cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Measured Epidural Depth for Midline Approach in Pediatric Patients With Scoliosis: Prospective Observational Study

The purpose of this study was to

1. investigate the degree of agreement between the ultrasound-measured depth (in the transverse median and paramedian sagittal oblique plane) and the actual depth to the epidural space in pediatric patients with scoliosis.
2. investigate the quality of ultrasound view for detecting ligamentum flavum and dura mater.


Eligibility Criteria:
Inclusion Criteria:

1. pediatric patients (aged 3-14 years) with scoliosis (cobb angle \>10 degree) scheduled for correctional osteotomy of the lower extremity and requesting epidural analgesia for postoperative pain control

Exclusion Criteria:

1. Contraindications to epidural analgesia (local infection, blood clotting disorder, anatomical abnormality, sepsis, etc.)
2. If all of the parents of the subject are foreigners or illiterate (if the parents of the subject can not read the agreement)
Previvors Recharge: A Resilience Program for Cancer Previvors

It is estimated that 1 in 279 people may be carriers of a Hereditary Cancer Syndromes (HCS), a cancer risk that is associated with germline mutations (inherited genetic mutations passed directly from a parent to a child that create a genetic predisposition to certain types of cancer). Individuals with an HCS who have never been diagnosed with cancer (Previvors) have up to an 80% lifetime risk of developing cancer and are at an increased risk of developing multiple primary cancers during their lifetime, often with onset at an early age. Previvors face multiple forms of adversity, including a multitude of annual cancer screenings and the uncertainty of not only their own health but the health of affected family members. This study will examine the acceptability and preliminary effects of PreCharge, a resilience-boosting solution specifically designed for Previvors and delivered primarily via bi-directional text messaging. PreCharge uses proven approaches to behavior change tailoring to increase resilience by promoting a positive mindset, strong social connections, and a deep sense of meaning and purpose while also proactively addressing scanxiety. Up to 150 Hereditary Cancer Previvors will be recruited for a 30-day pilot test. Participants will complete a baseline assessment, and then be provided with 30 days of access to the PreCharge program. At the end of the 30 days, they will be prompted to complete a follow-up assessment. Outcomes include 1) acceptability of the program, as evidenced by obtaining 75% endorsement that users would recommend the program to a fellow Previvor; (2) engagement as evidenced by continued receipt of text messages and one or more interactions with the online tools by at least 70% of participants; and (3) benefit from the program, evidenced by statistically significant pre-post improvement on the Connor Davidson Resilience Scale.


Eligibility Criteria:
Inclusion Criteria:

1. Identified as having Hereditary Cancer Syndrome
2. Never having been diagnosed with cancer
3. Over 18 years of age
4. Living in the United States
5. English speaking
6. Having a score of 26 or below on the Connor Davidson Resilience Scale (10 Item)
7. Access to a mobile phone
8. Agree to receive text messages.
Serum Metal Ion Concentrations Following Primary Hip Arthroplasty

The objective of this study is to compare serum chromium and cobalt levels of patients who have undergone metal on metal total hip arthroplasty. It is unknown if the presence of bilateral well-functioning large-head metal-on-metal (MOM) total hip arthroplasties (THAs) leads to higher serum metal ion concentrations than unilateral MOM THA. Elevated levels (chromium, 17 μg/L; cobalt, 19 μg/L) have been associated with poorly functioning MOM THA with metallosis. Fourteen patients having undergone bilateral and 25 patients having undergone unilateral large-head primary MOM THA were compared. Harris Hip Scores, University of California Los Angeles activity scores, radiographs, serum creatinine, and serum cobalt and chromium levels were obtained.

The objective of this study is to compare serum chromium and cobalt levels of patients who have undergone metal on metal total hip arthroplasty.

