cyrilzakka/clinical-trials huggingface dataset:
Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties

The study investigates the efficacy of a catheter with antibacterial surface coating in preventing central venous catheter related infection and the effect of an intensive hygiene and catheter care education of the nursing staff on preventing central venous catheter-related infection.

The risk of catheter-related bloodstream infection depends on catheter type, method and site of insertion, aseptic technique and number of manipulations. To address this problem, efforts have focused on engineering biomaterials and surfaces with antibacterial properties to prevent bacteria adhesion and biofilm formation.

In view of the necessity to reduce catheter-related bloodstream infections and of the inadequacy of currently available antimicrobially coated devices, a new antimicrobial catheter surface was developed.

Among other factors, the mode and quality of catheter handling and care of exit site is an important aspect with respect to catheter-related infections.

The clinical study aims at providing data on antimicrobial efficiency of the 2 types of CE certified double lumen catheters and a supposed additional preventive effect of intense hygiene training on catheter-related infections.

Eligibility Criteria:
Inclusion Criteria:

* central venous catheter placement
* Need for extracorporeal renal replacement therapy (acute and chronic renal failure)
* Age over 18 years
* Written informed consent
* Needed catheter length 15 cm or 20 cm

Exclusion Criteria:

* Known infectivity with Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV)
* Any infection associated with one or more positive blood cultures within 10 days prior to catheter implantation
* Bacteremia with a former catheter within 10 days prior to catheter implantation
* Known pregnancy
* Lactation
* Participation in another clinical study during the preceding 30 days
Low Level Lazer Therapy Effect on Vertebral Artery Blood Flow in Elderly With Cervical Disc Degeneration

This study will include 60 elderly patients with cervical disc degeneration, from both gender who are aged from 60 - 75 years old.

The 60 patients will divided into two groups, with 30 patients in each group. group(A): will receive low level lazer and exercises for three times per week for 12 weeks.

Group (B): will receive only exercises. Resistivity index of both right and left vertebral arteries will be measured before and after the 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. elderly patients with age range between 60 and 75 years old.
2. with cervical disc degeneration.

Exclusion Criteria:

1. patients with uncontrolled hypertension.
2. Patients with uncontrolled diabetes mellitus.
3. Patients with severe cardiac or chest diseases.
Evaluation of Immune Status Before and After Splenectomy in Immune Thrombocytopenia Patients

Evaluation of immune status before and after splenectomy in immune thrombocytopenia patients.

A total of 30 ITP patients will be enrolled in the study. These patients should fail to have sustained response to multiple first- and second-line treatments of ITP and agree to have splenectomy. Before splenectomy, these patients will be reassessed and still diagnosed with ITP.Their platelet level will be raised to a safe state before surgery, and the laparoscopic splenectomy will be performed in Tianjin People's Hospital. The investigators plan to take 20ml of peripheral blood (PB) of these patients at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and take a small amount of spleen tissue during surgery.

18 age- and gender- matched healthy donor will also be enrolled as controls and taken 20ml of peripheral blood. The investigators also plan to take splenic tissue from 10 patients who have splenectomy due to Hereditary spherocytosis or trauma.

And then the investigators will do the experiments step by step. 1, Isolation of peripheral blood and splenic mononuclear cells;2, Detection of the percentage of cell population;3, Activation and proliferation of B lymphocyte; 4, Activation and proliferation of T lymphocyte;5,Apoptosis of platelets by cytotoxic T cells;6,Phagocytosis of platelets by macrophages in spleen;7,Enzyme-linked immunosorbent assay (ELISA) for cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 60 years old, male or female;
* Conform to the diagnostic criteria of immune Thrombocytopenia (ITP)
* Needed splenectomy;
* People who are willing to sign the informed consent voluntarily and follow the research program.

Exclusion Criteria:

* Secondary thrombocytopenic purpura;
* Patients with poor compliance;
* Researchers believe that patients should not participate in the test of any other condition.
Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression

Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of transcranial magnetic stimulation with documented efficacy in treatment of depressed mood but with conflicting results regarding their efficacy in treatment of other symptoms of depression such as insomnia, daytime sleepiness and fatigue. This study will investigate the efficacy of iTBS over the left dorsolateral prefrontal cortex (DLPFC) and cTBS over the right DLPFC, compared to sham stimulation, in treatment of insomnia, daytime sleepiness and fatigue in depression.

Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of conventional repetitive transcranial magnetic stimulation (rTMS) with documented noninferiority in improving mood in depressive disorders. The effect of both modalities on other significant depression symptoms has not been studied. In this feasibility study investigators aim primarily to assess the safety and therapeutic potential of iTBS over the left dorsolateral prefrontal cortex (lDLPFC) and cTBS over the right dorsolateral prefrontal cortex (rDLPFC) on sleep quality, sleep propensity, fatigue, and daytime sleepiness in patients with major and bipolar depression.

