cyrilzakka/clinical-trials huggingface dataset:
Body Composition, Bone Health and Hormonal Status in HIV-1-infected Individuals

Improved survival of people living with HIV has resulted in an increased occurrence of other comorbidities, such as cardiovascular, renal, bone and endocrine pathologies.

The data that is currently available on cART-associated changes in bone mineral density, body composition and hormonal values is short-term and mainly derived from patients initiating cART in accordance with previous treatment guidelines. As current guidelines recommend earlier cART initiation and as PI-based regimens are becoming less frequently used, a favorable outcome on bone health, body composition measures and endocrine status might be expected.

This study will therefore prospectively document alterations in bone mineral density, body composition and endocrine status in HIV-infected patients in whom, in the current treatment era, an INSTI-based cART regimen is initiated as a first line regimen.

Patients will be included at the initiation of cART. The follow up for this study is planned to fit within the routine follow up consultations and includes some extra experimental investigations, such as the medical body composition measurements, resting energy expenditure measurement, Achilles bone ultrasonometer and DXA scans. Standard blood and urine samples will be taken, including standard analyses and some extra analyses for the study.

Physical activity will be monitored for 5 consecutive days using a bracelet device while patients will be asked to record their food intake using a standardized diet agenda.

Total follow up time will be 144 weeks and includes 12 visits in total.

Eligibility Criteria:
Inclusion Criteria:

* Documented and confirmed HIV-1-infection
* Aged 18 years or above
* Naïve to anti-retroviral treatment, unless anti-retrovirals were taken in the context of occupational or non-occupational post-exposure prophylaxis or in the context of prevention of mother-to-child transmission
* Willingness to sign the written informed consent

Exclusion Criteria:

* Pregnancy and breastfeeding
* Patients receiving medical care through an 'emergency care package'
Penetration of Ertapenem Into Bone

The aim of the study is to determine the penetration levels of ertapenem into bone tissues in patients with Diabetes Mellitus (D.M) or Peripheral Vascular Diseases (P.V.D) undergoing amputation, and to correlate theme to the concentration of the drug in blood and other soft tissues

Twelve patients with D.M or P.V.D who are undergoing bellow knee amputation with or without gangrene.

Within four weeks prior the amputation a vascular profile will be determined by Doppler and skin perfusion will be determined by transcutaneous oxygen pressure measurements (TcPO2) on the dorsal side of the mid foot of the affected limb.

Each patient will receive 1 g of Ertapenem in 100 ml of normal saline by IV infusion -during 30 minutes through IVAC:

* -2 days prior the amputation
* -1 day prior the amputation
* 1 hour before amputation The infusions will be started approximately at the same time of the 3rd infusion, prior the planned amputation.

Blood samples (approximately 6ml each) will be collected before Ertapenem administration, simultaneously with bone and soft tissue samples at the time of amputation and at the end of the surgery

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Diabetes Mellitus or Peripheral Vascular Disease
* Undergoing bellow knee amputation with or without gangrene
* Patients without clinical signs of acute infection
* Creatinine Clearence more than 60 cc/ min

Exclusion Criteria:

* Known hypersensitivity to any component of ertapenem or to other drugs in the same class.
* Patients who have demonstrated anaphylactic reactions to beta-lactams.
* CNS disorders (e.g., brain lesions or history of seizures).
* Patient treated with other antibiotics at least 72 hours.
* Pregnant women, nursing women, or fertile women not practicing adequate methods of contraception.
* Patient or legal representative of the patient is unable to provide written informed consent for any reason.
* Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug to the patient.
* Neutropenia
* Renal failure
* Hepatic Insufficiency: \> x 2 upper limit.
* A need for any additional concomitant systemic antibacterial agent.
* Life expectancy less than 6 month
* Patient is undergoing immunosuppressive therapy, including use of high dose corticosteroids (e.g.,20 mg or more prednisone or equivalent per day)
* Patient is in a situation or has a condition which, in the investigator's opinion, may interfere with optimal participation in the study.
* Participation in an another clinical trial.
Association Between Hepatitis C Virus Infection and Hematologic and Thyroid Cancers

