cyrilzakka/clinical-trials huggingface dataset:
Maternal Brain Imaging in Opioid Use Disorder

This research study aims to learn more about opioid use disorder (OUD) during pregnancy and how outcomes for pregnant women and their newborns can be improved. During pregnancy, people with OUD are prescribed medication-assisted therapy (MAT). The investigators are interested to know how the medication is broken down by the body during pregnancy and how effective it is. The investigators also want to learn if this medication and OUD have any effect on the different parts of the brain when compared to mothers without OUD.


Eligibility Criteria:
Pregnant Women with OUD

Inclusion Criteria:

* Age: \>18 years old
* Any subject that is currently on Buprenorphine at time of screening
* Singleton pregnancy

Exclusion Criteria:

* Serious maternal medical illness
* HIV or AIDs
* Polysubstance use
* Score \>9 on the PHQ-9, and score \>0 on item 9 which is about suicidality
* Score of 8 or more on GAD-7
* Any contraindications for MRI
* Known or suspected major fetal congenital abnormalities

Pregnant Women with no history of OUD

Inclusion:

* Age: \>18 years old
* Singleton pregnancy

Exclusion:

* Serious maternal medical illness
* HIV or AIDS
* Score of \>9 on the PHQ-9, and a score of \>0 on item 9 which is about suicidality
* Score of 8 or more on GAD-7
* Known or suspected major fetal congenital abnormalities
* Any contraindications for MRI
* Opioid or polysubstance abuse as identified on urine screening
The Detection of Barrett's Esophagus by Gastrointestinal Endoscopy Prevents Esophageal Carcinoma in Morbid Obese After Sleeve Gastrectomy

Severe Gastroesophageal reflux disease (GERD) leading to a chronic aggression of esophagus mucosa, called Barrett's esophagus is a main complication of Sleeve gastrectomy for morbid obesity. Barrett's esophagus is considered as a early stage of neoplastic transformation to adenocarcinoma. Since this last years, six european bariatric centers have adopted the policy to realize endoscopy before and five years or more after sleeve gastrectomy. Investigators worked out a database comprizing the Endoscopic features and patient characteristics. Refleeve projet aim to analyse the long term follow-up datas of 100 patients, evaluate the prevalence of Barret's esophagus and investigate the advantage of the systemetic detection to prevent esophagus adenocarcinomas.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had had SG with a minimum follow-up of 5 years, without signs of Barrett's esophagus before SG;
* An upper GI endoscopy before the SG;
* An upper GI endoscopy indicating that no Barrett's esophagus was present at the time of the SG;
* An upper GI endoscopy done with the scope of searching for the endoscopic anomalies of the Barrett's esophagus according to the international guidelines for the diagnosis of Barrett's esophagus 9.
* Endoscopic biopsies according to the international guidelines for the diagnosis of Barrett's esophagus 9.

Exclusion Criteria:

* SG as a conversional procedure from another bariatric procedure such as the gastric banding;
* No upper GI endoscopy before the SG
* Barrett's esophagus before the SG;
* A second procedure after the SG such as the conversion to Roux-en-Y gastric bypass or duodenal switch;
* An upper GI endoscopy done not following the international guidelines for the diagnosis of Barrett's esophagus9.
Inflammatory Bowel Disease (IBD) and Covid-19 Infection

Most of the inflammatory bowel disease (IBD: Crohn's disease and ulcerative colitis) in a tertiary expert Centre are on immunosuppressive and/or biological therapy. Theoretically, these treatments may increase patients' risk of infection, in particular viral infection. Therefore, the current SARS-Cov-2 pandemia, with its unprecedent worldwide morbidity and mortality, may have a negative impact on IBD patients' clinical course. Identifying an increased risk in this particular patients' population as well as the risk/protective factors is of outstanding importance, in order to adapt their treatment and surveillance. As a consequence, our aims were (i) to measure retrospectively the risk of SARS-CoV-2 (proven by biological testing or suspected due to record of potential clinical symptoms of COVID-19 infection) in this patients' cohort (principal objective), (ii) to identify risk or protective factors for SARS-CoV-2 infection in IBD, and (iii) to analyze the outcome of patients in case of suspected or confirmed COVID-19. The results of this study may be important to adjust our surveillance and therapeutic strategy in these patients, in particular if high virus circulation will occur in the future.


