cyrilzakka/clinical-trials huggingface dataset:
Dumping Syndrome and Esophageal Atresia

Dumping syndrome (DS) is frequent in oesophageal atresia (29%). In causing hypoglycaemia, it can be dangerous for neonates. Mechanisms of DS are actually partialy understood. This is also an affection difficult to diagnose, because it only occurs after meals and can be inconstantly present. To date, their is only symptomatic treatment for DS. This study aims to understand its pathological mechanisms so as to better treat it and avoid its consequences. Oesophageal atresia patients enrolled in this study will benefit from a continuous glycemic monitoring, a continuous cardiac monitoring, and an a gastric emptying scintigraphy at the age of 3 months


Eligibility Criteria:
Inclusion Criteria:

* Patients operated at birth for Oesophageal atresia type C
* Aged from 2 to 3 months at inclusion
* Off prokinetic treatment (suspended for at least 72 hours) before monitoring

Exclusion Criteria:

* History of dumping syndrome of other cause (microgastria, fundoplication, dysautonomia..)
* History of any disease that can modify glycemic regulation (hyperinsulinism, neonatal diabete)
* Treatment that can modify gastric motility
The Effect of Astym Treatment on Muscle Performance

Subjects were randomized into 3 treatment groups (15 subjects per group): 1) Control - received no treatment 2) Placebo - received a sham Astym® treatment 3) Astym® Treatment - received Astym® treatment to the lower extremity. Subjects were blinded to whether they received the Astym® treatment or placebo treatment intervention. After a 5-minute warm-up on a lower body ergometer the subjects were familiarized to the operations of a computerized leg press machine that measured the maximum force output (Newtons) during a unilateral isometric squat test. A baseline measure of maximal force output (pre-test) was determined by the average of 3 trials with a 30 second rest period between the trials. The subjects then received the designated treatment intervention. Immediately following the treatment intervention (0 minutes following treatment intervention) the subjects were retested (post-test) using identical testing procedures by an investigator blinded to the treatment intervention received by the subject. Maximum force output measured in Newtons for the post-test was subtracted from the maximum force output (Newtons) pre-test and then converted to a percentage of change \[(post-test - pretest)/pretest X 100). The percent change of maximal force output from pre-test to post-test measures was compared using a one-way analysis of variance with alpha set at 0.05. A Tukey's post-hoc analysis determined statistical differences between the groups.


Eligibility Criteria:
Inclusion Criteria:

1. Referral for physical therapy services to the student investigator for a musculoskeletal injury to the lower extremity.
2. Subjects must be aged between 18-65 years-old
3. Present with a 10% or greater deficit in maximum force output on computerized leg press machine when compared to the uninvolved side
4. Able to read and understand English language.
5. Read, comprehend, and sign informed consent procedures.

Exclusion Criteria:

1. Subjects who are pregnant
2. Subjects with a medical history of hemophilia or other clotting disorders of the blood
3. Subjects currently taking blood thinners (e.g. lovenox, Coumadin)
4. Subjects with neuropathy of the lower extremity
5. Subjects with a history of metastatic disease
6. Subjects with uncontrolled hypertension
7. Subjects that are unable to perform the strength test due to the nature of injury
8. Subjects with a recent history (within the past 4 weeks) of lower extremity surgery.
9. Subjects with compromised skin integrity. (e.g. open wounds, diabetic ulcers, lacerations, abrasions)
10. Subjects with any sign of infection including skin infections to the lower limbs.
Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

This study is designed to characterise P. falciparum transmission intensity in subjects aged ≥6 months and \<10 years by measurement of P. falciparum parasite prevalence, and to estimate the use of malaria control interventions at some centres selected for the EPI-MAL-002 and EPI-MAL-003 studies in sub-Saharan Western Africa.

