cyrilzakka/clinical-trials huggingface dataset:
Hypoglycemia- and Weight-related Quality of Life in Patients With Diabetes Mellitus Type 2 on Sulfonylurea Derivatives.

1. A prospective, non-interventional study, 125 patients with Diabetes Mellitus Type2 will be enrolled, who, while on metformin, have a sub-optimal glycemic control and who thus will receive additional treatment with a sulfonylurea (SU) derivative. At the start and at 3 and 6 months, during regular visits to the patient's General Practitioner, the patients will complete a series of questionnaires (Patient Reported Outcomes, PROs) directed at diabetes in general, at fear for hypoglycemia, at body weight, at treatment compliance and at general wellbeing. These PROs are the worry subscale of the Hypoglycaemic Fear Survey, Impact of Weight on Quality of Life, revised Diabetes Symptom Checklist, Problem Areas In Diabetes, EuroQol EQ-5D and Medication Adherence Report Scale. In total 75 questions. The frequency of hypoglycemic symptoms, incidence of hypoglycemic events and body weight changes will be assessed and the level of adherence to treatment will be investigated.
2. Diabetic patients, M/F, aged \>35, metformin treated, serum HbA1c ≥7.0% (within last month), informed consent provided, in whom a SU therapy is added. Patients with Type 1 diabetes and with secondary diabetes will be excluded, and patients unable to understand and complete the questionnaires.
3. Primary outcome variables are outcomes from HFS-w and IWQOL in relation to the frequency of hypoglycemic symptoms and body weight at 6 months and to weight change from 0 to 6 months. Secondary outcome variables are the other PROs. The frequency of hypoglycemic symptoms, incidence of hypoglycemic events, changes in body weight and level of compliance will be addressed.
4. The Intention To Treat analysis will be used, with Last Value Extended Forward from 3 to 6 months in case of withdrawal after 3 months. Changes in outcome variables will be analysed by modelling time and potential dummy variables in a Generalized Estimating Equations analysis.
5. Secondary, outcomes in HFS-w and IWQOL are compared with self-reported hypoglycemic symptoms, incidence of hypoglycemic events, body weight and change in body weight from 0 to 6 months. Changes in all PRO's from 0 to 3 and 6 months, potential relationships between (changes in) the different questionnaires, such as with hypoglycemia symptoms, weight (changes) and treatment compliance will be evaluated. A search is done for baseline characteristics which predict outcomes and changes in PRO's, hypoglycemic symptoms, hypoglycemic events and weight changes.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus Type 2 for \> 6 months on treatment with only metformin for \>4 weeks
* HbA1c value \>7.0 and therefore a sulfonylurea derivative is added
* Able to complete a series of questionnaires

Exclusion Criteria:

* Concomitant treatment with an other antidiabetic than metformin and SU derivative
* Contraindications for the use of metformin or SU derivative
* Concomitant diseases which may affect the patient's ability to complete study
Uterine Cavity Volume Measuring With Sonohysterography: A New Objective Method

Measuring of uterine cavity volume using sonohysterography will be done in two groups of patients, Group A included 35 patients for home hysterectomy were indicated and group B includes 150 infertile patients in the childbearing age.

Uterine cavity volume will be measured in group A before and after hysterectomy, and in the group, B will be measured using sonohysterography only using a mathematical method of the sum of a volume of a cone and part of a sphere.

Eligibility Criteria:
Inclusion Criteria:

1. Patients without any gross pathology within the uterus.
2. Patients admitted for hysterectomy.
3. Patients agreed with written consent to participate in the study.

Exclusion Criteria:

1. Virgins.
2. Pregnancy.
3. Systemic blood disease.
4. Any clinical evidence of cervical, uterine or tubal infection.
5. Refusal to undergo saline infusion sonography.
6. Any gross uterine pathology diagnosed clinically or with sonography.
Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye

InflammaDry is a rapid diagnostic test for the detection of elevated levels of Matrix Metalloproteinase-9 (MMP-9) protein in tear fluid.

