cyrilzakka/clinical-trials huggingface dataset:
Assessing Uniqueness of Inflammatory Bowel Disease Related Microbiome-derived Biomarkers

To assess the differential expression of IBD-related microbiome-derived biomarkers including bacterial strains and peptides such as antimicrobial peptides (AMP) found in inner-colonic samples (HygiSample™) in comparison to home collected stool samples in patients with active IBD colonic disease.

The HygiSample will be collected during a defecation-inducing high-volume (\>40 L) colon irrigation bowel prep (HygiPrepⓇ).

This study is a preliminary study aimed to assess the ability to differentially detect IBD-related microbiome-derived biomarkers in colon effluent samples collected using the Hygieacare System. The proposed sample size of 20 patients (10 in the control arm, 10 in the IBD arm), where each patient provides both stool and three inner-colonic samples is sufficient to provide preliminary results for such an assessment.

Categorical variables will be summarized by frequencies and percentages, while quantitative variables will be summarized by descriptive statistics (mean, median, standard deviation, minimum, and maximum).

The investigators will compare taxonomy and phylogeny biodiversity between the control and the IBD arms and between stool and colon effluent samples.

Eligibility Criteria:
Inclusion Criteria:

* The patient's age is between 18 and 80 years old
* For study arm - patients with known colonic IBD based on colonoscopic findings - diagnosed with either Ulcerative Colitis or Crohn's Disease scheduled for surveillance colonoscopy.
* For control arm - patients scheduled for routine colonoscopy without active IBD symptoms or IBD diagnosis

Exclusion Criteria:

* The patient has an underlying condition that in the opinion of the investigator may adversely affect the patient's ability to understand, comply with, or follow protocol instructions
* History of intestinal resection (appendectomy allowed)
* Active Clostridium difficile colitis
* Antibiotic use for 2 months prior to colonoscopy
* The patient has any of the contraindications listed below:

congestive heart failure, intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, renal insufficiency, cirrhosis, pregnancy, or recent colon, rectal, or abdominal surgery
PENG vs SIFI Block for Positioning Pain During Spinal Anesthesia

This study aims to compare the effectiveness of preoperative ultrasound-guided suprainguinal fascia iliaca compartment block (SFICB) and pericapsular nerve group block (PENG) in preventing positioning pain during spinal anesthesia in patients who are scheduled for surgery due to hip fracture.

Patients to whom an analgesic block was placed (either PENG or SIFI compartment analgesic block) to ameliorate positioning pain during spinal anesthesia for hip fracture surgery will be enrolled after written consent is obtained. Patients will be asked to report their pain intensity while sitting and their sitting angle will be measured. Patients will be observed for any possible complications( LAST, allergic reactions, hypotension, bradycardia). Pain intensity will then again be questioned postoperatively along with analgesic consumption at the 24th hour. Patients will be arranged into two cohorts according to the block (PENG vs SIFI) and the data obtained will be compared between two cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Adults with a hip fracture
* who were scheduled to undergo surgery with spinal anesthetics
* has no neurologic disorders that impair cooperation (e.g dementia)
* has no true allergies to local anesthetics
* has no contraindications for regional or neuraxial anesthesia (e.g bleeding diathesis, severe aortic stenosis)

Exclusion Criteria:

* Childer under the age of 18
* patients scheduled to undergo surgery with general anesthetics
* refusing to participate
* allergies to local anesthetics
* any neurologic disorder that impairs patient cooperation
* any contraindication to regional or neuraxial anesthetics
Unroofing Curettage for Pilonidal Disease

This study aimed to investigate the outcomes of patients who underwent UC as the primary intervention for simple or complex SPD

Sacrococcygeal pilonidal disease (SPD) is a well-known chronic inflammatory condition that affects young adults; There are many treatment options available today, from simple non-surgical methods to extensive flap procedures. However, elaborate treatment strategies can turn this easily treatable disease into a long-term surgical ordeal, causing complications worse than the primary disease itself.

While, UC is considered safe and effective for treating simple SPD, its suitability for treating complex disease is poor and controversial. To date, no studies have investigated the efficacy of UC specifically when treating complex SPD.

This is the first study to identify and compare efficacy and outcomes after UC in patients classified into simple and complex SPD groups.