This study will investigate the possible relationship between infection with hepatitis C virus (HCV) and the development of certain hematologic cancers (Non-Hodgkin's lymphoma, Hodgkin's lymphoma, chronic lymphocytic leukemia, multiple myeloma) and thyroid cancer. HCV causes chronic hepatitis, cirrhosis, and liver cancer. It is transmitted primarily through injection drug use and transfusion of infected blood. Studies have shown that HCV may also be linked to hematologic cancers and thyroid cancer.

This retrospective study will examine medical records from veterans with and without HCV infection who previously received treatment in the Veterans Administration medical system. Data collected on each subject will include the subject's race, sex, age and era of military service, presence of liver disease or thyroiditis at their baseline clinic visit, number of inpatient visits in the past 5 years and outpatient visits in the past year, and the presence of various specified cancers. The prevalence of cancer and other conditions among HCV-infected subjects and non-HCV infected subjects at baseline and the subsequent development of the cancers of interest in these two groups will be compared and analyzed for a possible causal relationship.

Hepatitis C virus (HCV) may be a cause of hematologic malignancies and thyroid cancer. HCV infection is common among U.S. military veterans receiving care in the Veterans Administration healthcare system. The investigators propose a retrospective cohort study using VA administrative databases. A cohort of approximately 147,000 HCV-infected veterans has been identified for the period 1997-2004. Likewise, a cohort of approximately 573,000 HCV-uninfected veterans has been identified for the same period. These subjects are being evaluated for the diagnosis of hematologic malignancies, thyroid cancer, and related medical conditions as recorded in VA databases. The comparison of the prevalence and incidence of these cancers in the two cohorts will provide a test of the hypothesis that HCV infection can cause these cancers.

The investigators will also evaluate the association between HCV infection and several other medical conditions, which might be related to HCV infection, specifically: immune thrombocytopenic purpura, autoimmune hemolytic anemia, cholangiocarcinoma, cholangitis, and pancreatic cancer.

Eligibility Criteria:
* None given.
Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus

To evaluate the dose-response relationship of AVE0010 administered once daily and twice daily with chronic dosing in metformin-treated subjects with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Males, females, age 30, - 75 years, type 2 diabetes mellitus, treated with metformin ≥1.0 g/day, at a stable dose for at least 3 months, BMI 25 - 40 kg/m2, HbA1C ≥7.0% and \<9.0%.

Exclusion Criteria:

* Type 1 diabetes, pregnancy, lactation, women of childbearing potential, treatment with other antidiabetic agents than metformin, history of metabolic acidosis, hemoglobinopathy or hemolytic anemia, clinically significant medical abnormalities.
Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction in Zanzibar

The purpose of this study is to assess the efficacy of artesuante + amodiaquine four years after its introduction as first line treatment for uncomplicated childhood malaria in Zanzibar. The hypothesis is that the treatment has a polymerase chain reaction (PCR)adjusted parasitological cure rate of at least 85% 42 days after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age below 60 months
* Weight ≥5kg
* No general danger signs or severe malaria present (see 4.4.2.1 \& 4.4.2.2)
* History of fever within 24 hours OR axillary temperature ≥ 37.5Cº
* No other cause of fever is detectable
* No severe malnutrition
* Presence of P. falciparum asexual parasite density between 2000- 200,000/ul
* Guardian/Patient has understood the procedures of the study and is willing to participate
* Patient able to come for stipulated follow up visits and has easy access to the Study Site

Exclusion Criteria:

* Not able to drink or breastfeed
* Persistent Vomiting
* Recent history of convulsions
* Lethargic or unconscious
* Unable to sit or stand (as appropriate for age)
* History of allergy to test drugs
* History of intake of any drugs other than paracetamol and aspirin within 3 days
Lipid Balance in Adult Sickle Cell Patients