The effect of the presence of bilateral large-head MOM THA on circulating metal ions levels has not been thoroughly studied. Metal ion levels in patients with unilateral MOM vs bilateral MOM resurfacing and small-head THA have been reported; however, to the investigators knowledge, no study has investigated the differences in serum metal ion levels in unilateral vs bilateral largehead (≥38 mm) MOM THA. The objective of this study was to compare serum cobalt and chromium levels in patients who have undergone unilateral vs bilateral large-head MOM THA to better understand the effect of the presence of bilateral implants on circulating metal ion levels. The investigators believe that further understanding baseline levels in well-functioning MOM THA will increase the clinical utility of checking serum metal ion levels in the workup of the painful MOM THA. The investigators hypothesis was that serum metal ion levels in patients with well-functioning bilateral large-head MOM THA would be higher than levels in patients with well functioning unilateral large-head MOM THA, but these levels would not approach those seen with metallosis.

Eligibility Criteria:
Inclusion Criteria:

* undergone unilateral large-head (≥38 mm) primary MOM THA
* undergone bilateral large-head primary MOM THA
* 18 years old or older
* at least one year out from their index procedure
* had well-positioned components

Exclusion Criteria:

* other metal implants
* renal insufficiency (estimated creatinine clearance b30 mL/min)
* component malpositioning (cup inclination angle N55°)
* evidence of osteolysis on radiographs
* a poorly functioning hip (Harris Hip Score \[HHS\] b70)
Visual Health Evaluation of Natural Color Display Technology

Study on visual fatigue and visual function under changing ambient light color temperature by natural color mode: The influence of electronic display devices on visual fatigue of human eyes is the main evaluation index and the main outcome index of this experiment. Secondary outcome indicators were visual function indicators such as regulation and aggregation. There are other outcome measures: effective reading efficiency, blink detection, retinal fundus blood flow. The baseline values of the above indicators were respectively measured, and then the specific values of different indicators when the natural color mode was enabled and not enabled were collected under the changing ambient light color temperature, and the baseline values were statistically compared and analyzed. Evaluate the effect of natural color patterns on the relief of visual fatigue and on visual function.


Eligibility Criteria:
Inclusion Criteria:

1. Adult population, regardless of gender
2. Refractive error is less than or equal to -2.5D and both eyes achieve corrected visual acuity of 0.8 or higher.
3. Normal intraocular pressure with no organic pathology.
4. No apparent symptoms of dry eye.
5. Willing to cooperate to complete all the tests.
6. Voluntarily signing the informed consent form.

Exclusion Criteria:

* 1: Individuals with strabismus and amblyopia exist.

  2: Suffering from congenital eye conditions such as congenital cataracts or congenital retinal diseases.

  3: Those who have undergone intraocular surgery (such as cataract removal, intraocular lens implantation, etc.).

  4: Individuals with refractive media opacity (such as corneal lesions, lens opacity, etc.).

  5: Abnormal intraocular pressure (IOP) (IOP \< 10 mmHg or IOP \> 21 mmHg, or a bilateral IOP difference of ≥5 mmHg).

  6: Only one eye meets the inclusion criteria.

  7: Active corneal infections such as bacterial, fungal, viral, or other acute or chronic anterior segment inflammations.

  8: Currently using medications that may lead to dry eye or affect vision and corneal curvature.

  9: Other ocular conditions, such as dacryocystitis, eyelid disorders and abnormalities, abnormal intraocular pressure, and glaucoma.

  10: Unable to undergo regular eye examinations.
Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise

Lactate is a compound produced as a by-product of glycolysis. The increase in lactate concentration can result from a variety of causes, such as during anaerobic metabolism in exercise or haemodynamic shock in conditions such as sepsis.

The study will aim to validate a novel microneedle-based minimally invasive device for the continuous measurement of lactate during exercise.

Lactate is a compound produced as a by-product of glycolysis. The increase in lactate concentration can result from a variety of causes, such as during anaerobic metabolism in exercise. The measurement of blood lactate during exercise has been routinely used to determine individual anaerobic thresholds, and optimise training in athletes.

