cyrilzakka/clinical-trials huggingface dataset:
Advancing Tobacco Use Treatment for African American Smokers

The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.

To have an impact on the premature mortality of African American smokers, effective treatment for smokers across the smoking continuum must be identified. Varenicline, the leading first-line medication for tobacco use treatment, triples the likelihood of long-term abstinence relative to placebo in those smoking \>10 cpd. To date, efficacy of varenicline has not been established in African American smokers or light smokers. The long-term goal of this research is to advance treatment for all African American smokers in order to reduce tobacco-related disease and death. Our primary objective is to evaluate the efficacy of varenicline for tobacco use treatment among 500 African American smokers, including a full range of cpd, within a double-blind, placebo-controlled, randomized clinical trial. We will randomize participants in a 3:2 ratio to receive varenicline (1 mg bid; n=300) or placebo (n=200) for 12 weeks, along with individualized health education counseling for all participants. Our specific aims are to evaluate the efficacy of varenicline to promote abstinence in African American smokers across the continuum of smoking level, to examine efficacy in light smokers and also in moderate to heavy smokers, and to describe biopsychosocial characteristics of this group and evaluate in relation to abstinence. This innovative study will provide the first placebo-controlled evaluation of varenicline in the full spectrum of African American smokers, and the first to examine varenicline in light smokers. Findings will contribute to advancing effective treatment for African American smokers and for light smokers, and enhancing individualized treatment. Increased treatment efficacy will have major impact on reducing tobacco-related morbidity and mortality in this high-risk population.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified African American
* Smokes ≥ 1 cigarette per day (cpd)
* Smoke on ≥ 25 days of the past 30 days
* Functioning telephone
* Interested in quitting smoking
* Interested in taking 3 months of varenicline
* Willing to complete all study visits

Exclusion Criteria:

* Renal impairment
* Evidence or history of clinically significant allergic reactions to varenicline
* A cardiovascular event in the past month
* History of alcohol or drug dependence in the past year
* Major depressive disorder in the last year requiring treatment
* History of panic disorder, psychosis, bipolar disorder, or eating disorders
* Use of tobacco products other than cigarettes in past 30 days
* Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
* Pregnant, contemplating getting pregnant, or breastfeeding
* Plans to move from Kansas City during the treatment and follow-up phase
* Another household member enrolled in the study
* Evidence of current severe major depressive disorder or suicidal ideation
Intravitreal Avastin in Proliferative Retinopathies

The study intends to assess the effect of Avastin injections in different proliferative retinopathies due to different causes

Proliferative retinopathies due to different causes represent important causes for the visual acuity loss. Conventional treatments may sometimes improve the visual function, whereas other times, the visual acuity continue to decrease, in spite of all the medical, surgical or laser treatments.

Intravitreal injections with anti-VEGF agents (ex. Avastin for our trial) seem to be an important tool for certain difficult situations in which at the ocular fundus, out of different reasons (advanced age, diabetes mellitus, retinal veins occlusions, etc)new pathologic vessels appear, causing devastating changes in the posterior and anterior segment as well.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of a proliferative retinopathy (AGE RELATED MACULAR DEGENERATION,DIABETIC PROLIFERATIVE RETINOPATHY, etc)
* distance acuity \< 0.5
* age \> 20 years

Exclusion Criteria:

* noncooperative patients
* ocular infections / inflammations
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects

The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI 655075 following intravenous administration of single rising doses of BI 655075 when administered alone and after administration of dabigatran.


Eligibility Criteria:
Inclusion criteria:

1. Healthy Japanese male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Randomised Study of Mucositis Prevention After Radiochemotherapy Treatment for Head and Neck Cancer

This randomised, double-blind study will compare an oral immunomodulatory solution to a placebo for the prevention of acute severe mucositis in head and neck cancer patients treated surgically and concomitantly with radiochemotherapy. The investigators expect a decrease of 25% of severe acute mucositis in experimental arm.


Eligibility Criteria:
Inclusion Criteria:

* Epidermal carcinoma proven histologically of the sphere ORL (all locations except nasopharynx).
* Patients with tumours of the oral cavity, the oropharynx, the hypopharynx and the larynx treated initially by surgery and eligible for post-operative radio- chemotherapy concomitantly.

NB. The patients with tumours of the larynx or hypopharynx are eligible if the radiotherapy to the oropharyngeal mucosa will be at least 54 Gy and the mucositis can be visualised without the use of instruments.

* Radio-chemotherapy to be given postoperatively.
* Maximum delay of 8 weeks between the operative date and the planned starting date of radio-chemotherapy.
* Performance status (grade OMS): 0, 1, 2
* Nutritional Risk Index ≥ 83.5
* No mucositis.
* Age: 18-75 years
* Life expectancy ≥ 3 months.
* Informed consent obtained from the patient.
* Affiliation with a social security system.

Exclusion Criteria:

* Tumour of nasopharynx
* Mucositis
* Severe sepsis
* Treatment by immunomodulators in the month preceding inclusion
* ATCD allergy to the components of Oral Impact.
* Parenteral nutrition at inclusion
* Usual contraindications to concomitant radio-chemotherapy
* Patient already included in another therapeutic trial involving an experimental molecule
* Female pregnant or susceptible to being pregnant, or breast-feeding. Patient not using appropriate contraceptive measures during the treatment
* Persons deprived of liberty or under guardianship
* Patients unable to commit to the trial schedule for geographical, social or psychological reasons.
Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure

The objectives of this study are to explore the efficacy and safety of a robotic procedure for a minimally invasive cochlear implantation.

The cochlear implant (CI) is a neural prothesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation surgery aims to atraumatically insert the electrode array of the cochlear implant into the cochlea. However, due to the location of the cochlea inside the skull, the surgeon is required to initially create an access from the surface of the temporal bone to the cochlea (inner ear). In conventional methods, this access is acquired by removal of large portions of the mastoid bone through a wide mastoidectomy and posterior tympanotomy. The outcome and success of the conventional procedure varies due to mainly two factors: surgeon skill and subject anatomical variation.

To overcome these variables toward a more consistent and less invasive cochlear implantation surgery, the development of robotic and image guided cochlear implantation has taken place.

This study primarily aims to explore the efficacy of the HEARO robotic cochlear implantation surgery.

Primary Objective

The primary objective of this study is to:

• explore the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.

Secondary Objectives

The secondary objectives of this study are to:

* explore the safety of a minimally invasive direct cochlear access via the HEARO procedure.
* exploratively evaluate the electrode array insertion outcomes through the direct tunnel access.

Eligibility Criteria:
Inclusion Criteria:

* Subjects scheduled for CI surgery according to clinical routine
* Subjects who will receive a cochlear implant of the MED-EL portfolio
* Signed and dated informed consent form

Exclusion Criteria:

* Lack of compliance with any inclusion criteria
* Age under 18 years
* Pregnancy
* Distance of the planned trajectory to the facial nerve is \< 0.4 mm as per screening CT scan
* Distance of the planned trajectory to the chorda tympani is \< 0.3 mm as per screening CT scan
* A safe inner ear access cannot be planned for preservation of RW membrane and cochlear structures
* Individuals where image guidance or robotic procedures are not indicated
* Individuals who have known allergy to components of the cochlear implant
A Comparison of Recall Rates Between Conventional 2d Mammography and 2d Plus 3d (Tomosynthesis) Mammography in a Screening Population

The primary aim of this study is to measure, document and compare recall rates of two-dimensional plus three dimensional (2D plus 3D) (Tomosynthesis) mammography to that of 2D mammography in a screening population. This study will compare recall rates for both non-cancer and cancer cases.


Eligibility Criteria:
Inclusion Criteria:

* Subject is female of any race and ethnicity
* The subject is asymptomatic and presents for routine screening mammography and chooses to have a combination 2D + 3D mammogram as her standard of care.

Exclusion Criteria:

* Patient chooses standard 2D mammography over a combination 2D + 3D mammogram
Virtual Interactive Platform (VIP) Transplant Research Study

The purpose of this study is to test a tablet-based application called VIP Transplant, devised to improve the recovery experience of patients that have recently had organ transplant surgery. The study will consist of two non-randomized arms: the first arm will consist of usual care and the second will be using the newly developed app for 21 days to replace their in-person visits. Using questionnaires and in-app usage metrics, the research team will track whether patients have a better medical outcome, greater patient satisfaction with care, and greater compliance rates as compared to patients who do not use VIP Transplant to manage their care.

