cyrilzakka/clinical-trials huggingface dataset:
Microbiome Test for the Detection of Colorectal Polyps and Cancer

The purpose if this study is to measure the sensitivity, specificity and accuracy of the Metabiomics Colon Polyp and Colorectal Cancer Assay for the non-invasive detection of colon polyps or colorectal cancer.

The purpose of this study is to conduct clinical research to investigate the association of the gut microbiome with colonic neoplasia. In this study patients will supply samples of their gut microbiome prior to scheduled colonoscopy; the relative abundance of microbes from those samples will be used to predict the presence or absence of colon polyps or colorectal cancer. Microbiome based predictions from blinded samples will be compared with colonoscopy and pathology results to quantify the sensitivity, specificity and accuracy (reported as %) of the Metabiomics Colon Polyp and Colorectal Cancer Assay for colon polyps. The limited sample size is anticipated to be insufficient to quantify sensitivity to colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Male or female,
* Age: 45-80 years,
* Patients undergoing polyp surveillance or screening colonoscopy who are ASA Class 1-3. No ASA Class 4 or 5 will be included.Footnote
* All ethnic and racial groups will be included,
* Able to comprehend, sign, and date the written informed consent form (ICF),
* Able to give informed consent in English.

Exclusion Criteria:

* History of Inflammatory Bowel Disease
* Inability to schedule the colonoscopy within 60 days of the initial stool sample
* Colonic pathology that in the opinion of the endoscopist could interfere with the accuracy of the colonoscopy. Examples include: colonic stricture, poor preparation, obstructing tumor.
* ASA class 4 or greater
* Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity.
Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating women who have breast cancer that is metastatic or cannot be treated with surgery.

OBJECTIVES:

* Determine the response rate in women with locally unresectable or metastatic breast cancer treated with docetaxel, leucovorin calcium, and fluorouracil as second or third-line chemotherapy.
* Evaluate the toxic effects of this regimen in these patients.
* Determine the time to progression in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on day 1 and leucovorin calcium IV over 1 hour followed by fluorouracil IV over 5 minutes on days 1-3. Treatment repeats every 4 weeks for 2-8 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 44 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed breast cancer

  * Metastatic or unresectable local disease
* Measurable or evaluable disease
* No ascites or pleural effusion as only metastatic site
* No brain or leptomeningeal metastases
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* Granulocyte count greater than 1,500/mm3
* Platelet count greater than 100,000/mm3

Hepatic:

* Bilirubin normal
* SGOT/SGPT less than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase less than 2.5 times ULN

Renal:

* Creatinine no greater than 2 times ULN

Cardiovascular:

* Adequate cardiac function
* No history of significant atherosclerotic coronary disease (e.g., uncontrolled angina)
* No history of significant cardiac arrhythmia

Other:

* No serious medical or psychiatric illness that would preclude study
* No active uncontrolled bacterial, viral, or fungal infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior high-dose chemotherapy and autologous transplantation

Chemotherapy:

* At least 3 weeks since prior chemotherapy and recovered
* No more than 2 prior chemotherapy regimens for metastatic breast cancer (in addition to adjuvant therapy)
* No prior docetaxel
* No prior high-dose chemotherapy and autologous transplantation
* Prior paclitaxel allowed

Endocrine therapy:

* No concurrent hormonal therapy, except as contraception

Radiotherapy:

* At least 3 weeks since prior radiotherapy and recovered
* Concurrent radiotherapy for relief of localized pain or obstruction allowed

Surgery:

* At least 2 weeks since prior major surgery and recovered

Other:

* No other concurrent cytotoxic agents
Effects of Occlusal Splint and Therapeutic Home Exercises

In this randomized controlled study, investigators planned to investigate the efficacy of oral occlusive splint and therapeutic home exercises in increasing the quality of life and reducing somatic and neuropathic pain in patients with temporomandibular joint dysfunction, determine their effects on other clinical data, and report long-term outcomes

The aim of the present study to compare the efficacy of oral occlusive splint and therapeutic home exercises in increasing the quality of life and reducing somatic and neuropathic pain in patients with temporomandibular joint dysfunction and report long-term outcomes.

