cyrilzakka/clinical-trials huggingface dataset:
Using Bedside Ultrasound to Screen for Sarcopenia in Older Adults

The loss of both muscle mass and quality with increasing age is called 'sarcopenia' and is a risk factor for falls, fractures and increased mortality. Sarcopenia is diagnosed with Dual-energy X-ray absorptiometry (DXA) scanning (according to current criteria), but in Canada DXA scans are not approved to screen for this condition. One potential solution is Point of Care Ultrasound (PoCUS), since recent advances have made bedside ultrasound technology readily available as a rapid bedside screening tool.

Some recent work has examined the possibility of using ultrasound as a measure of both muscle quantity and muscle quantity. Work done by Strasser et al, has shown that ultrasonic measures of muscle thickness in the quadriceps muscle has a highly significant correlation with maximal voluntary contration. Other work done by Miron-Mombiela et al has shown that measures of muscle thickness and echointensity (a measure of muscle quality) also show high correlations with grip strength. These findings (supported by our pilot data, see Pilot Data) and new technological advances in bedside ultrasonic devices suggest that these measures might be a valuable contribution to the process of screening for sarcopenia in older adults. In this proposal, Investigators hypothesize that bedside ultrasound, which is increasingly becoming a mainstream component of the standard physical exam, will be a much more specific and accurate alternative to our current best screening methods.

Eligibility Criteria:
Inclusion Criteria:

* each subject must be 65 years of age or greater

Exclusion Criteria:

* hemodialysis patients will be excluded, due to excessive fluid shifts with dialysis
* patients using chronic oral corticosteroids will be excluded, due to potential muscle atrophy
* hemiparesis due to a stroke or paresis of the lower limbs will be excluded
* subjects with pitting edema on physical exam (due to liver, renal or heart failure) or patients that are severely dehydrated will be excluded
* patients with myositis, systemic connective tissue disorders, systemic atrophies affecting the central nervous system (CNS) and CNS demyelinating diseases will be excluded
Prenatal Screening for Imprinting Anomalies Implicated in Beckwith Wiedemann and Silver Russell Syndromes

Losses of imprinting are involved in various syndromes. Those occurring in the 11p15 region lead to Beckwith-Wiedemann and Silver-Russell Syndromes. These losses of imprinting follow a mosaic pattern, rendering their detection difficult, especially given the scarcity of available DNA in amniotic fluid. Thus, in spite of growing demand, prenatal diagnosis (PND) for imprinting abnormalities of the 11p15 region is not available.

The recent development of a quantitative PCR method that permits the methylation index (MI) of imprinted regions to be calculated renders PND technically possible. Nevertheless, because of the mosaic nature of these anomalies, it is essential to verify that the methylation pattern of the 11p15 region obtained from the amniotic fluid matches that obtained from the blood.

To evaluate the agreement between the methylation index of the 11p15 region obtained using DNA extracted from amniocytes and that extracted from cord blood leukocytes, by calculating the intraclass correlation coefficient (ICC).

Ancillary study :

This second part of the study aims to determine the standard of methylation index of the 11p15 region (inclusion of 100 additional patients). The use of amniotic liquid will allow to calculate :

* the average of methylation index,
* the value of the standard deviation
* the inter-assay coefficient of variation for the test-used.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women, 18 years of age or older
* Requiring amniotic fluid sampling in the context of pregnancy care after 15 weeks of amenorrhea
* Having provided written informed consent
* Followed at Trousseau Hospital or Clinique des Bluets during their pregnancy
* Covered by or beneficiary of a state health insurance program (except for medical aid programs)

Exclusion Criteria:

* Warning signs on ultrasound that require a medical termination of pregnancy to be discussed even before amniocentesis is performed
Multiple Micronutrient Supplementation (MMS) Vs IFA Acceptability Crossover Trial

This is an individually randomized mixed methods cross-over trial to assess acceptability, preference, and side effects of IFA formulations with 60 mg of iron to MMS formulations with 60 mg of iron.


Eligibility Criteria:
Inclusion Criteria:

* Attending first ANC visit at the study clinic
* Pregnant women ≤ 15 weeks of gestation
* Aged ≥ 18 years
* Intending to stay in the study area for the duration of study
* Provides informed consent

Exclusion Criteria:

* Severe anemia (defined as Hb \<8.5 g/dL per Tanzania standard of care)
* Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC
* Concurrent participation in other nutritional supplementation trial
CHG0521 Oral Coating in Patients with Solid Tissue Tumor/Recurrent/Metastatic TSCC

This is a prospective single-arm loading test study of CHG0521 oral coating in patients with solid tissue tumor/recurrent/metastatic TSCC


Eligibility Criteria:
Inclusion Criteria:

* 1. Age range: 18-80 years, encompassing both males and females. 2. Confirmation of tongue squamous cell carcinoma through histopathology or cytology is required.