The measurement of the lactate trend requires multiple blood tests, and this can be uncomfortable. The need for repeated procedures may therefore restrict the full utility of the biomarker. Although point-of-care lactate measurements are possible, the barriers to initiating testing may also limit its role in clinical decision-making.

The aim of the study is the validation of the microneedle-based lactate biosensor for real-time continuous lactate measurement in healthy volunteers during exercise as proof-of-concept.

Eligibility Criteria:
Inclusion Criteria:

1. Consenting adults ≥ 18 years old
2. Healthy with no other previous medical history
3. Able to perform moderately intensive exercise without difficulty for at least 30 minutes continuously, and engages in regular aerobic exercise at least twice a week

Exclusion Criteria:

1. Active inflammatory skin condition such as eczema or dermatitis
2. Active soft tissue infection or infection at any site
3. Known hypersensitivity to any microneedle component or dressings
4. Presence of any implantable electronic devices such as a pacemaker or stimulators
An Observational Study on Efficacy and Safety in Subjects Using Levemir® for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes

This observational study is conducted in Africa. The aim of this observational study is to evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Any subject with Type 1 or Type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria:

* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
* Currently being treated with insulin detemir
* Previously enrolled in this study
* Hypersensitivity to insulin detemir or to any of the excipients
* Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures.
Iota-Carrageenan Nasal Spray in Common Cold

The aim of this clinical trial is to investigate the effect of Iota-Carrageenan treatment on cold symptoms. The effect of treatment on the duration of the cold and the patients viral load plus cytokine level indicating the inflammatory response will be analyzed.


Eligibility Criteria:
Inclusion criteria:

* Patients consider that they are in an early stage of common cold with symptoms of no more than 48 hours duration
* Symptom score of equal or more than 1 for for at least one of the symptoms sore throat, runny nose and blocked nose on a 0-3 verbal rating scale
* Total symptom score of equal or less 9 for symptoms headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough, and sneezing measured on a 0-3 verbal rating scale
* Patients agree to refrain from taking any products intended to prevent, intervene in, or treat cough/colds/flu, starting at study entry and continuing through day 10 (e.g. those containing zinc, Echinacea); use of a daily multivitamin is allowed.

Exclusion criteria:

* Known hypersensitivity or are allergic to any component of the test device
* Clinically significant cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or history or any current disease that is considered by the investigator as a reason for exclusion e.g. current allergic rhinitis, chronic obstructive pulmonary disease
* Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps.
* History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores
* Taking any prescribed medication other than for contraception, that is considered by the investigator as a reason for exclusion e.g. systemic steroids, intranasal medicines, antibiotics
* Common cold or flu like symptoms for more than 48 hours.
* Recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence symptom scores (analgesics, nasal decongestants, cough medicines)
* Current smoker (more than 10 cigarettes a day)
High-intensity Interval Training Enhances Mobilization/Functionality of Endothelial Progenitor Cells and Depressed Shedding of Vascular Endothelial Cells Undergoing Hypoxia

Exercise training improves endothelium-dependent vasodilation, whereas hypoxic stress causes vascular endothelial dysfunction. Monocyte- derived endothelial progenitor cells (Mon-EPCs) contribute to vascular repair process by differentiating into endothelial cells. This study investigates how high-intensity interval (HIT) and moderate intensity-continuous (MCT) exercise training affect circulating Mon-EPC levels and EPC functionality under hypoxic condition. Sixty healthy sedentary males were randomized to engage either HIT (3-minute intervals at 40% and 80%VO2max , n=20) or MCT (sustained 60%VO2max , n=20) for 30 minutes/day, 5 days/week for 6 weeks, or to a control group that did not received exercise intervention (n=20). Mon-EPC characteristics and EPC functionality under hypoxic exercise (HE, 100W under 12%O 2 ) were determined before and after various interventions.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary life
* Age 20\~28

Exclusion Criteria:

* Smokers
* Users of medication/vitamins
* Any cardiopulmonary/hematological risk
* Regular exercise habits at least 1 year
* Exposed to high altitudes (\>3000 m) for at least 1 year
Inflammatory Mediators in Erythema Migrans

The main objective of this study is to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with erythema migrans to gain better insight into pathogenesis of early Lyme borreliosis and to define new immune modulators that could serve as biomarkers of disease activity.


