertension
* Significant cardio or pulmonary co-morbidity
* Any malignancy
* Refusal to participate in the study
Brief Mobile Intervention for Prepartying

The primary objective of the research study is to develop and test a prepartying (aka "pregaming") specific brief mobile app intervention that is intended to help college students reduce their prepartying drinking behavior. Such behavior has been identified as a major contributor to alcohol-related negative consequences among young people. The investigators will first develop the intervention content based on theory and research supporting mechanisms of change in brief interventions with college students and document normative drinking information from 500 college students for inclusion in the intervention content. Investigators will then beta test the intervention with a sample of 14 heavy drinking college students. Focus group feasibility and acceptability feedback will inform the final intervention content. Investigators will then pilot test the mobile-based intervention in a randomized controlled trial of 500 college students who preparty frequently (n = 250 intervention, n = 250 attention control) and determine the efficacy of the intervention on (1) preventing heavy consumption levels during and after prepartying and on (2) reducing students' global levels of heavy drinking and consequences one and three months post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* full time undergraduate college student
* between the ages of 18 and 24
* report typically prepartying at least once per week

Exclusion Criteria:

* not meeting inclusion criteria
Role of Cherry Consumption in Reducing Risk Factors for Chronic Inflammatory Diseases

The goal of this study is to examine if chronic cherry consumption will decrease lipid peroxidation and serum concentration of inflammatory markers in human subjects with elevated serum C reactive protein (CRP), and to examine the relationship between serum concentrations of CRP and polyphenols. The investigators hypothesize that cherry consumption will reduce serum concentration of inflammatory markers, including CRP, inflammatory cytokines and adhesion molecules.

The study will last a total of 64 days with three different metabolic periods. First 8 days will be period 1, when base line fasting blood samples will be collected on day 1 and 8. For the next 28 days (period 2 or intervention period) subjects will supplement their diets with 280 g/d of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories. We will prefer that the subjects split the cherries into three equal portions and consume one with each meal; however, this will not be mandatory. Subjects will be asked to record all foods and drinks consumed for three 24-hr periods during the study. Fasting blood samples will be drawn on study days 22 and 36 (14 and 28 day after the start of cherry consumption). The third period of 28 days will be post-intervention, when the subjects will return to their normal diets without cherries. Post-intervention blood samples will be drawn on study day 64. All blood draws will follow a 12-hour fast. Blood samples will be processed within one hour of draw and the plasma stored frozen in different aliquots, until analysis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 45-65 years of age
* serum CRP concentrations between 3-25 mg/L
* BMI \< 35 kg/m2

Exclusion Criteria:

* BMI \> 35 kg/m2
* current infection
* taking anti-inflammatory medications
Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer

To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen


Eligibility Criteria:
Inclusion Criteria:

* Histologically and/or cytologically confirmed breast cancer
* Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen
* To have at least one measurable region
* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
* To have adequate organ function (bone marrow, liver and renal function)

Exclusion Criteria:

* To have interstitial pneumonia or pulmonary fibrosis
* To have inflammatory breast cancer
* Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
* To have brain metastases with symptoms
* To have severe complication (cardiac infarction, infection, drug hypersensitivity or diabetes)
Study to Prevent Negative Thoughts of Life

The purpose of the study is to test whether cognitive behaviour therapy (CBT) offered by trained therapists, to people with current active suicidal ideations, is efficacious as a secondary prevention strategy in Sri Lanka, when compared with treatment as usual provided by Medical Officers (Mental Health; MO (MH)) of government hospitals


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 - 64 years
* Self reported current active suicidal ideations
* Ability to speak and write Sinhala

Exclusion Criteria:

* An acute intent and planning of suicide
* In-patient/out-patient treatment following an attempted suicide during the previous two-year period
* A diagnosis of mental retardation
* A diagnosis of sensory deficit
* A diagnosis of alcohol abuse
* A diagnosis of psychotic illness
Topical Penlac Nail Lacquer for Onychomycosis in Children

Five months of therapy is sufficient to treat onychomycosis in children. Topical therapy of onychomycosis in children with Penlac nail lacquer has comparable efficacy and a superior cost and safety profile compared to systemic therapy.

Therapeutic trials for the treatment of onychomycosis have been conducted in the adult population, but there is limited data available in the pediatric population.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of two and sixteen years
* Clinical diagnosis of toenail onychomycosis involving at least 20% of one nail plate
* Positive DTM reading or fungal culture for onychomycosis-either dermatophytes or non-dermatophyte mold
* Consent to participate in the study
* Women of child-bearing potential must have a negative urine pregnancy test at the baseline visit and be willing to practice effective contraception for the duration of the study.