One hundred and one patients with temporomandibular joint dysfunction were included in the study. The patients were randomly divided into two groups: The first group received a mandibular oral occlusal splint and the second group was given a home exercise program for the temporomandibular joint. The patients were evaluated based on their maximum mouth opening, visual analog scale, short-form McGill pain questionnaire, painDETECT, oral health-related quality of health and hospital anxiety and depression scale scores at the beginning of treatment and at the end of the first and sixth months.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of temporomandibular joint disorders for more than one month
* Being aged 18 to 60 years

Exclusion Criteria:

* History of trauma to temporomandibular joint or face
* History of an inflammatory joint disease
* Chronic analgesic use lasting more than six months
* Previous treatment for temporomandibular joint disorders
* History of a major psychiatric, neurological or neuromuscular disease (Lambert-Eaton syndrome, orofacial or tardive dyskinesia, myasthenia gravis)
* Migraine diagnosis
* Chronic headache or neck pain
* Chronic pain syndrome
* Pregnancy
* Disc displacement with or without reduction
CHOICE OF SUBJECTIVE OCULAR REFRACTION TECHNIQUE AND CORNEAL TOPOGRAPHY OF KERATOCONUS

Keratoconus is a rare evolving corneal ectasia that alters visual acuity. To improve spectacle-corrected visual acuity, various subjective refraction techniques can be used.

The subjective refraction techniques of keratoconus-carrying patients have never been studied.

The main hypothesis is that the most suitable subjective ocular refraction method varies with the corneal topography of the keratoconus.

The main objective is to define the most appropriate refractive technique(s) based on corneal topographies in order to provide keratoconus-affected patients with the best spectacle-corrected visual acuity.

Keratoconus is a rare evolving corneal ectasia that alters visual acuity. To improve spectacle-corrected visual acuity, various subjective refraction techniques can be used. The Jackson Cylinder Cross Method, the Astigmatic Dial Technique and the Stenopeic Slit are three validated subjective refraction techniques for measuring astigmatism. The subjective refraction techniques of keratoconus-carrying patients have never been studied.

The main hypothesis is that the most suitable subjective ocular refraction method varies with the corneal topography of the keratoconus.

The investigators collect several characteristics of corneal topography of the keratoconus : the average value of the keratometry of the 3 central mm called Km ; the value of the point corresponding to the maximum keratometry (called Kmax), the distance between the center and the point of Kmax, (called d_Kmax) ; the corneal surface variance index called ISV ; the Belin/Ambrósio Enhanced Ectasia Display (called BAD-D).

The main objective is to define the most appropriate refractive technique(s) based on corneal topographies in order to provide keratoconus-affected patients with the best spectacle-corrected visual acuity.

Eligibility Criteria:
Inclusion Criteria:

* adult persons
* patients with keratoconus
* patients with alteration of visual acuity
* ability to give informed consent to participate in the study
* affiliation to a social security scheme

Exclusion Criteria:

* Keratoconus grafted with cornea or with intracorneal rings.
* Central corneal opacities.
* Presence of other eye diseases affecting visual acuity.
* Patients under guardianship, curatorship or justice protection.
* Pregnant or breastfeeding women.
* Refusal to participate in the study.
Effects of Glutamine on GLP-1 and Insulin Secretion in Man

This study investigated the effect of glutamine, an amino acid, glycemia, glucagon-like peptide-1 (GLP-1) and insulin in participants with type 2 diabetes.