The InflammaDry test will be used to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patient voluntarily reported at least 1 episode of any of the following ocular symptoms during the last month:

  1. Burning or stinging
  2. Sandy or gritty feeling
  3. Foreign body sensation
  4. Tearing
  5. Light sensitivity
  6. Intermittent or fluctuating vision
  7. Tired eyes

Exclusion Criteria

* Allergy to cornstarch or Dacron
* Allergy to topical anesthetic or fluorescein dye
* Prior eye injury, trauma, or ocular surgery within the last 3 months
* Known blockage of the lacrimal drainage system
* Contact lens wear in the last month
* Previous corneal refractive surgery including RK, LASIK or PRK surgery
* Have an active ocular infection or history of a recent ocular infection in the last month
* Have active intraocular inflammation or history of intraocular inflammation, e.g. Uveitis
* Use of oral doxycycline, corticosteroids, or immunomodulators in the last month
* Have received topical ocular corticosteroids, topical Nonsteroidal (NSAIDs) therapy, or topical ocular cyclosporine in the last month
* Pregnant or lactating
* Use of any topical ophthalmic medications, including artificial tears 2 hours prior to enrollment
Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

Purpose of study is to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) for post-operative pain control after a cesarean delivery compared to placebo and no TENS.


Eligibility Criteria:
Inclusion Criteria:

- Women undergoing scheduled or non-urgent cesarean section

Exclusion Criteria:

* Non-English speaking
* Subjects with a history of chronic pain or chronic opioid use
* Pre-operative use of opioids for more than 1 week in the preceding 6 months
* Previous exposure to the TENS unit
* Women with an allergy or contraindication to narcotics/NSAIDs/acetaminophen
* Subjects who had a midline vertical skin incision during this operation
* Subjects who did not receive intrathecal opioids at the time of their cesarean delivery
* Adhesive allergies
* Subjects with a pacemaker (due to the unknown effects of the TENS on the electrical activity of the heart)
* Intraoperative general anesthesia
* Inability to consent to the study
* Postpartum tubal ligation
Arrest of Interproximal Caries Lesion With 38% Silver Diamine Fluoride Solution

This study was conducted to assess the efficacy of 38% Silver Diamine fluoride and compare it with 5% sodium fluoride varnish in arresting interproximal caries in primary molars at 12 months follow-up. Bitewing radiographs were taken to diagnose as well as to assess caries depth at follow up visits. Each bitewing was scored based on ICCMS radiographic criteria and was compared (follow-ups to baseline)to check for caries arrest.

Interproximal caries included in this study, according to ICCMS criteria, were at stages- RA - caries limited to outer half of enamel RA2 - caries limited to the inner half of enamel RA3 - caries limited to outer third of dentine RA4 - caries limited to middle third of dentine


Eligibility Criteria:
Inclusion Criteria:

1. Children aged 5 to 9 years.
2. Presence of at least 2 primary molars with interproximal caries.
3. Carious lesions of enamel or outer or middle third of dentin in primary molars, as assessed by bitewing radiographs with ICCMSTM scoring (RA1, RA2, RA3, RB4).

Exclusion Criteria:

1. Presence of advanced carious lesions reaching inner third of dentin detected by bitewing radiographic examinations ICCMSTM (RC5, RC6).

3. Children or adolescents that refuse to participate in the study or present negative behaviours.

4. Teeth with premature hypermobility 5. Both physically and mentally disabled children
Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants

A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, in fentanyl and clonidine administered for analgesia and sedation to term newborn asphyxiated infants receiving hypothermic treatment in the NICU.

All patients that are admitted to the study neonatal intensive care units (NICUs) for hypothermic treatment due to perinatal asphyxia are potential study patients, and their parents will be asked for consent.

The patient will be treated according to clinical guidelines and will be included in the study if in need for fentanyl and clonidine according to clinical judgment (HIE and pain scores) and as decided by the responsible clinical doctor. The dosing and administration of the drugs will be implemented according to an algorithm based on pain scoring results.

Apart from extra blood sampling, the bedside monitoring, investigations (electroencephalography (EEG), echocardiography (ECG), ultrasound of the brain and magnetic resonance imaging, (MRI)) and follow-up (neurologic examination) are the same as for all infants receiving hypothermia according to national and international guidelines. A brief standardised pain stimulation will be performed as part of the pain and stress assessment.

