cyrilzakka/clinical-trials huggingface dataset:
Hepaticojejunostomy With or Without Permanent Duodenal Access Loop in Treatment of Iatrogenic Bile Ducts Injuries, a Comparative Study

A comparative study between two groups, group I; retrospective group, 21 patients underwent hepaticojejunostomy for treatment of iatrogenic bile duct injuries without access loop, in the period between January 2013 and December 2014, group II; a prospective group, 23 patients underwent hepaticojejunostomy for iatrogenic bile duct injuries with duodenojejunostomy as a permanent access loop, in the period between June 2017 and May 2019. Primary (early and late outcome) and management of complications data were collected and analyzed properly.

This study is a comparative study, comparing between two groups of patients with post cholecystectomy biliary injury, group (I) 21 patients, a retrospective group where data was collected from the medical records of the patients presented with post cholecystectomy biliary injury and managed with hepaticojejunostomy without access loop in a period of 2 years between January 2013 and December 2014, and group (II) 23 patients, a prospective group, where patients presented with post cholecystectomy biliary injury in a 2 years period between January 2017 and December 2018 , and managed by hepaticojejunostomy and jejunoduodenostomy as a permanent access loop .

the data collected from both groups included, demographic criteria of patients, type of the previous surgery, place of surgery, the class of the biliary injury according to bismuth classification, (according to Bismuth classification; type I (Low injury, stump length \> 2 cm), type II) (higher injury, stump length \< 2 cm), type III (high CHD injury but confluence is preserved), type IV (high injury both hepatic ducts are no more connected.). And any diagnostic or therapeutic intervention carried out before surgical management.

The detailed surgical management; in group I a roux en y hepaticojejunostomy was done, after abdominal exploration and identification of the level of injury or stricture a ROUX en Y loop of the jejunum was prepared 40 cm post duodenojujenal junction, it was separated and anastomosed to the jejunum at a more distal point ( 60 cm ) the proximal end of the distal loop was closed in two layers with Vicryl 3\\0 the loop was extracted retrocolic towards the site of injury where a hepaticojejunostomy was done end( biliary)to side (jejunum with Vicryl 4\\0 size single layer .

in the second group the same was done but with jejunoduodenostomy side to side at 5-10 cm distal to the site of hepaticoduodenostomy as a permanent access loop.

Follow up data either clinical, laboratory or radiologic were collected, findings of MRCP (if needed) was reported as primary outcome.

Secondary outcome (management of complications), including the operative time needed for correction of the complications, early and late postoperative morbidity and mortality.

The data was analyzed properly using SPSS 18, and presented in a suitable way using graphs figures and tables.

Eligibility Criteria:
Inclusion Criteria:

• Iatrogenic bile duct injuries

Exclusion Criteria:

• Hepatobiliary malignancies
Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension

The purpose of this clinical research is to learn if severe hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18 and older;
* Willing to provide written informed consent;
* Must have uncontrolled hypertension defined as: currently untreated with a diastolic blood pressure greater than 110 mmHg OR currently receiving antihypertensive monotherapy with a diastolic blood pressure greater than 100 mmHg. Monotherapy is defined as treatment with one antihypertensive medication for at least four weeks; fixed combination therapy does not represent monotherapy;
* Must be willing to discontinue antihypertensive medication, if applicable;
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to one week after the study in such a manner that the risk of pregnancy is minimized.
* WOCBP must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication.

Exclusion Criteria:

* Women who are pregnant or breastfeeding;
* Known or suspected secondary hypertension;
* Hypertension emergencies or stroke within the past 12 months;
* Heart attack, angina or bypass surgery within the past 6 months;
* Significant kidney disease;
* Significant liver disease;
* Systemic lupus erythematosus;
* Gastrointestinal disease or surgery that may interfere with drug absorption;
* Cancer during the past five years excluding localized squamous cell or basal cell carcinoma of the skin;
* Currently pregnant or lactating;
* Mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the study;
* Drug or alcohol abuse within the last five years;
* Known allergy to irbesartan or diuretics.
Twin SUBLIVAC® Grasses Clinical Efficacy Study

To show that treatment with SUBLIVAC® Grasses is clinically effective by means of reduction in allergic symptoms and/or use of allergic symptomatic medication in subjects suffering from IgE mediated allergic complaints triggered by grass pollen.

Indication under study: IgE mediated allergic disorders triggered by grass pollen.

Number of centres: approximately 50.

Study period planned: Q2-2006 until Q3-2008 Analysis after one exposed season (2007); based on the outcome the study will be stopped or continued for another season.

Subject selection criteria: Seasonal rhinitis and/or rhinoconjunctivitis with or without mild asthma (FEV1 \> 70%) related to grass pollen, age 12 years or older.

