cyrilzakka/clinical-trials huggingface dataset:
Knowledge and Practices of ADR Reporting in LMICs

The reported literature suggests that knowledge about pharmacovigilance is on a lower side and ADR reporting is not common in developing countries. This survey may help us to identify the common gaps in knowledge and practices about pharmacovigilance so that we can devise the strategy on the basis of outcome.

Safety evaluation of a product in a market is like a moving ball which need re-evaluation as the data gather in its life cycle.(1) As per the definition of International society of harmonization and World Health Organization, adverse reaction is Adverse drug reaction (ADR) is defined as "A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function." (2) Adverse reaction and adverse event are interchangeable use in pharmacovigilance sector by knowing the difference is that ADR term used when drug is causing the effect (1). The frequency of ADR is getting higher due to the increasing prevalence of chronic disease with the growing trend of combination drugs (3). The non-profitable organization of pharmacovigilance is playing tremendous role in disseminating the awareness of proper usage of drug globally.(3) According to Uppsala database statistics, approximately 3 million reports were listed as suspected ADRs. (4) Nearly 6.7% of hospitalizations were due to serious ADRs (5)

Eligibility Criteria:
Inclusion Criteria:

- Participants who would like to voluntarily fill the survey form

Exclusion Criteria:

* Students
* Other than Health care professionals (including but not limited to Physicians, Doctors, Nurses and/or pharmacist)
Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis

The purpose of this study is to evaluate the safety and tolerability of single doses of SBI-087 in Japanese subjects with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Must meet American College of Rheumatology criteria for rheumatoid arthritis with functional class I to III.
* Rheumatoid arthritis disease onset at \>16 years of age and duration of disease at least 6 months.
* Men or women of nonchildbearing potential (WONCBP), aged 20 to 70 years, inclusive at the screening visit.

Exclusion Criteria:

* Any significant health problems other than rheumatoid arthritis.
* Treatment of greater than 10 mg of prednisone per day.
* Therapy with immunosuppressants within 6 months before study day 1
Caffeinated Chewing Gum & Wrestling Performance

The purpose of this study was to investigate the effect of caffeinated chewing gum on sympathetic nerve activity on wrestling simulation match.

The purpose of this study was to investigated whether caffeine intake is effective in improving the performance of wrestlers in a simulated competition. The study was designed to involve 16 healthy adult male athletes who had been trained in professional wrestling and were divided into caffeine trial (CAF trial) and placebo trial (PL trial) in a randomized crossover double-blind study design. After three days of dietary control, participants arrived at the laboratory in the afternoon of the day of the trial to collect saliva samples in a quiet state and were fitted with a heart rate monitor. Participants chewed either caffeine-containing gum at 3 mg/kg body weight (CAF trial) or placebo-containing gum without caffeine (PL trial) for 10 minutes and then spit it out. Participants then underwent a 15-minute dynamic warm-up. At the end of the warm-up, participants performed 2 rounds of 3-minute wrestling-specific simulated matches, and the number of falls in the simulated matches was recorded. After the simulation match, saliva samples were collected from the participants again. The saliva samples were analyzed for caffeine alpha-amylase concentration. Differences between the two trials were analyzed using a paired sample t-test and significance was set at α\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* more than 6years of professional wrestling training;
* more than 6 months of continuous training;
* recovering from sports injuries such as strains and contusions for at least 3 months.

Exclusion Criteria:

* non-professionally wrestling athlete;
* none regular training in the past 6 months;
* less than 3 months of recovery from a sports injury, or present epilepsy, hypertension, hyperlipidemia, heart disease, arthritis, osteoporosis, or brain injury;
* a history of caffeine allergy.
Addressing Origins of the Opioid Epidemic by Improving Prescribing for Opioid-Naive Patients

Risk of long-term opioid dependence increases with initial opioid dose/duration, but despite recent Centers for Disease Control and Prevention (CDC)-endorsed minimum doses for initial opioid prescription, primary care providers are likely to overprescribe. In this quality improvement project, primary care departments at Weill Cornell and the Institute for Family Health (federally qualified health center in New York City) will implement an unobtrusive "nudge" in their electronic prescribing software to promote the CDC-endorsed low doses for all opioids. In the evaluation, we will employ a quasi-experimental design with rigorous interrupted time series analysis methods to assess the effect of the "nudge" on prescribing rates. The analysis will be performed at the provider level, with deidentified physician data and a limited data set (fully deidentified except for date of prescription) of patient-level data.

