cyrilzakka/clinical-trials huggingface dataset:
Effects of IGF-I in HIV Metabolic Disease

This study examines the effects of recombinant insulin like growth factor - I on body composition, glucose homeostasis, and lipids, in adults with HIV infection and signs of metabolic disease.

The main objectives of this study are the following:

1. Determine the effect of recombinant human insulin like growth factor-I (rhIGF-I) (generic: mecasermin) on subcutaneous adiposity in patients with HIV lipodystrophy syndrome.
2. Determine the effects of rhIGF-I on glucose homeostasis and lipids in patients with HIV lipodystrophy.
3. Determine the effects of rhIGF-I on apoptosis, mitochondria, and inflammation, in adipose tissue obtained from patients with HIV lipodystrophy.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive with undetectable viral load
* No change in antiretrovirals for 3 months
* Evidence of lipoatrophy in the limbs, and face or gluteal area
* Dyslipidemia defined as:
* Fasting triglycerides \> 200 OR
* HDL cholesterol \< 40 mg/dL
* Abnormal glucose homeostasis defined as:
* Fasting hyperinsulinemia \> 20 uU/mL OR
* Fasting glucose 100-125 mg/dL, inclusive

Exclusion Criteria:

* Two consecutive viral \>75 or \> 50 copies/mL using the tests listed above
* Presence of AIDS wasting
* Change in antiretroviral medication (not dose) in the prior 3 months
* Coronary artery disease, cerebrovascular, or peripheral arterial disease
* Diabetes mellitus
* Adrenal insufficiency, hypoglycemia, thyroid disease, or other endocrine disorder that is untreated
* Malignancy
* Eating disorder
* Pregnancy (urine pregnancy test is required of all females)
* Previous liposuction or bariatric surgery
* Other systemic conditions or other disorders at the discretion of the investigators
* Current use of systemic glucocorticoids, or other agent affecting body weight or glucose homeostasis or other drug at the discretion of the investigators
* Use of interferon within the past six months
* Use of insulin, insulin secretagogue, thiazolidinedione, or metformin in the prior 3 months
* Initiation or dose adjustment, within the prior 3 months, of any of the following drugs or drug classes: fibrate, cholesterol binding resin, statin, niacin, or omega 3 fatty acid (fish oil).
* Use of uridine, growth hormone, IGF-I, and growth hormone releasing factor analogues
Effects of Consumption of Orange Juice on Vascular Protection and Immune Function: Clinical Study on the Specific Contribution of Citrus Flavanones

Epidemiological studies have firmly established the health effects of high intakes of fruits and vegetables and in particular in regards to the prevention of cardiovascular diseases. Citrus fruits are the most widely consumed throughout the world, mainly as juice. Citrus fruits are rich in vitamin C but also in various plant micronutrients which are the most abundant polyphenols. Several in vitro studies and animal models suggest that the polyphenols of citrus are involved in the protective effects of citrus vis-à-vis the cardiovascular diseases. However, profits in health associated with taking these polyphenols are unknown and so far no clinical studies have been conducted to determine the contribution of polyphenols of citrus in this protection.

The main objectives of this project are (1) to characterize the effects of single dose and made repeated consumption of orange juice on vascular protection and the immune response and (2) to assess the specific role of polyphenols present in citrus fruits in this protection. To do this the investigators will conduct a clinical study, randomized and crossover, among healthy men 50 to 65 years that are slightly overweight. These volunteers, who continue to follow their usual diet, should consume daily for 4 weeks (1) orange juice or (2) an isocaloric control beverage or (3) the same drink spiked with a dose of polyphenols similar to that given by orange juice.

Clinical study, randomized, crossover, double-blind in healthy men 50 to 65 years who are slightly overweight.

Eligibility Criteria:
Inclusion Criteria:

* Males
* Age: 50 to 65 inclusive
* Body mass index of 25 to 30 kg / m² (inclusive

Exclusion Criteria:

* Hypertriglyceridemia or known hypercholesterolemia, treated or not
* Serology HIV and / or HCV positive
Pre-calculation for Frequency Lowering With Hearing Devices

Perceptual evaluation of the parametrization and pre-calculation of frequency lowering requires the participation of subjects with hearing loss.


Eligibility Criteria:
Inclusion Criteria:

* Experienced hearing aid user (minimum use duration 1 year)
* Adult (minimum age: 18 years),
* Experience with frequency lowering,
* Hearing thresholds with N5-N7, S1, S2, S3 hearing loss
* Symmetrical hearing loss (difference between ears \<= 10 dB for 1kHz-6kHz) ,
* Sensorineural hearing loss,
* Air Conduction - bone conduction gap \<= 10 dB,
* Written and spoken German,
* Ability to understand instruction,
* Ability to describe listening experiences,
* Ability to attend to the appointments,
* Ability to fill in a questionnaire conscientiously
* Healthy outer ear (without previous surgical procedures)
* Hearing loss within the fitting ranges of the investigational product,
* Informed consent as documented by signature.

