cyrilzakka/clinical-trials huggingface dataset:
Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease

The goal of this clinical trial is to learn whether a camera pill examination of the whole bowel can be used to diagnose Crohn's disease instead of colonoscopy and a small bowel examination (either MRI or camera pill) in patients aged 18-40 years suspected of having Crohn's disease.

The main question it aims to answer is:

How many patients examined with a camera pill examination of the whole bowel will have a complete examination of the whole bowel and have a diagnosis made without need for any more examinations?

Researchers will compare with patients examined with colonoscopy and a small bowel examination.

Participants will:

* Be examined with either a camera pill examination of the whole bowel, or a colonoscopy and a small bowel examination
* Have their electronic medical records checked to see if a diagnosis has been made
* Have an interview every three months if diagnosed with an inflammatory bowel disease or after a year if no disease was found


Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion of CD\*
* Age 18-40 years
* Signed informed consent

  \*A clinical suspicion of CD is based on the following definition:
* Diarrhea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) and either

  * fecal calprotectin ≥ 200 mg/kg or
  * fecal calprotectin ≥ 50 mg/kg plus one or more of the following findings:
* C-reactive protein (CRP) \> 5 mg/L
* Thrombocytosis (\> 400 x 109/L)
* Anemia (hemoglobin \< 7.0 mmol/L for women and \< 8.0 mmol/L for men or a decrease \> 0.5 mmol/L compared to the usual level)
* Prolonged fever (\> 37.5 ◦C for more than 2 weeks)
* Weight loss (≥ 3 kg or ≥ 5% compared to the normal body weight)
* Perianal abscess / fistula
* Family history of inflammatory bowel disease.

Exclusion Criteria:

* Previous intestinal resection
* Positive serologic markers for celiac disease
* Positive stool polymerase chain reaction for pathogenic bacteria
* Positive stool polymerase chain reaction for intestinal parasites
* Suspected or established acute bowel obstruction (ileus)
* Intake of NSAIDs or acetylsalicylic acid ≤ 4 weeks before inclusion, except low-dose, prophylactic acetylsalicylic acid (≤ 150 mg per day)
* Intake of opioid or opioid-like medications ≤ 1 week before inclusion
* Pregnancy or lactation
* Inability to comply with protocol requirements, e.g. for reasons including alcohol or recreational drug abuse
* Known gastrointestinal disorder other than functional gastrointestinal disorders
* Renal failure defined by a plasma-creatinine above the normal reference range
Efficacy and Safety Study of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292002)(P05722)

The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.


Eligibility Criteria:
Inclusion Criteria:

* Sexually active women, at risk for pregnancy and not planning to use condoms;
* Women in need for contraception and willing to use an oral contraceptive (OC) for 12 months (13 cycles);
* At least 18 but not older than 50 years of age at the time of screening;
* Body mass index \>=17 and \<=35;
* Good physical and mental health;
* Willing to give informed consent in writing.

Exclusion Criteria:

* Contraindications for contraceptive steroids
* In accordance with the Summary of Product Characteristics (SmPC)/Package Insert of DRSP-EE, additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predispose to hyperkalemia):
* Renal insufficiency;
* Hepatic dysfunction;
* Adrenal insufficiency.
* An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia \[CIN\], squamous intraepithelial lesion \[SIL\], carcinoma in situ, invasive carcinoma) at screening;
* Clinically relevant abnormal laboratory result at screening as judged by the investigator;
* Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;
* Before spontaneous menstruation has occurred following a delivery or abortion;
* Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication;
* Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and posttreatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort);
* Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
* Subjects with a diagnosis of the endometrial biopsy such as hyperplasia, atypical hyperplasia, carcinoma or any other abnormality judged clinically relevant by the investigator (This is applicable only for the subjects participating in the endometrial biopsy substudy).
Diagnostic Breath Analysis Study to Detect Sepsis

Analysis of exhaled breath samples using a high-speed gas chromatography medical device will identify Volatile Organic Compounds (VOC) that are specifically associated with SIRS and Sepsis.

Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis System, which includes high-speed gas chromatography, in the early detection of SIRS and Sepsis as compared with current SIRS and Sepsis evaluation methods.

Exhaled breath samples were collected in a Tedlar bag or with a proprietary collection tube. The collection devices are clean and intended for single-use. They are manufactured with approved medical grade materials. Patients were asked to breath into a single-use, medical grade mouthpiece which is connected to the collection bag or tube. The design of the collection devices does not allow the patient to rebreathe the exhaled gas sample. Patients enrolled in the clinical study were asked to breathe into the breath collection device for 2 to 4 breaths. Breath collection is completely non-invasive. Breath samples were held for 30 days and retested at the end of the 30 day period to determine if the VOC profile has changed over time.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria

1. Age 18 years of age or older
2. Able to give written and dated informed consent prior to any study specific procedures.
3. Able to follow instructions for specific breathing maneuvers.
4. Able to breath into a medical grade tube, vial or bag.
5. Initial assessment and screening indicates SIRS or Sepsis.

Exclusion Criteria:

Exclusion Criteria

1. Cognitively impaired and unable to complete informed consent documents.
2. Unable to follow instructions during testing.
3. Severe dyspnea.
4. Use of supplement oxygen which cannot be discontinued during testing.
5. Unable to perform breathing maneuvers required to provide multiple breath samples.
6. Swallowing disorders or chronic aspiration.
7. History of pneumothorax.
8. Patients requiring mechanical ventilation
9. Patients who are pregnant.
10. Patients who have smoked cigarettes or cigars within 30 days prior to trial admission.
A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation

The purpose of this study is to evaluate the usability of the iTEAR100 generation 2 device in combination with its newly developed iLIDS100 disposable cover.

This usability study is meant to validate treatment using the iLIDS100 in patients who already use the NuLids Device and iTEAR100. The patients will simply substitute the iLIDS100 cover in combination with the iTEAR100 for the NuLids product and otherwise maintain their same treatment regimen. The planned number of subjects was chosen to provide clinically relevant usability data

Eligibility Criteria:
Inclusion Criteria:

Must use iTEAR and NuLids at time of enrollment

Exclusion Criteria:

1. have any condition, which in the judgment of the PI would prevent a potential subject from safely completing the study or tolerating device use, such as mental illness, dementia, severe agitation, etc. and including inability to comply with the treatment regimen.
Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial Cancer

A Multi-Center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women with Suspected Ovarian or Endometrial Cancer.

Phase I - The proposed indication for FolateScan is disease or pathological assessment of ovarian or endometrial masses.

The study is designed to verify product safety, determine optimal imaging time, gather efficacy data for the radioactive drug product (Technetium Tc 99m EC20), and assay masses for presence of folate receptors, in women with suspected ovarian or endometrial cancer. Twelve subjects will be enrolled, with a minimum of five malignant cases, as determined by histopathological evaluation.

Women with a suspected ovarian or endometrial mass who either 1) have fixed, paraffin embedded tissue sample(s) available for immunohistochemical staining obtained from a previous pathological evaluation or 2) are scheduled for a procedure to obtain tissue for pathological evaluation that can be fixed and paraffin embedded for immunohistochemical staining are eligible for this study. The ovarian mass may be either an initial finding, e.g., found at a routine pelvic examination or to investigate symptoms, or the ovarian or endometrial mass may be a finding suspicious of recurrent or residual tumor at follow-up examination after surgical resection of confirmed ovarian or endometrial cancer. Patients may not be pregnant or breastfeeding at enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet the following eligibility requirements to be enrolled in the study.

  1. Subjects must be female, 18 years of age or older.
  2. Subjects must have suspected ovarian cancer or metastatic or recurrent ovarian or endometrial cancer with a known pelvic mass as diagnosed by ultrasound, MRI, or CT.
  3. Subjects either are scheduled to undergo a procedure to obtain tissue for pathological evaluation that can be fixed and paraffin embedded for immunohistochemical staining or have sufficient amounts of fixed, paraffin embedded tissue sample(s) available for immunohistochemical staining obtained from a previous pathological evaluation.
  4. Subjects must provide written informed consent prior to enrollment.
  5. Subjects must have kidney function with a creatinine value \<2.0 mg/dL (within the previous 30 days).

Exclusion Criteria:

* Subjects must be excluded if any of the following conditions are present:

  1. Subject is pregnant or breast-feeding.
  2. Subject is simultaneously participating in another investigative drug study.
  3. Subject has completed the follow-up phase of any previous study less than 30 days prior to enrollment in this study.
  4. Subject is unable to tolerate conditions for radionuclide imaging.
  5. Subject has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.
Renal Tubular Acidosis in Incident Renal Transplant Recipients

Metabolic acidosis is a common complication in incident renal transplant recipients. Protracted acidosis may be associated with osteoporosis, inflammation, negative protein balance and malnutrition, and last but not least may cause renal dysfunction. Preliminary data indicate an increased prevalence of nephrocalcinosis in renal transplant biopsies of incident patients presenting with metabolic acidosis. The present study aims (1)evaluate the prevalence and type of renal tubular acidosis (RTA) in incident renal transplant recipients and to identify clinical correlates and (2) to find associations between RTA, nephrolithiasis and nephrocalcinosis


Eligibility Criteria:
Inclusion Criteria:

* Recipient of a single kidney transplant included in the protocol biopsy program.
* eGFR \> 30 ml/min
* Age ≥ 18 years
* Written informed consent

Exclusion Criteria:

* none
Effect of a Soluble Fibre Blend and Medium Chain Triglycerides on Body Composition and Cardiometabolic Risk Factors

The purpose of this study is to investigate whether the addition of capsules containing soluble fibre complex emulsified with medium chain triglycerides and taken before with meals will lead to a significant amount of weight loss, reduced glycemic volatility and diminished cardio metabolic risk factors in overweight and obese individuals when compared to a placebo control.

We believe that those participants taking 3-6 capsules per day of the treatment capsules over a 14 week period will loose a significant amount of weight compared to the placebo group.


Eligibility Criteria:
Inclusion Criteria:

* BMI 27 - 35 kg/m2

Exclusion Criteria:

-
Cognitive Functions in Breastfed Preschool Children

The current work aims to assess of the cognitive development in breastefed children and compare it with artificially fed children as well as the duration of breastfeeding.

Breastfeeding provides nutritional and immunological benefits to infants and also prevents infections . Breastfeeding also has clear short-term benefits for child survival through reduction of morbidity and mortality from infectious diseases. Breastfeeding also has longterm benefits .Breastfeeding improves cognitive development and emotional interactions between the mother and infant .A previous meta-analysis of 20 studies that compared breastfeeding with formula-feeding reported that breastfeeding is associated with significantly improved cognitive development from infancy to adolescence .The results of a meta-analysis of these studies showed that breastfeeding was associated with an increase of 3•5 points (95% CI 1•9-5•0) on intelligence tests at childhood and adolescence. This beneficial effect of breastfeeding could be due to the presence of long-chain polyunsaturated fatty acids, such as arachidonic acid and docosahexaenoic acid in breast milk . Breastfed infants have higher concentrations of these fatty acids that are positively associated with brain development .

Child cognitive development is influenced by genetic and environmental factors . The child has a genetically determined potential for cognitive development. However environmental factors, such as adequate nutrition and the parents' ability to create a good and stimulating home environment may also have a positive influence on the child's cognitive development .Several studies have shown a positive correlation between breast feeding and cognitive development in children . In this study we measure the mental development of children by the use of Stanford binet intelligence test. It is a cognitive and intelligence test that is used diagnose developmental and intellectual deficiencies in young children .