In this study, we investigated the effect of glutamine, an amino acid, on glycemia and on GLP-1 and insulin in participants with type 2 diabetes. Preliminary data published by our group suggests that glutamine is a strong determinant of GLP-1 secretion in vitro. We tested the hypothesis that glutamine lowers postprandial blood glucose and investigated whether the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin modifies this effect.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes, on metformin or diet alone (not sulphonylureas or insulin)

Exclusion Criteria:

* Malabsorption, renal or liver disease, treatment with steroids
Pulmonary Tele-rehabilitation and Progressive Muscle Relaxation on Discharged Covid-19 Patients

The aim of this study is to investigate efficacy of internet based pulmonary rehabilitation and progressive muscle relaxation program on functional capacity, depression and anxiety, dyspnea, fatigue, sleep quality and quality of life in covid19 patients after hospital discharge

Novel coronavirus disease 2019 (covid19) could cause respiratory and physical dysfunction, anxiety and depression, fatigue and affect sleep quality and quality of life in infected patient after hospital discharge. there is expect that pulmonary rehabilitation can improve these symptoms and prevent complications in these cases. It seems that Progressive muscle relaxation exercise could improve pulmonary rehabilitation effect. Due to social isolation of Covid 19 patients after hospital discharge, internet base rehabilitation will be used in this study. participants will be randomized in two pulmonary tele-rehabilitation groups after hospital discharge. One group will be received pulmonary rehabilitation include education, breathing exercises, aerobic and upper and lower limbs muscle strengthening exercises. Another group will be perform progressive muscle relaxation in addition of these exercise. Treatment duration is 6 week with 5 days/week frequency. Two exercise sessions per week will be supervised with expert physiotherapist via videoconferencing.

Outcomes will be measured at baseline, within two week and at the end of six week exercises program.

Eligibility Criteria:
Inclusion Criteria:

* Covid 19 patient that confirmed with polymerase chain reaction test (PCR)
* Hospitalized Corvid 19 patients after discharge
* Accessibility to internet and using video call

Exclusion Criteria:

* Mental and physical disability
* Uncontrolled cardiac dysfunction such as arrhythmia
* Sever neurological condition such as guillain-barre and stroke
* Uncontrolled diabetes or blood pressure
* Pregnant women
* Re-hospitalization during treatment program
* Chronic pulmonary and kidney condition
Quality of Life and Sexuality in Patients With Prostate Cancer

The trial is to describe quality of life in patients affected by prostate cancer treated with exclusive radiotherapy and submitted to psychological and andrologic evaluation.

This trial is to describe quality of life and sexuality in patients with prostate cancer treated with exclusive radiotherapy. Descriptive analysis of baseline characteristics will be performed by using appropriate summary measures for continous and categorical data. Analysis of variation over time of FACT scores will be conducted by means of ANOVA analysis for repeated measures.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years.
* Histologically-proven of prostate cancer
* Indication to radical radiotherapy on prostate/ prostate + seminal vesicles / prostate + seminal vesicles + pelvic lymph nodes
* Informed consent

Exclusion Criteria:

* Other coexisting malignancies, uncontrolled intercurrent illness, active infectious processes, and exudative, bloody, or cytologically malignant effusions excluded patients from the trial.
* Previous surgery for prostate cancer, severe cardiac or vascular pathology
* Other major surgery in the preceding year or currently undergoing psychiatric care or psychological counseling.
A Post-market Study Of Use Of The OMNI® Surgical System In Open Angle Glaucoma

To prospectively compare the clinical effect of the OMNI surgical system in eyes with Open Angle Glaucoma.

First, to prospectively compare the clinical effect of the transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG) and second, to prospectively compare the clinical effect of the transluminal viscoelastic delivery using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG)

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 22 years or older
* Visually significant cataract
* Mild to moderate open angle glaucoma
* On 1-5 IOP-lowering medications
* Potential of good best corrected visual acuity post cataract extraction, in the investigator's judgment
* Able and willing to comply with the protocol, including all follow-up visits.
* Understand and sign the informed consent.

