cyrilzakka/clinical-trials huggingface dataset:
Cerclage for Twins With Short Cervix

A prospective randomized control trial that will compare cervical cerclage plus vaginal progesterone to vaginal progesterone along in twin pregnancies complicate by a short cervix (\</= 15.0mm) between 16w0d to 25w6d.

A prospective Randomized Trial that will test whether treatment with cervical cerclage plus vaginal progesterone improves pregnancy outcomes among women with twin pregnancy at 16 0/7 to 25 6/7 weeks of gestation who have a cervical length (CL) of 0.1 to 15.0 mm on transvaginal ultrasound exam, the rate of preterm birth at less than 32 weeks of gestation (PTB\<32 wks.) and the rate of adverse perinatal outcome will be lower in those treated with cervical cerclage plus vaginal progesterone than in those treated with vaginal progesterone alone.

Eligibility Criteria:
Inclusion Criteria:

* Twin pregnancy (see Exclusion Criterion (a) below re: monochorionic twins)
* Gestational age 16 0/7 to 25 6/7 weeks at time of enrollment by best-estimated age.
* Cervical length 0.1 to 15.0 mm on transvaginal ultrasound examination. (Cervical length is taken to mean the length of the closed portion of the cervical canal.

Exclusion Criteria:

* Maternal age less than 18 years
* Monochorionic twins (such as monochorionic-diamniotic, monochorionic-monoamniotic, or conjoined twins)
* Rupture of membranes, either twin
* One or both twins has no cardiac activity
* One or both twins has known or suspected major malformation, aneuploidy, or polyhydramnios
* Maternal congenital uterine anomaly (such as bicornuate uterus, unicornuate uterus)
* Pregnancy started as triplets or higher-order multifetal gestation and then reduced to twins, either spontaneously or via procedure
* Symptomatic uterine contractions, 6 or more per hour
* Ongoing bleeding from uterus
* Patient declines to consider cerclage
* Patient declines treatment with vaginal progesterone
* Allergy to progesterone or peanuts (because the vaginal progesterone formulation used will be a capsule of micronized progesterone in peanut oil.)
* Cerclage is already in place
* Cerclage placement is judged to be technically impossible
* Patient has a history of poor follow-up or poor adherence to physician recommendations
* Patient is planning to relocate outside the local area before the end of pregnancy such that delivery records will be unavailable
* Patient does not give consent to participate in this trial.
Integrated Navigation Services for Treatment Adherence, Counseling, and Research

The goal of this research is to determine whether a Community Health Worker (CHW) intervention including a mobile telehealth (M-Health) component can help achieve long term viral suppression among Black people with poorly controlled HIV.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 years or older
* patient from adult HIV outpatient clinic at University of Miami/Jackson Memorial Health System
* self-identify as Black
* uncontrolled viral suppression as determined by treating clinician
* English speaking

Exclusion Criteria:

* Any other condition(s) that the treating clinician determines would limit participant from meaningful study participation.
Brain Death Diagnosis at an Academic Tertiary Medical Care Center

The aim of this study is to assess and survey the quality of the process required to diagnose brain death in adult patients. This study of adult patients diagnosed brain dead or suspected of having brain death on the ICUs at the University Hospital Basel will be purely observational.


Eligibility Criteria:
Inclusion Criteria:

* patients with suspected and/or diagnosed brain death
* adults 18 years and over
Rosacea Prevalence in General Population - Pilot Study

The purpose of this study is to test and refine, a subject questionnaire aimed to be used in a general population rosacea prevalence study.

The study will test the subject questionnaire aimed to be used in a full general population prevalence study to screen potential subjects with rosacea.

Questionnaire will be self-administrated to Dermatology outpatients.

Testing will be performed at the practice of 2 Dermatologists experts in rosacea who will evaluate subjects' answers and propose fine-tuning of the questionnaire content, if needed.