This study was conducted at the Department of Surgery of the Diskapi Training and Research Hospital in Ankara, Turkey. The local ethics committee of the institution approved the study protocol (number 27/02, dated March 22, 2016), and written informed consent was obtained from all participants.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients aged 18 years or older

Exclusion Criteria:

* acute pilonidal abscess
* poorly controlled
* diabetes mellitus,
* immunosuppressive or coagulation disorders,
* pregnancy and/or lactation,
* other acute surgical diseases
Predictors and Outcomes of Time to Hemostasis After Cardiac Catheterization

This study aims to:

1. Assess the incidence of hemostasis failure after manual compression of trans-femoral arterial sheath post percutaneous coronary intervention.
2. Assess the predictors of time to hemostasis achieved by manual compression for trans-femoral arterial sheath post percutaneous coronary intervention.
3. Assess the association between time to hemostasis and the incidence of vascular access complications after manual compression for trans-femoral arterial sheath removal post percutaneous coronary intervention.
4. Assess the association between failed hemostasis and the incidence of vascular access complications after manual compression for trans-femoral arterial sheath removal post percutaneous coronary intervention.

Nurses and medical professionals have a vital role in detecting, preventing, and managing complications at the earliest possible stage. They should assess patients for high risk of complications, and plan management strategies to decrease those complications. In many acute and critical care settings, removing femoral sheaths and handling related complications after percutaneous coronary intervention. are primarily the responsibilities of nurses. Therefore, after catheterization procedures, assessing the predictors of required time to achieve optimal hemostasis at the time of trans-femoral arterial sheath removal is essential as one of the final modifiable measures to prevent access site complications. This study will be done in 6 Cardiac catheterization units representing governmental and private hospitals. A sample size of 266 patients will be recruited for the study. data will be analyzed by univariate and multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients who planned for elective or primary percutaneous coronary intervention with femoral access, and
* Agreed to participate in the study

Exclusion Criteria:

* Patients who had trans-femoral catheterization procedure within a 1-month duration
* patients with a known history of coagulation disorders,
* patients with sheath removed at the laboratory, and
* Patients who experience post - catheterization life-threatening events rather than vascular access complications
An Open-Label Study to Assess Safety

An Open-Label study to assess safety

An Open-Label study to assess the efficacy and potential for adrenal suppression following maximal use treatment with TA-102 topical formulations in subjects with Plaque Psoriasis.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of plaque psoriasis.
2. Definite clinical diagnosis of stable plaque psoriasis for at least 6 months.
3. Subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of plaque psoriasis.

Exclusion Criteria:

1. Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
2. History of allergy or sensitivity to retinoid, corticosteroids and/or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the Subject or the results of the study.
Percutaneous Diskectomy SpineJet x Open Microdiskectomy in Treatment of Lumbar Radiculopathy

Approximately 300,000 patients undergo open surgical procedures to treat symptoms caused by disc herniation.

Among the various surgical techniques practiced the percutaneous discectomy occupies its space since the first description of the technique by Hijikata, 1975. Throughout, many techniques have been described. Studies indicate that the treatment was successful for pain and disability resulting from herniated disc associated with radiculopathy small.

However, some methods remove very small amounts of tissue with little change in volume of the disc. Thus, studies on the cadaver with Percutaneous Diskectomy by SpineJet ® showed more macroscopic changes of the disc with a predictable amount of removal and significant disc material.

The Percutaneous Diskectomy by SpineJet ® is a new technique of percutaneous diskectomy which creates a suction effect in tissues adjacent to the exit point of the fluid and the opening point of the collector. However, no studies have examined the effect of the Percutaneous Diskectomy by SpineJet ® in humans about the disk size after treatment or measures of disc degeneration by imaging methods or how these characteristics might correlate with clinical outcomes.

Thus, the study will compare outcomes of patients with contained or extruded disc herniation, with complaints of radiculopathy, concordant with the imaging findings. With treatment by surgical technique or the traditional by SpineJet ®, in order to determine whether percutaneous discectomy with SpineJet ® will produce results comparable to open microdiskectomy.


Eligibility Criteria:
Inclusion Criteria:

* single disc herniation, posterolateral, at any lumbar level, with a size of up to 1 / 3 of the spinal canal sagittal diameter, with radicular pain correlated with findings at MRI
* Failure of nonoperative treatment with at least one anti-inflammatory medication and at least two weeks of physical therapy within a period of 6 months
* acceptance of completion of informed consent

Exclusion Criteria:

* Force \<4 / 5 in a muscle group in the lower limb
* Herniated Disc extrusa large (\> 1 / 3 of the sagittal canal diameter) or sequestered herniation
* moderate to grade stenosis of the central canal, lateral recess or foramen
* Surgery in the previous level involved
* Herniated disc at another level in the affected side
* Loss of disc height significantly (\> 60%) compared with the adjacent higher level
* Infection at the insertion of the device
* Pregnancy
* Any illness or medications that contraindicate surgical treatment
Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study

The aim of this multicenter, cross-sectional, observational flash mob study is to investigate the prevalence of cognitive impairment in hospitalized elderly aged 65 years or older, and the recognition of cognitive impairment by healthcare professionals.


