cyrilzakka/clinical-trials huggingface dataset:
The Sinonasal Microbiome

Chronic rhinosinusitis is an inflammatory disease of the sinonasal mucosa with significant impact and limited treatment options. Chronic rhinosinusitis (CRS) poses an important public health problem and causes a large impact on individual quality of life. Studies of CRS have been limited by access to tissue, the complexity of the sinonasal physiology, a lack of available biomarkers, the absence of useful animal models, a paucity of cohorts with biological samples for analysis, and limited well-designed clinical trials or investigations of immune function. Therefore, novel strategies for identifying biological mechanisms underlying this disease are in great need.

Using prospective samples from well characterized subjects, the investigators intend to profile the mucosa associated-bacteria in the nose and sinuses. In parallel, using sinus tissue from patients undergoing surgery, the site will interrogate the epithelium for mucosal immune function to understand host-microbe interaction. This study hypothesizes that the microbial profile of the sinuses initiates an immune responses which leads to chronic inflammation in susceptible people. This study would provide the first comprehensive data on what bacteria are present in the nose and sinus and could lead to important knowledge useful in sinonasal disease.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Diagnosis of chronic sinusitis (with or without nasal polyposis), perennial allergic rhinitis, or normal sinuses/absence of allergy

Exclusion Criteria:

* Use of immunosuppressants
* Immunodeficiency
* Inability to stop sinusitis related medications for 10 days
Deep Neuromuscular Block During General Anaesthesia in Robotic Surgery

The aim of this project is to show, whether the use of the deep neuromuscular block in certain laparoscopic robot-assisted surgery can positively influence main physiological functions compared to the use of standard neuromuscular block. Secondary outcome is to find out whether the targeted specific reversal of neuromuscular block by sugammadex improves and fastens the post-operative recovery of the patients.

Adequate muscle relaxation during general anaesthesia is crucial for easy, uncomplicated and safe laparoscopic and robot-assisted surgery. Perfect abdominal wall relaxation facilitates surgical working conditions, which makes surgery safer, faster and easier to perform. Besides this indirect advantage, there could be obvious benefit for patients. This is a result of decreased negative pathophysiological consequences of an increased intraabdominal pressure (capnoperitoneum) on important organ systems (cardiovascular, breathing system, kidneys etc.) Complete muscle relaxation during general anaesthesia can be achieved by using higher doses of rocuronium (non-depolarizing aminosteroid muscle relaxant) and special anaesthetic technique called deep neuromuscular block (DNMB). The primary focus of the project is to test the potential advantages of DNMB compared to standard relaxation technique. Safe and efficient use of NMBA is an important precondition in restoring a patient´s full muscle strength at the end of anaesthesia, to prevent effects of residual block. Modern practice of anaesthesia offers an option for complete and immediate rocuronium induced block reversal by using its specific antagonist - sugammadex. Combination of DNMB approach and sugammadex reversal also provide potential benefits for perioperative course and patient recovery after surgery. Secondary objective of the project is to verify this facts.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Informed Consent
* Elective robotic radical prostatectomy
* American Society of Anesthesiologists (ASA) status 1-3

Exclusion Criteria:

* Inability to obtain Informed ConsentAge under 18 years
* American Society of Anesthesiologists (ASA) status over 3
* Indication for rapid sequence induction, signs of difficult airway severe neuromuscular, liver or renal disease
* Known allergy to drugs used in the study
* Malignant hyperthermia (medical history)
Strength and Range of Motion in Women Undergoing Surgery for Breast Cancer

RATIONALE: Gathering information about strength and range of motion over time from women undergoing surgery for breast cancer may help doctors learn more about recovery from surgery and on-going care.

PURPOSE: This clinical trial is collecting information about strength and range of motion over time from women undergoing surgery for breast cancer.

OBJECTIVES:

* Collect data regarding diagnosis, type of surgery, receipt of adjuvant therapy, age, height, weight, waist circumference, arm strength, grip strength, shoulder range of motion, and physical activity participation from women undergoing surgery for breast cancer.
* Examine changes in physical activity participation, measures of body composition, shoulder range of motion, grip strength, and arm strength over time in these patients.
* Determine differences in changes in physical activity and indices of fitness according to type of surgery and adjuvant therapy.
* Examine relationships between exercise participation, fitness, and body composition over time.
* Correlate data with an ongoing randomized exercise trial that includes strength and flexibility assessments with no pre-surgery measures.