Eligibility Criteria:
Inclusion Criteria:

* Patient over the age of 18 years
* IBD patients (Crohn's disease, ulcerative colitis, indeterminate colitis)
* Patient agreeing to participate in the study

Exclusion Criteria:

* Patient unable to understand the study protocol or to answer simple anamnestic questions due to language barrier
* Patient under guardianship or trusteeship
* Patient under safeguard of justice
A Study to Estimate the Time Course of PF-00241939 Concentration in the Blood Following Dosing by Oral Inhalation From Dry Powder Inhalers

The purpose of this study is to investigate the time course of PF-00241939 concentrations in the blood following dosing by oral inhalation using dry powder inhalers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Pregnant or nursing females.
* A positive urine drug screen.
Effects of Nicotine-Free Hookah Smoking on Blood Flow to the Heart, Muscle and Skin

This is a pilot study on the acute effects of nicotine-free hookah (herbal/steam stones) smoking on the sympathetic neural control of the human cardiovascular system. Hookah smoking is known to transiently increase blood pressure and heart rate while decreasing heart rate variability suggesting - but not proving - sympathetic mediation. The contribution of nicotine to these effects is unknown. Here the investigators will directly measure the acute effects of nicotine-free Hookah smoking on sympathetic nerve activity with microneurography (intraneural microelectrodes) and quantify associated regional changes in vasomotor tone.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 39 years of age
* Habitual Hookah smoker defined as having smoked Hookah \>=12 times in the past 12 months
* Have not smoked cigarettes within the past 12 months

Exclusion Criteria:

* Exhaled carbon monoxide level greater than 10 ppm\* as evidence of current or recent cigarette (excluded if smoked cigarette within 12 months) or Hookah smoking (excluded if smoked Hookah within past 72 hours)
* History of cardiopulmonary disease
* Use of any prescription medication with exception of oral contraceptive pills
* History of psychiatric illness
* History of neurologic disease
* BMI ≥ 35
* Evidence of any of the above by physical examination, ECG or echocardiogram
* Smoked cigarette in the past 12 months
* History of illicit drug use
* Pregnant
* Any other condition(s) deemed by the physician investigators that put subjects at risk for participating in the study
Study on the Application of Hyperspectral Imaging Technique in the Treatment of IMN by TAC

We propose hyperspectral imaging analysis as a method to identify the efficacy of hormone-tacrolimus therapy for PMN, and to classify sensitive and insensitive patients treated with hormone-tacrolimus regimen. A variety of machine learning models were used to prove that hyperspectral imaging technology could assist patients in selecting the optimal treatment plan, and further explore the predictive indicators of PMN treatment effect.

Renal biopsy slides of patients with idiopathic membranous nephropathy diagnosed by renal biopsy in our hospital from February 2016 to February 2022 were collected. ENVI Classic software was used to process the hyperspectral images and delineate the region of interest. The one-dimensional spectral data of each pixel in each region were derived. Machine learning and deep learning methods were used to analyze the characteristics of hyperspectral data and classify them.

The data of the previous study came from the Department of Pathology and Nephrology of Qianfoshan Hospital in Shandong Province. Under the light microscope, electron microscope and immunofluorescence microscope, the pathological types of glomerular diseases in patients with proteinuria were identified. By scanning the corresponding patient's H\&E stained pathological sections, the hyperspectral microscopic images were classified by machine learning and deep learning methods, and the classification accuracy was greater than 85%. It was concluded that hyperspectral imaging technology can be used as a non-invasive diagnostic method to predict treatment response.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old;
* Patients with idiopathic membranous nephropathy confirmed by renal biopsy;
* Had not received hormone and/or immunosuppressive therapy before renal biopsy;
* Complete clinical data, all signed the "Admission Certificate of Qianfoshan Hospital of Shandong Province", and agreed to use relevant medical information, biological specimen examination and examination results for scientific research.