Exclusion Criteria:

* Clinical contraindications deformity of the ear (closed ear canal
* or absence of pinna),
* Not willing to wear the hearing aid,
* Fluctuating hearing that could influence the results,
* Contraindications to the MD in this study, e.g. known hypersen-sitivity or allergy to the investigational product,
* Limited mobility and not in the position to attend all appoint-ments,
* Limited ability to describe listening impressions/experiences and the use of the hearing aid,
* Inability to produce a reliable hearing test result,
* Massively limited dexterity,
* Known psychological problems,
* Known central hearing disorders.
Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking

The purpose of this study is to determine: 1) the short-term clinical efficacy and safety of bupropion for helping adolescent tobacco smokers quit, and 2) The role of withdrawal symptoms in the maintenance of smoking in adolescents.

This 10-week study consists of an unassisted (pretrial) acute tobacco withdrawal (AW) phase and a 7-week randomized double-blind placebo-controlled trial of bupropion (300 mg/day) for tobacco dependence. Neuropsychological examinations will be conducted at baseline, during acute withdrawal, and during treatment (incl. early withdrawal) with bupropion. We expect smoking cessation in approximately 25% of the active medication group and significant overall smoking reduction. We postulate that bupropion will also reduce the irritability, depressed mood and anxiety symptoms that typically occur during tobacco withdrawal. We expect to observe optimal cognitive performance, (i.e., attention, memory), and affective state during satiety, impairment during pre-treatment abstinence, and intermediate level cognitive performance in the abstinent active-treatment group. Because limited data are available on cognitive tasks in adolescent smokers, a non-smoking group will be included in order to establish the validity and appropriateness of our paradigm with a normative sample.

Eligibility Criteria:
Inclusion Criteria:

* More than 100 lbs
* IQ greater than 80
* General good health
* Not pregnant
* Non-Smoker: No cigarettes in last 6 months, less than 5 in lifetime
* Smokers: Smoke more than 6 cigarettes per day for at least 6 months

Exclusion Criteria:

* Cardiac, Central Nervous System (CNS) or severe psychiatric disorder
* Psychoactive medications (including nicotine replacement)
* Substance use disorder
Clinical and Basic Research of ETV Plus GM-CSF in Chronic Hepatitis B Patients

Previous studies indicated that Granulocyte Macrophage-colony Stimulating Factor (GM-CSF) could improve survival rate in patients with acute liver failure and obtain higher HBsAg seroconversion rate when in combination with peg-interferon for chronic hepatitis B (CHB) patients. In this study, investigators will study the clinical effect of entecavir (ETV) plus GM-CSF in patients with CHB compared to ETV monotherapy.

Antiviral treatment plays critical role in treatment of chronic HBV infection. Entecavir, an nucleos(t)ide analogs (NA) targeting the viral polymerase, is widely used in China as the first line drug in antiviral treatment for CHB patients. The sustained suppression of serum HBV DNA to undetectable level has been proven to be associated with the prevention of progression of liver disease and inhibition of the development of hepatocellular carcinoma. According to data published, a rate about 70% HBVDNA undetectable could be reached after 1 year therapy. However, the rate of HBsAg loss is very low about 0% to 1%. Granulocyte-macrophage colony-stimulating factor(GM-CSF) is an important cytokine for the generation and propagation of antigen-presenting cells and for priming a cellular immune response. It increases the production of macrophage precursors and, in turn,enhances the T-helper cell (Th cell)-mediated cytotoxicity and regulates the tumoricidal cytokines. Previous studies indicated that when combined with IFN in patients with chronic HBV infection, it increased the therapeutic efficacy of the latter. Recent studies showed that GM-CSF benefit patients with acute liver failure. In this study, entecavir (ETV) plus GM-CSF would be used in patients with CHB compared to ETV monotherapy. Primary objective of the study is to see if there is significant improvement in HBsAg loss, rates of HBeAg loss and HBV undetectable are also to be observed. Function of NK cell from the patients enrolled will be measured during the therapy.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg positive for more than 6 months
* HBeAg positive
* ALT≥80U/L or inflammation score ≥2 of histological examination

Exclusion Criteria:

* History of drug allergy to GM-CSF
* coinfection with HCV, HIV, HAV, HEV
* liver cirrhosis or CHILD score \>7
* diagnosis of hepatocellular carcinoma or AFP\>100ng/ml
* Allergic thrombocytopenic purpura
Knowledge and Attitude of Pregnant Women Towards Preeclampsia in Assiut Governorate

Our study will be a cross sectional study to evaluate the knowledge level and attitude of pregnant women towards preeclampsia and factors affecting it ,the study will be done at Assiut University Hospitals - Women's Health Hospital. all pregnant women who will come to ANC visits will be included .the study tool is a well structured questionnaire for assessment of our outcomes.