Exclusion Criteria:

* Children with allergy to Penlac or one of its ingredients
* Structural deformity of target nail plate
* Presence of active psoriasis or severe foot eczema
* Presence of immunodeficiency disorder
* Concurrent immune suppressive therapy or immune suppressive therapy within the last 3 months
* Previous systemic antifungal therapy within the last 6 months
* Previous topical antifungal therapy within the last 14 days
* Female subjects who are pregnant, nursing mothers, those planning a pregnancy during the course of the study, or who become pregnant
Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease

This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MGLL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a diagnosis of Alzheimer's disease with biomarker confirmation meeting the 2024 Alzheimer's Association criteria.
* The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) definition of agitation.
* History of agitation with onset at least four weeks prior to Screening
* MMSE-1 score \< 21
* NPI-NH agitation/aggression sub-score ≥ 4.
* Stable living environment for at least 8 weeks prior to Screening. Participants are eligible if they are in nursing homes, assisted living facilities, or living at home and have an identified study partner (caregiver).
* Capable of self-locomotion (alone or with the aid of an assistive device).

Exclusion Criteria:

* Clinically significant delusions/hallucinations requiring hospitalization.
* History of bipolar disorder, schizophrenia, or schizoaffective disorder.
* History of major depressive episode with psychotic features during the 12 months prior to Screening.
* History of delirium within 30 days of Screening.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-A )

To compare the door-to-needle time of patients with hyperacute ischemic stroke (within 4.5 hours after the onset of symptoms) managed in a standard stroke unit adherent to guidelines versus managed in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).

Intravenous thrombolysis is an effective reperfusion therapy for patients with acute ischemic stroke. Faster door-to-needle time (DNT) is associated with significantly better clinical outcomes. With the development of low-field magnetic resonance imaging, it is poised to play an increasingly significant role in the early diagnosis and management of acute ischemic stroke. This prospective, multicenter, week-wise randomized controlled trial will compare the door-to-needle time of patients with hyperacute ischemic stroke (within 4.5 hours after the onset of symptoms) managed in a standard stroke unit adherent to guidelines versus managed in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Can be treated within 4.5 hours of symptoms onset\*(\*Symptom onset is defined by the "last seen normal" principle);
3. Presenting with ischemic stroke symptoms;
4. Pre-stroke mRS score 0-1;
5. Baseline NIHSS score ≥ 5;
6. Eligible for rt-PA/TNK thrombolysis;
7. Informed consent signed.

Exclusion Criteria:

1. Baseline NIHSS score \< 5;
2. Unable to undergo MRI because of claustrophobia;
3. Patients with cardiac pacemaker/brain pacemaker/insulin pump implantation;
4. Definite contraindication for rt-PA/TNK thrombolysis;
5. Patients with postictal hemiparesis (Todd's paralysis) or those with concomitant neurological/psychiatric conditions who are unable or unwilling to cooperate;
6. Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial;
7. Participation in other interventional randomized clinical trials within 3 months before enrollment;
8. Patients deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.
Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes

This trial is conducted in Asia, Europe, South America, and the United States of America (USA).

The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes (diagnosed clinically) for at least 6 months prior to the screening visit (Visit 1)
* Current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, NPH for at least 3 months prior to the screening visit (Visit 1)
* Current treatment with a) metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b) metformin in combination with sulfonylurea (SU) or glinide or Dipeptidyl peptidase-IV inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg
* HbA1c by central laboratory a) 7.5-9.5% (58 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (Visit 1) or b) 7.5-9.0% (58 - 75 mmol/mol) (both inclusive) in the metformin + other oral antidiabetic drug (OAD) (sulphonylurea (SU), glinide, dipeptidyl peptidase-IV (DDP-IV) inhibitors, alpha-glucosidase inhibitors (AGI) combination group at the screening visit (Visit 1)
* Body mass index (BMI) equal or less than 40.0 kg/m\^2

Exclusion Criteria:

* Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days of consecutive treatment) and not within 3 months prior to the screening visit (Visit 1)
* Use of Glucagon-like peptide-1 (GLP-1) agonists and/or Thiazolidinediones (TZD) within the last 3 months prior to screening (visit 1)
* Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1)
Comparison of Ease of I-gel Insertion With Two Different Techniques in Adults

Study will evaluate the I-gel airway device standard insertion technique versus interventional (modified jaw thurst) insertion technique in adult patients. The half of the patients will receive standard and other half will receive the modified jaw thrust insertion technique

The I-gel is used to provide the oxygenation and ventilation in anaesthetised patients. The inventor suggested insertion technique is called standard technique.

Standard I-gel insertion technique: I-gel insertion will be performed by firmly grasping the lubricated I-gel along the integral bite block site. I-gel cuff outlet will face towards the patient's chin and before insertion chin will be gently pressed down. The I-gel soft tip will be introduced into patient's mouth in a direction towards the hard palate. Then I-gel will be slide downwards and backwards along the hard palate with a continuous but gentle push until a definitive resistance is felt.