Exclusion Criteria:

* There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or poisons, etc;
* Severe infection: fever, cough and expectoration, sore throat, abdominal pain, diarrhea, carbuncle and furuncle and other clinical manifestations of skin and soft tissue infection, blood routine white blood cell count beyond the normal range (10×109/L);
* Severe cardiovascular disease: including chronic heart failure grade 3 or above and various arrhythmias;
* Infectious diseases: active hepatitis, AIDS, syphilis, etc. ;
* Tumor evidence: it has been found that there is a certain tumor or clinical manifestations, tumor markers, etc.,suggesting the possibility of tumor;
* Patients with follow-up time less than 6 months, incomplete data or missed diagnosis.
Strength Measurement in Intrinsic Foot Muscles With Break and Make Tests

The human foot is a complex structure, which serves functions such as support and mobility. These functions are accomplished through the deformation of the arch, which is controlled by intrinsic and extrinsic foot muscles. The intrinsic muscles have an important role in dynamic stabilization of the foot due to their structurally short force levers and small diameters. There are many studies reporting that foot intrinsic muscle weakness is directly related to pathologies such as structural or functional toe deformities, pes planus, hallux valgus, plantar fasciitis .Therefore it is essential to evaluate the strength of these muscles in an objective and reliable way.

Two different methods are used in measuring muscle strength via a Hand Held Dynamometer; the "break test" and the "make test" . During these tests, the examiner and subject play opposite roles. During the make test, the subject applies maximal force against the examiner and the position is maintained by the examiner. During the break test, the subject holds the position of the muscle being evaluated and the examiner pushes until the subject's maximal force is overcome. In the two tests, force is applied differently; the dynamometer receives different amounts of force, and different results may be generated. Therefore, the aim of this study was to compare the reliability of intrinsic foot muscle strength assessment with break and make test in healthy young subjects.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary individuals,
* Category 1 and 2 according to the International Physical Activity Questionnaire
* Body mass index between the ranges ≥18.5 - \<24.9

Exclusion Criteria:

* Any orthopedic or neurological disorder
* Previous history of lower extremity surgery
* Having low back pain
* Having vestibular or visual system problems
* Having hallux rigidus or limitus, having a hallux valgus angle over 15 degrees
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of IONIS FXI-LRx in up to 84 Healthy Volunteers

To evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics, including Factor XI activity and antigen levels, activated partial thromboplastin time, prothrombin time and international normalized ratio of single and multiple doses of Factor XI antisense inhibitor administered subcutaneously to healthy volunteers.

This will be a Phase 1, double-blind, randomized, placebo-controlled, dose-escalation study conducted at a single center. The study consists of 4 escalating single-dose cohorts (n = 8 per cohort, randomized 3 IONIS FXI-LRx active:1 placebo), 3 escalating multiple-dose cohorts with weekly Study Drug (IONIS FXI-LRx or placebo) administration for 8 healthy volunteers per cohort, randomized 3 active:1 placebo, and 1 multiple-dose cohort of 10 healthy volunteers randomized 3 active:2 placebo with Study Drug administration every 4 weeks.

Approximately 66 healthy volunteers are planned to be enrolled in this study. Additional healthy volunteers may be added to better assess the safety, tolerability or pharmacokinetic profile of IONIS FXI-LRx to meet study objectives.

Eligibility Criteria:
Inclusion Criteria

* Body mass index (BMI) ≤ 35 kg/m2
* Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal
* Males must be surgically sterile, abstinent or, if engaged in sexual relations with a female of child-bearing potential, the subject must be using an acceptable contraceptive method from the time of signing the informed consent form until at least 30 days (single-dose cohorts) or 13 weeks (multiple-dose cohorts) after the last dose of Study Drug
* Willing to refrain from strenuous exercise/activity for at least 72 hrs prior to study visits
* Must abstain from alcoholic beverages for at least 48 hrs prior to clinic visits and not increase alcohol consumption during the study