Preeclampsia is a pregnancy-related hypertensive disorder that usually occurs after 20 weeks of gestation. It is characterised by hypertension and proteinuria . Preeclampsia is the leading cause of maternal death, complicating about one-tenth of all pregnancies worldwide . It is the second greatest cause of direct maternal death, accounting for 70,000 maternal mortality globally each year .The burden of preeclampsia and eclampsia is most significant in low- and middle-income countries (LMICs), where hypertensive disorders of pregnancy account for 10-15% of maternal deaths.

Early detection of symptoms, rapid presentation to healthcare facilities, and subsequent management with antihypertensive medications, magnesium sulphate, and delivery of the foetus and placenta improve outcomes in pregnancies complicated by preeclampsia and eclampsia . As a result, ANC visits and intrapartum admission are critical chances for patient counselling Despite the essential relationship between women's awareness of preeclampsia and health seeking behaviour, research on this topic is limited, particularly in underdeveloped countries. Even in developed countries, studies in high-income countries show that only half of patients were counselled about preeclampsia signs and symptoms, despite the fact that counselling by healthcare personnel is related to higher patient knowledge. So there is a gap in studying pregnant women's knowledge and attitudes concerning preeclampsia in underdeveloped countries, particularly Egypt, where studies on this topic are scarce.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women.
* pregnant women in first, second and third trimester.
* pregnant women who come to receive ANC at Assiut University Hospitals - Women's Health Hospital out patient clinic.

Exclusion Criteria:

* Pregnant women that are unwell to give consent.
* Pregnant women who are already diagnosed by preeclampsia and eclampsia.
Evaluation of the Effectiveness of a Quality Improvement Intervention

This rigorous evaluation demonstrated that implementation of a time-limited quality improvement strategy effectively improved coverage of some components of an integrated maternal and child health service in a complex health environment, but we were unable to achieve the changes needed to provide a comprehensive package of care for mothers and children.

Background: Despite policies and guidelines recommending integration of health services in South Africa, provision of maternal and child health services remains fragmented. This study evaluated a rapid, scaleable, quality improvement intervention to improve integration of maternal and child health and HIV services at a primary health level, in KwaZulu-Natal, South Africa.

Methods: A three-month intervention comprised of six quality improvement mentoring visits, learning sessions with clinic staff to share learnings, and a self-administered checklist aimed to assist health workers monitor and implement an integrated package of health services for mothers and children. The study evaluated 27 clinics in four sub-districts using a stepped-wedge design. Each sub-district received the intervention sequentially in a randomly selected order. Five waves of data collection were conducted in all participating clinics between December 2016-February 2017. A multi-level, mixed effects logistic regression was used to account for random cluster fixed time and group effects using Stata V13.1.

Eligibility Criteria:
Inclusion Criteria:

Women who attended the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.

Exclusion Criteria:

Women who did not attend the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.
Pain Assessment in Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbations.

The prevalence of chronic obstructive pulmonary disease (COPD) is between 8 and 12% of the adult population. This prevalence is expected to increase over the coming decades due to the aging of the population and the continued exposure to risk factors for the disease. The evolution of COPD is marked by the occurrence of exacerbations of varying severity and patients are frequently admitted to the emergency department for evaluation, treatment and / or hospitalization. Admission in emergency department for COPD exacerbation represents approximately 1% of emergency admission.

Chronic pain is common in patients with Chronic Obstructive Pulmonary Disease (COPD). The pain intensity may increase during acute episodes of exacerbations. This study is aimed to compare pain intensity during exacerbation and stable phase of patients with chronic obstructive pulmonary disease (COPD).

Chronic pain is common in patients with Chronic Obstructive pulmonary Disease (COPD). The pain intensity may increase during acute episodes of exacerbation. Fifty (50) patients in acute exacerbation of COPD will be included in the emergency department of CHU Grenoble Alpes and Hôpital du Sacré Coeur de Montréal. The intensity and characteristics of pain will be evaluated from the Short-Form McGill Pain Questionnaire (SF-MPQ) and the Brief Pain Inventory (BPI). Assessment of respiratory status, anxiety and depression, and clinical and biological data, defining the severity of exacerbation, will also be collected. A 30-day follow-up visit, after a return to the stable state of COPD, allowed the realization of Respiratory Functional Exploration and the same questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 40 years
* smoking at least ≥ 10 pack years
* previous FEV / FVC \<0.70 post bronchodilator
* admitted for exacerbations (GOLD definition)

Exclusion Criteria:

