cyrilzakka/clinical-trials huggingface dataset:
Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)

The purpose of this study is to test a counseling program for Black women at high risk for HIV


Eligibility Criteria:
Inclusion Criteria:

* HIV-negative
* Identify as Black and/or African American
* Age 18 or older
* Cis-gender Female
* English speaking
* Is capable of completing and fully understanding the informed consent process and the study procedures and
* Meets the Center for Disease Control's indications for PrEP use (17): (a) any sex with opposite sex partners in the past 6 months and (b) not in a monogamous partnership with a recently tested HIV-negative partner or (c) any injection of drugs not prescribed by a clinician in the past 6 months AND (d) at least one of the following: (i) infrequently uses condoms in sex with one/more partners of unknown HIV status (ii) in a sexual relationship with an HIV-positive partner or (iii) any sharing of injection/drug preparation equipment in past 6 months.

Exclusion Criteria:

* Not capable of completing/fully understanding the consent process and the study procedures.
Evaluation of Glistenings in Intraocular Lenses Implanted in Normal Patients Following Routine Cataract Extraction.

Evaluation of glistenings in intraocular lenses implanted in normal patients following routine cataract surgery. The lenses used will be Model X-60 made by the AVS company Vs AcrySof MA50BM made by the Alcon company.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Bilateral cataracts requiring surgery
* Potential visual acuity of 20/40 or better in both eyes
* Require IOL power in range of 15-25 diopters
* Pupillary dilation of at least 6mm
* Willing and able to provide informed consent and attend follow-up appointments to 3 years

Exclusion Criteria:

* Any co-existing ocular disease or previous ocular surgery that would confound findings in the study, especially those effecting quality of vision. Examples include Macular degeneration amblyopia and prior epiretinal membrane peel.
Gender Differences and SNPs in Asthmatic Patients

The GINA 2020 guidelines suggest that asthma affects approximately 300 million persons worldwide. Even if there is a specific drug treatment for each stage of disease (From mild to severe) in some patients it is not efficacy and it culd be reated to the gender difference Polymorphisms seems to be involved in asthma (allergic or not) even if no data have been published concerning the role of gender in this clinical manifestation. The aim of this study is to assess whether genetic variations involved in the genes encoding the two key leukotriene enzymes, ALOX5 and LTC4S, and CysLTR1 are implicated in the sex difference of allergic asthma in a well-characterized patient cohort.

The GINA 2020 guidelines suggest that asthma affects approximately 300 million persons worldwide. Even if there is a specific drug treatment for each stage of disease (From mild to severe) in some patients it is not efficacy and it culd be reated to the gender difference Polymorphisms seems to be involved in asthma (allergic or not) even if no data have been published concerning the role of gender in this clinical manifestation. The role of polymorphisms in susceptibility to allergic asthma has been partially investigated but no study has analysed gender subgroups separately, neglecting a their potential predictive role in symptomatological and functional variations in the allergic asthma in both sexes. The aim of this study is to assess whether genetic variations involved in the genes encoding the two key leukotriene enzymes, ALOX5 and LTC4S, and CysLTR1 are implicated in the sex difference of allergic asthma in a well-characterized patient cohort.

Eligibility Criteria:
Inclusion Criteria:

* asthma (allergic or not) diagnosed according to Global Initiative for Asthma guidelines (GINA 2020).
* signed informed consent

Exclusion Criteria:

* • infectious diseases

  * neurodegenerative diseases
  * autoimmune diseases
  * neoplasms
  * progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)
  * alcohol consumption (\>3 alcoholic beverages daily)
  * substanceabuse
  * inability to give written informed consent
  * those who will not sign the consent to the processing of personal data
SBRT Combined With PD-1 Antibody and Chemotherapy in Oligometastatic Nasopharyngeal Carcinoma

This is a multicenter, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT combined with programmed death 1 (PD-1) antibody and chemotherapy in nasopharyngeal carcinoma patients with oligometastasis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as metastatic NPC with no more than 3 metastatic lesions;
* Histopathological diagnosis of NPC;
* ECOG 0-1 point;
* Has not received prior systemic treatment, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
* No contraindications to immunotherapy and chemoradiotherapy;
* Every metastatic lesions could receive SBRT safely;
* Subject must have a measurable target lesion based on RECIST v1.1;
* Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
* Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
* Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
* Take effective contraceptions during and three months after treatment;
* Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

* Allergic to monoclonal antibodies, any PD-1 antibody components, gemcitabine and cisplatin;
* Unexplained fever \> 38.5 ℃, except for tumor fever;
* Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy);
* Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;
* Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
* Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment; Have known allergy to large molecule protein products or any compound of study therapy;
* Pregnant or breastfeeding;
* Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
* Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
* Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
Oral Antibiotic Treatment of Helicobacter Pylori Reduces Intestinal Colonization Rates With Oxalobacter Formigenes

The investigators are finding out if giving antibiotics for Helicobacter pylori will eliminate colonization of the colon by Oxalobacter formigenes.

Background and objectives: Oxalobacter formigenes (OF) may play a protective role in preventing calcium oxalate stones. Intestinal colonization by OF is associated with reduced urinary oxalate excretion. Exposure to antibiotics may be an important factor contributing to variable rates of colonization. This is the first prospective study to evaluate the effect of antibiotics on OF colonization.

Design, setting, participants, \& measurements: The effect of antibiotics on OF colonization was compared in 2 groups: a group receiving antibiotics for gastric infection with Helicobacter pylori (HP) and a group without HP that not receiving antibiotics. OF colonization in stool was detected by oxalate degradation at baseline and after 1 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* age 18-80 years old
* undergoing upper endoscopy
* H. pylori present or absent on gastric histology
* stool positive for Oxalobacter formigenes

Exclusion Criteria:

* unable to consent
* stool negative for Oxalobacter formigenes
A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in HBV-related Liver Transplant Recipients

This is a proof-of-concept study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.

GC1102 is a new recombinant hepatitis B immunoglobulin (HBIg) from Chinese Hamster Ovary (CHO) cells. It is a monoclonal antibody and has high affinity and avidity to hepatitis B surface antigen and several advantages compared to HBIg derived from blood plasma of human donors. Forty volunteers will participate in the study, receive 24-week treatment with low dose (50,000IU) of GC1102 or with high dose (80,000IU) and be followed up till 28 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Given written informed consent
* Aged 19 - 65 years
* Expected liver transplantation related to hepatitis B
* Positive HBsAg

Exclusion Criteria:

* Patients has participated in any other clinical trial within 30 days
* Patients who are scheduled re-operation for liver transplantation
* Patients with are co-infected with HAV, HCV or HIV
* History of malignant tumor within 5 years except primary liver cancer
* Patients with moderate or severe renal disorder (serum creatinine \> 1.5 X ULM) or anuria, acute renal failure or dialysis
* Patients who had experienced cardiovascular attack, myocardiac infarction, PTCA or coronary bypass or with angina, arrhythmia, or any other clinically meaningful valvular heart disease, cerebral infarction or cerebral hemorrhage within 6 months
* History of anaphylaxis against active ingredient or excipients of study drug
* Patients who had been vaccinated with parenteral live vaccine (measles vaccine, epidemic parotitis vaccine, rubella vaccine, cholera vaccine, chickenpox vaccine) within 3 months
* Patients who had been treated with any other immuno globulin within 3 months
* Pregnant or breast-feeding women
* Women of childbearing potential who do not agree to use appropriate contraceptive methods (condom, an intrauterine device, oral contraceptive hormones, or a vasectomy of male sex partner) during this study
* Alcohol or drug abuse within 6 months
* Patients who has any clinically meaningful disease in investigator's judgement to prevent participating in this study
Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

RATIONALE: Biological therapy such as lenalidomide use different ways to stimulate the immune system and stop tumor cells from growing. It may also stop the growth of tumor cells by stopping blood flow to the tumor.

PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients with advanced or unresectable kidney cancer.

OBJECTIVES:

Primary

* Determine the best response in patients with advanced or unresectable renal cell cancer treated with lenalidomide (CC-5013).
* Determine the time to disease progression in patients treated with this drug.

Secondary

* Determine the safety of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed renal cell carcinoma (RCC)

  * Advanced or unresectable disease
* At least 1 measurable lesion
* No active brain metastases

  * Prior brain metastases allowed provided patient has been treated with radiotherapy or surgery AND remains asymptomatic for ≥ 6 months

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Karnofsky 70-100%

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* Bilirubin ≤ 1.5 mg/dL
* AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
* No hepatitis A, B, or C infection

Renal

* Creatinine ≤ 2.0 mg/dL

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No known hypersensitivity to thalidomide
* No other serious medical condition, laboratory abnormality, or psychiatric illness that would preclude giving informed consent
* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, localized prostate cancer, or superficial bladder cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No more than 1 prior systemic immunotherapy regimen for RCC
* No prior lenalidomide (CC-5013)
* No prior or concurrent thalidomide

Chemotherapy

* No more than 1 prior systemic chemotherapy regimen for RCC

Endocrine therapy

* No more than 1 prior systemic hormonal therapy regimen for RCC

Radiotherapy

* See Disease Characteristics
* No concurrent radiotherapy

Surgery

* See Disease Characteristics
* At least 4 weeks since prior surgery and recovered

Other

* No more than 1 other prior systemic therapy regimen for RCC
* No other concurrent anticancer therapies
* No other concurrent investigational agents
Efficacy of Intermittent Abdominal Pressure Ventilation in Neuromuscular Patients

Non-Invasive Ventilation (NIV) is an established treatment to manage respiratory muscles dysfunction in neuromuscular disease, preventing the progression of respiratory failure to intubation and/or a tracheotomy. NIV is commonly needed at first during the night, but when the disease worsens, it is required during the day. It is provided via nasal or oronasal masks, causing discomfort and/or aesthetic issues that result in poor compliance.

Intermittent Abdominal Pressure Ventilation (IAPV) is a valid, though unconventional, alternative to daytime NIV: it consists of a portable ventilator with an internal battery and a corset as interface. The IAPV corset is lightweight, comfortable and, thanks to velcro fasteners, easier and better fitting than a face mask. Cyclical inflation of a rubber bladder inside the corset moves the diaphragm upwards like a pneumobelt causing air to enter in the lungs via the upper airways as gravity draws the diaphragm back to its resting position.

IAPV is indicated in neuromuscular disease and has already been tested in few preliminary studies and case reports. This study wants to verify the hypothesis of its application in population of neuromuscular patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Neuromuscular Disease (Amyotrophic Lateral Sclerosis, Duchenne Muscular Dystrophy, Spinal Muscular Atrophy, Pompe Disease)
* Non Invasive Ventilation \> 16 hours/day
* Informed consent signed

Exclusion Criteria:

- Diagnosis of kyphoscoliosis
Distress in Rheumatoid Arthritis Patients

The goal of this observational study is to determine the frequency of psychological distress caused by the rheumatoid arthritis disease in patients with rheumatoid arthritis and to determine the factors associated with the distress.

A routine rheumatoid arthritis patient examination (number of swollen and tender joints, disease activity, functional status, etc.) will be performed by the doctor to evaluate the patients. Patients will be asked to fill out the questionnaires to evaluate their functional status and distress levels.

Demographic data such as age, gender, body mass index and disease duration will be recorded during routine follow-up of the patients. The duration of morning stiffness, the number of swollen and tender joints, disease activity and functional status will be evaluated by the doctor. Disease activity will be evaluated with the DAS 28 score and functional status will be evaluated with the Health Assessment Questionnaire. Rheumatoid Arthritis Distress Scale (RADS) will be used to evaluate the distress due to rheumatoid arthritis.Patients will be asked to fill out the questionnaires to evaluate their functional status and distress levels.

Demographic data such as age, gender, body mass index and disease duration will be recorded during routine follow-up of the patients. The duration of morning stiffness, the number of swollen and tender joints, disease activity and functional status will be evaluated by the doctor. Disease activity will be evaluated with the DAS 28 score and functional status will be evaluated with the Health Assessment Questionnaire. Rheumatoid Arthritis Distress Scale (RADS) will be used to evaluate the distress due to rheumatoid arthritis.

DAS28 score is a score calculated by a mathematical formula based on the patient's swollen and tender joint counts, erythrocyte sedimentation rate and the patient's global assessment of disease activity.

The Health Assessment Questionnaire consists of twenty items and evaluates the degree of difficulty patients have in performing daily living activities. The total score varies between 0 and 3, with a higher score indicating a more serious impact on daily functional status.

Rheumatoid Arthritis Distress Scale (RADS) is a scale developed to evaluate the psychological distress experienced in patients with rheumatoid arthritis due to the effects of the disease. The total score varies between 0 and 5, with a higher score indicating more impact.

Eligibility Criteria:
Inclusion Criteria:

1. Having rheumatoid arthritis over the age of 18
2. Having the cognitive state to understand what you read and answer questions

Exclusion Criteria:

1. Being currently receiving treatment for known psychological disorders such as depression and anxiety.
2. Having another chronic disease that may cause psychological distress
Large-Bore Mechanic Thrombectomy for the Treatment of Symptomatic Portomesenteric Vein Thrombosis

A single site study evaluating the safety, feasibility, and effectiveness of percutaneous large-bore mechanical thrombectomy using the Inari Triever Aspiration Catheter for the treatment of portomesenteric vein thrombosis (PMVT).