Eligibility Criteria:
Inclusion Criteria:

* severe or moderate depressive episode (according to international classification of diseases (ICD)-10) without psychotic symptoms at the time of inclusion
* Diagnosis of major depression (F33.1 or F33.2) or bipolar disorder (F31.3 or F31.4).
* The score of the Athens Insomnia Scale five or more
* Unchanged antidepressive pharmacotherapy at least one month prior to inclusion

Exclusion Criteria:

* Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy
* Psychotic symptoms at the time of inclusion
* Suicidal ideations and/or attempts within three months prior to inclusion
Use of Electromyography With Bio-Feedback for the Treatment of Craniomandibular Disorders

The treatment of craniomandibular disorders is a challenging task. Many different treatments are yet available with occlusal splints being one of the most commonly used. A relative new diagnostic and treatment alternative is the Grindcare device. This enables the electromyographic (EMG) assessment of the activity of the temporal muscle and the contigent electrical stimulation of this muscle as bio-feedback whenever the EMG activity exceeds a certain limit. This stimulation results to a sudden break of the muscle activity.

Aim of this study is to compare the therapeutic efficacy of the Grindcare device in pain reduction at female non-chronic CMD patients to that of a Michigan-type splint. Our null-hypothesis was that there is no difference between the device and the splint in the reduction of pain intensity.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Age between 18 and 70 years
* Non-chronic painful CMD with/without mandibular movement restriction
* Female

Exclusion Criteria:

* Pregnancy or breastfeeding
* Chronic Pain Status higher than 2
* Known allergic reaction against the gel pads
* Electronic implants (pacemaker, defibrilator, insulin pump)
* Facial pain of dental or neuropathic etiology
* Traumatic injuries of the face / operations
* Dental treatment need
* Problems with swallowing reflex
Effectiveness of SisterTalk Hartford for Weight Loss Among African-American Women

The purpose of the SisterTalk Hartford study was to assess whether a theoretically- and scientifically-based, culturally acceptable weight loss program could be effectively translated into a faith-based program and subsequently delivered in the church to help African-American women lose weight.


Eligibility Criteria:
Inclusion Criteria:

* BMI of at least 25.0
* self-identifies as Black or African-American
* able to do mild physical activity such as walking or chair exercises

Exclusion Criteria:

* has insulin dependent diabetes
* is pregnant, nursing, or had a baby in the past 4 months
* has ever been treated for an eating disorder (e.g. anorexia nervosa, bulimia)
* had a heart attack in the past 2 years requiring hospitalization
* has ever had a stroke
* has congestive heart failure
* has uncontrolled hypertension
* currently participating in another study
* is on a doctor-prescribed diet that cannot be changed (e.g. very low protein diet for a person in liver failure)
Pelvic Floor Symptoms After Bilateral Sacrospinous Fixation

This study aims to the assessment of pelvic floor symptoms and patients´ satisfaction after bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage IV.


Eligibility Criteria:
Inclusion Criteria:

* age 18 and above
* pelvic organ prolapse ICS-POPQ Stage IV, with or without uterus
* signed informed consent

Exclusion Criteria:

* gynecologic surgery in the three past months before planned surgery
* history of prolapse surgery
* participation in another study
* need to simultaneously perform other surgical procedures (i.e. rectopexy)
* ongoing chemotherapy of treatment with immunosuppressant drugs
Autofluorescence for the Screening of Precancerous and Malignant Lesions

Diagnosis of oral squamous cell carcinoma is always too late. Due to this delay for diagnosis, prognosis is very bad. It has been demonstrate that systematic oral examination decrease mortality in tobacco and alcohol consumers population (Sankaranarayanan and al. Lancet 2005, 4, 1927-1933 ). An other study has demonstrate that autofluorescence is a useful technic for detection of dysplasia and squamous cell carcinoma that cannot be seen with conventional oral examination((Poh CF Wink Cancer Res on 2006 ( 22 ): 6616-22; Poh CF Head Neck 2007 ( 1 ) 7 71-6).However autofluorescence has never been evaluated has a screening tool for systematic oral examination and the reproductibility has never been studied.

The study of Sankaranarayanan and al. (Lancet on 2005, 4, 1927-1933) demonstrated the influence on the decline of mortality of a realized systematic screening, by a simple visual inspection of the oral cavity in alcohol-smoker patients. The sensibility of the visual inspection to diagnose the oral cancers is estimated at 85 % and the specificity in 97 %. However some lésions are not diagnosed with common oral examination(Downer MC Oral Oncol. 2004 ( 3 ) 264-73). The examination in autofluorescence coupled with the visual inspection could be a solution to improve early diagnosis of potentially malignant disorders . Indeed, dysplasia and cancerous lesions can be revealing by an autofluorescence examination (Lane PM J Biomed opt on 2006 ( 2 ): 024006). Other works demonstrated that infra-clinical lesions could be revealed by the autofluorescence (Poh CF Wink Cancer Res on 2006 ( 22 ): 6616-22; Poh CF Head Neck 2007 ( 1 ) 7 71-6). On the other hand the sensibility and the specificity of the autofluorescence in situation of screening were not estimated and studies carried out on sick subjects tend to overestimate the metrological performances of a technique. Besides the reliability of the technique (reproducibility) was not studied. For these reasons, it is recommended to realize in situation of screening in an alcohol-smoker population:

* a study of reliability to estimate the reproducibility inter-observer of the examination of the oral cavity in tissular autofluorescence and,
* a feasibility study to estimate the potential contribution of the autofluorescence with regard to a simple visual inspection in the screening of the potential malignant disorders.

Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized for alcoholic weaning
* consumption activates of tobacco or stop for less than one year
* consent form signed

Exclusion Criteria:

* patient presenting a disorder of the haemostasis (plaques \< 50G / L; INR \> 3, haemophilia, moderate or severe Willebrand disease),
* absorption of acid acetylsalicylic in seven days before inclusion,
* the patient with oral cavity precancerous pathology, dysplasia or known cancer patient
Use of Autologous Adipose-Derived Stromal Vascular Fraction To Treat Osteoarthritis of Hip, Knee, Ankle, and Thumb Joints

This study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells for treatment of hip, knee and thumb osteoarthritis (OA); monitoring adverse events and measuring pain, function and stiffness in the joints of osteoarthritic subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Grade II through Grade IV hip, knee, ankle osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI
2. Stage II through IV carpometacarpal (CMC) osteoarthritis using Eaton-Little's staging of CMC OA as diagnosed by X-ray and physical examination
3. Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed
4. Subjects with ASA grade I, II, or III
5. Males and females 25-85 years old
6. Subjects must have continued pain in their targeted/treatment joint despite conservative therapies for at least 3 months

Exclusion Criteria:

1. Subjects that are allergic to lidocaine, epinephrine or valium
2. Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as follows prior to injection; Thrombolytics and anti-platelet medication including but not limited to Coumadin (warfarin) for 3 days, Plavix (clopidogrel) for 3 days, acetylsalicylic acid (ASA)/NSAIDs/fish oil supplements for 7 days, Xeralta® (rivaroxaban) for 24 hours
3. Subjects with systemic immunosuppressant use within six (6) weeks from screening and subjects with HIV/viral hepatitis
4. Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis
5. Women that are pregnant or planning to become pregnant during the study
6. Subjects on long term use of oral steroids
7. History of any chemotherapy or radiation therapy on the targeted/treatment joint or adipose harvest site
Predictive Value of Preoperative Evaluation in Cases of Recurrent Endometriosis

To investigate the effect of preoperative evaluation parameters in predicting recurrent disease in women who have undergone cystectomy or unilateral salpingo-oophorectomy due to endometriosis.

Endometriosis is an estrogen-dependent gynecological disease characterized by the presence of endometrial-like tissue outside the uterine cavity, associated with pelvic pain and subfertility. Despite its benign character, endometriosis can recur after surgery and continues to be a disease that disrupts the quality of life of millions of women. This study aimed to examine the risk factors in women who underwent cystectomy or unilateral salpingo-oophorectomy due to endometriosis but had a recurrence. Therefore, the predictive value of parameters such as preoperative biochemical parameters, cyst size and the revised American Society for Reproductive Medicine (rASRM) Scoring system will be examined in recurrent cases.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-50 who had a cystectomy or unilateral oophorectomy due to endometriosis

Exclusion Criteria:

* Women who have had bilateral oophorectomy due to endometriosis
* Malignant conditions
* Smoking
* Women with autoimmune disease
Influence of Hesperidin and Vitamin C on Uric Acid Concentration

Aim of the study is to investigate the impact of hesperidin and/or vitamin C on elevated uric acid concentrations.

Duration of the study is 9 weeks. 1) a washout week, 2) two intervention weeks, 3) four weeks washout period, 4) two intervention weeks.

The study is conducted under free living conditions. During washout weeks consumption of orange juice or citrus fruits or vitamin C containing supplements is restricted.

During intervention weeks 200 mL of study drink is consumed daily. And participants are asked to maintain their normal physical activity and habitual diet. Additional citrus or vitamin C containing beverages are not allowed.

