cyrilzakka/clinical-trials huggingface dataset:
Gut Hormones as Mediators of Different Weight Loss Responses After Roux-en-Y Gastric Bypass

After gastric bypass, 10-20% of patients will obtain a suboptimal weight loss, often defined as \<50% of the excess body weight. Exaggerated meal related secretion of gut hormones seem important for appetite reduction and subsequent weight loss after gastric bypass, however it is not clear whether different gut hormone responses are responsible for different postoperative weight loss responses. The purpose of the study is to investigate gut hormone secretion, vagal integrity and the effect of octreotide on ad libitum food intake in patients with suboptimal weight loss after gastric bypass and compare results to a matched group of gastric bypass operated patients with high postoperative weight loss but similar age, sex and preoperative BMI.


Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated primary Roux-en-Y gastric bypass \>12 months ago
* Postoperative weight loss of \>60%EBL or \<50%EBL.

Exclusion Criteria:

* Inadequately treated thyroid disease
* Hemoglobin \<6.5 mM
* Pregnancy or breastfeeding
A Study to Evaluate the Effect of GRF6021 on Postoperative Recovery Following Primary Hip or Knee Arthroplasty

This study will evaluate the safety, tolerability and effect of GRF6021 on clinical recovery parameters in participants undergoing primary hip or knee arthroplasty.

This is a randomized, placebo-controlled, double-blind pilot study to investigate the effects of GRF6021, a 5% human plasma protein fraction administered by intravenous (IV) infusion, on intracellular signaling cascades in blood leukocytes in participants undergoing primary hip or knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 50-85 years of age scheduled to undergo primary total hip or knee replacement surgery.
* Estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2 .

Exclusion Criteria:

* Blood coagulation disorders.
* Participants who started chronic anticoagulant therapy (warfarin, heparin, low-molecular weight heparin, or Factor Xa inhibitors) in the last 6 months
* Hypercoagulable state.
* Prior hypersensitivity to any human blood product including plasma.
* Treatment with any human blood product, including transfusions and IV immunoglobulin, during the 6 months prior to screening.
* History of immunoglobulin A or haptoglobin deficiency.
* Major surgery, trauma or injury in the last 3 months or minor surgery in the last 1 month.
* Heart disease or congestive heart failure in the 6 months prior to dosing.
* Poorly controlled hypertension.
* Severe anemia.
* Functional impairment of major joint or lower extremity other than joint undergoing surgery.
Metabolic Assessment of Aging Men With Urinary Lithiasis

Urinary lithiasis is a common disease on young adults, but not so far on aging people. Nowadays, the investigators are seeing a gradative growth on men above sixty years old, mainly in industrialized countries. The purpose of this study is to investigate metabolic aspects of aging men with renal stones, towards blood tests, 24 hour-urinary samples, imagenological exams and bone densitometry. The investigators have made a case-control model.

Urolithiasis is a common disease, with an overall prevalence about 2% in the world. Accordingly growth of life expectancy, elderly people become more susceptible to present renal calculi.

The investigators have two purposes: (1) evaluate metabolic disturbances in aging men with urinary lithiasis, and (2) evaluate bone demineralization in aging men with renal calculi.

The investigators have made a case-control model. The case-group is compposed by men with more than fifty years-old who had their first lithiasic diagnosis (renal colic ou incidental finding) after that age. The control-group is compposed by men with more than fifty years-old who had never diagnosed with renal stones. So the investigators have excluded men with repetitive episodes of renal colic, that could be negatively influence the outcomes of aging factors on urinary lithiasis. All the people have to submitted to blood tests, 24-hour urinary samples, abdominal ultrassonography and abdominal X-ray (or abdominal CT, if necessary); and bone densitometry. The investigators hope to achieve reliable conclusions about urinary lithogenesis.

Blood tests: total calcium, ionized calcium, uric acid, phosphorus, creatinine, urea, testosterone and parathyroid hormone.

24-hour urinary sample(s): calcium, uric acid, creatinine, citrate, sodium, pH and volume. Patients of the case arm had to collect 6 24-hour urine samples, while the control arm had collected 3 24-hour urine samples.

Data were analyzed using the Fischer's exact, Chi-square and Mann-Whitney tests; a level of significance of 5% was adopted.

Eligibility Criteria:
Inclusion Criteria:

* Men above fifty years-old with urolithiasis diagnosis (case arm)
* Men above fifty years-old without urolithiasis diagnosis (control arm)

Exclusion Criteria:

* Urolithiasis diagnosis (clinical or incidental) before fifty years-old.
* Urinary culture positive
Impact of Laparoscopic Gastric Bypass Surgery and Weight Reduction on Lower Esophageal Sphincter (LES)

The purpose with this study is to investigate whether gastric bypass surgery and the following weight reduction impact the tone in esophageal sphincters and the esophageal function.