Other risk factors affecting children's mental development should be taken in consideration like the mothers' age, educational level (lower than high school, high school diploma, college degree, university degree, and higher than a university degree), family income, job status (employed/unemployed), sex of infant, gestational age, and infant birth weight.

Eligibility Criteria:
Inclusion Criteria:

* Children more than 3 years and till age of 5 years that present to Assiut University Hospital with acute diseases.

Exclusion Criteria:

1. Children known to have chronic disease.
2. Chidren with History of birth anoxia, birth trauma, kernictrus, epilepsy, metabolic diseases.
3. Positive family history of mental retardation.
Methotrexate in the Treatment of Chronic Idiopathic Urticaria

Chronic urticaria is defined by urticarial lesions persisting at 6 weeks. The cause is not found in about 75% of cases (chronic idiopathic urticaria). The gold standard treatment consists of anti-H1 molecules. In severe cases, refractory to anti-H1, few therapeutic alternatives exist. Methotrexate, which is not expensive and often prescribed by dermatologists, has been efficiently tried in an open study on severe chronic idiopathic urticaria, and also in few case reports.

Chronic urticaria, defined by its persistence beyond 6 weeks, is a common condition (0.1% to 3% of the general population), occurring at any age. The etiology is not found in nearly 75% of cases (chronic idiopathic urticaria). Chronic idiopathic urticaria may resolve over several months or years. The quality of life of patients is usually strongly spoiled. The gold standard treatment consist of anti-H1 molecules. In severe cases, which are refractory to anti-H1, few therapeutic alternatives exist. Two studies have shown a benefit when adding to anti-H1, montelukast, anti-leukotriene, or cyclosporine. Methotrexate, which is another immunosuppressive drug, cheap and commonly prescribed by dermatologists, has been efficient in severe chronic urticaria, in an open study and in few case reports.

Methotrexate, an anti-metabolite drug which inhibits dihydrofolate reductase, is indicated in hematologic malignancies and in autoimmune diseases. It may be given by oral or parenteral administration, once a week, and requires regular monitoring of renal and hepatic function, and blood count.

Eligibility Criteria:
Inclusion Criteria:

Patients who met the diagnostic criteria for chronic idiopathic urticaria, previously treated by

* 3 different molecules of anti-H1 or
* a combination of 2 different molecules of anti-H1 or
* 1 molecule of anti-H1 with at least a double dose for a total treatment duration of ≥ 3 months before inclusion
* With persistency of at least 7 days with urticarial lesions in the previous month

Exclusion Criteria:

* Differential diagnosis of chronic idiopathic urticaria (urticarial vasculitis)
* Treatment with montelukast or immunosuppressive drugs during the previous month
* Contraindications to methotrexate

  * Allergy to methotrexate
  * Treatment which are contraindicated with methotrexate
  * Pregnancy, possibility of getting pregnant (no effective contraception), breastfeeding
  * Anomalies in liver function (transaminases or liver failure at a rate 1.5 X normal)
  * Severe renal impairment (creatinine clearance calculated by the cockcroft formula \<50 ml / min)
  * Chronic respiratory failure
  * Active infectious chronic diseases (viral hepatitis, HIV)
  * History of neoplasia
  * Mental deficiency
  * Involvement in another drug clinical trial
Vvax001 Cancer Vaccine in (Pre) Malignant Cervical Lesions

Immune modulating effects and safety of Vvax001; different dosages will be tested in patients with a history of (pre) malignant cervical lesions.