OUTLINE: This is a prospective, cohort study.

Patients submit data comprising demographic/medical information, anthropometrics (weight, height, waist circumference), grip strength, bicep strength, shoulder range of motion, and physical activity participation prior to surgery, at each surgical follow-up visit, and at 2 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast cancer

  * Stage I-IV disease
* Planning to undergo surgery at the Comprehensive Cancer Center Breast Clinic at Wake Forest University Baptist Medical Center
Consequences of Changing Current Standards: Endocrine Status After Routine Fallopian Tube Removal

Two recently published articles need to be cited to explain the rationale for our study since both studies conclude with contrary findings: The first one is "The post-reproductive Fallopian tube: better removed?" and the other is termed "Factors associated with age of onset and type of menopause in a cohort of UK women".

In essence, while Dietl et al suggest to remove the Fallopian tube routinely in every hysterectomy and every sterilization procedure after 35 yrs of age, Pokoradi et al showed that pelvic surgical procedures and even simple tubal sterilization are associated with an earlier menopause. Hence, this is an important issue as early menopause leads to adverse health status.

Two study findings lead to conflictive points of view. On the one hand a routine removal of the Fallopian tubes is proclaimed to reduce cancer risk, on the other hand we know that surgical pelvic procedures result in early onset of menopause. Pokoradi et al were not able to distinctively tell which part of pelvic surgery (ie hysterectomy, oophorectomy, salpingectomy, tubal ligation?) is affecting menopause because data was not providing surgical details. Nevertheless, Dietl et al's statement "Timing of menopause and other long-term effects have not been studied yet...thus all negative effects are still speculative"1 can only partly be agreed upon regarding Pokoradi's findings. It might be too early to proclaim a routine Fallopian tube removal as long as there is no data on how much this procedure affects ovarian function. This is further supported by another statement in their study "Although most malignant serous "ovarian" carcinomas originate from the distal Fallopian tube, a smaller proportion of serous cancers as well as endometroid, clear cell, mucinous carcinomas are still thought to arise from ovarian surface epithelium.1" which means the exact impact on cancer prophylaxis can only be estimated due to a lack of studies. Other histopathologic entities might not be influenced by tube removal.

Eligibility Criteria:
Inclusion Criteria:

* benign indication for hysterectomy
* informed consent

Exclusion Criteria:

* Menopause
* Pregnancy
* Previous pelvic surgery (hysterectomy, salpingectomy, tubal ligation,...)
* malignancy
* hormone replacement therapy
Multi-dimensional Signatures for Precisely Predicting the Response and Prognosis of Lung Cancer Patients

This study aims to determine the clinical effectiveness of multi-dimensional signatures in predicting response and prognosis of lung cancer patients. The study is a multi-center perspective research of treatment planning for patients with lung cancer. To characterize clinical effectiveness, the progression-free survival (PFS) and overall survival (OS) impacts of multi-dimensional signatures will be estimated.

Multi-dimensional signatures, including NGS-based genotyping, and other essential detections such as immunohistochemistry (IHC), provides an opportunity to improve outcomes for patients by tailoring treatments to each individual's genomic profile. This is a multi-center single arm research study integrating multi-dimensional signatures into clinical decision-making for patients with lung cancer. The clinical effectiveness of multi-dimensional signatures is unknown in the real-world of clinics. To identify a counterfactual for Pred-lung approach, matching methods combined with administrative healthcare data will be used. The survival impacts of Pred-lung approach compared to usual care in matched controls will then be estimated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with locally-advanced or metastasis lung cancer
* Life expectancy \> 3 months

Exclusion Criteria:

* Age at diagnosis \<18
* refuse to enroll
Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer

This phase II trial studies how well thyroid gland removal with or without central lymph node dissection works in treating patients with thyroid cancer or suspected thyroid cancer that has not spread to the lymph nodes (randomized into Arms I and II). Arms I and II are compared to a standard of care (SOC) Arm III to enable comparison of quality of life among various surgical treatments. Currently, the standard treatment for thyroid cancer is total thyroidectomy, or complete removal of the thyroid. The lymph nodes in the central part of the neck may also be surgically removed, called central lymph node dissection. Prophylactic removal of the lymph nodes may increase the risk of life-threatening complications, and may reduce post-surgery quality of life. It may also prevent the cancer from returning and reduce the need for additional surgery. It is not yet known whether recurrence rates and complication levels are lower after thyroid gland removal alone or with central lymph node dissection.