In a previous study our group used high resolution solid-state manometry to investigate the pressure in the esophagus and esophageal sphincters in obese patients going through laparoscopic bariatric surgery. These studies showed that the barrier pressure between the stomach and esophagus is significantly lower in obese compared to lean patients. In this study the investigators will examine these patients once more, now after weight reduction to see whether the barrier pressure is back to normal compared to lean patients.

The prevalence of obesity has increased dramatically in recent decades. The gastrointestinal changes associated with obesity have clinical significance for the anesthesiologist in the perioperative period. The upper and lower esophageal sphincters (UES and LES) play a central role in preventing regurgitation and aspiration. The barrier pressure, defined as the difference between the LES pressure and the Intragastric pressure is known to be lower in obese patients compared to lean patients. This might result in a higher risk of regurgitation and aspiration of stomach contents in during induction of anesthesia.

Some studies are made on patients before and after bariatric surgery but results are sparse. In this study the investigators will examine 30 patients before and after bariatric surgery. Our group have performed the measurements on patients before surgery and presented the results in another article. Those patients will be asked to take part of another measurement now 12-18 months after surgery.

30 patients will be consecutively asked and enrolled in this study. Measurements will be performed using high-resolution-solid state manometry.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 year,
* BMI prior to surgery \> 35,
* ASA-classification 1-3

Exclusion Criteria:

* Patient refusal
Cities for Better Health Childhood Obesity Prevention Initiative

This research project is part of the 'Cities for Better Health Childhood Obesity Prevention Initiative' (CBH COPI), which aims to understand how interventions designed to improve diet and physical activity can impact children's health.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained by the child's parent or legal guardian before any study-related activities (where study-related activities are defined as any procedure related to recording of data according to the protocol). The specific consent form and procedures for obtaining consent will be outlined by the local project partner.
* Aged 6-13 years (both 6 and 13 allowed) at the time of signing consent. Deviations from or exceptions to this procedure must be agreed between the research team in the relevant country and the GIP, and are subject to the relevant local ethical amendment procedure. The exception must be due to a scientifically sound rationale and must further consider the following guiding principles: "it must be measurable, it must have marginal utility, it must be meaningful (i.e. linked to the ultimate impact and the primary and/or secondary objective)".

Exclusion Criteria:

- Children will be excluded from the study if their parent(s) do not provide fully informed consent for their data to be collected, if during the measurement day they do not agree to participate, or if the child's parent(s) or legal guardian(s) withdraw their consent for their child participating in the research at any point in line with processes described in local informed consent forms. In communications asking for consent, parents will be prompted to evaluate whether their children have issues with mental incapacity or language barriers that would preclude adequate understanding or cooperation.
Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age

The study participants are patients with uterine fibroids and healthy physical examination subjects from the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital). The main purpose of this study is to analyze the correlation between uterine fibroids and vaginal microecology and cervical local immune function in patients of childbearing age.

(1) In this study, 150 women of childbearing age who are diagnosed with uterine fibroids in the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) are selected as the study group; The differences of vaginal microenvironment and cervical local immune function are compared between 150 healthy women of childbearing age in the same period. (2) After the patients are enrolled, the general information (age, height, weight), menstrual status (age of menarche, menstrual period, cycle, bleeding pattern), clinical manifestations (abnormal uterine bleeding, infertility, abdominal pain), and previous medical history (hypertension, thyroid disease, etc.) of 150 patients with uterine fibroids will be collected. After the end of the first part of the experiment, 150 patients with uterine fibroids will be grouped according to vaginal microecological diagnosis, and the clinical characteristics of patients with uterine fibroids will be analyzed and compared.

Eligibility Criteria:
Inclusion Criteria:

Study group inclusion criteria:

* Age 20-49 years old
* Premenopausal
* Clinical diagnosis of uterine myoma
* Cervical liquid-based cytology and human papillomavirus typing test are negative

Healthy control group:

* Age 20-49 years old
* Premenopausal
* Uterine B-ultrasonography is normal
* Cervical liquid-based cytology and human papillomavirus typing test are negative
* No vaginal infection

Exclusion Criteria:

Exclusion criteria of the study group:

* Used antibiotics, hormones, immunosuppressants and regulators within 1 month
* Sex, vaginal irrigation or applied medicine 3 days before the vaginal discharge sampling
* Pregnant, lactating or menstruating women
* Uterus and uterine adnexa have other lesions

Exclusion criteria of healthy control group:

* Used antibiotics, hormones, immunosuppressants and regulators within 1 month
* Sex, vaginal irrigation or applied medicine 3 days before the vaginal discharge sampling
* Pregnant, lactating or menstruating women
Environmental Surveillance (ES) for Polio and AMR Using the TaqMan Array Card

This study will be used to develop a tool to streamline poliovirus environmental surveillance for the polio endgame and to provide a tool for detecting polio in places where there is no capacity to carry out the gold standard culture-based detection.

