cyrilzakka/clinical-trials huggingface dataset:
The Role of Congenital Mucosal Immune System in the Airways of Patients With Chronic Obstructive Pulmonary Disease

The purpose of the study is to explore the role of congenital mucosal immune system in the airways of patients with COPD including the impact of ILCs (Innate lymphoid cells) on metabolism of epithelial cells.During the research the following methods will be applied: measurement of Volatile Organic Compounds (VOCS), airway epithelial cytology and culture.

ILCs profiles, epithelium metabolism measured by VOCS and microbiome profiling (specific 16S rRNA-16S ribosomal RNA gene-targeted qPCR) will by determined in the airways of patients with COPD after the exacerbation. Microbiome profiling will be based on next generation sequencing (NGS) of the 16S rRNA encoding region.

Eligibility Criteria:
Exclusion Criteria:

* Neoplasm
* Diabetes
* Astma
* acute airway infection in last 2 weeks
Testing the Decoy Effect to Increase Tobacco Treatment Uptake

Prior research has shown that the context in which program options are presented to consumer impacts consumer choice (known as the 'decoy effect'). The aims of this study are to: (1) test whether the decoy effect can impact smokers' selection of hypothetical tobacco treatment options; (2) examine sociodemographic moderators of the decoy effect; and and (3) examine whether presenting the time and clinical effectiveness of of the different treatment options modifies the decoy effect.

The investigators will recruit and conduct a cross-sectional online survey through ResearchMatch (www.researchmatch.org) with 600 tobacco users across the country. The survey will ask participants for their preferences regarding hypothetical tobacco treatment programs. Participants will be randomized to 12 conditions (n=50 per condition). Each condition has a different combination of treatment options. The survey will also assess sociodemographics and tobacco use behaviors. All participants will be asked if they would like to receive information about the state's smoking cessation quitline. Participants who would like to receive information will be given the 1800-QUIT-NOW number and smokefree.gov website address.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported current tobacco use

Exclusion Criteria:

-
Long Acting Neuraxial Peri-prostatic Block in Cancer

Disease progression after definitive therapy for prostate cancer is a major source of morbidity and mortality. Adrenergic/sympathetic innervation of the prostate is essential for prostate cancer progression, and abrogation of these signals by blocking adrenergic innervation halts disease progression. Long-acting neuraxial block of the sympathetic nerves that innervate the pelvis with dehydrated alcohol (\>98% Ethanol) is a safe and effective tool in the treatment of chronic pelvic pain and cancer- induced pelvic pain. Furthermore, ultrasound guided periprostatic neuraxial block at the time of prostate biopsy with short-acting lidocaine is standard of care. Herein the research team proposes to administer a long-acting periprostatic neuraxial block with dehydrated alcohol and lidocaine under trans rectal ultrasound guidance in patients with high-risk clinical features for prostate cancer at the time of prostate biopsy.


Eligibility Criteria:
Inclusion Criteria:

* PSA \>10
* PSAD \>0.15
* PI-RADS 5 lesion on MRI
* Karnofsky performance status \>80
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Prior or concomitant treatment for prostate cancer, including radiation therapy, focal therapy, cryo therapy, androgen deprivation therapy.
* Imaging or clinical evidence of metastatic disease.
* PSA \> 100ng/mL
E-health Resilience Program For Chronic Spine Pain

This study will examine a e-health resilience based program, JOOL, for chronic spine pain patients through the following aims:

Aim 1: To test the effectiveness of a resilience based program known as JOOL Aim 2: To evaluate the characteristics of the participants most likely to benefit from this treatment

This is a pilot RCT in which 150 patients with chronic spine pain will be randomized to one of two arms: (1) a group that downloads the JOOL mobile application resilience program; and (2) a control group.The primary outcome will be a change in physical function.