An organ transplant requires a large time and financial investment for both the patient and provider over the course of a lifetime of follow-up visits and lifestyle monitoring. Patients return to the clinic 2-3 times a week for the first three months after surgery, and then visit the clinic twice a month with labs once a week 91-210 days post surgery. Check-ins for patients without complications occur 1-2 times a year, and these re-evaluations require patients to take time off work and travel to the transplant center often 2 hours away. Dr. David Mulligan, Chief of Transplant at Yale wanted to help patients reduce the time and cost associated with their regular checkups after surgery. Thus, we created VIP Transplant. The Virtual Interactive Platform allows patients to have a secure videoconference with their provider in order to eliminate the need for recurring travel and waiting in congested clinics for a short appointment. It will save patient time and cost to travel to the clinic. The application is integrated into the provider network in order to have a system that supports seamless communication between the patient and provider capabilities.

Research plan:

Dr. Mulligan will contact 8 of his patients who are willing to participate in the study. 4 of the patients will be assigned to the control group and the other 4 will be assigned to the experimental group.

Control group:

On day 1 after their surgery, patient will be asked to fill out a survey on their transplant care. On day 21, patient will be asked to fill out the same survey. The surgeon will be asked to take a survey to evaluate their each patient's progress.

Experimental group:

When the 4 patients attend orientation, patient will each be given the iPad with the VIP Transplant app and shown how to use the app. Patient will then be asked to fill out the survey on day 1 after their surgery and then asked to use VIP Transplant for their transplant care in the following days. Patient will then be asked to fill out the survey again on day 21, at the end of the study. The surgeon will be asked to take a survey to evaluate each of their patient's progress.

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate
* Familiarity with English
* Familiarity with iPad usage/technologically adept
Immunotherapy With CD19 CAR T-cells for B-Cell Lymphoma, ALL and CLL

This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ haematological malignancies.

This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CAR T-cells. Patients will receive the CD19CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with high risk relapsed CD19+ malignancies.

Eligibility Criteria:
Inclusion Criteria:

1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
2. KPS\>60.
3. Life expectancy\>3 months.
4. Gender unlimited, age from 18 years to 70 years.
5. CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
6. Patients who have failed at least one line of a standard treatment.
7. No serious mental disorder.
8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
10. No other tumors.
11. Patients volunteer to participate in the research.
12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial.

Exclusion Criteria:

1. KPS\<50.
2. Patients are allergic to cytokines.
3. Central nervous system leukemia within 28 days.
4. Uncontrolled active infection.
5. Acute or chronic GVHD.
6. Treated with T cell inhibitor.
7. Pregnancy and nursing females.
8. HIV/HBV/HCV Infection.
9. Other situations we think improper for the research.
A Clinical Trial Evaluating the Safety and Efficacy of the KLOX Biophotonic System in Moderate to Severe Acne

The purpose of this study is to evaluate the safety and efficacy of the KLOX Biophotonic System in patients with moderate to severe facial acne vulgaris using a split-face design (treated hemiface vs untreated hemiface).


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female 16 - 30 years of age.
2. Fitzpatrick skin type I through IV.
3. Known medical history of active acne vulgaris for at least 6 months.
4. Moderate-to-severe facial acne, as defined by:

   Moderate is defined as a patient with an IGA of 3 with 20 to 40 inflammatory lesions (papules and pustules) and no more than 1 nodule. Severe is defined as a patient with an IGA of 4 with a greater than 40 inflammatory lesions with the presence of no more than 2 nodules and/or inflammatory scaring type lesion. Also note that all patients should have a similar disease stage on both sides of their face.
5. The patient must have a clinical examination prior to treatment.
6. The patient must have signed the consent form.
7. The patient must be willing to return for follow-up visits.
8. Females of child bearing potential must have a negative pregnancy test result at baseline and both male and female patients must be willing to adhere to a birth control method.

Exclusion Criteria:

1. Active skin infection on the face. Patient must not have active, localized or systemic infection.
2. Facial aesthetic procedure, including laser therapy and injectables within the last 6 months.
3. Enrollment in another acne study or other dermatological study using light therapy including tanning beds within 120 days of enrollment. Patients must not take part or intend to take part in another study liable to interfere with this study whatever the region of the body considered for 30 days prior to the study start and 30 days following completion of the study.
4. History of head and/or neck irradiation.
5. Use of a hormonal contraception is prohibited unless the birth control has been stable for the past 3 months. Note that patient that are presently taking or have taken in past 30 days Cyproterone Acetate + Ethinyl Estradiol (Diane-35) are not eligible for this study.
6. Any facial dermatological conditions that could hinder or interfere with clinical assessments.
7. Immunosuppression and/or cortisone therapy in the past 4 months.
8. Bleeding diathesis.
9. Medications or supplements affecting coagulation.
10. Isotretinoin within the last 24 weeks.
11. Pregnant, breast-feeding or pregnancy planned during the trial.
12. History of facial nerve palsy or marked facial asymmetry.
13. History of neuromuscular disorder.
14. Prior facial surgery that alters subcutaneous tissues (e.g., rhytidectomy).
15. Use of non-acne topical medication that could interfere with study treatment.
16. Physical or psychiatric condition the investigator deems would preclude participation in the study. (e.g. Polycystic Ovary disease)
17. Unwillingness to refrain from excess sun exposure or tanning beds during the healing process -
A Study of Therapeutic Amplitude-modulated Electromagnetic Fields in Advanced Tumors

In vitro studies suggest that low levels of amplitude-modulated electromagnetic fields may modify cell growth. We have identified specific frequencies that may block cancer cell growth. We have developed a device delivering low levels of amplitude-modulated electromagnetic fields. The device is connected to a spoon-like coupler, which is placed in the patient's mouth during treatment. We will conduct a feasibility study consisting of three daily ambulatory treatments until disease progression.

Background: In vitro studies suggest that low levels of amplitude-modulated electromagnetic fields may modify cell growth. We have identified specific frequencies that may block cancer cell growth. We have developed a portable and programmable device delivering low levels of amplitude-modulated electromagnetic fields. The device is connected to a spoon-like coupler, which is placed in the patient's mouth during treatment.

Methods: We will conducted a feasibility study consisting of three daily treatments. All patients with advanced solid tumors and measurable disease will be eligible, irrespective of prior treatments. Patients will be assessed with laboratory exams (complete blood count, comprehensive profile, tumor markers), imaging studies every other month for the first six months, every third month thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Advanced tumor that is either metastatic or inoperable

Exclusion Criteria:

* Pregnancy,
* Other simultaneous anticancer therapies,
* ECOG performance status less than 3
Vitamin and Mineral Supplementation Post Bariatric Surgery

Bariatric surgery is emerging as an essential treatment option for the management of obesity and its associated comorbidities. Many patients present for surgery have pre-existing low blood vitamin levels, thus all bariatric surgical procedures compromise nutrition to varying extents, and may present potential threat of micronutrient deficiencies. Therefore, long term nutritional monitoring and follow-ups are vital components of all bariatric surgical patients. However, there are no current standard practices in United Arab Emirates (UAE) for the biochemical monitoring and replacement of essential micronutrients in patients undergoing bariatric surgery particularly the most performed Sleeve Gastrectomy. Medical practice guidelines recommend nutritional care however, the dose and route of administration supplementation after surgery based on randomized controlled trials is not yet established. Till tow no scientific study has been performed on monitoring vitamins and minerals levels following bariatric surgery among UAE population. Therefore, present study is aimed to determine the dose and route of administration of vitamins and minerals in improving the micronutrient deficiencies post-operatively. Two standard different dosage forms (oral /parenteral) of vitamins and minerals will be given to the patients who had undergone sleeve gastrectomy at Tawam Hospital. The dosages of the supplementations are within the international recommendations and patients will be followed up closely for a period of one year. The effect of nutritional deficiencies on micronutrient level and quality of life (QOL) will be assessed. This will help the medical practitioners to prove the optimal possible nutrition for patients.

The study will be conducted in Tawam Hospital where patients come for their routine bariatric surgery. A written informed consent will be taken from all the patients willing to participate in the study. Patients would be informed about the objectives / goals of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-60 years;
* No medical or psychiatric contraindications;
* BMI\>35 kg/m2 with co-morbidities or BMI \> 40 kg/m2 prior to the bariatric surgery.

Exclusion Criteria:

* • Documented severe micronutrient deficiency that require treatment

  * Documented poor compliance;
  * History of in concordance to medication;
  * Inflammatory bowel disease, malignant or debilitating medical conditions;
  * Known hemoglobinopathies or those diagnosed with pernicious anaemia;
  * Known history of kidney renal stones or history of hypercalcaemia;
  * Significant longstanding medical complications that affect micronutrient status;
  * Severe psychiatric illness;
  * Women who are lactating, pregnant or planning pregnancy.