cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics

The purpose of this study is to evaluate if type 2 diabetics who have inadequate glycemic control on metformin alone, have a similar, or not inferior, glycemic response when treated with the combination of muraglitazar and metformin compared to pioglitazone and metformin.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetics
* HbA1c ≥7.0% and ≤10.0%,currently receiving a stable dose of metformin 1500 to 2550 mg/day for at least 6 weeks prior to screening were enrolled in this study.
* Fasting C-peptide ≥1.0 ng/mL
* BMI≤41 kg/m2 mean fasting serum trig. ≤600 g/dL

Exclusion Criteria:

* symptomatic type 2 diabetics with \> 10% weight loss 3 months prior to study
* history of diabetic ketoacidosis, hyperosmolar nonketotic coma, insulin therapy, inability to take muraglitazar, pioglitazone, or metformin according to investigator brochure or labeling
* History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history of, or renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.
Surgical Treatment of Stage T3 Squamous Cell Carcinomas of the Scalp

This study examines tumor- en surgical characteristics of stage T3 cutaneous squamous cell carcinomas on the scalp, diagnosed between 2010 and 2018. Histological data and patient- and tumor characteristics were collected.

Cutaneous squamous cell carcinoma is the second most common type of non-melanoma skin cancer, following basal cell carcinoma. Following the American Joint Committee on Cancer Tumour, Node and Metastasis (TNM) Classification of Malignant Tumors staging system (TNM8), T3 cutaneous squamous cell carcinomas comprise an interesting group, especially on the scalp, because of the thin subcutaneous fat layer. According to the TNM8 criteria, T3 include all cutaneous squamous cel carcinomas with greatest tumor dimension ≥4cm, tumors with minimal bone erosion or perineural growth (defined as involvement of the nerve sheath of a nerve lying deeper than the dermis or measuring 0.1mm or larger in caliber or showing clinical or radiographic involvement of nerves without invasion of the skull base) or with deep invasion. Deep invasion is defined as invasion deeper than the subcutaneous fat or a tumor thickness \>6mm. The scalp has a natural anatomical and oncological barrier for extension in depth known as the epicranial aponeurosis, also called the galea aponeurotica.

This retrospective study, examines the tumor- en surgical characteristics of these stage T3 cutaneous squamous cell carcinomas on the scalp.

Eligibility Criteria:
Inclusion Criteria:

* stage T3 cutaneous squamous cell carcinoma of the scalp (histologically proven)
* surgical treatment or radiotherapy treatment

Exclusion Criteria:

* metastasis by diagnosis
* stage T1/T2/T4
Long Term Safety of Vildagliptin (100mg qd) In Patients With Type 2 Diabetes

This 52-week multicenter open-labeled extension study is designed to assess the long-term safety of vildagliptin (100 mg qd) in patients with Type 2 Diabetes. This extension study is open to patients who have completed core study CLAF237A1303.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis as Type 2 Diabetes
* Patients who have completed study CLAF237A1303
* Outpatients

Exclusion Criteria:

* Patients who prematurely discontinued Study CLAF237A1303
* Other protocol-defined inclusion/exclusioncriterial may apply
A Study To Evaluate The Effect Of Rifampin On Pharmacokinetics Of PF-06463922 In Healthy Volunteers

The purpose of this study is to estimate the effect of rifampin on the single dose PK of PF-06463922.

This will be a Phase 1, open-label, 2-period, 2-treatment, fixed-sequence, cross-over study in approximately 12 healthy subjects employing administration of a single oral dose of PF-06463922 in the fasted state alone, and with multiple dosing of rifampin 600 mg once a day to estimate the effect of multiple dose rifampin on the single dose PK of PF-06463922.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects of non-childbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Any condition possibly affecting drug absorption
* Positive urine drug screen
* History of HIV, Hep B or Hep C
* History of regular alcohol consumption
* History of cardiac arrhythmia, history of AV block, history of symptomatic bradycardia, history of QTc prolongation
* History of pancreatitis or hyperlipidemia, elevated lipase
Trifecta™ Durability Study

The Trifecta™ Durability Study was a multi-center, prospective, single-arm, post-market study conducted in Europe and Canada to collect long-term safety and performance data on the Trifecta™ valve. The Trifecta™ valve is a stented surgical aortic bioprosthesis with bovine pericardial leaflets designed for supra annular placement.