  3. Patients who are deemed unsuitable for surgery, have surgical indications but decline the treatment, or experience relapse and metastasis after surgery with no further surgical options available.

  4. No concurrent use of other traditional Chinese medicine orally or externally within the past 3 months.

  5. Presence of at least one measurable lesion according to RECIST 1.1 criteria. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

  7. Expected survival time should be equal to or greater than 3 months. 8. Liver function indicators: total bilirubin level ≤1.5 times the upper limit of normal (ULN), AST and ALT levels ≤2.5 times ULN (or ≤5 times ULN in case of liver metastasis).

  9.Renal function indicators: serum creatinine (CRE) ≤1.5×ULN and calculated creatinine clearance (using Cockcroft-Gault formula) ≥60 ml/min.

  10.The functionality of vital organs should be essentially normal.

Exclusion Criteria:

* 1. Patients with tongue squamous cell carcinoma who have undergone tumor resection without any residual tumor; 2. Patients with a known allergy to any therapeutic ingredient or a history of hypersensitivity or allergic constitution; 3. Patients who have experienced a severe infection within 4 weeks prior to the first use of the investigational drug, and whose common adverse reaction criteria were graded as \&gt;2; 4. Patients with a history of immune deficiency, organ transplantation, or allogeneic bone marrow transplantation; 5. Patients currently enrolled in another concurrent clinical study; 6. Pregnant and lactating women.
Effectiveness of Pharmacist Interventions in Difficult Asthma

Of the 5.2 million people with asthma in the UK, approximately one in every 40 have severe asthma that needs the maximum available treatments advised in national asthma guidelines (known as the 'British Thoracic Society / Scottish Intercollegiate Guidelines Network British Guideline on the Management of Asthma'). Despite this, asthma is still inadequately controlled in about half of these patients and they are classed as having 'difficult asthma'. There maybe potential for improvement of the care and health of these patients through better use of medicines and greater input from pharmacists, but more research is needed.

The aim of the study is to measure the effects over six months of coordinated information and advice about medicines from hospital and community pharmacists on asthma control in patients with difficult asthma. The patients in the study (52 in total) will be recruited from adult patients attending a specialist difficult asthma clinic in a hospital.

Patients will be randomly chosen to have either an appointment with the specialist pharmacist (intervention group), or usual medical care (control group). Usual care will involve seeing the Consultant or Specialist Registrar (doctor) in the clinic. Patients in the intervention group will receive i) assessment and education on asthma, and review of their inhaler technique, from a hospital Advanced Clinical Pharmacist and ii) will also be referred for a medicines use review from their usual community pharmacist (chemist), to take place 1-2 months after their hospital clinic appointment. The Advanced Clinical Pharmacist will be working closely with the Consultant.

Results will be measured using methods that have been developed by experts in asthma and tested in previous research. Asthma control will be measured using Juniper's Asthma Control Questionnaire. Other measurements will cover quality of life, use of medication, use of healthcare resources, and inhaler technique.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of asthma
* Fulfil the criteria for difficult asthma (defined as persistent symptoms and/or frequent exacerbations despite treatment at step 4 or step 5 of the British TYhoracic Society / SIGN asthma guidelines 2011)
* Adult patients age between 18 and 70 years
* Able to speak, read and write in English
* All patients must have received their regular medication from the same Community Pharmacy for at least 3 months prior to their baseline visit
* Their community pharmacy must be registered with Leeds Primary Care Trust(PCT) to undertake targeted Medicines Use Reviews (tMURs).

Exclusion Criteria:

* Failure to meet the inclusion criteria
* Patient is not responsible for administering their own medications
* Patient is unlikely to be available for the 6-month follow-up period
* Failure to provide written informed consent
* Patient has had an MUR within the 12 months preceding the study period.
South Asians Active Together (SAATH) Study

South Asian immigrant women and girls are at increased risk for insufficient physical activity and are not being reached by current approaches to physical activity promotion. This randomized control trial study will test the effectiveness and implementation of a multi component physical activity intervention directed at the environment, family, interpersonal and individual levels to promote physical activity among South Asian immigrant mothers and daughters.