This study aims to describe and/or searches for, in cohorts of adult sickle cell anemia (SCA) and SC sickle cell patients living in the French West Indies and followed by SCD Reference and Competence Centers: 1-lipids profiles and associations at steady state with occurrence of sickle cell disease (SCD) complications, 2-lipids profile evolution during and after prospective acute complications (vasoocclusive crises (VOC) and priapism), 3-lipids profile variation (inter /intra individuals) during 4 prospective years, 4- Genetic primary modulators of SCD complications, 5- insulin resistance (HOMA), free fatty acids and glycerol dosages, 6- lipids enzymes, lipidome and functionality of HDL in sub-groups of SCD population.

* Cohorts of sickle cell disease patients including sickle cell anemia (SCA) and SC sickle cell patients living in Guadeloupe and Martinique and followed by the Sickle cell disease (SCD) Reference and Competence Centers of French West Indies.
* Lipid profile includes total cholesterol, HDL-cholesterol, non-HDL-cholesterol, LDL-cholesterol and triglycerides, apolipoprotein A-I and B.

Medical histories and prospective collection of SCD complications include retinopathy, deafness, tinnitus, osteonecrosis, leg ulcers, strokes, acute chest syndrome, VOC, priapism, pulmonary arterial hypertension (PAH) and PAH sd (echocardiography diagnosed when tricuspid regurgitant jet velocity ≥2.5 m/sec), kidney disease: chronic renal insufficiency and/or nephropathy.

* Objective 4: to describe genetic primary modulators of SCD complications: fetal hemoglobin, alpha-thalassemia, haplotypes of beta S gene.
* Objective 5 will be performed in the entire cohort at inclusion and during prospective complications (VOC, priapism).
* Objective 6 will be performed in a sub-group of 90 individuals (n=15 with VOC and n= 15 without VOC, n=15 with priapism and n=15 without priapism, n= 15 with pulmonary arterial hypertension syndrome (PAH Sd) and n=15 without PAH Sd), as well as in a subgroup of n = 15 patients prospectively experiencing VOC and n = 15 patients prospectively experiencing priapism.

A collection of plasma is performed to fulfill objective 6, as well as a collection of blood cells for later researches.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 years and over
* Be affected with Sickle cell anemia or SC sickle cell
* Living in French Caribbean Islands of Guadeloupe or Martinique and followed by physicians issued from a French West Indies Sickle Cell Reference or Competence Center
* At steady state in the last month (without acute complication)
* To have given a written consent after information on the study.

Exclusion Criteria:

* Other hemoglobinopathies than sickle cell disease
* Pregnancy or lactation
* Patient under judicial protection or without freedom
* Patient not affiliated with a social security system
* Patient hospitalized for transfusion or bleeding in the last 3 months
A Randomised Trial With Irinotecan, Cetuximab and Everolimus (ICE)Compared to Capecitabine and Oxaliplatin (CapOx) for Patients With Gemcitabin Resistant Pancreatic Cancer

This is an open multicenter randomized phase I/II study. The main purpose with this study is to investigate dose and efficacy of a combination of Irinotecan, Cetuximab and Everolimus given biweekly to patients with local advanced or metastatic pancreatic cancer AFTER progression from 1. line treatment with Gemcitabine.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained prior to study entry?
2. Patient has histologically/cytologically proven, non-resectable or metastatic, adenocarcinoma of the pancreas?
3. Progressive disease during adjuvant chemotherapy (or within 6 month after) or progressive disease during or after first line chemotherapy?
4. Former treatment with chemotherapeutic agent containing gemcitabine?
5. Is the age of the patient ≥ 18 years?
6. Is the ECOG performance status 0-1?
7. Is the absolute neutrophil count (ANC) ≥ 1.5 x 109/l?
8. Is the platelet count ≥ 75 x 109/l?
9. Is the total bilirubin ≤1.5 x UNL (upper normal limit)?
10. Patient has normal liver function? (If liver metastases are present, there is no upper limit for ALAT/SPGT/alk phosph)?
11. Creatinine clearance ≥ 30 ml/min
12. Is the patient capable of following the treatment and the plan of evaluation?

