cyrilzakka/clinical-trials huggingface dataset:
Domestic Violence Intervention to Reduce Psychological Distress and Violence Among Women Experiencing IPV in Nepal

The aim of this study is to implement and evaluate the feasibility, acceptability, and effectiveness of a validated integrated multi-component intervention targeting secondary prevention of violence and addressing the mental health needs of women experiencing intimate partner violence.

This study's aim is to assess the feasibility and effectiveness of an integrated multicomponent intervention among women experiencing violence in Madhesh Province of Nepal.

1. To assess the feasibility of DeVI in health care centers in Nepal by exploring the views of key stakeholders, health care providers, and local women in the community.
2. To train non-specialist mental health care providers on the delivery of DeVI among women exposed to IPV.
3. To explore participants' and health care providers' experiences with DeVI Intervention and the opportunities and challenges encountered during implementation.
4. To measure the effectiveness of the DeVI intervention in addressing psychological distress, reducing the occurrence of IPV, and developing safety strategies among women experiencing IPV.
5. To measure the impact of the DeVI training on knowledge, attitudes, skills, and stigma towards IPV and its consequences, particularly on psychological trauma among health care providers.

Eligibility Criteria:
Inclusion Criteria:

* Women between the age of 18-49 years
* Having experienced abuse (physical, sexual, or psychological) in a heterosexual relationship from her husband or her family members in the last 12 months
* Non-pregnant or pregnant in the first trimester
* Score of 3 and above in the psychological distress scale (measured by General Health Questionnaire (GHQ-12))
* Living with her husband or in-laws for at least six months.

Exclusion Criteria:

* Have a severe cognitive impairment
* Seeking treatment for life-threatening emergency care
* Have suicidal thoughts
Research on Optimization and Evaluation of Oral Cancer Screening Methods

An evaluation and validation study on oral cancer screening methods will be carried out, and two different methods will be used for oral cancer screening among the population. The two different methods are: (1) clinical observation (including inspection and palpation) combined with pathological biopsy. (2) Clinical observation (including inspection and palpation), in vivo staining (toluidine blue) combined with pathological biopsy. By evaluating and comparing the sensitivity and specificity of the two screening methods, the more effective oral cancer screening method will be selected.

An evaluation and validation study on oral cancer screening methods will be carried out, and two different methods will be used for oral cancer screening among the population. The two different methods are: (1) clinical observation (including inspection and palpation) combined with pathological biopsy. That is, inspecting and palpating the oral cavity and neck of the screened object. If positive lesions are found, then further pathological biopsy will be performed. This is also the commonly used screening method for oral cancer now; (2) Clinical observation (including inspection and palpation), in vivo staining (toluidine blue) combined with pathological biopsy. That is, toluidine blue staining is performed at the same time as the inspection and palpation of the oral cavity and neck of the screening object. As long as the screening subjects found positive lesions or abnormal living body staining, pathological biopsy was performed. By evaluating and comparing the sensitivity and specificity of the two screening methods, the more effective oral cancer screening method will be selected. Finally, we will carry out prospective controlled population studies in high-risk areas and non-high-risk areas to further evaluate the effectiveness and feasibility of screening method after selection.

Eligibility Criteria:
Inclusion Criteria:

* aged 40-69 years old.

Exclusion Criteria:

* No.
A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®

To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus, Type 2 on oral agents
* Age \> 30 years

Exclusion Criteria:

* Severe Asthma, severe Chronic Obstructive Pulmonary Disease
* Smoking
Survey on Lymphedema After Sentinel Lymph Node Biopsy in People With Cervical or Vulvar Cancer

The purpose of this study is to collect information that may identify people who are at risk of developing lower extremity lymphedema (LEL) after sentinel lymph node biopsy (SLN) during surgery for early-stage vulvar or cervical cancer, and to improve the quality and accuracy of the information that is given to people who have this procedure.

Please note that, during this study, the researchers will collect information from a questionnaire completed by people who had SLN and LND+/- SLN during surgery for early-stage cervical or vulvar cancer. No form of treatment will be provided as part of the study, and no investigational tests or procedures will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Presented to MSK with newly diagnosed early-stage cervical cancer of any histologic profile or early stage vulvar cancer of any histologic profile.