Exclusion Criteria:

* Any of the following prior treatments for glaucoma:

  * Laser trabeculoplasty ≤3 months prior to baseline
  * Implanted with iStent (All types), Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device
  * Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC
* Acute angle closure, normal tension, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subjects' medical record.
* Concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet AMD, corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits).
* Participation (≤ 30 days prior to baseline) in an interventional trial which could have a potential effect on the study outcome, as determined by the study investigator
* Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
Fluorine-18-α-Methyltyrosine Positron Emission Tomography (18F-FMT PET) for Therapy Response in Lung Cancer

L-\[3-18F\]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for positron emission tomography (PET). The investigators evaluated the value of 18F-FMT PET for the assessment of therapy response in patients with lung cancer as compared with that of 2-\[18F\]-fluoro-2-deoxy-D-glucose (18F-FDG) PET.

The patients with lung cancer underwent PET studies with 18F-FDG and 18F-FMT before and after radio-/chemotherapy. The investigators used the ratio of the SUVmax of the mediastinal (N2) lymph node to the SUVmax of the primary tumor (N/P ratio ). All patients were divided into two groups of N/P ratio\<1 and N/P ratio≥1, and the survival time was estimated by Kaplan-Meier method.


Eligibility Criteria:
Inclusion Criteria:

* primary lung cancer All patients received first-line chemotherapy

Exclusion Criteria:

* Patients with diabetus mellitus
Ultrasound Evaluation of Cesarean Scar After Uterotomy Closure With Barbed and Conventional Sutures

The aim of this randomized control trial is to compare the residual myometrial thickness and the depth of cesarean section scar defect after uterine incision closure with barbed or conventional sutures.

The aim of this randomized control trial is to compare the residual myometrial thickness and the depth of cesarean section scar defect after uterine incision closure with barbed or conventional sutures. Primigravida patients undergoing transverse lower segment cesarean section will be included in the study.Cesarean section incision will be closed with double layers of continuous barbed or conventional sutures. Ultrasound examination will be performed 6 months after the operation to measure the residual myometrial thickness and the scar depth.

Eligibility Criteria:
Inclusion Criteria:

* Primigravida patients undergoing transverse lower segment cesarean section

Exclusion Criteria:

* Previous laparotomies
* Postoperative fever
* Patients with preterm pregnancies or in labor
Chemotherapy w/wo WeiLeShu in Metastatic Colorectal Cancer

A total of 50 patients with metastatic colorectal cancer will be enrolled in the study. The patients were randomly divided into the WLS-intervention group and the control group. The two groups of patients were given the most appropriate medication according to the specific conditions of the disease. Patients in the intervention group received additional oral administration of Weileshu, a probiotics product (Tongchuang Biotechnology).


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age, of any race or sex who are eligible to sign written consent and have undergone prior resection of histological evidence of colorectal cancer
* Hematologic function: ANC ≥ 1.5 x 10 /L, platelets ≥ 75 x 10 /L, and hemoglobin \> 9 g/dL Adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 5 ULN, albumin ≥ 2.5 g/dl Adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, \> 50 ml/min calculated by the C-G equation Non-pregnant women of childbearing potential and fertile men are required to use effective contraception (negative pregnancy test for women of child-bearing age) ECOG status ≤ 1 at screening

Exclusion Criteria:

-
Prophylactic Tranexamic Acid Versus Adrenaline During Flexible Bronchoscopy

Endobronchial bleeding is a common complication of bronchoscopy. Major bleeding, although rare, can be life threatening and often requires advanced therapeutic interventional pulmonary procedures which are not widely available. Minor bleeding can negatively impact outcomes such as diagnostic yield, sample size and bronchoscopy duration. Both adrenaline and tranexamic acid are successfully used topically for hemostasis during diagnostic bronchoscopy. The aim of this study is to evaluate the efficacy of prophylactically applied adrenaline and tranexamic acid in bleeding prevention during diagnostic bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing diagnostic bronchoscopy with sampling (including transbronchial biopsy, endobronchial forceps biopsy, brushing, transbronchial needle aspiration)
* Signed informed consent