Eligibility Criteria:
Inclusion Criteria:

* Patients implanted for less than 9 months with a Trifecta™ valve, or patients who are candidates for implant with a Trifecta™ valve, as per current guidelines
* Patient requires aortic valve replacement.
* Patient is legal age in host country.
* Patients must be able and willing to provide written informed consent to participate in this investigation
* Patients must be willing and able to comply with all follow-up requirements

Exclusion Criteria:

* Patients with contraindication for cardiac surgery
* Patients who are pregnant.
* Patient is unwilling to or has an inability that reduces his mobility in order to attend the required follow-up visits.
* Patient has active endocarditis
* Patient has had an acute preoperative neurological event defined as patient has not returned to baseline 30 days prior to the planned valve implantation surgery.
* Patient is undergoing renal dialysis.
* Patient has a documented history of substance abuse within one year of enrollment or is currently a prison inmate.
* Patient has a documented thrombus in left atrium or left ventricle.
* Patient had in the past mitral or tricuspid valve replacement.
* Patient needs mitral and/or tricuspid valve replacement.
* Patient has an Ejection Fraction \< 25%
* Patient had the Trifecta™ valve implanted as part of this study, but then had the device explanted
* Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
* Patient has a life expectancy less than two years.
Prevent Maternal Mortality Using Mobile Technology

Black women who reside in a rural area are at highest risk for maternal morbidity and mortality due to a combination of social and structural causes. The postpartum period is the most critical yet most neglected phase for preventing suboptimal or fatal maternal health outcomes. The goal of this project is to use a mobile app to provide personalized support and improve the lives of women during the early postpartum period. The information the study team gathers will help educate women and all who support them about the need to seek postpartum care and the impact postpartum care can have on pregnancy-related complications. Participation in this research requires taking part in a focus group discussion which will allow participants to share or the person that supports the participant's story and experience with postpartum complications and willingness to use and desired features of a postpartum mobile app.

Black women in Georgia have the highest risk for adverse maternal outcomes, with a staggering 66.6 deaths per 100,000 live births, compared to 18.1 for Hispanic women and 43.2 for white women. In rural Georgia, these statistics are more profound, with Black women experiencing 126.7 deaths per 100,000 live births compared to 78.3 deaths for White women. These disparities have existed for centuries and have also widened significantly over the last several decades.

The proposed research aims to increase the effectiveness of postpartum discharge education and improve rural Black women's compliance with postpartum care recommendations by developing and testing a culturally-informed "mhealth intervention" entitled Prevent Maternal Mortality using Mobile technology (PM3).

Eligibility Criteria:
Inclusion Criteria:

* Participants self -identify as female
* Participants must self-identify as African American/Black
* Aged 18-45 years
* Can speak or read English
* Participants must be able to give consent.
* Own a smart phone
* Reside in or near Albany, LaGrange, or Waynesboro (within a 40 mile radius)
* Be in third trimester or recently had a baby (≤4 weeks postpartum)
* Can be contacted by phone or email after hospital discharge.

Exclusion Criteria:

* Women will be excluded if they have known unavailability to follow-up
* An active severe mental health condition, or developmental disability precluding informed consent
Neuro Strengths-Based Approach to Autism

The Neuro-Strength-Based Approach to Autism (NSBAA) attempts to translate what research has discovered about the autistic brain into terms that autistics, and those involved with autistics, can understand. It is not intended to be a new approach to intervention but hopefully a unifying approach to understanding autism that all therapists, educators, clinicians, and parents can use when working with autistic individuals. It was developed by an autistic occupational therapist, based on her lifetime obsession of learning everything she could about how typical brains work, and, following her diagnosis, how the autistic brain works. Being on the autism spectrum herself and having worked with, and interacted with, autistic individuals of all ages and abilities in school, clinical, and personal settings, the author attempts to explain the autistic brain from both the scientific as well as autistic perspectives.


Eligibility Criteria:
Inclusion Criteria:

* 5-20 SLPs / OTR/Ls, regardless of nationality
* working in a clinical, home or school setting with less than 25 years of experience
* at least 2 years of experience working with autistic clients

Exclusion Criteria:

* Minors
* adults unable to consent
* undocumented individuals
* prisoners,
* uncertified therapists
* therapists from Baio Enterprises.
Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis

AL amyloidosis is caused by a clonal plasma cell dyscrasia and characterized by progressive deposition of amyloid fibrils derived from monoclonal Ig light chains, leading to multisystem organ failure and death. The prognosis for AL amyloidosis with conventional treatment remains poor, Autologous stem cell transplantation (ASCT) for AL amyloidosis produces high hematologic and organ responses. However, treatment-related mortality remains high and reported series are subject to selection bias.

A prospective randomized trial was conducted to compare in AL amyloidosis ASCT (melphalan 140 or 200 mg/m2 depending on age and clinical status supported with ASCT collected with G-CSF alone) and the oral regimen M-Dex (melphalan 10 mg/m2 and dexamethasone 40 mg for 4 days each months up to 18 months). The objectives were to compare survival and hematologic and clinical responses.

Eligibility Criteria:
Inclusion Criteria:

* below 70 years of age
* biopsy proven systemic AL amyloidosis
* no more than 2 prior courses of chemotherapy
* ECOG performance status \< 3
* Informed written consent

Exclusion Criteria:

* localized amyloidosis
* HIV seropositivity
* previous myelodysplasia
* concomitant serious disease
Validation of an Integrated Digital Solution (SUNrise®) Versus Polysomnography for Obstructive Sleep Apnea Diagnosis

Validation of an integrated digital solution (SUNrise®) of mandibular movement automatic analysis by artificial intelligence versus polysomnography for obstructive sleep apnea diagnosis: a prospective, randomized, parallel-arm, open-label, multicenter, national, controlled study.

The new Sunrise integrated digital solution is a disposable 3 gram sensor that sits on the chin for sleep disorders diagnosis. This device records mandibular movements, head movements and position during sleep. Data acquisition is done through a mobile application installed on the user smartphone. Data is then transferred automatically at the end of the test (overnight) to a cloud platform where it is automatically analyzed. The Health Care Professional (HCP) and the patient have access to sleep parameters and report.

The objective of this trial is to determine the place of the Sunrise device in the care pathway in France for patients suspected of having OSA. The assumption is that Sunrise is both non-inferior to the normal practice (i.e., the PSG) on sleepiness at 3 months post-diagnosis, and superior to the PSG (outpatient or in-lab) in terms of time between inclusion and diagnosis appointment and treatment initiation. By speeding up the treatment initiation, the hypothesis is that Sunrise is also superior to the PSG on sleepiness as well as quality of life and work productivity at 3 months post-inclusion. Another assumption is that Sunrise is non-inferior to the PSG on CPAP compliance at 3 months following treatment initiation.

The SUNSAS study will be launched in 19 centers (public and private) in France and will include 848 patients aged 18 to 80 years. Eligible patients will be included and randomized in 2 arms, i.e., the Sunrise arm and the PSG arm. An appointment to discuss the diagnosis and treatment options (for patients suffering from OSA) will be arranged after the procedure (PSG or Sunrise) is performed. On site follow-up visits will be then organized at 3 months post-inclusion and at 3 months post-diagnosis, and a phone call will be scheduled at 3 months post-treatment.

Eligibility Criteria:
Inclusion criteria:

* Man or woman aged between 18 to 80 years old
* Patient referred for a suspicion of OSA
* Patient having a smartphone and internet connection at home and able to use a mobile application
* Patient affiliated to the social security system

Main exclusion criteria:

* Patient with a previous sleep test performed within 5 years of inclusion
* Patient previously treated for OSA within 5 years of inclusion
* Patient suffering from severe chronic obstructive or restrictive pulmonary disease with or without oxygen at the discretion of the investigator
* Patient refusing to shave his beard that could prevent him to wear the device on the chin
Amotosalen and Platelet Transfusion in Pediatric Heart Surgery

High level of security during blood transfusion has been achieved by donor selection and pathogen detection using serology or direct identification. Nevertheless, blood banking becomes hazardous during epidemic outbreaks or facing new pathogens. Amotosalen, a psoralen, targets nucleic acids and destroys them after ultraviolet exposure, resulting in inactivation of pathogens.

Treatment inoccuity and efficacy have been demonstrated but preservation of platelet functions after treatment is still debated. Previous studies focused on hematological patients. There is no evidence for an increased requirement of transfused platelets to achieve platelet count target. Studies in heart surgery are lacking.

The investigators perform a multicenter, retrospective, "before/after", controlled study in minor patients requiring heart surgery with cardiopulmonary bypass. One center (Strasbourg) uses Amotosalen-treated platelet concentrates since 2006 (control arm). This treatment becomes available in Bordeaux in October 2017 (intervention arm). There is two periods of inclusion: one "before" (January 2016 to June 2017) and one "after" (January 2018 to June 2019).


Eligibility Criteria:
Inclusion criteria:

* Minor patient (\<18 years old)
* Cardiac surgery act under cardiopulmonary bypass for correction of congenital heart disease
* Platelet transfusion for any reason
* Cardiac surgery performed at Bordeaux or Strasbourg University Hospital over two periods:

  * Period A: January 01, 2016 - June 30, 2017 (before treatment)
  * Period B: January 01, 2018 - June 30, 2019 (after treatment)
* Subject (and / or his parental authority) not having expressed, after information, his opposition to the reuse of his data for the purposes of this research

Exclusion criteria

* Subject (and / or his parental authority) having expressed, after information, his opposition to the reuse of his data for the purposes of this research
* Presence or installation of transient circulatory assistance (outside of the CEC) or definitive
* Heart or cardiopulmonary transplantation
Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)