Eligibility Criteria:
Inclusion Criteria:

* erythema migrans in patients \> 18 years

Exclusion Criteria:

* pregnancy or immunocompromising conditions
* taking antibiotic with antiborrelial activity within 10 days
The Effect of Type 2 Diabetes and Dietary Regulation on VLDL1-and VLDL2-triglyceride Metabolism

In this study the investigators wish to compare Very Low-Density Lipoprotein (VLDL) kinetics in type 2 diabetic males and healthy males postabsorptive and during hyperinsulinemia. The kinetics is obtained using an ex-vivo VLDL1- and VLDL2-triglyceride labeling technique. The investigators hypothesis is that the investigators will find an increased VLDL1 production in type 2 diabetic males, which is not lowered by hyperinsulinemia. Also the investigators wish to investigate the influence of diet on VLDL1 and VLDL2 production in healthy males, where the investigators expect less variance in VLDL production when the subject is given an isocaloric diet.

Patients with type 2 diabetes are more likely to suffer from dyslipidemia. Earlier research has shown that these patients have an increased VLDL production and this could be a key factor in dyslipidemia development. Especially the production of VLDL1 seems to be increased where an inhibitory response to insulin is lacking. Further investigation in VLDL1 and VLDL2 kinetics is required.

The investigators wish:

1. To extend the method of ex vivo labeling of VLDL-triglyceride, to include separate labeling of VLDL1- and VLDL2-triglyceride for evaluation of the separate lipoprotein subtype kinetics.
2. To investigate VLDL1- and VLDL2-triglyceride kinetics in the post absorptive state and under experimental hyperinsulinemia in twelve type 2 diabetic males compared to twelve healthy age, sex, and BMI matched males.
3. To investigate the effect of a three day isocaloric diet compared to a non-restricted diet on the day-to-day variation in VLDL1 and VLDL2-triglyceride kinetics in healthy men. The investigators here examine six subjects on two different days who ingest a non-restricted diet and compare this group to six subjects examined on two different days, who have prior ingest a three day isocaloric diet.

Eligibility Criteria:
Inclusion Criteria:

* patients with type 2 diabetes during at least six month or healthy subjects
* male
* BMI 25-36 kg/m2
* age 35-65

Exclusion Criteria:

* other diseases (hypertension and hypercholesterolemia tolerated)
* Insulin treatment
* alcohol abuse
* smoking
* medication affecting lipid metabolism apart from statins and antihypertensive drugs paused 2 weeks prior to the study day.
* participation in studies involving radioactive isotopes or larger x-ray investigations within the last six month.
* blood donation within three month.
Study of Oxaliplatin, Irinotecan, and S-1 in Gastric Cancer

This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan, and S-1 as the first-line chemotherapy in patients with advanced gastric cancer.

It is widely accepted that the efficacy of chemotherapy for patients with inoperable, advanced, and metastatic gastric cancer is better than that compared to best supportive care. In general, combination chemotherapies are more efficient than monotherapy and so it is reasonable to give combination chemotherapy to patients with good performance status.