Exclusion Criteria:

1. CTC Grade 3 hyperlipidaemia (\>10.34 mmol/l) in spite of treatment
2. Active former or concurrent history of malignant neoplasm, in the last 2 years?
3. Any condition or therapy which, by the investigators opinion, will expose the patient to a risk or will affect the purpose of the clinical trial?
4. Pregnant or breast feeding patient (fertile patients must use contraceptives)?
5. Infections or other serious medical conditions, which can obstruct the patient's possibility of receiving the treatment? (for instance serious heart, metabolic or lung disease)
6. Known hypersensitivity toward one or more of the parts in the treatment?
Effects of a Bakery Product Enriched With Fibre and L-carnitine on Insulin Resistance in Patients With Metabolic Syndrome

The aim of this study was to evaluate the efficacy of a bakery product enriched with dietary fibre and L-carnitine on glucose homeostasis and insulin sensitivity in overweight patients with or without metabolic syndrome.

Conceivably, different biochemical changes in insulin-mediated signalling pathways may contribute to an impaired insulin-mediated glucose transport and metabolism that eventually results in insulin resistance and the clinical features of metabolic syndrome. According to this, both compounds -L-carnitine and dietary fiber- interacting by different mechanism of action could improve glucose homeostasis and insulin sensitivity. However, the health beneficial effects of the combination of both compounds are not shown and confirmation of the functionality of such products must be accomplished by conducting the appropriate studies intervention nutrition.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 35 Kg/m2

Exclusion Criteria:

* Pregnancy or lactation
* Kidney, liver and thyroid disease
* History of cardiovascular or chronic inflammatory disease
* Diabetes mellitus
* Lipid-lowering medication
* Triglyceride concentration \> 400 mg/dl
* Consumption of other carnitine and/or fibre-enriched foods
MOVING - MOtiVation, INtervention and Vascular chanGe

Background: The impact of demographic changes on workplace has increased the importance of effective occupational preventive health programs. The primary goal of these programs is the improvement of overall health status (and therefore increase productivity and decrease healthcare costs) of the increasingly older workforce through positive lifestyle behavior change.

A one- year preventive health behavior-change program for the employees of the company British Petrol (BP) shall be scientifically evaluated. The initial stage of the program consists of a health-behavior seminar and six weeks (twice a week for 90 minutes) of supervised endurance exercise (i.e. jogging, nordic walking, cycling or swimming) in groups. In the second phase of the program, the participants receive a recommendation to continue exercise regularly unsupervised for one year, and receive monthly supervised exercise training sessions. Clinical check-ups are performed at baseline (V1) at three months (V2) and at 12 months (V3).

The study will investigate the effect of one year of participation in a lifestyle- intervention- program on the participants' metabolic risk profile, exercise capacity and vascular health. A primary focus is on the endothelium, because poor endothelial health is a risk factor and prognostic indicator of atherosclerosis and cardiovascular events.

Hypothesis: One year of participation in endurance exercise (twice a week for 90 minutes) may positively influence endothelial health (RHI)

The primary aim:

change in endothelial function (reactive hyperemia index (RHI)) after one year.

Secondary aims:

Changes in other vascular parameters (AI: augmentation index, CAVI: Cardio ankle vascular index, ABI: ankle brachial index ), changes in anthropometric, inflammatory and metabolic parameters, exercise capacity (Watt/kg), physical activity, and health related quality of life (HRQoL).