In total 50 infants will be included.

Eligibility Criteria:
Inclusion Criteria:

* Term infants (≥ gw 36+0) who, according to national guidelines (6), will receive hypothermic treatment following perinatal asphyxia, and are in need for analgesic or sedative medication according to clinical judgment based on Thomsons score and ALPS-Neo.
* Existing arterial or venous cannulas/catheters for repeated non-traumatic blood sampling
* Informed and written parental consent.

Exclusion Criteria:

* Atrioventricular (AV)- block I-III or heart rate \< 70 .
* Serious coronary heart disease with need for postnatal surgery
* Mean arterial blood pressure \<35 mmHg despite adequate treatment.
Diurnal Variation of Uremic Solutes in Peritoneal Dialysis

Study on the daytime variation of uremic retention solutes and markers of bone-mineral metabolism in patients with end-stage kidney disease treated with peritoneal dialysis

Many epidemiological studies have pointed to the association between serum parameters of phosphate metabolism (phosphate, FGF23) and microbiotic protein fermentation (p-cresyl sulphate \[PCS\], indoxyl sulphate \[IS\]) on the one hand and increased risk of all-cause and cardiovascular death on the other hand.

Hypothesis: Due to failing feed-back mechanisms, diurnal variation of serum concentrations of serum phosphate and fermentation metabolites will be more pronounced in dialysis patients, especially in those with negligible residual kidney function.

Clinical studies assessing this issue are scarce to non-existing.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55
* Normal dietary habits

Exclusion Criteria:

* Treatment with systemic antibiotics within one month Major abdominal surgery Drugs known to affect gastrointestinal physiology (acid secretion inhibitors, prokinetics, laxatives, probiotics, prebiotics,..)
Drug Interaction Study of Azithromycin and Theophylline

Macrolides are potent inhibitors of cytochrome P450 isoenzyme 3A4（CYP3A4）and thus interfere with the pharmacokinetics of many other drugs that are metabolised by this enzyme like theophylline.The aim of this study is to determine whether azithromycin can effect theophylline metabolism in patients.

In this non-blinded,auto-control study,patients with Chronic Obstructive Pulmonary Disease（COPD）or asthma will serve as their own controls during the 2-week treatment phase.The subjects will be co-administered oral doses of sustained release theophylline (100mg tablets,twice daily) and azithromycin (2x250mg capsules,once daily )in the first week.Then patients will received theophylline therapy alone with the same dose in the second week.Blood samples for the measurement of theophylline plasma concentrations will be collected on Days 8 and 15 prior to dosing.All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Eligibility Criteria:
Inclusion Criteria:

* patients with COPD or asthma，aged 18-75 years;
* regularly visiting our hospital;
* meeting the indications for azithromycin and theophylline simultaneously;

Exclusion Criteria:

* patients with renal or hepatic dysfunction;
* patients with congestive heart failure;
* patients with hypothyroidism or hyperthyroidism;
* patients taking drugs likely to affect the theophylline metabolism in the preceding week;
* patients with severe chronic obstructive pulmonary disease,asthma or respiratory infection;
A Pilot Study to Finetune Skin Processing Procedures in Recent Vaccinees, Prior to GeKoSkimm Study Initiation (GeKoSkimm-pilot)

This pilot study aims to optimize the sample processing techniques for collecting and analyzing skin biopsies obtained from individuals routinely vaccinated against yellow fever. By addressing logistical challenges early, risks will be mitigated and the main study's efficiency will be enhanced.

In order to do so, 15 participants will be identified at the ITM polyclinic after receiving a yellow fever vaccination. Participants will be invited to one study visit at the ITM Clinical Trial Site (CTS) 28 days after vaccination to collect blood samples, skin punch biopsies and a minimally-invasive microbiopsy at the site of vaccination. To investigate the ideal location for the skin punch biopsies, participants will be divided in 3 groups; in the first 5 participants the biopsies will be taken directly on the vaccination site, for the next 5 participants, the biopsies will be taken at +/- 3 cm distance from the vaccination site, and for the last five participants, the biopsies will be taken at +/- 10 cm distance from the vaccination site.