Vvax001 is a therapeutic cancer vaccine consisting of a replication-incompetent Semliki Forest Virus (SFV) vector encoding HPV-derived tumor antigens. Patients will receive three consecutive doses, with an interval of 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* A history of CIN II and III OR cervical cancer
* Minimally 12 weeks after completion of treatment
* Age of 18 years and older
* Baseline laboratory findings; adequate hepatic, renal ,and bone marrow function, HIV- and HBV-negative
* Patients of child-bearing potential should test negative using a serum pregnancy test and agree to utilize effective contraception during the entire treatment and follow-up period of the study
* Written informed consent according to local guidelines

Exclusion Criteria:

* Prior treatment with immunotherapeutic agents against HPV
* History of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or current or prior use (4 weeks before start of the study) of high dose immunosuppressive therapy.
* History of a second malignancy except curatively treated low-stage tumors with a histology that can be differentiated from the cervical cancer type
* Participation in a study with another investigational drug within 30 days prior to the enrolment in this study
* Any condition that in the opinion of the investigator could interfere with the conduct of the study
Effect of Serum LDL Cholesterol Concentration on Pancreatic Insulin Secretion

Dyslipidemia is characterized by low levels of HDLs, hypertriglyceridemia as well as an increases proportion of small dense LDLs. Changes in lipoprotein particles and its concentrations, especially increased levels of pro-atherogenic LDL particles play an important role in the development of cardiovascular diseases. It is well established that statin/PCSK9-inhibitor treatment is very effective in lowering LDL cholesterol levels and therefore in preventing cardiovascular events. Besides the beneficial effects on cardiovascular system, these therapies are unfortunately linked to increased risk for type 2 diabetes.

However underlying mechanisms for the association between LDL cholesterol levels and the risk for type 2 diabetes remains largely unknown.Type 2 diabetes is especially characterized by insulin resistance and impaired insulin secretion from pancreatic beta-cells. Insulin resistance alone is insufficient to cause type 2 diabetes, as long as the ß-cell is able to compensate for the increased demand for insulin. Once this compensatory mechanism reaches its physiological limits, individuals progress to type 2 diabetes. Accordingly we aimed to investigate the associations between LDL cholesterol concentrations and the key issue in the pathogenesis of type 2 diabetes, insulin secretion before and after lowering cholesterol concentration by treatment with Evolocumab for 12 weeks in patients with medical indication for a treatment with a PCSK9-inhibitor. Therefore, patients will either undergo a hyperglycemic clamp or a oral glucose tolerance test in randomized manner.


Eligibility Criteria:
Inclusion Criteria:

* Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures
* Medical indication for the treatment with a PCSK9-inhibitor
* HbA1c \< 6,5%

Exclusion Criteria:

* Diabetes mellitus
* Pregnant women or breastfeeding
* Hb \< 11.5 g/dl (males) or Hb \< 10.5 g/dl (females)
* treatment with any medication that effects on blood glucose concentrations, e.g. antidiabetic drugs or steroids
* Any pancreatic disease
Continuous Versus Intermittent Oxytocin for Induction of Labor: A Randomized Study

This study evaluates continuous oxytocin versus intermittent oxytocin for induction of labor at term. Half of participants will be taken continuous oxytocin, while the other half will be taken intermittent oxytocin.

In the continuous oxytocin group, traditional treatment of oxytocin used at a starting dose of 1-2 mIU/min and the dose was increased by 2 mIU/min at every 15 minutes until regular contractions obtained at a rate of 3-5 contractions in a 10-minute period. The maximum dose of oxytocin was 40 mIU/min and oxytocin was administered until delivery. In the intermittent group, oxytocin was discontinued when cervical dilation was 5 cm and 2 hours after discontinuation oxytocin was reused at a starting dose of 1-2 mIU/min and was increased as the same protocol used for continuation oxytocin group.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy,
* 37≤ weeks of gestational age ,
* vertex presentation,
* women with cervical dilation 3 cm
* no contraindication to vaginal delivery.

Exclusion Criteria:

* fetal malpresentation,
* multifetal pregnancy,
* more than three contractions in 10 minutes,
* contraindications to oxytocin,
* a category II or III fetal heart rate pattern,
* fetal anomaly,
* fetal demise
* women with immediate delivery indications