At the beginning and the end of each intervention phase uric acid, insulin sensitivity, blood pressure, pulse wave velocity and bioavailability of hesperidin are assessed.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* higher uric acid concentration (≥5.5 mg/dL)
* Informed written consent

Exclusion Criteria:

* pregnancy
* fructose intolerance
* smoking
* gout or medicated hyperuricemia
* diabetes mellitus
* antidiabetic or cytostatic medication
* weight loss (≥5% in the past 3 months)
* consumption of vitamin C-containing supplements
* parallel participation in a clinical trial
* anemia and / or iron deficiency
Protective Ventilation Based on Alveolar Ventilation in Children

Protective ventilation decreased morbidity and mortality in adults' patients and is now a standard of care in intensive care unit and in anesthesiology. In children, there is no evidence in the literature to recommend protective ventilation during anaesthesia. Moreover the ratio of instrumental dead space to tidal volume is higher in children than in adults. Therefore, it is difficult to propose an "optimal" tidal volume for all children. The objective of this study is to evaluate the use of alveolar ventilation (estimated by the volumetric capnography) in children under anesthesia. The hypothesis is that in children, alveolar ventilation reported to ideal body weight is a constant to maintain normocarbia, unlike the tidal volume.


Eligibility Criteria:
Inclusion Criteria:

* Children aged \< 12 and
* Weight between 5 and 40kg
* General anesthesia
* Non-opposition of parents or legal guardians

Exclusion Criteria:

* History of bronchodysplasia or laryngo tracheo malacia, cyanotic heart disease or neuromuscular disease
* Airleaks \> 10%
* Bronchospasm during anesthesia
The Multimedia HIV/STI Prevention for Drug-Involved Female Offenders

The proposed study addresses a significant public health threat of Human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) among drug involved women on probation, parole or other community supervision. This randomized controlled trial aims to test the efficacy of a multimedia version of a 4-session, gender-specific, integrated drug use and HIV/STI prevention intervention (Multimedia Women On the Road To Health (WORTH)) in increasing condom use and decreasing the incidence of sexually transmitted infections (STIs) among 420 drug-involved, female offenders in a large community court setting in New York City, compared to a non-media version of the same intervention (Traditional WORTH) and to a 4-session Wellness Promotion condition.

While it is clear that women inmates in jails and prisons bear a high burden of Human immunodeficiency virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), the effective development of prevention interventions for this high-risk group require an understanding of HIV risk context, sexual behaviors and attitudes for women while they are still in the community and before they become heavily involved in the criminal justice system. HIV prevention interventions must focus on women at early points of entry into the criminal justice system, when they are still in the community and at higher risk of engaging in unsafe sex and drug behaviors. This study focuses on a population of drug-involved women who have been arrested and given a court sanction, but are still living in the community.

Eligibility Criteria:
Inclusion Criteria:

* She is 18 or older.
* She is currently supervised by a criminal justice entity, such as a community court or probation.
* She reports engaging in unprotected vaginal or anal sex with a male partner in the past 90 days
* She reports any illicit drug use or binge drinking in the past 6 months.

Exclusion Criteria:In addition, potential participants will be ineligible if any of the following criteria are met:

* Ability to speak and understand English is not sufficient to participate in assessments or intervention sessions.
* The woman's sexual activity is limited to a monogamous relationship lasting more than 12 months, and she has not engaged in any of the additional HIV risk behaviors in the past 90 days:

  * Having sex with more than one partner
  * Having sex with a partner known or suspected to be HIV positive or an injection drug user (IDU)
  * Sharing injection drug use needles or equipment
* The woman is actively trying to get pregnant/have a baby.
* Inability to complete informed consent process due to a psychiatric or cognitive impairment.
* The participant was born male.
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)

The objective of this study is to assess the efficacy, safety, and tolerability of CyclASol Ophthalmic Solution in comparison to vehicle for the treatment of the signs and symptoms of DED.

This Phase 2b/3 study will assess the efficacy, safety and and tolerability of CyclASol Ophthalmic Solution as one drop twice daily versus vehicle.

Eligibility Criteria:
Inclusion Criteria:

* Signed ICF (Informed Consent Form) and HIPAA (Health Insurance Portability and Accountability Act)
* Patient-reported history of DED in both eyes
* Current use of OTC (over-the-counter) and/or artificial tears for dry eye symptoms
* Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

* Women who are pregnant, nursing or planning a pregnancy
* Unwillingness to submit a urine pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
* Clinically significant slit-lamp findings or abnormal lid anatomy at screening
* Ocular/periocular malignancy
* History of herpetic keratitis
* Active ocular allergies or ocular allergies that may become active during the study period
* Ongoing ocular or systemic infection at screening or baseline
* Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study
* History of no response to previous topical Cyclosporine A and/or use of topical Cyclosporine A or Liftigrast within 2 months prior to screening
* Intraocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period
* Presence of uncontrolled systemic diseases
* Presence of known allergy and/or sensitivity to the study drug or its components