Modified jaw thrust technique: I-gel insertion will be performed by firmly grasping the lubricated I-gel along the integral bite block. I-gel cuff outlet will face towards the patient's chin and before insertion chin will be gently pressed down. The I-gel soft tip will be introduced into patient's mouth in a direction towards the hard palate and it slides gently into the oropharynx. I-gel will be left in oral cavity and both hands will be used to thrust the jaw by lifting the angle of mandible with little fingers and other fingers to stabilize the jaw then both thumbs will used to apply the balance force towards the final I-gel placement position by looking at the integral bite block mark at incisor teeth level.

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II patients.
* Age 16 years to 60 years.
* Patient scheduled for elective surgical procedure.

Exclusion Criteria:

* Gastroesophageal reflux disorders
* Obesity BMI more than 30.
* Pregnancy
* Reactive airway disease/asthma
* Patients with mallampati score III \& IV
* Anticipated difficult airway
* Emergent surgery.
* Known allergic to isoflurane and propofol.
A Megastudy of Single-Session Interventions for Depression

This project aims to learn if new kinds of digital single-session interventions (SSIs) for depression could be effective for American adults. Many existing SSIs are delivered in a simple text-based format. However, it might be that different kinds of SSIs (in terms of both content and style) also have potential for scalable impact. Specifically, this study will investigate the effectiveness of 11 innovative SSIs by comparing them to a passive control and to an existing SSI with established efficacy.


Eligibility Criteria:
Inclusion criteria:

* At least 18 years old
* Able to read and write fluently in English
* Have enough access to the internet to complete two sessions over four weeks
* Score at least 10 on the PHQ-9 screen (suggesting moderate depression; Kroenke et al., 2001)
* Pass the bot check during the screening survey

All participants who are randomized to an experimental condition (and therefore completed all baseline measures) will be included in analyses, except for participants who indicate at the end of either the baseline or week 4 session that they did not participate in the study seriously. Researchers will only keep data from the first survey session a participant begins.
The Effect of Vibration Therapy on the Bone Density of the Tiba in Patients With Spinal Cord Injury

The purpose of this investigation is to determine the effect of lower limb vibration therapy on bone density in the tibia in patients with spinal cord injury. The second purpose is to assess the neuromuscular junction variability at the motor units of the tibialis anterior muscle after a sequence of lower limb vibration therapy


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18 years
* A spinal cord injury patient with injury above T12
* Injury below T4 to avoid respiratory complication.
* An ASIA classification of A or B

Exclusion Criteria:

* Non complicating organic factors such as heart disease, high blood pressure, stroke
* Exercise where electrical therapy is used while the trial is being conducted
* A bone density measure 3 times below normal mineralization levels as measured on the first bone density scan prior to entry in to the study
* Surgical implants below the level of T12
* Local infection, acute inflammation, injury, tumors or other malignancy, recent wounds, diabetes
* Any unstable joints of the lower extremity, recent hip and knee joints or fitted hip or knee pins, bolts and/or plates
* Acute thrombosis
* Severe migraine, epilepsy
* Serious cardiovascular disease, wearing a pacemaker
* Any Spinal manipulation within one year of the study
* Any implanted device or prosthesis or intrauterine IUD type of device pregnancy
Lorraine Registry of Multiple Sclerosis

The RelSEP aims to register exhaustively every new case of multiple sclerosis (MS) occuring in Lorraine a French region, and follow up on them for an indefinite duration, registering disease evolution and intercurrent events.

As every patient registry in France, the RelSEP is periodically (every four years) evaluated by an independent committee.

The RelSEP interrogate multiple sources to insure its exhaustiveness :

* every neurologists of Lorraine
* MS patient network in Lorraine
* health insurance data
* PMSI (administrative French national database for hospitals)
* biological and imagery services in Lorraine Procedures (automatic and manual) are used to eliminate duplicates Once a patient has been identified its medical file are checked by investigators in order to retrieve the relevant information.

New MS cases are confirmed by neurologists. Automatics (implemented in EDMUS software)and manual checks are implemented in the registry database, looking for inconsistencies.

The following data are registered :

* Name, birthname
* Sex
* Date of birth
* Location (town)
* Birth location (town)
* Profession
* Number of siblings
* Marital status
* Number of children
* Date of onset
* Date and nature of clinical manifestations
* MRI reports
* CSF analysis reports
* Event-related potential reports
* Impairment and disability evolution
* Treatments (start and change of drug treatment)
* Drugs related events
* Cause of treatment discontinuation
* Disease progression Every case has a follow up at least every two years.

The quality of data is evaluated by periodically auditing cases at random from our database.

An annual report on the main data (incidence and prevalence) of MS in Lorraine is produced.

Data are also used for observational studies on prognostic factors.

Eligibility Criteria:
Inclusion Criteria:

* Having a confirmed multiple sclerosis diagnosis
* Living in Lorraine (French region)

Exclusion Criteria:

* Refusal to be registered