The two participating institutions, WCMC (Weill Cornell Medical College) and IFH (Institute for Family Health), intend to redesign the e-prescribing interface to create a minor "nudge" to encourage prescribers to prescribe the minimum dose set by the 2016 CDC guideline for opioid-naive patients in 2018. The change to the e-prescribing system is that after a prescriber chooses the drug they wish to prescribe, the minimum recommended dosage from the CDC guidelines will be displayed. The prescriber can choose to change the dosage by overwriting in the field box. The changes to the prescriber system will be implemented at two Weill Cornell clinical organizations: Weill Cornell Internal Medicine Associates (WCIMA) and Weill Cornell Medical Associates (CMA), and at all locations at our collaborating institution IFH (Institute for Family Health). Weill Cornell and IFH will provide data for the analysis, which will be conducted by the co-investigators on this protocol. The project will assess data pre- and post- implementation to study prescribing patterns.

Eligibility Criteria:
Inclusion Criteria:

* Prescriber - practices internal medicine at WCMC OR family practice at IFH and has prescribed opioids since 11/1/2015

Exclusion Criteria:

* Prescriber - has not written any opioid prescriptions during the study period
Somesthesic Role of the Ventro-lateral Prefrontal Cortex in Speech Motor Learning

These studies test the hypothesis that frontal areas of the brain participate in the cortical networks involved in the somotosensory processing that happens during speech motor learning.

This work aims to study the role of sensory systems in human motor learning and specifically addresses the involvement of somatosensory cortical networks in motor learning of speech. Previous studies in the literature have highlighted the plasticity of cortical sensory networks, notably the primary and secondary somatosensory cortex and the ventral premotor cortex, during motor learning tasks. The present project focuses on the somatosensory region with connections to the sensorimotor regions of the frontal and parietal cortex. We propose to use neuroimaging (fMRI), in order to verify which areas in the prefrontal cortex are part of the sensorimotor network used in the learning of speech motor tasks in humans. Subjects will be tested in the fMRI scanner while performing either a behavioral task in which the auditory feedback of their own speech is altered or while performing a vibrotactile discrimination task.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed subjects
* Subjects fluent in French
* Signed informed consent
* Affiliation to or beneficiary of a Social Security scheme

Exclusion Criteria:

* Left-handed subjects
* Criteria for contraindications to protocol fMRI scans
* Existence of a severe general condition: cardiac, respiratory, hematological, renal, hepatic, cancerous.
* Hearing, language (including dyslexia), neurological or psychiatric disorders.
* Participation in other ongoing intervention research protocols with exclusionary period or within the previous week
* Drug treatment likely to modulate brain activity: benzodiazepines, antidepressants, neuroleptics, lithium, etc.
* Protected persons referred to in articles L1121 5 to L1121 8 of the French CSP:

  * Pregnant women, parturients, nursing mothers,
  * Persons deprived of liberty by a judicial or administrative decision,
  * Persons under psychiatric care,
  * Individuals admitted to a health or social institution for purposes other than research,
  * Minors,
  * Persons over the age of majority who are subject to a legal protection measure or who are unable to express their consent
EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing

This is a multi-center clinical trial evaluating the effect of transbronchial mediastinal cryobiopsy for its ability to improve the likelihood of obtaining tissue sufficient for molecular analysis. Patients in outpatient clinics or pre-operative holding areas planning to undergo a bronchoscopic biopsy of a suspected malignant lesion (peripheral or mediastinal) for initial diagnosis, staging, or tissue acquisition for molecular analysis will be considered for enrollment and consented. Patients will only be enrolled if intraoperative ROSE suggests malignancy. Patients will be randomized to continue with the operator's initial EBUS-TBNA needle or switch to a cryoprobe to perform a sampling.

Primary Objective:

- To evaluate the utility of transbronchial mediastinal cryobiopsy on its ability to improve the likelihood of acquiring tissue sufficient for next-generation sequencing (NGS).

Safety Endpoints:

* Pneumothorax within 7 days of procedure
* Moderate bleeding defined as controlled with bronchoscope, saline, or epinephrine
* Serious bleeding is defined as uncontrolled, leading to respiratory failure, need for transfusion, or cardiovascular instability
* Respiratory failure is defined as a new oxygen requirement or escalation in oxygen delivery within 7 days of procedure
* Unplanned hospitalization related to the procedure within 7 days of procedure
* Death

Exploratory Endpoints:

* The proportion of samples adequate for NGS testing
* The proportion of samples with adequate PD-1 / PD-L1 immunohistochemical staining
* Proportion of samples that are adequate for complete NGS library sequencing
* Estimated total number of tumor cells per H\&E-stained slide
* Histological disease subtyping

Eligibility Criteria:
Inclusion Criteria:

* Lesions on PET or CT concerning for primary or metastatic malignancy that are amenable to biopsy by linear EBUS
* Malignant cells present on rapid on-site cytological evaluation (ROSE)

Exclusion Criteria:

* Patient is known to be less than 18 years old
* Patient is known to be pregnant
* Patient is known to be a prisoner
* Operator deems lesion is not safe to biopsy
Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions

Aim: The aim of this randomized clinical trial is to evaluate the use of the porcine acellular dermal matrix (PADM) for the treatment of RT1 localized gingival recessions.

Material and methods: Forthy patients (n=20) with RT1 localized gingival recessions with height ranging from 3 to 5 mm with and at least, 2mm of keratinized tissue width will be selected to participate in the study. Patients will be allocated randomly in two treatment groups: Coronally advanced flap (CAF) or coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM). The clinical parameters evaluated at the baseline, 6 and 12 months will be: Plaque index (IPL); gingival index (GI); relative gingival recession height (RGRH); gingival recession width (GRW); probing depth (PD); relative clinical attachment level (RCAL); keratinized tissue height (KTH); keratinized tissue thickness (KTT); papilla height (PH). Evaluations will be made by the professional and the patient regarding dentin hypersensitivity (HD) (Schiff and VAS scales respectively), aesthetics (RES and VAS scales, respectively) and patient\&#39;s centered outcomes, through the questionnaire referring to the OHIP-14.

Descriptive statistical analysis will be expressed as mean ± standard deviation (SD), median, quartiles, percentages and confidence intervals (95% CI). To analyze the normality of the residue, the Shapiro-Wilk test will be performed. Then, the Wilcoxon test will be applied to compare the periodontal parameters and a quality of life, before and post-treatment. Correlations between parameters and dental hypersensitivity will be analyzed through Spearman\&#39;s test. Key words: Gingival recession, Root coverage, Biomaterial, Acellular dermal matrix.


Eligibility Criteria:
Inclusion Criteria:

* RT1 localized gingival recessions with height ranging from 3 to 5 mm;
* 2mm or more of keratinized tissue width ;
* Probing depth less than 3mm;
* Plaque and gingival index less or equal to 20%.

Exclusion Criteria:

* Smokers;
* Pregnants;
* Nursing;
* Patients with diabetes mellitus or another condition that interfere in the tissue repair
* Patients who use drugs or medications that interfere in the tissue repair;
* Allergies to any composition of the devices of the study.
Prospective Observational Study Comparing Calcium and Sodium Levofolinate in Combination With 5-Fluorouracil (5FU) /or in FOLFIRI Regimen

Prospective observational study comparing calcium and sodium levofolinate in combination with 5FU/or in FOLFIRI regimen on patients affected by gastrointestinal cancer (any site of disease along with gastrointestinal tract) who have been prescribed FOLFIRI in standard clinical practice.

This is an observational, perspective trial on patients affected by gastrointestinal cancer (any site of disease along with gastrointestinal tract) who have been prescribed FOLFIRI in standard clinical practice. All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients affected by gastrointestinal cancer including:

   * advanced colon-rectal cancer,
   * biliary tract cancer,
   * pancreatic carcinoma,
   * advanced gastric or gastro-esophageal junction adenocarcinoma requiring treatment according to folfiri schedule
2. Participant is willing and able to give informed consent for participation in the study.
3. Male or Female aged \>18 years.
4. Life expectancy \> 3 months
5. Performance Status (PS) 0-1

Exclusion criteria:

1. Patients with known hypersensitivity to 5-FU or folinic acid , or to any of the excipients
An Optimal Dose Finding Study of N-Acetylcysteine in Patients with Myeloproliferative Neoplasms

This is a phase I/II study evaluating the optimal dose of N-acetylcysteine (N-AC) in patients with myeloproliferative neoplasms (MPN).

This is a phase I/II open-label clinical trial determining the optimal biological dose (OBD) of N-acetylcysteine in subjects with myeloproliferative neoplasms. These are subjects who have a diagnosis of essential thrombocythemia (ET), polycythemia vera (PV), or myelofibrosis (MF).

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Have a diagnosis of essential thrombocythemia (ET), polycythemia vera (PV), or myelofibrosis (MF) according to the 2016 WHO criteria
* Has not taken interferon-alpha or a JAK inhibitor (such as ruxolitinib or fedratinib) for treatment of MPN in the past 28 days before enrollment.
* May continue on current MPN treatment, including aspirin, hydroxyurea, or anagrelide. Therapeutic phlebotomies should continue per the patient's usual regimen.
* Has not taken N-Acetylcysteine (N-AC) or preparations containing N-AC in the past 28 days before enrollment.
* Baseline MPN-TSS score of ≥ 10 at the time of enrollment.
* Peripheral blast count \<10% during Screening.
* Free of other active or metastatic malignancies other than localized skin cancer.
* Amenable to blood draws and symptom assessments.
* Agree to the use of contraceptives. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential, should both use an effective contraception method during the study and continue to use contraception for 60 days after the last dose of study drug.

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) questionnaire score of ≥3
* Currently pregnant or planning on being pregnant within the study period.
* Currently breastfeeding.
* Known uncontrolled active viral or bacterial infection.
* Significant impairment of major organ function defined as

  1. Serum creatinine clearance less than 50 ml/min (calculated with Cockroft-Gault formula).
  2. Bilirubin more than 1.5 mg/dl except for Gilbert's disease. ALT or AST more than 2X upper normal limit or has radiologic evidence of liver cirrhosis.
  3. Platelets \< 100 × 10\^9/L
  4. Hgb \< 10 g/dL
  5. ANC \< 0.75 × 10\^9/L
* Known history of allergic reaction to N-AC.
Expansion Study of a Simplified Regimen of Medical Abortion Thru 63 Last Menstrual Period (LMP) in Tunisia

This open-label study is being conducted to determine whether national expansion of a 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions.

The goal of this study is to provide answers to the following four questions:

1. What is the effectiveness of this regimen of medical abortion with mifepristone followed by 400 mcg sublingual misoprostol up to 63 days since the last menstrual period (LMP)?
2. Are the side effects with sublingual use tolerable for women?
3. Is sublingual administration of misoprostol acceptable to women?
4. Are women satisfied with counseling and services received in new centers offering medical abortion?


Eligibility Criteria:
Inclusion Criteria:

* Women presenting for medical abortion who consent to participate
* Possibility of final gestational age of less than or equal to 63 days
* General good health
* Willing to provide contact information for purposes of follow-up

Exclusion Criteria:

* Conditions which contraindicate the use of mifepristone or misoprostol
* Women presenting for medical abortion who do not consent to participate
EFFECT OF RISPERIDONE vs ARIPIPRAZOLE ON OXIDATIVE STRESS IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMIZED CONTROLLED TRIAL

The goal of this Randomized Controlled Trial is to to compare the effect of Risperidone vs Aripiprazole in terms of change in serum Glutathione level in patients with Autism Spectrum Disorder over a period of 6 weeks.

The main questions it aims to answer are:

1. (Primary Outcome) Change in serum Glutathione levels following 6 weeks of intervention in both the arms
2. (Secondary Outcomes) Change in serum superoxide dismutase (SOD) levels following 6 weeks of intervention.

Change in ISAA score following 6 weeks of intervention. Change in ABC-C score following 6 weeks of intervention. • Adverse events reported in both groups

Details of intervention- One arm of the study population to get Risperidone 1mg/day for a total duration of 6 weeks and another arm to get Aripiprazole 2mg/day for a total duration of 6 weeks. Baseline assessment of Serum Glutathione, Serum SOD, ISAA scale, ABC-C scale will be done and same will be assesssed at 6 weeks follow up.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:

  * Patients diagnosed with Autism Spectrum Disorder (according to ICD-11 DCR) under the age group of 18 years.
  * Legally authorized representative (LAR) giving voluntary written consent for participation in the study.

Exclusion Criteria:

* History of ADHD

  * History of any major genetic disorder/ storage disorder/ any special syndromes.
  * History of seizure disorder or any major medical or surgical disorders
  * Legally authorized representative (LAR) not giving voluntary written consent for participation in the study.
Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma

This study will compare the effectiveness and safety of two different doses of temsirolimus (Torisel).


Eligibility Criteria:
Inclusion Criteria:

* Have confirmed mantle cell lymphoma diagnosis.
* Have measurable disease.
* Have received at least 2 prior treatment, which may include stem cell transplant.
* Have adequate organ and bone marrow function.
* There are other criteria--please discuss with your doctor.

Exclusion Criteria:

* Had any prior treatment with temsirolimus or mTOR inhibitor.
* Had allogeneic stem cell transplant within last 6 months and on immunosuppressive therapy.
* Has active or untreated brain or central nervous system metastases.
* There are other criteria--please discuss with your doctor.
A Study of NT 201 Doses in the Treatment of Platysma Prominence

The purpose of this study is to assess the safety and efficacy of NT 201 in adults with moderate to severe platysma prominence.


Eligibility Criteria:
Inclusion Criteria:

* Presence of four (medial and lateral, left and right) prominent platysmal bands
* Moderate to severe platysmal bands as assessed by the investigator and subject on the MAPS-D at maximum contraction

Exclusion Criteria:

* Any serious disease or disorder (medical or psychiatric) that could interfere with the safe completion of treatment or compromise subject safety
* Botulinum toxin treatment in the face (below the lower orbital rim), neck, or chest within the last 12 months prior to study treatment
* History of lower face surgery, neck or chest surgery, aesthetic procedures (e.g., ablative skin resurfacing, laser, chemical peel, micro-focused ultrasound, deoxycholic acid injections, micro-needling, non-surgical fat reduction procedure), and orthodontic procedures (e.g., braces) in the 12 months prior to study treatment
* Previous use of any permanent (non-biodegradable) or semi-permanent (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethyl methacrylate, etc.) facial tissue augmentation therapy, lifting sutures, permanent implants or autologous fat to the lower face (i.e., below the level of the bottom of the nose), neck, or chest within 24 months prior to study treatment
* Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy to the lower face (i.e., below the level of the bottom of the nose), neck, or chest within 12 months prior to study treatment
* Any medical condition that may put the subject at increased risk with exposure to botulinum toxin of any serotype, including myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function
* Female of childbearing potential not using a highly effective method of birth control, planning to get pregnant, or pregnant or lactating