cyrilzakka/clinical-trials huggingface dataset:
Doxycycline Effects on Inflammation in Cystic Fibrosis

Doxycycline is known to exhibit immune modulatory activities beyond its antibacterial effects. In particular, doxycycline is a potent inhibitor of matrix metalloproteinase 9, which is a protease derived largely from neutrophils. Recent studies demonstrate a significant correlation between pulmonary disease severity and sputum concentrations of MMP-9 in patients with CF. In addition, sputum MMP-9 levels are associated with airway remodeling in CF.

The goal of this study is to determine the therapeutic potential of doxycycline in modulating host airway inflammation in patients with CF. Specifically, the study will characterize the PK /PD of doxycycline, evaluate the safety of short term therapy, and explore the concentration effect relationship between doxycycline exposure and sputum biomarker levels.

This study will consist of a prospective, open-label, randomized, controlled trial conducted in 24 patients with cystic fibrosis. Twenty subjects will be stratified in a 1:2 ratio based on baseline FEV1 into mild (\> 70%) or moderate (40-70%) pulmonary disease in order to control for disease severity within each dose level. The subjects will be randomized in blocks of four to receive no drug, 40mg, 100mg, or 200mg daily for 28 days.

Sputum samples will be obtained in all groups by induction with hypertonic saline at baseline, 8, 24, and 48 hours following the first dose and then weekly for 4 weeks. Sputum will also be collected at two follow up visits after the treatment period at weeks 5 and 6.

In the doxycycline group, serial blood samples (5 mL) for determination of doxycycline concentrations will be obtained before and at 0, 0.5, 1, 2, 4, 12, 24, and 48 hours following the 1-hr infusion of a single IV dose. Once daily dosing of doxycycline will resume immediately following the 48-hour blood sample and will continue until day 28. Additional levels will be obtained pre-dose, and 1, 2, and 3 hours after doses administered on days 14 and 28. A sample of blood will be obtained at baseline, and at days 28 for inflammatory marker analyses.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Clinically stable (FEV1 within 10% of baseline)
* FEV1 \> 40% predicted

Exclusion Criteria:

* Use of clinically significant concomitant drug therapy such as long-term use of nonsteroidal anti-inflammatory drugs or corticosteroids
* Known hypersensitivity to doxycycline
* Pregnancy or attempting to conceive, breast feeding, initiation of or change in hormonal method of contraception within 4 weeks of baseline or during the study
* Use of systemic antibiotics (except oral azithromycin) within 4 weeks of baseline
* Use of doxycycline within 60 days of baseline
* Known history of gastrointestinal bleeding or gastrointestinal ulceration.
Interest of Ultrasonography in Electroneuromyography: Single-blind Randomised Controlled Clinical Trial

Echo-nerve tracking during an electroneuromyographic (ENMG) examination by identifying the optimal stimulation site would reduce the stimulation intensities delivered to the patient and thus improve the tolerance of this examination.


Eligibility Criteria:
Inclusion Criteria:

* Patient requiring an electroneuromyogram whose indication allows the application of a standard protocol of examination.
* Patient that has given his/her free and informed consent.
* Patient that signed the consent form.
* Patient with an health insurance plan.
* The patient is at least 18 years old (≥).
* he patient is under 80 years old (≤).

Exclusion Criteria:

* Patient with symptoms of neuropathy during the screening.
* Patient whose Neurological severity score (NSS) score is ≥ 3.
* Patient whose neurological examination is abnormal and suggestive of neuropathy.
* Patient presenting a pathology that could cause neuropathy (e.g. diabetes, renal failure, etc.).
* Patient already participating in a category 1 research study (Jardé law).
* Patient in an exclusion period determined by another study.
* Patient under the protection of justice, under guardianship or under curatorship.
* Patient refusing to sign the consent form.
* Patient for which it is impossible to provide information about the study.
* Pregnant patient, parturient, or breastfeeding.
Navigated Total Knee Arthroplasty, the Correlation to CT Scans and Clinical Results

Total knee replacement is one of the most commonly performed orthopedic procedures. As of 2010, about 600,000 total knee replacements were being performed annually in the United States and these numbers are rising. The normal knee joint functions as a complex hinge allowing primarily ﬂexion and extension, rotation and gliding. The knee joint is made up of three compartments, the lateral, medial and anterior (patellofemoral). Damage to the cartilage of one or more compartments may be the result of osteoarthritis (idiopathic or post-traumatic), inﬂammatory arthritis (rheumatoid,psoriatic, etc.), a-vascular necrosis, tumors, or congenital deformities. Osteoarthritis and rheumatoid arthritis are the causes of the overwhelming majority of total joint arthroplasties.