Two subsequent studies (EPI-MAL-002 and EPI-MAL-003) are planned to monitor vaccine safety prior to and after implementation of the RTS,S/AS01 candidate malaria vaccine. EPI-MAL-002 will take place before RTS,S is authorised and EPI-MAL-003 will start when RTS,S is registered and authorised in the country. A cross-sectional survey at peak transmission will provide by-site point estimates of Parasite prevalence (PP) and malaria control measure coverage in the areas participating in EPI-MAL-002/-003. EPI-MAL-006 will be conducted in advance of EPI-MAL-002/-003 in order to assess PP and malaria control measures to inform enrollment in these studies. The age group for enrollment (≥6 months - \<10 years) will permit analysis of PP according to the World Health Organization (WHO) definition (2-9 years) and by the Joint Technical Expert Group (JTEG) suggested age (\<5 years).

Eligibility Criteria:
Inclusion Criteria:

* Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* A male or female equal or more than 6 months of age and less than 10 years of age at the time of survey.
* Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the child.

Exclusion Criteria:

* Child in care.
* Current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.
Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetics With Coronary Artery Disease

The purpose of this study is to demonstrate that combined vildagliptin-metformin therapy is associated with clinically significant reductions in biological markers of inflammation, pro-thrombogenicity, and atherosclerosis as compared to metformin mono-therapy in a population of diabetic patients with coronary artery disease who undergo cardiac rehabilitation.

The pre-specified established biological markers of inflammation, pro-thrombogenicity, and atherosclerosis will include: interleukin-6 (IL-6 - primary biological marker), hs-CRP, platelet reactivity testing, MMP-9, Interleukin 1 beta (IL-1 beta) and adiponectin levels.

The study is designed as a single-center, randomized, non-blinded, clinical trial to provide evidence on the effects of vildagliptin on key biomarkers of atherothrombosis and inflammation. We plan to prospectively enroll 60 patients with proven coronary artery disease and randomize them in a 2:1 ratio to either vildagliptin-metformin therapy (n=40) or metformin therapy (n=20).

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus on oral mono-therapy or diet only treatment
* Stable documented ischemic Heart disease (\>30 days post AMI, CABG or PCI)
* Sub-optimal Hb A1c as defined ≥6.5%
* Age \> 21
* Life expectancy \>1 year

Exclusion Criteria:

* Significant renal impairment (creatinine ≥1.4 mg\\dL females or ≥1.5 mg\\dL males)
* Planned coronary intervention or planed surgical intervention (PCI or CABG)
* Planned surgical intervention
* Recent (\<30 day) acute coronary syndrome (ACS)
* Hypersensitivity to either of the study drug components
* History of lactic acidosis
* Type I diabetes
* Current Hb A1c \>9%
* Current Insulin treatment
* Active treatment with GLP-1 or DPP4i medication
* Hepatic impairment or ALT\\AST elevations beyond X2 upper normal limit or known hepatic failure
* Inability to comply with study protocol
* Active malignancy other than basal cell carcinoma (BCC)
* Clinically advanced congestive heart failure - NYHA III-IV
* Severe left ventricular dysfunction (LVEF\<30%) with NYHA II or any NYHA class with documented recent heart failure decompensation (\<3 months)
* Severe stable cardiac angina CCS III - IV or Unstable angina
* Chronic inflammation (i.e. IBD, Lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection)
* Pregnancy, lactation or child-bearing potential
Education for Prevention of Melanoma in Hispanic Populations

This clinical trial is to develop an educational platform to educate and prevent melanoma in Hispanic populations. Melanoma is cancer arising in the skin. Educational platforms to increase the knowledge and practice of sun smart behaviors (sunscreen use, sun protective clothing use, self-skin examination) may help reduce risk of and incidence of melanoma and improve cancer survival.

PRIMARY OBJECTIVES:

I. Develop online education platform to educate the Hispanic community. II. Demonstrate improvement in knowledge and practice of sun smart behaviors. III. Determine if the education platform leads to increase visits to their medical provider and increase diagnosis of skin cancers, particularly melanoma, in our population.

OUTLINE:

Participants complete an educational training module and complete questionnaire at baseline (before educational training module) and 3 months after completing educational training.