Especially dual combination chemotherapy with fluoropyrimidine and platinum has shown the objective response rate of 25-48% in patients with newly diagnosed advanced metastatic gastric cancer and several studies about triple combination with oxaliplatin, irinotecan, and fluoropyrimidine have shown the response rate of 53\~75% but also higher rate of hematologic adverse events. So the investigators had conducted the phase I study of these three drugs with modification of dosage and schedule and will conduct a phase II study with recommended dose of triple chemotherapy from this phase I study.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed advanced, recurrent or metastatic adenocarcinoma of stomach (stage IV by primary tumor, regional nodes, metastasis(TNM) staging system)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* More than 3 months expected life span
* Measurable lesion by RECIST criteria version 1.1
* Palliative chemotherapy naive
* Adequate organ functions
* Participants must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

* Positive Her2 status on participants' cancer tissue.
* Any prior 2 years or concurrent malignancy other than non-melanoma skin cancer, in situ cancer of uterine cervix, or papillary or follicular thyroid cancer.
* Participants who had received radiation therapy for target lesions 4 weeks before study enrollment
* Participants who had received major surgery 4 weeks before study enrollment
* Participants with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 12 months, pregnancy, or breast feeding
* Participants with central nervous system(CNS) metastases
* Participants with peripheral sensory neuropathies with impaired functional activities
* Participants with gastrointestinal obstruction or bleeding inducing mal-absorption of oral chemotherapeutic agents.
Biofeedback Treatment for Functional Constipation

The purpose of this randomized, controlled trial is to examine how well biofeedback treatment works to improve constipation. The study is comparing two kinds of biofeedback treatment: 1) anorectal-specific biofeedback therapy and 2) generalized biofeedback therapy using relaxation techniques.

The study will also examine which medical and psychological factors determine biofeedback success for treating constipation, such as bowel habits, emotional reactions to constipation, and levels of stress and psychological distress.

This is a randomized controlled trial (RCT) to evaluate the efficacy of anorectal biofeedback therapy for functional constipation secondary to pelvic floor dyssynergia. Participants will be randomized to either six sessions of anorectal biofeedback or to six sessions of generalized biofeedback.

Participants will complete questionnaires at baseline, at completion of randomized treatment(12 weeks), and six months after completion of treatment to measure change in bowel habits, constipation severity, constipation-related quality of life, and constipation-related disability. An examination of psychosocial factors will also be conducted prior to treatment to distinguish which ones are predictive of biofeedback success for functional constipation.

Eligibility Criteria:
Inclusion Criteria:

* chronic constipation
* medical recommendation to undergo biofeedback training
Effects of Cash Transfers on Severe Acute Malnutrition

Cash transfer, aims to strengthen food security for vulnerable households by giving families enough purchasing power to consume an adequate and balanced diet, maintain a good standard of hygiene, access health services, and invest in their own means of food production in addition to their children's growth and development.

While cash transfer to vulnerable households has shown a long-term positive impact on growth and on malnutrition-related mortality in children aged 0-5 years, there is little conclusive evidence their effectiveness in Sub-Saharan Africa that cash transfer has a direct effect on the Community-based Management of Acute Malnutrition (CMAM). Here, the investigators will perform a cluster-randomized trial to investigate during 6 months the effects of unconditional cash transfers on the management of severe acute malnutrition (SAM) in children from 6 to 59 months according to the national protocol in the Democratic Republic of Congo.


Eligibility Criteria:
Inclusion Criteria:

* Living in the catchment area of one of the 20 outpatient therapeutic program site participating in this cluster randomized trial;
* 6-59 months of age;
* Weight for Height Zscore \<-3 SD (WHO Growth Standards 2006) and/or Mid-Upper Arm Circumference \<115mm and/or with bilateral edema;
* No major clinical complications;
* Positive appetite test;
* Accept to participate at the study.

Exclusion Criteria:

* Not living in the catchment area of the outpatient therapeutic program site of the cluster randomized trial;
* Weight-for-Height Z-score ≥-3 (WHO Growth Standards 2006) and Mid-Upper Arm Circumference ≥115mm without bilateral edema;
* Major clinical complications;
* Failure to appetite test;
* Refuse to participate at the study.