Eligibility Criteria:
The sample of this study is South Asian mothers and their daughters. The inclusion criteria for the mother include:

* Identifying herself as South Asian,
* having a sedentary lifestyle as assessed using a self-report questionnaire
* having ability to communicate in Hindi, Gujarati, Urdu, or English.
* Having a daughter aged 11-16 years

Exclusion Criteria:

* having known medical condition that restricts ability to participate in moderate intensity Physical Activity
* Unable to complete study procedures (including not wearing accelerometer during run-in)
* Currently pregnant
* Unable to provide informed consent or assent.
Retrospective Analysis of the Neonatal Management of Patients with an Antenatal Diagnosis of Genital Development Variation At the Hospital of Lyon

Variations in genital development (VDG) account for 0.5% to 1% of births. Advances in ultrasound techniques, as well as in prenatal diagnosis techniques, particularly in genetics, have led to improvements in the prenatal diagnosis of these pathologies. However, to date, there is no consensus on etiological research and standardized management of these patients and their families, once VDG has been detected.

The value of multidisciplinary management has already been demonstrated, but a number of grey areas remain: the frequency of false-positive ultrasound findings, the place of invasive antenatal diagnostic tests, the role left to parents during the diagnostic process, the frequency of associated malformations discovered post-natally, and how to prepare for immediate management at birth.

The aim of this study is to improve the management of patients and their families as soon as a Disorders of Sexual Development is detected antenatally.

The primary objective is to describe the management, particularly complementary investigations performed in the antenatal management of ultrasound diagnoses of Disorders of Sexual Development over the last 10 years.

The secondary objectives are :

* To determine the correlation between pre- and post-natal morphological phenotype and the proportion of false positives in antenatal ultrasound diagnosis.
* To characterize prenatally diagnosed Disorders of Sexual Development
* To determine the proportion of isolated prenatally-diagnosed Disorders of Sexual Development that turn out not to be isolated during postnatal follow-up.
* The evaluation of the care pathway :

  * To establish the frequency of prenatal psychological support for parents
  * To establish the role of parents in prenatal diagnosis strategy decisions at our center


Eligibility Criteria:
Inclusion Criteria:

Fetuse of the hospital Femme-Mère-Enfant, the hospital Croix Rousse and Lyon-Sud hospital, reffered to Pluridisciplinary Centers for Prenatal Diagnosis (CPDPNs) for antenatal diagnosis (DAN) for a suspected isolated Disorders of Sexual Development (DSD) from January 2013 to December 2022.

Intrauterine growth retardation (RCIU), a muscular or minor ventricular septal defect, or a pyloric dilatation are not considered as an associated malformation.

Exclusion Criteria:

* No follow-up file at the CPDPN of the hospital Femme-Mère-Enfant, the hospital Croix Rousse or of Lyon-Sud hospital.
* Lack of data and identification of the child born.
* Referred to CPDPN for urinary malformation including no VDG.
Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

To be eligible to enter the study, each patient must comply with the following inclusion criteria:

* Provide written informed consent and aged between 18 and 75 years of age.
* Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.
* Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
* Able and agrees to remain off prior antipsychotic medication for the duration of study.
* Good physical health on the basis of medical history, physical examination, and laboratory screening.
* Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria:

* Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
* Any chronic organic disease of the CNS (other than schizophrenia)
* Used investigational compound within 30 days.
* Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse

The objective of the study is to assess the long term safety, durability of clinical effectiveness and cost effectiveness of the NeuGuide™ system when used for vaginal colpopexy in the treatment of uterine prolapse.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with POP-Q C point greater than (-) 1 cm.
2. Patients who have previously had a partial hysterectomy in which the cervix is intact may be included in this study.
3. Non-pregnant female (female of child bearing potential must have a negative pregnancy test).
4. Patient understands the nature and potential hazards of the procedure and provides written informed consent prior to any study specific assessments.
5. Patient is able to complete written questionnaires.
6. Patient is willing and able to comply with the specified study requirements and follow-up assessments, and can be contacted by telephone.

Exclusion Criteria:

1. Known diagnosis of reproductive tract abnormalities.
2. Prior pelvic radiation therapy, any malignancy or active pelvic inflammatory disease.
3. Known history of severe Pelvic Inflammatory Disease (PID).
4. Prior total hysterectomy.
5. Prior pelvic prolapse surgery using synthetic mesh.
6. Pathological PAP in the past year.
7. Moderate or severe bacterial cervicitis.
8. Moderate or severe pelvic pain (\> 3 on VAS).
9. Severe morbid obesity (BMI \>45).
10. Temperature \> 38°C (oral or equivalent), sepsis, or active infection requiring IV anti-microbial treatment.
11. Significant cognitive impairment.
12. Active malignancy other than non-melanoma skin cancer.
13. Planned surgery (more than a minor one) in the next 30 days.
14. Patient has a known hypersensitivity to device materials (Nickel, suture material).
15. Moribund patient or patient with severe or deteriorating damage in critical body systems.
16. Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
17. Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints.
Sodium Intake in Multiple Sclerosis

Recently, it has been shown that salt (ClNa, sodium chloride) can modulate the differentiation of human and mouse TH17 cells. Indeed, mice feed with high sodium diet were described to develop more aggressive course of EAE (Experimental Autoimmune Encephalitis).

