cyrilzakka/clinical-trials huggingface dataset:
Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial

Comparing second ejaculate and physiological ICSI (PICSI) as strategies for improvement of abnormal sperm DNA fragmentation in patients undergoing ICSI.

Sperm DNA fragmentation has shown a negative correlation with embryo quality, fertilization, implantation, clinical pregnancy, and live birth rates. And a positive correlation with the miscarriage rate. Abnormal sperm DNA fragmentation can be improved through the second ejaculate strategy, by limiting the time of sperm presence in the epididymis. PICSI is a robust sperm selection technique that can select individual mature intact sperm DNA. In our study, we will compare PICSI as a valid sperm selection technique to second ejaculate, as a natural cost-free strategy to manage abnormal SDF. In addition to a normal SDF arm as a control.

Eligibility Criteria:
Inclusion Criteria:

* Male partner with abnormal sperm DNA fragmentation index (\>20%) by TUNEL assay
* Male partner with at least 1 million progressive motile count
* Male aged 18-50 years
* Male with adjusted sexual abstinence days (1-2 days)
* Female aged 18-37 years
* Normo-responder females (at least 5 mature oocytes)

Exclusion Criteria:

* Leukocytospermia
* Varicocele
* Known genetic abnormality
* Use of oocyte or sperm donors
* Use of a gestational carrier
* Presence of any endometrial factors that can affect embryo implantation
* Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
Effect of Virtual Reality on TMD Following Maxillofacial Surgery

Sixty eight patients who have TMJ pain and ROM restriction after maxillofacial surgery participated in this study , they are selected from government hospitals (general and insurance ).

Will be randomly divided into two equal groups ( group A, group B ). Their ages range from 20 - 35 years.

The Purpose of the study is to evaluate the therapeutic efficacy of VR in decreasing pain and improve ROM for Patients after maxillofacial surgery.

Sixty eight patients who have TMJ pain and ROM restriction after maxillofacial surgery participated in this study , they are selected from government hospitals (general and insurance ).

Will be randomly divided into two equal groups ( group A, group B ). Their ages range from 20 - 35 years.

The VR glasses which were the source of visual and auditory feedback, were connected by Bluetooth to a mobile phone and all the videos of selected tasks (tasks of Active mobility exercises and isometric contraction exercises, massage exercises) were turned on. Active mobility exercises (jaw opening 6 times of 30 s; lateralization 10 times of 5 s; protrusion 10 times Of 5 s).

* Self-massage masticatory Muscles, After each session.
* Isometric contraction exercises The Purpose of the study is to evaluate the therapeutic efficacy of VR in decreasing pain and improve ROM for Patients after maxillofacial surgery.

Eligibility Criteria:
Inclusion Criteria:

* The subject selection will be according to the following criteria:

  * Patients after Arthrocentesis .
  * Patients after Temporomandibular joint condylar discopexy.
  * Age ranges between 30 - 45 years.
  * All patients will have informed consent .Exclusion Criteria:
* • Surgery That conducted on the temporomandibular joint (meniscectomy, arthroscopy, etc.).

  * oral surgery (e.g., surgery for impaction of the third molar), as well as patients with concomitant systemic or neurological conditions.
A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ

The purpose of this study is to find molecular signs (biomarkers) to better understand the role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed ductal carcinoma in situ (DCIS).

