cyrilzakka/clinical-trials huggingface dataset:
The Impact of Food on Gut Microbiome Composition - a Clinical Trial Determining the Influence of Diet in Gut Microbiome Colonisation and Host Health

The goal of this clinical trial is to examine the impact of food derived bacteria on gut microbiome composition and host health. The main questions it aims to answer are:

* what is the the rate of gastrointestinal colonisation of food derived bacteria?
* what is the contribution of food derived bacteria to gut microbiome stability?

Participants will complete a cross over feeding study of dietitian designed meals of known microbial load and will be asked to provide stool and blood samples for analysis.

To understand the role and stability of food derived bacteria in impacting microbiome composition, 20 healthy participants will be recruited for this single site double blinded randomised controlled crossover pilot trial. The study is divided into four 14 day diet phases - baseline habitual, specified diet 1, habitual washout and specified diet 2. Participants will be randomly assigned to receive a microbial or non-microbial diet in specified diet 1 phase. Each participant will then crossover to receive the alternative diet in the specified diet 2 phase. The microbial and non-microbial diets will be identical except for the removal of naturally occurring food derived bacteria in non-microbial diet. At the commencement of the study and at the end of each diet phase, participants will attend a research clinic to undergo comprehensive clinical and anthropometric assessment and dietary evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Have no genetic conditions (e.g. Prader Willi or Down's Syndrome)
* Not diagnosed with a significant medical conditions (e.g. irritable bowel syndrome, inflammatory bowel disease or type 1/2 diabetes)
* Do not require drug-therapy (e.g. steroids or insulin or antibiotics)
* Not taking dietary supplements, probiotics, prebiotics, symbiotics or fibre supplementation
* Any condition that will affect participation in the study
* Not pregnant, planning a pregnancy or breastfeeding
* Able to complete a two-month dietary study and agree to eating all meals provided
* Have no dietary allergies or dietary restrictions that prevent consumption of provided study meals
* Open bowels regularly - mostly daily
* Able to read, write and understand English

Exclusion Criteria:

* Dietary concerns identified by dietitian
* Aged less than 18 years and older than 65 years
* Diagnosed with a medical condition that requires drug therapy
* Taking medications or supplements known to alter gastrointestinal microbiota
* Women who are pregnant, planning a pregnancy or breastfeeding
* Anyone with a diagnosed gastrointestinal condition/disease e.g. irritable bowel syndrome or inflammatory bowel disease
* Known dietary allergy and/or intolerance, follows a vegan or vegetarian diet, or has coeliac disease
* Anyone with a preference for specific food avoidance or exclusion of certain ingredients in habitual diet
* Unable to tolerate blood collection procedures
* Unable to provide regular stool samples throughout the study
Effect of a New HA Filler in Correcting Nasolabial Fold

The investigators aimed to evaluate the efficacy and safety of new HA filler for nasolabial fold correction

A 24-week prospective, single-center, assessor-blinded, randomized, split-face study was conducted to compare the clinical efficacy and safety of new HA filler versus Juvederm for nasolabial fold correction

Eligibility Criteria:
Inclusion Criteria:

* Patients who had prominent NLFs with a WSRS score of 3 or 4 on both sides

Exclusion Criteria:

* patients with active facial skin diseases or history of severe allergies, autoimmune disorders, or hypersensitivity to HA or any of the excipients contained in the investigational filler
* participants who had used a local topical preparation (steroid and retinoid) within 2 weeks before the study
* participants who had undergone chemical peeling, laser procedures, or acne treatments within 4 months before the study
* participants who had been injected with other biomaterials, including HA within 6 months before the study.
Pulse Width 0.15ms vs 0.30ms in Electroconvulsive Therapy

The PWECT015 study was designed to compare the application of 0.15ms and 0.30ms pulse width in electroconvulsive therapy (ECT). Subjects will be compared both within groups and in-group via psychometric scales.

This study is a controlled randomized clinical trial. Patients (projected n=40 are randomized into two groups - blue (20) and red (20). Randomization will be blocked (size sample 4) - 1 allocator. ECT practitioners are aware which patient belongs to which group but are blinded to block size. Testers are blinded to what group the patients belong to and what ECT parameters are used. Patients and attending psychiatrists are also blinded as to which group the patient belongs to.

The MECTA SIGMA device will be used for ECT.

Cross-over titration by stimulation will be used during the application of ECT to find the seizure threshold (ST) as follows:

RED GROUP

1. Session - Titration with 0.15ms
2. Session - Titration with 0.3 ms
3. Session and further - continue with 0.3 ms pulse width and 6x ST found during the second session.