  °Early stage: Stage 1-2
* Underwent primary surgery at our institution between January 2006 and January 2022.
* Alive at the time of study activation
* English comprehension
* Capable of providing informed consent

Exclusion Criteria:

* Had documented macroscopic evidence of metastatic disease at the time of initial diagnosis
MRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery

To see if performing breast MRI before a lumpectomy will help the surgeon successfully remove the entire cancer with normal tissue margins in a single operation thereby reducing the need for additional surgical procedures. The study will also measure how well MRI can find unsuspected cancers in the same breast as the known cancer; how well MRI will find unsuspected cancers in the opposite breast; how often MRI will generate false positive MRI findings; whether routinely incorporating breast MRI delays care or adds unnecessary cost; and, whether breast MRI is able to reduce the frequency of cancer recurrence in the treated breast or elsewhere in the body.


Eligibility Criteria:
Inclusion Criteria:

* DCIS less than 5 cm. T1/T2 invasive breast cancer. Patient is a suitable candidate for breast conservation and wishes this as the primary clinical approach
* No breast MRI within the past year. Prior core biopsy, but no prior excision allowed. Patient has completed conventional imaging workup with mammography ultrasound as indicated and there is no clinical indication for breast MRI.
* Women with age \>= 18. No ethnic restrictions.
* No life expectancy restrictions.
* Performance status not a factor.
* No requirements for organ or marrow function.
* Ability to understand and the willingness to sign a written informed consent document.\&#xA;

Exclusion Criteria:

* Patient is unable to complete a breast MRI due to such factors as hardware and claustrophobia.
* No limitations as to other investigational agents. Patients who have received neoadjuvant chemotherapy will not be included in the study due to the limitations of MRI interpretation after neoadjuvant chemotherapy and because this represents a distinct scenario for interpretation of breast MRI in comparison with untreated patients.
* There are no comorbidities that would preclude entry into the study unless the patient is unable to lay still for breast MRI scanning.
* There are fewer reactions to MRI contrast media, but if there is such a history, the patient will be excluded from consideration.
* There are no exclusion criteria based on concomitant medications.
* There are no other agent specific exclusion criteria.
* Pregnancy is considered a contraindication given the uncertain effects of breast MRI on the fetus.
* Cancer survivors are candidates for the study unless the patient has a prior ipsilateral breast tumor.
Non-Invasive Oral Biofilm Characterization

There is a need for toothpastes that more effectively remove oral plaque and prevent re-formation. The objective of this study is to map the development and resolution of clinical gingivitis using conventional clinical examination and imaging data to determine how useful imaging techniques can be for evaluating how well a toothpaste cleans the teeth

The researcher can use imaging techniques to map changes in gingival blood flow during the development and resolution of fully reversible, early clinical gingivitis using standard-of-care clinical indices as gold standard

The researcher can use imaging techniques to map inflammatory microstructural changes in the oral mucosa including swelling, vasodilation and edema during the development and resolution of fully reversible, early clinical gingivitis using standard-of-care clinical indices as gold standard

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female 18-25 years of age
* Volunteers with gingivitis but no periodontitis

Exclusion Criteria:

* Subjects who must receive dental treatment during the study dates.
* History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses. Allergy to personal care/consumer products or their ingredients.
* Individuals who have taken antibiotics in the previous 3 months
* Individuals who are pregnant or nursing
Safety and Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Kidney Function

The primary objective is to evaluate pharmacokinetics of Fluzoparib and its main metabolite in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.

The secondary objective is to evaluate the safety of Fluzoparib in subjects with mild and moderate renal impairment and in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

-

Inclusion Criteria for subjects with impaired kidney function:

1. Sign the informed consent before the trial, and fully understand the content, process, and possible adverse reactions of the trial;
2. Male or female subjects aged 18 to 70 (including 18 and 70);
3. Body mass index (BMI) ranges from 18 kg/m2 to 28 kg/m2 (including 18 and 28);
4. The glomerular filtration rate should meet the following criteria (GFR, mL/min):Subjects with mild renal impairment (CKD2): 60-89 mL/min (including 60-89);Subjects with moderate renal impairment (CKD3): 30-59 mL/min (including 30-59 ends);
5. Renal function should be stable, and the GFR results should be tested twice before administration (at least 3 days apart) within the same CKD stage.

Inclusion Criteria for subjects with normal kidney function:

1. Sign the informed consent before the trial and fully understand the content, process, and possible adverse reactions of the trial;
2. Male or female subjects aged 18 to 70 (including 18 and 70);
3. Body mass index (BMI) ranges from 18 kg/m2 to 28 kg/m2 (including 18 and 28);
4. Glomerular filtration rate (GFR) ≥90 mL/min.