* A dementia or non-communicating patient
* Patient with chronic pain of neoplastic origin or severe trauma (fracture , dislocation or severe pain) within 15 days before the date of inclusion
* Patient with no social security insurance , with restricted liberty or under legal protection
* Pregnant woman parturient or nursing
Vitamin D in Fatty Liver Disease

This study evaluates the influence of vitamin D in reducing laboratory, elastographic (Fibroscan) and metabolic components of NAFLD. Half of the patients will receive vitamin D (Plivit D3) while the other half will receive placebo

In this study will participate patients who come to the regular ambulatory examinations (referred by gastroenterologists, or family physicians in the Department of Gastroenterology CHC Rijeka) and have one or more components of the metabolic syndrome (hypertension, diabetes, obesity, dyslipidemia).Nonalcoholic fatty liver disease will be defined by transient elastography (FibroScan, Echosens, Paris); Controlled Attenuation Parameter (CAP) for assesment of liver steatosis and Liver Stiffness Measurements (LSM) for liver fibrosis. In all patients other causes of chronic liver disease will be excluded; chronic viral hepatitis, autoimmune diseases and other metabolic liver diseases as well as use of drugs than can cause liver steatosis and fibrosis and alcoholic liver disease.

This study will include 450 patients. Taking into account the possible drop-out rate around 15% of the patients during the study period, a total of 400 patients will be randomized. Patients will be randomized into two groups. The first group will be consisted of the patients with NAFLD who will be receiving original medication during the 12 month period. The second group will be consisted of the patients with NAFLD who will be receiving placebo during the 12 months period, which will be identical to the original medication in its packaging and form.

After the 6 and 12 months of therapy in all patients will be evaluated: liver enzymes and metabolic laboratory parameters of NAFLD (insulin resistance, lipidogram and serum glucose), as well as the TE-CAP in order to evaluate the efficiency of Plivit D3 for the treatment of NAFLD.

Eligibility Criteria:
Inclusion Criteria:

* patients with Non-Alcoholic Fatty Liver Disease (NAFLD)
* signed informed consent
* possibility to follow instruction and the protocol

Exclusion Criteria:

* chronic B or C hepatitis
* usage of hepatotoxic drugs in the period of 6 months before inclusion
* chronic kidney insufficiency (grade 4 and 5), hemodialysis
* any other chronic liver disease
* opioid dependancy
* any malignancy
* HIV seropositivity
* alcohol abuse
* pregnancy
* inability to follow the protocol
A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.


Eligibility Criteria:
Inclusion Criteria:

* Study participant must be at least 18 years of age at the time of signing the informed consent.
* Study participant is being treated with commercial bimekizumab per locally approved prescribing information and in accordance with her treating physician.
* Study participant is breastfeeding and intends to breastfeed throughout the Sampling Period.
* The decision to treat with bimekizumab and to breastfeed is made independently from and prior to the study participant consenting to participate in the study.
* Study participant must be on bimekizumab treatment for at least 12 weeks after delivery and since starting/restarting/continuing bimekizumab prior to sampling (prior to start of the Sampling Period).
* A female study participant is eligible to participate if she is not pregnant and does not plan to become pregnant during the study.

Exclusion Criteria:

* Study participant has any medical, obstetrical, or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.
* The infant has any abnormality noted on physical examination or medical history that, in the opinion of the Investigator, may jeopardize or compromise study participation.
* Study participant has a history of chronic alcohol or drug abuse within the previous last year.
* Study participant has history of breast implants, breast augmentation, or breast reduction surgery.
* Study participant plans a surgical intervention during the Screening Period and Sampling Period or anticipates having surgery while participating in the Sampling Period (does not apply to tubal ligation).
* Study participant or her infant has participated in another study of an investigational medicinal product (IMP) (and/or an investigational device) within the previous 6 months or is currently participating in another study of an IMP (and/or an investigational device), unless the study is UCB PS0036 or a bimekizumab registry study.
* Study participant or her infant has previously participated (ie, entered the sampling period) in this study.
Complications in Hypertension and Obesity

The study in aimed to investigate epidemiology of risk factors in Russian Federation its prognostic value aimed on acceptance of national specific definition of metabolic syndrome and guidelines for its management.


Eligibility Criteria:
Inclusion Criteria:

* Age older 18 years
* Signed informed consent
* Blood pressure more than 130 and/or 85 mm Hg
* Waist circumference more than 80 sm in females and 94 in males and/or BMI more than 25 kg/m2
* Dyslipidemia (elevated TG and/or decreased level of HDLP or therapy for high triglyceride level)
* Fasting glucose more than 5,6 mmol/l

Exclusion Criteria:

* Associated clinical conditions (stroke, TIA, MI, heart failure, renal disease, diabetes mellitus)
* Severe concomitant diseases affecting outcome