BLUE GROUP

1. Session - Titration with 0.30ms
2. Session - Titration with 0.15ms
3. Session and further - continue with 0.15ms pulse width and 6x ST found during the second session.

Delivered energy is measured in percentage (%) of the maximum charge (in millicoulombs, mC) that the European version of the MECTA SIGMA device is able to administer. Total amount of ECT applications is individual and based on the clinical state of the patient. ECT outcome will be predicted via seizure duration (SD). If the seizure duration is less than 15s, the ECT dosage will be increased during next session by 100%. Throughout the ECT course, patients will be closely monitored by the testers via psychometric scales.

Primary outcome of the study is measured via Time To Recovery (TTR) - which is measured after each ECT application. TTR is the time (in minutes) after which the patient is fully vigilant and aware of his surroundings after an ECT procedure. TTR will be compared both in-group and between groups. Other psychometric measures are specified in the outcome measures section.

Eligibility Criteria:
Inclusion Criteria:

* age equal to 18 or higher
* score equal or higher than 20 on the Montgomery-Asberg Depression Scale (MADRS),
* major depressive disorder or bipolar depression

Exclusion Criteria:

* other axis 1 disorder
* ECT in the last 3 months
* neurological disease
* psychosis
* pregnancy
* any somatic condition that contraindicates ECT
Evaluation of the Effect of the Training Program Based on the Precede-Proceed Model on Guality Life Style

This study was conducted to evaluate the effect of a Precede-Proceed Model-based (PPM-based) training program on treatment adherence, healthy lifestyle behaviors, and quality of life of hemodialysis patients.

The Precede proceed model includes structured training phases to bring positive behavior change. The model, which consists of training phases, provides the researcher with the opportunity to identify the problem and the deficiencies that cause the problem, evaluate the quality of life with these deficiencies and develop a health program for its solution. In order to apply the nine-phase model, the individual-patient's voluntary cooperation, determination and active participation in health practices are required.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* Hemodialysis treatment for at least 6 months,
* A total score of 1 or more from the Dialysis Diet and Fluid Restriction Non-Compliance Scale,
* A score between 1 and 7 on the scale of compliance with medical treatment,
* Place, time, person orientation,
* Does not have a psychiatric illness or a problem that prevents written or verbal communication,

Exclusion Criteria:

* Diagnosed with psychiatric illness Individuals with a diagnosis of malignancy wanting to leave research
* Those who do not attend all of the trainings / do not want to continue
* Individuals whose general condition is deteriorated
Effectiveness of Pit and Fissure Sealants in the Prevention of Dental Caries

This randomized clinical trial is aimed at testing the efficacy of pit and fissure sealants, in a current environmental context different from that of the seventies and eighties. It has a split mouth design. 4OO subjects are included and the duration of follow up is 2 years.

This randomized clinical trial is aimed at testing the efficacy of pit and fissure sealants, in a current environmental context different from that of the seventies and eighties. This study assesses the cost-effectiveness of sealants according to the individual caries risk. This study takes place in Nice, Marseille and Paris (France) and the patients are to be enrolled both in the dental hospitals and in the private practice. In the hospitals, the subjects are recruited directly by the headmasters of the pediatric dentistry or public health departments in the three dental schools. In private practice, the head of the department of pediatric dentistry and / or public health dentistry, of each dental school chooses 4 to 6 private practitioners who are used to place dental sealants in their daily practice. They recruit the subjects among their own patients. The type of study corresponds to randomized clinical trial (Split mouth design) in which the tooth is the statistical unit (one pair of molars considered for each included patient). This study has a direct benefit for individuals. The number of necessary subjects is 328; the sample size is 400. The follow-up duration is 2 years. The treatment is a pit and fissure sealant on one randomized tooth by pair of permanent molars (Split mouth design). Sealant material is set up in accordance with the usual practice of each practitioner. Occlusal exams are conducted every 6 months. The effectiveness of dental sealants and the retention of sealing materials are statistically analyzed according to both the individual caries risk and the clinical protocol

Eligibility Criteria:
Inclusion Criteria:

* child over 6 years old
* patient with at least one carie
* patient with at least one pair of permanent molar: healthy or with equivalent injuries

Exclusion Criteria:

* not cooperating in care
* not speaking french or english
Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites

A small, pilot proof-of-concept placebo-controlled trial to explore the effects of albumin on diuresis in patients with cirrhosis, ascites and lower extremity edema. We will additionally investigate albumin's effect on preventing neurohumoral activation, and acute kidney injury after diuresis.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient patients with decompensated cirrhosis with past or current ascites and persistent lower extremity edema despite oral diuretic titration
* Serum albumin of \< 3.5 g/dL
* Age \>=18 years old

