cyrilzakka/clinical-trials huggingface dataset:
Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites

This study is to help determine the most effective type or combination of treatments to offer patients seeking lung cancer screening who are smokers to help them reduce the number of cigarettes they smoke, or quit smoking. The investigators long term goal is to increase the benefits of lung cancer screening by providing a blue print of best practices for screening sites to deliver tobacco treatment to their patients who are smokers, in a way that does not add burden to screening site staff and increases the chances of patients quitting smoking.


Eligibility Criteria:
Inclusion Criteria:

Site Eligibility (as per SC self-report)

\& Must be designated as an American College of Radiology (ACR) designated lung cancer screening site

* Reports at least one year of lung cancer screening experience
* Reports conducting at least 20 new initial screenings per month Site Coordinator (SC) Eligibility (as per SC self-report)
* Employed as a full-time Site Coordinator at participating lung cancer screening site Patient Eligibility (as per self-report)
* Between the ages of 50-80 years old
* Seeking baseline or annual follow-up LDCT lung cancer screening
* Have at least a 20 pack-year history of smoking
* Currently a smoker, defined as self-reported cigarette smoking (some days, every day) within the past 30 days.
* Must be reachable by telephone
* Must be English or Spanish speaking due to the study materials being available in only these languages and limited available resources for translation.

Exclusion Criteria:

Patient (as per self-report)

* NRT is medically contraindicated (e.g., recent heart attack within the last 2 weeks or, unstable/worsening angina).
* Smokers who are receiving other tobacco treatment services or have used cessation medications (NRT, bupropion, varenicline) within the past month.
Short-Term Exposure to Lipophilic Anti-proliferative Drugs Delivered by Angiographic Contrast Media

This was a randomized, placebo-controlled, multi-centre study, double-blind within each dose level, with four ascending dose levels to test the tolerability and safety of iopromide-paclitaxel in patients with de novo lesions in coronary arteries. Thirty-two patients were included into the trial, which were divided into four treatment groups. A total of four concentration levels of paclitaxel-iopromide concentrations were investigated. In each treatment group, six patients received iopromide-paclitaxel and two patients placebo (iopromide without paclitaxel). In each patient, the doses were adjusted individually as needed.

Background: Non-stent-based immediate release formulations of paclitaxel have been shown to reduce in-stent restenosis in animal experiments and initial clinical trials. Paclitaxel dissolved in the angiographic contrast agent iopromide was well tolerated and inhibited neointimal proliferation in a dose-dependent manner after injection into porcine coronary arteries.

Methods: As a first step in entering clinical development, a phase I trial was performed using 4 ascending paclitaxel dose/concentration levels: samples of up to 100 ml of the contrast agent containing 10, 50, 100 or 200 μM paclitaxel were randomly administered to 6 adult patients each assigned to bare metal stent implantation for single de novo coronary artery lesions, while 8 patients treated with plain contrast medium served as controls. Safety variables and tolerability as well as angiographic parameters were assessed.

Eligibility Criteria:
Inclusion Criteria:

* male and postmenopausal female patients
* aged 18 years and older
* clinical evidence of stable or unstable angina, a positive functional test and a stentable de novo lesion in a native coronary artery
* diameter stenosis \> 70% (visual estimate), lesion length \< 25 mm, and a vessel diameter ≥ 2.5 mm.

Exclusion Criteria:

* acute myocardial infarction
* left ventricular ejection fraction of \< 30%
* aorto-ostial lesion
* unprotected left main lesion or a bypass graft
* clear angiographic calcification in the target lesion
* visible thrombus proximal to the lesion
* chronic total occlusion
* platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
* WBC \<3,000 cells/mm3
* known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel, stainless steel
* sensitivity to contrast media not amenable to adequate premedication
* medical illness (i.e. cancer, liver disease or congestive heart failure) associated with a life expectancy of less than two years
Evaluation of Fibromyalgia With Disease Activity and Clinical Findings in Women With Behçet's Disease

In the literature, the relationship between fibromyalgia and disease activity has been assessed in a few studies without discrimination between women and men.In this study, it was aimed to evaluate the relationship between fibromyalgia and disease activity in women with Behçet's disease.

There are only a few studies in the literature evaluating the association of fibromyalgia with disease activity and clinical findings in Behçet's disease. In the literature, the relationship between fibromyalgia and disease activity has been assessed without discrimination between women and men. Behçet's disease is more active in men and fibromyalgia is more frequent in women. Evaluating the relationship between fibromyalgia and disease activity in Behçet's disease without gender discrimination may not be objective.There is not any study in literature evaluating relationship between fibromyalgia and disease activity in women with Behçet's disease.In this study, it was aimed to evaluate the relationship between fibromyalgia and disease activity in women with Behçet's disease.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with Behcet disease according to international study group criteria
* Patients older than 18
* Patients younger than 75

Exclusion Criteria:

* Participants which were previously diagnosed with diabetes mellitus
* Participants which were previously diagnosed with chronic renal failure
* Pregnant women
A Study to Evaluate Efficacy and Safety of Three W0027 Regimens in the Treatment of Moccasin Type Tinea Pedis (MTTP)

In this phase Ib, multi-centre, randomized, double-blind, placebo-controlled parallel group study, 120 subjects with moccasin type tinea pedis (MTTP) will be enrolled at approximately 11 centres in the USA, Canada and Australia.