Exclusion Criteria

* Clinically-significant abnormalities in medical history, screening laboratory results, physical examination that would render a subject unsuitable for inclusion. Including but not limited to:

  * Platelet count \< LLN
  * INR \> 1.4
  * aPTT \> ULN
  * FXI activity \< 0.7 U/mL
* Treatment with another investigational drug, biological agent, or device within 1 month of Screening, or 5 half-lives of investigational agent, whichever is longer
* Any history of previous treatment with an oligonucleotide
* History of bleeding diathesis or coagulopathy
* Uncontrolled hypertension (BP \> 160/100 mm Hg)
Study of Cancers After Solid Organs Transplants

About 1500 solid organs transplants are performed each year in the Paris agglomeration.

Cancer risk in the transplanted is about three times higher than in a population of the same age without any organ transplant. Thus cancer is an important problem for organ transplant.

These cancers can be related to many factors :

* Post-transplant cancers are due in part to the non specific immunosuppression, which leads to oncogenic viruses replication, and then produces virus inducted cancers (as lymphoma due to EBV virus).
* Post-transplant cancers can also be due to the carcinogenic factors of the immunosuppressive drugs (as cyclosporine or tacrolimus, which can cause the appearance of metastases). However, a new type of immunosuppressive drugs (mTOR inhibitors) appear to have anti-cancer properties.
* Post-transplant cancers which are not virus-inducted can be relied to genetic factors of the transplanted patient and/or the transplant donor.

There are 4 axes in this study :

* Axis 1 : Epidemiological, clinical and biological study of the incident cancers in transplanted patients.
* Axis 2 : Qualitative and quantitative immunological study of lymphocyte cells by the transplanted patient (determine their characteristics when a cancer appears).
* Axis 3 : Pathological and genetic study of the post-transplant cancer cells (see if the cancer is caused by the donor or the recipient). Creation of a biobank.
* Axis 4 : Pharmacogenetic study of the immunosuppressive drugs (determine the impact of patient genetic variability on tolerance and efficiency of the immunosuppressive drugs).

This is an observational and comparative study (2 control patients are recruited for each 1 case patient).

A case patient is a patient who has developed a cancer after his/her transplant.

A control patient is a patient who has not developed a cancer after his/her transplant.

These 2 groups will be matched according to specific inclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman after 18 years old
* Transplanted with a solid organ (heart, kidney, lung,liver)
* Informed Consent Form signed
* For the patients-case: Patients who developed a post-transplant cancer
* For the patients-control: Patients who didn't develop a post-transplant cancer

Exclusion Criteria:

* Cancer as transplant indication ( except liver )
* HIV positive
The Effect of Non-Surgical Periodontal Therapy on Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a chronic and recurrent inflammatory disease of the gastrointestinal tract characterised by complex interactions between genetic susceptibility, environmental factors, microbiota and host immune response. It has two main forms, Crohn's disease (CD) and Ulcerative colitis (UC). The main mechanism of IBD pathogenesis is dysregulated host immune response to commensal microbiota and disruption of the balance of pro- and anti-inflammatory cytokines in genetically predisposed individuals. Periodontitis is a multifactorial inflammatory disease associated with dental biofilm resulting in the loss of periodontal supporting tissues and subsequently teeth. Although the occurrence of the disease depends on multifactorial factors, bacterial plaque is the primary etiological factor and various bacterial species found in plaque are responsible for initiating and maintaining the inflammatory and immune response in periodontal disease. Periodontal diseases are known to contribute to many systemic diseases/conditions or systemic disorders are known to affect periodontal disease. Although the relationship between IBD and periodontitis is based on the potential link between oral and intestinal microbiomes and host immunoinflammatory response, the pathological interactions between the two diseases have not yet been determined. From this point of view, the aim of our study was to investigate the effect of periodontal status on serum, saliva and gingival biomarkers (TIM-3, TNF-α, IL-6 and IL-17) in patients with IBD and to evaluate the relationship between these values and periodontal clinical parameters. This is the first study to examine TIM-3 levels in saliva, serum and gingival samples in patients with IBD and periodontitis with IBD.