Exclusion Criteria:

* Patients with GFR \< 30mL/min/1.73 m2
* Changes in oral diuretic regimen in the past 7 days (\*\*patients can enter the study after 7 days of the change)
* Large Volume paracentesis (LVP) in the past 7 days (\*\*patients can enter the study after 7 days)
* Albumin infusion within the previous 14 days (\*\* patients can enter the study after 14 days)
* Spontaneous Bacterial Peritonitis in the past month
* Active variceal bleeding
* Current Hepatic encephalopathy (\>= Grade 2 based on West Haven criteria)
* Co-administration of other diuretics such as Hydrochlorothiazide (amiloride or eplerenone in place of spironolactone, and Bumex/Torsemide in place of furosemide are acceptable)
* Hypotension (Mean Arterial Pressure \<65 mmHg, Systolic Blood pressure \<90 mmHg)
* Severe hyponatremia (Sodium \<125 mEq/L)
* previous diagnosis of overt heart failure (systolic EF \< 50%)
* Baseline oxygen requirement
* Hypersensitivity to albumin preparations
Post-Transplant Cyclophosphamide in Patients Aged >/= 65 Years Undergoing Haploidentical Transplant

The purpose of this phase 1 study is to determine the optimal dose of the immune suppressive drug, cyclophosphamide, following standard allogeneic stem cell transplant in patients aged \>/= 65 years with hematologic malignancies.

The patients will receive a standard dose, or a reduced amount of the immune suppressive drug, cyclophosphamide, that is routinely administered after the transplant procedure. The following procedures will be performed: cardiac MRI scans and/or transthoracic echocardiogram (TTE); laboratory tests, geriatric assessments and tests to measure strength and stability.

Participation in the study is expected to last up to one year with follow-up visits occurring on Day +30, Day +100, Day +180 and Day +365 following allogenic stem cell transplant.

Eligibility Criteria:
Inclusion Criteria:

* Patient age \>/= 65 years
* Patient and related Donor (if applicable) sign the Informed Consent Form for the study. If donor is unrelated, donor does not sign Informed Consent Form and this will not affect recipient study eligibility.
* Patient meets standard criteria for allogeneic stem cell transplant
* Patient is deemed suitable to receive Flu/TBI 800 conditioning regimen as standard of care transplant
* Donor is willing to donate peripheral blood stem cells

Exclusion Criteria:

* Patient has a diagnosis of myelofibrosis
* Patient has high titer antibodies (\>10,000 mean fluorescent intensity) against one or more donor HLA antigens
* Patient has undergone prior autologous or allogeneic stem cell transplant
* Inability to collect at least 3 x 10\^6 CD34+ PBSCs/kg recipient weight from the donor
* Requiring sedation for cardiac MRIs.
* Prohibited Implants and/or Devices:

  * Mechanical, magnetic or electrical activated implants (i.e. cardiac pacemakers, neurostimulators and infusion pumps)
  * Ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial, aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged.
* Subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine.
Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

This is a Phase 1/2a, open-label, single-dose, PK study of VALTOCO with open-label safety period in pediatric epilepsy subjects age 2 to 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a clinical diagnosis of epilepsy and, in the opinion of the Investigator, may need benzodiazepine intervention for seizure control.
* Subjects having either partial or generalized epilepsy with motor seizures or seizures with clear alteration of awareness, for which rescue medications have been used at least once in the last 3 months or in the opinion of the investigator, may need a benzodiazepine intervention for seizure control 1-2 times every 3 months on average.

Exclusion Criteria:

* Subjects whose body weight are \< 6 kg or \> 33 kg.
* Subject is undergoing intracranial electroencephalogram (EEG) monitoring.
* In the opinion of the investigator, a history of clinically significant medical history that would jeopardize the safety of the subject or impact the validity of the study results (such as significant gastrointestinal, renal, nasal polyps or any nasal passage abnormality that could interfere with nasal spray administration.
* Subject has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening.
* Participation in a clinical trial within 30 days prior to the first dose of study drug.
* Inadequate or difficult venous access that may jeopardize the quality or timing of the PK samples.
Fluconazol Versus Medical Honey in the Treatment of Recurrent Vulvovaginal Candidiasis

The purpose of this study is to compare the efficacy of Flucanzol versus L-mesitran in the treatment of patients with recurrent vulvovaginal candidiasis. The investigator will look at vaginal swabs after 1, 6 and 12 months. The investigator included 252 patients.


