cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Visceral Pleural Lumbar Lymphatic Drainage

Anatomic variations of the pulmonary arterial tree can cause technical difficulties during pulmonary lobectomy in general and video-assisted thoracic surgery (VATS). Using CT angiography and 3D reconstruction, the investigators sought to identify anatomic variations of the pulmonary arterial tree and assess their respective frequencies.

Purpose Anatomic variations of the pulmonary arterial tree can cause technical difficulties during pulmonary lobectomy in general and video-assisted thoracic surgery (VATS). Using CT angiography and 3D reconstruction, the investigators sought to identify anatomic variations of the pulmonary arterial tree and assess their respective frequencies. Methods the investigators retrospectively studied 88 pulmonary arterial trees in 44 patients having undergone VATS lobectomy for lung cancer over an 18-month period in Amiens University Hospital's Department of Thoracic Surgery. Each CT angiography with 3D reconstruction of the pulmonary arterial tree was performed by two experienced operators, according to a standardized procedure.

Eligibility Criteria:
Inclusion Criteria:

* Any major patient aged 18 years and over who has undergone oncological lung lobectomy for non-small-cell lung cancer located in the thoracic surgery department of the University Hospital of Amiens.
* Nosologic criteria and related to acts: The pathology has already been diagnosed or suspected, and the surgical indication has been validated in the Multidisciplinary Thoracic Oncology Concertation Meeting according to national recommendations.
* These patients will be collected in a database already referenced in the register of the establishment of the University Hospital of Amiens under the reference DRCI T38

Exclusion Criteria:

* Criteria relating to the population:
* Patient under guardianship or curatorship
* Pathology Criteria: Patient with no pulmonary neoplastic disease, patient with locally advanced or metastatic bronchopulmonary cancer
* Criteria relating to the acts: the criteria altering the surgical specimen and thus its anatomical study: patient having had an extemporaneous examination, patient with the antecedents of ipsilateral pulmonary surgery and / or need of decortication
Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)

The primary objective in this proposed study is to determine the effect of dietary fish oil supplementation compared to standard care metformin treatment, and fish oil in combination with metformin on plasma lipids and apoB-remnant lipoprotein metabolism in overweight-obese young women with PCOS.

Specific Objectives;

1. To determine the effect of dietary fish oil supplementation, metformin, and fish oil in combination with metformin on fasting and non-fasting plasma TG, apoB48 and apoB100-lipoprotein concentrations.
2. To determine the physiological mechanisms associated with the effect of dietary fish oil supplementation and metformin on in vivo plasma lipid and apoB-lipoprotein kinetics. We will quantitate the in vivo production and kinetics of plasma TG, apoB48 and apoB100-lipoproteins in plasma and isolated lipoprotein fractions, using established methods.
3. To explore the effects of dietary fish oil supplementation, metformin and fish oil in combination with metformin, on plasma insulin and testosterone, and the association with changes in plasma lipids and apoB-lipoprotein metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age at time of enrollment \> 18 to \<30 years
* Diagnosis of PCOS: clinical and/or biochemical hyperandrogenemia and menstrual dysfunction and the exclusion of other disorders.
* Overweight-obese (BMI \>25 kg/m2) high-risk metabolically-resistant young women.
* Elevated fasting plasma TG (\>150 mg/dL) and apoB48-remnant cholesterol lipoproteins (\>20 ug/ml).
* Impaired insulin sensitivity (glucose 100-125 mg/dL and/or insulin \>15 (uM/ml); and
* May be diagnosed with T2D (blood glucose \>126 mg/dL).

Exclusion Criteria:

* Pregnancy
* Lactating women
* Recent illness that the investigator determines to pose a potential risk for the participant
* Concomitant medications that influence metabolism (e.g. statins)
* Excessive alcohol consumption, as determined by the investigator.
Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula

Adipose-derived stem cells have properties of differentiation to various types of cells, immunomodulatory effects. adipose-derived stem cells (ASCs) show also low immunogenicity.

Anterogen has developed ANTG-ASC(Autologous ASC) which has shown good efficacy and safety in Phase I and II study on the patients with Crohn's fistula.