This is a randomized, controlled, open-label, pragmatic, direct-to-participant trial designed for infants. The study will be conducted using a mobile application platform to engage parents with healthy infants and parents with infants with eczema in introducing complementary feeding in line with new feeding guidelines for diet diversity, gather parental experiences of feeding, support early introduction of different food proteins and support feeding of SpoonfulONE.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female 4-6 months of age at time of consent
2. Provision of signed and dated informed consent form parent/guardian(s)
3. Parent/guardian(s) stated willingness to introduce within 12 months and feed the participant 5 common foods, including peanuts, cashew, egg, sesame, and cod
4. In good general health as evidenced by medical history reported by the parent/guardian(s)
5. No known allergy to any of the ingredients in the study intervention (SO), their components, or excipients

Exclusion Criteria:

1. Known physician confirmed allergies to any of the ingredients in SO at the time of consent
2. Gastroesophageal reflux disease (GERD) diagnosed by a physician and requiring treatment (i.e., pharmacological and/or non-pharmacological treatments such as a wedge)
3. Participant or parent/guardian unsuitable for the study, at the discretion of the investigator
4. Sibling in the home is already enrolled in the study
The Effect of Using a Kaleidoscope During Central Venous Catheter Dressing Changes in Children With Cancer

Many medical interventions, including the dressing of central venous catheters, a common procedure used for children with cancer, cause anxiety and pain in children. This can adversely affect their care and recovery. This study aims to determine the effect of using a kaleidoscope during central venous catheter dressing on anxiety and pain in children with cancer.

This was a randomised controlled trial with 60 children aged 6-12 diagnosed with cancer who were placed either in a kaleidoscope group (n=30) or a control group (n=30). Each child's anxiety was evaluated by the child using the Child Fear Scale before, during and after a central venous catheter dressing procedure, and each child's pain during and after the procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale (WB-FACES). Each child's heart rate and oxygen saturation were measured with a pulse oximeter device before, during and after central venous catheter dressing.

The children in kaleidoscope group looked into the kaleidoscope and slowly turned it. This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished.

No intervention was performed to reduce pain and anxiety for children in the control group.

Parents accompanied their children during the procedure in both groups.

Eligibility Criteria:
Inclusion Criteria:

* a cancer diagnosis,
* having a central venous catheter,
* 6-12 years old,
* not having taken any analgesics in the 6 hours before the central venous catheter dressing, -being in a non-terminal phase of the disease,
* absence of neutropenia,
* volunteering to participate in the study,
* the absence of any health problems that prevent communication in the parent or the child.

Exclusion Criteria:

-the reporting of pain for another reason at the time of the central venous catheter dressing.
Screening of Pulmonary Veino Occlusive Disease in Heterozygous EIF2AK4 Mutation Carriers

Pulmonary Veino Occlusive Disease (PVOD) is a rare form of pulmonary arterial hypertension, characterised by a poor prognosis. Recent studies demonstrated that heritable form of pulmonary veino occlusive diseaseis due to bi-allelic mutations in EIF2AK4 gene. heritable pulmonary veino occlusive disease is an autosomal recessive disease. In the french referal center of severe PH, ulmonary veino occlusive disease patients carriers of bi-allelic mutations in EIF2AK4 gene were identified. Genetic counselling in these families allowed to identified herozygous carriers of a single mutation in EIF2AK4 gene. However, to date, nothing is known about the risk of these persons of developping pulmonary diseases. It appears essential to determine the clinical, functional, echocardiographic and radiologics characteristics of these persons, and their risk of developping Pulmonary veino occlusive disease

the investigators will evaluate the subjects at inclusion after informed by a clinical evaluation (dyspnea assessed by New York Heart Association functional class (I-IV), signs of right heart failure), a 6min walk test, a Computerized Tomography scan of the chest, an electrocardiogram, an echocardiography , an abdomina ulstrasound, a Cardiopulmonary exercise testing, a lung function tests , arterial blood gases.

At one and two years, a phone call will be made to to participants evaluate dyspnea and intercurrent events in all subjects. In the presence of pulmonary veino occlusive diseaseis symptoms, a new evaluation will be proposed in order to confirm of not pulmonary veino occlusive diseaseis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult (age ≥18 years of age at the date of inclusion),
* With an identification of the presence of a mutation of the EIF2AK4 gene in the heterozygous state,
* Having given free and informed consent.

Exclusion Criteria:

* Minor (age \<18 years),
* Patient with known Pulmonary veino occlusive disease or Pulmonary arterial hypertension
* Woman having started a pregnancy or breastfeeding
* protected adult persons,
* Persons deprived of their liberty,
* People in emergency,
* Those who refused or were unable to give informed consent,
* Contraindication to the exercise test (acute coronary syndrome, syncope, tight stenotic valve disease ...) See the list of relative and absolute contraindications to the exercise test (chapter 6.2).
* No affiliation to a social security scheme (beneficiary or beneficiary).