Many studies have shown that green tea may have anti-cancer and anti-inflammatory effects in cancer cells and animal models of breast cancer. Some studies have found that Asian women who drink many cups of green tea have lower rates of breast cancer. Green tea may have an effect on proliferative and inflammatory pathways. Women with ductal carcinoma in situ (DCIS) have been found to have inflammation in the breast tissue surrounding DCIS lesions. Inflammatory pathways are being studied for a possible link to cancer. This study is designed to evaluate changes in biomarkers of proliferation, inflammation, and angiogenesis in response to green tea intake.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed DCIS by breast core biopsy with a corresponding lesion on breast MRI of at least 1-cm3 in volume.
* Patients may have undergone treatment with prior chemotherapy if this was greater than 12 months prior to current diagnosis.
* Age \>18 years.
* ECOG performance status \<2 (Karnofsky \>60%)
* Life expectancy of greater than 12 months.
* Normal organ and marrow function as defined below:
* leukocytes \>3,000/mcL
* absolute neutrophil count \>1,500/mcL
* platelets \>100,000/mcL
* total bilirubin within normal institutional limits
* AST(SGOT) \& ALT(SGPT)within normal institutional limits
* creatinine \<1.5 times institutional upper limit of normal or creatinine clearance \>60 mL/min/1.73 m2
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Pregnancy
* Patients who have undergone prior excisional biopsy for DCIS.
* Patients who are unable to undergo MRI due to claustrophobia or other reason.
* Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study.
* Patients receiving any other chemotherapy or investigational agents.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extracts or sensitivity to green tea.
* Uncontrolled concurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Repurposing Colchicine to Improve Vascular Function in Hypertension

In this project the potential beneficial effect of the drug colchicine on vascular reactivity and blood pressure will be assessed. Colchicine is a commonly used anti-inflammatory medication approved for the treatment of gout, Familial Mediterranean Fever and pericarditis in Denmark. The current project idea is based on accumulating evidence in the literature for a beneficial role of colchicine treatment in the prevention of cardiovascular disease in parallel with novel mechanistic insight from our own research. Recently, colchicine was associated with a lower risk of cardiovascular disease, including reduced myocardial infarctions, strokes and acute coronary syndrome . However, none of these trials have investigated the effect of colchicine on arterial tone or stiffness, changes to which may underlie the reduced risk of cardiovascular disease associated with colchicine. In support of the hypothesis that colchicine will improve vascular reactivity, a study in 1985 by Lagrue et al. found that daily, low-dose colchicine improved arterial stiffness in a small cohort of hypertensive patients. More recently, colchicine was shown to improve arterial stiffness in patients with Familial Mediterranean fever supporting a cardiovascular protective role of colchicine. Finally, colchicine is also proposed to have anti-inflammatory effects in the vascular system.

In this project w the potential beneficial effect of the drug colchicine on vascular reactivity and blood pressure is evaluated. Colchicine is a commonly used anti-inflammatory medication approved for the treatment of gout, Familial Mediterranean Fever and pericarditis in Denmark. The current project idea is based on accumulating evidence in the literature for a beneficial role of colchicine treatment in the prevention of cardiovascular disease in parallel with novel mechanistic insight from research of the investigators. Recently, colchicine was associated with a lower risk of cardiovascular disease, including reduced myocardial infarctions, strokes and acute coronary syndrome. However, none of these trials have investigated the effect of colchicine on arterial tone or stiffness, changes to which may underlie the reduced risk of cardiovascular disease associated with colchicine. In support of thehypothesis that colchicine will improve vascular reactivity, a study in 1985 by Lagrue et al. found that daily, low-dose colchicine improved arterial stiffness in a small cohort of hypertensive patients. More recently, colchicine was shown to improve arterial stiffness in patients with Familial Mediterranean fever supporting a cardiovascular protective role of colchicine. Finally, colchicine is also proposed to have anti-inflammatory effects in the vascular system.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with essential hypertension
* BMI\<30
* blood pressure (sys/dia) ≥120 mmhg and/or ≥80 mmhg while on hypertensive medication OR
* blood pressure (sys/dia) ≥130 mmhg and/or ≥85 mmhg without hypertensive medication

Exclusion Criteria:

* smoking
* excessive alcohol use
* chronic diseases (beside essential hypertension)
SimCoach Evaluation: A Virtual Human Intervention to Encourage Servicemember Help-seeking for PTSD and Depression

SimCoach, a computer program featuring a virtual human that speaks and gestures in a videogame-like interface, is designed to encourage servicemembers, especially those with signs or symptoms of post-traumatic stress disorder (PTSD) or depression, to seek help to improve their psychological health. The assessment included a formative component assessing SimCoach's design, development, and implementation approaches, as well as a summative component assessing outcomes among participants in a user experience survey and a randomized controlled trial (RCT).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and
* active duty or Reserve servicemember or National Guard servicemember and
* being off duty