PRIMARY OBJECTIVES:

I. To determine the rate of transient and permanent hypocalcemia

SECONDARY OBJECTIVES:

I. To determine the rate of voice and swallowing problems.

II. To determine the degree to which quality of life (QOL) is compromised.

III. To determine the degree to which accurate quality of life measures can be extracted from patient interview narratives using natural language processing techniques.

IV. To determine clinical recurrence rates.

OUTLINE: Patients are randomized to 1 of 2 treatment arms, if ineligible into a SOC arm.

Arm I: Patients undergo total thyroidectomy alone.

Arm II: Patients undergo total thyroidectomy with ipsilateral prophylactic central neck dissection (CND).

Arm III: Patients ineligible to be randomized into Arm I or II, Standard of Care (SOC) comparator receiving same follow up.

After completion of study treatment, patients are followed up at day 1, 2 and 6 weeks, and 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Pre-operative diagnosis or suspicion of papillary thyroid cancer, usually by fine needle aspiration (FNA)
* No pre-operative evidence of cervical lymph node metastases on neck ultrasound (randomization arms only)
* No evidence of distant metastases
* Ability to read and write in English

Exclusion Criteria:

* Largest papillary thyroid carcinoma \< 1 cm in size on ultrasound
* Previous thyroid surgery
* Concurrent active malignancy of another type
* Inability to give informed consent or lacks decision making capacity
* T4 tumor
* Pre-existing vocal cord paralysis
* Chronic neurologic condition which affects voice or swallow (for instance, multiple sclerosis or Parkinson disease)
* Baseline laryngeal pathology that would warrant intervention that could affect voice or swallow function
* Becomes pregnant before surgery or at any time while on study

INTRA-OPERATION EXCLUSION CRITERIA (randomization arms only)

* Evidence of nodal involvement identified in the operating room (OR)
* Failure to confirm diagnosis of cancer in participant
A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.


Eligibility Criteria:
Inclusion:

* Adult subjects with previously treated recurrent CLL who have measurable lymphadenopathy
* Require therapy for CLL
* Have experienced CLL progression \< 24 months since the completion of the last prior therapy
* Currently not sufficiently fit to receive cytotoxic therapy because of chemotherapy-induced bone marrow damage or comorbidities.
Facial Mask Tightness: A Comparative Study

A correct preoxygenation can be obtained after a 3min delay of calm ventilation through a tight mask thereafter mask is used to make the patient breathing before intubation. Most tight masks are actually sold but they have never been compared in studies. The aim of this study is to compare air leaks with standard facial mask and QuadraLite masks during preoxygenation and induction of anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* edentulous patients
* age \> 55 years

Exclusion Criteria:

* pregnancy or breast-feeding, patients on tutelage or guardianship
* patient unable to understand the protocol
* anesthesia in emergency or with full stomach
Speech Perception in Noise in Children With ADHD

We are going to assess an ability of speech perception in voice in children diagnosed with ADHD (Attention Deficit Hyperactivity Disorder), comparing to normal control group. This is an attempt to understand the factors influencing on this ability.

Participants will undergo a battery of hearing tests -Standard Hearing Test; Speech Perception in Noise - Hebrew Matrix; Transient Evoked Otoacoustic Emission (TEOAE) and cognitive tests - Working Memory Test (from (Wechsler Intelligence Scale for Children, WISC); Visual Attention Test (TMT (Trail Making Test)); Non-Verbal Intelligence Test (RAVEN)

Eligibility Criteria:
Inclusion Criteria:

* Research group: Kids diagnosed with ADHD, without previous hearing problems.
* Control group: Kids with regular development without previous hearing problems.

Exclusion Criteria:

For both groups:

* Having previous hearing problems or disorders
* Other psychiatric disorders
* Treatment with psychiatric medications other than stimulants
* Having autism
* Having severe learning disabilities.
Concentrations of Raltegravir in the Semen of HIV-Infected Men

The objective of this study is to determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dose interval.

The secondary objective is to determine the extend of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval, to determine the area under the concentration time curve of raltegravir in semen, and to determine the variability in the penetration of raltegravir into the seminal compartment over the dosing period.

