cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)

The purpose of this study is to determine the efficacy and the safety of BLS-ILB-E710c for the the fertile women with Cervical Intraepithelial Neoplasia (CIN3).

This study is to see the regression rate of Cervical Intraepithelial Neoplasia (CIN3) and to see the inducement of Cytotoxic T Lymphocyte.

The First treatment group will be administered with BLS-ILB-E710c 500mg for 8 weeks followed by 1 week observation The Second treatment group will be administered with BLS-ILB-E710c 1000mg for 8 weeks followed by 1 week observation The Third treatment group will be administered with BLS-ILB-E710c 1500mg for 8 weeks followed by 1 week observation The fourth treatment group will be administered with BLS-ILB-E710c Optimum dose for 8 weeks followed by 8 weeks observation

Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal patients between age of 20 and 50.
* Patients with cervical intraepithelial neoplasia 3(CIN3).
* Only infection with HPV type 16.
* Patients with Capable of observation of all of lesions by Colposcopy biopsy.
* Be informed of the nature of the study and will give written informed consent.
* Be agree with contraception during study
* White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 /mm\^3
* Normal for EKG(Electrocardiography)
* AST/ALT : 2.5 times less than normal range

Exclusion Criteria:

* Autoimmune Disease or Prohibited drug(Therapy) bring about immunosuppressive.
* Patient that has medical history of hypersensitivity about Food containing Lactic acid bacteria or Lactic acid bacteria medication.
* Patient with Acute illness(ex. Acute Appendicitis, Myocardial infarction, Hemorrhage, meningitis etc.)
* Investigational product within three months before the start of the drug administration to patients treated with other test drug.
* Patient with Chronic pancreatitis currently or Patients diagnosed with acute pancreatitis.
* Organopathy Patient with Inflammatory intestine·bowel disease, gastrointestinal tumors, ulcers, bleeding, perforation etc.
* Pregnant or lactating women
* Patient with HBV or HCV infection (except for Asymptomatic)
* Patient that Investigator judge
* Deemed inappropriate for researchers to judge the patient
VitalFlow Healthy Volunteer Study

Find the stimulation threshold of the facial nerve (ganglion Geniculate) associated with tolerability and safety in subjects Healthy humans.

Magnetic stimulation of the facial nerve (geniculate ganglion) in humans can induce changes in cerebral blood flow safely, without generating adverse effects unknown to the technique.

Our specific objectives:

1. Perform tolerability and safety tests of magnetic stimulation on the facial nerve.
2. Establish the optimal stimulation threshold associated with tolerability in order to apply it to the final design of the Magnetic Stimulation (MS) system.
3. Measure whether the threshold found shows any increase in cerebral perfusion in the subject with respect to their baseline.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Normal audiometry chart (Evaluated at the time of your inclusion).
* Normal neurological examination at time of inclusion.

Exclusion Criteria:

* Subjects with a diagnosis of epilepsy, seizures, facial nerve palsy, migraine or recurrent headaches, glaucoma or neuropathies.
* Subjects in breastfeeding or in pregnancy. (To be confirmed with test strip).
* Subjects with acute or acute chronic medical conditions.
* Age less than 20 years or greater than 40 years.
* Carotid surgery.
* Episodes of syncope.
* Known arteriosclerosis anywhere on the body
* Metal implants (cochlear implants, pacemakers, metal prostheses).
* Intracranial abnormalities observed by MRI or MRA (Evaluated at time of inclusion of the subject).
* Intraocular pressure\> 22mmHg (Evaluated at time of inclusion of the subject)
Azithromycin for Child Survival in Niger: Programmatic Trial (AVENIR)

The MORDOR trial found that biannual distribution of azithromycin to children 1-59 months old reduced child mortality. The World Health Organization (WHO) released conditional guidelines for this intervention, which include targeting azithromycin distributions to children 1-11 months of age in high mortality settings. The proposed trial aims to demonstrate and evaluate large-scale implementation of azithromycin to children aged 1-11 months old in the context of a programmatic setting while monitoring mortality and resistance antimicrobial resistance.