Exclusion Criteria:

-

Exclusion Criteria for subjects with impaired kidney function:

1. History of kidney transplant;
2. Need Renal dialysis during the study;
3. Urinary incontinence or anuria;
4. Clinically significant heart disease, including but not limited to: congestive heart failure, symptomatic coronary artery disease, myocardial infarction, QTcF≥470 ms (female) or QTcF≥450 ms (male) within 12 months before the start of treatment;
5. Received any investigational drug within 3 months before the study started;
6. Taking any drugs which can affect the metabolic enzyme CYP3A within 14 days before the study started;
7. Smokers and alcoholics, or those screened positive for alcohol;
8. History of drug use, or drug abuse screening positive.

Exclusion Criteria for subjects with normal kidney function:

1. History of kidney transplant;
2. Clinically significant heart disease, including but not limited to: congestive heart failure, symptomatic coronary artery disease, myocardial infarction, QTcF≥470 ms (female) or QTcF≥450 ms (male) within 12 months before the start of treatment;
3. Received any investigational drug within 3 months before the study started;
4. Taking any drugs which can affect the metabolic enzyme CYP3A within 14 days before the study started;
5. Smokers and alcoholics, or those screened positive for alcohol;
6. History of drug use, or drug abuse screening positive.
Vitreous Hyper Reflective Dots in Association With Pseudophakic Cystoid Macular Edema

The aim of this study is to assess the association between vitreous hyper-reflective dots (VHD) and the macular thickness changes following uneventful phacoemulsification. In this prospective study the investigators performed optical coherence tomography (OCT) imaging in patients undergoing cataract surgery preoperatively and postoperatively after 1 week, 1 month and 3 months and analyzed the OCTs for VHDs. The investigators then measured the macular thickness in patients with VHDs and without VHDs and correlated the macular thickness with the number of VHDs.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cataract surgery
* minimum age 18 years
* phacoemulsification technique
* subsequent implantation of a monofocal hydrophobic acrylic intraocular lens

Exclusion Criteria:

* intraoperative complications including capsule rupture with or without anterior vitrectomy
* iris bites
* previous interventions including vitrectomy
* glaucoma surgery
* exudative or dry age-related macular degeneration
* presence of diabetes
* history or presence of retinal vein occlusion or uveitis
* epiretinal glioses
Alveolar Bone Loss Around 3 Different Designs of Dental Implant: Prospective Comparative Clinical Trail

comparison of alveolar bone resorbtion/ changes for a period of 12 month post loading of different designs and brands of oral implants. in this study, a comparison between straumann SLA-active implants to MIS Mistral and Mistral -X implants.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* \>18Y
* consent
* posterior mandibular missing teeth

Exclusion Criteria:

* chronic illness: diabetes, artheritis
* women: pregnancy, lactation
* non consent
* alcohol consumption
* smoking \>10 p day
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis

The study aims at identifying the type of B and CD4 T cell subsets with pathogenic properties in the different clinical forms of multiple sclerosis. This research might open new therapeutic approaches for the treatment of multiple sclerosis particularly progressive MS.

Multiple sclerosis (MS) is a chronic autoimmune disease damaging the central nervous system (CNS). MS is categorized into several distinct forms according to clinical symptoms and medical examinations. Relapsing-remitting multiple sclerosis (RRMS) is characterized by attacks of worsening neurologic function, followed by partial or complete recovery periods. Patients can also present a gradual but steady progression of the disease (progressive forms). While several treatment options are currently available, no treatment completely stops the disease progression. Therefore, a deeper understanding regarding the mechanism of the disease development is essential to generate more efficient treatment strategies. CD4 T cells are known to be significantly involved in the formation of the CNS lesions characteristic of MS.The investigators hypothesize that different types of B and CD4 T cells play major roles in different forms of the disease. They will determine the phenotype and functions of the cells from the immune system particularly B and CD4 T cells present in the blood and cerebro-spinal fluid (CSF) of patients diagnosed with multiple sclerosis or presenting a clinically isolated syndrome.

The study will recruit 150 patients followed in Bordeaux University Hospital and diagnosed for clinically isolated syndrome (CIS) or multiple sclerosis (MS). Blood and CSF will be collected during a scheduled visit to study the properties of cells from the immune system in particular CD4 T cells in multiple sclerosis. Clinical and biological disease activity, treatment and outcomes will be studied in correlation with the properties of blood and CSF lymphocytes. No extra visit will be needed and the blood and CSF samples will be collected at the same times as those collected for clinical purposes.

Eligibility Criteria:
Inclusion Criteria:

* male or female subjects ;
* Age ≥ 18 years;
* subjects with MS defined by 2010 revised McDonald criteria or presenting a clinical isolated syndrome;
* patients for which a blood draw and / or lumbar puncture to collect CSF is performed for diagnostic or therapeutic purpose;
* affiliated to an health insurance system;
* and who agree to participate in the study.