Eligibility Criteria:
Inclusion Criteria:

* Mayo Clinic patients who self-identify as Hispanic or Latino
* Age 18 and older
* Have an email on file with Mayo Clinic

Exclusion Criteria:

* All patients who do not meet inclusion criteria
Acupuncture and Pain Processing

The purpose of this study is to test the hypothesis that acupuncture will reduce Fibromyalgia pain, via alterations in the processing of pain in the central nervous system.

Patients and healthy controls will be enrolled in the study for a total of 6 weeks. This includes a screening and baseline visit, 8 acupuncture treatments (2 per week for 4 weeks), and a follow-up visit and treatment 1 week after completion of the study treatment sessions. To determine the effects of acupuncture on pain, patients and healthy controls will undergo psychophysical pain testing at four points throughout the study: Baseline (appointment 1), post-treatment 1 (appointment2), post treatment 8 (appointment 9), and at the final follow-up session (1 week from last treatment - appointment 10).Participants will also fill out a brief report on pain, sleep, and functioning on a palm pilot. This is expected to take less than 2 minutes per day and will occur throughout the 6 week study period.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-50
2. Fibromyalgia patient OR healthy control
3. No current opioid use
4. Patients: must have had Fibromyalgia for 6 months or longer

Exclusion Criteria:

1. Inflammatory disorder (lupus, rheumatoid arthritis)
2. Current untreated depression
3. Active infection
4. Healthy controls: pain disorder or major medical condition that in the discretion of the investigator interfere with the validity of the study
5. Heart disease or use of a cardiac pacemaker
Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II

Adjuvant radiotherapy (RT) plays an important role in reducing the risks of local recurrence after surgery in uterine cancers. Standard adjuvant pelvic radiation treatment targets the pelvic lymph nodes, the post-operative bed, and the upper vagina and is typically treated with intensity modulated radiation therapy (IMRT) which has been shown to improve patient reported gastrointestinal (GI) and genitourinary (GU) toxicities. Although pelvic radiation has been shown to be effective at decreasing locoregional recurrences, patient quality of life and experience can be significantly impacted as pelvic RT comprises of daily radiation for 25 daily treatments, which can be a substantial burden on patients with this disease. Hypofractionated radiotherapy to a dose of 30 Gy in 5 fractions (6 Gy given every other day) for adjuvant radiation treatment in uterine cancer is hypothesized to result in similar rates of acute gastrointestinal toxicities as conventional fractionated radiation.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with histologically confirmed endometrial adenocarcinoma, serous or clear cell carcinoma.
2. Patient is a candidate for adjuvant pelvic radiation for uterine cancer (+/- vault brachytherapy), meeting one of the following conditions:

   High grade histology (including serous and clear cell) OR Outer-half myometrial invasion and International Federation of Gynecology and Obstetrics (FIGO) grade 1-2 OR FIGO stage II - III.
3. Patients who are to receive adjuvant systemic therapy sequentially in addition to pelvic radiotherapy will be eligible.
4. Age ≥18 years.
5. Patient is willing and able to give informed consent to participate in this clinical trial.

Exclusion Criteria:

1. Patient has had prior pelvic radiotherapy.
2. Patient has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
3. Patient planned for concurrent chemoradiation therapy.
Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients

This study is designed to evaluate the effect of Tysabri on cognition in multiple sclerosis (MS) patients. During a period of 24 months, the study will assess the evolution of cognitive function in Tysabri treated MS patients using the Symbol Digit Modalities Test (SDMT) and the CogState battery of tests.

Tysabri reduces the relapse frequency, slows progression and preserves cognitive function as compared to placebo as per the AFFIRM trial. The benefit on relapse rate and progression appears to be sustained in longer-term studies such as STRATA. In clinical practice however despite a stable condition on the Expanded Disability Status Scale (EDSS) patients often complain of cognitive deterioration. It has yet to be shown that Tysabri will prevent cognitive deterioration after more than 2 years of treatment.