Dosage schedule: Start with two drops daily of SUBLIVAC® and increase by two drops daily, until the maintenance dose of 10 drops SUBLIVAC® GrassesSUBLIVAC® Grasses is reached.

Route of administration: Sublingual application (drops are to be held underneath the tongue for 2-3 minutes and then will be swallowed).

Duration of treatment: 6 to 12 months blinded per subject . Efficacy parameters

Eligibility Criteria:
Inclusion Criteria:

* Subjects with allergic rhinoconjunctivitis with or without mild asthma FEV1 ≥ 70%) for at least 2 years. Their allergic symptoms should be related to grass pollen Use of anti-allergy symptomatic medication in the last pollen season (or, in case of a low pollen season, in one of the two previous years)
* A positive skin prick test (\>3 mm) for early flowering treesgrasses and specific serum IgE-test(\>1 U/ml) for grass pollen (Lolium perenne, Phleum pratense and Poa pratensis).

Exclusion Criteria:

* A positive SPT for perennial allergens of house dust mite
* Allergy to any of the excipients
* Symptoms related to concomitant sensitisation to perennial allergens of pets
* Chronic asthma or emphysema, particularly with a FEV1 \< 70 % of predicted value or use of inhalation corticosteroids outside grass and tree pollen season for more than two episodes and/or longer than fourteen days
* Use of symptomatic medication for more than three episodes and/or longer than three days outside the tree- or grass pollen season
* Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV)
* Inflammation and infection of the target organ
* Severe atopic dermatitis requiring systemic immuno-suppressive medication
* Allergen specific immuno-therapy treatment within the last 5 years for a period longer than three months
* History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis
* A positive pregnancy test, lactation or inadequate contraceptive measures Alcohol- or drug abuse
* Lack of co-operation or severe psychological disorders
Reducing 30-day Readmissions in Patients With Heart Failure Through Pharmacist Discharge Medication Services

Patients admitted for heart failure that are provided discharge medication services by a pharmacist are less likely to be readmitted within 30 days of primary admission.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of heart failure, discharged from any medical service

Exclusion Criteria:

* Unwilling to participate, discharged to nursing/rehab facility, non-English speaking, resident unavailable
Randomized Study to Compare the Bioavailability of Two Clobetasol Propionate 0.05% Topical Foams

The purpose of this study was to compare the relative vasoconstrictive effects of test and reference Clobetasol Propionate 0.05% Topical Foam in healthy, female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Non-tobacco using female subjects, 18 to 50 years of age
* Demonstrated blanching response to Reference Drug
* Body Mass Index (BMI) of 30 or less
* Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator
* Signed and dated informed consent form which meets all criteria of current FDA regulations

Exclusion Criteria:

* History of allergy to systemic or topical corticosteroids
* Presence on any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching
* Presence of medical condition requiring regular treatment with prescription drugs
* Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing
* Use of any tobacco products in the 30 days prior to study dosing
* Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
* Receipt of any drugs as part of a research study within 30 days prior to study dosing
* Pregnant or lactating
18611 - Sun Protection Factor Assay

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing; Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA Form (Health Insurance Portability and Accountability Act).
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Rehabilitation, Quality of Life, and Exercise Tolerance in Patients With an ICD

RELAX-ICD Trial/Research Study; Quality of Life/Protocol No.P-KARE-01: A 3-month outpatient rehabilitation therapy and psychological counselling including informative talks with conventional therapy, by a cardiologist or general practitioner after implantation of an internal cardioverter defibrillator (ICD) in adult patients, whereby the effects of three different strategies are compared. Study hypothesis: the rehabilitation programme will be beneficial in the management of any psychological problems possibly as a result from the intervention, and will help to overcome anxiety, and contribute to improved quality of life.

University Hospital Inselspital Berne,Switzerland: Site Nr. 1 - Jean-Paul Schmid, MD, ... recruiting / Virga Jesseziekenhuis,Hasselt, Belgium: Site No. 2 - Paul Dendale,MD,.... recruiting / Medical University of Gdansk, Poland, Site No. 3 - Dominika Zielinska,PhD,.... recruiting / Cliniques Universitaires Saint Luc, Brussel, Belgium: Site No. 4 - Christian Brohet,MD Prof.... recruiting / State Hospital for Cardiology, Balantonfüred, Hungary: Site No. 5 - Gabor Veress, MD Prof, ...recruiting

Eligibility Criteria:
Inclusion Criteria:

* First ICD implant within past 12 weeks
* Agrees to sign patient/partner informed consent

Exclusion Criteria:

* Angina pectoris CCS III \& IV
* NYHA functional class IV
* Inability to follow rehabilitation programme
* Exercise limitations due to clinical condition
* Symptomatic exercise-induced tachyarrhythmias
* Any major non-cardiac condition that would adversely affect survival during study duration
* Unable to comply to study procedures
* Participates in a concurrent study
Outcomes After Chimeric Antigen Receptor Therapy and Radiation Therapy for Hematologic Malignancies

This study collects information on outcomes after chimeric antigen receptor therapy and radiation therapy for hematologic malignancies. Collecting information from patients before, during, and after receiving chimeric antigen receptor therapy or radiation therapy may help doctors to optimize patient selection, dose, timing, and sequencing of these treatments.