However, the role of sodium intake in MS has not been investigated. In this study we investigate the effect of sodium intake in Multiple Sclerosis (MS) clinical and radiological activity.


Eligibility Criteria:
Inclusion Criteria:

* Subject is between 18 and 50 years old
* Subject has diagnosis of relapsing-remitting MS according to McDonald criteria (2010)

Exclusion Criteria:

* Patient who had hyponatremia in the last 90 days
Pre-emptive Scalp Infiltration with Triamcinolone Acetonide Plus Ropivacaine for Post-Craniotomy Pain in Children

At present, pediatric postoperative analgesia has not been fully understood and controlled, particularly craniotomy surgery. On the one hand, professional evaluation of postoperative pain for young children is difficult; on the other hand, the particularity of craniotomy adds (such as consciousness obstacle, sleepiness, et al) disturbance to the pain assessment in children. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was unsatisfactory due to its short pain relief duration, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction.However, there has not been reported about local application of triamcinolone acetonide on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (triamcinolone acetonide) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.


Eligibility Criteria:
Inclusion Criteria:

-(1) Age 2 to 12 years. (2) American Society of Anesthesiologists (ASA) physical status I or II. (3)Participates with an anticipated fully recovery within 2 hours postoperatively.

(4)Informed consent by parent(s) and/or legal guardian.

Exclusion Criteria:

- (1) Allergy to local anesthetics. (2) Pediatric patients aged\>12 or \<2 years. (3) Under medication with analgesic drugs. (4) Psychiatric disorders. (5) Uncontrolled epilepsy. (6) Chronic headache. (7) Peri-incisional infection. (8) Coagulopathy or bleeding disorder. (9) Patients who are expected to remain intubated and mechanical ventilation after surgery.

(10) Emergency craniotomies. (11) Patients with cardiac insufficiency or severe kidney or liver diseases. (12) Patients whose authorized surrogates are unwilling to participate in the study
PackHealth: Asthma Engagement Tool

The purpose of this study is to test the impact of an innovative patient engagement solution on patient's quality of life and asthma-related outcomes, and evaluate the correlation between a patient reported outcome measure and clinical outcomes.

Patient engagement is a critical part of improving patient care and outcomes. Current patient engagement strategies only focus on the patient-physician interaction and have been shown to be ineffective.

The need for a comprehensive approach to patient engagement is no different among patients with asthma as it is in any other chronic condition. Patients with asthma must make complicated health decisions daily that impact their social and occupational activities, quality of life, and treatment adherence. Obtaining, communicating, processing, and understanding non- biased health information are crucial in making appropriate and informed treatment decisions.

Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care. Each Pack draws on the science of change management and patient activation and contains three categories of materials

Eligibility Criteria:
Inclusion Criteria:

* Patients with a physician diagnosis of asthma for at least the previous 12 months.
* Asthma that is not well controlled by NAEPP guidelines.
* Ability and willingness to provide informed consent

Exclusion Criteria:

* Significant alcohol consumption of more than three alcoholic drinks per day or active substance abuse.
* Chronic disease (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system or immunodeficiency that are not well addressed or controlled.
* A diagnosis of cancer with ongoing treatment.
* Any terminal illness or conditions that results in a life expectancy less than one year.
The Effect of Mild Weight Loss on Circulating Metabolite Profiles

To determine whether low calorie diet (LCD)-induced weight reduction caused changes in plasma metabolites and metabolic traits from baseline.

Over a 12-week clinical intervention period, a randomized, controlled study was carried out; overweight subjects consumed a LCD (approximately 300kcal/d deficit, n=47) or a weight-maintenance diet (control, n=50) were included for analyzing plasma samples and metabolites using an ultra-performance liquid chromatography and mass spectrometry (UPLC-LTQ/Orbitrap MS).

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* 20-65 years old
* Males and females
* Overweight (25.0 kg/m²≤ Body mass index \<30 kg/m²)
* Nondiabetic (Fasting glucose \<126 mg/dL)

Exclusion Criteria:

* Unstable body weight (body weight change \>1 kg within 3 months before screening)
* Consumption of medication that affects body weight or energy expenditure
* Pregnancy or breast-feeding
* Hypertension, type 2 diabetes, cardiovascular disease, cerebrovascular disease, or thyroid disease
* Liver disease, kidney disease, or gastrointestinal disease
* Acute or chronic infections
* Any acute or chronic disease requiring treatment