This environmental surveillance tool will also include antimicrobial resistance (AMR) genes to describe resistome profile in environmental samples and to better inform us of the potential risks of exposure to these environments

Eligibility Criteria:
Inclusion Criteria

* birth-4 years of age
* reside in selected urban slums of Mirpur Dhaka, Bangladesh
* receiving bOPV immunization

Exclusion Criteria:

* parent unwilling to consent
Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial

Cathodal tDCS decreases the excitability of the cerebral cortex and its daily application during intercritical phase, may have a therapeutic effect in chronic migraine.

During the interictal phase, the cerebral cortex is characterised by a hyperresponsiveness to repeated sensory stimuli, manifested by a lack of habituation or adaptation of cortical responses. Lack of habituation has been shown in the visual cortex in studies of visual evoked potentials (VEP) during the interictal period and it is possibly explained by a reduction in the cortical pre-activation level due to thalamo-cortical dysrhythmia. Just before and during the migraine attack, cortical reactivity changes drastically: habituation is restored and the amplitude increases. In chronic migraine (headache occurring on 15 or more days per month for more than 3 months with features of migraine headache on at least 8 days per month), VEPs habituate normally like those recorded during attacks of episodic migraine, but have in addition an increased amplitude in the 1st block of responses. Chronic migraine was therefore compared to a "never ending migraine attack" accompanied by cortical hypersensitivity.

In this study the investigators aim to demonstrate that cathodal tDCS over the visual cortex with simultaneous anodal tDCS over the left dorsolateral prefrontal cortex is able: 1) to reduce cortical hypersensitivity and habituation as assessed by VEPs and contact heat evoked nociceptive potentials (CHEPS), as well as to decrease pain perception assessed by quantitative sensory testing (QST) and the nociceptive blink reflex (nBR); 2) to decrease headache and migraine frequency.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse

Exclusion Criteria:

* others diseases or contraindications to tDCS (epilepsy, pacemaker, metal prosthetics)
Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury

Currently, those with spinal cord injury (SCI) demonstrate increased prevalence of obesity (75%) cardiovascular disease (30 - 50%), type II diabetes (21%) and osteoporosis in the legs (100%) when compared to the general population. It is important to identify the modes and intensities of exercise most likely to generate a reduction in these inactivity-related diseases in this population.

Therefore, the main purpose of this pilot research project is to implement and test a form of a spinal cord injury-specific exercise, known as FES rowing (FES: functional electrical stimulation).


Eligibility Criteria:
Inclusion Criteria:

* Have a spinal cord injury, C5-T12 (level), AIS A-D (severity)
* Be aged 18-75 for duration of study
* Medically stable and healthy enough to complete exercise requirements
* Willing and able to complete the at-home training requirements as prescribed
* Willing and able to complete the exercise sessions as prescribed
* Willing and able to complete the VO2 testing throughout the study
* Willing and able to complete the DEXA (Dual-energy X-ray absorptiometry) scans during the study
* Able to understand and follow written or verbal instructions from study staff

Exclusion Criteria:

* Current pressure ulcer(s) at sites of electrical stimulation
* Previous spontaneous or low-impact leg fracture
* Previous diagnosis of cardiovascular disease (ie enlarged heart, heart murmur)
* Unsatisfactory results of EKG (electrocardiogram) screening test
* Known thyroid dysfunction
* Kidney disease
* Cancer
* Blood pressure \> 140/90 mmHg
* Currently taking blood pressure medication
* History of epilepsy
* Current hand, arm or shoulder injury
* Current deep vein thrombosis
* Implanted electronic cardiac device (pace maker, defibrillator, etc)
* Ventilator-dependent
* Unable to follow written and verbal instructions
Rotator Cuff Tear Severity and Scapular and Rotator Cuff Muscle Activation Patterns

Rotator cuff tears are common musculoskeletal injuries that can lead to altered scapular and rotator cuff muscle activation patterns and reduced function. This study aims to investigate the relationship between rotator cuff tear severity and scapular and rotator cuff muscle activation patterns.