PRIMARY OBJECTIVE:

I. Record clinical outcomes of patients with hematologic malignancies receiving standard-of-care chimeric antigen receptor therapy (CAR-T) nd/or standard-of- care bispecific therapy, and radiation therapy (RT).

SECONDARY OBJECTIVES:

I. To record patient-specific factors and treatment-related factors in patients with hematologic malignancies receiving standard-of-care CAR-T, and/or standard-of-care bispecific therapy, and RT to ultimately improve patient selection and overall treatment strategy to optimize clinical outcomes. II. To record and explore the relationship between radiation dose, target, technique, and timing with respect to CAR-T, and/or standard-of-care bispecific therapy and clinical outcomes in patients with hematologic malignancies treated with standard-of-care CAR-T, and/ or standard-of-care bispecific therapy, and RT.

III. To record and study the relationship between patient-specific factors and treatment-related factors and treatment toxicity in patients with hematologic malignancies undergoing standard-of-care CAR-T, and/or standard-of-care bispecific therapy, and RT.

OUTLINE:

Patients medical records are reviewed for details about CAR-T and RT treatment and acute and late toxicities, disease outcomes such as any events related to local or distant disease progression, survival, and cause of death if available. Patients' imaging scan data is collected at baseline, within 2 months of the first treatment of RT or CAR-T, and at 3, 6, 12 months, and then annually for 5 years after RT completion.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Treatment with or intention to treat with radiation therapy, standard-of-care CAR-T cell therapy and/or standard-of-care bispecific therapy, within a 90 day window for a hematologic malignancy
A Clinical Study of Children With Status Epilepticus in China

Phase 1: The first part of study is a multi-center, retrospect study involving 38 hospitals. The program is a national epidemiological study on status epilepticus in Chinese children.The aims of the epidemiological study include:

1. to obtain national epidemiological data on the etiology, diagnosis,treatment,evaluation, risk factors , outcome and analyze the burden of disease.
2. to build a Collaborative Network in pediatric status epilepticus research.
3. to establish a national clinical database of pediatric status epilepticus.
4. to lay the foundation for the further prospective study.

Phase 2: The second part of study is a multi-center, prospective study involving 38 hospitals. The aim of the study is to set up guideline of Children with SE in China.

Methods:

1. Case retrieval: The investigators query cases with a diagnostic code of SE via usage of the International Classification of Diseases, 10th revision (ICD-10) code G41.
2. Data collection:The subjects will be recruited from all hospitals.The investigators collect detailed information by a standardized questionnaire ,which contains each patient's age, gender, the date of occurrence of SE, past history of SE and seizures, etiology of SE, developmental history, underlying diseases, family history of seizures, duration of SE, seizure types of SE, laboratory data,EEG findings during SE and/or after SE, cranial CT and/or MRI findings after SE, medical treatment during the acute period and the outcome.The outcome include neurological sequelae, recurrence and death following SE.
3. The establishment of the database and data entry :The investigators established a database according the standardized questionnaire. Then the information will be put in the database by the responsible person of each hospital.
4. The standardized management of the database and quality control:There is a special person administrating the database and controlling the quality of data.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who meet the diagnosis of Status Epilepticus(SE),which is defined as more than 30 minutes of either1).continuous seizure activity or 2).two or more sequential seizures without full recovery of consciousness between seizures, including Status Epilepticus (CSE) and Nonconvulsive Status Epilepticus(NCSE).
2. The age range: 29 days to \<18years
3. Cases with complete clinical information.
4. Inpatient. All cases those meet full of the above 4 criterias are included in our study.

Exclusion Criteria:

1. A seizure less than 30 minutes
2. The newborn and more than 18 years old.
Human Liver Explants for HIF-1 Alpha Analysis/Comparison (HIF HCC)

The purpose of the study is to compare levels of HIF-1 α (Hypoxia Inducing Factor 1-alpha) in patients who have been treated with various types of liver cancer treatments.