Eligibility Criteria:
Inclusion Criteria:

* Patient of the UM Back \& Pain Center
* Primary diagnosis of neck or back pain (spine pain)
* Age 18-70
* English speaking
* Able to provide consent
* Willing to download the mobile application and comply with study procedures
* Antidepressant medications stable for ≥ 4 weeks
* No plan to initiate a new non-pharmacological pain intervention during the 30-day study period (e.g. back surgery, physical therapy, behavioral therapy

Exclusion Criteria

* Having known psychotic disorder or the presence of another psychiatric condition (e.g. severe depression \[HADS scores ≥ 15\], suicidal ideation) or cognitive impairment (e.g. severe dyslexia, TBI) limiting ability to give consent and/or participate fully in the study
* Currently undergoing psychotherapeutic care at the Back \& Pain Center because many of the concepts that are the focus of this study are already employed in that treatment
* Other factors that at the discretion of the investigators would adversely affect study participation.
Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment

This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal renal function or severe (eGFR \<30 mL/min/1.73 m2) renal impairment to evaluate the effect of renal impairment on the pharmacokinetics (PK) of TD 4208.


Eligibility Criteria:
Inclusion Criteria:

For renal impairment group:

* Subject has severe renal impairment (eGFR \<30 mL/min/1.73 m2)

For normal renal function group:

* Subject is in good health

Exclusion Criteria:

* Women who are pregnant, lactating, breastfeeding, or planning to become pregnant during the study.
* Subject has received an investigational drug (or medical device) within 30 days
* Subject who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition that would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or is unable to comply with the study protocol.
Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer

The purpose of the study is to determine if probiotic bacteria have a beneficial effect on the colon cancer-associated microbiota and epigenetic alterations in colon cancer. Dietary supplementation consists of two ProBion Clinica tablets, yielding a daily dose of 1.4 x 10 ˄ 10 Bifidobacterium lactis Bl-04 (ATCC SD5219), 7x10 ˄ 9 Lactobacillus acidophilus NCFM (ATCC 700396), and 0.63 g inulin.


Eligibility Criteria:
Inclusion Criteria:

* At least one malignant tumor in the colon

Exclusion Criteria:

* Study subjects with adenomas, or
* who received recent antibiotic therapy or
* consumed probiotics regularly were excluded.
Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

The Visu-Loc spring clip is being used to occlude the cystic duct at the time of laparoscopic cholecystectomy. A hepato-iminodiacetic acid (HIDA) scan will be completed on post operative day one to check for biliary leaks.

The purpose of this study is to evaluate how effective the Visu-Lock clip is at preventing leakage of bile (liquid made by liver and stored in gall bladder) after gallbladder surgery. It is not known if the Visu-Lock clip stops leaks better than other clips that have been used during gallbladder surgery.

Null hypothesis: There is no difference in subclinical or clinical leak rate between spring and crush clips used for cystic duct ligation.

Alternative hypothesis: Titanium spring clips decrease the rate of subclinical or clinical biliary leak from the cystic duct stump after laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* Adult(18 or older)
* Diagnosis of cholelithiasis or cholecystitis
* Diagnosis of choledocholithiasis or biliary dyskinesia
* scheduled fo laparoscopic cholecystectomy
* Females: NOT pregnant

Exclusion Criteria:

* Breastfeeding
* Malignancy
* Inflammatory bowel disease (IBD)
* Ulcerative colitis (UC)
* Receiving steroids
* Severe chronic obstructive pulmonary disease (COPD) or pulmonary disorder
* History of connective tissue disorder
Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia

This is a prospective cohort study assessing measures of cardiometabolic status, body composition, IR and GH response to stimulation after therapy in children (age 7-21 years) treated for ALL. Patients and sibling controls will be recruited from the Pediatric Hematology-Oncology Clinic at the University of Minnesota Amplatz Children's Hospital.

This is a prospective cohort study with two groups: survivors of acute lymphoblastic leukemia (ALL) who have recently completed therapy (cases) and healthy siblings (controls) frequency matched by age and sex. Subjects in each group will have two visits. For cases, the first visit will be approximately 6 months after completion of treatment for ALL; for their siblings, the first visit occur at approximately the same time. For both cases and controls, the second visit will be 2 to 2.5 years after the first visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients

  * Age 7 years to less than or equal to 21 years at time of study enrollment.
  * Acute lymphoblastic leukemia (ALL) as first cancer diagnosis and in first complete remission. Any subtype is eligible.
  * Study enrollment must take place at/after six months of completion of all chemotherapy.
  * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients ≤ 16 years of age.
  * Any prior ALL therapy is allowable.
* Siblings

  * Age 7 years to less than or equal to 21 years at time of study enrollment.
  * Sibling of ALL patient.