This is a single center, prospective, investigator-initiated observational study of adults undergoing mechanical thrombectomy as part of clinical care for portomesenteric vein thrombosis (PMVT).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years,
* PMVT diagnosed on cross-sectional imaging such as contrast-enhanced CT or MRI abdomen
* Symptomatic PMVT (persistent symptom, worsening abdominal pain after initiation of anticoagulation, development of peritonitis, complication of portal hypertension in cirrhosis (variceal bleeding or worsening ascites), and poor surgical candidates
* Speaks and understands English language

Exclusion Criteria:

* Age \< 18 years
* no PMVT diagnosed on cross-sectional imaging such as contrast-enhanced CT or MRI abdomen
* Malignant PMVT
* chronic PMVT including presence of cavernoma and network of prominent collateral vessels in porta hepatis on cross-sectional imaging.
* asymptomatic PMVT
* life expectancy \< 6 months
* Does not speak or understand English language
Management of Peri-implant Mucositis With Ozone Water Jet: a Randomized Clinical Trial.

The aim of this study is to assess if ozonized water can be used for the treatment of peri-implant mucositis in patients with dental implants.

Patients willl undergo professional dental hygiene also with the use of glycine powders, then they will be randomly divided into two groups:

* Trial Group: irrigation of peri-implant periodontium with mucositis with ozonized water.
* Placebo Group: irrigation of peri-implant periodontium with mucositis with water.

Periodontal indices will be recorded at the baseline, after 1 and 2 months. After 1 and 2 months, only glycine powders will be performed, together with ozonized water or water irrigation and the collection of periodontal indices.

The aim of this study is to assess if ozonized water can be used for the treatment of peri-implant mucositis in patients with dental implants.

Patients who respond to eligibility criteria and that will sign the informed consent will undergo a professional oral hygiene procedure.

Patients willl undergo professional dental hygiene also with the use of glycine powders. Then, glycine powders air-flow will be administered. Then they will be randomly divided into two groups:

* Trial Group: irrigation of peri-implant periodontium with mucositis with ozonized water.
* Placebo Group: irrigation of peri-implant periodontium with mucositis with water.

Periodontal indices will be recorded at the baseline, after 1 and 2 months. After 1 and 2 months, only glycine powder will be performed, together with ozonized water/water irrigation and the collection of periodontal indices.

Eligibility Criteria:
Inclusion Criteria:

* Presence of one or more dental implants
* Presence of peri-implant mucositis at least at one implant
* Bleeding Score \> 0

Exclusion Criteria:

* Patents without dental implants
* Presence of systemic diseases
* Patients with cardiac pacemaker
Tobacco Cessation for Sexual Minorities

There is a growing body of evidence revealing disproportionately higher rates of tobacco use among sexual and gender minority (SGM) individuals, compared to their heterosexual peers. These disparities have led organizations to support the inclusion of SGM in all local, state, and national tobacco prevention and control activities. In an attempt to leverage the online milieu for health-related interventions, mobile apps have been created to support tobacco cessation. However, evidence-based apps promoted by the National Cancer Institute are unpopular, remain poorly supported, and were not studied for use by SGM persons. Commercial apps, on the other hand, have been downloaded millions of times, contain many valuable features, and enjoy better infrastructure. Unfortunately, they are not evidence-based and have not been rigorously tested.

The University of Pittsburgh (Pitt) is currently conducting a randomized controlled trial to assess the feasibility and efficacy of using the Kwit tobacco cessation app with patients at UPMC Montefiore and Presbyterian hospitals (PI: Chu). It is a pragmatic clinical trial applying a patient-centered outcomes framework to ensure that-rather than focusing only on successful cessation-the study includes measurements for quality of life, mobility, and social interactions. We propose to extend the study to underrepresented SGM young adults.

Survey measures will be adapted as needed to address issues specific to the SGM population.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-30
* Self-identified as a sexual minority (gay, lesbian, bisexual)
* Smokers interested in cessation (\>1 cigarettes/day over the past 30 days)
* Must own an Apple or Android based smartphone.

Exclusion Criteria:

* Already receiving pharmacological and/or behavioral intervention or counseling for smoking cessation