A successful Total knee arthroplasty(TKA) surgery includes: an accurate alignment( the mechanical axis in axial and rotational planes), as well as significant pain relief which improves function and quality of life. Incorrect alignment can lead to abnormal wear, premature mechanical loosening of the components and patellofemoral problems.

The common techniques for Total knee replacement are:

1. Conventional method TKR
2. CT/MRI-based preoperative navigated TKR
3. Image-free intraoperative navigated TKR In our research we focus on the 3rd method using the Orthopilot navigation system Aesculap®, Tutlingen, Germany. This system is an active PC based guiding system that helps the surgeon decide on the accurate alignment and orientation of the implant and cutting surfaces of the bone and thus avoid incorrect alignment.

We aim to compare between pre-operative and post-operative lower limb alignment (mechanical axis) in Aesculap based TKA using serview CT. Furthermore, we will try to examine the existence of a correlation between the CT scans and the Orthopilot navigation system output and assess the clinical outcome of the patient postoperatively.

Our Hypothesis is that the intra-operative navigation system is accurate and correlated to CT images results, moreover, allows the surgeon to achieve a good mechanical axis and high clinical outcome,


Eligibility Criteria:
Inclusion Criteria:

* age over 18
* severe osteoarthrosis of the knee
* failure of conservative treatment.

Exclusion Criteria:

* patients with severe vascular disease
* secondary knee deformation due to muscular atrophy or disease
* active infection
* morbid obesity
* neuropathic knee and osteomyelitis.
The Role of Meat-borne Carcinogens in Pancreatic Cancer

We propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic cancer. These subjects will ingest a very low dose of radiolabeled PhIP, a meat-derived carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly sensitive technology to determine if this carcinogen binds to DNA in the pancreas.

Pancreatic cancer is rapidly fatal in most cases and little is known about its causes. Identifying and modifying risk factors can reduce mortality through prevention. Carcinogens that form in meat cooked at high temperatures may be modifiable risk factors for pancreatic cancer, but direct evidence is needed to demonstrate involvement in pancreas tissue. We propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic cancer. These subjects will ingest a very low dose of radiolabeled PhIP, a meat-derived carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly sensitive technology to determine if this carcinogen binds to DNA in the pancreas. We hypothesize that the meat-derived carcinogen will bind to DNA in the pancreas. The amount of PhIP ingested is equivalent to the amount in two very well-done barbecued chicken breasts and the dose of radioactivity is comparable to a typical chest x-ray. This research can increase understanding of pancreatic carcinogenesis, facilitating the design of prevention strategies.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old.
* Adequate hepatic function within 4 weeks of study enrollment defined as bilirubin ≤ 2 mg/dl and ALT, AST, and alkaline phosphatase ≤ 2 times the upper limit of normal.
* Females of childbearing potential or males whose partners are of child bearing potential are required to use an effective method of contraception (i.e., a hormonal contraceptive. intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 4 months after PhIP administration.
* Voluntary written informed consent (PhIP consent and Caffeine assay consent) before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

* CA-19-9 equal to or above 400.
* Tumor size \>3.5 cm.
* Fluid in the abdomen (ascites).
* Conditions present, which, in the opinion of the surgeon, could make resection difficult, e.g., extensive vascular involvement.
* Pregnant or lactating (for women).
* Uncontrolled cardiovascular disease; e.g. hypertension, angina, etc.
* Patients who are intolerant of a 200 mg dose of caffeine or who otherwise do not wish to participate in the caffeine assay when consent is sought for the primary consent will be considered refusers and will not be enrolled in the study.
The Effects of Vitamin D3 Alone and in a Combination With Omega-3 on the Association of C-peptide With Glycemic Control

The Effects of Vitamin D3 alone and in a combination with omega-3 on the association of C-peptide with glycemic control

The data bout the effects of Vitamin D3 (VD3) alone and as a combination with omega-3 fatty acids (Omega-3FA) on the association between C-peptide (CP) and the glycated hemoglobin (HbA1c) is scarce, conflicting and nothing published in the literature review on the combined effect of VD3 and Omega-3FA as a combination on the association of CP with glycemic control.

This study will be conducted to investigate the effects of (VD3) alone and as a combination with Omega-3FA on the association between CP as an insulin secretion marker, and glycemic control parameters represented by glycated Hemoglobin (HbA1c), on people with vitamin D deficiency (VDD).

