cyrilzakka/clinical-trials huggingface dataset:
Understanding Disparities in Quitting in African American and White Smokers

The purpose of this study is to describe the differences in quitting smoking between African Americans (AA) and White smokers treated with varenicline.

While many studies have evaluated the use of drugs for quitting smoking among Whites, few have assessed efficacy with AAs. Racial/ethical differences in smoking are well documented. AAs smoke less than White smokers but experience disproportionately greater smoking disease and death.

Past studies by the researchers in this study looked at how effective other smoking cessation methods are in AAs. These methods included nicotine gum, nicotine patch and buproprion sustained release. This study will be evaluating varenicline in both AA and White smokers. There has not been a study conducted yet to prospectively research AA-White differences in smoking cessation and also to examine potential causal pathways explaining AA-White differences in quitting.

Eligibility Criteria:
Inclusion Criteria:

* Non-Hispanic African American or non-Hispanic White
* ≥ 18 years of age
* Smoked 3-20 cigarettes per day
* Smoked 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 Hospitalization in the past 2 months for any cardiovascular disease, including but not limited to:

  * Angina
  * Myocardial infarction
  * Peripheral vascular disease
  * Stroke
* New onset of chest pain or arrhythmia in the past 2 months
* History of alcohol or drug dependency 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
Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life

The neurological and psychiatric adverse effects of antiretroviral drugs is a concern for clinicians and people living with HIV. In addition, clinical trials conducted prior to market authorization often have stric inclusion and exclusion criteria in terms of age, co-morbidity or co-medication, and the patients included in the studies are not always representative of the population for whom the drugs will be prescribed in real life. We propose a prospective cohort study to assess the occurrence of neurological and psychiatric adverse events in HIV+ patients starting an association with dolutegravir or bictegravir.

Patients will be included on the day dolutegravir or bictegravir is prescribed. Neurological and psychiatric disorders will be assessed using self-administered questionnaires, at inclusion, one month, three months and six months.


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 years
* HIV-infected
* Initiation or modification of antiretroviral therapy, and starting a therapeutic combination including dolutegravir or bictegravir

Exclusion criteria:

* Intolerance to dolutegravir or bictegravir
* Addiction to a psychoactive product (drugs or medications) with the exception of amyl nitriles ("poppers") and occasional recreational cannabis
* Alcohol consumption \>10 standard drinks/week
* Active HCV coinfection
* Pregnant or breastfeeding woman
A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)

To assess the efficacy, safety and pharmacokinetics in participants treated with CD11301 gel vs. placebo for early stage CTCL (IA, IB, or IIA).

To assess the efficacy and safety of two concentrations (0.03% and 0.06%) of CD11301 gel in the treatment of early stage CTCL (stage IA, IB, or IIA) versus placebo.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of CTCL stage IA, IB, or IIA with biopsy within last 3 months
* Have BSA involvement corresponding to stages IA, IB or IIA CTCL with at least 3 distinct lesions

Exclusion Criteria:

* CTCL that is stage IIB or great or stage IIA with stage N2 with \>5% circulating Sezary cells or CD8+ or large cell transformation or Progressive CTCL
* History of autoimmune disease
* Laboratory test values at screening outside of the normal range and judged clinically significant by the investigator
* Current participation in another clinical trial of a drug or device or past participation within 4 weeks before Baseline or participant is in exclusion period from a previous clinical trial
Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients

This is an open label Phase 1b clinical trial of IV administration of OKN-007 in a pilot cohort of human recurrent malignant glioma patients. All patients will have been previously treated with the standard-of-care treatment which includes surgical resection, radiation and chemotherapy, and in some cases treatment for recurrent disease with investigational agents or bevacizumab (Avastin). Patients with unequivocal recurrence (first or greater) established by MRI with and without contrast (e.g., Gd-DTPA (Gadolinium-diethylene triamine pentacetic acid) and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on this protocol.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed histopathology of WHO grade III glioma or WHO grade IV GBM at primary diagnosis
2. Unequivocal radiographic evidence of tumor progression by MRI within 14 days prior to registration
3. Prior radiotherapy
4. Prior Temozolomide treatment
5. Last cytotoxic chemotherapy 28 or more days or biologic therapy treatment 14 or more days before study start (greater than or equal to 42 days if nitrosourea was administered)
6. Karnofsky performance status greater than or equal to 60%
7. Full recovery (\< grade 1) from the toxic effects of any earlier intervention and a minimum of 28 days from the administration of any investigational agent
8. Adequate renal, liver and bone marrow function:

   * Leukocytes \>3,000/mcL
   * Absolute neutrophil count \>1,500/mcL
   * Platelets \>100,000/mcL
   * Total bilirubin within normal limits
   * AST / ALT (SGPT) \<2.5 x ULN
   * Creatinine within normal limits
9. Patients must be \>_18 years of age