The Symbol Digit Modalities Test (SDMT) is a sensitive and validated test of cognition in MS. CogState offers a standardized battery of cognitive tests frequently used in clinical research in the fields of dementia and Parkinson's disease. The CogState battery of tests consisting of the Detection test (processing speed), Identification test (attention), One Back test (working memory), International Shopping List test (verbal learning) and the Groton Maze Learning test (reasoning and problem solving) will further confirm and validate the results of the Symbol Digit Modalities Test(SDMT) in MS patients as well as examine other cognitive parameters.

Together the above tests done prospectively can assess the evolution of cognitive function in Tysabri treated MS patients over the longer term.

Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple sclerosis who are receiving Tysabri per indication and are willing and able to give an informed consent.

Exclusion Criteria:

* Patients who are depressed as per the Beck depression questionnaire at screening or at any time during the study.
* Patients with cognitive decline from causes other than MS.
The Urinary Microbiome and Its Relationship to the Urinary and Serum Metabolome in Healthy Peri- and Postmenopausal Women

The presented project aims to characterize the microbiome of healthy peri- and postmenopausal women and its correlation with the metabolome of urine and serum.

At the beginning of their visit to the Blood Center of the University Hospital Ostrava, blood and plasma donors will be approached by one of the authorized members of the team with information about the possibility of participating in this study. The course of the study will be explained to them in detail, including the sampling methodology, their processing, and further handling. If the subject is interested in participating in the study, they will give written informed consent to participate in the study. Subsequently, the inclusion and exclusion criteria for participation in the study will be verified. If these are not met, the subject will be excluded from the study. Furthermore, the criteria for current valid blood and urine sampling will be verified. If the conditions for valid sampling are not met and the participant is still interested in participating in the study, she will be offered a new sampling date. If the study subject fulfills the conditions of valid sampling, she will fill out a simple questionnaire, which will be used to obtain data on basic demographic characteristics. Their knowledge is essential for the correct interpretation of urine and serum test results. Blood and serum will then be collected. In justified cases, sampling can also be carried out at the Urology Department of the University Hospital Ostrava. After submitting the first sample, the participant will be asked to submit another urine and serum sample in 3-6 months. By submitting the 2nd urine and serum sample, the participant ends her participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* Women over 50 years old
* Consent to participate in the study
* Willingness to take urine and blood samples according to the protocol

Exclusion Criteria:

* Known congenital developmental defects of the urinary tract (congenital hydronephrosis, vesicoureteral reflux, renal agenesis, and hypoplasia, multicystic and polycystic kidneys)
* Recurrent urinary tract infections (more than 3 episodes in the last 12 months)
* Presence of any lower-urinary tract symptoms (urgency, frequency, incontinence, stranguria, urge to urinate, weak urine stream, the feeling of post-micturition residue)
* The presence of a foreign body in the urinary tract - urolithiasis, urinary catheter, ureteral stent
* Acute or chronic diseases with possible influence on lower-urinary tract function
* Medications with possible influence on lower-urinary tract function
* Rheumatoid arthritis
* Diabetes mellitus
A Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.

This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue (at a dose of 20mg, or a starting dose of 20mg escalating to either 30mg or 40mg), weekly. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* male,and post-menopausal or surgically sterilized female, patients, 18-75 years of age;
* type 2 diabetes mellitus, with stable metformin treatment for \>=3 months;
* HbA1c \>=7.0% and \<=9.5% at screening;
* stable weight +/-10% for \>=3 months before screening.

Exclusion Criteria:

* type 1 diabetes mellitus;
* clinically significant gastrointestinal disease;
* treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
* use of weight-lowering medications in the last 3 months;
* uncontrolled hypertension;
* previous exposure to GLP-1 or GLP-1 analogues.
Cognitive Behavioral Therapy to Help HIV Infected Adults With Depression to Adhere to Antiretroviral Therapy

This study will compare the effectiveness of a cognitive behavioral intervention versus usual clinic care in helping HIV infected adults with depression to take their HIV medications on schedule.

