cyrilzakka/clinical-trials huggingface dataset:
Adipose Tissue Expandability and Type 2 Diabetes

The goal of the study is to analyze deviations in adipogenic potential and metabolic properties of preadipocytes in subjects with genetic predisposition to type 2 diabetes, and thus identify factors that underlie hypertrophic growth of adipose tissue associated with the development of this disease.

Adipose tissue (AT) expands in response to excessive energy intake by hyperplasia or hypertrophy. While hyperplasia is associated with preservation of insulin sensitivity, hypertrophic AT exerts a number of metabolic defects. The mechanisms by which hyperplasia is suppressed at the expense of AT hypertrophy remain unknown, but it is expected that the hypertrophy of adipocytes is primarily driven by insufficient recruitment and differentiation of available preadipocytes. The limitation of hyperplasia occurs already in non-obese healthy subjects who are genetically predisposed to Type 2 Diabetes. Using these and control subjects, the LIMEX project aims to analyze the mechanisms of AT expandability. The project will combine in vivo characterization of AT and in vitro studies on human preadipocytes derived from AT biopsies obtained during clinical study. In vitro, proliferation, adipogenesis and lipogenesis of adipose cells will be monitored and these properties will be related to the degree of AT hypertrophy in vivo, insulin sensitivity and genetic predisposition to metabolic complications.

Eligibility Criteria:
Inclusion Criteria:

* healthy non-obese men
* subject has genetic predisposition for T2DM- i.e. two first-degree relatives (parents, siblings) or one first-degree relative and two second-degree relatives with type 2 diabetes (grandparents, uncle, aunt) diagnosed with T2DM OR
* subject without any family history of T2DM.

Exclusion Criteria:

* any prior history of obesity
* elevated triglyceride concentration (above 1.7 mmol/l)
* hypertension
* thyroid or other endocrine disease
* smoking
* drug abuse
Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device

Diabetes is a leading cause of death in the Western World with medical costs increasing annually. There is no cure for diabetes, and blood glucose monitoring is a key component in diabetes treatment and management. Self-monitoring of blood glucose levels is essential to the self-management of diabetes and has become widespread over the past decade. Blood glucose determinations are currently done by invasive methods (finger tip pricking), followed by measuring the blood drop characteristics.

The purpose of this trail is to demonstrate the performance and use of GlucoTrack device in measuring blood glucose levels.

The rationale for development of the device is to improve the patient's quality of life by providing a device that is easily used and provides a painless measurement method, thereby leading to higher compliance, and to better managed diabetes

See Brief summary

Eligibility Criteria:
Inclusion Criteria:

* Type 1or 2 Diabetes
* Anatomically suitable earlobe

Exclusion Criteria:

* Subjects requiring dialysis
* Any conditions that may hamper good contact between the PEC and the earlobe
* Pregnancy
* Nursing mothers
Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients

The purpose of this study is to evaluate the safety of a standard volume replacement called HES 130/0.4 (Voluven) during surgery on recovery. HES 130/0.4 (Voluven) may offer an alternative to pure fluid replacement solutions that are associated with problems after surgery including fluid overload and respiratory difficulties. The safety of HES 130/0.4 (Voluven) will be evaluated by examining its effects on kidney function, and coagulation parameters and platelet (part of the blood that help it clot) function.

Participants will be randomized (like flipping a coin) to receive one of two possible volume replacements during surgery, if fluid volume decreases enough to need replacement with one of the fluids. The two possible volume replacements are Voluven (a starch-containing fluid) or human albumin 5% (a protein-containing solution).

To examine kidney function, urine will be-sampled when the participant is put under general anesthesia, before surgical incision, within one hour of arrival to the ICU and 24 hours after completion of surgery. Two tubes (2 teaspoons) of blood (from an already established line) will be taken the morning of the surgery, within one hour of arrival to the ICU, 24 hours after surgery and every morning during the participants postoperative ICU stay.

Additionally, health and recovery information will be recorded from the participant's medical record. We will phone participants around 90 days and one year after surgery to ask a few questions about one's health and recovery. We will also record blood sample analysis results from follow up appointments within the first year after surgery. If this analysis is not conducted at the Cleveland Clinic, with permission, we will obtain the results from a treating physician.