In the Programmatic Trial, community health centers (also known as "CSIs" or "Centres de Santé Intégrés") will be randomized to one of two arms: 1) programmatic azithro 1-11: biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers or 2) no intervention: no distribution of azithromycin. A total of 2,490 communities within selected CSIs will be included .

All communities in both arms receive routine health services offered by community health workers working for the Niger Ministry of Health's community health program.

Mortality will be monitored through birth histories. Mortality and morbidity will also be monitored using routinely collected community and clinic visit data. Antimicrobial resistance will be monitored in a subset of eligible CSIs.

Eligibility Criteria:
Intervention

At the community-level, eligibility includes:

Inclusion Criteria:

* Location in Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions
* Distinguishable from neighboring communities
* Verbal consent of community leader(s)

Exclusion criteria:

* Inaccessible or unsafe for study team
* "Quartier" designation on national census

At the individual-level, eligibility includes:

Inclusion criteria:

* Age 1-11 months
* Primary residence in a study community
* Verbal consent of caregiver/guardian for study participation

Exclusion criteria:

* Known allergy to macrolides

Population-based sample collections

At the community-level, eligibility includes:

Inclusion criteria:

* Location in study region
* Distinguishable from neighboring communities
* Verbal consent of community leader(s)

Exclusion criteria:

* Inaccessible or unsafe for study team
* Included in MORDOR trials
* Not randomly selected

At the individual-level, eligibility includes:

Inclusion criteria:

* Age 1-59 months or 7-12 years or caregiver/guardian of a child eligible for treatment
* Primary residence in a study community selected for sample collections
* Verbal consent of caregiver/guardian for study participation

Exclusion criteria:

* Not on list of randomly selected participants from the census
Diagnosis of Heart Failure in Chronic Obstructive Pulmonary Disease Using the Lung Ultrasound

Acute Heart failure (AHF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). This association is frequently underestimated with regard to the difficulty of clinical diagnosis. The investigators expect that the application of the lung ultrasound could be useful in this issue.

Chronic obstructive pulmonary disease (COPD) is a frequent disease in our population affecting mainly the elderly and males. Dyspnea is the most common reason for consultation for patients with COPD in ED. Distinguishing between pulmonary and/or cardiac origin can be challenging.Physical examination, laboratory findings and radiography are imperfect. Lung ultrasound sonography (LUS) has recently gained a large place in the diagnosis of heart failure (HF), but its contribution to the diagnosis of HF in COPD remains poorly studied.

Purpose: The purpose of this study is to assess the contribution of LUS in the diagnosis of HF in COPD patients with acute dyspnea

. Physical examination, laboratory findings and radiography are imperfect, resulting in a need for sophisticated test results that delay management. Lung ultrasonography is becoming a standard tool in critical cases in the ED. the investigators aim to perform ultrasonography on COPD patients admitted to the ICU with dyspnea, comparing lung ultrasonography results on initial presentation with the final diagnosis by the ICU team. Three items were assessed: artifacts (horizontal A lines or vertical B lines indicating interstitial syndrome), lung sliding, and alveolar consolidation and/or pleural effusion, these items were grouped to assess ultrasound profiles. This study assesses the potential of lung ultrasonography to diagnose heart failure.The second aim of this study was to evaluate the inter-observer reproducibility of LUS performed by ED residents in the evaluation of cardiac causes of acute dyspnea.This study includes patients with COPD consulting for acute dyspnea. We performed a lung ultrasound on all patients included. The diagnosis of heart failure (HF) was based on clinical, radiological, cardiac-ultrasound and expert data. The LUS diagnostic performance indicators were calculated using the different cut-off proposed by the LUS score.Then the probability of AHF was defined as : low probability (LUS\<15) intermediate probability (15≤ LUS\<30), and high probability (LUS≥30 ).