This randomized, placebo-controlled trial is designed to test the effects of (50,000 IU VD3/ weekly) and (300mg omega-3FA/daily) separately and as a combination for eight weeks, on the serum levels of CP, 25-hydroxy vitamin D (25OHD) and HbA1c. this study will be carried out during winter on 120 healthy Jordanian males and females with VDD with age range (25-50) years. Fasting serum levels for 25OHD, CP, HbA1c, PTH, Calcium, Phosphate, ALT (Alanine aminotransferase) and Urea were assessed at baseline and at the end of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Aged (30-64)
* Have a medical diagnosis of VDD

Exclusion Criteria:

* Chronic diseases, such as (osteoporosis, cancer, kidney disease(due to the association between prolonged administration of VD3 and kidney stones formation), an endocrine disorder, thalassemia).
* Documented history of allergic reactions to Omega-3FA supplementations
Evaluation of Efficacy and Safety of Gynomax® XL Ovule

Efficacy and safety of Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections will be evaluated in this open label, single-arm, multicentral study.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with age ≥ 18 and ≤ 45 years
* Patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis or mixed infections according to the investigator's decision
* Signed informed consent

Exclusion Criteria:

* Known hypersensitivity to active ingredients of the study medications
* Vaginismus, endometriosis, dyspareunia
* Detection of urinary tract infection in urinalysis
* Acute or chronic infections such as pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors
* Usage of herbal medicines that interfere with microsomal enzymes, especially cytochrome P450 (phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, topiramate, felbamate, griseofulvin, HIV protease inhibitors such as ritonavir, nucleoside reverse transcriptase inhibitors such as efavirenz)
* History of cardiovascular event
* Advanced hypertension and diabetes
* Presence or known risk or of venous or arterial thromboembolism
* Undiagnosed abnormal vaginal bleeding, bleeding disorders, genital tumors
* Use of drugs containing ombitasvir / paritaprevir / ritonavir or dasabuvir during or two weeks before initiation of the study
* Pregnancy and/or breastfeeding
* Participation in any other trial 30 days before initiation of the study
* Postmenopausal women
* Abuse of alcohol
* Usage of medications containing acenocoumarol, anisindione, dicoumarol, phenindione, phenprocoumon, warfarin, cholestyramine, cimetidine, cyclosporine, disulfiram, fluorouracil, fosphenitoin, ketoconazole, lithium, rifampin, tacrolimus or propranolol
* Presence of a sexually transmitted disease such as syphilis, gonorrhea, etc. according to the investigators decision
Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children

The primary purpose of this study is to find the dose of Efavirenz for young children. The safety and how the medication is tolerated will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected; \>=3 months of age to \<=6 years of age (at time of treatment); screening plasma viral load \>=1000 copies/mL

Exclusion Criteria:

* Genotypic or phenotypic resistance to EFV, ddl, or FTC/lamivudine (3TC) at screening
Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study

Gastric balloons are an evolving way of reducing weight. There are two types on the market, up to date. Air filled balloons seem to be more safe, and more tolerable.

Morbidly obese patients are categorized into two groups: the 1st group to whom intragastric air filled balloon and the 2nd group to whom saline filled balloon is applied for treatment of their morbid obesity. The aim of study is to compare both types of balloons regarding safety, efficacy and tolerance.

Eligibility Criteria:
Inclusion Criteria:

* Morbidly obese patients

Exclusion Criteria:

* Patient refused
* Non compliant patients
* Psychological patients
* Oesophageal varices, big hiatus hernia, ulcers
* Gastric vascular malformations
Multi-modality MRI Study on Differences in Conversion of aMCI Patients With APOEε4 to AD

This study is to find out the imaging marker and the changing laws of the marker during the course of the disease. The final purpose is to provide scientific evidence for new prevention, diagnosis and treatment of Alzheimer's disease.

It is an urgent problem in the field of cognitive neuroscience to tell the conversion progression of amnestic mild cognitive impairment(aMCI) patients with Apolipoproteinε4(APOEε4) to Alzheimer's Disease(AD). Based on our preliminary work, we will study the special group of aMCI patients with APOEε4 with multi-modality magnetic resonance imaging (resting-state functional MRI, structural MRI and diffusion tensor imaging) longitudinally. Besides, we will also detect the APOE genotype of each sample and enlarge the sample size. According to situation of the conversion or non-conversion and differences in the conversion progression, we will analyze the data between the inter-groups and intra-groups, compare the imaging data of baseline and follow-up, find the prediction imaging marker of AD and optimize the reliability and validity.