Eligibility Criteria:
Inclusion Criteria:

* Age 50 - 85 years old
* Scheduled for elective aortic valve replacement with or without coronary artery bypass grafting with or without additional minor surgical procedure.
* Written, informed consent for participation in this investigation.

Exclusion Criteria:

* Patients with renal failure with oliguria or anuria not related to hypovolemia.
* Patients receiving dialysis.
* Patients with preoperative renal insufficiency (Creatinine \> 1.6 mg/dL)
* Anticipated deep hypothermic circulatory arrest
* Known hypersensitivity or allergy to hydroxyethyl starch or the excipients of hydroxyethyl starch
* Clinical conditions with volume overload (e.g., patients in pulmonary edema or congestive heart failure)
* Patients with severe hypernatremia or severe hyperchloremia
* Patients with intracranial bleeding
* Pregnant or breast feeding women
* Critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy, (e.g. patients who are hospitalized in the intensive care unit prior to surgery)
* Severe liver disease
* Pre-existing coagulation or bleeding disorders
* Any contraindications to proposed interventions.
Muscle Fatigability and Trip-specific Fall Risk in Adults With Knee Osteoarthritis

The goal of this clinical trial is to learn about how fatigue affects the risk of falling in adults aged 55-70 years with and without knee osteoarthritis. The main questions this trial aims to answer are:

* Does fatigue increase the risk of tripping while walking? and
* Does fatigue increase the risk of falling in response to a trip while walking? Participants will
* Complete questionnaires
* Wear a device that measures physical activity for 5-7 days
* Complete a 30 minute walk on a treadmill
* Complete the following before and after the treadmill walk:

  * Computer test to measure mental fatigue
  * Maximal strength testing
  * Balance test

Researchers will compare adults with and without knee osteoarthritis to see if fall risk in adults with knee osteoarthritis is affected more by walking activity compared to adults without knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

For adults with knee osteoarthritis:

* presence of occasional to frequent knee pain
* knee pain that is primarily in the medial knee joint compartment
* minimal morning joint stiffness

For all participants:

* able to walk continuously for 30 minutes without an assistive device

Exclusion Criteria:

* fracture or surgery within 1 year
* history of joint replacement
* lower-extremity joint injections within 3 months
* history of stroke or other neurological condition
* cardiovascular or pulmonary conditions that limit daily activity or that preclude participation in exercise
* history of major lower extremity or back injury or pain (except for knee osteoarthritis)
* history of lower extremity amputation
* use an orthotic or prosthetic to walk
* use of beta blockers or other medications that affect fatigue
* use of medications that affect balance
* diabetic neuropathy
* acute illness or the presence of lesions on the torso or lower extremities
* BMI greater than 35
* body weight over 265 lbs
Constraint Induced Movement Therapy (CIMT) in Babies Home Program

The research objectives are to test the efficacy of a Modified CIMT treatment in babies diagnosed with hemiplegia, treated in a home program, as compared to a control group of babies receiving a parallel home program but with no CIMT.


Eligibility Criteria:
Inclusion Criteria:

* Babies age 7-18 months diagnosed with Hemiplegic cerebral palsy

Exclusion Criteria:

* Epilepsy not treated
Mothers' Respect/Mistreatment During Pregnancy & Childbirth

Pregnancy and childbirth are important events in a woman's and family's life and a time of great vulnerability for every country and culture on earth. Although the concept of "safe motherhood" is often limited to physical safety, the birth of a child is also an important life milestone for women and their familiesin our study for ssessing the degree of respectful maternity care, or mistreatment during pregnancy and childbirth in Assiut Governorate, Egypt and Exploring the factors associated with respectful maternity care and mistreatment among Egyptian women in Assiut governorate in rural and urban areas .