Eligibility Criteria:
Inclusion Criteria:

* patients with history of COPD admitted to the emergency department for dyspnea non traumatic dyspnea

Exclusion Criteria:

* instable hemodynamic or neurological status non consent to participate in the study
The remedē® System for the Treatment of Central Sleep Apnea in Daily Practice

The aim of this post market study is to assess the impact of sleep-disordered breathing on the well-being of patients according to the treatment chosen, i.e. with or without implantation of the remedē® system to treat sleep-disordered breathing.

The sponsor of this study, LivaNova, has a partnership with Respicardia, Inc who has developed a battery-powered implantable device that treats central sleep apnea. The device is used with a lead that delivers the stimulation therapy which causes the patient to breathe with a regular rhythm and an optional lead that senses breathing. This combination is called the remedē® system.

The aim of this study is

1. to collect data in order to get a better understanding of the characteristics and/or symptoms related to central sleep apnea
2. to collect safety information of all patients diagnosed with central sleep apnea
3. to obtain additional short and lang term information on the safety and performance of the remedē® system, including an evaluation if there's an impact on the quality of life of patients treated with the the remedē® system in daily practice.

The information obtained from this study may provide better insight on the symptoms related to central sleep apnea, risk factors related to central sleep apnea therapy and use of the remedē® system which may help to treat other patients with potential sleep disordered breathing more appropriately.

Approximately 300 patients (to be) implanted with the remedē® system will participate in this study at approximately 40 sites in Europe. For this purpose the investigators aim to screen approximately 1500 patients with sleep-disordered breathing. Also patients diagnosed with central sleep apnea, but not receiving the device will be followed through phone calls for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* All patients screened for sleep disordered breathing
* Age \> 18 years
* Signed Ethics Committee approved informed consent

Implant Inclusion criteria

* Diagnosis of moderate to severe central sleep apnea and referred for implant of the remedē system / implanted with remedē system

Implant Exclusion Criteria:

* Patients meeting the criteria as referred to in the latest version of the implant manual
EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Study

The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation for the treatment of pancreatic NET

Pancreatic neuroendocrine tumor, including insulinoma, increasingly are being encountered in clinical practice. Management of pancreatic NET is challenging because most are asymptomatic but may have malignant potential, and surgical resection of pancreatic neoplasm is associated with substantial morbidity of 20%-40% and a mortality rate of 2%. Management strategy needs to be individualized, applying a risk-benefit analysis to each patient. Recently, pancreatic tissue ablation by EUS-guided injection of ethanol or other chemotherapeutic agents can be performed safely, with few procedure-related complications. Levy et al. demonstrated that EUS-guided ethanol ablation for insulinoma was both safe and feasible, and symptomatic improvement was achieved in 8 of 8 patients (100%). However, previous study have included only a small number of patients and evaluated only short-term outcomes. In addition, lipiodol permits the drug to concentrate in the tumor. To obtain an embolic effect and prevent washout of the ethanol, ethanol/lipiodol mixture is administered into the tumor. The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation for the treatment of pancreatic NET

Eligibility Criteria:
Inclusion Criteria:

* Pancreas NET(including insulinoma) \< 2cm in diameter
* Poor surgical candidate (involving the head of the pancreas or multifocal NET, advanced comorbidity, age \>75 years of age)
* Refuse to surgery

Exclusion Criteria:

* Younger than 18 years of age
* Coagulopathy (INR \>1.5, Platelet \<50,000)
* Evidence of active pancreatitis
* Inability to safely undergo EUS
* Refuse to participate
Influence of Drug Transporter Expression on the Pharmacokinetics of the HIV Protease Inhibitor Kaletra

The aim of this study is to determine the pharmacokinetics of Kaletra™ (HIV protease inhibitors lopinavir and ritonavir) in different body compartments and to assess the role of four different drug transporters (MDR, MRP1, MRP2 and BCRP) in the tissue distribution of the two protease inhibitors. The latter will be studied by comparing intracellular concentrations of peripheral blood mononuclear cells (PBMCs) with total and free plasma concentrations in healthy individuals. These effects will be studied after single dose (day 1), during steady state (day 3), and during chronic treatment (day 14).