Eligibility Criteria:
Inclusion Criteria:

* Employees of the company British Petrol (BP) in Lingen, Germany
* men and woman of all age
* approval for being able to participate in physical activity
* existing, written agreement to study-participation with prior, detailed education

Exclusion Criteria:

* Acute or chronic disease of any kind, which does not allow participation in physical activity (missing approval of being able to participate in physical activity)
* Incompetent patient, who is not able to understand character, meaning and consequences of the study
The Effect of Reproductive Violence Education Given to Women on Perception of Violence, Conflict Resolution Styles and Awareness of Violence: A Randomized Controlled Trial

This study was planned as a methodological and randomized controlled experimental study to determine the effects of reproductive violence education given to women on women's perceptions of violence. H0a: There is no difference in the perception levels of reproductive violence between women who were given and those who were not given reproductive violence education.

H1a: There is a difference in the perception levels of reproductive violence between women who were given and those who were not given reproductive violence education.

H0b: There is no difference in the conflict resolution styles and violence awareness levels between women who were given and those who were not given reproductive violence education.

H1b: There is a difference in the conflict resolution styles and violence awareness levels between women who were given and those who were not given reproductive violence education.

In the second phase of the study, 4 hours of reproductive violence education will be given to women in the intervention group and brochures on reproductive violence will be distributed. The education will be held in the meeting hall of Hamidiye Faculty of Health Sciences in the form of a powerpoint presentation and case discussion. Before the training, the "Informed Consent Form", "Introductory Information Form", "Reproductive Violence Perception Form/Scale" and "Conflict and Violence Awareness Scale" will be applied to the intervention group. After the training, the "Reproductive Violence Perception Form/Scale" and "Conflict and Violence Awareness Scale" will be applied. As a follow-up test, the "Reproductive Violence Perception Form/Scale" and "Conflict and Violence Awareness Scale" will be applied after 4-6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Being literate
* Being a volunteer to participate in the research
* Being a female administrative staff other than academic staff working within the Health Sciences University Hamidiye Complex

Exclusion Criteria:

* Being in menopause

  * Having a mental health problem that would prevent participation in the study
  * Receiving psychiatric treatment
  * Being an adolescent
Effect of Pilates Exercises and TENS Acupuncture in Primary Dysmenorrhea Among Female Students At KAU

This study was done to determine the effect of Pilates exercises and TENS acupuncture in primary dysmenorrhea among female students at King Abdulaziz University (KAU).


Eligibility Criteria:
Inclusion Criteria:

* Participants suffering from primary dysmenorrhea.
* Their age ranged between 18-24 years
* Their BMI less than 30 kg/m2.

Exclusion Criteria:

* Gynecological disorders (secondary dysmenorrhea)
* Married females,
* Low back pain due to any other pathology
* Chronic diseases (diabetes, high blood pressure)
Evaluation of the Efficacy of Dissociation-Focused Cognitive Behavior Therapy: a Multicenter Randomized Controlled Trial

Dissociative symptoms and disorders are particularly prevalent in the general population and among people suffering from psychiatric disorders. To date, no treatment has proven effective for this type of problem. Exploratory studies (without control group) have been carried out. Among these studies, dissociation-focused cognitive behavioral therapy (DF-CBT) seems promising. DF-CBT is based on a solid empirical model that has received numerous scientific evidence.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Membership of a social security scheme
* Participant's express consent
* Have at least one diagnosis of dissociative disorder among the following:

depersonalization/derealization disorder, dissociative identity disorder, unspecified dissociative disorder.

* Be able to carry out psychotherapy sessions.
* If taking psychiatric medication, treatment must have been stable for at least 30 days.

Exclusion Criteria:

* Present one of the following current diagnoses: substance use disorder (excluding tobacco), neurodevelopmental disorder, anorexia nervosa, severe depressive disorder, schizophrenia spectrum disorder, bipolar disorder, personality disorder other than borderline personality disorder.
* Present cognitive deficits.
* Be engaged in psychotherapeutic work.
* Be undergoing benzodiazepine treatment.