However, Crohn's patients are sometimes not fat enough to extract fat tissue for culturing ASCs. Therefore the investigators have planned to study allogenic ASCs for safety and efficacy in patients with Crohn's fistula.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Crohn's disease
* Crohn's fistula which has been lasted at least for 3 months
* Negative for beta-HCG pregnancy test

Exclusion Criteria:

* Medical history with Variant Creutzfeldt Jacobs Disease
* Allergic to anesthetics or bovine protein or fibrin glue
* autoimmune disease other than Crohn's disease
* Infectious disease
* Sepsis or active tuberculosis
* pregnant or breast feeding woman
* Inflammatory Bowel disease other than Crohn's disease
* active crohn's disease with CDAI score \> 200
* malignant tumor
* fistula's diameter \> 2 cm
Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy

Pancreaticoduodenectomy is a commonly applied operation for the treatment of benign and malignant diseases of periampullary region. Although recent progress in surgical techniques and medical care reduced the mortality rate of this operation below 5% in some institutes, the morbidity rate still remains high as 40-50% (1,2). Pancreatic anastomotic leaks and fistulas continue to be the main source of morbidity and mortality after pancreaticoduodenectomy. Although there are several recommended techniques to reduce the rate of pancreatic fistulas, optimal pancreatic reconstruction technique is still controversial (3-5). One of the recommended techniques for pancreatic reconstruction is isolated Roux loop pancreaticojejunostomy (6). With this method, as pancreatic anastomosis is kept away from biliary and gastric anastomoses, activation of the pancreatic enzyme precursors is blocked and in this way a reduction in the rate and severity of pancreatic fistula and also in the overall morbidity and mortality can be achieved (6-8).

In this study, it is aimed to examine if isolated Roux loop pancreaticojejunostomy is superior to conventional pancreaticojejunostomy on postoperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent pancreaticoduodenectomy.

Exclusion Criteria:

* patients with missing data
* patients who underwent total pancreatectomy
* patients who had pancreaticogastrostomy as the reconstruction method
* patients who had emergency pancreaticoduodenectomy
An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants

The purpose of this study is to evaluate efficacy of the study intervention, based on hepatitis B surface antigen (HBsAg) levels at follow-up (FU) Week 24.

JNJ-73763989 (JNJ-3989) is a small interfering ribonucleic acid (siRNA) targeting all hepatitis B virus (HBV) messenger ribonucleic acid (mRNAs). The programmed cell death protein receptor-1 (PD-1) inhibitor aims at preventing the interaction of PD-1 with its ligands. The purpose of this study to determine whether at least one of the combination regimens of JNJ-3989 + PD-1 inhibitor + Nucleos(t)ide analog (NA) is more efficacious than JNJ-3989 + NA treatment. This study will be conducted in 3 periods: screening period, treatment period and follow-up (FU) period. Safety assessments will include adverse events (AEs), serious AEs, clinical safety laboratory tests, electrocardiograms (ECGs), vital signs, and physical examinations. Total duration of individual participation will be up to 78 weeks (including screening period).

Eligibility Criteria:
Inclusion Criteria:

* Participants must have chronic hepatitis B virus (HBV) infection
* Participants must have fibroscan liver stiffness measurement less than or equal to (\<=) 9.0 kilopascal (kPa) or a liver biopsy result classified as metavir F0-F2

Exclusion Criteria:

* Participants with evidence of hepatitis A virus infection (hepatitis A antibody immunoglobulin IgM), hepatitis C virus (HCV) infection (HCV antibody), hepatitis D virus (HDV) infection (HDV antibody), hepatitis E virus (HEV) infection (hepatitis E antibody IgM), or human immunodeficiency virus type 1 (HIV-1) or human immunodeficiency virus type 2 (HIV-2) infection (laboratory confirmed) at screening
* History or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to portal hypertension, ascites, hepatic encephalopathy, esophageal varices
* Participants with history or signs of cirrhosis or portal hypertension or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities
* Participants with personal/familial history/indicative of immune-mediated disease risk
Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation

This pilot, non-interventional, company-sponsored, multi-center study documents observational data on patients under routine treatment of Pulmonary Arterial Hypertension (PAH) with inhaled iloprost (using I-Neb device for the inhalation).

The planned study recruitment time is 18 months. The maximum follow up period in this study will be 12 months.

The data will be collected from patients who have initiated the treatment mentioned above (inhaled iloprost using I-Neb device) since February 1st, 2013.

Frequency of visits and procedures will be performed under routine conditions. The primary objective of this study is to assess the compliance of patients with WHO/NYHA (World Health Organization/New York Heart Association) functional Class III Pulmonary Arterial Hypertension treated with Inhaled Iloprost in clinical practice, using the I-neb Insight tool.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18years old), male or female
* Diagnosis of Pulmonary Arterial Hypertension, Group I of the Dana Point Pulmonary Hypertension classification (Diagnosis made at the discretion of the attending investigator, including mPAP ≥ 25 mmHg at rest, as measured by right heart catheterization.)
* The treating physician has chosen to initiate the treatment with inhaled iloprost with I-Neb device for the application, as described in the Summary of Product characteristics (SmPC).
* WHO/NYHA functional class III
* Willing to participate in the study (Informed Consent Sign)
* Patients who received the first inhaled iloprost treatment with I-Neb from February 1st, 2013.

Exclusion Criteria:

* Any contraindication for the treatment with Ventavis as described in the Summary of Product characteristics (SmPC)
* Patients are not to be enrolled if they were treated with inhaled iloprost with I-Neb or any other device for the application in the past, before the start of the observation period (February 1st, 2013)
ADORE: Efficacy of DORavirine in Adults Living With HIV Experiencing Virological Failure on First-line Efavirenz-based Antiretroviral Therapy With NNRTI Resistance

This is a pilot study investigating the efficacy of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in adults living with HIV-1 experiencing virological failure on first-line Efavirenz-based antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor resistance

This is a single-arm, phase 3 pilot study investigating the efficacy of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in adults living with HIV-1 experiencing virological failure on first-line Efavirenz-based antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor resistance.

Approximately 25 male and female participants 18 years and older infected with HIV-1 and experiencing virological failure on efavirenz-based ART will be administered a once-daily, fixed-dose combination of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF). The study includes screening and baseline visits, 4 study visits from Week 4 to Week 36, and an end of study visit at Week 48.

Eligibility Criteria:
Inclusion Criteria:

* Adults living with HIV-1, 18 years and older
* Viral load 5000 - 60 000 copies/mL on first-line efavirenz-based antiretroviral therapy
* HIV genotype resistance test with first generation NNRTI resistance (e.g. K103N, Y181C, etc as listed in the protocol)
* CD4 \> 200 cells/uL
* Creatinine clearance \> 50 mL/min
* Body mass ≥ 35 kg.

Exclusion Criteria:

* Resistance to TDF on genotype (K65R)
* "Significant resistance" to doravirine, denoted by a Stanford Score ≥ 15 on genotype
* Virologic failure on any other regimen
* Women who are pregnant at the time of the screening or enrolment visits
* Active tuberculosis and/or are on anti-tuberculous therapy at the time of the screening or enrolment visits
* Taking and cannot discontinue prohibited concomitant medications listed in protocol at least two weeks prior to the enrolment visit and for the duration of the study period.
Pharmacokinetics of Benapenem in Subjects With Renal Impairment

This is an open-label, multiple center, parallel-group Study to compare the pharmacokinetics and safety of single-dose benapenem (1.0mg) in subjects with mild or moderate Renal Impairment(RI) and healthy subjects. Subjects were enrolled with defined degrees of RI based on eGFR(estimated Glomerular Filtration Rate) calculated by MDRD (Modification of Diet in Renal Disease)formular as follows: nomal renal function(≥90ml/min/1.73m2 ; N=6); mild RI (60-89mL/min/1.73 m2 ; N=6), moderate RI (30-59 mL/min/1.73m2 ; N=6)


Eligibility Criteria:
Inclusion Criteria:

* 1.18\~75 years old
* 2. BMI 17 to 30 kg/m2
* 3. No known diseases or significant abnormalities on physical exam (subjects with normal renal function only)
* 4. eGFR ≥ 90 mL/min/1.73m2 (subjects with normal renal function only)
* 5. eGFR 30 to 59 mL/min/1.73m2 (subjects with mild renal impairment only); eGFR 60 to 89 mL/min/1.73m2 (subjects with moderate renal impairment only)

Exclusion Criteria:

* 1. Hypersensitivity to any of the beta-lactam antibiotics
* 2.Conditions or disease that may interfere with the evaluation of study drug
* 3. Acute disease requiring antibiotics within 30 days prior to administration, or a fever within 7 days prior to administration;
* 4. Drug abuse in 2 years
* 5. A blood donation or more than 400 ml of blood loss within 3 months
Studying Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia Previously Enrolled on Clinical Trial POG-9421

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at biomarkers in tissue samples from young patients with acute myeloid leukemia previously enrolled on clinical trial POG-9421.

OBJECTIVES:

* To profile basal and potentiated phospho-protein networks (PPPNs) using tissue samples from pediatric patients with de novo acute myeloid leukemia (AML) previously enrolled on clinical trial POG-9421.
* To classify AML-based signal transduction mechanisms.
* To correlate profiles of basal and PPPNs with specific molecular lesions (e.g., FLT3-ITD, NPM, WT1, c-kit, CEPBα, PASGΔ75, and karyotype) and profiles of gene expression in tumor tissue samples.

OUTLINE: Banked tissue samples are collected for laboratory studies, including phospho-protein signaling and gene expression profiling studies.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia, meeting 1 of the following criteria:

  * Primary induction failure (i.e., failed to achieve remission within the first 60 days of therapy)
  * Relapsed disease (early or late)
  * In continuous complete remission
* Previously enrolled on POG-9421
* Tissue samples available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Effect of Extraction Vs Non-extraction Orthodontic Treatment on Vertical Facial Dimension

The aim of the current clinical trial was to evaluate the effects of premolar extractions compared with non-extraction orthodontic treatment on the skeletal vertical dimension of the face.

The null-hypothesis is that there is no difference in post-treatment skeletal vertical characteristics of normodivergent and hyperdivergent patients treated orthodontically with first premolar extractions compared with patients treated in non-extraction manner.

The current protocol will be submitted for partial fulfillment of the PhD requirements in Faculty of Dentistry, Cairo University.

The trial will be conducted in the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Cairo University.

Primary examination and diagnosis of the patients seeking orthodontic treatment will be performed, to select a sample of the trial.

then, final diagnosis and planing of each participant will be performed by a trained orthodontists to be sure that all patients fallen with the inclusion criteria.

Interventions will be conducted with the same orthodontist, under supervision of orthodontic professors in the Orthodontic department, Cairo University.

Eligibility Criteria:
Inclusion Criteria:

* Normodivergent and hyperdivergent patients
* Cases with moderate crowding.
* Borderline cases which could be treated with extraction or non-extraction strategies

Exclusion Criteria:

* Hypodivergent patients.
* Cases with extremely sever crowding.
* Patients with high caries index or periodontal problems.
* Patients with systemic diseases, or syndromic conditions.
The Effect of One Session Osteopathic Manuel Treatment on Femoral Artery Diameter and Flow

The aim of this study was to investigate the effect of one session OMT on arterial circulation in patients with PAD.