A woman's experience with childbirth care is an important factor in her future decisions about whether to receive health care through a health care facility. Women's negative encounters with health workers long-term injury and emotional trauma can result during childbirth. Every woman has several rights. They include the following rights: 1- Freedom from harm and abuse, 2- Information, informed consent and refusal, and respect for women's choices and preferences, including companion during childbirth, 3- Privacy and confidentiality 4) Respectful and dignified treatment 5 - Equality, non-discrimination and appropriate care 6- Healthcare and attainable high standards of health and 7- Freedom, autonomy, self-determination and non-coercion. Reported forms of disrespect and abuse fell into seven categories: physical abuse, non-consensual care, non-confidential care, indecent care, discrimination based on patient characteristics, abandonment of care, and incarceration in institutions.. RMC focuses on eliminating unhealthy and abusive behaviors by healthcare providers and associated personnel, and providing a sensitive and encouraging work environment to help women feel satisfied during childbirth.To measure women's experience of respectful maternity care, vedam et la developed Mothers on Respect Index (MORi) assesses the nature of patient-provider interactions and their impact on human feelings of respect during obstetric care .The mistreatment index (MIST index), which is an indicator of abuse consistent with the seven dimensions ( physical abuse, sexual abuse, verbal abuse, stigma and discrimination. Failure to meet professional standards of care, poor rapport during interactions with Providors, and the poor state and limitations of the healthcare system )

Eligibility Criteria:
Inclusion Criteria:

Women who have delivered (either vaginally or cesarean) in the past 8 weeks.

Exclusion Criteria:

* Women who had complicated childbirth, or stillbirth/neonatal death during their Last delivery will be excluded. In addition, women with known psychiatric illness . These women will be excluded . women who refuse to participate in the study will be excluded.
Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Children in the Paediatric A&E.

Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Acutely Ill Children in a High Prevalent Setting: The Paediatric Accidents \& Emergencies through prospective observational data collection concerning specific items from the clinical and technical examination in diagnosing serious infections, such as meningitis, sepsis, pneumonia, pyelonephritis, bronchiolitis with hypoxia. Eventually we will attempt to validate a vital signs and symptoms rule derived from multiple low to high prevalent settings of acutely ill children.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 month to 16 years
* Acute illness episode of maximum 5 days

Exclusion Criteria:

* recent trauma
* neurological conditions
* intoxication
* psychiatric of behavioural disorders without a somatic cause
* acute exacerbation of a chronic condition (asthma, known immunodeficiency, diabetes, cystic fibrosis, etc)
Diaphragm Ultrasound to Predict Posteroperative Residual Blockade

This study is a prospective observational research approved by the Ethics Committee of the Peking Union medical college Hospital. Patients scheduled for elective non-abdominal and non-thoracic surgery among age of 19-65 years and American Society of Anesthesiologists Physical Status Classification(ASA) I or II were inrolled. Diaphragm ultrasonogram was measured pre and post operation. Diaphragm excursion and diaphragm thickening fraction during quiet breathing as well as deep breathing were assessed. Neuromuscular monitor was performed during operation, after proper calibration.


Eligibility Criteria:
Enrollment criteria：

1. Patients who were scheduled for elective non-abdominal and non-thoracic surgery in Peking Union medical college hospital.
2. age of 19-65 years
3. American Society of Anesthesiologists Physical Status Classification(ASA) I or II.
4. Agree to informed consent

Exclusion criteria ： Patients with neuromuscular diseases, diaphragmatic palsy, thoracic malformation, hand disabilities, chronic obstructive pulmonary disease, severe liver or kidney diseases, electrolyte or acid-base disorders, morbid obesity (body mass index ≥30 kg/m2), pregnancy, allergy to drugs used in the study, use of medication interfering neuromuscular transmission within 72hours and patients with predicted difficulty in maintenance of airway were excluded from this study. Written informed consent will be obtained before preoperative evaluation by an anesthesiologist.
Treatment of Chronic Insomnia According to Yin Yang Theory and Its Correlation With Circadian Rhythm

The purpose of this study is to assess the safety and efficacy of Traditional Chinese medicine (TCM) according to Yin Yang theory for treatment of chronic insomnia .