Exclusion Criteria:

* Patients

  * Diagnosis of diabetes mellitus prior to ALL diagnosis or at time of study enrollment.
  * Current pregnancy
  * Prior hematopoietic cell transplant.
  * Receiving growth hormone replacement or corticosteroids at the time of enrollment.
* Siblings

  * Previously diagnosed with malignancy.
  * Diagnosis of diabetes mellitus.
  * Current pregnancy
  * Receiving growth hormone replacement or corticosteroids at the time of enrollment.
The Ma'Anshan Birth Cohort (MABC)

The Ma'anshan Birth Cohort (MABC) is a population-based prospective pregnancy and birth cohort study that aims to explore the early environmental and genetic determinants of maternal and child health, with a focus on health outcomes including maternal health, children's cognitive and behavioral development, growth and physical development, video-screen behaviors, and asthma and allergic diseases.

MABC was officially launched in May 2013 at the Ma'anshan Maternal and Child Health Hospital in Anhui Province, and a total of 3,474 families were recruited as of September 2014 to continuously track the health status of mother-child pairs during pregnancy, delivery, and childhood, including basic family demographics, maternal pregnancy and birth history and past history, history of exposure to hazardous factors during pregnancy, children's diets and lifestyles, and children's physical and cognitive-behavioral development, MABC quantifies the attributional relationship between environmental chemicals, diet and nutrition, drug safety, psychological stress, lifestyle, biorhythm, endocrine metabolism and adverse birth outcomes, birth defects, neurodevelopmental disorders, developmental disabilities, etc., and identifies environmental, behavioral and genetic causative factors for birth defects and common developmental disorders, and identifies early warning signs and symptoms for early detection of birth defects. genetic causative factors, identify clinical biomarkers with early predictive effects, integrate and form a precise risk evaluation and early warning model, carry out regional comprehensive prevention and treatment applications, and promote the improvement of the quality of the birth population. Currently, MABC is conducting its 20th school-age follow-up visit.


Eligibility Criteria:
Inclusion Criteria

1. Permanent residents of Ma'anshan city;
2. Obstetric examination and delivery at Ma'anshan Maternal and Child Health Hospital;
3. Mother's age ≥ 18 years old and gestational week ≤ 14 weeks;
4. No serious neuropsychiatric disorders, with sufficient understanding and expression to complete the survey.

Exclusion criteria:

1. Intellectual disability or other serious mental disorders;
2. Suffering from serious underlying diseases and may have a significant impact on pregnancy outcome;
3. Those with poor compliance and difficulty in follow-up.
Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery

The purpose of this study is to learn about the feasibility and safety of using Peptide Receptor Radionuclide Therapy (PRRT) before and after surgical removal of a tumor. PRRT treatment is based on the administration of a radioactive product, 177-Lu DOTA-0-Tyr3-Octreotate (Lutathera®) and its use before and after surgery is thought to increase the overall survival benefit for patients with SSTR-positive gastroenteropancreatic neuroendocrine tumors GEP-NETs.

Primary Objective(s)

* To assess feasibility and safety of combination of perioperative 177Lu Dotatate and cytoreductive surgery in metastatic GEP NETs Secondary Objective(s)
* To assess response rate (RR) after 2 cycles 177Lu Dotatate
* To assess recurrence free survival (RFS) of the overall treatment strategy
* To assess overall survival (OS) of the overall treatment strategy

Eligibility Criteria:
Inclusion Criteria:

1. Metastatic gastroenteropancreatic NET with lymph nodes or liver metastases only.
2. WHO Grade 1 or 2, Ki 67 ≤ 20% (to be confirmed at Stanford)
3. Must be a candidate for cytoreductive surgery with the goal of R1 resection as determined by a multidisciplinary tumor board discussion
4. Measurable disease as determined by RECIST v1.1
5. Confirmed presence of somatostatin receptors on all target lesions as determined by 68Ga DOTA TATE PET scan
6. Patients ≥ 18 years of age.
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
8. Appropriate hematologic, liver and kidney function
9. Patients on octreotide long-acting release (LAR) at a fixed dose of 20 mg or 30 mg at 3 to 4 weeks intervals for at least 12 weeks prior to enrollment in the study

Exclusion Criteria:

1. Prior 177Lu Dotatate treatment
2. Any surgery or radiofrequency ablation within 12 weeks prior to enrollment in the study; or prior radioembolization; chemoembolization; or external beam radiation therapy (EBRT) to \> 25% of bone marrow, at any time
3. Any chemotherapy or targeted therapy (including everolimus and sunitinib) within 4 weeks prior to enrollment in the study
4. Known brain metastases
5. Known bone or peritoneal metastases
Evaluation of Photodynamic Therapy in Treatment of Peri-implantitis

Photodynamic therapy (PDT) is suggested as an adjuvant treatment method to the surgery in peri-implantitis treatment. The primary goal of peri-implantitis therapy is the removal of the causative bacteria from the implant surface and surrounding tissues in order to improve the process of re-osseointegration and achieve long term implant stability. Accordingly, the aims of the study were to evaluate clinical, immunological and microbiological outcomes after surgical therapy of peri-implantitis following PDT.

Treatment procedure

After clinical parameters were recorded and samples were taken, all patients underwent a single episode of non-surgical therapy. It implied a mechanical method for debridement of implants and remaining dentition in order to reduce signs of inflammation. Instructions for oral hygiene were proposed in the same visit.

Peri-implantitis surgical treatment was conducted by one experienced surgeon two weeks after non-surgical therapy. After granulation tissue removal and mechanical implant surface cleaning with graphite curettes (Straumann Dental Implant System Straumann AG, Basel, Switzerland), decontamination of implant surface was conducted. In the study group, for the decontamination of implant surfaces and peri-implant tissues photodynamic therapy was performed (HELBO, Photodynamic Systems GmbH, Wels, Austria), while in the control group, after removal of granulation tissue, 1% gel of chlorhexidine (Chlorhexamed® - Direkt) was put on the implant surface. One minute after exposing the implant surface with CHX, it was irrigated for 1 min by saline. Bone augmentation and bio-resorbable membrane were applied in peri-implant defects using the bovine bone substitute and collagen membrane (Bio-Oss and Bio Gide, GeistlichPharma; Dembone). The mucoperiosteal flaps were repositioned and sutured \[17, 19\].

Patients were prescribed antibiotics (Amoxicillin, 500 mg, three per day, 5 days). It was recommended that patients don't use mouthwash during the postoperative period.

Clinical, immunological and microbiological parameters were measured and assessed baseline, three, six, 12 and 24 months postoperatively. Immunological parameters (IL-17, IL-1β, IL-6) were analysed by ELISA while microbiological samples were collected before the therapy, during the surgery, and at follow-up periods.

Assessment of implant macro- and micro- design were additionally assessed.

Eligibility Criteria:
Inclusion Criteria:

1. More than 18 years old
2. No periodontal or peri-implant treatment in the last 3 months prior to the study
3. Presence of a minimum of one implant in function more than one year with signs of early and moderate peri-implantitis
4. Prosthetic rehabilitation of the implant with diagnosed peri-implantitis more than 6 months
5. Presence of peri-implant pocket depth more than 4 mm
6. Radiogrpih bone level loss more than 2 mm 7 Positive sign of bleeding on probing with or without suppuration

Exclusion Criteria:

1. Uncontrolled medical conditions
2. Use of systemic antibiotics in the previous 3 months
3. Use of anti-inflammatory drugs in the previous 6 months
A Comparison of Three Simulators for Colposcopy LEEP Training

This randomized controlled trial evaluates the learning effectiveness of three different types of Colposcopy simulators objectively with Objective Structured Assessment of Technical Skill (OSATS) and subjectively with self-reported confidence survey. A total of 60 participants, randomly assigned into 3 groups, will learn from Hefler's, Reeve's or authors' simulators. The investigators hypothesize that the proposed simulator affords better learning objectively and subjectively with improved functional fidelity.