Eligibility Criteria:
Inclusion Criteria:

* Complaint about memory loss and confirmed by an informant
* Cognitive impairment in single or multiple domains, adjusted for age and education
* Normal or near-normal performance on general cognitive function and no or minimum impairment of daily life activities
* A Clinical Dementia Rating (CDR) score is 0.5
* Failure to meet the criteria for dementia
* Carrying susceptible gene APOEε4
* Must be able to accept examination of MRI, sight and hearing allow to complete test

Exclusion Criteria:

* Other diseases that cause cognitive impairment,such as thyroid disease,stroke and so on
* people who have severe visual and hearing impairment
OurRelationship.Com Effectiveness Study

The purpose this study is to determine the continued reach and effectiveness of the OurRelationship.com program once paid advertising and payment for participation ceases. The answer to this question is essential to determining the sustainability of web-based interventions for couples. Specifically, this study has four aims:

1. Examine continued level of initial interest in the study, as measured by number of initial visits to the website, time spent on the page, and number of couples signing up for the study.
2. Measure any changes in the characteristics of the individuals expressing interest in the study, including demographics (e.g., race, ethnicity, education), relationship functioning (e.g., relationship satisfaction, previous help-seeking), and individual functioning (e.g., depression, anxiety)
3. Determine completion rates and effectiveness of the program once payments for participation have been removed.
4. Determine whether having a single Skype/phone call with a coach (rather than the four calls that were used in the NIH trial) significantly degrades completion rates.


Eligibility Criteria:
Inclusion Criteria:

* Currently in a heterosexual relationship
* Married, Engaged, or living with partner for 6 months or more
* Living in the United States
* Both partners score at least 0.5 standards below the community mean on relationship satisfaction

Exclusion Criteria:

* Clinically significant intimate partner violence
* Younger than 18 or older than 64 years of age
* Reporting infidelity in last three months
* Reporting severe suicidal ideation in last three months
Hand MOtor Rehabilitation Using a EMG-biofeedback: a Cross-sectional Study

Recovery of upper limb and hand gestures is fundamental for autonomy restoration after stroke. Innovative technologies are a valid support for the delivery of rehabilitation treatments. Embedding surface electromyographic (sEMG) into wearable devices, allows the customisation of rehabilitation exercises, based on the clinical profile of each patient.

The aims of this study are to determine safety and feasibility of a prototype EMG-control wearable device (REMO) and to individualise clinical features of stroke survivors able to control the EMG armband targeted to hand rehabilitation.

The device REMO consists in an armband composed by 8 bipolar electrodes able to record and process the electromyography of forearm muscles. The patterns of muscle activations are classified and used to perform EMG-biofeedback exercises in stroke rehabilitation training. The device is developed by clinicians of IRCCS San Camillo Hospital and spin-off Morecognition Srl.

A total of 100 stroke patients patients has been recruited. They are clinically assessed and then tested on the ability to control the sEMG wearable device. The test is composed of 10 hand and fingers gestures to be performed with the paretic hand. Baseline and activation sEMG signals are recorded and compared for each movement. Three conditions representing absent, partial or full control of the device are defined and logistic multivarialbes regression models are used to identify clinical features describing the group each patient belongs to. Clinical cut-off for each strata is identified by odds ratio.

Eligibility Criteria:
Inclusion Criteria:

* Single ischemic or haemorrhagic stroke;
* Score lower than 100 out of a total of 126 at the Functional Independence Measure (FIM) scale

Exclusion Criteria:

* Untreated epilepsy;
* Major depressive disorder;
* Fractures;
* Traumatic Brain Injurj;
* Severe Ideomotor Apraxia;
* Severe Neglect;
* Severe impairment of verbal comprehension.
Stepping Up 4 Your Child

Through Stepping Up 4 Your Child, non-custodial fathers will be provided with a comprehensive, solution-oriented program featuring group based parent education and individualized case management to help them achieve financial independence, increase their parenting skills, and develop a co-parenting alliance.

Fathers' involvement in their children's lives has received increased attention in recent years. In response, support has grown for responsible fatherhood programs aimed at improving the quantity and quality of fathers' involvement. Research on these programs has concluded that factors such as fathers' parenting skills, co-parenting relationship quality, and socioeconomic status all impact fathers' ability to contribute to their children's growth and development. Using this previous research as a foundation, the Stepping Up 4 Your Child project will go beyond traditional fatherhood initiatives by integrating the provision of responsible parenting, economic stability, and relationship education services to fathers at risk for paternal disengagement. To do so, the University of Louisville's Kent School of Social Work will leverage its existing relationship with the Kentucky Office of Child Support Enforcement. Specifically, through Stepping Up 4 Your Child, non-custodial fathers will be provided with a comprehensive, solution-oriented program featuring group based parent education and individualized case management to help them achieve financial independence, increase their parenting skills, and develop a co-parenting alliance. Given that each of these focus areas have all been cited as three of the strongest predictors of paternal engagement, Stepping Up 4 Your Child and the results of its evaluation will have significant implications for the families it serves, as well as the practitioners, researchers, and policymakers interested in responsible fatherhood. 1

Eligibility Criteria:
Inclusion Criteria:

* non-custodial father AND
* age 16-24 OR
* age 24 up + low income OR
* age 24 up + child support payment delinquent

Exclusion Criteria:

* female
* custodial father
* male but not a father
* younger than age 16