Exclusion Criteria:

* under the age of 18 years
* retired servicemember or not a servicemember
* currently on duty
* currently incarcerated, on parole, or on probation
Loading Vancomycin Doses in the Emergency Department

In 2008, our ED administered an average of 245 doses of vancomycin per month. Currently there is no consistency in the ED practice in regards to vancomycin dosing. In 2009, the IDSA put forth new recommendations for vancomycin dosing in order to achieve therapeutic levels more rapidly. It has been hypothesized that if therapeutic levels are reached more rapidly then patients will in turn have better clinical outcomes and that the development of resistant organisms will be decreased. Methicillin resistant Staphylococcus aureus (MRSA) has emerged as one of the most deadly pathogens that are currently plaguing our patient population. Vancomycin is one of only a few antibiotics that are effective for treating MRSA. It is imperative that the ED physicians consistently and correctly dose vancomycin in order to give the patients the best chance to fight infection while helping to prevent further resistance in this already highly resistant organism. It is believed this study will reveal that the new dosing recommendations by the IDSA will lead to the achievement of therapeutic levels more rapidly. This information will in turn help to convince ED physicians that a change in current clinical practice is warranted and ultimately lead to better clinically outcomes for the patients.

Recently, the Infectious Disease Society of America (IDSA) has released new dosing recommendations for intravenous (IV) vancomycin. These new recommendations suggest administering an initial dose of 25-30 mg/kg of vancomycin as opposed to 10-15 mg/kg which is more traditionally done. Currently in the Emergency Department (ED) some practitioners are using the new IDSA dosing recommendations for vancomycin, while other practitioners have not changed their clinical practice. There is currently little data available to suggest that implementing these new vancomycin dosing regimens in the ED will achieve therapeutic vancomycin levels more rapidly than our traditional dosing practice.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Treated in Christiana Emergency Department
* Receiving Vancomycin for an infection or presumed infection
* Being admitted to Christiana Hospital
* Planned continued use of Vancomycin after admission.

Exclusion Criteria:

* Less than 18 years of age
* Weight greater than 120 kg.
* Concurrent use of aminoglycosides or acyclovir
* Sepsis patients being admitted to ICU with presumed diagnosis of pneumonia
* Patients currently undergoing dialysis
* Pregnant or breast feeding
* No plan to continue Vancomycin after admission.
* Creatinine clearance less than 50ml/min.
Pre-genotype NUDT 15 R139C on Reducing Thiopurine-induced Leucopenia in Inflammatory Bowel Disease

NUDT15 R139C was comfirmed to be associated with thiopurine-induced leukopenia inflammatory bowel disease (IBD) cohort.The present study aim to explor the following questions:can optimizing thiopurine dose by NUDT15 genotype reduce thiopurine-induced leucopenia?What is the influence of this optimizing strategy on clinical outcome?Thus,we conduct a randomised controlled study.Subject in the conventional group detect NUDT15 genotype before thiopurine use and optimise dosage according to the genotype.While the subjects in the control group follow the conventional monitor strategy.The primary endpoint was the rate of leukopenia.The secondary endopoint was the efficacy of thiopurine.The follow up duration was 1 year.

We included patients diagnosis of IBD (\>18 yrs old) with indication of the use of thiopurine.Group A (intervention): AZA dose optimization by testing for NUDT15 R139C- testing results will be informed.Group B (control):AZA dose optimization according to standard guideline - testing results will not be informed.The participants will be followed for 9 month. The incidence of adverse events and efficacy will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of IBD with indication of the use of thiopurine

Exclusion Criteria:

* Contraindication of thiopurine
* Previous use of thiopurine
* co-treatment with 5-ASA or allopurinol
Mental Healthcare in Older Adults With Schizophrenia