Objective:

Measurement of AUC, Cmax, tmax, t1/2 and clearance (Cl) of the protease inhibitor Kaletra™ (lopinavir and ritonavir) each in the plasma of healthy individuals

* establish free and total plasma - blood cell concentration-relationship
* establish free and total plasma - saliva concentration-relationship
* establish blood cell concentration - drug transporter expression-relationship

Eligibility Criteria:
Inclusion Criteria:

* Good state of health

Exclusion Criteria:

* Drug treatment with known inhibitors or inducers of cytochrome P450 isozymes or ABC-transporters within the preceding 2 months
* Any acute or chronic illness
* Smoking
* Pregnancy
* Alcohol or drug abuse
COLISURG : Exploratory Analysis of Sexual Function and the Impact of Biotherapies on Postoperative Morbidity.

The surgical treatment of the ulcerative colitis (UC) remains associate to a significant morbidity (up to 60%). Anastomotic fistula and pelvic sepsis are the most severe complications which could dramatically compromise the surgical issue and functional status. Thanks to the current therapeutic arsenal and the evolution of health care paradigms, the quality of life of patients plays a key role in the modern global management of these medical conditions. Biotherapies (e.g anti-TNF) are widely used to treat patients with UC. Anti-TNF and anti-integrins have an effect on the immune response and can theoretically aggravate the infectious disease. Their potential impact on postoperative complications after ileo anal anastomosis (AIA) remains debated. Very few studies have looked at other biotherapies including vedolizumab. All studies are retrospective series with small sample size. Here again the conclusion remain contradictory. Lightner et al. showed an increased risk of surgical site infection for patients preoperatively exposed to vedolizumab (37% vs. 10%, p \<0.001). In a dedicated cohort to the RCH, the same author found a risk of increased pelvic abscess (31.3% vs 5.9%, NS) but the difference was not statistically significant probably for lack of power. Other studies did not find any impact of vedolizumab on the risk of postoperative complications. To clearly determine within a large prospective cohort the impact of anti-TNF agents and biotherapies on the postoperative complications seems to be essential in order to adapt and to optimize the therapeutic strategy, especially the surgical sequences, in patients with UCR whom benefit a surgery.


Eligibility Criteria:
Inclusion Criteria:

Age ≥ 13 ans

- Patients with ulcerative colitis requiring surgical treatment with ileal pouch-anal anastomosis

Exclusion Criteria:

* Age \< 13 ans
* Under any administrative or legal supervision
Knee Extension Deficit Following an Anterior Cruciate Ligament Reconstruction (Extension Loss)

Knee extension loss following an anterior cruciate ligament (ACL) reconstruction is believed to play an important role in quadriceps strength recovery. One of the main goals of the rehabilitation following ACL reconstruction is to restore knee extensor muscle strength. Deficits of more than a five-degree extension range of motion (ROM) could lead to delayed knee functionality and anterior knee pain. However, the effect of knee extension deficits in the early postoperative phase of the ACL reconstruction on knee extensor muscle strength recovery and knee functionality is not yet known.

This study aimed to investigate the difference between knee extensor muscle strength recovery and knee functionality in patients with ACL repair who had a knee extension ROM deficit (\>5°) in the early postoperative period and those who did not.

Knee range of motion deficits are significant surgical complications following an anterior cruciate ligament (ACL) reconstruction, and despite current advances in surgical techniques, knee range of motion cannot always be regained. Previous studies reported that knee range of motion (ROM) deficits play an important role in knee extensor muscle weakness and knee osteoarthritis. Thus, deficits in knee extension joint motion are more difficult to tolerate than flexion deficits. It has been reported that a five-degree decrease in the extension ROM of the affected knee compared to the healthy side can lead to secondary complications such as difficulty walking and anterior knee pain. However, the effect of knee extension deficits in the early postoperative phase of the ACL reconstruction on knee extensor muscle strength recovery and knee functionality is not yet known.