Antiretroviral therapy (ART) is a type of medication treatment for HIV that impairs the virus's ability to multiply. When used properly, it has been shown to be successful in reducing HIV-related deaths. A high adherence rate to ART is required to adequately suppress the virus, limit drug resistance, and reduce transmission. HIV infected people who are depressed often experience increased difficulty with adhering to their ART regimen. This study will compare the effectiveness of a cognitive behavioral intervention that targets both depression and adherence versus usual care practices which may or may not include mental health intervention with the goal of improving ART adherence among HIV infected adults with depression who are experiencing difficulty with adhering to their medication regimen.

This study will last 24 weeks. Participants will be randomly assigned to receive the cognitive behavioral intervention or usual care. Study visits for all participants will occur at baseline and Weeks 4, 8, 16, and 24. Those receiving the intervention will also have visits at Weeks 1 and 2. Participants receiving the intervention will attend five individual treatment sessions followed by one to three booster treatment sessions; these sessions will coincide with the study visits.

Eligibility Criteria:
Inclusion Criteria:

* reports significant depressive symptoms as indicated by score of 10 or greater on PHQ-9
* Currently taking ART for HIV infection
* Less than 90% adherence rate to ART regimen
* Capable of walking and in stable health
* Speaks fluent English

Exclusion Criteria:

* Depression therapy is needed immediately
* Meets criteria for current drug dependency
* Current diagnosis of psychotic disorder or bipolar depression
Corticosteroid and Lidocain Injections for Tennis Elbow

The investigators hypothesized that lidocain injection is as effective as corticosteroid injection in management of tennis elbow, and if so, it may replace corticosteroid injection in the management of tennis elbow.

Lateral epicondylitis or tennis elbow is a tendinopathy of the common extensor origin of the lateral elbow, and is estimated to have an annual incidence of 1-3%. It is characterized by tenderness over the lateral epicondyle of the humerus, normal range of motion, and pain on resisted extension of the wrist or fingers. Symptoms can persist for between 6 months and 2 years but usually resolve within 12 months. Although tennis elbow is often self-limited, around 20% of cases are refractory to conservative care. Tennis elbow is now thought to be non-inflammatory, and the pathologies are characterized by collagen degeneration, fibroblast proliferation, mucoid degeneration, and neovascularization.

Treatment of tennis elbow includes relative rest, physical therapy (therapeutic exercise, massage, therapeutic ultrasound, lower power laser, etc.), analgesics, non-steroidal anti-inflammatory drugs, glyceryl trinitrate patches, injection therapy (corticosteroid, hyaluronan gel, botulinum toxin, and autologous platelet-rich plasma), shock wave therapy, and even surgery. Previous studies showed corticosteroid injection is effective in the short term, but is harmful in the long-term, and is more likely to have a recurrence. In consideration of a degenerative lesion in tennis elbow, corticosteroid injection may be not an ideal agent. Although plate-rich plasma injection showed promising results, the high cost limited its widespread clinical use. Since local lidocain injection is commonly used in the management of myofascial pain syndrome, it might be effective in the treatment of tendinopathy like tennis elbow. The purpose of this study is to compare the effect of corticosteroid injection and lidocain injection in the treatment of tennis elbow. The investigators hypothesized that lidocain injection is as effective as corticosteroid injection in management of tennis elbow, and if so, it may replace corticosteroid injection in the management of tennis elbow.

Eligibility Criteria:
Inclusion Criteria:

* Between 20 and 75 years of age, with lateral elbow pain ≥4 in pain VAS for at least 1 month
* Reproducibility of pain by 2 or more of the following tests: palpation of the lateral epicondyle and/or the common extensor origin of the elbow; resisted wrist extension (dorsiflexion) and pronation with the elbow in extension
* Pain reproduced by static stretching of the pronated wrist in palmar flexion with the elbow in extension.

Exclusion Criteria:

* not fulfill inclusion criteria