The patient population will consist of 12 male HIV-positive patients who have been receiving stable antiretroviral therapy that includes raltegravir for a minimum of three months. Patients will be enrolled from one clinic in downtown Toronto and a hospital affiliated HIV specialty clinic in Ottawa, Ontario. Eligible patients will have evidence of full virologic suppression (HIV viral load \< 50 copies/mL) at least one month prior to enrollment in the study. No changes will be made to the patients antiretroviral therapy during the course of the study.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected male
* 18 years old or older
* on raltegravir twice daily as part of their antiretroviral regimen for at least 3 months prior to screening
* viral load \< 50 copies/mL at least one month prior to enrolling
* able to read, understand and sign a written informed consent prior to initiation of the study
* medically stable at the time of the study, with no evidence of acute illness

Exclusion Criteria:

* having difficulty adhering to current antiretroviral therapy
* patient is expected to have difficulties adhering with study protocol
* patients with malignancy, or acute renal or liver disease
* patient with active AIDS-defining illness
* patient with any medical, psychiatric or other circumstance that may impede the provision of informed consent
* patient with any of the following abnormalities at the time of screening:
* hemoglobin \< 85 g/L
* absolute neutrophil count \< 1000 cells/uL
* platelet count \< 50,000 cells/ microleter (uL)
* aspartate aminotransferase (AST), alanine transaminase (ALT) or total bilirubin \> 3 times the upper limit of normal
* serum creatinine \> 1.5 times upper limit of normal
* patient receiving concomitant therapy with rifampin or St. John's wort
A Non-interventional, Post-Marketing Study to Describe Outcome of Nitisinone Treatment in HT-1 Patients

This is a prospective, non-interventional, non-comparative, multicenter study to collect data on HT-1 patients in China treated with Nitisinone in a routine clinical setting. No tests or examinations are mandated in the study.

This is a prospective, non-interventional, non-comparative, multicenter study to collect data on HT-1 patients in China treated with Nitisinone in a routine clinical setting. No tests or examinations are mandated in the study, though the expectation is that most of the tests and examinations listed in the protocol will be performed in the context of routine clinical care and relevant data will be captured. At enrollment, data on patient treatment, medical and surgical history together with other patient characteristics will be captured.Patients enrolled in the study will be followed for at least 1 year and for a maximum of 3.5 years.

The study aims to enroll at least 15 HT-1 patients aged 0-18 years. If adult patients are enrolled the study population will be larger as all eligible patients will be invited to participate. However, the enrollment will close when the target of 15 patients aged 0-18 years has been reached.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a confirmed diagnosis of HT-1 treated with, or at enrollment prescribed, Nitisinone treatment (product manufactured by Sobi) in a routine clinical care setting. The decision to initiate treatment shall be made by the treating physician independently from the decision to include the patient in the study.
2. Signed and dated informed consent provided by the patient, or the patient's legally authorized representative(s) for patients under the legal age, should be obtained before any study-related activities are undertaken. Assent should be obtained from pediatric patients according to local regulations

Exclusion Criteria:

1. Enrollment in a concurrent clinical interventional study, or intake of an Investigational Medicinal Product (IMP), within three months prior to inclusion in this study
A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population

This randomized, parallel, multi-center, single-blind study is designed to compare the safety and efficacy of 3 bowel preparations in pediatric subjects scheduled to undergo a colonoscopy for a routinely accepted indication.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients who are undergoing colonoscopy for a routinely accepted indication, including:

  * Evaluation of BE results
  * Endosonography
  * Blood in stool
  * Anemia of unknown etiology
  * Abdominal Pain
  * Polypectomy
  * Unknown diarrhea or constipation etiology
  * Inflammatory bowel disease
* Between 6 and 16 years of age at screening.
* Otherwise in good health, as determined by physical exam and medical history.
* If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse).
* Negative urine pregnancy test at screening, if applicable
* In the investigator's judgment, parent/guardian is mentally competent to provide informed consent to participate in the study.

Exclusion Criteria:

* Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
* Subjects impacted at screening
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
* Subjects who are undergoing colonoscopy for foreign body removal and decompression
* Subjects with known difficulties for swallowing tablets
* Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics.
* Subjects who are taking drugs that may affect electrolyte levels with the exception of routine diuretics.
* Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
* Subjects who are pregnant or lactating, or intending to become pregnant during the study.
* Subjects of childbearing potential who refuse a pregnancy test.
* Subjects who are allergic to any preparation components
* Subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days.
* Any condition in parent/guardian associated with poor subject compliance (e.g., substance abuse); inability of parent/guardian to return for scheduled visits with their child.