Colposcopy and colposcopic treatment is a unique skill that is acquired only following careful training. A colposcopist plays an important role to correctly diagnose, take appropriate biopsies and perform appropriate safe and effective treatment of women with preinvasive cervical disease. However, no surgical treatment comes without risk and colposcopy treatment is no different. Risks from a colposcopy treatment can include intraoperative complication such as bleeding, injury to surrounding organs by the instrument used i.e. laser burns, diathermy burns and damage to bladder, rectum, vulva or vagina. Other complication may include insufficient tissue excised or ablated during treatment leading to failure of cure and risk of recurrent treatment. Recurrent treatment especially excisional treatment has been shown to increase the risk of preterm labour for future pregnancies. In view of this, training in colposcopy and colposcopy treatment is a crucial part of effective cervical cancer prevention.

In this study, the investigators aim to determine if Hefler's, Reeve's or authors' simulators are more effective at supporting the colposcopy training. The significance of the result lies in the effectiveness of training simulator for colposcopy training and the confidence of doctors when they perform their first colposcopy.

Eligibility Criteria:
Inclusion Criteria:

* Year 4 and Year 5 Medical students who have completed their Obstetrics and gynaecology attachment
* Practicing medical doctors who have and have not performed Colposcopy LEEP

Exclusion Criteria:

* Students who have not completed their Obstetrics and gynaecology attachment
Finding the Right Tenofovir/Emtricitabine Regimen for Pre-Exposure Prophylaxis (PrEP) in Transgender Women

This is an open-label, steady-state study of Tenofovir (TFV) and Emtricitabine (FTC) pharmacokinetics (PK) in transgender women taking feminizing hormones. Half of the participants will be transgender women on feminizing hormones, the other half will be male volunteers not taking any hormone therapy.

The investigators propose an open-label, steady-state study of TFV and FTC PK in blood and colon tissue in healthy TGW on feminizing hormones to be compared to healthy cis men, all at risk for HIV infection. Research participants will already have received eight days of TDF/FTC dosing. Evaluating TDF and FTC PK at steady-state is important as it reduces inter-individual variability since the rate of phosphorylation of TFV and FTC is highly variable, resulting in highly variable TFV-DP and Emtricitabine-Triphosphate (FTC-TP) PK among individuals in the first day and during rise to steady-state.

Eligibility Criteria:
Inclusion Criteria:

* TGW and cis men (male at birth and not a TGW)
* 18 to 65 years of age, inclusive on the date of screening
* Provides informed consent for the study
* Non-reactive HIV test results within four weeks of enrollment
* An estimated calculated creatinine clearance (eCcr) of at least 70 mL/min
* Agrees to use condoms for all sexual events during study participation.
* Taking daily oral Truvada® (Tenofovir disoproxil fumarate (TDF) 300 mg/Emtricitabine (FTC) 200 mg) for at least one week at the time of study PK sampling visit
* TGW have to be on an estradiol and have a serum total estradiol level \> 100 picograms(pg)/ml

Exclusion Criteria:

* Significant colorectal symptom(s) as determined by medical history or by participant self-report
* Participant-reported symptoms and/or clinical or laboratory diagnosis of active rectal infection requiring treatment per current Centers for Disease Control (CDC) guidelines
* A positive test for Herpes Simplex Virus -2 (HSV-2) (individuals with active lesions only)
* Co-enrollment in any other HIV interventional research study (excluding behavioral only interventions) or prior enrollment in the active arm of a HIV vaccine trial.
* Positive hepatitis B surface antigen (HBsAg) test
* Interleukin therapy; medications with significant nephrotoxic potential, including but not limited to amphotericin B, aminoglycosides, cidofovir, foscarnet and systemic chemotherapy; medications that may inhibit or compete for elimination via active renal tubular secretion (including but not limited to probenecid); systemic immunomodulatory medications
* Participants with a history of having a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract or drug absorption
* Medications that prolong clotting time
* Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements.