cyrilzakka/clinical-trials huggingface dataset:
Isolated Systolic Hypertension in the Elderly and Very Elderly

To evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan medoxomil compared to nitrendipine in elderly and very elderly patients with isolated systolic hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 32 weeks, including a 24-week treatment period. After 12 weeks hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 15 visits during the trial period.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older
* Mean sitting BP \>160 mmHg and mean sitting dBP\<90 mmHg

Exclusion Criteria:

* Secondary hypertension
* Malignant hypertension
* Severe Heart Failure (NYHA III-IV)
* Recent history of myocardial infarction
* Hypersensitivity to study medications
* History of drug or alcohol abuse
* History or evidence of renal disease
A Study of Two Doses of 18F-AV-45 in Alzheimer's Disease and Healthy Volunteers

This study will test two different doses of florbetapir F 18 to determine which dose is best to image amyloid plaques in the brains of Alzheimer's Disease (AD) patients using a positron emission tomography (PET) scanner.


Eligibility Criteria:
Inclusion Criteria (AD group):

* Greater than 50 years of age
* Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
* Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening
* History of cognitive decline gradual in onset and progressive over a period of at least 6 months

Inclusion Criteria (healthy volunteer group):

* 35 to 55 years of age, inclusive
* MMSE of 29 or greater

Exclusion Criteria (both groups):

* Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy
* Diagnosis of other dementing / neurodegenerative disease
* Diagnosis of mixed dementia
* Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
* Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
* Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
* Clinically significant psychiatric disease
* History of epilepsy or convulsions
* Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
* Current clinically significant cardiovascular disease
* Received investigational medication within the last 30 days
Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia

To assess the feasibility of an expedited referral process for the obese endometrial cancer or EIN patient from her gynecologic oncologist to the Brigham Center for Metabolic and Bariatric Surgery (CMBS) in order to undergo concurrent weight loss surgery and hysterectomy within 8 weeks of first appointment with a gynecologic oncologist (or 12 weeks for EIN patients).

The most common risk factor for endometrial cancer is obesity. However, because early-stage endometrial cancer has a very high survival rate, patients more often suffer from long-term issues related to their weight, like heart disease, stroke, and diabetes. Weight loss surgery has been shown to help patients lose weight and also decrease their risk for obesity-related diseases.

This research study is a Feasibility Study. This is the first-time investigators are studying both 1) the referral process of patients with endometrial cancer to the Center for Metabolic and Bariatric Surgery without delaying curative treatment of endometrial cancer 2) the combined surgery of both hysterectomy and weight loss surgery. The combined surgery of hysterectomy and weight loss surgery has been performed both at this institution and others without increased complications, but it has not been formally studied.

Approximately 30 patients are expected to participate in this study at Brigham and Women's Hospital (BWH).

Eligibility Criteria:
Inclusion Criteria:

* Female adults at least 18 years of age
* A BMI of 35-39.99 and 1 or more severe obesity-related co-morbidities

  --including T2D,112 hypertension, hyperlipidemia, obstructive sleep apnea (OSA), obesity-hypoventilation syndrome (OHS), Pickwickian syndrome (a combination of OSA and OHS), nonalcoholic 4 fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease (GERD), asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis, or considerably impaired quality of life) OR a BMI ≥ 40
* Tissue diagnosis (usually endometrial biopsy) of grade 1 endometrial carcinoma or EIN.

Exclusion Criteria:

* Younger than 18 years old
* BMI \< 35
* Without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissue diagnosis
* Pregnant participants will be excluded from this study.
* Patients with contraindications to bariatric surgery will also be excluded.

  --This includes active smokers, prior bariatric surgery, active substance abuse, recent suicide attempt, bulimia nervosa, large abdominal hernias, or poorly controlled psychiatric illness
* include inability to read an English informed consent form, and unwillingness to provide informed consent.
Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection

This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or treatment-experienced Japanese participants with chronic genotype 1 HCV infection. Participants receive 12 weeks of treatment and continue assessments during a 24-week posttreatment follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Body weight ≥ 40 kg
* HCV RNA ≥ 10\^5 IU/mL at screening

Exclusion Criteria:

* Current or prior history of any clinically-significant illness (other than HCV)
* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of a non-HCV etiology
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
A ProspectiveTrial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery

Prospective randomized controlled study, at Colon and Rectal Surgery, WMC/NYPH. Subjects undergoing Laparoscopic Left Colectomy will be randomized into 1 of 2 groups based on the instrument used for tissue dissection and vessel ligation: Group 1 - THUNDERBEAT Group 2

- Ligasure Population

Prospective randomized controlled study, at Colon and Rectal Surgery, WMC/NYPH. Subjects undergoing Laparoscopic Left Colectomy will be randomized into 1 of 2 groups based on the instrument used for tissue dissection and vessel ligation: Group 1 - THUNDERBEAT Group 2

- Ligasure Population: 60 subjects, with colon neoplasm or diverticulitis will be invited in the study after surgery is deemed necessary Study Procedures: This project will consist only of prospective data collection. No interventions will be done for research purpose. Data will be collected prospectively on: -Patients (before, during and after surgery) -The THUNDERBEAT and LigaSure instruments Data will be collected on data collection sheets and entered in a password protected database Primary Outcomes/Definitions- Overall time for dissection of the soft tissues necessary for specimen removal during colon resection, measured in minutes, from the start of colon mobilization to specimen removal from the abdominal cavity.

Eligibility Criteria:
Inclusion Criteria:

* Patients that will be undergoing a Left Laparoscopic Colon Resection
* Older than 18 years old
* ASA 1 to 3
* Elective surgeries
* Patients who willingly provide informed consent

Exclusion Criteria:

* Morbidly obese patients (BMI \>35)
* Patients with acute diverticulitis
* Patients with multiple previous abdominal surgeries
* Patients on anticoagulants
* Patients who can not, tolerate a major surgery
* Patients for whom electrosurgery is contraindicated
* Patients who are pregnant
* Patient with IBDs
3D Printed Models in 3D Virtual Treatment Planning of Orthognathic Surgery

Despite the shift from 2D towards 3D virtual treatment planning of orthognathic surgery, traditional plaster cast are still gold standard. The investigators aimed to compare the overall reliability and time efficiency of an digital workflow using 3D printed models, in comparison to the conventional plaster workflow.

Twenty real-life cases were planned according to both workflows and timed by a single resident.


Eligibility Criteria:
Inclusion Criteria:

* planned for orthognathic surgery
* planning by a single resident
* planning based on 3D virtual workflow

Exclusion Criteria:

* not eligible according to abovementioned criteria
Multivisceral Resections for Locally Advanced Gastric Cancer

The goal of this observational study is to assess whether the postoperative course and survival of patients subject to multivisceral resections for locally advanced gastric cancer (cT4b) were affected by the extent of surgery. An electronic database of 1476 patients with non-metastatic gastric cancer treated between January 1996 and December 2020 will be reviewed. The main questions it aims to answer are:

* Does splenectomy, distal pancreatectomy or partial colectomy affect postoperative complications
* What factors affect prognosis of patients with locally advanced gastric cancer


Eligibility Criteria:
Inclusion Criteria:

* gastric adenocarcinoma
* intraoperatively suspected infiltration of surrounding organs (stage cT4bN0-3bM0)
* partial or total gastrectomy

Exclusion Criteria:

* distant metastases (M1)
* gastrectomy combined with resection of organs other than spleen, pancreas, or colon
MR-HIFU for Recurrent Gynaecological Cancer

The primary objective of this pilot study is to determine whether or not it is feasible to use MRgHIFU to treat symptomatic (pain, bleeding) recurrent pelvic malignancy with an acceptable safety profile when conventional treatment options are not available. The ultimate goal is to be able not only to offer a viable method of symptom palliation in patients with recurrent pelvic tumours and improve their quality of life; but also to control tumour growth and extend life in a group of relatively young patients with isolated local recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent pelvic gynaecological malignancy (cervix and endometrial cancer).
* Recurrent lesion is painful (NRS\>4) and not suitable for alternative treatments
* Intended target volume accessible for MRgHIFU treatment
* Intended target volume visible on noncontrast MR imaging
* Distance between target and skin ≥1cm

Exclusion Criteria:

* MRI contraindicated (e.g. by incompatible metal implants or claustrophobia)
* Pregnancy
* Sedation contraindicated
* MRI contrast agent contraindicated
* Scar, internal or external fixation device along the beam path or at the target
OASIS Wound Matrix (Oasis) Mechanism of Action

OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing wounds to explore the mechanism of action.

Wound types will be Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU).

Eligibility Criteria:
Inclusion Criteria:

* Diabetic foot ulcer (DFU) or venous stasis ulcer (VSU) of the leg, with certain restrictions on size, duration and underlying health

Exclusion Criteria:

* Contraindications or hypersensitivity to the use of the study medications or their components
A Real World Study on Fabulous® Thoracic Aortic Stent System for Stanford B Aortic Dissection

A multicenter, retrospective study to evaluate the real-world efficacy of the Fabulous thoracic aortic stent system in the treatment of Stanford Type B aortic dissection.

Fabulous Thoracic Aortic Stent System is specially designed for aortic dissection based on PETTICOAT technique.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old, regardless of gender;
* Subject was diagnosed with Stanford Type B dissection and treated with Fabulous thoracic aortic stent system, including either a covered stent system, a bare stent, or both;
* With appropriate arterial access and suitable for endovascular aortic repair;
* Subjects could understand the purpose of the trial, volunteered to participate in the study, signed the informed consent form by themselves or their legal representatives, and were willing to complete the follow-up as required by the protocol.

Exclusion Criteria:

* Patients have participated in clinical trials of other drugs or medical devices related to target lesion treatment or have participated in clinical trials of other drugs or medical devices and have not reached the primary endpoint;
* Patients were unable or unwilling to participate in the study;
* Patients were judged by the investigator to be ineligible for participation in the trial.
Bariatric Arterial Embolization for Morbid Obesity

The purpose of this study is to evaluate the safety and effectiveness of left gastric artery embolization(bariatric arterial embolization) for morbid obesity. When the target vessel is blocked, some of the body's signals for feeling hungry will be suppressed and lead to weight loss.

Although there are many ways to treat morbid obesity, surgery is currently the only effective method to be confirmed. But surgical treatment is likely to carry a high risk of treatment-related complications, such as fistula or intestinal obstruction, etc. This study is designed to help treat obesity using a method of transvascular interventional therapy, which is minimally invasive and non-surgical.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) \>30.
2. No history of gastrointestinal surgery.
3. Willing, able and mentally competent to provide written informed consent.
4. Suitable for protocol therapy as determined by the interventional radiology Investigator.
5. Adequate hematological, hepatic and renal function as follows:

   Hematological Neutrophils \> 1.5 x 109/L Platelets \> 100 x 109/L INR \<1.5 Hepatic Bilirubin ≤ 2.0 mg/dL Albumin ≥ 2.5 g/L Renal Estimated GFR \> 60ml/min.1.73m2
6. Aged between18 and 65 years old.
7. More than one year's follow-up can be obtained reliably

Exclusion Criteria:

1. Prior history of gastric pancreatic, hepatic, and/or splenic surgery
2. Prior embolization to the stomach, spleen or liver
3. Prior or current history of peptic ulcer disease
4. Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
5. Portal venous hypertension or cirrhosis
6. Less than 18 years or older than 65 years of age
7. Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of \< 60 milliliters per minute an estimated glomerular filtration rate of \< 60 milliliters per minute
8. Major comorbidity such as cancer, significant cardiovascular disease, or peripheral arterial disease
9. Pregnant or intend to become pregnant within one year Known history of allergy to iodinated contrast media
10. Patients with certain psychiatric disorders such as schizophrenia, borderline personality disorder, and uncontrolled depression, and mental/cognitive impairment that limits the individual's ability to understand the proposed therapy.
11. Patients currently taking or requiring chronic use of NSAID or steroid medications
A Study of Topical Steroids as Preemptive Therapy for EGFR Inhibitor-Induced Papulopustular Eruption

This randomized, controlled, phase II clinical study is designed to assess the efficacy of preemptive treatment with topical steroids in preventing the papulopustular eruption induced by epidermal growth factor receptor inhibitor (EGFRI) treatment in cancer patients. Participants will be followed up for 6 weeks of twice daily application of triamcinolone cream to the face, chest, and back.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a histologically or cytologically confirmed cancer diagnosis for which EGFRI treatment is indicated
* Initiation of topical steroids or control treatment within 3 days of initiation of cetuximab, erlotinib, panitumumab, or afatinib
* Patients must be age ≥ 18 years.
* Life expectancy of greater than 6 weeks
* Patient able to use topical medications reliably and complete questionnaires with assistance if needed
* Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.

Exclusion Criteria:

* Patients who have used systemic or topical steroids within 7 days of trial registration, or start systemic or topical steroids for reasons unrelated to trial during the 6-week follow up period
* Patients who have used antibiotics within 7 days of trial registration, or start antibiotics for other conditions during the 6-week follow up period
* History of allergic reactions to topical steroids
* Patients with any rash at the time of study registration
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients using any other topical medications in the treatment areas (face, chest, or back).
Observational Retrospective Cohort Study of Systemic Therapies for R/R DLBCL

To compare the efficacy outcomes of the L-MIND cohort with the effectiveness in a matched patient population treated with systemic NCCN/ESMO guideline listed regimens administered in routine clinical care.

This retrospective observational cohort study aims to generate a historical control consisting of R/R DLBCL patients who received currently guideline recommended therapies.

Eligibility Criteria:
Eligibility Criteria:

1. Age ≥ 18 years at the initial DLBCL diagnosis.
2. One of the following histologically confirmed diagnosis: DLBCL not otherwise specified (NOS); T-cell/histiocyte rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive DLBCL), Grade 3b Follicular Lymphoma (FL), Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification. Additionally, patients with the evidence of histological transformation to DLBCL from an earlier diagnosis of low grade lymphoma (i.e., an indolent pathology such as FL, marginal zone lymphoma, chronic lymphocytic leukemia) into DLBCL with a subsequent DLBCL relapse are also eligible.
3. Relapsed or refractory DLBCL and received at least 2 systemic regimens for the treatment of DLBCL, including at least 1 anti-CD20 containing therapy.

Non-Eligibility Criteria:

1. Patients with central nervous system (CNS) involvement by lymphoma at initial DLBCL diagnosis.
2. Patients who were treated with CD19-targeted therapy or immunomodulatory drugs (IMiDs) (e.g., thalidomide, LEN) as a frontline DLBCL therapy.
3. Patients who underwent an allogeneic stem cell transplant.
4. Patients who had a prior history of malignancies other than DLBCL, unless the patient has been free of the disease for ≥5 years prior to inclusion.

   Note: Patients with the following malignancies within the 5 years period are still eligible:
   1. basal cell carcinoma of the skin
   2. squamous cell carcinoma of the skin
   3. carcinoma in situ of the cervix
   4. carcinoma in situ of the breast
   5. carcinoma in situ of the bladder
   6. incidental histological finding of prostate cancer (Tumor/Node/Metastasis \[TNM\] stage of T1a or T1b)
5. Patients who received tafasitamab.
Comparison of Botulinum Toxin and Sphincterotomy in the Treatment of Chronic Anal Fissure

Intra-sphincteric injection of botulinum toxin seems to be a reliable option causing temporary alleviation of sphincter spasm and allowing the fissure to heal. study is to compare the outcome of surgical sphincterotomy and botulinum toxin injection treatments in patients with uncomplicated chronic anal fissure.

consecutive patients with uncomplicated chronic anal fissure who had failed conservative treatment were randomized to receive either intra-sphincteric injection of botulinum toxin (BT) or lateral internal sphincterotomy (LIS). Postoperative pain relief, healing of fissure, continence scores and fissure relapse during 18 weeks of follow up was the outcomes assessed.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of chronic anal fissure was based on evidence of circumscribed ulcer at anal canal with indurations at the edges and exposure of the horizontal fibers of the internal anal sphincter at its floor.

Exclusion Criteria:

* Anal fissure that had been operated on before, complicated fissure with cicatricial deformation, large sentinel pile, associated hemorrhoids, suspected inflammatory bowel disease, or malignancy.