This study aimed to investigate the difference between knee extensor muscle strength recovery and knee functionality in patients with ACL repair who had a knee extension ROM deficit (\>5°) in the early postoperative period and those who did not.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent ACL repair using hamstring tendon autograft
* volunteered to participate in the study between the ages of 18-45
* a non-contact injury mechanism
* a Tegner Activity Score \>5 before the injury
* regularly attended the rehabilitation program after surgery (not missing more than three sessions)

Exclusion Criteria:

* Patients who underwent ACL repair with patellar tendon autograft or allograft, revision surgery
* underwent meniscus and or cartilage repair in addition to ACL repair
* a history of previous knee, ankle, or groin injuries
* concomitant systemic and/or neurological pathologies
* a history of injury to the contralateral lower extremity
* do not want to participate in the evaluations that should be done before the study.
Communication Strategies to Introduce Psychology Services

The goal of this research study is to learn about advanced cancer patients' preferences about how psychology services are introduced.

This is an investigational study.

Up to 110 participants will be enrolled in this study. All will take part at MD Anderson.

If you agree to take part in this study, during an already-scheduled office visit, you will complete 3 questionnaires about your symptoms, your emotional health, and if you have ever participated in psychiatric or psychology services. These questionnaires should take about 9 minutes to complete.

All participants will watch 2 short videos. The videos show actors playing a doctor, counselor, and patient, discussing psychology service options. Each video is about 1 minute and 30 seconds long and will discuss the same material, but the content of each video will be different. The order in which they are presented will be randomly assigned (as in the flip of a coin). You will have an equal chance of seeing either video first.

After you watch the second video, you will complete 3 questionnaires about whether you think 1 of the videos was better than the other, and about your attitude toward psychology services. These questionnaires should take about 4 minutes to complete.

Length of Study:

It should take about 16 minutes to watch both videos and to complete all questionnaires. Your participation on this study will be over after you have completed the last questionnaire.

Other Information:

We will ask your caregiver(s) to leave the room while the videos are played. In case they decide to stay, we will ask them to keep silent.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>/= 18 years-old
2. Can speak, read, and understand English
3. Diagnosis of locally advanced, recurrent, or metastatic disease
4. Patients treated as outpatients by the supportive and palliative care team
5. Normal cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process

Exclusion Criteria:

1. Previous psychological counseling received in supportive care department
2. Patients with severe symptom distress as assessed by nursing staff
Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma

To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a likelihood of benefit from the pomalidomide treatment while the medication is not commercially available

Several clinical studies indicate that pomalidomide has activity in relapsed and refractory multiple myeloma with response rates ranging between 30% and 60% at pomalidomide doses at 2 mg/day and/or 4 mg/day.

Eligibility Criteria:
Inclusion Criteria:

1. Must have documented diagnosis of relapsed or relapsed/refractory multiple myeloma and have measurable disease (serum or urine M-protein)
2. Age ≥ 18 years
3. Must have had at least ≥ 2 prior anti-myeloma therapies
4. Must have received at least 2 consecutive cycles of both lenalidomide and bortezomib, either alone or in combination
5. Must have failed treatment with the last lenalidomide-containing regimen and the last bortezomib-containing regimen
6. Must have documented disease progression during or after the last antimyeloma regimen
7. Females of childbearing potential (FCBP) must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting drug, while participating in the study and for at least 28 days after study treatment discontinuation.
8. Males must agree to use a latex condom during sexual contact with FCBP while participating in the study and for 28 days following discontinuation from study treatment.

Exclusion Criteria:

1. Peripheral Neuropathy ≥ Grade 2
2. Non-secretory multiple myeloma
3. Previous therapy with pomalidomide
4. Use of any investigational agents within 28 days or 5 half lives (whichever is longer) of initiating study treatment
5. Subjects with conditions requiring chronic steroid or immunosuppressive treatment.
6. Hypersensitivity to thalidomide, lenalidomide or dexamethasone
7. Known Human Immunodeficiency Virus positive, active or chronic Hepatitis A, B or C
8. Pregnant or breastfeeding females
9. Unacceptable hematological or biochemical laboratory abnormalities