Exclusion Criteria:

1. Second primary malignancy (except adequately treated basal cell carcinoma of the skin). Patients who had another malignancy in the past, but have been free of active disease for more than 2 years, are eligible
2. Have received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study entry
3. Serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study
4. Patients with moderate or severe renal impairment (calculated creatinine clearance of \< 60 mL/min)
5. Patients with sodium, potassium, or creatinine serum electrolytes \> grade 2.
6. Patients with PT/PTT above the upper limit of normal
7. Screening ECG abnormality documented by the investigator as medically significant
Telerehabilitation for Multiple Sclerosis

Multiple sclerosis (MS) is a neurodegenerative disease affecting the central nervous system and is a leading cause of disability in young adults. It often produces strength deficits. Exercise has been shown to improve strength, mobility, and quality of life while reducing fatigue. Telerehabilitation offers a convenient, accessible alternative for MS patients. This study explores the use of an AI-powered application for prescribing and monitoring strength exercises, ensuring continuous feedback and adherence. Methods: Randomized clinical trial. Intervention of 3 weekly strength training ses-sions for 20 weeks, patients in the experimental group used the AI application, while patients in the control group followed the conventional method, paper-based exercises with access to videos.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis according to the McDonald criteria 2017:
* Age between 35 and 60 years.
* Score on the Expanded Disability Status Scale in Multiple Sclerosis by Kurtzke (EDSS) between 2 and 6 points.
* Patients who do not require assistive devices for home mobility.
* Patients with no changes in disease-modifying treatment in the last 3 months.
* Patients who have understood, completed, and signed the informed consent and the study information sheet.

Exclusion Criteria:

* Patients who have been regularly performing strength exercises for more than 3 months prior.
* Moderate/severe cognitive impairment that may interfere with the understanding and/or execution of the study.
* History of alcohol and/or drug abuse.
* Presence of a relapse and/or treatment with corticosteroids within the four weeks prior to the start of the study.
* Patients with severe comorbidities other than MS that may pose a risk for following the exercise guidelines or for their participation in the study for other reasons.
Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism

Some individuals with autism spectrum disorders (ASD) also demonstrate irritability or aggression, which can interfere with functioning. The purpose of this pilot study is to test whether transdermal nicotine is effective for irritability and/or aggression in adults with ASD using a double-blind, placebo-controlled clinical trial. Subjects will participate in three visits. At the first visit, subjects are screened for eligibility and enrolled. Baseline measures include rating scales and a frustrative computerized task. They will then wear seven days of transdermal nicotine or placebo. Visit two is on day seven and the study measures are repeated, vital signs and side effects monitored. Subjects will return for a third and final visit on day 21 to repeat the study measures performed during visit two.


Eligibility Criteria:
Inclusion criteria:

* Age: 18-60
* Gender: All
* Language: Communicative in English
* Participants with a prior diagnosis of DSM-5 ASD at some point in their lifetime OR a DSM-4 diagnosis of Autism OR a DSM-4 diagnosis of Asperger's syndrome OR a DSM-4 diagnosis of Pervasive Developmental Disorder Not Otherwise Specified.
* Symptoms of irritability, agitation or aggression as reported by parent and/or participant
* Aberrant behavior checklist - Irritability Subscale (ABC-I) score of 16 or higher
* No changes in psychotropic medications within the past 14 days.
* Either lives with a primary caregiver or closely engaged with a primary caregiver who interacts with the patient daily
* BMI \> 17.5 and \< 45

Exclusion criteria:

* Age \< 18 or \> 60
* BMI \< 17.5 or \> 45
* Currently using tobacco or any nicotine products (transdermal, gum, e-cigarettes)
* Changes in psychotropic medication management within the past 14 days
* Previous allergy to transdermal patches
* Patients with heart rate \> 100 or \< 50 or known history of cardiac rhythm abnormalities
* Systolic blood pressure \> 150 or \< 95; diastolic blood pressure \> 90 or \< 50
* No symptoms of irritability, agitation, or aggression as reported by parent and/or participant
* ABC-I score of less than 16
* No primary caregiver, or primary caregiver unable to assist with rating scales
E-support for Healthcare Processes - ASTHMA

The purpose of the study is to establish and clinically evaluate a new approach to treating asthma by using information and communication technologies (ICT). A mobile environment, and organizational interventions to improve the process of an integrated treatment of people with asthma will be identified, developed, introduced and clinically evaluated.

A mobile environment to improve the process of an integrated treatment of people with asthma will be identified, developed, introduced and clinically evaluated. The study will include 120 patients diagnosed with asthma that is poorly managed. The study will use the ACT (Asthma Control Test) questionnaire and an evaluation questionnaire that will cover issues regarding the satisfaction of subjects with asthma care offered. Subjects with a PEF meter, will be able to enter the value of PEF (Peak Expiratory Flow).

In addition to this, users can enter values (1) physical activity (type, duration, intensity), and (2) food (type, quantity).

Eligibility Criteria:
Inclusion Criteria:

* ACT points \<19
* Daily symptoms\> = 2 days/week
* Night symptoms\> = 1 night/week
* Rescue medication \> 2days/week
* At least one asthma exacerbation in the past year, but not in the last month, which was treated with oral glucocorticoid

Exclusion Criteria:

* Worsening of asthma in the last 4 weeks (treated with oral corticosteroids)
* Age \>70 or \<18 years
* Significant co-morbidity
* Does not own or know how to handle a mobile phone
* No internet access
* Not able to perform a PEF measurment
* Not able to use inhalor
Graves' Disease Induced by Epstein-Barr Virus Lytic Reactivation

Previous studies have proved that the lytic reactivation of latent Epstein-Barr virus (EBV) was significantly associated with the onset of Graves'disease (GD), however, the morbidity of GD and recurrence rate of hyperthyroidism after antithyroid drugs treatment due to lytic reactivation of EBV is not understood. We will recruit patients with newly diagnosed GD and recurrence of hyperthyroidism after antithyroid drugs treatment. In order to confirm lytic reactivation of EBV, the number of EBV DNA copies，mRNA and protein expression of immediate-early, early and late lytic EBV genes，EBV +TRAb+cells will be tested. The proportion of lytic reactivation of EBV in newly diagnosed GD and recurrence of hyperthyroidism was evaluated.

The lytic reactivation of latent EBV play importment roles in development of GD and recurrence rate of hyperthyroidism. The aim of this study is to evaluate the proportion of lytic reactivation of EBV in newly diagnosed GD and recurrence of hyperthyroidism.

All patients satisfied the diagnostic criteria for GD. The diagnotic remission of hyperthyroidism was included of clinical symptoms and elevated FT3 and FT4, the patients who have been received antithyroid drugs (methimazole or propylthiouracil) titration treatment for 18 or more months and of antithyroid drugs titration treatment and withdrawal antithyroid drugs at least 3 months.

The evaluation of lytic reactivation of latent EBV including EBV DNA copies，mRNA and protein expression of immediate-early, early and late lytic genes，and EBV +TRAb+cells. The EBV DNA copies was tested with PCR, mRNA and protein expression of immediate-early, early and late lytic EBV genes were analysed with RT-qPCR or Western blot and EBV +TRAb+cells were evaluated with flow cytometry.

All statistical tests were performed using GraphPad Prism V8.0.

Eligibility Criteria:
Inclusion Criteria:

* The clinical evaluation included patient history, physical examination, and thyroid ultrasonography. Laboratory and diagnostic testing included determination of serum levels of free thyroxine (FT4), T3 ( FT3), thyrotropin (TSH), TPOAb, TGAb, and serum levels of thyrotropin receptor antibody (TRAb).

Exclusion Criteria:

* Patients with subacute thyroiditis, hyperfunctioning thyroid nodules, iodine hyperthyroidism, drug-induced hyperthyroidism, or other causes of hyperthyroidism were also excluded. The exclusion criteria for both patients with GD included diabetes, infectious diseases, other chronic diseases, and cancer.
Measurement of Tricuspid Regurgitation Volume for Assessment of Tricuspid Regurgitation Using 3D Transesophageal Echocardiography

This study is a prospective observational chart review. The aim of the study is to evaluate tricuspid regurgitation volume using 3D volumetric assessment as an accurate method for tricuspid regurgitation severity in comparison to VCA.


Eligibility Criteria:
Inclusion Criteria:

-All degrees of tricuspid regurgitation minimal, mild, moderate and severe will be included

Exclusion Criteria:

* Exclusion criteria will be non-sinus rhythm, more than mild pulmonary regurgitation, more than trace aortic regurgitation.
Expanded Access to Provide BAY2927088 for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutation

The purpose of this Expanded Access Program (EAP) is to allow patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with mutations in the human epidermal growth factor receptor 2 (HER2) gene, which have no other therapeutic option, to receive BAY2927088.


Eligibility Criteria:
Diabetes Mellitus and Inflammatory Bowel Disease

Diabetes mellitus is a hyperglycemic metabolic disorder due to insulin deficiency or resistance at its receptors, leads to impaired glucose metabolism and multi-organ affection; (optic, peripheral neurological, cardiovascular and renal).

Inflammatory bowel disease; (Crohn's disease and ulcerative colitis), is chronic relapsing inflammation in the gastrointestinal tract due to complex interactions among genetic, environmental, gut microbiome, and immunologic factors.

Inflammatory bowel disease treatment inhibits the abnormal inflammatory response to heal intestinal tissue, relieve the abdominal pain, the diarrhea and the fresh bleeding per rectum, also decreases the frequency of flare-ups and maintains remission.

Amino-salicylates and antibiotics are step I drugs act on the intestinal lining and on presented inflammatory masses.

Corticosteroids are step II drugs on failure of step I drugs for adequate control of the Inflammatory bowel disease and rapid relief of symptoms and inflammation.

The immune modifying agents as azathioprine and 6 mercaptopurine are step III drugs on failure of the steroids.

Biologic agents are anti Tumor necrotic factor agents (infliximab and adalimumab) and non anti Tumor necrotic factor agents (vedolizumab, ustekinumab and natalizumab).

Inflammatory bowel disease may have endocrinal and metabolic associations in the form of; lipid abnormalities and insulin resistance. Also, insulin resistance and hyperglycemia may be due to steroid use as steroid upgrades (hepatic gluconeogenesis, inhibition of glucose uptake in adipose tissue, and impairment of insulin action).

There is no epidemiological evidence that Inflammatory bowel disease is a definite risk factor for diabetes. In this study, the association of diabetes in patients with Inflammatory bowel disease will be determined.

Eligibility Criteria:
Inclusion Criteria:

- All patients with IBD admitted at EL-Raghy Assiut university hospital in the period of first of October 2019 to the end of September 2020 The diagnosis of DM is confirmed by high random blood glucose level more than 200mg/dl three times per day or high HbA1c more than 6.5%.

The diagnosis of IBD is confirmed by colonic biopsy results after colonoscopy.

Exclusion Criteria:

* Patients didn't do colonoscopy or didn't get biopsy or with normal colonoscopy and biopsy
Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT Therapy With Acarovac® Hausstaubmilbe

Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT therapy With Acarovac® Hausstaubmilbe

This prospective open multi-centre non-interventional study was initiated to document the tolerability and the safety profile of the subcutaneous allergen-specific immunotherapy with Acarovac® in house dust mite allergic patients in routine medical care.

During the up-dosing phase with Acarovac®, patients will receive 4 injections in 1-2 week intervals with increasing allergen amount up to the individual maximum tolerable dose. After reaching the individual maximum tolerable dose patients will receive one maintenance dose in a 4 - 8 week interval.

Data on tolerability are documented by the physicians.

Eligibility Criteria:
Inclusion Criteria:

* Patients of the age of 5 years and older suffering from a house dust mite induced allergic rhinitis

Exclusion Criteria:

* Patients suffering from acute or chronic infections or inflammations
* Patients suffering from secondary modifications of the target organ with function impairment (emphysema, bronchiectasis)
* Patients suffering from severe and uncontrolled asthma
* Patients with a known severe autoimmune disease
* Patients with active malignant disease
* Patients requiring beta-blockers
* Patients having any contraindication for the use of adrenaline
* Patients with a hypersensitivity to the excipients of the drug
Biological Effects of Treatment With Resveratrol in ART Patients

To evaluate the effects of a new nutraceutical formulation containing resveratrol (trademark GENANTE) on gamete quality in order to improve the reproductive process during ART.

The purpose of the study is to evaluate the effect of a new nutraceutical formulation containing resveratrol (trademark Genante) on gamete quality in order to improve the reproductive protocols during Assisted reproductive technology (ART) protocols.

The study is a randomized, single blind, parallel, comparative, experimental study during the pre-treatment before in vitro fertilization-embryo transfer (IVF-ET). A total number of 100 patients will be enrolled: 50 patients with a pretreatment control group (control group) and 50 patients with experimental pretreatment study group (resveratrol group). Patients will be assigned to groups during the recruitment phase in a randomized manner. In the control group, the treatment will consist of taking 400 microg once a day of folic acid commonly suggested as part of clinical practice, while in the Resveratrol Group, patients will receive one tablet twice a day (two tablets/day) of Genante. It is specified that the pretreatment with Genante includes folic acid in accordance with the clinical practice, 400 total microg per day. Both treatments will last for 3 months before the IVF procedure.

Eligibility Criteria:
Inclusion Criteria:

* Women with a diagnosis of infertility
* BMI between 18 and 30 kg/m2,
* regular uterine cavity
* normal thyroid function
* normal blood parameters

Exclusion Criteria:

* primary or secondary ovarian failure
* patients who adhered to Bologna Criteria (at least two of the following: advanced maternal age \>40, less than 3 oocytes recovered in previous attempts, abnormal ovarian reserve test)
* presence of ovaries inaccessible to the oocyte pick-up,
* persistent ovarian cysts \> 20 mm,
* presence of sactosalpinx
* heterologous fertilization, significant systemic disease or other situations unsuitable for ovarian stimulation