Eligibility Criteria:
Inclusion Criteria:

* Dutch-speaking
* Hospitalized
* Age ≥ 65 years old

Exclusion Criteria:

* Unable to perform the Mini-Cog (e.g. due to visual impairment, severe hearing loss, being too ill, or otherwise unable to speak or write)
* Patients who require medical isolation
* Not willing to participate.
A mHealth Application as a Screening Tool for Neonatal Jaundice in Filipino Neonates

The purpose of the study is to test the reliability of the Picterus smartphone application in Filipino neonates. A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application

The purpose of the study is to test the reliability of the Picterus smartphone application.

The study is designed for Filipino neonates, but implemented in other LMIC. The participants include newborns with or without jaundice, Gestational age \>37 weeks, Age0-14days, Weight \>2500 gram and absence of congenital malformations. Demographic data of the neonates will be collected together with all the performed tests and it will be stored in a secured system. Blood will be drawn and measure the bilirubin level of the neonates in a standard clinical routine and will be compared to the estimated bilirubin performed with the Picterus smartphone application.

A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application.

It will provide an answer to whether the Picterus smartphone application is reliable to other populations, especially to darker skin and with high melanin content such as Filipino neonates.

Eligibility Criteria:
Inclusion Criteria:

* Newborns with or without jaundice
* Gestational age ≥ 37 weeks
* Age 0 - 14 days
* Weight 2500 to 4500 grams
* Absence of congenital malformations

Exclusion Criteria:

* Newborns with life-threatening conditions or significant illness

  * Newborns diagnosed with inborn errors of metabolism
  * Jaundiced newborns that have undergone phototherapy before screening
Ph II OSI-774 (Erlotinib,Tarceva) In Advanced Bronchioloalveolar Cell Lung Cancer

The primary objective of this study is to determine the major objective response rate of OSI-774 in participants with unresectable or metastatic bronchioloalveolar cell variant of non-small cell lung cancer.

This study is a Phase II study. The first study of OSI-774 was done to evaluate what dose should be given to patients with cancer has been completed. The purpose of this research study is to see whether this experimental treatment, called OSI-774, can cause a type of non-small cell lung cancer to stop growing or shrink. This study is sponsored by a company called Genentech, and is being done at Memorial Hospital, as well as other cancer centers around the country interested in developing new drugs for the treatment of this type of cancer.


Eligibility Criteria:
Inclusion Criteria:

* Either bronchioloalveolar cell carcinoma or a variant thereof after review
* Clinical stage IIIB (malignant pleural or pericardial effusion) or IV or recurrent/medically inoperable disease
* Measurable or evaluable indicator lesions
* No prior or one chemotherapy regimen for NSCLC
* Three weeks since last chemotherapy, and three weeks since prior radiation therapy to a major bone-marrow containing area
* Karnofsky performance status \> or = to 80% OR ECOG performance status ≤ or = to 1
* Life expectancy \> or = to 8 weeks
* Adequate hematologic, renal and/or hepatic function: WBC \> or = to 3,000/ul, hemoglobin \> or = to 9.0 g/dl, platelet count \> or = to 100,000/ul, total bilirubin \< or = to 1.0 mg/dl, AST \< than or = to 2.5 X UNL, creatinine \< or = to 1.5 mg/dl or Clcr \> or = to 55ml/min.
* Effective contraception

Exclusion Criteria:

* Prior exposure to OSI-774 or other treatments targeting the HER family axis (e.g.-trastuzumab, ZD1839, C225, etc.)
* Two or more prior chemotherapy regimens
* Concurrent active cancer
* Uncontrolled central nervous system metastases (i.e. any known CNS lesion which is radiographically unstable, symptomatic and/or requiring escalating doses of corticosteroids)
* Pregnant or lactating women
* Malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
* Prior systemic cytotoxic chemotherapy for other malignant disease
* Significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure, recent MI, unstable angina, active infection, uncontrolled hypertension).
Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients

This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162.