All subjects giving written informed consent. In this multicenter, controlled, prospective cohort study, the outpatient and inpatient chronic insomnia patients' baseline demographic data were collected, including age, gender, education background, and medication history. Venous blood samples were collected and sent to laboratory test for blood routine, and blood biochemistry at Baseline and Week 4. The Pittsburgh sleep quality index (PSQI) was used to assess the patients' sleep quality at baseline and week 4. Objective sleep quality data is assessed by wearing a Sleep wearable devices. The classic Morningness-Eveningness Questionnaire and wearable devices was used to assess the patients' chronotype at baseline and week 4.Subjects who visit the TCM clinic of this project received Suanzaoren Decoction and Huanglian Wendan Decoction orally twice daily for 4 weeks. Add or subtract Chinese herbal medicine according to the different clinical manifestations of each patient. Subjects from TCM clinic who had previously taken Western medicine hypnotics continued taking them, and for those who had not taken before, Western medicine hypnotics shall not be given/prescribed. Subjects who visit the Western medicine clinic of this project received Estazolam 1mg tablet orally once daily for 4 weeks. The participants will have a follow-up visit every two weeks, and the prescription would be adjusted according to the condition of illness.Cessation rate of Western medicine hypnotics was assessed at Month 6.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients or inpatients.
* It conforms to the chronic insomnia diagnosis standard of Chinese adult insomnia diagnosis and treatment guide (2017 Edition).
* Chronic insomnia patients with Yin yang imbalance and Ying Wei Disharmony Syndrome.
* Informed consent, voluntary participation in the study.

Exclusion Criteria:

* Sleep apnea syndrome leads to insomnia.
* Severe depression, suicidal tendency or having committed suicide.
* Pregnant and lactating women.
* It has serious primary heart, liver, lung, kidney, blood or serious diseases affecting its survival, such as: tumor or AIDS, SCR \> 1.5n (n is the upper limit of normal value), ALT \> 2n (n is the upper limit of normal value), WBC \< 3.0 × 109 / L;
* Those who cannot give full informed consent due to mental disorders.
* According to the researcher's judgment, other situations that are not suitable for the group, such as the change of working environment.
* Subjects who are participating in other clinical studies.
Silver Diamine Fluoride Pilot Study (SDF)

This pilot trial is randomized, double-blind, and placebo-controlled trial with two parallel arms: an intervention group using silver diamine fluoride (SDF) and a placebo group (control). 60 eligible healthy adults will be enrolled in the study and randomly assigned to one of the two treatment groups. Both groups will receive the traditional preventive measures including cleanings, Fluoride varnish, diet analysis and counseling. Study participants will be followed for one year and caries progression will be radiographically monitored.

This pilot study will compare 1) Silver diamine fluoride (SDF) and fluoride varnish to 2) Placebo and fluoride varnish (conventional prevention) in the management of early approximal carious lesions. Early approximal carious lesions refers to decay between teeth, diagnosed with radiographs, not extending more than 1/3 of the way into dentin. Management of early approximal carious lesions refers to halting lesion progression, or encouraging lesion reversal after an early carious lesion is detected.

SDF provides a novel, low-cost intervention option for managing early carious lesions that could potentially bridge the 'gap' between non-operative and operative options; thus, postponing the first placement of a restoration. SDF has been used in arresting carious lesions for more than 100 years. However, SDF has never been tested in the arrest of approximal caries lesions in permanent teeth.

SDF acts to both prevent and arrest tooth decay in multiple ways: 1) it acts on the body of carious lesions by precipitating silver ion into the lesion, thus blocking diffusion pathways for cariogenic acids; 2) it interacts with dental enamel leading to the formation of fluoroapatite crystals making the tooth surface more acid resistant; and 3) the precipitated silver from SDF acts as a bactericidal agent disturbing the formation of cariogenic biofilm.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least one approximal caries lesion (scores RA1, RA2, RA3 according to the ICCMS radiographic scoring system) in one of the posterior teeth (premolars and molars) presented with full contact with the adjacent tooth.
* All the surfaces eligible for this study will be included.

Exclusion Criteria:

* The approximal lesion detected in the radiograph has advanced dentine lesion (RB4, RC5, or RC6)
* or is adjacent to a lesion that is either filled or will receive a filling at the time of enrollment.
Comparison of Mesh Fixation Wit Cyanoacrylate vs Suture in Inguinal Hernia Surgery

To compare fixation with glubran2 with suture during surgery por primary inguinal hernia.