15 patients with PAD were included in the study. The OMT circulation model was applied to the participants for one session. Before and after the application, femoral artery diameter and flow rate in the patients were evaluated by doppler ultrasound

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least 3 months of clinical onset of peripheral vascular disease
* Patients with ABI between 0.4-1.4
* Patients up to Stage 2b according to the Fontaine classification system

Exclusion Criteria:

* Patients undergoing vascular or endovascular surgery in the last 3 months
* Patients with unstable angina
* Patients with myocardial infarction (MI)
* Patients with stroke
* Patients with heart failure
* Patients with significant liver or renal failure (ie, dialysis)
* Acute infectious diseases
* Patients with neoplasia
Randomized, Controlled Trial of an Intervention for Preschool Children With Autism: TEACCH

This study is design to evaluate the efficacy of the Treatment and Education of Autistic and Communication Handicapped Children (TEACCH) on the rehabilitation for preschool children with autism spectrum disorders (ASD) in China.A case-randomized controlled study was conducted.Sixty children diagnosed with ASD between 36 and 90 months of age were randomly assigned to the a TEACCH intervention group or a control group.The control group was subjected to regular rehabilitation training, the TEACCH group carried out TEACCH training besides regular rehabilitation training for 6 months. Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3) was used to evaluate the effectiveness of TEACCH rehabilitation training.

Statistical analysis plan:The results were analyze using descriptive, t-test and ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed by two children's psychiatrists above the level of the attending physician, in accordance with the diagnostic criteria of DSM-V (Diagnostic and Statistical Manual of Mental Disorder, fifth revised) children's autism spectrum disorder issued by the United States in 2013. Diagnostic screening scales include Autism Behavior Checklist (ABC), Childhood Autism Rating Scale (CARS), and Modified Checklist for Autism in Toddlers (M-CHAT) (for under 4 years old), Social Communication Questionnaire (SCQ) (for over 4 years old), all children' scores above the scale suggest ASD performance;
* able to cooperate with clinical evaluation and related examinations, and the guardian signs the informed consent to agree to participate in the study.

Exclusion Criteria:

* combined with other mental illnesses such as ADHD, with major physical and nervous system diseases;
* serious self-harm.
Dialysate Sodium Lowering Trial

This is a pilot randomized clinical trial in which patients treated with 3X per weekly conventional hemodialysis will be treated to a dialysate sodium 135 mEq/L vs. 138 mEq/L and followed for safety and tolerability, effects on BP and volume.

This is a pilot randomized clinical trial in which hypertensive hemodialysis patients will be randomized to a low dialysate sodium (Na) of 135 mEq/L or a standard dialysate Na of 138 mEq/L. Patients will be randomized 2:1 to the low arm. Dialysate Na will be lowered 1 mEq/L every 2 weeks, as tolerated. Tolerance will be assessed by symptoms, intradialytic hypotension (IDH) episodes (systolic BP \<90 or intervention for symptoms or BP drop during dialysis), achievement of dry weight. The trial will last for 6 to 12 months, for an individual, depending on when they entered the trial. The primary outcome is feasibility and safety of using the lower dialysate sodium which is assessed by symptoms during or immediately after dialysis, intradialytic hypotension episodes and the frequency of emergency room visits and hospitalizations. Several secondary outcomes will be measured including blood pressure prior to dialysis and at home, change in plasma Na over time, dry weight, post-dialysis weight, interdialytic weight change, symptoms of thirst and dry mouth, self-reported dialysis recovery time, relative blood volume change during a single treatment (via 'Critline') and, in patients without an implanted electronic device, extraceullular fluid volume (via bioimpedance).

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patients undergoing thrice weekly in-center conventional HD
* At least 90 days since start of hemodialysis
* Absence of pulmonary edema / signs of fluid overload on physical exam
* Currently dialyzing at a DNa \>=137 mEq/L
* Single session Kt/V \>=1.3 each month for the past 2 months
* Hypertensive, defined by a pre-dialysis BP of \>140/90 or treatment with 1 or more antihypertensive agents
* No more than 1 skipped treatment and no more than 1 session per month shortened by \>10 min
* Life expectancy \>12 months
* Able to provide Informed Consent
* Speaks and understands English

Exclusion Criteria:

* Prone to IDH, defined as IDH occurring in \>10% of treatments in the past 3 months. IDH will be defined as symptoms (e.g. cramps, dizziness, loss of consciousness) and/or intra- or post-dialytic systolic BP \<90 mm Hg and/or use of intervention(s) (UF goal lowered, treatment stopped early, or saline given) because of IDH
* Pregnancy