The primary objective of the study is to assess the patient response to three W0027 regimens in subjects with MTTP. Secondary objectives include assessment of the safety, tolerability and skin and nail pharmacokinetics to the three Albaconazole regimens.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18-65 years, who have been diagnosed with moccasin type tinea pedis (by positive dermatophyte culture, positive potassium hydroxide/calcofluor white preparation, and a Total Signs and Symptoms Score of at least 4).
* Females of childbearing potential must use contraceptive methods .

Exclusion Criteria:

* Subjects who are receiving any CYP3A substrates with potential for QT prolongation;
* have used systemic antifungal drugs within 30 days of first dose; or topical antifungals within 2 weeks of first dose.
* Also excluded are those who have a clinically significant medical condition.
Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

The purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization. The investigators comparisons included assessments of patient comfort and satisfaction with fit, as well as dynamic kinematic assessment using X-Ray Reconstruction of Moving Morphology (XROMM) a novel high-speed, high-resolution, bi-plane video radiography system.

In the past decade, advances in upper limb socket design and technology have been proposed to increase comfort and decrease perceived weight of the prosthesis. There have been no scientific studies to date that have evaluated the benefits of these designs, and thus no evidence to support use of one type of prosthetic socket design over another. Thus, the overall purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization.

Eligibility Criteria:
Inclusion Criteria:

* Male and female transhumeral amputees, 18 years or older of any ethnicity, who are current prosthetic users.

Exclusion Criteria:

* Subjects with frozen shoulder of the residual side, and/or severely limited active range of motion of the shoulder joint of the residual limb
* Inability to tolerate wearing of a prosthetic socket
* Mental impairment that renders a subject unable to comply with the study
* Skin conditions such as burns or poor skin coverage as well as those with severe contractures that prevent prior prosthetic wear
* Any electrically controlled medical device including pacemaker, implanted defibrillator or drug pumps
* Neuropathy, uncontrolled diabetes, receiving dialysis
* Any other significant comorbidity which would interfere with the study
* Severe circulatory problems including peripheral vascular disease and pitting edema will be excluded
* Cognitive deficits or mental health problems that would limit ability to participate fully in the study protocol
* Women who are pregnant or who plan to become pregnant in the near future
S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study

Assess the efficacy and safety of S1 combined with cisplatin in treatment of recurrence/metastasis of ESCC


Eligibility Criteria:
Inclusion Criteria

* Joined the study voluntarily and signed informed consent form;
* Age 18-75

  .Presence of at least one index lesion measurable by CT scan or MRI
* recurrence/metastasis of Esophageal carcinoma or gastroesophageal cancer confirmed by pathology
* No radiotherapy, chemotherapy or other treatments prior to enrollment
* PS ECOG 0-1
* Life expectancy of more than 3 months
* ANC≥2×109/L，PLT≥100×109/L，Hb≥90g/L

  * Cr≤1.0×UNL
  * TBIL≤1.25×UNL； ALT/AST≤2.5×UNL，with hepatic metastases ALT/AST≤5.0×UNL；AKP≤2.5×UNL

Exclusion Criteria:

* there is radical cure of the cancer

  * uncontrolled chronic diarrhea and esophageal obstruction
  * Neurological or mental abnormalities Influence of cognitive ability include central nervous system metastases
  * Severe complication(s), e.g.,uncontrolled active infection,myocardial infarction,hypertension,arrhythmia,stenocardia
  * Patient who has metastasis except cured skin basal cell carcinoma and carcinoma in situ of cervix
* accept other antitumor therapy •Female patients during their pregnant and lactation period, or patients without contraception
Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World

This study is to determine the effectiveness and safety of WR 279,396, a topical cream for the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo control under double-blind conditions in a local population group in Tunisia where leishmaniasis is endemic.

WR 279,396 is a paromomycin-based topical cream that has shown some suggestion of being effective for the treatment of non-serious, non-complicated cutaneous leishmaniasis in previous clinical studies. The goal of this study is to expand those observations in a larger, more rigorous study to clearly define the efficacy of this product and collect information about adverse effects. Subjects will be randomized to receive either WR 279,396 or vehicle placebo; applied twice a day for 20 days.