As in the general population, there is a gradual and steady increase in life expectancy of patients with schizophrenia. But this increase is at a smaller scale, with a rate of premature death that is still 2 to 3 times higher than that found in the general population. This excessive early mortality is explained by an overrepresentation of suicide deaths, but also a higher prevalence of somatic diseases, mainly cardiovascular. But today there are only very few epidemiological data on the mortality of patients with schizophrenia, including those aged over 60 years. What are the sociodemographic and clinical characteristics (psychiatric and somatic) of these schizophrenic elderly patients? Do they benefit from a somatic follow-up adequate and systematic? What are their levels of social independence and of quality of life? the answers these questions and the description of the offer of geriatric care and of psychiatric care currently provided by different sectors of psychiatry in France is an indispensable prerequisite for any project to improve the quality of life, state of health and mortality of older patients with schizophrenia.

Evaluate prospectively over 5 years, the rates and causes of mortality in a cohort of schizophrenic patients older than 60 years, followed by adult psychiatry sectors, compared to those patients matched for sex and age and monitored by the same sectors for a chronic psychiatric disorder other than schizophrenia

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged than 60 years with a diagnosis of schizophrenia, according to the DSM-IV criteria
* Men or women aged than 60 years with chronic psychiatric disorder other than schizophrenia
* Patients consenting to participate to the study
* Patients enrolled in the national healthcare insurance program

Exclusion Criteria:

-Disease affecting the central nervous system
Androgens and NAFLD Longitudinal Cohort Study

The researchers want to learn how androgens, a type of sex hormone, might affect nonalcoholic fatty liver (NAFLD) in young women over time. NAFLD happens when fat builds up in the liver which can cause damage to the liver such as inflammation or scarring.

Young women with a condition called polycystic ovary syndrome (PCOS) have a high risk for NAFLD, and they often have high androgen levels too. So the researchers are recruiting young women with PCOS as well as those without PCOS, and will compare changes in NAFLD over time between young women with and without PCOS.

This study is funded by the National Institutes of Health

The studies central hypothesis is that androgens promote liver injury and NAFLD/NASH progression in PCOS, which occurs through aberrant lipid activity (including lipotoxicity and dysregulated de novo lipogenesis), in part from androgenic effects on visceral adipose tissue (VAT). Data in young women taking exogenous testosterone show redistribution of fat from subcutaneous to visceral stores In the general population, VAT promotes NASH through several established pathways, including production of tissue injurious or "lipotoxic" lipids such as some phospholipid, sphingomyelin, and ceramide species. Recent data show androgen- associated increase in serum glycerophospholipids in women with PCOS, a lipid class that is associated with NASH in women. Additionally, androgen-associated de novo lipogenesis (DNL) may contribute to NASH in women. Hepatic DNL is a key source of lipid accumulation, and co-investigators at Duke University recently discovered an enzymatic balance that regulates hepatic DNL with dysregulation of this pathway (reflected by branched-chain keto and amino acids) predictive of prevalent NASH in humans. Androgen-induced de novo lipogenesis also occurs in cultured hepatocytes from women (but not men) supporting the researchers focused evaluation of the relationship between androgens, dysregulated hepatic DNL, and NASH in PCOS.

As existing data support androgenic effects on hepatic and visceral fat in women, the researchers will now determine the relationship of androgens with liver injury and progression in PCOS and the potential mechanistic contributions of VAT and aberrant lipid metabolism to this process. The team includes clinical and translational researchers at two centers (UCSF and Duke) with expertise in NAFLD, PCOS, obesity, and lipid metabolism, with a track record of collaboration. The study team will leverage an existing well-characterized PCOS cohort29 to follow 150 reproductive-aged women with NASH (125 PCOS and 25 non-PCOS controls) to accomplish this.

Eligibility Criteria:
Inclusion Criteria:

* Metabolic associated steatohepatitis (MASH) (formerly NASH)
* PCOS
* Non-PCOS

Exclusion Criteria:

* High levels of alcohol use (more than 7 drinks a week)
* Current pregnancy
* Other causes of hepatic steatosis
* Weight loss of more than 10% body weight in the last 6 months
Usability Study of Spaced Retrieval Exercise Using Mobile Devices for Alzheimer's Disease Rehabilitation

The focus of this work is to explore the use of modern mobile technology to enable people with Alzheimer's disease to improve their abilities to perform activities of daily living and hence to promote independence and participation in social activities. This work also aims at reducing the burden on caregivers by increasing the AD patients' sense of competence and ability to handle behavior problems.