Eligibility Criteria:
* Male or Female aged between 18 (or locally accepted majority) and 65 years old both included.
* Subject visiting one of the study dermatology practices for daily care/routine dermatology consultation.
* Subject have to read and sign the approved Informed Consent form prior to any participation in the study,
* Subject willing and capable of cooperating to the extend and degree required by the protocol
Safety and Tolerability of Buprenorphine/Naloxone Film Strips

This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a stable regimen of buprenorphine/naloxone.

Buprenorphine and naloxone soluble film was developed as an alternative dosage form to Suboxone (buprenorphine and naloxone) sublingual tablets and was evaluated for both sublingual and buccal administration. The soluble film dosage is expected to provide the following enhancements and potential advantages over the current Suboxone (buprenorphine and naloxone) product:

* mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format.
* improvement in subject convenience and compliance by ensuring rapid disintegration.
* protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. This provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting.
* provision of a unit dose product format for hospital and institutional use.
* decreased product damage during shipping as compared to Suboxone tablets.

Eligibility Criteria:
Inclusion Criteria:

Subjects must:

* Be 18-to-65 years of age, inclusive.
* Have a diagnosis of opioid dependence by medical history according to DSM-IV-TR criteria.
* Be on stable dose of 4 to 32 mg (expressed as the buprenorphine component)daily of Suboxone for at least 30 days.
* If female, have a negative pregnancy test during screening and agree to use an acceptable method of birth control which may include:

Exclusion Criteria:

Subjects must not:

* Have participated in an experimental drug or device study within the last 30 days.
* If female, be breast feeding or lactating.
* Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study.
* Have a clinically significant abnormal finding (in the opinion of the Investigator) on oral cavity exam (e.g., active mouth ulcers).
* Have any piercing of the tongue or mouth within 30 days prior to the first dose of study medication.
Attention Deficit/Hyperactivity Disorder Internet Survey Study in a College Student Population

Attention Deficit/Hyperactivity Disorder (ADHD) is a common condition in young adults. There are many safe oral therapies that require daily use to be effective. Because frequent follow-up visits have been shown to increase adherence to medication, we will determine if adherence to oral therapy for ADHD will improve with an intervention involving weekly internet-based contact without an office visit.

The primary aim is to determine the effectiveness of an Internet-based survey in improving adherence to therapy for ADHD. Subjects in this study will be either receive a weekly Internet-based survey assessing the prescribed medication and their ADHD, or to receive standard-of-care therapy in which they will take their medication. The following hypothesis is to be tested: A weekly Internet survey will promote improved adherence to oral ADHD medications.

This is an investigator-blinded, prospective study of subjects diagnosed with ADHD.Forty-four subjects ages 18 years and older will be enrolled. An Internet-based survey will be piloted to evaluate its effect on adherence to oral ADHD medication. Subjects randomized in a 1:1 ratio to the Internet-survey group will log their impression of the state of their disease on a weekly basis. Subjects in both the intervention and control groups will receive standard-of-care medication, stimulants. Adherence to the medication will be assessed using Medication Event Monitoring System (MEMS®) caps, electronic monitors affixed to the medication containers. Investigators and subjects will be blinded to the adherence data until the final (Month 2) treatment visit.

Eligibility Criteria:
Inclusion Criteria:

* Any male or female 18 years or older of age with a diagnosis of mild to severe ADHD by a psychiatrist at Wake Forest University Student Health Clinic
* Use of the Wake Forest University Student Health Clinic Pharmacy to fill medication for ADHD
* Subject is a good candidate to receive a stimulant for the treatment of their ADHD
* Subject is capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed
* The subject is able to complete the study and comply with study instructions, including attending all study visits
* Will be filling a prescription for ADHD

Exclusion Criteria:

* Subject is less than 18 years of age
* Inability to complete all study-related visits or inability to complete the Internet survey due to inadequate Internet access
* Patients who are homicidal, suicidal, or psychotic
* Female patients whose medications may be harmful during pregnancy must be on an acceptable form of birth control, otherwise they will not be eligible for participation
Cardiomyopathy in DMD: Lisinopril vs. Losartan