The primary objective of this study is to determine whether a relationship exists between the severity of rotator cuff tears and the activation patterns of scapular and rotator cuff muscles. Secondary objectives include:

1. Identifying differences in muscle activation patterns between varying tear sizes.
2. Evaluating the potential of these activation patterns as an indicator for the severity of rotator cuff tears.
3. Assessing the influence of muscle activation patterns on the functional capacity of the affected shoulder.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years.
* Diagnosis of rotator cuff tear confirmed by a qualified orthopedic surgeon.
* MRI scan showing the size of the tear (small, medium, large, or massive).
* Ability to provide informed consent and comply with the study protocol.

Exclusion Criteria:

* History of shoulder surgery or other shoulder disorders unrelated to rotator cuff tears.
* Presence of neurological, cardiovascular, or respiratory disorders that could influence muscle activation patterns.
* Contraindications for sEMG assessment, such as skin allergies or infections.
* Inability to perform the required functional tasks due to severe pain or disability.
Gd-EOB-DTPA-enhanced T1 Map for Predicting Postoperative Liver Failure

Researchers designed this study to compare the value of the conventional circular region-of-interest (ROI) and whole-liver histogram-based analysis on gadoxetic acid disodium (Gd-EOB-DTPA)-enhanced T1 map for predicting postoperative liver failure (PHLF). Researchers collected and analyzed the data of patients who underwent partial hepatectomy for focal liver lesions. Researchers drew circular ROIs on Gd-EOB-DTPA-enhanced T1 maps to get the mean T1 values. Researchers used a multiparametric analysis software to get histogram parameters. Then researchers compared the differences of these parameters between the PHLF group and non-PHLF group.

The objective of this study is to compare the value of the circular region-of-interest (ROI) and whole-liver histogram-based analysis on gadoxetic acid disodium (Gd-EOB-DTPA)-enhanced T1 map for predicting postoperative liver failure. Forty patients who underwent partial hepatectomy for focal liver lesions were retrospectively analyzed. All subjects underwent 1.5T Gd-EOB-DTPA-enhanced MRI including pre-contrast and hepatobiliary-phase T1 mapping. Patients were divided into two groups with (16 patients) and without (24 patients) postoperative liver failure according to the criteria established by the International Study Group for Liver Surgery (ISGLS). T1 values before enhancement (T1pre) and in the hepatobiliary phase (T1HBP) were measured by outlining a circular ROI on the axial T1 maps. The reduction rate of T1 relaxation time (rrT1) = (T1 pre - T1HBP) / T1 pre. The whole-liver histogram analysis was performed using the prototype MR Multiparametric Analysis software (Siemens Healthcare, Erlangen, Germany). Differences of the circular ROI-based mean values and the histogram parameters between the two groups were compared. The receiver operating characteristic curve (ROC) was plotted. The circular ROI-based mean values and the histogram parameters for predicting PHLF was assessed by the area under the curve (AUC).

Eligibility Criteria:
Inclusion Criteria:

1. underwent liver resection; 2. underwent gadoxetic acid-enhanced MRI including, T1 mapping before and 20 minutes after gadoxetic acid administration within four weeks before the surgery ; 3. had an international normalized ratio (INR) and bilirubin examination on or after postoperative day five.

Exclusion Criteria:

1. patients who had undergone non-resection treatment, including chemotherapy, radiofrequency ablation, percutaneous ethanol injection, or transarterial chemoembolization; 2. patients whose images had severe respiratory motion artifacts.
Clinical Evaluation of Investigational Multifocal Contact Lenses

3-visit dispensing study to evaluate the subjective feedback of a multifocal contact lens in a population of presbyopic patients. Subjects will wear the contact lenses for a total of 12-16 days.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Healthy adult males or females that are at least 40 years of age and no more than 70 years of age.
4. The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not, respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".(Appendix B).
5. The subject is a current soft spherical or toric contact lens wearer (defined as a minimum of 6 hours of wear per day at least two days of the week for a minimum of 1 month prior to the study).
6. The subject's refractive spherical component must be between +1.25 Diopters (D) to +3.75 D in each eye.
7. The subject's refractive cylinder must be -1.00 D to -1.50 D in each eye.
8. The subject's refractive cylinder axis must be 90°±30° or 180°±30° in each eye.
9. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
10. The subject must have best corrected distance visual acuity of 20/20-3 or better in each eye.
11. The subject must have a wearable pair of spectacles if required for their distance vision.

Exclusion Criteria:

1. Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
2. Pregnancy or lactation.
3. Currently diagnosed with diabetes.
4. Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
5. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
6. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
7. Any previous, or planned, ocular or intraocular surgery (e.g.radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), lid procedures, cataract surgery, retinal surgery, etc.).
8. A history of amblyopia, strabismus or binocular vision abnormality.
9. Any ocular infection or inflammation.
10. Any ocular abnormality that may interfere with contact lens wear.
11. Use of any ocular medication, with the exception of rewetting drops.
12. History of herpetic keratitis.
13. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.