Exclusion Criteria:

* Any existing contraindication for diagnostic bronchoscopy
* Coagulopathy (PV INR \> 1.3)
* Thrombocytopenia (\<50x10\*9 or anemia (Hgb \<80 g/L)
* DOAC, LMWH or antiplatelet drug therapy
* Thrombophilia, history of pulmonary embolism or deep vein thrombosis
* Contraindication for endobronchial application of adrenaline
* Uncontrolled coronary artery disease, cerebrovascular disease or arrhythmia
* Uncontrolled pulmonary hypertension
* Cardiovascular decompensation
* Severe hypoxia (PaO2 \<60mmHg, SaO2 \<90% with an FiO2 \>=60%)
Novel Approaches for Quantitative Assessment of Adherence

Approximately 12 adults subjects will be enrolled. Participants will be randomized to one of two directly observed dosing regimens with 2mg adenine 5+ (five stable-labeled nitrogens) as follows: 1 dose/week followed by 4 doses/week OR 3 doses/week followed by 7 doses/week. Each dose regimen will have a duration of approximately 12 weeks and will be separated by a 12-week washout period for a total study duration of approximately 36 weeks.

Dried blood spots (DBS) and whole blood will be collect weekly. Urine will be collected less frequently, about every 2 weeks. The ratio of ATP 5+ to naturally occurring ATP 2+ is dried blood spots will be the primary outcome, as adenine is phosphorylated to ATP in red blood cells. Breakdown products will be measured in urine.

Investigators will allow flexibility in terms of which days are used for dosing for the 1, 3, and 4 dose(s)/week regimens. This is scientifically justified as investigators expect a 20-30 day half-life of ATP 5+ in DBS.

Approximately twelve healthy adult volunteers with no contraindicated medical conditions or medications will be recruited from CU/Denver and the surrounding community.

Participants will be randomized to one of 2 sequences consisting of two directly observed dosing regimens with 2mg adenine 5+ per dose, 1 dose/week followed by 4 doses/week or 3 doses/week followed by 7 doses/week. Each dose regimen will have a duration of approximately 12 weeks and will be separated by an approximately 12-week washout period for a total study duration of approximately 36 weeks. The rationale for this study design is several fold. First, the lower doses are given initially to minimize the potential effects of carry-over in the second regimen. Second, 1 to 7 doses/week encompass a wide range of simulated adherence rates to assess the promise of this taggant, adenine 5+, as an adherence biomarker. Third, the 12 week duration is designed to achieve \~90% of steady-state given an estimated half-life of 20-30 days.

Eligibility Criteria:
Inclusion:

1. Ambulatory 18-40 year old adults.
2. Ability to comply with study procedures, including directly observed dosing visits and availability and use of video streaming technology.

Exclusion:

1. Inability to give informed consent
2. Pregnancy or plan to become pregnant in the next 12 months or unwillingness to use birth control
3. Current breastfeeding
4. Active psychiatric illness, social condition, or alcohol/drug abuse that, in the opinion of the investigators, would interfere with study requirements.
5. GFR estimate \< 60 ml/min (MDRD equation).
6. Total bilirubin and/or hepatic transaminases (ALT and AST) ≥ 2.5x upper limit of normal
7. Absolute neutrophil count ≤ 1,500/mm3, platelets count ≤ 100,000/mm3, or hemoglobin ≤ 10 g/dL.
8. Symptomatic hemoglobinopathies or active hemolysis.
9. Any laboratory value or uncontrolled medical conditions that, in the opinion of the investigators, would interfere with the study conditions such as, heart disease and/or cancer.
10. Any investigational agents within 30 days of enrollment.
11. Plan to donate blood or plasma during study enrollment.