This trial is a double-blind randomized clinical trial of lisinopril versus losartan for the treatment of cardiomyopathy in Duchenne Muscular Dystrophy (DMD). Both drugs are known to be effective for the treatment of dilated cardiomyopathy. ACEi have been reported to delay the onset and progression of left ventricle dysfunction in children with DMD. Multiple studies show therapeutic efficacy of losartan in animals with cardiomyopathy related to muscular dystrophy and in patients with cardiomyopathy from diverse causes. ARBs are often reserved for patients in whom heart failure is not adequately treated or where side effects preclude the use of an ACEi. However, in DMD, losartan might be a better choice as a first line drug because of studies demonstrating a potential benefit for skeletal muscle in the mdx mouse. Considering that both skeletal and cardiac muscles are major contributors of the disability of DMD, a drug that could improve both heart and skeletal muscles simultaneously would need consideration as the drug of choice for the cardiomyopathic DMD patient.


Eligibility Criteria:
Inclusion Criteria:

* Duchenne muscular dystrophy patients of all ages
* Null mutation of the dystrophin gene or muscle with \<5% dystrophin
* Doppler echocardiogram with ejection fraction (EF) \<55% within 30 days of enrollment
* Ability to cooperate for testing
* Glucocorticoid treatment acceptable including daily or weekend administration of prednisone or deflazacort

Exclusion Criteria:

* Patients with EF 55% or greater
* Patients with EF \<40% after washout
* Patients taking \>5 mg lisinopril, or \>25 mg losartan or \>5 mg enalapril
* Skeletal deformities or pulmonary anatomical variants that preclude consistent measures of Doppler echocardiography
Comparison Between Two Revascularization Strategies in MVD Patients With Uncomplicated ST-elevation MI

The study aimed to compare major adverse cardiac and cerebrovascular events(MACCE) and mortality at one year between two strategies: complete revascularization including non-culprit lesions percutaneous coronary intervention(PCI) during primary PCI(PPCI) versus complete revascularisation during the same hospital admission in multi-vascular coronary artery disease(MVD) patients presenting with ST-elevation myocardial infarction(STEMI) uncomplicated by cardiogenic shock.

Complete revascularisation in MVD patients with STEMI uncomplicated by cardiogenic shock has been shown to improve outcomes, however the optimal timing of treatment of the non-culprit lesions is not known. The 2018 ESC/EACTS Guidelines on myocardial revascularization states that "routine revascularization of non-IRA (infarct related artery) lesions should be considered in patients with multivessel disease before hospital discharge". Our trial showed that among the fore mentioned patients there was no difference regarding outcomes when using a strategy of complete revascularization with non-culprit lesions PCI during PPCI or during the same hospital admission.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women with successful PCI (preferably using a drug-eluting stent) to the culprit lesion for STEMI ( PCI for STEMI should be primary PCI in the first 12 hours after symptom onset) and complete revascularization of non-culprit lesions during the index PPCI procedure or during a different procedure performed before index hospital discharge.
2. Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has:

   * At least 75% diameter stenosis (visual estimation) or
   * At least 50% diameter stenosis (visual estimation) with fractional flow reserve (FFR) ≤ 0.80
3. Age between 18 and 90 years
4. Written informed consent could be obtained from all the patients

Exclusion Criteria:

1. Rescue PCI for failed fibrinolysis or a combination strategy where PCI is performed routinely 3-12 hours after fibrinolysis
2. Cardiogenic shock
3. Non-cardiovascular known co-morbidity reducing life expectancy to \< 2 years
4. Any factor precluding 1year follow-up
5. Prior Coronary Artery Bypass Graft (CABG) Surgery
6. A different operator from the previously designated
7. Unable to provide consent for any other reason
Fluvoxamine and Sertraline in Childhood Autism - Does SSRI Therapy Improve Behaviour and/or Mood?

The purpose of this study is to determine if fluvoxamine or sertraline reduce the fequency or severity of aggressive behaviour, obsessive symptoms, or anxiety in young children with autism. The within-patient variability in this patient population using standard neuropsychological instruments will also be determined and a predictor model for SSRI responsitivity based on baseline neuropsychological testing will be developed.