Eligibility Criteria:
Inclusion Criteria:

* BMI lower than 30kg/m²
* Able and willing to provide written informed consent
* Having received a yellow fever vaccination 28 days (+2 or -2 days) ago

Exclusion Criteria:

* Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer); asplenia; recurrent severe infections and use of immunosuppressant medication within the last 6 months prior to recruitment, except topical or short-term oral steroids
* History of bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following venipuncture
* Any other significant disease, disorder, planned surgery, or finding which may significantly affect the ability of the volunteer to participate in the study
* Tendency to keloid (scar) formation in response to skin damage

Skin diseases at the biopsy or vaccination site
The Impact of Obstructive Sleep Apnea in Erectile Dysfunction

The syndrome of obstructive sleep apnea (OSA) is a common condition that affects 2-4% of the general population, causing an increase in sympathetic activity, changes in systemic blood pressure, and is associated with cardiovascular disease. The pathophysiological mechanisms that are altered as a result of the events associated with obstructive sleep apnea (hypoxia-reoxygenation, arousals and sleep fragmentation), are associated with an increased risk of developing erectile dysfunction in patients with Obstructive Sleep Apnea. Until today, the studies linking Erectile Dysfunction with Obstructive Sleep Apnea (OSA) are epidemiological studies.

The alterations in the expression profile of endothelial and cardiovascular dysfunction biomarkers and sex hormones disorders that are altered as a result of the events associated with OSA are associated to erectile dysfunction development.

Treatment with continuous positive airway pressure (CPAP) reverses the effects of OSA and patients with erectile dysfunction may improve erectile function.

The primary objective of the study is:

1. To evaluate the impact of CPAP treatment on erectile dysfunction in OSA patients.

The secondary objectives are:

1. To determine the profile of synthesis of different biomarkers related to endothelial dysfunction and cardiovascular disorder, which are altered as a result of the syndrome of obstructive sleep apnea and its relation to the risk of developing erectile dysfunction.
2. To compare the secretion profile of sex hormones related to control erectile function in a group of patients with syndrome of obstructive sleep apnea with and without erectile dysfunction.
3. To assess the prevalence of erectile dysfunction in patients with OSA.
4. To compare the psychological profile of patients with OSA with and without erectile dysfunction in order to detect psychological distress associated with the risk of developing erectile dysfunction.
5. To evaluate the impact of CPAP treatment on the secretion profile of sex hormones related to control erectile function in OSA patients.
6. To evaluate the impact of CPAP treatment on the psychological profile of patients with erectile disfunction in OSA patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of "obstructive sleep apnea syndrome" (Apnea-Hypopnea Index \>10)
* Diagnosis of erectile dysfunction (International Index of Erectile Function score \<25)
* Signed informed consent

Exclusion Criteria:

* Psycho-physical inability to perform or collaborate with performing tests.
* Patients presenting any of the following conditions:

  * cardiovascular diseases, neurological diseases (multiple sclerosis, Parkinson's disease, spinal disc disease).
  * history of pelvic or retroperitoneal surgery.
  * congenital or acquired malformations (Peyronie's disease, hypospadias, epispadias, penile fracture).
  * hormonal disorders (hypogonadism, hyperprolactinemia, hyper or hypothyroidism, Cushing's disease).
  * drug addiction and/or alcoholics and treatment with any of the following drugs: antidepressants, antipsychotics.
Body Parameters as an Independent Predictor of Acute Pancreatitis

This study is to assess the predictive significance of visceral adipose tissue (VAT) and visceral adipose tissue /skeletal muscle tissue ratio (VAT/SMT ratio) for the prognosis in acute pancreatitis (AP) patients.

Acute pancreatitis (AP) is a sudden inflammation of the pancreas. However, one-fifth of patients may develop severe complications with a mortality between 10%-20% It remains a difficulty to find an effective method for prediction of severity of AP at early stage.