Eligibility Criteria:
Inclusion Criteria:

* Age 5-75 years
* Lesions must measure at least 1 cm and be primarily ulcerative
* Have cutaneous leishmaniasis proven parasitologically in the lesion selected for study
* Must have given written informed consent to participate in the study

Exclusion Criteria:

* Known drug intolerance to aminoglycosides in the patient or immediate family
* Previous use of antileishmanial drugs (within 3 months) or present use of routinely nephrotoxic or ototoxic drugs
* Patients with tuberculosis under treatment
* Potential for follow-up: have less than 7 months time remaining in present address and/or plan to leave the area for more than 30 days
* Extent of disease: more than 5 lesions or lesion equal to or greater than 5 cm or a lesion less than 5 cm from the eye, or a lesion in the face that, in the opinion of the attending dermatologist could potentially cause significant disfigurement
* Location of disease: mucosal involvement
* Disseminated disease: clinically significant lymphadenitis with nodules that are painful and greater than 1 cm in size in the lymphatic drainage of the ulcer
* Concomitant medical problems: significant medical problems of the kidney or liver as determined by history and by the following laboratory studies:
* Hearing abnormality
* Ongoing pregnancy or have plans to become pregnant
* Females of child bearing age (Tunisia Only)
* Signs or symptoms of peripheral neuropathy

Kidney: clinically significant abnormalities of urine analysis, serum levels of creatinine, BUN, total proteins greater than the upper limit of normal for the laboratory.

Liver: AST or ALT greater than the upper limit of normal for the laboratory General: glucose, Na+, or K+ greater than the upper limit of normal for the laboratory
Immunological Reset to Allow Access to HLA Compatible Transplantation in Highly Sensitized Kidney Transplant Candidates Through Non-myeloablative Autologous Stemm Cell Transplantation

This is a study for hypersensitized patients who have been waiting for more than 3 years for an offer for a kidney transplant. The objective is to perform a transplant of autologous hematopoietic precursors with the aim of producing what we call an immunological reset to make the maximum number of anti-HLA antibodies disappear and thus increase the chances of the patient receiving an offer for a kidney transplant.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must be able to understand and give written consent.
2. Women and men between 18 and 65 years old.
3. Patients with chronic kidney disease who are on renal therapy replacement with dialysis.
4. Patient who is on the waiting list for kidney transplant from a death donor and who has not received an offer for a compatible transplant in the last 3 years within the national PATHI prioritization program.
5. cPRA calculated of more than 97% and having been in the program of prioritization for more than 3 years
6. Positive IgG serologies for Cytomegalovirus and Epstein Barr.
7. Women of childbearing potential must have a negative pregnancy test upon entry to the study and must agree to use safe contraceptive methods according to the guideline CTFG recommendations on contraception in clinical trials during duration of the study (condoms are considered safe methods male and female, oral contraceptives, etc.).
8. Patients vaccinated against tetanus, influenza, pneumococcus and herpes zoster

Exclusion Criteria:

1. Current known infection, recurrent bacteria, virus, fungus or fungus bacteria, or other infections (such as HIV, hepatitis B, hepatitis C, or zoster).
2. Concomitant serious uncontrolled major organ disease.
3. Any infection that requires hospitalization and intravenous treatment with antibiotics during the 4 weeks prior to screening, or oral treatment with antibiotics the previous 2 weeks.
4. Patients with primary or secondary immunodeficiencies.
5. Patient with an active history of tuberculosis (even if treated) or patients with untreated latent tuberculosis.
6. Malignancy during the 5 years prior to screening, except for carcinoma of the basal cell or squamous cell carcinoma properly removed.
7. Known abuse of alcohol, drugs or chemicals within 1 year prior to screening.
8. Patients with complicated peripheral venous access
9. Neutropenia (ANC \<1000/uL) or thrombocytopenia (platelet count \<100,000/uL) during the 4 weeks prior to screening.
10. Severe allergic or anaphylactic reactions to human monoclonal antibodies, humanized or murine.
11. Treatment with any investigational agent during the 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) prior to screening.
12. Immunization with live vaccine during the 2 months prior to screening.
13. Pregnant or breastfeeding women.
Dermacyd Tina Gel Tangerina Mix - Photo Evaluation

The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Tina Gel Tangerina Mix.


Eligibility Criteria:
Inclusion Criteria:

* Phototype Skin II and III
* Integral skin test in the region

Exclusion Criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection
* Diseases which can cause immunity decrease, such as HIV, diabetes
* Use of drug photosensitizer
* History of sensitivity or irritation for topic products
* Active cutaneous disease which can change the study results
* History or photodermatosis active
* Family or personal antecedent of cutaneous photoinduced neoplasias
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium
* Intense solar exposure in the study area
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Diacutaneous Fibrolysis on Lateral Epicondylitis

Diacutaneous Fibrolysis (DF) is a manual method of treatment, usually adjuvant, addressed to the mechanical pain of the locomotor system. In our clinical practice a favorable effect is observed in patients with chronic lateral epicondylitis, but there are no published studies evaluating the results of this technique.