Eligibility Criteria:
Inclusion Criteria:

* To be between the ages of 18-65,
* Having at least 8 teeth excluding wisdom teeth,
* No periodontal treatment in the last 3 months,
* Not having used antibiotics in the last 3 months,
* Not being pregnant or breastfeeding,
* The individuals to be included in the control group should not have any systemic disease that may change the periodontal status, and the individuals to be included in the experimental group should not have any systemic disease that may affect periodontal health except IBD.

Exclusion Criteria:

* Under 18 years of age and over 65 years of age,
* Having less than 8 teeth,
* Having undergone periodontal treatment in the last 3 months,
* Having used antibiotics in the last 3 months,
* Being pregnant or breastfeeding,
* Individuals to be included in the control group should have any systemic disease that may change the periodontal status, and individuals to be included in the test group should have any systemic disease that may affect periodontal health except IBD.
Clinical Characteristics for the Critical Ill Patients With Klebsiella Pneumoniae Infection

The detection of Klebsiella pneumoniae virulence gene and antibiotics resistance gene takes a long time and high cost with equipment requirements. Distinguishing the Klebsiella pneumoniae by gene were late for clinical treatment. Therefore, the investigators aim to study the clinical characteristics of critically ill patients with Klebsiella pneumoniae infection which expressed different drug sensitivity test results.

Clinical data of adult patients in integrated ICUs of 6 hospitals of Fujian Province China from January 2015 to July 2019 were collected, who had been examined for sputum, urine, blood, pleural effusion, ascites, cerebrospinal fluid and wound secretions and other body fluid samples. And the results showed that Klebsiella pneumoniae was positive, including demographic data, underlying disease status, drug sensitivity test, infection-related indicators, life support, prognostic indicators.

Eligibility Criteria:
Inclusion Criteria:

* Adult whose body fluid were sampled during ICU stay and Klebsiella pneumoniae was detected, followed by drug sensitivity test (including reporting the test results after the patient was transferred out of ICU or died).

Exclusion Criteria:

* Age were less than 18 years old;
* Patients stayed in ICU was less than 48 hours.
Comparative Analysis of Outcomes Among Patients Treated With Xeljanz vs Biologics

To compare rheumatoid arthritis (RA) patient characteristics, adherence, and costs between patients treated with tofacitinib (IR, XR and combined groups) to patients treated with each of the bDMARDs.


Eligibility Criteria:
Inclusion Criteria:

* At least one claim for methotrexate during the variable-length pre-index period.
* At least one claim for tofacitinib or bDMARDs between 01 February 2016 and 31 July 2019 (the identification period).

Exclusion Criteria:

* Patients with claims for other conditions for which bDMARDs are used during the one-year pre-index period or on the index date: ankylosing spondylitis, Crohn's disease, psoriasis, psoriatic arthritis, or ulcerative colitis will be excluded from the study.
* Patients with evidence of the index medication during the one-year pre-index period will be removed from the analysis. Patients will be allowed to have been treated with (other) bDMARDs during the one-year pre-index period.
* Patients with more than 1 bDMARD or bDMARD with tofacitinib filled on the index date will be removed from the study.
Pneumostasis With Use of Bio-absorbable Mesh and Fibrin Sealant in Lung Resection

Prolonged air leak, defined as air leak present 5 days after lung resection, is one of the most common complications after lung resection. This leads to patient discomfort (as the chest tube has to stay in place while air leak is present), prolonged stay, and increased cost.

NeoVeil is a bioabsorbable glycolic acid which has been used in Japan and other Asian countries for air leak prevention after lung resections. NeoVeil is impregnated with fibrin sealant materials and is placed on the lung surface at the time of operation. It then acts as a scaffold on resected area which is prone to air leak.

This randomized clinical trial will be the first in the United States to test its efficacy for air leak prevention.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective lung resection at BMC
* Intra-operative diagnosis of air leak

Exclusion Criteria:

* Patients undergoing emergency lung resection