Study drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Histologically/ cytologically confirmed, advanced non resectable solid tumors
* Measurable or non-measurable, but evaluable disease as determined by RECIST

Exclusion Criteria:

* Patients with primary CNS tumor or CNS tumor involvement.
* Diabetes mellitus
* Unacceptable ocular/retinal conditions
Wide Margin vs. Narrow Margin in Postneoadjuvant Lumpectomy

Breast cancer patients often receive systemic drugs as the initial curative treatment of their disease. The initial systemic therapy leads to a variable degree of tumor shrinkage. At present, there is no evidence-based consensus among breast surgeons on the optimal extent of resection after considerable tumor shrinkage and whether resection margin should be designed according to the tumor extent before treatment or the extent after treatment. This trial will help determine the optimal extent of resection in tumors that exhibits a significant change in volume after primary systemic therapy.

Primary systemic (neoadjuvant) therapy (NAT) is a widely practised curative treatment for invasive breast cancer. Neoadjuvant chemotherapy (before surgery) and adjuvant chemotherapy (after surgery) had equivalent survival rates in major randomized trials. In these studies, preoperative systemic therapy increased the patient's chance to achieve breast conservation. The down side was a clear trend towards increased ipsilateral breast tumor recurrence. Preoperative chemotherapy leads to patchy, irregular cell death known as honeycomb effect and thus may lead to a misleading false negative resection margin of a tumorectomy operation. Even with the advent of oncoplastic techniques which allowed larger resection volumes with satisfactory cosmetic results, rates of re-excision, mastectomy and local relapse did not differ from those after traditional lumpectomy operations. As of today, there is no consensus -based on evidence- on the optimal width of margin in patients who are offered breast conservative surgery (BCS) after systemic therapy. In view of the current uncertainty and lack of evidence, The present trial is designed to answer the following question (Specific aim): Does planning the resection margin according to the pre-treatment tumor extent improve the local recurrence rate in patients receiving breast conservative surgery after systemic therapy?

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven diagnosis of invasive adenocarcinoma of the breast.
* Tumor stage T 1-4b
* Nodal stage N 0-2
* ASA (American Society of Anesthesiologists) class I-II

Exclusion Criteria:

* Patients opting for mastectomy.
* Patients advised for mastectomy by the treating physician.
* Patients opting for primary surgical treatment.
* Patients advised for primary surgical treatment by the treating physician.
* Metastatic patients.
* Multifocal tumors.
* Lobular neoplasia.
* Current pregnancy or pregnancy less than 6 months from the enrollment date.
* Active second cancer.
Type 2 Diabetes and the Effect of Probiotics

Insulin-resistance in type 2 diabetes is associated with chronic inflammation. Anti-inflammatory actions might increase sensitivity to insulin. Since some probiotics have anti-inflammatory properties, ingestion of the probiotic bacteria Lactobacillus Acidophilus NCFM might increase insulin-sensitivity.

The inflammatory response to endotoxin injection and the insulin-sensitivity is examined before and after four weeks ingestion of probiotics.

Numerous studies have shown an association between insulin-resistance in type 2 diabetes and chronic low-grade inflammation. Some probiotics have an anti-inflammatory properties. Ingestion of probiotics might therefore, due to this property, increase sensitivity to insulin.

In this study type 2 diabetics (N=24) and healthy control (N=24) are given the probiotic bacteria Lactobacillus Acidophilus NCFM for four weeks. The anti-inflammatory effect is examined by evaluating the inflammatory response (White blood cell count, plasma-cytokines) to an iv injection of endotoxin (0,3 ng/kg) before and after the intervention. Also the insulin-sensitivity is measured with an hyperinsulinemic euglycemic clamp before and after L. acidophilus NCFM.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Type 2 diabetes

Exclusion Criteria:

* Heart failure
* Lung disease
* Infections in the last two weeks before endotoxin injections.
* Treatment with antibiotics
Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring

The goal of this study is to create a data set to add to Carevive's registry from real world clinical and patient reported data collected using an electronic care planning system (CPS) with remote symptom monitoring that is used in routine care for cancer patients on active treatment.

Patients will complete a baseline survey in person using a secured device or remotely using their own electronic device in a location of their choice. Weekly electronic patient reported outcome (PRO) surveys are collected from the patients using the Carevive platform for a minimum of 12 weeks. Patients may continue weekly surveys as long as they are receiving treatment.


Eligibility Criteria:
Inclusion Criteria:

* All participants must be 18 years of age or older.
* Subjects may be any stage and anywhere in the treatment continuum.
* Subject participants must have a diagnosis of a breast, lung, AML, ovarian cancer or multiple myeloma.
* Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer.
* All participants must be able to understand English.

Exclusion Criteria:

* Any patient who cannot understand written or spoken English.
* Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer.
* Any patient on a treatment clinical trial.
* Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).