The investigators developed ADcope, an integrated application that includes several modules that target individuals with Alzheimer's disease , using mobile devices. The investigators developed two different user interfaces: a text-based and a graphic-based. To evaluate the usability of the application, participants with early stages of AD were asked to run the two user interfaces of the spaced retrieval memory exercise using a tablet mobile device.

Eligibility Criteria:
Inclusion Criteria:

- Have early stages of Alzheimer's decease
Study of the Expression of Met Receptor Fragments in Non Small Cell Lung Cancers

Our project, established through collaboration between clinicians (Oscar Lambret Center-University Hospital) and scientists (IBL), aims to evaluate the expression of Met fragments in the lung cancer (LC). Unlike previous studies on Met by sequencing, in situ hybridization or immunohistochemistry, the investigators propose a protein analysis by Western blot of tumor samples and healthy tissue. This approach will evaluate the expression of full-length receptor, the potential presence of intracellular fragments, and their phosphorylation status.

* Patient information and collection of signed inform consent
* Blood sample collection before bronchoscopy or before surgery, at the same time as a usual blood assessment.
* Prospective collection of bronchial biopsies of patients with metastatic non small cell lung cancer, during a bronchoscopy at the Oscar Lambret Center (Dr Dansin)
* Prospective collection of resected specimens of patients with localized non small cell lung cancer, who were operated at the thoracic surgery unit of the University hospital (Pr Porte)
* Transportation of the samples to the pathology laboratories (Dr Robin, Pr Copin)
* Selection of blocks of interest and preparation of tumor samples
* Clinical data collection : date of biopsy or surgery, disease-free survival, overall survival, tumor characteristics, EGFR status, ALK, BRAF, HER2
* Transportation of tumor blocks and blood samples to the Institute of Biology of Lille for analyses: Western blot, immunohistochemistry and ELISA test)
* Return to storage of the tumor samples at the Oscar Lambret Center and at the University hospital of Lille

Eligibility Criteria:
Inclusion Criteria:

* Patients with non small cell lung cancer (NSCLC)
* Patients candidate for bronchial biopsies at the Oscar Lambret Center (metastatic stage) or candidate for thoracic surgery at University Hospital of Lille (localized stage)
* Treatment naive patient for metastatic NSCLC
* Patients with or without neoadjuvant therapy for localized NSCLC
* Male or female patients aged ≥ 18 years
* Patient registered with the social security system
* Having signed a written Informed Consent

Exclusion Criteria:

* Malignant tumors which are not carcinoma
* Small-cell malignant tumors
* Secondary bronchial lesions
* Revision surgery
* Pregnant or breastfeeding women
* Patient under guardianship or tutorship
* Previous cancer
Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer

Phase III Clinical Trial to Compare the Efficacy and the Safety of AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Taxotere Versus AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Nanoxel M as Neoadjuvant Chemotherapy in Patients With Breast Cancer

The purpose of this study is to evaluate efficacy and safety of AC followed by Taxotere versus AC followed by Nanoxel M as neoadjuvant chemotherapy in breast caner patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who were diagnosed with primary breast cancer by core biopsy
2. Patients who have been identified as HER2 negative in the tissue obtained through core needle biopsy and have confirmed the positive / negative status of ER (Estrogen receptor) and Progesterone receptor (PR)

   * HER2 positive is defined as IHC 3+ or FISH +
3. Patinets whose TNM stage confirmed by CT or MRI (T2-T3, anyN, M0 or T1-3, N1-3, M0)

Exclusion criteria:

1. Patients who have distant metastasis
2. Patients who have cystitis or urinary obstruction
3. Patients who have history of thromboembolism or coagulation disorder
4. Patients who have Interstitial lung disease ans liver cirrhosis ( \> Child-Pugh class B)
5. Patients who have Insulin-Dependent Type II diabete mellitus