Hypothesis: Glue may induce less complications and chronic pain than suture


Eligibility Criteria:
Inclusion Criteria:

* Male patients
* Aged more than 18 years
* Primary inguinal hernia

Exclusion Criteria:

* Inguinoscrotal hernia
The Population Pharmacokinetics of Montelukast in Infants and Children

The investigators' aim was to evaluate the population pharmacokinetics of montelukast in infants and children and define the appropriate dose in order to optimize Montelukast treatment in this vulnerable population.


Eligibility Criteria:
Inclusion Criteria:

* patients have been diagnosed with asthma; age range: 1 month to 12 years old; montelukast used as part of regular treatment.

Exclusion Criteria:

* expected survival time less than the treatment cycle; patients with other factors that researcher considers unsuitable for inclusion.
Comparison of Two Apical Repair Methods in Women Undergoing Repairs for Prolapse

To date no study has determined prospectively which technique is superior to prevent recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical need. The aim of the study is to determine objective anatomical recurrent prolapse after Sacrospinous Ligament Fixation (SLF) vs McCall.

The aim of the study is to determine objective anatomical recurrent prolapse after SLF vs McCall. The study is designed as a Randomized Controlled Trial (RCT). Primary study endpoint will be at 12 months, secondary study endpoint at 24 months. The following parameters will be evaluated after one year: anatomical outcome, Quality of Life (QoL), sexual health, reoperations, and complications.

Eligibility Criteria:
Inclusion Criteria:

* declined/ failed conservative treatment for POP
* planned vaginal hysterectomy with anterior/posterior colporrhaphy as indicated
* any symptomatic POP or stage II prolapse in any compartment
* at least stage I prolapse in the apical department
* women between 35 and 80 years of age
* good German language skills
* any concomitant prolapse surgery (anterior, posterior vaginal repair, suburethral tapes) as indicated
* concomitant salpingo-oophorectomy if indicated

Exclusion Criteria:

* Unwillingness to participate
* Neurological disorders
* Previous hysterectomy
* Desire to have children
* Connective tissue disorders (i.e. Ehlers-Danlos syndrome, Marfan syndrome)
Hemodynamics Response to Upper Airway Obstruction in Marfan Syndrome

Upper airway obstruction (UAO) is an unrecognized source of hemodynamic stress that may contribute to aortic adverse events in persons with Marfan Syndrome (MFS). UAO occurs during snoring and sleep apnea and is characterized by repetitive partial or complete obstruction of the upper airway during sleep. These obstructive breathing events lead to intermittent surges in blood pressure (BP) REF and large decreases in pleural pressure (Pes), thereby increasing the trans-mural aortic pressure (TMP) and imposing mechanical stress on the aorta during sleep. Although UAO is known to increase mechanical stress on the aorta, the magnitude of the increase is not known for persons with MFS.

In this project, therefore, the investigators will also examine the changes in Pes and BP responses in periods of obstructed breathing and compare the diurnal markers or vascular stress between Baseline and CPAP studies in MFS persons.

Research Objective/Significance:

Specific Aim 1a: To quantify the Pes and BP during periods with and without UAO during sleep in persons with MFS.

Specific Aim 1b: To examine the effect of CPAP treatment of UAO on Pes and BP in MFS persons.

Specific Aim 2: To examine the effect of CPAP treatment of UAO on daytime markers of hemodynamic stress (augmentation index, reactive hyperemia index) in MFS persons.

Primary Outcomes:

* Overnight measure of hemodynamic stress (blood pressure, pleural pressure swings)

Secondary Outcomes:

* Changes in diurnal markers of hemodynamic stress (augmentation index, reactive hyperemia index)

Eligibility Criteria:
Inclusion Criteria:

People with Marfan syndrome.

* Age ≥ 18yrs
* Able and willing to provide informed consent
* Willing to sleep connected to research apparatus

Exclusion Criteria:

* Unstable cardiovascular disease (CHF, myocardial infarction or revascularization procedures, and unstable arrhythmias)
* Uncontrolled hypertension (BP \> 190/110)
* Underlying obstructive or other intrinsic lung disease
* Renal failure on dialysis
* Cirrhosis
* Pregnancy