The objective of this trial is to evaluate if DF provides a further improvement in pain intensity, pain-pressure threshold, function and pain-free grip strength, in patients with chronic lateral epicondylitis being treated with physiotherapy. For this purpose, we conduct a randomized controlled trial, double-blind (patient and evaluator) in a Public Primary Care Center.

Sixty subjects will be randomized (computer application) into three groups: Intervention Group, Placebo Group and Control Group. All the three groups receive the same protocolized treatment of physiotherapy and additionally. Additionally, the Intervention Group receives six sessions (two sessions in a week during three weeks) of real DF and the Placebo Group receives six sessions (two sessions in a week during three weeks) of sham DF. The Control Group receives the protocolized treatment of physiotherapy only.

Pain intensity (VAS), pain-pressure threshold (pressure algometry), function (DASH questionnaire) and pain-free grip strength (digital dynamometer) will be measured at baseline, after treatment period, and three months after discharge from treatment. After discharge for treatment the patient subjective opinion about their evolution will be collected through the Global Rating of Change (GROC) scale.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old and over
* Diagnosis of chronic lateral epicondylalgia
* Sign the informed consent form

Exclusion Criteria:

* Concomitant conditions affecting the same upper extremity
* Contraindications for Diacutaneous Fibrolysis
* Corticosteroid injections or similar agents in the three months prior to study inclusion
* Pending litigation or legal claim
* Poor language and communication skills making difficult to understand the informed consent
Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy

Pars-plana vitrectomy (PPV) is the cornerstone of surgical treatment for eyes with complicated proliferative diabetic retinopathy. Anti-VEGF intravitreal injection before PPV has shown a good effect on surgical outcomes. However, many patients present with co-morbidities that contraindicate the usage of anti-VEGF in the pre-operative period. Thus, cryoapplication, an old therapeutic tool for proliferative diabetic retinopathy may be a good alternative. The investigators present herein a comparative study between peripheral retinal cryoapplication and anti-VEGF before vitrectomy for complicated proliferative diabetic retinopathy.

Pars-plana vitrectomy (PPV) is the cornerstone of surgical treatment of complicated proliferative diabetic retinopathy allowing the removal of vitreous opacity and releasing tractions from the retina. Surgical outcomes, however, are variable depending on a large array of pre, per, and post-operative conditions.

The preoperative anti-VEGF intravitreal injection has shown a good effect on surgical outcomes in patients with vitreous hemorrhage or tractional retinal detachment.

However, a great number of patients present with co-morbidities that contraindicate the usage of anti-VEGF in the pre-operative period.

Thus, an alternative to this adjunctive therapy is worth investigating. In another hand, cryoapplication, an old therapeutic tool for proliferative diabetic retinopathy had been used in patients with non-clear ocular media with vitreous hemorrhage.

The investigators present herein a comparative study between peripheral retinal cryoapplication and anti-VEGF before vitrectomy for complicated proliferative diabetic retinopathy.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or 2 diabetes mellitus
* Vitreous or retro-hyaloidal hemorrhage and/or tractional retinal detachment threatening or involving the macula
* No or less than 1000 impacts of preoperative retinal photocoagulation and/or iris rubeosis
* Only one eye per participant

Exclusion Criteria:

* Negative light perception
* Previous vitrectomy
* Contraindication to anti-VEGF therapy or retinal cryoapplication
* Associated rhegmatogenous retinal detachment
Fenofibrate Bioequivalence Study (0767-031)

This study will determine definitive bioequivalence of the United States (U.S.) and United Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good health
* Subject is willing to follow all study guidelines

Exclusion Criteria:

* Subject has uncontrolled high blood pressure, impaired glucose tolerance, diabetes, or other major diseases or chronic conditions that would confound the results of the study or make participation unsafe
* Female subject is receiving oral contraceptives or hormone replacement therapy
Clinical Study to Evaluate the IBS Symptoms Improving Effect and Safety of GTB1

This study was conducted to investigate the effects of daily supplementation of L. plantarum APsulloc 331261(GTB1TM) on improvement of IBS symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects older than 19 years old
* Diagnosed case of IBS using Rome IV criteria
* Who had type 6 or 7 stools according to the BSFS on at least 2 weeks ≥ 25%
* Who voluntarily agreed to participate in the study and signed an informed consent form

Exclusion Criteria:

* Who had been ingesting products containing probiotics or prebiotics in the 4 weeks preceding entry into the trial
* Who had antibiotic agents during the 4 weeks prior to study entry
* Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives
* Who is determined ineligible for study participation by investigators for any other reasons