cyrilzakka/clinical-trials huggingface dataset:
DIALYSIS-TIR Study

This study will look at control of blood sugar levels in persons with type 2 diabetes mellitus currently on chronic dialysis. Researchers will compare blood sugar levels in people taking semaglutide to people taking "dummy" medicine. The treatment participants get will be decided randomly.

Participants will need to inject the study medication once a week. The study will last for 1 year and a month. Participants will be asked to wear a sensor that measures blood sugar levels for a period of 10 days at five different time points during the study.

The researchers also have a Data Safety Monitoring Plan in place.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide informed consent before any trial-related activities. Trial-related activities are any procedures that are carried out as a part of trial, including activities to determine suitability for the trial.
2. Male or female Adults (age \> 18 years at the time of signing the consent)
3. Type 2 diabetes mellitus diagnosed \> 6 months prior to screening
4. On current chronic treatment with Hemodialysis or Peritoneal dialysis for \> 6 months prior to screening
5. Current treatment with any glucose lowering pharmacotherapy, at a stable dose for at least 30 days. DPP-4 Inhibitors will be allowed at study entry and will be stopped at randomization.
6. Minimum of 80% valid data on the 10-day Continuous Glucose Monitor download
7. Time in Range 15 to 60%

Exclusion Criteria:

1. BMI \< 23 kg/m2 at screening
2. Current (within the past 90 days of screening) use of any GLP-1 RA
3. Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia type 2
4. Known or suspected hypersensitivity to GLP-1 RA (trial medication(s), excipients, or related products)
5. Pregnant, breast-feeding or the intention of becoming pregnant, or not using effective contraceptive measures
6. Active weight loss, defined as weight loss of \>5% of body weight in the past 3 months
7. Current participation in other interventional trials or last dose of any investigational product within 4 half- lives at the time of randomization
8. Any medical condition which in the judgement of the investigator precludes safe participation in the trial (includes, but not limited to active neoplasm, severe heart failure, recent cardiovascular event, severe frailty, planned cardiac or vascular surgeries on the day of screening etc)
9. If weight loss is not desired by the participant, or if the provider or investigator considers intentional weight loss to be detrimental to the health of the participant
10. Other or secondary forms of diabetes (like type 1 diabetes, pancreatogenic diabetes mellitus, MODY, LADA, drug induced, etc.)
11. Current diagnosis of gastroparesis or enteropathywhich in the opinion of investigator precludes safe treatment with GLP-1 RA.
12. Hypoglycaemia unawareness, or history of frequent or severe hypoglycaemia (in the opinion of the investigator)
13. Personal history of chronic pancreatitis, or acute pancreatitis within 180 days of screening
14. Known current uncontrolled or unstable retinopathy (by medical history)
Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation

Investigation of photopheresis as new therapy regimen in patients with bronchiolitis obliterans syndrome after lung transplantation in a controlled, randomized study

Bronchiolitis obliterans syndrome is the major cause of mortality after lung transplantation. 5 years after lung transplantation about 50% of all patients have this syndrome. There are nearly none therapy options. Besides effective therapy of any gastrooesophageal reflux and an oral medication with azithromycin none further regimens are known. Photopheresis could show in several studies a benefit for patients with gvhd after bone marrow transplantation or for chronic rejection after any other solid organ transplantation. Just little case reports could show beneficial effect in patients with bos after lung transplantation.

This is the first controlled, randomized study with patients with bos after lung transplantation to investigate the effectiveness of this therapy in that patients.

Eligibility Criteria:
Inclusion Criteria:

* Single/Double lung transplantation
* at least 6 months after lung transplantation
* bronchiolitis obliterans syndrome, Stadium \> 1 (nach ISHLT 2001, FEV1 \<80% Best), none other reason for worsening lung function (eg acute rejection, infection, extrapulmonary reasons, airway obstruction)
* none gastroesophageal reflux
* medication for \> 3 months with Azithromycin with further decrease of FEV1, MEF 25-75
* bioptic prove that there is no acute rejection
* no improvement under steroid pulse therapy

Exclusion Criteria:

* tumor or hematologic disease
* acute rejection
* respiratory insufficiency (O2\>2l/min, pCO2 \>50 mm Hg)
* weight \< 40 kg
* acute infection
* colonization with multiresistant pathogens
Effects of Osteopathic Manual Therapy on Infant Colic

Infant colic (CL) is a common disorder that affects approximately 8-33% of newborns during the first months of life. Typically defined as "crying that lasts at least 3 hours a day, and occurs at least 3 days a week over a 3-week period." Osteopathic manual therapy is presented as an effective and safe alternative to CL treatment.

The main objective of the study is to quantify possible changes in daily crying hours and hours of sleep, the severity of CL, the frequency of episodes, changes in stool and possible adverse effects.

The study hypothesis argues that the application of osteopathic manual therapy in babies with CL produces an improvement in the hours of daily crying, the frequency of episodes, the severity of colic and the hours of sleep. A controlled RCT will be performed where the evaluator and the parents will be blinded with respect to the allocation group for each subject. Subjects who meet the inclusion and exclusion criteria will be randomly assigned to the experimental group (EG) and control group (CG) using a table of random numbers by a person from outside the research. The EG diagnosis treatment using techniques of osteopathic manual therapy, vertebral mobilization, cranial techniques and visceral mobilization, according to the diagnostic criteria of the therapist. The CG has no treatment.

A total of 3 procedures were performed, one per week, problems with the chronology in all groups (days 0, 7 and 14 if required).

The therapist in charge of performing the operations will be a Physiotherapist and Osteopath with more than 10 years of experience.

The evaluations will be carried out by a healthcare professional with more than 10 years of experience. The evaluator will be blinded. Parents blinded with respect to the allocation group of each subject until the end of the study.

To analyze the main variable of the study (total hours of excessive crying per day), use the crying diary completed by the parents. The Infantile Colic Severity Questionnaire (ICSQ) will be applied to evaluate the secondary variables (sleep, feces, frequency of episodes and severity of colic).


Eligibility Criteria:
Inclusion Criteria:

* Inconsolable crying for more than 3 hours a day, at least 3 days a week for at least 3 weeks.
* Age 2 - 12 weeks.
* Gestation equal to or greater than 38 weeks.
* Birth weight equal to or greater than 2,500 grams.
* Weight gain of at least 150 grams. per week.
* Appropriate pediatric general physical examination (height, weight, head circumference and psychomotor development).
* Sign the informed consent.

Exclusion Criteria:

* Signs and / or symptoms of other pathologies.
* Signs of lactose intolerance.
* Having had benefits with the withdrawal of milk from maternal feeding or the use of milk with hydrolyzed casein.
* Having received the subjects and / or siblings, previous treatment with Osteopathy and / or Chiropractic.
* Contraindication to the treatment and / or some of its techniques; presence of congenital malformations.
A Study of LY3374849 in Healthy Participants

The aim of this trial is to evaluate the safety and tolerability of the study drug known as LY3374849, when given as an injection to healthy participants.

The study will also investigate how quickly the body absorbs and gets rid of LY3374849 and how it affects the levels of blood sugar in comparison to insulin degludec, after a single dose is given by injection under the skin and directly into a vein.

Participation in this study includes screening, which is required within 28 days before start of study and a follow up at least 28 days after receiving the last dose of study drug.

This study has 3 parts:

* Participants in Part A will complete 1 study period (approximately 1 week).
* Participants in Part B will complete 3 study periods (approximately 3 weeks).
* Participants in Part C will complete 2 study periods (approximately 2 weeks).

Parts B and C added per protocol amendment, approved in April 2019.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or a female who cannot become pregnant
* Have a body mass index (BMI) of at least 18 kilogram per square meter (kg/m²)
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
* Have veins suitable for easy blood collection and glucose solution infusion

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Had donated or had blood loss of more than 450 milliliters (mL) within the last 3 months
* Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female)
* Smoke more than 10 cigarettes per day
* Are infected with hepatitis B or human immunodeficiency virus (HIV)
* Have a history of allergies or reactions to more than one drug, or significant severe drug allergy
* Are taking illegal drugs
A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model

An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1).

Exclusion Criteria:

-
Biomarkers for the Diagnosis of Transient Ischemic Attack

A transient ischemic attack (TIA) should be considered an emergency prevention opportunity in order to avoid recurrence as cerebral infarction (CI) serious (fatal or disabling). Indeed, about 20% of patients who have IC had in previous days or weeks, a TIA, which can be defined as a brief episode of cerebral dysfunction (or eye) do not result in permanent brain damage and thus no sequelae. Moreover, about 20% of ischemic events observed in practice are AIT. Despite the progress achieved in the treatment in the acute phase of an IC, prevention remains the most effective way to fight against this disease. This prevention can be put in place before the occurrence of a first IC, or after a first IC, especially when minor as a TIA.

However, the diagnosis of TIA remains particularly difficult and it is necessary now to identify new tools for the diagnosis of transient ischemic attack. Our study focused on the identification of one or more molecules (called biological markers or biomarkers) present in the bloodstream of patients, which will serve to facilitate the differential diagnosis of patients with TIA.


Eligibility Criteria:
Inclusion Criteria:

* TIA lasting 18h
* NIHSS \< 0
* MRI diffusion hypersignal less than 5 ml
* follow up during 3 month
* written informed consent prior to any study procedures

Exclusion Criteria:

* Pregnant or breastfeeding women
* major comorbidity (cancer, chronic infection)
* recent trauma (less than 30 days) (cranial or extracranial)
* Surgical or endovascular recent surgery(within 30 days).
* Any old brain injury
* Any acute pathology likely to induce inflammation, hemostasis disorders ...
* Contraindications to MRI: Patients with a pacemaker, an implanted material activated by an electrical, magnetic or mechanical carriers hemostatic clips intracerebral aneurysms or carotid arteries, bearing orthopedic implants, claustrophobic ...
* Patient under guardianship
Clinical Drug Trial in Healthy Male Subjects to Determine and Compare the Blood Concentrations of BI 144807 Following Administration as Oral Solution and Tablet Under Fasted and Fed Conditions

The purpose of this trial is to investigate the relative bioavailability of a BI 144807 tablet formulation compared to the oral solution formulation after single dose administration (intermediate and high dose) under fasted conditions. Further objectives are to assess whether and to what extent food affects single dose pharmacokinetics of BI 144807 administered as tablet, and to compare the relative bioavailability of two different tablet formulations.


Eligibility Criteria:
Inclusion criteria:

- Healthy male subjects

Exclusion criteria:

- Any relevant deviation from healthy condition
Analysis and Reducing Modalities for Artefacts Generated by Bone Conduction Implants and Cochlear Implants Subjected to an MRI Magnetic Field

Investigator team hypothesize that artifacts generated by the presence of an acoustic implant subjected to the magnetic field of the MRI are variable depending on the type of sequence and can be reduced by structural modifications of the implant and by variations in its appearance positioning with respect to the magnetic field MRI.

Little scientific data is available on the artifacts generated by hearing implants. Indeed, hearing rehabilitation for deaf people was given priority over the potential constraints of imaging. Investigator team find less than 10 articles with a search of following keywords on the pubmed database: Artifacts AND MRI AND cochlear implants. Only one of these articles deals with demagnetization. There is only one article dealing with artifacts with the Bonebridge implant. There are no studies with the Attract implant and a recent one with the new Synchrony mobile magnet implant, but by removing the magnet which implies a minimum response time and therefore not compatible with emergency care.

In total, the literature is quite poor mainly considering the priority of auditory rehabilitation on the realization of subsequent imaging.

However, the current "democratization" of hearing implants and their increasing use in children and adults requires reflection on not only the safety of examinations of healthy volunteers, but also of the implant itself. also on the relevance of the interpretation of imaging especially cerebral.

The pilot study done, suggested that the placement of the implant (in this case the Bonebridge) has an influence on the size of the artifact and the possibilities of interpretation.

It seems appropriate to continue this protocol of analysis, both on the implants in bone conduction, and also on the cochlear implants to demonstrate the impact of the implant on the MRI images and also the impact of the magnetic field on the implant itself, and possibly publish recommendations for clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more
* free of otological, neurological or psychiatric pathology
* absence of contraindication to MRI \*
* free and informed consent signed

Exclusion Criteria:

* minor subject, major guardianship or trusteeship and major protected under the law (pregnant women, nursing, parturiante, persons deprived of their liberty)
* suject carrier of an implantable device or para magnetic
* contraindication to MRI \*
* revious otological pathology, tinnitus, deafness
* revious cerebral pathology
* unable to understand the objectives, issues and risks of the study and to give free and informed consent.

  * Contraindications to MRI are:

Claustrophobia Anxiety attack Morphotype does not allow access to MRI

Wearing a metal implant, for example:

* a pacemaker
* ferromagnetic surgical clips
* foreign bodies
Relative Bioavailability of of Olodaterol and Ketoconazole

This clinical trial is intended to investigate a possible effect of the p-gp inhibitor ketoconazole on the bioavailability of olodaterol


Eligibility Criteria:
Inclusion criteria Healthy male and female volunteers

Exclusion criteria
A Prospective Evaluation of Infraorbital Filler Injection

The goal of this clinical trial is to measure the facial volumetric changes over time in patients injected with hyaluronic acid dermal filler (Juvéderm Volbella XC) in the infraorbital (under eye) region. Participants will be injected with Juvéderm Volbella XC filler and asked to return for 3D photography at 2 weeks, 1 month, and 3 months post-injection.

Undereye or infraorbital hollowing is a result of a loss of volume causing shadowing and darkness of the infraorbital region often interpreted as a tired, stressed, and aged appearance.

The goal of this clinical trial is to measure the facial volumetric changes over time in patients injected with hyaluronic acid dermal filler (Juvéderm Volbella XC) in the infraorbital (under eye) region. Participants will be injected with Juvéderm Volbella XC filler and asked to return for 3D photography and to complete a validated patient satisfaction questionnaire at 2 weeks, 1 month, and 3 months post-injection. 3D photogrammetry technology allows for high level feature enhancement and microscopic anatomical evaluation that was not previously possible and can be used to make volumetric measurements at injection sites to evaluating minimally invasive injection efficacy.

Eligibility Criteria:
Inclusion Criteria:

* female
* age 22 to 65
* interested in filler injections to reduce undereye volume loss

Exclusion Criteria:

* male
* age \<22 or \>65
* prior undereye filler
* filler/neurotoxin injection within the past 12 months
* prior facial cosmetic surgery
* prior facial trauma
* planned dental work within next 2 weeks
* travel 1 week prior or 2 weeks after injection
Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa

The study aimed to assess the long-term safety of topical use of Zorblisa (SD-101-6.0) in participants with Epidermolysis Bullosa (EB).

This was an open label, multi-center extension study to assess the long-term safety of topically applied SD-101-6.0 in participants with simplex, recessive dystrophic, and junctional non-Herlitz EB. SD-101-6.0 was applied topically once a day to the entire body. The planned duration of treatment with SD-101-6.0 for Study SD-006 was up to 48 months, with a safety follow-up period of 30 days; however, the study was terminated early by the sponsor. The maximum study duration completed by at least 1 participant, treatment and safety follow-up, was 37 months.

Participants who successfully completed Study SD-005 had the option to rollover into Study SD-006. The screening/baseline visit (Visit 1) occurred at Visit 5 (approximately 90 days from baseline) of Study SD-005. The Body Surface Area (BSA) assessments of lesional skin and wound burden performed at Visit 5 (approximately 90 days from baseline) for Study SD-005 were utilized as the baseline assessments for Study SD-006. Participants returned for follow-up visits at Month 1 then every 3 months.

At each visit, assessments included BSA of lesional skin and wound burden. For target wounds that are not closed by the end of Study SD-005, the ARANZ picture and calculation of target wound area at the final visit for Study SD-005 was used as the baseline area size of the target wound for Study SD-006. These unhealed target wounds from Study SD-005 were assessed via ARANZ SilhouetteStar™ at each subsequent scheduled visit until the target wound was documented as closed. Closed wounds were assessed for scarring.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent Form signed by the participant or participant's legal representative; if the participant was under the age of 18 but capable of providing assent, signed assent from the participant.
* Participant (or caretaker) must have been willing to comply with all protocol requirements.
* Participants who completed the SD-005 study (on study drug at Visit 5, approximately 90 days from baseline).

Exclusion Criteria:

* Participants who did not meet the entry criteria outlined above.
* Pregnancy or breastfeeding during the study. (A urine pregnancy test was performed at the final visit for Study SD-005 for female participants of childbearing potential and repeated at screening/baseline visit of Study SD-006 if these visits did not occur on the same day).
* Female participants of childbearing potential who were not abstinent or not practicing a medically acceptable method of contraception.
A PET Study to Determine Alterations in Serotonin Levels in Human Brain After a Single Dose of Escitalopram

Healthy males were examined with positron emission tomography (PET) and the radioligand 11C-AZ10419369, before and after administration of a single dose escitalopram. A change in the binding potential of 11C-AZ10419369 between the baseline and the post-dose condition was hypothesized to reflect a change in serotonin concentration.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Male gender
3. Age 20 to 30 years
4. Healthy according to physical examination, ECG, MRI and blood chemistry

Exclusion Criteria:

1. Past or present psychiatric disease
2. Past or present brain disorder or injury, including loss of consciousness for more than five minutes
3. Past or present drug or alcohol abuse
4. Past or present use of antidepressant or antipsychotic medications
5. Regular use of medications (including herbals), that could interfere with the pharmacodynamics or pharmacokinetics of escitalopram
6. Significant abnormality on ECG
7. Structural abnormality in the brain confirmed by MR examination
8. Claustrophobia
9. Any metal devises or implants in the body
10. Intolerance to escitalopram or any of the components of the formula
11. Predisposition to motion sickness
12. Inability to understand and comply with the study requirements
13. Any medical condition that, in the opinion of the investigator, make the subject unsuitable for the study or put the subject at additional risk