In the currently ongoing retrospective aspect of the study, we will obtain pathologic tumor explant specimens from the tumor explant population from 8/1/1994 to 12/31/2005. We will prepare 5-10 slides from each tumor explant block and measure HIF-1α using immunohistochemical staining. We will also be performing a retrospective chart review for specific data points which we believe are needed to assist us in our analysis of the histopathologic specimens.

In addition, we will be looking at data in the United Network for Organ Sharing (UNOS) database: www.unos.org, which will allow us to develop a more thorough and robust analysis of the subject's experience with liver cancer. This is a public, mandatory reporting vehicle that the government mandates all transplant centers to report to. Even if the subject was transplanted at Northwestern, and moved, accessing UNOS data will allow us to see what the morbidity/mortality for that patient is.

Secondly, we will start enrolling subjects in a prospective fashion. Those that either have been treated, those currently undergoing treatment, or those newly diagnosed. From these subjects we will obtain informed consent to; a) look at the medical records (current, future and retrospective data), b) collect blood specimens for future analysis and correlation with their explant slide data, c) allow us to follow these subjects indefinitely to obtain ongoing outcomes data, morbidity and mortality information.

Eligibility Criteria:
Inclusion Criteria:

* Adults, any gender ≥ to 18 years of age
* Previous, or current diagnosis of hepatocellular carcinoma (clinical or biopsy proven)
* Resection for hepatoma and/or transplant
* Patients with diagnosis of hepatocellular carcinoma from 8/1/94 thru 12/31/05 (retrospective) with biopsy, explant and/or liver transplantation here at Northwestern Memorial Hospital (NMH).
* Patients previously diagnosed or, recently diagnosed with liver cancer that were treated, currently are being treated our will potentially undergo treatment for the disease.

Exclusion Criteria:

* Any subject outside of the above inclusion criteria
The Effect of OrthoPulse™ Photobiomodulation on Tooth Movement and Treatment Time When Used With Invisalign Treatment

The aim of the study is to determine if, and to what degree photobiomodulation treatment with OrthoPulse has an effect on the rate of tooth movement during alignment for patients receiving Invisalign orthodontic aligner treatment.


Eligibility Criteria:
Inclusion Criteria:

* Invisalign "Full Treatment" product only
* Have a permanent dentition

  * 18 years-old
* Angle Class I or ½ cusp Class II molar and canine relationship
* Moderate to mild crowding in at least one arch

Exclusion Criteria:

* Subjects who do not fulfill all inclusion criteria requirements
* Craniofacial anomaly present
* Past or present signs and symptoms of periodontal disease
* A significant medical or medication history that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement
* Previous orthodontic or orthopedic relapse within 1 year
* History of trauma, bruxism, or parafunction
* Skeletal jaw discrepancy
* Use of osteoporosis drugs
* Initial use of auxiliary mechanics such as elastics
Rapid Identification of Mycobacteria in Acid-fast Bacilli Smear-positive Respiratory Specimens

The aim of the study is to evaluate the polymerase chain reaction (PCR)-Reverse Blot Hybridization Assay (REBA) for identification of nontuberculous mycobacteria (NTM) species in acid-fast bacilli (AFB) smear-positive respiratory specimens.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AFB-smear positive sputum

Exclusion Criteria:

* Non-applicable
Epilepsy-related Brain Tumors Register

Epilepsy is defined by a cerebral disorder characterized by a lasting predisposition to generate epileptic seizures and by the neurobiological, cognitive, psychological and social consequences of this affection. The definition of epilepsy requires the occurrence of at least one epileptic seizure. 1% of the population suffers from epilepsy. The most common causes are genetic and vascular, 10% of epileptic syndromes are caused by a tumor.

The incidence of brain tumors in people with epilepsy is approximately 4%. Among patients with brain tumor (s), the frequency of epilepsy is 30% or more depending on type of tumeur. 30-50% of brain tumors are revealed by an epileptic seizure and 10 to 30% of patients with brain tumor (s) will develop seizures during their evolution.

The main objective is to evaluate the frequency of epileptic seizures according to the type of brain tumor.


Eligibility Criteria:
Inclusion Criteria:

* patient whose age ≥ 18 years
* Patient hospitalized or seen in consultation in the Department of Neurology within the Hospital Group Paris Saint-Joseph
* Diagnosis of primary or secondary brain tumor, radiologically and / or histologically
* Epilepsy revealing or occurring in a patient developing a brain tumor
* Francophone patient

Exclusion Criteria:

* Pre-existing and known epilepsy before the diagnosis of brain tumors
* Epilepsy occurring within 2 weeks postoperatively
* Anteriority of taking antiepileptic treatment
* Patient under tutorship or curatorship
* Patient deprived of liberty
* Patient with comprehension disorders making it impossible to understand the protocol
* Patient or relative opposing the use of his data