It is well-established that obesity (defined as body mass index\[BMI\]\>30kg/m2 by the World Health Organization) is a risk factor for AP and increases the incidence of systemic complication, motality. There are a lot of parameters related to saropenic obesity, including areas of visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), skeletal muscle tissue (SMT), and VAT/SMT ratio. it is unclear which parameter is the best predictor of severe AP. Thus, this study is aimed to investigate the association between these parameters and AP severity and find the best predictor of AP.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with AP
2. age \>18 years

Exclusion Criteria:

1. age\<18years
2. missing data in the electronic medical record
3. history of AP
Outcome of Bilateral Thoracoscopic Sympathectomy for Patients with Primary Focal Hyperhidrosis

The goal of this clinical trial is to examine the overall efficiency of Bilateral Thoracoscopic Sympathectomy on the permanent reduction of Primary focal hyperhidrosis of predilective parts of the body, palms, armpits, face, and soles.

The aims of this study are:

1. examine the efficiency of Bilateral Thoracoscopic Sympathectomy (BTS) with different levels of transection among the persons with the Primary focal Hyperhidrosis (PFH)
2. examine the influence of BTS on cardio-pulmonary function tests in persons with PFH after the operation.
3. examine the incidence, duration, and intensity of compensatory sweating after BTS among persons with PFH
4. examine the incidence, duration, localization, and treatment of postoperative pain after BTS among persons with PFH.
5. determine postoperative complications of BTS among persons with PFH
6. examine the influence of BTS on quality of life among persons with PFH

Eligibility Criteria:
Inclusion Criteria:

* a. persons with confirmed and estimated Primary Focal Hyperhidrosis accepted to participate in this investigation, fulfilling pre and postoperative questionnaires about BTS effects and quality of life after the operation
* b. Satisfactory CardioPulmonary Function

Exclusion Criteria:

* previous thoracic surgical procedures, rib fractures, massive pneumonias, or pleural empyema
* Secondary Hyperhidrosis
Neoadjuvant 5-fluorouracil, Epirubicin and Cyclophosphamide (FEC) Followed by Weekly Paclitaxel and Trastuzumab in Her2 Positive Breast Cancer

The main purpose of this study is to confirm the high pathologic complete response rate after neoadjuvant chemotherapy with FEC followed by weekly paclitaxel and concurrent trastuzumab in Human Epidermal growth factor receptor2 (HER2) positive non operable breast cancer


Eligibility Criteria:
Inclusion Criteria

1. Performance StatusEstearn Cooperative Oncology Group (ECOG) 0-1
2. Histologically confirmed invasive breast cancer,
3. Primary tumour greater ≥ 2 cm diameter, measured by clinical examination and mammography or echography or Nuclear Magnetic Resonance (NMR) candidate to neoadjuvant chemotherapy ,
4. Any N,
5. No evidence of metastasis (M0);
6. Over expression and/or amplification of HER2 in the invasive component of the primary tumour according to one of the following definitions:
7. 3+ over expression by immunohistochemistry (IHC) (\> 30% of invasive tumour cells),
8. 2+ or 3+ (in 30% o less neoplastic cells) overexpression by IHC and in situ hybridization (FISH/CISH) test demonstrating Her2 gene amplication ,
9. Her 2 gene amplication by FISH/CISH (ratio \> 2.2);
10. Known hormone receptor status
11. Hematopoietic status:

    1. absolute neutrophil count ≥ 1.5 x 109/L,
    2. platelet count ≥ 100 x 109/L,
12. Hepatic status:

    1. serum total bilirubin ≤ 1.5 x ULN. In the case of known Gilbert's syndrome a higher serum total bilirubin (\< 2 x ULN) is allowed,
    2. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN,
    3. alkaline phosphatase ≤ 2.5 times ULN;
13. Renal status:

    a. Creatinine ≤ 2.0 mg/dL;
14. Cardiovascular:

    a. baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by echocardiography or multigate acquisition scan (MUGA);
15. For women of childbearing potential negative serum pregnancy test
16. Written informed consent.

Exclusion Criteria:

1. Male gender
2. Pregnant or lactating women
3. Received any prior treatment for primary invasive breast cancer
4. Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (\> 180/110), unstable diabetes mellitus, dyspnoea at rest or chronic therapy with oxygen;
5. Active or uncontrolled infection,
6. Dementia altered mental status or any psychiatric condition that would prevent the under standing or rendering of informed consent,
7. Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies),
8. Previous or concomitant malignancy within the past 3 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
9. Concurrent disease or condition that would have make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.