Eligibility Criteria:
Inclusion Criteria:

* • Women of at least 18 years old

  * Recurrent vulvovaginal candidiasis (At least 3 episodes of clinical symptoms during the last year)
  * Clinical and microbiological diagnosis of (recurrent) vulvovaginal candidiasis at time of consultation
  * Capacity to understand, consent, and comply with the trial procedures

Exclusion Criteria:

* Mixed vaginal infections

  * Pregnancy or the intention to become pregnant during the study period
  * Women using systemic or topical antifungal medication during the last 2 weeks prior to inclusion
  * Known allergies for Fluconazole or honey
  * Candida with resistance for Fluconazole
Inflammation and Organ Impact During Hepatic Surgery

Monitoring of inflammatory substances (such as interleukins, CRP, albumine), and markers of organ dysfunction (such as creatinine, proenkephaline, amylase, troponine, IFABP and lactate) during elective liver resection. The study also includes monitoring of hemodynamic parameters, blood loss and postoperative complications. Results are to be used för power calculation for future trials.

During hepatic surgery, blood and urine samples will be obtained at 3 times during surgery, at 3 h after resection of liver, at 24 h after resection of liver and at post operative day 2, and subsequntly analyzed for the above mentioned substances. Routine labs will be monitored until patient is discharged from hospital. During surgery, hemodynamic parameters will be monitored by Picco calculations. Urine output and blood loss will be registred.

Eligibility Criteria:
Inclusion Criteria:

ASA I-III Patient has given informed consent to participate in study.

Exclusion Criteria:

preoperative kidney failure (E-GFR \>30), current infection treatment with corticosteroids coagulopathy surgical or anatomical conditions that makes patient unsuitable for participation (for example reoperation, need of vascular bypass, single tumor)
The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI

The primary objective is to evaluate if patent foramen ovale (PFO) closure and antiplatelet medical management can reduce the risk of recurrent stroke or transient ischemic attack (TIA) when compared to antiplatelet medical management alone in elderly patients above 50 years of age with a PFO and a history of cryptogenic stroke or TIA.

Prior to birth the fetal heart has a connection between the two atrias of the heart. After labour this connection often closes. About 10-15 % these connections remains open. This phenomenon is called patent foramen ovale or PFO, and is in most cases unsymptomatic.

The prevalence of PFO in patients with crytogenic (without known causes) stroke is much higher (about 40%)than the general population (about 10%). This has led to the theory that the presence of PFO can lead to stroke, by the passage of emboli from the peripheral venous circulation through the PFO to the brain by right-to-left shunting of the blood.

There are no existing data from prospective randomized studies focusing on the effect of device closure PFO in patients with cryptogenic stroke. Some observational retrospective studies have shown a beneficial effect in the reduction of recurrent stoke in patients younger that 50 years with cryptogenic stroke when PFO has been closed with a percutaneous device closure(PCD). Some studies have reported an 0% to 3.4% annual recurrence rate of stroke or TIA in patients treated with PDC. The recurrence rate of stroke or TIA in patients with crytogenic stroke or TIA in ordinary antithrombotic treatment is about 5-15 %.

The primary objective of this study is to assess whether percutaneous device closure of patent foramen ovale is superior to conventional antithrombotic treatment in preventing stroke recurrence in elderly patients above 50 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Stroke or TIA within 30 days
* Above 50 years of age

Exclusion Criteria:

* Deceases og the esophagus
* Dementia
* Allergy to aspirin
* Risk of non-compliance
* Lacking ability to give written or oral consent
* Atrial Fibrillation
* Neurological deficit lasting less than 6 hours
Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures

The study objective is to determine if intranasal dexmedetomidine is a safe and effective sedative drug during small painful procedures in the pediatric emergency room. Patients of the pediatric emergency room at Oulu university hospital with any medical condition requiring a small painful procedure like i.v. cannulation or lumbar puncture are asked to join the investigator's study if they would seem to benefit from a sedative drug during the procedure. Patients are randomly assigned to treatment group receiving intranasal dexmedetomidine 1µg/kg and to placebo group receiving 4,5% saline solution. The primary outcome is the success of the procedure. Cardiovascular and respiratory effects, the pain experienced by the patient, sedation scores and duration of crying are also monitored.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged 1-12 years at the Oulu University Hospital emergency room who would benefit from sedative medication during small painful procedures like i.v. cannulation or lumbar puncture are asked to take part in our study

Exclusion Criteria:

* Allergy to dexmedetomidine or any supplementary elements of the Dexdor®-solution
* II or III degree AV-blockage without pacemaker
* Uncontrollable hypotension
* Stroke
* Critically ill patients who are admitted to the PICU
* Patients with clear cardiac or respiratory dysfunction
* Lowered level of consciousness
* Patients with increased risk of apnoeic events due to neurologic or metabolic conditions or extreme obesity
* A single patient can only take part in this study once.