Exclusion Criteria:

* Pregnant or breastfeeding women,
* patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
Brain Ketone Metabolism in Type 1 Diabetes

This study is designed to examine the value of infusing BHB in type 1 diabetic subjects during experimentally induced hypoglycemic episode in conjunction with testing of cognitive function. This will lay the basis for subsequent trials exploring the novel use of therapeutic doses of oral ketone formulations that are currently under commercial development, which could serve as adjunct therapies to protect the brain from hypoglycemia in type 1 diabetic subjects experiencing recurrent hypoglycemia.

Healthy controls as well as type 1 diabetic subjects will undergo a hyperinsulinemic-hypoglycemic clamp with concomitant BHB or saline (control) infusion in random order. During each experimental condition the participants will complete a battery of validated cognitive tests that are sensitive to the cognitive impairment typically caused by hypoglycemia. An additional healthy control arm was added to the study design after the initial registration as a 2 arm study, to provide imaging results of normal healthy responses to hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

1. Type 1 diabetes mellitus of \> 5 years (C-peptide negative, age 18-60 years, on intensive insulin therapy (HbA1c \<7.5%)
2. Non-diabetic volunteers, age 18-65 years that do not meet any of the exclusion criteria.

Exclusion Criteria:

1. Pregnancy
2. Significant baseline anemia (hemoglobin \<11.0 or hematocrit \< 33%)
3. A history of liver cirrhosis or porto-caval shunt surgery.
4. Any contraindications for MRI scanning.
5. Subjects that follow a vegetarian diet
6. Subjects that exercise heavily on a regular basis (i.e. marathon runners, body builders or other forms of excessive exercise as determined by the PI)
7. Subjects with a history of anxiety/ panic attacks
Investigating the Relationships Among Illness Cognition, Social Support, Stress, and Emotional Reactions of Infertile Patients

The current study attempted to explore the relationships among stressors (cognitions of illness, socioeconomic status, social support, marital stressor, social stressor, etc), perceived stress level, and emotional reactions (anxiety and depression) of infertile patients and to propose the measurement and structural models of infertile aniexty and depression.

The current study attempted to explore the relationships among stressors (cognitions of illness, socioeconomic status, social support, marital stressor, social stressor, etc), perceived stress level, and emotional reactions (anxiety and depression) of infertile patients and to propose the measurement and structural models of infertile aniexty and depression.

Structural Equation Modeling (SEM) will be utilized through AMOS 17 to analyze the data, construct the initial model, and afterward present the modified structural model of the psychological responses for infertile patients.

Eligibility Criteria:
Inclusion Criteria:male infertile patients(ICD-9:606) and female infertile patients(ICD-9:628).

Exclusion Criteria:non-infertile patients.
Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma

To explore the effect of Camrelizumab and chemotherapy combining with endoscopic surgery in the treatment of recurrent nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed recurrent nasopharyngeal carcinoma
* American Joint Committee on Cancer recurrent rT2(recurrent T2)(including deep parapharyngeal space), recurrent T3, recurrent T4 which can be surgically removed
* Age ≥18 years old
* Informed consent signed
* With or without lymph node metastasis, which can be surgically removed
* No massive hemorrhage risk recently
* No distant metastasis
* ≥6 months from initial radiotherapy to recurrence
* Radical radiation only once
* Sufficient organ function
* Eastern Cooperative Oncology Group score 0-2

Exclusion Criteria:

* With a history of allergic to platinum drugs and similar compounds
* Evidence of distant metastasis or radiation encephalopathy or leptomeningeal disease (LMD)
* Have received radioactive seed implantation in the treatment area
* Suffer from uncontrolled disease which could interfere with treatment
* Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.)
* The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on
* The patients have autoimmune diseases
* The patient is using immunosuppressive agents or systemic glucocorticoid to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other), and continues to use it within 2 weeks before the first administration
* Severe allergic reaction to other monoclonal antibodies
* Previously received PD-1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody that acts on T cell co-stimulation or checkpoint pathway) treatment
* Live vaccines have been inoculated within 4 weeks before the first administration or during the study period
* The patient has any situation that may hinder study compliance or the safety during the study period
* Existence of serious neurological or psychiatric diseases, such as dementia and seizures
* Uncontrolled active infection
* Pregnant or breastfeeding women
* Those who have no personal freedom and independent capacity for civil conduct
* There are other situations that are not suitable for entry into the study