Autism is a neuropsychiatric disorder diagnosed in early childhood. Approximately 10 Canadian children per 10 000 live births suffer from the disorder, which is three to four times more common in males than in females. It is characterized by social and and communicative deficits and restricted, repetitive interests and behaviours. Most autistic children are delayed in the acquisition of both verbal and non-verbal communication skills and many never develop useful language. Three-quarters of autistic children have mild to severe mental retardation and a quarter develop seizures during later childhood or adolescence. Its etiology is heterogenous and there is no cure. Although behaviour therapy is an important tool in management, pharmacotherapy remains a necessity for many children. Current therapy is limited to antipsychotic drugs that can carry an unacceptable risk of chronic neurotoxicity (tardive dyskinesia) or tricyclic antidepressants that have undesireble cardiovascular effects. This study proposes to evaluate the potential benefit of selective seratonin reuptake inhibitors (SSRIs) in autism.

All autistic children whose symptoms are not currently well controlled will be offered entry into the trial. Each child will randomized to eight weeks of fluvooxamine, sertraline, or placebo. If they do not improve on their initial dose, they may have a dose increase and continue in the study for a further eight weeks. Due to the significant amount of within- and between- patient variability, multiple baseline evaluations will be completed prior to the initiation of drug therapy. Parents may choose to continue therapy that was effective for their child; if their child was randomized to placebo, parents may choose to try an SSRI for a period of 8 weeks to assess effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of autism based on Autism Dignostic Interview -Revised and/or Autism Diagnostic Observation Schedule, depending on which is appropriate for the child's chronological age
* ages 3-10 inclusive
* free of psychoactive medication for at least 3 months prior to entry into the trial

Exclusion Criteria:

* known contra-indications to SSRIs (i.e. hepatic dysfunction)
* Lactose intolerance
* concurrent psychotropic medications (SSRIs can interact with lithium, tricyclic antidepressants, monoamine oxidase inhibitors, and benzodiazepines)
* taking warfarin (SSRIs can increase levels)
* Inability of parents to give informed consent, travel to the clinic visits, administer study medication, or arrange for completion of rating scales by self/school staff
K-BASKET, TAS-117, PI3K/AKT Gene Aberration

The phosphatidylinositol 3-kinase (PI3K)-v-akt murine thymoma viral oncogene homolog (AKT)-mammalian target of rapamycin (mTOR) signaling pathway is one of the most frequently aberrantly regulated pathways in human tumors. TAS-117 is a highly potent and selective oral allosteric AKT inhibitor. It has high affinity for AKT1, 2, and 3 and shows potent anti-proliferative activity against multiple tumor cell lines in vivo. Therefore, we propose to conduct a phase II trial of TAS-117, potent and selective AKT inhibitor, in patients with advanced solid tumor with PI3K/AKT genetic aberrancy by NGS focusing panel in part of K-BASKET trial.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed recurrent or advanced solid cancers with PI3K/ATK aberration
2. Progressive disease who failed to previous standard treatment.
3. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria
4. Eastern Cooperative Oncology Group performance status 0 or 1
5. Able to take medications orally
6. Adequate organ function
7. A life expectancy of at least 60 days

Exclusion Criteria:

1. Previous treatment with anti-PI3K or AKT directed therapies
2. Known hypersensitivity to any drugs similar to TAS-117 in structure or class.
3. History or current evidence of type 1 or type 2 diabetes mellitus that requires insulin and/or oral antidiabetic therapy.
4. Current evidence of retinopathy that requires ophthalmological therapy.
5. History or current evidence of cardiac arrhythmia and/or conduction abnormality.
6. Treatment with any of the following within the specified time frame prior to study drug administration:

   * Major surgery within prior 4 weeks
   * Radiation therapy for extended field within 4 weeks prior to study drug administration or limited field radiation therapy within 2 weeks prior to study drug administration.
   * Any anticancer treatment within 3 weeks prior to study drug administration (mitomycin within prior 5 weeks).
7. A serious illness or medical condition(s)
8. Unresolved toxicity of Grade \>1 attributed to any prior therapies (excluding alopecia, skin pigmentation and anemia).
9. Patients with the risk of hypokalemia
10. Receiving oral steroid medication.
11. Pregnant or lactating female
Glycemic Variability in Intermittent Fasting

The aim was to test the difference in glycemic variability after meal consumption during intermittent fasting and the usual diet.

Healthy participants were recruited for this crossover study aiming to determine the difference in glycemic variability after meal consumption while practicing intermittent fasting and the usual diet. Prior to the protocol assignment, participants were followed for 3 days - they were instructed to maintain their usual sleep pattern, level of physical activity and diet. Control of dietary pattern was conducted by using the 3-day food diary. Day zero was preparation day for the protocol (Intermittent fasting or Control diet) when all participants received individualized 3-day diet plan. Each protocol lasted 3 days with a 7-day washout period. Each protocol consisted of 3 meals per day, each providing a third of the total energy requirement. Control diet protocol was set at 12 hours eating/12 hours fasting, and Intermittent fasting protocol 6 hours eating/18 hours fasting. Blood glucose was measured at zero, 15, 30, 45 and 90 minutes after meal consumption. Before breakfast, blood glucose was measured also at minus 5 minutes prior meal consumption.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index in the range between 18.5 and 29.9 kg/m\^2
* stable sleep pattern (going to bed between 21:30h and midnight)
* for women: regular menstrual cycle lasting between 21 and 35 days, with average bleeding time 2 to 6 days

Exclusion Criteria:

* Body Mass Index below 18.5 or above 29.9 kg/m\^2
* irregular sleeping pattern
* work in nightshift
* high intensity workout routine
* irregular dietary patterns (e.g. skipping meals)
* regularly fasting for more than 15 hours per day
* diagnosis of diabetes (or other conditions related to glycemic disorders)
* hypertension or other cardiovascular disease
* neurologic conditions
* disease affecting metabolism (like liver, kidney, thyroid or lung)
* use of medications for glycemia, hypertension, steroids, adrenergic stimulators, laxatives or supplements affecting glycemia, circadian rhythm, sleep or metabolism in general
Metabo-lipidomics of the Ocular Surface for Cataract Surgery

Cataract is the world's leading cause of blindness, the treatment of which, exclusively surgical, offers excellent results in terms of visual recovery. It represents the most frequently performed surgery in France with more than 800,000 procedures each year. However, some patients develop postoperative ocular surface disease that can affect final visual acuity and quality of life. For example, dry eye disease, very common in the elderly, can be worsened by cataract surgery.

The identification of ocular surface biomarkers predictive of the postoperative risk of ocular surface disease carries the promise of better personalized perioperative care.

Conjunctival impression cytology represents a rapid, minimally invasive method of collecting conjunctival cells, which has proven its usefulness in the evaluation of diseases of the ocular surface. The aqueous humor is directly accessible at the beginning of the surgery.

An approach combining ultra-high performance liquid chromatography coupled with high-resolution mass spectrometry on the cells of the ocular surface and on the aqueous humor could improve our understanding of the physiopathology of ocular surface disease following cataract surgery.

This study will aim to 1) search for prognostic biomarkers of ocular surface disease after cataract surgery using a metabo-lipidomic approach 2) improve our understanding of the pathophysiological mechanisms involved.


Eligibility Criteria:
Inclusion criteria:

* Patient with cortico-nuclear and/or subcapsular cataract
* Age \> or = 50 years
* Patient affiliated to a social security system
* Patient agreeing to participate in the study who provided his/her free and informed written consent

Exclusion criteria:

* History of ocular surgery or trauma (≤ 3 months)
* Other types of cataract excepted age-related or diabetic cataract
* Any eye drops or treatments that may interfere with the ocular surface
* Lens wearer
* Any general pathology with a known impact on the ocular surface (auto-immune disease, allergy)
* Proven allergy to povidone-iodine or to a component of the postoperative treatment
* Patient under legal protection (safeguard of justice, curatorship and guardianship), or in a situation of deprivation of freedom
* Patient unable to understand the nature and objectives of the study